Transcript
Unpredictable Arts: Patenting Bio, Chem, and Emerging Technologies.
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
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things at the intersection of business, technology, and patents.
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This podcast is a monthly discussion amongst experts in the field of patenting
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it's for inventors, founders and IP professionals alike,
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established or aspiring. In today's episode, we're looking
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into how to get more predictable results from the unpredictable arts. Think your
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innovation is sufficiently enabled to secure, defend, and assert your patent rights?
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If it's a biological, chemical, or emerging technology invention,
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then you might want to think again. And there's that word again enabled.
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If you're a regular listener, you're probably noticing a common thread among
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several of our recent episodes the concept of enablement is
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one of the sharpest corners in the world of IP. In fortifying life
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science patents, we first explored section 112 rejections and
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the concept of enablement, or whether or not the patent teaches
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those skilled in the art how to make and use the full scope of
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the claimed invention without undue experimentation.
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In our From Alice to Axel episode, we looked at how the courts have conflated
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eligibility with enablement and the grave threats this poses to the
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innovation economy. And then in episode eight this season, we examine
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the use of means plus function, claiming in the enablement risks
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that come with using overly broad language that only describes what
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an invention is versus what it does. Why is this such a
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big topic worth so much discussion? Well, remember,
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enablement is the fundamental deal of the patent system.
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You're trading disclosure for exclusivity so you can't
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hold back on the key details. Longterm progress of science and the useful
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arts is promoted by trading a government granted window of exclusivity
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to inventors in exchange for an enabling public disclosure.
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This disclosure must teach the public how to make and use the invention.
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Enablement is teaching how to make and use the invention
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that requires a certain level of specificity. And that level of specificity
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is where we start traveling into the gray. Depending on the subject matter
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or technology area for the innovation, this level of specificity
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can have very different requirements. Some technologies, like those
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rooted in physics and mechanics, are considered predictable by the US.
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Patent Office, while others, like biological and chemical technologies,
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are generally considered unpredictable. It follows that the amount
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of disclosure required to enable invention is related to the predictability
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of the technology, and so called unpredictable arts require more description
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to teach a reader how to make and use the technology.
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Similarly, emerging technologies, being less wellknown,
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also require more disclosure to be fully enabled. In this month's
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episode, David Jackrel, President of Jackrel Consulting, leads a discussion along
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with our Allstar Patent panel exploring enablement for the unpredictable arts
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and emerging technologies. The panel discusses peculiarities
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of patenting, unpredictable art and emerging technologies with a focus
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on modern case law and statutes to arrive at a set of best practices
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for getting more predictable results and patenting. These technologies.
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Dave is also joined today by our always exceptional group of IP experts,
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including Dr. Ashley Sloat, President and Director of Patent Strategy
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here at Aurora. Kristen Hansen, patent strategist at Aurora, and Shelley
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Couturier are patent strategist and search specialist. And before joining the
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group, as we often do, we'd like to provide a short primer on some key
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concepts in this episode for those newer to the world of patenting.
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Our legal scope for this talk once again falls under Title 35 of
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US. Code section 112, which is largely concerned
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with the topic of enablement. Patents can be rejected by the Patent Office or
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later invalidated by the courts if the invention is deemed to be insufficiently
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enabled. Regarding statute interpretation, the group also makes
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reference to the MPEP for those newer to the space. This might sound like another
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snoozeworthy acronym for Practitioners and Examiners. It's the
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Bible for patenting. MPEP stands for Manual
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of Patent Examining Procedure. It's a 3000 plus page
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manual published by the United States Patent and Trademark Office, produced by examiners,
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applicants, attorneys and agents. It is the reference guide for
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Practices and procedures for the prosecution of patent apps before the USPTO.
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Patent practitioners use the MPEP as a handbook of rules for
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drafting a patent application and examiners use the MPEP guidelines
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to decide whether to grant or reject the application. Along with patent
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laws and rules, the MPEP also attempts to explain the Patent Office's
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stance on current patent case law. In case you have trouble sleeping,
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we've linked to the MPEP in the show notes. As it often does,
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a lot of nuance comes down to understanding the difference between the spec or specification
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versus the claims of a patent application. We review this
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distinction in great depth in our patent anatomy episode from season one,
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but in brief, the specification describes the invention and provides
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context for interpreting the claims, whereas the claims are the heart of the
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application and point out the exact invention boundaries of the idea space
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the applicant believes she's entitled to own. Panel also
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uses the terms genus and species when talking about the breadth of a claim,
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much like the traditional definitions of genius being a group defined by common
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characteristics in a species being a logical division
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of a genus. In chemical, biotech and pharma patents,
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a genus claim covers a group of related chemicals,
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whereas a species claim covers a single compound without coverage of analogs
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derivatives or compounds in the same family. Inventors ideally want
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the broadest umbrella possible with genus claims,
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but a big question explored in this episode is what does that require from
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an enablement perspective? In the final bit of patent ease before
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handing you off to the panel is the concept of Marcosque groups.
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This is a claim drafting technique used to COVID multiple related alternatives
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or species in a single claim. It can appear in a patent with language like
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selected from the group consisting of A, B and C.
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The elements of the group must share some common characteristics and allow the group
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to be treated like a substitute variable. It is considered a closed
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group, though, so the variable can only be one of those things when claimed in
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that manner. For today's conversation, the practical application is using
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Marcos groups to specify groups of related chemical
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compounds. If you'd like to know more about Marcoche group instructions,
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please check out our blog post on how to read chemical and drug patents linked
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in the show notes. All right, hopefully you're now sufficiently
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enabled to enjoy the episode. Take it away, Dave.
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Well, I'm going to jump right in because I
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think that in a way, I could breeze
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right through this. But at the same time, I think it would be more
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interesting and fun if anybody has any comments or
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stories or examples of their own to, like,
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add in as we go. I don't have, like, specific prompts for
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places for that. So please, like, if you think of
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something or have something to mention,
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please do, please join. And I
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will. And don't laugh too hard. I've worked in Predictable Arts 99.99%,
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so I'll add some stupid questions for you. Great, that's perfect.
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So I thought, especially since for the
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podcast and the broader audience out there, we'll start at the beginning,
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we'll start at Enablement and the MPEP.
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We'll go through what is a predictable versus an unpredictable technology?
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How can we think about that? And then the meat of this is really two
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sections, chemical and biological technologies, which are
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basically the way that in this context are very similar.
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And then something actually interesting in a
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related vein, although not exactly unpredictable per se,
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is emerging technologies and the enablement requirement there, which is
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actually a little bit different. So M Pep
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21 64, what is enabling?
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So this is what we call 112 A. And in the specification,
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you describe how to make and use the invention.
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And that's a requirement. You have to enable someone
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to be able to make and use the invention in order for the
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patent office to grant you as a parent and a nice piece
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of case law that a lot of people kind of fall back on when they're
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thinking about this. How to determine whether or not you've met
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that far, is the test of enablement, is whether one reasonably
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skilled in the art a positive could make,
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use, make or use the invention from the disclosures in the
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patent coupled with information known in the art without
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undue experimentation. And that's really a key
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phrase. And what does that mean, undo experimentation? It's a
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bit vague, but there's been a lot
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of case law around this. And essentially,
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if there is a number of
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finite possibilities that someone could explore,
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then that may not be that
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it would be enabled if it's only a small number of possibilities.
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But if somebody had to do a lot of experimenting to figure something
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out how to make something that worked, then that would be undo
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experimentation. Again, quantitatively, that's a little bit of
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a tricky thing to unravel, but that's
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the idea behind it. Is this why you use
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Marcus groups so often in this art?
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Sometimes in some ways, yes. I think not.
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Maybe so much for enablement, but because you want the
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scope of your claim to be broad, but you also want it to
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be specific, because if you make something too raw,
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then you risk not enabling things. So by listing a specific list of
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things for each one of those things you know is enabled because it's described
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well, that can help you get the best
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practice, have everything enabled.
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Okay, interesting, because I think I could say I went 15 years never
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using it because it's not useful in predictable ours,
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but I see it everywhere in this space.
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It's a good point, I didn't think of it that way. But as we go
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through things, we can talk about that. I'm like how Marcus group may have
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been better than some of these other claims which were invalidated for
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lack of enablement. Well, and then
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too, even some countries, we've even been seeing that some countries, even with kind of
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Marcos groups, they're not okay with it if
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you don't have enough support for all
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the various types of and stuff. That's pretty routine, like detergents
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and things like that. They don't like it if you don't have more experimental
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support for some of those other classes. So that's kind
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of an interesting thing too. Right?
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So this I thought was pretty interesting. Same section.
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A subsection of this in the MPPP 21 64.3
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is a relationship of predictability of the art and the enablement
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requirements. So these are quotes now, right, from the MPEP.
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The amount of guidance or direction needed to enable the invention is
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inversely related to the amount of knowledge in the state of
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the art as well as the predictability in the art.
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So determining predictability or
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determining how much enablement you need,
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actually you have to go back and know about the art. You need
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to know the state of the art, how much knowledge is out in the art,
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what a Posito would reasonably know. And that's really
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the crux, I think, of both these unpredictable arts and the
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emerging fields. So another
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quote, the predictability, or lack thereof, in the art refers to the ability of one
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skilled in the art to extrapolate, to disclose our known results
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to the claimed invention. So in the field of chemistry,
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there may be times when well known unpredictability of chemical
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reactions will alone be enough to create a reasonable doubt as
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to the accuracy of a particular broad statement put forward
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as enabling support for a claim. I think through
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examples this will all become more clear. But I
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think the important takeaway here is this is in the MPEP,
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this is not sort of like something that's kind of
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come out has come out in case law. But it's
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explicitly in the MPEP as well that there is
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actually a different bar for different fields depending
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on the state of the art as well as the predictability of
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the technology. And so the scope
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of the required enablement varies adversely with the degree of unpredictability
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involved. But even in unpredictable
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arts, a disclosure of every operable species is not
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required. So this is something we're also going to talk about then. How do you
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do this? Extrapolating and teaching
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you can enable someone to create a
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whole slew of compounds, let's say by a number of examples and then
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also instructions or some information,
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some description about how to extrapolate between those examples to
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arrive at all of the other examples that may be in abroad
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definition. So as we said, chemical and
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biological chemical species with substitutable
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groups is sort of the main example of this. And we're
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going to talk a bit about that as we go through these examples. But also
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in emerging technologies, new fields, even if they're predictable,
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need more description to satisfy their disclosure obligations
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and more mature fields. So for example, broad claims that
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cover different embodiments need to have all of those variations
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enabled with a sufficient description. And as we get
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into the emerging technologies examples, you're going to see a pattern that
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arises there where someone tried to claim a genus
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and there are several species under the genus. One or two of those species
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was described really well and a couple of the other species were not described
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very well and the entire claim can be invalidated
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because of that. So the other thing that's really important
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for this is thinking about the terms and really
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what is the scope of this claim and is everything that
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this claim covers sufficiently enabled? It's kind of the crux
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of it. Okay, so now some fun examples.
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Predictable. What is predictable? So in
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a very famous example of a predictable
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technology, which is physics, physics, mechanical inventions
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are often pointed to as being predictable. So in 1916,
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Einstein published his theory of general Relativity, which said
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that mass curves, FaceTime all on paper, all equations,
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took three years. But three years later, in 1919,
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English scientists led by Sir Arthur Eddington traveled to
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Africa to observe a total solar eclipse which confirmed that the
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light from stars was bent by the gravity of the sun.
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So there's even older examples of this.
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The orbit of Neptune famously
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was predicted by the
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other planets around it having strange orbits which
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must have been affected by another mass that someone could tell was there.
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So these are predictable. And I'll tell you one other because
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I think it's very interesting, but it's also personally related.
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Also in 1009, Einstein predicted that gravity traveled
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in a wave and this one took 100
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years to prove. But LIGO, the Laser Interferometer
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Gravitational Wave Observatory, confirmed the observance
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of gravitational waves in 2016. And this
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is personal for me because this was the project that I worked on
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in grad school. I was designing photo
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detectors for LIGO and there you can see some pictures of
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these facilities. There's one up in Hanford, Washington. There's one
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in Livingston, Louisiana. These interferometers
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are Lshaped devices that
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each arm of the interferometer is 4 km long
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and the entire path of the laser is all under
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vacuum. And so these are just massive, massive installations.
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And you can see the data on the right, which was the observation of the
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first gravitational wave event, which I believe was two
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black holes or black holes or neutron
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stars smashing into each other. They are orbiting
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around each other and at the end, right before they coalesce
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into each other into one, they spin around each other so
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fast that they give off massive amounts of energy in the form
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of gravitational waves, which is what was observed. But the crazy thing
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is why it took so long to find is that the effect
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is so small. I know you can see on those plots but the
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screen is ten to the -20 1st so over
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4 distance the relative change in
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the length of the arm is one one zero of
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the diameter of the nucleus of an atom
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like ten to the -20 first meters extremely that's insane.
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It is insane. A lot
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of technology. How did they like
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I imagine like you get so much noise in that system,
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how do you pair together? That's what was causing that
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exactly right. And that's probably like more than what
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we have time for today. It is. I'll give you a short answer though.
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So there's these plots, and these are the plots that the
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people who made these systems were using, where you have a
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frequency spectrum of noise and there's like
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thermal noise up at really high frequencies, there's like ground noise
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at low frequencies. But there's a frequency band right in the sweet spot
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where you can through seismic isolation and
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all kinds of advanced optics and really advanced
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systems. It's active, active noise reduction and stuff like that.
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They can get the noise in certain frequency bands down low
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enough where they can see certain types of gravitational events.
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Yes, but also even in those bands,
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one big reason why there are two installations,
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two detectors so far away from each other is they wanted to rule
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out a local event, you know, so if it's something
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local up in near Hamford, Washington, Livingston, Louisiana wouldn't
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see the same signal. But the signals were exactly the same
18:42.340 --> 18:45.892
and they were offset by exactly the amount of time that you would expect.
18:46.015 --> 18:49.197
So there's also other detectors like in Europe,
18:49.242 --> 18:52.672
there's one called Virgo and there's one, I think in Japan as well
18:52.705 --> 18:56.750
now. And so kind of just like with
18:58.387 --> 19:01.807
earthquakes and seismometers, you can triangulate the
19:01.810 --> 19:05.542
position, you can triangulate where the gravitational wave event came
19:05.590 --> 19:09.512
from by the lag by when the detector is detected.
19:10.762 --> 19:15.202
When we lived in the Tri Cities, we toured the
19:15.220 --> 19:18.972
LIGO. Yeah. Neat. Oh, my gosh.
19:19.092 --> 19:22.282
It was something amazing, right? I know, it was amazing.
19:22.360 --> 19:25.047
I spent most of my time in the lab trying to make photo detectors.
19:25.092 --> 19:28.492
But two or three times a year I get to go to the sites and
19:28.540 --> 19:32.332
help them with a science run or for a meeting or
19:32.335 --> 19:35.472
something. It's so amazing to see it. And it's
19:35.517 --> 19:38.612
all in the ground, the whole observatory,
19:39.712 --> 19:43.027
like the pipeline or whatever they're calling it.
19:43.045 --> 19:46.177
It was very interesting. Yeah. Super neat, right?
19:46.195 --> 19:52.017
Yeah. So predictable physics
19:52.077 --> 19:55.372
is predictable, like proven time and time
19:55.405 --> 19:59.112
again. On the other hand, organic molecules,
19:59.187 --> 20:01.662
especially those with biological effects,
20:01.737 --> 20:05.122
are unpredictable. And so that's what
20:05.155 --> 20:08.242
we're going to dive into now. So starting
20:08.290 --> 20:12.097
with that, starting with chemical and biological technologies, it can be
20:12.130 --> 20:15.897
difficult for a skilled person to predict which functional activity a chemical
20:15.942 --> 20:19.672
or biological substance may possess. So this
20:19.705 --> 20:23.982
has some advantages in the patent space. So a newly found substance
20:24.072 --> 20:27.457
and its use is more likely to be deemed not obvious
20:27.535 --> 20:31.237
to the person. So that would be patentable over,
20:31.300 --> 20:35.450
you know, what's called so called business or 101, so 103.
20:35.812 --> 20:39.277
But it also creates a burden. So when you try to claim a
20:39.295 --> 20:43.792
group of compounds providing one synthetic route and
20:43.840 --> 20:47.302
the activity data of one compound may not be sufficient to support the
20:47.320 --> 20:50.872
assumption that all claim permutations of a certain compound can
20:50.905 --> 20:53.612
be synthesized and are active.
20:54.412 --> 20:57.657
So another kind of general rule.
20:57.747 --> 21:00.967
I'm going to use these molecules for the next couple of slides to talk about
21:01.015 --> 21:03.200
this in a little more detail.
21:03.787 --> 21:07.762
There's a known kind of law
21:07.825 --> 21:11.662
rule in patents in the US and around the world where
21:11.725 --> 21:16.122
a generic formula does not necessarily inherently disclose
21:16.167 --> 21:20.002
the specific compounds falling under the formula. You might
21:20.020 --> 21:24.267
say to yourself, really? That seems odd. But if you take it to its extreme,
21:24.402 --> 21:28.347
it makes sense because really no future chemistry
21:28.392 --> 21:32.062
invention would ever be possible. Since all conceivable compounds fall
21:32.125 --> 21:35.872
under one known generic formula or another, we take
21:35.905 --> 21:39.727
it to the extreme. More useful. Maybe a specific
21:39.820 --> 21:43.602
example is what we're showing here with a generic formula
21:43.632 --> 21:47.652
and then these two other compounds which were modified
21:47.757 --> 21:51.127
from it. So this case actually
21:51.220 --> 21:55.132
came from the German Supreme Court. It's a really good example,
21:55.210 --> 21:58.647
I think, of these principles. The generic formula
21:58.692 --> 22:02.712
One does not disclose this claimed compound,
22:02.787 --> 22:06.867
Olenzapin, which is number two, claimed compound
22:06.927 --> 22:10.632
one. There on the left, you can see a bunch of rings and other sick
22:10.647 --> 22:14.377
things coming off of it. But the important pieces for this discussion are that
22:14.395 --> 22:17.782
there are two variable groups in that compound, r One
22:17.860 --> 22:21.522
and R Two. The claim compound, a lensbin
22:21.567 --> 22:24.837
had for R One, nothing, just a hydrogen,
22:24.987 --> 22:28.542
and for R Two, it had a methane. Another compound
22:28.602 --> 22:32.167
from the art flumezapine has the same
22:32.215 --> 22:36.402
methyl group in R Two. But on R one, it has a fluorine.
22:36.582 --> 22:40.662
And so the question before the Supreme Court was, is compound
22:40.737 --> 22:44.112
two, the claimed compound rendered obvious by compound
22:44.187 --> 22:47.527
three? So in order to figure that out, you have to go back to
22:47.545 --> 22:51.402
the prior art. This also relates with enablement, but it's easier
22:51.432 --> 22:55.297
to talk about for obviousness first.
22:55.480 --> 22:58.582
So when you look at the art, the activity data in
22:58.585 --> 23:02.122
the prior art, all leads one
23:02.155 --> 23:06.492
to believe that fluorine would enhance the biological
23:06.627 --> 23:10.337
efficacy of this compound. In this case, it was an antipsychotic.
23:11.287 --> 23:14.767
And I think very importantly too, the prior art
23:14.815 --> 23:18.202
had no individualized compound under the
23:18.220 --> 23:23.122
generic formula one that was not halogenated. So basically
23:23.305 --> 23:27.067
the prevailing wisdom in this space was
23:27.115 --> 23:30.567
that fluorine, fluorogeneted, halogenated compounds
23:30.627 --> 23:33.522
were beneficial,
23:33.642 --> 23:36.927
improve the efficacy. So a person of skill
23:36.957 --> 23:40.747
in the yard, a positor, had no reason or incentive to
23:40.780 --> 23:44.562
modify compound three to compound
23:44.637 --> 23:48.442
one with no halogen. And therefore they found it that
23:48.640 --> 23:51.512
it was not obvious and it should be allowed.
23:51.862 --> 23:56.047
How this relates to enablement is
23:56.230 --> 23:59.947
if you general compound one,
24:00.055 --> 24:03.727
if you tried to claim that you
24:03.745 --> 24:07.872
would need to show and enable every variation
24:07.917 --> 24:11.232
of R One and R two, and if you showed a bunch
24:11.247 --> 24:14.542
of examples, let's say, and they were all fluorinated or halved needed,
24:14.665 --> 24:18.137
that wouldn't necessarily enable
24:18.937 --> 24:22.797
compound number two. Or from the other perspective,
24:22.842 --> 24:25.175
it doesn't make compound number two obvious.
24:26.962 --> 24:28.250
Does that make sense?
24:30.637 --> 24:33.200
Is there a be following at this point or is there any questions?
24:34.462 --> 24:38.167
I think the one question I have for you David, is do you believe then
24:38.215 --> 24:42.822
there's kind of this. I feel like at one point broader
24:42.867 --> 24:46.867
claims were allowed that maybe you didn't have
24:46.915 --> 24:50.062
support for all the different permutations under
24:50.125 --> 24:53.947
it, but if you showed enough like a
24:53.980 --> 24:56.422
fourth of the possibilities or something,
24:56.605 --> 25:00.147
then that was enough. But it seems like we're shifting
25:00.192 --> 25:03.682
towards this like these some of you are saying the death of the
25:03.685 --> 25:07.447
genus claim. Do you think that's really happening? And you think that's a good
25:07.480 --> 25:11.047
thing or a bad thing? It's a great question and
25:11.080 --> 25:14.617
you know, I don't have a solid answer like with
25:14.665 --> 25:17.827
case law etc. These cases we're looking at here are
25:17.845 --> 25:21.352
all from mainly or from like 20 08 20
25:21.370 --> 25:24.697
09 so it hasn't changed much, I'd say, in the last
25:24.730 --> 25:28.192
sort of decade. So everything that we've been sort of
25:28.240 --> 25:31.947
taught, I think still holds. It's not like there's been a change recently
25:31.992 --> 25:35.722
or anything. So that's sort of the first comment. But I
25:35.755 --> 25:39.702
think putting together best practice from what I've looked at in the prior
25:39.732 --> 25:42.967
art, even the MDP says you don't have
25:43.015 --> 25:46.332
to describe every single variation.
25:46.497 --> 25:49.597
However, what I think
25:49.630 --> 25:52.467
best practice is to extrapolate,
25:52.527 --> 25:55.407
to explain to someone how to extrapolate.
25:55.572 --> 25:59.877
So by saying R one, let's say for instance, can be halogenated,
25:59.907 --> 26:03.382
but it doesn't have to be Halloween, things like that.
26:03.535 --> 26:07.072
Extrapolate some guidance about which compounds fall in
26:07.105 --> 26:09.500
and which compounds don't and why they all work,
26:10.762 --> 26:14.242
I think is the best way to go.
26:14.365 --> 26:17.602
But your question is valid, and I think it's a bit of
26:17.620 --> 26:21.502
a gray area that comes down to, unfortunately, I think the
26:21.520 --> 26:25.387
individual examiner that you may be dealing with, but also probably
26:25.525 --> 26:29.647
in some cases, and it may be in many cases, something that would really
26:29.680 --> 26:32.537
come out in litigation, not so much in prosecution.
26:33.412 --> 26:36.742
Yeah, that's fair. I think it'll be interesting to see kind of what happens
26:36.790 --> 26:40.327
longer term with some of these, especially the chemical the chemical side
26:40.345 --> 26:43.100
of the world and what happens over time if, you know,
26:44.062 --> 26:47.150
you can show support for some and some guidance, like you said.
26:47.962 --> 26:50.750
Is that going to be enough for the courts, or do we have to do
26:51.187 --> 26:54.847
more? What I think is how
26:54.880 --> 26:58.062
I'm starting to think about this and putting this together for me is really helpful,
26:58.137 --> 27:02.167
is that it really I think there is some general kind
27:02.215 --> 27:05.847
of logical logical
27:05.892 --> 27:09.417
tool, logical questions you can ask yourself. Looking at a claim
27:09.477 --> 27:13.850
language, would someone be able to make and use every
27:14.437 --> 27:20.872
variation that I'm describing here, including synthesis and
27:20.905 --> 27:24.447
including is it enabled? Have we shown that every variation
27:24.567 --> 27:28.527
has efficacy? That generic
27:28.557 --> 27:32.197
compound on the left with R one and R two? Considering how
27:32.230 --> 27:35.900
many things r one and R two could be, I think having
27:39.037 --> 27:42.477
you know, I'm not that familiar
27:42.507 --> 27:45.802
with antipsychotics, so I'm not sure what a good example there would
27:45.820 --> 27:50.362
be. But, you know, putting the enough
27:50.425 --> 27:53.782
description that you not only have, like you said, maybe a
27:53.785 --> 27:57.132
quarter or some reasonable fraction of concrete examples,
27:57.147 --> 28:00.967
but also logic. Logic and
28:01.090 --> 28:04.732
direction for how to extrapolate between them to arrive at anything
28:04.810 --> 28:08.542
that you're claiming, you know? Yeah, I think. Interesting point.
28:08.590 --> 28:12.277
Do you think it's, you know, because some would argue that a person's skilled in
28:12.295 --> 28:16.027
the art to make and use a claim just has to
28:16.045 --> 28:19.777
be able to, based on the claim language and the stuff in the spec
28:19.945 --> 28:24.042
has to be able to make one chemical
28:24.102 --> 28:27.862
that fits the bill. But you also kind of said something interesting. You said somebody
28:27.925 --> 28:30.657
would have to be able to kind of make all the permutations.
28:30.822 --> 28:34.267
So do you think we need to enable them to make
28:34.315 --> 28:38.302
one, or do you think we need to enable them to make all the
28:38.320 --> 28:40.037
things that falls under the claim?
28:42.637 --> 28:46.027
There may even be some quotes from some case law that support that.
28:46.120 --> 28:49.207
But everything that I've been reading says yes.
28:49.285 --> 28:53.302
Not only supporting what the compound is and
28:53.320 --> 28:57.172
all variations, but also how to make you need how to synthesize them
28:57.280 --> 29:00.697
and how to use them. What the biological efficacy is.
29:00.730 --> 29:04.642
Not just for some example, but really, somehow not
29:04.690 --> 29:07.897
necessarily writing explicitly each one,
29:07.930 --> 29:12.147
but teaching someone how to extrapolate or interpolate,
29:12.192 --> 29:16.102
if you will. No, that's interesting. I would agree based on what
29:16.120 --> 29:19.257
I've heard and seen, you know what I mean? So it's interesting I think there's
29:19.272 --> 29:21.457
been a little bit of a shift over, like, set up with me in the
29:21.460 --> 29:24.142
last couple of decades in that direction. But yeah,
29:24.190 --> 29:27.642
interesting. So what we're about to talk about is KSR.
29:27.777 --> 29:31.327
And I think KSR is very confusing in this world.
29:31.420 --> 29:34.927
So KSR, that was
29:34.945 --> 29:39.725
a German case shifting over to the US. Case in 2007,
29:40.162 --> 29:44.122
famous landmark US. Supreme Court case was
29:44.230 --> 29:48.622
really putting more guidelines around. What does it mean to be obvious? And so
29:48.730 --> 29:52.252
what KSR establishes there does not need to
29:52.270 --> 29:56.202
be an explicit motivation in the prior art to modify teaching
29:56.232 --> 30:00.202
to arrive at a claimed subject matter. So what
30:00.220 --> 30:04.257
it did say is if there's a finite number of identified predictable solutions
30:04.347 --> 30:08.150
that could lead to the claimed solution, then it is likely obvious.
30:09.187 --> 30:13.467
However, the underlying technology behind KSR
30:13.527 --> 30:17.277
was from a predictable art. It was a mechanism for combining an electronic
30:17.307 --> 30:20.637
sensor with an adjustable automobile pedal.
30:20.787 --> 30:24.547
So all elements and their functions were
30:24.580 --> 30:28.327
known. And the result of a combination of those things
30:28.345 --> 30:30.275
was predictable and hence obvious.
30:31.987 --> 30:35.902
The courts have since clarified this
30:36.070 --> 30:39.912
specifically for chemical and unpredictable
30:39.987 --> 30:43.527
arts. And so the CIFC at least has ruled
30:43.557 --> 30:47.077
that there still needs to be some reason motivation to modify a
30:47.095 --> 30:50.617
starting compound to arrive at the claim compound. So this is,
30:50.665 --> 30:54.852
I mean, I think this is interesting and this is possibly
30:55.032 --> 30:58.417
partially where the gray area and confusion comes
30:58.465 --> 31:01.992
from. Is that's basically exactly the opposite of what KSR
31:02.052 --> 31:05.662
says? Right? No motivation is needed.
31:05.725 --> 31:08.902
And they say, well, no, in some cases a motivation is needed.
31:09.070 --> 31:12.547
So here's an example of this case. I think we actually have covered this
31:12.580 --> 31:15.747
one before. The ESI versus Dr. Reddy's Laboratory.
31:15.792 --> 31:20.382
Inteva. Tiva Pharmaceuticals. The CASC
31:20.547 --> 31:24.582
found soapprozole
31:24.672 --> 31:27.582
was known from the art and a very similar compound,
31:27.672 --> 31:31.917
Leperazole, was claimed. And interestingly
31:31.977 --> 31:35.322
again, the known compound was halogenated,
31:35.367 --> 31:39.012
had those three fluorine down there on the right bottom corner.
31:39.162 --> 31:42.877
But the claim compound did not have the
31:42.895 --> 31:46.942
fluorine, was not halogen needed. And so the CASC again found
31:47.140 --> 31:51.072
did not find any motivation in the art to substitute the active groups.
31:51.192 --> 31:55.122
And quote from that case, the record shows no discernible
31:55.167 --> 31:58.822
reason for a skilled artist. And to begin with, the lens soap resolve only to
31:58.855 --> 32:02.307
drop the very feature, the fluorinated substituent
32:02.397 --> 32:06.217
that gave this advantage advantageous property.
32:06.415 --> 32:10.492
So, you know, this kind of again, to me this shows that
32:10.690 --> 32:14.277
if someone had described this class of compounds
32:14.307 --> 32:17.872
and said it could be halogenated, but by the way, it doesn't have to be
32:17.905 --> 32:20.932
halogenated, it can have this group at the end, it could have that. Because it
32:20.935 --> 32:24.342
could have a metal, it can have that. I think there's a reasonable
32:24.402 --> 32:28.312
pretty good chance that this case
32:28.375 --> 32:31.497
specifically would have come out differently.
32:31.617 --> 32:35.127
But since it's
32:35.157 --> 32:39.217
acknowledged that these fields are unpredictable and small changes
32:39.415 --> 32:43.767
can change the efficacy in ways that are not easy to discern
32:43.827 --> 32:47.152
beforehand, bias one skilled in the art. This was this
32:47.170 --> 32:50.917
was deemed non obvious. And again, I think it's a good
32:50.965 --> 32:54.457
illustrative example when you think about enablement. How do you enable a
32:54.460 --> 32:58.377
class of compounds to have all kinds of different groups
32:58.407 --> 33:02.182
at the end? And not only I think and this is where
33:02.335 --> 33:07.177
you're getting into possibly what
33:07.195 --> 33:10.387
I was going to say is not technically the best
33:10.450 --> 33:13.617
case, but this way the best case you would have not only you would describe
33:13.677 --> 33:17.737
structures you'd also describe how to synthesize all of those and
33:17.800 --> 33:21.012
that they would still have biological efficacy,
33:21.087 --> 33:23.542
which, if you think about it, in this case, it's a pretty high bar.
33:23.665 --> 33:27.127
How do you know if it's going to be an antipsychotic or not?
33:27.295 --> 33:30.442
So it makes it pretty difficult for people to just
33:30.640 --> 33:34.297
claim a whole bunch of compounds without actually going through and having
33:34.330 --> 33:38.347
the data. I think that's where sometimes this is equated with
33:38.380 --> 33:42.487
experimental data. I think that's an example of how experimental data
33:42.550 --> 33:46.737
can be required almost at some point in order to really fully enable
33:46.812 --> 33:51.142
something. So if you do enable something in your spec like that,
33:51.265 --> 33:54.702
you have what you need, but you also have some description
33:54.732 --> 33:58.302
for some things that are not exactly fully covered
33:58.407 --> 34:01.262
correctly. They're just kind of listed elements.
34:01.987 --> 34:05.825
What about arguments around unexpected results? If you have
34:06.712 --> 34:10.312
data in your spec that isn't necessarily talked
34:10.375 --> 34:14.092
about, but it's put in there as experimental data,
34:14.290 --> 34:17.857
can you make those arguments and come out
34:17.935 --> 34:21.412
on top? Are you asking would that data possibly be
34:21.475 --> 34:25.477
enabling or those it
34:25.495 --> 34:27.350
could be. I think it comes out of the case.
34:29.662 --> 34:33.292
Do you really need experimental data to prove that
34:33.340 --> 34:37.362
something has antipsychotic effects? This is an ulcer
34:37.437 --> 34:39.200
to pre ulcers, right?
34:41.442 --> 34:45.427
A it's good question. Do you actually need to prove it
34:45.445 --> 34:47.975
with experimental data, or is a statement enough?
34:49.987 --> 34:53.697
Okay. Yeah. I mean, I only ask because when I get into that territory,
34:53.742 --> 34:57.132
I actually think this is the worst possible thing I could be arguing.
34:57.222 --> 35:00.262
But it's all I have. Right, right, exactly.
35:00.400 --> 35:03.757
And I think especially some of the later cases are going
35:03.760 --> 35:07.327
to see things exactly in that camp where
35:07.495 --> 35:10.962
there was a couple of things that were described really well, but the claim
35:11.037 --> 35:14.982
language was broader and covered things that weren't described
35:14.997 --> 35:18.282
that well, and they were invalidated for lack
35:18.297 --> 35:22.392
of enablement. So I think it's definitely something like you said in the specification
35:22.527 --> 35:26.022
and making sure the description is good, but then really looking at the claim language
35:26.067 --> 35:30.142
and being like, what how broad is this and what
35:30.190 --> 35:33.050
should we go after? What do we really have here?
35:34.762 --> 35:38.617
Okay, I'd almost argue that I mean, it seems to me
35:38.740 --> 35:42.050
lately that statements are not enough in the spec,
35:42.712 --> 35:46.177
which is a huge burden, arguably, for inventors and
35:46.195 --> 35:46.862
labs.
35:50.887 --> 35:54.097
You could argue their choice right. For how much broad coverage do you
35:54.130 --> 35:57.717
want. But if you have to have even just some kind of basic
35:57.777 --> 36:01.827
kind of data for a number of compounds that delays
36:01.932 --> 36:05.497
how quickly you can move for any one
36:05.605 --> 36:08.312
particular goal.
36:11.962 --> 36:15.022
It's exactly right. There are some
36:15.055 --> 36:18.897
some benefits to being able to claim
36:18.942 --> 36:22.252
something is an unexpected result or nonobvious, but there
36:22.270 --> 36:25.672
are some large burdens with having
36:25.705 --> 36:29.227
to have the data. And I've actually, maybe as a quick aside, I've talked
36:29.245 --> 36:32.677
to some scientists in this field that's particularly scientists at
36:32.695 --> 36:35.812
startup and small companies that are like, this is super
36:35.875 --> 36:39.882
important and I'm so glad that the system is like that. Otherwise Dow
36:39.897 --> 36:43.297
and Dupont would have patented everything already. They could just
36:43.330 --> 36:46.882
list giant lists of compounds and just patent them without
36:46.960 --> 36:50.300
having data, without knowing if they work. And so,
36:50.887 --> 36:54.427
yeah, there's pros and cons, I think. Yeah,
36:54.445 --> 36:57.202
I think that's really fair. I think that was some of what you saw in
36:57.220 --> 37:01.042
the early chemical arts too. Not from all the different compounds, but one
37:01.090 --> 37:04.977
compound that they found works for some kind of condition
37:05.157 --> 37:09.342
and then they would list like paragraphs of other conditions
37:09.402 --> 37:13.242
that were like so cursorly related to the target condition
37:13.377 --> 37:16.422
that you're like. You have no idea if this is going to work for Ms
37:16.467 --> 37:17.975
and that there it is.
37:20.287 --> 37:24.127
Right. I would
37:24.145 --> 37:27.667
imagine that an examiner during
37:27.715 --> 37:30.952
prosecution is not going to be able to answer all those questions.
37:31.120 --> 37:34.477
There's not enough time, there's not enough motivation for them to
37:34.495 --> 37:37.552
do that. I don't even know if it's really in their marching orders, within their
37:37.570 --> 37:40.747
scope. You know, those sort of things I feel like,
37:40.780 --> 37:42.812
are most often come up in litigation.
37:47.062 --> 37:49.187
So unpredictable arts,
37:50.437 --> 37:53.952
detailed description and supporting examples summarizing
37:53.982 --> 37:57.472
that if you want to claim a class of
37:57.505 --> 38:00.937
compounds, you need to make sure the class is enabled over the whole
38:01.075 --> 38:04.777
range. You're in full possession of the invention on
38:04.795 --> 38:08.197
the filing date. This is related to something that we were talking about and that
38:08.230 --> 38:11.962
the activity of the underlying claim compound is also present over
38:12.025 --> 38:15.802
the whole range claimed. And that's really key. Like the
38:15.820 --> 38:20.457
claim language gets to be very important. There's a couple of examples
38:20.472 --> 38:23.382
of this before I kind of finish up this section.
38:23.547 --> 38:27.042
Additional examples. There's Abby versus Jansson,
38:27.177 --> 38:30.742
which was invalidated a claim for a class of
38:30.790 --> 38:34.377
antibodies. And there was no structural definition in the claim,
38:34.557 --> 38:38.622
no structural definition in the patent at all, only defined
38:38.667 --> 38:42.442
functionally in terms of certain dissociation constants at a certain
38:42.490 --> 38:45.717
binding sites. And the quote there was the claim scope
38:45.777 --> 38:48.847
reaches beyond what the inventors have contributed to the
38:48.880 --> 38:52.702
art. Right. This is the grand bargain in
38:52.720 --> 38:56.497
a way. You teach the world how to make and use something
38:56.680 --> 38:59.982
in exchange for a limited amount of exclusivity.
39:00.072 --> 39:04.192
So that after the patent term expires, you've now contributed something
39:04.240 --> 39:08.137
to the world. Whereas if you don't enable something
39:08.275 --> 39:11.842
now, you aren't really holding up your end of the bargain. And then
39:11.890 --> 39:15.972
therefore no patent for you. And Ya
39:16.017 --> 39:19.872
vs. Abbott. In a similar case, there was a broad genus
39:19.917 --> 39:22.737
claim with only one supported single compound.
39:22.887 --> 39:27.177
And what the opinion
39:27.207 --> 39:31.262
said in this case, and these are 20 13, 20, 14 cases, slightly more recent.
39:32.137 --> 39:35.527
In that case, the skilled person would have had to synthesize and
39:35.545 --> 39:39.297
biologically evaluate thousands of compounds to see if they have the claim
39:39.342 --> 39:42.725
properties. So that in
39:43.312 --> 39:47.052
the CAFC's opinion, in this case, evaluating thousands
39:47.082 --> 39:50.647
of compounds was undo experimentation. Now, if you only
39:50.680 --> 39:54.022
had to do ten or five or 100, where is that
39:54.055 --> 39:56.947
line exactly? I think it's hard to say. I think it may be case by
39:56.980 --> 40:00.552
case in some ways, but oh, and that was the Rapamycin
40:00.582 --> 40:03.852
case, which I think we've also talked about in other meetings
40:03.882 --> 40:07.402
that we have had. So, okay, talked a lot
40:07.420 --> 40:11.592
about the pitfalls, what to do, what do we do in unpredictable
40:11.652 --> 40:14.687
arts? I think in the specification,
40:15.262 --> 40:18.667
cover as much breads as possible with examples and data,
40:18.865 --> 40:22.417
both synthesis and activity, and also provide
40:22.465 --> 40:26.602
guidance in the description how to extrapolate from the examples given
40:26.695 --> 40:29.782
to the remaining scope. And now we're going to
40:29.785 --> 40:33.562
shift into emerging technologies. But another thing that's as
40:33.625 --> 40:36.457
important here, this is more I think this one really covers what to do in
40:36.460 --> 40:40.657
the specification, in the claims. It's really important to
40:40.810 --> 40:45.072
pick phrases and to claim things that are enabled.
40:45.117 --> 40:48.877
Think about the genus claim and all
40:48.895 --> 40:52.147
the species that go underneath that sort of a claim and are they really
40:52.180 --> 40:55.552
all enabled? If not, maybe you're better off with some kind of a
40:55.570 --> 40:59.197
marqueous group or narrowing in some other way
40:59.230 --> 41:00.875
to make sure that it is.
41:02.962 --> 41:06.387
So that was predictable and unpredictable.
41:06.462 --> 41:09.622
Biological and chemicals are really the main examples there.
41:09.805 --> 41:14.142
Emerging technologies is similar, it's a lot of overlated concepts,
41:14.202 --> 41:18.067
but it's a bit different in that the question here is
41:18.115 --> 41:21.672
how much does this patent specification rely on the knowledge
41:21.792 --> 41:24.817
of a person of ordinary skill in the art to
41:24.865 --> 41:29.152
provide support for certain claimed embodiments? If a technology
41:29.245 --> 41:33.172
is very new, there may be very little information
41:33.280 --> 41:36.637
out in the field and a positor in that field may actually
41:36.700 --> 41:38.912
not have very much knowledge.
41:39.712 --> 41:43.347
So you need to err on the side of disclosing
41:43.392 --> 41:46.717
more disclosing, more enablement. How is this
41:46.765 --> 41:49.925
made? All the different components that go into something
41:50.287 --> 41:54.172
naturally that can create a tension between a company's desire to
41:54.205 --> 41:57.457
protect valuable trade secrets versus the need to provide
41:57.535 --> 41:59.462
and enabling disclosure.
42:00.562 --> 42:03.897
So what is an emerging
42:03.942 --> 42:08.162
technology? It's hard to define.
42:08.962 --> 42:12.312
We'll go through some examples which I think are very illustrative,
42:12.462 --> 42:15.502
but even in the
42:15.520 --> 42:19.797
previous case it's a little bit difficult. It was unpredictable
42:19.842 --> 42:23.487
arts, it's a little bit difficult to know exactly how much enablement is necessary.
42:23.637 --> 42:27.447
Similar kind of questions occur here from a different perspective,
42:27.567 --> 42:31.237
not so much unpredictability. But if it's so
42:31.300 --> 42:34.702
new, there might not be a lot of information out there. You might need to
42:34.720 --> 42:39.072
put a little bit more background, a little bit more enablement
42:39.192 --> 42:43.177
of different components. And things like that of your systems than
42:43.195 --> 42:46.342
you would otherwise. So as we've been talking
42:46.390 --> 42:49.722
about and this is that predictable arts,
42:49.767 --> 42:53.917
historically predictable arts can be enabled by a single example.
42:54.115 --> 42:57.667
This was a landmark case in 1987 with which
42:57.715 --> 43:01.372
as spectrophysics versus coherent where they had where this was
43:01.405 --> 43:05.457
established. New fields, however, even if they're predictable,
43:05.547 --> 43:09.102
may not rely on knowledge of a positive to satisfy
43:09.132 --> 43:11.387
disclosure obligations to the same extent.
43:12.487 --> 43:15.747
And the example we're going to go through in a minute here is automotive
43:15.792 --> 43:19.612
Technologies versus BMW, which was the 2006
43:19.675 --> 43:22.912
case. And there's actually
43:22.975 --> 43:26.900
some recent cases from 2018 to 2019 which
43:27.562 --> 43:31.347
also deal with some newer
43:31.392 --> 43:36.547
emerging technologies and how
43:36.580 --> 43:40.647
to enable that such that a positive can make and use the entire claim
43:40.692 --> 43:43.362
scope without undo experimentation.
43:43.512 --> 43:47.242
So there's a couple of cases on that as well
43:47.290 --> 43:50.872
that I've listed there. But to
43:50.905 --> 43:54.282
dive into this automotive Technologies
43:54.372 --> 43:57.922
case, because I think it's very interesting, goes back,
43:57.955 --> 44:01.177
this was a 2006 decision, but the application
44:01.270 --> 44:05.422
was filed in 1092 in this case, found all
44:05.455 --> 44:09.477
claims in balance due to that lack of enablement. And it dealt
44:09.507 --> 44:13.297
with crash sensing devices in cars. So when
44:13.330 --> 44:17.247
airbags were deployed in 92, airbag deployment
44:17.292 --> 44:20.225
sensors were arguably still an emerging technology.
44:20.662 --> 44:24.352
And what's interesting in this case is that I have
44:24.370 --> 44:27.472
this claim on the next slide. There was a broad claim which covered a lot
44:27.505 --> 44:31.587
of different embodiments. The specification
44:31.737 --> 44:35.247
described an embodiment of the device utilizing a mechanical sensor
44:35.292 --> 44:38.797
in considerable detail. You can see those I pulled out some figures on the right
44:38.830 --> 44:42.567
there from the actual patent and all different kinds of mechanical
44:42.627 --> 44:46.557
sensors were shown. It also described using an electronic sensor,
44:46.572 --> 44:50.225
but included less detail, no figures and
44:50.587 --> 44:53.600
only a paragraph or two of explanation of that.
44:54.637 --> 44:57.937
I think this is even the thing that sticks out of my mind the most.
44:58.075 --> 45:01.632
At trial, an expert testified
45:01.722 --> 45:05.017
that a positive could use off the shelf components and well
45:05.065 --> 45:09.217
known circuit design and programming to create everything
45:09.340 --> 45:13.702
within the claimed scope. And I don't think that there was any argument about that.
45:13.795 --> 45:17.127
Off the shelf components, welldesigned circuit design, well known circuit
45:17.157 --> 45:20.827
design and programming, there was no
45:20.845 --> 45:23.437
argument about that. That was true.
45:23.575 --> 45:27.577
However, the CISC still said
45:27.670 --> 45:31.402
it was invalid due to lack of enablement. Because you look
45:31.420 --> 45:34.887
at this claim, the claim is a side impact
45:34.962 --> 45:39.142
crash sensor. It has a housing, it has a mass and then C
45:39.265 --> 45:43.327
means responsive to the motion of said mass upon acceleration of
45:43.345 --> 45:47.497
said housing in excess of a prefrontal threshold for initiating an
45:47.530 --> 45:50.827
occupant protection apparatus. So really all the
45:50.845 --> 45:55.012
claims said is means for initiating this
45:55.150 --> 45:59.047
airbag system. And they described in detail some
45:59.230 --> 46:02.572
possible ways to do that mechanically, but there are a lot of different
46:02.605 --> 46:05.932
ways to do that and they hadn't enabled all of them in the
46:05.935 --> 46:09.350
specification. Even though the
46:09.787 --> 46:13.447
sort of vague, let's say the minimal description that they
46:13.630 --> 46:17.452
did include could have been made using
46:17.620 --> 46:21.022
off the shelf components. It's still the
46:21.055 --> 46:24.852
claim language, I feel like really hurt them in this case. It was so broad
46:24.957 --> 46:28.747
and their disclosure was really focused in one area that they
46:28.780 --> 46:31.112
ended up losing the entire patent.
46:33.412 --> 46:37.057
Any comments about that one? This to
46:37.060 --> 46:41.047
me was very interesting and I thought it
46:41.080 --> 46:45.867
made me think a little differently about alternative
46:45.927 --> 46:49.497
embodiments. A client may have a main kind of angle
46:49.542 --> 46:53.442
that they're going after, described really well, all kinds of mechanical drawings,
46:53.577 --> 46:56.907
but you can also do it these other ways. If it's
46:56.922 --> 47:00.562
an emerging technology, if there's not a lot of information out there
47:00.625 --> 47:02.750
about the general space,
47:03.712 --> 47:07.632
having a broad claim that covers everything could be risky.
47:07.722 --> 47:11.307
You may want to one or the other narrow the claim
47:11.397 --> 47:14.952
or beef up the description of the other embodiments,
47:14.982 --> 47:18.427
even if you're like. This is all off the shelf. This is all known in
47:18.445 --> 47:21.832
this case, at least in the automotive technology case, that would have made a
47:21.835 --> 47:25.132
big difference. I think this kind of surprises me,
47:25.285 --> 47:29.752
honestly, because it does to me, this seems like a but
47:29.770 --> 47:33.800
I guess I would agree that the claim hurt them. But if you
47:34.687 --> 47:38.300
just think about the spec, it seems kind of crazy.
47:40.612 --> 47:44.137
I would consider this pretty highly predictable art,
47:44.200 --> 47:47.587
right? Yes. Emerging, but highly predictable. So it seems
47:47.650 --> 47:50.997
a little and if Kristin has anything coming from the more predictable
47:51.042 --> 47:54.772
side of the world, if you have any thoughts does this surprise you or
47:54.955 --> 47:58.327
whatever? Is it really just the problem of the claims? They went
47:58.420 --> 48:01.722
a little too crazy with the claims? Well, it surprised
48:01.767 --> 48:05.112
me because it's back from 92 and that in six they decided
48:05.187 --> 48:08.697
that this was why this was too broad
48:08.742 --> 48:11.675
and this was how we were going to knock this out of the water.
48:12.412 --> 48:15.532
That seems like a lot of time and a lot of tech time too,
48:15.610 --> 48:18.142
including electronics development. Right.
48:18.265 --> 48:22.047
Chips, semiconductors, etc. And so that's
48:22.092 --> 48:26.407
peculiar. But when you look at the claim language itself, it really
48:26.485 --> 48:30.800
is quite broad. And so when you begin to use a means
48:32.287 --> 48:36.587
responsive to the motion of the mass upon acceleration,
48:37.012 --> 48:40.642
that could be almost anything. So I guess
48:40.690 --> 48:43.972
what I do when I see claims like this and
48:44.005 --> 48:47.302
Ashley can attest to this because I'm always asking her, hey,
48:47.470 --> 48:50.062
do you know this could read on this, this or this?
48:50.125 --> 48:54.577
And she does the same to me. And it
48:54.595 --> 48:58.487
just makes you remember that be really careful,
49:00.187 --> 49:03.547
don't try to claim a cardboard cooler when you're really
49:03.580 --> 49:07.392
trying to claim a freezing device right. With all the electronics
49:07.452 --> 49:10.897
and what not. So even though this is a
49:10.930 --> 49:14.347
great first claim and a first idea
49:14.455 --> 49:17.977
of this is everything that's needed, you do have to ask yourself as
49:17.995 --> 49:21.847
a practitioner, as you go through just the claim that you
49:21.880 --> 49:25.252
wrote, what else does this read on? How else could
49:25.270 --> 49:28.897
this be taken? Because this to me, there's a lot
49:28.930 --> 49:32.107
of things that this could be. I think
49:32.185 --> 49:35.812
some of the other problem too that I've been realizing is I think
49:35.950 --> 49:39.597
there is this like ideal that everybody has that I want this really broad
49:39.642 --> 49:43.612
claim and blah, blah, blah. But honestly, the best and I think
49:43.750 --> 49:47.122
your presentation Dave, is kind of hitting at this, that the
49:47.155 --> 49:50.632
best claim is really one that is
49:50.710 --> 49:54.397
narrow to the product that you are developing that
49:54.430 --> 49:57.132
has significant commercial, patient,
49:57.297 --> 50:00.962
clinical, whatever impact, but is broad
50:01.462 --> 50:03.875
in every other aspect. Right.
50:05.812 --> 50:08.937
Like Chris and I have talked about this before. Like every catheter,
50:09.012 --> 50:12.427
for example, has X features. So you don't need to
50:12.445 --> 50:16.700
go nitty gritty in every single feature that every single catheter has.
50:17.287 --> 50:20.722
But is there one thing of your catheter that
50:20.755 --> 50:24.582
has clinical efficacy? Okay, so claim that narrowly,
50:24.747 --> 50:28.722
not crazy narrow, but within reason, and then leave everything else broad
50:28.767 --> 50:32.437
because at the end of the day, competitors are going to copy that
50:32.500 --> 50:35.472
one thing and stick it on their own catheter.
50:35.517 --> 50:37.927
That may be slightly different, but again, like a cater to the cabinet or the
50:37.945 --> 50:42.897
catheter, generally speaking. So keeping that in mind that broad
50:42.942 --> 50:45.275
claims aren't actually all they're cracked up to be.
50:45.787 --> 50:49.252
Yeah. What's the invention in a
50:49.270 --> 50:53.637
way, right? Yeah, exactly. Don't get lost in this lofty.
50:53.712 --> 50:56.837
And I think it's hard because I think market pressures, investors,
50:57.937 --> 51:02.067
all these things have this pressure on companies. You have to have this broad
51:02.127 --> 51:06.027
claim. It's like, well, but is that really the good decision
51:06.207 --> 51:10.550
or does that just look good on paper but ends up causing problems later?
51:11.512 --> 51:15.247
Yeah, that's exactly what this whole investigation has
51:15.280 --> 51:18.457
exactly made me start thinking of that way too. And I feel like in a
51:18.460 --> 51:21.517
way, this is something that I don't know,
51:21.640 --> 51:26.302
I've always thought this way and in some ways this is like I
51:26.320 --> 51:28.492
want to look at the prior art and I want to make sure that whatever
51:28.540 --> 51:31.702
we're claiming doesn't read on something in the art. And this is giving me
51:31.720 --> 51:34.332
another kind of perspective on it. I want to make sure that what we're claiming
51:34.347 --> 51:37.717
is actually also enabled, that we've taught someone
51:37.765 --> 51:40.972
how to make and use everything within the scope of this
51:41.005 --> 51:43.747
claim. Yeah.
51:43.855 --> 51:47.000
And I will tell you, even if a larger company
51:47.362 --> 51:51.087
got this broad claim, it's really typical
51:51.162 --> 51:55.042
of large companies who have a lot of money to spend on it to
51:55.090 --> 51:58.252
say, great, we got this nice broad claim, let's go a different direction with it,
51:58.270 --> 52:02.237
in a couple of continuations, just to protect the original.
52:02.662 --> 52:06.427
If for some reason like this happened, the original has gone away,
52:06.520 --> 52:07.175
Right.
52:12.187 --> 52:15.612
Very similar case actually. Dream or Citric?
52:15.762 --> 52:19.702
Individual inventor versus DreamWorks. Again, all claims were found in
52:19.720 --> 52:23.322
value due to lack of enablement. The claim
52:23.517 --> 52:27.327
was describing using integrating a user's
52:27.432 --> 52:31.677
audio or visual signal into a preexisting video game or movie.
52:31.857 --> 52:35.392
And the specification was 99%
52:35.440 --> 52:39.772
about video games. And then they also kind of mentioned movies and
52:39.880 --> 52:44.225
that's again, what hurt him here. The district court essentially said that
52:48.337 --> 52:52.672
it was lack of enablement as to movies but they didn't even
52:52.780 --> 52:56.062
talk about whether it would have been enabled for video
52:56.125 --> 53:00.522
games. And again, here's the claim language which it's
53:00.567 --> 53:05.197
just that the presentation output and
53:05.230 --> 53:08.902
it's this presentation output was vague and
53:08.995 --> 53:12.307
if it was a video game that may have gotten through, but since it
53:12.310 --> 53:16.102
was vague and movies and other types of presentation outputs were
53:16.120 --> 53:19.252
not enabled, it was invalidated. It's a very kind of
53:19.270 --> 53:23.450
similar thing. And so what to do in
53:23.812 --> 53:26.997
emerging arts and unpredictable arts.
53:27.042 --> 53:30.627
Again, cover as much breadth as possible with examples, provide guidance
53:30.657 --> 53:34.187
on how to extrapolate and additionally,
53:34.837 --> 53:37.712
I would say for emerging technologies,
53:38.137 --> 53:41.617
which will, as we've talked about,
53:41.665 --> 53:45.382
may be a little difficult to define precisely. But if
53:45.385 --> 53:49.332
you're working in a field that is relatively new, err on the side of describing
53:49.422 --> 53:52.897
things more completely, if even if something is off
53:52.930 --> 53:56.262
the shelf or a component or a circuit, it should be known,
53:56.412 --> 54:00.575
you know, in the description. Having a little bit more description in there
54:02.962 --> 54:06.887
would probably be a worthwhile use of resources.
54:07.687 --> 54:10.897
And then carefully consider the scope of the
54:10.930 --> 54:14.600
claim terms being construed and make sure that
54:15.637 --> 54:18.952
the bread is really this goal in the Goldilock situation. It's not
54:18.970 --> 54:23.077
too broad. It's not too narrow, but it's broad enough
54:23.170 --> 54:25.852
that I art is not going to read on it and it's narrow enough that
54:25.870 --> 54:29.557
it's going to be enabled. And then I
54:29.560 --> 54:33.667
think another thing that we often talk about with clients, but maybe even
54:33.715 --> 54:37.297
more applicable here is maybe
54:37.405 --> 54:40.942
in certain cases in order to fully enable something, you're going to have to give
54:40.990 --> 54:45.622
up too much. You're going to have to describe too many process
54:45.730 --> 54:49.422
parameters and other things that would not be reverse engineer
54:49.467 --> 54:53.527
able and therefore might be better kept as a
54:53.545 --> 54:57.007
trade secret rather than going into a claim in a
54:57.010 --> 54:57.662
patent.
55:00.112 --> 55:04.107
David, quick question. What's your thoughts
55:04.197 --> 55:08.825
on I just lost my train of thought on
55:09.862 --> 55:13.475
oh, pointing. So let's say you are an emerging field, right?
55:13.837 --> 55:18.672
What are your thoughts or have you seen pointing
55:18.717 --> 55:21.712
to some art? Like,
55:21.775 --> 55:25.402
maybe not, like pointing to you. Like, here's the perfect car to
55:25.420 --> 55:29.127
do exactly the same thing. Because ideally, that's not the case, especially with emerging.
55:29.157 --> 55:32.722
But pointing to certain art somewhere in the
55:32.755 --> 55:36.097
background that kind of lays the groundwork for this new emerging field
55:36.130 --> 55:39.322
to kind of set the stage that this is
55:39.355 --> 55:43.250
the shoulders that we're stepping on. And here's the state of it.
55:43.987 --> 55:47.150
Have you seen that or would you recommend that?
55:49.462 --> 55:53.077
Great question. More or less, I guess that's what some of the
55:53.095 --> 55:56.237
articles that I was reading were advising.
55:56.587 --> 55:59.257
Not in so many words, more between the lines, I guess.
55:59.335 --> 56:02.692
But yeah, from these last few cases especially,
56:02.890 --> 56:05.450
I think like, okay,
56:06.262 --> 56:09.622
it's 1992. Your average car,
56:09.655 --> 56:13.267
maybe no car has ever had an airbag in it so this is something new.
56:13.390 --> 56:17.152
And they said to themselves, everybody knows how to use an
56:17.170 --> 56:19.707
electronic circuit to trigger a squib,
56:19.797 --> 56:24.027
to then explode an airbag
56:24.057 --> 56:28.017
or whatever. But I think that they miscalculated.
56:28.077 --> 56:31.372
And I think what they would have been better served by doing would be,
56:31.555 --> 56:35.772
hey, this is a new system or sub system, and also here's
56:35.817 --> 56:39.537
a circuit, here's a chip that you can use to control a squib,
56:39.612 --> 56:42.007
or you could do it this way, or you can do it that way.
56:42.160 --> 56:45.672
Even though I think they were just relying
56:45.717 --> 56:49.327
too much on the
56:49.345 --> 56:52.627
prior art and not explicitly stating how to
56:52.645 --> 56:55.250
make it. How to make it, how to use it.
56:57.562 --> 57:00.882
Yeah. I think oftentimes when I've
57:00.897 --> 57:04.597
been in this situation and other people I've heard say if
57:04.630 --> 57:08.602
it's in the art, if you can point to a
57:08.620 --> 57:12.127
textbook, let's say, that has this information in it, then you don't really need
57:12.145 --> 57:15.297
to describe it in detail. And I think in some cases,
57:15.342 --> 57:19.062
it might actually be okay. Sure. In many cases
57:19.137 --> 57:22.332
it's probably good advice. And in some cases, though, in emerging fields,
57:22.347 --> 57:25.792
you might want to go that extra little bit and describe a little bit more,
57:25.840 --> 57:28.957
even if you're like, someone should know this.
57:29.110 --> 57:32.087
So I don't think hurts to be a little more comprehensive.
57:32.962 --> 57:35.617
Yes, I think it's one of those cases where this shouldn't be the case.
57:35.665 --> 57:39.237
I think it is. You have to remember your audience. And the audience isn't
57:39.312 --> 57:42.652
just the
57:42.670 --> 57:46.147
inventors, it's really the courts. And I
57:46.180 --> 57:49.897
would argue that historically, judges and things like that have
57:49.930 --> 57:53.857
not been as technology savvy as maybe they should be to be weighing in
57:53.935 --> 57:57.202
on these topics. So I think you have to kind of
57:57.220 --> 58:01.452
remember your audience to some degree. Yes, patents are supposed to be written
58:01.482 --> 58:04.852
for one of skill in the art, but I think they
58:04.870 --> 58:08.122
also need to be read for judges and attorneys and things like that that
58:08.155 --> 58:11.262
maybe aren't as skilled as a positive.
58:11.412 --> 58:14.692
So I think that's kind of the weird balancing I strike, too, is that,
58:14.740 --> 58:18.072
yes, it's written for positive, but it's also written for people who need to interpret
58:18.117 --> 58:21.382
it and make judgments on it when they're not a
58:21.385 --> 58:25.177
positive. Good point. Yeah, that makes sense.
58:25.270 --> 58:28.862
Absolutely. Well, and from my perspective,
58:29.287 --> 58:33.592
I never put prior art specific content
58:33.790 --> 58:37.432
in my spec. I never point to,
58:37.585 --> 58:40.747
like, in this patent or like in that textbook or as
58:40.780 --> 58:44.152
well known in whatever, if I need to say something like that in
58:44.170 --> 58:47.932
order to not, first, denigrate the art and second, tie myself
58:48.010 --> 58:51.382
to that piece of art like I do in
58:51.385 --> 58:54.772
Europe. Right. European style summaries have that they want
58:54.805 --> 58:58.437
to know the closest prior art and then begin at your invention.
58:58.512 --> 59:01.792
But I never do that. I was taught to never do that. It could only
59:01.840 --> 59:05.317
hurt you from a
59:05.515 --> 59:08.977
well, look at this disclosure. It talks about this and you've covered this and
59:08.995 --> 59:12.247
said, this is new. But this other disclosure talks about it even
59:12.280 --> 59:15.097
though it doesn't do exactly what you say, it talks about it. And that could
59:15.130 --> 59:18.502
just be a slippery slope. So what
59:18.520 --> 59:21.887
I do is I say conventional systems
59:22.387 --> 59:25.927
such as blah, blah, blah, perform this,
59:26.095 --> 59:29.652
and the claim to subject matter or the disclosure
59:29.682 --> 59:33.327
discarded herein does this instead or provides
59:33.357 --> 59:36.502
this improvement over conventional systems. And so
59:36.520 --> 59:40.072
if you seeded in that language, even the courts who go looking for things
59:40.105 --> 59:44.150
in your specification to either help you or harm you
59:45.262 --> 59:48.597
can lean on that. And they can say, well, look, this is what conventional
59:48.642 --> 59:51.877
systems do and make sure that's accurate, by the way. You can't just
59:51.895 --> 59:55.477
make it up. And what they're doing in
59:55.495 --> 59:57.950
this invention is quite different. And this is why.
59:58.912 --> 1:00:02.757
Right. The more you can lean on technical problems, technical effects,
1:00:02.922 --> 1:00:05.375
technical solution, the better you are.
1:00:06.712 --> 1:00:10.297
And like you said, not characterizing the prior art or
1:00:10.330 --> 1:00:14.002
any specific reference. Yeah, and then
1:00:14.020 --> 1:00:17.442
the other thing I had to add was just for a practice
1:00:17.502 --> 1:00:21.127
tip and things that I think as a draft in
1:00:21.145 --> 1:00:25.112
order to make sure everything is described fully in your specification.
1:00:25.762 --> 1:00:28.850
So let's take your example with the movie and the video game.
1:00:29.812 --> 1:00:33.717
If you are ever tempted to put a comma delimited
1:00:33.777 --> 1:00:37.867
list of something in your specification that should
1:00:37.915 --> 1:00:41.677
trigger you to think, do I really want to just list these things? Is there
1:00:41.695 --> 1:00:45.942
anything important in here where they should be broken out into single sentences
1:00:46.077 --> 1:00:49.752
or examples thoroughly done in full paragraph
1:00:49.782 --> 1:00:53.527
form, interesting? Or is it really okay to be a list? It's just a
1:00:53.545 --> 1:00:57.097
trigger and I don't always do it. It's a lazy thing
1:00:57.130 --> 1:01:00.442
that as practitioners and drafters, we just kind of go, yeah,
1:01:00.490 --> 1:01:03.350
and this and this and this and this, and move on. Right.
1:01:04.162 --> 1:01:07.702
But I do try to make myself think
1:01:07.870 --> 1:01:11.872
if there's something in that list I really should dive into instead of just
1:01:12.055 --> 1:01:15.350
list. Yeah. How similar are they really,
1:01:16.312 --> 1:01:20.047
that the list prevails? Or are you shoving things
1:01:20.080 --> 1:01:23.227
into a list that yeah, maybe shouldn't be?
1:01:23.395 --> 1:01:27.232
Yes, because we all do it. You take a
1:01:27.235 --> 1:01:30.362
shortcut because you're like, I am so done with this concept.
1:01:32.587 --> 1:01:34.325
20 chemicals in,
1:01:38.362 --> 1:01:41.287
you can't think of anything else you're like, yeah, at least the three. That's good.
1:01:41.350 --> 1:01:45.050
And maybe those three things should have been three paragraphs, not three words.
1:01:46.612 --> 1:01:50.352
Right. Exactly. Well, this is cool, Dave, I appreciate
1:01:50.382 --> 1:01:53.647
it. And now I know more about the LIGO. Now I have to go
1:01:53.680 --> 1:01:58.267
see one of those next
1:01:58.315 --> 1:02:01.477
meeting. I'll do a presentation on LIGO. I've got lots of slides on
1:02:01.495 --> 1:02:03.725
that. That's cool. Yes.
1:02:05.212 --> 1:02:07.550
Our son is really getting into space.
1:02:09.112 --> 1:02:11.827
We are going to go to NASA in two days. We went a couple of
1:02:11.845 --> 1:02:15.552
years ago, but he was too little to appreciate it. But yeah, so it's
1:02:15.582 --> 1:02:19.437
just we start seeing these huge centers
1:02:19.512 --> 1:02:23.587
set up to measure phenomena that are crazy
1:02:23.650 --> 1:02:25.775
far away. It's cool to see.
1:02:26.662 --> 1:02:29.692
When I send her a presentation, I'll send a link to a really short video
1:02:29.815 --> 1:02:36.132
that they made in kind of explaining
1:02:36.147 --> 1:02:39.472
what LIGO is and the great discovery that they made and everything.
1:02:39.580 --> 1:02:43.102
And, like, all the people in the video are people that I
1:02:43.120 --> 1:02:46.612
worked with when I was in grad school. So pretty fun.
1:02:46.750 --> 1:02:47.837
Superstar.
1:02:50.587 --> 1:02:54.650
Hundreds of people worked on it. Right. But it was still a great project.
1:02:55.537 --> 1:02:58.777
That's cool. That's like one of those
1:02:58.870 --> 1:03:01.775
grad school projects that you don't have to market very hard.
1:03:05.437 --> 1:03:09.112
Thank you, David. I really appreciate I appreciate you going into enough chemical detail
1:03:09.175 --> 1:03:12.562
that my high school chemistry and maybe one class of chemistry in college
1:03:12.625 --> 1:03:16.602
got me there. Thank you. The flooring.
1:03:16.707 --> 1:03:23.527
I got the halogen group. I got that awesome.
1:03:23.620 --> 1:03:27.397
Great. Thanks. All right, well, thanks again,
1:03:27.430 --> 1:03:30.157
Dan, and everybody, I guess, have the rest of the rest of your week.
1:03:30.310 --> 1:03:33.952
Thank you, Ashley. Enjoy your time. I will soak up some sun for
1:03:33.970 --> 1:03:37.717
all of you, I promise. All right,
1:03:37.765 --> 1:03:41.377
take care. Have a great week. Bye. All right, that's all
1:03:41.395 --> 1:03:45.397
for today, folks. Thanks for listening, and remember to check us out@aurorapatins.com
1:03:45.430 --> 1:03:49.662
for more great podcasts, blogs, and videos covering all things patent strategy.
1:03:49.737 --> 1:03:52.147
And if you're an agent or attorney and would like to be part of the
1:03:52.180 --> 1:03:56.002
discussion or an inventor with a topic you'd like to hear discussed, email us at
1:03:56.020 --> 1:03:59.827
podcast@aurorapatins.com. Do remember that this podcast does
1:03:59.845 --> 1:04:03.300
not constitute legal advice, and until next time, keep calm and patent on.
00:05.112 --> 00:08.572
Good day and welcome to the Patently Strategic Podcast, where we discuss all
00:08.605 --> 00:11.952
things at the intersection of business, technology, and patents.
00:12.057 --> 00:15.837
This podcast is a monthly discussion amongst experts in the field of patenting
00:15.912 --> 00:18.957
it's for inventors, founders and IP professionals alike,
00:19.047 --> 00:22.372
established or aspiring. In today's episode, we're looking
00:22.405 --> 00:26.077
into how to get more predictable results from the unpredictable arts. Think your
00:26.095 --> 00:30.237
innovation is sufficiently enabled to secure, defend, and assert your patent rights?
00:30.312 --> 00:33.522
If it's a biological, chemical, or emerging technology invention,
00:33.642 --> 00:37.392
then you might want to think again. And there's that word again enabled.
00:37.452 --> 00:41.022
If you're a regular listener, you're probably noticing a common thread among
00:41.067 --> 00:44.377
several of our recent episodes the concept of enablement is
00:44.395 --> 00:47.872
one of the sharpest corners in the world of IP. In fortifying life
00:47.905 --> 00:51.607
science patents, we first explored section 112 rejections and
00:51.610 --> 00:54.927
the concept of enablement, or whether or not the patent teaches
00:54.957 --> 00:58.432
those skilled in the art how to make and use the full scope of
00:58.435 --> 01:01.827
the claimed invention without undue experimentation.
01:02.007 --> 01:05.892
In our From Alice to Axel episode, we looked at how the courts have conflated
01:05.952 --> 01:09.202
eligibility with enablement and the grave threats this poses to the
01:09.220 --> 01:12.897
innovation economy. And then in episode eight this season, we examine
01:12.942 --> 01:16.347
the use of means plus function, claiming in the enablement risks
01:16.392 --> 01:19.927
that come with using overly broad language that only describes what
01:19.945 --> 01:23.452
an invention is versus what it does. Why is this such a
01:23.470 --> 01:26.572
big topic worth so much discussion? Well, remember,
01:26.680 --> 01:29.557
enablement is the fundamental deal of the patent system.
01:29.710 --> 01:32.802
You're trading disclosure for exclusivity so you can't
01:32.832 --> 01:36.897
hold back on the key details. Longterm progress of science and the useful
01:36.942 --> 01:40.347
arts is promoted by trading a government granted window of exclusivity
01:40.392 --> 01:43.752
to inventors in exchange for an enabling public disclosure.
01:43.857 --> 01:47.772
This disclosure must teach the public how to make and use the invention.
01:47.967 --> 01:51.462
Enablement is teaching how to make and use the invention
01:51.612 --> 01:55.902
that requires a certain level of specificity. And that level of specificity
01:55.932 --> 01:59.767
is where we start traveling into the gray. Depending on the subject matter
01:59.815 --> 02:02.997
or technology area for the innovation, this level of specificity
02:03.042 --> 02:06.847
can have very different requirements. Some technologies, like those
02:06.880 --> 02:10.147
rooted in physics and mechanics, are considered predictable by the US.
02:10.180 --> 02:14.367
Patent Office, while others, like biological and chemical technologies,
02:14.427 --> 02:18.097
are generally considered unpredictable. It follows that the amount
02:18.130 --> 02:22.257
of disclosure required to enable invention is related to the predictability
02:22.347 --> 02:26.352
of the technology, and so called unpredictable arts require more description
02:26.382 --> 02:29.300
to teach a reader how to make and use the technology.
02:29.812 --> 02:33.402
Similarly, emerging technologies, being less wellknown,
02:33.507 --> 02:37.152
also require more disclosure to be fully enabled. In this month's
02:37.182 --> 02:41.272
episode, David Jackrel, President of Jackrel Consulting, leads a discussion along
02:41.305 --> 02:45.177
with our Allstar Patent panel exploring enablement for the unpredictable arts
02:45.207 --> 02:48.702
and emerging technologies. The panel discusses peculiarities
02:48.732 --> 02:52.192
of patenting, unpredictable art and emerging technologies with a focus
02:52.240 --> 02:55.992
on modern case law and statutes to arrive at a set of best practices
02:56.052 --> 02:59.442
for getting more predictable results and patenting. These technologies.
02:59.577 --> 03:02.877
Dave is also joined today by our always exceptional group of IP experts,
03:02.907 --> 03:06.852
including Dr. Ashley Sloat, President and Director of Patent Strategy
03:06.882 --> 03:10.707
here at Aurora. Kristen Hansen, patent strategist at Aurora, and Shelley
03:10.722 --> 03:14.707
Couturier are patent strategist and search specialist. And before joining the
03:14.710 --> 03:17.947
group, as we often do, we'd like to provide a short primer on some key
03:17.980 --> 03:21.672
concepts in this episode for those newer to the world of patenting.
03:21.792 --> 03:25.477
Our legal scope for this talk once again falls under Title 35 of
03:25.495 --> 03:28.902
US. Code section 112, which is largely concerned
03:28.932 --> 03:32.947
with the topic of enablement. Patents can be rejected by the Patent Office or
03:32.980 --> 03:37.047
later invalidated by the courts if the invention is deemed to be insufficiently
03:37.092 --> 03:40.567
enabled. Regarding statute interpretation, the group also makes
03:40.615 --> 03:44.617
reference to the MPEP for those newer to the space. This might sound like another
03:44.665 --> 03:48.367
snoozeworthy acronym for Practitioners and Examiners. It's the
03:48.415 --> 03:52.017
Bible for patenting. MPEP stands for Manual
03:52.077 --> 03:55.597
of Patent Examining Procedure. It's a 3000 plus page
03:55.630 --> 03:59.967
manual published by the United States Patent and Trademark Office, produced by examiners,
04:00.027 --> 04:03.997
applicants, attorneys and agents. It is the reference guide for
04:04.030 --> 04:08.547
Practices and procedures for the prosecution of patent apps before the USPTO.
04:08.742 --> 04:12.277
Patent practitioners use the MPEP as a handbook of rules for
04:12.295 --> 04:15.882
drafting a patent application and examiners use the MPEP guidelines
04:15.897 --> 04:19.797
to decide whether to grant or reject the application. Along with patent
04:19.842 --> 04:23.847
laws and rules, the MPEP also attempts to explain the Patent Office's
04:23.892 --> 04:27.942
stance on current patent case law. In case you have trouble sleeping,
04:28.002 --> 04:31.882
we've linked to the MPEP in the show notes. As it often does,
04:31.960 --> 04:36.372
a lot of nuance comes down to understanding the difference between the spec or specification
04:36.492 --> 04:39.922
versus the claims of a patent application. We review this
04:39.955 --> 04:43.387
distinction in great depth in our patent anatomy episode from season one,
04:43.450 --> 04:47.202
but in brief, the specification describes the invention and provides
04:47.307 --> 04:50.797
context for interpreting the claims, whereas the claims are the heart of the
04:50.830 --> 04:54.382
application and point out the exact invention boundaries of the idea space
04:54.460 --> 04:58.042
the applicant believes she's entitled to own. Panel also
04:58.090 --> 05:02.067
uses the terms genus and species when talking about the breadth of a claim,
05:02.202 --> 05:05.767
much like the traditional definitions of genius being a group defined by common
05:05.815 --> 05:09.117
characteristics in a species being a logical division
05:09.177 --> 05:13.077
of a genus. In chemical, biotech and pharma patents,
05:13.182 --> 05:16.212
a genus claim covers a group of related chemicals,
05:16.287 --> 05:20.502
whereas a species claim covers a single compound without coverage of analogs
05:20.532 --> 05:24.727
derivatives or compounds in the same family. Inventors ideally want
05:24.745 --> 05:28.137
the broadest umbrella possible with genus claims,
05:28.212 --> 05:32.077
but a big question explored in this episode is what does that require from
05:32.095 --> 05:35.647
an enablement perspective? In the final bit of patent ease before
05:35.680 --> 05:38.937
handing you off to the panel is the concept of Marcosque groups.
05:39.087 --> 05:43.077
This is a claim drafting technique used to COVID multiple related alternatives
05:43.107 --> 05:47.377
or species in a single claim. It can appear in a patent with language like
05:47.470 --> 05:50.812
selected from the group consisting of A, B and C.
05:50.950 --> 05:54.622
The elements of the group must share some common characteristics and allow the group
05:54.655 --> 05:57.957
to be treated like a substitute variable. It is considered a closed
05:57.972 --> 06:01.732
group, though, so the variable can only be one of those things when claimed in
06:01.735 --> 06:05.617
that manner. For today's conversation, the practical application is using
06:05.665 --> 06:08.817
Marcos groups to specify groups of related chemical
06:08.877 --> 06:12.207
compounds. If you'd like to know more about Marcoche group instructions,
06:12.297 --> 06:16.332
please check out our blog post on how to read chemical and drug patents linked
06:16.347 --> 06:19.722
in the show notes. All right, hopefully you're now sufficiently
06:19.767 --> 06:22.862
enabled to enjoy the episode. Take it away, Dave.
06:23.512 --> 06:26.797
Well, I'm going to jump right in because I
06:26.830 --> 06:30.402
think that in a way, I could breeze
06:30.432 --> 06:34.492
right through this. But at the same time, I think it would be more
06:34.540 --> 06:38.197
interesting and fun if anybody has any comments or
06:38.230 --> 06:41.137
stories or examples of their own to, like,
06:41.200 --> 06:45.200
add in as we go. I don't have, like, specific prompts for
06:45.562 --> 06:49.402
places for that. So please, like, if you think of
06:49.420 --> 06:52.325
something or have something to mention,
06:52.762 --> 06:55.822
please do, please join. And I
06:55.855 --> 07:01.192
will. And don't laugh too hard. I've worked in Predictable Arts 99.99%,
07:01.240 --> 07:05.375
so I'll add some stupid questions for you. Great, that's perfect.
07:07.537 --> 07:10.822
So I thought, especially since for the
07:10.855 --> 07:14.457
podcast and the broader audience out there, we'll start at the beginning,
07:14.547 --> 07:17.427
we'll start at Enablement and the MPEP.
07:17.532 --> 07:20.872
We'll go through what is a predictable versus an unpredictable technology?
07:20.980 --> 07:24.997
How can we think about that? And then the meat of this is really two
07:25.030 --> 07:28.312
sections, chemical and biological technologies, which are
07:28.375 --> 07:31.882
basically the way that in this context are very similar.
07:32.035 --> 07:35.977
And then something actually interesting in a
07:35.995 --> 07:39.787
related vein, although not exactly unpredictable per se,
07:39.850 --> 07:43.477
is emerging technologies and the enablement requirement there, which is
07:43.495 --> 07:47.262
actually a little bit different. So M Pep
07:47.337 --> 07:50.367
21 64, what is enabling?
07:50.427 --> 07:53.847
So this is what we call 112 A. And in the specification,
07:53.892 --> 07:57.162
you describe how to make and use the invention.
07:57.312 --> 08:01.175
And that's a requirement. You have to enable someone
08:01.912 --> 08:05.452
to be able to make and use the invention in order for the
08:05.470 --> 08:09.697
patent office to grant you as a parent and a nice piece
08:09.730 --> 08:12.402
of case law that a lot of people kind of fall back on when they're
08:12.432 --> 08:15.997
thinking about this. How to determine whether or not you've met
08:16.030 --> 08:19.887
that far, is the test of enablement, is whether one reasonably
08:19.962 --> 08:23.242
skilled in the art a positive could make,
08:23.290 --> 08:27.052
use, make or use the invention from the disclosures in the
08:27.070 --> 08:30.727
patent coupled with information known in the art without
08:30.895 --> 08:34.147
undue experimentation. And that's really a key
08:34.180 --> 08:37.327
phrase. And what does that mean, undo experimentation? It's a
08:37.345 --> 08:40.777
bit vague, but there's been a lot
08:40.795 --> 08:43.562
of case law around this. And essentially,
08:44.062 --> 08:47.197
if there is a number of
08:47.230 --> 08:50.337
finite possibilities that someone could explore,
08:50.487 --> 08:54.697
then that may not be that
08:54.730 --> 08:58.347
it would be enabled if it's only a small number of possibilities.
08:58.392 --> 09:02.167
But if somebody had to do a lot of experimenting to figure something
09:02.215 --> 09:06.312
out how to make something that worked, then that would be undo
09:06.387 --> 09:09.982
experimentation. Again, quantitatively, that's a little bit of
09:09.985 --> 09:13.302
a tricky thing to unravel, but that's
09:13.332 --> 09:17.437
the idea behind it. Is this why you use
09:17.500 --> 09:20.900
Marcus groups so often in this art?
09:22.612 --> 09:26.317
Sometimes in some ways, yes. I think not.
09:26.365 --> 09:30.022
Maybe so much for enablement, but because you want the
09:30.055 --> 09:33.352
scope of your claim to be broad, but you also want it to
09:33.370 --> 09:36.642
be specific, because if you make something too raw,
09:36.702 --> 09:40.627
then you risk not enabling things. So by listing a specific list of
09:40.645 --> 09:44.427
things for each one of those things you know is enabled because it's described
09:44.457 --> 09:48.517
well, that can help you get the best
09:48.565 --> 09:51.582
practice, have everything enabled.
09:51.747 --> 09:55.372
Okay, interesting, because I think I could say I went 15 years never
09:55.405 --> 09:58.337
using it because it's not useful in predictable ours,
09:58.837 --> 10:01.100
but I see it everywhere in this space.
10:02.137 --> 10:04.702
It's a good point, I didn't think of it that way. But as we go
10:04.720 --> 10:08.527
through things, we can talk about that. I'm like how Marcus group may have
10:08.545 --> 10:12.247
been better than some of these other claims which were invalidated for
10:12.280 --> 10:15.547
lack of enablement. Well, and then
10:15.580 --> 10:19.447
too, even some countries, we've even been seeing that some countries, even with kind of
10:19.480 --> 10:23.122
Marcos groups, they're not okay with it if
10:23.155 --> 10:27.022
you don't have enough support for all
10:27.055 --> 10:30.747
the various types of and stuff. That's pretty routine, like detergents
10:30.792 --> 10:34.827
and things like that. They don't like it if you don't have more experimental
10:34.857 --> 10:38.377
support for some of those other classes. So that's kind
10:38.395 --> 10:41.375
of an interesting thing too. Right?
10:43.237 --> 10:47.037
So this I thought was pretty interesting. Same section.
10:47.112 --> 10:51.877
A subsection of this in the MPPP 21 64.3
10:52.045 --> 10:55.497
is a relationship of predictability of the art and the enablement
10:55.542 --> 10:59.112
requirements. So these are quotes now, right, from the MPEP.
10:59.187 --> 11:03.097
The amount of guidance or direction needed to enable the invention is
11:03.130 --> 11:06.502
inversely related to the amount of knowledge in the state of
11:06.520 --> 11:10.267
the art as well as the predictability in the art.
11:10.390 --> 11:15.262
So determining predictability or
11:15.400 --> 11:17.900
determining how much enablement you need,
11:18.262 --> 11:21.997
actually you have to go back and know about the art. You need
11:22.030 --> 11:24.697
to know the state of the art, how much knowledge is out in the art,
11:24.730 --> 11:28.117
what a Posito would reasonably know. And that's really
11:28.165 --> 11:31.732
the crux, I think, of both these unpredictable arts and the
11:31.810 --> 11:35.257
emerging fields. So another
11:35.335 --> 11:39.247
quote, the predictability, or lack thereof, in the art refers to the ability of one
11:39.280 --> 11:42.627
skilled in the art to extrapolate, to disclose our known results
11:42.657 --> 11:45.822
to the claimed invention. So in the field of chemistry,
11:45.942 --> 11:49.542
there may be times when well known unpredictability of chemical
11:49.602 --> 11:53.452
reactions will alone be enough to create a reasonable doubt as
11:53.470 --> 11:57.562
to the accuracy of a particular broad statement put forward
11:57.700 --> 12:01.417
as enabling support for a claim. I think through
12:01.465 --> 12:05.377
examples this will all become more clear. But I
12:05.395 --> 12:08.562
think the important takeaway here is this is in the MPEP,
12:08.637 --> 12:12.127
this is not sort of like something that's kind of
12:12.145 --> 12:15.417
come out has come out in case law. But it's
12:15.477 --> 12:19.147
explicitly in the MPEP as well that there is
12:19.180 --> 12:22.452
actually a different bar for different fields depending
12:22.482 --> 12:25.747
on the state of the art as well as the predictability of
12:25.780 --> 12:29.367
the technology. And so the scope
12:29.427 --> 12:33.402
of the required enablement varies adversely with the degree of unpredictability
12:33.507 --> 12:37.572
involved. But even in unpredictable
12:37.617 --> 12:41.167
arts, a disclosure of every operable species is not
12:41.215 --> 12:44.197
required. So this is something we're also going to talk about then. How do you
12:44.230 --> 12:47.997
do this? Extrapolating and teaching
12:48.192 --> 12:52.177
you can enable someone to create a
12:52.195 --> 12:56.362
whole slew of compounds, let's say by a number of examples and then
12:56.425 --> 13:00.037
also instructions or some information,
13:00.175 --> 13:04.027
some description about how to extrapolate between those examples to
13:04.045 --> 13:08.172
arrive at all of the other examples that may be in abroad
13:08.217 --> 13:11.752
definition. So as we said, chemical and
13:11.770 --> 13:15.732
biological chemical species with substitutable
13:15.822 --> 13:19.137
groups is sort of the main example of this. And we're
13:19.637 --> 13:23.347
going to talk a bit about that as we go through these examples. But also
13:23.455 --> 13:27.282
in emerging technologies, new fields, even if they're predictable,
13:27.447 --> 13:31.572
need more description to satisfy their disclosure obligations
13:31.617 --> 13:35.152
and more mature fields. So for example, broad claims that
13:35.170 --> 13:39.012
cover different embodiments need to have all of those variations
13:39.087 --> 13:42.877
enabled with a sufficient description. And as we get
13:42.895 --> 13:46.597
into the emerging technologies examples, you're going to see a pattern that
13:46.630 --> 13:50.307
arises there where someone tried to claim a genus
13:50.397 --> 13:53.877
and there are several species under the genus. One or two of those species
13:53.907 --> 13:57.597
was described really well and a couple of the other species were not described
13:57.642 --> 14:00.732
very well and the entire claim can be invalidated
14:00.822 --> 14:03.892
because of that. So the other thing that's really important
14:03.940 --> 14:08.422
for this is thinking about the terms and really
14:08.605 --> 14:12.097
what is the scope of this claim and is everything that
14:12.130 --> 14:15.852
this claim covers sufficiently enabled? It's kind of the crux
14:15.882 --> 14:19.112
of it. Okay, so now some fun examples.
14:19.537 --> 14:23.047
Predictable. What is predictable? So in
14:23.155 --> 14:26.202
a very famous example of a predictable
14:26.307 --> 14:30.627
technology, which is physics, physics, mechanical inventions
14:30.657 --> 14:34.602
are often pointed to as being predictable. So in 1916,
14:34.707 --> 14:38.122
Einstein published his theory of general Relativity, which said
14:38.155 --> 14:42.287
that mass curves, FaceTime all on paper, all equations,
14:42.637 --> 14:46.797
took three years. But three years later, in 1919,
14:46.992 --> 14:51.022
English scientists led by Sir Arthur Eddington traveled to
14:51.055 --> 14:54.952
Africa to observe a total solar eclipse which confirmed that the
14:54.970 --> 14:58.012
light from stars was bent by the gravity of the sun.
14:58.150 --> 15:01.282
So there's even older examples of this.
15:01.360 --> 15:04.887
The orbit of Neptune famously
15:04.962 --> 15:08.317
was predicted by the
15:08.365 --> 15:11.797
other planets around it having strange orbits which
15:11.830 --> 15:15.350
must have been affected by another mass that someone could tell was there.
15:15.937 --> 15:19.925
So these are predictable. And I'll tell you one other because
15:20.362 --> 15:24.512
I think it's very interesting, but it's also personally related.
15:25.687 --> 15:29.622
Also in 1009, Einstein predicted that gravity traveled
15:29.667 --> 15:32.812
in a wave and this one took 100
15:32.875 --> 15:36.717
years to prove. But LIGO, the Laser Interferometer
15:36.777 --> 15:41.022
Gravitational Wave Observatory, confirmed the observance
15:41.067 --> 15:44.917
of gravitational waves in 2016. And this
15:45.115 --> 15:48.457
is personal for me because this was the project that I worked on
15:48.460 --> 15:51.852
in grad school. I was designing photo
15:51.882 --> 15:55.972
detectors for LIGO and there you can see some pictures of
15:56.005 --> 15:59.602
these facilities. There's one up in Hanford, Washington. There's one
15:59.620 --> 16:03.312
in Livingston, Louisiana. These interferometers
16:03.387 --> 16:06.907
are Lshaped devices that
16:06.985 --> 16:11.150
each arm of the interferometer is 4 km long
16:11.512 --> 16:14.617
and the entire path of the laser is all under
16:14.665 --> 16:18.747
vacuum. And so these are just massive, massive installations.
16:18.867 --> 16:22.192
And you can see the data on the right, which was the observation of the
16:22.240 --> 16:26.107
first gravitational wave event, which I believe was two
16:26.185 --> 16:29.367
black holes or black holes or neutron
16:29.427 --> 16:33.267
stars smashing into each other. They are orbiting
16:33.327 --> 16:36.882
around each other and at the end, right before they coalesce
16:36.897 --> 16:40.117
into each other into one, they spin around each other so
16:40.165 --> 16:44.047
fast that they give off massive amounts of energy in the form
16:44.080 --> 16:47.917
of gravitational waves, which is what was observed. But the crazy thing
16:47.965 --> 16:51.532
is why it took so long to find is that the effect
16:51.610 --> 16:55.132
is so small. I know you can see on those plots but the
16:55.135 --> 16:59.407
screen is ten to the -20 1st so over
16:59.485 --> 17:03.352
4 distance the relative change in
17:03.370 --> 17:07.222
the length of the arm is one one zero of
17:07.405 --> 17:11.237
the diameter of the nucleus of an atom
17:12.412 --> 17:16.337
like ten to the -20 first meters extremely that's insane.
17:16.687 --> 17:20.242
It is insane. A lot
17:20.290 --> 17:24.442
of technology. How did they like
17:24.640 --> 17:28.625
I imagine like you get so much noise in that system,
17:32.587 --> 17:36.187
how do you pair together? That's what was causing that
17:36.250 --> 17:39.877
exactly right. And that's probably like more than what
17:39.895 --> 17:43.462
we have time for today. It is. I'll give you a short answer though.
17:43.600 --> 17:46.702
So there's these plots, and these are the plots that the
17:46.720 --> 17:50.647
people who made these systems were using, where you have a
17:50.680 --> 17:54.097
frequency spectrum of noise and there's like
17:54.130 --> 17:57.717
thermal noise up at really high frequencies, there's like ground noise
17:57.777 --> 18:01.497
at low frequencies. But there's a frequency band right in the sweet spot
18:01.617 --> 18:05.542
where you can through seismic isolation and
18:05.590 --> 18:09.372
all kinds of advanced optics and really advanced
18:09.417 --> 18:13.132
systems. It's active, active noise reduction and stuff like that.
18:13.210 --> 18:16.672
They can get the noise in certain frequency bands down low
18:16.705 --> 18:20.097
enough where they can see certain types of gravitational events.
18:20.292 --> 18:23.127
Yes, but also even in those bands,
18:23.232 --> 18:27.732
one big reason why there are two installations,
18:27.822 --> 18:31.242
two detectors so far away from each other is they wanted to rule
18:31.302 --> 18:35.137
out a local event, you know, so if it's something
18:35.200 --> 18:38.472
local up in near Hamford, Washington, Livingston, Louisiana wouldn't
18:38.517 --> 18:42.292
see the same signal. But the signals were exactly the same
18:42.340 --> 18:45.892
and they were offset by exactly the amount of time that you would expect.
18:46.015 --> 18:49.197
So there's also other detectors like in Europe,
18:49.242 --> 18:52.672
there's one called Virgo and there's one, I think in Japan as well
18:52.705 --> 18:56.750
now. And so kind of just like with
18:58.387 --> 19:01.807
earthquakes and seismometers, you can triangulate the
19:01.810 --> 19:05.542
position, you can triangulate where the gravitational wave event came
19:05.590 --> 19:09.512
from by the lag by when the detector is detected.
19:10.762 --> 19:15.202
When we lived in the Tri Cities, we toured the
19:15.220 --> 19:18.972
LIGO. Yeah. Neat. Oh, my gosh.
19:19.092 --> 19:22.282
It was something amazing, right? I know, it was amazing.
19:22.360 --> 19:25.047
I spent most of my time in the lab trying to make photo detectors.
19:25.092 --> 19:28.492
But two or three times a year I get to go to the sites and
19:28.540 --> 19:32.332
help them with a science run or for a meeting or
19:32.335 --> 19:35.472
something. It's so amazing to see it. And it's
19:35.517 --> 19:38.612
all in the ground, the whole observatory,
19:39.712 --> 19:43.027
like the pipeline or whatever they're calling it.
19:43.045 --> 19:46.177
It was very interesting. Yeah. Super neat, right?
19:46.195 --> 19:52.017
Yeah. So predictable physics
19:52.077 --> 19:55.372
is predictable, like proven time and time
19:55.405 --> 19:59.112
again. On the other hand, organic molecules,
19:59.187 --> 20:01.662
especially those with biological effects,
20:01.737 --> 20:05.122
are unpredictable. And so that's what
20:05.155 --> 20:08.242
we're going to dive into now. So starting
20:08.290 --> 20:12.097
with that, starting with chemical and biological technologies, it can be
20:12.130 --> 20:15.897
difficult for a skilled person to predict which functional activity a chemical
20:15.942 --> 20:19.672
or biological substance may possess. So this
20:19.705 --> 20:23.982
has some advantages in the patent space. So a newly found substance
20:24.072 --> 20:27.457
and its use is more likely to be deemed not obvious
20:27.535 --> 20:31.237
to the person. So that would be patentable over,
20:31.300 --> 20:35.450
you know, what's called so called business or 101, so 103.
20:35.812 --> 20:39.277
But it also creates a burden. So when you try to claim a
20:39.295 --> 20:43.792
group of compounds providing one synthetic route and
20:43.840 --> 20:47.302
the activity data of one compound may not be sufficient to support the
20:47.320 --> 20:50.872
assumption that all claim permutations of a certain compound can
20:50.905 --> 20:53.612
be synthesized and are active.
20:54.412 --> 20:57.657
So another kind of general rule.
20:57.747 --> 21:00.967
I'm going to use these molecules for the next couple of slides to talk about
21:01.015 --> 21:03.200
this in a little more detail.
21:03.787 --> 21:07.762
There's a known kind of law
21:07.825 --> 21:11.662
rule in patents in the US and around the world where
21:11.725 --> 21:16.122
a generic formula does not necessarily inherently disclose
21:16.167 --> 21:20.002
the specific compounds falling under the formula. You might
21:20.020 --> 21:24.267
say to yourself, really? That seems odd. But if you take it to its extreme,
21:24.402 --> 21:28.347
it makes sense because really no future chemistry
21:28.392 --> 21:32.062
invention would ever be possible. Since all conceivable compounds fall
21:32.125 --> 21:35.872
under one known generic formula or another, we take
21:35.905 --> 21:39.727
it to the extreme. More useful. Maybe a specific
21:39.820 --> 21:43.602
example is what we're showing here with a generic formula
21:43.632 --> 21:47.652
and then these two other compounds which were modified
21:47.757 --> 21:51.127
from it. So this case actually
21:51.220 --> 21:55.132
came from the German Supreme Court. It's a really good example,
21:55.210 --> 21:58.647
I think, of these principles. The generic formula
21:58.692 --> 22:02.712
One does not disclose this claimed compound,
22:02.787 --> 22:06.867
Olenzapin, which is number two, claimed compound
22:06.927 --> 22:10.632
one. There on the left, you can see a bunch of rings and other sick
22:10.647 --> 22:14.377
things coming off of it. But the important pieces for this discussion are that
22:14.395 --> 22:17.782
there are two variable groups in that compound, r One
22:17.860 --> 22:21.522
and R Two. The claim compound, a lensbin
22:21.567 --> 22:24.837
had for R One, nothing, just a hydrogen,
22:24.987 --> 22:28.542
and for R Two, it had a methane. Another compound
22:28.602 --> 22:32.167
from the art flumezapine has the same
22:32.215 --> 22:36.402
methyl group in R Two. But on R one, it has a fluorine.
22:36.582 --> 22:40.662
And so the question before the Supreme Court was, is compound
22:40.737 --> 22:44.112
two, the claimed compound rendered obvious by compound
22:44.187 --> 22:47.527
three? So in order to figure that out, you have to go back to
22:47.545 --> 22:51.402
the prior art. This also relates with enablement, but it's easier
22:51.432 --> 22:55.297
to talk about for obviousness first.
22:55.480 --> 22:58.582
So when you look at the art, the activity data in
22:58.585 --> 23:02.122
the prior art, all leads one
23:02.155 --> 23:06.492
to believe that fluorine would enhance the biological
23:06.627 --> 23:10.337
efficacy of this compound. In this case, it was an antipsychotic.
23:11.287 --> 23:14.767
And I think very importantly too, the prior art
23:14.815 --> 23:18.202
had no individualized compound under the
23:18.220 --> 23:23.122
generic formula one that was not halogenated. So basically
23:23.305 --> 23:27.067
the prevailing wisdom in this space was
23:27.115 --> 23:30.567
that fluorine, fluorogeneted, halogenated compounds
23:30.627 --> 23:33.522
were beneficial,
23:33.642 --> 23:36.927
improve the efficacy. So a person of skill
23:36.957 --> 23:40.747
in the yard, a positor, had no reason or incentive to
23:40.780 --> 23:44.562
modify compound three to compound
23:44.637 --> 23:48.442
one with no halogen. And therefore they found it that
23:48.640 --> 23:51.512
it was not obvious and it should be allowed.
23:51.862 --> 23:56.047
How this relates to enablement is
23:56.230 --> 23:59.947
if you general compound one,
24:00.055 --> 24:03.727
if you tried to claim that you
24:03.745 --> 24:07.872
would need to show and enable every variation
24:07.917 --> 24:11.232
of R One and R two, and if you showed a bunch
24:11.247 --> 24:14.542
of examples, let's say, and they were all fluorinated or halved needed,
24:14.665 --> 24:18.137
that wouldn't necessarily enable
24:18.937 --> 24:22.797
compound number two. Or from the other perspective,
24:22.842 --> 24:25.175
it doesn't make compound number two obvious.
24:26.962 --> 24:28.250
Does that make sense?
24:30.637 --> 24:33.200
Is there a be following at this point or is there any questions?
24:34.462 --> 24:38.167
I think the one question I have for you David, is do you believe then
24:38.215 --> 24:42.822
there's kind of this. I feel like at one point broader
24:42.867 --> 24:46.867
claims were allowed that maybe you didn't have
24:46.915 --> 24:50.062
support for all the different permutations under
24:50.125 --> 24:53.947
it, but if you showed enough like a
24:53.980 --> 24:56.422
fourth of the possibilities or something,
24:56.605 --> 25:00.147
then that was enough. But it seems like we're shifting
25:00.192 --> 25:03.682
towards this like these some of you are saying the death of the
25:03.685 --> 25:07.447
genus claim. Do you think that's really happening? And you think that's a good
25:07.480 --> 25:11.047
thing or a bad thing? It's a great question and
25:11.080 --> 25:14.617
you know, I don't have a solid answer like with
25:14.665 --> 25:17.827
case law etc. These cases we're looking at here are
25:17.845 --> 25:21.352
all from mainly or from like 20 08 20
25:21.370 --> 25:24.697
09 so it hasn't changed much, I'd say, in the last
25:24.730 --> 25:28.192
sort of decade. So everything that we've been sort of
25:28.240 --> 25:31.947
taught, I think still holds. It's not like there's been a change recently
25:31.992 --> 25:35.722
or anything. So that's sort of the first comment. But I
25:35.755 --> 25:39.702
think putting together best practice from what I've looked at in the prior
25:39.732 --> 25:42.967
art, even the MDP says you don't have
25:43.015 --> 25:46.332
to describe every single variation.
25:46.497 --> 25:49.597
However, what I think
25:49.630 --> 25:52.467
best practice is to extrapolate,
25:52.527 --> 25:55.407
to explain to someone how to extrapolate.
25:55.572 --> 25:59.877
So by saying R one, let's say for instance, can be halogenated,
25:59.907 --> 26:03.382
but it doesn't have to be Halloween, things like that.
26:03.535 --> 26:07.072
Extrapolate some guidance about which compounds fall in
26:07.105 --> 26:09.500
and which compounds don't and why they all work,
26:10.762 --> 26:14.242
I think is the best way to go.
26:14.365 --> 26:17.602
But your question is valid, and I think it's a bit of
26:17.620 --> 26:21.502
a gray area that comes down to, unfortunately, I think the
26:21.520 --> 26:25.387
individual examiner that you may be dealing with, but also probably
26:25.525 --> 26:29.647
in some cases, and it may be in many cases, something that would really
26:29.680 --> 26:32.537
come out in litigation, not so much in prosecution.
26:33.412 --> 26:36.742
Yeah, that's fair. I think it'll be interesting to see kind of what happens
26:36.790 --> 26:40.327
longer term with some of these, especially the chemical the chemical side
26:40.345 --> 26:43.100
of the world and what happens over time if, you know,
26:44.062 --> 26:47.150
you can show support for some and some guidance, like you said.
26:47.962 --> 26:50.750
Is that going to be enough for the courts, or do we have to do
26:51.187 --> 26:54.847
more? What I think is how
26:54.880 --> 26:58.062
I'm starting to think about this and putting this together for me is really helpful,
26:58.137 --> 27:02.167
is that it really I think there is some general kind
27:02.215 --> 27:05.847
of logical logical
27:05.892 --> 27:09.417
tool, logical questions you can ask yourself. Looking at a claim
27:09.477 --> 27:13.850
language, would someone be able to make and use every
27:14.437 --> 27:20.872
variation that I'm describing here, including synthesis and
27:20.905 --> 27:24.447
including is it enabled? Have we shown that every variation
27:24.567 --> 27:28.527
has efficacy? That generic
27:28.557 --> 27:32.197
compound on the left with R one and R two? Considering how
27:32.230 --> 27:35.900
many things r one and R two could be, I think having
27:39.037 --> 27:42.477
you know, I'm not that familiar
27:42.507 --> 27:45.802
with antipsychotics, so I'm not sure what a good example there would
27:45.820 --> 27:50.362
be. But, you know, putting the enough
27:50.425 --> 27:53.782
description that you not only have, like you said, maybe a
27:53.785 --> 27:57.132
quarter or some reasonable fraction of concrete examples,
27:57.147 --> 28:00.967
but also logic. Logic and
28:01.090 --> 28:04.732
direction for how to extrapolate between them to arrive at anything
28:04.810 --> 28:08.542
that you're claiming, you know? Yeah, I think. Interesting point.
28:08.590 --> 28:12.277
Do you think it's, you know, because some would argue that a person's skilled in
28:12.295 --> 28:16.027
the art to make and use a claim just has to
28:16.045 --> 28:19.777
be able to, based on the claim language and the stuff in the spec
28:19.945 --> 28:24.042
has to be able to make one chemical
28:24.102 --> 28:27.862
that fits the bill. But you also kind of said something interesting. You said somebody
28:27.925 --> 28:30.657
would have to be able to kind of make all the permutations.
28:30.822 --> 28:34.267
So do you think we need to enable them to make
28:34.315 --> 28:38.302
one, or do you think we need to enable them to make all the
28:38.320 --> 28:40.037
things that falls under the claim?
28:42.637 --> 28:46.027
There may even be some quotes from some case law that support that.
28:46.120 --> 28:49.207
But everything that I've been reading says yes.
28:49.285 --> 28:53.302
Not only supporting what the compound is and
28:53.320 --> 28:57.172
all variations, but also how to make you need how to synthesize them
28:57.280 --> 29:00.697
and how to use them. What the biological efficacy is.
29:00.730 --> 29:04.642
Not just for some example, but really, somehow not
29:04.690 --> 29:07.897
necessarily writing explicitly each one,
29:07.930 --> 29:12.147
but teaching someone how to extrapolate or interpolate,
29:12.192 --> 29:16.102
if you will. No, that's interesting. I would agree based on what
29:16.120 --> 29:19.257
I've heard and seen, you know what I mean? So it's interesting I think there's
29:19.272 --> 29:21.457
been a little bit of a shift over, like, set up with me in the
29:21.460 --> 29:24.142
last couple of decades in that direction. But yeah,
29:24.190 --> 29:27.642
interesting. So what we're about to talk about is KSR.
29:27.777 --> 29:31.327
And I think KSR is very confusing in this world.
29:31.420 --> 29:34.927
So KSR, that was
29:34.945 --> 29:39.725
a German case shifting over to the US. Case in 2007,
29:40.162 --> 29:44.122
famous landmark US. Supreme Court case was
29:44.230 --> 29:48.622
really putting more guidelines around. What does it mean to be obvious? And so
29:48.730 --> 29:52.252
what KSR establishes there does not need to
29:52.270 --> 29:56.202
be an explicit motivation in the prior art to modify teaching
29:56.232 --> 30:00.202
to arrive at a claimed subject matter. So what
30:00.220 --> 30:04.257
it did say is if there's a finite number of identified predictable solutions
30:04.347 --> 30:08.150
that could lead to the claimed solution, then it is likely obvious.
30:09.187 --> 30:13.467
However, the underlying technology behind KSR
30:13.527 --> 30:17.277
was from a predictable art. It was a mechanism for combining an electronic
30:17.307 --> 30:20.637
sensor with an adjustable automobile pedal.
30:20.787 --> 30:24.547
So all elements and their functions were
30:24.580 --> 30:28.327
known. And the result of a combination of those things
30:28.345 --> 30:30.275
was predictable and hence obvious.
30:31.987 --> 30:35.902
The courts have since clarified this
30:36.070 --> 30:39.912
specifically for chemical and unpredictable
30:39.987 --> 30:43.527
arts. And so the CIFC at least has ruled
30:43.557 --> 30:47.077
that there still needs to be some reason motivation to modify a
30:47.095 --> 30:50.617
starting compound to arrive at the claim compound. So this is,
30:50.665 --> 30:54.852
I mean, I think this is interesting and this is possibly
30:55.032 --> 30:58.417
partially where the gray area and confusion comes
30:58.465 --> 31:01.992
from. Is that's basically exactly the opposite of what KSR
31:02.052 --> 31:05.662
says? Right? No motivation is needed.
31:05.725 --> 31:08.902
And they say, well, no, in some cases a motivation is needed.
31:09.070 --> 31:12.547
So here's an example of this case. I think we actually have covered this
31:12.580 --> 31:15.747
one before. The ESI versus Dr. Reddy's Laboratory.
31:15.792 --> 31:20.382
Inteva. Tiva Pharmaceuticals. The CASC
31:20.547 --> 31:24.582
found soapprozole
31:24.672 --> 31:27.582
was known from the art and a very similar compound,
31:27.672 --> 31:31.917
Leperazole, was claimed. And interestingly
31:31.977 --> 31:35.322
again, the known compound was halogenated,
31:35.367 --> 31:39.012
had those three fluorine down there on the right bottom corner.
31:39.162 --> 31:42.877
But the claim compound did not have the
31:42.895 --> 31:46.942
fluorine, was not halogen needed. And so the CASC again found
31:47.140 --> 31:51.072
did not find any motivation in the art to substitute the active groups.
31:51.192 --> 31:55.122
And quote from that case, the record shows no discernible
31:55.167 --> 31:58.822
reason for a skilled artist. And to begin with, the lens soap resolve only to
31:58.855 --> 32:02.307
drop the very feature, the fluorinated substituent
32:02.397 --> 32:06.217
that gave this advantage advantageous property.
32:06.415 --> 32:10.492
So, you know, this kind of again, to me this shows that
32:10.690 --> 32:14.277
if someone had described this class of compounds
32:14.307 --> 32:17.872
and said it could be halogenated, but by the way, it doesn't have to be
32:17.905 --> 32:20.932
halogenated, it can have this group at the end, it could have that. Because it
32:20.935 --> 32:24.342
could have a metal, it can have that. I think there's a reasonable
32:24.402 --> 32:28.312
pretty good chance that this case
32:28.375 --> 32:31.497
specifically would have come out differently.
32:31.617 --> 32:35.127
But since it's
32:35.157 --> 32:39.217
acknowledged that these fields are unpredictable and small changes
32:39.415 --> 32:43.767
can change the efficacy in ways that are not easy to discern
32:43.827 --> 32:47.152
beforehand, bias one skilled in the art. This was this
32:47.170 --> 32:50.917
was deemed non obvious. And again, I think it's a good
32:50.965 --> 32:54.457
illustrative example when you think about enablement. How do you enable a
32:54.460 --> 32:58.377
class of compounds to have all kinds of different groups
32:58.407 --> 33:02.182
at the end? And not only I think and this is where
33:02.335 --> 33:07.177
you're getting into possibly what
33:07.195 --> 33:10.387
I was going to say is not technically the best
33:10.450 --> 33:13.617
case, but this way the best case you would have not only you would describe
33:13.677 --> 33:17.737
structures you'd also describe how to synthesize all of those and
33:17.800 --> 33:21.012
that they would still have biological efficacy,
33:21.087 --> 33:23.542
which, if you think about it, in this case, it's a pretty high bar.
33:23.665 --> 33:27.127
How do you know if it's going to be an antipsychotic or not?
33:27.295 --> 33:30.442
So it makes it pretty difficult for people to just
33:30.640 --> 33:34.297
claim a whole bunch of compounds without actually going through and having
33:34.330 --> 33:38.347
the data. I think that's where sometimes this is equated with
33:38.380 --> 33:42.487
experimental data. I think that's an example of how experimental data
33:42.550 --> 33:46.737
can be required almost at some point in order to really fully enable
33:46.812 --> 33:51.142
something. So if you do enable something in your spec like that,
33:51.265 --> 33:54.702
you have what you need, but you also have some description
33:54.732 --> 33:58.302
for some things that are not exactly fully covered
33:58.407 --> 34:01.262
correctly. They're just kind of listed elements.
34:01.987 --> 34:05.825
What about arguments around unexpected results? If you have
34:06.712 --> 34:10.312
data in your spec that isn't necessarily talked
34:10.375 --> 34:14.092
about, but it's put in there as experimental data,
34:14.290 --> 34:17.857
can you make those arguments and come out
34:17.935 --> 34:21.412
on top? Are you asking would that data possibly be
34:21.475 --> 34:25.477
enabling or those it
34:25.495 --> 34:27.350
could be. I think it comes out of the case.
34:29.662 --> 34:33.292
Do you really need experimental data to prove that
34:33.340 --> 34:37.362
something has antipsychotic effects? This is an ulcer
34:37.437 --> 34:39.200
to pre ulcers, right?
34:41.442 --> 34:45.427
A it's good question. Do you actually need to prove it
34:45.445 --> 34:47.975
with experimental data, or is a statement enough?
34:49.987 --> 34:53.697
Okay. Yeah. I mean, I only ask because when I get into that territory,
34:53.742 --> 34:57.132
I actually think this is the worst possible thing I could be arguing.
34:57.222 --> 35:00.262
But it's all I have. Right, right, exactly.
35:00.400 --> 35:03.757
And I think especially some of the later cases are going
35:03.760 --> 35:07.327
to see things exactly in that camp where
35:07.495 --> 35:10.962
there was a couple of things that were described really well, but the claim
35:11.037 --> 35:14.982
language was broader and covered things that weren't described
35:14.997 --> 35:18.282
that well, and they were invalidated for lack
35:18.297 --> 35:22.392
of enablement. So I think it's definitely something like you said in the specification
35:22.527 --> 35:26.022
and making sure the description is good, but then really looking at the claim language
35:26.067 --> 35:30.142
and being like, what how broad is this and what
35:30.190 --> 35:33.050
should we go after? What do we really have here?
35:34.762 --> 35:38.617
Okay, I'd almost argue that I mean, it seems to me
35:38.740 --> 35:42.050
lately that statements are not enough in the spec,
35:42.712 --> 35:46.177
which is a huge burden, arguably, for inventors and
35:46.195 --> 35:46.862
labs.
35:50.887 --> 35:54.097
You could argue their choice right. For how much broad coverage do you
35:54.130 --> 35:57.717
want. But if you have to have even just some kind of basic
35:57.777 --> 36:01.827
kind of data for a number of compounds that delays
36:01.932 --> 36:05.497
how quickly you can move for any one
36:05.605 --> 36:08.312
particular goal.
36:11.962 --> 36:15.022
It's exactly right. There are some
36:15.055 --> 36:18.897
some benefits to being able to claim
36:18.942 --> 36:22.252
something is an unexpected result or nonobvious, but there
36:22.270 --> 36:25.672
are some large burdens with having
36:25.705 --> 36:29.227
to have the data. And I've actually, maybe as a quick aside, I've talked
36:29.245 --> 36:32.677
to some scientists in this field that's particularly scientists at
36:32.695 --> 36:35.812
startup and small companies that are like, this is super
36:35.875 --> 36:39.882
important and I'm so glad that the system is like that. Otherwise Dow
36:39.897 --> 36:43.297
and Dupont would have patented everything already. They could just
36:43.330 --> 36:46.882
list giant lists of compounds and just patent them without
36:46.960 --> 36:50.300
having data, without knowing if they work. And so,
36:50.887 --> 36:54.427
yeah, there's pros and cons, I think. Yeah,
36:54.445 --> 36:57.202
I think that's really fair. I think that was some of what you saw in
36:57.220 --> 37:01.042
the early chemical arts too. Not from all the different compounds, but one
37:01.090 --> 37:04.977
compound that they found works for some kind of condition
37:05.157 --> 37:09.342
and then they would list like paragraphs of other conditions
37:09.402 --> 37:13.242
that were like so cursorly related to the target condition
37:13.377 --> 37:16.422
that you're like. You have no idea if this is going to work for Ms
37:16.467 --> 37:17.975
and that there it is.
37:20.287 --> 37:24.127
Right. I would
37:24.145 --> 37:27.667
imagine that an examiner during
37:27.715 --> 37:30.952
prosecution is not going to be able to answer all those questions.
37:31.120 --> 37:34.477
There's not enough time, there's not enough motivation for them to
37:34.495 --> 37:37.552
do that. I don't even know if it's really in their marching orders, within their
37:37.570 --> 37:40.747
scope. You know, those sort of things I feel like,
37:40.780 --> 37:42.812
are most often come up in litigation.
37:47.062 --> 37:49.187
So unpredictable arts,
37:50.437 --> 37:53.952
detailed description and supporting examples summarizing
37:53.982 --> 37:57.472
that if you want to claim a class of
37:57.505 --> 38:00.937
compounds, you need to make sure the class is enabled over the whole
38:01.075 --> 38:04.777
range. You're in full possession of the invention on
38:04.795 --> 38:08.197
the filing date. This is related to something that we were talking about and that
38:08.230 --> 38:11.962
the activity of the underlying claim compound is also present over
38:12.025 --> 38:15.802
the whole range claimed. And that's really key. Like the
38:15.820 --> 38:20.457
claim language gets to be very important. There's a couple of examples
38:20.472 --> 38:23.382
of this before I kind of finish up this section.
38:23.547 --> 38:27.042
Additional examples. There's Abby versus Jansson,
38:27.177 --> 38:30.742
which was invalidated a claim for a class of
38:30.790 --> 38:34.377
antibodies. And there was no structural definition in the claim,
38:34.557 --> 38:38.622
no structural definition in the patent at all, only defined
38:38.667 --> 38:42.442
functionally in terms of certain dissociation constants at a certain
38:42.490 --> 38:45.717
binding sites. And the quote there was the claim scope
38:45.777 --> 38:48.847
reaches beyond what the inventors have contributed to the
38:48.880 --> 38:52.702
art. Right. This is the grand bargain in
38:52.720 --> 38:56.497
a way. You teach the world how to make and use something
38:56.680 --> 38:59.982
in exchange for a limited amount of exclusivity.
39:00.072 --> 39:04.192
So that after the patent term expires, you've now contributed something
39:04.240 --> 39:08.137
to the world. Whereas if you don't enable something
39:08.275 --> 39:11.842
now, you aren't really holding up your end of the bargain. And then
39:11.890 --> 39:15.972
therefore no patent for you. And Ya
39:16.017 --> 39:19.872
vs. Abbott. In a similar case, there was a broad genus
39:19.917 --> 39:22.737
claim with only one supported single compound.
39:22.887 --> 39:27.177
And what the opinion
39:27.207 --> 39:31.262
said in this case, and these are 20 13, 20, 14 cases, slightly more recent.
39:32.137 --> 39:35.527
In that case, the skilled person would have had to synthesize and
39:35.545 --> 39:39.297
biologically evaluate thousands of compounds to see if they have the claim
39:39.342 --> 39:42.725
properties. So that in
39:43.312 --> 39:47.052
the CAFC's opinion, in this case, evaluating thousands
39:47.082 --> 39:50.647
of compounds was undo experimentation. Now, if you only
39:50.680 --> 39:54.022
had to do ten or five or 100, where is that
39:54.055 --> 39:56.947
line exactly? I think it's hard to say. I think it may be case by
39:56.980 --> 40:00.552
case in some ways, but oh, and that was the Rapamycin
40:00.582 --> 40:03.852
case, which I think we've also talked about in other meetings
40:03.882 --> 40:07.402
that we have had. So, okay, talked a lot
40:07.420 --> 40:11.592
about the pitfalls, what to do, what do we do in unpredictable
40:11.652 --> 40:14.687
arts? I think in the specification,
40:15.262 --> 40:18.667
cover as much breads as possible with examples and data,
40:18.865 --> 40:22.417
both synthesis and activity, and also provide
40:22.465 --> 40:26.602
guidance in the description how to extrapolate from the examples given
40:26.695 --> 40:29.782
to the remaining scope. And now we're going to
40:29.785 --> 40:33.562
shift into emerging technologies. But another thing that's as
40:33.625 --> 40:36.457
important here, this is more I think this one really covers what to do in
40:36.460 --> 40:40.657
the specification, in the claims. It's really important to
40:40.810 --> 40:45.072
pick phrases and to claim things that are enabled.
40:45.117 --> 40:48.877
Think about the genus claim and all
40:48.895 --> 40:52.147
the species that go underneath that sort of a claim and are they really
40:52.180 --> 40:55.552
all enabled? If not, maybe you're better off with some kind of a
40:55.570 --> 40:59.197
marqueous group or narrowing in some other way
40:59.230 --> 41:00.875
to make sure that it is.
41:02.962 --> 41:06.387
So that was predictable and unpredictable.
41:06.462 --> 41:09.622
Biological and chemicals are really the main examples there.
41:09.805 --> 41:14.142
Emerging technologies is similar, it's a lot of overlated concepts,
41:14.202 --> 41:18.067
but it's a bit different in that the question here is
41:18.115 --> 41:21.672
how much does this patent specification rely on the knowledge
41:21.792 --> 41:24.817
of a person of ordinary skill in the art to
41:24.865 --> 41:29.152
provide support for certain claimed embodiments? If a technology
41:29.245 --> 41:33.172
is very new, there may be very little information
41:33.280 --> 41:36.637
out in the field and a positor in that field may actually
41:36.700 --> 41:38.912
not have very much knowledge.
41:39.712 --> 41:43.347
So you need to err on the side of disclosing
41:43.392 --> 41:46.717
more disclosing, more enablement. How is this
41:46.765 --> 41:49.925
made? All the different components that go into something
41:50.287 --> 41:54.172
naturally that can create a tension between a company's desire to
41:54.205 --> 41:57.457
protect valuable trade secrets versus the need to provide
41:57.535 --> 41:59.462
and enabling disclosure.
42:00.562 --> 42:03.897
So what is an emerging
42:03.942 --> 42:08.162
technology? It's hard to define.
42:08.962 --> 42:12.312
We'll go through some examples which I think are very illustrative,
42:12.462 --> 42:15.502
but even in the
42:15.520 --> 42:19.797
previous case it's a little bit difficult. It was unpredictable
42:19.842 --> 42:23.487
arts, it's a little bit difficult to know exactly how much enablement is necessary.
42:23.637 --> 42:27.447
Similar kind of questions occur here from a different perspective,
42:27.567 --> 42:31.237
not so much unpredictability. But if it's so
42:31.300 --> 42:34.702
new, there might not be a lot of information out there. You might need to
42:34.720 --> 42:39.072
put a little bit more background, a little bit more enablement
42:39.192 --> 42:43.177
of different components. And things like that of your systems than
42:43.195 --> 42:46.342
you would otherwise. So as we've been talking
42:46.390 --> 42:49.722
about and this is that predictable arts,
42:49.767 --> 42:53.917
historically predictable arts can be enabled by a single example.
42:54.115 --> 42:57.667
This was a landmark case in 1987 with which
42:57.715 --> 43:01.372
as spectrophysics versus coherent where they had where this was
43:01.405 --> 43:05.457
established. New fields, however, even if they're predictable,
43:05.547 --> 43:09.102
may not rely on knowledge of a positive to satisfy
43:09.132 --> 43:11.387
disclosure obligations to the same extent.
43:12.487 --> 43:15.747
And the example we're going to go through in a minute here is automotive
43:15.792 --> 43:19.612
Technologies versus BMW, which was the 2006
43:19.675 --> 43:22.912
case. And there's actually
43:22.975 --> 43:26.900
some recent cases from 2018 to 2019 which
43:27.562 --> 43:31.347
also deal with some newer
43:31.392 --> 43:36.547
emerging technologies and how
43:36.580 --> 43:40.647
to enable that such that a positive can make and use the entire claim
43:40.692 --> 43:43.362
scope without undo experimentation.
43:43.512 --> 43:47.242
So there's a couple of cases on that as well
43:47.290 --> 43:50.872
that I've listed there. But to
43:50.905 --> 43:54.282
dive into this automotive Technologies
43:54.372 --> 43:57.922
case, because I think it's very interesting, goes back,
43:57.955 --> 44:01.177
this was a 2006 decision, but the application
44:01.270 --> 44:05.422
was filed in 1092 in this case, found all
44:05.455 --> 44:09.477
claims in balance due to that lack of enablement. And it dealt
44:09.507 --> 44:13.297
with crash sensing devices in cars. So when
44:13.330 --> 44:17.247
airbags were deployed in 92, airbag deployment
44:17.292 --> 44:20.225
sensors were arguably still an emerging technology.
44:20.662 --> 44:24.352
And what's interesting in this case is that I have
44:24.370 --> 44:27.472
this claim on the next slide. There was a broad claim which covered a lot
44:27.505 --> 44:31.587
of different embodiments. The specification
44:31.737 --> 44:35.247
described an embodiment of the device utilizing a mechanical sensor
44:35.292 --> 44:38.797
in considerable detail. You can see those I pulled out some figures on the right
44:38.830 --> 44:42.567
there from the actual patent and all different kinds of mechanical
44:42.627 --> 44:46.557
sensors were shown. It also described using an electronic sensor,
44:46.572 --> 44:50.225
but included less detail, no figures and
44:50.587 --> 44:53.600
only a paragraph or two of explanation of that.
44:54.637 --> 44:57.937
I think this is even the thing that sticks out of my mind the most.
44:58.075 --> 45:01.632
At trial, an expert testified
45:01.722 --> 45:05.017
that a positive could use off the shelf components and well
45:05.065 --> 45:09.217
known circuit design and programming to create everything
45:09.340 --> 45:13.702
within the claimed scope. And I don't think that there was any argument about that.
45:13.795 --> 45:17.127
Off the shelf components, welldesigned circuit design, well known circuit
45:17.157 --> 45:20.827
design and programming, there was no
45:20.845 --> 45:23.437
argument about that. That was true.
45:23.575 --> 45:27.577
However, the CISC still said
45:27.670 --> 45:31.402
it was invalid due to lack of enablement. Because you look
45:31.420 --> 45:34.887
at this claim, the claim is a side impact
45:34.962 --> 45:39.142
crash sensor. It has a housing, it has a mass and then C
45:39.265 --> 45:43.327
means responsive to the motion of said mass upon acceleration of
45:43.345 --> 45:47.497
said housing in excess of a prefrontal threshold for initiating an
45:47.530 --> 45:50.827
occupant protection apparatus. So really all the
45:50.845 --> 45:55.012
claims said is means for initiating this
45:55.150 --> 45:59.047
airbag system. And they described in detail some
45:59.230 --> 46:02.572
possible ways to do that mechanically, but there are a lot of different
46:02.605 --> 46:05.932
ways to do that and they hadn't enabled all of them in the
46:05.935 --> 46:09.350
specification. Even though the
46:09.787 --> 46:13.447
sort of vague, let's say the minimal description that they
46:13.630 --> 46:17.452
did include could have been made using
46:17.620 --> 46:21.022
off the shelf components. It's still the
46:21.055 --> 46:24.852
claim language, I feel like really hurt them in this case. It was so broad
46:24.957 --> 46:28.747
and their disclosure was really focused in one area that they
46:28.780 --> 46:31.112
ended up losing the entire patent.
46:33.412 --> 46:37.057
Any comments about that one? This to
46:37.060 --> 46:41.047
me was very interesting and I thought it
46:41.080 --> 46:45.867
made me think a little differently about alternative
46:45.927 --> 46:49.497
embodiments. A client may have a main kind of angle
46:49.542 --> 46:53.442
that they're going after, described really well, all kinds of mechanical drawings,
46:53.577 --> 46:56.907
but you can also do it these other ways. If it's
46:56.922 --> 47:00.562
an emerging technology, if there's not a lot of information out there
47:00.625 --> 47:02.750
about the general space,
47:03.712 --> 47:07.632
having a broad claim that covers everything could be risky.
47:07.722 --> 47:11.307
You may want to one or the other narrow the claim
47:11.397 --> 47:14.952
or beef up the description of the other embodiments,
47:14.982 --> 47:18.427
even if you're like. This is all off the shelf. This is all known in
47:18.445 --> 47:21.832
this case, at least in the automotive technology case, that would have made a
47:21.835 --> 47:25.132
big difference. I think this kind of surprises me,
47:25.285 --> 47:29.752
honestly, because it does to me, this seems like a but
47:29.770 --> 47:33.800
I guess I would agree that the claim hurt them. But if you
47:34.687 --> 47:38.300
just think about the spec, it seems kind of crazy.
47:40.612 --> 47:44.137
I would consider this pretty highly predictable art,
47:44.200 --> 47:47.587
right? Yes. Emerging, but highly predictable. So it seems
47:47.650 --> 47:50.997
a little and if Kristin has anything coming from the more predictable
47:51.042 --> 47:54.772
side of the world, if you have any thoughts does this surprise you or
47:54.955 --> 47:58.327
whatever? Is it really just the problem of the claims? They went
47:58.420 --> 48:01.722
a little too crazy with the claims? Well, it surprised
48:01.767 --> 48:05.112
me because it's back from 92 and that in six they decided
48:05.187 --> 48:08.697
that this was why this was too broad
48:08.742 --> 48:11.675
and this was how we were going to knock this out of the water.
48:12.412 --> 48:15.532
That seems like a lot of time and a lot of tech time too,
48:15.610 --> 48:18.142
including electronics development. Right.
48:18.265 --> 48:22.047
Chips, semiconductors, etc. And so that's
48:22.092 --> 48:26.407
peculiar. But when you look at the claim language itself, it really
48:26.485 --> 48:30.800
is quite broad. And so when you begin to use a means
48:32.287 --> 48:36.587
responsive to the motion of the mass upon acceleration,
48:37.012 --> 48:40.642
that could be almost anything. So I guess
48:40.690 --> 48:43.972
what I do when I see claims like this and
48:44.005 --> 48:47.302
Ashley can attest to this because I'm always asking her, hey,
48:47.470 --> 48:50.062
do you know this could read on this, this or this?
48:50.125 --> 48:54.577
And she does the same to me. And it
48:54.595 --> 48:58.487
just makes you remember that be really careful,
49:00.187 --> 49:03.547
don't try to claim a cardboard cooler when you're really
49:03.580 --> 49:07.392
trying to claim a freezing device right. With all the electronics
49:07.452 --> 49:10.897
and what not. So even though this is a
49:10.930 --> 49:14.347
great first claim and a first idea
49:14.455 --> 49:17.977
of this is everything that's needed, you do have to ask yourself as
49:17.995 --> 49:21.847
a practitioner, as you go through just the claim that you
49:21.880 --> 49:25.252
wrote, what else does this read on? How else could
49:25.270 --> 49:28.897
this be taken? Because this to me, there's a lot
49:28.930 --> 49:32.107
of things that this could be. I think
49:32.185 --> 49:35.812
some of the other problem too that I've been realizing is I think
49:35.950 --> 49:39.597
there is this like ideal that everybody has that I want this really broad
49:39.642 --> 49:43.612
claim and blah, blah, blah. But honestly, the best and I think
49:43.750 --> 49:47.122
your presentation Dave, is kind of hitting at this, that the
49:47.155 --> 49:50.632
best claim is really one that is
49:50.710 --> 49:54.397
narrow to the product that you are developing that
49:54.430 --> 49:57.132
has significant commercial, patient,
49:57.297 --> 50:00.962
clinical, whatever impact, but is broad
50:01.462 --> 50:03.875
in every other aspect. Right.
50:05.812 --> 50:08.937
Like Chris and I have talked about this before. Like every catheter,
50:09.012 --> 50:12.427
for example, has X features. So you don't need to
50:12.445 --> 50:16.700
go nitty gritty in every single feature that every single catheter has.
50:17.287 --> 50:20.722
But is there one thing of your catheter that
50:20.755 --> 50:24.582
has clinical efficacy? Okay, so claim that narrowly,
50:24.747 --> 50:28.722
not crazy narrow, but within reason, and then leave everything else broad
50:28.767 --> 50:32.437
because at the end of the day, competitors are going to copy that
50:32.500 --> 50:35.472
one thing and stick it on their own catheter.
50:35.517 --> 50:37.927
That may be slightly different, but again, like a cater to the cabinet or the
50:37.945 --> 50:42.897
catheter, generally speaking. So keeping that in mind that broad
50:42.942 --> 50:45.275
claims aren't actually all they're cracked up to be.
50:45.787 --> 50:49.252
Yeah. What's the invention in a
50:49.270 --> 50:53.637
way, right? Yeah, exactly. Don't get lost in this lofty.
50:53.712 --> 50:56.837
And I think it's hard because I think market pressures, investors,
50:57.937 --> 51:02.067
all these things have this pressure on companies. You have to have this broad
51:02.127 --> 51:06.027
claim. It's like, well, but is that really the good decision
51:06.207 --> 51:10.550
or does that just look good on paper but ends up causing problems later?
51:11.512 --> 51:15.247
Yeah, that's exactly what this whole investigation has
51:15.280 --> 51:18.457
exactly made me start thinking of that way too. And I feel like in a
51:18.460 --> 51:21.517
way, this is something that I don't know,
51:21.640 --> 51:26.302
I've always thought this way and in some ways this is like I
51:26.320 --> 51:28.492
want to look at the prior art and I want to make sure that whatever
51:28.540 --> 51:31.702
we're claiming doesn't read on something in the art. And this is giving me
51:31.720 --> 51:34.332
another kind of perspective on it. I want to make sure that what we're claiming
51:34.347 --> 51:37.717
is actually also enabled, that we've taught someone
51:37.765 --> 51:40.972
how to make and use everything within the scope of this
51:41.005 --> 51:43.747
claim. Yeah.
51:43.855 --> 51:47.000
And I will tell you, even if a larger company
51:47.362 --> 51:51.087
got this broad claim, it's really typical
51:51.162 --> 51:55.042
of large companies who have a lot of money to spend on it to
51:55.090 --> 51:58.252
say, great, we got this nice broad claim, let's go a different direction with it,
51:58.270 --> 52:02.237
in a couple of continuations, just to protect the original.
52:02.662 --> 52:06.427
If for some reason like this happened, the original has gone away,
52:06.520 --> 52:07.175
Right.
52:12.187 --> 52:15.612
Very similar case actually. Dream or Citric?
52:15.762 --> 52:19.702
Individual inventor versus DreamWorks. Again, all claims were found in
52:19.720 --> 52:23.322
value due to lack of enablement. The claim
52:23.517 --> 52:27.327
was describing using integrating a user's
52:27.432 --> 52:31.677
audio or visual signal into a preexisting video game or movie.
52:31.857 --> 52:35.392
And the specification was 99%
52:35.440 --> 52:39.772
about video games. And then they also kind of mentioned movies and
52:39.880 --> 52:44.225
that's again, what hurt him here. The district court essentially said that
52:48.337 --> 52:52.672
it was lack of enablement as to movies but they didn't even
52:52.780 --> 52:56.062
talk about whether it would have been enabled for video
52:56.125 --> 53:00.522
games. And again, here's the claim language which it's
53:00.567 --> 53:05.197
just that the presentation output and
53:05.230 --> 53:08.902
it's this presentation output was vague and
53:08.995 --> 53:12.307
if it was a video game that may have gotten through, but since it
53:12.310 --> 53:16.102
was vague and movies and other types of presentation outputs were
53:16.120 --> 53:19.252
not enabled, it was invalidated. It's a very kind of
53:19.270 --> 53:23.450
similar thing. And so what to do in
53:23.812 --> 53:26.997
emerging arts and unpredictable arts.
53:27.042 --> 53:30.627
Again, cover as much breadth as possible with examples, provide guidance
53:30.657 --> 53:34.187
on how to extrapolate and additionally,
53:34.837 --> 53:37.712
I would say for emerging technologies,
53:38.137 --> 53:41.617
which will, as we've talked about,
53:41.665 --> 53:45.382
may be a little difficult to define precisely. But if
53:45.385 --> 53:49.332
you're working in a field that is relatively new, err on the side of describing
53:49.422 --> 53:52.897
things more completely, if even if something is off
53:52.930 --> 53:56.262
the shelf or a component or a circuit, it should be known,
53:56.412 --> 54:00.575
you know, in the description. Having a little bit more description in there
54:02.962 --> 54:06.887
would probably be a worthwhile use of resources.
54:07.687 --> 54:10.897
And then carefully consider the scope of the
54:10.930 --> 54:14.600
claim terms being construed and make sure that
54:15.637 --> 54:18.952
the bread is really this goal in the Goldilock situation. It's not
54:18.970 --> 54:23.077
too broad. It's not too narrow, but it's broad enough
54:23.170 --> 54:25.852
that I art is not going to read on it and it's narrow enough that
54:25.870 --> 54:29.557
it's going to be enabled. And then I
54:29.560 --> 54:33.667
think another thing that we often talk about with clients, but maybe even
54:33.715 --> 54:37.297
more applicable here is maybe
54:37.405 --> 54:40.942
in certain cases in order to fully enable something, you're going to have to give
54:40.990 --> 54:45.622
up too much. You're going to have to describe too many process
54:45.730 --> 54:49.422
parameters and other things that would not be reverse engineer
54:49.467 --> 54:53.527
able and therefore might be better kept as a
54:53.545 --> 54:57.007
trade secret rather than going into a claim in a
54:57.010 --> 54:57.662
patent.
55:00.112 --> 55:04.107
David, quick question. What's your thoughts
55:04.197 --> 55:08.825
on I just lost my train of thought on
55:09.862 --> 55:13.475
oh, pointing. So let's say you are an emerging field, right?
55:13.837 --> 55:18.672
What are your thoughts or have you seen pointing
55:18.717 --> 55:21.712
to some art? Like,
55:21.775 --> 55:25.402
maybe not, like pointing to you. Like, here's the perfect car to
55:25.420 --> 55:29.127
do exactly the same thing. Because ideally, that's not the case, especially with emerging.
55:29.157 --> 55:32.722
But pointing to certain art somewhere in the
55:32.755 --> 55:36.097
background that kind of lays the groundwork for this new emerging field
55:36.130 --> 55:39.322
to kind of set the stage that this is
55:39.355 --> 55:43.250
the shoulders that we're stepping on. And here's the state of it.
55:43.987 --> 55:47.150
Have you seen that or would you recommend that?
55:49.462 --> 55:53.077
Great question. More or less, I guess that's what some of the
55:53.095 --> 55:56.237
articles that I was reading were advising.
55:56.587 --> 55:59.257
Not in so many words, more between the lines, I guess.
55:59.335 --> 56:02.692
But yeah, from these last few cases especially,
56:02.890 --> 56:05.450
I think like, okay,
56:06.262 --> 56:09.622
it's 1992. Your average car,
56:09.655 --> 56:13.267
maybe no car has ever had an airbag in it so this is something new.
56:13.390 --> 56:17.152
And they said to themselves, everybody knows how to use an
56:17.170 --> 56:19.707
electronic circuit to trigger a squib,
56:19.797 --> 56:24.027
to then explode an airbag
56:24.057 --> 56:28.017
or whatever. But I think that they miscalculated.
56:28.077 --> 56:31.372
And I think what they would have been better served by doing would be,
56:31.555 --> 56:35.772
hey, this is a new system or sub system, and also here's
56:35.817 --> 56:39.537
a circuit, here's a chip that you can use to control a squib,
56:39.612 --> 56:42.007
or you could do it this way, or you can do it that way.
56:42.160 --> 56:45.672
Even though I think they were just relying
56:45.717 --> 56:49.327
too much on the
56:49.345 --> 56:52.627
prior art and not explicitly stating how to
56:52.645 --> 56:55.250
make it. How to make it, how to use it.
56:57.562 --> 57:00.882
Yeah. I think oftentimes when I've
57:00.897 --> 57:04.597
been in this situation and other people I've heard say if
57:04.630 --> 57:08.602
it's in the art, if you can point to a
57:08.620 --> 57:12.127
textbook, let's say, that has this information in it, then you don't really need
57:12.145 --> 57:15.297
to describe it in detail. And I think in some cases,
57:15.342 --> 57:19.062
it might actually be okay. Sure. In many cases
57:19.137 --> 57:22.332
it's probably good advice. And in some cases, though, in emerging fields,
57:22.347 --> 57:25.792
you might want to go that extra little bit and describe a little bit more,
57:25.840 --> 57:28.957
even if you're like, someone should know this.
57:29.110 --> 57:32.087
So I don't think hurts to be a little more comprehensive.
57:32.962 --> 57:35.617
Yes, I think it's one of those cases where this shouldn't be the case.
57:35.665 --> 57:39.237
I think it is. You have to remember your audience. And the audience isn't
57:39.312 --> 57:42.652
just the
57:42.670 --> 57:46.147
inventors, it's really the courts. And I
57:46.180 --> 57:49.897
would argue that historically, judges and things like that have
57:49.930 --> 57:53.857
not been as technology savvy as maybe they should be to be weighing in
57:53.935 --> 57:57.202
on these topics. So I think you have to kind of
57:57.220 --> 58:01.452
remember your audience to some degree. Yes, patents are supposed to be written
58:01.482 --> 58:04.852
for one of skill in the art, but I think they
58:04.870 --> 58:08.122
also need to be read for judges and attorneys and things like that that
58:08.155 --> 58:11.262
maybe aren't as skilled as a positive.
58:11.412 --> 58:14.692
So I think that's kind of the weird balancing I strike, too, is that,
58:14.740 --> 58:18.072
yes, it's written for positive, but it's also written for people who need to interpret
58:18.117 --> 58:21.382
it and make judgments on it when they're not a
58:21.385 --> 58:25.177
positive. Good point. Yeah, that makes sense.
58:25.270 --> 58:28.862
Absolutely. Well, and from my perspective,
58:29.287 --> 58:33.592
I never put prior art specific content
58:33.790 --> 58:37.432
in my spec. I never point to,
58:37.585 --> 58:40.747
like, in this patent or like in that textbook or as
58:40.780 --> 58:44.152
well known in whatever, if I need to say something like that in
58:44.170 --> 58:47.932
order to not, first, denigrate the art and second, tie myself
58:48.010 --> 58:51.382
to that piece of art like I do in
58:51.385 --> 58:54.772
Europe. Right. European style summaries have that they want
58:54.805 --> 58:58.437
to know the closest prior art and then begin at your invention.
58:58.512 --> 59:01.792
But I never do that. I was taught to never do that. It could only
59:01.840 --> 59:05.317
hurt you from a
59:05.515 --> 59:08.977
well, look at this disclosure. It talks about this and you've covered this and
59:08.995 --> 59:12.247
said, this is new. But this other disclosure talks about it even
59:12.280 --> 59:15.097
though it doesn't do exactly what you say, it talks about it. And that could
59:15.130 --> 59:18.502
just be a slippery slope. So what
59:18.520 --> 59:21.887
I do is I say conventional systems
59:22.387 --> 59:25.927
such as blah, blah, blah, perform this,
59:26.095 --> 59:29.652
and the claim to subject matter or the disclosure
59:29.682 --> 59:33.327
discarded herein does this instead or provides
59:33.357 --> 59:36.502
this improvement over conventional systems. And so
59:36.520 --> 59:40.072
if you seeded in that language, even the courts who go looking for things
59:40.105 --> 59:44.150
in your specification to either help you or harm you
59:45.262 --> 59:48.597
can lean on that. And they can say, well, look, this is what conventional
59:48.642 --> 59:51.877
systems do and make sure that's accurate, by the way. You can't just
59:51.895 --> 59:55.477
make it up. And what they're doing in
59:55.495 --> 59:57.950
this invention is quite different. And this is why.
59:58.912 --> 1:00:02.757
Right. The more you can lean on technical problems, technical effects,
1:00:02.922 --> 1:00:05.375
technical solution, the better you are.
1:00:06.712 --> 1:00:10.297
And like you said, not characterizing the prior art or
1:00:10.330 --> 1:00:14.002
any specific reference. Yeah, and then
1:00:14.020 --> 1:00:17.442
the other thing I had to add was just for a practice
1:00:17.502 --> 1:00:21.127
tip and things that I think as a draft in
1:00:21.145 --> 1:00:25.112
order to make sure everything is described fully in your specification.
1:00:25.762 --> 1:00:28.850
So let's take your example with the movie and the video game.
1:00:29.812 --> 1:00:33.717
If you are ever tempted to put a comma delimited
1:00:33.777 --> 1:00:37.867
list of something in your specification that should
1:00:37.915 --> 1:00:41.677
trigger you to think, do I really want to just list these things? Is there
1:00:41.695 --> 1:00:45.942
anything important in here where they should be broken out into single sentences
1:00:46.077 --> 1:00:49.752
or examples thoroughly done in full paragraph
1:00:49.782 --> 1:00:53.527
form, interesting? Or is it really okay to be a list? It's just a
1:00:53.545 --> 1:00:57.097
trigger and I don't always do it. It's a lazy thing
1:00:57.130 --> 1:01:00.442
that as practitioners and drafters, we just kind of go, yeah,
1:01:00.490 --> 1:01:03.350
and this and this and this and this, and move on. Right.
1:01:04.162 --> 1:01:07.702
But I do try to make myself think
1:01:07.870 --> 1:01:11.872
if there's something in that list I really should dive into instead of just
1:01:12.055 --> 1:01:15.350
list. Yeah. How similar are they really,
1:01:16.312 --> 1:01:20.047
that the list prevails? Or are you shoving things
1:01:20.080 --> 1:01:23.227
into a list that yeah, maybe shouldn't be?
1:01:23.395 --> 1:01:27.232
Yes, because we all do it. You take a
1:01:27.235 --> 1:01:30.362
shortcut because you're like, I am so done with this concept.
1:01:32.587 --> 1:01:34.325
20 chemicals in,
1:01:38.362 --> 1:01:41.287
you can't think of anything else you're like, yeah, at least the three. That's good.
1:01:41.350 --> 1:01:45.050
And maybe those three things should have been three paragraphs, not three words.
1:01:46.612 --> 1:01:50.352
Right. Exactly. Well, this is cool, Dave, I appreciate
1:01:50.382 --> 1:01:53.647
it. And now I know more about the LIGO. Now I have to go
1:01:53.680 --> 1:01:58.267
see one of those next
1:01:58.315 --> 1:02:01.477
meeting. I'll do a presentation on LIGO. I've got lots of slides on
1:02:01.495 --> 1:02:03.725
that. That's cool. Yes.
1:02:05.212 --> 1:02:07.550
Our son is really getting into space.
1:02:09.112 --> 1:02:11.827
We are going to go to NASA in two days. We went a couple of
1:02:11.845 --> 1:02:15.552
years ago, but he was too little to appreciate it. But yeah, so it's
1:02:15.582 --> 1:02:19.437
just we start seeing these huge centers
1:02:19.512 --> 1:02:23.587
set up to measure phenomena that are crazy
1:02:23.650 --> 1:02:25.775
far away. It's cool to see.
1:02:26.662 --> 1:02:29.692
When I send her a presentation, I'll send a link to a really short video
1:02:29.815 --> 1:02:36.132
that they made in kind of explaining
1:02:36.147 --> 1:02:39.472
what LIGO is and the great discovery that they made and everything.
1:02:39.580 --> 1:02:43.102
And, like, all the people in the video are people that I
1:02:43.120 --> 1:02:46.612
worked with when I was in grad school. So pretty fun.
1:02:46.750 --> 1:02:47.837
Superstar.
1:02:50.587 --> 1:02:54.650
Hundreds of people worked on it. Right. But it was still a great project.
1:02:55.537 --> 1:02:58.777
That's cool. That's like one of those
1:02:58.870 --> 1:03:01.775
grad school projects that you don't have to market very hard.
1:03:05.437 --> 1:03:09.112
Thank you, David. I really appreciate I appreciate you going into enough chemical detail
1:03:09.175 --> 1:03:12.562
that my high school chemistry and maybe one class of chemistry in college
1:03:12.625 --> 1:03:16.602
got me there. Thank you. The flooring.
1:03:16.707 --> 1:03:23.527
I got the halogen group. I got that awesome.
1:03:23.620 --> 1:03:27.397
Great. Thanks. All right, well, thanks again,
1:03:27.430 --> 1:03:30.157
Dan, and everybody, I guess, have the rest of the rest of your week.
1:03:30.310 --> 1:03:33.952
Thank you, Ashley. Enjoy your time. I will soak up some sun for
1:03:33.970 --> 1:03:37.717
all of you, I promise. All right,
1:03:37.765 --> 1:03:41.377
take care. Have a great week. Bye. All right, that's all
1:03:41.395 --> 1:03:45.397
for today, folks. Thanks for listening, and remember to check us out@aurorapatins.com
1:03:45.430 --> 1:03:49.662
for more great podcasts, blogs, and videos covering all things patent strategy.
1:03:49.737 --> 1:03:52.147
And if you're an agent or attorney and would like to be part of the
1:03:52.180 --> 1:03:56.002
discussion or an inventor with a topic you'd like to hear discussed, email us at
1:03:56.020 --> 1:03:59.827
podcast@aurorapatins.com. Do remember that this podcast does
1:03:59.845 --> 1:04:03.300
not constitute legal advice, and until next time, keep calm and patent on.