​​Patently Strategic - Patent Strategy for Startups

Unpredictable Arts: Patenting Bio, Chem, and Emerging Technologies

November 29, 2022 Aurora Patent Consulting | Ashley Sloat, Ph.D. Season 2 Episode 10
​​Patently Strategic - Patent Strategy for Startups
Unpredictable Arts: Patenting Bio, Chem, and Emerging Technologies
Show Notes Transcript Chapter Markers

Think your innovation is sufficiently enabled to secure, defend, and assert your patent rights? If it’s a biological, chemical, or emerging technology invention then you might want to think again. In today’s episode we’re looking into how to get more predictable results from the unpredictable arts.

Some technologies, like those rooted in physics and mechanics, are considered “predictable” by the US Patent Office, while others, like biological and chemical technologies, are generally considered “unpredictable.” It follows that the amount of disclosure required to enable an invention is related to the predictability of the technology, and so-called unpredictable arts require more description to teach a reader how to “make and use” the technology. Similarly, emerging technologies, being less well known, also require more disclosure to be fully enabled.

In this month’s episode, David Jackrel, President of Jackrel Consulting, leads a discussion along with our all star patent panel, exploring enablement for the unpredictable arts and emerging technologies. The panel discusses peculiarities of patenting unpredictable art and emerging technologies, with a focus on modern case law and statutes to arrive at a set of best practices for getting more predictable results when patenting these technologies.

Dave is also joined today by our always exceptional group of IP experts including:
⦿ Dr. Ashley Sloat, President and Director of Patent Strategy at Aurora
⦿ Kristen Hansen, Patent Strategist at Aurora
⦿ Shelley Couturier, Patent Strategist and Search Specialist

Before joining the group, as we often do, we’d like to provide a short primer on some key concepts in this episode for those newer to the world of patenting. This primer covers:

⦿ Section 112
⦿ What is the MPEP?
⦿ Specification vs. Claims
⦿ Genus vs. Species Claims
⦿ Markush Groups

** Resources **


⦿ Show Notes: https://www.aurorapatents.com/blog/predictable-results-from-unpredictable-arts
⦿ Slides: https://www.aurorapatents.com/uploads/9/8/1/1/98119826/unpredictable_art.pdf
⦿ MPEP: https://www.uspto.gov/web/offices/pac/mpep/index.html
⦿ How to Read Chemical and Drug Patents: https://www.aurorapatents.com/blog/how-to-read-chemical-and-drug-patents

** Follow Aurora Consulting **

⦿ Home: https://www.aurorapatents.com/
⦿ Twitter: https://twitter.com/AuroraPatents
⦿ LinkedIn: https://www.linkedin.com/company/aurora-cg/
⦿ Facebook: https://www.facebook.com/aurorapatents/
⦿ Instagram: https://www.instagram.com/aurorapatents/ 

And as always, thanks for listening! 

---
Note: The contents of this podcast do not constitute legal advice.

WEBVTT

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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

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.

Intro
Episode Primer
Section 112: Enablement
What is the MPEP?
Specification vs. Claims
Genus vs. Species Claims
Markush Groups
Panel Overview
What is enablement?
Predictability and Enablement
Unpredictable Art and Emerging Technologies
Predictable vs. Unpredictable Art Examples
Unpredictable Art: Chemical and Biological Technologies Advantages and Burdens
Case Law: KSR
Detailed Description and Supporting Examples
Unpredictable Arts: Best Practices
Emerging Technologies
Emerging Technologies and Enablement
Case Law: Automotive Technologies International v. BMW of North America
Case Law: Sitrick vs. Dreamworks
Emerging Technologies: Best Practices
Outro