Paper 38
`Filed: November 4, 2020
`
`
`
`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
`Patent 9,089,519
`________________
`
`
`
`PETITIONER’S REPLY TO PATENT OWNER RESPONSE
`
`
`
`
`
`
`Filed: November 4, 2020
`
`
`
`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
`Patent 9,089,519
`________________
`
`
`
`PETITIONER’S REPLY TO PATENT OWNER RESPONSE
`
`
`
`
`
`
`
`IPR2020-00084
`Patent 9,089,519
`
`I.
`II.
`
`TABLE OF CONTENTS
`
`INTRODUCTION .........................................................................................15
`PERSPECTIVE OF THE POSITA ................................................................17
`A. POSITAs knew about competitive products and their properties ................ 17
`B. DeVore qualifies as a POSITA ..................................................................... 19
`C. DeVore’s opinions are supported by the prior art, as Berkland conceded .... 21
`1. Evidence corroborates DeVore’s testimony POSITAs could make the
`proposed modifications ............................................................................21
`2. Testing something does not make it unpredictable ..................................22
`3. DeVore articulated sufficient rationales for his opinions .........................24
`FDA DOCUMENTS ARE PRIOR ART .......................................................25
`GROUNDS 4 AND 5 ....................................................................................26
`A. POSITA was motivated to add lidocaine to either Lebreton or P050047 .... 26
`B. Ground 4: Expectation of success ................................................................ 29
`C. Ground 5: Expectation of success ................................................................ 32
`D. The totality of the art suggests success ......................................................... 33
`E. Performance features are inherent and expected .......................................... 35
`GROUNDS 1-3 ..............................................................................................39
`II.
`III. CONCLUSION ..............................................................................................41
`
`
`III.
`I.
`
`2
`
`
`
`IPR2020-00084
`Patent 9,089,519
`
`
`
`Exhibit
`No.
`
`PETITIONER’S EXHIBIT LIST
`
`Description
`
`1001
`
`1002
`1003
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`U.S. Patent No. 9,089,519 to Lebreton
`(issued July 28, 2015)(the ‘519 patent or the challenged
`patent)
`Declaration of Dale Devore, Ph.D.
`CV of Dale Devore, Ph.D.
`Steven Fagien & Arnold W. Klein, A Brief Overview and
`History of Temporary Fillers: Evolution, Advantages, and
`Limitations, Plastic and Reconstructive Surgery, Vol. 120
`Supplement 6S, 8S–16S (Nov. 2007)
`Mary P. Lupo, Hyaluronic Acid Fillers in Facial
`Rejuvenation, Seminars in Cutaneous Medicine and Surgery,
`Vol. 25, No. 6, 122–126 (Sept. 2006)
`Seth L. Matarraso, Understanding and Using Hyaluronic
`Acid, Aesthetic Surgery Journal Vol. 24, No. 4, 361–364
`(July/August 2004)
`Rhoda S. Narins & Paul H. Bowman, Injectable Skin Fillers,
`Clinics in Plastic Surgery, Vol. 32, Issue 2, 151–162 (April
`2005)
`Clifford P. Clark III, Animal-Based Hyaluronic Acid Fillers:
`Scientific and Technical Considerations, Plastic and
`Reconstructive Surgery, Vol. 120 Supplement 6S, 27S-32S
`(Nov. 2007)
`Kevin C. Smith, Practical Use of Juvéderm: Early
`Experience, Plastic and Reconstructive Surgery, Vol. 120
`Supplement 6S, 67S-73S (Nov. 2007)
`Rod J. Rohrich, et al., The Role of Hyaluronic Acid Fillers
`(Restylane) in Facial Cosmetic Surgery: Review and
`Technical Considerations, Plastic and Reconstructive Surgery,
`Vol. 120 Supplement 6S, 41S-54S (Nov. 2007)
`Michael H. Gold, Use of Hyaluronic Acid Fillers for the
`Treatment of the Aging Face, Clinical Interventions in Aging,
`Vol. 2, Issue 3, 369-376 (Sept. 2007)
`
`Filed
`in this
`case?
`X
`
`X
`X
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`3
`
`
`
`IPR2020-00084
`Patent 9,089,519
`Exhibit
`No.
`
`Description
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`Brian M. Kinney, Injecting Puragen Plus Into the Nasolabial
`Folds: Preliminary Observations of FDA Trial, Aesthetic
`Surgery Journal, Vol. 26, Issue 6, 741-748 (Nov. 2006), also
`available at
`https://academic.oup.com/asj/article/26/6/741/238376
`U.S. Provisional App. Serial No. 61/085,956 (filed Aug. 4,
`2008) (priority document for challenged patent)
`Gary D. Monheit & Chad L. Prather, Juvéderm: A Hyaluronic
`Acid Dermal Filler, Journal of Drugs in Dermatology, Vol. 6,
`Issue 11, 1091-1095 (Nov. 2007)
`Leslie S. Baumann, et al., Comparison of Smooth-Gel
`Hyaluronic Acid Dermal Fillers with Cross-linked Bovine
`Collagen: A Multicenter, Double-masked, Randomized,
`Within-Subject Study, Dermatologic Surgery, Vol. 33
`Supplement 2, S128-S135 (Dec. 2007)
`Deborah, S. Sarnoff, et al., Comparison of Filling Agents for
`Lip Augmentation, Aesthetic Surgery Journal, Vol. 28, Issue 5,
`556-563 (September/October 2008)
`Michael S. McCracken, et al., Hyaluronic Acid Gel
`(Restylane) Filler for Facial Rhytids: Lessons Learned From
`American Society of Ophthalmic Plastic and Reconstructive
`Surgery Member Treatment of 286 Patients, Ophthalmic
`Plastic and Reconstructive Surgery, Vol. 22, Issue 3, 188-191
`(May-Jun 2006)
`Barry L. Eppley & Babak Dadvand, Injectable Soft-Tissue
`Fillers: Clinical Overview, Plastic and Reconstructive
`Surgery, Vol. 118, Issue 4, 98e-106e (Sept. 15, 2006)
`M.J.A. Sapijaszko, Dermal Fillers: Ever-Expanding Options
`for Esthetic Use, Skin Therapy Letter, Vol. 12, No. 8, 4–7
`(Oct. 2007)
`Update on Drugs, Skin Therapy Letter, Vol. 13, No. 3, 8 (Apr.
`2008)
`
`Filed
`in this
`case?
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`4
`
`
`
`IPR2020-00084
`Patent 9,089,519
`Exhibit
`No.
`
`Description
`
`1021
`
`1022
`
`1023
`
`1024
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`Carol A. Toth, et al., Preclinical evaluation of a novel
`hyaluronic acid 28 mg/ml lidocaine 0.3% stable combination
`product, (abstract), Journal of the American Academy of
`Dermatology, Vol. 56, No. 2, AB94 (Feb. 2007), Abstract
`P1039
`
`
`and
`
`
`C. William Hanke, et al., Effectiveness and durability of a
`hyaluronic acid 28 mg/ml, lidocaine 0.3% stable combination
`product as demonstrated in a multicenter, randomized trial
`(abstract), Journal of the American Academy of Dermatology,
`Vol. 56, No. 2, AB94 (Feb. 2007), Abstract P1040
`Gary D. Monheit, Hyaluronic Acid Fillers: Hylaform and
`Captique, Facial Plastic Surgery Clinics, Vol. 15, No. 1, 77
`(Feb. 2007)
`Excerpts from file history of U.S. Application 12/393,884
`(filed 2/26/2009)
`Lebreton Declaration
`Yu jia Cui, et al., The Comparison of Physicochemical
`Properties of Four Cross-Linked Sodium Hyaluronate Gels
`with Different Cross-Linking Agents, Advanced Materials
`Research, Vols. 396-398, 1506-1512 (2012)
`Excerpts from file history of U.S. Application 13/419,079
`(filed 3/13/2012)
`Claim Construction Order, Allergan USA, Inc. v. Medicis
`Aethetics, Inc., No. 8:13-cv-01436-AG-JPR, slip op. (C.D.
`Cal. Aug. 12, 2014), ECF No. 79, also available at 2014 WL
`5488895
`U.S. Provisional App. Serial No. 61/087,934 (filed Aug. 11,
`2008) (priority document for challenged patent)
`U.S. Patent Publication No. 2006/0194758 to Lebreton
`(Lebreton), published Aug. 31, 2006
`U.S. Patent Publication No. 2005/0136122 to Sadozai et al.
`(Sadozai), published June 23, 2005
`CTA Product Insert (“Label”)
`
`Filed
`in this
`case?
`X
`
`X
`
`X
`
`X
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`5
`
`
`
`IPR2020-00084
`Patent 9,089,519
`Exhibit
`No.
`
`Description
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`Amy E. Newburger, Cosmetic Medical Devices and Their
`FDA Regulation, Archives of Dermatology, Vol. 142, 225–
`228 (Feb. 2006)
`Excerpts from file history of U.S. Application 12/393,768
`(filed 2/26/2009)
`Kumuda C. Das & Hara P. Misra, Lidocaine: A Hydroxyl
`Radical Scavenger and Singlet Oxygen Quencher, Molecular
`and Cellular Biochemistry, Vol. 115, Issue 2, 179–185 (Oct.
`1992)
`Inja Bogdan Allemann & Leslie Baumann, Hyaluronic Acid
`Gel (Juvedérm) Preparations in the Treatment of Facial
`Wrinkles and Folds, Clinical Interventions in Aging, Vol. 3,
`Issue 4, 629–634 (Dec. 2008)
`Åke Öhrlund, et al., Extrusion Force and Syringe Dimensions
`of Two Hyaluronic Acid Dermal Fillers, 8th Anti-aging
`Medicine World Congress (AMWC) (April 2010)
`U.S. Patent Publication No. 2008/0188441 to Reinmuller et
`al. (Reinmuller 2008), published Aug. 7, 2008, and filed in
`the U.S. on July 14, 2006
`U.S. Patent Publication No. 2005/0142152 to Leshchiner et
`al., published June 30, 2005
`Samuel J. Falcone & Richard A. Berg, Crosslinked
`Hyaluronic Acid Dermal Fillers: A Comparison of
`Rheological Properties, Journal of Biomedical Materials
`Research, Vol. 87A, Issue 1, 264–271 (Jan. 15, 2008)
`Excerpts from file history of U.S. Application 13/746,170
`(filed 1/21/2013)
`PCT Application Publication No. WO 2006/002365 A2,
`published Jan. 5, 2006
`U.S. Patent Publication No. 2007/0184087 to Voigts et al.,
`published Aug. 9, 2007 and filed on Jan. 8, 2007
`
`Filed
`in this
`case?
`X
`
`X
`
`
`
`X
`
`X
`
`X
`
`
`
`X
`
`X
`
`
`
`
`
`6
`
`
`
`IPR2020-00084
`Patent 9,089,519
`Exhibit
`No.
`
`Description
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`1052
`1053
`
`1054
`
`1055
`
`Anti-aging Medicine World Congress, April 10-12, 2008,
`Final Program (containing posters Phillip Levy, et al., “A
`Split-Face Comparison of Two Hyaluronic Acid Facial Fillers
`in the Treatment of Naso-labial Folds,” and Gregor Wahl, et
`al., “The Juvederm ULTRA European Expert Evaluation,”
`page 138)
`U.S. Provisional App. Serial No. 61/096,278 (filed Sept. 11,
`2008) (priority document for challenged patent)
`Ahmet Tezel & Glenn H. Fredrickson, The Science of
`Hyaluronic Acid Dermal Fillers, Journal of Cosmetic and
`Laser Therapy, Vol. 10, Issue 1, 35-42 (Mar. 2008)
`Update on Drugs, Skin Therapy Letter, Vol. 12, No. 7, 8
`(Sept. 2007)
`U.S. Patent Publication No. 2005/0271729 to Wang,
`published Dec. 8, 2005
`U.S. Patent No. 6,521,223 to Calias et al. (issued Feb. 18,
`2003) (Calias)
`Excerpts from file history of U.S. Application 14/242,747
`(filed 4/1/2014)
`CTA Summary of Safety and Effectiveness, December 20,
`2006
`December 20, 2007 FDA Letter to Anika Therapeutics, Inc.
`Prevelle Silk; PMA P030032, February 26, 2008
`Mentor Corp. Announces FDA Approval of Prevelle Silk,
`https://www.businesswire.com/news/home/20080321005064/
`en/Mentor-Corporation-Announces-FDA-Approval-Prevelle-
`Silk (Mar. 21, 2008)
`Food and Drug Administration, Medical Devices; Availability
`of Safety and Effectiveness Summaries for Premarket
`Approval Applications, 72 Fed. Reg. 15,885 (Apr. 3, 2007)
`Mark A. Pinsky, et al., Juvéderm Injectable Gel: A
`Multicenter, Double-Blind, Randomized Study of Safety and
`Effectiveness, Aesthetic Surgery Journal, Vol. 28, Issue 1, 17–
`23 (January/February 2008)
`
`Filed
`in this
`case?
`
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`
`X
`X
`
`
`
`
`
`7
`
`
`
`IPR2020-00084
`Patent 9,089,519
`Exhibit
`No.
`
`Description
`
`1056
`
`1057
`
`1058
`
`1059
`
`1060
`
`1061
`
`1062
`
`1063
`
`1064
`
`1065
`
`1066
`
`1067
`
`1068
`
`1068
`
`1069
`
`Robert Stern, et al., The Many Ways to Cleave Hyaluronan,
`Biotechnology Advances, Vol. 25, Issue 6, 537–557
`(November/December 2007)
`J.W. Kuo, Practical Aspects of Hyaluronan Based Medical
`Products, CRC Press, Taylor & Francis Group, 2006, pp. 34-
`43, 79-93
`U.S. Patent Publication No. 2005/0250939 to Zhao (Zhao),
`published Nov. 10, 2005
`U.S. Patent No. 5,731,298 to Reinmuller (issued Mar. 24,
`1998) (Reinmuller 298)
`Premarket Approval (PMA) Supplement Summary Review
`Memo for P050047/S005 (Jan. 6. 2010), available at
`https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pm
`a.cfm?id=P050047S005
`U.S. Provisional App. Serial No. 60/953,661 (filed Aug. 2,
`2007)
`U.S. Patent No. 4,605,691 to Balazs et al. (issued Aug. 12,
`1986) (Balazs 691)
`U.S. Patent No. 4,713,448 to Balazs et al. (issued Dec. 15,
`1987) (Balazs 448)
`Excerpts from file history of U.S. Application 13/891,052
`(filed 5/9/2013)
`Transcript of Claim Construction Hearing, Allergan USA, Inc.
`v. Medicis Aethetics, Inc., No. 8:13-cv-01436-AG-JPR (Aug.
`12, 2014), ECF No. 81
`Petition for IPR of ’475 patent by Galderma S.A. & Q-Med
`AB, IPR2014-01417, Paper 4 (filed Aug. 29, 2014)
`Petition for IPR of ’475 patent by Teoxane S.A., IPR2017-
`02002, Paper 1 (filed Aug. 24, 2017)
`Declaration of John W. Harbin in Support of Motion for
`Admission Pro Hac Vice (Jan. 8, 2020)
`Petition for IPR of ’795 patent by Galderma S.A. & Q-Med
`AB, IPR2014-01422, Paper 4 (filed Aug. 29, 2014)
`Petition for IPR of ’795 patent by Teoxane S.A., IPR2017-
`01906, Paper 1 (filed Aug. 2, 2017)
`
`Filed
`in this
`case?
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`
`
`
`
`
`
`
`
`
`
`8
`
`
`
`IPR2020-00084
`Patent 9,089,519
`Exhibit
`No.
`
`Description
`
`1070
`
`1071
`1072
`
`1073
`
`1074
`
`1075
`
`1076
`
`1077
`
`1078
`
`1079
`
`1080
`
`Susan H. Weinkle, et al., A multi-center, double-blind,
`randomized controlled study of the safety and effectiveness of
`Juvéderm® injectable gel with and without lidocaine, Journal
`of Cosmetic Dermatology, Vol. 8, No. 3, 205-2010 (Sept.
`2009), also available at
`https://onlinelibrary.wiley.com/doi/10.1111/j.1473-
`2165.2009.00451.x
`RESERVED
`U.S. Patent Publication No. 2010/0028438 to Lebreton (’438
`publication), published June 23, 2005
`Update on Drugs, Skin Therapy Letter, Vol. 15, No. 3, 6
`(March 2010)
`Premarket Approval (PMA) Summary Review Memo for
`P050047 (June 2, 2006), available at
`https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050047B.pd
`f
`Food and Drug Administration, Medical Devices; Availability
`of Safety and Effectiveness Summaries for Premarket
`Approval Applications, 71 Fed. Reg. 56,157 (September 26,
`2006)
`Update on Drugs, Skin Therapy Letter, Vol. 11, No. 6, 10
`(July-August 2006)
`January 7, 2010, FDA Letter to Allergan, available at
`https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050047S00
`5A.pdf
`Gary D. Monheit et al., Novel Hyaluronic Acid Dermal Filler:
`Dermal Gel Extra Physical Properties and Clinical
`Outcomes, Dermatologic Surgery, Vol. 36, No. S3, 1833-1841
`(Nov. 2010)
`Lynnelle Smith et al., Hyaluronic acid dermal fillers: can
`adjunctive lidocaine improve patient satisfaction without
`decreasing efficacy or duration?, Patient Preference and
`Adherence, Vol. 5, 133-139 (Mar. 14, 2011)
`Hylaform – Instructions for Use - USA
`
`Filed
`in this
`case?
`X
`
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`9
`
`
`
`IPR2020-00084
`Patent 9,089,519
`Exhibit
`No.
`
`Description
`
`1081
`
`1082
`1083
`
`1084
`
`1084
`
`1085
`
`1085
`
`1086
`1086
`
`1087
`
`1088
`
`1089
`
`1090
`
`Restylane Summary of Safety and Effectiveness, March 25,
`2005, available at
`https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pm
`a.cfm?id=P140029
`U.S. Patent No. 8,357,795 to Lebreton. (issued Jan. 22, 2013)
`U.S. Patent No. 6,921,819 to Piron et al. (issued Jul. 26,
`2005)
`Joint Claim Construction Chart, Allergan USA, Inc. v.
`Prollenium US, Inc., No. 1:19-cv-00126 (D. Del. Jan. 16,
`2020), ECF No. 57
`Declaration of John W. Harbin in Support of Motion for
`Admission Pro Hac Vice (Jan. 8, 2020)
`Renewed Declaration of John W. Harbin In Support of
`Motion for Admission Pro Hac Vice (Jan. 21, 2020)
`Allergan Industrie, SAS’s September 12, 2019 Response to
`European Patent Office Opposition Division Preliminary
`Opinion in proceeding against European Patent 2 323 617 B1,
`available at
`https://register.epo.org/application?number=EP09785852&ln
`g=en&tab=doclist
`Transcript of January 10, 2020, Conference Call with Board
`Atoosa Maleki et al., Effect of pH on the Behavior of
`Hyaluronic Acid in Dilute and Semidilute Aqueous Solutions,
`Macromolecular Symposia, Vol. 274, 131-140 (Dec. 29,
`2008)
`Iuliana Gatej et al., Role of the pH on Hyaluronan Behavior
`in Aqueous Solution, Biomacromolecules, Vol. 6, Issue 1
`(Jan. 2005) (published on web Nov. 6, 2004), available at
`https://pubs.acs.org/doi/10.1021/bm040050m.
`Excerpts from file history of U.S. Application 16/186,448
`(filed 11/09/2018)
`Excerpts from file history of U.S. Application 16/186,451
`(filed 11/09/2018)
`Y. Tokita & A. Okamoto, Hydrolytic Degradation of
`Hyaluronic Acid, Polymer Degradation and Stability, Vol. 48,
`Issue 2, 269-273 (1995)
`
`Filed
`in this
`case?
`X
`
`X
`X
`
`
`
`X
`
`
`
`
`
`
`
`
`X
`
`
`
`
`
`
`
`10
`
`
`
`IPR2020-00084
`Patent 9,089,519
`Exhibit
`No.
`
`Description
`
`1091
`
`1092
`
`1101
`
`1102
`
`1103
`
`1104
`
`1105
`1106
`1107
`
`1108
`
`1109
`
`1110
`
`Order Granting Motion to Stay Pending IPR, Allergan USA,
`Inc. v. Prollenium US Inc., No. 1:20-cv-00104-CFC, slip op.
`(D. Del. July 16, 2010), ECF No. 34
`Declaration of John W. Harbin In Support of Motion for
`Admission Pro Hac Vice
`Dale P. DeVore, Oxygen Update in Post-Rigor Bovine Semi-
`membranosus Muscle (1973) (Ph.D. thesis, Rutgers
`University)
`Leslie Baumann, MD, Cosmetic Dermatology: Principles and
`Practice (2d ed. Apr. 8, 2009) (excerpt)
`Allergan FDA Advisory Committee Briefing Document, May
`2, 2013, Meeting of the General and Plastic Surgery Devices
`Panel, available at https://wayback.archive-
`it.org/7993/20170113134Pi502/http://www.fda.gov/download
`s/AdvisoryCommittees/CommitteesMeetingMaterials/Medica
`lDevices/MedicalDevicesAdvisoryCommittee/GeneralandPla
`sticSurgeryDevicesPanel/UCM349428.pdf
`Pierre Lebreton Emails (Redacted) Relating to HA Products
`with Lidocaine, produced by Patent Owner in Allergan USA,
`Inc. v. Prollenium US Inc., No. 1:19-cv-00126
`Declaration of Glenn D. Prestwich (Nov. 4, 2020)
`Prestwich CV
`U.S. Patent No. 5,079,236 to Drizen et al. (“Drizen”) (issued
`Jan. 7, 1992)
`Excerpts from Allergan, Inc. Opposition against European
`Patent 2 349 203 B1
`Excerpts from Allergan Industrie, SAS’s June 4, 2018
`Response to the Communication of Notices of Opposition in
`proceeding against (Allergan’s) European Patent
`2 323 617 B1
`PCT Application Publication No. WO 2005/067994 A1 to
`Sadozai et al. (“Sadozai PCT”), published July 28, 2005
`(claiming priority to U.S. Application No. 10/743,557)
`
`Filed
`in this
`case?
`
`
`
`
`X
`
`X
`
`X
`
`X
`
`X
`X
`X
`
`X
`
`X
`
`X
`
`11
`
`
`
`IPR2020-00084
`Patent 9,089,519
`Exhibit
`No.
`
`Description
`
`1111
`
`1112
`
`1113
`
`1114
`
`1115
`
`1116
`
`1117
`
`1118
`1200
`
`1201
`
`1202
`
`1203-
`1209
`
`Catherine J. Sinnott et al., Addition of sodium bicarbonate to
`lidocaine decreases the duration of peripheral nerve block in
`the rat, Anesthesiology, Vol. 93, No. 4, 1045-1052 (Oct.
`2000)
`Excerpts from file history of U.S. Application 09/920,286
`(filed 8/2/2001)
`X. Zhao, Synthesis and Characterization of a Novel
`Hyaluronic Acid Hydrogel, Journal of Biomaterials Science,
`Polymer Edition, Vol. 17, Issue 4, 419-433 (2006)
`Sven Lindvall et al., Influence of various compounds on the
`degradation of hyaluronic acid by a myeloperoxidase system
`Chemico-Biological Interactions Vol. 90, 1-12 (1994)
`U.S. Patent Publication No. 2008/0226724 to Ji et al. (Ji),
`filed January 22, 2008, published September 18, 2008
`U.S. Patent No. 8,318,695 to Stroumpoulis et al.
`(Stroumpoulis) (issued November 27, 2012)
`U.S. Patent No. 9,062,130 to Lebreton (Lebreton 130) (issued
`June 23, 2015)
`Declaration of Laura N. Heidt
`Transcript of the Deposition of Cory J. Berkland, Ph.D (Oct.
`7-9, 2020)
`Declaration of Cory J. Berkland, Ph.D, Exhibit 1002 in
`Actavis LLC v. Abraxis Bioscience, LLC, IPR2017-01103
`(PTAB filed Apr. 4, 2017)
`Amir Fakhari & Cory Berkland, Applications and Emerging
`Trends of Hyaluronic Acid in Tissue Engineering, as a
`Dermal Filler, and in Osteoarthritis Treatment, author
`manuscript submitted for publication, available at
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3669638,
`published in final edited form as Acta Biomaterialia, Vol. 9,
`Issue 7, 7081-7092 (July 2013))
`RESERVED
`
`Filed
`in this
`case?
`X
`
`X
`
`X
`
`X
`
`X
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`X
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`X
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`X
`X
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`X
`
`X
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`12
`
`
`
`IPR2020-00084
`Patent 9,089,519
`Exhibit
`No.
`
`Description
`
`1210
`
`1211-
`1215
`1216
`
`
`
`PCT Application Publication No. WO 2008/068297 A1 to
`Piron (“Piron 2008”), published June 12, 2008 (includes
`English translation, Declaration of Translator, and original
`French document combined)
`RESERVED
`
`Fredric S Brandt & Alex Cazzaniga, Hyaluronic acid gel
`fillers in the management of facial aging, Clinical
`Interventions in Aging, Vol. 3, Issue 1, 153-159 (Mar. 7,
`2008)
`
`Filed
`in this
`case?
`X
`
`
`
`X
`
`13
`
`
`
`IPR2020-00084
`Patent 9,089,519
`
`Abbreviation
`’519 patent
`
`BDDE
`DEO
`DVS
`FDA
`HA
`ID
`PMA
`SSED
`PBCDI
`Pet.
`POSITA
`Response
`
`
`
`
`
`TABLE OF ABBREVIATIONS
`
`Term
`U.S. Patent No. 9,089,519 to Lebreton
`(issued July 28, 2015)
`butanediol diglycidyl ether
`1,2,7,8-diepoxyoctane
`divinyl sulfone
`U.S. Food & Drug Administration
`hyaluronic acid
`Institution Decision, Paper 12
`FDA Premarket approval
`Summary of Safety and Effectiveness Data
`pBCDI p-phenylene-bis(ethylcarbodiimide)
`Petition, Paper 1
`Person of Ordinary Skill in the Art
`Patent Owner Response, Paper 35
`
`All emphasis in this Petitioner’s Reply is added unless otherwise indicated.
`
`
`
`
`
`14
`
`
`
`IPR2020-00084
`Patent 9,089,519
`INTRODUCTION
`I.
`
`Allergan’s protestations notwithstanding, the questions here are simple:
`
`would the POSITA have been motivated to combine BDDE-crosslinked HA with
`
`lidocaine, and would the POSITA have reasonably expected success in doing so?
`
`The overwhelming prior art compels each be answered in the affirmative. Even if it
`
`were true that “inventing [a] new filler was a formidable task,” (Response 1), those
`
`are not the Grounds. Rather, the Grounds are based on routine modifications of
`
`fillers disclosed in the prior art.
`
`It is undisputed that injection pain was a known problem for dermal fillers.
`
`Incorporating 0.3% lidocaine was a specific, well-known solution implemented in
`
`many types of fillers, including crosslinked HA fillers. Pet. 9-10. The POSITA had
`
`every reason to try that same solution in a BDDE-crosslinked filler (the most
`
`popular HA-based filler at the time), with at least a reasonable expectation of
`
`success in doing so. Under those circumstances, “the claimed invention is the
`
`product not of innovation but of ordinary skill and common sense.” In re Kubin,
`
`561 F.3d 1351, 1360 (Fed. Cir. 2009) (quoting KSR Int’l Co. v. Teleflex Inc., 550
`
`U.S. 398, 421 (2007)).
`
`Allergan and its expert, Dr. Berkland, contend there was not even a
`
`motivation to produce a BDDE-crosslinked filler with lidocaine, despite myriad
`
`evidence to the contrary. E.g., EX1016, 561 (describing lidocaine in HA was
`
`15
`
`
`
`IPR2020-00084
`Patent 9,089,519
`“common theme” citing the same fillers discussed in the Petition); EX1002 ¶¶ 112-
`
`131 (citing references); EX2024, 1-2, 7. To support this argument, Allergan’s
`
`expert relies on an unreasonably narrow definition of a POSITA that ignores the
`
`prior art and the law. And Berkland opines that adding lidocaine HCl and adjusting
`
`the pH “would lead to a cascade of unpredictable, interrelated changes to various
`
`physical and rheological properties” due to many “complex and interrelated
`
`factors.” E.g., EX2013 ¶¶ 110, 190, 216. It would not, nor would a POSITA have
`
`thought so. Berkland repeatedly exaggerates the magnitude of the alleged changes,
`
`despite the simple truth: modifications to pH and other properties—particularly the
`
`slight modifications at issue—are within the level of skill and do not convert a
`
`dermal filler into something entirely different.
`
`The prior art informed the POSITA’s reasonable expectation that making a
`
`BDDE-crosslinked filler with lidocaine would be successful. See e.g., Pet. 37-38,
`
`46-47. Even considering Berkland’s theoretical analysis, a POSITA in the rapidly
`
`moving field of HA-based fillers would place more weight on the closer, practical
`
`examples of lidocaine incorporated into a variety of crosslinked HA gels. Allergan
`
`disputes whether certain products were “successful,” but they were successful and
`
`stable enough for their manufacturers to distribute to clinicians, inject into patients,
`
`earn FDA-approval, and be described in the art. Berkland’s testimony regarding
`
`unpredictability discounts these examples and leans, instead, on several references
`
`16
`
`
`
`IPR2020-00084
`Patent 9,089,519
`not describing dermal fillers. Even so, only a reasonable probability of success is
`
`needed. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007) (rejecting
`
`“a rule of law equating unpredictability to patentability”).
`
`Once the POSITA arrives at the core composition, the remaining claim
`
`limitations recite known properties, in ranges overlapping the prior art, or
`
`observed, inherent properties the POSITA would have expected.
`
`Dr. DeVore’s perspective on these issues is grounded in the prior art and his
`
`decades of practical experience—including at the relevant time. In any case,
`
`Prollenium supplements the record with testimony from Dr. Glenn Prestwich to
`
`respond to the issues (and exaggerations) raised in Berkland’s testimony. Prestwich
`
`is an undisputed expert in HA chemistry and brings the perspective of an academic
`
`researcher (like Berkland) to aid the Board’s analysis of the testimony.
`
`II.
`
`PERSPECTIVE OF THE POSITA
`
`A.
`
`POSITAs knew about competitive products and their properties
`
`While Allergan argues Prollenium “improperly adds” knowledge the
`
`POSITA wouldn’t have, Response 18, Prollenium’s position follows the law and
`
`prior art. Allergan contends a POSITA is just a “scientist[] in a lab;” similarly,
`
`Berkland testified that a POSITA would not consider “commercial aspects”1 or
`
`
`1 Presumably this includes how product characteristics compare within the market.
`
`17
`
`
`
`IPR2020-00084
`Patent 9,089,519
`FDA documents expressly cited in the art. See EX2013 ¶¶ 28-30; EX1200, 112:14-
`
`119:2 (testifying “market demand” is not “relevant” to technical matter of
`
`“formulating”).
`
`KSR mandates the Board reject Allergan’s constricted definition of the
`
`POSITA because “demands known to the design community or present in the
`
`marketplace” must be considered. 550 U.S. at 418-419 (“[O]ften … market
`
`demand, rather than scientific literature, will drive design trends”). Allergan and
`
`Berkland also incorrectly disregard the extensive documentary evidence showing
`
`POSITAs knew about market trends and public regulatory filings. Randall Mfg. v.
`
`Rea, 733 F.3d 1355, 1362-63 (Fed. Cir. 2013).
`
`That evidence shows the art frequently reviewed competitive products and
`
`their properties and frequently cited FDA databases as sources. E.g., EX2015, 14-
`
`15, 198-201 (FDA documents “a useful information source” citing PMA
`
`documents);2 EX2079, 164-165; EX1005, 125; EX1011, 370-375; EX1016, 560-
`
`561; EX1035, 631; EX1039 (generally, and citing PMA documents); EX2019, 309,
`
`312 nn. 15-16, 19-20; EX1009, 67S-68S; EX1032, 226-227; EX1216, 154-156
`
`(describing FDA-approved fillers and others “not yet available in the US”);
`
`
`2 Berkland was unaware the cited information referred to PMA numbers. EX1200,
`
`83:5-85:23. Cf. EX1002 ¶¶ 118-119 (DeVore referring to PMA numbers).
`
`18
`
`
`
`IPR2020-00084
`Patent 9,089,519
`EX1015, S135 nn. 4, 7, 12 (citing PMAs); EX1055, 22-23 (pre-launch citation to
`
`“Elevess (formerly CTA)” package insert).
`
`Emails from the inventor, produced by Allergan, undercut Allergan and its
`
`expert. They show the inventor monitoring and sharing information about
`
`competitors’ lidocaine HA products. See EX1104, 1 (2005: forwarding Mentor
`
`press release announcing Canadian approval of Puragen Plus and plans for PMA in
`
`US), 3 (2006: forwarding “Yahoo! Alert” about Anika’s “nouveau HA filler avec
`
`lidocaine” in Europe, although the alert did not mention lidocaine), 7-9 (2008:
`
`replying about Prevelle Silk’s approval), 11 (2008: sending “ClinicalTrials.gov”
`
`information about Restylane with lidocaine), 4 (2008: receiving Elevess
`
`announcement).
`
`Prollenium’s position is correct: the POSITA was aware of market
`
`developments. Pet. 14; EX1002 ¶¶ 72-73; EX1105 ¶ 35.
`
`B. DeVore qualifies as a POSITA
`
`Allergan argues DeVore “misrepresented” his credentials and therefore lacks
`
`candor, although Allergan does not specifically dispute that DeVore qualifies as a
`
`POSITA. See Response 29-30. He does.
`
`DeVore’s CV (EX1003) incorrectly lists his degrees as “Biochemistry.” On
`
`cross-examination, he testified candidly that his degree was “formally in food
`
`science and technology, but it’s … in the area of biochemistry.” EX2100, 311:11-
`
`19
`
`
`
`IPR2020-00084
`Patent 9,089,519
`312:1. He repeatedly testified that he believed his degrees were “in the field” of
`
`biochemistry based on his academic work and extensive research. EX1002 ¶ 5;
`
`EX2100, 501:4-507:20 (describing courses and research on redirect); cf. EX2172,
`
`1.3 And DeVore’s thesis illustrates biochemical research, notwithstanding the
`
`department where it was conducted. See generally EX1101, 45-73 (describing
`
`methods and experiments in “Oxygen Uptake in Post-Rigor Bovine Semi-
`
`Membranosus Muscle”).
`
`Allergan agrees the POSITA’s education may be in a “related field” to the
`
`open-ended list of degrees. Response 17. DeVore testified his degrees were, at
`
`minimum, “related” to those in his POSITA description. EX2100, 509:13-20.
`
`Allergan did not challenge that testimony.4
`
`Moreover, DeVore’s degrees, awarded around 50 years ago, are of lesser
`
`relevance given his undisputed “35 years of experience working with polymers in
`
`
`3 Allergan misleadingly cites one passage where counsel asked about what the CV
`
`“says” on its face. Compare Response 30 (citing EX2100, 48:14-17), with
`
`EX2100, 47:10-49:13.
`
`4 Nor did DeVore “cabin” the “related” fields. Response 29. Counsel asked about
`
`“fields like … those kinds of fields.” EX2100, 255:2-6. Berkland’s definition also
`
`does not exclude DeVore’s degree. EX2013 ¶ 27.
`
`20
`
`
`
`IPR2020-00084
`Patent 9,089,519
`the field of soft tissue fillers.” EX2100, 28:11-29:3; EX1002 ¶¶ 6-15. He worked
`
`as a “Research Biochemist,” and has directed R&D work. EX1003, 1, 8; EX2100,
`
`52:10-53:1, 100:2-23, 133:10-134:21; see also EX1003, 1. He is an inventor and
`
`author in the field—including in journals cited in this IPR. E.g., EX2100, 196:9-
`
`198:9 (discussing EX2128); EX1003, 10-15 (listing articles, see e.g., Numbers 61-
`
`66), 16-20 (patent). Authors within our record cite DeVore’s work as relevant. E.g.,
`
`EX2015, 95 (n.39, 41).
`
`DeVore’s education and experience are sufficient to qualify him as POSITA
`
`and offer opinions from that perspective. His knowledge and perspective are
`
`relevant to the issues.
`
`C. DeVore’s opinions are supported by the prior art, as Berkland
`conceded
`
`1.
`
`Evidence corroborates DeVore’s testimony POSITAs could
`make the proposed modifications
`Allergan argues there is “no support” for DeVore’s opinions that a POSITA
`
`“could have easily” made the proposed modifications. Response 26. But Allergan
`
`ignores the POSITA’s “significant abilities” in this field. See Kubin, 561 F.3d at
`
`1360. The variety of optimized formulations taught in the record and the
`
`specification’s admissions establish the POSITA’s capabilities. E.g. EX1013,
`
`12:16-17, 19:16-19, 18:11-23 (provisional admitting that preparing fillers with
`
`mixtures of “crosslinked and free HA” was well known, and POSITA knew how to
`
`21
`
`
`
`IPR2020-00084
`Patent 9,089,519
`carry out crosslinking “to an optimized degree”); EX1105 ¶ 41.
`
`Berkland also mostly confirms that the modifications proposed in the
`
`Grounds were within the POSITA’s skill, contradicting Allergan’s picture of
`
`complexity. For example, Berkland agrees a POSITA was able to make a buffered
`
`solution of lidocaine HCl and mix it into a gel (specifically including Lebreton).
`
`EX1200, 199:24-200:8, 204:6-205:24, 243:10-21. He also agrees the POSITA
`
`could optimize crosslinking degree and particle size, incorporate free HA, and
`
`adjust the pH if necessary. EX1200, 197:17-198:8, 238:17-239:13, 222:19-223:2,
`
`206:14-23, 237:7-238:10.5
`
`Testing something does not make it unpredictable
`2.
`DeVore did not “backtrack[]” on any testimony about the POSITA’s ability
`
`to modify the cited art. He testified that “designing” a dermal filler was a
`
`“formidable task.” EX2100, 201:4-203:24 (all questions about “design[ing]”). But
`
`that does not mean modifying an existing filler was outside the technical grasp of
`
`the POSITA. See also EX1105 ¶ 41.
`
`
`5 Berkland suggested he didn’t “know that it would be a gel anymore” after
`
`adjusting the pH, but the POSITA would have no doubt. EX2100, 206:14-23;
`
`EX1105 ¶¶ 71-75.
`
`22
`
`
`
`IPR2020-00084
`Patent 9,089,5
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