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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`SLAYBACK PHARMA LLC,
`
`Petitioner,
`
`v.
`
`EYE THERAPIES, LLC,
`
`Patent Owner.
`
`__________________
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`__________________
`
`PATENT OWNER’S SUR-REPLY REGARDING DISCRETIONARY
`DENIAL UNDER 35 U.S.C. §§ 314(a) AND 325(d)
`
`(Filed Pursuant to Paper 9)
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`
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`
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`I.
`II.
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`Case IPR2022-00142
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`Table of Contents
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`
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`The Board Should Deny Institution Under 35 U.S.C. § 314(a) ...................... 1
`The Board Should Deny Institution Under 35 U.S.C. § 325(d) ...................... 3
`The Board can deny institution even if the exact references or
`disclosures were not before the Examiner ............................................ 3
`The ’553 patent contains substantially the same disclosure as the
`references before the Examiner during prosecution.............................. 4
`Norden 2002 contains substantially the same disclosure as the
`references before the Examiner during prosecution.............................. 5
`Petitioner’s arguments regarding Ground 3 are unavailing .................. 7
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`i
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`Case IPR2022-00142
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`Table of Abbreviations
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`Petition (Paper 2)
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`Patent Owner’s Preliminary Response
`(Paper 7)
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`Petitioner’s Pre-Institution Reply
`(Paper 10)
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`Pet.
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`P.R.
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`Reply
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`Slayback action
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`Lupin action
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`
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`Bausch & Lomb, Inc. et al. v. Slayback
`Pharma LLC et al., Civil Action No.
`21-16766 (D.N.J.)
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`Bausch & Lomb, Inc. et al. v. Lupin
`Ltd., Civil Action No. 22-534 (D.N.J.)
`
`
`
`ii
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`TABLE OF AUTHORITIES
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`Case IPR2022-00142
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` Page(s)
`
`Cases
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper No. 15 (P.T.A.B. May 13, 2020) .................................... 2
`Apple Inc. v. Pinn, Inc.,
`IPR2020-00999, Paper No. 15 (P.T.A.B. Dec. 8, 2020) ...................................... 2
`BMW of N. Am., LLC v. Stragent, LLC,
`IPR2021-00427, Paper No. 13 (P.T.A.B. July 19, 2021) ................................. 4-5
`Dropworks, Inc. v. The Univ. of Chicago,
`IPR2021-00100, Paper No. 9 (P.T.A.B. May 14, 2021) ...................................... 4
`Mylan Labs. Ltd. v. Janssen Pharmaceutica NV,
`IPR2020-00440, Paper No. 17 (P.T.A.B. Sept. 16, 2020) .................................... 1
`Regents of the Univ. of California v. Eli Lilly & Co.,
`119 F.3d 1559 (Fed. Cir. 1997) ............................................................................ 4
`Semiconductor Energy Lab. Co., Ltd., v. Samsung Elecs. Co., Ltd.,
`204 F.3d 1368 (Fed. Cir. 2000) ........................................................................ 3, 4
`SK Innovation Co., Ltd. v. LG Chem, Ltd.,
`IPR No. 2020-00982, Paper No. 14 (P.T.A.B. Nov. 30, 2020) ............................ 2
`Federal Statutes
`35 U.S.C. § 314(a) ..................................................................................................... 1
`35 U.S.C. § 325(d) ................................................................................................. 3, 4
`Other Authorities
`MPEP § 707.07(g) ...................................................................................................... 7
`MPEP § 904.03 .......................................................................................................... 7
`
`iii
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`
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`PTAB Standard Operating Procedure 2 ……………………………………………2
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`Case IPR2022-00142
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`
`
`iv
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`Case IPR2022-00142
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`I.
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` The Board Should Deny Institution Under 35 U.S.C. § 314(a)
`Patent Owner addresses Petitioner’s arguments regarding Fintiv factors 1, 4,
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`5, and 6 herein, but rests on its Preliminary Response for the remaining factors.
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`Fintiv Factor 1: Petitioner concedes that a stay has not been entered in the
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`related litigation. Reply at 1. But Petitioner conspicuously fails to address whether
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`it intends to file a motion to stay or the likelihood that the district court would grant
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`such a motion. Id. The reason for that is clear. A motion to stay is unlikely to be
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`granted in view of the 30-month regulatory stay. Mylan Labs. Ltd. v. Janssen
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`Pharmaceutica NV, IPR2020-00440, Paper No. 17 at 14 (P.T.A.B. Sept. 16, 2020).
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`A stay has not been, and is unlikely to be, entered. Fintiv factor 1 thus favors denial.
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`Fintiv Factor 4: After Patent Owner filed its Preliminary Response, Petitioner
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`filed a “Sotera Stipulation,” which Petitioner contends “removes the asserted
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`overlap if IPR is instituted.” Reply at 1. Petitioner did not, however, inform the
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`Board that Slayback and Lupin have agreed to consolidation of the Slayback action
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`and the Lupin action, leaving only the details of the consolidation stipulation to be
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`worked out. But the Lupin defendant has not agreed to be bound by the terms of
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`Petitioner’s stipulation and is thus free to challenge the validity of the ’742 patent
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`on any grounds, including those raised in the petition. Slayback can, therefore, use
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`Lupin as a strawman to make the very same arguments raised in the petition while
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`1
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`Case IPR2022-00142
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`still technically abiding by its Sotera stipulation. Petitioner’s stipulation thus does
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`nothing to eliminate the overlap, and Fintiv factor 4 continues to favor denial.
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`That there is not complete overlap in the claims is of no moment because
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`Petitioner has failed to establish that the non-overlapping claims raise material issues
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`not present in the related litigation. Apple Inc. v. Pinn, Inc., IPR2020-00999, Paper
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`No. 15 at 17 (P.T.A.B. Dec. 8, 2020); SK Innovation Co., Ltd. v. LG Chem, Ltd., IPR
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`No. 2020-00982, Paper No. 14 at 14 (P.T.A.B. Nov. 30, 2020).
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`Fintiv Factor 5: This factor asks a straightforward question: Is the petitioner
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`the same party as the defendant in the parallel proceeding? If the answer is yes, this
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`factor weighs in favor of discretionary denial. Apple Inc. v. Fintiv, Inc., IPR2020-
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`00019, Paper No. 15 at 17 (P.T.A.B. May 13, 2020) (informative).1 Petitioner seeks
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`to complicate this issue by raising the relative timing of the final written decision
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`and trial date. But that is a separate factor (i.e., Fintiv factor #2).
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`Fintiv Factor 6: The merits of the petition are far from “strong.” Petitioner
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`has failed to prove the presence of at least one element of the challenged claims for
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`each of the anticipation grounds. P.R. at §§ IV.C.1 and IV.C.2. Petitioner’s
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`obviousness ground is predicated on impermissible hindsight and relies on
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`1 The Fintiv decision was designated “informative” and thus “should be followed
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`in most cases, absent justification.” PTAB Standard Operating Procedure 2 at 11.
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`2
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`Case IPR2022-00142
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`selectively chosen art to the exclusion of later-in-time references that undermine
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`Petitioner’s argument. P.R. at § IV.C.3.
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`II. The Board Should Deny Institution Under 35 U.S.C. § 325(d)
`Petitioner’s reply focuses exclusively on part one of the two-part Advanced
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`Bionics framework. Because Petitioner makes no attempt to show any error on the
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`part of the Examiner in allowing the claims, it has conceded that Becton Dickinson
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`factors (c), (e), and (f) rest in Patent Owner’s favor. Petitioner suggests its references
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`“are substantively different” from the prior art considered by the Examiner, but its
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`analysis is flawed. For the reasons set forth below and in Patent Owner’s Preliminary
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`Response (P.R. at § III), Becton Dickinson factors (a), (b), and (d) also favor denial.
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` The Board can deny institution even if the exact references
`or disclosures were not before the Examiner
`First, Petitioner repeatedly argues that the ’553 patent (EX-1004) was not
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`before the Examiner during prosecution. Reply at §§ II.A, II.D, II.E. It was not, but
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`that in and of itself is not dispositive. The statute makes clear that denial is warranted
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`when “the same or substantially the same prior art or arguments previously were
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`presented to the Office.” 35 U.S.C. § 325(d) (emphasis added).
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`Second, Petitioner alleges that the ’553 patent (EX-1004) is not cumulative of
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`the references identified in Patent Owner’s Preliminary Response, suggesting there
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`exists some per se rule that a single reference is not cumulative of four references,
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`“collectively.” See Reply at 3 (citing Semiconductor Energy Lab. Co., Ltd., v.
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`3
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`Case IPR2022-00142
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`Samsung Elecs. Co., Ltd., 204 F.3d 1368, 1374 (Fed. Cir. 2000)). But no such rule
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`per se exists, and Petitioner’s cited case dealt with a fact specific inequitable conduct
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`inquiry that is not at issue here. Moreover, the Federal Circuit recognizes that
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`multiple references can convey, cumulatively, the content of a single reference. See,
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`e.g., Regents of the Univ. of California v. Eli Lilly & Co., 119 F.3d 1559, 1575 (Fed.
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`Cir. 1997).
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`Petitioner further argues that the references identified in the Preliminary
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`Response purportedly do not teach the “critical disclosures” in the ’553 patent. Reply
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`at 3. That is incorrect. See P.R. at § III.B.5; § II.B, infra. And to the extent Petitioner
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`suggests that the references before the Examiner need to include the identical
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`disclosure upon which Petitioner relies, Petitioner is wrong, as identity of disclosure
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`is not required. Dropworks, Inc. v. The Univ. of Chicago, IPR2021-00100, Paper No.
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`9 at 13-14 (P.T.A.B. May 14, 2021). Instead, denial is warranted if the references
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`before the Examiner contains substantially the same substantive teachings. Id.
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`
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`The ’553 patent contains substantially the same disclosure
`as the references before the Examiner during prosecution
`To avoid discretionary denial under § 325(d), Petitioner must demonstrate that
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`the disclosures upon which it relies in the ’553 patent (EX-1004) are materially
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`different from the disclosures in the references before the Examiner. BMW of N. Am.,
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`LLC v. Stragent, LLC, IPR2021-00427, Paper No. 13 at 12 (P.T.A.B. July 19, 2021)
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`(finding the petition relied on “the same or substantially the same” art where the
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`4
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`Case IPR2022-00142
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`prior art was “not materially different from the prior art presented to the Examiner.”)
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`Petitioner has failed to do so.
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`Petitioner contends that the references before the Examiner do not teach the
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`“critical disclosures” in the ’553 patent. Reply at 3. But Petitioner ignores the very
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`disclosures identified in Patent Owner’s Preliminary Response. For example,
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`Petitioner fails to explain how the ’553 patent’s disclosure of “0.03% brimonidine
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`to reduce ocular inflammation caused by refractive surgery” is materially different
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`from the ’416 patent’s (EX-2010 at 4:11-16) disclosure of reducing or maintaining
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`intraocular pressure by administering a (2-imidazolin-2-ylamino) quinoxaline
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`derivative—a drug class that includes brimonidine—at a preferred concentration in
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`the range of 0.05% to 0.5%, in view of Lee (EX-2009), which the Examiner similarly
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`relied upon for its teachings related to the use of brimonidine after LASIK surgery.
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` Norden 2002 contains substantially the same disclosure as
`the references before the Examiner during prosecution
`Recognizing the vulnerabilities of its primary obviousness reference,
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`Petitioner seeks to elevate Norden 2002 (EX-1006), one of four secondary references
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`upon which it relies for Ground 3, to a primary reference. Reply at § II.E. But like
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`the ’553 patent, Norden 2002 contains the substantially the same disclosure as the
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`references before the Examiner during prosecution. See P.R. at § III.B.4.
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`Petitioner alleges that neither the ’442 patent (EX-1007) nor Lee (EX-2009)
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`discloses brimonidine to reduce eye redness or use of brimonidine in conjunction
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`5
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`Case IPR2022-00142
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`with LASIK without inducing flap slippage. Reply at 5. As an initial matter, any
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`argument related to flap slippage misses the point and is inconsistent with
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`Petitioner’s position in its petition. In its petition, Petitioner relies on Norden 2002
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`for its purported disclosure regarding the use of brimonidine in conjunction with
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`LASIK surgery. Pet. at § IV.C.1.b. While Petitioner notes Norden 2002’s conclusion
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`regarding flap slippage, it does not rely on this disclosure in connection with its
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`obviousness argument. The reason is clear: the claims of the ’742 patent say nothing
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`about flap slippage. See EX-1001 at 22:17-39. Instead, dependent claim 4 is directed
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`to a method “wherein said composition is topically administered within about 24
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`hours after a Lasik surgery on said patient.” Id. at claim 4. And, as the Examiner
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`explained during prosecution, Lee discloses the use of brimonidine in connection
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`with LASIK surgery. EX-2009 at 1-2; EX-1024 at 98.
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`Additionally, Petitioner’s argument regarding redness is inconsistent not only
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`with the Examiner’s explanation of the ’442 patent but also with Petitioner’s position
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`in its petition. In initially rejecting the claimed methods as unpatentable, the
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`Examiner contended that the ’442 patent taught, inter alia, that brimonidine is a
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`vasoconstrictor that constricts ocular vessels thereby reducing blood flow. EX-1024
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`at 96. Notably, in its petition, Petitioner contends that a skilled person would have
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`purportedly known that brimonidine would reduce redness of the eye based upon
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`these same properties. Pet. at §§ I.D.1-D.3. Petitioner’s suggestion that Norden 2002
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`6
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`Case IPR2022-00142
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`is “not substantively the same” simply because it specifically mentions reducing eye
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`redness is thus disingenuous and unavailing.
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`Petitioner’s arguments regarding Ground 3 are unavailing
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`Petitioner notes that it relies upon a different primary reference. Reply at 6.
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`This is irrelevant because Petitioner’s primary reference is substantially the same as
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`the references before the Examiner. See P.R. at § III.B.5; § II.B, supra.
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`Petitioner then notes that it is relying on the ’442 patent as background. Reply
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`at 6. But this too is irrelevant. The Examiner is presumed to have considered the
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`reference for all it taught and fairly suggested. MPEP §§ 707.07(g) and 904.03. That
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`Petitioner is relying on the ’442 patent as a secondary reference does not change the
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`fact that it was considered and overcome during prosecution.
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`Finally, Petitioner contends that the ’442 patent and Lee do not contain the
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`disclosures from the ’553 patent and Norden 2002 upon which Petitioner relies.
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`Reply at 6-7. Petitioner has failed to establish that the disclosures upon which it
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`relies in the ’553 patent (EX-1004) are materially different from the disclosures in
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`the references before the Examiner. See § II.B, supra. Petitioner also misrepresents
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`its reliance on Norden 2002 regarding use of brimonidine in conjunction LASIK,
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`and Lee’s disclosure is substantially the same as the disclosure in Norden 2002 upon
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`which Petitioner relies. See § II.C, supra.
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`7
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`Date: April 5, 2022
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`Case IPR2022-00142
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`Respectfully submitted,
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`
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`
`
`
`
`By: /Bryan C. Diner/
`Bryan C. Diner, Reg. No. 32,409
`Justin J. Hasford, Reg. No. 62,180
`Caitlin E. O’Connell, Reg. No. 73,934
`Christina Ji-Hye Yang, Reg. No. 79,103
`
`Finnegan, Henderson, Farabow,
` Garrett & Dunner, LLP
`
`Counsel for the Patent Owner
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`8
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`Case IPR2022-00142
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`
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing Patent Owner’s Sur-
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`Reply Regarding Discretionary Denial Under 35 U.S.C. §§ 314(a) and 325(d)
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`was served electronically via email on April 5, 2022, in its entirety on the following:
`
`Louis H. Weinstein
`Patrick G. Pollard
`Windels Marx Lane & Mittendorf, LLC
`1 Giralda Farms
`Madison, NJ 07940
`lweinstein@windelsmarx.com
`ppollard@windelsmarx.com
`
`
`The Petitioner has consented to service by electronic mail.
`
`
`
`
`
`
`
`
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`
`
`/Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER LLP
`
`Dated: April 5, 2022
`
`
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`
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