UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` ______________
`PROLLENIUM US INC.,
`Petitioner,
`
`v.
`
`ALLERGAN INDUSTRIE, SAS,
`Patent Owner.
` ______________
`IPR2019-01505 (Patent 8,450,475 B2)
`IPR2019-01506 (Patent 8,357,795 B2)
`IPR2019-01508 (Patent 9,238,013 B2)
`IPR2019-01509 (Patent 9,358,322 B2)
`IPR2019-01617 (Patent 8,822,676 B2)
`IPR2019-01632 (Patent 8,357,795 B2)
`IPR2020-00084 (Patent 9,089,519 B2)
` ______________
`PATENT OWNER’S IDENTIFICATION OF IMPROPER NEW
`ARGUMENTS AND EVIDENCE1
`
`
`
`
`
`
`
`1 Authorization for the use of a joint caption page was received on April 27, 2020.
`
`Neither party opposes the use of a joint caption page. An identical paper has been
`
`filed in each case recited in the joint caption.
`
`

`

`Patent Owner identifies improper arguments and evidence in Petitioner’s
`
`Reply (Paper 43) and Prestwich Declaration (EX1105) under 37 C.F.R. § 42.23(b).
`
`See EX3003. Unless otherwise noted, all citations refer to papers and exhibits filed
`
`in IPR2019-01617 as representative of all related IPRs.
`
`Citation
`Reply and
`EX1105 in
`their entirety
`
`Reply 23:1-3
`
`Reply 24 n.7
`Reply 25:7–
`28:4; EX1105
`¶¶ 73, 163
`
`
`Explanation and Identification of Improper Evidence
`The Board “is not required to attempt to sort proper from
`improper portions of the reply” and should thus disregard the
`Reply and EX1105 entirely (Nov. 2019 TPG at 74);
`inadmissible under Fed. R. Evid. 402, 403, 702, and 703.
`Improper incorporation by reference of 16 pages of EX1105
`¶¶ 46–69.
`Improper incorporation by reference of EX1105 ¶¶ 71-75.
`Advancing new obviousness grounds based on evidence not
`cited in the Petition—“Prollenium’s Ground is that a POSITA
`would simply add lidocaine to Lebreton’s gels” (citing EX2067)
`(Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359,
`1367 (Fed. Cir. 2015) (striking a reply that relied on “previously
`unidentified portions of a prior-art reference to make a
`meaningfully distinct contention”)).
`Reply 29:12-13 Improper incorporation by reference of EX1105 ¶¶ 46-51.
`Reply 30:1-
`Asserting for the first time that the increase in ionic strength
`31:6; EX1105
`caused by addition of 0.3% lidocaine HCl would not discourage
`¶¶ 52-56
`a POSA from making the claimed composition.
`Reply 19:3-10,
`Citing non-public emails of inventor Lebreton to argue POSA
`26 n.9, 32:8-9
`was aware of successful addition of lidocaine to HA fillers.
`Reply 31:2-3
`Improper incorporation by reference of EX1105 ¶¶ 53-55.
`Reply 31:7-20;
`Providing new evidence for argument of reasonable expectation
`EX1105 ¶¶ 39,
`of success and newly arguing that a POSA would have known
`63, 159
`Elevess used a pBCDI crosslinker (citing EX1216).
`Reply 33:3-4,
`Improper incorporation by reference of EX1105 ¶¶ 52-59, 68-
`7-9, 14-17
`69, 74-75, 80-81; 71-75, 76-83, 84, 88-89.
`Reply 35:2-18;
`Altering obviousness grounds by arguing Sadozai’s “controlled
`EX1105 ¶¶ 78-
`release” of lidocaine inherently meets the “freely released”
`79
`claim limitation.
`
`
`
`1
`
`

`

`Explanation and Identification of Improper Evidence
`Improper incorporation by reference of EX1105 ¶¶ 37, 76-83.
`
`Citation
`Reply 35:12-
`14, 35:19-36:2
`Reply 37:1-7;
`EX1105 ¶ 44
`
`Reply 37:8-19;
`EX1105 ¶ 94
`Reply 38:9–
`40:8; EX1105
`¶¶ 107-10
`
`Altering obviousness grounds with new evidence (EX1210)
`(“[P]rior art show[s] methods of including free (uncrosslinked)
`HA were well-known.”)
`Arguing for a new theory of obviousness, that the claimed
`degree of crosslinking is a result-effective variable.
`Altering motivation to combine Kinney and Zhao with new
`evidence/argument on BDDE/DEO interchangeability, citing
`previously unidentified part of Zhao (Tables 1-3), new EX1112,
`and teaching of different crosslinker in the challenged patents.
`Reply 39:16-18 Improper incorporation by reference of EX1105 ¶¶ 98-100.
`Reply 40:2-3
`Improper incorporation by reference of EX1105 ¶¶ 108-10.
`Reply 41 n.17
`Improper incorporation by reference of EX1105 ¶¶ 114-16.
`EX1105 ¶¶ 36-
`Providing new claim construction for “freely released.”
`37
`EX1105 ¶¶ 75,
`179
`EX1105 ¶ 96
`
`EX1105
`(paragraphs
`listed below)
`
`
`
`
`¶¶ 28, 38-39,
`70, 72-75, 97-
`113, 117-18,
`122, 138-163,
`178-79
`
`
`
`
`
`
`
`Altering motivation to combine Kinney and Zhao, citing new
`EX1114 and EX1115 to claim that lidocaine stabilized HA.
`Altering motivation to combine Kinney and Zhao, alleging
`POSA would have known of authors’ professional connections.
`Adding new testimony and evidence to fill gaps in Dr. DeVore’s
`conclusory statements, “sandbag[ging] . . . by raising new
`matter in reply.” (Intri-Plex Techs., Inc. v. Saint-Gobain
`Performance Plastics Rencol Ltd., No. IPR2014-00309, Paper
`83 at 13 (PTAB, Mar. 23, 2014) (citation omitted)) (illustrative
`examples of Dr. DeVore’s testimony (EX1002) listed below):
`
`Citing new EX1083, EX1093, EX1102, EX1103, EX1114,
`EX1115, EX1210, and EX1216 and opining on motivation to
`“add 0.3% (w/w) lidocaine to the BDDE-crosslinked fillers,” as
`BDDE, DEO, BCDI, and DVS are allegedly similar, BDDE-
`crosslinked HA had been approved, and lidocaine was used in
`other crosslinked HA fillers—cf. EX1002, ¶¶ 139-40 (0.3%
`lidocaine would be used as it was used in other products), ¶ 189
`(BDDE and DEO have “high degree of similarity”); ¶ 188
`(would choose BDDE as it was already approved); ¶¶ 153, 189
`(BDDE similar to BCDI and DVS), ¶ 180 (“double crosslinking
`with either DEO or BDDE would be very similar”);
`
`
`
`2
`
`

`

`Explanation and Identification of Improper Evidence
`Opining on new EX1210 allegedly disclosing the claimed
`amounts of free HA, cf. EX1002, ¶¶ 155–56 (POSA would have
`determined amount of free HA by routine optimization); f
`Citing new (and unsubmitted) “Karp” reference and EX1016 for
`the first time and arguing POSA would not have expected
`interactions between lidocaine and HA, cf. EX1002, ¶ 147
`(same without citation), ¶ 169 (POSA would have expected
`lidocaine and BDDE-crosslinked HA to have shelf-life
`“comparable to other BDDE-crosslinked fillers”);
`Citing Sadozai, and EX1041 and EX1053 for the first time, and
`arguing lidocaine freely releases from crosslinked HA without
`further steps—cf. EX1002, ¶ 143 (“[L]idocaine incorporated
`into a gel (whether crosslinked with BDDE or BDCI) would
`freely release . . . .”); ¶ 180 (POSA would not have expected
`BDDE to inhibit lidocaine free release);
`Citing new EX1083, EX1093, EX1107 and EX1114, EX1210,
`EX1216, and EX1041 and EX1048 for the first time, and
`alleging “autoclaving was used to sterilize virtually all types of
`HA compositions prior to 2008,” and “BDDE-crosslinked HA
`was autoclave sterilized”—cf. EX1002, ¶ 97 (unsupported
`assertion that autoclaving was “[b]y far the most common
`method for sterilizing dermal fillers”), ¶ 169 (“no reason to
`expect BDDE-crosslinked HA would be more susceptible to
`degradation” than others);
`Opining on Lebreton for the claimed degree of crosslinking—cf.
`EX1002, ¶ 165 (POSA could have and would have prepared a
`filler “having any of the [claimed] degrees of crosslinking”).
`Incorporating dozens of pages from Dr. Prestwich’s Galderma
`and Teoxane declarations attacking two of the same patents
`challenged here (’795 and ’475 patents)—particularly egregious
`as Dr. Prestwich’s declarations from those unsuccessful IPR
`petitions were known to Petitioner prior to Petitioner’s original
`filings.
`New exhibits cited in Reply, even though previously cited in the
`Teoxane or Galderma IPRs and thus known to Petitioner when
`it filed the Petitions. (Nov. 2019 TPG at 80 (Board may strike
`“belatedly presented evidence”)).
`
`3
`
`Citation
`¶¶ 44, 153-56
`
`
`¶¶ 58-61, 64-
`69, 78-90
`
`
`
`
`¶¶ 64-69, 76-
`90
`
`
`
`
`¶¶ 75, 138-52,
`157-163, 166-
`68
`
`
`
`
`
`
` ¶
`
` 94
`
`EX1105 ¶¶ 42-
`45, 62-63, 70,
`120-180
`
`EXHIBITS:
`1103, 1107,
`1114, 1115,
`1210
`
`
`
`

`

`
`
`
`
`Dated: November 20, 2020
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`
`/s/ Anthony M. Insogna
`Anthony M. Insogna (Reg. No. 35,203)
`Tamera M. Weisser (Reg. No. 47,856)
`S. Christian Platt (Reg. No. 46,998)
`aminsogna@jonesday.com
`tweisser@jonesday.com
`cplatt@jonesday.com
`JONES DAY
`4655 Executive Drive, Suite 1500
`San Diego, CA 92121
`Telephone: 858-314-1200
`Fax: 844-345-3178
`
`Sarah A. Geers (Reg. No. 69,123)
`sgeers@jonesday.com
`JONES DAY
`250 Vesey Street
`New York, NY 10281
`Telephone: 212-326-3939
`Fax: 212-755-7306
`
`Jennifer M. Hartjes (Reg. No. 77,687)
`jhartjes@jonesday.com
`JONES DAY
`90 South Seventh Street, Suite 4950
`Minneapolis, MN 55402
`Telephone: 612-217-8800
`Fax: 844-345-3178
`
`Attorneys for Patent Owner Allergan
`Industrie, SAS
`
`
`4
`
`

`

`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on November
`
`20, 2020, a true and correct copy of PATENT OWNER’S IDENTIFICATION
`
`OF IMPROPER NEW ARGUMENTS AND EVIDENCE has been served in its
`
`entirety by e-mail on the following counsel of record for Petitioner:
`
`Lead Counsel:
`Christopher L. Curfman, Ph.D.
`(Reg. No. 52,787)
`MEUNIER CARLIN & CURFMAN LLC
`999 Peachtree Street NE, Suite 1300
`Atlanta, GA 30309
`ccurfman@mcciplaw.com
`
`
`
`
`
`Dated: November 20, 2020
`
`
`
`
`
`
`Backup Counsel:
`William W. Cutchins (Reg. No. 63,451)
`Warren J. Thomas (Reg. No. 70,581)
`John Harbin (pro hac vice motion filed)
`MEUNIER CARLIN & CURFMAN LLC
`999 Peachtree Street NE, Suite 1300
`Atlanta, GA 30309
`wcutchins@mcciplaw.com
`wthomas@mcciplaw.com
`mcc.prollenium.ipr@mcciplaw.com
`
`
`Respectfully submitted,
`
`/s/ Anthony M. Insogna
`Anthony M. Insogna (Reg. No. 35,203)
`JONES DAY
`4655 Executive Drive, Suite 1500
`San Diego, CA 92121
`Telephone: 858-314-1200
`Fax: 844-345-3178
`
`Attorney for Patent Owner Allergan
`Industrie, SAS
`
`
`5
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`