`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________
`
`AMNEAL PHARMACEUTICALS, LLC,
`Petitioner,
`
`vs.
`
`PURDUE PHARMA, L.P.,
`THE P.F. LABORATORIES, INC., and
`PURDUE PHARMACEUTICALS, L.P.,
`Patent Owner
`__________
`
`
`Cases IPR2016-01027 and IPR 2016-01028
`Patent 9,060,976 B2
`__________
`
`Record of Oral Hearing
`Held: August 2, 2017
`
`__________
`
`
`
`
`Before LORA M. GREEN, CHRISTOPHER G. PAULRAJ, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`
`
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`Cases IPR2016-01027 and IPR 2016-01028
`Patent 9,060,976 B2
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`APPEARANCES:
`
`ON BEHALF OF PETITIONER:
`
`
`TEDD W. VAN BUSKIRK, ESQUIRE
` Lerner, David, Littenberg, Krumholz &
`
` Mentlik, LLP
`
` 600 South Avenue West
` Westfield, New Jersey 07090
` (908) 654-5000
` tvanbuskirk@lernerdavid.com
`
` NICHOLE M. VALEYKO, ESQUIRE
` Lerner, David, Littenberg, Krumholz &
` Mentlik, LLP
` 600 South Avenue West
` Westfield, New Jersey 07090
` (908) 654-5000
` nvaleyko@lernerdavid.com
`
`
`ON BEHALF OF PATENT OWNER:
`
`
`GASPER J. LAROSA, ESQUIRE
` Jones Day
` 250 Vesey Street
` New York, New York 10281
` (212) 326-3939
` gjlarosa@jonesday.com
`
` KELSEY I. NIX, ESQUIRE
` Jones Day
`
` 250 Vesey Street
` New York, New York 10281
`
` (212) 326-8390
`
` knix@jonesday.com
`
`The above-entitled matter came on for hearing on Wednesday, August
`
`2, 2017, commencing at 1:00 p.m., at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia.
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`Patent 9,060,976 B2
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`P R O C E E D I N G S
` JUDGE PAULRAJ: Good afternoon. This is
` the oral hearing of IPR2016-01027 and 01028, both
` of which involve U.S. Patent Number 9,060,976.
` I'm Judge Paulraj. And with me in the room
` here is Judge Green. And participating
` remotely -- you guys can see Judge Harlow. She's
` from our Denver office. So let's start with
` introductions first, with petitioner's counsel and
` then patent owner's counsel.
` MR. VAN BUSKIRK: Good morning, Your
` Honors -- or good afternoon, Your Honors. May it
` please the Court, my name is Ted Van Buskirk. I am
` here on behalf of the petitioner, Amneal
` Pharmaceuticals. With me at the counsel table, I
` have my colleague, Nichole Valeyko. Also, Michael
` Teschner from my firm. And finally, from Amneal,
` Lars Taavola.
` JUDGE PAULRAJ: Thank you.
` MR. LAROSA: Good afternoon, Your Honor.
` My name is Gasper LaRosa. I'm from Jones Day of
` New York. I'm here on behalf of the patent owner,
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` Purdue Pharma. I'm joined here at the counsel
` table by Sarah Geers. Behind me is Mr. Kelsey Nix,
` directly behind me. He may be handling part of the
` argument today related to commercial success, if we
` get to that point. We also have John Normile here.
` And from Purdue Pharma, Bruce Koch.
` JUDGE PAULRAJ: All right. Thank you, Mr.
` LaRosa. Pursuant to our trial hearing order, each
` party will have 45 minutes to present their
` argument. Petitioner will present its case first
` and reserve time for rebuttal. Patent owner will
` then respond followed by any rebuttal arguments
` from petitioner.
` In order to make a clear record, counsel
` should identify the specific demonstratives they're
` referring to during their presentation. This will
` also help Judge Harlow follow along as she may not
` be able to see the specific demonstratives that are
` being shown in this room.
` Additionally, I want to remind the parties
` that this is a public hearing. If for some reason
` we need to discuss any confidential information, we
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` can do that separately. With that, Mr. Van
` Buskirk -- is that how I pronounce it, right?
` MR. VAN BUSKIRK: That's correct, Your
` Honor.
` JUDGE PAULRAJ: How much time would you
` like for rebuttal?
` MR. VAN BUSKIRK: Your Honor, I would like
` to reserve 25 minutes for rebuttal, please.
` JUDGE PAULRAJ: Okay. So that would give
` you 20 minutes for your primary argument.
` MR. VAN BUSKIRK: Okay.
` JUDGE PAULRAJ: And let me put that on the
` clock behind me. And I will set it so that it
` turns -- the light turns yellow with five minutes
` left.
` MR. VAN BUSKIRK: Very good. Thank you.
` JUDGE PAULRAJ: And I'll also try to give
` you a warning when you're close to the end of your
` time.
` Mr. Van Buskirk, before you proceed -- you
` may come to the podium.
` MR. VAN BUSKIRK: Thank you.
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` JUDGE PAULRAJ: I noted that you included a
` total of 109 slides as part of your demonstratives.
` Now, I'm not going to tell you how to do your
` presentation, but I don't see how you can possibly
` cover all 109 slides in the 45 minutes that you're
` given.
` MR. VAN BUSKIRK: You're absolutely
` correct, Your Honor. We have no intention of
` covering all of those slides. Nobody would want to
` here all of those. But one of the issues that has
` come up here, is that somehow we have changed
` positions, or didn't have proper support in the
` record for our arguments; and simply to cross Ts
` and dot Is, we wanted the panel to be aware that
` whatever we have said has, in fact -- does find
` support in the record.
` JUDGE PAULRAJ: Okay. So I would
` definitely recommend that you focus on those slides
` that are most relevant to the dispute here. And
` I'd also remind all the parties that demonstratives
` are not evidence. They're only here to help us
` with oral arguments. So you may proceed whenever
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` you're ready.
` MR. VAN BUSKIRK: Thank you, Your Honor. I
` do have hard copies, if that's helpful to the
` panel.
` JUDGE PAULRAJ: That would be helpful.
` Thank you.
` MR. VAN BUSKIRK: I have a copy for Judge
` Harlow. But as a practical matter, I don't know
` how to do that.
` JUDGE PAULRAJ: That's fine. We'll
` teleport it later. So you may start.
` MR. VAN BUSKIRK: Thank you, Your Honor.
` As I said, my name is Ted Van Buskirk. I'm here on
` behalf of the petitioner, Amneal. I know that the
` panel is familiar with the papers and with the
` arguments raised therein. What I'd like to do this
` afternoon is give a brief summary of the three
` grounds and the references relied on, and then move
` immediately to some of the points that have been
` raised by the patent owner, primarily those in the
` most recent sur-reply.
` The Board has instituted on three
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` grounds -- those are shown on Slide 56. But using
` the patent owner's demonstratives as a guide, it
` would be very easy to overlook the Palermo Ground,
` that is Ground 1 of the 1028 Petition. Palermo is
` actually one of patent owner's own references. And
` it's important, not only to the ground itself, but
` also to questions that have been raised against the
` two McGinity Grounds.
` Palermo itself, Exhibit 1011, teaches an
` extended-release abuse-deterrent matrix
` formulation. Palermo's matrix includes meltable
` matrix-forming polymers, opioids, including
` oxycodone, magnesium stearate, and a PEG-containing
` coating.
` Importantly, Palermo's core matrix is
` heated to melt just as is claimed in the 976
` patent. Palermo describes heating the core matrix
` by melting either via a melt extrusion or melt
` granulation. And while Purdue levels many
` criticisms against melt extrusion, with which we
` disagree, none of those criticisms apply to melt
` granulation. Palermo's disclosure of melt
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` granulation is exactly the same as that disclosed
` in the 976 patent. And if we take a look at Slides
` 30 and 31, we see that these are virtually
` identical disclosures of melt granulation. Both
` specifically cite to and incorporate by reference
` Oshlack, U.S. Patent Number 4,861,598, which is
` Exhibit 1037. Oshlack teaches melt granulation.
` It's important to remember that the claim
` here, the 976 -- and if I were savvy enough to be
` able to put it up on the ELMO, I'd do so. But the
` claim itself is not an original Purdue claim.
` Instead, it was copied from a third party in order
` to provoke an interference. And to show support
` for that claim in the supplemental amendment that
` Purdue filed, Purdue pointed to this very same
` paragraph as support for the core matrix is heated
` to melt limitation.
` Purdue does not dispute our allegation that
` Purdue teaches a melt granulated core. And how can
` they? Because Palermo teaches the same melt
` granulation as the 976 patent, relies upon the same
` language to do so, and cites to the same reference:
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` Oshlack. All three, by the way, are Purdue
` patents.
` JUDGE PAULRAJ: Now, Mr. Van Buskirk, on
` this point -- and we do have the claims in front of
` us, so -- now, how do you define the term "core
` matrix"? I didn't see, at least not in my review,
` a construction proposed for the term core matrix.
` Mr. Van Buskirk: Well, I believe in our
` original papers, Your Honor, there was some back
` and forth as to it. But I think the parties are
` now in agreement that the core matrix is anything
` that is contained within the PEG coating.
` JUDGE PAULRAJ: Okay. But more
` specifically -- so the claimer cites a core matrix
` comprising of three ingredients.
` MR. VAN BUSKIRK: That's correct.
` JUDGE PAULRAJ: The PEO, the magnesium
` stearate, and the oxycodone. So would you agree
` that the core matrix, as defined by Claim 1, must
` include all three ingredients?
` MR. VAN BUSKIRK: We do, Your Honor.
` JUDGE PAULRAJ: Okay. So to follow up on
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` this issue, when the claim further cites that the
` core matrix is heated, don't all three ingredients
` have to be heated during the melting process -- or
` heated to melt?
` MR. VAN BUSKIRK: All three need to be
` together to define a core, Your Honor. The melting
` -- or the heating, I should say. The heating can
` occur at any point during preparation of the dosage
` form.
` JUDGE GREEN: Do you have any support for
` that construction?
` MR. VAN BUSKIRK: We do. In fact, it is
` exactly what Purdue argued to to the examiner after
` the claim was allowed. And, Nichole, if you're able
` to pull up the after-allowance communication, that
` may be helpful.
` JUDGE GREEN: So is that Exhibit 2009?
` MR. VAN BUSKIRK: It is. It's Exhibit
` 2009. The examiner's statement --
` JUDGE GREEN: And then is that -- does that
` comport with your Exhibit 1031 at Page 3 where they
` state why they added that limitation? And I
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` apologize, I've got a really bad cold, so --
` MR. VAN BUSKIRK: No. That's okay. I'm
` looking into what 1031 is, Your Honor.
` MS. VALEYKO: I'm sorry. Did you mean the
` petitioner's amendment in response to 1031?
` JUDGE GREEN: Exhibit 1031, Page 3. This
` is part of the prosecution history. And it starts
` with remarks. And it's Part C, remarks and
` continued request for interference. Let me just
` read it into the record.
` MR. VAN BUSKIRK: Thank you, Your Honor.
` JUDGE GREEN: By way of example, the
` addition of the term "core" is merely to address an
` alleged antecedence issue. The addition of the
` terminology during preparation of the dosage form
` is to clarify that the heated limitation is not
` performed during use of the claimed dosage form,
` e.g. prior to administration to a patient.
` MR. VAN BUSKIRK: Understood, Your Honor.
` My apologies for the confusion. That was something
` we addressed in our petition. And I think the
` parties came to an agreement afterwards that that
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` really wasn't an issue here. In our petition, we
` addressed that the heating must be of the dosage
` form and not some later stage. But for present
` purposes, I think we're in agreement that it is the
` three elements which make up the core matrix:
` Oxycodone, PEO of a particular molecular weight,
` and mag stearate. And those three must be together
` in some form to constitute a core matrix. And it
` is that core matrix, which is heated to melt at
` some point during preparation of the dosage form,
` not necessarily limited to hot-melt extrusion or
` melt granulation. And that is the point that
` Purdue made in the after-allowance communication to
` the examiner.
` JUDGE GREEN: So you now agree with the
` patent owner that the PEO, the magnesium stearate,
` and the oxycodone all have to be together and
` heated at the same time?
` MR. VAN BUSKIRK: We do.
` JUDGE GREEN: So your arguments made in
` your reply that you could add the magnesium
` stearate at the end and blend it in, you're no
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` longer relying on those arguments?
` MR. VAN BUSKIRK: The magnesium
` stearate -- so the point made in the reply is that
` oxy and PEO can be melted -- extruded together,
` magnesium stearate added to that to create a core,
` and then some further application of heat applied.
` That is exactly what Purdue argued in Exhibit 2009,
` saying that our claim covers melt extrusion and
` melt granulation, but is not limited to that. They
` said that there is some other application of heat
` that may be available. And we're simply adopting
` and relying on that construction addressing the --
` JUDGE GREEN: Now, there wasn't a further
` application of heat, which you say that -- so you
` have the oxycodone and the PEO together, you heat
` that, you extrude it, you add your magnesium
` stearate, and you don't heat it again. Would say
` that that's not covered by claim then?
` MR. VAN BUSKIRK: Let me make sure I
` understand your question, Your Honor. What I'm
` hearing is that you have two components that are
` together, magnesium stearate added subsequently, no
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` heat applied to that --
` JUDGE GREEN: Right. Right. So it's
` blended in.
` MR. VAN BUSKIRK: So you have a core
` matrix --
` JUDGE GREEN: Right.
` MR. VAN BUSKIRK: -- but that core
` matrix -- your question is, has that been heated to
` melt?
` JUDGE GREEN: Right. So if you heat the
` PEO and the oxycodone and you get some melting of
` the PEO, and then you stir in your magnesium
` stearate at the end to avoid any kind of
` interactions or anything else that may occur, and
` you do no further heating, I mean, at some
` point -- at that level there is going to be some
` heat there after the initial -- but you add it in
` and you don't do an additional specific heating
` step, you just rely on the heating that happened
` while you were meting your PEO and your oxycodone
` together making that part of the core matrix.
` MR. VAN BUSKIRK: I understand. It sounds
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` like you're referring to residual heat perhaps.
` JUDGE GREEN: Right.
` MR. VAN BUSKIRK: And that's not something
` we've thought about. But what Dr. Timko testified
` to, and what his declaration said, is that heat can
` be applied at any point in the process and there
` are further processing steps. Purdue doesn't tell
` us what they are. But it is known that in
` tabletting -- under compression creates heat.
` There could also be spray drying, which creates
` heat. There could be curing. There could be
` annealing.
` JUDGE GREEN: And do you know where you all
` cited Dr. Timko's testimony on that point?
` MR. VAN BUSKIRK: Well, Dr. Timko in his
` deposition testified to that. In his declaration
` he --
` JUDGE GREEN: No. I understand that. But
` where is that in your papers? Where do you --
` MR. VAN BUSKIRK: In his papers he simply
` said that the heat is not limited to --
` JUDGE GREEN: No. I understand that. But
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` where in your papers did you --
` MR. VAN BUSKIRK: Let me get that for you.
` JUDGE GREEN: You can have your associate
` look for it.
` MR. VAN BUSKIRK: Thank you. It's in his
` declaration, and I'll be happy to get you the cite
` for that.
` JUDGE GREEN: Thank you.
` JUDGE PAULRAJ: One other question on this
` limitation, would you characterize it as a
` product-by-process limitation? And if that is the
` case, why should we give that limitation any
` weight?
` MR. VAN BUSKIRK: That's a very good
` question. It's something we struggled with early
` on in this. And it could be construed that way.
` That is not how we proceeded forward. We look for
` an art teaching application of heat. But it is a
` good and valid question.
` JUDGE PAULRAJ: So at least your position
` has not been that it's a product-by-process
` limitation?
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` MR. VAN BUSKIRK: We have not stated that
` position, no. It's important to note, that
` regardless of what Purdue says about melt
` extrusion, there's no question that Palermo's
` disclosure of melt granulation satisfies the core
` matrix as heated to melt limitation because it's
` exactly the same core as is disclosed in the 976
` patent. So again, whatever criticisms are leveled
` as to melt extrusion don't apply to Palermo's melt
` granulation.
` Getting back to our Palermo Ground.
` Palermo also teaches the use of mag stearate. And
` importantly, Palermo tells us that it can be
` included either in the melt or after.
` As far as abuse deterrence, three points
` that I want to make quickly --
` JUDGE GREEN: Where is that in Palermo? Do
` you have --
` MR. VAN BUSKIRK: Yes. So if you look at
` Palermo, the bottom of the Page 32, Lines 26
` through 30, and compare that to the top of Page 33,
` Lines 1 through 5, you see two disclosures there
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` pointing out that it can be applied either in the
` melt or after.
` JUDGE GREEN: Thank you.
` MR. VAN BUSKIRK: As to abuse deterrence,
` we believe the Board agrees it's not a claim
` limitation, instead merely a statement of intended
` use. That said, Palermo is also directed to
` abuse-deterrent formulations. Purdue -- I've done
` this before. Palermo -- my apologies. Palermo
` achieves abuse deterrence by using an antagonist,
` which as the Board recognized, is encompassed by
` the comprising language of the 976 patent.
` Finally, Palermo also teaches us that abuse
` deterrents can be improved by the addition of a
` gelling agent.
` So what is Palermo missing? Palermo says
` that its matrix can be formed using any hydrophilic
` and/or hydrophobic materials, which are capable of
` melting or softening. That's what we see on Slide
` 33. Palermo also explicitly states that its list
` of materials is not meant to be exclusive. That
` would invite a POSA to look for further information
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` as to appropriate hydrophilic matrix formers, and
` in doing so, a POSA would go to the handbook. The
` handbook, as we all know, is a well-known reference
` available to any formulator. Looking to the index
` of the handbook from hydrophilic matrix formers, a
` POSA, or a formulator, would see a list of exactly
` one entry, PEO.
` As we see in Slide 39 and Slide 40, the PEO
` entry identifies it as a hydrophilic matrix former
` that melts between 60 and 75 degrees and is
` available in a wide range of molecular weights that
` provide extended release based upon its capacity to
` swell. So Palermo points us to the handbook, the
` handbook lists PEO as meeting all of Palermo's
` requirements. That puts it at the very top of the
` list.
` But McGinity would also confirm that.
` McGinity tells us that a POSA would see high
` molecular weight PEO with a molecular-weight range,
` for example between one million and ten million
` daltons, can be formulated with oxycodone and
` magnesium stearate in a meltable dosage form that
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` provides extended release.
` Now, having introduced McGinity as a
` secondary reference, let's flip things around and
` look at it as a primary reference for the other two
` grounds. And as to the differences between the
` secondary references used there, I think I can
` address those together.
` As I just mentioned, McGinity is directed
` to the use of high-molecular weight PEO to prepare
` a melt-extruded extended release dosage form
` applicable to a wide variety of therapeutic
` compounds, including oxycodone. The Court has
` already found that, and the Board recognized that.
` McGinity's disclosure of "analgesics, dot, dot,
` dot, and the like," has been found to disclose of
` oxycodone. That finding, of course, as well as all
` of the Southern District's findings, were upheld on
` appeal by the Federal Circuit. McGinity,
` like Palermo, teaches that its compounds can be
` combined with lubricants, including magnesium
` stearate.
` JUDGE GREEN: Excuse me just for a second.
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` You said the finding -- all the findings were
` upheld. It sounds like -- I mean, my recollection
` is that there was just a one-page, you know,
` conclusion, affirmance. So the result was upheld,
` but does that mean every finding was upheld as
` well?
` MR. VAN BUSKIRK: We maintain that it is,
` Your Honor.
` JUDGE GREEN: Okay.
` MR. VAN BUSKIRK: Purdue's principal
` criticism of the McGinity reference is that the art
` allegedly teaches away from including mag stearate
` in a hot-melt extrusion. Purdue now says that
` adding mag stearate to a hot-melt would adversely
` affect the mag stearate itself, or would cause
` problems with drug release. So according to
` Purdue, a POSA wouldn't add mag stearate to
` McGinity's hot-melt extrusion, and therefore,
` McGinity doesn't teach this limitation of a core
` matrix being heated to melt.
` We've already talked about this briefly,
` but before the Patent Office, Purdue repeatedly
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` represented that its process covered both melt
` extrusion and melt granulation, including magnesium
` stearate. The examiner's notice of allowance was
` based on that understanding. And Purdue went back
` and said it's not just hot-melt or hot -- or melt
` granulation, it's broader than that. So Purdue's
` attempt to back away from the melt extrusion now
` appears to be nothing more than some
` litigation-driven attempt to avoid McGinity, which
` otherwise teaches all the limitations of the claim.
` And to allow them to do so now would effectively
` allow them to carve that limitation out of the
` claim.
` So what is McGinity missing? It's missing
` abuse deterrence. But again, we contend that
` that's not a claim limitation. So arguably it's
` missing nothing. You don't need any motivation to
` make McGinity abuse deterrent.
` JUDGE PAULRAJ: Let me stop you right
` there.
` MR. VAN BUSKIRK: Please.
` JUDGE PAULRAJ: Going back to the
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` discussion we had before about whether the process
` limitation requires all three components in the
` core matrix to be heated at the same time. If we
` were to interpret the claims in that manner, would
` McGinity meet that requirement?
` MR. VAN BUSKIRK: It would.
` JUDGE PAULRAJ: Okay.
` MR. VAN BUSKIRK: We believe -- nothing in
` McGinity tells you that you can't put magnesium
` stearate in a core. That may not be the
` conventional way, but a POSA thinks that magnesium
` stearate in its traditional role as a
` lubricant -- but this claim has no detail as to the
` amount of magnesium stearate or what its function
` would be. So while perhaps not -- what's typically
` done is mag stearate could be included in
` McGinity's hot-melt extrusion, or it could be added
` after and some further processing steps -- what
` Purdue told the examiner in Exhibit 2009, what
` other forms of heat could also be applied.
` JUDGE GREEN: But is there any explicit
` teaching of that in McGinity, I think is what Judge
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` Paulraj's question is?
` MR. VAN BUSKIRK: There is no explicit
` teaching one way or another in McGinity or others.
` JUDGE GREEN: Thank you.
` MR. VAN BUSKIRK: McGinity tells us that
` this therapeutic compound can be combined with
` lubricants, such as magnesium stearate. It
` specifically says compounds. This would motivate a
` POSA to combine, at any time, not limited to
` afterwards.
` So McGinity teaches us everything we need,
` we contend; and there's already a motive, the
` Southern District found that. To the extent that
` we rely on secondary references for abuse
` deterrence, it's not for modifying McGinity by
` adding anything to become abuse deterrent, it
` already is.
` As to the remaining secondary references,
` Joshi tells us that PEO is a preferred gelling
` agent that provides abuse deterrence. The PDR
` teaches us that oxycodone is a well-known opioid
` analgesic available in sustained- and
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` extended-release form. Palermo teaches us
` conventional coatings containing PEG. And Bastin
` also teaches us conventional PEG coatings.
`
` But more importantly, Bastin teaches us
` that gelling agents provide not only abuse
` deterrence, but also extended release. Bastin
` itself was directed to an immediate-release
` abuse-deterrent formulation. The gelling agent
` there in Bastin was actually found to delay the
` release. Now, that's a bad thing for purposes of
` an immediate-release formulation. But if your goal
` is to formulate extended release, that gives you
` exactly what you want and would provide a
` motivation. It is not a teaching away, as Purdue
` has argued.
` In their sur-reply, Purdue accuses us of
` changing positions, primarily on the core matrix
` being heated to melt limitation. And I think -- I
` hope I've addressed your questions and the
` questions you've posed to me. What I would like to
` do because my time is running short, is address two
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` other points that came up in the sur-reply. Those
` are extended release and the alleged
` unpredictability of gelling agents.
` As far as extended release, contrary to
` what you're probably going to hear from Purdue, Dr.
` Timko did not ignore the claim construction
` proposed by us and adopted by the Board. He
` actually endorsed it. He said so in both his
` declaration and in his deposition. His declaration
` is Paragraph 17 of Exhibit 1040. During his
` deposition, which is 2147, it was on Page 42 and
` 44.
` And what he testified to was only that the
` claim itself does not expressly recite any specific
` amount of oxycodone or any specific time period.
` And that's true, it does not. So Dr. Timko clearly
` analyzed the prior art's teaching of providing
` therapeutic levels. But even if he hadn't, that
` doesn't change the art's teachings themselves. Any
` POSA reading McGinity or Palermo would understand
` that they are, in fact, directed to therapeutic
` extended-release dosage forms.
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` Finally, regarding unpredictability, Purdue
` argues that gelling agents are inherently
` unpredictable based on statements made in two of
` Dr. Timko's own patent applications directed to a
` different active ingredient, quetiapine and
` Seroquel. That's entirely irrelevant here.
` First, Dr. Timko never said that using
` gelling agents was unpredictable. Instead, he
` actually acknowledged that numerous such
` formulations have already been made, and simply
` pointed to the fact that they could be difficult.
` More to the point, however, Dr. Timko's statements
` reflect his understanding as an inventor, not as a
` hypothetical POSA who is assumed to have knowledge
` of all the references in front of him. He was
` never asked if he knew of these references cited in
` the prior art.
` More importantly here, Purdue's own Palermo
` and McGinity references, as well as Joshi and
` Bastin, actually teach formulating opioids,
` including oxycodone, with gelling agents, including
` PEO. And in that case, a POSA would certainly have
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