Trials@uspto.gov
`571-272-7822
`
`
`
`
`Paper 12
`Entered: April 10, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________________________
`PROLLENIUM US INC.,
`Petitioner,
`v.
`ALLERGAN INDUSTRIE, SAS,
`Patent Owner.
`________________________________________
`IPR2020-00084
`Patent 9,089,519 B2
`________________________________________
`
`
`Before JOHN G. NEW, SHERIDAN K. SNEDDEN, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`NEW, Administrative Patent Judge.
`
`
`
`
`DECISION
`Instituting Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
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`IPR2020-00084
`Patent 9,089,519 B2
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`
`I. INTRODUCTION
`Petitioner Prollenium US Inc. filed a Petition (Paper 1, “Petition”)
`requesting inter partes review of claims 1–8 of US Patent 9,089,519 B2 (Ex. 1001,
`“the ’519 patent”). Patent Owner Allergan Industrie SAS (the “Patent Owner”)
`timely filed a Preliminary Response. Paper 11 (“Prelim. Resp.”).
`Under 35 U.S.C. § 314, the Board “may not authorize an inter partes review
`to be instituted unless … the information presented in the petition … and any
`response … shows that there is a reasonable likelihood that the petitioner would
`prevail with respect to at least one of the claims challenged in the petition.” Upon
`consideration of the Petition and the Preliminary Response we determine that the
`evidence presented demonstrates a reasonable likelihood that Petitioner would
`prevail, on Petitioner’s Grounds 4 and 5, in establishing the unpatentability of at
`least one claim of the ’519 patent. We determine that Petitioner has not
`demonstrated a reasonable likelihood it would prevail as to Grounds 1–3.
`Although the panel finds that Petitioner is not likely to prevail on some Grounds,
`the Board here institutes on all grounds in the petition. PGS Geophysical AS v.
`Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a
`simple yes-or-no institution choice respecting a petition, embracing all challenges
`included in the petition”).
`
`
`II. BACKGROUND
`
`A.
`
`Related Matters
`The parties identify the following consolidated civil action:
`Allergan USA, Inc. and Allergan Industrie SAS v. Prollenium US Inc.
`and Prollenium Medical Technologies Inc., Civil Action No. 19-126-
`CFC (D. Del. filed Jan. 22, 2019).)
`
`
`
`Paper 4, 1–2.
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`
`Petitioner has filed Petitions for inter partes review of related U.S. patents as
`follows: US Patent No. 8,450,475 B2 (the “’475 patent”) in IPR2019-01505; US
`Patent No. 9,238,013 (the “’013 patent”) in IPR2019-01508; US Patent No.
`8,822,676 B2 (the “’676 patent”) in IPR2019-01617; and US Patent No. 9,358,322
`B2 (the “’322 patent”) in IPR2019-01509. Pet. 68–69.
`B.
`The Asserted Grounds of Unpatentability
`Petitioner contends that claims 1–8 of the ’519 patent are unpatentable based
`on the following grounds:
`Claim(s) Challenged
`1–4
`1–4
`1–4
`1–8
`
`35 U.S.C. §
`102(a)(1)
`102(a)(1)
`102(a)(1)
`103
`
`Reference(s)/Basis
`PMA P050047/S0051
`Weinkle2
`U.S. 2010/0028438 A13
`Lebreton4, Sadozai5,
`
`
`1 Summary Review Memo Template, P050047/S005, Juvederm Ultra Xc And
`Juvederm Ultra Plus XC (January 6, 2010”) (“P050047/S005”) (Ex. 1060).
`
` S.H. Weinkle et al., A Multi-Center, Double-Blind, Randomized Controlled Study
`of the Safety and Effectiveness of Juvederm® Injectable Gel with and without
`Lidocaine, 8 J. COSMETIC DERMATOL. 205–10 (2009) (“Weinkle”) (Ex. 1070).
`
` Lebreton (U.S. 2010/0028438 A1, February 4, 2010) (the “’438 application) (Ex.
`1072).
`
` Lebreton (US 2006/0194758 A1, August 31, 2006) (“Lebreton”) (Ex. 1029).
`
` Sadozai et al. (US 2005/0136122 Al, June 23, 2005) (“Sadozai”) (Ex. 1030).
`
`3
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`Claim(s) Challenged
`1–8
`
`
`
`35 U.S.C. §
`103
`
`Reference(s)/Basis
`P0500476, Kinney7
`
`C.
`
`Petitioner also relies upon the Declaration of its declarant, Dr. Dale P.
`DeVore (the “DeVore Declaration”) (Ex. 1002).
`
`The ’519 Patent
`The ’519 patent is generally directed to cohesive soft tissue fillers, for
`example, dermal and subdermal fillers, based on hyaluronic acids (“HA”) and
`pharmaceutically acceptable salts thereof. Ex. 1001 Abstr. More specifically, the
`’519 patent teaches soft tissue filler compositions generally comprising: a
`hyaluronic acid component crosslinked with a crosslinking agent selected from the
`group consisting of 1,4-butanediol diglycidyl ether (BDDE), 1,4-bis(2,3-
`epoxypropoxy) butane, 1,4-bisglycidyloxybutane, 1,2-bis(2,3-epoxypropoxy)
`ethylene and 1-(2,3-epoxypropyl)-2,3-epoxycyclohexane, and 1,4-butanediol
`diglycidyl ether; and at least one anesthetic agent, generally lidocaine, combined
`with the crosslinked HA component. Ex. 1001 col. 2, ll. 54–62.
`
`D.
`
`Illustrative Claim
`Claim 1 is illustrative and recites:
`
`
`6 Inamed Corporation, Summary Of Safety And Effectiveness Data:
`JUVEDERM™: Premarket Approval Application (PMA) Number P050047
`(June 2, 2006) (“P050047”) (Ex. 1074).
`
` B.M. Kinney, Injecting Puragen Plus into the Nasolabial Folds: Preliminary
`Observations of FDA Trial, 26(6) AESTHETIC SURG. J. 741–48 (2006) (“Kinney”)
`(Ex. 1012).
`
`4
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`A first sterile dermal filler composition comprising hyaluronic
`1.
`acid crosslinked with 1,4-butanediol diglycidyl ether (BDDE), and
`about 0.3% lidocaine by weight, wherein the first composition fills in
`facial lines and depressions substantially the same as a second sterile
`dermal filler comprising hyaluronic acid crosslinked with BDDE
`wherein the second composition does not include lidocaine but
`otherwise has the same composition as the first composition.
`
`Ex. 1001 col. 19, ll. 16–23.
`Independent claims 3 and 5 are similar, but recite, respectively, that the first
`sterile dermal filler composition “restores fat loss-related tissue volume loss
`substantially the same,” or “is substantially as stable during storage under ambient
`conditions for at least 3 months,” as the second dermal filler. Id. at col. 20, ll. 2–3,
`12–13.
`
`Prosecution History of the ’519 Patent
`E.
`In August and September 2008, Allergan filed a trio of provisional
`
`applications (US Appl. Ser. No. 61/085,956, August 04, 2008 (the “’956
`application”); US Appl. Ser. No. 61/087,934, August 11, 2008 (the “’934
`application”); and US Appl. Ser. No. 61/096,278, September 11, 2008 (the “’278
`application”) to which the ’519 patent claims the priority benefit. Pet. 11.
`
`The parent application of the ʼ519 patent, US Appl. Ser. No. 14/242,747 (the
`“’747 application”) was filed on April 1, 2014, as a continuation of US
`Appl. Ser. No. 13/419,079 (“the ‘079 application”), which is, in turn, a
`continuation of US Appl. Ser. No. 12/393,884 (the “ʼ884 application”). Pet. 13.
`The Examiner issued a first action Notice of Allowance on October 10, 2014,
`citing arguments and evidence relied upon by the Patent Owner in the examination
`of the ’884 application. Id. (citing Ex. 1049 6–7). Specifically, the then-applicant
`argued, citing a declaration submitted by the inventor, that a person of ordinary
`
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`skill in the art would not have expected a lidocaine-containing HA composition
`could be sterilized by autoclave. Id. (citing Ex. 1023 25–28). Specifically, the
`then-applicant argued that “it was a surprising and unexpected discovery … that
`certain [HA] gels … when mixed with lidocaine, could be made to be heat stable
`and thus useful as dermal fillers.” Id. at 13–14 (quoting Ex. 1023 23). At the time
`of this response, some pending claims were directed to BDDE-crosslinked HA, and
`other claims were directed to HA crosslinked with any crosslinker. Id. at 54 (citing
`Ex. 1023, 18–20 (claims 51–67)).
`The Patent Owner also argued that a skilled artisan would have expected that
`autoclave sterilization would unacceptably reduce the composition’s viscosity,
`thereby making it unsuitable for use as a filler. Pet. 14 (citing Ex. 1023 25). The
`Examiner accepted these arguments in the ʼ884 application and they were
`expressly cited again by the Examiner in the reasons for allowance of the ʼ519
`patent. Id. (citing Ex. 1049 7).
`The ’519 patent issued on July 28, 2015 (Ex. 1001).
`
`
`
`III. ANALYSIS
`
`A.
`
`Claim Construction
`In an inter partes review for a petition filed on or after November 13, 2018,
`the “[claims] of a patent … shall be construed using the same claim construction
`standard that would be used to construe the [claims] in a civil action under 35
`U.S.C. § 282(b), including construing the [claims] in accordance with the ordinary
`and customary meaning of such claims as understood by one of ordinary skill in
`the art and the prosecution history pertaining to the patent.” See 37 C.F.R.
`§ 42.100(b) (2019); see also Phillips v. AWH Corp., 415 F.3d 1303, 1312–14 (Fed.
`Cir. 2005) (en banc). Only those terms that are in controversy need be construed,
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`and only to the extent necessary to resolve the controversy. See Nidec Motor
`Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed.
`Cir. 2017) (citing Vivid Techs., Inc. v. America Sci. & Eng’g, Inc., 200 F.3d 795,
`803 (Fed. Cir. 1999)).
`In a related district court litigation, Allergan USA, Inc. v. Medicis Aesthetics,
`Inc., Case No. SACV 13-1436 AG (JPRx) (C.D. Calif.), 2014 WL 5488895 (C.D.
`Calif. Aug. 12, 2014),8 the district court judge entered a claim construction order
`following a Markman hearing. Ex. 1027. Petitioner proposes constructions for
`certain claim terms, viz., “sterile,” “stable,” and “freely released in vivo” that are
`consistent with those of the district court. Pet. 15–18. The Patent Owner does not
`concede that Petitioner’s proposed constructions are the correct interpretation of
`these claims under the Phillips standard, but does not expressly contest any of
`Petitioner’s proposed constructions. Prelim. Resp. 18–19.
`We find that resolving the parties’ dispute regarding whether we should
`institute inter partes review does not require any express claim construction at this
`stage of the proceedings.
`
`B. A Person of Ordinary Skill in the Art
`
`Petitioner proposes that a person of ordinary skill, at and before the priority
`date of the patent, would have been: (1) a scientist involved in the development of
`dermal fillers; (2) would have an advanced degree, such as an M.S., M.D., or
`Ph.D.; and (3) possessed several years of experience developing dermal fillers for
`cosmetic use, including HA-based dermal fillers. Pet. 14. Petitioner contends that
`
`
`8 This case relates to the ’795 patent, which issued from the ’884 application, of
`which the application that issued as the ’519 patent is a continuation. See Pet. 19;
`Ex. 1027.
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`such a skilled artisan would have been aware of commercially sold dermal fillers,
`in the United States and abroad, as well as those products for which approvals were
`being publicly sought. Id. (citing Ex. 1002 ¶¶ 69–72).
`Petitioner also states that a person of ordinary skill in the art would also have
`been aware of the process by which FDA reviews dermal filler products, and how
`FDA communicates the results of such reviews to the public. Pet. 14.
`Specifically, Petitioner posits that a skilled artisan would have known that once the
`FDA approved a dermal filler, the Agency would have posted information about
`that filler on its webpage. Id. (citing Ex. 1002 ¶¶ 73–75; Ex. 1032 227).
`
`The Patent Owner points to the Board’s related findings in a prior inter
`partes proceeding, IPR2017-01906, which involved the ’795 patent. Prelim. Resp.
`20. In that proceeding, the Board adopted a definition of the level of skill of a
`person of ordinary skill in the art consistent with Petitioner’s characterizations (1)–
`(3), supra. Id. The Patent Owner rejects Petitioner’s additional qualifications
`respecting “products for which approvals were being publicly sought” and
`awareness “of the process by which FDA reviews dermal filler products and how
`FDA communicates the results of such review to the public.” Id. The Patent
`Owner notes that Petitioner fails to offer any reason why the Board’s previous
`definition of a person of ordinary skill in the art is incorrect, or any reason why the
`Board should accept Petitioner’s new definition. Id.
`
`We do not find the Patent Owner’s argument persuasive. The Patent Owner
`specifically objects to the additional qualification proposed by the Petitioner as
`being characteristic of a person of ordinary skill in the art, viz.:
`A POSITA would also be aware of the process by which FDA reviews
`dermal filler products, and how FDA communicates the results of such
`reviews to the public. In particular, the POSITA would have known that
`once FDA had approved a dermal filler, the FDA would have hosted
`information about that filler on its webpage.
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`See Pet. 14. We find that whether a person of ordinary skill in the art, as defined
`by the petitioner in the prior proceedings would have also had this specific
`knowledge, as part of the performance of her qualifications and duties, is a finding
`of fact. Petitioner has presented testimony, via the DeVore Declaration, that:
`The POSITA would be aware of both currently marketed dermal fillers,
`as well as those being publicly tested by medical device companies.
`The POSITA would have been aware of the process by which FDA
`reviews applications for new dermal filler products, as well as how the
`results of those reviews are communicated to the public.
`
`Ex. 1002 ¶ 70.
`The Patent Owner presents no evidence or testimony to rebut Dr. DeVore’s
`opinion, and we consequently agree with the Petitioner’s definition of a person of
`ordinary skill in the art would have the additional knowledge and abilities testified
`to by Dr. DeVore. We find this to be particularly so because the qualifications
`recited as defining a person of ordinary skill in the art typically define the broad
`contours of an artisan’s education and capabilities and do not speak to every
`particular aspect of their knowledge and duties. Given that, we adopt for our
`present purposes that a person of ordinary skill in this particular art would be
`“aware of the process by which FDA reviews dermal filler products, and how FDA
`communicates the results of such reviews to the public.” Pet. 14. The Patent
`Owner may adduce evidence at trial to rebut this definition.
`
`C. Grounds 1, 2, and 3: Anticipation of Claims 1–4 by PMA P050047/S005,
`Weinkle, or the ’438 application, respectively
`
`
`1.
`
`
`
`Priority claims of the ’519 patent
`For the cited prior art references to anticipate claims 1–4 of the ’519 patent,
`the ’519 patent must not be able to claim the priority benefit of the ’956, ’934, or
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`’278 applications (the “priority applications”), thereby rendering the cited
`references eligible as prior art. Petitioner argues that the effective filing date of
`claims 1–4 is the actual filing date of the application that issued as the’519 patent,
`April 1, 2014, rather than the claimed priority date, because the parent applications
`do not provide sufficient support for the claims as filed. Pet. 18–19.
`
`a. Alleged lack of literal support for claims 1–4
`Petitioner first argues that effective filing date of claims 1–4 of the ’519
`patent is April 1, 2014 filing date of the ’747 application, the application that
`issued as the ’519 patent, rather than the earlier priority date(s) claimed by the
`Patent Owner, because the parent applications do not provide literal support for the
`claims as filed. Pet. 20. Petitioner points out that independent claims 1 and 3 are
`directed to sterile dermal fillers comprising BDDE-crosslinked HA and 0.3%
`lidocaine, and notes that there are no other structural limitations. Id. To the
`contrary, Petitioner contends, each claim is directed to a functional result—the
`filler’s cosmetic performance. Id. Petitioner asserts that claim 1 recites a filler
`with lidocaine that “fills in facial lines and depressions substantially the same” as
`an otherwise same filler that does not contain lidocaine. Id. Similarly, argues
`Petitioner, claim 3 recites a filler with lidocaine that “restores fat loss-related tissue
`volume loss substantially the same” as an otherwise same filler that does not
`contain lidocaine. Id.
`According to Petitioner, no disclosure in the priority documents suggests
`that the disclosed fillers have the claimed functional characteristics. Pet. 21 (citing
`Ex. 1002 ¶ 146). Petitioner asserts that the there are no comparative tests in the
`’956, ’934, or ’278 applications from which equivalent performance could be
`deduced or inferred, and that no example shows that the claimed fillers fill in facial
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`lines and depression, or restore fat loss-related tissue volume loss at all, much less
`that they do so substantially the same relative to a comparative filler that does not
`contain lidocaine. Id. (citing Ex. 1002 ¶¶ 146–147).
`Petitioner contends that, although filling facial lines and depressions or
`restoring fat loss-related tissue volume loss may be intended objectives of the
`claimed dermal fillers, as they are with all dermal fillers, compositions having
`those characteristics are not demonstrated or described anywhere in the priority
`documents, much less in enough detail to identify how the “fill[ing]” or
`“restor[ing]” is performed in either lidocaine or non-lidocaine fillers. Pet. 21
`(citing, e.g., Ex. 1082 col. 1, ll. 30–34; also citing Ariad Pharm., Inc. v. Eli Lilly &
`Co., 598 F.3d 1336, 1349–50 (Fed. Cir. 2010) (en banc)). Petitioner contends that
`the disclosure is silent as to how any composition—whether prior art or supposedly
`inventive filler—performs at filling or whether and how the disclosed
`embodiments perform “substantially the same” at filling facial lines or restoring
`tissue volume loss. Id. Therefore, argues Petitioner, there is nothing in the
`specification of the claimed priority documents that would clearly allow a person
`of ordinary skill in the art to recognize fillers having the claimed performance. Id.
`(citing Ex. 1002 ¶¶ 144–147, 152).
`The Patent Owner responds that each of the ’956, ’934, and ’278
`applications discuss the ability of these compositions to retain their viscosity so
`that they can function to fill in facial lines and restore fat loss-related tissue
`volume. Prelim. Resp. 23. By way of example, the Patent Owner notes that these
`priority applications state: “Soft tissue fillers have been developed to help fill in
`facial lines and depressions, and for restoring volume of tissues due to fat loss.”
`Id. (quoting Ex. 1013 11; Ex. 1028 4; Ex. 1044 16). The Patent Owner further
`argues that these priority applications further describe problems that soft tissue
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`fillers exhibited in performing these functions, disclosing that: “The development
`of HA-based fillers which exhibit ideal in vivo properties as well as ideal surgical
`usability has proven difficult.” Id. (quoting Ex. 1013 12; Ex. 1028 5; Ex. 1044 17).
`Furthermore, argues the Patent Owner, in the case of HA-injectable compositions,
`the priority applications attribute these problems to lidocaine-induced degradation,
`disclosing that: “HA-based injectable compositions which incorporate lidocaine
`during the manufacturing process are prone to partial or almost complete
`degradation prior to injection, particularly during high temperature sterilization
`steps and/or when placed in storage for any significant length of time.” Id. at 23–
`24 (quoting Ex. 1013 12; Ex. 1028 5; Ex. 1044 17). The Patent Owner contends
`that the ’956, ’934, and ’278 applications subsequently characterize the invention
`as solving the degradation problem, leading to improved stability and comparable
`performance to HA-based compositions lacking lidocaine. Id. at 24 (citing Ex.
`1013 13–14; Ex. 1028 6–7; Ex. 1044 18).
`The Patent Owner contends that support for claims 1–4 can also be found in
`the ’956, ’934, and ’278 applications via their disclosures with respect to the
`stability experiments involving the claimed compositions. Prelim. Resp. 25. The
`Patent Owner responds that, because the claimed compositions are stable, they are
`able to perform the filling features recited in claims 1–4. Id. The Patent Owner
`points to the tables provided in the priority applications summarizing the “stability
`testing results on the composition manufactured in accordance with the invention.”
`Id. (quoting Ex. 1013 25; Ex. 1028 18; Ex. 1044 29). According to the Patent
`Owner, the data in the Table show that the extrusion force of the compositions
`containing lidocaine remained constant over a period of 3–9 months, and thus
`maintain their integrity to function as claimed over a period of 3–9 months. Id.
`
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`The Patent Owner argues further that the ’956, ’934, and ’278 applications
`also include figures and discussion that demonstrate changes in viscosity between
`the autoclaved samples with and without lidocaine. Prelim. Resp. 25. The Patent
`Owner points to these figures as demonstrating that the viscosity at 0.1 Hz of
`BDDE-crosslinked cohesive Samples 4, 5, and 6, which embody the invention, did
`not decrease to any appreciable extent (not greater than about 30%) when lidocaine
`was added and the combination was autoclaved. Id. (citing Ex. 1013 40–44; Ex.
`1028 39–43; Ex. 1044 43–45).
`Summarizing, the Patent Owner contends that the ’956, ’934, and ’278
`applications convey to a person of skill in the art that, because the lidocaine-
`containing samples embodying the claimed invention retain their viscosity and
`extrusion force, and consequently solve the lidocaine degradation problem, they
`are able to perform the filling functions as well as identical compositions lacking
`lidocaine. Prelim. Resp. 26.
`We agree with the Patent Owner. The priority applications, as exemplified
`by the ’956 application, expressly state that: “Soft tissue fillers have been
`developed to help fill in facial lines and depressions, and for restoring volume of
`tissues due to fat loss, thereby temporarily restoring a smoother, more youthful
`appearance.” Ex. 1013 11. The ’956 applications continues:
`The search for fillers that do not provoke allergic reactions has brought
`about the development of hyaluronic acid (HA)-based products. In
`December 2003, the first HA-based filler was approved by the FDA.
`This was soon followed by other HA-based fillers.
`
`Hyaluronic acid, also known as hyaluronan, is a naturally occurring,
`water soluble polysaccharide, specifically a glycosaminoglycan, which
`is a major component of the extracellular matrix and is widely
`distributed
`in animal
`tissues. Hyaluronic acid has excellent
`biocompatibility and does not cause allergic reaction when implanted
`
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`into a patient. In addition, hyaluronic acid has the ability to bind to large
`amounts of water, making it an excellent volumizer of soft tissues.
`….
`Crosslinked HA is formed by reacting uncrosslinked HA with a
`crosslinking agent under suitable reaction conditions. Methods of
`preparing HA based soft tissue fillers including both crosslinked and
`uncrosslinked HA are well known.
`
`Id. at 11–12.
`
`The ’956 application further discloses that:
`The next step in the manufacturing process comprises the step of
`crosslinking the hydrated, alkaline NaHA gel with a suitable
`crosslinking agent. The crosslinking agent may be any agent known to
`be suitable for crosslinking polysaccharides and their derivatives via
`their hydroxyl groups. Suitable crosslinking agents include but are not
`limited to, for example, 1,4-butanediol diglycidyl ether (or 1,4-bis(2,3-
`epoxypropoxy)butane or 1,4-bisglycidyloxybutane=BDDE), 1,2-
`bis(2,3-epoxypropoxy)ethylene
`and
`1-(2,3-epoxypropyl)-2,3-
`epoxycyclohexane.
`
`Id. at 18. The priority applications thus disclose that HA dermal fillers crosslinked
`with BDDE, as claimed in the ’519 patent, were well-known in the art at the time
`of filing. Indeed, Petitioner’s declarant, Dr. DeVore, testifies that it was known in
`the art, as of August 2008, that:
`Facial dermal fillers are a class of implantable medical devices that are
`used to fill wrinkles or add volume to portions of the face where facial
`tissue has been lost. Dermal fillers are viscous liquid compositions
`which are injected using a syringe into a patient’s face in order to
`restore lost volume and remove facial wrinkle lines and folds.
`
`Ex. 1002 ¶ 78. Dr. DeVore further attests that:
`Although many different compounds can be used to crosslink HA, as
`of August 2008 the vast majority of dermal fillers were prepared from
`a small number of crosslinker compounds: 1,4-butanediol diglycidyl
`ether
`(“BDDE”),
`divinylsulfone
`(“DVS”),
`p-phenylene-
`bis(ethylcarbodiimide) (“BDCI”), and diepoxyoctane (“DEO”)….
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`Ex. 1002 ¶ 85. It is therefore evident to us that, as of the time of filing of the
`priority applications, it was well known in the art, as attested to by Dr. DeVore,
`that dermal fillers were used for “fill[ing] wrinkles or add[ing] volume to portions
`of the face where facial tissue has been lost,” and that, among such dermal fillers,
`HA crosslinked with BDDE was not only a commonly used and well understood
`formulation, but was known by the trade name of Juvéderm Ultra Plus. See id. ¶
`192.
`Furthermore, the Examples in the priority applications demonstrate that
`
`adding lidocaine to BDDE-crosslinked HA-based dermal fillers results in
`compositions that demonstrate essentially similar thermal stability and viscosity
`properties possessed by BDDE-crosslinked HA based dermal fillers9 without
`lidocaine, i.e., both compositions behave in the same way as dermal fillers
`“fill[ing] wrinkles or add[ing] volume to portions of the face where facial tissue
`has been lost.” Figure 6 of the ’956 application is reproduced below:
`
`
`9 In viewing these data, we have concerns about the lack of repetitive sampling and
`concurrent statistical analysis in the Examples of the priority applications as well
`as in the Specification of the ’519 patent. Nevertheless, the data presented
`support a prima facie argument that the thermal stability properties of the
`samples are similar, the which point is not disputed by the parties at this time.
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`Figure 6 of the ’956 application demonstrates the post-sterilization
`thermal stability of a commercially available BDDE-crosslinked HA
`dermal filler (Juvéderm Ultra Plus): (1) without lidocaine; (2) with 0.3%
`lidocaine; and (3) with 0.3% lidocaine and with pH adjusted to 7.2
`
`Figure 6 of the ’965 application (and the other priority applications) thus
`demonstrates that a BDDE-crosslinked HA-based dermal filler exhibits similar
`viscosities post-autoclaving whether paired with 0.3% lidocaine or sterile water
`(control). We agree that a person of ordinary skill in the art would have
`comprehended, from these disclosures of the priority documents, that a BDDE-
`crosslinked HA-based dermal filler containing 0.3% lidocaine would act in the
`same manner as the commercially-available, BDDE-crosslinked HA dermal filler
`(Juvéderm Ultra Plus) in its intended purpose of “fill[ing] wrinkles or add[ing]
`volume to portions of the face where facial tissue has been lost.” Or, as Petitoner’s
`declarant declarant opines:
`Because the POSITA would expect the lidocaine to be voided from the
`gel quickly after implantation, the POSITA would have expected the
`lidocaine-containing gel to have substantially the same clinical
`performance, including the claimed filling in facial lines and wrinkles
`(claim 1) and restoring fat loss related tissue volume loss, as an
`otherwise same gel that did not contain lidocaine.
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`Ex. 1002 ¶ 196 (emphasis added). We therefore do not find convincing
`Petitioner’s argument that claims 1–4 of the ’519 patent lack literal support in the
`disclosures of the ’956, ’934, and ’278 applications.
`
`
`b. Whether the disclosed species support claims 1–4
`Petitioner next argues that the species disclosed in the ’956, ’934, and ’278
`applications do not describe the full scope of the fillers recited in the claims. Pet.
`22 (citing Ex. 1002 ¶ 152). Petitioner notes that, in an unpredictable art, the
`disclosure of many species will not describe a genus if the genus is much broader
`than the species. Id. (citing Abbvie Deutschland GmbH & Co. v. Janssen Biotech,
`Inc., 759 F.3d 1285, 1301 (Fed. Cir. 2014)). According to Petitioner, the Patent
`Owner has repeatedly argued that the claims were patentable because it was not
`expected that lidocaine could be combined with hyaluronic acid and that it was an
`unexpected discovery that cohesive gels could be successfully combined with
`lidocaine. Id. at 23 (citing Ex. 104 ¶¶ 5–10; Ex. 1023, 23–25).
`Petitioner asserts that the claims of the ʼ519 patent are broad, requiring only
`the presence of BDDE-crosslinked HA and 0.3% lidocaine. Pet. 23. The claims
`cover fillers with essentially any degree of crosslinking, any particle size, any
`amount of free HA and almost any ratio of high and low molecular weight HA. Id.
`(Ex. 1002 ¶¶ 149–150). However, Petitioner argues the ’956, ’934, and ’278
`applications disclose only three species, each of which is a cohesive gel having 6%
`crosslinking or less. Id. (citing Ex. 1001 col. 15, ll. 38–52).
`Petitioner contends that, in view of the breadth of the claims, the Patent
`Owner’s repeated assertions that the art was unpredictable compels a finding that
`the claims are not entitled to the claimed priority date, even if one or more of the
`species disclosed therein might have the claimed performance. Pet. 24. Petitioner
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`argues that the ʼ519 patent and the priority documents all contend that it was
`unpredictable whether lidocaine could be added to a dermal filler. Id. (citing Ex.
`1001 col. 2, ll. 26–31). Petitioner also observes that the ʼ956 application (which is
`incorporated by reference into each of the priority applications) explicitly states
`that it was “recognized” by the “conventional knowledge in the art” that adding
`lidocaine to HA compositions resulted in degradation. Id. (citing Ex. 1013 col. 4,
`ll. 14–20) (emphasis added).
`Petitioner also points to the Declaration of inventor Dr. Pierre Lebreton (the
`“Lebreton Declaration” (Ex. 1024)), submitted during examination, which states
`that “shortly prior to August 4, 2008,” “it was believed that adding lidocaine to
`hyaluronic acid gel compositions during manufacturing caused degradation of the
`hyaluronic acid prior to injection of the HA as a dermal filler.” Pet. 25 (quoting
`Ex. 1024 ¶¶ 4–5). Petitioner asserts that the Lebreton Declaration states that it was
`discovered that a subset of dermal fillers, e.g., cohesive gels, could be successfully
`combined with lidocaine: “To my knowledge, it was a surprising and unexpected
`discovery, not appreciated prior to the present invention, that certain cohesive HA
`gels, as defined in the application, when mixed with lidocaine, could be made to be
`heat and shelf stable.” Id. (quoting Ex. 1024 ¶ 15).
`Summarizing, Petitioner contends that the alleged breadth of the claims, the
`alleged lack of a sufficient number of examples, and the Patent Owner’s asserted
`unpredictability of the art compel a finding that the claims are not described by any
`of the claimed priority documents. Pet. 26.
`
`The Patent Owner responds that claims 1–4 are drawn to sterile dermal filler
`compositions containing BDDE-crosslinked HA and 0.3% lidocaine that perform
`the claimed filler functions that are substantially the same as identical dermal
`fillers lacking lidocaine. Prelim. Resp. 27–28 (citing Ex. 1001 col. 19