`Entered: 07/14/22
`
`Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________
`
`THORNE RESEARCH, INC.,
`Petitioner,
`
`v.
`
`TRUSTEES OF DARTMOUTH COLLEGE.,
`Patent Owner.
`___________
`
`IPR2021-00491
`Patent 8,197,807 B2
`___________
`
`Record of Oral Hearing
`Held: May 17, 2022
`_____________
`
`
`
`Before SUSAN L. C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`MICHAEL T. ROSATO, ESQUIRE
`TASHA M. THOMAS, ESQUIRE
`Wilson, Sonsini, Goodrich & Rosato
`1750 K Street, N.W.
`Washington, D.C. 20006
`
`
`
`
`
`
`ON BEHALF OF PATENT OWNER:
`
`
`JOHN L. ABRAMIC, ESQUIRE
`Steptoe & Johnson, LLC
`227 W. Monroe Street
`Unit 4700
`Chicago, IL 60606
`
`
`The above-entitled matter came on for hearing on Tuesday, May 17,
`2022, commencing at 10:01 a.m., EDT, by video/by telephone.
`
`
`
`
`
`
`
`
` 2
`
`
`
` P
`
`IPR2021-00491
`Patent 8,197,807 B2
`
`
`
`
`
` R O C E E D I N G S
` - - - - -
`JUDGE SCHNEIDER: Good morning everyone. We're
`
`here this morning for the hearing in IPR 2021- 00491 which is
`Thorne Research, Inc. v. Trustees of Dartmouth College. The
`patent at issue is U.S. 8,197,807 and today we have -- who do we
`have appearing for Petitioner today?
`
`MR. ROSATO: Good morning, Your Honor. My name is
`Michael Rosato for Petitioner and I have with me Tasha Thomas
`who is under the LEAP program.
`
`JUDGE SCHNEIDER: All right. Welcome, Ms. Thomas.
`And for Patent Owner, who do we have?
`
`MR. ABRAMIC: Good morning, Your Honor. This is John
`Abramic on behalf of Patent Owner.
`JUDGE SCHNEIDER: All right. Very good. Because of
`the presence of a LEAP practitioner, Petitioner, you will have
`one hour to present your argument. Do you wish to reserve any
`time for rebuttal?
`MR. ROSATO: I'd like to reserve 15 minutes, Your
`Honor.
`JUDGE SCHNEIDER: And Patent Owner, you will have 45
`minutes as was stated in the original order. Do you wish to
`reserve any time for rebuttal?
`MR. ABRAMIC: Five minutes, Your Honor.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
` 3
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`JUDGE SCHNEIDER: All right. Thank you very much.
`Before we begin a few ground rules. Please mute yourselves
`when you're not speaking. I see that several of you have
`headsets, I appreciate that. I'm hearing impaired so having the
`headset helps me hear you a little bit better but I may have to
`stop and ask you for pronunciations as we go forward. I'd ask
`you to please identify yourself when you first start speaking for
`the court reporter to help identify who's speaking here. For the
`panel today we have myself, Judge Schneider, we have Judge
`Mitchell and Judge Paulraj on the panel today. Before we begin
`are there any questions?
`MR. ROSATO: Not a question, Your Honor, but a
`comment. I've had mixed (indiscernible) success with the
`computer audio if it's not working for you, I'm happy to pause
`and take time out of my argument time to connect by telephone.
`Just please let me know and I'm happy to do that.
`JUDGE SCHNEIDER: No problem. We'll try to keep track
`and let you know if we can't hear you or understand you and
`we'll adjust the time as necessary to allow for reconnection. We
`understand the issues. With that, Petitioner, you may begin.
`MR. ROSATO: Thank you, Your Honor, and may it please
`the Board. We're going to address the argument in two parts.
`I'll start by first addressing the legal standard for disqualifying
`prior art as not being “by another” and that standard in view of
`through the undisputed facts and procedural history here and I'll
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 4
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`turn things over to my colleague, Ms. Thomas, who will address
`the issues of corroboration and insufficient corroboration in a
`priority claim at issue here.
`
`With that outline in mind, we'll get started by turning to
`slide 2 of Petitioner's demonstrative exhibits and this lays out for
`reference the grounds of challenge here. Ground 1 as we know is
`based on the Bieganowski reference, Exhibit 1008, which is
`referred to in the briefing as the Cell article. We may use that
`terminology here. Ground 2 is based on the Brenner reference in
`Exhibit 1007 which has been referred to as the ‘337 PCT. We
`may use that terminology here.
`JUDGE SCHNEIDER: So counsel, just for clarity these are
`the only three references that are at issue presently. You're not
`relying on Goldberger or Goldberger and Tanne r or Stamler or
`any of the other references that have been involved in the other
`IPRs; is that correct?
`MR. ROSATO: The references you mentioned are not
`formally relied on. Of course, you know, we'll observe the
`requirement under the case law of background art and some of
`the issues we will talk about here is in response to efforts to, and
`this is one of the issues I'm going to go into, is efforts to
`disqualify a reference if there's, you know, responsive argument
`to that. Some of the things they're trying to disqualify are things
`and subject matter that was already in the public domain so to
`the extent --
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 5
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`JUDGE SCHNEIDER: Excuse me, counsel. My
`understanding that the test, right, and I think it's laid out in one
`of your slides or one of the others, is looking at the subject
`matter of the claims and then looking at the subject matter of the
`references that you're putting forward which is the Cell article
`and the PCT application and then looking at who is the inventor
`of the subject matter with respect to what's disclosed in those
`references. So why is all this other prior art or that things that
`may or may not be in the prior art relevant to the inquiry?
`MR. ROSATO: Well, I appreciate that, Your Honor. I
`think the slide you're referring to is slide 5 and we can turn to
`that and we've cited cases like Emer aChem Holdings, LLC v.
`Volkswagon Gp. of Am., which is illustrated here on this slide.
`Those cases articulate an inquiry and that inquiry is, as you
`noted, whether the portions of the relied upon references and the
`subject matter of the claims in question is the work of a common
`inventive entity. So if the question looks at the overlapping
`subject matter and is tethered to the claims themselves.
`JUDGE SCHNEIDER: But the question is whether or not
`the work of the Bieganowski article and the PCT application is
`the work of another vis-à-vis the claims and you're trying to say,
`well, but there's other articles out there and this stuff's already
`invented maybe by somebody else. But those references aren't
`what you're relying upon here. You're relying upon
`Bieganowski, the Cell article and you're relying on the PCT
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 6
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`application. So why is all that other inquiry into, you know, NR
`was purified by somebody else in another article or people knew
`that it was in milk, why is that at all relevant to this inquiry
`which, as you've got here in the EmeraChem quoted here it's the
`subject matter of the claims versus what's in the article and
`who's the inventor of those two different things. Why are we
`concerned with what's allegedly in the prior art?
`MR. ROSATO: I wouldn't characterize it as who's the
`inventor of those two different things, Your Honor. I think the
`inquiry that's articulated in the case law is whether the common
`subject matter is also the work of a common inventive entity
`(indiscernible) --
`JUDGE SCHNEIDER: Okay. Where is that discussed in
`EmeraChem? I mean, I see the test here but I'm also thinking the
`other one big case is the Duncan Parking Techs Inc. v. IPS Grp.
`Inc. There there wasn't another art -- they weren't saying that
`these were invented by third parties and that was part of the
`analysis. It was looking at the article or evidence there was that
`somebody else had invented what was described in the other
`article that was being put forward as a piece of prior art and
`there's joint inventorship there. So why are we concerned with
`all this other prior art that you do not rely upon in your basis or
`your grounds?
`MR. ROSATO: So there's a couple of questions there. The
`first question is goes to the standard and, again, the standard as
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 7
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`articulated and you see this in all of the cases, the inquiry is
`whether the portions of the art as well as the subject matter of
`the claims is the work of a common inventive entity. So we are
`looking at both of those things and that makes sense that we
`would do so. Other cases like the In re F acius case listed here
`very, you know, hit this point precisely and say that as we're
`determining this issue of inventorship and sort of looking at the
`contribution of a person and that person merely brought the prior
`art to the attention of the group, that's not inventive activity. So
`there's (indiscernible) --
`JUDGE SCHNEIDER: So doesn't that discount the issue of
`whether or not Dr. Bieganowski is an inventor and don't have any
`of the stuff because all he did was look up how to make and how
`to isolate these things and (indiscernible) the prior art, but it still
`doesn't show the invention that Dr. Brenner is claiming is his
`which is what's the subject matter of the claims in all the
`features of the claims.
`MR. ROSATO: Yes --
`JUDGE SCHNEIDER: I mean, you're very good at pointing
`out each of those individual features is available in the prior art
`but where's all that together in something that's what Dr. Brenner
`claims is his invention?
`MR. ROSATO: Yes. I mean, to get to these one at a time.
`So your previous question also asked about Duncan Parking
`Meter, so I'll respond to that too as a completely different
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 8
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`situation where the issue there is not what the issue is here;
`right? Or I should say the fact pattern is not what's going on
`here. In Duncan Parking Meter we were trying to distinguish
`between, you know, whether -- there is no dispute that both
`parties had a contribution and the issue was whether those
`contributions could be sufficiently distinguished; okay? That
`issue may come up here when we get to the corroboration but as
`a threshold issue I don't think ever comes up because I don't
`think there's any dispute here that neither Dr. Brenner or Dr.
`Bieganowski had any inventive activity with anything that's
`claimed here; okay? That’s (indiscernible) --
`JUDGE SCHNEIDER: Isn’t -- you're saying that --
`MR. ROSATO: -- neither the individual --
`JUDGE SCHNEIDER: -- (indiscernible) tried to sneak it in
`
`--
`
`MR. ROSATO: -- (indiscernible) any of the subject matter
`of the claims that we're looking at and when we turn to the prior
`art that's cited neither of them has any inv entive contribution to
`any of the content of the prior art. This is all corroborated. It's
`already in the prior art at the time so this notion that Dr. Brenner
`can say that, you know, that Dr. Bieganowski didn't invent this
`and therefore awards himself inventorship (indiscernible) --
`JUDGE SCHNEIDER: So why are you relying, why is your
`-- so counsel, why is your grounds for unpatentability limited to
`just the Bieganowski article or the PCT application? Why didn't
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 9
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`you bring in all these other references as part of the prior art
`analysis?
`MR. ROSATO: Well, I would say our grounds are
`illustrated by Bieganowski and this PCT article. Those
`references are prior art to this patent (indiscernible) --
`JUDGE SCHNEIDER: But you did not cite them -- you did
`not specify them as grounds for unpatentability in your petition,
`did you?
`MR. ROSATO: (Indiscernible) --
`JUDGE SCHNEIDER: Did you specify those articles -- did
`you specify that art as grounds for unpatentability in your
`petition?
`MR. ROSATO: So to finish my --
`JUDGE SCHNEIDER: Yes or no. I'm waiting for an
`answer.
`MR. ROSATO: Yes (indiscernible) --
`JUDGE SCHNEIDER: I'm looking at your slide 2 -- I'm
`looking at your slide 2 and you list ground 1 as Bieganowski and
`Rosenbloom, ground 2 is Brenner PCT article. Where's all this
`other prior art that you're trying to bring in?
`MR. ROSATO: I would point you to pages 30 through 33
`of the petition which lays out background art. Page
`(indiscernible) --
`JUDGE SCHNEIDER: But that's the background art, but
`you did not put them forward as the basis of your -- in your
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 10
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`petition.
`MR. ROSATO: Sorry --
`JUDGE SCHNEIDER: You're asking us to go beyond the
`grounds listed in your petition to find this patent invalid.
`MR. ROSATO: We are not doing that, Your Honor. We're
`citing prior art and the issue is whether that prior art can be
`disqualified on the basis that this background public domain
`information was invented by Dr. Brenner. It cannot be
`disqualified on that basis and there's corroborating evidence
`that's a fact. So it's not a matter of going beyond grounds, it's an
`issue of valid prior art as cited in the petition. Patent Owner is
`trying to disqualify that as prior art with this argument that Dr.
`Brenner invented subject matter that they admit he didn't invent,
`that the Board has already determined he didn't invent and that
`the prior art corroborates he didn't invent. That's the issue and
`that's how it's characterized.
`It's not a matter of switching grounds and that's plainly laid
`out in the petition as well as the briefing. So I don't agree with
`that characterization of what's going on. I would say there's
`valid prior art cited and nobody has demonstrated otherwise, and
`we can walk through this and go through, you know, all of these
`points which are beyond dispute, right, and we can start with the
`prior claims, excuse me, slides 6 through 8 here lay out the
`claims of this patent, the claims of the '086 patent which were
`already determined invalid and a comparison of the two and you
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 11
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`see there's virtually no daylight left between what's claimed here
`and what's already been invalidated as not the inventive work of
`Dr. Brenner. As to anything that's left here, what we see is
`identified in the patent as background prior art. It's admitted by
`the witnesses here as background art not invented by Dr. Brenner
`and it's corroborated by multiple additional references as not the
`work of Dr. Brenner.
`So this is Patent Owner's argument that Dr. Brenner
`invented this. They're arguing this is a disqualified re ference
`and we're responding to that argument and the argument that
`they're advancing should be rejected wholesale because neither
`of these individuals invented anything covered by these claims
`and there's no reasonable dispute left to that fact.
`What we see on slide 10 as it is, and we'll walk through
`each of those, we see on slide 10 this illustration that the patent
`itself, the '807 patent itself, is characterizing its claims as
`encompassing background art subject matter, known methods and
`compositions comprising NR starting with commercially
`available NR as well as isolated extracts using standard methods.
`In slide 11 is evidence during discovery here confirming
`that the claims were meant to cover known compositions existing
`in the public domain at the time and Dr. Bieganowski readily
`conceded that neither he nor Dr. Brenner invented the claimed
`compositions here.
`And as we turn to slide 12, just to outline this stuff --
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 12
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`JUDGE PAULRAJ: Mr. Rosato, so I’ll break it down into
`two questions for you. So the first one for me is you recognize
`-- the extent of your argument is that the named inventor is not
`the actual named inventor of the ‘807 patent. You recognize
`there’s a presumption, right, associated with the fact that if a
`patent names an inventor that’s the true and only inventor. The
`caselaw recognized that presumption; right?
`MR. ROSATO: Well, sure. But that applies equally to the
`337 PCT and --
`JUDGE PAULRAJ: Well, let’s break that down, let’s break
`that down. So let’s stick with the ‘807 patent for a second. So
`you recognize that Dr. Brenner is presumed to be the named, the
`true named inventor of the ‘807 patent and then presumptions
`can be overcome but the burden would be on you to show that
`Dr. Brenner is not the named inventor. Can you at least agree
`with that point?
`MR. ROSATO: If we were to dismiss all the procedural
`history here in fact and the fact that if this has already been
`finally determined is not his inventive activity I would
`acknowledge as a general point of law we start with this idea that
`the named inventor is an inventor, and there’s no presumption of
`validity at the PTAB so with all those things in mind I think
`that’s where we start off.
`JUDGE PAULRAJ: Right. So with that, I mean you
`brought in the presumption of validity, you think that’s related to
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 13
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`the presumption that the named inventors are properly named? Is
`there a relationship between those two concepts?
`MR. ROSATO: I can’t think of a legal basis why there
`would be a formal presumption of validity based on named
`inventorship.
`JUDGE PAULRAJ: Leaving that aside, so I just wanted to,
`you know, you threw in presumption of validity and I think
`that’s a separate concept. At least, you know, I haven’t seen any
`indication that that would be related to the presumption
`associated with inventorship.
`So my next question then, and you alluded to it, was the
`‘337 PCT but that’s not, you know, it’s not a U.S. patent so is
`the same presumption associated with the named inventors on a
`U.S. patent, is that applicable to the PCT application? Is there
`any case law that you can point to associated with that?
`MR. ROSATO: Well, the PCT you recall is not just the
`PCT. There’s a U.S. provisional that was filed with the same –
`listing the same two individuals as inventors and they have the
`same claims if I recall and the same context. That provisional
`was essentially copied and filed as a PCT so I’m not sure there’s
`a meaningful distinction there to be had between the U.S.
`application, the PCT, because in that instance we actually have
`both of them.
`JUDGE PAULRAJ: All right. Yes, again, that was a
`provisional. It wasn’t an issued patent that they were talking
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 14
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`about so is there any presumptions associated with the fact that a
`provisional listed inventors is not something that gets examined;
`right? Provisional applications don’t get examined so is it
`reasonable to assume that the inventors may not have actually
`been properly named in that instance?
`MR. ROSATO: Actually, and we’ll get into this but in this
`case I don’t think that’s a reasonable presumption for a couple of
`reasons because as we learned as we went through the discovery
`process, this wasn’t just some random mistake, this was a listing
`in the PCT the provisional -- the corresponding Australian
`application -- this was a listing of inventorship that occurred
`after paperwork and diligence was performed by the lawyers at
`the Dartmouth Tech Transfer Office after consulting with outside
`counsel, so after this diligent review this was the determination.
`So in this case --
`JUDGE SCHNEIDER: Counsel?
`MR. ROSATO: -- it’s reasonable to assume, and not only
`is it reasonable to assume, we don’t have to assume anything --
`JUDGE SCHNEIDER: But counsel --
`MR. ROSATO: -- because we know this --
`JUDGE SCHNEIDER: Counsel?
`MR. ROSATO: -- went through the diligence process --
`JUDGE SCHNEIDER: Counsel?
`MR. ROSATO: -- and an inventorship --
`JUDGE SCHNEIDER: Counsel?
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 15
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`MR. ROSATO: -- (indiscernible) was determined.
`JUDGE SCHNEIDER: Counsel?
`MR. ROSATO: Yes, Your Honor.
`JUDGE SCHNEIDER: Counsel, the claims in the PCT
`application cover more than what’s in the current case before us.
`So you can have inventorship of the claims with different subject
`matter and you only have to be as an inventor of at least one of
`the claims and, for example, in the PCT application claim 1 is to
`an isolated nucleic acid. So it’s not the subject of what we’re
`dealing with here. So you can have inventorship and be correct
`in inventorship in an application that has claims of different
`subject matter.
`So I think it’s, you know, this argument that yes, they went
`through all this diligence and they, you know, it’s not just a
`simple mistake, but again it sort of ignores the fact that you’ve
`got different claim scope here in the PCT application and the
`provisional application and so, you know, we change
`inventorship all the time because as claims are broadened or
`narrowed or what have you. You’re reminded during prosecution
`to confirm inventorship, so why does it matter that they went
`through this diligent review when they filed the PCT case and
`even some of the other applications that have different claim
`scope?
`MR. ROSATO: It’s a great question, Your Honor. I totally
`agree with you on one point and that is that there seems to be,
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 16
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`you know, when we put all this evidence together there seems to
`be, you know, no argument on Patent Owner’s side that Dr.
`Bieganowski was appropriately listed. So, you know, it presents
`two completely separate issues.
`The first issue is the one I was talking about which is when
`we look at these claims, if we’re going to focus on the claims, if
`we look at these claims and the subject matter in dispute there is
`no dispute that Dr. Brenner didn’t invent anything about these
`claims nor did Dr. Bieganowski. Neither of them did. So Dr.
`Brenner cannot disqualify art that he didn’t invent by claiming
`that he invented it. It just doesn’t make sense. It’s an oddity of
`this case given the procedural history and the admissions.
`There’s nothing left.
`The second issue which you’re getting to is the one that
`Patent Owner never grapples with in their attempt to disqualify
`this stuff and this is what implicates more than the Duncan
`Parking meter issue; right? So in Duncan Parking Meter we had
`a second individual that was trying to, you know, disclaim
`themselves as -- that was trying to be disclaimed as an inventor
`but the problem was that their inventive contribution could not
`be disassociated with what was claimed.
`So what you mentioned here, Your Honor, is that Dr.
`Bieganowski must have invented, like the gene or the protein
`that was claimed or something. So I would ask, and this is a
`question Patent Owner has never answered or addressed, I would
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 17
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`ask if Dr. Bieganowski made a meaningful contribution to the
`discovery of the gene or the enzyme here that processes NR, how
`can he possibly be disassociated from this broad concept of a
`composition that has NR in it? My answer to that is he cannot.
`You cannot disassociate those two. But we -- Patent Owner
`never even gets to the point of making thar argument because
`they focus on trying to essentially disqualify these things that
`everybody admits Dr. Brenner didn’t invent. So I think the
`whole analysis gets tripped up by this, you know, sort of
`absurdity given the procedural history.
`When we get to the PCT they’ve never come out and said
`okay, we’re going to fess up. Here’s why Dr. Bieganowski is
`listed, here’s his contribution, and then made some argument
`why his discovery of the gene or the enzyme can possibly be
`disassociated from this broad, you know, composition claim that
`they’re trying to get.
`JUDGE SCHNEIDER: Counsel, do you have any case law
`that supports your position regarding the fact that we can look to
`the other art to determine that neither Bieganowski nor Brenner
`are inventors of anything here and that therefore that ends the
`inquiry into whether or not the references are available as prior
`art? You said this is an oddity. I’m just wondering if this has
`come up before somewhere and there’s something we can look to
`for guidance on that because reading the cases I sort of see that
`you’re looking at the article that you’re putting forward and the
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 18
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`claims and everything sort of looks at those two things and then
`there’s a question of corroboration which I understand your co-
`counsel will address but then, okay, we’ll start pulling in
`everything else and say, well, we really didn’t invent anything
`here so therefore they can’t try to disclaim or swear behind it
`with a In re Katz declaration or an In re Mathews declaration.
`So is there any case you can point me to that’s got that -- is close
`to the fact pattern that we have right here which you’re alleging
`right now?
`MR. ROSATO: It’s hard to find that fact pattern but that’s
`a different question. Pointing to case law that supports this I
`would point to EmeraChem, I would point to In re Facius that
`stands for the proposition that the inquiry focuses on the
`combination of what’s cited and what’s claimed and looking for
`a common inventorship and what’s stated plainly in In re Facius
`is that a person is not an inventor if they’re merely bringing up
`prior art concepts. So I would say, you know, those are directly
`on point.
`As far as the fact pattern I would agree with you to the
`extent that the typical fact pattern that arises is that, you know,
`you start with an assumption that these other cases are starting
`with an established, you know, established fact pattern that there
`is something inventive in the claims; right? That’s the starting
`proposition and with this starting assumption that the claims are
`covering something inventive and that inventive thing it’s also
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 19
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`describing in the reference there’s this process, inventorship by a
`process of elimination, okay?
`So if we start -- and this is laid out on slide 4 as well.
`Patent Owner’s argument is, you know, inventorship by this
`process of elimination. They assume that there’s something
`inventive in the subject matter dispute, then they assume that the
`only two possible individuals that are inventors are Dr. Brenner
`and Dr. Bieganowski and then their argument is, well, Dr.
`Bieganowski didn’t invent anything here so therefore we should
`all award inventorship to Dr. Brenner by default. But it doesn’t
`work that way. That analysis might work when you start with
`valid assumptions that something inventive is at stake and a
`valid assumption that there are only two possibilities, but none
`of those assumptions apply here. Here to start, we don’t have to
`assume the starting facts are there’s nothing inventive here.
`There’s nothing that Dr. Brenner could possibly claim is his
`inventive activity, so when we start with that assumption which
`we have to here, and we start this process of elimination sure, we
`might be able to eliminate Dr. Bieganowski but we eliminate Dr.
`Brenner too.
`So to answer your question, Your Honor, the case law
`absolutely supports and dictates this type of analysis. This
`particular fact pattern I would say has not necessarily come up in
`the art because you don’t have the situation where 99 percent of
`the claim has already been wiped out and finally litigated and
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 20
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`then anything left is, you know, covered essentially six ways to
`Sunday between admissions in the patent itself, admissions by
`the witnesses, corroborating prior art. So yes, there is case law
`and from that standpoint there is also case law, Board case law,
`that says we as petitioners are perfectly entitled to respond to an
`argument that’s advanced. So when we say, as Petitioner, valid
`prior art that on its face is valid prior art and the Patent Owner
`comes forward with a response argument trying to disqualify
`that, we are allowed to fully respond to that and part of that
`response is pointing out that what they’re trying to disqualify
`from the art is covered all over the place in admissions, prior
`decisions, additional prior art. So absolutely we can address it
`in that manner.
`JUDGE SCHNEIDER: Counsel, aren’t you sort of equating
`at least those portions of the PCT article and the Cell article that
`you’re relying upon with respect to these claims is more
`analogous to what I might call a review article where you’re
`summarizing what’s known in the art and you’ve gathered
`together bits of information and put it all together in one article.
`So aren’t you sort of characterizing that sort of like a review
`article this is all stuff that’s known in the art and all they’ve
`done is sort of summarize it in their specification?
`MR. ROSATO: I wouldn’t say we’re characterizing it as a
`review article but I would say that everything at stake here is
`beyond dispute in the public domain even before the Cell article
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 21
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`and the PCT, right, and we see that corroborated and we can see
`-- we also always start with, you know, construction of the claim
`or interpretation of the claim but as we know here, the ‘807 was
`intentionally meant to encompass prior art compositions
`including isolates using known standard techniques and their
`exact language is, you know, isolated extracts but the natural
`sources can be repaired using standard methods. That is looking
`at the specification of the ‘807. That’s what the claims are
`intended to cover.
`Now if we look at, I’ll use Bieganowski as an example, if
`we look at Bieganowski it’s disclosing an isolate using standard
`methods. We’ve asked Dr. Bieganowski about h is methodology
`to use that and he told us he used nothing beyond, you know,
`nothing inventive but the standard laboratory protocols. So he
`confirmed that what he did in his work was pure standard
`methods, exactly what the patent says it’s trying to cover and
`then if we want -- if there’s any doubt on this, and we look at
`references like the Booher reference which is cited in the
`petition and lays out that, yes, indeed, these types of
`compositions were isolated using standard methodology.
`So it all checks out, so it’s not necessarily a review article
`approach. It's the fact that they didn’t invent anything here;
`right? They just didn’t invent anything, at least nothing that’s
`claimed. Maybe some gap in the determination (indiscernible)
`but it doesn’t entitle them to go draw a claim to a composition
`
`1
`2
`3
`4
`