Filed: December 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.
`
`_________________
`
`IPR2019-01505 (Patent 8,450,475)
`IPR2019-01506 (Patent 8,357,795)
`IPR2019-01508 (Patent 9,238,013)
`IPR2019-01509 (Patent 9,358,322)
`IPR2019-01617 (Patent 8,822,676)
`IPR2019-01632 (Patent 8,357,795)
`IPR2020-00084 (Patent 9,089,519)
`
`_________________
`
`PETITIONER’S RESPONSE TO PATENT OWNER’S IDENTIFICATION OF
`ALLEGED NEW IMPROPER 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 consolidated caption.
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`Petitioner responds to Patent Owner Allergan’s table of identified arguments
`
`and evidence as follows. Like Allergan’s submission, all citations refer to papers
`
`and exhibits filed in IPR2019-01617. Allergan also cites alleged improper
`
`incorporation by reference, which was not raised in its request for authorization or
`
`authorized by the Board. See EX3003, 2 (citing only Rule § 42.23(b) as basis of
`
`relief). In any case, Prollenium contends its citations are proper (and in accord with
`
`Allergan’s similar citations, e.g., Patent Owner Response (POR) 6 (citing EX2013
`
`Sections IV.C-F), 8 (citing EX2013 ¶¶ 64-78), 41 (citing EX2013 ¶¶ 229-41)).
`
`Citation
`Reply and
`EX1105 in
`their
`entirety
`Reply
`25:7–28:4;
`EX1105
`¶¶ 73, 163
`
`Reply 30:1-
`31:6;
`EX1105
`¶¶ 52-56
`Reply 19:3-
`10, 26 n.9,
`32:8-9
`
`Responsive To Citation and/or Explanation
`Both respond to Allergan’s Response as supported by Berkland
`declaration. The Board denied Allergan’s request to move to strike
`the Reply and EX1105 in their entirety, EX3003, and doing so is an
`“exceptional remedy.” Nov. 2019 Trial Practice Guide, 80.
`Cf. POR 38-46 (arguing, inter alia, lidocaine had not been
`incorporated into crosslinked HA before; crosslinkers and
`processes are not interchangeable; that Petitioner “provides no
`rationale” for why “POSA would have ignored numerous pain-
`management techniques;” that Sadozai discourages use of BDDE,
`and “fundamental differences” between the references make them
`“incompatible”); EX2013 ¶¶ 218-236. See also Pet. 28-30, 39-40
`(arguing obviousness of “adding lidocaine to Lebreton” and “the
`prior art suggests” that “simply adding lidocaine to a BDDE-
`crosslinked filler with pH control” is only thing “necessary to
`obtain the claimed fillers”).
`Cf. POR 14-15 (arguing lidocaine raises concerns with rheology
`not remedied by neutralization); EX2013 ¶¶ 84, 109-10, 180, 190,
`234, 237-40, 264
`
`The inventor’s emails reflect his knowledge and access to publicly
`available information and belie Allergan’s arguments (1) about the
`POSA’s purported lack of knowledge of competitive product
`
`1
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`Citation
`
`Reply 31:7-
`20;
`EX1105
`¶¶ 39, 63,
`159
`
`Reply 35:2-
`18;
`EX1105
`¶¶ 78-79
`
`Reply 37:1-
`7; EX1105
`¶ 44
`
`Reply 37:8-
`19;
`EX1105
`¶ 94
`Reply
`38:9–40:8;
`EX1105
`¶¶ 107-10
`EX1105
`¶¶ 36-37
`EX1105
`¶¶ 75, 179
`
`Responsive To Citation and/or Explanation
`information, POR 17-18, 36, (2) that Dr. Lebreton’s “concerns had
`merit,” id. at 34-35, and (3) that Petitioner’s positions rely on
`hindsight or a “fiction” of products including lidocaine, id. at 41-
`43; see also EX2013 ¶¶ 28-30; EX1200 112:14-119:2.
`Cf. POR 41 (arguing “Petitioner has not established” POSA knew
`crosslinker identities and arguing Petitioner relied only on
`DeVore’s “personal knowledge”). See also EX1002 ¶¶ 115-16, 152
`(opinion testimony about what POSA would have known about
`crosslinkers); EX2100, 26:11-22 (DeVore testifying his
`“assessment of the art” was from the POSA’s perspective);
`EX1035 (document submitted with Petition expressly describing
`DVS crosslinker in Prevelle).
`Cf. POR 16, 48-52, 64; EX2013 ¶¶ 19, 211, 243-45. Argument
`does not alter the ground but merely elaborates why lidocaine is
`freely released in Sadozai and in the Ground. Pet. 31-32. Apple
`Inc. v. Andrea Elecs. Corp., 949 F.3d 697, 706 (Fed. Cir. 2020);
`Chamberlain Grp., Inc. v. One World Techs., Inc., 944 F.3d 919,
`925 (Fed. Cir. 2019) (“Parties are not barred from elaborating on
`their arguments on issues previously raised."); Ericsson Inc. v.
`Intellectual Ventures I LLC, 901 F.3d 1374, 1381 (Fed. Cir. 2018).
`The argument and evidence show methods of adding free HA were
`“well known,” rebutting Allergan’s contention that Monheit gives
`no “guidance” as to amount or method of incorporating free HA or
`its effect on a so-called “monophasic” gel. Cf. POR 22, 58-59;
`EX2013 ¶¶ 260-61 (adding free HA was unpredictable).
`Cf. POR 53-54; EX2013 ¶¶ 269-272. Not new; Petition and cited
`evidence argued obviousness of overlapping ranges and no
`criticality or unexpected results. Pet. 22, 35-36, 46-47 & n.11.
`
`Cf. POR 60-63; EX2013 ¶¶ 279-280). Also, Allergan alleges
`Prollenium provides “new evidence/argument on BDDE/DEO
`interchangeability.” But this is the theory originally relied upon
`(Pet. 40-42); Reply elaborates based on Allergan’s arguments.
`Cf. EX2013 ¶¶ 208-12; EX1002 ¶¶ 134-137. Prestwich’s testimony
`responds to Berkland and harmonizes the experts’ views.
`Cf. EX2013 ¶¶ 250-52. Prestwich’s testimony is about expectation
`of success, not motivation, and responds to Berkland’s opinions
`that lidocaine would degrade HA gels.
`
`2
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`Citation
`EX1105
`¶ 96
`
`EX1105
`¶¶ 28, 38-
`39, 70, 72-
`75, 97-113,
`117-18,
`122, 138-
`163, 178-79
`
`EX1105
`¶¶ 44, 153-
`56
`
`EX1105
`¶¶ 58-61,
`64-69, 78-
`90
`EX1105
`¶¶ 64-69,
`76-90
`EX1105
`¶¶ 75, 138-
`52, 157-
`163, 166-68
`
`EX1105
`¶¶ 94
`
`EXHIBITS:
`1103, 1107,
`1114, 1115,
`1210
`
`Responsive To Citation and/or Explanation
`Cf. EX2013 ¶¶ 277 (pointing to Kinney’s “limited” disclosure and
`lack of process information); 279 (suggesting lack of interest in a
`double crosslinked filler). See also EX2200, 421:16-24.
`These paragraphs are plainly responsive to arguments Allergan and
`Berkland raised about lack of motivation and expectation of
`success, e.g., different pain relief methods, differences between the
`chemistry of the compositions and processes in respective
`Grounds, and often expressly cite responded-to material. Citations
`in the “Detailed Discussion” section (¶ 122 onward) merely
`provide “complete context” (EX1105 ¶¶ 120, 32) and background
`foundation for the specific testimony and opinions expressed
`above. See also EX2200, 466:22-477:6, 220:10-221:7.
`Allergan raised ¶ 44 in connection with Reply 37:1-7 (see above in
`this table). EX1210 is relied on as evidence of the “conventional”
`step of adding free HA to fillers and not as “disclosing the claimed
`amounts” of free HA as Allergan’s Paper suggests (though it does,
`as Allergan concedes).
`Cf. POR 14-15, 40, 48-52; EX2013 ¶¶ 85-87, 125, 237, 243-47.
`Allergan and Berkland argued “significant non-covalent
`interactions” between lidocaine and the HA polymer suggest
`lidocaine would not freely release.
`Cf. POR Section VII.E.1; EX2013 ¶¶ 87, 243-46, 288.
`
`Cf. EX2013 ¶¶ 250-52, 67-72, 192-94, 195-97, 105-112. The
`citations here span multiple topics, but generally cite to the
`“background” section of Prestwich’s testimony, which provides
`foundation for his more substantive opinions actually cited in
`Reply. As to the sterilization topic specifically noted by Allergan,
`this testimony responds to Berkland suggesting autoclaving led to
`“unpredictable effects.” EX2013 ¶¶ 93-95, 250-52, 293-96.
`Cf. EX2013 ¶¶ 270-72 (suggesting no expectation of “specific”
`crosslinking degrees). See also Pet. 35 (citing specific crosslinking
`degrees, including the specific examples in Lebreton).
`Each exhibit is cited in response to some argument or evidence
`presented in the POR, and Allergan has no prejudice because (1)
`by its admission, it made those arguments knowing of their
`existence, and (2) it can address in its sur-reply.
`
`3
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`Respectfully submitted,
`
`
`/Warren Thomas/
`Warren J. Thomas (Reg. No. 70,581)
`
`4
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`CERTIFICATE OF SERVICE
`
`
`
`Pursuant to 37 C.F.R. §§ 42.6(e)(4) and consent of the Patent Owner, I certify
`that on December 4, 2020, a copy of Petitioner’s Response to Patent Owner’s
`Identification of Alleged Improper New Arguments and Evidence was served on
`the counsel of record by email to:
`aminsogna@jonesday.com
`tweisser@jonesday.com
`cplatt@jonesday.com
`sgeers@jonesday.com
`jhartjes@jonesday.com
`
`
`
`
`/Warren Thomas/
`Warren J. Thomas (Reg. No. 70,581)
`
`5
`
`