`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`AYLA PHARMA LLC,
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`Patent Owner.
`__________________
`
`Case No. IPR2020-00295
`Patent 9,533,053
`__________________
`
`PATENT OWNER’S SUR-REPLY
`
`
`
`
`
`
`

`

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`Case No. IPR2020-00295
`Patent 9,533,053
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`TABLE OF CONTENTS
`INTRODUCTION ..................................................................................................... 1 
`I. 
`Ayla’s Petition Should Be Denied under § 325(d) .......................................... 2 
`II. 
`Ayla’s Petition Should Be Denied under § 314(a) .......................................... 6 
`CONCLUSION ........................................................................................................ 12 
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`Case No. IPR2020-00295
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`TABLE OF AUTHORITIES
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`
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH,
`IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020). ............................................. 1, 2
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) ......................................... 6-12
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) ................................................. 4
`Edge Endo, LLC v. Scianamblo,
`IPR2018-01322, Paper 15 (PTAB Jan. 14, 2019) ................................................ 8
`ESET, LLC v. Finjan, Inc.,
`IPR2017-01969, Paper 8 (PTAB Jan. 9, 2018) .................................................... 8
`General Plastic Industrial Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Paper 19 (PTAB Sept. 6, 2017) ................................................. 9
`Next Caller Inc. v. TRUSTID, Inc.,
`IPR2019-00963, Paper 8 (PTAB Oct. 28, 2019) .............................................. 7, 8
`NHK Spring Co. v. Intri-Plex Techs., Inc.,
`IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) ............................................... 10
`Robert Bosch Tool Corp. v. SD3, LLC,
`IPR2016-10751, Paper 15 (PTAB Mar. 22, 2007) ............................................. 11
`Stryker Corp. v. KFx Medical, LLC,
`IPR2019-00817, Paper 10 (PTAB Sept. 16, 2019) ......................................... 8, 12
`ZTE (USA) Inc. v. Fractus, S.A.,
`IPR2018-01451, Paper 12 (PTAB Feb. 19, 2019) ................................................ 8
`35 U.S.C. § 325(d) ......................................................................................... 1-4, 6, 8
`35 U.S.C. § 314(a) ......................................................................................... 1, 6, 7, 8
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`Ayla does not dispute that the examiner and the Court previously considered
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`the same references and arguments that Ayla advances; that they did so with
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`respect to the same or “undisputedly similar” claims; that the examiner allowed the
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`’053 patent over those same references and arguments; and that the Court rendered
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`numerous factual findings that run directly contrary to Ayla’s asserted grounds.
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`Ayla nevertheless insists, without any valid justification, that the Board should
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`retread that ground and institute Ayla’s petition. The Board should not do so.
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`Institution under these circumstances would render meaningless the effi-
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`ciency aims of the AIA. With respect to § 325(d), Ayla points to nothing in its
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`petition or declaration that the examiner failed to consider. Without any genuine
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`basis for alleging examiner error under Advanced Bionics, Ayla wholly ignores
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`that case and resorts instead to misconstruing the prosecution record. With respect
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`to § 314(a), despite conceding the close similarity of the claims of the related ’154
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`and ’053 patents, Ayla provides no reason to second-guess the Court’s post-trial
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`findings bearing directly on Ayla’s art and arguments. And rather than addressing
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`the known objective evidence of record, Ayla instead asserts unabashedly that the
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`Court’s findings are unsupported by “competent expert testimony” (which is un-
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`true) and that “it is premature to address” those findings “at this stage” (which
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`ignores several Board decisions holding precisely the opposite).
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`The Board thus should exercise its discretion and deny Ayla’s petition.
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`1
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`I.
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`Case No. IPR2020-00295
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`Ayla’s Petition Should Be Denied under § 325(d)
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`Despite the issuance of Advanced Bionics being a principal basis for its
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`request for a reply, Ayla’s reply never once cites that decision or applies its two-
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`part framework. See, e.g., EX1044 (Hearing Tr.) at 22 (“the Bionics case put forth
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`the two-factor test ... and we should be allowed to address that”). Untethered to the
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`relevant Board precedent, Ayla instead argues (at 1) that the Board must institute
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`because “‘the mere citation of references in an IDS’” does not justify denial.
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`As an initial matter, Ayla fails to appreciate that “if either condition” of the
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`first part of Advanced Bionics is satisfied, then the only remaining question is
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`“whether the petitioner has demonstrated that the Office erred.” IPR2019-01469,
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`Paper 6, at 8 (emphasis added). Because Ayla does not dispute that every one of
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`its relied-upon references was considered by the examiner, part one of Advanced
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`Bionics is necessarily met. Id. at 20; see Pat. Owner Prelim. Resp. (POPR) 30-31.
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`Under part two of Advanced Bionics, Ayla has not demonstrated Office
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`error. POPR 38-42. Unlike in Ayla’s cited cases (at 1-2), Ayla’s references were
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`not simply listed on an IDS. Rather, Patent Owner disclosed to the examiner a
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`complete IPR petition and two accompanying declarations—which discussed the
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`relevant disclosures of each of Ayla’s references; combined those references in the
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`same way as Ayla; and presented Ayla’s same unpatentability arguments directed
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`to substantially the same claim limitations. POPR 14-15, 30-36; EX1021;
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`2
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`

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`EX2003; EX2004.
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`Ayla is therefore simply wrong in asserting (at 5) that “the record is silent”
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`with respect to the references making up its grounds. This is not a situation, like in
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`the ZTE case cited by Ayla, where the record lacks any explicit analysis of the
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`relied-upon references. To the contrary, the prosecution record of the ’053 patent
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`evidences the examiner’s consideration of a painstakingly detailed discussion of
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`Ayla’s entire case for unpatentability. The Board should reject Ayla’s unfounded
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`assertion (at 5) that this detailed disclosure was “misapprehended or overlooked.”
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`Ayla’s argument (at 2) concerning its third ground does not salvage its
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`petition. The third ground is effectively an afterthought; it recycles the same
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`references and it cross-references the same arguments from the other two grounds.
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`See POPR 27, 31-32. All three of Ayla’s grounds, therefore, mirror those in the
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`Argentum petition over which the examiner allowed the ’053 patent.
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`Regarding the substantive consideration of Schneider during examination of
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`the parent patent, see POPR 7, 36-38, Ayla makes only one argument (at 2): that
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`Patent Owner “does not cite a single decision” involving a denial under § 325(d) in
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`which a reference “was relied upon in a related application.” Ayla is wrong again.
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`In the cited Becton Dickinson case, the Board denied institution under § 325(d)
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`because the same art was “previously substantively considered” by the examiner
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`“during prosecution of the parent application”—which, like the ’154 parent patent
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`3
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`here, had “claims with scope similar to that of the [challenged] patent ... as evi-
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`denced by the Terminal Disclaimer filed” over the parent patent. IPR2017-01586,
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`Paper 8, at 23 (PTAB Dec. 15, 2017) (informative); see also id. at 16 n.6, 28.
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`Next, Ayla baselessly asserts (at 3-5) that, without the Argentum institution
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`decision, the examiner was “deprived” of “any meaningful insight” from the
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`“highly material teachings” of Ayla’s art. Not so. Ayla points to nothing in the
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`Argentum decision that is not also found in the Argentum petition over which the
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`’053 patent was allowed. That is not surprising, as the Argentum decision was
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`based on the Board’s “consideration of the [Argentum] Petition.” EX1015 at 027.
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`Moreover, Ayla overstates the significance of the institution decision—which
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`preceded, and thus was uninformed by, the post-trial factual findings of the District
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`Court. See POPR 49, 60-61. Ayla’s hollow insinuations concerning the Argentum
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`decision should not sway the Board’s § 325(d) calculus.
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`Finally, Ayla argues that the Laskar declaration, which was adopted in
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`Ayla’s Dyar declaration, contains “evidence and facts that w[ere] not before the
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`Examiner,” including a discussion of “the prior art disclosures.” Reply 4 (citing
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`EX1014 at 25-29, 83-91). But that, too, mischaracterizes the record. During pros-
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`ecution, the examiner considered and allowed the ’053 patent over two Argentum
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`declarations. See EX1002 at 003 (listing EX2003, EX2004 as References Cited).
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`Those declarations contain the same assertions as in the Laskar declaration, as the
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`4
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`examples in the following table illustrate:
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`Laskar declaration relied on by
`Ayla (EX1014)
`“Bhowmick does not suggest … a
`particular upper limit to the amount
`of olopatadine…” EX1014 ¶ 183.
`“Bhowmick taught that the inclusion
`of cyclodextrin in these olopatadine
`formulations increases the solution
`stability, thereby preventing olopata-
`dine from precipitating and/or crys-
`tallizing out.” EX1014 ¶ 59.
`“Yanni taught that olopatadine effi-
`cacy increases with increasing con-
`centration, with 1 w/v % having a
`longer-lasting effect.” EX1014 ¶ 61
`(citing Yanni Table 3).
`
`“Castillo … taught aqueous solution
`comprising approximately 0.2-0.6%
`olopatadine for the treatment of vari-
`ous allergic or inflammatory disor-
`ders of the eye.” EX1014 ¶ 62.
`“Schneider describes concentrations
`of olopatadine in solution of ‘about
`0.05% … 0.60% w/v, or higher.’”
`EX1014 ¶ 63.
`“Hayakawa … teaches ... solutions
`including olopatadine concentrations
`of up to about 5 w/v % for the treat-
`ment of allergic eye disease.”
`EX1014 ¶ 65.
`
`
`
`Argentum’s declarations considered by
`the examiner (EX2003, EX2004)
`“Bhowmick does not suggest an upper
`limit to the amount of olopatadine…”
`EX2003 ¶ 54; see also id. ¶ 59.
`“Bhowmick discloses that cyclodextrins
`… may be used to prepare the stable
`aqueous topical solutions … [and] keep
`olopatadine in solution and prevent pre-
`cipitation or crystallization of olopata-
`dine.” EX2003 ¶ 53.
`“Yanni’s disclosure that solutions with
`1 w/v % olopatadine exhibited superior
`reductions in symptoms … and provided
`significantly longer durations of action
`than lower concentrations.” EX2003 ¶ 59
`(citing Yanni Table 3).
`“Castillo discloses topical solutions for
`treating allergic or inflammatory disorders
`of the eye that include approximately
`0.2-0.6% olopatadine…” EX2003 ¶ 56.
`
`“Schneider explicitly discloses concentra-
`tions of olopatadine in solution of ‘about
`0.05%, … 0.60%, or higher.’” EX2003
`¶ 66.
`“Hayakawa describes topically applying
`ophthalmic solutions containing up to
`5% w/v of olopatadine for treating aller-
`gic eye disease…” EX2004 ¶ 53.
`
`5
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`At bottom, Ayla cites not a single salient fact overlooked by the examiner
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`and points to no plausible way in which the examiner might have erred. Under
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`these circumstances, the Board should deny institution under § 325(d).
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`II. Ayla’s Petition Should Be Denied under § 314(a)
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`“[T]he Board takes a holistic view” under § 314(a) driven in substantial part
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`by “concerns about inefficiency and duplication of efforts.” Apple Inc. v. Fintiv,
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`Inc., IPR2020-00019, Paper 11, at 6 (PTAB Mar. 20, 2020) (precedential). Ayla’s
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`chief argument (at 6-7, 9-10) is that the Board should disregard the District Court’s
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`findings because they involve a different patent. But Ayla’s myopic focus on the
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`identity of the challenged patents ignores crucial considerations under § 314(a).
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`Here, the two proceedings involve closely related patents with claims having such
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`“undisputedly similar limitations” that the examiner viewed them as patentably in-
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`distinct, leading to a terminal disclaimer. Reply 5; POPR 7-13, 51-53. Here, Ayla
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`cites not a single difference between the two claim sets that is even arguably rele-
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`vant to its patentability challenge. Reply 6; POPR 35-36. And here, following a
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`multi-day trial and over the course of a 47-page final decision, the District Court
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`evaluated the same art and arguments as in Ayla’s petition and rendered numerous
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`findings undercutting Ayla’s asserted grounds. POPR 15-21, 45-53, 56-60. Ayla’s
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`unsupported assertion (at 6) that there is “no conflict” between its arguments and
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`the Court’s findings stems from an inappropriate cabining of § 314(a) that cannot
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`6
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`be reconciled with the Board’s holistic approach.
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`The Board’s analysis under § 314(a) properly considers “‘all relevant cir-
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`cumstances of the case,’” including the similarity of the claims and the art and ar-
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`guments asserted in the two proceedings. See Apple, at 5.
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`First, Board precedent dictates that a chief concern underlying § 314(a) is
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`“the similarity of the claims challenged in the petition to those at issue in the
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`district court.” Id. at 13 (emphasis added). Denial is particularly favored where, as
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`here, even though the petition and related court proceeding challenge non-
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`overlapping claims, the petitioner “does not argue that the non-overlapping claims
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`differ significantly in some way.” Next Caller Inc. v. TRUSTID, Inc., IPR2019-
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`00963, Paper 8, at 12-13 (PTAB Oct. 28, 2019); see POPR 9-13, 51-53.
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`The Board’s focus on the similarity of the claims makes good sense. Where
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`the claims challenged in the two proceedings are similar, the court is more likely to
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`“resolve key issues in the petition,” thus rendering institution inefficient. See
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`Apple, at 13. To be sure, where the parties dispute the similarity of the claims
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`challenged in the related court proceeding, the question of relevance might be a
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`closer call. But here, the answer is easy: Ayla expressly agrees (at 5) that the
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`claims analyzed by the Court and those challenged by Ayla have “undisputedly
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`similar limitations,” and points to no material difference between them.
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`7
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`Second, another key focus of the Board’s analysis is the prior art and argu-
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`ments asserted in the two proceedings. As “NHK makes clear,” the Board may
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`consider a related “district court litigation considering the same art.” Stryker
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`Corp. v. KFx Med., LLC, IPR2019-00817, Paper 10, at 23 (PTAB Sept. 16, 2019)
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`(emphasis added). Where, as here, the same references and arguments are asserted
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`in both the petition and the related court proceeding, denial under § 314(a) is war-
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`ranted. See Next Caller, IPR2019-00963, Paper 8, at 12 (same art in both cases);
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`ZTE (USA) Inc. v. Fractus, S.A., IPR2018-01451, Paper 12, at 20 (PTAB Feb. 19,
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`2019) (same art and arguments in both cases); see also POPR 17-19, 25-27, 45-51.
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`Finally, the identity of the patent challenged in the prior proceeding does not
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`control the Board’s exercise of its discretion. In a case involving denial under
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`§ 325(d), for example, prior factual findings rendered in connection with a differ-
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`ent but related patent “clearly weigh[ed] in favor of denying institution”—
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`especially because the petitioner, like Ayla here, knew about the findings but failed
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`to “‘argue that those factual findings can be distinguished from the similar claims
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`of the [challenged] patent.’” Edge Endo, LLC v. Scianamblo, IPR2018-01322, Pa-
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`per 15, at 15-16 (PTAB Jan. 14, 2019). Similarly, in ESET, LLC v. Finjan, Inc.,
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`the Board credited a factual finding in a prior proceeding involving the parent
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`patent; did “not find it productive to revisit this finding” in a subsequent challenge
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`by a different petitioner to a child patent with similar claims; and thus exercised its
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`8
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`discretion to deny. IPR2017-01969, Paper 8, at 10 (PTAB Jan. 9, 2018).
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`In arguing the Apple factors, Ayla maintains its blinkered focus on the
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`patents’ identities and provides the Board no basis to eschew the Court’s findings
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`and institute Ayla’s petition. POPR 45-53, 56-60.
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`Apple factors 1 and 2 support denial. Ayla cannot wish away the District
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`Court’s findings simply because they involve “the [parent] ’154 patent.” Reply 7;
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`Pet. 62. The Court’s findings are unquestionably material to Ayla’s petition.
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`POPR 45-53. Moreover, the fact that the District Court trial “did not involve
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`Ayla,” Reply 7, does not cure Ayla’s failure to explain why revisiting the subject
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`matter of those findings “would not be duplicative of the prior case even [though]
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`the petition is brought by a different party,” see Apple, at 14; POPR 53-56.
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`Ayla also claims (at 7 n.3) that its “intent” is “to avoid needless litigation.”
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`That is simply false. Without any products or pharmaceutical development activi-
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`ties, Ayla has nothing to litigate. POPR 23. And having challenged only one of
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`two patents covering Pazeo®, see EX1032 at 003, Ayla is not seeking any freedom
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`to operate as to that product. Rather, Ayla’s game plan is clear: As it now con-
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`cedes (at 8), it “effectively copied” a prior petition and declaration; filed them; and
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`then immediately contacted Patent Owner about settlement. Ayla’s scheme is
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`more akin to an “abuse of the review process” than “an effective and efficient alter-
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`native to district court litigation.” See Gen. Plastic Indus. Co. v. Canon Kabushiki
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`9
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`Kaisha, IPR2016-01357, Paper 19, at 16-17 (PTAB Sept. 6, 2017) (precedential).
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`Apple factor 3 supports denial. Again fixating on the identities of the pa-
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`tents in the two proceedings, Ayla argues (at 7) that no party “has invested any re-
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`sources related to the ’053 patent.” But the Court’s factual findings are highly
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`relevant to both related patents, see POPR 45-53; thus, the extensive efforts under-
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`taken by the Court and Patent Owner throughout the years-long litigation are ap-
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`propriately considered under this factor. POPR 44-45; see Apple, at 9-10. Even
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`though Ayla now admits (at 8) that it “‘spent only minimal resources’” preparing
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`its copycat petition, the fact remains that “instituting a trial under the facts and cir-
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`cumstances here would be an inefficient use of Board resources.” See NHK Spring
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`Co. v. Intri-Plex Techs., Inc., IPR2018-00752, Paper 8, at 20 (PTAB Sept. 12,
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`2018) (precedential); POPR 43-45.
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`Apple factors 4 and 5 support denial. Ayla next complains (at 9-10, 12)
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`that the Court’s “validity determination” concerning the ’154 patent should not “in-
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`sulate[] the ’053 patent.” Reply 9-10, 12. But no one is claiming that the Court’s
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`judgment insulates the ’053 patent. Rather, Ayla could have explained why insti-
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`tution is warranted notwithstanding the Court’s many contrary factual findings.
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`POPR 52-53, 56. But even given a second opportunity to do so, Ayla continues to
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`ignore virtually all of them. Compare POPR 45-53, with Reply 9-11 (ignoring all
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`District Court findings concerning Bhowmick, Castillo, and Hayakawa).
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`10
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`At bottom, Ayla seems to think that Apple was wrongly decided and it is
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`improper to weigh the “existence of non-overlapping claim challenges.” Apple, at
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`13. But Apple is binding Board authority; and Ayla’s SteadyMed case, which in-
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`volves a request to cancel claims of patents not involved in the IPR, is not remotely
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`“analogous.” Reply 9. Ayla also flouts precedent in arguing (at 10) that the Board
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`should skip over Apple factors 4 and 5 because those issues are “best resolved after
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`institution.” The Board should not excuse Ayla’s failure “to discuss why address-
`
`ing the same or substantially the same issues would not be duplicative of the prior
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`case”—nor should it reward Ayla’s evasion with institution. See Apple, at 14.
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`Apple factor 6 supports denial. Rather than addressing the Court’s find-
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`ings of secondary considerations supporting nonobviousness, see POPR 56-60,
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`Ayla instead asserts (at 12) that they are not based on “competent expert testi-
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`mony” and their consideration “is premature” at this stage. Ayla is wrong on both
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`counts. The Court’s findings are based squarely on the expert trial testimony of a
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`clinician with extensive experience in ophthalmology. See POPR 16; EX1030
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`(District Court Op.) at 045-047 (crediting Dr. Torkildsen’s testimony, e.g.,
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`EX2007 at 671:7-22, 688:15-17, 688:18-689:1). And the Board has repeatedly
`
`warned petitioners that “known evidence of secondary considerations should be
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`addressed in the petition.” Robert Bosch Tool Corp. v. SD3, LLC, IPR2016-10751,
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`Paper 15, at 23-24 (PTAB Mar. 22, 2007) (emphasis added) (collecting cases); see
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`11
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`POPR 59 (discussing Stryker, IPR2019-00817, Paper 10, at 29). Particularly in
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`light of the undisputed similarity of the claims challenged in the two proceedings,
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`Ayla has no excuse for failing to address the Court’s findings.
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`Ayla also tries (at 10-12) to score points by claiming that its declaration is
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`“unrebutted.” But Patent Owner laid out the Court’s numerous factual findings
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`running contrary to Ayla’s position, POPR 45-53, and Ayla points to nothing in its
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`declaration that justifies revisiting any of those findings.
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`Finally, there is no merit to Ayla’s policy argument (at 12) that denial of its
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`petition will “promote gamesmanship.” If a petitioner is aware of a prior court
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`case centered on the same art, arguments, and claim limitations as the petitioner’s
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`challenge, then principles of candor and transparency dictate that the petitioner
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`should explain to the Board why institution “would not be duplicative of the prior
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`case.” See Apple, at 12-14. Because Ayla failed to do so here, denial of its petition
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`is both appropriate and consistent with Board precedent.
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`CONCLUSION
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`Patent Owner respectfully requests that the Board exercise its discretion un-
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`der §§ 325(d) and 314(a) to deny institution of Ayla’s petition.
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`Date: June 19, 2020
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`
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`Case No. IPR2020-00295
`Patent 9,533,053
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`Respectfully submitted,
`/Andrew V. Trask/
`Andrew V. Trask (Reg. No. 59,239)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`T: (202) 434-5000
`F: (202) 434-5029
`atrask@wc.com
`
`Counsel for Patent Owner
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`Case No. IPR2020-00295
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`CERTIFICATION UNDER 37 C.F.R. § 42.24(d)
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`Pursuant to 37 C.F.R. 42.6(e), the undersigned certifies that a true and cor-
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`rect copy of the foregoing was served on June 19, 2020, by email to the following
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`attorneys of record:
`
`Jitendra Malik
`Alissa M. Pacchioli
`Guylaine Haché
`KATTEN MUCHIN ROSENMAN LLP
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`guylaine.hache@katten.com
`
`/Andrew V. Trask/
`Andrew V. Trask
`Reg. No. 59,239
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`
`
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` 
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