Paper No. 62
`Trials@uspto.gov
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`571-272-7822
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`THORNE RESEARCH, INC.,
`Petitioner,
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`v.
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`TRUSTEES OF DARTMOUTH COLLEGE,
`Patent Owner.
`_________________
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`IPR2021-00268
`Patent 8,383,086 B2
`_________________
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`Record of Oral Hearing
`Held Virtually: Tuesday, March 15, 2022
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`Before SUSAN L.C. MITCHELL, ROBERT J. POLLOCK, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
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`Trials@uspto.gov
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`571-272-7822
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________
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`THORNE RESEARCH, INC.,
`Petitioner,
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`v.
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`TRUSTEES OF DARTMOUTH COLLEGE,
`Patent Owner.
`_________________
`
`IPR2021-00268
`Patent 8,383,086 B2
`_________________
`
`Record of Oral Hearing
`Held Virtually: Tuesday, March 15, 2022
`_________________
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`Before SUSAN L.C. MITCHELL, ROBERT J. POLLOCK, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
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`IPR2021-00268
`Patent 8,383,086 B2
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`LORA M. GREEN, ESQUIRE
`TASHA THOMAS, ESQUIRE
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street NW, Fifth Floor
`Washington, DC 20006
`(202) 973-8800
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`ON BEHALF OF THE PATENT OWNER:
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`JOHN L. ABRAMIC, ESQUIRE
`BENJAMIN R. HOLT, ESQUIRE
`STEPTOE & JOHNSON LLP
`227 West Monroe Street, Suite 4700
`Chicago, Illinois 60606
`(312) 577-1300
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`The above-entitled matter came on for hearing on Tuesday, March 15,
`2022, commencing at 10:00 a.m., EDT, by video/by telephone.
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`IPR2021-00268
`Patent 8,383,086 B2
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`P R O C E E D I N G S
` JUDGE SCHNEIDER: Good morning, everyone. This is
`Judge Schneider. I'm here with Judges Mitchell and Pollock.
`We're here for the oral hearing for IPR2021-00268. Before we
`begin, would counsel for the parties, please, identify
`themselves, beginning with Petitioner.
` MS. GREEN: Good morning, Your Honor. This is Lora
`Green representing Petitioner Thorne.
` JUDGE SCHNEIDER: All right. And for Patent Owner,
`who do we have today?
` MR. ABRAMIC: Good morning, Your Honors. This is
`John Abramic on behalf of Patent Owner, and with me is my
`colleague Benjamin Holt.
` JUDGE SCHNEIDER: Okay. All right. I understand
`that Mr. Holt will be participating as a LEAP practitioner.
`For that reason, Patent Owner, you will have an extra 15
`minutes. Mr. Holt is expected to present a significant part
`of the argument, and we'll see how that plays out.
` Mr. Holt, welcome. Good luck to you today, and I
`hope this experience proves to be a good one for you.
` Since the burden rests with the Petitioner,
`Petitioner, you will go first. You've been allotted 45
`minutes of time. Do you wish to reserve any time for
`rebuttal?
` MS. GREEN: We wish to reserve ten minutes for
`rebuttal.
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`Patent 8,383,086 B2
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` JUDGE SCHNEIDER: All right. And, Patent Owner, you
`have one hour. Do you wish to reserve any rebuttal time?
` MR. ABRAMIC: Five minutes, Your Honor, if that's all
`right.
` JUDGE SCHNEIDER: All right. I'd ask that the
`parties -- when you're not speaking to, please, keep your
`microphones on mute so that it doesn't disturb the other
`counsel. I appreciate you're using headphones and speaker
`mics on this. It makes it a little bit easier for me to
`hear.
` One question I'd like to ask before we begin: What
`is the status of the District Court litigation on this
`patent?
` MR. ABRAMIC: Your Honor, the -- I believe it is up
`on appeal at the Federal Circuit on the 101 decision.
` JUDGE SCHNEIDER: Okay. That's -- that's what I
`thought. I just wanted to confirm that.
` All right. Are there any questions before we begin?
` MS. GREEN: No, Your Honor.
` MR. ABRAMIC: No, Your Honor.
` JUDGE POLLOCK: If not, Petitioner, you have 35
`minutes. Please begin.
` ORAL ARGUMENT ON BEHALF OF PETITIONER
` MS. GREEN: Good morning. May it please the Board.
`Thank you for your time today. I would like to point out
`that my colleague Tasha Thomas is here today with me in the
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`conference room.
` Turning to Slide 2, we brought in five grounds in the
`Petition, all of which were instituted. Grounds 1 and 2 rely
`on Stamler, and Grounds 3 through 5 rely on Bieganowski,
`which I will refer to as the Cell article, as well as
`Brenner, which I will refer to as the '337 PCT.
` Turning to Slide 3, I wanted to start with a little
`bit of background. There is only one claim at issue in this
`IPR, and this is Claim 2, but it is dependent from canceled
`Claim 1.
` So canceled Claim 1 read, A pharmaceutical
`composition comprising nicotinamide riboside, which I will
`refer to as NR, in admixture with a carrier, wherein said
`composition is formulated for oral administration. Claim 2
`is then dependent on Claim 1 and adds the limitation wherein
`the NR is isolated from a natural or synthetic source. Claim
`1 was found to be unpatentable in the previous Elysium IPR
`and is, thus, not inventive or cannot be inventive to Dr.
`Brenner.
` Turning to Slide 4, I would like to start with the
`challenge of Claim 2 based on the Stamler reference.
` Slide 5. Relevant to all the issues over Stamler is
`the construction of the claims. The Board made multiple
`constructions in the previous IPR, and those claim
`constructions are now final. These are the claim
`constructions that were applied in the petition materials and
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`also applied by our expert, Dr. Jaffrey. As we could see
`here, "pharmaceutical composition" was construed as being a
`composition, including a food composition, which contains NR
`as an active agent.
` Turning to Slide 6, the Board also construed
`"carrier," and that construction is also now final. As can
`be seen on the slide, the Board construed "carrier" as a
`liquid or solid filler, diluent, excipient, or solvent
`encapsulating material.
` Turning to Slide 7, finally, another construction
`that is also final is "isolated from a natural or synthetic
`source." The Board in the Elysium IPR construed this as
`requiring that the NR constitute at least 25 percent of the
`composition.
` Turning to Slide 8, Stamler teaches all of the
`aspects of Claim 2. This is plainly stated in the reference
`itself and is beyond dispute. As illustrated in this slide,
`Stamler discloses a method of treatment using a
`therapeutically effective amount of an inhibitor of
`glutathione-dependent formaldehyde dehydrogenase.
` Stamler discloses further that one class of
`competitors -- one class of compounds that may use -- that
`may be used are competitors for NAD+ binding. And the first
`compound of this class and actually the first compound
`disclosed by Stamler is NR.
` Turning to Slide 9, Stamler also disclosed, but at a
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`minimum at least suggests, the use of a carrier. As can be
`seen in this slide, Stamler teaches dosage of the active as
`well as the preferred route of administration, which is oral.
`As Dr. Jaffrey confirms, the POSA would understand that the
`active would be provided with a carrier to allow for
`administration via the preferred route, which would be oral
`administration.
` Turning to Slide 10, Dartmouth can't argue that
`Stamler does not teach all of the elements of the challenged
`claim. To get past that, Dartmouth attempts to argue for a
`different claim construction. The most glaring example of
`this is on the top left where Dr. Amiji states that the term
`"pharmaceutical composition" excludes milk. But we know that
`isn't correct from the Board's prior decision in the Elysium
`IPR, wherein Claim 1 as well as Claim 3 were found to be
`unpatentable over a reference that taught the use of milk.
` Dr. Amiji is also reading additional limitations,
`such as regulatory approval, into the claim. This improper
`claim construction infects all of Dr. Amiji's analysis in his
`declaration.
` JUDGE POLLOCK: Counsel, this is Judge Pollock.
`Stepping back to Slide 9, would you go over in a little more
`detail Ground 1, where you're finding the carrier in Stamler.
` MS. GREEN: So, as -- I'm sorry.
` JUDGE POLLOCK: Are you relying solely on your
`expert's say-so that, well, there must've been one, or is
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`there some other information?
` MS. GREEN: No. If you actually look at the examples
`of Stamler, they -- they administer the actives, and they use
`a carrier, which is, in this case, as simple as saline. So
`Stamler does teach a carrier.
` And it is the only way to provide the active to the
`patient if you're going to administer a therapeutically
`effective amount of an active agent. So even though they may
`not explicitly say "carrier," I think as the reference would
`be read -- and we know that we have to read the references as
`a POSA would -- one would understand that you would need a
`carrier to administer the active, i.e., to perform the method
`of treatment.
` JUDGE POLLOCK: Thank you, Counsel.
` MS. GREEN: Thank you, Judge Pollock.
` So turning to Slide 11, we can see that Dr. Amiji is
`importing or baking into his analysis additional limitations,
`such as regulatory approval, which is simply not required by
`the claim.
` Turning to Slide 12, in sum, when the proper claim
`construction is applied, Stamler discloses all that is
`required by the claim. This is supported by Stamler, which
`provides a composition of an active agent with a carrier,
`such as saline, and you can see that at the bottom part of
`the slide. And this is --
` JUDGE SCHNEIDER: Counsel, I understand that there
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`are different parts of Stamler -- this is Judge Schneider;
`I'm sorry -- different parts of Stamler that have carrier and
`NR and oral administration and everything else, but there's
`no one example that has everything put together; is that
`correct?
` MS. GREEN: Stamler --
` JUDGE SCHNEIDER: That has NR -- administering NR in
`a particular dosage with a carrier. I mean, the examples are
`use other inhibitors with saline, not NR, no -- and so
`there's no one composition that has NR compounded with a
`carrier for oral administration, at least with respect to
`claim language of Claim 1.
` I understand there's an argument also about whether
`or not it's been isolated or not, and we'll get to that in a
`minute.
` But there's no one space in Stamler where everything
`in the claim is all in one section or paragraph; is that
`correct?
` MS. GREEN: Stamler does not exemplify a composition
`--
` JUDGE SCHNEIDER: So -- so you're pulling from pieces
`from different parts of the spec to come up with your 102
`analysis?
` MS. GREEN: I don't think I would say it that way
`because what Stamler specifically does teach is a method of
`treatment using NR. And, again, the reference has to be read
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`as the POSA would, and a POSA would understand that if you're
`doing a method of treatment, you have to mix that active with
`a carrier. So if we read the reference as a POSA would, one
`would understand that for that method of treatment, you would
`have to use a carrier.
` And there's no requirement in the law that the
`invention be reduced to practice. So those examples -- we're
`just using those examples as instances of the types of
`carriers that Stamler was thinking about.
` JUDGE SCHNEIDER: Thank you, Counsel.
` JUDGE POLLOCK: Counsel, on Slide 11, you talk about
`Patent Owner's contention the term "admixture" requires that
`the ingredients are purposefully mixed. If we were to accept
`Patent Owner's contention there, would it affect your
`outcome, Grounds 1 and 2?
` MS. GREEN: First, as to that, that was something
`that Patent Owner argued in the previous IPR, in the Elysium
`IPR, and that's now final, so this construction is final for
`the purposes of this proceeding.
` And I don't think so. It would not change what we're
`doing, our position in this particular proceeding, especially
`with Stamler. Stamler teaches obtaining NR using -- from a
`commercial source, which would just be assumedly a bottle of
`NR, or using standard synthetic methods. So if you were to
`obtain that, if you just had solid NR, you would have to mix
`it with a carrier in order to administer it to a patient to
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`achieve your desired therapeutic effect.
` JUDGE POLLOCK: Counsel, just as a matter of context,
`I've been reading this on the assumption that NR, as it is,
`you know, purchased from a supplier, is a solid, a crystal.
`Is that correct, and can you point me to evidence as to its
`physical state?
` MS. GREEN: I think if you look at Franchetti and
`look at the synthetic scheme and when they talk about the
`isolation of NR, what they do is they purify it by
`chromatography on activated charcoal and then they isolate it
`as a white solid. So that is Exhibit 1010, 46-56.
` JUDGE SCHNEIDER: So it's your position that one
`skilled in the art -- this is Judge Schneider, again -- would
`be reading the disclosure of Stamler, particularly when he
`talks about oral administration, would understand that you
`would have to take the NR, whatever form it may be -- in this
`case, probably a solid -- and then combine it with some sort
`of excipient to be able to reduce it to a tablet or add a
`diluent to make it into an elixir -- that you're -- the
`common way is administering something orally -- capsule being
`the third, but even then you would probably have an
`excipient.
` So that's -- that's your position, that someone
`skilled in the art reading it and seeing the word "oral
`administration" would understand automatically that you would
`have to mix the NR with some sort of carrier or excipient to
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`be able to administer it?
` MS. GREEN: That's correct, and that's consistent
`with the testimony of our expert, Dr. Jaffrey.
` And when we asked Dr. Amiji about this during
`deposition, he agreed that that's usually how an active is
`administered, is that you have to mix it with a carrier. I
`could find that cite if you need me to.
` JUDGE SCHNEIDER: No, that's fine. Thank you,
`Counsel.
` MS. GREEN: So, turning back to Slide 12, Stamler
`provides compositions of an active with a carrier such as
`saline. And then, as Dr. Jaffrey testifies, if a carrier is
`not specified, you would use a generic or standard form, and
`the POSA would look at the chemical structure of the active
`in order to determine compatible carriers.
` Turning to Slide 13, as can be seen here, the
`disclosure of the '086 patent is consistent with this
`understanding. Specifically, as noted by the '086 patent,
`the pharmaceutical compositions can be prepared by methods --
`by known methods and can take carriers which are well known
`in the art.
` Turning to Slide 14, as discussed earlier, this slide
`shows the now final construction of the claim term "isolated
`from a natural or synthetic source." In order to distinguish
`the challenged claim from the disclosure of Stamler,
`Dartmouth now provides a new construction for the term
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`"isolated."
` And turning to Slide 15, we can see how this is the
`case. It is undisputed that Stamler discloses sources of NR
`that meet the 25 percent limitation; that is, Stamler states
`that the NR is available commercially or may be synthesized
`as described in or rendered obvious over methods in the prior
`art. That understanding is confirmed by the reaction scheme
`of Franchetti as well as the testimony of Dr. Jaffrey.
` Turning to Slide 16, the disclosure of the '086
`patent explicitly confirms this understanding; that is, there
`is nothing new or unusual about isolated NR. The '086
`patent, like Stamler, teaches that NR is available
`commercially or may be isolated or synthesized using known
`methods.
` Turning to Slide --
` JUDGE SCHNEIDER: Counsel, doesn't Tanimori also
`teach an isolation or purification step as well?
` MS. GREEN: Yes. And you can see that from the '086
`patent on the bottom left-hand corner, where it says, May be
`synthesized using established methods --
` JUDGE SCHNEIDER: So the -- so the two --
` MS. GREEN: -- citing Tanimori --
` JUDGE SCHNEIDER: -- the two methods, at least that
`we have of record in this case, both include a purification
`step as part of the synthetic method?
` MS. GREEN: Franchetti definitely does. I -- to be
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`honest, I didn't recently review Tanimori, but I believe it
`does, but I could look at that and answer your question on
`rebuttal.
` JUDGE SCHNEIDER: That's fine. That's good. Thank
`you, Counsel.
` MS. GREEN: So, turning to Slide 17, it was also
`undisputed that isolated NR was known and that it was not
`invented by Dr. Brenner. This is stated in the '086 patent
`and confirmed by Dartmouth's own witnesses.
` We asked Dr. Bieganowski how he obtained NR. He
`testified he obtained it from Sigma-Aldrich and then
`synthesized it using known methods.
` The fact that there's nothing special about isolated
`NR is not only beyond dispute in this proceeding but also in
`the Elysium District Court case. In the District Court case
`101 opinion, the licensee ChromaDex did not dispute that
`isolating NR is not an inventive concept.
` Turning to Slide 18, so, given that Dartmouth cannot
`rely on isolation to impart patentability, Dartmouth attempts
`to read in additional aspects into the claim, which aspects
`are not required by the language of the claims; that is,
`Dartmouth is attempting to read in an additional isolating
`step of a source even if that source has itself been isolated
`to the required purity.
` JUDGE SCHNEIDER: Counsel, doesn't -- again, I'm
`going back -- let's go to Franchetti, I think it is. I mean,
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`you have a -- you'd go through a chemical reaction. You have
`some mixture that has the desired product and side products,
`byproducts, unused beginning materials, and what have
`you. I mean, isn't it just sort of basic organic chemistry
`that when you're trying to get to that product you would then
`go through an isolation step?
` MS. GREEN: That's correct, and that's exactly what
`our expert, Dr. Jaffrey, testified. Basically, he said you
`do a synthesis and then you do a method of isolation so that
`you can get and also confirm that you have the product you
`were trying to synthesize.
` JUDGE SCHNEIDER: So your reaction product before
`isolation could be the source, as Patent Owner is saying you
`have to isolate something from, and then you go through the
`isolation step to get your final product?
` MS. GREEN: That's correct. And Dartmouth has
`actually admitted that -- that's on another slide -- that in
`the District Court case against Elysium, they used Franchetti
`for specifically for that purpose, to say that you got to
`this reaction mixture or this reaction broth, and then you
`isolated the NR from that reaction broth.
` JUDGE SCHNEIDER: Thank you, Counsel.
` MS. GREEN: So, turning to Slide 19, Patent Owner
`cannot dispute that isolated NR was known. And any doubt
`that Dr. Amiji is ignoring the Board's prior construction,
`which is now final, is dispelled by this slide.
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`Specifically, even if the NR had a purity of 99 percent,
`according to Dr. Amiji, it would not meet the isolated, as
`required by Claim 2; rather, you would have to undergo yet a
`further isolation step in order to meet the limitations of
`the claim.
` On Slide 20 -- and even if we were to read that extra
`isolation step, it is met by the art. And as can be seen
`here, as we've already discussed in Franchetti, NR is
`synthesized and then isolated, and as we can see on the right
`from the District Court proceeding, Dartmouth argued exactly
`that.
` Turning to Slide 21, I would like to turn to the next
`grounds unless there are any more questions about Stamler.
` JUDGE SCHNEIDER: Not right now, Counsel. Thank you.
` MS. GREEN: Okay. Thank you.
` Turning to Slide 22, Dartmouth attempts to disqualify
`whether the Cell article and the '337 PCT qualify as prior
`art, but the office has already made the determination as to
`the priority date of the '086 patent, and the public should
`be entitled to rely upon that determination. The petition
`materials point that out.
` Dartmouth was aware of the filing date determined by
`the office, and if it wanted to correct that filing date, it
`could have done so by following the proper procedures. The
`office told Dartmouth how to correct the filing date.
`Dartmouth chose not to do that, and it is unfair to change
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`IPR2021-00268
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`that date here as, at the end of the day, that is where
`things stand.
` Turning to Slide 23, but even if we were to put aside
`that filing date as it now stands and if the Board wants to
`change the office's determination, the issue becomes whether
`Dartmouth can disqualify the Cell article and the '337 PCT as
`prior art. As the record currently exists and stands to this
`day, Drs. Brenner and Bieganowski are both listed as authors
`on the Cell article and inventors of the '337 PCT.
` JUDGE SCHNEIDER: Counsel, this is the issue here:
`The sufficiency of the affidavit submitted by Drs. Brenner
`and Bieganowski in light of the prior -- the precedential
`opinion by our reviewing court in In Re Katz.
` So why isn't at least the second Brenner declaration
`-- and I understand we found deficiencies with the first one
`-- but the second Brenner declaration combined with the first
`Bieganowski declaration -- lots of numbers here -- why aren't
`those two declarations together in light of In Re Katz
`sufficient to resolve the issue that the PCT application and
`the Cell article are not by another, at least with respect to
`the claims we have here?
` MS. GREEN: Even in Katz, the CCPA said you have to
`look at the totality of the evidence. And in Katz --
` JUDGE SCHNEIDER: The only evidence in Katz was the
`declaration, and the declaration -- or at least in the
`language that appears in the Katz decision -- was even more
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`IPR2021-00268
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`scant than what we have in the second Bieganowski -- excuse
`me -- the second Brenner declaration.
` And, now, we realize there were issues with the first
`declaration, and they've submitted a second one, and it
`really seems to be -- meet the requirements of Katz.
` And in Katz alone, there was only that declaration.
`Here we have the confirming declaration or disclaiming
`declaration by Dr. Bieganowski. Why under the case law are
`those two declarations not sufficient?
` I know we've got people listed and everything else
`and articles, but that, again, was the situation in Katz.
`And in Katz, they said this declaration does it, and it's --
`that's the end of the story.
` MS. GREEN: Well, in Katz, the only thing at issue
`was an article. Inventorship was not an issue, so only
`authorship was. And, in Katz, the court specifically
`distinguished authorship and inventorship and found that --
` JUDGE SCHNEIDER: So wasn't that at least part of the
`Cell article? I mean, I know we've got him listed in the
`article there, but it's -- it's -- you know, what's his
`contribution to the article has never really been made clear
`here.
` You're asking us to infer that somehow he added some
`-- something about what Bieganowski contributed to the Cell
`article rises to the level of inventorship, and you really
`haven't shown what he invented that's in there. There's a
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`IPR2021-00268
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`lot of inference in there, but I don't see any real evidence
`that anything in that Cell article was invented by Dr.
`Bieganowski.
` MS. GREEN: This is the problem going back to 2004.
`This is the problem with declarations. We don't know exactly
`what we're talking --
` JUDGE SCHNEIDER: But it's your burden, isn't it?
` MS. GREEN: It's our burden of --
` JUDGE SCHNEIDER: In this proceeding, it's your
`burden to go forward, that if you haven't got the evidence,
`I'm sorry, but I'm not sure that that puts -- makes it we
`have to find the patent invalid if you can't meet your
`burden.
` MS. GREEN: We have the burden of persuasion, but the
`totality of the evidence shows why you would need
`corroboration as well as evidence. Looking at the Cell
`article, when we asked Dr. Bieganowski about it, Dr.
`Bieganowski admitted he did not review the Cell article for
`his first declaration, but he said he didn't need to because
`it was his work. So, even after 18 years, that work was so
`near and dear to Dr. Bieganowski that he didn't feel like he
`needed to review it in coming up with his first declaration.
` In addition, if we look at it in the context of the
`'337 PCT, when you look at what Dr. Brenner claims as he
`invented, he invented the whole disclosure of both the Cell
`article as well as the '337 PCT. And Dr. Bieganowski was
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`IPR2021-00268
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`listed as an inventor on the '337 PCT.
` JUDGE SCHNEIDER: Well, the claims we have at issue
`here are -- are different than what's in the PCT. The PCT
`also includes genetic structures and things like that, and
`there's only a few claims in there that come close to
`matching what we currently have at issue here.
` And as you change the claims in a patent, you're
`required to confirm or -- confirm inventorship, so why isn't
`that what happened here? That seems to be more in natural
`courses as the claims were narrowed down to the specific
`method of treatment that we're talking about here or the
`composition for treating that's here in these claims.
`Wouldn't it be natural for them to have dropped an inventor
`who maybe didn't contribute to that part of the invention?
` MS. GREEN: The discovery that made all of this
`relevant -- and these are all tied together -- was the
`discovery that, similar to a bacteria, there is also an
`enzyme and eukaryotes that takes NR and transforms it
`directly into NAD+. And that's where the vitamin activity of
`NR comes from, the discovery of NR -- of NR as a vitamin.
` And if you look at the Cell paper, they admit that
`other known precursors of NAD+ were known to be given as
`vitamin supplements. So the fact that you would take a known
`precursor to NAD+ and use it as a vitamin supplement was --
`was routine, was understood by the ordinary artisan. So
`everything --
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` JUDGE SCHNEIDER: Well, that goes to whether or not
`the invention is obvious or not, but that doesn't necessarily
`mean -- it doesn't go to the inventorship issue. The
`inventorship issue is who made the conception or recognized
`that it could be used for that. And we've got Dr. Brenner
`clearly saying, I'm the one that came up with that idea, and
`Bieganowski in his declaration saying, yeah, that's probably
`right. So why isn't that enough under Katz?
` MS. GREEN: Again, Katz dealt with -- with just
`authorship and not inventorship, and we believe that the
`closer case, which was also an IPR which dealt with
`inventorship, was EmeraChem. And EmeraChem specifically said
`that you have to look at these declarations by inventors with
`skepticism because they have an interest in going back and
`seeing events from long-past -- long-past events in a light
`that is most favorable to themselves. And so I don't think
`Katz really talks about inventorship at all.
` And we can see from the time of invention, everybody
`thought Dr. Bieganowski should be listed as an inventor. Dr.
`Bieganowski was listed as an inventor on the provisional.
`This was after Dr. Brenner --
` JUDGE SCHNEIDER: But, again, the claims in the -- in
`the provisional, the PCT, even the Cell article are much more
`expansive in their coverage than the narrow issue we're
`facing here. So, again, how do we not know that they just
`narrow the inventorship based upon the claims that were being
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`IPR2021-00268
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`put forward here?
` MS. GREEN: Well, the claims in the '337 PCT all deal
`with the discovery of that there is an enzyme that converts
`NR to NAD+. And so there were claims to the nucleic acid
`that encode that -- that enzyme. There are claims to the
`polypeptide. There were claims to NR discovered using the
`processes of the invention. I don't think you can tease
`apart inventorship or conception of the nucleic acid or the
`polypeptide from using the NR as a vitamin supplement.
` And, in fact, neither the Cell article nor the '337
`PCT actually administer NR as a vitamin supplement. Rather,
`they just confirm that in these particular yeasts that they
`can grow when you give them NR.
` So the -- so the three -- the '086 patent itself does
`not have an example using a vitamin supplement. It just says
`it can be used as a vitamin supplement.
` The claims of the PCT are important because they're
`all drawn to that discovery. You can't tease the
`inventorship of one claim apart from another claim, and
`Dartmouth has never tried to do so. Dartmouth has never
`explained what Dr. Bieganowski was -- why he was in fact
`listed on the provisional and the '337 PCT as an inventor.
` If you look at what Dr. Brenner claimed he invented,
`he still claims things -- and as you saw in the -- in his
`first declaration -- he claims things that were part of the
`prior art, such as the well-known carriers and well-known
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`IPR2021-00268
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`everything else. So --
` JUDGE SCHNEIDER: He fixed -- Counsel, he fixes that
`in his second declaration. I'm not proposing to rely upon
`the first declaration. We found issues with that in this
`IPR, and I know we found it in the related IPR. But the
`second declaration goes through it in more detail, and it
`distinguishes between what's in the prior art and what his
`inventions are, particularly, as you pointed out, the
`distinction between the prokaryotic and eukaryotic organisms.
` So why isn't the second declaration, other than your
`issues of bias, sufficient under Katz, disclaiming -- saying,
`look, this
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