trials@ustpo.gov
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`571-272-7822
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`IPR2015-00902, Paper No. 83
`IPR2015-00903, Paper No. 75
`May 10, 2016
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`RECORD OF ORAL HEARING
`UNITED STATES PATENT AND TRADEMARK OFFICE
`- - - - - -
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`INNOPHARMA LICENSING, INC.,
`Petitioner,
`vs.
`SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`- - - - - -
`Case IPR2015-00902 (Patent No. 8,669,290 B2)
`Case IPR2015-00903 (Patent No. 8,129,431 B2)
`Technology Center 1600
`
`
`
`Oral Hearing Held: Tuesday, April 19, 2016
`
`
`Before: FRANCISCO C. PRATS, ERICA A. FRANKLIN,
`and GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`The above-entitled matter came on for hearing on Tuesday,
`April 19, 2016, at 10:02 a.m., Hearing Room D, taken at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`REPORTED BY: RAYMOND G. BRYNTESON, RMR,
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`CRR, RDR
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`571-272-7822
`
`IPR2015-00902, Paper No. 83
`IPR2015-00903, Paper No. 75
`May 10, 2016
`
`
`
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`RECORD OF ORAL HEARING
`UNITED STATES PATENT AND TRADEMARK OFFICE
`- - - - - -
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`- - - - - -
`INNOPHARMA LICENSING, INC.,
`Petitioner,
`vs.
`SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`- - - - - -
`Case IPR2015-00902 (Patent No. 8,669,290 B2)
`Case IPR2015-00903 (Patent No. 8,129,431 B2)
`Technology Center 1600
`
`
`
`Oral Hearing Held: Tuesday, April 19, 2016
`
`
`Before: FRANCISCO C. PRATS, ERICA A. FRANKLIN,
`and GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`The above-entitled matter came on for hearing on Tuesday,
`April 19, 2016, at 10:02 a.m., Hearing Room D, taken at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
`REPORTED BY: RAYMOND G. BRYNTESON, RMR,
`
`CRR, RDR
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`JITENDRA MALIK, ESQ.
`Alston & Bird LLP
`4721 Emperor Boulevard
`Suite 400
`Durham, North Carolina 27703-8580
`919-862-2200
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`HIDETADA JAMES ABE, ESQ.
`Alston & Bird LLP
`333 South Hope Street
`16th Floor
`Los Angeles, California 90071-3004
`213-576-1000
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`JOSEPH M. JANUSZ, ESQ.
`Alston & Bird LLP
`Bank of America Plaza
`101 South Tryon Street
`Suite 4000
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`Charlotte, North Carolina 28280-4000
`704-444-1000
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`APPEARANCES:
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`BRYAN C. DINER, ESQ.
`JUSTIN J. HASFORD, ESQ.
`CHIAKI FUJIWARA, ESQ.
`JOSHUA L. GOLDBERG, ESQ.
`Finnegan, Henderson, Farabow,
` Garrett & Dunner, LLP
`901 New York Avenue, N.W.
`Washington, D.C. 20001-4413
`202-408-4000
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`JESSICA M. LEBEIS, ESQ.
`Finnegan, Henderson, Farabow,
` Garrett & Dunner, LLP
`3500 SunTrust Plaza
`303 Peachtree Street, NE
`Atlanta, Georgia 30308-3263
`404-653-6400
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`Case IPR2015-00903 (Patent No. 8,129,431 B2)
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`P R O C E E D I N G S
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`(10:02 a.m.)
`JUDGE OBERMANN: Please be seated. Welcome
`to the PTAB. I want to apologize, first of all, I did try to get
`the bigger courtroom but there is another Pharma case that has
`five cases going on today and they wouldn't switch with me, so
`I apologize for the smaller quarters. Hopefully we will make
`due. I know that they set up the other courtroom for your
`overflow.
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`This is a consolidated final hearing in
`IPR2015- 00902 and IPR2015- 00903. I'm Judge Grace
`Obermann. And with me today on the Panel are Judge Frank
`Prats and Judge Erica Franklin.
`Let's start with counsel introductions, beginning
`with Petitioner. Please identify who will present argument and
`who is at the table.
`MR. MALIK: Good morning, Your Honors.
`Jitendra Malik. I will be presenting arguments for
`InnoPharma. With me is James Abe and also Joe Janusz.
`JUDGE OBERMANN: Thank you. And for Patent
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`Owner?
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`MR. DINER: Good morning, Your Honor. My
`name is Bryan Diner. I will be presenting for the Patent
`Owners. And with me is Justin Hasford at the table and Chiaki
`Fujiwara.
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`Would you like me to introduce the rest of my --
`JUDGE OBERMANN: You may introduce
`whomever you want.
`MR. DINER: Thank you, Your Honor. Jessica
`Lebeis and Joshua Goldberg.
`JUDGE OBERMANN: Thank you. Welcome. I
`just have a couple of preliminary things I wanted to say. As
`you know from the hearing order, each side will have 60
`minutes to present their case.
`I know that Petitioner has already reserved 15
`minutes. Is that still the structure that you would like, Mr.
`Malik?
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`MR. MALIK: Yes, Your Honor.
`JUDGE OBERMANN: Okay. Thank you very
`much. I wanted to say a word about objections. One of my
`goals is to keep the hearing focused on the merits.
`So toward that end I'm going to ask counsel not to
`interrupt their opponents in order to interject objections. You
`may raise and discuss any objections during your own
`response time or rebuttal time but, in other words, I don't want
`you to make objections while the other person has their time
`running.
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`The one exception to that is, we're very aware,
`we've read the briefs, we know that there is quite a bit of
`briefing that has been done on secondary considerations and
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`Case IPR2015-00903 (Patent No. 8,129,431 B2)
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`some of that material that has been cited for us is designated
`under seal as confidential.
`So I do want to make one exception. If anybody
`accidentally discloses some confidential information or,
`horrors of horrors, if one of us does, please jump up right
`away and let the Court Reporter know so we can designate it
`right away on the record.
`Other than that I would really like you to try to
`refrain from objecting during your opponent's presentation.
`The Panel has considered the joint list of
`objections to demonstratives that was filed on April 14. In
`view of the courtesy copies of the demonstratives that were
`provided to us by counsel on April 15th, no objection warrants
`exclusion of any demonstrative exhibit.
`The parties may use their demonstratives during
`their presentation and the Panel will take account of any
`objection that was previously raised as to any particular
`exhibit.
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`In that regard we are equipped to recognize new or
`unsupported argument in a demonstrative and we will
`disregard any impermissible content.
`So with that we will begin the final argument. Mr.
`Malik, you may proceed to the podium and I will start your
`time ticking at 45 minutes when you begin to speak.
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`MR. MALIK: Good morning, Your Honors.
`Jitendra Malik, counsel for InnoPharma. I'm here to explain
`why in Innopharma's view the claims of the '290 and the '431
`patent are invalid. The comments that I provide today apply
`equally to both petitions since, as Your Honors probably
`noted, the claims are very similar.
`Just an overview, the Board instituted claims on
`the 920 patent, which is the 290 -- I'm sorry, the 902
`proceeding which is the '290 patent, basically finding that
`claims 1 through 30 of the '290 patent are obvious over Ogawa
`in view of Sallmann.
`In connection with the 903 case, which relates to
`the '431 patent, the Board found that claims 1 through 5, 7
`through 14, 18 through 19 are obvious over Ogawa and
`Sallmann and then adding the Fu reference for claim 6, 15
`through 17, 20 through 22.
`Well, the first question is why we focus on Ogawa
`and specifically example 6? Well, looking at the Ogawa
`patent itself, we note that example 6 right off the bat has the
`best stability of the examples that were tested. In this case the
`stability is noted as 109. It is better than example 7 and
`example 8.
`But, more importantly, example 6 also is the
`commercialized formulation known as Bronuck, which was
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`described in printed publications. Bronuck was a formulation,
`an ophthalmic formulation that was in Japan.
`And if you note, the ingredients between Bronuck
`and example 6, they are the same. So a person of ordinary
`skill in the art would have known that the formulation of
`Bronuck from prior printed publications represented example
`6.
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`And if you take a look at Ogawa, example 6,
`vis- a-vis an exemplary claim, in this case the '431, claim 18,
`you know that the only real difference between the two is the
`inclusion of polysorbate and tyloxapol.
`And it is well known to persons of ordinary skill in
`the art that polysorbate and tyloxapol are interchangeable.
`In fact, the Aviv reference, that's Exhibit 2062,
`actually said these two are interchangeable and one of the
`reasons they are interchangeable is because these are FDA
`approved for ophthalmic formulation.
`JUDGE PRATS: Counsel, if I could interject, I
`don't remember the argument being made in the petition that
`I'm hearing you making now, that when you are selecting one
`or the other you really only add two of that category of
`surfactant?
`MR. MALIK: Your Honor, it was in the opening
`petition where we cited the Aviv, Guy and Kataba reference. I
`can give you the specific citation also in the declaration.
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`JUDGE PRATS: Does Aviv say that? Where does
`Aviv say that?
`MR. MALIK: If you have Aviv, Your Honor, or I
`can direct you.
`JUDGE PRATS: Just tell me where it is.
`MR. MALIK: It's on page 11. This is InnoPharma
`Exhibit 1026, page 13.
`If I can direct your attention to page 11, line 7
`through, I'm sorry, 8 through 10, and let me read it into the
`record: The tyloxapol and Tween surfactants -- Tween is
`another name for polysorbate -- are preferred because they are
`FDA-approved for human use.
`And now if you look at Aviv, Aviv itself is
`directed to ophthalmic formulations. So one of the reasons --
`JUDGE PRATS: So even though your petition
`didn't actually say that, we should say that that's part of your
`prima facie case of obviousness, for lack of a better way of
`putting it, we should say that's part of your prima facie case
`because you cited Aviv in support of what the state of the art
`is?
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`MR. MALIK: Your Honor, we did discuss the
`interchangeability of polysorbate and tyloxapol. And that was
`discussed in our opening petition and that was one of the
`reasons that we posited that a person of ordinary skill in the
`art, knowing the limited choices that are out there, certainly
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`would be inclined, given they have polysorbate, also tyloxapol
`would be a natural choice.
`In fact, when we deposed Petitioner's expert, Dr.
`Williams, and asked him, in 2003 what commercial ophthalmic
`surfactants were out there, he could only name three:
`Polysorbate 80, octoxynol 40 and tyloxapol.
`So we really are talking about a very, very limited
`class of surfactants that can be used.
`And as the Board noted on page 12 of its decision:
`An express suggestion to substitute one known equivalent
`nonionic surfactant for another in Ogawa's ophthalmic
`preparation is not needed to render the substitution obvious if
`these were known as interchangeable surfactants.
`JUDGE OBERMANN: I do have a bit of a qualm
`about that because, as far as I can tell, I can't read Ogawa and
`know what polysorbate 80 is for, and you are asking us to say
`that they were interchangeable for the same purpose, and it is
`not clear to me on this record that somebody of ordinary skill
`in the art was going to recognize the purpose of the
`polysorbate 80 and sub in the tyloxapol.
`MR. MALIK: Let me address that because Dr.
`Williams addressed that point, and let me get the exact citation
`so I can address it.
`So in connection with the Ogawa patent -- just bear
`with me as I go through this. Okay.
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`This is the deposition transcript of Dr. Williams.
`While he gets that let me read into the record.
`I'm at page 93, column -- line 7 through 14:
`"Question: And therein you say 'there is no role
`ascribed to polysorbate in Ogawa.' Do you see that?
`"Answer: Yes.
`"Question: A person of ordinary skill in the art
`would know that polysorbate 80 is a surfactant, isn't that
`correct?
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`"Answer: Yes."
`So even though Ogawa may not have a role for
`polysorbate 80, that's what Dr. Williams essentially says
`polysorbate 80 would be. When specifically directed to
`Ogawa and the very paragraph where he said there is no role, I
`asked him, what is the role in Ogawa, and he said a person of
`ordinary skill -- he agreed with the statement that a person of
`ordinary skill in the art would know that polysorbate is a
`surfactant.
`JUDGE OBERMANN: Well, we need to find that
`someone would have subbed in tyloxapol for the purpose of
`stabilizing this composition. That's in the claim.
`MR. MALIK: Yes, Your Honor. But that's one of
`the roles of a surfactant, to stabilize, to prevent things from
`crashing out.
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`And certainly if everyone recognizes that both
`tyloxapol and polysorbate 80 are well-known surfactants, I
`mean, as I said, these were the surfactants that were commonly
`used in 2003. References such as Aviv note that these are
`commonly known surfactants. There really is no dispute about
`the fact that polysorbate 80 is a surfactant.
`I would also add that, this is the Bronuck
`formulation right here, and you can see the polysorbate 80 was
`added in there. So clearly polysorbate 80 which, as Dr.
`Williams noted is a surfactant, could not be removed from the
`composition. Ogawa needed polysorbate 80. So did Bronuck.
`JUDGE OBERMANN: I thought they had evidence
`that in some of the examples they took polysorbate 80 out and
`it had nothing to do with the stabilization, it was really the
`sulfite that was doing it?
`MR. MALIK: Your Honor, the sulfite obviously is
`an antioxidant, but the fact remains there is now discussion
`about whether polysorbate 80 is actually an oxidant. And that
`was an argument --
`JUDGE OBERMANN: Don't they have testing
`side-by-side that shows it with the polysorbate 80 and without
`it, and polysorbate 80 really wasn't doing anything toward
`stabilizing it? It was the sulfite.
`MR. MALIK: Your Honor, what you are talking
`about there is chemical stability. And one of the things that
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`InnoPharma is also talking about is physical stability. And if
`you remember, physical stability is the ability of something to
`crash out, to precipitate out.
`And the art clearly showed that when you have, in
`this case, when you have -- let me go here -- when you have an
`acidic NSAID with a carboxylic acid group, in combination
`with the preservative benzalkonium chloride, one of the
`problems that was seen in the art is that the carboxylic acid
`ion would associate with the benzalkonium chloride ion and
`basically crash out of solution.
`JUDGE OBERMANN: But that's disputed. Is that
`a disputed issue of fact? They dispute that, is that correct?
`MR. MALIK: They do dispute that fact, but, Your
`Honor, I will note that the propensity for acid NSAID to
`complex with BAC was well recognized in the art.
`JUDGE OBERMANN: What is your best evidence
`on that point?
`MR. MALIK: Our best evidence on that point?
`The references, each one of these references discuss the same
`thing. Benzalkonium chloride and other quaternary
`compounds are generally considered to be incompatible with
`ophthalmic compositions with acidic groups, such as NSAIDS.
`Desai, same thing. Same statement in Bergamini.
`Same statement in Wong. Same statement in Fu. Same
`statement in Lucero.
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`In fact, this knowledge was so common that it even
`ended up in Remington. Benzalkonium chloride is a
`quaternary -- well, sorry. As a cationic surface active material
`of high molecular weight, it is not compatible with anionic
`compounds. And then Remington says, given that
`benzalkonium chloride is by far the preservative of choice, the
`one that is most commonly used, 65 percent, and that's also
`substantially, if you look at the FDA inactive ingredients
`guide, benzalkonium chloride is used 77 times in ophthalmic
`formulations.
`But if there is a complexation issue, Remington
`also tells us, given the alternative, it would be preferable to
`modify a formulation to remove the incompatibility rather than
`include a less compatible and effective preservative.
`In essence, Remington is telling you don't take out
`BAC notwithstanding the incompatibility issue. Figure out a
`solution around it. And the background of the patents also say
`the same thing.
`This is the Japanese equivalent of Desai which is
`mentioned, Desai is right there, and the inventors also
`recognized, quoting Desai, that benzalkonium chloride is a
`widely used preservative in ophthalmic solutions.
`Benzalkonium chloride is considered incompatible with
`ophthalmic compositions of acidic drugs such as NSAIDS.
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`And these preservatives will lose their function as they form
`complexes because they crash out of solution.
`And the solution that we are talking about in the
`case of as discussed by Fu, is nothing more than taking -- let
`me go back to, bear with me -- nothing more than taking
`polysorbate 80 and replacing it with tyloxapol, taking one
`FDA-approved surfactant and replacing it with another.
`This is the easiest solution and this was discussed
`in Fu because Fu basically teaches that the entire class of
`ethoxylated octylphenol surfactants solved this problem.
`So we are talking about a very simple solution that
`a person of ordinary skill in the art, which involves no more
`than replacing one, with probably, you know, one of its
`recognized alternatives, as Dr. Williams said, what ophthalmic
`formulations were in commercial use in 2003, octoxynol 40,
`tyloxapol and polysorbate 80.
`And going -- do you want me to discuss Fu and the
`solutions of Fu?
`JUDGE OBERMANN: Whatever you think is the
`best use of your time.
`MR. MALIK: Of course. Thank you, Your Honor.
`Let's skip to Fu. And let me just add a couple more points.
`JUDGE PRATS: Counsel, if I could interject.
`Let's just go back to Ogawa. What does Petitioner think the
`red insoluble matters in Ogawa are?
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`MR. MALIK: I don't think anyone knows exactly
`what it is. It has never been identified. Now, I know that
`Petitioner -- Patent Owner says that it is a dimerization
`product which is insoluble. I mean, that's -- because it
`changed colors, Patent Owner is saying, Senju is saying that it
`represents the product chemical degradation. But it is still a
`precipitate. And no one has actually identified the precipitate.
`No expert has come in and said here is a test, here is what it
`is.
`
`So it certainly is a precipitate. And we know --
`and presumably it's red. That's what Ogawa says. But, you
`know, again, this complexation issue also causes the same kind
`of problem. And given we just had -- it is basically straight
`acid based chemistry. We have a carboxylic acid and we have
`ammonium groups and they basically react.
`And this thing, this reaction --
`JUDGE PRATS: Well, you are not saying that it is
`a BAC diclofenac -- well, I guess in that case it would be
`bromfenac, it is not a BAC/bromfenac complex, you can't say
`that on this record?
`MR. MALIK: Your Honor, we can say that
`everybody was predicting that acidic NSAIDS with carboxylic
`acids form complexes.
`And I know that Senju's expert, Dr. Davies, says,
`well, these are all different. But regardless of these
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`differences, okay, all of these were either complexed with
`BAC, it was especially discussed, or actually predicted in the
`prior art.
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`So, you know, when you have something that is so
`common that basically it ends up in Remington that, you know,
`this is a recognized problem with BAC and acidic NSAIDS
`across the board.
`So, you know, a person of ordinary skill in the art,
`looking at, you know, considering this problem that is out
`there, notwithstanding the fact that they also knew that
`tyloxapol and polysorbate 80 was interchangeable, they also
`knew about this complexation problem which was so widely
`reported in Remington.
`And one of the things that Dr. Williams, Patent
`Owner's expert, said is a person of ordinary skill in the art
`would look to Remington quite frequently because Remington
`is, you know, a very respected treatise in this area.
`And the solution, you know, one of the solutions
`was discussed by Fu. And what Fu said the solution to address
`the complexation issue was, he said that, look, here is the data
`in Fu, an octoxynol 40 is the ethoxylated octylphenol
`surfactant, Tween is polysorbate 80, and there is Myrj 52.
`And Fu said, if you look at the conditions, at 60
`degrees C it was clear in every condition. At 40 degrees C
`you can see that octoxynol 40 remained clear, not only after
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`one month but also five months. But in the case of Tween and
`Myrj 52, you can see that it became turbid under some
`conditions.
`And Dr. Williams, Senju's expert, said that the data
`in Fu showed that octoxynol 40 was superior to Tween 80 and
`Myrj. So the data for addressing the complexation issue
`looking at Fu says, look, this is clearly superior.
`And, you know, what he was trying to address in
`ketorolac is the NSAID. And he basically says the purpose is
`essentially to address this complex. And there was no
`turbidity whatsoever, no precipitate.
`And so the solution of Fu is to use this complex, I
`mean the octoxynol 40 class of compounds. And if you take a
`look at Fu, obviously a patent or a prior art is not limited just
`to its preferred disclosure, what Fu essentially says is that
`octoxynol 40 includes all the ethoxylated octylphenol
`compounds so long as they are bounded by this mole ratio, 3 to
`40, and you can see it in the claim.
`And Fu, just so you know, the claim is not limited
`to any particular NSAID. Basically there is an NSAID, it has
`for ophthalmic treatment, quaternary ammonium preservative,
`that's BAC, a stabilizing amount of a nonionic ethoxylated
`octylphenol compound.
`JUDGE OBERMANN: In the 902 case you don't
`apply Fu in the ground. Is that a problem?
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`MR. MALIK: No, Your Honor, because the -- we
`discuss Fu extensively in the background. If you take a
`look --
`
`JUDGE OBERMANN: It sounds like you are using
`it for a reason to combine these things?
`MR. MALIK: Your Honor, I will cite to you eBay
`v. Moneycat, CBM2014- 0091, Paper 50, final written decision,
`pages 41 through 43. The same argument was made where, in
`essence, you're using the prior art as to provide motivation.
`A couple points. First of all, KSR allows the --
`KSR essentially says that you don't have to focus just on the
`explicit references. The motivation can come from anywhere,
`including, you know, a problem that is recognized even
`beyond the solution.
`But I think that the point you are trying to make is,
`and it was discussed in the eBay case, contrary to Patent
`Owner's contention, prior art references are highly relevant,
`and I'm going to add this in the paraphrase, it is to motivation
`to combine, regardless of whether or not the references are
`relied upon to disclose or teach the features of the challenged
`claims. We used -- and that's on page 48 to 49.
`We used Sallman and Ogawa to show that the
`elements were there. Fu does not explicitly discuss tyloxapol.
`Fu, however, does say that anything that falls within this mole
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`ratio, and tyloxapol, as Dr. Laskar pointed out, as discussed by
`the Schott reference, is essentially an oligomer of octoxynol 9.
`But more importantly, tyloxapol, if you work out
`the mole ratio -- give me one second, I'm on slide 14 -- when
`we deposed Dr. Williams, again, Senju's expert, he
`acknowledged that this mole ratio means that there is a series
`of compounds that fall within it. And he also acknowledged
`that Fu says that the surfactant is the octoxynol 40, superior to
`the other one, I guess to say polysorbate.
`Dr. Laskar explained that tyloxapol, in his second
`declaration, has a corresponding mole ratio of 9.6 to 1,
`squarely falling into this ratio right here.
`And if you take a look at the prior art, this is the 3
`million patent, it's discussed in Dr. Laskar's reply, you can
`see, again, it is 10 ether groups per one tertiary-octylphenol
`nucleus. It clearly falls within that ratio. So there is a lot of
`discussion by Fu.
`Also going to your point, Your Honor, you also
`said about Fu, whether it is a primary ground, you know, the
`case that I cited, eBay v. Moneycat is useful. KSR is also
`useful because we are not bounded by the explicit disclosures.
`I would also add that it was in our initial petition.
`And if you take a look at Senju's responses, they spend pages
`and pages and pages on Fu. I believe in the 903 case, I
`believe it starts on page 35, and they go on for five pages.
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`Their expert also recognized in their expert report that the
`motivation, you know, the additional motivation is discussed.
`They say Ogawa, Sallman and also they also mention Fu as
`part of that.
`So I think everyone understands the proper role of
`Fu, regardless of whether or not it is -- the Board found that
`the primary elements, you know, I believe the Board found
`that the primary elements are discussed in Ogawa and Sallman,
`but certainly Fu can be used from the prior art for additional
`motivation.
`And it is additional motivation because, if you
`remember, in addition we are also saying that tyloxapol and
`polysorbate are interchangeable.
`Let me just jump to here. This is the FDA inactive
`ingredient list. One of the arguments that Petitioners make is,
`in essence, that -- I'm sorry, that Senju makes is that the --
`even if tyloxapol is in there, the ethoxylated octylphenol
`surfactants are a huge class, how you get from that huge mole
`ratio to the two that are mentioned -- to just tyloxapol.
`As I mentioned, when we talked to Dr. Williams,
`when we asked, well, which surfactants were commercially
`available, he said polysorbate, octoxynol 40 and tyloxapol.
`That's confirmed by the FDA inactive ingredient list, and also,
`as in the case of ophthalmic solutions, tyloxapol is used nine
`times. Octoxynol 40 is used one time. So you can see that
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`tyloxapol, just looking at the FDA ingredient guide, which Dr.
`Williams, Senju's expert, acknowledged is, you know,
`something that he consults, because if it is not in the inactive
`ingredient guide, it would require additional safety tests.
`So we're looking at something that the FDA, an
`ophthalmic solution, a surfactant that the FDA has
`acknowledged is safe and effective, and the inactive ingredient
`guide also shows that.
`JUDGE PRATS: Counsel, that argument that you
`just showed on that slide right there, that's just a purely
`responsive argument to what is being argued in the Patent
`Owner response.
`MR. MALIK: Yes, Your Honor.
`JUDGE PRATS: That exhibit clearly wasn't
`submitted as part of the original disclosure.
`MR. MALIK: Your Honor, you are correct. If you
`take a look at both Dr. Williams' declaration and the Patent
`Owner's, and I'm happy to get you the citations, they dispute
`that tyloxapol is even within Fu and then they talk about
`the enormous class. If you want those citations I can get them
`for you.
`
`JUDGE PRATS: No, that's fine.
`MR. MALIK: And so it is in response. First,
`tyloxapol is within that mole ratio. Second, they say, well,
`there is an enormous class. How do you get to tyloxapol?
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`The only reason we showed this was to show that
`this is probably the most likely -- this is how you would get
`from the "enormous class" to what was actually likely to be
`used, or what would be obvious to be used. And, like I said,
`tyloxapol and octoxynol 40 are the only two.
`Additional limitations, these are just a sample of
`them. There are others. pH limitations, some of the claims
`have 7.5 to 8.5. I will note that Ogawa's preferred range is 7.5
`to 8.5. The amount of bromfenac, again, this is discussed in
`Ogawa's range.
`The amount of tyloxapol, I just focus on the 0.02.
`This is where Fu was brought in. There are other ranges, too.
`Examples 2 and examples 5 teach 0.02. In fact, one of the, if
`you look at the table of Fu for the octoxynol 40, we have one
`of the examples of 0.2.
`Moving on --
`JUDGE PRATS: Counsel, let me pick up a little
`bit. Is there any evidence of record as to what the usable pH
`range is of eyedrops in general?
`MR. MALIK: I think certainly in the case of the
`prior art Bronuck it was 8.3, which also falls within the range.
`Bear with me. I believe the pH is on here. 8.0 to 8.6, you can
`see the pH. I believe Prolensa has a pH of 7.8.
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`In the case of PTX-4, in Bronuck, this is published
`in New Drugs in Japan, in 2000, we have a pH of 8 to 8.6.
`Ogawa discloses its preferred range of 7.5 to 8.5.
`JUDGE OBERMANN: I have a question along
`those lines, because you are pointing out what the prior art
`drops, what the pH was. What was the pH of tears?
`MR. MALIK: I believe it is between 7 and 7.4.
`JUDGE OBERMANN: And is it true that one of
`the goals in this art was to get as close to the pH of tears as
`possible to make it more comfortable?
`MR. MALIK: I don't think that there's, I mean, I
`guess there is -- obviously getting closest to the physiological
`parameters of the body, I mean, I suppose that's the goal of
`anybody. But the fact is the prior art, Ogawa, popped those
`same ranges.
`What I gave in Ogawa was the preferred range.
`Ogawa was actually even broader. I think it is 6 to 9.
`JUDGE OBERMANN: But isn't it true that by
`using tyloxapol they were able to get the pH of Prolensa closer
`to th
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