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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`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 REPLY 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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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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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 REPLY 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 .......... 1
`A. The Preamble Limits the Claims but Does Not Require Efficacy ........... 1
`B. Petitioner Has Proven Inherent Anticipation ........................................... 3
`1.
`Inherent Anticipation Applies to “Intent” Limitations .................... 3
`2. There Is No Difference in the Method Claimed and the Method
`Disclosed in Gil ................................................................................ 5
`3. Even If Efficacy Is Required, Gil Anticipates Claims 1–2 .............. 6
`ISSUE #2: “CONSISTING ESSENTIALLY OF” ....................................... 7
`A. Patent Owner Misconstrues “Consisting Essentially Of” ........................ 7
`B. Petitioner Has Proven Gil Anticipates Claims 1–2 ................................. 9
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`I.
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`II.
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`Case IPR2022-00142
`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
`Apotex Inc. v. Regeneron Pharms., Inc.,
`IPR2022-01524, Paper 9 (P.T.A.B. Mar. 10, 2023) ............................................ 5
`GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA,
`No. CV 14-877-LPS-CJB, 2017 WL 2290141 (D. Del. May 25,
`2017) ..................................................................................................................... 4
`Jansen v. Rexall Sundown, Inc.,
`342 F.3d 1329 (Fed. Cir. 2003) ............................................................................ 2
`King Pharms., Inc. v. Eon Labs, Inc.,
`616 F.3d 1267 (Fed. Cir. 2010) ........................................................................ 4, 7
`Mylan Pharms. Inc. v. Regeneron Pharms., Inc.,
`No. IPR2021-00881, 2022 WL 16842073 (P.T.A.B. Nov. 9, 2022) ................ 1, 2
`Perricone v. Medicis Pharm. Corp.,
`432 F.3d 1368 (Fed. Cir. 2005) ........................................................................ 4, 5
`Pordy v. Land O’Lakes, Inc.,
`97 F. App’x 921 (Fed. Cir. 2004) ......................................................................... 9
`Sanofi Mature IP v. Mylan Lab’ys Ltd.,
`757 F. App’x 988 (Fed. Cir. 2019) ....................................................................... 2
`SmithKline Beecham Corp. v. Apotex Corp.,
`403 F.3d 1331 (Fed. Cir. 2005) ............................................................................ 7
`Tech. Props. Ltd. LLC v. Huawei Techs. Co.,
`849 F.3d 1349 (Fed. Cir. 2017) ............................................................................ 8
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`Case IPR2022-00142
`U.S. Patent No. 8,293,742
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`Petitioner respectfully submits this response to Patent Owner’s Brief
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`Addressing the Board’s Questions (Paper 70, “PO Br.”).
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`I.
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`ISSUE #1: THE PREAMBLE AND INHERENT ANTICIPATION
`A. The Preamble Limits the Claims but Does Not Require Efficacy
`The parties do not dispute that the preamble phrase “for reducing eye redness”
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`is a statement of intentional purpose for which the method must be performed. See
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`PO Br. at 2–4. Patent Owner, however, asks the Board to go beyond the plain
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`meaning of “for” and find that the preamble also requires “achiev[ing] the stated
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`purpose of administrating brimonidine to a patient with ocular hyperemia—to reduce
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`the eye redness” (i.e., efficacy). Id. at 5–6. This is improper.
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`Patent Owner asserts, without explanation, that efficacy is required because
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`the preamble is “written with the gerund form of the verb.” Id. at 5. Patent Owner,
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`however, fails to address the Board’s decision in Mylan Pharms. Inc. v. Regeneron
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`Pharms., Inc., No. IPR2021-00881, 2022 WL 16842073 (P.T.A.B. Nov. 9, 2022).
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`There, the Board determined the preamble—“[a] method for treating an angiogenic
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`eye disorder in a patient”—required the “therapeutic [be] administered with the
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`‘intentional purpose’ of treating an angiogenic eye disorder, without showing actual
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`therapeutic effectiveness.” Id. at *8–*9. The Board determined “it is the
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`administration of the VEGF antagonist to such patient for the purpose of providing
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`an improvement of or beneficial effect on their angiogenic eye disorder that satisfies
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`1
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`the ‘treating’ portion of the preamble.” Id. The same conclusion applies here. “[F]or
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`reducing eye redness” does not require the method to actually reduce eye redness.
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`The cases cited by Patent Owner do not change the plain meaning of “for
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`reducing eye redness.” Jansen focused on whether a limiting preamble was
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`infringed. Even in that case, however, the Federal Circuit did not require efficacy to
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`find infringement. Rather, infringement turned on intent: if the patients did not “take
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`the Rexall product knowingly to treat or prevent macrocytic-megaloblastic anemia,”
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`then they would not infringe the patent. Jansen v. Rexall Sundown, Inc., 342 F.3d
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`1329, 1333–34 (Fed. Cir. 2003). In Sanofi, the Federal Circuit remanded to the Board
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`because “[t]he Board erred by treating the preamble here as non-limiting.” Sanofi
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`Mature IP v. Mylan Lab’ys Ltd., 757 F. App’x 988, 994 (Fed. Cir. 2019). In the
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`Federal Circuit’s view, the preamble in that case “expresse[d] the ‘intentional
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`purpose [increasing survival]’ for which the method must be performed.” Id. at 993
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`(quoting Jansen, 342 F.3d at 1333) (emphasis added). Patent Owner goes too far
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`when it suggests Sanofi endorsed an efficacy requirement.1
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`1 Contrary to Patent Owner’s assertion, Petitioner has not shifted positions. Petitioner
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`always treated the preamble as a limiting statement of intentional purpose. The
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`testimony from Dr. Sher on which Patent Owner relies did not “effectively conced[e]
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`an efficacy requirement.” PO Br. at 3. The portion of Dr. Sher’s declaration cited by
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`2
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`B.
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`Petitioner Has Proven Inherent Anticipation
`Inherent Anticipation Applies to “Intent” Limitations
`1.
`Patent Owner conflates the issue of claim construction (whether the preamble
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`is limiting) with the issue of inherency (whether a prior art reference inherently
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`discloses that limitation). Patent Owner seems to argue that the preamble’s “intent”
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`limitation effectively prevents the application of inherent anticipation. That misses
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`the point of inherency. Even if the preamble limits the claims to administering
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`brimonidine for the purpose of reducing eye redness, and even if Gil were limited to
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`administering brimonidine to RK patients for the purposes of treating ocular pain,2
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`the method in Gil still inherently anticipates claims 1–2 because there is no
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`difference between the methods of using low doses of brimonidine in (1) Gil to
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`reduce pain and inflammation in RK patients, and (2) the claimed method to reduce
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`Patent Owner expresses an opinion about the inherency of the disclosure in Gil. EX-
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`1002 ¶ 55. Dr. Sher confirmed that administration of 0.03% brimonidine would
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`reduce redness in the radial keratotomy (“RK”) patients regardless of whether Gil
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`intended that purpose. Id. Dr. Sher never opined that the claims required efficacy.
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`2 For the reasons the Board acknowledged in the Institution Decision, Petitioner does
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`not agree that Gil is limited to administration of brimonidine for treating only ocular
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`pain. Paper 13 at 20; Paper 43 at 8; Paper 71 at 7.
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`3
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`eye redness in patients with ocular conditions, including after RK. See
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`GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA, No. CV 14-877-LPS-CJB,
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`2017 WL 2290141, at *2 (D. Del. May 25, 2017) (“[A] patentee may not circumvent
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`the doctrine of inherent anticipation simply by adding an ‘intent’ limitation to a
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`claim.”). At most, applicant claimed an allegedly new benefit associated with the
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`same prior art method of treatment. King Pharms., Inc. v. Eon Labs, Inc., 616 F.3d
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`1267, 1275 (Fed. Cir. 2010) (“[I]t is a general rule that merely discovering and
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`claiming a new benefit of an old process cannot render the process again
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`patentable.”) (quotations omitted). In King, the Federal Circuit found the
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`preamble—“which [patent owner] argues is the claim’s source of novelty”—to be
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`inherently anticipated by comparing the claimed “steps required to increase
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`metaxalone’s bioavailability” to the “steps … disclosed by the prior art.” Id. at 1274–
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`76. Finding the same steps disclosed in the prior art, the court concluded the
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`preamble—“[a] method of increasing bioavailability”—to be the “natural result
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`flowing from the [prior art’s] explicitly explicated limitations” and therefore
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`inherently anticipated. Id. at 1276 (quotations omitted).
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`Patent Owner points to Perricone, but it supports Petitioner. In Perricone, the
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`court held claims that required administering a composition to sunburned skin were
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`not inherently anticipated by prior art applying the same composition to skin
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`generally. Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377–80 (Fed. Cir.
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`2005). The analysis turned on the purpose for administration, not its result. See id.
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`Similarly, in Apotex, the Board found that the efficacy limitations—which, unlike
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`here, were recited in the body of the claims—were not inherent in the prior art
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`because the prior art disclosed a different method than the one claimed. See Apotex
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`Inc. v. Regeneron Pharms., Inc., IPR2022-01524, Paper 9 at 36 (P.T.A.B. Mar. 10,
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`2023) (“We find that effectiveness of aflibercept administered at a different dosing
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`regimen than that claimed to be very weak evidence that the claimed and disclosed
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`regimen would exhibit the claimed results limitations.”).
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`2.
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`There Is No Difference in the Method Claimed and the
`Method Disclosed in Gil
`Gil’s method is the exact same method claimed. Patent Owner suggests that
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`patient populations may differ, repeating the same flawed argument that Dr. Sher
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`“admitted” that RK patients may not suffer from eye redness. PO Br. 6–7. The cited
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`testimony, however, stands for the unremarkable proposition that the cornea is
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`avascular. EX-2162 at 113:12–17. On the relevant question, Dr. Sher was express
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`and unequivocal: “[A]s I detailed in my declaration and based on my experience in
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`RK surgery … I have never seen a patient who I’ve cut the cornea on … who have
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`not had some eye redness …. That’s my experience.” EX-2213 at 35:1–10. Patent
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`Owner similarly misstates Dr. Sher’s testimony as admitting that the method in Gil
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`would not result in redness in all patients. Rather, the cited testimony—EX-2213 at
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`5
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`18:10–21:8—only discusses the different types of eye drops that may or may not be
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`administered before, during, or after RK. But in Dr. Sher’s experience, all of those
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`patients still “had some eye redness.” EX-1049 ¶ 40.3 Patent Owner’s reliance on
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`Galderma is, therefore, misplaced. Gil does not have “permissible variations in the
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`parameters” of the method. PO Br. at 7. The method of Gil consists simply of
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`administering brimonidine to RK patients—a class of patients that present with eye
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`redness regardless of what other drugs may have been administered.
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`Even If Efficacy Is Required, Gil Anticipates Claims 1–2
`3.
`Finally, even if the Board finds that the preamble imposes an efficacy
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`requirement on the claims, the claims are still inherently anticipated. Patent Owner
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`cites the Federal Circuit’s statement that inherency cannot be proven by
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`“possibilities and probabilities” in an attempt to argue that Petitioner must prove the
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`method disclosed in the prior art produces a result on every administration. The
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`Federal Circuit has made clear, however, that inherent anticipation is proven where
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`3 In contrast, Patent Owner’s expert, Dr. Noecker, testified only in the abstract—he
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`never testified that he has seen a patient that did not have redness after RK surgery.
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`Dr. Noecker also ignored that, regardless of the vascularity of the cornea, corneal
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`incisions result in tissue damage that triggers an inflammatory cascade that
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`ultimately results in, inter alia, eye redness. See, e.g., EX-2020 ¶¶ 104–105.
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`the “natural result flowing from the [method] as taught would result in the
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`performance of the questioned function.” King, 616 F.3d at 1275. In King, the court
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`rejected the argument that the prior art needed to increase bioavailability in every
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`instance: “To anticipate, the prior art need only meet the inherently disclosed
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`limitation to the extent the patented method does.” Id. (“As the district court aptly
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`stated, to inherently anticipate, the prior art need only give the same results as the
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`patent, not better.”) (quotations omitted); see also SmithKline Beecham Corp. v.
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`Apotex Corp., 403 F.3d 1331, 1343 (Fed. Cir. 2005) (holding that inherency does
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`not require proving that it was impossible to not obtain the alleged inherent
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`limitation). As explained at length in Petitioner’s papers, the “natural result flowing
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`from” administration of 0.03% brimonidine disclosed in Gil is the same redness
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`reducing benefit recited in the preamble of claims 1–2.
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`II.
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`ISSUE #2: “CONSISTING ESSENTIALLY OF”
`Patent Owner Misconstrues “Consisting Essentially Of”
`A.
`Patent Owner’s construction of “consisting essentially of” extends the
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`meaning of this phrase beyond any reasonable interpretation of the intrinsic record
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`and is contrary to Federal Circuit precedent.
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`Patent Owner’s representation that “one of the basic and novel characteristics
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`of the claimed methods is administering brimonidine at the claimed concentrations
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`as the sole drug” is wrong. PO Br. at 11. Patent Owner bases this assertion solely on
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`statements made during prosecution, but applicant’s arguments were not as broad as
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`Patent Owner contends. During prosecution, applicant distinguished Dean on the
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`basis that both brimonidine and brinzolamide were necessary active agents for
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`glaucoma treatment. Applicant argued that the pending claims were directed to a
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`method where brimonidine alone was sufficient to treat glaucoma, but said nothing
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`about drugs not required to practice the method. EX-1024 at 116–17. As Patent
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`Owner acknowledges, applicant argued Dean discloses that brinzolamide increases
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`blood flow in ocular tissues, and as a result, materially affected brimonidine’s ability
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`to induce vasoconstriction. Id. at 116. Notably, in the same amendment, applicant
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`maintained claims directed to administering brimonidine in conjunction with LASIK
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`surgery (which would include administration of other drugs). Id. at 112. The
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`prosecution history, therefore, does not support the assertion that a basic and novel
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`property of the claimed method is the complete absence of other drugs in the patient.
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`Patent Owner effectively requests the Board find that applicant disclaimed
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`brimonidine “administered with other drugs,” even drugs that are entirely unrelated
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`to reducing redness. PO Br. at 12. Prosecution disclaimer, however, “does not apply
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`unless the disclaimer is ‘both clear and unmistakable to one of ordinary skill in the
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`art,’” and “[i]f the challenged statements are ambiguous or amenable to multiple
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`reasonable interpretations, prosecution disclaimer is not established.” Tech. Props.
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`Ltd. LLC v. Huawei Techs. Co., 849 F.3d 1349, 1357–58 (Fed. Cir. 2017) (citations
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`omitted). There is no statement in applicant’s amendment, or anywhere else in the
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`prosecution history, that the “patentee surrendered that interpretation [that allows for
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`unclaimed elements that do not materially affect the invention] with reasonable
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`clarity and deliberateness.” Pordy v. Land O’Lakes, Inc., 97 F. App’x 921, 928 (Fed.
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`Cir. 2004) (emphasis in original). Therefore, Patent Owner has not met its burden of
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`showing administration of brimonidine with any “other drug” has been disclaimed.
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`Finally, Patent Owner basically seeks to transform “consisting essentially of”
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`into the narrower “consisting of” transitional phrase, and asks the Board to ignore
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`its deliberate claim drafting choice. If applicant were aiming to exclude any other
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`unrecited elements or steps from the method, including any other drug administered
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`to the patient, it could have drafted the claim accordingly. Patent Owner did not, and
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`its litigation-driven attempt to improperly rewrite the claims should be rejected.
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`Petitioner Has Proven Gil Anticipates Claims 1–2
`B.
`The Petition correctly states that Gil does not identify any other drugs being
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`administered. No expert testimony from Patent Owner disputes that evidence. Dr.
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`Sher’s deposition testimony regarding the drugs typically administered during eye
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`surgeries does not impact the conclusion that Gil inherently anticipates claims 1–2.
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`Properly construed, only drugs that “materially affect the basic and novel
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`characteristics” of the claimed method are excluded. Pordy, 97 F. App’x at 927.
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`Here, the record shows that none of the drugs that may be administered with RK had
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`a material impact on the redness that patients experienced after the surgery. EX-1049
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`¶¶ 45–50. Despite these other drugs used for various purposes during surgery, all
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`RK patients had eye redness. EX-2213 at 35:1–10. Therefore, none of these drugs
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`that could have been used during surgery materially affected brimonidine’s ability
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`to reduce that redness.
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`The fact that Gil does not even mention the other drugs that could be used
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`during surgery confirms that these drugs would not impact the outcome of Example
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`1. The study in Example 1 was designed to test the effect of brimonidine on pain and
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`neurogenic inflammation. If other drugs used during surgery would impact
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`neurogenic inflammation or the ability to discern the impact of brimonidine, it is
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`illogical that a study would either ignore this variable or fail to control for it. The
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`only reasonable conclusion is in line with Dr. Sher’s testimony—none of these drugs
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`would materially affect the occurrence of redness in RK patients or the activity of
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`brimonidine to reduce inflammation and redness.
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`As explained in Petitioner’s Opening Supplemental Brief, both Gil and
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`Norden disclose methods that consist essentially of administration of brimonidine
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`under the proper construction of that phrase in the challenged claims.
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`Respectfully submitted,
`March 27, 2023
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`/Linnea P. Cipriano/
`Linnea P. Cipriano
`(Reg. No. 67,729)
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`10
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`U.S. Patent No. 8,293,742
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`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`Fax: (212) 937-2204
`lcipriano@goodwinlaw.com
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`Counsel for Petitioner
`Slayback Pharma LLC
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`11
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`CERTIFICATE OF SERVICE
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`
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`I, Linnea P. Cipriano, certify that I caused to be served a true and correct
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`copy of the foregoing PETITIONER’S REPLY SUPPLEMENTAL BRIEF by
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`email, as follows:
`
`
`Bryan Diner
`Justin Hasford
`Caitlin O’Connell
`Christina Yang
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`bryan.diner@finnegan.com
`Justin.hasford@finnegan.com
`caitlin.oconnell@finnegan.com
`christina.yang@finnegan.com
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`March 27, 2023
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`/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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