Transcript
Fortifying Life Science Patents: Sections 101 and 112.
The following is a computer-generated transcript from the Patently Strategic Podcast. The results aren't always perfect, but we will continue working on improving the quality of the automation.
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Good day and welcome to the Patently Strategic Podcast, where we discuss all things at
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the intersection of business, technology and patents. This podcast
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is a monthly discussion amongst experts in the field of patenting. It is
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for inventors, founders, founders and IP professionals alike, established or aspiring.
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And in today's episode, we're providing a multivitamin to help with fortifying
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your life science patents against the plagues of section 101 and 112.
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Life sciences are currently faced by at least two major plagues in our patent
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world. The first is that many life science innovations have been deemed
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ineligible in terms of patentable subject matter. In other words,
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the courts and the Patent office believe that the patent laws are not meant to
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protect these innovations. The second plague is that the courts believe
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that many life science patents are not enabled. In other words, they're not
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described in sufficient detail to enable one of skill in the art to make
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and use the invention the subject matter eligibility and enablement
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plagues manifest in dreaded section 101 and 112 rejections.
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The practical implications are staggering when it comes to
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eligible subject matter. In the last five years, over 80%
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of abandoned life science applications had a final rejection from
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the USPTO. Stating that the innovation did not include
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patentable subject matter based on subject matter eligibility
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criteria. And as we'll explore, 101 and 112
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rejections can surface in a myriad of ways, but no idea is too big
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to fail. Case law is now littered with patents whose innovators
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ideas proved to be revolutionary, but whose patent claims ended up invalidated because
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they failed to demonstrate in their applications how their observations
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could be practically applied, or failed to prove that they deserve the breadth of coverage
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they sought. In this month's episode, Dr. Ashley Sloat, President and Director
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of Patent Strategy here at Aurora, leads a discussion along with our
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all star patent panel, delving deeply into these rejections. And in
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the interest of avoiding a podcast, 101 rejection provided some very practical
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application tips that will help to fortify your life science patent applications.
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Ashley is joined today by our always exceptional group of IP experts,
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including Kristen Hansen, patent strategist at Aurora
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daniel Wright, patent strategist david Jackrow, president of
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Jacob Consulting shelley Kerrier, patent strategist and search specialist
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david Cohen, principal at Cohen Sciences amy Fine,
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patent attorney at Vancouver and adjunct professor at BYU and Steve
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STUP, partner at STUP Associates, LLC. Now, before taking you
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into the group conversation, as we often do, I sat down with Ashley to
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discuss a few concepts that could use some extra color and context for those newer
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to patenting. All right, thanks for joining me, Ashley.
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Based on feedback we've received, I know these primers that we front load with have
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been incredibly helpful on ramps to the deeper conversations that follow,
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and I know this one will be no exception. A couple of episodes
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ago, in discussing ownership, we explored sections 102 and 103,
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which deal with rejections around novelty and obviousness.
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In this month's episode, Rejection focus, if you will, is around
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sections 101 and 112. Could you talk briefly
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about each for those who haven't yet been on the receiving end?
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Absolutely. So section 101 deals with what
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subject matter is eligible for patenting and generally speaking,
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this should be essentially everything under the sun.
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However, it implicitly has been read into
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this section 101 by the courts that things that are
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natural phenomenon, abstract ideas or
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natural laws do not fall,
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are not protectable under the patent laws. And so, unfortunately for
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life sciences, they have basically had that many life science innovations
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are natural phenomenon and so they are not eligible for
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patenting. And so what we talk about in
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today's podcast is how do you better shore
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up your patent application to be eligible under section 101 and
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what can you do? So it can be as simple as I think
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one of the homework cases for section 101 was around fetal
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DNA, detecting fetal DNA in the mother's blood. And of course
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this is amazing technology because it really reduced
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the risk of the fetus and the mother over current methods
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like amniocentesis and things like that.
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But because of how the claim was drafted,
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it very much centered on the natural phenomenon and
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didn't more directly tie in practical applications
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or things like that. And so a lot of the patents around
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this technology were invalidated because they were deemed to not be
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eligible subject matter. But in case that section
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101 and probably I think other podcasts that we've
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done also talk about software being a difficult one under this section
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as well. But as you know, today we're focusing on life science.
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The other one is section 112, which has three components written
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description, enablement and best mode. So the written description
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requirement means that the specification must describe
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the claimed invention in a manner that is understandable to a person
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of ordinary skill in the art. So it shows that the inventor actually
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had possession of the invention at the time of filing.
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The enablement requirement, which is different than a written description
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requirement, is that the specification must teach those
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in skills in the art how to make and use the full scope of the
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claimed invention. And this is the key part without undo
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experimentation. And as you'll hear in today's discussion that
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undo experimentation is a lot of
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discussion in the courts around that. And what really does qualify as
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undo experimentation is
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it still undo if you teach want to
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skill in the art exactly how to arrive at various chemicals
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that may be covered under your patent, or do you have
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to actually teach every single chemical or can you just teach them a process to
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get to those chemicals and what constitutes unto experimentation?
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And then best mode is exactly what it sounds like. You have to describe
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the best mode. You can't keep the best mode for yourself and only describe
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those that were not the best. Now, you don't have to label it as
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the best mode, but you do need to describe it. All right? So I think
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that's actually a pretty good segue to the next question. You and the group talk
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about genus and species several times during the conversation.
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Now this talk is about life science patents, but these references aren't
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strictly biological. Could you explain what genus and species
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can mean in the world of patenting and claims in particular? Yeah,
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absolutely. It is a little bit of a misnomer, just as it
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is in classical Phylogeny.
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Genus comes before species,
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right? And genus is a broader classification
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than species. And so if you think about it in that lens,
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a genus claim is a claim that
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covers a broader range of more narrow species,
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right? So you could have a broad chemical class,
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a broad genus class of chemicals, and then more
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narrow species that fall under that genus.
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So think about it from an umbrella perspective. A lot
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of inventors, especially in the life science, invent one vertical,
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right? They invent a new chemical, they invent a new drug treatment
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or something like that. But there may be other drugs that look like
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that drug or other chemicals that look like that chemical or behave like
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that chemical that they believe that they also deserve protection
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for, right? That they deserve a broader umbrella that covers
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all those chemicals and all those drugs that look similar. And so in that
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case, you would say that the broad claim is the genus claim
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and the more narrow claims around each chemical or
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each drug is a species claim. And so what we'll talk about
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today in the podcast is essentially the death of
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the genus claim, meaning that the courts are increasingly saying
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that you need to show some kind of
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proof of possession or reduction to practice
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some data or something for each of these specific species
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that would fall under your genus claim. And if
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you can't do that, then you don't deserve the broad genus claim. And so
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this is kind of one of those unfortunate things that's happening as well, that you
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could fully lead the horse to water, walk them through
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the exact process that they would need to do to create new
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chemicals, create new drugs that look like that, behave like that. But because
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they're in an unpredictable science, because being
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predictable can be difficult, the courts have basically said that that's not enough,
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that's still under experimentation and you actually need to reduce the practice at least
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one example of each of those species. And so it's becoming much harder for
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life science inventors to get broad claims, broad genus
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claims. Thanks. All right, two other legal
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terms pop up in this episode. They're more in the sides and not quite
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as essential to understanding the thrust of the conversation,
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but they're still very important in patent law. So definitely worth taking a second
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to define the first is just what is a wands factor?
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So when looking at section 112, which remember is your rent description,
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enablement and best mode requirement or part of the statute,
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the wands factors were developed by the courts and it is a test for
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enablement. Does the specification in the figures
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teach one of skill in the art to make and use the invention? And so
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they walk through several factors to determine
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if the pet application is truly
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enabled or the claims are truly enabled. And what is an
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estoppel in pet and law? This is a general legal principle,
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but it basically precludes or prevents a person from
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asserting something today that is contrary
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to something that they did or said previously.
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And so, for example, in patent lawn during
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prosecution, which is the bartering that happens between you and the Patent Office to get
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your issue patent, if you say that
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my claims definitely don't include X,
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and then later in a litigation proceeding or some kind of post grant proceeding,
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you say, Oh, my claims totally do cover X,
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that you are stopped from saying that it definitely includes X,
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because you just said it didn't include X. So it basically prevents you from
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talking out of both sides of your mouth. Makes sense. Thanks, Ashley.
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Just one more thing before joining the panel, we have some exciting news to share.
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Back in March, in our Adventure Stories Volume One episode,
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we introduced you to three impressive innovators who are all past recipients
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of our annual Rise Award. This award provides a free provisional US.
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Patent application or $5,000 towards a nonprovisional
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US. Patent application to a selected applicant. This is in recognition of their innovative
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startup excellence. We received an overwhelming response to applications
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for this year's award, and the selection process was incredibly difficult.
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But I'm happy to announce that our selection committee has chosen hearsight,
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LLC is the winner of the 2022 Rise Award.
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Hearsight is tackling the important mission of reimagining assistive hearing
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technology. When we look for ideal Rise recipients, we look closely at
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potential for societal good matched with a team that can execute.
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And Hearsight is just this kind of impactful innovation backed
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by the kind of DNA it takes to see through to market success.
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Assistive technology is a corner of the market that unfortunately still has way
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too much white space, and we're happy to help fill it in any way we
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can. Due to the high volume of quality submissions and our desire
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to help as many as possible, we decided to once again expand the offering beyond
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the single first place award. The first runner up this year is thermo
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Verse. They're focusing their efforts on much needed solutions
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that will greatly improve the heating and cooling economics for low to
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moderate income housing properties. Their innovations are both timely
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and necessary, given skyrocketing energy costs,
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storing home prices, and housing shortages across the country. Disruption in
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this space is essential to maintain viability to as many
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LMI properties as possible. And the second runner up is Spirit Fire.
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Aftermarket with their vehicle lighting solution. We love gritty entrepreneurs
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who roll up their sleeves and find ways to innovate. Spirit Fire
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story is a great example of finding a real market need self bootstrapping
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and doing a practical thing very well. We'd love to say more,
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but we can't since public disclosure on an IP podcast is
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beyond forgivable. But do stay tuned. We'll hopefully be introducing
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you to these innovators in a future Adventure Stories episode.
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All right, without further ado take it away, Ashley. All right.
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So kind of what we wanted. And Dan's going to jump in here too,
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towards the end with some different thoughts as well. What we wanted to do
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is kind of jump through and walk through some of the issues
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plaguing life, science, patents. And so I kind of named these the first
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and the second plague. So the first plague is section 101
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issues, which is patentable subject matter, as you all know.
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And then the section 112 is adequate written description.
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And so the section 101 thing
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has been around for a long time. I don't think it's necessarily new to anybody,
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but what I kind of wanted to do is sift through some of the case
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law and kind of pull out some of the nuggets. But from a
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background perspective, the main Art unit that deals with a lot of these diagnostic
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methods of treatment, you can see that the name of the Art unit is
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molecular biology, bioinformatics nucleic acids. We're coming at DNA
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and RNA gene regulation is Art Unit 1631.
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And over the last five years, they've had about a 60% allowance
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rate, which isn't awful, but maybe it could be a little
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higher. Ten to 20 points. They've had 718 allowed
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patent applications, 485 abandoned applications.
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And of those that were abandoned,
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80% of them had a 101 rejection at the final Office section.
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Wow. Yeah, not a great outlook from that perspective.
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And so when you look at it, I found this graph through a great
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website. I'll have to put that in the notes.
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But if you look at this is the Art
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unit for the last five years, that same 1631 Art unit. And you
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can see that there was about
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50% 101 rejections,
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obviously wasn't that bad. They had the
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references around Alice or Mayo or Myriad, which are all
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those key cases. You can see that those were relatively frequently referenced
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in the Office actions and then a little bit of double patenting.
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But the biggest issue was the section 101 issues. And then
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actually 112 is right up there as well, probably around, I don't know,
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40%, 35%. So that's really
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kind of thing plaguing the industry. And I think the
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biggest issue is how do you delineate when something
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is just a natural phenomena versus when you're actually applying
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it in a reasonable way? And then the other part of that is,
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is your written description enough? And I definitely touch way more on the 101
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issue and then just briefly on the 112 issues. But there's a really
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great paper out by Mark Lemley and a few others just in
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2021, and I haven't read the whole thing yet because it's almost
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80 pages, but it's called The Death of the Genus Claim.
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And it's a really good read from what I've read so far, just around
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the shift over the last 40 years or
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50 years from companies
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being able to claim these broader genus claims when they've discovered
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a class of compounds that have certain biological properties to now
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the courts kind of restricting them down to potentially just one species.
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And I'll kind of explain why they think that shift is happening because I think
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it's kind of interesting and I kind of saw it happening a little
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bit, but I probably couldn't have articulated it and the reasoning
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behind it like they did. So it's
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really interesting. So anyways, we'll get touch on that briefly. You know what's interesting,
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when you start to see 112 and one on one uptick, they often
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coincide with examiner training. And so
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three years or so after 112 training, here we are and everything has
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a 112, right?
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Not to be cynical, right? For sure. And the other
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interesting thing is the courts. I feel like the courts are,
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I don't know, I feel like the courts could use some one false training.
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The courts could use some patent training too, because I feel like they read
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a lot of things into the statutes that aren't there,
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which is then impacting a
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lot of precedent and how things are drafted and maybe not necessarily supported
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by the original laws. And so I think that's kind of the other interesting
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thing that's happening. Everybody can use
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all of it more patents, right? So nobody
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is probably unfamiliar with this, but just really briefly,
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the subject Matter eligibility guidance, they basically ask
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whether your claims are directed to a statutory category,
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which is process, machine, manufacturer, or composition of matter.
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And if it's not in that category, it's not eligible.
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If they think it is in one of those categories, they ask if
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it's directed to a judicial exception. And as we all
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know, it's laws of nature, natural phenomena and abstract ideas.
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If it's not directed to a judicial exception,
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and it's eligible. If it is, they ask whether it's integrated into
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a practical application. If it is, it is eligible.
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If it is not, they ask whether it has significantly more
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than the judicial exception. And if the answer is no, it's not eligible.
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And if the answer is yes, then it's not eligible. So that's generally
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kind of what examiners walk through. Of course, in the life science,
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they're going to rely on more of the life science, case law,
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myriad and things like that,
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whereas in the software they're going to rely more on Alice and other related cases.
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So then briefly, the second plague, I'll touch more on this one
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here briefly and then we'll jump back into 101 is and
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I do think a lot of this is the death of the genus thinking.
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I'm really summed up with that statement from Lenley and others.
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But where the shift has been happening is
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that previously what
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you have to distinguish is whether you're dealing with known unknowns.
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Because I believe if you're dealing with known unknowns then
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that's not undue experimentation, right? If a researcher knows how to navigate
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all the known unknowns
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and they should be able to do that to process the invention,
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but what you don't want is a whole bunch of unknown unknowns
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because then that is probably undue experimentation.
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And so there has been argument around is whether
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a person of skilled in the art needs to find a species
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that works in order to practice the claim. Or whether they
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need to find every species that works to
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make and use the invention. And I think what a lot of experts
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would argue right now is that the way the courts are interpreting section 112
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is that a person of skill needs to find every species
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that works. And so even when the spec is
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super clear around what needs to be done to find a species,
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they say that, well, it still would be undo because there's too many species
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to find. And so it's a really weird shift that's happening
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that you're
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basically shifting from the question of whether making
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and using the invention requires undue experimentation to whether
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such experimentation is required to define the full scope of
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the invention by figuring out all the possible species.
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And so I think that's where a lot of this 112 issues coming from.
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Just briefly, there's a few cases up on the slide, but the
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things that obviously if the field is supernat and
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unpredictable and rife with failure, then of course you probably need to have a really
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significant description to support those claims. I don't necessarily disagree with
325
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that. Right? And so that was the ends of biochem versus Calgene case
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and that was antisemitic DNA technology at that time. It was super
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new and so they probably didn't need to describe more adequately
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in their description various ways to practice
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their technology. This was surprising. Even iterative
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trial and error led by the spec can still create an enablement
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issue because this was one of those where it was for rampamycin chemicals for
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the treatment of restinosis and if
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you multiplied all the different R groups that one could have
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on rampamycin, there was a huge amount of potential chemicals that
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could have been created. But one of skill in the art could
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have very easily found one chemical that worked that was
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within the scope of the claim. But where the court kind of, I think aired
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is again, they thought that somebody would have to find all of them
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to make the claims. Work. And I think that's
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kind of crazy because somebody just needs to build a fine one to practice it
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right, because that shows that they can use the spec to their benefit.
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And then there's another case. This is Identics Pharma
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versus Gilead and describe the screening process allowed
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for straightforward identification of working in bodies embodiments.
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But still the court said that it required undue experimentation because again,
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this two methyl nucleotide for the treatment of
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hepatitis C virus. They basically, again said there's so many
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two methyl nucleicides out there, how is any person supposed
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to understand the full scope of the claim?
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And instead of just saying, are they able to practice it? And it's
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like, well, for sure, because the screening process was very clearly delineated
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and was very much within the skill of they actually even had experts basically saying
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it was within the skill of one in the art. So it's honestly kind of
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ridiculous. But this is where I think Lemley and others
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are kind of saying this is the death of the genus claim because the
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courts want somebody to be able to find all of
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the possible working examples or all the possible
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chemicals that fall into a genius rather than just be able to practice
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one. And I think that's an error. Yeah,
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actually I had a question about so given
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all this case that you've got into something
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that I had always heard about the genus and having good support
363
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for it would be like having enough
364
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examples in the specification that you have like a cross section of
365
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the species. So maybe you'd say if you have
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a molecule in your genus with like four positions for a side group and then
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four options for that side group, you don't need to show
368
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data for all 16 combinations.
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But if you did sort of one or two side groups of
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cutting across all the categories in some of those positions,
371
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cutting across all of them, would that based
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on your reading and what you were just describing, do you think that would still
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be enough? Or are they really saying, no, you need to
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have experimental data on all of the combinations?
375
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Yeah, I think that's a good rule of thumb that a lot of people and
376
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I think Dan could speak to this even more so probably than I could.
377
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But I think that's a lot of what everybody's been doing now is saying
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we got to make sure you support. But I think where
379
00:23:10,948 --> 00:23:14,870
people are struggling, though, is that you don't necessarily have working
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examples for all of those chemicals. And so potentially,
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if they can show at some later date that
382
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different methods that you described don't support that
383
00:23:29,188 --> 00:23:33,042
class, that could call into question whether you deserve
384
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the full genus right versus just
385
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the subject. But Dan, do you have additional stuff? Yeah,
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David, your tactics
387
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there is generally what I've heard and more or less kind
388
00:23:45,976 --> 00:23:49,910
of has done it as well, that if you've got all these variants,
389
00:23:51,850 --> 00:23:55,998
it's very easy to just name them all. Chemical software
390
00:23:56,034 --> 00:23:59,790
can just spit out all the chemical names. That makes the list incredibly
391
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long. But what's more valuable is to show the
392
00:24:03,652 --> 00:24:07,046
cross section so that you indeed have each type of group
393
00:24:07,108 --> 00:24:10,446
in each type of place, as opposed to enumerating each variant
394
00:24:10,518 --> 00:24:14,718
of each type of group. But critically, what I have seen examiners
395
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do, especially in foreign jurisdictions, the US.
396
00:24:18,076 --> 00:24:22,250
Is still a little bit more flexible than I found in particular East Asia
397
00:24:23,290 --> 00:24:27,306
and increasingly perhaps Europe, that in addition
398
00:24:27,378 --> 00:24:30,938
to just depicting a cross section of the
399
00:24:30,964 --> 00:24:34,494
compounds, your data also needs to reflect
400
00:24:34,542 --> 00:24:38,066
that cross section. So even if you've only
401
00:24:38,128 --> 00:24:42,642
got, even if you showed methyl
402
00:24:42,726 --> 00:24:46,900
and halogens in these positions, if you've only got data
403
00:24:47,530 --> 00:24:50,510
for halogens, for a halogen,
404
00:24:50,950 --> 00:24:54,110
some more strict jurisdictions
405
00:24:56,570 --> 00:25:00,006
may not go for the methods if you've only got data for halogen. Okay,
406
00:25:00,068 --> 00:25:03,438
so increasingly, yes, I feel
407
00:25:03,464 --> 00:25:07,206
like the cross section strategy is still
408
00:25:07,328 --> 00:25:10,854
kind of what people go for, but the
409
00:25:10,892 --> 00:25:14,218
data of what you show in that cross section is increasingly
410
00:25:14,254 --> 00:25:16,940
more valuable than just naming them.
411
00:25:17,570 --> 00:25:21,270
Yeah, in some of the case law too, David, is that
412
00:25:21,440 --> 00:25:25,086
even with different experts stating that
413
00:25:25,148 --> 00:25:29,070
the process was clearly laid out to be able to
414
00:25:29,240 --> 00:25:32,658
implement to identify all these different ones that they had put into
415
00:25:32,684 --> 00:25:36,174
the claims, it wasn't enough because
416
00:25:36,212 --> 00:25:39,462
it still would have been like in order to quote, unquote, find all of
417
00:25:39,476 --> 00:25:42,834
the species, it would have taken a lot of experimentation to do
418
00:25:42,872 --> 00:25:46,338
so rather than just saying could somebody find one or
419
00:25:46,364 --> 00:25:49,854
make one, well, sure, they could just make one and probably it would work,
420
00:25:49,892 --> 00:25:53,250
or they could make four or five and one of them would probably work,
421
00:25:53,360 --> 00:25:57,130
but that's no longer enough. So that's I think encouraging
422
00:25:57,190 --> 00:26:00,522
there to be some working examples of a
423
00:26:00,536 --> 00:26:04,110
few or one at least in each cross section or something, might be
424
00:26:04,220 --> 00:26:08,854
advantageous to kind of find what process differences
425
00:26:08,902 --> 00:26:10,520
may be occur for each one.
426
00:26:12,530 --> 00:26:15,860
Yeah, okay, thanks. Yeah. Interesting.
427
00:26:16,430 --> 00:26:19,758
So then here's some the wands factors that a lot of times are kind of
428
00:26:19,784 --> 00:26:22,998
used for the section 112. And so I'm not going to go through these in
429
00:26:23,024 --> 00:26:26,278
detail, but many of you, maybe everybody is familiar
430
00:26:26,314 --> 00:26:29,350
with these, but obviously the quantity of experimentation
431
00:26:29,410 --> 00:26:32,746
necessary, this is kind of deciding what's undo
432
00:26:32,818 --> 00:26:36,514
versus not undo experimentation, amount of direction or guidance
433
00:26:36,562 --> 00:26:40,422
presented. Like how well does the spec teach present or absence of
434
00:26:40,436 --> 00:26:43,678
working examples? I've even heard more and more that prophetic
435
00:26:43,714 --> 00:26:47,314
examples are kind of not super helpful
436
00:26:47,362 --> 00:26:51,198
anymore. The nature of the event, what kind of art is it? State of the
437
00:26:51,224 --> 00:26:54,750
prior art? What was the level of skill at that time?
438
00:26:54,920 --> 00:26:58,158
How much would they have to experiment to understand the technology?
439
00:26:58,244 --> 00:27:01,842
Like I said, the anti sens DNA case,
440
00:27:01,976 --> 00:27:05,238
the antisens DNA technology was so new at that time
441
00:27:05,384 --> 00:27:08,838
and they just didn't teach enough or how decent that field was
442
00:27:08,864 --> 00:27:11,634
and how much failure there was in that field. I can kind of understand that
443
00:27:11,672 --> 00:27:15,174
case more in the sense that it's just so new. So you really
444
00:27:15,212 --> 00:27:18,982
needed to bolster more support for all the different other use cases
445
00:27:19,006 --> 00:27:22,606
or other DNA that you could make with that technology, the predictability
446
00:27:22,678 --> 00:27:26,060
or unpredictability of the arts and the breadth of the claims. And so kind of
447
00:27:26,690 --> 00:27:30,474
walking through this with clients, thinking about all these different factors and
448
00:27:30,632 --> 00:27:34,062
how you describe the technology, but kind
449
00:27:34,076 --> 00:27:37,662
of going back to 101. Now, obviously everybody's familiar with
450
00:27:37,676 --> 00:27:41,362
the Mayo Prometheus case. So they did describing the claims,
451
00:27:41,386 --> 00:27:45,022
the relationship between metabolite concentration and the likelihood
452
00:27:45,046 --> 00:27:49,018
of drug effectiveness, but did not necessarily determine
453
00:27:49,174 --> 00:27:52,398
or did not necessarily describe using the
454
00:27:52,424 --> 00:27:56,158
improved treatment and the claims. And I think, as you'll see from the few examples
455
00:27:56,194 --> 00:27:59,718
I have that follow, that really seems to be the critical step as
456
00:27:59,744 --> 00:28:04,350
some kind of almost like treatment step or some kind of really clear application of
457
00:28:04,520 --> 00:28:06,090
the natural phenomenon.
458
00:28:07,370 --> 00:28:11,530
So for method of treatment claims, a lot of these had an active treatment
459
00:28:11,590 --> 00:28:14,938
step. So the Vanda
460
00:28:14,974 --> 00:28:18,586
Pharmaceuticals versus Westward and End of Pharmaceuticals versus Teva,
461
00:28:18,718 --> 00:28:21,990
they both had more of an active treatment. And then
462
00:28:22,160 --> 00:28:25,594
the Safinani Diagnostics versus Mayo, they had detecting
463
00:28:25,642 --> 00:28:29,254
not natural auto antibodies, but again, they were just correlating
464
00:28:29,302 --> 00:28:32,394
with the disease state and there wasn't any step around. Okay,
465
00:28:32,432 --> 00:28:35,742
so now that we've correlated these things, now we're going to give more drugs to
466
00:28:35,756 --> 00:28:39,522
this individual, or less drug to this other individual, we're not
467
00:28:39,536 --> 00:28:42,390
going to give any treatment to this one, but more treatment to this one.
468
00:28:42,440 --> 00:28:45,514
So in Vonda Pharmaceuticals versus Westward,
469
00:28:45,562 --> 00:28:49,246
you can see that this one was found eligible,
470
00:28:49,438 --> 00:28:52,870
and you can see this as a treatment method for schizophrenia.
471
00:28:53,050 --> 00:28:57,054
And so they do talk about determining patients with a certain point
472
00:28:57,092 --> 00:29:01,342
mutation, but in response to them detecting that point mutation
473
00:29:01,426 --> 00:29:04,642
in the individual, they then treat the patient differently,
474
00:29:04,726 --> 00:29:08,146
better, whether or not that point mutation exists. So if they're
475
00:29:08,158 --> 00:29:12,382
a poor metabolizer, then they have one treatment paradigm.
476
00:29:12,526 --> 00:29:16,002
If they're a different kind of genotype, then they have a
477
00:29:16,016 --> 00:29:18,380
different treatment paradigm. And so,
478
00:29:18,890 --> 00:29:22,518
again, you can see that pretty clear language around
479
00:29:22,664 --> 00:29:26,002
actual application of what happens now that you've understood what this natural
480
00:29:26,026 --> 00:29:29,842
phenomenon means. And then similarly, in Endoparmaceuticals
481
00:29:29,866 --> 00:29:33,898
versus Tava, you can see that, again, this is another method
482
00:29:33,934 --> 00:29:37,460
of treatment claim. And you can see here that,
483
00:29:37,850 --> 00:29:41,530
again, they're providing a solid oral controlled release dosage
484
00:29:41,590 --> 00:29:44,850
form and then orally administering it,
485
00:29:45,020 --> 00:29:48,378
depending on how the Cratinine clearance rate was
486
00:29:48,404 --> 00:29:51,870
found. So depending on how that was determined to be in the patient.
487
00:29:52,730 --> 00:29:56,418
And so, again, they measured or
488
00:29:56,444 --> 00:30:00,078
determined this natural phenomenon, but they actually really, truly applied it
489
00:30:00,224 --> 00:30:04,038
from a treatment setting. And so you can see where this falls short.
490
00:30:04,124 --> 00:30:08,190
In this Athena versus Collaborative male,
491
00:30:09,590 --> 00:30:12,546
you can even see just the length of the claim is already kind of a
492
00:30:12,548 --> 00:30:15,958
little bit of an indicator. They're basically determining this muscle
493
00:30:15,994 --> 00:30:19,400
specific tyrosine kinase and they basically just detect it,
494
00:30:20,690 --> 00:30:24,750
different antibiotics to it in bodily fluid as
495
00:30:24,860 --> 00:30:29,494
a diagnosis for transmission of a developmental disorder.
496
00:30:29,662 --> 00:30:33,178
But they never say that we've detected this and then we're
497
00:30:33,214 --> 00:30:36,860
going to treat them with a certain drug or
498
00:30:37,910 --> 00:30:41,806
there was no just active step and I think that's
499
00:30:41,818 --> 00:30:45,258
where they fell short and so you'll kind of see that
500
00:30:45,344 --> 00:30:46,340
carry through.
501
00:30:48,570 --> 00:30:51,938
So method of treatment is one aspect of the natural product claims.
502
00:30:51,974 --> 00:30:55,066
Obviously more and more natural products are coming out and more companies want to protect
503
00:30:55,128 --> 00:30:58,466
their natural products. So I think that's also interesting. So there's
504
00:30:58,478 --> 00:31:01,982
a few cases into that end. One included
505
00:31:02,006 --> 00:31:05,002
this one. It's not exactly natural products I guess,
506
00:31:05,076 --> 00:31:08,614
but it's about detecting bacteria. I think the first
507
00:31:08,652 --> 00:31:14,594
case was the Roche versus stuffed and that was for detecting Mycoplasma.
508
00:31:14,762 --> 00:31:19,270
And here they talked about a specific set of DNA primers
509
00:31:19,830 --> 00:31:23,246
for detecting Mycobacterium tuberculosis.
510
00:31:23,438 --> 00:31:27,238
And again, what the courts had argued is that
511
00:31:27,384 --> 00:31:31,030
the development of primers was kind of routine and conventional
512
00:31:31,590 --> 00:31:35,542
and use the PCR was routine and conventional and
513
00:31:35,556 --> 00:31:39,254
so there was no true application of the natural phenomenon
514
00:31:39,362 --> 00:31:43,270
into a new space, no extension beyond that. So maybe
515
00:31:43,320 --> 00:31:46,594
if they had to do PCR in a different
516
00:31:46,632 --> 00:31:49,942
way because it is Mycobacterium, or whether they had to maybe design
517
00:31:50,016 --> 00:31:53,810
more unique, maybe a different kind of PCR,
518
00:31:53,870 --> 00:31:57,338
different kind of primer set to accommodate
519
00:31:57,374 --> 00:32:00,478
for the fact that it's Mycobacterium, or whether they
520
00:32:00,504 --> 00:32:05,050
had to isolate it in a weird way because there was that other cells
521
00:32:05,670 --> 00:32:09,322
direct case, I can't remember if that's the correct one or not, but where
522
00:32:09,396 --> 00:32:13,570
they had this different free spot cycle of the cells and then determined viability,
523
00:32:14,130 --> 00:32:17,674
but the whole point around the free spot was to have better viability for
524
00:32:17,712 --> 00:32:20,990
later assays. So if even there was something like that in the claim,
525
00:32:21,110 --> 00:32:24,122
I think I probably could have pushed them over the edge towards eligibility.
526
00:32:24,206 --> 00:32:28,402
But just the pure primers and
527
00:32:28,416 --> 00:32:31,906
then routine PCR isn't enough for this case. And there
528
00:32:31,908 --> 00:32:35,362
was another canine case, there was a case around
529
00:32:35,436 --> 00:32:38,942
golden retrievers and identifying genetically
530
00:32:39,086 --> 00:32:42,626
golden retrievers based on a snip that they carry for genotyping
531
00:32:42,638 --> 00:32:46,150
golden retrievers. And that one was also found in eligible because it's highly similar
532
00:32:46,200 --> 00:32:50,102
to this one. There's also natural alternatives
533
00:32:50,126 --> 00:32:53,638
versus creative compound. This was found eligible and
534
00:32:53,664 --> 00:32:57,118
again it's had an active treatment step because what the
535
00:32:57,144 --> 00:33:01,058
court had said is that when you give this beta alanine
536
00:33:01,094 --> 00:33:04,930
to a human, it actually alters their natural state.
537
00:33:05,100 --> 00:33:08,890
And so this results in your better performance for
538
00:33:08,940 --> 00:33:09,850
athletes.
539
00:33:12,250 --> 00:33:15,662
Again, it changes an extension beyond the
540
00:33:15,676 --> 00:33:20,178
natural phenomenon, it adjusts their person's
541
00:33:20,214 --> 00:33:23,882
natural state, it's no longer their natural chemistry and
542
00:33:23,896 --> 00:33:27,254
it has specific dosing requirements. Obviously it
543
00:33:27,292 --> 00:33:30,530
puts them well above the typical beta alanine dosage
544
00:33:31,210 --> 00:33:34,910
in a person. So that's why this one was found eligible over
545
00:33:34,960 --> 00:33:38,414
some of the other cases. Ashley, I don't know if you were going to touch
546
00:33:38,452 --> 00:33:42,174
on this, but these treatment steps
547
00:33:42,222 --> 00:33:46,086
seem to have a pretty big implication on who infringes
548
00:33:46,278 --> 00:33:49,720
on the claim. Right? Yeah.
549
00:33:50,050 --> 00:33:53,198
Basically we're going to be way more induced infringement, right,
550
00:33:53,224 --> 00:33:56,690
because it's going to be some products supplier, right,
551
00:33:56,740 --> 00:34:00,206
some drug supplier, some natural product supplier who
552
00:34:00,268 --> 00:34:03,954
then presumably has to put in their label
553
00:34:04,062 --> 00:34:07,634
in their docs that
554
00:34:07,732 --> 00:34:11,478
this is how it's supposed to be taken and this is the effective
555
00:34:11,514 --> 00:34:14,894
dose and things like that, or some of these more
556
00:34:14,932 --> 00:34:18,614
even diagnostic claims. It's going to be some kind of hospital right,
557
00:34:18,652 --> 00:34:23,210
that is running these tests because nobody is at home seeing
558
00:34:23,380 --> 00:34:26,666
what the levels of some snip are to determine if they have
559
00:34:26,728 --> 00:34:30,460
schizophrenia, you know what I mean? And so it is definitely
560
00:34:31,210 --> 00:34:35,118
I think that's an interesting weighing
561
00:34:35,154 --> 00:34:38,800
that from a company perspective, weighing the value
562
00:34:39,490 --> 00:34:42,618
in a claim that I think medical treatment
563
00:34:42,654 --> 00:34:46,286
still has a lot of value, but I think it has more value
564
00:34:46,348 --> 00:34:49,934
in a portfolio that has claims directed to
565
00:34:49,972 --> 00:34:53,918
the actual composition or directed to the actual kit or the
566
00:34:53,944 --> 00:34:57,434
system that's being sold that is then
567
00:34:57,472 --> 00:35:00,782
used by some kind of health care provider to execute on the method of
568
00:35:00,796 --> 00:35:04,370
treatment. Right, yeah. Actually, just a follow
569
00:35:04,420 --> 00:35:08,258
up on that, do you have any more detail as to what the
570
00:35:08,284 --> 00:35:10,540
extent of a method of treatment is needed?
571
00:35:13,910 --> 00:35:17,262
I forget the exact citation, but there was a
572
00:35:17,276 --> 00:35:21,018
case 2013 time frame where they were
573
00:35:21,044 --> 00:35:25,126
just doing a threshold comparison based on a metabolite
574
00:35:25,318 --> 00:35:29,302
that was during body's processing
575
00:35:29,326 --> 00:35:33,942
of a particular drug and they were using that to adjust treatment and
576
00:35:33,956 --> 00:35:37,662
that was not found to be patentable. That was deemed to be sort
577
00:35:37,676 --> 00:35:41,478
of trivial. The question is, is there a
578
00:35:41,564 --> 00:35:44,938
threshold or guidance as to what level of guidance
579
00:35:44,974 --> 00:35:48,390
for treatment is needed as a claim element to provide patentability?
580
00:35:50,330 --> 00:35:53,550
Yeah, so from these cases that I've
581
00:35:53,870 --> 00:35:54,620
seen,
582
00:36:00,030 --> 00:36:03,898
I remember hearing what you're talking about is a threshold above and
583
00:36:03,924 --> 00:36:06,850
below. Do you remember what the actual treatment step was? Steve,
584
00:36:07,710 --> 00:36:11,098
you know, they gave him a drug and it was metabolized, I think, in the
585
00:36:11,124 --> 00:36:15,098
liver and it was a cancer
586
00:36:15,134 --> 00:36:19,030
treatment and they were basically trying
587
00:36:19,080 --> 00:36:22,294
to dial in how much to give the patient and it was just based
588
00:36:22,332 --> 00:36:26,470
on a threshold and it was deemed ineligible
589
00:36:27,630 --> 00:36:31,714
because I think in that case it was more still
590
00:36:31,752 --> 00:36:35,090
the natural phenomenon. They weren't altering the natural
591
00:36:35,150 --> 00:36:39,430
chemistry of the person or anything like that. It was purely
592
00:36:40,410 --> 00:36:43,750
saying, you know, they're above or below and then we're going to
593
00:36:43,920 --> 00:36:47,506
treat you accordingly. But it wasn't because
594
00:36:47,568 --> 00:36:51,362
they were not altering anything around the natural phenomenon. The natural
595
00:36:51,386 --> 00:36:54,622
phenomena was just a means to an end, it's my understanding. Because if you look
596
00:36:54,636 --> 00:36:58,822
at some of these other cases you have in
597
00:36:59,016 --> 00:37:02,858
the Vonda one, they're actually administering
598
00:37:03,014 --> 00:37:06,478
actual drugs for the patient that allows them
599
00:37:06,504 --> 00:37:09,634
to either better metabolize or less prevent this
600
00:37:09,732 --> 00:37:12,922
QTc prolongation of a patient. And so it
601
00:37:12,936 --> 00:37:16,450
actually affects the patient's biology. And then same
602
00:37:16,500 --> 00:37:20,220
with Endo. They are here
603
00:37:20,670 --> 00:37:23,590
determining cratening clearance rate,
604
00:37:23,760 --> 00:37:27,142
but again, then the drug amount changes. I guess that one
605
00:37:27,156 --> 00:37:30,962
would be a little bit more similar potentially. I'd have to read the claim
606
00:37:31,046 --> 00:37:34,262
that 2013 claim set, but that one could be kind of similar to Endo.
607
00:37:34,286 --> 00:37:37,982
So maybe would want to compare that one to this endo
608
00:37:38,006 --> 00:37:41,422
versus Taylor case in 2019 to see because I
609
00:37:41,436 --> 00:37:44,040
think this one's probably the most similar I've seen.
610
00:37:44,670 --> 00:37:49,722
I've seen changing
611
00:37:49,806 --> 00:37:53,730
something other than what occurs naturally in normal biology
612
00:37:53,910 --> 00:37:56,620
is one sort of safe harbor, right,
613
00:37:56,950 --> 00:38:00,498
for genetic material. Like there's that one case where you're creating
614
00:38:00,534 --> 00:38:04,418
synthetic biology, no problem whether or not that's 102
615
00:38:04,444 --> 00:38:07,986
or 103 patentable, it's 101 patentable.
616
00:38:08,118 --> 00:38:11,790
If you're making something new that doesn't exist naturally occurring,
617
00:38:11,970 --> 00:38:15,314
you're in good shape. And I've seen
618
00:38:15,352 --> 00:38:19,146
those kind of cases get allowed without having a treatment.
619
00:38:19,338 --> 00:38:23,702
And it looks like for what you're showing here is a much richer set
620
00:38:23,776 --> 00:38:27,770
of alternatives. There's ranges and different values.
621
00:38:28,270 --> 00:38:31,718
It's not just a simple threshold. And I think the
622
00:38:31,744 --> 00:38:35,414
issue becomes, for lack of better words,
623
00:38:35,512 --> 00:38:38,742
is something analogous to static business logic.
624
00:38:38,886 --> 00:38:43,178
If you're always doing the same thing for
625
00:38:43,204 --> 00:38:47,298
every patient, you're not going to be patent eligible.
626
00:38:47,454 --> 00:38:51,234
And the closer you are, the less likely
627
00:38:51,282 --> 00:38:54,762
you are to be patent eligible. So if you have a simple threshold and you're
628
00:38:54,786 --> 00:38:58,434
just looking at the naturally occurring metabolite
629
00:38:58,482 --> 00:38:59,990
as something is metabolized,
630
00:39:01,330 --> 00:39:05,258
as best I can understand from the Federal Circuit ruling, is there in
631
00:39:05,284 --> 00:39:09,230
essence saying that's trivial?
632
00:39:12,050 --> 00:39:13,760
How would you even regulate that?
633
00:39:15,170 --> 00:39:18,738
Everybody would be infringing then that would be in that camp, but maybe that was
634
00:39:18,764 --> 00:39:22,570
part of it too. Yeah, so thanks, that helps.
635
00:39:22,750 --> 00:39:25,314
No, it's a great question. I'm going to go look up that case now because
636
00:39:25,352 --> 00:39:29,790
then I'll pass it around to everybody too once I find it because that's really
637
00:39:29,840 --> 00:39:33,222
great point and I think that's some of the parsing that's kind
638
00:39:33,236 --> 00:39:37,158
of going on as well in this world to kind of
639
00:39:37,184 --> 00:39:40,698
build on that, or just another little example quickly is that
640
00:39:40,784 --> 00:39:44,322
I had a case recently, not in biotech but in software, where there
641
00:39:44,336 --> 00:39:48,834
was a 101 rejection and the
642
00:39:48,872 --> 00:39:52,758
claim that was rejected had a lot of determining and measuring and
643
00:39:52,784 --> 00:39:56,466
calculating and then taking information
644
00:39:56,528 --> 00:40:00,222
into account to determine different courses of action. And that was
645
00:40:00,236 --> 00:40:03,646
rejected. But what the examiner pointed us to and what was eventually
646
00:40:03,718 --> 00:40:07,210
allowed is that there had to be an active
647
00:40:07,270 --> 00:40:10,110
step in there. You're measuring things, you're determining things.
648
00:40:10,160 --> 00:40:13,590
What do you actually then do? What do you change? What do you
649
00:40:13,700 --> 00:40:17,000
sort of affect in the system based on all of this?
650
00:40:18,590 --> 00:40:23,158
It was a very small wording change. Instead of determining
651
00:40:23,254 --> 00:40:26,850
a method for blah blah blah, it was determining that and then
652
00:40:26,900 --> 00:40:30,378
doing the blah blah blah all we had to do was
653
00:40:30,404 --> 00:40:33,740
add a little clause. So that made sense to me. This whole
654
00:40:35,930 --> 00:40:39,654
adding a treatment step made sense to me sort of from that
655
00:40:39,692 --> 00:40:43,422
angle as well. Just where you need to have, like you said, in a way,
656
00:40:43,556 --> 00:40:46,722
affect the system, change the chemistry of the person
657
00:40:46,796 --> 00:40:50,082
or whatever. Do something active. Yeah, there has to be
658
00:40:50,096 --> 00:40:53,874
like that active, that active step. Right. How are you
659
00:40:53,912 --> 00:40:57,534
kind of influencing the system? I guess to turn this back to
660
00:40:57,572 --> 00:41:01,446
machines in software, you have to have an output of some kind.
661
00:41:01,508 --> 00:41:05,002
You have to do something. So it's
662
00:41:05,026 --> 00:41:11,662
kind of a weird parallel, but I
663
00:41:11,676 --> 00:41:15,166
guess that's the practical application trying to
664
00:41:15,168 --> 00:41:18,514
get everybody to do. Yes, I mean
665
00:41:18,552 --> 00:41:22,342
this is obviously some random kind of tricks, but they
666
00:41:22,356 --> 00:41:25,510
don't like the extra solution activity. Adding the fact that you did it by
667
00:41:25,560 --> 00:41:29,806
PCR, that you're using
668
00:41:29,868 --> 00:41:33,170
some kind of like routine testing,
669
00:41:33,230 --> 00:41:37,262
that's not going to help at all because they still again believe you're
670
00:41:37,286 --> 00:41:40,282
still kind of capturing the natural phenomenon. Again, this kind of gets into the 102
671
00:41:40,296 --> 00:41:43,534
103 world because, well, PCR was known or whatever
672
00:41:43,572 --> 00:41:46,582
method you're using was known. That's more of a 102 103 issue.
673
00:41:46,656 --> 00:41:50,314
But nonetheless, it kind of finds itself in the 101 camp
674
00:41:50,472 --> 00:41:54,626
and then you don't need to have the insignificant limitations
675
00:41:54,758 --> 00:41:58,870
because they're not going to provide any benefit.
676
00:41:59,190 --> 00:42:02,170
And then like general treatments and things like that aren't probably going to help much
677
00:42:02,220 --> 00:42:05,614
either. But it has to be some kind of true
678
00:42:05,652 --> 00:42:06,840
effect on the system.
679
00:42:09,550 --> 00:42:12,938
Yeah, this kind of goes towards the computer side
680
00:42:12,964 --> 00:42:17,274
of the world as well. But how are you actually applying that phenomenon
681
00:42:17,322 --> 00:42:20,958
in an unconventional way? I think you can even think of detecting
682
00:42:21,114 --> 00:42:24,834
the field DNA in the mother's blood. Again, what they were doing was just detecting
683
00:42:24,882 --> 00:42:27,890
it. But then maybe what would have helped them is,
684
00:42:27,940 --> 00:42:31,286
okay, now that you've detected, now that you've isolated fetal DNA, what are you
685
00:42:31,288 --> 00:42:34,718
going to do about it? Right. And I think had they
686
00:42:34,744 --> 00:42:38,910
maybe couched it more in the way of technical
687
00:42:38,970 --> 00:42:42,618
challenges and the avoiding amniocentesis
688
00:42:42,714 --> 00:42:48,278
and things like that, maybe it would have had a better chance then
689
00:42:48,304 --> 00:42:52,022
overcoming a particular technical challenge. Like I said, I think
690
00:42:52,036 --> 00:42:55,614
there's a good recommendation too to also include lots of different claim
691
00:42:55,662 --> 00:42:59,462
types in this area. The methods of treatment, methods of diagnosis, methods of
692
00:42:59,476 --> 00:43:02,870
detection, and going over those that are easier first,
693
00:43:02,920 --> 00:43:06,362
which would probably be method of treatment assuming you have some kind of active step
694
00:43:06,556 --> 00:43:09,580
and it may be going towards the other ones later,
695
00:43:10,930 --> 00:43:14,234
especially through divisional practice and things like that. And hopefully the case
696
00:43:14,272 --> 00:43:18,242
law changes. Honestly, I looked through case law
697
00:43:18,316 --> 00:43:21,722
for 101 in the life science versus the software. There is
698
00:43:21,796 --> 00:43:25,758
way fewer life science section 101 cases.
699
00:43:25,794 --> 00:43:29,642
And I don't know if that's like a general reflection of
700
00:43:29,776 --> 00:43:32,750
obviously software is rapidly changing.
701
00:43:33,130 --> 00:43:37,110
Lots of people have their hands in software versus
702
00:43:37,170 --> 00:43:39,520
the life science. It's a slower moving field.
703
00:43:40,270 --> 00:43:43,562
There's arguably fewer people that are going
704
00:43:43,576 --> 00:43:46,974
to touch life science in their lifetime versus somebody who's going to touch software,
705
00:43:47,022 --> 00:43:51,102
maybe, or whether that's some other meaningful metric
706
00:43:51,186 --> 00:43:54,698
of what that case
707
00:43:54,724 --> 00:43:58,850
law has done to those fields, or whether the cost
708
00:43:58,900 --> 00:44:02,462
of kind of pursuing these longer or over a greater period of time in
709
00:44:02,476 --> 00:44:04,600
the court system, I don't know. But it was just interesting.
710
00:44:05,650 --> 00:44:10,094
Like I said, it had to have been. I feel like for every one life
711
00:44:10,132 --> 00:44:13,670
science case, there was probably at least three software cases, it seems.
712
00:44:13,720 --> 00:44:16,682
So it's interesting. So in that sense, it was easier, I feel like,
713
00:44:16,696 --> 00:44:20,366
to make sense of it to some degree, because it was less
714
00:44:20,548 --> 00:44:24,822
all over the board, but also less examples
715
00:44:24,846 --> 00:44:26,440
to draw from, I guess.
716
00:44:27,730 --> 00:44:30,350
Anyways oh, yeah, Dan, sorry, Dan.
717
00:44:35,270 --> 00:44:38,910
So I decided to take a little different spin here on 101,
718
00:44:38,960 --> 00:44:42,958
because while the eligible
719
00:44:42,994 --> 00:44:47,202
subject matter is certainly the dominant topic from
720
00:44:47,336 --> 00:44:51,090
that section, it's a fairly recent
721
00:44:51,410 --> 00:44:55,158
development. Comparatively speaking, for the most part, section 101 historically has
722
00:44:55,184 --> 00:44:58,110
been about whether or not an invention is useful,
723
00:44:58,430 --> 00:45:01,866
which is also historically quite a low bar, and so
724
00:45:01,928 --> 00:45:05,934
it is reasonable that it gets overlooked. But towards life
725
00:45:05,972 --> 00:45:09,198
sciences, the requirement is still there. And as
726
00:45:09,224 --> 00:45:13,026
we'll get to the end here, there are a couple of places where people can
727
00:45:13,088 --> 00:45:16,520
mess up, and it's a bit of an embarrassing mistake to make.
728
00:45:17,630 --> 00:45:21,082
And the law around it, I still think merits
729
00:45:21,166 --> 00:45:24,380
some discussions. So that fundamental bit about
730
00:45:25,310 --> 00:45:29,278
invention must be useful. Case law ends up generating
731
00:45:29,434 --> 00:45:33,514
three main aspects of utility and inventions.
732
00:45:33,562 --> 00:45:37,134
Utility must be specific, it must be substantial, and it must
733
00:45:37,172 --> 00:45:41,062
be credible. So specific must mean it's directed,
734
00:45:41,206 --> 00:45:47,938
it's well defined, it is directed towards a
735
00:45:47,964 --> 00:45:51,470
particular activity, a particular role, and this is primarily
736
00:45:51,530 --> 00:45:55,402
used to deny or avoid general statements. So one
737
00:45:55,416 --> 00:45:58,678
of my favorite lines out of the MPEP is in the section where it's like,
738
00:45:58,704 --> 00:46:03,718
you can't state that the invention is simple for
739
00:46:03,744 --> 00:46:06,660
mere landfill, can't just take up space.
740
00:46:07,410 --> 00:46:10,978
Now, taking up space, though, is actually can be a very valuable thing.
741
00:46:11,064 --> 00:46:15,514
Think of all the washers on mechanical inventions that keep
742
00:46:15,552 --> 00:46:18,434
place things where they're supposed to be, or balanced on ships.
743
00:46:18,482 --> 00:46:22,222
That's just weight, that takes up space, that keeps balance there.
744
00:46:22,416 --> 00:46:26,040
And so indeed, taking up space can be
745
00:46:26,430 --> 00:46:29,762
can be a legitimate use. But the examples
746
00:46:29,786 --> 00:46:33,482
I gave there are specific, they're specifically valuable.
747
00:46:33,626 --> 00:46:37,402
So you can't just say, oh, it just takes up space. And how
748
00:46:37,416 --> 00:46:40,762
this applies to life sciences is you can't just say, oh,
749
00:46:40,896 --> 00:46:46,034
these compounds have biological
750
00:46:46,202 --> 00:46:49,894
activity, and leave it at that. You got to be specific.
751
00:46:49,992 --> 00:46:54,070
And you can't just say, oh, you could use this to treat diseases.
752
00:46:55,410 --> 00:46:59,098
It's like, all right, well, which diseases? What diseases? So it
753
00:46:59,124 --> 00:47:02,750
does must be specific. Your utility must be directed
754
00:47:02,810 --> 00:47:06,430
towards something, it must be substantial.
755
00:47:06,930 --> 00:47:10,800
So in this case, this is probably the more flexible of
756
00:47:11,550 --> 00:47:14,460
these terms that I found while looking into this.
757
00:47:15,090 --> 00:47:18,926
And its primary concern is that your invention
758
00:47:18,998 --> 00:47:23,170
that use sort of has an immediately recognizable effect.
759
00:47:23,340 --> 00:47:27,298
This most commonly pops up to defeat the
760
00:47:27,324 --> 00:47:30,730
sort of hunting license applications of oh,
761
00:47:30,780 --> 00:47:33,610
here's a bunch of compounds that could be useful.
762
00:47:35,310 --> 00:47:38,618
We can do some broad speculation that perhaps
763
00:47:38,654 --> 00:47:42,094
this will be useful towards some disease, but we have
764
00:47:42,132 --> 00:47:46,078
no actual data, we have no actual support, we don't know.
765
00:47:46,104 --> 00:47:48,720
And then this is where again, it bumps into 112.
766
00:47:49,110 --> 00:47:52,250
But the substantial
767
00:47:52,310 --> 00:47:55,342
means that from what you've got ready at hand here,
768
00:47:55,416 --> 00:48:00,418
there is an identifiable real world benefit that
769
00:48:00,564 --> 00:48:04,610
it treats this disease or even it inhibits
770
00:48:04,670 --> 00:48:08,098
this protein and then finally it must be
771
00:48:08,124 --> 00:48:11,842
credible. This is perhaps the
772
00:48:11,856 --> 00:48:15,334
least interesting out of the three because does
773
00:48:15,372 --> 00:48:18,298
your invention, in light of all the evidence you've given,
774
00:48:18,384 --> 00:48:21,614
behave according to known and appreciated
775
00:48:21,782 --> 00:48:25,894
scientific principles? So credibility only really pops up when
776
00:48:25,932 --> 00:48:29,630
people are trying to put in time machines,
777
00:48:29,750 --> 00:48:33,482
perpetual motion machines in life sciences.
778
00:48:33,626 --> 00:48:37,702
I saw some examples of like using magnetic fields to change things
779
00:48:37,776 --> 00:48:41,520
flavor you might end up with some
780
00:48:42,750 --> 00:48:46,450
wild homeopathy related type stuff as well,
781
00:48:46,560 --> 00:48:50,410
might show up under credibility. But the MPEP strongly
782
00:48:50,970 --> 00:48:55,334
suggests that the credibility bar is fairly
783
00:48:55,442 --> 00:48:59,614
low. As long as there is even an inkling, some sort of suggestions like okay,
784
00:48:59,772 --> 00:49:02,962
we'll go along with this. And then as a
785
00:49:02,976 --> 00:49:07,178
curious logical necessity, if you somehow fail the necessity
786
00:49:07,334 --> 00:49:11,114
or the utility requirement of 101, you therefore
787
00:49:11,162 --> 00:49:14,554
fail enablement. If enablement is that
788
00:49:14,592 --> 00:49:17,758
you adequately instruct one of skill in the art
789
00:49:17,904 --> 00:49:21,670
to make and use the invention and there's no use
790
00:49:21,720 --> 00:49:24,874
for the invention, you therefore can't teach
791
00:49:24,912 --> 00:49:28,426
people how to use it. So you will find hand in hand
792
00:49:28,548 --> 00:49:32,290
a utility one on one rejection with an enablement 112
793
00:49:32,340 --> 00:49:36,106
rejection. And important for
794
00:49:36,228 --> 00:49:39,190
these considerations, particularly towards substantial,
795
00:49:39,570 --> 00:49:42,998
is that the USPTO is not the FDA. And this is something that's
796
00:49:43,034 --> 00:49:46,394
popped up in a number of cases, although it's at this point fairly
797
00:49:46,442 --> 00:49:50,710
old news. In order for a pharmaceutical
798
00:49:51,330 --> 00:49:54,794
to qualify as a substantial utility,
799
00:49:54,962 --> 00:49:58,186
no, you don't need to go through the entire process, the entire
800
00:49:58,248 --> 00:50:01,882
clinical process of showing that the drug is
801
00:50:01,956 --> 00:50:04,810
a commercially viable, safe,
802
00:50:05,250 --> 00:50:08,510
effective drug. The mere
803
00:50:08,570 --> 00:50:12,878
identification and notably demonstration, at least a token demonstration
804
00:50:13,034 --> 00:50:16,846
of biological or pharmacological activity towards a
805
00:50:16,848 --> 00:50:20,350
specific protein that's associated target,
806
00:50:20,790 --> 00:50:24,250
associated with certain diseases is sufficient.
807
00:50:24,570 --> 00:50:27,982
And this has come up again and again and again since the 80s.
808
00:50:28,176 --> 00:50:31,930
Some of this language has, some of the earlier language said things
809
00:50:32,040 --> 00:50:36,010
as near in vitro. The fact that you identify
810
00:50:36,750 --> 00:50:40,294
activity in vitro has utility towards
811
00:50:40,392 --> 00:50:41,400
pharma companies.
812
00:50:43,590 --> 00:50:47,090
Whereas I'll say in that last case with their enray Braun
813
00:50:47,150 --> 00:50:51,240
from 95 there's maybe a bit more telling statement in there
814
00:50:51,990 --> 00:50:55,810
about how, due to the expense
815
00:50:56,190 --> 00:50:59,760
and duration of full clinical trials, that if
816
00:51:00,930 --> 00:51:05,674
drug applications failed utility before
817
00:51:05,772 --> 00:51:10,154
the clinical stage, that would be a huge economic barrier
818
00:51:10,322 --> 00:51:13,738
and discourage barrier to
819
00:51:13,764 --> 00:51:17,938
pharmaceutical development economically. So for a
820
00:51:17,964 --> 00:51:20,820
practical economic reason,
821
00:51:21,450 --> 00:51:25,630
mirror in vitro activity is sufficient.
822
00:51:25,950 --> 00:51:29,554
And so in each of these cases, the examples, what was
823
00:51:29,592 --> 00:51:33,674
generally challenged for most of these cases was the specification stated,
824
00:51:33,722 --> 00:51:37,070
hey, here's a target,
825
00:51:37,250 --> 00:51:41,074
here's a protein. It's known that
826
00:51:41,172 --> 00:51:45,250
this type of molecule can
827
00:51:45,360 --> 00:51:48,670
inhibit this molecule or it can inhibit the target.
828
00:51:49,650 --> 00:51:53,434
Here are some new variants of it. Here is literally some
829
00:51:53,472 --> 00:51:56,050
data showing in vitro activity.
830
00:51:56,910 --> 00:52:01,200
Did they test the whole entire scope? Not necessarily. Did they fully develop
831
00:52:02,130 --> 00:52:05,174
the compounds into proper pharmaceuticals?
832
00:52:05,222 --> 00:52:09,490
No. But they at least had the
833
00:52:09,660 --> 00:52:13,286
background of the knowledge of this specific disease
834
00:52:13,358 --> 00:52:16,994
is related to these specific proteins. And here is token
835
00:52:17,042 --> 00:52:20,950
evidence, here is literally some evidence that our class,
836
00:52:21,060 --> 00:52:24,874
our molecules can inhibit, can interact with
837
00:52:24,972 --> 00:52:28,630
these proteins,
838
00:52:29,130 --> 00:52:32,822
and that is sufficient for the utility. So now we'll
839
00:52:32,846 --> 00:52:36,442
look at some examples. It would actually be sufficient for 112,
840
00:52:36,516 --> 00:52:40,534
especially now though, because a lot of those early EPO patents that
841
00:52:40,572 --> 00:52:44,474
try to protect variants or different ways of creating
842
00:52:44,522 --> 00:52:48,142
EPO had section 112
843
00:52:48,216 --> 00:52:52,006
issue. Because again, they didn't enable somebody
844
00:52:52,068 --> 00:52:55,034
to practice the full scope of the claim.
845
00:52:55,142 --> 00:52:58,570
They may be taught one or two ways to do it, like using
846
00:52:58,620 --> 00:53:01,774
some of those assays, but they didn't teach the full scope of it. So I
847
00:53:01,812 --> 00:53:05,578
wonder in the current interpretation of
848
00:53:05,604 --> 00:53:08,878
112, whether they maybe would have
849
00:53:08,904 --> 00:53:11,626
survived 101, but London survived 112.
850
00:53:11,808 --> 00:53:14,460
Yeah, quite possibly. Yeah,
851
00:53:17,590 --> 00:53:21,110
absolutely. Legitimate observation there that perhaps indeed
852
00:53:21,430 --> 00:53:24,318
it wouldn't be enough to enable the full scope,
853
00:53:24,474 --> 00:53:27,578
but for the purposes of determining that specific and
854
00:53:27,604 --> 00:53:28,850
substantial utility,
855
00:53:30,730 --> 00:53:34,802
literally something token evidence is enough,
856
00:53:34,876 --> 00:53:38,490
as long as it is directed towards treatment of specific diseases,
857
00:53:38,550 --> 00:53:42,786
inhibition of known specific biological targets.
858
00:53:42,978 --> 00:53:45,866
So how would you fix that?
859
00:53:46,048 --> 00:53:49,578
Would you just have to go extremely narrow if you didn't
860
00:53:49,614 --> 00:53:52,360
have enough to support full enablement of everything?
861
00:53:54,950 --> 00:53:59,014
So you're talking about an example where you've got a class of molecules
862
00:53:59,062 --> 00:54:03,094
and then you get rejected for lack of enablement for the whole scope,
863
00:54:03,262 --> 00:54:06,822
right? Yeah. So that's a hard one
864
00:54:06,896 --> 00:54:10,290
to fix. Sometimes examiners
865
00:54:11,390 --> 00:54:16,158
are content to listen to if
866
00:54:16,184 --> 00:54:20,574
there's information. Sometimes you can show them data
867
00:54:20,672 --> 00:54:23,826
related that ends up in the case file. Not everyone
868
00:54:23,888 --> 00:54:27,354
likes that. Sometimes you can find publications that
869
00:54:27,392 --> 00:54:30,822
show the relevant state of the
870
00:54:30,836 --> 00:54:34,326
knowledge at the time of the filing that you got to be careful with that,
871
00:54:34,388 --> 00:54:37,858
so you don't end up making it obvious. But sometimes you can play games
872
00:54:37,894 --> 00:54:41,518
with that. Is that like submitted like a 132 deck,
873
00:54:41,554 --> 00:54:45,080
like an affidavit of inventors or yeah,
874
00:54:48,230 --> 00:54:52,460
you can do affidavits from inventors. That's possible.
875
00:54:54,650 --> 00:54:57,450
Being careful with all other publications,
876
00:54:58,670 --> 00:55:02,540
that's another process. But it's hard sometimes.
877
00:55:04,430 --> 00:55:08,530
And what I have found is depending on the practicalities
878
00:55:08,650 --> 00:55:13,090
of the case, of what's important and considering your jurisdiction,
879
00:55:13,150 --> 00:55:15,858
sometimes it's not worth it to fight it.
880
00:55:15,944 --> 00:55:20,370
Sometimes the estoppel that you would introduce
881
00:55:22,190 --> 00:55:25,350
by putting it forward in less important jurisdictions,
882
00:55:26,270 --> 00:55:29,730
it's just not worth it. And hopefully you
883
00:55:29,780 --> 00:55:32,910
have enabled what is the critical,
884
00:55:34,250 --> 00:55:37,642
the golden goose or the golden egg of your genus.
885
00:55:37,726 --> 00:55:41,262
Hopefully that's enabled and so you find comfort in that.
886
00:55:41,456 --> 00:55:44,946
But it's a tough spot to be in when you get hit with those
887
00:55:45,128 --> 00:55:48,498
enablement bits because you're generally not allowed to
888
00:55:48,524 --> 00:55:51,380
just dump new stuff into the record.
889
00:55:56,730 --> 00:56:01,090
So here are some examples of where utility failed
890
00:56:01,770 --> 00:56:04,982
in life science cases. So the first one, which ended
891
00:56:05,006 --> 00:56:08,962
up being sort of the fundamental precedent for pretty much
892
00:56:09,096 --> 00:56:12,322
all the cases on the previous slide. Renault v.
893
00:56:12,336 --> 00:56:16,142
Manson from 1966. The patent claimed
894
00:56:16,166 --> 00:56:19,678
a novel method for manufacturing a certain
895
00:56:19,824 --> 00:56:23,674
subgenus of a type of steroid. Now at
896
00:56:23,712 --> 00:56:27,118
the time there was no known utility for the
897
00:56:27,144 --> 00:56:30,982
class of compounds. The only blurb in
898
00:56:30,996 --> 00:56:34,282
the whole application that's actually about what this thing is for is a
899
00:56:34,296 --> 00:56:38,966
paragraph that says, hey, these compounds are like these other compounds
900
00:56:39,098 --> 00:56:43,200
and these other compounds are being considered for
901
00:56:43,590 --> 00:56:46,858
diseases in which these certain properties could be
902
00:56:46,884 --> 00:56:50,040
useful. That was it.
903
00:56:50,730 --> 00:56:54,970
So it did not specify a specific type of disease
904
00:56:55,710 --> 00:56:59,794
nor did it show any data that it could
905
00:56:59,892 --> 00:57:03,086
inhibit or could interact with the pathways
906
00:57:03,158 --> 00:57:04,020
that it mentioned.
907
00:57:07,150 --> 00:57:10,722
Next slide please. The decision here, what was their motivation
908
00:57:10,806 --> 00:57:12,460
to filing the patent then,
909
00:57:13,990 --> 00:57:17,138
behind the name. So this is where we
910
00:57:17,164 --> 00:57:21,210
fundamentally this is the case where the patent is not a hunting license
911
00:57:21,270 --> 00:57:24,582
line comes out of from the decision.
912
00:57:24,666 --> 00:57:28,502
And what I think what they were after was that they were related to
913
00:57:28,516 --> 00:57:32,682
the lab that was testing this broader cast of class of molecules.
914
00:57:32,826 --> 00:57:36,698
So they were like hey, we found a cool way of making these class of
915
00:57:36,724 --> 00:57:40,598
molecules that looks like this other class of molecules which we're currently
916
00:57:40,684 --> 00:57:44,534
interested in. But the state of their technology,
917
00:57:44,632 --> 00:57:48,642
the state of their knowledge didn't actually suggest at all that those compounds
918
00:57:48,666 --> 00:57:50,320
would be useful for anything.
919
00:57:51,650 --> 00:57:55,170
But they sort of put in the cart before the horse. They wanted
920
00:57:55,220 --> 00:57:59,946
to protect that research that they had done before
921
00:58:00,008 --> 00:58:03,642
they actually knew it was going to be valuable. And to some extent you kind
922
00:58:03,656 --> 00:58:07,074
of can't fault them for that. With R and D and
923
00:58:07,172 --> 00:58:10,422
pharma companies you're testing, especially now with high throughput screen and
924
00:58:10,436 --> 00:58:13,700
you're testing all kinds, you can test all kinds of stuff.
925
00:58:15,650 --> 00:58:19,254
But the decision came back that no utility is
926
00:58:19,292 --> 00:58:23,358
not satisfied by showing that
927
00:58:23,384 --> 00:58:27,030
it's classes are currently being screened.
928
00:58:28,670 --> 00:58:32,550
That alone is not sufficient. And furthermore, a bit more fundamental
929
00:58:32,870 --> 00:58:36,994
that a process is not useful simply
930
00:58:37,042 --> 00:58:40,040
by the fact that it produces its intended result.
931
00:58:41,030 --> 00:58:44,394
It's interesting that what
932
00:58:44,432 --> 00:58:48,358
makes that process the process, I guess is valued
933
00:58:48,394 --> 00:58:52,220
holistically by the utility in some sense of the result.
934
00:58:52,910 --> 00:58:56,610
And so yes, indeed, simply that because their method indeed
935
00:58:57,050 --> 00:59:00,490
produced the compound, but the compounds
936
00:59:00,610 --> 00:59:04,458
were not substantial. So in this case it was specific they
937
00:59:04,484 --> 00:59:08,370
said, hey, this method makes these specific compounds. So, hey, it's specific.
938
00:59:08,480 --> 00:59:11,970
But because it did not promise, it did not show or suggest
939
00:59:14,030 --> 00:59:16,040
a real world value,
940
00:59:17,870 --> 00:59:21,994
it was not substantial. So then more recently,
941
00:59:22,042 --> 00:59:25,580
let's jump forward 40 years,
942
00:59:26,570 --> 00:59:30,270
2005. And Ray Fisher, this was the case
943
00:59:30,320 --> 00:59:35,278
that attempted to claim five est sequence
944
00:59:35,314 --> 00:59:39,490
tags from Corn. And he has their cDNA
945
00:59:39,550 --> 00:59:43,746
sequences, which are, I think, notably one of the things thrown about
946
00:59:43,868 --> 00:59:48,138
as well. Those are patentable because you
947
00:59:48,164 --> 00:59:51,942
take out the bits that don't matter and they
948
00:59:51,956 --> 00:59:55,138
don't naturally exist. So cDNAs falls
949
00:59:55,174 --> 00:59:59,022
under the patentable subject matter. And est can
950
00:59:59,036 --> 01:00:02,530
be useful for a variety of things within genomics.
951
01:00:02,590 --> 01:00:06,258
You can help map genomes. You can find which genes are where and
952
01:00:06,284 --> 01:00:10,266
what they coordinate to. But in this case, the function
953
01:00:10,328 --> 01:00:14,614
and structure of the claim sequences and their corresponding
954
01:00:14,662 --> 01:00:18,150
proteins were unknown at the time of filing. This case
955
01:00:18,200 --> 01:00:20,960
just includes a lot of genomics data.
956
01:00:21,650 --> 01:00:25,054
It says that their ests created,
957
01:00:25,102 --> 01:00:28,750
extracted from the specific breed
958
01:00:28,810 --> 01:00:30,390
of maze.
959
01:00:32,310 --> 01:00:34,320
But what these five tags did,
960
01:00:35,130 --> 01:00:38,722
unknown. Specifically, they name the common
961
01:00:38,796 --> 01:00:44,220
uses for este standard,
962
01:00:45,570 --> 01:00:49,054
general, generic uses for what est can do. Of course,
963
01:00:49,092 --> 01:00:52,860
you can use ests to map where genes are
964
01:00:54,030 --> 01:00:59,558
in the genome. You can use them to
965
01:00:59,584 --> 01:01:02,810
find similar genes in other organisms.
966
01:01:03,370 --> 01:01:06,578
But it was completely unknown at the time of filing, what they did, what they
967
01:01:06,604 --> 01:01:09,950
encoded. And that's really what the case
968
01:01:10,000 --> 01:01:13,180
with the Federal Circuit locked in on. Next slide, please.
969
01:01:14,830 --> 01:01:18,966
That these uses for these specific ests remain
970
01:01:19,038 --> 01:01:22,382
hypothetical in general. So although sure you could use it
971
01:01:22,396 --> 01:01:27,426
to find you potentially use it to detect variance
972
01:01:27,498 --> 01:01:31,466
mutations. Are mutations in those
973
01:01:31,528 --> 01:01:34,482
genes useful, valuable,
974
01:01:34,626 --> 01:01:38,090
noteworthy, completely unknown.
975
01:01:38,590 --> 01:01:42,098
And the specification contains no guidance as
976
01:01:42,124 --> 01:01:46,614
to why those claimed ests were more useful than the tens of thousands
977
01:01:46,782 --> 01:01:50,570
that are present in the genome. And then
978
01:01:50,620 --> 01:01:54,522
furthermore, there was no data, there was no evidence
979
01:01:54,606 --> 01:01:58,718
that those ests would specifically would
980
01:01:58,744 --> 01:02:01,610
succeed at doing any of the things like, hey,
981
01:02:01,720 --> 01:02:03,770
let's use this to find mutations.
982
01:02:05,350 --> 01:02:08,798
There was no such data. So again, similar to that
983
01:02:08,824 --> 01:02:12,374
case from the court relied on that this is sort of
984
01:02:12,412 --> 01:02:15,902
another use testing sort of situation. You have
985
01:02:15,916 --> 01:02:20,140
a research group that's trying to protect their research.
986
01:02:21,310 --> 01:02:24,806
Although there's no value yet out of the research,
987
01:02:24,928 --> 01:02:28,742
they're still early on, or at least they did not provide what the
988
01:02:28,756 --> 01:02:32,260
utility of these ests were.
989
01:02:33,490 --> 01:02:36,734
And so the next step for them would be, okay, let's figure
990
01:02:36,772 --> 01:02:40,310
out what these ests actually do. And that is
991
01:02:40,420 --> 01:02:44,118
insufficient standing for an eligible
992
01:02:44,154 --> 01:02:48,050
patent. You got to tell us what these things do. They must be specific
993
01:02:48,160 --> 01:02:51,302
and substantial in their utility to
994
01:02:51,316 --> 01:02:54,866
meet that fundamental bar. So,
995
01:02:54,988 --> 01:02:58,838
yeah, the last thing here is make
996
01:02:58,864 --> 01:03:01,958
sure you do have a goal in mind or at least you provide the
997
01:03:01,984 --> 01:03:05,594
context, that substantial context towards what these
998
01:03:05,632 --> 01:03:09,338
things are for. And so if you're too early on in
999
01:03:09,424 --> 01:03:12,818
development and you're just seeing what you
1000
01:03:12,844 --> 01:03:16,770
can make in the realm of biotech and the realm of chemistry.
1001
01:03:16,830 --> 01:03:20,118
Just because you can make it doesn't
1002
01:03:20,154 --> 01:03:23,618
mean it's necessarily useful. And then you
1003
01:03:23,644 --> 01:03:27,470
fail the forgotten portion of section 101, the part
1004
01:03:27,520 --> 01:03:31,094
no one talks about. Well honestly, even if you
1005
01:03:31,132 --> 01:03:34,250
find what it does, if they had found in current
1006
01:03:34,300 --> 01:03:37,778
case, if they had found what these ESC do, it still
1007
01:03:37,804 --> 01:03:41,282
wouldn't have been protectable from the other side of 101 because there would have
1008
01:03:41,296 --> 01:03:46,238
been like it would have been one thing if they were like you
1009
01:03:46,264 --> 01:03:50,034
genotype for this thing and then you give more round
1010
01:03:50,082 --> 01:03:54,038
up to the corn versus less roundup to the corn or something and
1011
01:03:54,064 --> 01:03:57,266
then maybe that active step would have saved them from the other part of 101.
1012
01:03:57,328 --> 01:04:00,510
So yeah, it's kind of fun to look at these historically
1013
01:04:00,570 --> 01:04:03,878
how they've kind of come over time and yeah that's interesting.
1014
01:04:03,964 --> 01:04:07,322
You do forget about the other side of 101. So that was interesting. That's a
1015
01:04:07,336 --> 01:04:09,170
good historical lesson.
1016
01:04:13,070 --> 01:04:16,578
Some questions of law that feel obvious
1017
01:04:16,664 --> 01:04:19,974
or standard now they maybe weren't always like
1018
01:04:20,012 --> 01:04:23,142
that. You go poke at the case law, you go do a
1019
01:04:23,156 --> 01:04:27,140
bit of digging and you can find a legitimate question in the record
1020
01:04:28,490 --> 01:04:32,082
because for example, that case from the 60s, there is
1021
01:04:32,096 --> 01:04:35,382
a dissenting opinion. I didn't read
1022
01:04:35,396 --> 01:04:38,694
the dissenting opinion but I'm going to assume it to some extent argues that no
1023
01:04:38,732 --> 01:04:42,414
the fact that they could make it, the fact that there was perhaps the amount
1024
01:04:42,452 --> 01:04:46,098
of speculation, maybe there's an argument in there that the level
1025
01:04:46,124 --> 01:04:49,842
of speculation was sufficient but instead
1026
01:04:49,916 --> 01:04:53,720
now that case from the 60s ends up being the grounding precedent for
1027
01:04:54,650 --> 01:04:58,666
40 plus years of biological
1028
01:04:58,738 --> 01:05:02,502
and chemical utility. So even though now we
1029
01:05:02,516 --> 01:05:05,622
don't think about the utility requirements so much,
1030
01:05:05,816 --> 01:05:09,174
there was at a time a legitimate question,
1031
01:05:09,272 --> 01:05:12,570
a legitimate inquiry
1032
01:05:13,250 --> 01:05:16,978
and I think it's worthwhile going back and looking at. So you have the fundamental
1033
01:05:17,014 --> 01:05:21,020
principle at hand and not just the working convenient result.
1034
01:05:22,670 --> 01:05:24,200
Yeah, absolutely.
1035
01:05:26,210 --> 01:05:29,190
Cool. Does anyone have any questions, comments?
1036
01:05:31,470 --> 01:05:33,060
I wanted to say something.
1037
01:05:34,830 --> 01:05:39,540
So back to the genus versus species issue.
1038
01:05:40,770 --> 01:05:44,890
From the client perspective that is the financial perspective,
1039
01:05:47,070 --> 01:05:51,274
when you're facing a question like that it seems like it might
1040
01:05:51,312 --> 01:05:56,040
be better just to accept the species right,
1041
01:05:56,730 --> 01:06:00,302
get the insurance, file a continuation
1042
01:06:00,386 --> 01:06:02,760
and kick it down road.
1043
01:06:03,390 --> 01:06:07,286
Yes it's a tendency
1044
01:06:07,358 --> 01:06:11,102
I think get all up and arms blah blah
1045
01:06:11,126 --> 01:06:14,774
blah blah but from the client
1046
01:06:14,822 --> 01:06:18,434
perspective please give us a patent.
1047
01:06:18,542 --> 01:06:22,322
And then the second thing I was going to say is that if you're
1048
01:06:22,346 --> 01:06:26,290
waiting into an area like this it might make
1049
01:06:26,340 --> 01:06:30,646
sense to describe the genus really
1050
01:06:30,768 --> 01:06:34,822
extensively and if you're talking about a
1051
01:06:34,836 --> 01:06:38,782
structure maybe you can attach mechanism to
1052
01:06:38,796 --> 01:06:42,120
the structure. Why does the structure work?
1053
01:06:44,950 --> 01:06:48,558
You're not necessarily going to get the claims
1054
01:06:48,594 --> 01:06:51,854
that you want, that you're creating prior art that could
1055
01:06:51,892 --> 01:06:56,080
block others which is also important.
1056
01:06:56,650 --> 01:07:00,340
So those are my ideas there.
1057
01:07:00,970 --> 01:07:05,294
Yeah, I think two companies have to weigh how much maybe
1058
01:07:05,332 --> 01:07:08,320
it's worthwhile spending a little bit of R, amp, D time,
1059
01:07:09,250 --> 01:07:11,450
at least proof of concept,
1060
01:07:12,850 --> 01:07:16,158
a few different members of a genius.
1061
01:07:16,254 --> 01:07:19,794
You know what, just some, like, really rough
1062
01:07:19,842 --> 01:07:23,402
in vitro data right, that we can make this compound and
1063
01:07:23,416 --> 01:07:26,558
we said that it increases insulin production. Look, when we put
1064
01:07:26,584 --> 01:07:30,686
it into healing cells that are meant to produce insulin, we can get
1065
01:07:30,808 --> 01:07:33,698
a modest increase in insulin, you know what I mean? Just doing a little bit
1066
01:07:33,724 --> 01:07:36,878
of those studies and a few random different ones to
1067
01:07:36,904 --> 01:07:40,758
hopefully show that more of the full scope
1068
01:07:40,794 --> 01:07:44,714
of the claim and things like that. But I agree that getting
1069
01:07:44,752 --> 01:07:47,882
the species is better than nothing. And so maybe getting the
1070
01:07:47,896 --> 01:07:50,990
species and then being willing to get a whole bunch of species patents, right?
1071
01:07:51,040 --> 01:07:55,278
A whole bunch of other ones that are if you think about your particular species
1072
01:07:55,314 --> 01:07:58,710
being the bullseye and then some of the closest
1073
01:07:58,770 --> 01:08:02,114
next ones hopefully trying to get patents on some of those ones.
1074
01:08:02,152 --> 01:08:05,894
So do you block a competitor in the most
1075
01:08:05,932 --> 01:08:09,110
effective way with the genus claim? No. But you still block them through
1076
01:08:09,160 --> 01:08:12,966
multiple pen, through like, all the different ways that they could conceivably
1077
01:08:13,038 --> 01:08:16,946
get around it? Yes. And maybe a little bit more painfully longer,
1078
01:08:17,068 --> 01:08:19,300
but yeah,
1079
01:08:19,750 --> 01:08:23,714
right. Anyway, it's a good session. Thank you, Ashley. Thank you.
1080
01:08:23,872 --> 01:08:27,038
Yeah, so no guy said, this is something I've been meaning to do
1081
01:08:27,064 --> 01:08:30,530
for a while. All right, well, thanks everybody.
1082
01:08:30,700 --> 01:08:33,700
Have a good rest of your week. Thank you.
1083
01:08:34,090 --> 01:08:37,530
Thanks everybody. Thank you. Bye bye.
1084
01:08:37,710 --> 01:08:40,898
All right, that's all for today, folks. Thanks for listening. And remember to check
1085
01:08:40,924 --> 01:08:43,878
us out@aurorapatins.com for more great podcasts,
1086
01:08:43,914 --> 01:08:47,690
blogs, and videos covering all things patent strategy. And if you're an agent
1087
01:08:47,740 --> 01:08:50,582
or attorney and would like to be part of the discussion or an inventor with
1088
01:08:50,596 --> 01:08:55,262
a topic you'd like to hear discussed, email us at podcast@aurorapatins.com.
1089
01:08:55,396 --> 01:08:59,090
Do remember that this podcast does not constitute legal advice. And until next time,
1090
01:08:59,140 --> 01:09:00,440
keep calm and patent on.
00:00:05,350 --> 00:00:08,922
Good day and welcome to the Patently Strategic Podcast, where we discuss all things at
2
00:00:08,936 --> 00:00:12,634
the intersection of business, technology and patents. This podcast
3
00:00:12,682 --> 00:00:16,158
is a monthly discussion amongst experts in the field of patenting. It is
4
00:00:16,184 --> 00:00:20,614
for inventors, founders, founders and IP professionals alike, established or aspiring.
5
00:00:20,722 --> 00:00:24,178
And in today's episode, we're providing a multivitamin to help with fortifying
6
00:00:24,214 --> 00:00:28,110
your life science patents against the plagues of section 101 and 112.
7
00:00:28,220 --> 00:00:32,134
Life sciences are currently faced by at least two major plagues in our patent
8
00:00:32,182 --> 00:00:35,914
world. The first is that many life science innovations have been deemed
9
00:00:35,962 --> 00:00:39,510
ineligible in terms of patentable subject matter. In other words,
10
00:00:39,620 --> 00:00:43,062
the courts and the Patent office believe that the patent laws are not meant to
11
00:00:43,076 --> 00:00:46,590
protect these innovations. The second plague is that the courts believe
12
00:00:46,640 --> 00:00:50,358
that many life science patents are not enabled. In other words, they're not
13
00:00:50,384 --> 00:00:53,790
described in sufficient detail to enable one of skill in the art to make
14
00:00:53,840 --> 00:00:57,238
and use the invention the subject matter eligibility and enablement
15
00:00:57,274 --> 00:01:01,162
plagues manifest in dreaded section 101 and 112 rejections.
16
00:01:01,306 --> 00:01:04,902
The practical implications are staggering when it comes to
17
00:01:04,916 --> 00:01:08,718
eligible subject matter. In the last five years, over 80%
18
00:01:08,804 --> 00:01:12,078
of abandoned life science applications had a final rejection from
19
00:01:12,104 --> 00:01:15,274
the USPTO. Stating that the innovation did not include
20
00:01:15,322 --> 00:01:18,490
patentable subject matter based on subject matter eligibility
21
00:01:18,550 --> 00:01:22,170
criteria. And as we'll explore, 101 and 112
22
00:01:22,220 --> 00:01:25,974
rejections can surface in a myriad of ways, but no idea is too big
23
00:01:26,012 --> 00:01:29,338
to fail. Case law is now littered with patents whose innovators
24
00:01:29,374 --> 00:01:33,474
ideas proved to be revolutionary, but whose patent claims ended up invalidated because
25
00:01:33,512 --> 00:01:36,766
they failed to demonstrate in their applications how their observations
26
00:01:36,838 --> 00:01:40,654
could be practically applied, or failed to prove that they deserve the breadth of coverage
27
00:01:40,702 --> 00:01:44,602
they sought. In this month's episode, Dr. Ashley Sloat, President and Director
28
00:01:44,626 --> 00:01:47,982
of Patent Strategy here at Aurora, leads a discussion along with our
29
00:01:47,996 --> 00:01:51,402
all star patent panel, delving deeply into these rejections. And in
30
00:01:51,416 --> 00:01:55,510
the interest of avoiding a podcast, 101 rejection provided some very practical
31
00:01:55,570 --> 00:01:59,518
application tips that will help to fortify your life science patent applications.
32
00:01:59,614 --> 00:02:02,698
Ashley is joined today by our always exceptional group of IP experts,
33
00:02:02,734 --> 00:02:06,442
including Kristen Hansen, patent strategist at Aurora
34
00:02:06,586 --> 00:02:10,218
daniel Wright, patent strategist david Jackrow, president of
35
00:02:10,244 --> 00:02:14,782
Jacob Consulting shelley Kerrier, patent strategist and search specialist
36
00:02:14,926 --> 00:02:18,318
david Cohen, principal at Cohen Sciences amy Fine,
37
00:02:18,404 --> 00:02:21,958
patent attorney at Vancouver and adjunct professor at BYU and Steve
38
00:02:21,994 --> 00:02:25,422
STUP, partner at STUP Associates, LLC. Now, before taking you
39
00:02:25,436 --> 00:02:28,878
into the group conversation, as we often do, I sat down with Ashley to
40
00:02:28,904 --> 00:02:32,626
discuss a few concepts that could use some extra color and context for those newer
41
00:02:32,638 --> 00:02:35,710
to patenting. All right, thanks for joining me, Ashley.
42
00:02:35,770 --> 00:02:39,222
Based on feedback we've received, I know these primers that we front load with have
43
00:02:39,236 --> 00:02:42,702
been incredibly helpful on ramps to the deeper conversations that follow,
44
00:02:42,836 --> 00:02:46,162
and I know this one will be no exception. A couple of episodes
45
00:02:46,186 --> 00:02:50,298
ago, in discussing ownership, we explored sections 102 and 103,
46
00:02:50,444 --> 00:02:53,650
which deal with rejections around novelty and obviousness.
47
00:02:53,830 --> 00:02:57,846
In this month's episode, Rejection focus, if you will, is around
48
00:02:57,908 --> 00:03:01,618
sections 101 and 112. Could you talk briefly
49
00:03:01,654 --> 00:03:05,060
about each for those who haven't yet been on the receiving end?
50
00:03:05,570 --> 00:03:09,126
Absolutely. So section 101 deals with what
51
00:03:09,188 --> 00:03:12,666
subject matter is eligible for patenting and generally speaking,
52
00:03:12,728 --> 00:03:15,510
this should be essentially everything under the sun.
53
00:03:15,680 --> 00:03:19,266
However, it implicitly has been read into
54
00:03:19,328 --> 00:03:22,938
this section 101 by the courts that things that are
55
00:03:22,964 --> 00:03:27,020
natural phenomenon, abstract ideas or
56
00:03:27,590 --> 00:03:30,680
natural laws do not fall,
57
00:03:31,010 --> 00:03:34,998
are not protectable under the patent laws. And so, unfortunately for
58
00:03:35,024 --> 00:03:39,058
life sciences, they have basically had that many life science innovations
59
00:03:39,154 --> 00:03:42,474
are natural phenomenon and so they are not eligible for
60
00:03:42,512 --> 00:03:46,062
patenting. And so what we talk about in
61
00:03:46,076 --> 00:03:49,918
today's podcast is how do you better shore
62
00:03:49,954 --> 00:03:53,982
up your patent application to be eligible under section 101 and
63
00:03:53,996 --> 00:03:57,678
what can you do? So it can be as simple as I think
64
00:03:57,704 --> 00:04:01,582
one of the homework cases for section 101 was around fetal
65
00:04:01,606 --> 00:04:05,334
DNA, detecting fetal DNA in the mother's blood. And of course
66
00:04:05,492 --> 00:04:09,418
this is amazing technology because it really reduced
67
00:04:09,454 --> 00:04:12,922
the risk of the fetus and the mother over current methods
68
00:04:12,946 --> 00:04:15,260
like amniocentesis and things like that.
69
00:04:15,650 --> 00:04:18,210
But because of how the claim was drafted,
70
00:04:19,010 --> 00:04:22,518
it very much centered on the natural phenomenon and
71
00:04:22,544 --> 00:04:26,050
didn't more directly tie in practical applications
72
00:04:26,110 --> 00:04:29,814
or things like that. And so a lot of the patents around
73
00:04:29,852 --> 00:04:33,018
this technology were invalidated because they were deemed to not be
74
00:04:33,044 --> 00:04:36,694
eligible subject matter. But in case that section
75
00:04:36,742 --> 00:04:40,486
101 and probably I think other podcasts that we've
76
00:04:40,498 --> 00:04:43,858
done also talk about software being a difficult one under this section
77
00:04:43,894 --> 00:04:47,038
as well. But as you know, today we're focusing on life science.
78
00:04:47,194 --> 00:04:51,598
The other one is section 112, which has three components written
79
00:04:51,634 --> 00:04:55,438
description, enablement and best mode. So the written description
80
00:04:55,474 --> 00:04:58,894
requirement means that the specification must describe
81
00:04:59,002 --> 00:05:02,598
the claimed invention in a manner that is understandable to a person
82
00:05:02,684 --> 00:05:06,654
of ordinary skill in the art. So it shows that the inventor actually
83
00:05:06,752 --> 00:05:09,994
had possession of the invention at the time of filing.
84
00:05:10,162 --> 00:05:13,438
The enablement requirement, which is different than a written description
85
00:05:13,474 --> 00:05:17,240
requirement, is that the specification must teach those
86
00:05:17,630 --> 00:05:20,982
in skills in the art how to make and use the full scope of the
87
00:05:20,996 --> 00:05:24,310
claimed invention. And this is the key part without undo
88
00:05:24,370 --> 00:05:27,894
experimentation. And as you'll hear in today's discussion that
89
00:05:27,932 --> 00:05:31,278
undo experimentation is a lot of
90
00:05:31,304 --> 00:05:34,734
discussion in the courts around that. And what really does qualify as
91
00:05:34,772 --> 00:05:39,022
undo experimentation is
92
00:05:39,036 --> 00:05:42,562
it still undo if you teach want to
93
00:05:42,576 --> 00:05:46,742
skill in the art exactly how to arrive at various chemicals
94
00:05:46,766 --> 00:05:50,146
that may be covered under your patent, or do you have
95
00:05:50,148 --> 00:05:53,674
to actually teach every single chemical or can you just teach them a process to
96
00:05:53,712 --> 00:05:56,882
get to those chemicals and what constitutes unto experimentation?
97
00:05:57,026 --> 00:06:00,554
And then best mode is exactly what it sounds like. You have to describe
98
00:06:00,602 --> 00:06:04,718
the best mode. You can't keep the best mode for yourself and only describe
99
00:06:04,814 --> 00:06:08,554
those that were not the best. Now, you don't have to label it as
100
00:06:08,592 --> 00:06:11,302
the best mode, but you do need to describe it. All right? So I think
101
00:06:11,316 --> 00:06:14,338
that's actually a pretty good segue to the next question. You and the group talk
102
00:06:14,364 --> 00:06:18,370
about genus and species several times during the conversation.
103
00:06:18,810 --> 00:06:22,574
Now this talk is about life science patents, but these references aren't
104
00:06:22,622 --> 00:06:25,946
strictly biological. Could you explain what genus and species
105
00:06:26,018 --> 00:06:29,158
can mean in the world of patenting and claims in particular? Yeah,
106
00:06:29,184 --> 00:06:33,202
absolutely. It is a little bit of a misnomer, just as it
107
00:06:33,216 --> 00:06:35,830
is in classical Phylogeny.
108
00:06:36,690 --> 00:06:39,026
Genus comes before species,
109
00:06:39,098 --> 00:06:42,830
right? And genus is a broader classification
110
00:06:43,010 --> 00:06:46,322
than species. And so if you think about it in that lens,
111
00:06:46,466 --> 00:06:49,762
a genus claim is a claim that
112
00:06:49,896 --> 00:06:54,010
covers a broader range of more narrow species,
113
00:06:54,510 --> 00:06:58,020
right? So you could have a broad chemical class,
114
00:06:58,350 --> 00:07:01,954
a broad genus class of chemicals, and then more
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narrow species that fall under that genus.
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So think about it from an umbrella perspective. A lot
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of inventors, especially in the life science, invent one vertical,
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right? They invent a new chemical, they invent a new drug treatment
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or something like that. But there may be other drugs that look like
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that drug or other chemicals that look like that chemical or behave like
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that chemical that they believe that they also deserve protection
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for, right? That they deserve a broader umbrella that covers
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all those chemicals and all those drugs that look similar. And so in that
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case, you would say that the broad claim is the genus claim
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and the more narrow claims around each chemical or
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each drug is a species claim. And so what we'll talk about
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today in the podcast is essentially the death of
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the genus claim, meaning that the courts are increasingly saying
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that you need to show some kind of
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proof of possession or reduction to practice
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some data or something for each of these specific species
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that would fall under your genus claim. And if
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you can't do that, then you don't deserve the broad genus claim. And so
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this is kind of one of those unfortunate things that's happening as well, that you
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could fully lead the horse to water, walk them through
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the exact process that they would need to do to create new
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chemicals, create new drugs that look like that, behave like that. But because
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they're in an unpredictable science, because being
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predictable can be difficult, the courts have basically said that that's not enough,
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that's still under experimentation and you actually need to reduce the practice at least
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one example of each of those species. And so it's becoming much harder for
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life science inventors to get broad claims, broad genus
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claims. Thanks. All right, two other legal
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terms pop up in this episode. They're more in the sides and not quite
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as essential to understanding the thrust of the conversation,
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but they're still very important in patent law. So definitely worth taking a second
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to define the first is just what is a wands factor?
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So when looking at section 112, which remember is your rent description,
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enablement and best mode requirement or part of the statute,
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the wands factors were developed by the courts and it is a test for
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enablement. Does the specification in the figures
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teach one of skill in the art to make and use the invention? And so
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they walk through several factors to determine
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if the pet application is truly
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enabled or the claims are truly enabled. And what is an
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estoppel in pet and law? This is a general legal principle,
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but it basically precludes or prevents a person from
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asserting something today that is contrary
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to something that they did or said previously.
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And so, for example, in patent lawn during
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prosecution, which is the bartering that happens between you and the Patent Office to get
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your issue patent, if you say that
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my claims definitely don't include X,
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and then later in a litigation proceeding or some kind of post grant proceeding,
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you say, Oh, my claims totally do cover X,
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that you are stopped from saying that it definitely includes X,
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because you just said it didn't include X. So it basically prevents you from
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talking out of both sides of your mouth. Makes sense. Thanks, Ashley.
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Just one more thing before joining the panel, we have some exciting news to share.
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Back in March, in our Adventure Stories Volume One episode,
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we introduced you to three impressive innovators who are all past recipients
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of our annual Rise Award. This award provides a free provisional US.
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Patent application or $5,000 towards a nonprovisional
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US. Patent application to a selected applicant. This is in recognition of their innovative
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startup excellence. We received an overwhelming response to applications
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for this year's award, and the selection process was incredibly difficult.
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But I'm happy to announce that our selection committee has chosen hearsight,
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LLC is the winner of the 2022 Rise Award.
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Hearsight is tackling the important mission of reimagining assistive hearing
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technology. When we look for ideal Rise recipients, we look closely at
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potential for societal good matched with a team that can execute.
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And Hearsight is just this kind of impactful innovation backed
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by the kind of DNA it takes to see through to market success.
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Assistive technology is a corner of the market that unfortunately still has way
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too much white space, and we're happy to help fill it in any way we
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can. Due to the high volume of quality submissions and our desire
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to help as many as possible, we decided to once again expand the offering beyond
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the single first place award. The first runner up this year is thermo
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Verse. They're focusing their efforts on much needed solutions
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that will greatly improve the heating and cooling economics for low to
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moderate income housing properties. Their innovations are both timely
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and necessary, given skyrocketing energy costs,
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storing home prices, and housing shortages across the country. Disruption in
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this space is essential to maintain viability to as many
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LMI properties as possible. And the second runner up is Spirit Fire.
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Aftermarket with their vehicle lighting solution. We love gritty entrepreneurs
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who roll up their sleeves and find ways to innovate. Spirit Fire
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story is a great example of finding a real market need self bootstrapping
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and doing a practical thing very well. We'd love to say more,
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but we can't since public disclosure on an IP podcast is
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beyond forgivable. But do stay tuned. We'll hopefully be introducing
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you to these innovators in a future Adventure Stories episode.
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All right, without further ado take it away, Ashley. All right.
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So kind of what we wanted. And Dan's going to jump in here too,
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towards the end with some different thoughts as well. What we wanted to do
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is kind of jump through and walk through some of the issues
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plaguing life, science, patents. And so I kind of named these the first
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and the second plague. So the first plague is section 101
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issues, which is patentable subject matter, as you all know.
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And then the section 112 is adequate written description.
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And so the section 101 thing
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has been around for a long time. I don't think it's necessarily new to anybody,
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but what I kind of wanted to do is sift through some of the case
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law and kind of pull out some of the nuggets. But from a
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background perspective, the main Art unit that deals with a lot of these diagnostic
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methods of treatment, you can see that the name of the Art unit is
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molecular biology, bioinformatics nucleic acids. We're coming at DNA
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and RNA gene regulation is Art Unit 1631.
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And over the last five years, they've had about a 60% allowance
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rate, which isn't awful, but maybe it could be a little
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higher. Ten to 20 points. They've had 718 allowed
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patent applications, 485 abandoned applications.
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And of those that were abandoned,
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80% of them had a 101 rejection at the final Office section.
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Wow. Yeah, not a great outlook from that perspective.
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And so when you look at it, I found this graph through a great
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website. I'll have to put that in the notes.
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But if you look at this is the Art
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unit for the last five years, that same 1631 Art unit. And you
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can see that there was about
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50% 101 rejections,
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obviously wasn't that bad. They had the
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references around Alice or Mayo or Myriad, which are all
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those key cases. You can see that those were relatively frequently referenced
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in the Office actions and then a little bit of double patenting.
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But the biggest issue was the section 101 issues. And then
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actually 112 is right up there as well, probably around, I don't know,
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40%, 35%. So that's really
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kind of thing plaguing the industry. And I think the
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biggest issue is how do you delineate when something
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is just a natural phenomena versus when you're actually applying
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it in a reasonable way? And then the other part of that is,
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is your written description enough? And I definitely touch way more on the 101
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issue and then just briefly on the 112 issues. But there's a really
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great paper out by Mark Lemley and a few others just in
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2021, and I haven't read the whole thing yet because it's almost
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80 pages, but it's called The Death of the Genus Claim.
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And it's a really good read from what I've read so far, just around
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the shift over the last 40 years or
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50 years from companies
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being able to claim these broader genus claims when they've discovered
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a class of compounds that have certain biological properties to now
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the courts kind of restricting them down to potentially just one species.
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And I'll kind of explain why they think that shift is happening because I think
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it's kind of interesting and I kind of saw it happening a little
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bit, but I probably couldn't have articulated it and the reasoning
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behind it like they did. So it's
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really interesting. So anyways, we'll get touch on that briefly. You know what's interesting,
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when you start to see 112 and one on one uptick, they often
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coincide with examiner training. And so
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three years or so after 112 training, here we are and everything has
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a 112, right?
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Not to be cynical, right? For sure. And the other
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interesting thing is the courts. I feel like the courts are,
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I don't know, I feel like the courts could use some one false training.
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The courts could use some patent training too, because I feel like they read
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a lot of things into the statutes that aren't there,
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which is then impacting a
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lot of precedent and how things are drafted and maybe not necessarily supported
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by the original laws. And so I think that's kind of the other interesting
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thing that's happening. Everybody can use
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all of it more patents, right? So nobody
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is probably unfamiliar with this, but just really briefly,
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the subject Matter eligibility guidance, they basically ask
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whether your claims are directed to a statutory category,
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which is process, machine, manufacturer, or composition of matter.
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And if it's not in that category, it's not eligible.
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If they think it is in one of those categories, they ask if
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it's directed to a judicial exception. And as we all
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know, it's laws of nature, natural phenomena and abstract ideas.
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If it's not directed to a judicial exception,
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and it's eligible. If it is, they ask whether it's integrated into
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a practical application. If it is, it is eligible.
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If it is not, they ask whether it has significantly more
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than the judicial exception. And if the answer is no, it's not eligible.
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And if the answer is yes, then it's not eligible. So that's generally
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kind of what examiners walk through. Of course, in the life science,
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they're going to rely on more of the life science, case law,
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myriad and things like that,
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whereas in the software they're going to rely more on Alice and other related cases.
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So then briefly, the second plague, I'll touch more on this one
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here briefly and then we'll jump back into 101 is and
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I do think a lot of this is the death of the genus thinking.
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I'm really summed up with that statement from Lenley and others.
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But where the shift has been happening is
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that previously what
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you have to distinguish is whether you're dealing with known unknowns.
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Because I believe if you're dealing with known unknowns then
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that's not undue experimentation, right? If a researcher knows how to navigate
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all the known unknowns
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and they should be able to do that to process the invention,
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but what you don't want is a whole bunch of unknown unknowns
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because then that is probably undue experimentation.
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And so there has been argument around is whether
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a person of skilled in the art needs to find a species
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that works in order to practice the claim. Or whether they
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need to find every species that works to
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make and use the invention. And I think what a lot of experts
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would argue right now is that the way the courts are interpreting section 112
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is that a person of skill needs to find every species
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that works. And so even when the spec is
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super clear around what needs to be done to find a species,
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they say that, well, it still would be undo because there's too many species
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to find. And so it's a really weird shift that's happening
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that you're
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basically shifting from the question of whether making
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and using the invention requires undue experimentation to whether
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such experimentation is required to define the full scope of
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the invention by figuring out all the possible species.
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And so I think that's where a lot of this 112 issues coming from.
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Just briefly, there's a few cases up on the slide, but the
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things that obviously if the field is supernat and
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unpredictable and rife with failure, then of course you probably need to have a really
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significant description to support those claims. I don't necessarily disagree with
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that. Right? And so that was the ends of biochem versus Calgene case
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and that was antisemitic DNA technology at that time. It was super
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new and so they probably didn't need to describe more adequately
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in their description various ways to practice
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their technology. This was surprising. Even iterative
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trial and error led by the spec can still create an enablement
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issue because this was one of those where it was for rampamycin chemicals for
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the treatment of restinosis and if
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you multiplied all the different R groups that one could have
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on rampamycin, there was a huge amount of potential chemicals that
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could have been created. But one of skill in the art could
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have very easily found one chemical that worked that was
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within the scope of the claim. But where the court kind of, I think aired
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is again, they thought that somebody would have to find all of them
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to make the claims. Work. And I think that's
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kind of crazy because somebody just needs to build a fine one to practice it
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right, because that shows that they can use the spec to their benefit.
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And then there's another case. This is Identics Pharma
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versus Gilead and describe the screening process allowed
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for straightforward identification of working in bodies embodiments.
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But still the court said that it required undue experimentation because again,
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this two methyl nucleotide for the treatment of
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hepatitis C virus. They basically, again said there's so many
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two methyl nucleicides out there, how is any person supposed
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to understand the full scope of the claim?
350
00:21:23,170 --> 00:21:26,526
And instead of just saying, are they able to practice it? And it's
351
00:21:26,538 --> 00:21:30,870
like, well, for sure, because the screening process was very clearly delineated
352
00:21:30,930 --> 00:21:34,634
and was very much within the skill of they actually even had experts basically saying
353
00:21:34,792 --> 00:21:37,922
it was within the skill of one in the art. So it's honestly kind of
354
00:21:37,936 --> 00:21:41,594
ridiculous. But this is where I think Lemley and others
355
00:21:41,632 --> 00:21:45,398
are kind of saying this is the death of the genus claim because the
356
00:21:45,424 --> 00:21:48,638
courts want somebody to be able to find all of
357
00:21:48,664 --> 00:21:52,286
the possible working examples or all the possible
358
00:21:52,468 --> 00:21:55,890
chemicals that fall into a genius rather than just be able to practice
359
00:21:55,950 --> 00:21:58,778
one. And I think that's an error. Yeah,
360
00:21:58,804 --> 00:22:02,666
actually I had a question about so given
361
00:22:02,788 --> 00:22:07,070
all this case that you've got into something
362
00:22:07,120 --> 00:22:10,598
that I had always heard about the genus and having good support
363
00:22:10,684 --> 00:22:14,174
for it would be like having enough
364
00:22:14,272 --> 00:22:18,014
examples in the specification that you have like a cross section of
365
00:22:18,052 --> 00:22:21,662
the species. So maybe you'd say if you have
366
00:22:21,676 --> 00:22:25,538
a molecule in your genus with like four positions for a side group and then
367
00:22:25,624 --> 00:22:30,350
four options for that side group, you don't need to show
368
00:22:30,400 --> 00:22:34,278
data for all 16 combinations.
369
00:22:34,374 --> 00:22:38,222
But if you did sort of one or two side groups of
370
00:22:38,356 --> 00:22:42,042
cutting across all the categories in some of those positions,
371
00:22:42,066 --> 00:22:45,794
cutting across all of them, would that based
372
00:22:45,832 --> 00:22:49,010
on your reading and what you were just describing, do you think that would still
373
00:22:49,060 --> 00:22:52,720
be enough? Or are they really saying, no, you need to
374
00:22:53,770 --> 00:22:57,950
have experimental data on all of the combinations?
375
00:22:58,450 --> 00:23:01,262
Yeah, I think that's a good rule of thumb that a lot of people and
376
00:23:01,276 --> 00:23:03,698
I think Dan could speak to this even more so probably than I could.
377
00:23:03,724 --> 00:23:07,058
But I think that's a lot of what everybody's been doing now is saying
378
00:23:07,084 --> 00:23:10,766
we got to make sure you support. But I think where
379
00:23:10,948 --> 00:23:14,870
people are struggling, though, is that you don't necessarily have working
380
00:23:14,980 --> 00:23:19,734
examples for all of those chemicals. And so potentially,
381
00:23:19,782 --> 00:23:23,140
if they can show at some later date that
382
00:23:23,950 --> 00:23:29,126
different methods that you described don't support that
383
00:23:29,188 --> 00:23:33,042
class, that could call into question whether you deserve
384
00:23:33,066 --> 00:23:36,458
the full genus right versus just
385
00:23:36,484 --> 00:23:38,942
the subject. But Dan, do you have additional stuff? Yeah,
386
00:23:39,136 --> 00:23:42,834
David, your tactics
387
00:23:42,882 --> 00:23:45,962
there is generally what I've heard and more or less kind
388
00:23:45,976 --> 00:23:49,910
of has done it as well, that if you've got all these variants,
389
00:23:51,850 --> 00:23:55,998
it's very easy to just name them all. Chemical software
390
00:23:56,034 --> 00:23:59,790
can just spit out all the chemical names. That makes the list incredibly
391
00:23:59,850 --> 00:24:03,614
long. But what's more valuable is to show the
392
00:24:03,652 --> 00:24:07,046
cross section so that you indeed have each type of group
393
00:24:07,108 --> 00:24:10,446
in each type of place, as opposed to enumerating each variant
394
00:24:10,518 --> 00:24:14,718
of each type of group. But critically, what I have seen examiners
395
00:24:14,814 --> 00:24:18,002
do, especially in foreign jurisdictions, the US.
396
00:24:18,076 --> 00:24:22,250
Is still a little bit more flexible than I found in particular East Asia
397
00:24:23,290 --> 00:24:27,306
and increasingly perhaps Europe, that in addition
398
00:24:27,378 --> 00:24:30,938
to just depicting a cross section of the
399
00:24:30,964 --> 00:24:34,494
compounds, your data also needs to reflect
400
00:24:34,542 --> 00:24:38,066
that cross section. So even if you've only
401
00:24:38,128 --> 00:24:42,642
got, even if you showed methyl
402
00:24:42,726 --> 00:24:46,900
and halogens in these positions, if you've only got data
403
00:24:47,530 --> 00:24:50,510
for halogens, for a halogen,
404
00:24:50,950 --> 00:24:54,110
some more strict jurisdictions
405
00:24:56,570 --> 00:25:00,006
may not go for the methods if you've only got data for halogen. Okay,
406
00:25:00,068 --> 00:25:03,438
so increasingly, yes, I feel
407
00:25:03,464 --> 00:25:07,206
like the cross section strategy is still
408
00:25:07,328 --> 00:25:10,854
kind of what people go for, but the
409
00:25:10,892 --> 00:25:14,218
data of what you show in that cross section is increasingly
410
00:25:14,254 --> 00:25:16,940
more valuable than just naming them.
411
00:25:17,570 --> 00:25:21,270
Yeah, in some of the case law too, David, is that
412
00:25:21,440 --> 00:25:25,086
even with different experts stating that
413
00:25:25,148 --> 00:25:29,070
the process was clearly laid out to be able to
414
00:25:29,240 --> 00:25:32,658
implement to identify all these different ones that they had put into
415
00:25:32,684 --> 00:25:36,174
the claims, it wasn't enough because
416
00:25:36,212 --> 00:25:39,462
it still would have been like in order to quote, unquote, find all of
417
00:25:39,476 --> 00:25:42,834
the species, it would have taken a lot of experimentation to do
418
00:25:42,872 --> 00:25:46,338
so rather than just saying could somebody find one or
419
00:25:46,364 --> 00:25:49,854
make one, well, sure, they could just make one and probably it would work,
420
00:25:49,892 --> 00:25:53,250
or they could make four or five and one of them would probably work,
421
00:25:53,360 --> 00:25:57,130
but that's no longer enough. So that's I think encouraging
422
00:25:57,190 --> 00:26:00,522
there to be some working examples of a
423
00:26:00,536 --> 00:26:04,110
few or one at least in each cross section or something, might be
424
00:26:04,220 --> 00:26:08,854
advantageous to kind of find what process differences
425
00:26:08,902 --> 00:26:10,520
may be occur for each one.
426
00:26:12,530 --> 00:26:15,860
Yeah, okay, thanks. Yeah. Interesting.
427
00:26:16,430 --> 00:26:19,758
So then here's some the wands factors that a lot of times are kind of
428
00:26:19,784 --> 00:26:22,998
used for the section 112. And so I'm not going to go through these in
429
00:26:23,024 --> 00:26:26,278
detail, but many of you, maybe everybody is familiar
430
00:26:26,314 --> 00:26:29,350
with these, but obviously the quantity of experimentation
431
00:26:29,410 --> 00:26:32,746
necessary, this is kind of deciding what's undo
432
00:26:32,818 --> 00:26:36,514
versus not undo experimentation, amount of direction or guidance
433
00:26:36,562 --> 00:26:40,422
presented. Like how well does the spec teach present or absence of
434
00:26:40,436 --> 00:26:43,678
working examples? I've even heard more and more that prophetic
435
00:26:43,714 --> 00:26:47,314
examples are kind of not super helpful
436
00:26:47,362 --> 00:26:51,198
anymore. The nature of the event, what kind of art is it? State of the
437
00:26:51,224 --> 00:26:54,750
prior art? What was the level of skill at that time?
438
00:26:54,920 --> 00:26:58,158
How much would they have to experiment to understand the technology?
439
00:26:58,244 --> 00:27:01,842
Like I said, the anti sens DNA case,
440
00:27:01,976 --> 00:27:05,238
the antisens DNA technology was so new at that time
441
00:27:05,384 --> 00:27:08,838
and they just didn't teach enough or how decent that field was
442
00:27:08,864 --> 00:27:11,634
and how much failure there was in that field. I can kind of understand that
443
00:27:11,672 --> 00:27:15,174
case more in the sense that it's just so new. So you really
444
00:27:15,212 --> 00:27:18,982
needed to bolster more support for all the different other use cases
445
00:27:19,006 --> 00:27:22,606
or other DNA that you could make with that technology, the predictability
446
00:27:22,678 --> 00:27:26,060
or unpredictability of the arts and the breadth of the claims. And so kind of
447
00:27:26,690 --> 00:27:30,474
walking through this with clients, thinking about all these different factors and
448
00:27:30,632 --> 00:27:34,062
how you describe the technology, but kind
449
00:27:34,076 --> 00:27:37,662
of going back to 101. Now, obviously everybody's familiar with
450
00:27:37,676 --> 00:27:41,362
the Mayo Prometheus case. So they did describing the claims,
451
00:27:41,386 --> 00:27:45,022
the relationship between metabolite concentration and the likelihood
452
00:27:45,046 --> 00:27:49,018
of drug effectiveness, but did not necessarily determine
453
00:27:49,174 --> 00:27:52,398
or did not necessarily describe using the
454
00:27:52,424 --> 00:27:56,158
improved treatment and the claims. And I think, as you'll see from the few examples
455
00:27:56,194 --> 00:27:59,718
I have that follow, that really seems to be the critical step as
456
00:27:59,744 --> 00:28:04,350
some kind of almost like treatment step or some kind of really clear application of
457
00:28:04,520 --> 00:28:06,090
the natural phenomenon.
458
00:28:07,370 --> 00:28:11,530
So for method of treatment claims, a lot of these had an active treatment
459
00:28:11,590 --> 00:28:14,938
step. So the Vanda
460
00:28:14,974 --> 00:28:18,586
Pharmaceuticals versus Westward and End of Pharmaceuticals versus Teva,
461
00:28:18,718 --> 00:28:21,990
they both had more of an active treatment. And then
462
00:28:22,160 --> 00:28:25,594
the Safinani Diagnostics versus Mayo, they had detecting
463
00:28:25,642 --> 00:28:29,254
not natural auto antibodies, but again, they were just correlating
464
00:28:29,302 --> 00:28:32,394
with the disease state and there wasn't any step around. Okay,
465
00:28:32,432 --> 00:28:35,742
so now that we've correlated these things, now we're going to give more drugs to
466
00:28:35,756 --> 00:28:39,522
this individual, or less drug to this other individual, we're not
467
00:28:39,536 --> 00:28:42,390
going to give any treatment to this one, but more treatment to this one.
468
00:28:42,440 --> 00:28:45,514
So in Vonda Pharmaceuticals versus Westward,
469
00:28:45,562 --> 00:28:49,246
you can see that this one was found eligible,
470
00:28:49,438 --> 00:28:52,870
and you can see this as a treatment method for schizophrenia.
471
00:28:53,050 --> 00:28:57,054
And so they do talk about determining patients with a certain point
472
00:28:57,092 --> 00:29:01,342
mutation, but in response to them detecting that point mutation
473
00:29:01,426 --> 00:29:04,642
in the individual, they then treat the patient differently,
474
00:29:04,726 --> 00:29:08,146
better, whether or not that point mutation exists. So if they're
475
00:29:08,158 --> 00:29:12,382
a poor metabolizer, then they have one treatment paradigm.
476
00:29:12,526 --> 00:29:16,002
If they're a different kind of genotype, then they have a
477
00:29:16,016 --> 00:29:18,380
different treatment paradigm. And so,
478
00:29:18,890 --> 00:29:22,518
again, you can see that pretty clear language around
479
00:29:22,664 --> 00:29:26,002
actual application of what happens now that you've understood what this natural
480
00:29:26,026 --> 00:29:29,842
phenomenon means. And then similarly, in Endoparmaceuticals
481
00:29:29,866 --> 00:29:33,898
versus Tava, you can see that, again, this is another method
482
00:29:33,934 --> 00:29:37,460
of treatment claim. And you can see here that,
483
00:29:37,850 --> 00:29:41,530
again, they're providing a solid oral controlled release dosage
484
00:29:41,590 --> 00:29:44,850
form and then orally administering it,
485
00:29:45,020 --> 00:29:48,378
depending on how the Cratinine clearance rate was
486
00:29:48,404 --> 00:29:51,870
found. So depending on how that was determined to be in the patient.
487
00:29:52,730 --> 00:29:56,418
And so, again, they measured or
488
00:29:56,444 --> 00:30:00,078
determined this natural phenomenon, but they actually really, truly applied it
489
00:30:00,224 --> 00:30:04,038
from a treatment setting. And so you can see where this falls short.
490
00:30:04,124 --> 00:30:08,190
In this Athena versus Collaborative male,
491
00:30:09,590 --> 00:30:12,546
you can even see just the length of the claim is already kind of a
492
00:30:12,548 --> 00:30:15,958
little bit of an indicator. They're basically determining this muscle
493
00:30:15,994 --> 00:30:19,400
specific tyrosine kinase and they basically just detect it,
494
00:30:20,690 --> 00:30:24,750
different antibiotics to it in bodily fluid as
495
00:30:24,860 --> 00:30:29,494
a diagnosis for transmission of a developmental disorder.
496
00:30:29,662 --> 00:30:33,178
But they never say that we've detected this and then we're
497
00:30:33,214 --> 00:30:36,860
going to treat them with a certain drug or
498
00:30:37,910 --> 00:30:41,806
there was no just active step and I think that's
499
00:30:41,818 --> 00:30:45,258
where they fell short and so you'll kind of see that
500
00:30:45,344 --> 00:30:46,340
carry through.
501
00:30:48,570 --> 00:30:51,938
So method of treatment is one aspect of the natural product claims.
502
00:30:51,974 --> 00:30:55,066
Obviously more and more natural products are coming out and more companies want to protect
503
00:30:55,128 --> 00:30:58,466
their natural products. So I think that's also interesting. So there's
504
00:30:58,478 --> 00:31:01,982
a few cases into that end. One included
505
00:31:02,006 --> 00:31:05,002
this one. It's not exactly natural products I guess,
506
00:31:05,076 --> 00:31:08,614
but it's about detecting bacteria. I think the first
507
00:31:08,652 --> 00:31:14,594
case was the Roche versus stuffed and that was for detecting Mycoplasma.
508
00:31:14,762 --> 00:31:19,270
And here they talked about a specific set of DNA primers
509
00:31:19,830 --> 00:31:23,246
for detecting Mycobacterium tuberculosis.
510
00:31:23,438 --> 00:31:27,238
And again, what the courts had argued is that
511
00:31:27,384 --> 00:31:31,030
the development of primers was kind of routine and conventional
512
00:31:31,590 --> 00:31:35,542
and use the PCR was routine and conventional and
513
00:31:35,556 --> 00:31:39,254
so there was no true application of the natural phenomenon
514
00:31:39,362 --> 00:31:43,270
into a new space, no extension beyond that. So maybe
515
00:31:43,320 --> 00:31:46,594
if they had to do PCR in a different
516
00:31:46,632 --> 00:31:49,942
way because it is Mycobacterium, or whether they had to maybe design
517
00:31:50,016 --> 00:31:53,810
more unique, maybe a different kind of PCR,
518
00:31:53,870 --> 00:31:57,338
different kind of primer set to accommodate
519
00:31:57,374 --> 00:32:00,478
for the fact that it's Mycobacterium, or whether they
520
00:32:00,504 --> 00:32:05,050
had to isolate it in a weird way because there was that other cells
521
00:32:05,670 --> 00:32:09,322
direct case, I can't remember if that's the correct one or not, but where
522
00:32:09,396 --> 00:32:13,570
they had this different free spot cycle of the cells and then determined viability,
523
00:32:14,130 --> 00:32:17,674
but the whole point around the free spot was to have better viability for
524
00:32:17,712 --> 00:32:20,990
later assays. So if even there was something like that in the claim,
525
00:32:21,110 --> 00:32:24,122
I think I probably could have pushed them over the edge towards eligibility.
526
00:32:24,206 --> 00:32:28,402
But just the pure primers and
527
00:32:28,416 --> 00:32:31,906
then routine PCR isn't enough for this case. And there
528
00:32:31,908 --> 00:32:35,362
was another canine case, there was a case around
529
00:32:35,436 --> 00:32:38,942
golden retrievers and identifying genetically
530
00:32:39,086 --> 00:32:42,626
golden retrievers based on a snip that they carry for genotyping
531
00:32:42,638 --> 00:32:46,150
golden retrievers. And that one was also found in eligible because it's highly similar
532
00:32:46,200 --> 00:32:50,102
to this one. There's also natural alternatives
533
00:32:50,126 --> 00:32:53,638
versus creative compound. This was found eligible and
534
00:32:53,664 --> 00:32:57,118
again it's had an active treatment step because what the
535
00:32:57,144 --> 00:33:01,058
court had said is that when you give this beta alanine
536
00:33:01,094 --> 00:33:04,930
to a human, it actually alters their natural state.
537
00:33:05,100 --> 00:33:08,890
And so this results in your better performance for
538
00:33:08,940 --> 00:33:09,850
athletes.
539
00:33:12,250 --> 00:33:15,662
Again, it changes an extension beyond the
540
00:33:15,676 --> 00:33:20,178
natural phenomenon, it adjusts their person's
541
00:33:20,214 --> 00:33:23,882
natural state, it's no longer their natural chemistry and
542
00:33:23,896 --> 00:33:27,254
it has specific dosing requirements. Obviously it
543
00:33:27,292 --> 00:33:30,530
puts them well above the typical beta alanine dosage
544
00:33:31,210 --> 00:33:34,910
in a person. So that's why this one was found eligible over
545
00:33:34,960 --> 00:33:38,414
some of the other cases. Ashley, I don't know if you were going to touch
546
00:33:38,452 --> 00:33:42,174
on this, but these treatment steps
547
00:33:42,222 --> 00:33:46,086
seem to have a pretty big implication on who infringes
548
00:33:46,278 --> 00:33:49,720
on the claim. Right? Yeah.
549
00:33:50,050 --> 00:33:53,198
Basically we're going to be way more induced infringement, right,
550
00:33:53,224 --> 00:33:56,690
because it's going to be some products supplier, right,
551
00:33:56,740 --> 00:34:00,206
some drug supplier, some natural product supplier who
552
00:34:00,268 --> 00:34:03,954
then presumably has to put in their label
553
00:34:04,062 --> 00:34:07,634
in their docs that
554
00:34:07,732 --> 00:34:11,478
this is how it's supposed to be taken and this is the effective
555
00:34:11,514 --> 00:34:14,894
dose and things like that, or some of these more
556
00:34:14,932 --> 00:34:18,614
even diagnostic claims. It's going to be some kind of hospital right,
557
00:34:18,652 --> 00:34:23,210
that is running these tests because nobody is at home seeing
558
00:34:23,380 --> 00:34:26,666
what the levels of some snip are to determine if they have
559
00:34:26,728 --> 00:34:30,460
schizophrenia, you know what I mean? And so it is definitely
560
00:34:31,210 --> 00:34:35,118
I think that's an interesting weighing
561
00:34:35,154 --> 00:34:38,800
that from a company perspective, weighing the value
562
00:34:39,490 --> 00:34:42,618
in a claim that I think medical treatment
563
00:34:42,654 --> 00:34:46,286
still has a lot of value, but I think it has more value
564
00:34:46,348 --> 00:34:49,934
in a portfolio that has claims directed to
565
00:34:49,972 --> 00:34:53,918
the actual composition or directed to the actual kit or the
566
00:34:53,944 --> 00:34:57,434
system that's being sold that is then
567
00:34:57,472 --> 00:35:00,782
used by some kind of health care provider to execute on the method of
568
00:35:00,796 --> 00:35:04,370
treatment. Right, yeah. Actually, just a follow
569
00:35:04,420 --> 00:35:08,258
up on that, do you have any more detail as to what the
570
00:35:08,284 --> 00:35:10,540
extent of a method of treatment is needed?
571
00:35:13,910 --> 00:35:17,262
I forget the exact citation, but there was a
572
00:35:17,276 --> 00:35:21,018
case 2013 time frame where they were
573
00:35:21,044 --> 00:35:25,126
just doing a threshold comparison based on a metabolite
574
00:35:25,318 --> 00:35:29,302
that was during body's processing
575
00:35:29,326 --> 00:35:33,942
of a particular drug and they were using that to adjust treatment and
576
00:35:33,956 --> 00:35:37,662
that was not found to be patentable. That was deemed to be sort
577
00:35:37,676 --> 00:35:41,478
of trivial. The question is, is there a
578
00:35:41,564 --> 00:35:44,938
threshold or guidance as to what level of guidance
579
00:35:44,974 --> 00:35:48,390
for treatment is needed as a claim element to provide patentability?
580
00:35:50,330 --> 00:35:53,550
Yeah, so from these cases that I've
581
00:35:53,870 --> 00:35:54,620
seen,
582
00:36:00,030 --> 00:36:03,898
I remember hearing what you're talking about is a threshold above and
583
00:36:03,924 --> 00:36:06,850
below. Do you remember what the actual treatment step was? Steve,
584
00:36:07,710 --> 00:36:11,098
you know, they gave him a drug and it was metabolized, I think, in the
585
00:36:11,124 --> 00:36:15,098
liver and it was a cancer
586
00:36:15,134 --> 00:36:19,030
treatment and they were basically trying
587
00:36:19,080 --> 00:36:22,294
to dial in how much to give the patient and it was just based
588
00:36:22,332 --> 00:36:26,470
on a threshold and it was deemed ineligible
589
00:36:27,630 --> 00:36:31,714
because I think in that case it was more still
590
00:36:31,752 --> 00:36:35,090
the natural phenomenon. They weren't altering the natural
591
00:36:35,150 --> 00:36:39,430
chemistry of the person or anything like that. It was purely
592
00:36:40,410 --> 00:36:43,750
saying, you know, they're above or below and then we're going to
593
00:36:43,920 --> 00:36:47,506
treat you accordingly. But it wasn't because
594
00:36:47,568 --> 00:36:51,362
they were not altering anything around the natural phenomenon. The natural
595
00:36:51,386 --> 00:36:54,622
phenomena was just a means to an end, it's my understanding. Because if you look
596
00:36:54,636 --> 00:36:58,822
at some of these other cases you have in
597
00:36:59,016 --> 00:37:02,858
the Vonda one, they're actually administering
598
00:37:03,014 --> 00:37:06,478
actual drugs for the patient that allows them
599
00:37:06,504 --> 00:37:09,634
to either better metabolize or less prevent this
600
00:37:09,732 --> 00:37:12,922
QTc prolongation of a patient. And so it
601
00:37:12,936 --> 00:37:16,450
actually affects the patient's biology. And then same
602
00:37:16,500 --> 00:37:20,220
with Endo. They are here
603
00:37:20,670 --> 00:37:23,590
determining cratening clearance rate,
604
00:37:23,760 --> 00:37:27,142
but again, then the drug amount changes. I guess that one
605
00:37:27,156 --> 00:37:30,962
would be a little bit more similar potentially. I'd have to read the claim
606
00:37:31,046 --> 00:37:34,262
that 2013 claim set, but that one could be kind of similar to Endo.
607
00:37:34,286 --> 00:37:37,982
So maybe would want to compare that one to this endo
608
00:37:38,006 --> 00:37:41,422
versus Taylor case in 2019 to see because I
609
00:37:41,436 --> 00:37:44,040
think this one's probably the most similar I've seen.
610
00:37:44,670 --> 00:37:49,722
I've seen changing
611
00:37:49,806 --> 00:37:53,730
something other than what occurs naturally in normal biology
612
00:37:53,910 --> 00:37:56,620
is one sort of safe harbor, right,
613
00:37:56,950 --> 00:38:00,498
for genetic material. Like there's that one case where you're creating
614
00:38:00,534 --> 00:38:04,418
synthetic biology, no problem whether or not that's 102
615
00:38:04,444 --> 00:38:07,986
or 103 patentable, it's 101 patentable.
616
00:38:08,118 --> 00:38:11,790
If you're making something new that doesn't exist naturally occurring,
617
00:38:11,970 --> 00:38:15,314
you're in good shape. And I've seen
618
00:38:15,352 --> 00:38:19,146
those kind of cases get allowed without having a treatment.
619
00:38:19,338 --> 00:38:23,702
And it looks like for what you're showing here is a much richer set
620
00:38:23,776 --> 00:38:27,770
of alternatives. There's ranges and different values.
621
00:38:28,270 --> 00:38:31,718
It's not just a simple threshold. And I think the
622
00:38:31,744 --> 00:38:35,414
issue becomes, for lack of better words,
623
00:38:35,512 --> 00:38:38,742
is something analogous to static business logic.
624
00:38:38,886 --> 00:38:43,178
If you're always doing the same thing for
625
00:38:43,204 --> 00:38:47,298
every patient, you're not going to be patent eligible.
626
00:38:47,454 --> 00:38:51,234
And the closer you are, the less likely
627
00:38:51,282 --> 00:38:54,762
you are to be patent eligible. So if you have a simple threshold and you're
628
00:38:54,786 --> 00:38:58,434
just looking at the naturally occurring metabolite
629
00:38:58,482 --> 00:38:59,990
as something is metabolized,
630
00:39:01,330 --> 00:39:05,258
as best I can understand from the Federal Circuit ruling, is there in
631
00:39:05,284 --> 00:39:09,230
essence saying that's trivial?
632
00:39:12,050 --> 00:39:13,760
How would you even regulate that?
633
00:39:15,170 --> 00:39:18,738
Everybody would be infringing then that would be in that camp, but maybe that was
634
00:39:18,764 --> 00:39:22,570
part of it too. Yeah, so thanks, that helps.
635
00:39:22,750 --> 00:39:25,314
No, it's a great question. I'm going to go look up that case now because
636
00:39:25,352 --> 00:39:29,790
then I'll pass it around to everybody too once I find it because that's really
637
00:39:29,840 --> 00:39:33,222
great point and I think that's some of the parsing that's kind
638
00:39:33,236 --> 00:39:37,158
of going on as well in this world to kind of
639
00:39:37,184 --> 00:39:40,698
build on that, or just another little example quickly is that
640
00:39:40,784 --> 00:39:44,322
I had a case recently, not in biotech but in software, where there
641
00:39:44,336 --> 00:39:48,834
was a 101 rejection and the
642
00:39:48,872 --> 00:39:52,758
claim that was rejected had a lot of determining and measuring and
643
00:39:52,784 --> 00:39:56,466
calculating and then taking information
644
00:39:56,528 --> 00:40:00,222
into account to determine different courses of action. And that was
645
00:40:00,236 --> 00:40:03,646
rejected. But what the examiner pointed us to and what was eventually
646
00:40:03,718 --> 00:40:07,210
allowed is that there had to be an active
647
00:40:07,270 --> 00:40:10,110
step in there. You're measuring things, you're determining things.
648
00:40:10,160 --> 00:40:13,590
What do you actually then do? What do you change? What do you
649
00:40:13,700 --> 00:40:17,000
sort of affect in the system based on all of this?
650
00:40:18,590 --> 00:40:23,158
It was a very small wording change. Instead of determining
651
00:40:23,254 --> 00:40:26,850
a method for blah blah blah, it was determining that and then
652
00:40:26,900 --> 00:40:30,378
doing the blah blah blah all we had to do was
653
00:40:30,404 --> 00:40:33,740
add a little clause. So that made sense to me. This whole
654
00:40:35,930 --> 00:40:39,654
adding a treatment step made sense to me sort of from that
655
00:40:39,692 --> 00:40:43,422
angle as well. Just where you need to have, like you said, in a way,
656
00:40:43,556 --> 00:40:46,722
affect the system, change the chemistry of the person
657
00:40:46,796 --> 00:40:50,082
or whatever. Do something active. Yeah, there has to be
658
00:40:50,096 --> 00:40:53,874
like that active, that active step. Right. How are you
659
00:40:53,912 --> 00:40:57,534
kind of influencing the system? I guess to turn this back to
660
00:40:57,572 --> 00:41:01,446
machines in software, you have to have an output of some kind.
661
00:41:01,508 --> 00:41:05,002
You have to do something. So it's
662
00:41:05,026 --> 00:41:11,662
kind of a weird parallel, but I
663
00:41:11,676 --> 00:41:15,166
guess that's the practical application trying to
664
00:41:15,168 --> 00:41:18,514
get everybody to do. Yes, I mean
665
00:41:18,552 --> 00:41:22,342
this is obviously some random kind of tricks, but they
666
00:41:22,356 --> 00:41:25,510
don't like the extra solution activity. Adding the fact that you did it by
667
00:41:25,560 --> 00:41:29,806
PCR, that you're using
668
00:41:29,868 --> 00:41:33,170
some kind of like routine testing,
669
00:41:33,230 --> 00:41:37,262
that's not going to help at all because they still again believe you're
670
00:41:37,286 --> 00:41:40,282
still kind of capturing the natural phenomenon. Again, this kind of gets into the 102
671
00:41:40,296 --> 00:41:43,534
103 world because, well, PCR was known or whatever
672
00:41:43,572 --> 00:41:46,582
method you're using was known. That's more of a 102 103 issue.
673
00:41:46,656 --> 00:41:50,314
But nonetheless, it kind of finds itself in the 101 camp
674
00:41:50,472 --> 00:41:54,626
and then you don't need to have the insignificant limitations
675
00:41:54,758 --> 00:41:58,870
because they're not going to provide any benefit.
676
00:41:59,190 --> 00:42:02,170
And then like general treatments and things like that aren't probably going to help much
677
00:42:02,220 --> 00:42:05,614
either. But it has to be some kind of true
678
00:42:05,652 --> 00:42:06,840
effect on the system.
679
00:42:09,550 --> 00:42:12,938
Yeah, this kind of goes towards the computer side
680
00:42:12,964 --> 00:42:17,274
of the world as well. But how are you actually applying that phenomenon
681
00:42:17,322 --> 00:42:20,958
in an unconventional way? I think you can even think of detecting
682
00:42:21,114 --> 00:42:24,834
the field DNA in the mother's blood. Again, what they were doing was just detecting
683
00:42:24,882 --> 00:42:27,890
it. But then maybe what would have helped them is,
684
00:42:27,940 --> 00:42:31,286
okay, now that you've detected, now that you've isolated fetal DNA, what are you
685
00:42:31,288 --> 00:42:34,718
going to do about it? Right. And I think had they
686
00:42:34,744 --> 00:42:38,910
maybe couched it more in the way of technical
687
00:42:38,970 --> 00:42:42,618
challenges and the avoiding amniocentesis
688
00:42:42,714 --> 00:42:48,278
and things like that, maybe it would have had a better chance then
689
00:42:48,304 --> 00:42:52,022
overcoming a particular technical challenge. Like I said, I think
690
00:42:52,036 --> 00:42:55,614
there's a good recommendation too to also include lots of different claim
691
00:42:55,662 --> 00:42:59,462
types in this area. The methods of treatment, methods of diagnosis, methods of
692
00:42:59,476 --> 00:43:02,870
detection, and going over those that are easier first,
693
00:43:02,920 --> 00:43:06,362
which would probably be method of treatment assuming you have some kind of active step
694
00:43:06,556 --> 00:43:09,580
and it may be going towards the other ones later,
695
00:43:10,930 --> 00:43:14,234
especially through divisional practice and things like that. And hopefully the case
696
00:43:14,272 --> 00:43:18,242
law changes. Honestly, I looked through case law
697
00:43:18,316 --> 00:43:21,722
for 101 in the life science versus the software. There is
698
00:43:21,796 --> 00:43:25,758
way fewer life science section 101 cases.
699
00:43:25,794 --> 00:43:29,642
And I don't know if that's like a general reflection of
700
00:43:29,776 --> 00:43:32,750
obviously software is rapidly changing.
701
00:43:33,130 --> 00:43:37,110
Lots of people have their hands in software versus
702
00:43:37,170 --> 00:43:39,520
the life science. It's a slower moving field.
703
00:43:40,270 --> 00:43:43,562
There's arguably fewer people that are going
704
00:43:43,576 --> 00:43:46,974
to touch life science in their lifetime versus somebody who's going to touch software,
705
00:43:47,022 --> 00:43:51,102
maybe, or whether that's some other meaningful metric
706
00:43:51,186 --> 00:43:54,698
of what that case
707
00:43:54,724 --> 00:43:58,850
law has done to those fields, or whether the cost
708
00:43:58,900 --> 00:44:02,462
of kind of pursuing these longer or over a greater period of time in
709
00:44:02,476 --> 00:44:04,600
the court system, I don't know. But it was just interesting.
710
00:44:05,650 --> 00:44:10,094
Like I said, it had to have been. I feel like for every one life
711
00:44:10,132 --> 00:44:13,670
science case, there was probably at least three software cases, it seems.
712
00:44:13,720 --> 00:44:16,682
So it's interesting. So in that sense, it was easier, I feel like,
713
00:44:16,696 --> 00:44:20,366
to make sense of it to some degree, because it was less
714
00:44:20,548 --> 00:44:24,822
all over the board, but also less examples
715
00:44:24,846 --> 00:44:26,440
to draw from, I guess.
716
00:44:27,730 --> 00:44:30,350
Anyways oh, yeah, Dan, sorry, Dan.
717
00:44:35,270 --> 00:44:38,910
So I decided to take a little different spin here on 101,
718
00:44:38,960 --> 00:44:42,958
because while the eligible
719
00:44:42,994 --> 00:44:47,202
subject matter is certainly the dominant topic from
720
00:44:47,336 --> 00:44:51,090
that section, it's a fairly recent
721
00:44:51,410 --> 00:44:55,158
development. Comparatively speaking, for the most part, section 101 historically has
722
00:44:55,184 --> 00:44:58,110
been about whether or not an invention is useful,
723
00:44:58,430 --> 00:45:01,866
which is also historically quite a low bar, and so
724
00:45:01,928 --> 00:45:05,934
it is reasonable that it gets overlooked. But towards life
725
00:45:05,972 --> 00:45:09,198
sciences, the requirement is still there. And as
726
00:45:09,224 --> 00:45:13,026
we'll get to the end here, there are a couple of places where people can
727
00:45:13,088 --> 00:45:16,520
mess up, and it's a bit of an embarrassing mistake to make.
728
00:45:17,630 --> 00:45:21,082
And the law around it, I still think merits
729
00:45:21,166 --> 00:45:24,380
some discussions. So that fundamental bit about
730
00:45:25,310 --> 00:45:29,278
invention must be useful. Case law ends up generating
731
00:45:29,434 --> 00:45:33,514
three main aspects of utility and inventions.
732
00:45:33,562 --> 00:45:37,134
Utility must be specific, it must be substantial, and it must
733
00:45:37,172 --> 00:45:41,062
be credible. So specific must mean it's directed,
734
00:45:41,206 --> 00:45:47,938
it's well defined, it is directed towards a
735
00:45:47,964 --> 00:45:51,470
particular activity, a particular role, and this is primarily
736
00:45:51,530 --> 00:45:55,402
used to deny or avoid general statements. So one
737
00:45:55,416 --> 00:45:58,678
of my favorite lines out of the MPEP is in the section where it's like,
738
00:45:58,704 --> 00:46:03,718
you can't state that the invention is simple for
739
00:46:03,744 --> 00:46:06,660
mere landfill, can't just take up space.
740
00:46:07,410 --> 00:46:10,978
Now, taking up space, though, is actually can be a very valuable thing.
741
00:46:11,064 --> 00:46:15,514
Think of all the washers on mechanical inventions that keep
742
00:46:15,552 --> 00:46:18,434
place things where they're supposed to be, or balanced on ships.
743
00:46:18,482 --> 00:46:22,222
That's just weight, that takes up space, that keeps balance there.
744
00:46:22,416 --> 00:46:26,040
And so indeed, taking up space can be
745
00:46:26,430 --> 00:46:29,762
can be a legitimate use. But the examples
746
00:46:29,786 --> 00:46:33,482
I gave there are specific, they're specifically valuable.
747
00:46:33,626 --> 00:46:37,402
So you can't just say, oh, it just takes up space. And how
748
00:46:37,416 --> 00:46:40,762
this applies to life sciences is you can't just say, oh,
749
00:46:40,896 --> 00:46:46,034
these compounds have biological
750
00:46:46,202 --> 00:46:49,894
activity, and leave it at that. You got to be specific.
751
00:46:49,992 --> 00:46:54,070
And you can't just say, oh, you could use this to treat diseases.
752
00:46:55,410 --> 00:46:59,098
It's like, all right, well, which diseases? What diseases? So it
753
00:46:59,124 --> 00:47:02,750
does must be specific. Your utility must be directed
754
00:47:02,810 --> 00:47:06,430
towards something, it must be substantial.
755
00:47:06,930 --> 00:47:10,800
So in this case, this is probably the more flexible of
756
00:47:11,550 --> 00:47:14,460
these terms that I found while looking into this.
757
00:47:15,090 --> 00:47:18,926
And its primary concern is that your invention
758
00:47:18,998 --> 00:47:23,170
that use sort of has an immediately recognizable effect.
759
00:47:23,340 --> 00:47:27,298
This most commonly pops up to defeat the
760
00:47:27,324 --> 00:47:30,730
sort of hunting license applications of oh,
761
00:47:30,780 --> 00:47:33,610
here's a bunch of compounds that could be useful.
762
00:47:35,310 --> 00:47:38,618
We can do some broad speculation that perhaps
763
00:47:38,654 --> 00:47:42,094
this will be useful towards some disease, but we have
764
00:47:42,132 --> 00:47:46,078
no actual data, we have no actual support, we don't know.
765
00:47:46,104 --> 00:47:48,720
And then this is where again, it bumps into 112.
766
00:47:49,110 --> 00:47:52,250
But the substantial
767
00:47:52,310 --> 00:47:55,342
means that from what you've got ready at hand here,
768
00:47:55,416 --> 00:48:00,418
there is an identifiable real world benefit that
769
00:48:00,564 --> 00:48:04,610
it treats this disease or even it inhibits
770
00:48:04,670 --> 00:48:08,098
this protein and then finally it must be
771
00:48:08,124 --> 00:48:11,842
credible. This is perhaps the
772
00:48:11,856 --> 00:48:15,334
least interesting out of the three because does
773
00:48:15,372 --> 00:48:18,298
your invention, in light of all the evidence you've given,
774
00:48:18,384 --> 00:48:21,614
behave according to known and appreciated
775
00:48:21,782 --> 00:48:25,894
scientific principles? So credibility only really pops up when
776
00:48:25,932 --> 00:48:29,630
people are trying to put in time machines,
777
00:48:29,750 --> 00:48:33,482
perpetual motion machines in life sciences.
778
00:48:33,626 --> 00:48:37,702
I saw some examples of like using magnetic fields to change things
779
00:48:37,776 --> 00:48:41,520
flavor you might end up with some
780
00:48:42,750 --> 00:48:46,450
wild homeopathy related type stuff as well,
781
00:48:46,560 --> 00:48:50,410
might show up under credibility. But the MPEP strongly
782
00:48:50,970 --> 00:48:55,334
suggests that the credibility bar is fairly
783
00:48:55,442 --> 00:48:59,614
low. As long as there is even an inkling, some sort of suggestions like okay,
784
00:48:59,772 --> 00:49:02,962
we'll go along with this. And then as a
785
00:49:02,976 --> 00:49:07,178
curious logical necessity, if you somehow fail the necessity
786
00:49:07,334 --> 00:49:11,114
or the utility requirement of 101, you therefore
787
00:49:11,162 --> 00:49:14,554
fail enablement. If enablement is that
788
00:49:14,592 --> 00:49:17,758
you adequately instruct one of skill in the art
789
00:49:17,904 --> 00:49:21,670
to make and use the invention and there's no use
790
00:49:21,720 --> 00:49:24,874
for the invention, you therefore can't teach
791
00:49:24,912 --> 00:49:28,426
people how to use it. So you will find hand in hand
792
00:49:28,548 --> 00:49:32,290
a utility one on one rejection with an enablement 112
793
00:49:32,340 --> 00:49:36,106
rejection. And important for
794
00:49:36,228 --> 00:49:39,190
these considerations, particularly towards substantial,
795
00:49:39,570 --> 00:49:42,998
is that the USPTO is not the FDA. And this is something that's
796
00:49:43,034 --> 00:49:46,394
popped up in a number of cases, although it's at this point fairly
797
00:49:46,442 --> 00:49:50,710
old news. In order for a pharmaceutical
798
00:49:51,330 --> 00:49:54,794
to qualify as a substantial utility,
799
00:49:54,962 --> 00:49:58,186
no, you don't need to go through the entire process, the entire
800
00:49:58,248 --> 00:50:01,882
clinical process of showing that the drug is
801
00:50:01,956 --> 00:50:04,810
a commercially viable, safe,
802
00:50:05,250 --> 00:50:08,510
effective drug. The mere
803
00:50:08,570 --> 00:50:12,878
identification and notably demonstration, at least a token demonstration
804
00:50:13,034 --> 00:50:16,846
of biological or pharmacological activity towards a
805
00:50:16,848 --> 00:50:20,350
specific protein that's associated target,
806
00:50:20,790 --> 00:50:24,250
associated with certain diseases is sufficient.
807
00:50:24,570 --> 00:50:27,982
And this has come up again and again and again since the 80s.
808
00:50:28,176 --> 00:50:31,930
Some of this language has, some of the earlier language said things
809
00:50:32,040 --> 00:50:36,010
as near in vitro. The fact that you identify
810
00:50:36,750 --> 00:50:40,294
activity in vitro has utility towards
811
00:50:40,392 --> 00:50:41,400
pharma companies.
812
00:50:43,590 --> 00:50:47,090
Whereas I'll say in that last case with their enray Braun
813
00:50:47,150 --> 00:50:51,240
from 95 there's maybe a bit more telling statement in there
814
00:50:51,990 --> 00:50:55,810
about how, due to the expense
815
00:50:56,190 --> 00:50:59,760
and duration of full clinical trials, that if
816
00:51:00,930 --> 00:51:05,674
drug applications failed utility before
817
00:51:05,772 --> 00:51:10,154
the clinical stage, that would be a huge economic barrier
818
00:51:10,322 --> 00:51:13,738
and discourage barrier to
819
00:51:13,764 --> 00:51:17,938
pharmaceutical development economically. So for a
820
00:51:17,964 --> 00:51:20,820
practical economic reason,
821
00:51:21,450 --> 00:51:25,630
mirror in vitro activity is sufficient.
822
00:51:25,950 --> 00:51:29,554
And so in each of these cases, the examples, what was
823
00:51:29,592 --> 00:51:33,674
generally challenged for most of these cases was the specification stated,
824
00:51:33,722 --> 00:51:37,070
hey, here's a target,
825
00:51:37,250 --> 00:51:41,074
here's a protein. It's known that
826
00:51:41,172 --> 00:51:45,250
this type of molecule can
827
00:51:45,360 --> 00:51:48,670
inhibit this molecule or it can inhibit the target.
828
00:51:49,650 --> 00:51:53,434
Here are some new variants of it. Here is literally some
829
00:51:53,472 --> 00:51:56,050
data showing in vitro activity.
830
00:51:56,910 --> 00:52:01,200
Did they test the whole entire scope? Not necessarily. Did they fully develop
831
00:52:02,130 --> 00:52:05,174
the compounds into proper pharmaceuticals?
832
00:52:05,222 --> 00:52:09,490
No. But they at least had the
833
00:52:09,660 --> 00:52:13,286
background of the knowledge of this specific disease
834
00:52:13,358 --> 00:52:16,994
is related to these specific proteins. And here is token
835
00:52:17,042 --> 00:52:20,950
evidence, here is literally some evidence that our class,
836
00:52:21,060 --> 00:52:24,874
our molecules can inhibit, can interact with
837
00:52:24,972 --> 00:52:28,630
these proteins,
838
00:52:29,130 --> 00:52:32,822
and that is sufficient for the utility. So now we'll
839
00:52:32,846 --> 00:52:36,442
look at some examples. It would actually be sufficient for 112,
840
00:52:36,516 --> 00:52:40,534
especially now though, because a lot of those early EPO patents that
841
00:52:40,572 --> 00:52:44,474
try to protect variants or different ways of creating
842
00:52:44,522 --> 00:52:48,142
EPO had section 112
843
00:52:48,216 --> 00:52:52,006
issue. Because again, they didn't enable somebody
844
00:52:52,068 --> 00:52:55,034
to practice the full scope of the claim.
845
00:52:55,142 --> 00:52:58,570
They may be taught one or two ways to do it, like using
846
00:52:58,620 --> 00:53:01,774
some of those assays, but they didn't teach the full scope of it. So I
847
00:53:01,812 --> 00:53:05,578
wonder in the current interpretation of
848
00:53:05,604 --> 00:53:08,878
112, whether they maybe would have
849
00:53:08,904 --> 00:53:11,626
survived 101, but London survived 112.
850
00:53:11,808 --> 00:53:14,460
Yeah, quite possibly. Yeah,
851
00:53:17,590 --> 00:53:21,110
absolutely. Legitimate observation there that perhaps indeed
852
00:53:21,430 --> 00:53:24,318
it wouldn't be enough to enable the full scope,
853
00:53:24,474 --> 00:53:27,578
but for the purposes of determining that specific and
854
00:53:27,604 --> 00:53:28,850
substantial utility,
855
00:53:30,730 --> 00:53:34,802
literally something token evidence is enough,
856
00:53:34,876 --> 00:53:38,490
as long as it is directed towards treatment of specific diseases,
857
00:53:38,550 --> 00:53:42,786
inhibition of known specific biological targets.
858
00:53:42,978 --> 00:53:45,866
So how would you fix that?
859
00:53:46,048 --> 00:53:49,578
Would you just have to go extremely narrow if you didn't
860
00:53:49,614 --> 00:53:52,360
have enough to support full enablement of everything?
861
00:53:54,950 --> 00:53:59,014
So you're talking about an example where you've got a class of molecules
862
00:53:59,062 --> 00:54:03,094
and then you get rejected for lack of enablement for the whole scope,
863
00:54:03,262 --> 00:54:06,822
right? Yeah. So that's a hard one
864
00:54:06,896 --> 00:54:10,290
to fix. Sometimes examiners
865
00:54:11,390 --> 00:54:16,158
are content to listen to if
866
00:54:16,184 --> 00:54:20,574
there's information. Sometimes you can show them data
867
00:54:20,672 --> 00:54:23,826
related that ends up in the case file. Not everyone
868
00:54:23,888 --> 00:54:27,354
likes that. Sometimes you can find publications that
869
00:54:27,392 --> 00:54:30,822
show the relevant state of the
870
00:54:30,836 --> 00:54:34,326
knowledge at the time of the filing that you got to be careful with that,
871
00:54:34,388 --> 00:54:37,858
so you don't end up making it obvious. But sometimes you can play games
872
00:54:37,894 --> 00:54:41,518
with that. Is that like submitted like a 132 deck,
873
00:54:41,554 --> 00:54:45,080
like an affidavit of inventors or yeah,
874
00:54:48,230 --> 00:54:52,460
you can do affidavits from inventors. That's possible.
875
00:54:54,650 --> 00:54:57,450
Being careful with all other publications,
876
00:54:58,670 --> 00:55:02,540
that's another process. But it's hard sometimes.
877
00:55:04,430 --> 00:55:08,530
And what I have found is depending on the practicalities
878
00:55:08,650 --> 00:55:13,090
of the case, of what's important and considering your jurisdiction,
879
00:55:13,150 --> 00:55:15,858
sometimes it's not worth it to fight it.
880
00:55:15,944 --> 00:55:20,370
Sometimes the estoppel that you would introduce
881
00:55:22,190 --> 00:55:25,350
by putting it forward in less important jurisdictions,
882
00:55:26,270 --> 00:55:29,730
it's just not worth it. And hopefully you
883
00:55:29,780 --> 00:55:32,910
have enabled what is the critical,
884
00:55:34,250 --> 00:55:37,642
the golden goose or the golden egg of your genus.
885
00:55:37,726 --> 00:55:41,262
Hopefully that's enabled and so you find comfort in that.
886
00:55:41,456 --> 00:55:44,946
But it's a tough spot to be in when you get hit with those
887
00:55:45,128 --> 00:55:48,498
enablement bits because you're generally not allowed to
888
00:55:48,524 --> 00:55:51,380
just dump new stuff into the record.
889
00:55:56,730 --> 00:56:01,090
So here are some examples of where utility failed
890
00:56:01,770 --> 00:56:04,982
in life science cases. So the first one, which ended
891
00:56:05,006 --> 00:56:08,962
up being sort of the fundamental precedent for pretty much
892
00:56:09,096 --> 00:56:12,322
all the cases on the previous slide. Renault v.
893
00:56:12,336 --> 00:56:16,142
Manson from 1966. The patent claimed
894
00:56:16,166 --> 00:56:19,678
a novel method for manufacturing a certain
895
00:56:19,824 --> 00:56:23,674
subgenus of a type of steroid. Now at
896
00:56:23,712 --> 00:56:27,118
the time there was no known utility for the
897
00:56:27,144 --> 00:56:30,982
class of compounds. The only blurb in
898
00:56:30,996 --> 00:56:34,282
the whole application that's actually about what this thing is for is a
899
00:56:34,296 --> 00:56:38,966
paragraph that says, hey, these compounds are like these other compounds
900
00:56:39,098 --> 00:56:43,200
and these other compounds are being considered for
901
00:56:43,590 --> 00:56:46,858
diseases in which these certain properties could be
902
00:56:46,884 --> 00:56:50,040
useful. That was it.
903
00:56:50,730 --> 00:56:54,970
So it did not specify a specific type of disease
904
00:56:55,710 --> 00:56:59,794
nor did it show any data that it could
905
00:56:59,892 --> 00:57:03,086
inhibit or could interact with the pathways
906
00:57:03,158 --> 00:57:04,020
that it mentioned.
907
00:57:07,150 --> 00:57:10,722
Next slide please. The decision here, what was their motivation
908
00:57:10,806 --> 00:57:12,460
to filing the patent then,
909
00:57:13,990 --> 00:57:17,138
behind the name. So this is where we
910
00:57:17,164 --> 00:57:21,210
fundamentally this is the case where the patent is not a hunting license
911
00:57:21,270 --> 00:57:24,582
line comes out of from the decision.
912
00:57:24,666 --> 00:57:28,502
And what I think what they were after was that they were related to
913
00:57:28,516 --> 00:57:32,682
the lab that was testing this broader cast of class of molecules.
914
00:57:32,826 --> 00:57:36,698
So they were like hey, we found a cool way of making these class of
915
00:57:36,724 --> 00:57:40,598
molecules that looks like this other class of molecules which we're currently
916
00:57:40,684 --> 00:57:44,534
interested in. But the state of their technology,
917
00:57:44,632 --> 00:57:48,642
the state of their knowledge didn't actually suggest at all that those compounds
918
00:57:48,666 --> 00:57:50,320
would be useful for anything.
919
00:57:51,650 --> 00:57:55,170
But they sort of put in the cart before the horse. They wanted
920
00:57:55,220 --> 00:57:59,946
to protect that research that they had done before
921
00:58:00,008 --> 00:58:03,642
they actually knew it was going to be valuable. And to some extent you kind
922
00:58:03,656 --> 00:58:07,074
of can't fault them for that. With R and D and
923
00:58:07,172 --> 00:58:10,422
pharma companies you're testing, especially now with high throughput screen and
924
00:58:10,436 --> 00:58:13,700
you're testing all kinds, you can test all kinds of stuff.
925
00:58:15,650 --> 00:58:19,254
But the decision came back that no utility is
926
00:58:19,292 --> 00:58:23,358
not satisfied by showing that
927
00:58:23,384 --> 00:58:27,030
it's classes are currently being screened.
928
00:58:28,670 --> 00:58:32,550
That alone is not sufficient. And furthermore, a bit more fundamental
929
00:58:32,870 --> 00:58:36,994
that a process is not useful simply
930
00:58:37,042 --> 00:58:40,040
by the fact that it produces its intended result.
931
00:58:41,030 --> 00:58:44,394
It's interesting that what
932
00:58:44,432 --> 00:58:48,358
makes that process the process, I guess is valued
933
00:58:48,394 --> 00:58:52,220
holistically by the utility in some sense of the result.
934
00:58:52,910 --> 00:58:56,610
And so yes, indeed, simply that because their method indeed
935
00:58:57,050 --> 00:59:00,490
produced the compound, but the compounds
936
00:59:00,610 --> 00:59:04,458
were not substantial. So in this case it was specific they
937
00:59:04,484 --> 00:59:08,370
said, hey, this method makes these specific compounds. So, hey, it's specific.
938
00:59:08,480 --> 00:59:11,970
But because it did not promise, it did not show or suggest
939
00:59:14,030 --> 00:59:16,040
a real world value,
940
00:59:17,870 --> 00:59:21,994
it was not substantial. So then more recently,
941
00:59:22,042 --> 00:59:25,580
let's jump forward 40 years,
942
00:59:26,570 --> 00:59:30,270
2005. And Ray Fisher, this was the case
943
00:59:30,320 --> 00:59:35,278
that attempted to claim five est sequence
944
00:59:35,314 --> 00:59:39,490
tags from Corn. And he has their cDNA
945
00:59:39,550 --> 00:59:43,746
sequences, which are, I think, notably one of the things thrown about
946
00:59:43,868 --> 00:59:48,138
as well. Those are patentable because you
947
00:59:48,164 --> 00:59:51,942
take out the bits that don't matter and they
948
00:59:51,956 --> 00:59:55,138
don't naturally exist. So cDNAs falls
949
00:59:55,174 --> 00:59:59,022
under the patentable subject matter. And est can
950
00:59:59,036 --> 01:00:02,530
be useful for a variety of things within genomics.
951
01:00:02,590 --> 01:00:06,258
You can help map genomes. You can find which genes are where and
952
01:00:06,284 --> 01:00:10,266
what they coordinate to. But in this case, the function
953
01:00:10,328 --> 01:00:14,614
and structure of the claim sequences and their corresponding
954
01:00:14,662 --> 01:00:18,150
proteins were unknown at the time of filing. This case
955
01:00:18,200 --> 01:00:20,960
just includes a lot of genomics data.
956
01:00:21,650 --> 01:00:25,054
It says that their ests created,
957
01:00:25,102 --> 01:00:28,750
extracted from the specific breed
958
01:00:28,810 --> 01:00:30,390
of maze.
959
01:00:32,310 --> 01:00:34,320
But what these five tags did,
960
01:00:35,130 --> 01:00:38,722
unknown. Specifically, they name the common
961
01:00:38,796 --> 01:00:44,220
uses for este standard,
962
01:00:45,570 --> 01:00:49,054
general, generic uses for what est can do. Of course,
963
01:00:49,092 --> 01:00:52,860
you can use ests to map where genes are
964
01:00:54,030 --> 01:00:59,558
in the genome. You can use them to
965
01:00:59,584 --> 01:01:02,810
find similar genes in other organisms.
966
01:01:03,370 --> 01:01:06,578
But it was completely unknown at the time of filing, what they did, what they
967
01:01:06,604 --> 01:01:09,950
encoded. And that's really what the case
968
01:01:10,000 --> 01:01:13,180
with the Federal Circuit locked in on. Next slide, please.
969
01:01:14,830 --> 01:01:18,966
That these uses for these specific ests remain
970
01:01:19,038 --> 01:01:22,382
hypothetical in general. So although sure you could use it
971
01:01:22,396 --> 01:01:27,426
to find you potentially use it to detect variance
972
01:01:27,498 --> 01:01:31,466
mutations. Are mutations in those
973
01:01:31,528 --> 01:01:34,482
genes useful, valuable,
974
01:01:34,626 --> 01:01:38,090
noteworthy, completely unknown.
975
01:01:38,590 --> 01:01:42,098
And the specification contains no guidance as
976
01:01:42,124 --> 01:01:46,614
to why those claimed ests were more useful than the tens of thousands
977
01:01:46,782 --> 01:01:50,570
that are present in the genome. And then
978
01:01:50,620 --> 01:01:54,522
furthermore, there was no data, there was no evidence
979
01:01:54,606 --> 01:01:58,718
that those ests would specifically would
980
01:01:58,744 --> 01:02:01,610
succeed at doing any of the things like, hey,
981
01:02:01,720 --> 01:02:03,770
let's use this to find mutations.
982
01:02:05,350 --> 01:02:08,798
There was no such data. So again, similar to that
983
01:02:08,824 --> 01:02:12,374
case from the court relied on that this is sort of
984
01:02:12,412 --> 01:02:15,902
another use testing sort of situation. You have
985
01:02:15,916 --> 01:02:20,140
a research group that's trying to protect their research.
986
01:02:21,310 --> 01:02:24,806
Although there's no value yet out of the research,
987
01:02:24,928 --> 01:02:28,742
they're still early on, or at least they did not provide what the
988
01:02:28,756 --> 01:02:32,260
utility of these ests were.
989
01:02:33,490 --> 01:02:36,734
And so the next step for them would be, okay, let's figure
990
01:02:36,772 --> 01:02:40,310
out what these ests actually do. And that is
991
01:02:40,420 --> 01:02:44,118
insufficient standing for an eligible
992
01:02:44,154 --> 01:02:48,050
patent. You got to tell us what these things do. They must be specific
993
01:02:48,160 --> 01:02:51,302
and substantial in their utility to
994
01:02:51,316 --> 01:02:54,866
meet that fundamental bar. So,
995
01:02:54,988 --> 01:02:58,838
yeah, the last thing here is make
996
01:02:58,864 --> 01:03:01,958
sure you do have a goal in mind or at least you provide the
997
01:03:01,984 --> 01:03:05,594
context, that substantial context towards what these
998
01:03:05,632 --> 01:03:09,338
things are for. And so if you're too early on in
999
01:03:09,424 --> 01:03:12,818
development and you're just seeing what you
1000
01:03:12,844 --> 01:03:16,770
can make in the realm of biotech and the realm of chemistry.
1001
01:03:16,830 --> 01:03:20,118
Just because you can make it doesn't
1002
01:03:20,154 --> 01:03:23,618
mean it's necessarily useful. And then you
1003
01:03:23,644 --> 01:03:27,470
fail the forgotten portion of section 101, the part
1004
01:03:27,520 --> 01:03:31,094
no one talks about. Well honestly, even if you
1005
01:03:31,132 --> 01:03:34,250
find what it does, if they had found in current
1006
01:03:34,300 --> 01:03:37,778
case, if they had found what these ESC do, it still
1007
01:03:37,804 --> 01:03:41,282
wouldn't have been protectable from the other side of 101 because there would have
1008
01:03:41,296 --> 01:03:46,238
been like it would have been one thing if they were like you
1009
01:03:46,264 --> 01:03:50,034
genotype for this thing and then you give more round
1010
01:03:50,082 --> 01:03:54,038
up to the corn versus less roundup to the corn or something and
1011
01:03:54,064 --> 01:03:57,266
then maybe that active step would have saved them from the other part of 101.
1012
01:03:57,328 --> 01:04:00,510
So yeah, it's kind of fun to look at these historically
1013
01:04:00,570 --> 01:04:03,878
how they've kind of come over time and yeah that's interesting.
1014
01:04:03,964 --> 01:04:07,322
You do forget about the other side of 101. So that was interesting. That's a
1015
01:04:07,336 --> 01:04:09,170
good historical lesson.
1016
01:04:13,070 --> 01:04:16,578
Some questions of law that feel obvious
1017
01:04:16,664 --> 01:04:19,974
or standard now they maybe weren't always like
1018
01:04:20,012 --> 01:04:23,142
that. You go poke at the case law, you go do a
1019
01:04:23,156 --> 01:04:27,140
bit of digging and you can find a legitimate question in the record
1020
01:04:28,490 --> 01:04:32,082
because for example, that case from the 60s, there is
1021
01:04:32,096 --> 01:04:35,382
a dissenting opinion. I didn't read
1022
01:04:35,396 --> 01:04:38,694
the dissenting opinion but I'm going to assume it to some extent argues that no
1023
01:04:38,732 --> 01:04:42,414
the fact that they could make it, the fact that there was perhaps the amount
1024
01:04:42,452 --> 01:04:46,098
of speculation, maybe there's an argument in there that the level
1025
01:04:46,124 --> 01:04:49,842
of speculation was sufficient but instead
1026
01:04:49,916 --> 01:04:53,720
now that case from the 60s ends up being the grounding precedent for
1027
01:04:54,650 --> 01:04:58,666
40 plus years of biological
1028
01:04:58,738 --> 01:05:02,502
and chemical utility. So even though now we
1029
01:05:02,516 --> 01:05:05,622
don't think about the utility requirements so much,
1030
01:05:05,816 --> 01:05:09,174
there was at a time a legitimate question,
1031
01:05:09,272 --> 01:05:12,570
a legitimate inquiry
1032
01:05:13,250 --> 01:05:16,978
and I think it's worthwhile going back and looking at. So you have the fundamental
1033
01:05:17,014 --> 01:05:21,020
principle at hand and not just the working convenient result.
1034
01:05:22,670 --> 01:05:24,200
Yeah, absolutely.
1035
01:05:26,210 --> 01:05:29,190
Cool. Does anyone have any questions, comments?
1036
01:05:31,470 --> 01:05:33,060
I wanted to say something.
1037
01:05:34,830 --> 01:05:39,540
So back to the genus versus species issue.
1038
01:05:40,770 --> 01:05:44,890
From the client perspective that is the financial perspective,
1039
01:05:47,070 --> 01:05:51,274
when you're facing a question like that it seems like it might
1040
01:05:51,312 --> 01:05:56,040
be better just to accept the species right,
1041
01:05:56,730 --> 01:06:00,302
get the insurance, file a continuation
1042
01:06:00,386 --> 01:06:02,760
and kick it down road.
1043
01:06:03,390 --> 01:06:07,286
Yes it's a tendency
1044
01:06:07,358 --> 01:06:11,102
I think get all up and arms blah blah
1045
01:06:11,126 --> 01:06:14,774
blah blah but from the client
1046
01:06:14,822 --> 01:06:18,434
perspective please give us a patent.
1047
01:06:18,542 --> 01:06:22,322
And then the second thing I was going to say is that if you're
1048
01:06:22,346 --> 01:06:26,290
waiting into an area like this it might make
1049
01:06:26,340 --> 01:06:30,646
sense to describe the genus really
1050
01:06:30,768 --> 01:06:34,822
extensively and if you're talking about a
1051
01:06:34,836 --> 01:06:38,782
structure maybe you can attach mechanism to
1052
01:06:38,796 --> 01:06:42,120
the structure. Why does the structure work?
1053
01:06:44,950 --> 01:06:48,558
You're not necessarily going to get the claims
1054
01:06:48,594 --> 01:06:51,854
that you want, that you're creating prior art that could
1055
01:06:51,892 --> 01:06:56,080
block others which is also important.
1056
01:06:56,650 --> 01:07:00,340
So those are my ideas there.
1057
01:07:00,970 --> 01:07:05,294
Yeah, I think two companies have to weigh how much maybe
1058
01:07:05,332 --> 01:07:08,320
it's worthwhile spending a little bit of R, amp, D time,
1059
01:07:09,250 --> 01:07:11,450
at least proof of concept,
1060
01:07:12,850 --> 01:07:16,158
a few different members of a genius.
1061
01:07:16,254 --> 01:07:19,794
You know what, just some, like, really rough
1062
01:07:19,842 --> 01:07:23,402
in vitro data right, that we can make this compound and
1063
01:07:23,416 --> 01:07:26,558
we said that it increases insulin production. Look, when we put
1064
01:07:26,584 --> 01:07:30,686
it into healing cells that are meant to produce insulin, we can get
1065
01:07:30,808 --> 01:07:33,698
a modest increase in insulin, you know what I mean? Just doing a little bit
1066
01:07:33,724 --> 01:07:36,878
of those studies and a few random different ones to
1067
01:07:36,904 --> 01:07:40,758
hopefully show that more of the full scope
1068
01:07:40,794 --> 01:07:44,714
of the claim and things like that. But I agree that getting
1069
01:07:44,752 --> 01:07:47,882
the species is better than nothing. And so maybe getting the
1070
01:07:47,896 --> 01:07:50,990
species and then being willing to get a whole bunch of species patents, right?
1071
01:07:51,040 --> 01:07:55,278
A whole bunch of other ones that are if you think about your particular species
1072
01:07:55,314 --> 01:07:58,710
being the bullseye and then some of the closest
1073
01:07:58,770 --> 01:08:02,114
next ones hopefully trying to get patents on some of those ones.
1074
01:08:02,152 --> 01:08:05,894
So do you block a competitor in the most
1075
01:08:05,932 --> 01:08:09,110
effective way with the genus claim? No. But you still block them through
1076
01:08:09,160 --> 01:08:12,966
multiple pen, through like, all the different ways that they could conceivably
1077
01:08:13,038 --> 01:08:16,946
get around it? Yes. And maybe a little bit more painfully longer,
1078
01:08:17,068 --> 01:08:19,300
but yeah,
1079
01:08:19,750 --> 01:08:23,714
right. Anyway, it's a good session. Thank you, Ashley. Thank you.
1080
01:08:23,872 --> 01:08:27,038
Yeah, so no guy said, this is something I've been meaning to do
1081
01:08:27,064 --> 01:08:30,530
for a while. All right, well, thanks everybody.
1082
01:08:30,700 --> 01:08:33,700
Have a good rest of your week. Thank you.
1083
01:08:34,090 --> 01:08:37,530
Thanks everybody. Thank you. Bye bye.
1084
01:08:37,710 --> 01:08:40,898
All right, that's all for today, folks. Thanks for listening. And remember to check
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us out@aurorapatins.com for more great podcasts,
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blogs, and videos covering all things patent strategy. And if you're an agent
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or attorney and would like to be part of the discussion or an inventor with
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a topic you'd like to hear discussed, email us at podcast@aurorapatins.com.
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Do remember that this podcast does not constitute legal advice. And until next time,
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keep calm and patent on.