Trials@uspto.gov
`571-272-7822
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`Paper No. 37
`Entered: May 22, 2023
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`TRANSGENE and BIOINVENT INTERNATIONAL, AB,
`Petitioner,
`
`v.
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`REPLIMUNE LIMITED,
`Patent Owner.
`________________
`
`PGR2022-00014
`Patent 10,947,513 B2
`________________
`
`Record of Oral Hearing
`Held: March 17, 2023
`________________
`
`
`
`
`Before CHRISTOPHER G. PAULRAJ, RYAN H. FLAX, and
`JAMIE T. WISZ, Administrative Patent Judges.
`
`
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`571-272-7822
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`
`
`
`Paper No. 37
`Entered: May 22, 2023
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`TRANSGENE and BIOINVENT INTERNATIONAL, AB,
`Petitioner,
`
`v.
`
`REPLIMUNE LIMITED,
`Patent Owner.
`________________
`
`PGR2022-00014
`Patent 10,947,513 B2
`________________
`
`Record of Oral Hearing
`Held: March 17, 2023
`________________
`
`
`
`
`Before CHRISTOPHER G. PAULRAJ, RYAN H. FLAX, and
`JAMIE T. WISZ, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`
`PGR2022-00014
`Patent 10,947,513 B2
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`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`TRAVIS W. BLISS, ESQ.
`Panitch Schwarze
`2200 Concord Pike
`Wilmington, DE 19803
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`DION M. BREGMAN, ESQ.
`GUYLAINE HACHE, Ph.D, ESQ.
`Morgan, Lewis & Brockius, LLP
`1400 Page Mill Road
`Palo Alto, CA 94304
`
`
`
`
`
`The above-entitled matter came on for hearing, by video, on Friday,
`March 17, 2023, commencing at 1:00 p.m., EDT, at the U.S. Patent and
`Trademark Office.
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`PGR2022-00014
`Patent 10,947,513 B2
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`P R O C E E D I N G S
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`JUDGE PAULRAJ: Good afternoon, everyone. This is the oral
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`hearing for PGR 2022-20014 before the Patent Trial and Appeal Board. I'm
`Judge Paulraj, and with me in the hearing room to my left is Judge Flax and
`joining us by video on the screens you see here is Judge Wisz. Let's go
`ahead and do appearances, with Petitioner's counsel first.
`MR. BLISS: Thank you, Your Honor. My name's Travis Bliss. I'll
`be presenting on behalf of Petitioners today. With me today are my
`colleagues Erin Dunston and Philip Hirschhorn.
`JUDGE PAULRAJ: All right. Thank you. Can you pronounce your
`name again counsel?
`MR. BLISS: Travis Bliss B-L-I-S-S.
`JUDGE PAULRAJ: All right. Thank you, Mr. Bliss. All right. And
`who do we have for Patent Owner?
`MR. BREGMAN: Dion Bregman, for Patent Owner, with my
`colleague, Guylaine Hache.
`JUDGE PAULRAJ: Thank you, Mr. Bregman, and I know Ms.
`Hache was approved as a LEAP practitioner so, welcome and we'll be giving
`you 15 extra minutes for the LEAP program.
`So as set forth in our Hearing Order, each side will have 60 minutes to
`present their arguments, plus the 15 extra minutes for Patent Owner. We'll
`start with Petitioner first and then turn it over to Patent Owner and Petitioner
`and Patent Owner may each reserve a portion of their argument for rebuttal
`and surrebuttal respectively and I would remind counsel that rebuttal and
`surrebuttal are intended to reply to the other side's arguments, not an
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`opportunity to just go in a completely different direction.
`So this will be a public hearing, and there may be members of the
`public listening to the hearing as well as in the room. To the extent that the
`parties anticipate getting into any confidential information, please police
`yourself and let us know if we need to go on the confidential record. So I'd
`also note that we have one of our law clerks in the back, so welcome and
`however, I don't anticipate any confidential information being discussed in
`the hearings given the record of this case.
`I'd also remind counsel to please refrain from interrupting the other
`side during their arguments. If there are any objections that need to be
`raised, you can do so after opposing counsel has presented their arguments.
`We did receive the parties demonstratives and we'll be able to follow along
`with those demonstratives as we present your respective arguments. If you
`have hard copies, we're happy to take those demonstrative the hard copies as
`well, and I would ask for an extra hard copy. I can give it to Judge Wisz
`whenever she is available, and as with normal practice, please make sure to
`refer to the slide number you're referencing during the course of your
`argument so it's clear for the record. I'll also remind counsel that
`demonstratives themselves are not evidence, they're only used to aid us in
`the matter with respect to where evidence and arguments in the record are.
`So please keep that in mind. We're also in receipt of Petitioner's unopposed
`Motion for a Refund of Fees, and we'll issue an order on that Motion in due
`course. So before we get to arguments, are there any other preliminary
`matters we need to discuss?
`MR. BLISS: No, Your Honor, but we do have hard copies. Should
`we handed --
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`JUDGE PAULRAJ: Yes, I appreciate that, Mr. Bliss. Oh, that's
`okay. But we're so used to the virtual world where hard copies were no
`longer needed but I appreciate it every once in a while, so thank you.
`JUDGE FLAX: Also, Jamie can’t see what they put up on the screen,
`just so they know.
`JUDGE PAULRAJ: Sorry?
`JUDGE FLAX: Jamie can’t see what they put on the screen. Our
`Judge who’s not here can’t see what you put on the screen, but she has your
`demonstratives in front of her. So if you identify the slide number she can
`go directly to it.
`MR. BLISS: Okay.
`JUDGE PAULRAJ: So that’s another reason to refer to the slide
`number so Judge Wisz can follow along. So let’s turn it over to Petitioner.
`Mr. Bliss, how much time would you like to reserve for rebuttal?
`MR. BLISS: Ten minutes, please.
`JUDGE PAULRAJ: Ten minutes, and Mr. Bregman, how much time
`would you like to reserve for --
`MR. BREGMAN: Fifteen.
`JUDGE PAULRAJ: I'm sorry?
`MR. BREGMAN: Fifteen.
`JUDGE PAULRAJ: Fifteen. Okay. All right. We'll have some
`flexibility, depending on how the argument goes. But I'll go ahead and put
`down 15 minutes now for Petitioner. So whenever you're ready, Mr. Bliss.
`MR. BLISS: Thank you, Your Honor.
`JUDGE PAULRAJ: Let me go ahead and set up the time here. I
`think I'm doing this right. Okay. Whenever you're ready.
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`MR. BLISS: Okay. Thank you, Your Honor. I'll jump right in.
`There's a lot of issues in this case, despite the fact that it's down to one claim
`so we'll get moving right away.
`I'd like to start just with a brief discussion of the subject matter of the
`claims and this is a Petitioner’s slide 5. In this case, initially we challenged
`25 claims by PGR. 24 of those claims were disclaimed during the course of
`the proceeding. So the only claim that remains in the case is claim 13.
`Claim 13 depends from claim 11 which depends from claim 1.
`So if you were to assemble all that together elements of claim 13
`taking those dependencies into account are effectively five pieces. There's
`an oncolytic virus and that virus is HSV. That's for claims 1 and 11.
`There’s a heterologous GM-CSF encoding gene and a heterologous CTLA-4
`inhibitor encoding gene. Those are from claim 1 and throughout the day we
`will largely be talking about the CTLA-4 inhibitor as anti-CTLA4 antibody.
`The fourth element is that both genes are inserted into the viral
`genome, which is in claim 1 and then claim 13 as they're both inserted at
`ICP34.5 locus and then the fifth element is that the genes are inserted in
`back-to-back orientation under separate regulatory control. Those last two
`elements are found in claim 13.
`Now, throughout the day and as you saw in the papers, there's
`effectively no dispute that these elements all exist in the cited art. The cases
`essentially come down to a question whether there's motivation to combine
`the elements, the motivation to combine the known techniques that relate to
`the claim 13 insertion method with what's cited in the other references.
`JUDGE FLAX: Counsel, a question for you. You said that all of
`these limitations are indisputably in the prior art that's asserted. Which
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`reference has the back-to-back orientation?
`MR. BLISS: So all of the elements are sort of indisputably in the
`prior art The last elements, so for claim 13 we're relying on common
`knowledge for the teaching of that insertion strategy, both the locus and
`strategy, and what's undisputed is that ICP34.5 was a known insertion site
`that had been used for HSV before and that back-to-back orientation was a
`well-known technique at the time that had also been used for insertion into
`oncolytic viruses including oncolytic HSV. But we're not relying on a
`particular reference as teaching that, we're relying on common knowledge in
`the art.
`JUDGE FLAX: Other than your expert’s conclusion that it was
`known in the art, what evidence do we have that it was known in the art?
`MR. BLISS: So the evidence that exists at this point in the case is
`there are references that have been cited throughout the case. There's
`Exhibit 1084, which shows a back-to-back insertion of two genes into the
`ICP34.5 locus in an oncolytic HSV. There's also three references that were
`cited during the course of the deposition of Dr. Bell, which is Petitioner's
`expert and those are Exhibits --
`JUDGE FLAX: Before you move on past 1084. That's a big one for
`you all; right? Why did they do that? I recognize that they did it, but what
`was the purpose of using that orientation?
`MR. BLISS: Of using that particular orientation?
`JUDGE FLAX: Right. I mean, it's clear that that they did the back-
`to-back orientation, but they don't really explain why they did it or what
`purpose it served, other than that it was possible.
`MR. BLISS: So with regard to the insertion strategies, there's a
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`number of suitable strategies that exist, and it's sort of just selecting one that
`works for you or that you choose to use at that time. So back-to-back
`insertion allows you to get two genes into a single locus. Dr. Bell discussed
`during his deposition the fact that using back-to-back orientation because the
`genes are being transcribed outwardly, there's no interference between the
`genes, there's no read through, but it's just one of these suitable insertion
`strategies that have been known.
`Dr. Bell also testified at deposition that it was in use from the 80s. So
`this is an old technique back-to-back insertion. So why did they use it in
`that particular case? Because they wanted to insert two genes. ICP34.5 was
`a locus that was known to be advantageous to knock out in herpes viruses
`and so it was a good locus to use and the insertion strategy was just the one
`they chose.
`JUDGE FLAX: So lack of interference as a reason? Am I hearing
`you correctly?
`MR. BLISS: Yes. During Dr. Bell's deposition, he testified that
`because they're transcribed in opposite directions, there’s no read through so
`you don't get sort of reading into the next frame.
`JUDGE FLAX: Right. So they need to be separated. So other than
`his saying that, is there any evidence in the case that that is an advantage to
`the technique of back-to-back orienting?
`MR. BLISS: I don't know that there's any other evidence of real
`advantages of the technique. I don't know that there's any evidence that the
`back-to-back insertion technique is an improvement over some other
`technique. It's just one of the suitable techniques that existed.
`JUDGE FLAX: Well, let's just say a reason to use. I don't want to
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`make you think that we're requiring an advantage, but an objective, let's call
`it right, of the non-interference objective. Is there any evidence that that is
`so other than his saying it?
`MR. BLISS: I don't believe there's any evidence in this hearing other
`than his statement and sort of common knowledge in the art that was one of
`the techniques and that one of the advantages.
`JUDGE PAULRAJ: So Mr. Bliss, just to follow up on what Judge
`Flax asked, what were the other two techniques or what were the other
`techniques that were known for insertion of two heterologous genes into a
`single virus?
`MR. BLISS: Well, there's some papers that were referenced where
`genes were inserted into different sites so you could insert into two different
`locations.
`JUDGE PAULRAJ: No, I'm just talking about inserting into the same
`locus in a single virus.
`MR. BLISS: There's only a handful of options really because there's
`two genes, you can insert them back-to-back, which means they can
`transcribe outwardly. You can insert them front-to-front we’ll call it so they
`transcribe this way which would be a little strange. Or you could insert them
`so that they run in the same direction, sort of like a freight train.
`JUDGE PAULRAJ: Were they all equivalent or considered just you
`could do any one of those?
`MR. BLISS: Yes, essentially yes.
`JUDGE PAULRAJ: And there's a reference I think I may be
`mispronouncing it [bicistronic], is that a technique?
`MR. BLISS: So bicistronic means that the promoter will go both
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`directions. So it sort of rather than having two separate regulatory elements,
`it's a single regulatory element that will go both ways.
`JUDGE PAULRAJ: So our claims do require a single regulatory
`element?
`MR. BLISS: They do. So that would be a fourth option would be
`using a single regulatory element that goes both ways because the claims
`require a separate regulator.
`JUDGE PAULRAJ: All right. So let me let me keep track of that. So
`we have back-to-back insertion. We have, for lack of a better term, front-to-
`front insertion. We have front-to-back insertion, and we have bicistronic
`insertion and you're not saying that back-to-back insertion is advantageous
`in any way over those other three that we just talked about?
`MR. BLISS: There may be some advantages to it, but that's not really
`evidence in the case.
`JUDGE PAULRAJ: Okay. We as a party should be prepared to
`discuss the recent Intel Corporation v. PACT XPP Schweiz AG case and the
`reason we did that, we thought there was a lot to apply in this case, as I think
`both sides may agree to some extent. To the extent is it your position that
`back-to-back was a known technique as that case discussed? You know, is
`this a known technique rationale that you're relying upon?
`MR. BLISS: We are, and so it was a known technique. In fact, both
`experts in this case have agreed that back-to-back insertion was a known
`technique. Dr. Chiocca, Patent Owner’s expert specifically said he's not
`disputing that it’s a known technique.
`JUDGE PAULRAJ: All right. So my issue though, or at least my
`question related to that particular rationale though is, don't you still have to
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`have a known problem to address before you get to the known technique and
`what’s the problem you're addressing by insertion back-to-back?
`MR. BLISS: In this case, the known problem was simply inserting
`genes into a virus. So inserting two genes we’ll say into a virus. So the
`known problem was we want to get two genes into the virus and this is one
`of the suitable techniques that existed for doing it.
`JUDGE PAULRAJ: But what's a problem? I'm not sure I get what --
`it seems like a problem, at least if you're reading the Intel case, there was
`some hurdle that a skilled artisan would have to surpass. This is just one of
`many options that you could do. It wasn't necessarily a problem, at least
`that's the way I see it. But explain why it's a problem like inserting two
`genes. What challenges would there have been?
`MR. BLISS: Well, I think frankly, I think there's very little challenge
`in inserting in two genes. You can do it a number of ways, all were known
`techniques, all were suitable techniques and I think that is really what the
`Intel case is about. It doesn't really focus when they are referring to KSR. It
`doesn't really focus on there being a problem. It says that if a technique has
`been used to improve one device and a person of ordinary skill the art would
`recognize that it would improve similar devices in the same way, using the
`technique is obvious unless its application is beyond his or her skill. So, and
`then it specifies that the word improve doesn't really mean improve as much
`as much as it means it's just a suitable option. It doesn't have to be an
`improvement.
`JUDGE PAULRAJ: I don't know if you can ignore the non-problem
`part of that analysis, though. It clearly says, you know, and I'm reading from
`the Intel case that if there’s a known technique to address a known problem,
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`then you can apply that known technique rationale and the Court in that case
`expressly identified a problem that needed to be solved by those techniques.
`So what, if we were to adopt or accept your argument that this is a known
`technique and you can use the known technique rationale as a prerequisite to
`that if we needed to find a known problem, what's that problem? Again, if
`you could just say it in one sentence.
`MR. BLISS: So, yes. In this case that problem would be inserting
`two genes into the genome of a virus and there is discussion in Dr. Bell's
`declaration about the difficulties that you can face when you're trying to
`insert genes into a virus or two genes into a virus and what Dr. Bell talks
`about is that you can avoid the difficulties and the trial and error process that
`you would otherwise have to go through by following what was shown to
`work before. So I think the problem is how do you get two genes into the
`virus without disrupting its function and this is the solution that had already
`been shown, which is you can insert two genes in back-to-back orientation
`into the ICP34.5 locus and the virus can still function.
`JUDGE PAULRAJ: Okay. I didn't want to interrupt your flow, but I
`appreciate you answering those questions.
`MR. BLISS: Yes. Well, that was actually the first part I was going to
`talk about. So now we've gotten through the Intel issue.
`JUDGE FLAX: You want to talk about the Xerox, Inc. v. Bitemark,
`Inc., issue, too?
`MR. BLISS: Sure.
`JUDGE FLAX: Because they're related; right? How do you balance
`the two where potentially your expert is correct, that this was a well known
`way of adding genes to a virus or a vector, and then you have Xerox which
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`says that if you were supplying a limitation of a claim with a conclusory
`statement by an expert that's unsupported by any other evidence, that may
`not be sufficient. So how do you balance that?
`MR. BLISS: So I think this case is different from Xerox, primarily
`because in the Xerox case what happened was there was an expert on one
`side that said something and the other side disputed that it was known. They
`disputed that that was true. In this case, the difference is primarily, No. 1,
`there is no dispute. It's accepted by both sides. This is slide 43 of
`Petitioner's demonstratives, which is Dr. Chiocca’s discussion of the
`ICP34.5 locus at deposition, and he agreed that it was a published insertion
`locus and when asked if a person of ordinary skill in 2016 was seeking to
`insert genes into that locus where they have a reasonable expectation of
`success, he said it was done, to use that as an example. So there's really no
`dispute that the locus and the same is true of the back-to-back insertion.
`When asked if back-to-back insertion was a well-known technique, he said,
`I'm not disputing that. So, I’m sorry, that’s slide No. 49.
`JUDGE PAULRAJ: Thank you, counsel.
`JUDGE FLAX: Forty-nine is the back-to-back?
`MR. BLISS: Yes. So the real distinction here is there's simply no
`dispute that this was a known technique, that these were known things. So
`you know, there's no challenge to what Dr. Bell’s saying. On top of that,
`there is evidence in Dr. Bell's declaration that does have back-to-back
`insertion in it. Exhibit 1084 is cited in there and that shows back-to-back
`insertion of two genes into ICP34.5. So there is evidence in the Bell
`declaration that he can rely on.
`But I think beyond that, even if you were to apply the Xerox case and
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`say Dr. Bell's declaration itself should be given little weight, it would have
`no impact on the outcome of this because in that case, that one statement by
`the one expert in a declaration was the only evidence of something and in
`this case, at this point, with the record we have today, there is a lot more
`evidence. There's the statement of Dr. Bell. Then there's Exhibit 1084, and
`then there were multiple exhibits cited during his declaration, during his
`deposition, sorry, that show back-to-back insertion. Those were Exhibits
`1101, 1102, 1103 and he testified about those, and then there's the
`statements by Patent Owner’s expert that he is in agreement. So in this case,
`you could effectively discount Dr. Bell's declaration. It doesn't change the
`outcome because we could rely at this point on the testimony of Patent
`Owner’s expert.
`JUDGE PAULRAJ: So I mean, I guess it begs the question, like, if it
`was so well known, why didn’t Dr. Bell cite more references in support of
`back-to-back insertion. I mean, I don't want to second guess what Dr. Bell
`said, but you can answer that question as you see fit right.
`MR. BLISS: Right. So Dr. Bell, he relied on common knowledge
`and didn't cite a lot of documents that show that. We could have put forth a
`separate ground where we used an additional reference. Part of the practical
`issue that happened in this case is we add a word limit of whatever we had to
`challenge 25 claims. We challenged 25 claims under that word limit on six
`different grounds and then all but one of those claims was abandoned which
`got rid of most of the grounds. If we were only challenging claim 13 from
`the beginning, would we have laid that ground out differently, we likely
`would have. But we are with the petition that we have, that's the one we're
`going forward with because that's the one that's in the case and in that
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`petition where we're relying on common knowledge, as supported by all of
`the evidence that now has been made of record in the case.
`JUDGE PAULRAJ: So we know Dr. Bell backtracked from some of
`the statements that he made in his declaration, that it was the simplest and
`most common. He did say, and I may have overstated that. You know, I
`think that's clear in the deposition. I think my next question is, you know, if
`his initial premise was based on it’s the simplest and most common, that's
`why it would have been obvious. Now he's backing off on that, at least the
`way I see it. Does that raise any, first of all, credibility issues that we should
`be concerned about and second, at this point how simple and how common
`does it need to be before it's obvious and you know, can you answer that
`question?
`MR. BLISS: Yes. I'll start with the first part of it. So if you look at
`how much Dr. Bell backed off of his statements, it's really not very much.
`This is Petitioner's slide 45. When asked about this during his deposition, he
`indicated that back-to-back insertion was a simple way very commonly used
`since the late 80s and it's very common, very straightforward, and then said
`given that it had been effective in a herpes virus construct earlier, this would
`seem to be the simplest way to go about it.
`So he did back off slightly, but really was still saying it's extremely
`common. It was very straightforward. It was known to be successful by that
`point in herpes viruses. So I don't know that he backed off a whole lot and
`because of that, I don't think there's a whole lot of impact to his credibility. I
`think he pretty much stuck with his statement that this is a very common
`technique. He was very straightforward. That was the first part.
`JUDGE PAULRAJ: Okay. Thank you.
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`MR. BLISS: Now I need to remember the second part of your
`question.
`JUDGE PAULRAJ: I wish I remembered it too, but so you can
`proceed. If I have a follow up on that I can (indiscernible).
`MR. BLISS: Okay. Oh, I do remember the second part. It was how
`common or how straightforward --
`JUDGE PAULRAJ: Yes.
`MR. BLISS: -- does it have to be --
`JUDGE PAULRAJ: Right.
`MR. BLISS: -- in order to be obvious?
`JUDGE PAULRAJ: Yes, and I guess a related question you can
`answer as part of the same answer is when we talk about a known technique,
`and you use the word well-known, right, you know, how well known does it
`need to be? You know, if it was just one reference that we have on the
`record 1084 and I know you cited some others, whether or not we're going to
`consider that’s a separate issue, but at least 1084 was cited in the petition so
`it's probably fair game to consider that. But if we have that one reference,
`can we draw an inference from that one reference in addition to what Dr.
`Bell said, that this was well known as opposed to just one technique that
`may have been out there?
`MR. BLISS: Well, first and foremost, I think there's the Patent
`Owner’s expert also agreed well known is the language they used. Back-to-
`back insertion was a well-known technique. He said, I'm not disputing that.
`So the experts are agreeing that it was a well-known, commonly used
`technique.
`With regard to the question of how well known it has to be, I don't
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`know that that's really addressed directly in the Intel case, but I think the
`Intel case sort of leads to the conclusion that if the experts are in agreement
`that this was a known technique or even further a well known technique at
`the time, that there would be motivation to apply it, and then in the same
`vein as we're talking about how common it has to be, I think as we're talking
`about back-to-back insertion, as we talked about at the beginning, there's not
`a lot of options. It's not one of a million options. It's, you know, one of a
`couple of options of how you would insert into the same locus.
`So you know, from that standpoint, I think that adds to how common
`the technique is or how well known it would be, you know, someone's only
`picking a few options there and this is one of the options that they could
`pick. It’s a suitable option. There's no evidence that it would be outside the
`ability of a person of ordinary skill in the art. It's applying the known
`technique under using its established functions, which this is all language
`out of the Intel case that where they said in this situation there is motivation
`to combine and I think that's the situation we're in here. Okay.
`So that sort of covers claim 13 aspects. I do want to step back and
`talk a bit about claims 1 and 11 and their anticipation by the Silvestre
`reference. So in the petition --
`JUDGE PAULRAJ: So maybe my first question on that. So it seems
`like Petitioner agrees that before we get to claim 13, Petitioner still has a
`burden to show anticipation of claims 1 and 11 or are you disputing that
`premise?
`MR. BLISS: With regard to ground 4, we agree with that. Ground 4
`
`--
`
`JUDGE PAULRAJ: Yes. But we only have ground 4, I agree with, I
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`mean obviously claims 1 and 11 are no longer in the patent but before we get
`to claim 13 we need to meet the limitations of claim 1 and 11.
`MR. BLISS: Sure.
`JUDGE PAULRAJ: Right, and in order to meet the limitations of
`claim 1 and 11 you agree that you still have to show that, at least as to the
`Silvestre ground, that you have to show Silvestre anticipates claims 1 and 11
`before we get to the obviousness of claim 13.
`MR. BLISS: Agreed. We're not trying to switch grounds and say that
`this is obvious over Silvestre if those claims are anticipated by Silvestre and
`we have to show that and we have shown that, that claims 1 and 11 are
`anticipated by Silvestre. We've also shown that they're obvious over the
`combination of Du, Choi and Zitvogel so for ground 6 we’re relying strictly
`on obviousness.
`So with regard to claims 1 and 11 and Silvestre, this is Petitioner’s
`slide 6, and this is the first part of the chart from the petition where we
`pointed out where each and every element of claims 1 and 11 are found in
`Silvestre, and we put forth strong evidence of where each and every element
`are found in both the petition and the expert declaration and at this point,
`there doesn't seem to be dispute. There's no argument that Silvestre is
`lacking in elements.
`In fact, again, Dr. Chiocca, this is slide 9 of Petitioner's
`demonstratives, Dr. Chiocca agreed that Silvestre has all the ingredients, as
`he called them and then he went on to say it doesn't have them arranged in
`the same order. So it's really not a question of lacking element here. The
`question is whether they're sufficiently arranged for Silvestre to anticipate,
`and in order to support his argument that they are not sufficiently arranged,
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`Dr. Chiocca put together this table where he concluded that there are over
`5,000 options and this is Petitioner’s slide 10.
`And to put this table together, Dr. Chiocca first broke out the three
`major pieces, components of claims 1 and 11, which are an oncolytic virus,
`you know, using the language of Sylvestre, an immune checkpoint
`modulator and a therapeutic gene and keeping in mind that for claim 1 it's
`really only the second and third category because claim 1 doesn't specify a
`virus. Claim 11 specifies virus and then there’s three components there and
`for each of these components he listed every possible element for that that he
`found in Silvestre and he treated them all the same. He said there's 11
`possibilities for the first part, there’s 14 possibilities for the second
`component, and there's 33 for the third component and he multiplied those
`together and said there's 5,000 possibilities, and he got there by treating
`them all the same. But Silvestre doesn't treat them all the same because it
`points out which ones are preferred. It has three --
`JUDGE PAULRAJ: Yes. To that point, you know, so Patent Owner
`points out, and I think it's in one of your next slides, as to where Silvestre
`talks about preferred HSV1 and HSV2. I think Patent Owner points out that
`you know when it talks about preferred HSV1 and HSV2, that's only when
`you would choose a herpes virus, you know, it's not preferred among all 11
`viruses. It's just -- if you happen to choose a herpes virus, those are the
`strains that would be particularly preferred. Can you address that point?
`MR. BLISS: So while that is a fair reading of that, the same is true of
`vaccinia so Silvestre does not say that pox viruses are preferred. What it
`says is of the pox viruses you would use vaccinia. So the only virus is that it
`calls out as preferred are vaccinia HSV1 and HSV2, and Patent Owner
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