There are problems and then there are good problems. We once again received an overwhelming response, and the quality of your submissions blew us away! This made for an incredibly difficult selection process. It’s clear that although this past year has presented the world with unprecedented challenges, your resolve, steadfastness, and creative spirits have not been tempered one bit. After deadlocked deliberation by our selection committee and our desire to help as many as possible during these trying times, we opted to once again lift the constraints of the original award plan beyond the single $5,000 award to include the addition of $2,500 awards to two other exceptional finalists.
Using a weighted matrix, our team scored applications based on the following criteria:
We can't say it enough, but the recipients are a truly gifted collection of entrepreneurs who will surely do great things. We couldn’t be more thrilled about the potential to be a part of their journey and endurance during this critical time.
Drumroll please! And the 2021 awards go to..
We're so very pleased to announce that the first place, full $5,000 award goes to Awayr AI. Awayr’s mission is to enable designs of the future, with a relentless focus on end-user well-being and system performance. In 2009, co-founder Adam Beal was hit by a distracted driver trying to adjust his radio. In an effort to save others from similar fates, he and Dr. Ben D. Sawyer launched Awayr AI and began creating a new class of modeling and simulation AI that can model and predict human factors in ways not previously possible. Their critical innovations have the potential to save lives and improve driving safety for millions of people, while also decreasing the time it takes for futuristic technologies, such as vehicle autonomy, to make it to market.
Our thought bubble. We live in a distraction-fueled economy, and it’s coming at a great cost to driver and pedestrian safety. This seems like an incredible opportunity to apply advanced machine technologies to address preventable human failure. Backed by a team with a world-renowned automotive scientist and former Fortune 10 automotive strategy expert, we’re confident Awayr AI will deliver on its mission!
We’re excited to share that we’ve selected Aspirational Technology as our first runner-up, to receive a $2,500 award. Aspirational Technology is on a mission to end water poverty with an affordable and immediate solution to the global health crisis of waterborne diseases. They’ve developed an ultra low-cost, easy to use water filter for low income consumers in developing countries. Their filter is easy to use and screws directly onto the type of faucets commonly found in low-income houses. A family of five will spend less than a penny a day for water—less than any other filter available on the market in emerging countries. Their approach doesn’t end with a device, though. They’ve also architected a scalable and profitable manufacturing and distribution model centered around regional production that will create economic opportunity in developing countries and reduce carbon emissions from long supply chains. Added sustainability and environmental impact comes by way of a reduced carbon footprint compared to other clean water solutions since filtering water at home eliminates wasteful consumption of plastic.
Our thought bubble. Water, food, shelter – those are the essential needs and Aspirational Technology is tackling the most important in a very big, very scalable way. It’s tragic that anyone could be denied access to the most vital ingredient to life. Their mission is focused on a truly great cause, and we firmly believe they have the backgrounds and passion to make a big difference. Every startup says they’re trying to make the world a better place, but Aspirational Technology is actually going to do it!
We are delighted to report that we've selected Karybdis as our second runner-up, also receiving a $2,500 award. Karybdis aims to improve patient care in gynecological surgeries through technique and device innovation. Their product is a device that will increase the speed and safety of minimally-invasive abdominal laparoscopic hysterectomies. The current methods of operation take 30-60 minutes, and according to Karybdis, every single minute saved in the operating room saves the hospital approximately $100. Nearly 1/3 of all women in the United States will undergo a hysterectomy by the age of 60, and almost half of hysterectomies conducted in the U.S. are abdominal laparoscopic hysterectomies.
Our thought bubble. Given skyrocketing healthcare costs and the number of women impacted by this type of operation, disruption is essential. This innovation is both timely and necessary. Their group comprises an interdisciplinary team of graduate students at the University of Michigan from the schools of medicine, business and biomedical engineering – and they are backed by support from leaders in the field of Gynecology. Karybdis is a winning combination of a great idea and execution ability, with big potential for both societal and economic impact.
We certainly hope we'll be able to put COVID and its path of destruction in the rearview soon enough. Consistent with that and a strong urge to look forward, we're firmly committed to the RISE award being an annual fixture, but it will come back next year as the “Recognition for Innovative Startup Excellence” Award. We love helping entrepreneurs. It's what gets us out of bed in the morning. Getting to help even more in an epically difficult time has proved to be exceptionally rewarding for us and we're certain it will prove to be such for the recipients. Please stay tuned for updates on these great companies.
Digital Health Entrepreneurship
Aurora is partnering with InnovatorMD and our good friend Lindsay Klee, Founder of Intent Venture Management LLC, to deliver a two-part Master Class series on Digital Health Entrepreneurship. Our very own Ashley Sloat, Ph.D. will be the instructor for a Global and US Patents talk focused on the patenting of digital health technologies. Lindsay will follow-up with a class looking at the Regulatory and Reimbursement implications for digital health innovations.
Global & US Patents Master Class
Time & Location: Weds., May 12 | 5:00-6:30 p.m. PT | Live Webinar via Zoom
About the talk: Digital health technologies are pervasive in every aspect of life and will likely be the future of improving patient outcomes beyond the clinic. Using patents to provide a competitive advantage for companies in this space has never been more paramount, but also never more difficult. We’ll discuss the generalities of the US and international patent systems and the specifics around patenting digital health technologies, including artificial intelligence and machine learning innovations.
Tickets: $25 general admission provides full access to the class.
Regulatory & Reimbursement Master Class
Time & Location: Weds., May 19 | 5:00-6:30 p.m. PT | Live Webinar via Zoom
About the talk: Regulatory and Reimbursement Implications for Digital Health Innovations
Tickets: $25 general admission provides full access to the class.
About InnovatorMD: InnovatorMD's mission is to globally advance the work of physician innovators and entrepreneurs delivering solutions that revolutionize patient care. They are a group of physician innovators from various backgrounds with a single vision - to spread physician innovation to the rest of the world and to have a positive impact on patient outcomes and physician wellness while moving the healthcare industry forward.
XLerateHealth 2021 (Flint, Michigan - held virtually)
Jul 15 - Sep 23 | Flint, MI, USA
XLerateHealth Flint is now accepting applications to their 12-week virtual acceleration program. Through the 12 weeks, companies will have the opportunity to work closely with four health systems, universities, and investors. Founders will have access to experienced coaches and mentors to build their commercialization strategy, including their intersection with customers, payers, and providers.
About the XLerateHealth Program
XLerateHealth was founded in 2013 and is one of the oldest and most visible healthcare accelerators in the United States. XLerateHealth's team has a unique depth of knowledge in successfully developing healthcare and life sciences startups. They are enterprise-focused and help early stage healthcare companies validate their business model, build out their commercialization strategy, and get ready to attract funding (both non-dilutive and non-dilutive). In its 9 year history, XLH has received recognition from both the National Institutes of Health (NIH) and the Small Business Administration (SBA) for its work.
All that and a great talk
Aurora's President and Director of Patent Strategy, Dr. Ashley Sloat, will also be participating and delivering an IP Strategy Talk at 9:00 AM on July 22.
We're thrilled to be welcoming Shelley Couturier to the Aurora family! Shelley joins us this week, starting her role as a Patent Strategist and Search Specialist. She brings with her a wealth of experience and a very deep talent stack that perfectly combines business acumen, product development smarts, patent strategy insights, and meticulous search abilities. She's a joy to work with and without a doubt, will be an instant asset to our clients and their portfolios. Shelley will head up our search services and also be actively involved in patent portfolio management.
Patent Strategist. Shelley is a registered USPTO patent agent with over 20 years of experience in patent drafting and prosecution as well as extensive prior art searching, ensuring clients’ emerging products are knowledgeably designed and protected. Previously with Scientific-Atlanta (acquired by Cisco), she was responsible for a large telecommunications portfolio, which included hardware and software along with its various transport standards and protocols.
Search Specialist. Shelley has extensive experience as a search analyst researching and reporting on prior art for numerous law firms and corporations that were involved in litigation, product development, and licensing opportunities. These searches included patentability, infringement, non-infringement, validity, invalidity, freedom to operate, and state of the art in a range of technology areas, including electrical, electronics, optics, medical and biological equipment, gas and petroleum products, telecommunications, and manufacturing and business methods.
Having experienced all sides of the patent process and combined with her business knowledge, Shelley has a unique background where she is able to provide individual inventors, engineering R&D teams, and businesses with valuable insight as they develop their product roadmaps, new products, and strong patent portfolios.
We're very proud to announce the launch of Patently Strategic, a podcast designed for inventors, founders, and IP professionals, covering the finer points, sharp edges, and nuances of patent strategy. Each monthly episode will feature a round-table style discussion amongst experts in the field of patenting.
Episode One: On-sale Bar
Patentability and Selling Your Invention
In our first episode, Dr. Ashley Sloat, President & Director of Patent Strategy here at Aurora leads a deep dive into the on-sale bar and the trapdoor-esque implications of selling your innovation before filing. Ashley is joined by an exceptionally great group of co-hosts, who combined, represent over 56 years of patenting experience.
**Spoiler alert** There are some very sneaky triggers – many types of activities that you might not traditionally think of as sales transactions that can trigger the bar and really jeopardize patentability.
Patently Strategic is available on all major podcasting directories, including Apple Podcasts, Spotify, and Google Podcasts. We're also available on 12 other directories including Stitcher, iHeart Radio, and TuneIn, so you should be able to find us wherever you listen to podcasts.
Topic and guest participant requests
If you’re an agent or attorney and would like to be part of the discussion or an inventor with a topic you’d like to hear discussed, please reach out.
For the visual learners out there, we also like to make our presenter slides available for your reference. This particular deck includes great visuals highlighting key takeaways from on-sale bar related court rulings, as well as a breakdown of examples on what may and may not constitute offers for sale.
Relief for Innovative Startup Endurance
In 2020 at the height of the COVID-19 crisis, Aurora Consulting announced the RISE Award to help small businesses and inventors through these challenging times. Consistent with our mission to support emerging growth companies, we feel that weathering this crisis should not come at the loss of hard-fought R&D efforts. To that end, we’re proud to announce that we’re bringing the RISE Award back for 2021, offering a free provisional U.S. patent application or $5,000 towards a non-provisional U.S. patent application to a selected applicant. We hope that this award will continue to help provide stability and encouragement to diligent innovators.
What is the on-sale bar?
The on-sale bar is part of Section 102 within patent law that can prevent an invention from being patented if it was sold prior to patent filing.
Can I get a patent for something I have already sold?
Yes...but like with all complex matters, there is a lot of gray area. In the U.S., selling or offering for sale a product that is ready for patenting before applying for a patent can prevent you from getting a patent later. HOWEVER, the U.S. does have a one year grace period - meaning that if your sales activity was less than one year before your applying for a patent, you can still apply for and possibly get a patent. Further, if you have made improvements, those improvements may be eligible for patenting, while the base invention may not be eligible due to your sales activity. All of this is not necessarily true for international protection. Various countries have different laws around sales activity - with a general rule of thumb being don't sell or offer for sale your technology before filing for an international patent. All said, there are a lot of gray areas and nuances around the on-sale bar in US patent law, some of which are described below.
Practical tip: The U.S. does have a one year grace period, but as a general rule of thumb, don't sell or offer for sale your technology before filing for an international patent.
The America Invents Act (AIA) broadens the on-sale bar
The America Invents Act, or better known as AIA, was signed into law in 2011. Most notably, several provisions of U.S. patent law were changed, as of March 16, 2013, to better align the U.S. with the rest of the world. For discussion in this post, the scope of 35 U.S.C 102 was broadened to encapsulate art or activities worldwide, as opposed to just in the U.S. The USPTO and practitioners affectionately refer to these two eras in patent law as “pre-AIA,” or before the law change, and “AIA,” or after the law change.
Pre-AIA, the public use provision of 35 U.S.C. 102 included “public use or on sale in this country,” more than one year prior to the date of application for patent in the United States.
After AIA, the public use provision of 35 U.S.C. 102 dropped the geographical restrictions and now includes “on sale, or otherwise available to the public,” more than one year prior to the date of application for patent in the United States.
Further, the Supreme Court in Helsinn held that, outside of the “in this country” provision, AIA did not change the meaning of the on-sale bar – including secret sales still being a trigger for the on-sale bar. More to come on this later in the post.
When is the on-sale bar triggered?
According to Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67 (1998), the on-sale bar is triggered, pre-AIA or AIA, when the following two criteria are met:
For example, although Pfaff had not actually reduced the invention to practice, he had constructively reduced the invention to practice - a socket - to such a degree that he was able to provide Texas Instruments with detailed engineering drawings. Accordingly, Texas Instruments placed an order for the sockets more than one year before the filing date. Taken together, Pfaff satisfied both provisions of the on-sale bar: a commercial offer for sale and a set of specifications indicating that the sockets were ready for patenting.
What kinds of activities trigger the on-sale bar?
It’s important to also consider the kinds of transactions that you may not even traditionally think of as sales activities when it comes to inadvertently triggering the on-sale bar.
Request for Proposal Response
Submitting a response to a Request for Proposal can trigger the on-sale bar if the above provisions are met. In RCA Corp. v. Data General Corp., 887 F.2d 1056, 12 USPQ2d 1449 (Fed. Cir. 1989), RCA submitted a proposal to the Federal Aviation Administration (FAA) in response to a Request for Proposal. At the time of the proposal submission, RCA had reduced the character generation equipment to practice and offered it for sale, by virtue of submitting the proposal. Contrast this to a grant submission, for example, in which the submission is usually a “promise” to have an innovation rather than an innovation that is already reduced to practice.
Leases, licenses, and offers
Leases, licenses, and offers, even if refused or cancelled, can trigger the on-sale bar. In Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041, 1048 (Fed. Cir. 2001), Group One developed a machine to cut and curl ribbon and offered it to Hallmark on a license or royalty basis. Although Hallmark dismissed the offer and developed their own technology, the offered licensing or royalty triggered the on-sale bar. See also, Merck & Cie v. Watson Labs., Inc., 822 F.3d 1347 (Fed. Cir. 2016).
However, in In Re John Kollar, 286 F.3d 1326 (Fed. Cir. 2002), the Federal Circuit held that the mere “transfer of technical information about the claimed process” and “a license under any future patents to practice the process and sell the resulting products” does not necessarily trigger the on-sale bar. The rationale given by the Federal Circuit was that the transfer of the technical information still requires the transferee to develop a product using the technical information before commercialization – as such, the transfer is not a commercial sale. In the same vein, payment for manufacturing services does not trigger the on-sale bar. (See also, e.g., Meds. Co. v. Hospira, Inc., 827 F.3d 1363 (Fed. Cir. 2016) and Minton v. NASDAQ Inc. 336 F.3d 1473 (Fed.Cir.2003)).
Providing reports or performing claimed methods for a customer
In Quest Integrity USA, LLC v. Cokebusters USA Inc., No. 2017-2423 (Fed. Cir. May 21, 2019), more than one year prior to the patent filing, Quest allowed technicians to collect inspection data for a refinery at predetermined time intervals using the patented system and method for collecting and displaying furnace inspection data. While Quest did not provide the software or any hardware to the refinery, Quest did provide commercial services to the refinery that tracked succinctly to the issued method claims in the patent. As such, invalidity of the patent, based on triggering the on-sale bar, was upheld.
Even “secret sales” – sales in which details are not made public – still trigger the on-sale bar. There was much hope that the new language of 35 U.S.C. 102 brought about by the AIA would prevent secret sales from triggering the on-sale bar, based on the “otherwise available to the public” provision of AIA 5 U.S.C. 102. However, we found in Helsinn v. Teva Pharma 586 U.S. (Supreme Court 2019) that this wasn’t the case. Helsinn executed a license and supply and purchase agreement with MGI Pharma. The agreement required confidentiality but was also publicized. Nearly two years later, Helsinn filed a patent covering the dosages that were used in the MGI Pharma agreement. Although MGI Pharma was required to keep the dosages used in the agreement confidential and the details of the invention were not included in the public announcement, the agreement with MGI Pharma triggered the on-sale bar due to its commercial nature and the invention being ready for patenting. So…selling your invention, even though how it works is secret and difficult to reverse engineer, still triggers the on-sale bar.
What we’ve learned from the caselaw over the past few decades can be summarized as follows:
However, as I am sure is evident from the above caselaw, each situation is nuanced, so discussion with a practitioner is highly recommended. Further, if you are planning on offering for sale or selling your invention, consider filing a provisional patent application. Contact us if you’d like to discuss your unique situation!
This topic is SO important that we made it the main focus of our first podcast episode. Listen in as Dr. Ashley Sloat, President & Director of Patent Strategy here at Aurora, leads a deep dive into the on-sale bar and the trapdoor-esque implications of selling your innovation before filing. Ashley is joined by an exceptionally great group of co-hosts, who combined, represent over 56 years of patenting experience.
By: Daniel D. Wright
What to expect during patent prosecution
Getting a patent is no quick process. In the time between filing and issuance, a time known as patent prosecution, your application will navigate a number of stages and amass a wealth of official documents, often from multiple patent offices and with months or years between them. Knowing what to expect and when to expect it can be critical for planning your business. Thus, an understanding of this timeline is necessary for those who want to maximize their operations in sync with the wave of filing dates, publication dates, and office actions that ebb and flow with this process.
Patent prosecution: The time and work done between filing for and the issuance of a patent.
How long does it take to get a patent?
The full timeline for a patent generally looks like this:
Even with some of these steps being optional, the process from filing to issuance of a patent can take two to five or more years.
Patent Prosecution Stages
Let’s look at each of these stages in more detail.
1 year or less (Optional)
The majority of US inventors begin their patent journey with a provisional application. Provisional applications operate as a placeholder to secure your filing date for up to one year while you prepare a follow-on formal non-provisional application (an international PCT application or a national US non-provisional application). In a process called “conversion,” you can file the full-fledged application but still claim the earlier filing date so long as your conversion happens within the time limit. Having fairly loose requirements, a provisional could be prepared somewhat quickly, but beware the dangers in not taking this step seriously. A poorly written provisional application can sometimes jeopardize the real deal’s ability to claim that earlier filing date.
Furthermore, provisional applications are entirely optional. If you have all the materials ready, you can file your non-provisional right away, but do check with your patent practitioner before skipping the provisional stage as there can be strategic value to proceeding with one anyway.
Beware the dangers in not taking the provisional step seriously. A poorly written provisional application can sometimes jeopardize the real deal’s ability to claim that earlier filing date.
International PCT application
30 months or less; often 18 months (Optional)
For those interested in pursuing patent protection in multiple countries, the next step is usually a “patent cooperation treaty” (PCT) application. Facilitated by the World Intellectual Property Organization (WIPO), a PCT application enjoys a streamlined route for transforming your one international application into a plurality of individual national applications that are examined and issued separately. Once filed, you have 30 months from the application’s earliest filing date (i.e., 18 months from your provisional application anniversary) to provide your selection of countries and any necessary translations.
Simultaneously, a participating patent office of your choice (e.g., the USPTO, EPO, etc.) will perform a preliminary prior art search and produce a preliminary opinion on your invention’s patentability. No response from you is due for these reports; they merely serve to provide a launching point to begin patent prosecution.
Despite the fact that a PCT application is called an “international patent application,” there is no such thing as an “international patent.” WIPO itself never issues any documents that grant patent rights across multiple countries. Rather the PCT process only simplifies the mechanism previously needed to pursue patent rights in multiple countries simultaneously. The resulting national applications are all reviewed independently according to the legal principles and practices of each selected jurisdiction, so although they would all share an original PCT filing date and application number, your issued patents in the US and China, for example, will likely look very different.
Despite that a PCT application is called an “international patent application,” there is no such thing as an “international patent.”
18 months to 3+ years
Whether or not you started from a provisional application or went through the PCT process, you will ultimately end up with one or more non-provisional applications before examiners in the selected countries. The examiners will then review your application according to their nations’ patent laws and report to you an allowance or rejection via official communications referred to as “office actions.” Here is where the real work begins.
Office actions: Official communications from patent examiners, regarding allowance or rejection of your application.
Rejections are common in patent prosecution. The examiner will almost certainly find at least one reason to reject your application at the start, and, in fact, you should be a bit suspicious of receiving a “first action allowance” or an allowance without receiving any rejections. In the grand game of trying to secure the strongest position for your invention, drafting broad claims at the outset should push the boundaries of the invention by being as reductive and expansive as possible. As such, for many busy industries, a first action allowance likely indicates that you asked for too little in this first attempt.
For many busy industries, a first action allowance likely indicates that you asked for too little in this first attempt.
Regardless, no rejection is necessarily the end of the road. After each office action comes an opportunity for you to amend the claims and argue against the examiner’s cited references. Often, you’ll have to do this more than once, but through this exchange, you should arrive at a claim set commensurate with the due scope of your invention in light of the state of the art in your field. For some technologies, this process can take around eighteen months; others will require three or more years. It all depends on the details of the invention and the USPTO backlog. When things are settled, the examiner will grant allowance, and after a few months of processing time, you’ll exit patent prosecution with an issued patent.
Congratulations on the issued patent! With the official document in hand, you can replace “patent pending” with the patent number on all your products, because you now possess an enforceable property right to exclude others from making, using, selling, and importing your invention within the issued jurisdiction. This right lasts for the duration of the patent’s term, often called its lifespan or lifetime.
How long does the patent protection last?
In the US, a patent’s term is twenty years from its first non-provisional filing date. That’s right. Filing date, not issued date, so all that time spent at the PCT stage and arguing with the examiner does eat away at your patent term, but this is just how the practice works. In cases where the USPTO takes inordinately long to respond, they will append extra days according to the Patent Term Adjustment rules; however, this time can be forfeited if you yourself took extensions of time during prosecution to file your responses. For the most part, there’s no need to hurry, but do timely reply to all office actions.
Post issuance responsibilities
Be sure to pay your maintenance fees or annuities after issuance by the scheduled deadlines if you want the patent’s term to continue out to its maximum. Failing to pay these fees will terminate your patent rights early, and reinstating a case after a lapse of right can sometimes be impossible. However, these fees are increasingly expensive, so perhaps confirm with your patent practitioner that you’re still acquiring sufficient value from the living patent before paying the maintenance fee.
Failing to pay maintenance fees or annuities will terminate your patent rights early, and reinstating a case after a lapse of right can sometimes be impossible.
What happens when the patent term expires?
At the termination of a patent’s term, the invention enters the public’s hands as part of the fundamental bargain of the patent system: by revealing the details of your scientific advancement for the improvement of society, the government grants you exclusive rights for a limited time. When the patent expires, you can continue to practice your invention, but so can everyone else. Such is the nature of the patent system in its efforts to “promote the Progress of Science and useful Arts'' as declared in its foundational clause in the US Constitution.
A Journey’s End
From start to finish, patent prosecution is indeed a long process. For some, a few options exist to speed things along, but for most, the act of filing commits the application to a long road. Your application will pass through many stages on its way to become an enforceable document, but with this roadmap, you can hopefully now recognize some landmarks on the way and can move your company along in confident strides.
By: Daniel D. Wright
Patenting in the fog of unknowns
Application disclosure requires a certain level of specificity and scope restraint to satisfy Written Description and Enablement requirements, but rarely is the route from prototype to product a clear and straight line. Especially in biotech, R&D can take you all over the map, and the full picture develops slowly as the data amasses and candidates rise and fall in favor.
In our previous post on provisional patent applications, we explored the valuable flexibility of provisional applications but described the dangers of being too casual with the disclosure. A related concern stalks patent applications at all stages of prosecution – provisional or otherwise. When does imagination and, more insidiously, hindsight overreach the due scope of your application?
The Written Description and Enablement requirements, both encoded into 35 U.S.C. 112(a), establish the legal basis for your application’s disclosure, and therefore, what justly can be claimed. As two separate requirements with two different motivations:
Satisfying Both Requirements: Live Together, Die Alone
Though closely related, you can meet or fail these rules independently. Stating what the invention is with no context or instruction meets the written description requirement but fails the enablement requirement, and providing a laundry list of techniques and options for its construction or use without ever clearly stating what the invention is meets the enablement requirement but falls short of the written description requirement.
IRL: Business Demand v. Available Data
In chemical and pharmaceutical patents, it’s easy to outpace your own invention and run afoul of one or both of these rules. The story normally goes like this. In the early stages of a drug program, the business demand for IP outpaces the collected data. You might have a vague molecular scaffold in mind, but the present data availability is not sufficiently clear to know the boundaries of what’s viable, let alone what specific groups or variants will yield your lead candidate. Considering the ease of imagining all the possible variables, you might try to stretch those variable positions to be maximally inclusive beyond the reasonable scope of your data.
Hindsight is (like the year) 2020
This can facilitate the temptation to “figure it out later” and to argue that as long as all the broad terms (e.g., alkyl, heteroalkyl, etc.) are in there, you can narrow it to the valuable bits by piecemeal selection in prosecution when you have had more time to collect more data. At the end of that road, though, you’ll often find that this hindsight-fueled strategy often breaks one or both of these requirements.
Lesson from the Courts
Novozymes: A cautionary tale of disclosure scope
Novozymes A/S v. DuPont Nutrition Biosciences APS, No. 12-1433 (Fed. Cir. July 22, 2013) shows an instance of clearly overrunning the mark. Novozymes had filed an application outlining numerous possible variants of alpha-amylases derived from genus Bacillus bacteria with the variants purported to exhibit improved stability at industrially relevant conditions. The application lists seven parent enzymes with extensive mutations possible at one or more of thirty-three positions. Considering the tremendous breadth of possibility described and lack of commensurate data, Novozymes ultimately failed to acquire a patent in their first efforts during prosecution, encountering difficulties with both the enablement and written description requirements.
If at first you don’t succeed...
Meanwhile, DuPont successfully engineered a modified alpha-amylase having superior stability under the desired conditions and secured it with a patent. Upon noting that DuPont’s site of mutation was among the thirty-three listed in their own disclosure (although an express mention of the specific mutation was not), Novozymes filed a continuation application with new claims directed to that class of variants, thereby covering the specific enzyme of DuPont. This time, they succeeded in acquiring a patent and soon filed an infringement suit against DuPont.
Just cause the PTO says...
Before the court, DuPont pressed hard on their written description and enablement weak points. They demonstrated that in addition to the absurd wealth of possible embodiments, Novozyme’s disclosure contained no successful embodiment of the claimed class of enzymes. Siding with Dupont on appeal, the court weighed in heavily against Novozymes’s hindsight-informed approach:
Taking each claim … as an integrated whole rather than as a collection of independent limitations, one searches the [application] in vain for the disclosure of even a single species that falls within the claims or for any “blaze marks” that would lead an ordinarily skilled investigator toward such a species among a slew of competing possibilities. “Working backward from a knowledge of [the claims], that is by hindsight,” Novozymes seeks to derive written description support from an amalgam of disclosures plucked selectively from the [application].
Although the USPTO is comparatively generous with revised or new claim language, your claims must still reflect a singular invention, duly described and present from the start. Thus, when you file a patent application, provisional or otherwise, you must do so seeking a property right for an invention in hand, not one that you’ll divine later.
When you file a patent application, provisional or otherwise, you must do so seeking a property right for an invention in hand, not one that you’ll divine later.
The Constraint Takeaway
R&D often takes you to wild places not apparent at the start of the journey when you filed your first application, and it can be tempting to try to shoehorn recent developments into established filing dates. Sometimes that might be what you need to do, even with the above risks in mind. However, first consider whether those new revelations can stand on their own as a fresh filing. Since they weren’t expected at the start, they just might be novel and non-obvious enough to stand over your previous work, earning you a new patent term. To this end, take care to structure and schedule your applications accordingly so that each advancement of your tech is given the due space and support it needs, as broadly or narrowly as it deserves. Hindsight is seldom your friend in these matters.
The Midwest Growth Capital Symposium and InvestMidwest present the Midwest Venture Showcase
The showcase is back April 27th and 28th for its second installment with 60-70 pre-selected Midwest companies seeking seed, series-A, and series-B funding that span the Life Sciences, Healthcare, Tech, Food/Agriculture, and Energy sectors. Each will be presented to an online audience of investors, entrepreneurs, researchers, and executives. The virtual event will highlight industry trends, expert insights, and growing Midwest companies seeking venture capital investments.
Interested in pitching?
Application deadline (just extended): February 8, 2021 11:59pm cst
Who can apply?
Ashley Sloat, Ph.D.
Startups have a unique set of patent strategy needs - so let this blog be a resource to you as you embark on your patent strategy journey.