UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICAL LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioner,
`
`v.
`
`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.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICAL LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioner,
`
`v.
`
`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.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`APPEARANCES:
`
`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.
`
`
`
`2
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`P R O C E E D I N G S
`
`- - - - -
`
`
` 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.
`
`Okay, with that let's move on to appearances starting with Petitioner.
`Please stand; introduce yourself; and who you have with you today.
`
`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.
`
`JUDGE SNEDDEN: Can you pronounce your name one more time?
`
`MR. VARUGHESE: Dennies Varughese.
`
`JUDGE SNEDDEN: Thank you, Mr. Varughese.
`
`MR. VARUGHESE: Thank 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
`26
`
`
`
`3
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`MR. TRAINOR: Good morning, Your Honors. James Trainor of the
`
`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.
`
`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?
`
`MR. VARUGHESE: Yes, Your Honor, I'd like to reserve 20 minutes
`for rebuttal.
`
`JUDGE SNEDDEN: You may begin when you're ready.
`
`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.
`
`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.
`
`MR. VARUGHESE: If it pleases the Board, so that we have a clear
`
`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
`
`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
`26
`
`
`
`4
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`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.
`
`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
`
`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
`26
`
`
`
`5
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`important to note here, Almirall has not come forth with any objective
`evidence of non-obviousness.
`
`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.
`
`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.
`
`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
`26
`
`
`
`6
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`JUDGE OBERMANN: They didn't include a section, I agree with
`
`you; but they do allude and directly cite this declaration.
`
`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 --
`
`JUDGE OBERMANN: I would submit they don't have to; it's your
`burden, Counsel.
`
`MR. VARUGHESE: I respect that. I understand. It's a point that I'm
`raising.
`
`JUDGE OBERMANN: Okay.
`
`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.
`
`JUDGE OBERMANN: Is your position that they haven't fairly raised
`unexpected results?
`
`MR. VARUGHESE: I believe they have not fairly responded to our
`refutation of the unexpected results from prosecution.
`
`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
`
`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
`26
`
`
`
`7
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`petition, pages 54 to 62; and specifically referencing her opinions at Exhibit
`1002, paragraphs 99 to 106.
`
`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
`
`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
`26
`
`
`
`8
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`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.
`
`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
`
`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
`26
`
`
`
`9
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`between dapsone and the related and analogous compounds. There are
`ample disclosures in Garrett that expressly show a POSA what dapsone
`means.
`
`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.
`
`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.
`
`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
`26
`
`
`
`10
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`Slide 12. If there's any doubt -- and, I think, there is not after what I
`
`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.
`
`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.
`
`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.
`
`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
`
`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
`26
`
`
`
`11
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`unless the patentee comes forward with evidence of teaching away
`unexpected results or some other objective indicia of non-obviousness.
`
`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?
`
`MR. VARUGHESE: The doxydiclycol?
`
`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.
`
`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.
`
`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
`
`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
`26
`
`
`
`12
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`they selected works better than one that was in your list. I'm having some
`difficulty.
`
`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.
`
`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.
`
`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
`
`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
`26
`
`
`
`13
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`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.
`
`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.
`
`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.
`
`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.
`
`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
`
`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
`26
`
`
`
`14
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`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.
`
`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.
`
`Now, to answer Your Honor's question about the 4 percent -- if we
`could go to --
`
`JUDGE OBERMANN: It's the 2 to 6 percent of the thickener.
`
`MR. VARUGHESE: So, 2 to 6 percent or 4 percent -- I think Your
`Honor would agree --
`
`JUDGE OBERMANN: Right; 4 percent.
`
`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?
`
`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.
`
`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
`26
`
`
`
`15
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`JUDGE OBERMANN: But how do you know that you're going to
`
`use the same amount of Carbopol that you would of ASA?
`
`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.
`
`JUDGE PAULRAJ: Counsel, just to clarify for the record. I think
`you're referring to Dupont vs. Synvina?
`
`MR. VARUGHESE: Yes, Your Honor.
`
`JUDGE PAULRAJ: And that's a 2018 case?
`
`MR. VARUGHESE: 2018; correct; yes.
`
`JUDGE PAULRAJ: Yes; okay.
`
`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.
`
`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
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`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 --
`
`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?
`
`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.
`
`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 --
`
`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?
`
`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
`26
`
`
`
`17
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`MR. VARUGHESE: Your Honor, we'll double check. I think Dr.
`
`Michniak-Kohn does get us there.
`
`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.
`
`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.
`
`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?
`
`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
`
`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
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`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
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
