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