Trials@uspto.gov
`571-272-7822
`
`Paper No. 61
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PROLLENIUM U.S., INC.,
`Petitioner,
`
`v.
`
`ALLERGAN INDUSTRIE, SAS
`Patent Owner.
`____________
`
`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`____________
`
`Record of Oral Hearing
`Held: January 12, 2021
`____________
`
`Before GRACE KARAFFA OBERMANN, JOHN G. NEW,
`SHERIDAN K. SNEDDEN, and
`ROBERT A. POLLOCK, Administrative Patent Judges.1
`
`
`1 This is not an expanded panel. The panel for IPR2019-01506 and
`IPR2019-01632 includes Judges Obermann, Snedden, and Pollock. The
`panel for IPR2019-01505, IPR2019-01508, IPR2019-01509, IPR2019-
`01617, and IPR2020-00084 includes Judges Pollock, Snedden, and New.
`
`
`571-272-7822
`
`Paper No. 61
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PROLLENIUM U.S., INC.,
`Petitioner,
`
`v.
`
`ALLERGAN INDUSTRIE, SAS
`Patent Owner.
`____________
`
`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`____________
`
`Record of Oral Hearing
`Held: January 12, 2021
`____________
`
`Before GRACE KARAFFA OBERMANN, JOHN G. NEW,
`SHERIDAN K. SNEDDEN, and
`ROBERT A. POLLOCK, Administrative Patent Judges.1
`
`
`1 This is not an expanded panel. The panel for IPR2019-01506 and
`IPR2019-01632 includes Judges Obermann, Snedden, and Pollock. The
`panel for IPR2019-01505, IPR2019-01508, IPR2019-01509, IPR2019-
`01617, and IPR2020-00084 includes Judges Pollock, Snedden, and New.
`
`
`
`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`WARREN J. THOMAS, ESQUIRE
`JOHN W. HARBIN, ESQUIRE
`ANTHONY J. ZUCCHERO, ESQUIRE
`Meunier Carlin & Curfman LLC
`999 Peachtree Street NE, Suite 1300
`Atlanta, Georgia 30309
`(404) 645-7717
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`ANTHONY M. INSOGNA, ESQUIRE
`S. CHRISTIAN PLATT, ESQUIRE
`Jones Day
`4655 Executive Drive
`Suite 1500
`San Diego, CA 92121-3134
`(858) 314-1200
`
`SARAH A. GEERS, ESQUIRE
`Jones Day
`250 Vesey Street
`New York, NY 10281-1047
`
`
`
`
`The above-entitled matter came on for hearing on Tuesday, January 12,
`2021, commencing at 1:00 p.m. EDT, by video/by telephone.
`
`
`
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`
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
`
`
`
`P R O C E E D I N G S
`- - - - -
`JUDGE POLLOCK: Good afternoon. Thank you for your patience.
`I'm Judge Pollock. With me are Judges Obermann, Snedden and New. This
`is the final hearing in a series of IPRs: IPR 2019-01505, -01506, -01508, -
`01509, -01617, -01632, and 2020-00084. The Petitioner in each case is
`Prollenium US, Inc. The Patent Owner is Allergan Industrie, SAS.
`These cases are not consolidated but we are hearing them together in
`light of their overlapping records and arguments. This hearing is open to the
`public, and a full transcript of the proceeding will be made part of the record
`in each case.
`Counsel for Petitioner Prollenium, would you kindly identify yourself
`and your colleagues?
`MR. THOMAS: Good afternoon. Good afternoon, this is Warren
`Thomas for Petitioner. And with me all our co-counsel John Harbin and
`Anthony Zucchero. And Mr. Harbin will be primarily presenting the
`argument today.
`MR. HARBIN: Good afternoon.
`JUDGE POLLOCK: Counsel for Allergan, would you kindly identify
`yourself and your colleagues?
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
`
`
`
`MR. INSOGNA: Good afternoon, Your Honor. This is Anthony
`Insogna, from Jones Day. And with me is Mr. Christian Platt, and Ms.
`Sarah Geers. And Mr. Platt and Ms. Geers will lead us today.
`JUDGE POLLOCK: Very good. Both parties have filed motions to
`exclude evidence. Earlier today we entertained argument on both parties’
`motions, although Petitioner declined to argue its motion. We're also aware
`of the parties’ submissions regarding allegedly improper new arguments and
`evidence. We will not rule on these today, but we'll address them in the
`final written decision to the extent necessary.
`Each side this afternoon has 120 minutes to present its case and may
`address the issues as they see fit. My colleagues and I will do our best to
`keep track of time, but we suggest the parties do the same.
`That said, the counsel for Petitioner, would you like to reserve any
`time for rebuttal?
`MR. HARBIN: Yes, Your Honor. This is John Harbin, 45 minutes,
`please.
`JUDGE POLLOCK: Counsel for Patent Owner, you may have the
`last word today. Would you like to reserve any of your time?
`MR. PLATT: Patent Owner would like to reserve 30 minutes, Your
`Honor.
`JUDGE POLLOCK: Very good. We're looking forward to the
`parties’ presentations today, but I would like to cover some things before we
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
`
`
`begin. On behalf of the board, we thank you for your flexibility in
`participating in this all video hearing. We already had a delay for technical
`issues at the beginning. I trust that it will be smooth from here on out.
`I’d like to emphasize that our primary concern is your right to be
`heard. If at any time during the proceedings you encounter technical or
`other difficulties that you feel fundamentally undermine your ability to
`adequately represent your client, please let us know immediately. For
`example, by contacting the team members who provided you with the
`connection information.
`Please mute your microphone when not speaking. And please identify
`yourself each time you speak, both for the panel and to keep the record clear.
`We have access to the entire record, including the demonstratives.
`When referring to each demonstrative paper or exhibit, please do so by slide
`or page number. And then, and I emphasize, please pause a few seconds to
`allow us time to find it. We also remind the parties that the demonstratives
`are not evidence. To the extent there are any objections to be
`demonstratives, we will take those under advisement.
`Finally, should you come to a good faith belief that the pace of the
`proceeding present, prevents you from adequately explaining your position,
`please speak up and we will consider some expansion of the allotted time.
`Petitioner, you will go first, as you bear the burden of showing
`unpatentability to the challenged claims. You may begin.
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
`
`
`
`MR. HARBIN: Thank you, Your Honors. Again, my name is John
`Harbin with Meunier Carlin & Curfman for the Petitioner. Also presenting
`today will be my colleague, Anthony Zucchero. I may turn to him, refer to
`him for some answers to some of the questions, as he's more knowledgeable
`on some of the chemistry and some of the particular references.
`Let me give you an overview of our planned argument today, subject
`to your questions and guidance. First, we will cover some preliminary
`matters for the analysis, the background of the art, the patents, disclosure
`and prosecution, the level of skill in the art and claim construction. Then
`we’ll talk about the challenged claims.
`We do not intend to walk through all 96 claims element by element
`today, that's covered in our petitions. What we propose to do is provide an
`overview of the claims and talk about the various features and how are good
`mixes and matches across the six patents.
`We'll start with an exemplary claim, Claim One of the ’676 Patent that
`apply to grounds of unpatentability, beginning with the Lebreton, Sadozai
`ground. Once we've reviewed why that claim is obvious, we'll walk through
`the different groups of claim features that together encompass all the
`challenge claims and why those do not alter the conclusion of obviousness.
`The questions presented today are really, we submit quite simple.
`Would the POSITA have been motivated to prepare a BDDE cross-linked
`dermal filler containing lidocaine? And would the POSITA have reasonably
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
`
`
`expected the composition could be autoclave sterilized, and that the
`lidocaine would be freely released to mitigate pain? We believe the answer
`to all three is clearly yes. And the additional claim limitations reflect
`conventional design choices, well within the level of those with skill in the
`art, or expected inherent providence.
`In arguing otherwise, Allergan ignores the prior art and poses that
`POSITA blinds too much of. For example, Allergan argues there is not
`enough motivation to make the combination, when the motivation is explicit
`in the prior art. And Allergan proposes all sorts of possible degradations
`that could take place during autoclaving. But Allergan’s speculations are
`contradicted by the repeated disclosures in the prior art of successful cross-
`linked HA dermal fillers of lidocaine. And Allergan has not provided any
`credible evidence why BDDE would be different.
`Two other points I've asked the board to keep in mind as we go
`through our evidence and the discussion. This regards Allergan’s argument
`that rheological changes are unpredictable. First, they have not shown any
`prior art showing this was actually a problem in the development of cross-
`linked HA fillers. Second, none of the claims include any meaningful
`rheological limitations. And the expectation of success here is governed by
`the claims. The evidence shows the combinations could be made in if there
`was more than a reasonable expectation of success.
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
`
`
`
`With that I will turn, if you have this -- Petitioner’s slides, I'll turn to
`Slide 3. I’ll give you a moment. I’m going to talk briefly about the
`development of dermal fillers prior to the critical date of August 4, 2008.
`Your Honors are familiar now with dermal fillers generally. Just a couple of
`points.
`One, that while many cross-linkers are theoretically possible only four
`cross-linkers have been employed in clinically used fillers as of 2008.
`That’s BDDE, DDO, DBS and PBCDI. If it’s okay with the board, I may
`sometimes refer to the last one is BCDI, just a shorthand. Second, by 2008
`BDDE cross-linked fillers were the most popular in the United States.
`When the Slide 4, dermal fillers exhibit a range of characteristics. No
`single dermal filler is suitable for all applications and usable dermal fillers
`exist having a very wide range of viscosities, gel hardness and other
`properties such as cross-linking particle size, amount of free HA.
`Here we've excerpted two exhibits. On the left is one showing
`multiple products by multiple suppliers. And you can -- it shows wide
`variation be, for example, between Restylane, certain Restylane products
`and Juvéderm, which are most successful filler products. And on the right
`shows variations just within the Juvéderm family.
`Going to Slide 5, briefly wanted to talk about --
`JUDGE POLLOCK: Excuse me --
`MR. HARBIN: -- the term of --
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
`
`
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`JUDGE POLLOCK: Mr. Harbin, this is Judge Pollock. On Slide 4,
`you have an excerpt from Exhibit 1039. Can you tell us what these
`rheological properties are? There are a lot of things there.
`MR. HARBIN: Yes, I'll defer to Mr. Zucchero to answer that, Your
`Honor, Slide 4.
`MR. ZUCCHERO: Yes, this is A.J. Zucchero for Petitioner. They
`relate to different rheological parameters that are routinely measured in the
`art. The first one is sort of the -- the G prime value. The gel hardness value.
`You'll hear that routinely. Focused on. And then there are a few numbers
`on the percent elasticity in the right column and ten delta in the second to the
`right column. Those are also common values that are routinely used. So,
`you'll see these are just sort of metrics that are used to analyze and assess
`rheological behavior of cross-linked fillers.
`JUDGE POLLOCK: Okay, thank you.
`MR. HARBIN: Thank you, John Harbin resuming. On the timeline,
`this is Slide 5, a short retrospective reveals that dermal fillers go back
`decades and a lidocaine has also been included to control injection pain and
`collagen fillers which were prevalent in the 1980’s and 1990’s contain a
`lidocaine.
`In the early 2000’s, there was a move to Hyaluronic Acid, and I'll
`refer to that of course as HA fillers. First developed HA fillers did not
`include a lidocaine, but within a few years from the launch of the first cross-
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
`
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`linked HA filler which was Restylane. HA fillers with lidocaine began to
`emerge.
`Prior to August of 2008, there were three cross-linked HA dermal
`fillers containing lidocaine, that had been disclosed and approved in the
`United States or abroad.
`Going to Slide 6, so on --
`JUDGE NEW: Mr. Harbin, excuse me for one minute, John New
`here. Can you point to an exhibit that shows the link or the nexus between
`CTA and Elevess? The same composition.
`MR. HARBIN: I'll defer to Mr. Zucchero on that, Your Honor.
`MR. ZUCCHERO: So, we would point, we would point to a few.
`Sort of the first one I'll point you to is Exhibit 1216. This is the Brand
`reference that describes the cross-linker used in the Elevess product as
`PBCDI. And the POSITA -- that would confirm sort of that POSITA’s
`understanding of the art, that Sadozai Therapeutics was working with cross-
`linkers of this type and a POSITA, as both Dr. DeVore and Dr. Prestwich
`have confirmed, would have understood the link existed between the two.
`Also one other, and a couple other important things to note. First,
`there is a mention of CTA in Sadozai itself. And that would have further
`reinforced the POSITA’s understanding that Sadozai was describing
`compositions such as CTA.
`JUDGE NEW: Thank you.
`
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
`
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`MR. HARBIN: Thank you. So, we're back to Slide 6, by early 2008,
`0.3 percent lidocaine had successfully been incorporated into HA fillers
`cross-linked with three of the four conventional cross-linking agents DBS,
`BCDI and DDO. Doing so with the fourth cross-linking agent, BDDE was
`an obvious next up. Under these circumstances, we submit the claimed
`invention is a product not of innovation but of ordinary skill and common
`sense.
`Going to Slide 7, with that backdrop of the prior art, Allergan filed
`three provisional applications, two of which the challenged patents claimed
`priority. The challenged patents we submit misrepresent the state of the art
`and rely on the inventor’s Declaration, Lebreton -- I apologize, I fall into the
`habit of calling, using, pronouncing it Labret, but I believe it's Lebreton.
`And I'll try to do that. But that also misrepresented the state of the art.
`Allergan convinced the examiner that it was unexpected that HA
`cross-linked fillers with lidocaine could be autoclave sterilized. But the art
`of record here, unquestionably refutes the picture Allergan painted to obtain
`these patents.
`For example, the patent stated it had only been proposed to
`incorporate lidocaine into injectable HA based compositions, and that there
`was a risk the compositions would -- or that the compositions are prone to
`partial or almost complete degradation. At Sadozai, a reference we know
`Allergan was familiar with, directly refutes these representations. It shows,
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
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`along with others, that lidocaine had been added to cross-linked HA fillers.
`And keep in mind at the time the application was not limited to BDDE, by
`the way.
`And so those shows no rheological degradation when cross-linked HA
`and lidocaine are autoclaved together. In fact, it reports lidocaine can have a
`synergistic effect and increase the initial storage modulus.
`Going to the next slide, excuse me. Going to the next, Slide 10.
`Lebreton declaration also misrepresented the state of the art. It stated that
`viscosity reduction could, or the HA would make it unsuitable for soft tissue
`filling. When again, there's evidence that it had been, lidocaine had been
`incorporated in cross-linked HA fillers successfully.
`And one reference here is Kinney, which disclosed, it said lidocaine
`containing filler that was more viscous than Restylane. And that patients
`wished to have further injections of.
`Going to Slide 11. Another art reference that rebuts, that rebuts that
`represent, those representations by Lebreton is the Sadozai and Kinney,
`reference Exhibit 1021, talking about Anika’s CTA product that became out
`of this. And it says, the lidocaine containing HA filler of Anika, behaved
`similarly with respect to extrusion force, compared with a leading marketed
`HA product.
`Going to Slide 20, or excuse me, going to Slide 12, I apologize.
`Lebreton also alleged that the results in Example 4 constitute evidence of
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
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`unexpected results. The declaration explicitly contrasts samples one to three
`with samples four to six.
`Going to the next Slide, number 13. We have a lot of criticisms of the
`assertions about these -- this example. But just a couple I want to touch on
`today. Regardless of any measured viscosity drops, samples one to six all
`exhibited viscosity suitable for use in fillers. And the experiment did not
`establish that any observed changes are statistically significant.
`For example, the viscosity decrease in Sample 3, what Allergan said,
`the POSITA would expect. And Sample 4, the alleged unexpected result
`without pH adjustment, are essentially the same or certainly similar. Thirty
`five percent reduction in Sample Three, and 30 percent in Sample 4. And it
`shows no decrease upon pH control.
`Going to Slide 14. Allergan also cited a Cui reference in the
`prosecution as evidence to support the alleged unexpected results. But Cui
`query does not compare BDDE to the other three conventional cross-linkers
`with similar functionality in this application, BCDI, DEO, or DBS. It looks
`at BDDE compared to other very different compositions, compounds.
`And Cui was published, well first off as a -- as Your Honors are I’m
`sure aware, for a comparison to establish unexpected results, it must be the
`closest available prior art. And these examples are clearly not the closest
`available prior art. While Cui was published in 2012, and therefore it could
`not have informed the POSITA’s expectations in 20 -- in 2008.
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
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`Going to Slide 16. I wanted to address a few issues about the person
`of ordinary skill. There is no dispute about the technical skills the POSITA
`would have, but there is a dispute about the background knowledge of the
`POSITA. Allergan claims the POSITA would not be aware of competitive
`products and our properties, and would not be, would not know of published
`FDA documents such as PMA’s.
`Allergan argues that Prollenium, we, to quote Allergan, “mistakenly
`important specialized rare knowledges, knowledge that doctors DeVore and
`Prestwich acquired as executives.” And that they contend the articles
`mentioning the products in FDA documents are irrelevant.
`But, and they rely in part, they rely on Dr. Berkland, their expert, who
`asserts that only a regulatory liaison, or sales, or competitive intelligence
`executive would know anything about commercial aspects, or PMA filings.
`But that's not relevant to their jobs.
`But his opinion and Allergan’s position conflicts with KSR, which
`provides that demands known to the design community present in the
`marketplace must be considered. Market demand, rather than scientific
`literature, can often design --drive design trends.
`Moreover, Allergan’s restricted view and Dr. Berkland's restricted
`view of the POSITA’s knowledge is contradicted by the prior art in this
`case. Publications frequently described current and upcoming products and
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
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`compared their properties. And we have an example here in Slide, excuse
`me, 18.
`And then going to Slide 19, the prior art shows the POSITAs were
`interested in and aware of and had access to FDA filings. The -- one of the
`exhibits Allergan relies on Exhibit 2015, it's a 2000 foot quote that their
`expert Dr. Berkland cites at least 51 times in his Declaration, provides that
`FDA review and approval documents serve as a useful information source
`and database regarding safety and performance of the products.
`And we have given other examples here. Again, it's not just PMA,
`there's several references to the PMA applications. But there's also
`references in these multiple prior art references to the summary of safety and
`effectiveness documents, announcements by companies of approval, got
`regulatory approval of their product, etc.
`Going to the next slide, Slide 20. Allergen’s disregard of KSR
`continues in their sur-replies, where they are, asserting the cited documents
`are irrelevant. And they contend that we have not shown the POSITA would
`locate and consult the underlying FDA documents. But and notably, with
`only one or two exceptions, Allergan does not dispute that these documents
`qualify as patents or printed publications.
`And Allergan, as far as access, Allergan posits an incorrect standard.
`The question is not whether they pose or actually access the documents. The
`standard is whether interested members of the relevant public could obtain
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
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`the information using only reasonable diligence if they wanted to. And we
`submit that test is right here.
`Going to the next slide, Slide 21, the inventor’s own internal emails
`also undercut Allergan’s contention. In illustrating Dr. Lebreton’s interest
`and access to competitor product developments using press releases, to use
`keyword searches and access government websites.
`We have several other slides, I'll just refer to two or three of them.
`The first one here is in Slide 22, where Dr. Lebreton forwarded an
`announcement by Mentor that it had received approval to begin marketing
`and distributing Puragen and Puragen Plus, an HA based dermal filler.
`JUDGE POLLOCK: Mr. Harbin --
`MR. HARBIN: Which is lidocaine -- Yes, Your Honor.
`JUDGE POLLOCK: Are you bringing in these emails as business
`record?
`MR. HARBIN: I’m bringing as showing interest of the, of the
`inventor himself, not necessarily his business records, but there's been no
`objection to the admissibility of the emails.
`JUDGE POLLOCK: Very good. Thank you for clearing that up.
`MR. HARBIN: These are produced in the District Court litigation.
`The redactions are by Allergan in the District Court litigation. Looking at
`another example, and in Slide 23, Dr. Lebreton picked up an announcement
`by Anika of EU approval of its cosmetic tissue product, using a keyword
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
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`search. And I may have misspoken, Your Honors. Allergan may have
`objected to these as hearsay, but they did not argue that this morning, but I
`believe they may have objected to these as hearsay. But they were produced
`by Allergan in the District Court litigation.
`JUDGE POLLOCK: Okay. Thank you.
`MR. HARBIN: And in this email, Dr. Lebreton notes, it's an HA
`filler adapt (phonetic) lidocaine, though the announcement actually doesn’t
`mention lidocaine.
`Another example, is slipping to, moving to Slide 25, Dr. Lebreton
`circulated a 2008 mentor announcement that the FDA had approved Prevelle
`Silk, an HA dermal filler with a lidocaine. Which we have separately
`introduced as Exhibit 1053. You can tell that from the title and the other
`relevant information, which was dated March of 2008.
`And finally, Dr. Lebreton, in 2008, forwarded information from a
`safety study about Restylane with lidocaine from ClinicalTrials.gov, in the
`government website. So, we believe this information, this, these emails and
`the other information clearly show that persons of skill in the art had access
`to and were, not only had access to, but were interested in and reviewed
`FDA, PMA documents and other relevant documents, and other competitive
`information about the market.
`Looking at Claim Construction briefly, this is Slide 28. There's a
`general -- we only have a few comments we want to make about Claim
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
`
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`Construction. There's a general agreement on constructions, but there's
`some differences, but we submit that they don't really, they're not material to
`the resolution of the issues.
`The parties agree that free and uncross-linked, soluble, HA, those
`adjectives are effectively interchangeable. Regarding cohesive, regarding
`stable departments to be sterile (phonetic) sufficient to establish that
`element. Regarding cohesive, contrary to Perlane, or excuse me, contrary to
`Allergan’s argument, Prollenium does not seek to limit that element to
`monophasic gels. Our point is that term encompasses monophasic gels, and
`Allergan concedes, as Lebreton describes, making a monophasic cohesive
`gel.
`
`Freely release, you have its plain meaning that disputes here about
`whether certain prior art fillers disclosed free release. And the reasonable
`expectation of the POSITA. Our relevant point about unbound is that the
`limitation is demonstrated by free release under either construction. And
`about heat sterile or stable to autoclaving, the limitations are met by
`autoclaving under either construction.
`Moving to Slide 30, we'll talk about the Challenged Claims. The
`Challenged Claims generally relate to fillers that include BDDE crossed-
`linked with HA and lidocaine. The claims generally recite these features
`along with one or more addition, additional conventional or inherent or
`inspect -- expected elements. Regardless of how they are combined, none of
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
`
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`these elements provide a basis for patentability. The trial has been instituted
`on over 90 claims, but they involve a relatively small number of these
`conventional or inherent claim elements among the past, the patent claims.
`Going to Slide 31, looking at these additional elements, some are
`linked to conventional design choices made when formulating a filler. A
`free HA and how much, the degree of cross-linking, the HA concentration of
`these other features listed here. As I -- as we will explain going forward all
`of these, all the combinations merely reflect routine design choices regularly
`made by POSITA’s developing fillers for different clinical applications. So,
`there are no unexpected results or criticalities associated with any of the
`combinations.
`The remaining elements are all inherent or expected functional
`limitations such as sterility, viscosity, stability, extrusion force, etc.
`Regarding extrusion force and viscosity, we may talk about this more later.
`But, while these are rheological characteristics, they are so broadly claimed
`here as to cover any usable dermal filler. Moreover, the challenged patents
`explicitly refer the POSITA to the Lebreton reference to understand how to
`obtain the desired rheological characteristics.
`And regarding the remaining limitations, each of the claimed features
`reflects an observed property of the claimed filler, a property that would
`have been completely expected, based on the teachings of the prior art.
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`IPR2019-01505, Patent 8,450,475 B2
`IPR2019-01506, Patent 8,357,795 B2
`IPR2019-01508, Patent 9,238,013 B2
`IPR2019-01509, Patent 9,358,322 B2
`IPR2019-01617, Patent 8,822,676 B2
`IPR2019-01632, Patent 8,357,795 B2
`IPR2020-00084, Patent 9,089,519 B2
`
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`Going to Slide 33, as Allergan has repeatedly argued in District Court,
`the entire supposed invention was all about adding a lidocaine. This is an
`excerpt from an Allergan -- Markman hearing in 2014, the litiga
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