Filed: December 17, 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 Opposition to Patent Owner’s Motion to Exclude1
`
`
`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.
`
`

`

`I.
`II.
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`TABLE OF CONTENTS
`
`INTRODUCTION ........................................................................................... 1
`ARGUMENT ................................................................................................... 1
`A. A Motion to Exclude is for admissibility, not Allergan’s other purposes....... 1
`B. Arguments about DeVore’s testimony repeat merits arguments about weight
`and do not warrant exclusion .......................................................................... 2
`C. The arguments about Prestwich repeat “improper new reply” and merits
`arguments and do not justify exclusion .......................................................... 3
` Allergan’s complaints about “new claim construction” lack merit ............ 3
` Allegedly “contradicted” testimony ........................................................... 4
` Prestwich testimony is not new or “unfairly prejudicial” .......................... 5
`a. No improper new evidence on Lebreton and Sadozai Ground ............. 9
`b. There is no improper new Kinney and Zhao evidence .......................10
`c. Remaining arguments about “new” evidence ..................................... 11
`d. Prollenium properly rebutted Allergan and Berkland testimony and
`did not attempt to “erase” anything .....................................................12
`e. Presenting reply evidence does not “evade” 314 or 325(d) ................13
`D. Allergan’s few evidentiary objections lack merit ......................................... 14
` Documents showing level of skill and knowledge around the priority date
`are relevant even if they slightly post-date the filing ...............................14
` Inventor emails are admissible to corroborate availability of public
`information about lidocaine-containing HA gels .....................................16
` Documents or information relied upon for Prestwich’s opinions are not
`“improper” ................................................................................................16
` There is no need to exclude unfiled or uncited evidence .........................18
`III. CONCLUSION ..............................................................................................18
`
`
`i
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`TABLE OF ABBREVIATIONS
`
`
`
`Abbreviation
`BDDE
`DEO
`Challenged
`Patents
`FDA
`FRE
`HA
`POSITA
`ID Paper
`
`ID Resp.
`
`MTE
`
`Pet.
`PO Resp.
`
`Reply
`
`Sur-Reply
`
`Term
`butanediol diglycidyl ether
`1,2,7,8-diepoxyoctane
`U.S. Patent Nos. 8,450,475; 8,357,795; 9,238,013;
`9,358,322; 8,822,676; and 9,089,519, collectively
`U.S. Food & Drug Administration
`Federal Rule(s) of Evidence
`hyaluronic acid
`Person of Ordinary Skill in the Art
`IPR2019-01617, Patent Owner’s Identification of [Alleged]
`Improper New Arguments and Evidence, Paper 50
`(identical paper filed in all proceedings)
`IPR2019-01617, Petitioner’s Response to Patent Owner’s
`Identification of Alleged Improper New Arguments and
`Evidence, Paper 51
`(identical paper filed in all proceedings)
`Patent Owner’s Motion to Exclude, IPR2019-01617, Paper
`55
`(identical paper filed in all proceedings)
`Petition
`Patent Owner’s Response to the Petition in IPR2019-01617,
`Paper 40 (cited as representative and exemplary of citations
`for the remaining proceedings)
`Petitioner’s Reply to Patent Owner Response in IPR2019-
`01617, Paper 43 (cited as representative and exemplary of
`citations for the remaining proceedings)
`Patent Owner’s Sur-Reply in IPR2019-01617, Paper 53
`(cited as representative and exemplary of citations for the
`remaining proceedings)
`
`ii
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`Abbreviation
`Sur-Replies
`[plural]
`
`Term
`IPR2019-01505, Patent Owner’s Sur-Reply, Paper 52;
`IPR2019-01506, Patent Owner’s Sur-Reply, Paper 54;
`IPR2019-01508, Patent Owner’s Sur-Reply, Paper 55;
`IPR2019-01509, Patent Owner’s Sur-Reply, Paper 53;
`IPR2019-01617, Patent Owner’s Sur-Reply, Paper 53;
`IPR2019-01632, Patent Owner’s Sur-Reply, Paper 54; and
`IPR2020-00084, Patent Owner’s Sur-Reply, Paper 48,
`collectively
`
`
`
`All emphasis in this Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`is added unless otherwise indicated.
`
`iii
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`INTRODUCTION
`I.
`
`Allergan’s Motion to Exclude (MTE) is mostly an improper attempt to argue
`
`(1) the merits of the evidence and (2) that the Prollenium’s Replies exceed the
`
`proper scope of a reply. Allergan’s FRE 702 “unreliable” arguments just recycle
`
`arguments from its Responses and Sur-Replies about the weight of the experts’
`
`testimony. And under the guise of citing FRE 403 “unfair prejudice,” Allergan
`
`argues the motion to strike it was denied leave to file. Allergan’s MTE is one of
`
`many ways it is seeking to distract the Board from the merits. The Board should
`
`reject Allergan’s attempts to abuse the motion to exclude process. The few actual
`
`evidentiary objections lack merit as well.
`
`II. Argument
`A. A Motion to Exclude is for admissibility, not Allergan’s other purposes
`A motion to exclude addresses admissibility of evidence, not the weight or
`
`sufficiency of that evidence. PTAB CONSOLIDATED TRIAL PRACTICE GUIDE 79
`
`(Nov. 2019); see also Daiichi Sankyo Co. v. Alethia Biotherapeutics, Inc., No.
`
`IPR2015-00291, Paper 75, 24 (June 14, 2016) (Snedden, J.) (denying motion to
`
`exclude declaration testimony); InnoPharma Licensing, Inc. v. Senju Pharm. Co.,
`
`No. IPR2015-00903, Paper 82, 33 (July 28, 2016) (Obermann, J.) (denying motion
`
`to exclude under FRE 702). A motion to exclude also should not “address
`
`arguments or evidence that a party believes exceeds the proper scope of reply.”
`
`1
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`Guide 79; see also Conopco, Inc. v. Proctor & Gamble Co., No. IPR2013-00505,
`
`Paper 69, 29-30 (Feb. 10, 2015) (Obermann, J.) (same, citing cases).
`
`Allergan’s MTE violates both of these principles. Its attempt to “exclude”
`
`Prestwich is particularly bold, as Allergan was denied leave to file a motion to
`
`strike. Though acknowledging that denial, Allergan raises the same “new
`
`argument” issues here (MTE Section IV). Allergan also made these same
`
`arguments in its Sur-Replies. The Board should reject Allergan’s attempt to
`
`shoehorn merits and scope arguments into an MTE.
`
`B. Arguments about DeVore’s testimony repeat merits arguments about
`weight and do not warrant exclusion
`Allergan moves to exclude both experts under FRE 702 and Daubert. But
`
`the Board generally sees no need to exercise a “gatekeeping role” as it is capable of
`
`taking weaknesses into account when weighing the evidence. E.g., InnoPharma,
`
`No. IPR2015-00903, Paper 82, 33; Coastal Indus., Inc. v. Shower Enclosures Am.,
`
`Inc., No. IPR2017-00573, Paper 85, 106 (Nov. 19, 2018) (noting the “policy
`
`considerations” under Daubert “are less compelling in bench proceedings, such as
`
`[IPRs], than in jury trials” (quoting Legend3D, Inc. v. Prime Focus Creatives
`
`Servs. Canada Inc., No. IPR2016-00806, Paper 73, 10-11 (Sept. 18, 2017))).2
`
`
`2 Neither Intelligent Bio-Systems. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369
`
`
`
`2
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`Beyond that fundamental flaw, Allergan’s argument that DeVore’s testimony
`
`is “unreliable” improperly rehashes arguments made in merits briefs. Cf. PO Resp.
`
`27-29 (many of same arguments citing same testimony); cf. also Sur-Reply 5, 13,
`
`19. Allergan’s “candor” argument improperly repeats its merits arguments made in
`
`both the Response and Sur-Reply, citing a case (Blackberry) that likewise
`
`addressed the weight of the evidence not admissibility. See PO Resp. 31 (citing
`
`alleged lack of candor to argue DeVore’s opinions “merit little weight”); Sur-Reply
`
`5.3 These duplicated arguments present no basis to exclude DeVore’s entire
`
`declaration under FRE 702.
`
`C. The arguments about Prestwich repeat “improper new reply” and
`merits arguments and do not justify exclusion
`Allergan next argues the Prestwich declaration should be excluded under
`
`FRE 703 because it is “unreliable” and “lacks support,” and excluded under FRE
`
`403 because Allergan lacked “adequate notice and opportunity to respond to the
`
`new arguments and evidence” in the declaration. These arguments fail.
`
` Allergan’s complaints about “new claim construction” lack merit
`
`
`(Fed. Cir. 2016), nor Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.2
`
`(Fed. Cir. 2008), cited at PO Mot. 3 and 5, support Allergan’s FRE 702 argument;
`
`neither addresses exclusion under rules of evidence.
`
`3 Allergan’s Sur-Reply cites a related Blackberry decision issued the same day.
`
`3
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`As to the “new claim construction,” MTE 5-6, Allergan’s position rehashes
`
`its argument at Sur-Reply 21-22 (and ID Paper 2), citing the same Prestwich
`
`testimony, but now cites five new exhibits purported to “contradict” Prestwich’s
`
`claim construction. Such arguments are improper in an MTE.
`
`Anyway, Prestwich did not offer any new “claim construction” of the term
`
`freely released. First, he agreed with Berkland that the term had ordinary meaning
`
`and found DeVore’s testimony to be consistent. EX1105 ¶ 37. Next, Allergan
`
`misconstrues Prestwich’s testimony about so-called controlled release. Prestwich
`
`was not opining on claim construction, rather he explains why a POSITA would
`
`understand that “the controlled or sustained release of the bioactive agent” in
`
`Sadozai (EX1030 ¶ [0059]) does not exclude a faster rate of release that would
`
`meet the freely released limitation. See, e.g., EX1105 ¶¶ 79, 82; cf. EX1002
`
`¶¶ 149-153 (also explaining why POSITA would not interpret Sadozai as limited to
`
`controlled release formulations).
`
` Allegedly “contradicted” testimony
`Allergan also contends certain “scientific theories” lack support and are
`
`contradicted by prior testimony. MTE 6-8. Even if Allergan was correct, any such
`
`contradictions at best impeach Prestwich, which goes to weight not admissibility.4
`
`
`4 Allergan’s papers concede these exhibits are only “for impeachment” and
`
`
`
`4
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`In any case, no contradictions exist.
`
`Prestwich’s prior statements about the impact of lidocaine HCl and
`
`osmolarity on rheology were made as part of his analysis of flaws in the study
`
`design in Example 3 of the provisional applications—specifically the failure to use
`
`“adequate controls” to isolate the relevant variable. See EX2200G ¶¶ 177-184.
`
`Further, Prestwich’s solubility analysis was not performed using a “cherry-picked”
`
`value for lidocaine solubility; rather, he used the only value identified (at
`
`EX2200FFF, 7) as available in the art by August 2008. And contrary to Allergan’s
`
`claim that Prestwich “deleted” information recognizing differences between BDDE
`
`and DEO, Prestwich specifically acknowledges those differences here while
`
`explaining they would not be so great as to render the material unsuitable for use as
`
`a filler. EX1105 ¶¶ 98, 100 (noting the crosslinkers are “chemically different” but
`
`the “differences in hydrophobicity [etc.] … would not be so great as to produce a
`
`material … unsuitable for use as a filler”). Prestwich’s testimony is not
`
`contradicted and is sufficiently reliable; it should not be excluded.
`
` Prestwich testimony is not new or “unfairly prejudicial”
`Under the guise of raising “unfair prejudice” under FRE 403, Allergan
`
`improperly (and incorrectly) argues Prestwich’s testimony exceeds the proper
`
`
`“credibility.” PO Mot. 32 n.6; Sur-Reply xiv n.1 (same).
`
`5
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`scope of a reply. “‘Unfair prejudice’ … means an undue tendency to suggest
`
`decision on an improper basis, commonly, though not necessarily, an emotional
`
`one.” Rule 403 Advisory Committee Note. Notably, among the several cases cited
`
`by Allergan in this section of the MTE, only one relates to FRE 403 at all—and not
`
`in the portion cited by Allergan: Intri-Plex Techs., Inc. v. Saint-Gobain
`
`Performance Plastics Rencol Ltd., IPR2014-00309, Paper 83, 17 (Mar. 23, 2015)
`
`(denying exclusion under FRE 403 because the Board is not a “jury” and thus
`
`“little danger of unfair prejudice” or confusion); see also Guide 80.
`
`And there is no unfair prejudice to Allergan—much less any that
`
`substantially outweighs the probative value of the testimony. First, the only wrinkle
`
`here is the identity of the reply declarant. It is beyond dispute that a petitioner may
`
`submit testimony (along with other evidence) with its reply; the Federal Circuit has
`
`even affirmed the Board’s consideration of new reply testimony when the
`
`petitioner did not submit any with the initial petition. Belden Inc. v. Berk-Tek LLC,
`
`805 F.3d 1064, 1078 (Fed. Cir. 2015).
`
`The proper inquiry is whether the evidence “fairly responds” to the Patent
`
`Owner. Id. at 1078; Genzyme Therapeutic Prod. Ltd. P’ship v. Biomarin Pharm.
`
`Inc., 825 F.3d 1360, 1366 (Fed. Cir. 2016) (no requirement for a petition “to
`
`anticipate and set forth every legal or factual issue that might arise” during the
`
`trial); Chamberlain Grp., Inc. v. One World Techs., Inc., 944 F.3d 919, 925 (Fed.
`
`6
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`Cir. 2019) (“Parties are not barred from elaborating on their arguments on issues
`
`previously raised.”). A reply may also “document the knowledge that skilled
`
`artisans would bring to bear in reading the prior art.” Anacor Pharm., Inc. v. Iancu,
`
`889 F.3d 1372, 1380-81 (Fed. Cir. 2018). As shown in Prollenium’s ID Resp.
`
`(Paper 51)—not to mention in the Replies and EX1105—Prollenium’s arguments
`
`and evidence counter issues raised by Allergan and Berkland. In fact, Prestwich’s
`
`declaration is littered with both explicit and implicit references to Berkland’s and
`
`Allergan’s positions. E.g., EX1105 ¶¶ 44-49, 76-82, 98-119.
`
`Second, there is no “sandbagging” (see MTE 9) simply because the reply
`
`declarant is different than in the petition. Allergan protests that Prestwich
`
`“incorporates large swathes” of the background sections from his prior IPR
`
`declarations. MTE 15; see also ID Paper 3; Sur-Reply 7-8 (referring to “significant
`
`portions” of overlapping testimony). Allergan thus concedes it possessed and been
`
`able to consider that prior testimony since at least 2014.5 Berkland had already
`
`considered (and responded to) Prestwich’s testimony in the district court, too.
`
`EX2013 ¶ 13; EX1105 ¶ 21.6
`
`
`5 Allergan indisputably possessed the earlier Prestwich testimony, so there was no
`
`need for Prollenium to “serve” it under 37 C.F.R. § 42.51(b)(1)(iii).
`
`6 Allergan’s familiarity with Prestwich—both his (undisputed) expertise and his
`
`
`
`7
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`Finally, any supposed prejudice was obviated because Allergan could and
`
`did cross-examine Prestwich and respond to Prollenium and Prestwich’s points
`
`(whether or not they are deemed “new”) in its seven sur-reply briefs. Allergan’s
`
`citations to the NuVasive and Nestle cases, which pre-date the current practice of
`
`allowing patent owners the last word, illustrate why there is no prejudice here. In
`
`NuVasive, the party was not allowed a sur-reply brief or the opportunity to address
`
`the alleged “new” information. In re NuVasive, Inc., 841 F.3d 966, 973 (Fed. Cir.
`
`2016) (concluding the prior “observations” practice gave insufficient opportunity
`
`to respond to the issues raised in reply). And in Nestle the patent owner was
`
`allowed only a 3-page sur-reply to address the alleged “new” information about a
`
`limitation the Board had previously found neither reference in the combination at
`
`issue disclosed. Nestle-Purina Petcare Co. v. Oil-Dri Corp. of Am., IPR2015-
`
`00737, Paper 37, 22-25 (Jun. 20, 2016).
`
`Allergan’s situation here is totally different. The Board did not find any
`
`element lacking based on the original petitions or evidence, which included
`
`substantial discussion about the presently disputed facts of motivation and
`
`expectation of success. Allergan presented lengthy substantive arguments in its
`
`Sur-Replies, and it was allowed to submit a 3-page paper (as in Nestle) to identify
`
`
`prior testimony—indeed minimized any potential for unfair prejudice.
`
`8
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`the supposed new arguments and evidence.
`
`Prollenium’s Replies focus on the alleged lack of motivation and reasonable
`
`expectation of success, which Allergan and Berkland addressed in detail. Given
`
`Allergan’s arguments about DeVore’s testimony, particularly from the academic
`
`perspective of Dr. Berkland, Prollenium was entitled to counter, including by
`
`offering testimony from a similarly credentialed witness to rebut Berkland’s
`
`assertions about the art, the skills of a POSITA, and critiques of DeVore. It is plain
`
`that Allergan is trying to avoid consideration of the merits any way it can. The
`
`evidence should not be excluded under FRE 403 or on any other basis. Prollenium
`
`next addresses the specific arguments raised against Prestwich in Allergan’s MTE.7
`
`a. No improper new evidence on Lebreton and Sadozai Ground
`Allergan’s arguments at MTE 10-11 again duplicate its Sur-Reply (at 10, 18)
`
`and ID Paper. Allergan argues Prollenium “alters the instituted ground … to just
`
`Lebreton.” MTE, 10. But Prollenium’s position has always been that it was
`
`obvious to add 0.3% lidocaine, as exemplified in Sadozai, to Lebreton’s gels. 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
`
`
`7 Prollenium previously discussed the alleged “new claim construction” of freely
`
`released, so it will not be repeated here.
`
`9
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`pH control” is only thing “necessary to obtain the claimed fillers”). Likewise,
`
`Prestwich does not offer a “new basis” for expectation of success based on
`
`EX1216, a journal article expressly noting Elevess’s crosslinker. Rather, the
`
`document is offered to rebut Allergan and Berkland’s positions that the POSITA
`
`had no knowledge of the crosslinker and that DeVore relied only on his personal
`
`knowledge. Cf. ID Resp. 2 (refuting same).
`
`b. There is no improper new Kinney and Zhao evidence
`This argument (MTE 11-12) repackages arguments raised at Sur-Reply 26.
`
`In any case, the cited Prestwich testimony and related arguments are directly
`
`responsive to Allergan and Berkland’s position that there was no motivation to
`
`combine and that the differences between BDDE and DEO would have prevented a
`
`POSITA from having a reasonable expectation of success. See Reply 39.
`
`That Prestwich pointed to another table in Zhao or referenced another
`
`exhibit to rebut Allergan’s positions does not render the testimony (or argument)
`
`improper. At MTE 11-12, Allergan cites Ariosa Diagnostics v. Verinata Health,
`
`Inc., 805 F.3d 1359, 1367 (Fed. Cir. 2015), but there the reply improperly
`
`referenced an embodiment of the prior art not discussed in the petition. Here the
`
`same embodiment of Zhao is still the basis for the obviousness contention; the
`
`newly cited portion of Zhao shows other crosslinkers having greater differences
`
`than between DEO and BDDE were used to crosslink, rebutting Allergan’s
`
`10
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`assertion of no reasonable expectation of success.8
`
`c. Remaining arguments about “new” evidence
`Allergan’s remaining, terse arguments (MTE 12-13) about alleged “new”
`
`arguments and evidence also improperly repeat its ID Paper. The 2013 Allergan
`
`Brief (EX1103) is plainly not cited to “demonstrate” the claimed “lidocaine
`
`concentration requirement but for Allergan’s admissions that the wide-range of
`
`collagen and HA fillers all used the same lidocaine concentration. Cf. PO Resp. 49;
`
`see also, e.g., Reply 26 (“lidocaine was a well-established solution”); EX1105 ¶ 39
`
`(including EX1103 among evidence that crosslinker identities were widely
`
`reported and known to POSITAs), ¶ 63 (citing as additional evidence that POSITAs
`
`knew same concentration was used in all approved dermal fillers).
`
`Prestwich cited EX1107 (Drizen) merely as background about the common
`
`use of autoclaving with HA, which is plainly responsive to Allergan’s arguments
`
`about supposed unpredictable heat degradation.9 Prestwich cites EX1210 (Piron
`
`
`8 Allergan mischaracterizes Prestwich’s testimony about lidocaine stabilizing HA
`
`formulations. MTE 12 (citing ¶¶ 75, 179); ID Paper 2. That testimony is about
`
`expectation of success, not motivation, responding to Berkland. E.g., EX1105 ¶ 75.
`
`9 Other than in IPR2020-00084, Prollenium did not present additional argument in
`
`its Replies about the presence of the “sterile” limitations, opting instead to stand on
`
`
`
`11
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`2008) in his section on “routine” post-crosslinking processing for HA gels
`
`(EX1104 ¶ 44) as an example of the simplicity of adding free HA to a gel—i.e., the
`
`skill of a POSITA—and sterilizing it, not for motivation. Berkland, for example,
`
`testified that the POSITA would not expect success in adding free HA because of
`
`the “unpredictable” effects, and that a POSITA would not have known “when or
`
`how to add free HA.” EX2013 ¶¶ 260-261. So the cited evidence is responsive,
`
`further showing POSITAs knew how to add free HA and did not fear any
`
`“unpredictable” effects.
`
`d. Prollenium properly rebutted Allergan and Berkland testimony
`and did not attempt to “erase” anything
`Allergan’s arguments that Prollenium cannot “provide new evidence and
`
`argument” to support DeVore’s declaration (MTE 13-14) and related arguments
`
`about DeVore’s testimony were all made in its Responses. See PO Resp. 28, 48, 59,
`
`62. Prollenium countered with both argument and evidence, as it is entitled to do.
`
`Doing so with a different witness in no way constitutes unfair prejudice.
`
`In any event, Allergan’s arguments are irrelevant. As one example, Allergan
`
`notes DeVore “conceded” that Monheit does not (literally) “suggest adding free as
`
`a lubricant to a monophasic HA gel.” MTE 14. But Monheit need not expressly
`
`describe adding free HA “to a monophasic HA gel” to provide a motivation to
`
`
`the arguments and evidence cited in the Petition.
`
`12
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`combine. And Prestwich does not cite “EX1210 instead,” but in addition to the
`
`arguments and evidence in the Petition and Reply. Likewise, responding to
`
`Allergan’s contention about differences between BDDE and DEO by citing
`
`crosslinkers with greater differences in use within the reference is proper.
`
`e. Presenting reply evidence does not “evade” 314 or 325(d)
`Allergan’s arguments about alleged evasion of §§ 314 and 325(d) is
`
`incorrect and has nothing to do with admissibility. See MTE 15. The Board did not
`
`“reject[]” all of Prestwich’s prior opinions in the Teoxane case; it declined to
`
`institute trial given deficiencies in the petitions, including failure to cite to
`
`Prestwich’s testimony. See, e.g., IPR2019-01505, Pet. 63. And Reply evidence in a
`
`trial is not a “serial and repetitive attack[]”merely because Prollenium presented
`
`testimony about disputed issues of fact from a witness who testified years before
`
`for an unrelated petitioner. These trials address different Grounds citing different
`
`evidence in support. That there is some overlap in the evidence is expected since
`
`Allergan asserted the same patents and family.
`
`Last, Allergan cites “Board Rules” that are not grounds for a motion to
`
`exclude. Rule 42.6(c) does not require witnesses to refer only to information filed
`
`as an exhibit in the proceeding. And in the five identified paragraphs (MTE 16),
`
`Prestwich provided sufficient identifying information to point Allergan to the bases
`
`for his statements. Allergan’s contentions about improper incorporation are,
`
`13
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`ironically, cumulative of its arguments in the ID Paper, to which Prollenium has
`
`responded. See also Sur-Reply 19 (same).
`
`D. Allergan’s few evidentiary objections lack merit
` Documents showing level of skill and knowledge around the
`priority date are relevant even if they slightly post-date the filing
`Allergan concedes that evidence from “around” the filing date can be used
`
`as evidence of the knowledge or skill of a POSITA. MTE 17; Plant Genetic Sys.,
`
`N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1344 (Fed. Cir. 2003). And Allergan
`
`must so concede, since it relied on at least 7 documents post-dating the priority
`
`date, some with publication dates many years after the filing date. E.g., EX2019
`
`(February 2009), EX2056 (May 2009), EX2061 (2011), EX2063 (October 2009).10
`
`Allergan’s duplicity is best illustrated by its moving to exclude EX1086
`
`(“Maleki”) as irrelevant because it “postdate[s]” the priority date. MTE 17.
`
`Allergan files and relied on the same article, published in December 2008, to argue
`
`HA was known to be pH-sensitive. PO Resp. xii, 13-14; EX2094.11
`
`
`10 Prollenium only moved to exclude Allergan documents long post-dating the
`
`priority date and unrelated to level of skill around the priority date.
`
`11 Allergan also argues EX1086 and EX1090 (Tokita) are irrelevant because they
`
`were identified in Prollenium’s Exhibit List but not filed. As with EX1086,
`
`Allergan relied on the same article that is EX1090, filing and citing it as EX2037,
`
`
`
`14
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`Other documents complained of are proper. Exhibits 1116 and 1117 claim
`
`earlier priority dates, so they are evidence of the level of skill at that time.12
`
`EX1102 is a book cited for general knowledge of the POSITA. Reply 36; EX1105
`
`¶ 39. It was published in April 2009,13 earlier than several of Allergan’s submitted
`
`references, as noted above. EX1103, a brief Allergan submitted to FDA in 2013, is
`
`cited given Allergan’s characterizations of the established use of lidocaine in the
`
`prior art fillers and its admission that, even as of 2013, FDA-approved HA dermal
`
`fillers used only “3 different crosslinking agents.” Reply 26; EX1105 ¶¶ 39, 63.
`
`These documents are therefore relevant.
`
`The remaining two documents Allergan moves to exclude are non-issues.
`
`
`for arguments that that HA is heat- and pH-sensitive. PO Resp. vii, 12, 14; see also
`
`EX2013 ¶¶ 99-100 (same).
`
`12 EX1116 is a patent that issued from an application filed in July 2008, so it is
`
`prior art under § 102(e). EX1117 claims priority to Application No. 10/552,309,
`
`filed Oct. 7, 2005.
`
`13 Allergan does not argue the exhibit was not published as of the stated date
`
`(Reply 11), but the date is also reflected on the publisher’s website. See
`
`https://www.mhprofessional.com/9780071490627-usa-cosmetic-dermatology-
`
`principles-and-practice-second-edition-group.
`
`15
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`Allergan moved to exclude EX1077 “in all but IPR2020-00084,” but that is the
`
`only proceeding where Prollenium or its witnesses relied upon it. And EX1202 was
`
`only used during the Berkland deposition (and filed by Prollenium as part of the
`
`complete record of that deposition to accompany the transcript).
`
` Inventor emails are admissible to corroborate availability of
`public information about lidocaine-containing HA gels
`Dr. Lebreton’s emails are not hearsay because they are not offered for their
`
`truth—a necessary element Allergan fails to assert. The emails are cited to “show
`
`the inventor monitoring and sharing information about competitors’ lidocaine HA
`
`products,” rather than the truth of any statement within the press releases and other
`
`public information that he accessed and shared. Reply 26 (emphasis in original);
`
`see also id. at 32 (they “underscore how easily a POSITA could find out about”
`
`other lidocaine products). The emails are thus not hearsay. They are plainly
`
`relevant to the issues for which they were cited. While not an evidentiary
`
`objection, Allergan’s complaint that Prollenium provided no translation lacks
`
`merit: There are a total of 5 lines in French on two of 11 total pages, and the
`
`meaning of the one French phrase cited (“HA filler avec lidocaine”) is apparent.
`
` Documents or information relied upon for Prestwich’s opinions
`are not “improper”
`Allergan next identifies 8 exhibits that are “never cited” in the Replies, but it
`
`identifies no rule of evidence requiring their exclusion and cites no authority for
`
`16
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`the proposition that every source an expert cites to support or corroborate his
`
`opinions must also be cited or discussed directly by the party in its brief.14
`
`Allergan implausibly moves to exclude EX1083, but this patent is
`
`incorporated by reference by the Challenged Patents. EX1001, 13:28-33. Prestwich
`
`thus cites EX1083 as a background “example[]” of a process describing
`
`crosslinking HA with BDDE, EX115 ¶ 142. As noted in Section II.C.3.c above,
`
`EX1107 is cited in the background as an example of autoclaving “virtually all
`
`types of HA compositions.” EX1105 ¶ 166. Prestwich cites EX1111 (Sinnott) in
`
`¶ 63 to support his opinions on why a POSITA would not be concerned with
`
`lidocaine precipitation, and EX1114 and EX1115 (Lindvall and Ji) in ¶ 75
`
`discussing why he disagreed with Berkland about the POSITA expecting
`
`“lidocaine-induced degradation during autoclave sterilization.” See also EX1105
`
`¶ 179 (citing EX1114 in background). Prestwich cites EX1116 and 1117 in ¶¶ 104-
`
`105 in his technical discussion of opinions about the interchangeability of the
`
`BDDE and DEO crosslinkers, again responding to Berkland’s opinions about the
`
`
`14 Allergan cites Kaz USA, but there the Board declined to consider evidence of a
`
`nexus where the Patent Owner had not cited any of that evidence in its Response
`
`and had not explained how the commercial embodiments were the claimed
`
`inventions. IPR2016-01437, Paper 43, 35-36.
`
`17
`
`

`

`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`same. Cf. EX2013 ¶¶ 72-73, 279-280, 291.
`
`Last, EX1088 is not improperly “incorporated” because its reference in
`
`EX1105 ¶ 80 is an obvious typographical error: The sentence refers to “the study
`
`reported in EX2088.” EX1088 is not cited in any of these seven proceedings.
`
` There is no need to exc