Fortifying Life Science Patents: Eligibility and Enablement

The life sciences are currently facing at least two major plagues in our patent world. The first is that many life science innovations have been deemed ineligible in terms of patentable subject matter. In other words, the courts and the patent office believe that the patent laws are not meant to protect these innovations. The second plague is that the courts believe that many life sciences patents are not enabled. In other words, they are not described in sufficient detail to enable one of skill in the art to make and use the invention.

These subject matter eligibility and enablement plagues manifest in dreaded Section 101 and 112 rejections. In this month’s episode, Dr. Ashley Sloat, President and Director of Patent Strategy at Aurora, leads a discussion, along with our all star patent panel, delving deeply into these rejections and, in the interest of avoiding a podcast 101 rejection, provides some very practical application tips that will help to fortify your life science patent applications.

Ashley is also joined today by our always exceptional group of IP experts including:

⦿ Kristen Hansen, Patent Strategist at Aurora
⦿ Daniel Wright, Patent Strategist
⦿ David Jackrel, President of Jackrel Consulting
⦿ Shelley Couturier, Patent Strategist and Search Specialist
⦿ David Cohen, Principal at Cohen Sciences
⦿ Amy Fiene,  Patent attorney at Vancott and adjunct professor at BYU
⦿ Steve Stupp, Partner at Stupp Associates, LLC.

** Resources **

⦿ Show Notes
⦿ Slides
⦿ The Death of the Genus Claim
⦿ Final office action rejection frequency for life science patents
⦿ Examiner statistics (not an endorsement)

** Follow Aurora Consulting **

⦿ Home
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And as always, thanks for listening! 

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

Chapters

• 0:00 Intro
• 2:45 Sections 101 and 112 explained
• 6:10 Genus ad Species defined
• 9:04 Wands Factors defined
• 9:35 Estoppel defined
• 10:24 RISE winners announcement
• 13:00 First Plague: Section 101
• 16:38 Subject matter eligibility guidance
• 17:43 Second Plague: Section 112
• 27:34 Section 101 meets life sciences
• 28:07 MOT Claims: active treatment step
• 28:43 Case Law: Vanda Pharmaceuticals v. West-Ward Pharmaceuticals
• 29:29 Case Law: Endo Pharmaceuticals Inc. v. Teva Pharms USA, Inc.
• 30:04 Case Law: Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC
• 30:52 Natural Product Claims
• 31:19 Case Law: Roche Molecular Systems, Inc. v. Cepheid
• 32:48 Case Law: Natural Alternatives v. Creative Compounds
• 41:16 Drafting tricks to avoid
• 42:07 Drafting Solutions
• 44:28 The Other Part of 101 - Specific, Substantial, and Credible
• 49:33 The USPTO is not the FDA
• 55:55 Examples where utility failed
• 1:08:37 Outro

Transcript

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Good day and welcome to the Patently Strategic Podcast, where we discuss all things at

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the intersection of business, technology and patents. This podcast

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is a monthly discussion amongst experts in the field of patenting. It is

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for inventors, founders, founders and IP professionals alike, established or aspiring.

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And in today's episode, we're providing a multivitamin to help with fortifying

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your life science patents against the plagues of section 101 and 112.

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Life sciences are currently faced by at least two major plagues in our patent

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world. The first is that many life science innovations have been deemed

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ineligible in terms of patentable subject matter. In other words,

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the courts and the Patent office believe that the patent laws are not meant to

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protect these innovations. The second plague is that the courts believe

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that many life science patents are not enabled. In other words, they're not

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described in sufficient detail to enable one of skill in the art to make

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and use the invention the subject matter eligibility and enablement

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plagues manifest in dreaded section 101 and 112 rejections.

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The practical implications are staggering when it comes to

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eligible subject matter. In the last five years, over 80%

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of abandoned life science applications had a final rejection from

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the USPTO. Stating that the innovation did not include

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patentable subject matter based on subject matter eligibility

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criteria. And as we'll explore, 101 and 112

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rejections can surface in a myriad of ways, but no idea is too big

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to fail. Case law is now littered with patents whose innovators

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ideas proved to be revolutionary, but whose patent claims ended up invalidated because

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they failed to demonstrate in their applications how their observations

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could be practically applied, or failed to prove that they deserve the breadth of coverage

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they sought. In this month's episode, Dr. Ashley Sloat, President and Director

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of Patent Strategy here at Aurora, leads a discussion along with our

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all star patent panel, delving deeply into these rejections. And in

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the interest of avoiding a podcast, 101 rejection provided some very practical

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application tips that will help to fortify your life science patent applications.

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Ashley is joined today by our always exceptional group of IP experts,

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including Kristen Hansen, patent strategist at Aurora

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daniel Wright, patent strategist david Jackrow, president of

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Jacob Consulting shelley Kerrier, patent strategist and search specialist

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david Cohen, principal at Cohen Sciences amy Fine,

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patent attorney at Vancouver and adjunct professor at BYU and Steve

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STUP, partner at STUP Associates, LLC. Now, before taking you

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into the group conversation, as we often do, I sat down with Ashley to

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discuss a few concepts that could use some extra color and context for those newer

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to patenting. All right, thanks for joining me, Ashley.

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Based on feedback we've received, I know these primers that we front load with have

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been incredibly helpful on ramps to the deeper conversations that follow,

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and I know this one will be no exception. A couple of episodes

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ago, in discussing ownership, we explored sections 102 and 103,

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which deal with rejections around novelty and obviousness.

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In this month's episode, Rejection focus, if you will, is around

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sections 101 and 112. Could you talk briefly

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about each for those who haven't yet been on the receiving end?

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Absolutely. So section 101 deals with what

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subject matter is eligible for patenting and generally speaking,

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this should be essentially everything under the sun.

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However, it implicitly has been read into

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this section 101 by the courts that things that are

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natural phenomenon, abstract ideas or

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natural laws do not fall,

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are not protectable under the patent laws. And so, unfortunately for

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life sciences, they have basically had that many life science innovations

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are natural phenomenon and so they are not eligible for

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patenting. And so what we talk about in

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today's podcast is how do you better shore

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up your patent application to be eligible under section 101 and

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what can you do? So it can be as simple as I think

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one of the homework cases for section 101 was around fetal

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DNA, detecting fetal DNA in the mother's blood. And of course

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this is amazing technology because it really reduced

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the risk of the fetus and the mother over current methods

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like amniocentesis and things like that.

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But because of how the claim was drafted,

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it very much centered on the natural phenomenon and

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didn't more directly tie in practical applications

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or things like that. And so a lot of the patents around

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this technology were invalidated because they were deemed to not be

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eligible subject matter. But in case that section

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101 and probably I think other podcasts that we've

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done also talk about software being a difficult one under this section

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as well. But as you know, today we're focusing on life science.

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The other one is section 112, which has three components written

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description, enablement and best mode. So the written description

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requirement means that the specification must describe

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the claimed invention in a manner that is understandable to a person

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of ordinary skill in the art. So it shows that the inventor actually

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had possession of the invention at the time of filing.

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The enablement requirement, which is different than a written description

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requirement, is that the specification must teach those

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in skills in the art how to make and use the full scope of the

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claimed invention. And this is the key part without undo

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experimentation. And as you'll hear in today's discussion that

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undo experimentation is a lot of

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discussion in the courts around that. And what really does qualify as

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undo experimentation is

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it still undo if you teach want to

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skill in the art exactly how to arrive at various chemicals

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that may be covered under your patent, or do you have

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to actually teach every single chemical or can you just teach them a process to

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get to those chemicals and what constitutes unto experimentation?

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And then best mode is exactly what it sounds like. You have to describe

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the best mode. You can't keep the best mode for yourself and only describe

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those that were not the best. Now, you don't have to label it as

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the best mode, but you do need to describe it. All right? So I think

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that's actually a pretty good segue to the next question. You and the group talk

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about genus and species several times during the conversation.

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Now this talk is about life science patents, but these references aren't

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strictly biological. Could you explain what genus and species

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can mean in the world of patenting and claims in particular? Yeah,

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absolutely. It is a little bit of a misnomer, just as it

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is in classical Phylogeny.

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Genus comes before species,

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right? And genus is a broader classification

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than species. And so if you think about it in that lens,

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a genus claim is a claim that

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covers a broader range of more narrow species,

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right? So you could have a broad chemical class,

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a broad genus class of chemicals, and then more

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narrow species that fall under that genus.

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So think about it from an umbrella perspective. A lot

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of inventors, especially in the life science, invent one vertical,

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right? They invent a new chemical, they invent a new drug treatment

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or something like that. But there may be other drugs that look like

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that drug or other chemicals that look like that chemical or behave like

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that chemical that they believe that they also deserve protection

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for, right? That they deserve a broader umbrella that covers

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all those chemicals and all those drugs that look similar. And so in that

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case, you would say that the broad claim is the genus claim

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and the more narrow claims around each chemical or

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each drug is a species claim. And so what we'll talk about

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today in the podcast is essentially the death of

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the genus claim, meaning that the courts are increasingly saying

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that you need to show some kind of

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proof of possession or reduction to practice

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some data or something for each of these specific species

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that would fall under your genus claim. And if

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you can't do that, then you don't deserve the broad genus claim. And so

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this is kind of one of those unfortunate things that's happening as well, that you

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could fully lead the horse to water, walk them through

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the exact process that they would need to do to create new

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chemicals, create new drugs that look like that, behave like that. But because

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they're in an unpredictable science, because being

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predictable can be difficult, the courts have basically said that that's not enough,

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that's still under experimentation and you actually need to reduce the practice at least

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one example of each of those species. And so it's becoming much harder for

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life science inventors to get broad claims, broad genus

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claims. Thanks. All right, two other legal

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terms pop up in this episode. They're more in the sides and not quite

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as essential to understanding the thrust of the conversation,

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but they're still very important in patent law. So definitely worth taking a second

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to define the first is just what is a wands factor?

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So when looking at section 112, which remember is your rent description,

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enablement and best mode requirement or part of the statute,

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the wands factors were developed by the courts and it is a test for

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enablement. Does the specification in the figures

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teach one of skill in the art to make and use the invention? And so

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they walk through several factors to determine

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if the pet application is truly

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enabled or the claims are truly enabled. And what is an

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estoppel in pet and law? This is a general legal principle,

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but it basically precludes or prevents a person from

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asserting something today that is contrary

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to something that they did or said previously.

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And so, for example, in patent lawn during

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prosecution, which is the bartering that happens between you and the Patent Office to get

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your issue patent, if you say that

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my claims definitely don't include X,

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and then later in a litigation proceeding or some kind of post grant proceeding,

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you say, Oh, my claims totally do cover X,

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that you are stopped from saying that it definitely includes X,

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because you just said it didn't include X. So it basically prevents you from

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talking out of both sides of your mouth. Makes sense. Thanks, Ashley.

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Just one more thing before joining the panel, we have some exciting news to share.

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Back in March, in our Adventure Stories Volume One episode,

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we introduced you to three impressive innovators who are all past recipients

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of our annual Rise Award. This award provides a free provisional US.

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Patent application or $5,000 towards a nonprovisional

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US. Patent application to a selected applicant. This is in recognition of their innovative

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startup excellence. We received an overwhelming response to applications

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for this year's award, and the selection process was incredibly difficult.

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But I'm happy to announce that our selection committee has chosen hearsight,

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LLC is the winner of the 2022 Rise Award.

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Hearsight is tackling the important mission of reimagining assistive hearing

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technology. When we look for ideal Rise recipients, we look closely at

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potential for societal good matched with a team that can execute.

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And Hearsight is just this kind of impactful innovation backed

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by the kind of DNA it takes to see through to market success.

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Assistive technology is a corner of the market that unfortunately still has way

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too much white space, and we're happy to help fill it in any way we

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can. Due to the high volume of quality submissions and our desire

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to help as many as possible, we decided to once again expand the offering beyond

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the single first place award. The first runner up this year is thermo

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Verse. They're focusing their efforts on much needed solutions

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that will greatly improve the heating and cooling economics for low to

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moderate income housing properties. Their innovations are both timely

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and necessary, given skyrocketing energy costs,

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storing home prices, and housing shortages across the country. Disruption in

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this space is essential to maintain viability to as many

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LMI properties as possible. And the second runner up is Spirit Fire.

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Aftermarket with their vehicle lighting solution. We love gritty entrepreneurs

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who roll up their sleeves and find ways to innovate. Spirit Fire

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story is a great example of finding a real market need self bootstrapping

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and doing a practical thing very well. We'd love to say more,

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but we can't since public disclosure on an IP podcast is

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beyond forgivable. But do stay tuned. We'll hopefully be introducing

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you to these innovators in a future Adventure Stories episode.

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All right, without further ado take it away, Ashley. All right.

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So kind of what we wanted. And Dan's going to jump in here too,

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towards the end with some different thoughts as well. What we wanted to do

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is kind of jump through and walk through some of the issues

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plaguing life, science, patents. And so I kind of named these the first

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and the second plague. So the first plague is section 101

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issues, which is patentable subject matter, as you all know.

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And then the section 112 is adequate written description.

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And so the section 101 thing

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has been around for a long time. I don't think it's necessarily new to anybody,

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but what I kind of wanted to do is sift through some of the case

214
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law and kind of pull out some of the nuggets. But from a

215
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background perspective, the main Art unit that deals with a lot of these diagnostic

216
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methods of treatment, you can see that the name of the Art unit is

217
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molecular biology, bioinformatics nucleic acids. We're coming at DNA

218
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and RNA gene regulation is Art Unit 1631.

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And over the last five years, they've had about a 60% allowance

220
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rate, which isn't awful, but maybe it could be a little

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higher. Ten to 20 points. They've had 718 allowed

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patent applications, 485 abandoned applications.

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And of those that were abandoned,

224
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80% of them had a 101 rejection at the final Office section.

225
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Wow. Yeah, not a great outlook from that perspective.

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And so when you look at it, I found this graph through a great

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website. I'll have to put that in the notes.

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But if you look at this is the Art

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unit for the last five years, that same 1631 Art unit. And you

230
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can see that there was about

231
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50% 101 rejections,

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obviously wasn't that bad. They had the

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references around Alice or Mayo or Myriad, which are all

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those key cases. You can see that those were relatively frequently referenced

235
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in the Office actions and then a little bit of double patenting.

236
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But the biggest issue was the section 101 issues. And then

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actually 112 is right up there as well, probably around, I don't know,

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40%, 35%. So that's really

239
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kind of thing plaguing the industry. And I think the

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biggest issue is how do you delineate when something

241
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is just a natural phenomena versus when you're actually applying

242
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it in a reasonable way? And then the other part of that is,

243
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is your written description enough? And I definitely touch way more on the 101

244
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issue and then just briefly on the 112 issues. But there's a really

245
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great paper out by Mark Lemley and a few others just in

246
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2021, and I haven't read the whole thing yet because it's almost

247
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80 pages, but it's called The Death of the Genus Claim.

248
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And it's a really good read from what I've read so far, just around

249
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the shift over the last 40 years or

250
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50 years from companies

251
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being able to claim these broader genus claims when they've discovered

252
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a class of compounds that have certain biological properties to now

253
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the courts kind of restricting them down to potentially just one species.

254
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And I'll kind of explain why they think that shift is happening because I think

255
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it's kind of interesting and I kind of saw it happening a little

256
00:15:33,964 --> 00:15:37,662
bit, but I probably couldn't have articulated it and the reasoning

257
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behind it like they did. So it's

258
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really interesting. So anyways, we'll get touch on that briefly. You know what's interesting,

259
00:15:44,320 --> 00:15:47,846
when you start to see 112 and one on one uptick, they often

260
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coincide with examiner training. And so

261
00:15:52,930 --> 00:15:56,558
three years or so after 112 training, here we are and everything has

262
00:15:56,584 --> 00:15:58,420
a 112, right?

263
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Not to be cynical, right? For sure. And the other

264
00:16:04,372 --> 00:16:08,140
interesting thing is the courts. I feel like the courts are,

265
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I don't know, I feel like the courts could use some one false training.

266
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The courts could use some patent training too, because I feel like they read

267
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a lot of things into the statutes that aren't there,

268
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which is then impacting a

269
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lot of precedent and how things are drafted and maybe not necessarily supported

270
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by the original laws. And so I think that's kind of the other interesting

271
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thing that's happening. Everybody can use

272
00:16:34,576 --> 00:16:38,694
all of it more patents, right? So nobody

273
00:16:38,742 --> 00:16:42,426
is probably unfamiliar with this, but just really briefly,

274
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the subject Matter eligibility guidance, they basically ask

275
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whether your claims are directed to a statutory category,

276
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which is process, machine, manufacturer, or composition of matter.

277
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And if it's not in that category, it's not eligible.

278
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If they think it is in one of those categories, they ask if

279
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it's directed to a judicial exception. And as we all

280
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know, it's laws of nature, natural phenomena and abstract ideas.

281
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If it's not directed to a judicial exception,

282
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and it's eligible. If it is, they ask whether it's integrated into

283
00:17:14,452 --> 00:17:17,994
a practical application. If it is, it is eligible.

284
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If it is not, they ask whether it has significantly more

285
00:17:22,150 --> 00:17:26,142
than the judicial exception. And if the answer is no, it's not eligible.

286
00:17:26,226 --> 00:17:29,898
And if the answer is yes, then it's not eligible. So that's generally

287
00:17:29,934 --> 00:17:33,498
kind of what examiners walk through. Of course, in the life science,

288
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they're going to rely on more of the life science, case law,

289
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myriad and things like that,

290
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whereas in the software they're going to rely more on Alice and other related cases.

291
00:17:43,870 --> 00:17:47,078
So then briefly, the second plague, I'll touch more on this one

292
00:17:47,104 --> 00:17:50,486
here briefly and then we'll jump back into 101 is and

293
00:17:50,548 --> 00:17:53,270
I do think a lot of this is the death of the genus thinking.

294
00:17:53,320 --> 00:17:56,246
I'm really summed up with that statement from Lenley and others.

295
00:17:56,308 --> 00:17:59,894
But where the shift has been happening is

296
00:17:59,932 --> 00:18:03,302
that previously what

297
00:18:03,316 --> 00:18:07,614
you have to distinguish is whether you're dealing with known unknowns.

298
00:18:07,722 --> 00:18:11,474
Because I believe if you're dealing with known unknowns then

299
00:18:11,512 --> 00:18:15,954
that's not undue experimentation, right? If a researcher knows how to navigate

300
00:18:16,122 --> 00:18:19,722
all the known unknowns

301
00:18:19,746 --> 00:18:22,782
and they should be able to do that to process the invention,

302
00:18:22,926 --> 00:18:26,514
but what you don't want is a whole bunch of unknown unknowns

303
00:18:26,562 --> 00:18:29,270
because then that is probably undue experimentation.

304
00:18:29,830 --> 00:18:34,060
And so there has been argument around is whether

305
00:18:34,510 --> 00:18:38,046
a person of skilled in the art needs to find a species

306
00:18:38,118 --> 00:18:41,522
that works in order to practice the claim. Or whether they

307
00:18:41,536 --> 00:18:45,122
need to find every species that works to

308
00:18:45,136 --> 00:18:48,294
make and use the invention. And I think what a lot of experts

309
00:18:48,342 --> 00:18:52,070
would argue right now is that the way the courts are interpreting section 112

310
00:18:52,120 --> 00:18:55,578
is that a person of skill needs to find every species

311
00:18:55,614 --> 00:18:58,826
that works. And so even when the spec is

312
00:18:58,948 --> 00:19:02,910
super clear around what needs to be done to find a species,

313
00:19:03,090 --> 00:19:06,858
they say that, well, it still would be undo because there's too many species

314
00:19:06,894 --> 00:19:10,658
to find. And so it's a really weird shift that's happening

315
00:19:10,804 --> 00:19:14,022
that you're

316
00:19:14,046 --> 00:19:17,450
basically shifting from the question of whether making

317
00:19:17,500 --> 00:19:21,050
and using the invention requires undue experimentation to whether

318
00:19:21,100 --> 00:19:24,482
such experimentation is required to define the full scope of

319
00:19:24,496 --> 00:19:27,906
the invention by figuring out all the possible species.

320
00:19:28,038 --> 00:19:31,778
And so I think that's where a lot of this 112 issues coming from.

321
00:19:31,924 --> 00:19:36,038
Just briefly, there's a few cases up on the slide, but the

322
00:19:36,064 --> 00:19:39,398
things that obviously if the field is supernat and

323
00:19:39,424 --> 00:19:43,300
unpredictable and rife with failure, then of course you probably need to have a really

324
00:19:43,690 --> 00:19:47,198
significant description to support those claims. I don't necessarily disagree with

325
00:19:47,224 --> 00:19:51,460
that. Right? And so that was the ends of biochem versus Calgene case

326
00:19:52,270 --> 00:19:55,526
and that was antisemitic DNA technology at that time. It was super

327
00:19:55,588 --> 00:20:00,786
new and so they probably didn't need to describe more adequately

328
00:20:00,858 --> 00:20:04,218
in their description various ways to practice

329
00:20:04,254 --> 00:20:08,874
their technology. This was surprising. Even iterative

330
00:20:08,982 --> 00:20:13,074
trial and error led by the spec can still create an enablement

331
00:20:13,122 --> 00:20:16,826
issue because this was one of those where it was for rampamycin chemicals for

332
00:20:16,828 --> 00:20:20,462
the treatment of restinosis and if

333
00:20:20,476 --> 00:20:24,074
you multiplied all the different R groups that one could have

334
00:20:24,112 --> 00:20:27,758
on rampamycin, there was a huge amount of potential chemicals that

335
00:20:27,784 --> 00:20:31,202
could have been created. But one of skill in the art could

336
00:20:31,216 --> 00:20:35,258
have very easily found one chemical that worked that was

337
00:20:35,284 --> 00:20:38,742
within the scope of the claim. But where the court kind of, I think aired

338
00:20:38,766 --> 00:20:42,230
is again, they thought that somebody would have to find all of them

339
00:20:42,400 --> 00:20:45,618
to make the claims. Work. And I think that's

340
00:20:45,654 --> 00:20:48,938
kind of crazy because somebody just needs to build a fine one to practice it

341
00:20:48,964 --> 00:20:52,998
right, because that shows that they can use the spec to their benefit.

342
00:20:53,154 --> 00:20:57,078
And then there's another case. This is Identics Pharma

343
00:20:57,114 --> 00:21:00,582
versus Gilead and describe the screening process allowed

344
00:21:00,606 --> 00:21:04,122
for straightforward identification of working in bodies embodiments.

345
00:21:04,146 --> 00:21:08,666
But still the court said that it required undue experimentation because again,

346
00:21:08,848 --> 00:21:12,206
this two methyl nucleotide for the treatment of

347
00:21:12,328 --> 00:21:15,974
hepatitis C virus. They basically, again said there's so many

348
00:21:16,012 --> 00:21:19,694
two methyl nucleicides out there, how is any person supposed

349
00:21:19,732 --> 00:21:22,610
to understand the full scope of the claim?

350
00:21:23,170 --> 00:21:26,526
And instead of just saying, are they able to practice it? And it's

351
00:21:26,538 --> 00:21:30,870
like, well, for sure, because the screening process was very clearly delineated

352
00:21:30,930 --> 00:21:34,634
and was very much within the skill of they actually even had experts basically saying

353
00:21:34,792 --> 00:21:37,922
it was within the skill of one in the art. So it's honestly kind of

354
00:21:37,936 --> 00:21:41,594
ridiculous. But this is where I think Lemley and others

355
00:21:41,632 --> 00:21:45,398
are kind of saying this is the death of the genus claim because the

356
00:21:45,424 --> 00:21:48,638
courts want somebody to be able to find all of

357
00:21:48,664 --> 00:21:52,286
the possible working examples or all the possible

358
00:21:52,468 --> 00:21:55,890
chemicals that fall into a genius rather than just be able to practice

359
00:21:55,950 --> 00:21:58,778
one. And I think that's an error. Yeah,

360
00:21:58,804 --> 00:22:02,666
actually I had a question about so given

361
00:22:02,788 --> 00:22:07,070
all this case that you've got into something

362
00:22:07,120 --> 00:22:10,598
that I had always heard about the genus and having good support

363
00:22:10,684 --> 00:22:14,174
for it would be like having enough

364
00:22:14,272 --> 00:22:18,014
examples in the specification that you have like a cross section of

365
00:22:18,052 --> 00:22:21,662
the species. So maybe you'd say if you have

366
00:22:21,676 --> 00:22:25,538
a molecule in your genus with like four positions for a side group and then

367
00:22:25,624 --> 00:22:30,350
four options for that side group, you don't need to show

368
00:22:30,400 --> 00:22:34,278
data for all 16 combinations.

369
00:22:34,374 --> 00:22:38,222
But if you did sort of one or two side groups of

370
00:22:38,356 --> 00:22:42,042
cutting across all the categories in some of those positions,

371
00:22:42,066 --> 00:22:45,794
cutting across all of them, would that based

372
00:22:45,832 --> 00:22:49,010
on your reading and what you were just describing, do you think that would still

373
00:22:49,060 --> 00:22:52,720
be enough? Or are they really saying, no, you need to

374
00:22:53,770 --> 00:22:57,950
have experimental data on all of the combinations?

375
00:22:58,450 --> 00:23:01,262
Yeah, I think that's a good rule of thumb that a lot of people and

376
00:23:01,276 --> 00:23:03,698
I think Dan could speak to this even more so probably than I could.

377
00:23:03,724 --> 00:23:07,058
But I think that's a lot of what everybody's been doing now is saying

378
00:23:07,084 --> 00:23:10,766
we got to make sure you support. But I think where

379
00:23:10,948 --> 00:23:14,870
people are struggling, though, is that you don't necessarily have working

380
00:23:14,980 --> 00:23:19,734
examples for all of those chemicals. And so potentially,

381
00:23:19,782 --> 00:23:23,140
if they can show at some later date that

382
00:23:23,950 --> 00:23:29,126
different methods that you described don't support that

383
00:23:29,188 --> 00:23:33,042
class, that could call into question whether you deserve

384
00:23:33,066 --> 00:23:36,458
the full genus right versus just

385
00:23:36,484 --> 00:23:38,942
the subject. But Dan, do you have additional stuff? Yeah,

386
00:23:39,136 --> 00:23:42,834
David, your tactics

387
00:23:42,882 --> 00:23:45,962
there is generally what I've heard and more or less kind

388
00:23:45,976 --> 00:23:49,910
of has done it as well, that if you've got all these variants,

389
00:23:51,850 --> 00:23:55,998
it's very easy to just name them all. Chemical software

390
00:23:56,034 --> 00:23:59,790
can just spit out all the chemical names. That makes the list incredibly

391
00:23:59,850 --> 00:24:03,614
long. But what's more valuable is to show the

392
00:24:03,652 --> 00:24:07,046
cross section so that you indeed have each type of group

393
00:24:07,108 --> 00:24:10,446
in each type of place, as opposed to enumerating each variant

394
00:24:10,518 --> 00:24:14,718
of each type of group. But critically, what I have seen examiners

395
00:24:14,814 --> 00:24:18,002
do, especially in foreign jurisdictions, the US.

396
00:24:18,076 --> 00:24:22,250
Is still a little bit more flexible than I found in particular East Asia

397
00:24:23,290 --> 00:24:27,306
and increasingly perhaps Europe, that in addition

398
00:24:27,378 --> 00:24:30,938
to just depicting a cross section of the

399
00:24:30,964 --> 00:24:34,494
compounds, your data also needs to reflect

400
00:24:34,542 --> 00:24:38,066
that cross section. So even if you've only

401
00:24:38,128 --> 00:24:42,642
got, even if you showed methyl

402
00:24:42,726 --> 00:24:46,900
and halogens in these positions, if you've only got data

403
00:24:47,530 --> 00:24:50,510
for halogens, for a halogen,

404
00:24:50,950 --> 00:24:54,110
some more strict jurisdictions

405
00:24:56,570 --> 00:25:00,006
may not go for the methods if you've only got data for halogen. Okay,

406
00:25:00,068 --> 00:25:03,438
so increasingly, yes, I feel

407
00:25:03,464 --> 00:25:07,206
like the cross section strategy is still

408
00:25:07,328 --> 00:25:10,854
kind of what people go for, but the

409
00:25:10,892 --> 00:25:14,218
data of what you show in that cross section is increasingly

410
00:25:14,254 --> 00:25:16,940
more valuable than just naming them.

411
00:25:17,570 --> 00:25:21,270
Yeah, in some of the case law too, David, is that

412
00:25:21,440 --> 00:25:25,086
even with different experts stating that

413
00:25:25,148 --> 00:25:29,070
the process was clearly laid out to be able to

414
00:25:29,240 --> 00:25:32,658
implement to identify all these different ones that they had put into

415
00:25:32,684 --> 00:25:36,174
the claims, it wasn't enough because

416
00:25:36,212 --> 00:25:39,462
it still would have been like in order to quote, unquote, find all of

417
00:25:39,476 --> 00:25:42,834
the species, it would have taken a lot of experimentation to do

418
00:25:42,872 --> 00:25:46,338
so rather than just saying could somebody find one or

419
00:25:46,364 --> 00:25:49,854
make one, well, sure, they could just make one and probably it would work,

420
00:25:49,892 --> 00:25:53,250
or they could make four or five and one of them would probably work,

421
00:25:53,360 --> 00:25:57,130
but that's no longer enough. So that's I think encouraging

422
00:25:57,190 --> 00:26:00,522
there to be some working examples of a

423
00:26:00,536 --> 00:26:04,110
few or one at least in each cross section or something, might be

424
00:26:04,220 --> 00:26:08,854
advantageous to kind of find what process differences

425
00:26:08,902 --> 00:26:10,520
may be occur for each one.

426
00:26:12,530 --> 00:26:15,860
Yeah, okay, thanks. Yeah. Interesting.

427
00:26:16,430 --> 00:26:19,758
So then here's some the wands factors that a lot of times are kind of

428
00:26:19,784 --> 00:26:22,998
used for the section 112. And so I'm not going to go through these in

429
00:26:23,024 --> 00:26:26,278
detail, but many of you, maybe everybody is familiar

430
00:26:26,314 --> 00:26:29,350
with these, but obviously the quantity of experimentation

431
00:26:29,410 --> 00:26:32,746
necessary, this is kind of deciding what's undo

432
00:26:32,818 --> 00:26:36,514
versus not undo experimentation, amount of direction or guidance

433
00:26:36,562 --> 00:26:40,422
presented. Like how well does the spec teach present or absence of

434
00:26:40,436 --> 00:26:43,678
working examples? I've even heard more and more that prophetic

435
00:26:43,714 --> 00:26:47,314
examples are kind of not super helpful

436
00:26:47,362 --> 00:26:51,198
anymore. The nature of the event, what kind of art is it? State of the

437
00:26:51,224 --> 00:26:54,750
prior art? What was the level of skill at that time?

438
00:26:54,920 --> 00:26:58,158
How much would they have to experiment to understand the technology?

439
00:26:58,244 --> 00:27:01,842
Like I said, the anti sens DNA case,

440
00:27:01,976 --> 00:27:05,238
the antisens DNA technology was so new at that time

441
00:27:05,384 --> 00:27:08,838
and they just didn't teach enough or how decent that field was

442
00:27:08,864 --> 00:27:11,634
and how much failure there was in that field. I can kind of understand that

443
00:27:11,672 --> 00:27:15,174
case more in the sense that it's just so new. So you really

444
00:27:15,212 --> 00:27:18,982
needed to bolster more support for all the different other use cases

445
00:27:19,006 --> 00:27:22,606
or other DNA that you could make with that technology, the predictability

446
00:27:22,678 --> 00:27:26,060
or unpredictability of the arts and the breadth of the claims. And so kind of

447
00:27:26,690 --> 00:27:30,474
walking through this with clients, thinking about all these different factors and

448
00:27:30,632 --> 00:27:34,062
how you describe the technology, but kind

449
00:27:34,076 --> 00:27:37,662
of going back to 101. Now, obviously everybody's familiar with

450
00:27:37,676 --> 00:27:41,362
the Mayo Prometheus case. So they did describing the claims,

451
00:27:41,386 --> 00:27:45,022
the relationship between metabolite concentration and the likelihood

452
00:27:45,046 --> 00:27:49,018
of drug effectiveness, but did not necessarily determine

453
00:27:49,174 --> 00:27:52,398
or did not necessarily describe using the

454
00:27:52,424 --> 00:27:56,158
improved treatment and the claims. And I think, as you'll see from the few examples

455
00:27:56,194 --> 00:27:59,718
I have that follow, that really seems to be the critical step as

456
00:27:59,744 --> 00:28:04,350
some kind of almost like treatment step or some kind of really clear application of

457
00:28:04,520 --> 00:28:06,090
the natural phenomenon.

458
00:28:07,370 --> 00:28:11,530
So for method of treatment claims, a lot of these had an active treatment

459
00:28:11,590 --> 00:28:14,938
step. So the Vanda

460
00:28:14,974 --> 00:28:18,586
Pharmaceuticals versus Westward and End of Pharmaceuticals versus Teva,

461
00:28:18,718 --> 00:28:21,990
they both had more of an active treatment. And then

462
00:28:22,160 --> 00:28:25,594
the Safinani Diagnostics versus Mayo, they had detecting

463
00:28:25,642 --> 00:28:29,254
not natural auto antibodies, but again, they were just correlating

464
00:28:29,302 --> 00:28:32,394
with the disease state and there wasn't any step around. Okay,

465
00:28:32,432 --> 00:28:35,742
so now that we've correlated these things, now we're going to give more drugs to

466
00:28:35,756 --> 00:28:39,522
this individual, or less drug to this other individual, we're not

467
00:28:39,536 --> 00:28:42,390
going to give any treatment to this one, but more treatment to this one.

468
00:28:42,440 --> 00:28:45,514
So in Vonda Pharmaceuticals versus Westward,

469
00:28:45,562 --> 00:28:49,246
you can see that this one was found eligible,

470
00:28:49,438 --> 00:28:52,870
and you can see this as a treatment method for schizophrenia.

471
00:28:53,050 --> 00:28:57,054
And so they do talk about determining patients with a certain point

472
00:28:57,092 --> 00:29:01,342
mutation, but in response to them detecting that point mutation

473
00:29:01,426 --> 00:29:04,642
in the individual, they then treat the patient differently,

474
00:29:04,726 --> 00:29:08,146
better, whether or not that point mutation exists. So if they're

475
00:29:08,158 --> 00:29:12,382
a poor metabolizer, then they have one treatment paradigm.

476
00:29:12,526 --> 00:29:16,002
If they're a different kind of genotype, then they have a

477
00:29:16,016 --> 00:29:18,380
different treatment paradigm. And so,

478
00:29:18,890 --> 00:29:22,518
again, you can see that pretty clear language around

479
00:29:22,664 --> 00:29:26,002
actual application of what happens now that you've understood what this natural

480
00:29:26,026 --> 00:29:29,842
phenomenon means. And then similarly, in Endoparmaceuticals

481
00:29:29,866 --> 00:29:33,898
versus Tava, you can see that, again, this is another method

482
00:29:33,934 --> 00:29:37,460
of treatment claim. And you can see here that,

483
00:29:37,850 --> 00:29:41,530
again, they're providing a solid oral controlled release dosage

484
00:29:41,590 --> 00:29:44,850
form and then orally administering it,

485
00:29:45,020 --> 00:29:48,378
depending on how the Cratinine clearance rate was

486
00:29:48,404 --> 00:29:51,870
found. So depending on how that was determined to be in the patient.

487
00:29:52,730 --> 00:29:56,418
And so, again, they measured or

488
00:29:56,444 --> 00:30:00,078
determined this natural phenomenon, but they actually really, truly applied it

489
00:30:00,224 --> 00:30:04,038
from a treatment setting. And so you can see where this falls short.

490
00:30:04,124 --> 00:30:08,190
In this Athena versus Collaborative male,

491
00:30:09,590 --> 00:30:12,546
you can even see just the length of the claim is already kind of a

492
00:30:12,548 --> 00:30:15,958
little bit of an indicator. They're basically determining this muscle

493
00:30:15,994 --> 00:30:19,400
specific tyrosine kinase and they basically just detect it,

494
00:30:20,690 --> 00:30:24,750
different antibiotics to it in bodily fluid as

495
00:30:24,860 --> 00:30:29,494
a diagnosis for transmission of a developmental disorder.

496
00:30:29,662 --> 00:30:33,178
But they never say that we've detected this and then we're

497
00:30:33,214 --> 00:30:36,860
going to treat them with a certain drug or

498
00:30:37,910 --> 00:30:41,806
there was no just active step and I think that's

499
00:30:41,818 --> 00:30:45,258
where they fell short and so you'll kind of see that

500
00:30:45,344 --> 00:30:46,340
carry through.

501
00:30:48,570 --> 00:30:51,938
So method of treatment is one aspect of the natural product claims.

502
00:30:51,974 --> 00:30:55,066
Obviously more and more natural products are coming out and more companies want to protect

503
00:30:55,128 --> 00:30:58,466
their natural products. So I think that's also interesting. So there's

504
00:30:58,478 --> 00:31:01,982
a few cases into that end. One included

505
00:31:02,006 --> 00:31:05,002
this one. It's not exactly natural products I guess,

506
00:31:05,076 --> 00:31:08,614
but it's about detecting bacteria. I think the first

507
00:31:08,652 --> 00:31:14,594
case was the Roche versus stuffed and that was for detecting Mycoplasma.

508
00:31:14,762 --> 00:31:19,270
And here they talked about a specific set of DNA primers

509
00:31:19,830 --> 00:31:23,246
for detecting Mycobacterium tuberculosis.

510
00:31:23,438 --> 00:31:27,238
And again, what the courts had argued is that

511
00:31:27,384 --> 00:31:31,030
the development of primers was kind of routine and conventional

512
00:31:31,590 --> 00:31:35,542
and use the PCR was routine and conventional and

513
00:31:35,556 --> 00:31:39,254
so there was no true application of the natural phenomenon

514
00:31:39,362 --> 00:31:43,270
into a new space, no extension beyond that. So maybe

515
00:31:43,320 --> 00:31:46,594
if they had to do PCR in a different

516
00:31:46,632 --> 00:31:49,942
way because it is Mycobacterium, or whether they had to maybe design

517
00:31:50,016 --> 00:31:53,810
more unique, maybe a different kind of PCR,

518
00:31:53,870 --> 00:31:57,338
different kind of primer set to accommodate

519
00:31:57,374 --> 00:32:00,478
for the fact that it's Mycobacterium, or whether they

520
00:32:00,504 --> 00:32:05,050
had to isolate it in a weird way because there was that other cells

521
00:32:05,670 --> 00:32:09,322
direct case, I can't remember if that's the correct one or not, but where

522
00:32:09,396 --> 00:32:13,570
they had this different free spot cycle of the cells and then determined viability,

523
00:32:14,130 --> 00:32:17,674
but the whole point around the free spot was to have better viability for

524
00:32:17,712 --> 00:32:20,990
later assays. So if even there was something like that in the claim,

525
00:32:21,110 --> 00:32:24,122
I think I probably could have pushed them over the edge towards eligibility.

526
00:32:24,206 --> 00:32:28,402
But just the pure primers and

527
00:32:28,416 --> 00:32:31,906
then routine PCR isn't enough for this case. And there

528
00:32:31,908 --> 00:32:35,362
was another canine case, there was a case around

529
00:32:35,436 --> 00:32:38,942
golden retrievers and identifying genetically

530
00:32:39,086 --> 00:32:42,626
golden retrievers based on a snip that they carry for genotyping

531
00:32:42,638 --> 00:32:46,150
golden retrievers. And that one was also found in eligible because it's highly similar

532
00:32:46,200 --> 00:32:50,102
to this one. There's also natural alternatives

533
00:32:50,126 --> 00:32:53,638
versus creative compound. This was found eligible and

534
00:32:53,664 --> 00:32:57,118
again it's had an active treatment step because what the

535
00:32:57,144 --> 00:33:01,058
court had said is that when you give this beta alanine

536
00:33:01,094 --> 00:33:04,930
to a human, it actually alters their natural state.

537
00:33:05,100 --> 00:33:08,890
And so this results in your better performance for

538
00:33:08,940 --> 00:33:09,850
athletes.

539
00:33:12,250 --> 00:33:15,662
Again, it changes an extension beyond the

540
00:33:15,676 --> 00:33:20,178
natural phenomenon, it adjusts their person's

541
00:33:20,214 --> 00:33:23,882
natural state, it's no longer their natural chemistry and

542
00:33:23,896 --> 00:33:27,254
it has specific dosing requirements. Obviously it

543
00:33:27,292 --> 00:33:30,530
puts them well above the typical beta alanine dosage

544
00:33:31,210 --> 00:33:34,910
in a person. So that's why this one was found eligible over

545
00:33:34,960 --> 00:33:38,414
some of the other cases. Ashley, I don't know if you were going to touch

546
00:33:38,452 --> 00:33:42,174
on this, but these treatment steps

547
00:33:42,222 --> 00:33:46,086
seem to have a pretty big implication on who infringes

548
00:33:46,278 --> 00:33:49,720
on the claim. Right? Yeah.

549
00:33:50,050 --> 00:33:53,198
Basically we're going to be way more induced infringement, right,

550
00:33:53,224 --> 00:33:56,690
because it's going to be some products supplier, right,

551
00:33:56,740 --> 00:34:00,206
some drug supplier, some natural product supplier who

552
00:34:00,268 --> 00:34:03,954
then presumably has to put in their label

553
00:34:04,062 --> 00:34:07,634
in their docs that

554
00:34:07,732 --> 00:34:11,478
this is how it's supposed to be taken and this is the effective

555
00:34:11,514 --> 00:34:14,894
dose and things like that, or some of these more

556
00:34:14,932 --> 00:34:18,614
even diagnostic claims. It's going to be some kind of hospital right,

557
00:34:18,652 --> 00:34:23,210
that is running these tests because nobody is at home seeing

558
00:34:23,380 --> 00:34:26,666
what the levels of some snip are to determine if they have

559
00:34:26,728 --> 00:34:30,460
schizophrenia, you know what I mean? And so it is definitely

560
00:34:31,210 --> 00:34:35,118
I think that's an interesting weighing

561
00:34:35,154 --> 00:34:38,800
that from a company perspective, weighing the value

562
00:34:39,490 --> 00:34:42,618
in a claim that I think medical treatment

563
00:34:42,654 --> 00:34:46,286
still has a lot of value, but I think it has more value

564
00:34:46,348 --> 00:34:49,934
in a portfolio that has claims directed to

565
00:34:49,972 --> 00:34:53,918
the actual composition or directed to the actual kit or the

566
00:34:53,944 --> 00:34:57,434
system that's being sold that is then

567
00:34:57,472 --> 00:35:00,782
used by some kind of health care provider to execute on the method of

568
00:35:00,796 --> 00:35:04,370
treatment. Right, yeah. Actually, just a follow

569
00:35:04,420 --> 00:35:08,258
up on that, do you have any more detail as to what the

570
00:35:08,284 --> 00:35:10,540
extent of a method of treatment is needed?

571
00:35:13,910 --> 00:35:17,262
I forget the exact citation, but there was a

572
00:35:17,276 --> 00:35:21,018
case 2013 time frame where they were

573
00:35:21,044 --> 00:35:25,126
just doing a threshold comparison based on a metabolite

574
00:35:25,318 --> 00:35:29,302
that was during body's processing

575
00:35:29,326 --> 00:35:33,942
of a particular drug and they were using that to adjust treatment and

576
00:35:33,956 --> 00:35:37,662
that was not found to be patentable. That was deemed to be sort

577
00:35:37,676 --> 00:35:41,478
of trivial. The question is, is there a

578
00:35:41,564 --> 00:35:44,938
threshold or guidance as to what level of guidance

579
00:35:44,974 --> 00:35:48,390
for treatment is needed as a claim element to provide patentability?

580
00:35:50,330 --> 00:35:53,550
Yeah, so from these cases that I've

581
00:35:53,870 --> 00:35:54,620
seen,

582
00:36:00,030 --> 00:36:03,898
I remember hearing what you're talking about is a threshold above and

583
00:36:03,924 --> 00:36:06,850
below. Do you remember what the actual treatment step was? Steve,

584
00:36:07,710 --> 00:36:11,098
you know, they gave him a drug and it was metabolized, I think, in the

585
00:36:11,124 --> 00:36:15,098
liver and it was a cancer

586
00:36:15,134 --> 00:36:19,030
treatment and they were basically trying

587
00:36:19,080 --> 00:36:22,294
to dial in how much to give the patient and it was just based

588
00:36:22,332 --> 00:36:26,470
on a threshold and it was deemed ineligible

589
00:36:27,630 --> 00:36:31,714
because I think in that case it was more still

590
00:36:31,752 --> 00:36:35,090
the natural phenomenon. They weren't altering the natural

591
00:36:35,150 --> 00:36:39,430
chemistry of the person or anything like that. It was purely

592
00:36:40,410 --> 00:36:43,750
saying, you know, they're above or below and then we're going to

593
00:36:43,920 --> 00:36:47,506
treat you accordingly. But it wasn't because

594
00:36:47,568 --> 00:36:51,362
they were not altering anything around the natural phenomenon. The natural

595
00:36:51,386 --> 00:36:54,622
phenomena was just a means to an end, it's my understanding. Because if you look

596
00:36:54,636 --> 00:36:58,822
at some of these other cases you have in

597
00:36:59,016 --> 00:37:02,858
the Vonda one, they're actually administering

598
00:37:03,014 --> 00:37:06,478
actual drugs for the patient that allows them

599
00:37:06,504 --> 00:37:09,634
to either better metabolize or less prevent this

600
00:37:09,732 --> 00:37:12,922
QTc prolongation of a patient. And so it

601
00:37:12,936 --> 00:37:16,450
actually affects the patient's biology. And then same

602
00:37:16,500 --> 00:37:20,220
with Endo. They are here

603
00:37:20,670 --> 00:37:23,590
determining cratening clearance rate,

604
00:37:23,760 --> 00:37:27,142
but again, then the drug amount changes. I guess that one

605
00:37:27,156 --> 00:37:30,962
would be a little bit more similar potentially. I'd have to read the claim

606
00:37:31,046 --> 00:37:34,262
that 2013 claim set, but that one could be kind of similar to Endo.

607
00:37:34,286 --> 00:37:37,982
So maybe would want to compare that one to this endo

608
00:37:38,006 --> 00:37:41,422
versus Taylor case in 2019 to see because I

609
00:37:41,436 --> 00:37:44,040
think this one's probably the most similar I've seen.

610
00:37:44,670 --> 00:37:49,722
I've seen changing

611
00:37:49,806 --> 00:37:53,730
something other than what occurs naturally in normal biology

612
00:37:53,910 --> 00:37:56,620
is one sort of safe harbor, right,

613
00:37:56,950 --> 00:38:00,498
for genetic material. Like there's that one case where you're creating

614
00:38:00,534 --> 00:38:04,418
synthetic biology, no problem whether or not that's 102

615
00:38:04,444 --> 00:38:07,986
or 103 patentable, it's 101 patentable.

616
00:38:08,118 --> 00:38:11,790
If you're making something new that doesn't exist naturally occurring,

617
00:38:11,970 --> 00:38:15,314
you're in good shape. And I've seen

618
00:38:15,352 --> 00:38:19,146
those kind of cases get allowed without having a treatment.

619
00:38:19,338 --> 00:38:23,702
And it looks like for what you're showing here is a much richer set

620
00:38:23,776 --> 00:38:27,770
of alternatives. There's ranges and different values.

621
00:38:28,270 --> 00:38:31,718
It's not just a simple threshold. And I think the

622
00:38:31,744 --> 00:38:35,414
issue becomes, for lack of better words,

623
00:38:35,512 --> 00:38:38,742
is something analogous to static business logic.

624
00:38:38,886 --> 00:38:43,178
If you're always doing the same thing for

625
00:38:43,204 --> 00:38:47,298
every patient, you're not going to be patent eligible.

626
00:38:47,454 --> 00:38:51,234
And the closer you are, the less likely

627
00:38:51,282 --> 00:38:54,762
you are to be patent eligible. So if you have a simple threshold and you're

628
00:38:54,786 --> 00:38:58,434
just looking at the naturally occurring metabolite

629
00:38:58,482 --> 00:38:59,990
as something is metabolized,

630
00:39:01,330 --> 00:39:05,258
as best I can understand from the Federal Circuit ruling, is there in

631
00:39:05,284 --> 00:39:09,230
essence saying that's trivial?

632
00:39:12,050 --> 00:39:13,760
How would you even regulate that?

633
00:39:15,170 --> 00:39:18,738
Everybody would be infringing then that would be in that camp, but maybe that was

634
00:39:18,764 --> 00:39:22,570
part of it too. Yeah, so thanks, that helps.

635
00:39:22,750 --> 00:39:25,314
No, it's a great question. I'm going to go look up that case now because

636
00:39:25,352 --> 00:39:29,790
then I'll pass it around to everybody too once I find it because that's really

637
00:39:29,840 --> 00:39:33,222
great point and I think that's some of the parsing that's kind

638
00:39:33,236 --> 00:39:37,158
of going on as well in this world to kind of

639
00:39:37,184 --> 00:39:40,698
build on that, or just another little example quickly is that

640
00:39:40,784 --> 00:39:44,322
I had a case recently, not in biotech but in software, where there

641
00:39:44,336 --> 00:39:48,834
was a 101 rejection and the

642
00:39:48,872 --> 00:39:52,758
claim that was rejected had a lot of determining and measuring and

643
00:39:52,784 --> 00:39:56,466
calculating and then taking information

644
00:39:56,528 --> 00:40:00,222
into account to determine different courses of action. And that was

645
00:40:00,236 --> 00:40:03,646
rejected. But what the examiner pointed us to and what was eventually

646
00:40:03,718 --> 00:40:07,210
allowed is that there had to be an active

647
00:40:07,270 --> 00:40:10,110
step in there. You're measuring things, you're determining things.

648
00:40:10,160 --> 00:40:13,590
What do you actually then do? What do you change? What do you

649
00:40:13,700 --> 00:40:17,000
sort of affect in the system based on all of this?

650
00:40:18,590 --> 00:40:23,158
It was a very small wording change. Instead of determining

651
00:40:23,254 --> 00:40:26,850
a method for blah blah blah, it was determining that and then

652
00:40:26,900 --> 00:40:30,378
doing the blah blah blah all we had to do was

653
00:40:30,404 --> 00:40:33,740
add a little clause. So that made sense to me. This whole

654
00:40:35,930 --> 00:40:39,654
adding a treatment step made sense to me sort of from that

655
00:40:39,692 --> 00:40:43,422
angle as well. Just where you need to have, like you said, in a way,

656
00:40:43,556 --> 00:40:46,722
affect the system, change the chemistry of the person

657
00:40:46,796 --> 00:40:50,082
or whatever. Do something active. Yeah, there has to be

658
00:40:50,096 --> 00:40:53,874
like that active, that active step. Right. How are you

659
00:40:53,912 --> 00:40:57,534
kind of influencing the system? I guess to turn this back to

660
00:40:57,572 --> 00:41:01,446
machines in software, you have to have an output of some kind.

661
00:41:01,508 --> 00:41:05,002
You have to do something. So it's

662
00:41:05,026 --> 00:41:11,662
kind of a weird parallel, but I

663
00:41:11,676 --> 00:41:15,166
guess that's the practical application trying to

664
00:41:15,168 --> 00:41:18,514
get everybody to do. Yes, I mean

665
00:41:18,552 --> 00:41:22,342
this is obviously some random kind of tricks, but they

666
00:41:22,356 --> 00:41:25,510
don't like the extra solution activity. Adding the fact that you did it by

667
00:41:25,560 --> 00:41:29,806
PCR, that you're using

668
00:41:29,868 --> 00:41:33,170
some kind of like routine testing,

669
00:41:33,230 --> 00:41:37,262
that's not going to help at all because they still again believe you're

670
00:41:37,286 --> 00:41:40,282
still kind of capturing the natural phenomenon. Again, this kind of gets into the 102

671
00:41:40,296 --> 00:41:43,534
103 world because, well, PCR was known or whatever

672
00:41:43,572 --> 00:41:46,582
method you're using was known. That's more of a 102 103 issue.

673
00:41:46,656 --> 00:41:50,314
But nonetheless, it kind of finds itself in the 101 camp

674
00:41:50,472 --> 00:41:54,626
and then you don't need to have the insignificant limitations

675
00:41:54,758 --> 00:41:58,870
because they're not going to provide any benefit.

676
00:41:59,190 --> 00:42:02,170
And then like general treatments and things like that aren't probably going to help much

677
00:42:02,220 --> 00:42:05,614
either. But it has to be some kind of true

678
00:42:05,652 --> 00:42:06,840
effect on the system.

679
00:42:09,550 --> 00:42:12,938
Yeah, this kind of goes towards the computer side

680
00:42:12,964 --> 00:42:17,274
of the world as well. But how are you actually applying that phenomenon

681
00:42:17,322 --> 00:42:20,958
in an unconventional way? I think you can even think of detecting

682
00:42:21,114 --> 00:42:24,834
the field DNA in the mother's blood. Again, what they were doing was just detecting

683
00:42:24,882 --> 00:42:27,890
it. But then maybe what would have helped them is,

684
00:42:27,940 --> 00:42:31,286
okay, now that you've detected, now that you've isolated fetal DNA, what are you

685
00:42:31,288 --> 00:42:34,718
going to do about it? Right. And I think had they

686
00:42:34,744 --> 00:42:38,910
maybe couched it more in the way of technical

687
00:42:38,970 --> 00:42:42,618
challenges and the avoiding amniocentesis

688
00:42:42,714 --> 00:42:48,278
and things like that, maybe it would have had a better chance then

689
00:42:48,304 --> 00:42:52,022
overcoming a particular technical challenge. Like I said, I think

690
00:42:52,036 --> 00:42:55,614
there's a good recommendation too to also include lots of different claim

691
00:42:55,662 --> 00:42:59,462
types in this area. The methods of treatment, methods of diagnosis, methods of

692
00:42:59,476 --> 00:43:02,870
detection, and going over those that are easier first,

693
00:43:02,920 --> 00:43:06,362
which would probably be method of treatment assuming you have some kind of active step

694
00:43:06,556 --> 00:43:09,580
and it may be going towards the other ones later,

695
00:43:10,930 --> 00:43:14,234
especially through divisional practice and things like that. And hopefully the case

696
00:43:14,272 --> 00:43:18,242
law changes. Honestly, I looked through case law

697
00:43:18,316 --> 00:43:21,722
for 101 in the life science versus the software. There is

698
00:43:21,796 --> 00:43:25,758
way fewer life science section 101 cases.

699
00:43:25,794 --> 00:43:29,642
And I don't know if that's like a general reflection of

700
00:43:29,776 --> 00:43:32,750
obviously software is rapidly changing.

701
00:43:33,130 --> 00:43:37,110
Lots of people have their hands in software versus

702
00:43:37,170 --> 00:43:39,520
the life science. It's a slower moving field.

703
00:43:40,270 --> 00:43:43,562
There's arguably fewer people that are going

704
00:43:43,576 --> 00:43:46,974
to touch life science in their lifetime versus somebody who's going to touch software,

705
00:43:47,022 --> 00:43:51,102
maybe, or whether that's some other meaningful metric

706
00:43:51,186 --> 00:43:54,698
of what that case

707
00:43:54,724 --> 00:43:58,850
law has done to those fields, or whether the cost

708
00:43:58,900 --> 00:44:02,462
of kind of pursuing these longer or over a greater period of time in

709
00:44:02,476 --> 00:44:04,600
the court system, I don't know. But it was just interesting.

710
00:44:05,650 --> 00:44:10,094
Like I said, it had to have been. I feel like for every one life

711
00:44:10,132 --> 00:44:13,670
science case, there was probably at least three software cases, it seems.

712
00:44:13,720 --> 00:44:16,682
So it's interesting. So in that sense, it was easier, I feel like,

713
00:44:16,696 --> 00:44:20,366
to make sense of it to some degree, because it was less

714
00:44:20,548 --> 00:44:24,822
all over the board, but also less examples

715
00:44:24,846 --> 00:44:26,440
to draw from, I guess.

716
00:44:27,730 --> 00:44:30,350
Anyways oh, yeah, Dan, sorry, Dan.

717
00:44:35,270 --> 00:44:38,910
So I decided to take a little different spin here on 101,

718
00:44:38,960 --> 00:44:42,958
because while the eligible

719
00:44:42,994 --> 00:44:47,202
subject matter is certainly the dominant topic from

720
00:44:47,336 --> 00:44:51,090
that section, it's a fairly recent

721
00:44:51,410 --> 00:44:55,158
development. Comparatively speaking, for the most part, section 101 historically has

722
00:44:55,184 --> 00:44:58,110
been about whether or not an invention is useful,

723
00:44:58,430 --> 00:45:01,866
which is also historically quite a low bar, and so

724
00:45:01,928 --> 00:45:05,934
it is reasonable that it gets overlooked. But towards life

725
00:45:05,972 --> 00:45:09,198
sciences, the requirement is still there. And as

726
00:45:09,224 --> 00:45:13,026
we'll get to the end here, there are a couple of places where people can

727
00:45:13,088 --> 00:45:16,520
mess up, and it's a bit of an embarrassing mistake to make.

728
00:45:17,630 --> 00:45:21,082
And the law around it, I still think merits

729
00:45:21,166 --> 00:45:24,380
some discussions. So that fundamental bit about

730
00:45:25,310 --> 00:45:29,278
invention must be useful. Case law ends up generating

731
00:45:29,434 --> 00:45:33,514
three main aspects of utility and inventions.

732
00:45:33,562 --> 00:45:37,134
Utility must be specific, it must be substantial, and it must

733
00:45:37,172 --> 00:45:41,062
be credible. So specific must mean it's directed,

734
00:45:41,206 --> 00:45:47,938
it's well defined, it is directed towards a

735
00:45:47,964 --> 00:45:51,470
particular activity, a particular role, and this is primarily

736
00:45:51,530 --> 00:45:55,402
used to deny or avoid general statements. So one

737
00:45:55,416 --> 00:45:58,678
of my favorite lines out of the MPEP is in the section where it's like,

738
00:45:58,704 --> 00:46:03,718
you can't state that the invention is simple for

739
00:46:03,744 --> 00:46:06,660
mere landfill, can't just take up space.

740
00:46:07,410 --> 00:46:10,978
Now, taking up space, though, is actually can be a very valuable thing.

741
00:46:11,064 --> 00:46:15,514
Think of all the washers on mechanical inventions that keep

742
00:46:15,552 --> 00:46:18,434
place things where they're supposed to be, or balanced on ships.

743
00:46:18,482 --> 00:46:22,222
That's just weight, that takes up space, that keeps balance there.

744
00:46:22,416 --> 00:46:26,040
And so indeed, taking up space can be

745
00:46:26,430 --> 00:46:29,762
can be a legitimate use. But the examples

746
00:46:29,786 --> 00:46:33,482
I gave there are specific, they're specifically valuable.

747
00:46:33,626 --> 00:46:37,402
So you can't just say, oh, it just takes up space. And how

748
00:46:37,416 --> 00:46:40,762
this applies to life sciences is you can't just say, oh,

749
00:46:40,896 --> 00:46:46,034
these compounds have biological

750
00:46:46,202 --> 00:46:49,894
activity, and leave it at that. You got to be specific.

751
00:46:49,992 --> 00:46:54,070
And you can't just say, oh, you could use this to treat diseases.

752
00:46:55,410 --> 00:46:59,098
It's like, all right, well, which diseases? What diseases? So it

753
00:46:59,124 --> 00:47:02,750
does must be specific. Your utility must be directed

754
00:47:02,810 --> 00:47:06,430
towards something, it must be substantial.

755
00:47:06,930 --> 00:47:10,800
So in this case, this is probably the more flexible of

756
00:47:11,550 --> 00:47:14,460
these terms that I found while looking into this.

757
00:47:15,090 --> 00:47:18,926
And its primary concern is that your invention

758
00:47:18,998 --> 00:47:23,170
that use sort of has an immediately recognizable effect.

759
00:47:23,340 --> 00:47:27,298
This most commonly pops up to defeat the

760
00:47:27,324 --> 00:47:30,730
sort of hunting license applications of oh,

761
00:47:30,780 --> 00:47:33,610
here's a bunch of compounds that could be useful.

762
00:47:35,310 --> 00:47:38,618
We can do some broad speculation that perhaps

763
00:47:38,654 --> 00:47:42,094
this will be useful towards some disease, but we have

764
00:47:42,132 --> 00:47:46,078
no actual data, we have no actual support, we don't know.

765
00:47:46,104 --> 00:47:48,720
And then this is where again, it bumps into 112.

766
00:47:49,110 --> 00:47:52,250
But the substantial

767
00:47:52,310 --> 00:47:55,342
means that from what you've got ready at hand here,

768
00:47:55,416 --> 00:48:00,418
there is an identifiable real world benefit that

769
00:48:00,564 --> 00:48:04,610
it treats this disease or even it inhibits

770
00:48:04,670 --> 00:48:08,098
this protein and then finally it must be

771
00:48:08,124 --> 00:48:11,842
credible. This is perhaps the

772
00:48:11,856 --> 00:48:15,334
least interesting out of the three because does

773
00:48:15,372 --> 00:48:18,298
your invention, in light of all the evidence you've given,

774
00:48:18,384 --> 00:48:21,614
behave according to known and appreciated

775
00:48:21,782 --> 00:48:25,894
scientific principles? So credibility only really pops up when

776
00:48:25,932 --> 00:48:29,630
people are trying to put in time machines,

777
00:48:29,750 --> 00:48:33,482
perpetual motion machines in life sciences.

778
00:48:33,626 --> 00:48:37,702
I saw some examples of like using magnetic fields to change things

779
00:48:37,776 --> 00:48:41,520
flavor you might end up with some

780
00:48:42,750 --> 00:48:46,450
wild homeopathy related type stuff as well,

781
00:48:46,560 --> 00:48:50,410
might show up under credibility. But the MPEP strongly

782
00:48:50,970 --> 00:48:55,334
suggests that the credibility bar is fairly

783
00:48:55,442 --> 00:48:59,614
low. As long as there is even an inkling, some sort of suggestions like okay,

784
00:48:59,772 --> 00:49:02,962
we'll go along with this. And then as a

785
00:49:02,976 --> 00:49:07,178
curious logical necessity, if you somehow fail the necessity

786
00:49:07,334 --> 00:49:11,114
or the utility requirement of 101, you therefore

787
00:49:11,162 --> 00:49:14,554
fail enablement. If enablement is that

788
00:49:14,592 --> 00:49:17,758
you adequately instruct one of skill in the art

789
00:49:17,904 --> 00:49:21,670
to make and use the invention and there's no use

790
00:49:21,720 --> 00:49:24,874
for the invention, you therefore can't teach

791
00:49:24,912 --> 00:49:28,426
people how to use it. So you will find hand in hand

792
00:49:28,548 --> 00:49:32,290
a utility one on one rejection with an enablement 112

793
00:49:32,340 --> 00:49:36,106
rejection. And important for

794
00:49:36,228 --> 00:49:39,190
these considerations, particularly towards substantial,

795
00:49:39,570 --> 00:49:42,998
is that the USPTO is not the FDA. And this is something that's

796
00:49:43,034 --> 00:49:46,394
popped up in a number of cases, although it's at this point fairly

797
00:49:46,442 --> 00:49:50,710
old news. In order for a pharmaceutical

798
00:49:51,330 --> 00:49:54,794
to qualify as a substantial utility,

799
00:49:54,962 --> 00:49:58,186
no, you don't need to go through the entire process, the entire

800
00:49:58,248 --> 00:50:01,882
clinical process of showing that the drug is

801
00:50:01,956 --> 00:50:04,810
a commercially viable, safe,

802
00:50:05,250 --> 00:50:08,510
effective drug. The mere

803
00:50:08,570 --> 00:50:12,878
identification and notably demonstration, at least a token demonstration

804
00:50:13,034 --> 00:50:16,846
of biological or pharmacological activity towards a

805
00:50:16,848 --> 00:50:20,350
specific protein that's associated target,

806
00:50:20,790 --> 00:50:24,250
associated with certain diseases is sufficient.

807
00:50:24,570 --> 00:50:27,982
And this has come up again and again and again since the 80s.

808
00:50:28,176 --> 00:50:31,930
Some of this language has, some of the earlier language said things

809
00:50:32,040 --> 00:50:36,010
as near in vitro. The fact that you identify

810
00:50:36,750 --> 00:50:40,294
activity in vitro has utility towards

811
00:50:40,392 --> 00:50:41,400
pharma companies.

812
00:50:43,590 --> 00:50:47,090
Whereas I'll say in that last case with their enray Braun

813
00:50:47,150 --> 00:50:51,240
from 95 there's maybe a bit more telling statement in there

814
00:50:51,990 --> 00:50:55,810
about how, due to the expense

815
00:50:56,190 --> 00:50:59,760
and duration of full clinical trials, that if

816
00:51:00,930 --> 00:51:05,674
drug applications failed utility before

817
00:51:05,772 --> 00:51:10,154
the clinical stage, that would be a huge economic barrier

818
00:51:10,322 --> 00:51:13,738
and discourage barrier to

819
00:51:13,764 --> 00:51:17,938
pharmaceutical development economically. So for a

820
00:51:17,964 --> 00:51:20,820
practical economic reason,

821
00:51:21,450 --> 00:51:25,630
mirror in vitro activity is sufficient.

822
00:51:25,950 --> 00:51:29,554
And so in each of these cases, the examples, what was

823
00:51:29,592 --> 00:51:33,674
generally challenged for most of these cases was the specification stated,

824
00:51:33,722 --> 00:51:37,070
hey, here's a target,

825
00:51:37,250 --> 00:51:41,074
here's a protein. It's known that

826
00:51:41,172 --> 00:51:45,250
this type of molecule can

827
00:51:45,360 --> 00:51:48,670
inhibit this molecule or it can inhibit the target.

828
00:51:49,650 --> 00:51:53,434
Here are some new variants of it. Here is literally some

829
00:51:53,472 --> 00:51:56,050
data showing in vitro activity.

830
00:51:56,910 --> 00:52:01,200
Did they test the whole entire scope? Not necessarily. Did they fully develop

831
00:52:02,130 --> 00:52:05,174
the compounds into proper pharmaceuticals?

832
00:52:05,222 --> 00:52:09,490
No. But they at least had the

833
00:52:09,660 --> 00:52:13,286
background of the knowledge of this specific disease

834
00:52:13,358 --> 00:52:16,994
is related to these specific proteins. And here is token

835
00:52:17,042 --> 00:52:20,950
evidence, here is literally some evidence that our class,

836
00:52:21,060 --> 00:52:24,874
our molecules can inhibit, can interact with

837
00:52:24,972 --> 00:52:28,630
these proteins,

838
00:52:29,130 --> 00:52:32,822
and that is sufficient for the utility. So now we'll

839
00:52:32,846 --> 00:52:36,442
look at some examples. It would actually be sufficient for 112,

840
00:52:36,516 --> 00:52:40,534
especially now though, because a lot of those early EPO patents that

841
00:52:40,572 --> 00:52:44,474
try to protect variants or different ways of creating

842
00:52:44,522 --> 00:52:48,142
EPO had section 112

843
00:52:48,216 --> 00:52:52,006
issue. Because again, they didn't enable somebody

844
00:52:52,068 --> 00:52:55,034
to practice the full scope of the claim.

845
00:52:55,142 --> 00:52:58,570
They may be taught one or two ways to do it, like using

846
00:52:58,620 --> 00:53:01,774
some of those assays, but they didn't teach the full scope of it. So I

847
00:53:01,812 --> 00:53:05,578
wonder in the current interpretation of

848
00:53:05,604 --> 00:53:08,878
112, whether they maybe would have

849
00:53:08,904 --> 00:53:11,626
survived 101, but London survived 112.

850
00:53:11,808 --> 00:53:14,460
Yeah, quite possibly. Yeah,

851
00:53:17,590 --> 00:53:21,110
absolutely. Legitimate observation there that perhaps indeed

852
00:53:21,430 --> 00:53:24,318
it wouldn't be enough to enable the full scope,

853
00:53:24,474 --> 00:53:27,578
but for the purposes of determining that specific and

854
00:53:27,604 --> 00:53:28,850
substantial utility,

855
00:53:30,730 --> 00:53:34,802
literally something token evidence is enough,

856
00:53:34,876 --> 00:53:38,490
as long as it is directed towards treatment of specific diseases,

857
00:53:38,550 --> 00:53:42,786
inhibition of known specific biological targets.

858
00:53:42,978 --> 00:53:45,866
So how would you fix that?

859
00:53:46,048 --> 00:53:49,578
Would you just have to go extremely narrow if you didn't

860
00:53:49,614 --> 00:53:52,360
have enough to support full enablement of everything?

861
00:53:54,950 --> 00:53:59,014
So you're talking about an example where you've got a class of molecules

862
00:53:59,062 --> 00:54:03,094
and then you get rejected for lack of enablement for the whole scope,

863
00:54:03,262 --> 00:54:06,822
right? Yeah. So that's a hard one

864
00:54:06,896 --> 00:54:10,290
to fix. Sometimes examiners

865
00:54:11,390 --> 00:54:16,158
are content to listen to if

866
00:54:16,184 --> 00:54:20,574
there's information. Sometimes you can show them data

867
00:54:20,672 --> 00:54:23,826
related that ends up in the case file. Not everyone

868
00:54:23,888 --> 00:54:27,354
likes that. Sometimes you can find publications that

869
00:54:27,392 --> 00:54:30,822
show the relevant state of the

870
00:54:30,836 --> 00:54:34,326
knowledge at the time of the filing that you got to be careful with that,

871
00:54:34,388 --> 00:54:37,858
so you don't end up making it obvious. But sometimes you can play games

872
00:54:37,894 --> 00:54:41,518
with that. Is that like submitted like a 132 deck,

873
00:54:41,554 --> 00:54:45,080
like an affidavit of inventors or yeah,

874
00:54:48,230 --> 00:54:52,460
you can do affidavits from inventors. That's possible.

875
00:54:54,650 --> 00:54:57,450
Being careful with all other publications,

876
00:54:58,670 --> 00:55:02,540
that's another process. But it's hard sometimes.

877
00:55:04,430 --> 00:55:08,530
And what I have found is depending on the practicalities

878
00:55:08,650 --> 00:55:13,090
of the case, of what's important and considering your jurisdiction,

879
00:55:13,150 --> 00:55:15,858
sometimes it's not worth it to fight it.

880
00:55:15,944 --> 00:55:20,370
Sometimes the estoppel that you would introduce

881
00:55:22,190 --> 00:55:25,350
by putting it forward in less important jurisdictions,

882
00:55:26,270 --> 00:55:29,730
it's just not worth it. And hopefully you

883
00:55:29,780 --> 00:55:32,910
have enabled what is the critical,

884
00:55:34,250 --> 00:55:37,642
the golden goose or the golden egg of your genus.

885
00:55:37,726 --> 00:55:41,262
Hopefully that's enabled and so you find comfort in that.

886
00:55:41,456 --> 00:55:44,946
But it's a tough spot to be in when you get hit with those

887
00:55:45,128 --> 00:55:48,498
enablement bits because you're generally not allowed to

888
00:55:48,524 --> 00:55:51,380
just dump new stuff into the record.

889
00:55:56,730 --> 00:56:01,090
So here are some examples of where utility failed

890
00:56:01,770 --> 00:56:04,982
in life science cases. So the first one, which ended

891
00:56:05,006 --> 00:56:08,962
up being sort of the fundamental precedent for pretty much

892
00:56:09,096 --> 00:56:12,322
all the cases on the previous slide. Renault v.

893
00:56:12,336 --> 00:56:16,142
Manson from 1966. The patent claimed

894
00:56:16,166 --> 00:56:19,678
a novel method for manufacturing a certain

895
00:56:19,824 --> 00:56:23,674
subgenus of a type of steroid. Now at

896
00:56:23,712 --> 00:56:27,118
the time there was no known utility for the

897
00:56:27,144 --> 00:56:30,982
class of compounds. The only blurb in

898
00:56:30,996 --> 00:56:34,282
the whole application that's actually about what this thing is for is a

899
00:56:34,296 --> 00:56:38,966
paragraph that says, hey, these compounds are like these other compounds

900
00:56:39,098 --> 00:56:43,200
and these other compounds are being considered for

901
00:56:43,590 --> 00:56:46,858
diseases in which these certain properties could be

902
00:56:46,884 --> 00:56:50,040
useful. That was it.

903
00:56:50,730 --> 00:56:54,970
So it did not specify a specific type of disease

904
00:56:55,710 --> 00:56:59,794
nor did it show any data that it could

905
00:56:59,892 --> 00:57:03,086
inhibit or could interact with the pathways

906
00:57:03,158 --> 00:57:04,020
that it mentioned.

907
00:57:07,150 --> 00:57:10,722
Next slide please. The decision here, what was their motivation

908
00:57:10,806 --> 00:57:12,460
to filing the patent then,

909
00:57:13,990 --> 00:57:17,138
behind the name. So this is where we

910
00:57:17,164 --> 00:57:21,210
fundamentally this is the case where the patent is not a hunting license

911
00:57:21,270 --> 00:57:24,582
line comes out of from the decision.

912
00:57:24,666 --> 00:57:28,502
And what I think what they were after was that they were related to

913
00:57:28,516 --> 00:57:32,682
the lab that was testing this broader cast of class of molecules.

914
00:57:32,826 --> 00:57:36,698
So they were like hey, we found a cool way of making these class of

915
00:57:36,724 --> 00:57:40,598
molecules that looks like this other class of molecules which we're currently

916
00:57:40,684 --> 00:57:44,534
interested in. But the state of their technology,

917
00:57:44,632 --> 00:57:48,642
the state of their knowledge didn't actually suggest at all that those compounds

918
00:57:48,666 --> 00:57:50,320
would be useful for anything.

919
00:57:51,650 --> 00:57:55,170
But they sort of put in the cart before the horse. They wanted

920
00:57:55,220 --> 00:57:59,946
to protect that research that they had done before

921
00:58:00,008 --> 00:58:03,642
they actually knew it was going to be valuable. And to some extent you kind

922
00:58:03,656 --> 00:58:07,074
of can't fault them for that. With R and D and

923
00:58:07,172 --> 00:58:10,422
pharma companies you're testing, especially now with high throughput screen and

924
00:58:10,436 --> 00:58:13,700
you're testing all kinds, you can test all kinds of stuff.

925
00:58:15,650 --> 00:58:19,254
But the decision came back that no utility is

926
00:58:19,292 --> 00:58:23,358
not satisfied by showing that

927
00:58:23,384 --> 00:58:27,030
it's classes are currently being screened.

928
00:58:28,670 --> 00:58:32,550
That alone is not sufficient. And furthermore, a bit more fundamental

929
00:58:32,870 --> 00:58:36,994
that a process is not useful simply

930
00:58:37,042 --> 00:58:40,040
by the fact that it produces its intended result.

931
00:58:41,030 --> 00:58:44,394
It's interesting that what

932
00:58:44,432 --> 00:58:48,358
makes that process the process, I guess is valued

933
00:58:48,394 --> 00:58:52,220
holistically by the utility in some sense of the result.

934
00:58:52,910 --> 00:58:56,610
And so yes, indeed, simply that because their method indeed

935
00:58:57,050 --> 00:59:00,490
produced the compound, but the compounds

936
00:59:00,610 --> 00:59:04,458
were not substantial. So in this case it was specific they

937
00:59:04,484 --> 00:59:08,370
said, hey, this method makes these specific compounds. So, hey, it's specific.

938
00:59:08,480 --> 00:59:11,970
But because it did not promise, it did not show or suggest

939
00:59:14,030 --> 00:59:16,040
a real world value,

940
00:59:17,870 --> 00:59:21,994
it was not substantial. So then more recently,

941
00:59:22,042 --> 00:59:25,580
let's jump forward 40 years,

942
00:59:26,570 --> 00:59:30,270
2005. And Ray Fisher, this was the case

943
00:59:30,320 --> 00:59:35,278
that attempted to claim five est sequence

944
00:59:35,314 --> 00:59:39,490
tags from Corn. And he has their cDNA

945
00:59:39,550 --> 00:59:43,746
sequences, which are, I think, notably one of the things thrown about

946
00:59:43,868 --> 00:59:48,138
as well. Those are patentable because you

947
00:59:48,164 --> 00:59:51,942
take out the bits that don't matter and they

948
00:59:51,956 --> 00:59:55,138
don't naturally exist. So cDNAs falls

949
00:59:55,174 --> 00:59:59,022
under the patentable subject matter. And est can

950
00:59:59,036 --> 01:00:02,530
be useful for a variety of things within genomics.

951
01:00:02,590 --> 01:00:06,258
You can help map genomes. You can find which genes are where and

952
01:00:06,284 --> 01:00:10,266
what they coordinate to. But in this case, the function

953
01:00:10,328 --> 01:00:14,614
and structure of the claim sequences and their corresponding

954
01:00:14,662 --> 01:00:18,150
proteins were unknown at the time of filing. This case

955
01:00:18,200 --> 01:00:20,960
just includes a lot of genomics data.

956
01:00:21,650 --> 01:00:25,054
It says that their ests created,

957
01:00:25,102 --> 01:00:28,750
extracted from the specific breed

958
01:00:28,810 --> 01:00:30,390
of maze.

959
01:00:32,310 --> 01:00:34,320
But what these five tags did,

960
01:00:35,130 --> 01:00:38,722
unknown. Specifically, they name the common

961
01:00:38,796 --> 01:00:44,220
uses for este standard,

962
01:00:45,570 --> 01:00:49,054
general, generic uses for what est can do. Of course,

963
01:00:49,092 --> 01:00:52,860
you can use ests to map where genes are

964
01:00:54,030 --> 01:00:59,558
in the genome. You can use them to

965
01:00:59,584 --> 01:01:02,810
find similar genes in other organisms.

966
01:01:03,370 --> 01:01:06,578
But it was completely unknown at the time of filing, what they did, what they

967
01:01:06,604 --> 01:01:09,950
encoded. And that's really what the case

968
01:01:10,000 --> 01:01:13,180
with the Federal Circuit locked in on. Next slide, please.

969
01:01:14,830 --> 01:01:18,966
That these uses for these specific ests remain

970
01:01:19,038 --> 01:01:22,382
hypothetical in general. So although sure you could use it

971
01:01:22,396 --> 01:01:27,426
to find you potentially use it to detect variance

972
01:01:27,498 --> 01:01:31,466
mutations. Are mutations in those

973
01:01:31,528 --> 01:01:34,482
genes useful, valuable,

974
01:01:34,626 --> 01:01:38,090
noteworthy, completely unknown.

975
01:01:38,590 --> 01:01:42,098
And the specification contains no guidance as

976
01:01:42,124 --> 01:01:46,614
to why those claimed ests were more useful than the tens of thousands

977
01:01:46,782 --> 01:01:50,570
that are present in the genome. And then

978
01:01:50,620 --> 01:01:54,522
furthermore, there was no data, there was no evidence

979
01:01:54,606 --> 01:01:58,718
that those ests would specifically would

980
01:01:58,744 --> 01:02:01,610
succeed at doing any of the things like, hey,

981
01:02:01,720 --> 01:02:03,770
let's use this to find mutations.

982
01:02:05,350 --> 01:02:08,798
There was no such data. So again, similar to that

983
01:02:08,824 --> 01:02:12,374
case from the court relied on that this is sort of

984
01:02:12,412 --> 01:02:15,902
another use testing sort of situation. You have

985
01:02:15,916 --> 01:02:20,140
a research group that's trying to protect their research.

986
01:02:21,310 --> 01:02:24,806
Although there's no value yet out of the research,

987
01:02:24,928 --> 01:02:28,742
they're still early on, or at least they did not provide what the

988
01:02:28,756 --> 01:02:32,260
utility of these ests were.

989
01:02:33,490 --> 01:02:36,734
And so the next step for them would be, okay, let's figure

990
01:02:36,772 --> 01:02:40,310
out what these ests actually do. And that is

991
01:02:40,420 --> 01:02:44,118
insufficient standing for an eligible

992
01:02:44,154 --> 01:02:48,050
patent. You got to tell us what these things do. They must be specific

993
01:02:48,160 --> 01:02:51,302
and substantial in their utility to

994
01:02:51,316 --> 01:02:54,866
meet that fundamental bar. So,

995
01:02:54,988 --> 01:02:58,838
yeah, the last thing here is make

996
01:02:58,864 --> 01:03:01,958
sure you do have a goal in mind or at least you provide the

997
01:03:01,984 --> 01:03:05,594
context, that substantial context towards what these

998
01:03:05,632 --> 01:03:09,338
things are for. And so if you're too early on in

999
01:03:09,424 --> 01:03:12,818
development and you're just seeing what you

1000
01:03:12,844 --> 01:03:16,770
can make in the realm of biotech and the realm of chemistry.

1001
01:03:16,830 --> 01:03:20,118
Just because you can make it doesn't

1002
01:03:20,154 --> 01:03:23,618
mean it's necessarily useful. And then you

1003
01:03:23,644 --> 01:03:27,470
fail the forgotten portion of section 101, the part

1004
01:03:27,520 --> 01:03:31,094
no one talks about. Well honestly, even if you

1005
01:03:31,132 --> 01:03:34,250
find what it does, if they had found in current

1006
01:03:34,300 --> 01:03:37,778
case, if they had found what these ESC do, it still

1007
01:03:37,804 --> 01:03:41,282
wouldn't have been protectable from the other side of 101 because there would have

1008
01:03:41,296 --> 01:03:46,238
been like it would have been one thing if they were like you

1009
01:03:46,264 --> 01:03:50,034
genotype for this thing and then you give more round

1010
01:03:50,082 --> 01:03:54,038
up to the corn versus less roundup to the corn or something and

1011
01:03:54,064 --> 01:03:57,266
then maybe that active step would have saved them from the other part of 101.

1012
01:03:57,328 --> 01:04:00,510
So yeah, it's kind of fun to look at these historically

1013
01:04:00,570 --> 01:04:03,878
how they've kind of come over time and yeah that's interesting.

1014
01:04:03,964 --> 01:04:07,322
You do forget about the other side of 101. So that was interesting. That's a

1015
01:04:07,336 --> 01:04:09,170
good historical lesson.

1016
01:04:13,070 --> 01:04:16,578
Some questions of law that feel obvious

1017
01:04:16,664 --> 01:04:19,974
or standard now they maybe weren't always like

1018
01:04:20,012 --> 01:04:23,142
that. You go poke at the case law, you go do a

1019
01:04:23,156 --> 01:04:27,140
bit of digging and you can find a legitimate question in the record

1020
01:04:28,490 --> 01:04:32,082
because for example, that case from the 60s, there is

1021
01:04:32,096 --> 01:04:35,382
a dissenting opinion. I didn't read

1022
01:04:35,396 --> 01:04:38,694
the dissenting opinion but I'm going to assume it to some extent argues that no

1023
01:04:38,732 --> 01:04:42,414
the fact that they could make it, the fact that there was perhaps the amount

1024
01:04:42,452 --> 01:04:46,098
of speculation, maybe there's an argument in there that the level

1025
01:04:46,124 --> 01:04:49,842
of speculation was sufficient but instead

1026
01:04:49,916 --> 01:04:53,720
now that case from the 60s ends up being the grounding precedent for

1027
01:04:54,650 --> 01:04:58,666
40 plus years of biological

1028
01:04:58,738 --> 01:05:02,502
and chemical utility. So even though now we

1029
01:05:02,516 --> 01:05:05,622
don't think about the utility requirements so much,

1030
01:05:05,816 --> 01:05:09,174
there was at a time a legitimate question,

1031
01:05:09,272 --> 01:05:12,570
a legitimate inquiry

1032
01:05:13,250 --> 01:05:16,978
and I think it's worthwhile going back and looking at. So you have the fundamental

1033
01:05:17,014 --> 01:05:21,020
principle at hand and not just the working convenient result.

1034
01:05:22,670 --> 01:05:24,200
Yeah, absolutely.

1035
01:05:26,210 --> 01:05:29,190
Cool. Does anyone have any questions, comments?

1036
01:05:31,470 --> 01:05:33,060
I wanted to say something.

1037
01:05:34,830 --> 01:05:39,540
So back to the genus versus species issue.

1038
01:05:40,770 --> 01:05:44,890
From the client perspective that is the financial perspective,

1039
01:05:47,070 --> 01:05:51,274
when you're facing a question like that it seems like it might

1040
01:05:51,312 --> 01:05:56,040
be better just to accept the species right,

1041
01:05:56,730 --> 01:06:00,302
get the insurance, file a continuation

1042
01:06:00,386 --> 01:06:02,760
and kick it down road.

1043
01:06:03,390 --> 01:06:07,286
Yes it's a tendency

1044
01:06:07,358 --> 01:06:11,102
I think get all up and arms blah blah

1045
01:06:11,126 --> 01:06:14,774
blah blah but from the client

1046
01:06:14,822 --> 01:06:18,434
perspective please give us a patent.

1047
01:06:18,542 --> 01:06:22,322
And then the second thing I was going to say is that if you're

1048
01:06:22,346 --> 01:06:26,290
waiting into an area like this it might make

1049
01:06:26,340 --> 01:06:30,646
sense to describe the genus really

1050
01:06:30,768 --> 01:06:34,822
extensively and if you're talking about a

1051
01:06:34,836 --> 01:06:38,782
structure maybe you can attach mechanism to

1052
01:06:38,796 --> 01:06:42,120
the structure. Why does the structure work?

1053
01:06:44,950 --> 01:06:48,558
You're not necessarily going to get the claims

1054
01:06:48,594 --> 01:06:51,854
that you want, that you're creating prior art that could

1055
01:06:51,892 --> 01:06:56,080
block others which is also important.

1056
01:06:56,650 --> 01:07:00,340
So those are my ideas there.

1057
01:07:00,970 --> 01:07:05,294
Yeah, I think two companies have to weigh how much maybe

1058
01:07:05,332 --> 01:07:08,320
it's worthwhile spending a little bit of R, amp, D time,

1059
01:07:09,250 --> 01:07:11,450
at least proof of concept,

1060
01:07:12,850 --> 01:07:16,158
a few different members of a genius.

1061
01:07:16,254 --> 01:07:19,794
You know what, just some, like, really rough

1062
01:07:19,842 --> 01:07:23,402
in vitro data right, that we can make this compound and

1063
01:07:23,416 --> 01:07:26,558
we said that it increases insulin production. Look, when we put

1064
01:07:26,584 --> 01:07:30,686
it into healing cells that are meant to produce insulin, we can get

1065
01:07:30,808 --> 01:07:33,698
a modest increase in insulin, you know what I mean? Just doing a little bit

1066
01:07:33,724 --> 01:07:36,878
of those studies and a few random different ones to

1067
01:07:36,904 --> 01:07:40,758
hopefully show that more of the full scope

1068
01:07:40,794 --> 01:07:44,714
of the claim and things like that. But I agree that getting

1069
01:07:44,752 --> 01:07:47,882
the species is better than nothing. And so maybe getting the

1070
01:07:47,896 --> 01:07:50,990
species and then being willing to get a whole bunch of species patents, right?

1071
01:07:51,040 --> 01:07:55,278
A whole bunch of other ones that are if you think about your particular species

1072
01:07:55,314 --> 01:07:58,710
being the bullseye and then some of the closest

1073
01:07:58,770 --> 01:08:02,114
next ones hopefully trying to get patents on some of those ones.

1074
01:08:02,152 --> 01:08:05,894
So do you block a competitor in the most

1075
01:08:05,932 --> 01:08:09,110
effective way with the genus claim? No. But you still block them through

1076
01:08:09,160 --> 01:08:12,966
multiple pen, through like, all the different ways that they could conceivably

1077
01:08:13,038 --> 01:08:16,946
get around it? Yes. And maybe a little bit more painfully longer,

1078
01:08:17,068 --> 01:08:19,300
but yeah,

1079
01:08:19,750 --> 01:08:23,714
right. Anyway, it's a good session. Thank you, Ashley. Thank you.

1080
01:08:23,872 --> 01:08:27,038
Yeah, so no guy said, this is something I've been meaning to do

1081
01:08:27,064 --> 01:08:30,530
for a while. All right, well, thanks everybody.

1082
01:08:30,700 --> 01:08:33,700
Have a good rest of your week. Thank you.

1083
01:08:34,090 --> 01:08:37,530
Thanks everybody. Thank you. Bye bye.

1084
01:08:37,710 --> 01:08:40,898
All right, that's all for today, folks. Thanks for listening. And remember to check

1085
01:08:40,924 --> 01:08:43,878
us out@aurorapatins.com for more great podcasts,

1086
01:08:43,914 --> 01:08:47,690
blogs, and videos covering all things patent strategy. And if you're an agent

1087
01:08:47,740 --> 01:08:50,582
or attorney and would like to be part of the discussion or an inventor with

1088
01:08:50,596 --> 01:08:55,262
a topic you'd like to hear discussed, email us at podcast@aurorapatins.com.

1089
01:08:55,396 --> 01:08:59,090
Do remember that this podcast does not constitute legal advice. And until next time,

1090
01:08:59,140 --> 01:09:00,440
keep calm and patent on.