IPR2020-00084
`Patent 9,089,519
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`PROLLENIUM US INC.,
`Petitioner,
`
`v.
`
`ALLERGAN INDUSTRIE, SAS,
`Patent Owner.
`
`_________________
`
`Case IPR2020-00084
`U.S. Patent 9,089,519
`_________________
`
`PATENT OWNER’S SUR-REPLY TO PETITIONER’S REPLY TO
`PATENT OWNER’S RESPONSE
`
`
`
`
`
`

`

`IPR2020-00084
`Patent 9,089,519
`
`TABLE OF CONTENTS
`
`
`
`I.
`II.
`
`INTRODUCTION .......................................................................................... 1
`PETITIONER BELABORS IRRELEVANT POINTS THAT FAIL
`TO ADDRESS ITS OVERSIMPLIFIED VIEW OF THE ART ................... 2
`A.
`Petitioner’s “New” Versus “Modified” Dichotomy Is Irrelevant ........ 2
`B. What The POSA “Could” Do Is Insufficient ....................................... 3
`C.
`“Routine Testing” Is Insufficient ......................................................... 4
`D.
`Petitioner Fails To Rehabilitate Dr. DeVore’s Admissions ................. 5
`III. DR. PRESTWICH DOES NOT REHABILITATE THE PETITION ........... 6
`IV. POSA DEFINITION ...................................................................................... 9
`V.
`CLAIMS 1-8 WOULD NOT HAVE BEEN OBVIOUS OVER
`LEBRETON IN VIEW OF SADOZAI (GROUND 4) OR P050047 IN
`VIEW OF KINNEY (GROUND 5) ............................................................. 10
`A.
`Petitioner Failed To Establish Prior Art ............................................. 10
`B.
`The POSA Would Not Have Been Motivated To Combine
`Lebreton And Sadozai Or P050047 And Kinney ............................... 10
`C. No Reasonable Expectation of Success For Lebreton And
`Sadozai ............................................................................................... 13
`1.
`Petitioner’s Rheology Arguments Are Unsupported ............... 13
`2.
`Petitioner’s Acidic-Degradation Arguments Are
`Unsupported ............................................................................. 15
`Petitioner Fails To Establish A Reasonable Expectation Of
`Success Combining P050047 And Kinney ........................................ 17
`The Art Was Unpredictable ................................................................ 18
`E.
`The Petition Fails On Specific Limitations ........................................ 20
`F.
`VI. CLAIMS 1-4 ARE NOT ANTICIPATED (GROUNDS 1-3) ..................... 23
`VII. CONCLUSION ............................................................................................. 24
`
`
`D.
`
`
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`IPR2020-00084
`Patent 9,089,519
`
`EXHIBIT LIST
`
`Exhibit No.
`
`Exhibit Description
`
`2001
`2002
`2003
`2004
`
`2005
`2006
`2007
`2008
`2009
`2010
`2011
`
`2012
`
`2013
`2014
`2015
`
`2016
`
`2017
`
`Juvéderm Ultra™ XC Label
`Juvéderm Ultra Plus™ XC Label
`Juvéderm Voluma® XC Label
`U.S. Patent Publication No. 2004/0101959 to Marko et al,
`published May 27, 2004
`Excerpts from U.S. 8,822,676 file history
`Excerpts from U.S. 9,089,519 file history
`About Juvéderm Ultra Plus™ XC
`About Juvéderm Volbella® XC
`About Juvéderm Voluma® XC
`Reserved
`Declaration in support of unopposed motion for pro hac vice
`admission of Elizabeth Flanagan
`Updated Declaration in support of unopposed motion for pro hac
`vice admission of Elizabeth Flanagan
`Declaration of Cory J. Berkland, Ph.D
`Curriculum Vitae, Cory J. Berkland, Ph.D.
`Kuo, Practical Aspects of Hyaluronan Based Medical Products,
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`Vol. 15, 1982; 386-395. (“Cleland”)
`
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`IPR2020-00084
`Patent 9,089,519
`
`Exhibit No.
`
`Exhibit Description
`
`2018
`
`2019
`
`2020
`2021
`
`2022
`
`2023
`
`2024
`2025
`2026
`
`2027
`
`2028
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`and Biomedical Engineering, 2004; 779-789. (“Leach”)
`
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`IPR2020-00084
`Patent 9,089,519
`
`Exhibit No.
`
`Exhibit Description
`
`2029
`
`2030
`
`2031
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
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`2037
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`2038
`
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`(“Lefebvre”)
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`(“Tokita 1995”)
`
`
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`-iv-
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`IPR2020-00084
`Patent 9,089,519
`
`Exhibit No.
`
`Exhibit Description
`
`2039
`
`2040
`
`2041
`
`2042
`
`2043
`
`2044
`
`2045
`2046
`2047
`
`2048
`2049
`
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`Osteoarthritis, Biomaterials, Vol. 23, 2002; 4503-4513.
`(“Barbucci”)
`Reserved
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`Perlane, Facial Plastic Surgery Clinics of North America, Vol. 15,
`2007; 63-76. (“Brandt”)
`
`
`
`-v-
`
`
`
`

`

`Exhibit No.
`
`Exhibit Description
`
`IPR2020-00084
`Patent 9,089,519
`
`2050
`2051
`
`2052
`
`Declaration of Amelia E. Murray.
`Zhao, et al., Synthesis and Characterization of A Novel Double
`Crosslinked Hyaluronan Hydrogel, Journal of Materials Science:
`Materials in Medicine, Vol. 13, 2002; 11-16. (“Zhao”)
`Ballin, et al., Long-term Efficacy, Safety and Durability of
`Juvéderm® XC, Clinical, Cosmetic and Investigational
`Dermatology, Vol. 6, 2013; 183-189. (“Ballin”)
`2053-2054 Reserved
`2055
`Khabarov, et al., Chemical Modifications, Solid Phase, Radio-
`Chemical and Enzymatic Transformations of Hyaluronic Acid,
`Polyak Ch. 5, Hyaluronic Acid: Preparation, Properties,
`Application in Biology and Medicine, 1st Ed., 2015; 121-141.
`(“Khabarov”)
`Onesti et al., Assessment of A New Hyaluronic Acid Filler.
`Double-blind, Randomized, Comparative Study Between Puragen
`and Captique in the Treatment of Nasolabial Folds, In Vivo, Vol.
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`Application for Patent Term Extension of U.S. Pat. No. 5,827,937
`(Ågerup).
`U.S. Patent No. 5,827,937 (Ågerup).
`Micheels et al., Effect of Difference Crosslinking Technologies on
`Hyaluronic Acid Behavior: A Visual and Microscopic Study of
`Seven Hyaluronic Acid Gels, Journal of Drugs in Dermatology,
`Vol. 15, No. 5, 2016; 600-606. (“Micheels 2016”)
`Micheels and Eng, Rheological Properties of Several Hyaluronic
`Acid-Based Gels: A Comparative Study, Journal of Drugs in
`Dermatology, Vol. 17, No. 9, 2018; 948-954. (“Micheels 2018”)
`Stocks et al., Rheological Evaluation of the Physical Properties of
`Hyaluronic Acid Dermal Fillers, Journal of Drugs in
`Dermatology, Vol. 10, No. 9, 2011; 974-980. (“Stocks”)
`
`2056
`
`2057
`
`2058
`2059
`
`2060
`
`2061
`
`
`
`-vi-
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`IPR2020-00084
`Patent 9,089,519
`
`Exhibit No.
`
`Exhibit Description
`
`2062
`
`2063
`
`2064
`
`2065
`2066
`2067
`2068
`
`2069
`2070
`
`2071
`
`2072
`
`2073
`
`Shah and Barnett, Hyaluronic Acid Gels, Harland and
`Prud’homme Ch. 7, Polyelectrolyte Gels, 1992; 116-130. (“Shah”)
`Busso, Calcium Hyroxylapatite (Radiesse®): Safety, Techniques
`and Pain Reduction, Journal of Drugs in Dermatology, Vol. 8, No.
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`Busso and Voigts, An Investigation of Changes in Physical
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`when Mixed with Lidocaine and with Lidocaine/Epinepherine,
`Dermatologic Surgery, Vol. 34, 2008; s16-s24. (“Busso 2008”)
`Reserved
`U.S. Patent No. 5,880,107 (Buenter).
`U.S. Patent No. 8,455,465 (Molliard).
`Balazs, et al., Applications of Hyaluronan and Its Derivatives,
`Biotechnological Polymers, 1993; 41-65. (“Balazs”)
`U.S. Patent No. 5,017,229 (Burns).
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`Collins and Birkinshaw, Physical Properties of Crosslinked
`Hyaluronic Acid Hydrogels, Journal of Materials Science:
`Materials Science in Medicine, Vol. 19, 2008; 3335–3343.
`(“Collins 2008”)
`Shah and Barnett, Swelling Behavior of Hyaluronic Acid Gels,
`Journal of Applied Polymer Science, Vol. 45, 1992; 293-298.
`(“Shah II”)
`Reserved
`
`
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`

`Exhibit No.
`
`Exhibit Description
`
`IPR2020-00084
`Patent 9,089,519
`
`2074
`
`2075
`
`Liao, et al., Hyaluronan: Pharmaceutical Characterization and
`Drug Delivery, Drug Delivery, Vol. 12, No. 6, 2005; 327-342.
`(“Liao”)
`Artes Medical Initiates Market Launch and Commercial Sale of
`Elevess, a New FDA-Approved Hyaluronic Acid-Based Dermal
`Filler, Business Wire, 2008,
`https://www.businesswire.com/news/home/20080805005349/en/A
`rtes-Medical-Initiates-Market-Launch-Commercial-Sale.
`2076-2077 Reserved
`2078
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`https://www.fda.gov/regulatory-information/search-fda-guidance-
`documents/shelf-life-medical-devices. (“Clark”)
`Falcone, et al., Biomedical Applications of Hyaluronic Acid,
`Marchessault et al. Ch. 8, Polysaccharides for Drug Delivery and
`Pharmaceutical Applications, 2006; 155-174. (“Falcone”)
`Wieland, et al., Non-Viral Vector Delivery From PEG-Hyaluronic
`Acid Hydrogels, Journal of Controlled Release, Vol. 120, No. 3,
`2007. (“Wieland”)
`Curriculum Vitae, Pierre F. Lebreton, Ph.D.
`Reserved
`Vivacy Laboratories Testing Report on FR0857575, with
`translation,
`https://register.epo.org/application?documentId=ER83XYVA8475
`754&number=EP09768146&lng=fr&npl=true.
`Vivacy Laboratories Testing Report on EP2 349 203 B1, with
`translation,
`https://register.epo.org/application?documentId=EWD1Y85G8021
`FI4&number=EP09768146&lng=fr&npl=false.
`
`2079
`
`2080
`
`2081
`2082
`2083
`
`2084
`
`
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`-viii-
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`IPR2020-00084
`Patent 9,089,519
`
`Exhibit No.
`
`Exhibit Description
`
`2085
`
`2086
`2087
`
`2088
`
`2089
`
`2090
`
`2091
`
`2092
`
`2093
`
`Kuo, et al., Chemical Modification of Hyaluronic Acid by
`Carbodiimides, Bioconjugate Chemistry, Vol. 2, 1991; 232-241.
`(“Kuo 1991”)
`U.S. Patent No. 4,963,666 (Mälson).
`Agalloco, et al., Aseptic Processing: A Review of Current Industry
`Practice, Pharmaceutical Technology, 2004; 126-150.
`(“Agalloco”)
`Kuroda, et al., Interactions Between Local Anesthetics and Na+
`Channel Inactivation Gate Peptides in Phosphatidylserine
`Suspensions as Studied by 1H-NMR Spectroscopy, Chemical and
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`(“Kuroda”)
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`Forces, Ch. 3, Modern Physical Organic Chemistry, 2006; 145-
`205. (“Anslyn”)
`Simon, et al., Mechanisms Controlling Diffusion and Release of
`Model Proteins Through and From Partially Esterified
`Hyaluronic Acid Membranes, Journal of Controlled Release, Vol.
`61, 1999; 267-279. (“Simon”)
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`http://www.annualreports.co.uk/HostedData/AnnualReportArchiv
`e/a/NASDAQ_ANIK_2006.pdf.
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`Membranes as Potential Wound Dressings: Evaluation of Water
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`1639-1643. (“Ruiz-Cardona”)
`Bulpitt and Aeschlimann, New Strategy for Chemical Modification
`of Hyaluronic Acid: Preparation of Functionalized Derivatives
`and Their Use in the Formation of Novel Biocompatible
`Hydrogels, Journal of Biomaterials Research, Vol. 47, No. 2,
`1999; 152-169. (“Bulpitt”)
`
`
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`Exhibit No.
`
`Exhibit Description
`
`IPR2020-00084
`Patent 9,089,519
`
`2094
`
`Maleki, et al., Effect of pH on the Behavior of Hyaluronic Acid in
`Dilute and Semidilute Aqueous Solutions, Macromolecular
`Symposia, Vol. 274, 2008; 131-140. (“Maleki”)
`2095-2099 Reserved
`2100
`Transcript of the Deposition of Dale DeVore
`2101-2104 Reserved
`2105
`Anika Therapeutics, Inc., SEC Form 10-k, 2006,
`https://www.sec.gov/Archives/edgar/data/898437/0001104659070
`18715/0001104659-07-018715-index.htm. (Ex. 05 to DeVore
`Dep.)
`FDA Premarket Approval, CTA Suppl. 004,
`https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cf
`m?id=P050033S004. (Ex. 06 to DeVore Dep.)
`2107-2121 Reserved
`2122
`FDA Premarket Approval, CTA Suppl. 001. (Ex. 22 to DeVore
`Dep.)
`FDA Premarket Approval, CTA Suppl. 003,
`https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cf
`m?id=P050033S001. (Ex. 23 to DeVore Dep.)
`2124-2127 Reserved
`2128
`U.S. Pat. No. 9,352,046 (DeVore). (Ex. 28 to DeVore Dep.)
`2129
`ESM Technologies, Inc. v BIOVA, LLC and Matthew Stegenga,
`C.A. No. 6:10-cv-03009-RED (W.D. Mo. 2011), Declaration of
`Dale Paul DeVore, Ph.D. (Ex. 29 to DeVore Dep.)
`Curriculum Vitae of Dale P. DeVore, Ph.D, submitted in Biocell
`Technology, LLC v. ARTHRO-7 INC., C.A. No. 8:12-cv-00516-
`JVS-RNB (C.D. Ca. Mar. 25, 2013). (Ex. 30 to DeVore Dep.)
`2131-2134 Reserved
`
`2106
`
`2123
`
`2130
`
`
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`-x-
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`

`2136
`
`2137
`
`2138
`
`2139
`
`2140
`
`Exhibit No.
`
`Exhibit Description
`
`IPR2020-00084
`Patent 9,089,519
`
`2135
`
`Mentor Corporation, Press Release and Third Quarter Financial
`Results, 2006,
`https://www.sec.gov/Archives/edgar/data/64892/00000648920600
`0005/k8feb0606results.htm. (Ex. 35 to DeVore Dep.)
`Mentor Corporation, SEC Form 10-Q, 2006,
`https://www.sec.gov/Archives/edgar/data/64892/00010032970600
`0047/0001003297-06-000047-index.htm. (Ex. 36 to DeVore Dep.)
`Mentor Corporation, SEC Form 10-K, 2006,
`https://www.sec.gov/Archives/edgar/data/64892/00000648920600
`0023/0000064892-06-000023-index.htm. (Ex. 37 to DeVore Dep.)
`Mentor Corporation, SEC Form 10-K, 2007,
`https://www.sec.gov/Archives/edgar/data/64892/00013623100700
`0951/0001362310-07-000951-index.htm. (Ex. 38 to DeVore
`Dep.)
`Mentor Corporation, SEC Form 10-K, 2008,
`https://www.sec.gov/Archives/edgar/data/64892/00013623100800
`3062/0001362310-08-003062-index.htm. (Ex. 39 to DeVore Dep.)
`Identification of Expert Witness in International Trade
`Commission Inv. No. 337-TA-515 (2004). (Ex. 40 to DeVore
`Dep.)
`2141-2147 Reserved
`2148
`Silver, et al., Viscoelastic Evaluation of Different Hyaluronic Acid
`Based Fillers Using Vibrational Optical Coherence Tomography,
`Materials Sciences and Applications, Vol. 10, 2019; 423-431. (Ex.
`48 to DeVore Dep.)
`Pendant Modification Figure. (Ex. 49 to DeVore Dep.)
`2149
`2150-2151 Reserved
`2152
`Figure Depicting Chemical Structure of DEO. (Ex. 52 to DeVore
`Dep.)
`
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`Exhibit No.
`
`Exhibit Description
`
`IPR2020-00084
`Patent 9,089,519
`
`2153
`
`2154
`
`2155
`
`Figure Depicting Chemical Structure of BDDE. (Ex. 53 to DeVore
`Dep.)
`Figure Depicting Chemical Structure of DVS. (Ex. 54 to DeVore
`Dep.)
`Figure Depicting Incorrect Chemical Structure of pBCDI. (Ex. 55
`to DeVore Dep.)
`Figure Depicting Correct Chemical Structure of pBCDI. (Ex. 56 to
`DeVore Dep.)
`Reserved
`Figure Depicting Chemical Structure of NaHA. (Ex. 58 to DeVore
`Dep.)
`2159-2164 Reserved
`2165
`Lidocaine Quiz. (Ex. 65 to DeVore Dep.)
`2166-2171 Reserved
`2172
`Declaration of Dale P. DeVore in U.S. Patent Application No.
`13/813,557. (Ex. 72 to DeVore Dep.)
`Declaration of Dale P. Devore in U.S. Patent Application No.
`14/430,741. (Ex. 73 to DeVore Dep.)
`Figures Depicting Chemical Structures of Crosslinked HA. (Ex. 74
`to DeVore Dep.)
`
`2156
`
`2157
`2158
`
`2173
`
`2174
`
`
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`-xii-
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`IPR2020-00084
`Patent 9,089,519
`
`Exhibit No.
`
`2200
`
`Exhibit Description
`
`Deposition Transcript of Glenn Prestwich, Ph.D. (Nov. 23-24,
`2020)
`Dep. Ex. 2200B – Declaration of Glenn Prestwich in Galderma v.
`Allergan, IPR2014-01417, Ex. 1041 (April 17, 2014)1
`Dep. Ex. 2200E – Declaration of Glenn Prestwich in Galderma v.
`Allergan, IPR2014-01422, Ex. 1041 (April 17, 2014)
`Dep. Ex. 2200G – Declaration of Glenn Prestwich in Teoxane v.
`Allergan, IPR2017-02002, Ex. 1041 (Aug. 19, 2017)
`Dep. Ex. 2200I – Declaration of Glenn Prestwich in Teoxane v.
`Allergan, IPR2017-01906, Ex. 1041 (July 31, 2017)
`
`
`
`
`
`1 Patent Owner submits Dr. Prestwich’s prior declarations as part of the
`
`deposition transcript. These declarations regard two of the patents at issue in these
`
`related IPR proceedings and contradict numerous positions taken by Petitioner and
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`Dr. Prestwich in these proceedings. Petitioner did not serve them pursuant to 37
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`C.F.R. § 42.51(b)(1)(iii). Patent Owner uses these exhibits for impeachment
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`purposes to evaluate the credibility of Dr. Prestwich’s statements in these
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`proceedings. See e.g., Actelion Pharms. LTD v. ICOS Corp., IPR2015-00562,
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`Paper 50 at 32 (PTAB Aug. 3, 2015 (Snedden, APJ)).
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`-xiii-
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`

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`IPR2020-00084
`Patent 9,089,519
`
`
`
`
`Abbreviation
`’519 patent
`BDDE
`BCDI
`DEO
`DVS
`Challenged
`Claims
`Challenged
`Patents
`
`ID
`HA
`pBCDI
`Pet.
`POSA
`Response
`Reply
`
`TABLE OF ABBREVIATIONS
`
`Term
`
`U.S. Patent No. 9,089,519
`butanediol diglycidyl ether
`class of crosslinkers made using biscarbodiimide derivatives
`1,2,7,8-diepoxyoctane
`divinyl sulfone
`Claims 1-8 of U.S. Patent No. 9,089,519
`
`U.S. Patent Nos. 8,450,475; 8,357,795; 9,238,013; 9,358,322;
`8,822,676; and 9,089,519, challenged in one or more of
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-
`01509, IPR2019-01617, IPR2019-01632, and IPR2020-00084
`Institution Decision, Paper 12
`hyaluronic acid
`p-phenylene-bis(ethylcarbodiimide)
`Petition, Paper 1
`Person of Ordinary Skill in the Art
`Patent Owner Response, Paper 35
`Petitioner’s Reply, Paper 38
`
`
`All emphasis in this Sur-Reply is added unless otherwise indicated.
`
`
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`-xiv-
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`

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`IPR2020-00084
`Patent 9,089,519
`
`I.
`
`INTRODUCTION
`The Petition relied heavily on the now discredited testimony of Dr. DeVore
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`to disparage inventor Dr. Lebreton’s declaration describing the unexpected success
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`of the claimed inventions. Indeed, the Board instituted based on preliminarily
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`crediting Dr. DeVore. ID 34, 50.
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`In view of Dr. DeVore’s admissions and the undisputed unpredictability in
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`the art, Petitioner scrambles to rehabilitate its grounds. It attempts to erase
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`Dr. DeVore’s cross-examination, disregards glaring holes in its grounds, and now
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`ignores Dr. Lebreton’s declaration entirely. Instead, for nearly half its Reply,
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`Petitioner offers lofty rhetoric that sidesteps what it must prove and is far removed
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`from the Petition’s assertions upon which the Board instituted. (Section II, infra.)
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`Petitioner’s attempt to refashion its case includes citing a new declarant,
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`Dr. Prestwich. (Section III, infra.) He offers a new construction for “freely
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`released,” new references, and new opinions. But trotting these out now is
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`improper. The Reply even omits that Dr. Prestwich previously opined—
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`unsuccessfully—on several of the Challenged Patents and issues here. Petitioner
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`has no basis for engaging one expert for institution and now offering another
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`whose undisclosed prior opinions undermine the Petition.
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`New evidence or old, Petitioner’s Reply is also substantively inadequate,
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`failing to address several issues. (Sections IV-VI, infra.) And Dr. Prestwich
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`IPR2020-00084
`Patent 9,089,519
`cherry-picks points, without supporting (or even knowing) the grounds in full—for
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`instance, he offers no rebuttal to Allergan’s showing of the priority date of the ’519
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`patent. Given the incompleteness of his opinions alone, and even setting aside the
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`lateness of his opinions, he cannot supplant Dr. DeVore’s cross-examination
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`concessions. And regardless, Petitioner’s grounds fail. Grounds 1-3 rely on art
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`that post-dates the priority date. For Grounds 4-5, without hindsight or
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`oversimplification of the art, there is no motivation to combine Petitioner’s
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`references, nor any reasonable expectation of success.
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`II.
`
`PETITIONER BELABORS IRRELEVANT POINTS THAT FAIL TO
`ADDRESS ITS OVERSIMPLIFIED VIEW OF THE ART
`A.
`Petitioner’s “New” Versus “Modified” Dichotomy Is Irrelevant
` Petitioner, sidestepping its own grounds, argues that the claims merely
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`involve “modifying” an existing BDDE-crosslinked filler to include lidocaine.
`
`Reply 21-22. But “[v]irtually all inventions are combinations”; the inquiry is
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`“what the prior art as a whole would have suggested.” Envtl. Designs, Ltd. v.
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`Union Oil Co., 713 F.2d 693, 698 (Fed. Cir. 1983). Petitioner ignores evidence
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`showing small “modifications” in this art have significant and unpredictable
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`effects. Response 4-17; Sections IV-VI, infra. It fails to show why a POSA would
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`disregard teachings and alter an already successful filler to incorporate lidocaine.
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`And even setting aside the discouraging unpredictability, Petitioner still does not
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`show any reasonable expectation of success. Response 32-34; Section IV-VI,
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`
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`-2-
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`IPR2020-00084
`Patent 9,089,519
`infra. These are evidentiary burdens Petitioner bears; its characterization of the
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`claims as “modifications of fillers disclosed in the prior art” does not suffice.
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`Reply 15.
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`Petitioner says Dr. Berkland “exaggerates” the unpredictability (Reply 16),
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`but that is pure rhetoric. Dr. Berkland’s opinions on the complexity and
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`unpredictability in the art are supported by publications and patents. E.g.,
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`Response 4-17.
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`Petitioner half-heartedly argues that Allergan “stretches” Dr. DeVore’s
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`testimony about unpredictability (Reply 23), but it is Petitioner that rewrites his
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`damaging testimony, including to support its new line-drawing between “new” and
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`“modified” fillers. Id.; see EX2100, 103:20-104:4. Likewise, Petitioner cannot set
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`aside Dr. DeVore’s testimony about difficulties from “varying crosslinking density
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`alone,” as somehow “abstract.” Reply 24 n.6. And the contexts in which he
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`recognized that dermal fillers require a “multifactorial design” involving “many
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`complex factors” presenting “a formidable task” (EX2100, 156:14-158:24;
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`EX2128, 6:30-36) do not render those concessions irrelevant. Reply 22-23, 24 n.6.
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`B. What The POSA “Could” Do Is Insufficient
`The Reply attempts to turn Dr. Berkland’s testimony about the POSA’s
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`“capabilities” in its favor. Reply 21-22 (citing Berkland on a POSA “could
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`optimize,” and that “modifications proposed in the Grounds were within the
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`
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`-3-
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`IPR2020-00084
`Patent 9,089,519
`POSITA’s skill”); id. 16, 22 (resting on tasks within the POSA’s skill). But as
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`Petitioner’s expert acknowledges, the POSA’s tools and capabilities cannot carry
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`Petitioner’s burden. EX2200, 303:13-306:23. “The obviousness inquiry does not
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`merely ask whether a skilled artisan could combine the references, but instead asks
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`whether ‘they would have been motivated to do so.’” Adidas AG v. Nike, Inc., 963
`
`F.3d 1355, 1359 (Fed. Cir. 2020). And Petitioner ignores that Dr. Berkland
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`distinguished capability from motivation or expectation of success. EX1200,
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`358:21-359:14.
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`Likewise, Petitioner cannot rest on “the POSITA’s ‘significant abilities’ in
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`this field.” Reply 21. A patent challenger “cannot simply invoke ‘the high level of
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`skill in the art’ as proof positive of its findings.” In re NuVasive, Inc., 842 F.3d
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`1376, 1383 (Fed. Cir. 2016).
`
`C.
`“Routine Testing” Is Insufficient
` Although the Reply posits “[t]esting something does not make it
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`unpredictable,” Petitioner’s arguments go further—emphasizing “it was routine” to
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`test. Reply 23. The availability of “routine” testing, however, matters only
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`“[o]nce the POSITA arrives” at a composition to test. See Reply 17. It remains
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`Petitioner’s burden to show motivation to make the claimed composition in the
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`first place, and a reasonable expectation of success of achieving it. See, e.g.,
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`Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1089 (Fed. Cir. 2008) (rejecting
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`
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`-4-
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`IPR2020-00084
`Patent 9,089,519
`obviousness arguments on “whether it would have been obvious to separate and
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`test” the claimed properties). Petitioner’s cited case credited routine testing
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`because the “particularized” facts showed predictable results, which testing merely
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`“verified.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1367 (Fed. Cir. 2007)
`
`(emphasis in original). Petitioner has not shown similar facts here.
`
`D.
`Petitioner Fails To Rehabilitate Dr. DeVore’s Admissions
` As Allergan showed, Dr. DeVore made numerous admissions highlighting
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`his use of hindsight and lack of candor. Response 26-32. Petitioner reverts to his
`
`earlier declaration. E.g., Reply 26-27. But Petitioner cannot disregard
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`Dr. DeVore’s admissions, elicited on cross-examination, that support Allergan.
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`Petitioner seeks to cast aside Dr. DeVore’s concessions about
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`unpredictability on the basis that “the standard” is a “reasonable probability of
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`success.” Reply 23 (Petitioner’s emphasis). That is unresponsive; unpredictability
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`directly relates to reasonable probability of success. In view of such concessions,
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`Petitioner cannot credibly argue the existence of motivation to combine and
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`expectation of success.
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`Petitioner also chalks up Dr. DeVore’s cross-examination testimony to
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`“forgetfulness” and his lack of candor as “lesser relevance.” Reply 20, 25. But
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`these views are inappropriate in light of Petitioner’s evidentiary burden. As the
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`Board held, “even the slightest accommodation of deceit or a lack of candor in any
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`IPR2020-00084
`Patent 9,089,519
`material respect quickly erodes the validity of the process.” Blackberry Corp. v.
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`Zipit Wireless, Inc., IPR2014-01508, Paper 49 at 10 (PTAB Mar. 29, 2016)
`
`(rejecting argument that expert’s “description of his Master’s degree is merely
`
`harmless embellishment or an artful rewording having the same effective
`
`meaning”). Nor are they consistent with the record. Despite Petitioner’s
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`insistence, Dr. DeVore never described Food Science as a “related” field.
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`Response 29-30; see EX2100, 509:9-20. Petitioner’s focus on Dr. DeVore’s work
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`experience, Reply 20-21, doesn’t excuse his misrepresentations and ignores that he
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`and Petitioner define a POSA by both a required education and work experience.
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`EX1002, ¶ 70.
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`As Allergan explained (Response 26-33), Dr. DeVore’s declaration warrants
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`no weight, and without the admitted hindsight, Petitioner fails to show
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`obviousness.
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`III. DR. PRESTWICH DOES NOT REHABILITATE THE PETITION
`Notwithstanding Dr. DeVore’s concessions, Petitioner has not offered any
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`rebuttal evidence from him. Instead, Petitioner turns to Dr. Prestwich. But the
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`opportunity of a reply, or a rebuttal declaration, is not permission for Petitioner to
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`reinvent the record. See The Scotts Co. v. Encap, LLC, IPR2013-00110, Paper 79
`
`at 5 (PTAB June 24, 2014). Petitioner’s grounds—as Dr. DeVore admitted—
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`pieced together disparate references using hindsight. EX2100, 370:3-371:16.
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`IPR2020-00084
`Patent 9,089,519
`Petitioner cannot erase this hindsight by untimely enlisting Dr. Prestwich. Indeed,
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`he acknowledged it was Dr. DeVore who selected the grounds raised by
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`Prollenium, and that he (Dr. Prestwich) did not opine on all references in the
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`grounds and was not even sure what the grounds included. EX2200, 218:14-20;
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`429:10-432:13.
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`In any event, Dr. Prestwich’s incomplete testimony does not provide the
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`necessary motivation to combine or reasonable expectation of success that
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`Petitioner must show. His declaration largely boils down to previously dismissed
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`characterizations of the state of the art and a recitation of certain contested
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`statements of fact where Dr. Prestwich “agree[ed]” with Dr. DeVore. E.g.,
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`EX1105, ¶¶ 70, 97. But Dr. Prestwich cannot usurp the Board’s role of weighing
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`evidence or making credibility determinations. Nor can Dr. Prestwich’s agreement
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`with Dr. DeVore’s declaration (but not his cross-examination testimony) satisfy
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`Petitioner’s burden. EX2200, 465:15-466:9. Also, as highlighted below, Dr.
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`Prestwich ignores the undisputed unpredictability and teachings in the references
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`themselves—key problems with Dr. DeVore’s declaration.
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`Nor can Petitioner escape the fact that significant portions of Dr. Prestwich’s
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`“rebuttal” declaration, allegedly describing the “state of the art,” were already
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`rejected by the Board in declining IPR institution for two patents challenged here
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`(U.S. Patent Nos. 8,450,475; 8,357,795), and by the Examiner in granting three
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`-7-
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`IPR2020-00084
`Patent 9,089,519
`others (U.S. Patent Nos. 9,238,013 (p. 4); 9,358,322 (p. 6); 9,089,519 (p. 3)).
`
`EX2200, 20:23-21:1; Teoxane v. Allergan, Nos. IPR2017-01906 (Paper 15) &
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`IPR2017-02002 (Paper 14); EX2200B; EX2200E; EX2200G; EX2200I.2
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`Moreover, all of those prior declarations and proceedings were available when
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`Petitioner filed its Petitions. The Reply’s reliance on those same opinions fails to
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`rectify the Petition. Indeed, it exceeds the proper scope of a reply and improperly
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`skirted the Board’s evaluation of § 325(d) discretionary denial. ID 35-43.
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`For any of these reasons, and as discussed in the context of Petitioner’s
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`gro