Case IPR2022-00142
`U.S. Patent No. 8,293,742
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`—————
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`—————
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`SLAYBACK PHARMA LLC,
`Petitioner,
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`v.
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`EYE THERAPIES, LLC,
`Patent Owner.
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`—————
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`Case No.: IPR2022-00142
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`U.S. Patent No.: 8,293,742
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`PETITIONER’S OPENING SUPPLEMENTAL BRIEF
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`U.S. Patent No. 8,293,742
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`—————
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`—————
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`SLAYBACK PHARMA LLC,
`Petitioner,
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`v.
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`EYE THERAPIES, LLC,
`Patent Owner.
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`—————
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`Case No.: IPR2022-00142
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`U.S. Patent No.: 8,293,742
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`—————
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`PETITIONER’S OPENING SUPPLEMENTAL BRIEF
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`Case IPR2022-00142
`U.S. Patent No. 8,293,742
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`TABLE OF CONTENTS
`ISSUE #1: THE PREAMBLE AND INHERENT ANTICIPATION .......... 2
`A. The Preamble Limits the Claims to Treating Eye Redness ..................... 2
`B. Gil Inherently Anticipates Claims 1–2 .................................................... 3
`1. An “Intent” Limitation Does Not Avoid Inherent Anticipation ..... 3
`2. Gil Inherently Discloses Reducing Eye Redness in Radial
`Keratotomy Patients with Brimonidine .......................................... 6
`ISSUE #2: “CONSISTING ESSENTIALLY OF” ....................................... 8
`A. “Consisting Essentially of” Limits Claims Only with Respect to the
`“Basic and Novel Properties” of the Invention........................................ 8
`B. The Prior Art Disclosed Methods Consisting Essentially of
`Administering Brimonidine ...................................................................11
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`I.
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`II.
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`U.S. Patent No. 8,293,742
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
`AK Steel Corp. v. Sollac and Ugine,
`344 F.3d 1234 (Fed. Cir. 2003) ............................................................................ 8
`Bristol-Myers Squibb Co. v. Ben Venue Lab’ys, Inc.,
`246 F.3d 1368 (Fed. Cir. 2001) ............................................................................ 3
`Bristol-Myers Squibb Co. v. Boehringer Ingelheim Corp.,
`86 F. Supp. 2d 433 (D.N.J. 2000), vacated on other grounds by
`Bristol-Myers Squibb Co. v. Ben Venue Laby’s, Inc., 246 F.3d
`1368 (Fed. Cir. 2001) ............................................................................................ 7
`Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002) .............................................................................. 4
`Ecolab, Inc. v. FMC Corp.,
`569 F.3d 1335 (Fed. Cir. 2009) ................................................................ 9, 10, 13
`Eli Lilly & Co. v. Barr Laby’s, Inc.,
`251 F.3d 955 (Fed. Cir. 2001) .............................................................................. 6
`Eli Lilly & Co. v. Teva Pharmaceuticals Int’l GmbH,
`8 F.4th 1331 (Fed. Cir. 2021) ........................................................................... 2, 3
`GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA,
`No. CV 14-877-LPS-CJB, 2017 WL 2290141 (D. Del. May 25,
`2017) ................................................................................................................. 4, 5
`GlaxoSmithKline LLC v. Teva Pharms. USA Inc.,
`No. 14-878-LPS-CJB, D.I. 346 (D. Del. May 2, 2017) .................................... 5, 8
`HZNP Meds. LLC v. Actavis Laby’s UT, Inc.,
`940 F.3d 680 (Fed. Cir. 2019) .............................................................................. 9
`Jansen v. Rexall Sundown, Inc.,
`342 F.3d 1329 (Fed. Cir. 2003) ........................................................................ 2, 3
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`U.S. Patent No. 8,293,742
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`Kim v. Earthgrains Co.,
`No. 01 C 3895, 2010 WL 625220 (N.D. Ill. Feb. 18, 2010), aff’d,
`451 F. App’x 922 (Fed. Cir. 2011) ................................................................. 9, 13
`King Pharms., Inc. v. Eon Labs, Inc.,
`616 F.3d 1267 (Fed. Cir. 2010) ........................................................................ 5, 8
`Mylan Pharms. Inc. v. Regeneron Pharms., Inc.,
`No. IPR2021-00881, 2022 WL 16842073 (P.T.A.B. Nov. 9, 2022) .................... 3
`Perricone v. Medicis Pharm. Corp.,
`432 F.3d 1368 (Fed. Cir. 2005) ............................................................................ 4
`Pordy v. Land O’Lakes, Inc.,
`97 F. App’x 921 (Fed. Cir. 2004) ................................................................. 11, 13
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`Case IPR2022-00142
`U.S. Patent No. 8,293,742
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`Pursuant to the Board’s Order dated March 6, 2023, Petitioner submits this
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`supplemental brief to address the Board’s questions regarding the preamble and
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`transitional phrases of the challenged claims. The preamble limits the challenged
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`claims to methods of treating eye redness. By doing so, the preamble identifies the
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`patients to whom brimonidine should be administered: patients suffering from eye
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`redness. The identification of a particular patient population, however, does not
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`change the inherent anticipation analysis. Gil inherently anticipates claims 1 and 2
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`because Gil discloses all steps of the claimed method in patients that necessarily
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`suffer from eye redness. The natural result of administering 0.03% brimonidine to
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`the patients in Gil is the reduction of eye redness. In such circumstances, courts have
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`found newly discovered benefits of old methods are not patentable.
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`The “consisting essentially of” transitional phrase excludes from the claims
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`only those methods that include unclaimed elements or steps that materially affect
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`the basic and novel properties of the claimed method. Here, the specification makes
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`clear that the basic and novel property of the claimed method is brimonidine’s ability
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`to reduce eye redness. Therefore, only elements that materially affect the redness
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`reducing effects of brimonidine are excluded from the coverage of the claimed
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`methods. In Gil and Norden, the only difference between the treatment and control
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`groups is the administration of brimonidine. The record shows that, despite any other
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`active ingredients administered to those patients, the patients had eye redness and no
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`other drugs materially affected brimonidine’s ability to reduce that redness.
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`Therefore, both Gil and Norden disclose methods consisting essentially of
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`administration of brimonidine.
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`I.
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`ISSUE #1: THE PREAMBLE AND INHERENT ANTICIPATION
`A. The Preamble Limits the Claims to Treating Eye Redness
`Petitioner has treated the preamble—“[a] method for reducing eye redness”—
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`as a claim limitation, requiring brimonidine to be administered for reducing eye
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`redness, and not some other condition (e.g., lowering intraocular pressure). The
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`Federal Circuit’s decision in Eli Lilly & Co. v. Teva Pharmaceuticals Int’l GmbH, 8
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`F.4th 1331 (Fed. Cir. 2021), is instructive. There, the Court found the preamble—“a
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`method for treating or reducing the incidence of vasomotor symptoms”—to be
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`limiting because it “embod[ies] the essence of the claimed invention.” Id. at 1341–
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`42 (discussing Jansen v. Rexall Sundown, Inc., 342 F.3d 1329 (Fed. Cir. 2003)).1 In
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`1 Although Jansen invokes the same claim construction principles, the issue in
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`Jansen was infringement. Beyond the general statement of law, Jansen has limited
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`applicability to the issue of inherency presented here. As the Federal Circuit noted
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`in Eli Lilly, there is no “binary distinction between statements of mere intended
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`purpose on the one hand and limiting preambles on the other.” Eli Lilly, 8 F.4th at
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`1340. Notably, the claims in Jansen recited that they were for “treating or
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`such circumstances, “[t]he preambles limit the scope of the claims because these
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`claims would not [be infringed by], for example, the performance of the same
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`method step to treat other conditions.” Id. at 1342. Here, Petitioner acknowledges
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`that the specification and prosecution history place as much emphasis on “reducing
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`redness” as the specification and prosecution history in Eli Lilly placed on “treating
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`vasomotor symptoms” or “migraines.”
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`The preamble, however, limits only the claims to the condition to be treated—
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`eye redness—and, for the reasons already explained in Petitioner’s Reply, does not
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`require efficacy. See, e.g., Mylan Pharms. Inc. v. Regeneron Pharms., Inc., No.
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`IPR2021-00881, 2022 WL 16842073, *9–*11 (P.T.A.B. Nov. 9, 2022).
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`B. Gil Inherently Anticipates Claims 1–2
`An “Intent” Limitation Does Not Avoid Inherent
`1.
`Anticipation
`The question of inherency is different from the question of whether a preamble
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`operates as a claim limitation. This is because “[n]ewly discovered results of known
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`processes directed to the same purpose are not patentable because such results are
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`inherent.” Bristol-Myers Squibb Co. v. Ben Venue Lab’ys, Inc., 246 F.3d 1368, 1376
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`preventing” a condition “to a human in need thereof.” See Jansen, 342 F.3d at 1333.
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`Those phrases, central to the court’s decision in Jansen, do not appear in the
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`challenged claims here.
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`(Fed. Cir. 2001); see also Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289
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`F.3d 801, 809–10 (Fed. Cir. 2002). “In some cases, the inherent property
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`corresponds to a claimed new benefit or characteristic of an invention otherwise in
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`the prior art[,]” but “the new realization alone does not render the old invention
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`patentable.” Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir.
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`2005). Inherent anticipation “examines the natural and inherent results in that
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`method without regard to the full recognition of those benefits or characteristics
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`within the art field at the time of the prior art disclosure.” Id. at 1378.
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`After surveying Federal Circuit law on inherency, the District of Delaware
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`court concluded that “a patentee may not circumvent the doctrine of inherent
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`anticipation simply by adding an ‘intent’ limitation to a claim.” GlaxoSmithKline
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`LLC v. Glenmark Pharms. Inc., USA, No. CV 14-877-LPS-CJB, 2017 WL 2290141,
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`at *2 (D. Del. May 25, 2017). Rather:
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`[I]f the only distinction between the prior art and the asserted claim is
`an express intent limitation in the asserted claim—and there is no
`manipulative difference in the physical steps in the asserted claims as
`compared to those in the prior art—then the asserted claim is
`anticipated.
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`Id. “[T]he proper test for determining whether a use is patentably ‘new’ is to compare
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`‘the methods disclosed in the prior art’ to those disclosed in the patent to determine
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`if ‘they teach the same physical steps’ or whether there is a ‘manipulative difference’
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`in the disclosed steps.” Id. (quoting Magistrate Judge Burke’s report and
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`recommendation, GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA, No. CV
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`14-877-LPS-CJB, 2017 WL 8944995, at *11, *14 (D. Del. May 2, 2017)). In
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`reaching its conclusion, the district court rejected the argument that a new,
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`patentable use can be found when “the physical steps of the treatment method are
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`exactly the same and the patient populations are identical—and the only difference
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`is that the invention at issue states that the administration will be for a different
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`purpose than that focused upon in the prior art.” GlaxoSmithKline LLC v. Teva
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`Pharms. USA Inc., No. 14-878-LPS-CJB, D.I. 346, at 29–30 (D. Del. May 2, 2017)
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`(emphasis in original). Indeed, “were an intent limitation enough to claim around
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`inherent anticipation, that would essentially eviscerate the doctrine.” Id. at 37. Thus,
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`the Federal Circuit has held that “[w]hile inherent anticipation may not be
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`established by probabilities or possibilities, if the prior art’s disclosure is sufficient
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`to show that the natural result flowing from the operation as taught would result in
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`the performance of the questioned function, it seems to be well-settled that the
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`disclosure should be regarded as sufficient.” King Pharms., Inc. v. Eon Labs, Inc.,
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`616 F.3d 1267, 1276 (Fed. Cir. 2010) (internal quotations and citations omitted).
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`2. Gil Inherently Discloses Reducing Eye Redness in Radial
`Keratotomy Patients with Brimonidine
`Example 1 in Gil discloses all of the method steps required by claims 1 and 2.
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`EX-1004 at 4:45–5:2. The only arguable difference between claims 1 and 2 and
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`Example 1 in Gil, however, is that Example 1 does not expressly state that the
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`brimonidine was being administered with the intent to reduce patients’ eye redness.
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`Nevertheless, as explained by Dr. Sher, all patients in Example 1 would suffer from
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`eye redness and the “natural result” of administering low concentrations of
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`brimonidine to those patients for the purpose of reducing neurogenic inflammation
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`is to similarly reduce their eye redness. See, e.g., EX-1049 ¶¶ 51–56. Accordingly,
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`Gil inherently anticipates claims 1 and 2.
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`There is no manipulative difference between the method disclosed in Gil and
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`claims 1 and 2 of the ’742 patent. As explained by Dr. Sher, the patients in Gil
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`necessarily suffer from eye redness following radial keratotomy surgery. See, e.g.,
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`EX-1049 ¶¶ 45–50. Radial keratotomy also causes pain. The eye redness that
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`presents in Gil’s patients falls within the broad genus of “ocular conditions” claimed.
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`See Eli Lilly & Co. v. Barr Laby’s, Inc., 251 F.3d 955, 971 (Fed. Cir. 2001) (“[C]ase
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`law firmly establishes that a later genus claim limitations is anticipated by … an
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`early species claim.”). Gil discloses a method “consisting essentially of
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`administering brimonidine.” See infra at Section II. And Gil discloses the
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`administration of concentrations that fall within the claimed ranges. See Paper 2 at
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`27–31, 35–37; Paper 43 at 2–7. Even if Gil were limited to treating pain associated
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`with radial keratotomy surgery (and it is not for the reasons set out below), this
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`would not avoid anticipation because the only difference between Gil and claims 1
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`and 2 is the express intent of the treatment. Put another way, the evidence establishes
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`that low concentrations of brimonidine help the same patient population—namely,
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`patients that have undergone radial keratotomy surgery—by treating both pain and
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`eye redness. That is sufficient to establish inherent anticipation. See Bristol-Myers
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`Squibb Co. v. Boehringer Ingelheim Corp., 86 F. Supp. 2d 433, 442 (D.N.J. 2000)
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`(“[W]here the prior art discloses the steps of a process and” the patentee “did not
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`manipulate or otherwise alter the basic application … disclosed in the prior art[,]”
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`the patentee cannot patent as a new invention “unexpected or unappreciated results
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`from” that method.) (internal citations omitted), vacated on other grounds by
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`Bristol-Myers Squibb Co. v. Ben Venue Laby’s, Inc., 246 F.3d 1368 (Fed. Cir. 2001).
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`The case for inherency is even stronger because, as the Board recognized in
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`the institution decision, Gil is not limited to the administration of brimonidine for
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`the treatment of pain. Paper 13 at 20. Rather, Gil discloses an intent to treat
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`neurogenic inflammation using low concentrations of brimonidine. EX-1004 at
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`1:17–19 (“This invention relates to the topical application of brimonidine for treating
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`ocular pain and neurogenic inflammation and compositions useful for such
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`application.”). Gil describes the direct, causal link between neurogenic inflammation
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`and redness: “Neuropeptides enhance inflammatory reactions in the injured tissue,
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`contributing to vasodilation, edema, and increased vascular permeability, this
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`phenomenon is called ‘neurogenic inflammation’.” Id. at 1:40–43 (emphasis added).
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`Gil expressly identifies “redness” as an “[o]cular response[] characteristic of
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`neurogenic inflammation[.]” Id. at 5:38–41. And, as Dr. Sher explains, Example 1
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`expressly indicates that “[s]ymptoms of ocular inflammation (burning/stinging,
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`tearing, etc.) are also recorded,” which a POSA would immediately understand to
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`signal that the inventors expected those symptoms—including redness—to be
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`reduced. EX-1049 ¶ 53.
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`If not held unpatentable, claims 1 and 2 of the ’742 patent would block doctors
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`from practicing the prior art methods disclosed in Gil to use low concentrations of
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`brimonidine to treat neurogenic inflammation and the eye redness it causes. See King
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`Pharms., 616 F.3d at 1275 (“The preamble to claim 1 is inherently anticipated. To
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`hold otherwise would remove from the public a method of treating muscle pain that
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`has been performed for decades.”).
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`II.
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`ISSUE #2: “CONSISTING ESSENTIALLY OF”
`“Consisting Essentially of” Limits Claims Only with Respect to
`A.
`the “Basic and Novel Properties” of the Invention
`The transitional phrase “consisting essentially of” is a middle ground between
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`the open-ended “comprising” and closed-ended “consisting of.” AK Steel Corp. v.
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`Sollac and Ugine, 344 F.3d 1234, 1239 (Fed. Cir. 2003). This middle ground allows
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`a claim to cover a method that includes unclaimed elements, provided the additional
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`elements do not “materially affect the basic and novel properties of the invention.”
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`HZNP Meds. LLC v. Actavis Laby’s UT, Inc., 940 F.3d 680, 693 (Fed. Cir. 2019).
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`To determine whether an element not listed in the claims “materially affect[s]
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`the basic and novel properties of the invention,” the Federal Circuit turns to the
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`specification. See Ecolab, Inc. v. FMC Corp., 569 F.3d 1335, 1343–44 (Fed. Cir.
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`2009). In Ecolab, the court was asked to determine whether claims directed to use
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`of a solution “consisting essentially of” peracetic acid (PAA) were limited to use of
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`solutions where PAA was the “sole antimicrobial agent.” Id. at 1342. The court
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`declined to find the claims so limiting, noting that the specification included
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`disclosure of compositions that included other components that had antimicrobial
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`properties, despite not being identified as such in the specification. Id. at 1344; see
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`also Kim v. Earthgrains Co., No. 01 C 3895, 2010 WL 625220, at *4 (N.D. Ill. Feb.
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`18, 2010) (finding Ecolab suggests “additional active ingredients which improve the
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`performance of the basic claim formula, but do not otherwise change its function, do
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`not materially alter the ‘basic and novel’ characteristics of the invention”), aff’d, 451
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`F. App’x 922 (Fed. Cir. 2011).
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`Here, the ’742 patent states that an allegedly novel aspect of the claimed
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`invention is brimonidine’s ability to reduce eye redness at low doses, but does not
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`exclude administration of other drugs. The patent states “[o]ne of the key discoveries
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`of the present invention lies in using low doses of [brimonidine] to achieve
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`vasoconstriction with significantly reduced hyperemia.” EX-1001 at 2:38–41.
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`Indeed, Patent Owner has emphasized the reduction of redness with brimonidine in
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`its attempts to distinguish the claims from the prior art. See, e.g., Paper 30 at 40–43.
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`Further, like Ecolab, an analysis of the specification makes clear that the claimed
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`methods are not limited to administration of solely brimonidine, apart from any other
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`drugs. For example, the specification contains an entire section titled “Combination
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`Treatments.” See EX-1001 at 15:35–16:43. One embodiment of the “invention
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`generally relates to a composition formulated for treating and/or preventing an
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`allergic response with reduced rebound hyperemia, comprising a selective a-2
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`adrenergic receptor agonist … and a histamine antagonist.” Id. at 16:2–10.
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`The Board specifically inquired whether there are temporal or intent aspects
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`to the phrase “consisting essentially of.” For method of treatment claims, both timing
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`and intent can inform whether other drugs “materially affect” the redness reducing
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`properties of brimonidine. The discussion of Dean (EX-1007) during prosecution of
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`the ’742 patent illustrates the point. During prosecution, the claims were directed to
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`methods of inducing vasoconstriction of small blood vessels with selective α-2
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`adrenergic receptor agonists. EX-1024 at 51. The examiner rejected the then-
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`pending claims as anticipated by Dean, which discloses administration of
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`brimonidine with another drug—brinzolamide—for lowering intraocular pressure
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`(IOP) in the treatment of glaucoma. Id. at 95–97. In response, the applicant (1)
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`substituted “consisting essentially of” for “comprising” and (2) limited the
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`adrenergic receptor agonist to brimonidine. Id. at 111. The applicant distinguished
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`the amended claims from Dean by arguing that one of the basic and novel
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`characteristics of the claimed methods was that “they do not require the use of any
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`other active ingredients,” noting that Dean taught that brimonidine alone was
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`insufficient and that near-simultaneous administration of brinzolamide was “an
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`essential active ingredient” for the treatment of the target ocular condition
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`(glaucoma). Id. at 114–116. In other words, Dean did not teach a method consisting
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`essentially of administration of brimonidine because the unclaimed element
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`(brinzolamide) materially affected the method of reducing IOP. Id. Both the purpose
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`of administering brinzolamide (i.e., for purposes of reducing IOP) and the timing of
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`the administration (near simultaneous) impliedly bore on that conclusion.
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`B.
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`The Prior Art Disclosed Methods Consisting Essentially of
`Administering Brimonidine
`For purposes of these claims, a material effect is one that disrupts or impedes
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`performance of the claimed method—namely, brimonidine’s ability to reduce
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`redness. See Pordy v. Land O’Lakes, Inc., 97 F. App’x 921, 927–28 (Fed. Cir. 2004)
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`(finding that unclaimed elements in a composition did not materially affect the
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`claimed invention because additional whitening agents did not alter the performance
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`of the claimed composition). Patent Owner contended for the first time at oral
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`argument that Gil and Norden failed to disclose methods consisting essentially of
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`brimonidine because a POSA would understand that other active ingredients were
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`administered.2 As explained above, however, the phrase “consisting essentially of”
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`does not exclude administration of all other drugs, only those that materially affect
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`the basic and novel characteristics of the claims. In both Gil and Norden, the
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`disclosed studies were designed such that the only difference between the control
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`group and the treatment group was the administration of brimonidine. Even
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`assuming that Patent Owner’s contentions about the types of drugs administered in
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`connection with the surgeries is correct, neither Gil nor Norden discloses methods
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`that include other drugs that materially affect the basic and novel characteristics of
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`the claims (i.e., brimonidine’s ability to reduce redness).
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`Example 1 of Gil describes a method in which patients received topical
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`brimonidine before and after radial keratotomy surgery. EX-1004 at 4:45–5:2. There
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`2 Petitioner maintains its objections to Patent Owner’s arguments regarding whether
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`the prior art at issue discloses methods consisting essentially of administration of
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`brimonidine. Petitioner did not have an opportunity to present evidence or expert
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`testimony regarding this issue.
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`is no dispute that radial keratotomy surgery would have included administration of
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`other drugs to facilitate aspects of the surgery. For example, Dr. Sher testified that
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`the surgeon would need to apply an anesthetic before performing surgery on the eye.
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`EX-2213 at 22:24–23:13. But as Dr. Sher testified, most of the drugs to which Patent
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`Owner points do not have an impact on redness at all. EX-2213 at 25:13–26:15,
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`40:15–41:5. Without any supporting expert testimony, Patent Owner speculates that
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`drugs like anti-inflammatory agents or steroids could have been used in connection
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`with radial keratotomy, but these drugs, if used, did not materially affect the eye
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`redness seen after ocular surgery. Despite the potential use of other drugs, Dr. Sher’s
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`unrebutted testimony confirmed that in his experience every radial keratotomy
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`patient has some degree of redness after surgery. EX-1049 at ¶ 47; EX-2213 at
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`34:22–35:10, 36:2–17. Therefore, additional drugs used in typical radial keratotomy
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`surgery do not materially affect brimonidine’s ability to reduce redness, and it was
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`brimonidine alone that Gil administered to see a reduction in pain and neurogenic
`
`inflammation. See Kim, 2010 WL 625220, at *4; Ecolab, 569 F.3d at 1343–44;
`
`Pordy, 97 F. App’x at 927–28. Thus, Gil discloses a method consisting essentially
`
`of administering brimonidine as in the challenged claims.
`
`Similarly, Norden describes a study where patients received topical
`
`brimonidine before Lasik surgery. EX-1006 at 5. Norden expressly discloses the
`
`drugs that were used in connection with the LASIK surgery performed. Id. at 4–5.
`
`13
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`Case IPR2022-00142
`U.S. Patent No. 8,293,742
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`Importantly, like Example 2 of the ’742 patent, Norden showed reduced redness after
`
`the administration of brimonidine when compared to the control group. Compare
`
`EX-1001 at 20:27–21:4 with EX-1006 at 6. The control group presented with
`
`substantial eye redness; the brimonidine group did not.3 Plainly, any other drugs
`
`administered in the Norden study did not impact—let alone “materially affect”—
`
`brimonidine’s redness reducing properties.4
`
`Patent Owner’s argument that the administration of other drugs during ocular
`
`surgeries, as disclosed in Gil and Norden, offends the “basic and novel properties of
`
`
`3 In fact, Norden concluded “[t]he amount of hyperemia, however, was notably lower
`
`in eyes treated prophylactically with brimonidine (Fisher’s exact P<.0001). Eighty-
`
`four percent of treated eyes had grade 1 or no hyperemia, as compared with just 10%
`
`of the untreated eyes (Figure).” EX-1006 at 6.
`
`4 Notably, the question of whether the method explicitly disclosed in Norden
`
`“consists essentially of” administration of brimonidine is less important in an
`
`obvious analysis. Norden’s controlled clinical trial of brimonidine establishes that a
`
`POSA would have understood brimonidine to be a vasoconstrictor and eye redness
`
`reducer, even if other drugs were used during the surgery. See EX-2175 at 4
`
`(“Studies have shown that the use of perioperative brimonidine can significantly
`
`decrease the incidence of bleeding complications after LASIK.”).
`
`14
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`Case IPR2022-00142
`U.S. Patent No. 8,293,742
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`the invention” cannot be squared with the ’742 patent itself. The specification
`
`describes the claimed methods as covering administration of brimonidine in
`
`connection with ocular surgeries, which would necessarily include the medications
`
`administered with those surgeries. See, e.g., EX-1001 at 12:13–59 (defining “ocular
`
`condition” to include the results of LASIK and other ocular surgeries). Example 2
`
`expressly describes the administration of brimonidine in connection with LASIK
`
`surgery, and notes that “[c]osmetically, the patients are much improved from day 1
`
`vs. no vasoconstrictor and vs. Naphcon-A.” Id. at 21:1–2. Finally, claim 4 is directed
`
`to a method of administering brimonidine “within about 24 hours after a Lasik
`
`surgery.” Id. at 22:33–35. LASIK surgery would necessarily include administration
`
`of other drugs to facilitate patient comfort. See, e.g., EX-2213 at 23:11–13; Paper 59
`
`at 9. Thus, the inventors conveyed that administration of brimonidine before (like
`
`Example 2) or after (like claim 4) a typical LASIK surgery would practice the
`
`claimed invention. A reading of the “consisting essentially of” phrase to exclude
`
`methods performed in conjunction with drugs typically administered with ocular
`
`surgery would contradict the disclosures in the specification and should not be
`
`adopted.
`
`
`
`Respectfully submitted,
`March 20, 2023
`
`/Linnea P. Cipriano/
`
`15
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`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`
`
`
`
`Linnea P. Cipriano
`(Reg. No. 67,729)
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`Fax: (212) 937-2204
`lcipriano@goodwinlaw.com
`
`Counsel for Petitioner
`Slayback Pharma LLC
`
`16
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`
`CERTIFICATE OF SERVICE
`
`I, Linnea P. Cipriano, certify that I caused to be served a true and correct
`
`copy of the foregoing PETITIONER’S OPENING SUPPLEMENTAL BRIEF by
`
`email, as follows:
`
`
`Bryan Diner
`Justin Hasford
`Caitlin O’Connell
`Christina Yang
`
`bryan.diner@finnegan.com
`Justin.hasford@finnegan.com
`caitlin.oconnell@finnegan.com
`christina.yang@finnegan.com
`
`March 20, 2023
`
`/Linnea P. Cipriano/
` Linnea P. Cipriano
`(Reg. No. 67,729)
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8000
`Fax: (212) 937-2204
`lcipriano@goodwinlaw.com
`
`Counsel for Petitioner
`Slayback Pharma LLC
`
`1
`
`
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