`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICAL LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioner,
`
`v.
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`ALLERGAN, INC.,
`Patent Owner.
`____________
`
`Appeal IPR2018-00608
`Patent 9,161,926 B2
`____________
`
`Record of Oral Hearing
`Held June 5, 2019
`____________
`
`Before GRACE KARAFFA OBERMANN, SHERIDAN K. SNEDDEN,
`and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
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`IPR2018-00608
`Patent 9,161,926 B2
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
`
`DENNIES VARUGHESE, ESQUIRE
`ADAM LAROCK, ESQUIRE
`Sterne Kessler Goldstein & Fox
`1100 New York Avenue, N.W.
`Washington, D.C. 20005
`
`ON BEHALF OF THE PATENT OWNER:
`
`JAMES TRAINOR, ESQUIRE
`ELIZABETH HAGAN, ESQUIRE
`Fenwick & West
`902 Broadway, Suite 14
`New York, NY 10010-6035
`
`The above-entitled matter came on for hearing on Monday, June 5,
`2019, commencing at 9:59 a.m., at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia.
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`IPR2018-00608
`Patent 9,161,926 B2
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`P R O C E E D I N G S
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`- - - - -
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`
` JUDGE SNEDDEN: Please be seated. Good morning. This is the
`final hearing in IPR 2018-00608. I'm Judge Snedden. I have with me Judge
`Paulraj and Judge Obermann with me on the panel today. I'll begin by
`stating that we have received Petition Owner's objections to Patent Owner's
`demonstratives, and we understand that Patent Owner untimely served their
`demonstratives on May 27th, Memorial Day, and not May 24th, the Friday
`before Memorial Day; and we have considered that issue and determined
`that under the circumstances it would be not in the interest of justice to not
`allow Patent Owner access to its slides today. Although Petitioner objects,
`they raise no persuasive reasons that outweigh the interest of justice in
`providing Patent Owner the ability to refer to their demonstratives today.
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`Okay, with that let's move on to appearances starting with Petitioner.
`Please stand; introduce yourself; and who you have with you today.
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`MR. VARUGHESE: Good morning, Your Honors. If it pleases the
`Board, my name is Dennies Varughese from the law firm of Sterne Kessler
`Goldstein & Fox. Joining me today is my colleague, Adam LaRock, also
`from the Sterne Kessler law firm on behalf of Petitioner, Amneal.
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`JUDGE SNEDDEN: Can you pronounce your name one more time?
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`MR. VARUGHESE: Dennies Varughese.
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`JUDGE SNEDDEN: Thank you, Mr. Varughese.
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`MR. VARUGHESE: Thank you.
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`IPR2018-00608
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`MR. TRAINOR: Good morning, Your Honors. James Trainor of the
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`law firm of Fenwick & West here on behalf of the Patent Owner, Almirall.
`With me today is my colleague Elizabeth Hagan also from Fenwick & West.
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`JUDGE SNEDDEN: Per our order granting this oral hearing, each
`party will have 60 minutes of total time to present its arguments. Petitioner
`will open the hearing by presenting its case regarding the challenged claims
`for which we institute a trial; and Patent Owner will then respond to
`Petitioner's argument. Each side may reserve time for rebuttal. Patent
`Owner is limited to five minutes of rebuttal time.
`Okay, Mr. Varughese, you may begin when you're ready. Are you reserving
`any time for rebuttal?
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`MR. VARUGHESE: Yes, Your Honor, I'd like to reserve 20 minutes
`for rebuttal.
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`JUDGE SNEDDEN: You may begin when you're ready.
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`MR. VARUGHESE: Good morning, Your Honors. Once again, if it
`pleases the Board, my name is Dennies Varughese from Sterne Kessler
`Goldstein & Fox here on behalf of Petitioners, Amneal Pharmaceuticals
`LLC and Amneal Pharmaceuticals of New York, LLC.
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`Your Honors, we brought with us printed copies of the
`demonstratives. If it pleases the Board, we're happy to hand them out to
`you.
`JUDGE SNEDDEN: I'll take one; thank you.
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`MR. VARUGHESE: If it pleases the Board, so that we have a clear
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`record, I'm going to call out each slide number before we flip to it, unless the
`Board has some type of rejection to that -- slide 2. Your Honors, the parties
`have submitted an extensive record comprising briefing, and exhibits, and
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`IPR2018-00608
`Patent 9,161,926 B2
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`declaration of experts that we believe demonstrate, overwhelmingly, the
`obviousness of the challenged claims -- claims 1 to 6 in the '926 Patent.
`
`It's certainly not my intention to rehash every single one of those
`points, but, rather, what I intended to do today is to provide the Board with
`an overview of the key points that demonstrate obviousness.
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`In terms of an overview of my presentation, we're going to start with a
`quick overview of the claims themselves; and then we're going to begin by
`talking about Almirall's claim construction argument. As I'm going to
`discuss in just a few minutes, we think this argument is really a red herring,
`there's no dispute. Amneal does not dispute what dapsone means; and we'll
`talk about that. And then we're going to dive right into the two separate and
`independent grounds that Amneal put forward to demonstrate that claims 1
`to 6 are obvious.
`
`Ground one is that the claims are obvious over the Garrett reference in
`view of Nadu-Fourcade; and ground two is that those same claims are
`obvious over, again, the Garrett reference in view of Bonacucina. After an
`overview of the grounds themselves and the strong prima facie case that
`Amneal's put forward, I'd like to spend some time addressing what we
`believe to be a number of ineffective, unpersuasive, and legally and factually
`flawed arguments that Almirall has advanced in trying to save it's claims
`from obviousness.
`
`And a quick point, I think, it's noteworthy right now -- as this Board
`and counsel for parties is well aware, there's an oft-quoted passage from
`federal circuit jurisprudence that says that oftentimes objective indicia or
`evidence of secondary considerations, so-called real-world evidence is often
`the most cogent or probative evidence of non-obviousness. I think it's
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`IPR2018-00608
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`important to note here, Almirall has not come forth with any objective
`evidence of non-obviousness.
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`JUDGE OBERMANN: They directed us to Exhibit 1017, which is
`the Warner declaration; and that declaration itself contains evidence of
`unexpected results that seems to cast doubt on your evidence of
`interchangeability. And I'm particularly interested in what Petitioner has
`come forward with that would justify reopening an issue that was already
`decided by the Examiner on that point.
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`MR. VARUGHESE: Yes, Your Honor, and I will touch upon that,
`but since you asked the question, I think I'd like to highlight just a few points
`here. In our petition, we addressed the inventor Warner's declaration and the
`evidence of unexpected results; and we believe we effectively refuted what
`we believe to be our evidence that really was of Carbopol not being
`compatible, not necessarily any unexpected results of the claimed
`acrylamide copolymer being compatible. So, we put that in our petition.
`
`JUDGE OBERMANN: Can you direct me to any evidence that's
`objective? For example, your expert, did he, in particular, address the issues
`that were raised before the Examiner in that regard?
`
`MR. VARUGHESE: Yes, Your Honor. Our expert Dr. Bozena
`Michniak-Kohn -- and if I can just ask my colleague to refer me to the exact
`paragraph so that I don't waste the Board's time, we'll point to the paragraphs
`in where she addresses that and also our papers where we cite to the
`declarations from both of her opening declaration and her reply declaration.
`
`And so, in our petition, we believe that we rebutted the evidence of
`unexpected results. In Patent Owner's response --in their brief -- they did
`not include a section on unexpected results or any other objective indicia.
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`JUDGE OBERMANN: They didn't include a section, I agree with
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`you; but they do allude and directly cite this declaration.
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`MR. VARUGHESE: I understand, Your Honor. I guess beyond that
`declaration, from prosecution, they haven't put forward any new arguments
`in this proceeding, and then --
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`JUDGE OBERMANN: I would submit they don't have to; it's your
`burden, Counsel.
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`MR. VARUGHESE: I respect that. I understand. It's a point that I'm
`raising.
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`JUDGE OBERMANN: Okay.
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`MR. VARUGHESE: And I've been on both sides of this. Oftentimes,
`Patent Owners will, you know, have a prominent section about objective
`indicia and unexpected results. But, I certainly accept that, Your Honor. It
`is our burden throughout.
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`JUDGE OBERMANN: Is your position that they haven't fairly raised
`unexpected results?
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`MR. VARUGHESE: I believe they have not fairly responded to our
`refutation of the unexpected results from prosecution.
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`JUDGE OBERMANN: Okay; that's fair. Thank you.
`
`MR. VARUGHESE: You're welcome, Your Honor; thank you. And
`so, as I mentioned, in our reply brief, again, we highlighted that omission in
`their Patent Owner response; and in their sur-reply, they don't say anything
`to respond to that. I just wanted to close the loop on that.
`
`We can go to slide 4. Your Honors, these are the two independent
`claims of the 6 claims. So, if I could just go back to answer Judge
`Obermann's question. We cited to Dr. Michniak-Kohn's testimony at the
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`IPR2018-00608
`Patent 9,161,926 B2
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`petition, pages 54 to 62; and specifically referencing her opinions at Exhibit
`1002, paragraphs 99 to 106.
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`JUDGE PAULRAJ: 99 to 106; thank you so much.
`
`MR. VARUGHESE: You're welcome, Your Honor. These are the
`two independent claims -- claims 1 and claim 5. I don't think Mr. Trainor
`will disagree that the parties have not disputed the independent claims versus
`the dependent claims. We've treated this proceeding as if all six claims rise
`and fall together. I think claim 5 is representative; it's a little bit narrower
`than claim 1. Claim 5 recites a topical pharmaceutical composition
`comprising dapsone as the active ingredient, about 30 percent weight-by-
`weight of diethylene glycol monethyl ether, also referred to here as DGME
`or also referred to as doxydiclycol; and then 4 percent weight-by-weight of
`the polymeric viscosity builder. For simplicity, Your Honors may hear me
`refer to that as PVB or the thickener, or the thickening agent, or gelling
`agent; these are all the same synonyms for the same concept.
`
`So, the claims recite -- and this is the only time I'll use the full name
`acrylamide sodium acryloyldimethyl taurate copolymer. The parties, for
`simplicity, have referred to that as A/SA or ASA, or the acrylamide
`copolymer. The claims also recite water as an additional solvent; and
`finally, the claims conclude with a negative limitation that is wherein the
`composition does not comprise adaptably.
`
`Slide 7. So, Your Honors, to begin I want to address this claim
`construction argument. Patent Owner Almirall states that dapsone, as used
`in the '926 Patent, should be construed to mean the chemical name 4,4
`prime-diaminodiphenyl sulfone with that corresponding structure. We don't
`disagree. We believe that is how a POSA would understand the term
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`IPR2018-00608
`Patent 9,161,926 B2
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`dapsone. We believe that's how POSA would understand it from the patent,
`and we believe that's how POSA would understand dapsone for the decades
`leading up to the patent in which dapsone was available. And that's why we
`didn't think it was worthy of construction because there is no dispute.
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`Slide 10. But Almirall's reasons for wanting this construed and
`making an issue where none exist, I think, become apparent when we
`compare Almirall's construction to the disclosure in the Garrett reference
`that forms the basis for both of the obviousness grounds. Garrett says as
`used herein, dapsone refers to the chemical compound, dapsone, having the
`chemical formula -- and recites the value pack formula; and then it recites
`the same 4,4 prime-diaminodiphenyl sulfone chemical name that's used in
`the patent. And then I won't butcher these names, but Garrett goes on to
`give some synonyms of that same chemical structure. And that's not in
`dispute between the parties that these other terms that follow the 4.4 prime
`chemical name are synonyms for that same compound.
`
`But here is where the rubber meets the road -- Garrett concludes by
`also discussing dapsone analogs and dapsone-related compounds. We can
`go to slide 7. What Almirall does is they seize on that -- I apologize, slide 8
`-- Almirall seizes on that disclosure of dapsone-related compounds and
`dapsone analogs to state -- and this is from their Patent Owner response --
`dapsone of Garrett refers to a family of thousands of distinct chemical
`compounds. Because they want to give off this impression that a POSA
`reading Garrett somehow wouldn't know what dapsone means. I would
`expressly submit to this Board, that a POSA reading Garrett would know
`exactly what dapsone means. And while, at most, Almirall has shown that
`Garrett's authors could have been a little bit more artful in delineating
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`IPR2018-00608
`Patent 9,161,926 B2
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`between dapsone and the related and analogous compounds. There are
`ample disclosures in Garrett that expressly show a POSA what dapsone
`means.
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`We can turn to slide 11. The top box here is an excerpt from Garrett.
`Garrett begins by stating dapsone analogs and related compounds; and then
`goes on to say that some of these compounds were also tested against
`dapsone, citing various references in the art that access the effectiveness or
`potency of dapsone against these related dapsone analogs or related
`compounds. A POSA would clearly understand reading that sentence that
`you have dapsone on the one hand, defined according to its chemical name;
`and these other related compounds that have the same activity. And that's
`not the only time that Garrett makes that distinction. Garrett repeats that
`same phrase a few lines down there; and at the very bottom it, specifically,
`states these analogs and related compounds have activity similar to dapsone.
`Reading that, a POSA would know that you have dapsone on the one hand,
`and you have related compounds on the other; and Garrett talks about all of
`them because they all have similar activity.
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`Now, the bottom box there is from the Patent Owner response where
`they cite to the patent; and there's a quotation there from the '926 Patent
`where the '926 Patent says dapsone and its derivatives are also effective for
`treatment of bacterial infections. Accordingly, this is clear that when you
`have literature discussing dapsone, it's common to also discuss its
`derivatives or related compounds because they all have the same activity.
`Just because Garrett is inclusive of these other related compounds, that
`doesn't automatically render a POSA, a highly-trained pharmaceutic
`scientist, incapable of discerning what the teachings in Garrett are.
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`Slide 12. If there's any doubt -- and, I think, there is not after what I
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`just covered -- Garrett also, specifically, references the Aczone, 5 percent
`gel that was commercially available prior to November of 2012. Garrett
`says Aczone gel, 5 percent, a topical formulation of dapsone; and a POSA
`would know that the active ingredient in Aczone was the same 4.4 prime
`chemical name that was recited in the '926 Patent to describe dapsone. So, I
`think, this argument by Almirall that a POSA reading Garrett would not
`know what dapsone is, is simply not creditable.
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`Slide 14 -- I'm sorry, slide 13. So, Your Honors, I'd like to now move
`into a few highlights of Almirall's prima facie case in terms of both of the
`grounds. So, all claims, 1 to 6 of the '926 Patent, are obvious over Garrett in
`view of Nadau-Fourcade; and obvious over Garrett in view of Bonacucina.
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`Slide 14. I want to begin by illustrating again, as we did in our
`papers, where each and every limitation of the claims is met in Garrett, save
`one. So, I understand there's quite a bit of color on this slide. I just want to
`take a minute to walk the Board through the slide and what we're trying to
`depict here.
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`The top box is claim 5 of the '926 Patent, and the colored highlights
`attempt to map where each of those claim limitations are disclosed in
`Garrett. For example, the orange highlight shows that the claims recite
`about 7.5 percent weight-by-weight of dapsone as the active ingredient.
`Garrett teaches a range of 5 percent to 10 percent dapsone. Now, as we
`demonstrated in our papers, citing among other cases, the In Re Dupont case,
`under well-settled Federal Circuit case law -- going back to In Re Geisler,
`and even as recent as Dupont, which was 2017 -- when you have a range like
`this disclosed in the prior art, a point within that range is prima facie obvious
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`IPR2018-00608
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`unless the patentee comes forward with evidence of teaching away
`unexpected results or some other objective indicia of non-obviousness.
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`JUDGE OBERMANN: This is where I'm having a problem, Counsel,
`because a lot of the cases have one range, and I can understand where one
`range in a composition could be a result effected variable, but here you have
`-- let's see, one, two, three, four, five, six ranges that you have to meet --
`you're picking and choosing among those ranges; and they've come forward
`with some evidence that there was something special about picking ASA
`when you have more of the -- what did you call it -- the one that has to be 30
`to 40 percent the doxydiclycol?
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`MR. VARUGHESE: The doxydiclycol?
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`JUDGE OBERMANN: Yeah. So, you're threading a needle here
`where you have to sort of pick and choose among the ranges that are in this
`claim; and I'd like to hear more about how you get there from the actual
`disclosures of the prior art.
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`MR. VARUGHESE: Yes, Your Honor, and I'm going to address each
`one. Now, while it might be true that the cases that we rely on only talk
`about a single range. I don’t think the cases turn, respectfully, on that fact
`that it's just one range.
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`JUDGE OBERMANN: I've been on cases where parties have tried to
`do this. Where you have a composition claim -- and maybe you have six
`ingredients in six ranges -- it's really hard when you start saying that all of
`those were result-effective and all of those would have gotten you to the
`particular ranges that are required by the claim. Maybe I could get there; but
`when you have this idea that you're going to substitute the thickener -- and
`they have evidence that it wasn't truly interchangeable because the thickener
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`they selected works better than one that was in your list. I'm having some
`difficulty.
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`MR. VARUGHESE: Sure; and let me address both of those just
`because you asked and I'll get to it again. In terms of the interchangeability,
`I think we provided plenty of evidence that shows that at the time of
`invention a POSA had every reason to think that Carbopol and ASA are
`interchangeable - sure, after the fact maybe some differences became
`apparent with the inventor declaration, but a POSA at the time of invention
`would have viewed both of those interchangeable.
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`JUDGE OBERMANN: Okay. So, that's an interesting point. So, at
`the time -- and I think even Dr. Warner would say even he expected them to
`be the same. He discovered that they weren't, and that's what he's saying his
`invention is. He discovered that when you get to about 30 percent of the
`diethylene glycol something happens and they're not interchangeable
`anymore. And I just read your brief -- the brief pages that you cited to me --
`and I don’t' read that part of your brief -- the petition at 54 to 62 -- as
`disputing that fact. It looks to me like you're trying to say that the person
`would have been led by this reference that isn't even stated in your grounds -
`- Orsini -- would have been led to the same conclusion. That's different
`from saying they're interchangeable. So, I would like you to distinguish are
`you really relying on interchangeability or are you relying on some kind of
`external reference to say that you would have threaded the needle and met
`your burden of showing that they would have been led to ASA.
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`MR. VARUGHESE: So, first of all, we're saying that they're
`interchangeable. The inquiry here is at the time of invention, a POSA
`having the knowledge that it has based on the store of human knowledge and
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`the references that we relied on, would the claims as arranged, would that
`have been obvious to a POSA to arrive at those claims; and the known
`interchangeable of Carbopol and Sepineo, the ASA-claimed polymer, we
`think, would render that obvious.
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`JUDGE OBERMANN: And you already said that could be rebutted
`by evidence of unexpected results; and I'm seeing here that they've directed
`us to a declaration that has evidence that there was an unexpected result
`when you selected ASA. And when I look at what you've just directed me to
`in your petition, I'm not seeing any persuasive argument that wasn't true --
`that there was an unexpected result.
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`MR. VARUGHESE: So, what all the inventor Warner's declaration
`showed was that -- given him the benefit of the doubt -- that Carbopol
`exhibited unacceptable grittiness. There's nothing unexpected about the fact
`that Sepineo or ASA worked to create a gel. That's not unexpected, and that
`was the point that we made in our petition and in the declarations, and they
`didn't respond to that. There's nothing unexpected that the claimed ASA co-
`polymer would achieve a stable, stiff, smooth-textured gel. Even if you
`discover that Carbopol resulted in grittiness, that's not what's claimed here.
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`JUDGE OBERMANN: Well, he claimed ASA, specifically; he didn't
`claim any thickener. He claimed one out of the universe of interchangeable
`ones and said look, this one really isn't interchangeable. This one works
`better; and that's my unexpected result.
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`MR. VARUGHESE: Right; but it's not unexpected because, as we
`showed in Nadau-Fourcade that universe is only four. It's Carbopol -- it's
`two different kinds of Carbopol, it's Sepineo and xanthan gum; and Nadau-
`Fourcade teaches a POSA that those are interchangeable. Now, the fact that
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`ASA works, Nadau-Fourcade says ASA is a great candidate for gels;
`Bonacucina calls it a prime candidate for gels. The fact that ASA works is
`not unexpected.
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`JUDGE OBERMANN: Okay. So, let's say we get there, how do you
`get to the two to six percent that's required by the claim?
`
`MR. VARUGHESE: Your Honor mentioned that there are six ranges;
`it's actually three ranges -- three limitations. There's an independent claim
`that recites a range -- claim 1 -- but claim 5 pinpoints a certain point within
`those ranges; so, we think if we demonstrated that claim 5 is obvious --
`which we do -- it also renders the broader independent claim that has the
`range of limitations obvious also. So, we're talking about three different
`features, not six. I just want to clear that up for the record.
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`Now, to answer Your Honor's question about the 4 percent -- if we
`could go to --
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`JUDGE OBERMANN: It's the 2 to 6 percent of the thickener.
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`MR. VARUGHESE: So, 2 to 6 percent or 4 percent -- I think Your
`Honor would agree --
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`JUDGE OBERMANN: Right; 4 percent.
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`MR. VARUGHESE: -- if I could show 4 percent, it would run 2 to 6
`percent obvious. I just want to find the slides so we can flip up. Can we go
`to slide 28, please?
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`So, Your Honor, here -- this is Garrett's disclosure again. The only
`difference between Garrett and claim 5 is that Garrett teaches Carbopol as
`the thickening agent; and Garrett also discloses this range of 0.2 percent to
`about 4 percent. So, the upper range of Garrett overlaps with the range that's
`recited in claim 5.
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`JUDGE OBERMANN: But how do you know that you're going to
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`use the same amount of Carbopol that you would of ASA?
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`MR. VARUGHESE: Garrett also expressly teaches that this
`limitation, a POSA would understand how to vary that to achieve a desired
`result. And this goes right to the Federal Circuit 2017 case In Re Dupont --
`and I just want to read a quote for Your Honor, if I may. We cited this case.
`It's 904 F.3d 996, at page 1008.
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`JUDGE PAULRAJ: Counsel, just to clarify for the record. I think
`you're referring to Dupont vs. Synvina?
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`MR. VARUGHESE: Yes, Your Honor.
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`JUDGE PAULRAJ: And that's a 2018 case?
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`MR. VARUGHESE: 2018; correct; yes.
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`JUDGE PAULRAJ: Yes; okay.
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`MR. VARUGHESE: The court says there, the Federal Circuit,
`"where there is a range disclosed in the prior art and the claimed invention
`falls within that range, the burden of production falls upon the patentee to
`come forward with evidence of teaching away unexpected results for
`criticality or other pertinent objective indicia indicating that the overlapping
`range would not be obvious in light of the prior art." And there're a few
`points here I want to unpack.
`
`Number one -- they've argued teaching away, with regard to the 7.5
`percent of dapsone; the 30 percent of diethylene glycol; and the 4 percent of
`the polymeric viscosity builder. But they haven't come forward -- number
`one -- with evidence, I think, of the dapsone limitation or the doxydiclycol.
`And I'm going to get to those points why there isn't no teaching away there.
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`I just want to make sure that we can focus on the polymeric viscosity builder
`-- I'm sorry, Your Honor, I didn't mean to --
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`JUDGE OBERMANN: I just wanted to know -- the case that you just
`cited, they're talking about a range of a chemical moiety that's in the prior art
`reference itself. So, if I have a reference that says let's use 10 to 20 percent
`ethanol, and my claim says let's use 1 to 3 percent ethanol. I get you. I get
`that then its result effective. But here you have a reference that says use a
`thickener in this range, but it doesn't mention the thickener that's at issue.
`Does that matter?
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`MR. VARUGHESE: No, Your Honor; because we've argued
`interchangeability. They've given a range here -- Garrett has given a range
`for Carbopol that is known interchangeable with Sepineo.
`
`JUDGE OBERMANN: Chemical ingredients can be interchangeable;
`but do you also have to show that they're absolutely interchangeable in terms
`of concentration that's going to be effective for the purpose.
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`MR. VARUGHESE: So, I think I have a little bit of difficulty with
`the word absolutely interchangeable.
`
`JUDGE OBERMANN: Well, let's just say interchangeable
`concentrations. Do you have any evidence that there would have been
`interchangeability on that particular feature of these two ingredients?
`
`MR. VARUGHESE: I think to a POSA if the teaching shows that
`they're interchangeable, then the POSA would understand that the
`concentrations also are interchangeable; and the POSA's armed with --
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`JUDGE OBERMANN: That's nice of you to say, Counsel; but do you
`have someone who's competent to opine from the perspective from an
`ordinary artisan saying that?
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`MR. VARUGHESE: Your Honor, we'll double check. I think Dr.
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`Michniak-Kohn does get us there.
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`JUDGE OBERMANN: That's a very specific point. I'm looking to
`see that they would have been interchangeable and interchangeable at the
`same concentration.
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`MR. VARUGHESE: I think her opinion is that Carbopol and Sepineo
`are interchangeable, and that opinion would support the finding that a
`disclosed range with respect to Carbopol, a POSA would understand that to
`apply to the interchangeable Sepineo with that.
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`JUDGE OBERMANN: I think that's a very important point because
`we have very different compositions here as between Garrett and what's
`claimed -- which is what's the name of the game, right?
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`MR. VARUGHESE: I disagree, respectfully, Your Honor. I don't
`think they're very different from what we have in Garrett and what we have
`in terms of what's claimed. The only difference is Carbopol versus Sepineo;
`and we've established that those are interchangeable. In fact, Almirall,
`themselves, have taken the position that -- just recently -- that Carbopol and
`Sepineo are functional equivalents for documental (inaudible) purposes.
`
`JUDGE PAULRAJ: So, Counsel, just following up on Judge
`Obermann's questions. So, once you establish interchangeability, do you
`agree that interchangeability -- at least as we've been talking about that term
`-- is Petitioner's burden; do you agree with that?
`
`MR. VARUGHESE: Yes.
`
`JUDGE PAULRAJ: So, once we establish that Carbopol and Sepineo
`are interchangeable, the range question per Dupont vs. Synvina, are you
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`arguing that burden shifts over to Patent Owner to show unexpected results
`at that point?
`
`MR. VARUGHESE: Thank you, Your Honor. Yes, that's exactly
`what we're arguing; and I'd like to just expand on that. In Patent Owner's
`response, I want to correct a misstatement of law that, I think, is critical that
`they made here that's related to your question. And this is page 45 of Patent
`Owner's response. And I'll read it into the record. They say -- in trying to
`distinguish the In Re Geisler case -- they say Geisler was an appeal from the
`Examiner's decision to reject an applicant's claims during prosecution. In
`the inter parties' review adjudicatory context the burden shifting framework
`used during prosecution does not apply." That is incorrect. The In Re
`Dupont case, the Federal Circuit says clearly, since Dynamic Drinkwear and
`Magnum Oil -- Magnum Oil is a case that Patent Owner relied on for that
`proposition -- did not alter the framework governing overlapping range
`cases. And that quote that I read five minutes ago, the Federal Circuit
`reiterated that once overlapping ranges are shown in the prior art, the burden
`of production -- not the burden of proof -- but the burden of production is
`with the Patent Owner to show teaching away or criticality. Patent Owner
`hasn't come forward with any criticality or teaching away with respect to the
`ranges.
`
`The Warner declaration was about the ingredient itself, Sepineo; and
`our argument is that there is nothing unexpected about Sepineo. It's not that
`the art show that Sepineo doesn't work and the inventor, Warner, discovered
`that Sepineo all of a sudden works. Giving them the full benefit of the
`doubt, all inventor Warner demonstrated in his declaration was that
`Carbopol was unexpectedly gritty, and that Sepineo fi