throbber
Paper No. 8
`Filed: January 8, 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 MOTION FOR ADMISSION PRO HAC VICE OF
`JOHN W. HARBIN
`
`

`

`
`
`Pursuant to 37 C.F.R. § 42.10, Petitioner requests that the board admit John
`
`W. Harbin pro hac vice in this proceeding.
`
`The Board may recognize counsel pro hac vice during a proceeding on a
`
`showing of good cause. “[W]here lead counsel is a registered practitioner, a motion
`
`to appear pro hac vice may be granted upon a showing that counsel is an
`
`experienced litigation attorney and has an established familiarity with the subject
`
`matter at issue in the proceeding.” 37 C.F.R. § 42.10(c).
`
`Here, lead counsel Christopher J. Curfman is a registered practitioner. Mr.
`
`Harbin has over 25 years of experience in patent litigation, and he is familiar with
`
`the subject matter at issue in this proceeding. Accompanying this motion is the
`
`Declaration of John W. Harbin, where Mr. Harbin attests to his experience and
`
`familiarity. See generally Harbin Decl. (Ex. 1084). Specifically, Mr. Harbin attests
`
`that:
`
` he has been practicing intellectual property litigation, including patent
`
`litigation, for more than 25 years;
`
` he has been lead trial counsel on numerous patent litigation cases;
`
` he has previously represented the Petitioner on patent-related matters;
`
`and
`
` he is lead counsel in the related district court action where the Patent
`
`Owner has asserted the challenged patents against Petitioner.
`
`1
`
`

`

`
`
`Ex. 1084 ¶¶ 2, 9.
`
`These facts establish good cause to recognize Mr. Harbin in this proceeding.
`
`Respectfully submitted,
`
`/Christopher L. Curfman/
`Christopher L. Curfman (Reg. No. 52,787)
`
`
`
`
`
`2
`
`

`

`
`
`
`
`Exhibit
`No.
`1001
`
`1002
`1003
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`PETITIONER’S EXHIBIT LIST
`
`Description
`
`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)
`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
`
`3
`
`

`

`
`
`Exhibit
`No.
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`1021
`
`Description
`
`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)
`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
`
`4
`
`

`

`
`
`Exhibit
`No.
`1022
`
`1023
`
`1024
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`1032
`
`1033
`
`1034
`1035
`
`Description
`
`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. (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”)
`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)
`RESERVED
`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)
`
`5
`
`

`

`
`
`Exhibit
`No.
`1036
`
`1037
`
`1038
`1039
`
`1040
`
`1041–
`1043
`1044
`
`1045
`
`1046
`1047
`
`1048
`
`1049
`
`1050
`1051
`1052
`
`Description
`
`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
`RESERVED
`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)
`RESERVED
`
`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
`RESERVED
`Prevelle Silk; PMA P030032, February 26, 2008
`
`6
`
`

`

`
`
`Exhibit
`No.
`1053
`
`1054
`1055
`1056
`
`1057
`
`1058
`
`1059
`
`1060
`
`1061
`1062
`
`1063
`
`1064
`
`1065
`
`1066–
`1069
`
`Description
`
`Mentor Corp. Announces FDA Approval of Prevelle Silk,
`https://www.businesswire.com/news/home/20080321005064/en/Ment
`or-Corporation-Announces-FDA-Approval-Prevelle-Silk (Mar. 21,
`2008)
`RESERVED
`RESERVED
`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/pma.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
`RESERVED
`
`7
`
`

`

`
`
`Exhibit
`No.
`1070
`
`1071
`1072
`
`1073
`
`1074
`
`1075
`
`1076
`
`1077
`
`1078
`
`1079
`
`1080
`1081
`
`Description
`
`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),
`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.pdf
`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/P050047S005A.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
`Restylane Summary of Safety and Effectiveness, March 25, 2005,
`available at
`https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id
`=P140029
`
`8
`
`

`

`Exhibit
`No.
`1082
`1083
`1084
`
`
`
`
`
`
`Description
`
`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)
`Declaration of John W. Harbin In Support of Motion for Admission
`Pro Hac Vice
`
`
`
`9
`
`

`

`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e)(4) and consent of the Patent Owner, I certify
`that on January 8, 2020, a copy of Petitioner’s Motion for Admission Pro Hac Vice
`of John W. Harbin and related exhibit was served on the counsel of record by
`email to IPR13351-0081IP1@fr.com.
`
`
`/Margaret A. Cogburn/
`Margaret A. Cogburn
`Meunier Carlin & Curfman LLC
`999 Peachtree St. NE, Suite 1300
`Atlanta, GA 30309
`(404) 645-7700
`
`10
`
`

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