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`IPR2022-00142
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`United States Patent No. 8,293,742
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`SLAYBACK PHARMA LLC
`
`Petitioner
`v.
`EYE THERAPIES LLC
`
`Patent Owner
`
`___________________
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`___________________
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`PETITIONER’S REPLY
`TO FINTIV AND §325(d) ARGUMENTS
`IN PATENT OWNER’S PRELIMINARY RESPONSE
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`(Filed Pursuant to Paper 9)
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`TABLE OF CONTENTS
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`IPR2022-00142
`United States Patent No. 8,293,742
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`Page
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`TABLE OF AUTHORITIES .................................................................................... ii
`ABREVIATIONS and CITATION FORMAT ......................................................... ii
`I.
`Fintiv factors do not support denying institution under §314(a) ..................... 1
`II.
`Institution Should Not Be Denied Under §325(d) ........................................... 2
`A. Ground 1 relies on a reference not before the Examiner ...................... 2
`B.
`‘553 patent is not cumulative of four references “collectively” ........... 3
`C. Grounds 1-2 avoid the precise limitation added by applicant
`to overcome rejection and obtain allowance ......................................... 3
`The primary reference of Ground 3 was not before the Examiner ....... 4
`Norden 2002 discloses safe and effective use of brimonidine
`to reduce eye redness and was also not before the Examiner .............. 5
`Norden 2002 is not substantively the same as ‘442 patent and Lee ..... 6
`F.
`G. Ground 3 is very different from the Examiner’s art and argument ....... 6
`III. Conclusion ....................................................................................................... 7
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`D.
`E.
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`IPR2022-00142
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`United States Patent No. 8,293,742
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`TABLE OF AUTHORITIES
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`Page
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`Cases
`Facebook, Inc. v. USC IP Partnership, L.P.,
`IPR 2021-00033 .................................................................................................... 2
`Sand Revolution II, LLC v. Continental Intermodal Group-Trucking LLC,
`IPR 2019-01393 .................................................................................................... 1
`Semiconductor Energy Laboratory Co. Ltd., v. Samsung Electronics Co., Ltd.,,
`204 F.3d 1368, 1374 (Fed. Cir. 2000) .................................................................. 3
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`ABREVIATIONS and CITATION FORMAT
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`Exhibit____, page _
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`Petition (Paper 2), page _
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`EX___, _
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`Pet, _
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`PR, _
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`related litigation Bausch & Lomb, Inc. et al. v. Slayback Pharma LLC et al.,
`Civil Action No. 21-16766 (D.N.J.)
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`Preliminary Response (Paper 7), page _
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`Scheduling Order (EX2003) in related litigation
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`Schedule
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`{80284533:1}
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`ii
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`I.
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`IPR2022-00142
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`United States Patent No. 8,293,742
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`Fintiv factors do not support denying institution under §314(a)
`Fintiv Factor 1: Patent Owner says a stay of the related litigation “is
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`unlikely.” Paper 7, PR, 2. No motion to stay was filed and District Court did not
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`address whether stay would be granted if IPR is instituted. Factor 1 is at most
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`neutral. Sand Revolution II, LLC v. Continental Intermodal Group-Trucking LLC,
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`IPR 2019-01393, Paper 24 at 7 (PTAB June 16, 2020) (Informative).
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`Fintiv Factor 2: Trial in the related litigation is four months or more after
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`the May 22, 2023 anticipated deadline for Final Written Decision. EX2003
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`(Schedule). Factor 2 does not favor denial.
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`Fintiv Factor 3: Investment in the related litigation is small. District Court
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`has made no decision on the ‘742 patent. The Markman hearing is no earlier than
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`November 8, 2022, followed by close of fact discovery, followed by expert
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`discovery. EX2003 (Schedule). Factor 3 does not favor denial.
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`Fintiv Factor 4: Patent Owner asserts “substantial overlap” between
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`Petition and the related litigation (PR, 8-10), and that “defendants [] have not
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`agreed to forego any invalidity challenges in the related litigation based on the
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`grounds and art raised in the petition” (Id. 9). Petitioner filed a Sotera Stipulation
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`(EX1043, 4) that removes the asserted overlap if IPR is instituted. Also, Petition
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`addresses all claims of the ‘742 patent (claims 1-6). Factor 4 does not favor denial.
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`Case IPR2022-00142
`United States Patent No. 8,293,742
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`Fintiv Factor 5: Petitioner is a defendant in the related litigation. But trial
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`in the related litigation is at least four months after final written decision
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`(EX2003, Schedule), and Factor 5 “depends on which tribunal [i]s likely to address
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`the challenged patent first.” Facebook, Inc. v. USC IP Partnership, L.P., IPR
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`2021-00033, Paper 13 at 15 (PTAB Apr. 30, 2021). Factor 5 does not favor denial.
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`Fintiv Factor 6: The merits are strong. Grounds 1-2 (Paper 2, Pet, 32-44)
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`show claims 1-2 anticipated by art not presented to Examiner, i.e. ‘553 patent
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`(EX1004) and Walters 1991 (EX1005). Ground 3 (Pet, 44-64) shows claims 1-6
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`obvious over a primary reference, ‘553 patent, and a secondary reference, Norden
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`2002 (EX1006), both not presented to Examiner. Petition is supported by
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`unrebutted expert testimony, EX1002 and EX1003. Patent Owner submitted no
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`expert testimony and relies on attorney argument. Factor 6 does not favor denial.
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`Alone or together, the Fintiv factors do not support denying institution.
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`II.
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`Institution Should Not Be Denied Under §325(d)
`Institution should not be denied under §325(d) because the prior art and
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`arguments relied on by Petitioner are substantively different from the prior art and
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`arguments considered or relied on by the Examiner.
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`A. Ground 1 relies on a reference not before the Examiner
`Ground 1 (Pet, 32-37) shows ‘553 patent (EX1004) anticipates claims 1-2.
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`‘553 patent and its PCT counterpart were not presented to the Examiner.
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`United States Patent No. 8,293,742
`B. ‘553 patent is not cumulative of four references “collectively”
`Patent Owner contends four references “collectively provide the same
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`substantive teachings on which the Petitioner relies from the ‘553 patent.” PR, 24
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`(emphasis added). A single reference is not cumulative of four references,
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`“collectively.” See Semiconductor Energy Laboratory Co. Ltd., v. Samsung
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`Electronics Co., Ltd., 204 F.3d 1368, 1374 (Fed. Cir. 2000).
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`Moreover, among other reasons, Petitioner relies on ‘553 patent for
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`teaching: 0.03% brimonidine to reduce ocular inflammation caused by refractive
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`surgery (Pet, 45-46); and use of brimonidine to reduce eye redness caused by
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`inflammation (id.). Not one of the four references relied on by Patent Owner
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`“collectively,” i.e. ‘442 patent (EX-1007), Lee (EX-2009), Cantor 2006 (EX-
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`2007), and ‘416 patent (EX-2010) (PR, 24), includes either of these critical
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`disclosures, and Patent Owner did not assert they do (PR, 23-26). Patent Owner’s
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`argument that the four references “collectively contain essentially the same
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`disclosure as the ‘553 patent” (PR, 25) is incorrect and disingenuous.
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`C. Grounds 1-2 avoid the precise limitation added by
`applicant to overcome rejection and obtain allowance
`Patent Owner (PR, 26) makes much that ‘442 patent (EX1007) “was applied
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`and overcome during prosecution.” However, this is beside the point because the
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`anticipatory art in Grounds 1-2, ‘553 patent and Walters 1991, respectively, avoids
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`the precise amendment and argument made by applicant to overcome the rejection.
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`In particular, to obtain allowance applicant limited the claims to brimonidine
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`as a single active ingredient (EX1024, 10/19/2011 Amendment, pp. 111-112, 114),
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`and applicant argued ‘442 patent only disclosed administering brimonidine with a
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`second drug (id., pp. 115-117 (“Dean [the ‘442 patent] only discloses the use of
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`brimonidine in a combination with brinzolimide”) (emphasis by applicant)). The
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`Examiner accepted applicant’s amendment and argument to allow the claims:
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`Dean [‘442 patent] teaches a combination of brimonidine
`and brinzolamide for a variety of ocular conditions. As
`amended and set forth in the arguments, Applicant
`specifically states that the presently claimed methods do
`not require the use of any other active ingredients []
`in addition to brimonidine (page 6 of 18), thereby
`instating the ‘consisting essentially of’ language.
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`EX1024, 01/30/2012, Reasons for Allowance, p. 144 (emphasis Examiner).
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`Most significantly, Grounds 1-2 rely on anticipatory art disclosing
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`brimonidine without a second active ingredient, i.e. Example 1 of ‘553 patent
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`(EX1004, 4) and Walters 1991 (EX1005, 4), respectively. Thus, the basis for each
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`of Grounds 1-2 avoids the precise amendment, applicant argument, and Reason for
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`Allowance relied on by Examiner to allow the claims.
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`D. The primary reference of Ground 3 was not before the Examiner
`The primary reference for Ground 3, ‘553 patent (EX1004) was not before
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`Examiner, and Patent Owner does not assert that either ‘553 patent or its PCT
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`equivalent were presented or considered in the prosecution of the ‘742 patent.
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`United States Patent No. 8,293,742
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`E. Norden 2002 discloses safe and effective use of brimonidine
`to reduce eye redness and was also not before the Examiner
`In Ground 3, Norden 2002 (EX1006) is the primary reference after ‘553
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`patent. Petitioner relies on Norden 2002 because Norden 2002 discloses safe and
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`effective use of brimonidine to reduce eye redness (i.e. subconjunctival
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`hemorrhage and hyperemia). Pet, 47. Norden 2002 was not before Examiner.
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`Patent Owner’s Preliminary Response (Paper 7) did not assert any reference
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`presented to Examiner in prosecution of ‘742 patent disclosed safe and effective
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`use of brimonidine to reduce eye redness, and this is reason enough to not deny
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`institution under §325(d).
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`F. Norden 2002 is not substantively the same as ‘442 patent and Lee
`Patent Owner asserts that the combination of ‘442 patent (EX1007) and Lee
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`(EX2009) “includes substantively the same disclosure as Norden 2002.” PR, 21
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`(emphasis added). Patent Owner is incorrect because, while Norden 2002
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`discloses brimonidine to reduce eye redness (Pet, 46-47; EX1002, ¶83) and that
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`brimonidine can be used in conjunction with LASIK surgery without inducing flap
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`slippage (Pet, 47, EX1002, §85), neither ‘442 patent nor Lee include either of these
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`two disclosures that Petitioner relies on in Ground 3.
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`Case IPR2022-00142
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`United States Patent No. 8,293,742
`G. Ground 3 is very different from the Examiner’s art and argument
`In any event, the art and argument in Ground 3 is substantively different
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`from the Examiner’s art and argument for at least the following reasons:
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`First, ‘442 patent (EX1007) was Examiner’s primary reference. EX1024, 95-
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`98. The primary reference in Ground 3 is ‘553 patent (EX1004).
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`Second, Ground 3 relies on ‘442 patent as background to show: location of
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`brimonidine’s vasoconstrictor activity; relative safety; association with hyperemia
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`in some patients; and expected result of lower brimonidine concentrations on side
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`effects. Pet, 48.
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`Third, Petitioner relies on ‘553 patent for teaching: 0.03% brimonidine to
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`reduce inflammation caused by refractive surgery (Pet, 32-33); brimonidine to
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`reduce eye redness caused by ocular inflammation (id. 45-46); and a dose ranging
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`study for reducing eye redness caused by ocular inflammation in a brimonidine
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`range that overlaps the claimed ranges of the ‘742 patent (id. 46). ‘442 patent does
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`not contain any of these disclosures and Patent Owner did not argue otherwise.
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`Fourth, the other reference relied on by Examiner is Lee (EX2009).
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`Examiner cited Lee to show brimonidine use after LASIK surgery. (EX1024,
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`p. 98). But Lee is directed to “reducing halos,” it does not mention redness, and it
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`does not address flap adherence. Lee (EX2009), passim. Unlike Examiner’s
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`reliance on Lee, Ground 3 relies on disclosure in Norden 2002 (EX1006) that
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`brimonidine is safe and effective to reduce eye redness (i.e. subconjunctival
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`Case IPR2022-00142
`United States Patent No. 8,293,742
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`hemorrhage and hyperemia) and Norden 2002’s disclosure that brimonidine did
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`not induce flap slippage. Pet, 46-47. Lee does not contain either of these important
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`disclosures, and again, Patent Owner did not argue otherwise.
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`For at least these reasons institution should not be denied under §325(d).
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`III. Conclusion
`Taken individually and collectively Fintiv Factors do not support denial and
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`the Petition Grounds are substantively different from the Examiner’s art and
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`argument. Simply put, Petitioner seeks no duplication. Therefore, institution should
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`not be denied on the Fintiv Factors or §325(d).
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`Dated: March 29, 2022
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`Respectfully submitted,
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`/s/ Louis H. Weinstein
`Louis H. Weinstein
`Reg. No. 45,205
`Counsel for Petitioner
`Slayback Pharma LLC
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`{80284533:1}
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`IPR2022-00142
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`United States Patent No. 8,293,742
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`CERTIFICATE OF SERVICE
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`I, Louis H. Weinstein, certify that, after receiving Patent Owner’s
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`agreement, pursuant to 37 C.F.R. § 42.6(e)(1), I caused to be served a true and
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`correct copy of the foregoing PETITIONER’S REPLY TO FINTIV AND
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`§325(d) ARGUMENTS
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`IN PATENT OWNER’S PRELIMINARY
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`RESPONSE and associated Exhibit 1043 by email, as follows:
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`Bryan Diner
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`bryan.diner@finnegan.com
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`Justin Hasford
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`Justin.hasford@finnegan.com
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`Caitlin O’Connell caitlin.oconnell@finnegan.com
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`Christina Yang
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`christina.yang@finnegan.com
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`Dated: March 29, 2022
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`/s/ Louis H. Weinstein
`Louis H. Weinstein
`Reg. No. 45,205
`Counsel for Petitioner Slayback
`Pharma LLC
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`{80284533:1}
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