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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,
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`Petitioner,
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`v.
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`EYE THERAPIES, LLC,
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`Patent Owner.
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`__________________
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`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`__________________
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`PATENT OWNER’S OPENING BRIEF ADDRESSING THE BOARD’S
`QUESTIONS
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`
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`Case IPR2022-00142
`Patent Owner’s Opening Brief Addressing the Board’s Questions
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`Table of Contents
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`I.
`II.
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`
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`
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`Introduction ...................................................................................................... 1
`Question 1: Should the preamble of the claims, “A method for reducing eye
`redness,” be construed as limited to a “statement of the intentional purpose for
`which the method must be performed,” see Jansen v. Rexall Sundown, Inc.,
`342 F.3d 1329, 1333 (Fed. Cir. 2003), and, if so, what impact does that
`construction have on inherent anticipation? .................................................... 2
`The preamble is limiting, and it requires redness reduction ................. 3
`Petitioner cannot prove inherent anticipation under either party’s
`construction of the preamble ................................................................. 6
`III. Question 2: What impact does the transitional phrase “consisting essentially
`of” have on the claims? Is there a temporal aspect to the term (e.g., for drugs
`that are administered before or after brimonidine, but not together)? Is there
`an intent aspect to the term (e.g., for drugs that are administered for a different
`purpose)? ........................................................................................................10
`The transitional phrase “consisting essentially of” impacts the
`steps and drugs that can be used in the claimed methods for
`reducing eye redness ...........................................................................10
`Petitioner has not met its burden with respect to the “consisting
`essentially of” transitional phrase .......................................................13
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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) ............................................. 9
`In re Armodafinil Pat. Litig. Inc.,
`939 F. Supp. 2d 456 (D. Del. 2013)...................................................................... 8
`Bettcher Indus., Inc. v. Bunzl USA, Inc.,
`661 F.3d 629 (Fed. Cir. 2011) .................................................................... 7, 9, 15
`Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp.,
`320 F.3d 1339 (Fed. Cir. 2003) ............................................................................ 5
`In re Depomed Pat. Litig.,
`No. CV 13-4507 (CCC-MF), 2016 WL 7163647 (D.N.J. Sept. 30,
`2016), aff’d sub nom. Grunenthal GMBH v. Alkem Lab’ys Ltd.,
`919 F.3d 1333 (Fed. Cir. 2019) ............................................................................ 8
`Eli Lilly & Co. v. Teva Pharms. Int’l GmbH,
`8 F. 4th 1331 (Fed. Cir. 2021) .......................................................................... 4, 5
`Galderma Lab’ys, L.P. v. Teva Pharms. USA, Inc.,
`799 F. App’x 838 (Fed. Cir. 2020) ................................................................... 7-8
`Glaxo Inc. v. Novopharm Ltd.,
`52 F.3d 1043 (Fed. Cir. 1995) .................................................................... 7, 8, 15
`Jansen v. Rexall Sundown, Inc.,
`342 F.3d 1329 (Fed. Cir. 2003) .................................................................... 2, 3, 4
`Kowa Co. v. Amneal Pharms., LLC,
`Civ. A. No. 14-CV-2758 (PAC), 2017 WL 10667089 (S.D.N.Y.
`Sept. 19, 2017) ...................................................................................................... 8
`PPG Indus. v. Guardian Indus. Corp.,
`156 F.3d 1351 (Fed. Cir. 1998) .......................................................................... 10
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`Perricone v. Medicis Pharm. Corp.,
`432 F.3d 1368 (Fed. Cir. 2005) .................................................................. 8-9, 15
`Rapoport v. Dement,
`254 F.3d 1053 (Fed. Cir. 2001) ............................................................................ 6
`Sanofi Mature IP v. Mylan Lab’ys Ltd.,
`757 F. App’x 988 (Fed. Cir. 2019) ................................................................... 5, 6
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`Introduction
`Patent Owner respectfully submits the following responses to the Board’s
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`I.
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`questions relating to the preamble and the transitional phrase of the ’742 patent. See
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`Paper 69. The preamble “a method for reducing eye redness” is limiting, and it
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`should be construed to require redness reduction because if it is not so construed, the
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`steps recited in the body of the claim do not make sense. But regardless of which
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`party’s construction the Board ultimately adopts, Petitioner cannot prove inherent
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`anticipation. Under either construction, Example 1 of the ’553 patent does not
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`anticipate because the patient population would not necessarily have redness (claims
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`1-2), and “about 0.025%” does not encompass 0.03% (claim 2). Additionally,
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`Example 1 fails under Patent Owner’s construction because it does not disclose,
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`expressly or inherently, that administration of 0.03% brimonidine alone reduced any
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`hypothetical eye redness. And Example 1 further fails under Petitioner’s flawed
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`construction because Petitioner cannot rely on inherency to prove a subjective intent
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`to reduce redness, particularly where Example 1 explicitly states that brimonidine
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`was administered with the intent to block the perception of pain, not reduce redness.
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`Petitioner’s anticipation theory fails for another reason—it cannot show that
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`Example 1 satisfies the transitional phrase “consisting essentially of,” which
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`replaced “comprising” during prosecution to overcome a prior art reference in which
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`brimonidine was ocularly dosed with another drug. Both experts in this proceeding
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`1
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`confirmed that the eyedrop dosing protocol for a refractive surgery, such as radial
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`keratotomy and LASIK, includes administration of other drugs (e.g., steroids,
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`NSAIDs, antibiotics). Because “consisting essentially of” was inserted to exclude
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`ocularly dosing brimonidine with another drug in the claimed method, the presence
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`of these drugs runs afoul of the “consisting essentially of” transitional phrase.
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`II. Question 1: Should the preamble of the claims, “A method for reducing
`eye redness,” be construed as limited to a “statement of the intentional
`purpose for which the method must be performed,” see Jansen v. Rexall
`Sundown, Inc., 342 F.3d 1329, 1333 (Fed. Cir. 2003), and, if so, what
`impact does that construction have on inherent anticipation?
`Patent Owner submits that the preamble—a method for reducing eye
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`redness—is a claim limitation that must be satisfied to practice the claimed method.
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`In Jansen v. Rexall Sundown, Inc., the Federal Circuit held that the preamble “[a]
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`method of treating or preventing anemia in humans” is limiting because it is “not
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`merely a statement of effect that may or may not be desired or appreciated,” but
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`rather, “it is a statement of the intentional purpose for which the method must be
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`performed.” 342 F.3d 1329, 1333 (Fed. Cir. 2003). Thus, the Federal Circuit held,
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`“administering the claimed vitamins in the claimed doses for some purpose other
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`than treating or preventing macrocytic megaloblastic anemia is not practicing the
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`claimed method, because Jansen limited his claims to treatment or prevention of that
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`particular condition in those who need such treatment or prevention.” Id. at 1334.
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`As applied here, the “intentional purpose for which the method must be performed”
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`2
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`is reducing eye redness in a patient having an ocular condition (i.e., hyperemia).
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`Administering the brimonidine composition in the claims of the ’742 patent for some
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`purpose other than reducing eye redness, for example, treating ocular pain, is not
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`practicing the claimed method. See id.
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` The preamble is limiting, and it requires redness reduction
`The parties agree that the preamble is limiting. Patent Owner argued
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`throughout this proceeding that the preamble requires reduction in a patient’s ocular
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`hyperemia. Petitioner, changing its position from the petition, argued for the first
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`time in its reply that the preamble is limiting and requires “the composition be
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`administered with the intent to reduce redness.” Paper 43 at 7-8.1
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`1 This position-shift is evidenced by Petitioner’s own documents. As an example, in
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`its original papers, Petitioner’s expert Dr. Sher argued that administration of 0.03%
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`brimonidine was “inherently a method ‘for reducing eye redness” “whether intended
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`or not,” effectively conceding an efficacy requirement. EX-1002 at ¶55. The Board
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`specifically noted this in its Institution Decision. (Paper 13 at 15 (citing EX-1002 at
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`¶55).) Now Petitioner argues the claims merely require intent, not efficacy. This
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`begs the question: Why was Petitioner’s original position that inherency was met
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`even without intent? Both simply cannot be true, and this demonstrates the failures
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`of Petitioner’s positions, both legally and scientifically.
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`As an initial matter, despite Petitioner’s agreement that the preamble is
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`limiting, its construction is not limiting at all. Instead, Petitioner effectively argues
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`that the preamble is merely a statement of effect that may or may not be desired or
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`realized—contrary to the Federal Circuit’s holding in Jansen. 342 F.3d at 1333.
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`Petitioner is forced to take this position because it cannot meet its burden to prove
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`inherent anticipation based on the ’553 patent—that the population of radial
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`keratotomy patients in Example 1 would inevitably have ocular hyperemia (eye
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`redness), much less that 0.03% brimonidine alone, without other co-administered
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`drugs, would have necessarily reduced such hyperemia, even in the sub-set of
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`patients who may have had redness.
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`Whether and how a preamble limits an invention depends “on the facts of each
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`case, in light of the claim as a whole and the invention described in the patent.” Eli
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`Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F. 4th 1331, 1340 (Fed. Cir. 2021); see
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`also Jansen, 342 F.3d at 1341. In a method claim, the preamble is generally limiting
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`because it recites what the claimed method does, unlike apparatus and composition
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`claims, which recite what they are. Eli Lilly, 8 F. 4th at 1341. Thus, the preamble in
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`a method claim typically provides the essential element without which the steps
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`recited in the body of the claim do not make sense. See id. at 1341-42. In the ’742
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`patent, the preamble articulates the intentional purpose for which the method must
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`be performed—reducing eye redness—with a direct link to a patient having an ocular
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`condition that can give rise to the patient’s eye redness (hyperemia). See Sanofi
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`Mature IP v. Mylan Lab’ys Ltd., 757 F. App’x 988, 993 (Fed. Cir. 2019). Reducing
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`eye redness in a patient having an ocular condition does not merely provide context
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`for the invention but instead, it is the essence of the invention, without which
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`performance of the recited steps would be but an academic exercise. Eli Lilly, 8 F.
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`4th at 1341 (citing Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp.,
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`320 F.3d 1339, 1345 (Fed. Cir. 2003)).
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`The specification further confirms the limiting nature of the preamble. The
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`specification repeatedly teaches using brimonidine as the sole drug to reduce eye
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`redness in a patient having ocular hyperemia. See EX-1001 at 14:19-22 (treating
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`conjunctival hyperemia), 14:23-24 (reducing redness in the eye), 14:7-14 (achieving
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`scleral whitening), Examples 1, 4, and 5; see also id. at 7:9-16, 7:20-25, 9:28-31,
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`9:35-39, 10:3-8, 12:60-64, 14:15-18, 14:37-39 (consisting essentially of
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`administering low-concentration brimonidine). The examiner also considered the
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`preamble limiting. During prosecution of the ’742 patent, as a condition precedent
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`to a notice of allowance, the examiner narrowed the preamble to specifically recite
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`reducing eye redness of a patient and specifically stated that the prior art (Dean)
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`“does not teach reducing eye redness.” See EX-1024 at 143-144. Based on the
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`totality of evidence, the most natural interpretation of the preamble , which is written
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`with the gerund form of the verb, is to achieve the stated purpose of administering
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`brimonidine to a patient with ocular hyperemia—to reduce the eye redness. Sanofi,
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`757 F. App’x at 992 (citing Rapoport v. Dement, 254 F.3d 1053, 1058-61 (Fed. Cir.
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`2001)). Thus, the preamble requires reduction of eye redness. See id. at 994 (holding
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`that the preamble “[a] method of increasing survival” clearly requires increasing
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`survival). Petitioner’s argument to the contrary lacks merit.
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`Petitioner cannot prove inherent anticipation under either
`party’s construction of the preamble
`Regardless of how the preamble is construed—requiring reduction in eye
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`redness or requiring merely the hope or intent to reduce eye redness—Petitioner has
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`not, and cannot, prove inherency for multiple discrete reasons.
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`First, Petitioner cannot show that patients after radial keratotomy surgery (the
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`patient population in Example 1) would necessarily have eye redness, and as such
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`the hypothetical patients may not have any redness to reduce. The testimony from
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`Dr. Noecker, an ophthalmologist with nearly 30 years of experience who has
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`performed numerous radial keratotomy procedures, supports such a conclusion.
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`Indeed, Dr. Noecker testified that it is possible to perform radial keratotomy on
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`patients without causing eye redness because the procedure involves creating precise
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`microscopic incisions in the cornea, which, importantly, does not contain any blood
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`vessels. EX-2020, ¶¶104-105, 149; EX-1053 at 95:1-3. Dr. Sher, Petitioner’s expert,
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`confirmed as much. EX-2162 at 113:12-17. Relying solely on the possibility that
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`radial keratotomy patients may have eye redness, Petitioner cannot carry the heavy
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`burden of proving inherent anticipation—indeed, if the prior art can be practiced in
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`a way that yields a result lacking the allegedly inherent property, the prior art in
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`question does not inherently anticipate. See Glaxo Inc. v. Novopharm Ltd., 52 F.3d
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`1043, 1047-48 (Fed. Cir. 1995) (affirming the district court’s finding of no inherency
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`where practicing the prior art resulted in the claimed invention thirteen times but did
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`not result in the claimed invention twice); see also Bettcher Indus., Inc. v. Bunzl
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`USA, Inc., 661 F.3d 629, 639 (Fed. Cir. 2011) (“Inherency, however, may not be
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`established by probabilities or possibilities. The mere fact that a certain thing may
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`result from a given set of circumstances is not sufficient.”) (citation omitted).
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`Stated another way, although following Example 1 of the ’553 patent may
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`result in redness in some patients, it would not result in redness in all patients
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`because, as Dr. Sher admitted, the patients either had a successful surgery or other
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`eyedrop medicines that impact redness development were co-administered. EX-
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`2213 at 18:10-21:8. Courts have consistently found no inherent anticipation where,
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`as here, a POSA practicing the prior art would have undisclosed but reasonable
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`choices available, which could lead to an outcome different from what is claimed.
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`See Galderma Lab’ys, L.P. v. Teva Pharms. USA, Inc., 799 F. App’x 838, 846 (Fed.
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`Cir. 2020) (finding the prior art did not inevitably achieve the claimed efficacy
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`limitations where permissible variations in the parameters of the prior art
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`formulation could undoubtedly affect the results achieved from its use); Kowa Co.
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`v. Amneal Pharms., LLC, Civ. A. No. 14-CV-2758 (PAC), 2017 WL 10667089, at
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`*21 (S.D.N.Y. Sept. 19, 2017) (finding no inherent anticipation where “several
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`reasonable selections were available to one of skill in the art and that even slight
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`differences in procedure may lead to differences in the form of [pitavastatin calcium]
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`produced.”) (quoting In re Armodafinil Pat. Litig. Inc., 939 F. Supp. 2d 456, 486 (D.
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`Del. 2013)); see also Glaxo, 52 F.3d at 1048, n.4 (affirming the conclusion of no
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`inherent anticipation and finding the experiments Plaintiff’s expert performed was
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`consistent with how a POSA would understand the prior art example even though it
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`“sometimes departed from the strict letter of Example 23”); In re Depomed Pat.
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`Litig., No. CV 13-4507 (CCC-MF), 2016 WL 7163647, at *48-49 (D.N.J. Sept. 30,
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`2016), aff'd sub nom. Grunenthal GMBH v. Alkem Lab'ys Ltd., 919 F.3d 1333 (Fed.
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`Cir. 2019) (finding Plaintiff’s expert made permissible choices not disclosed in the
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`prior art in faithfully reproducing the prior art and establishing it did not inevitably
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`produce the claimed product).
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`As such—even setting aside the fact that Example 1 violates the “consisting
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`essentially of” element (see § III, infra)—administration of 0.03% brimonidine as
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`contemplated by Example 1 of the ’553 patent cannot, as a matter of law, establish
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`inherency where some patients would not have had any redness to reduce. See
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`Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1376-79 (Fed. Cir. 2005) (if
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`providing the claimed treatment may have different results based upon the specific
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`patient (with or without sunburn) treated, the results are not inherent); see also
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`Apotex Inc. v. Regeneron Pharms., Inc., IPR2022-01524, Paper 9 at 33-34 (P.T.A.B.
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`Mar. 10, 2023) (denying institution where “the evidence shows that the claimed
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`results limitations may typically flow from the claimed method, but not necessarily”
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`and explaining the importance of the patient population).
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`Second, even if the preamble were construed as Petitioner suggests, i.e.,
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`requiring merely an intent to reduce a patient’s eye redness regardless of whether
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`redness reduction is achieved, Petitioner cannot prove that Example 1 inherently
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`anticipates where it discloses an express intent to alleviate ocular pain, not redness.
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`The only evidence regarding the state of mind of someone practicing Example 1 is
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`the expressly stated intent to reduce ocular pain. EX-1004 at 4:46-48, 5:1-2. In fact,
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`Petitioner’s proposed construction is directly at odds with its reliance on
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`inherency—one cannot necessarily and inevitably have a subjective, undisclosed
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`intent to reduce redness where, as here, an intent is expressly stated—alleviating
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`ocular pain. See Bettcher, 661 F.3d at 639. Not only is this illogical, but it
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`contravenes the meaning of the word “intent,” which requires a state of mind or
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`purpose. Akin to the maxim that which is inherent is unknown, and obviousness
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`cannot be predicated on what is unknown, here, by analogy, that which is inherent
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`is unknown, and one cannot intend what is unknown.
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`Third, Example 1, which discloses 0.03% brimonidine, cannot inherently
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`anticipate claim 2 of the ’742 patent, which recites “about 0.025%.” As fully briefed
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`in Patent Owner’s papers filed in this proceeding, “about 0.025%” does not
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`encompass 0.03%. See Paper 30, 27-39; Paper 59, 3-7. If Patent Owner’s claim
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`construction is accepted as to “about 0.025%,” Petitioner’s anticipation argument as
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`to claim 2 fails for that reason alone.
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`Finally, even if the Board determines that inherency can be established where
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`only a sub-set of patients may have eye redness, Petitioner cannot meet the
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`“consisting essentially of” element, as discussed below.
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`III. Question 2: What impact does the transitional phrase “consisting
`essentially of” have on the claims? Is there a temporal aspect to the term
`(e.g., for drugs that are administered before or after brimonidine, but not
`together)? Is there an intent aspect to the term (e.g., for drugs that are
`administered for a different purpose)?
` The transitional phrase “consisting essentially of” impacts
`the steps and drugs that can be used in the claimed methods
`for reducing eye redness
`The transitional phrase “consisting essentially of” limits the scope of a claim
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`to the ingredients listed in the claim and “unlisted ingredients that do not materially
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`affect the basic and novel properties of the invention.” PPG Indus. v. Guardian
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`Indus. Corp., 156 F.3d 1351, 1354 (Fed. Cir. 1998). For a method claim, it excludes
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`steps that materially affect the basic and novel characteristics of the claimed
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`invention. See id.
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`As stated during the prosecution of the ’742 patent, one of the basic and novel
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`characteristics of the claimed methods is administering brimonidine at the claimed
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`concentrations as the sole drug. EX-1024 at 115. Thus, the transitional phrase in the
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`claimed methods excludes any steps involving administration of drugs other than
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`brimonidine to patients with eye redness (hyperemia). For example, administration
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`of both low-dose brimonidine and an anti-inflammatory agent drop, such as a steroid
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`or NSAID, violates the transitional phrase. EX-2213 at 18:23-19:25. Similarly,
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`administration of both low-dose brimonidine and an antibiotic drop violates the
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`transitional phrase. Id. at 20:3-21:8.
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`Specifically, during the prosecution of the ’742 patent, the patentee replaced
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`the broader transitional term “comprising” with “consisting essentially of” to avoid
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`a prior art reference cited by the examiner, Dean, EX-1007. The Dean reference is
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`directed to administering low-dose brimonidine with another active ingredient,
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`brinzolamide, in a single composition or separate compositions administered
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`together or sequentially, to treat ocular diseases associated with compromised blood
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`flow. EX-1007 at 2:22-29, 2:51-57, claim 2. As the patentee argued during
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`prosecution, Dean teaches only that brinzolamide lowers intraocular pressure and
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`actually increases blood flow in ocular tissue—inconsistent with a vasoconstrictive
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`effect. EX-1024 at 115-116; EX-1007 at 3:29-34.
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`To overcome the examiner’s argument that Dean discloses low-dose
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`brimonidine, the patentee amended the claims, changing the transitional phrase from
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`“comprising” to “consisting essentially of” (EX-1024 at 111) and explained that
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`“methods consisting essentially of administering brimonidine” are “methods which
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`do not include administering other active agents.” Id. at 124, 116-117, 120.
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`Distinguishing Dean, the patentee argued that Dean fails to teach or suggest the use
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`of brimonidine as the only active ingredient (id.), but instead teaches the opposite,
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`i.e., that “the administration of brimonidine alone is not sufficient to treat an ocular
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`condition.” Id. at 116. Thus, the ’742 patented methods for reducing redness, by
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`virtue of the transitional phase “consisting essentially of” that was inserted to
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`overcome Dean, do not cover a method where brimonidine is administered with
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`other drugs as part of a dosing protocol, whether concurrently or sequentially.
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`As to the temporal and intent questions, Patent Owner notes that no expert in
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`this case specifically addressed either question, thus making the record somewhat
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`incomplete. Indeed, this phrase was not identified as a phrase needing construction
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`because both parties understood it was being used consistent with ordinary tenets of
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`patent law.
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`Regardless of timing and intent, if another medicated eye drop is dosed with
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`brimonidine to a patient with eye redness (hyperemia), that would violate the
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`“consisting essentially of” transitional phrase in the claimed methods. Most relevant
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`to this case, because Example 1 of the ’553 patent relates to a radial keratotomy
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`procedure involving a protocol in which 0.03% brimonidine would be ocularly
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`administered with
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`other
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`drugs—preoperatively,
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`intraoperatively,
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`or
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`postoperatively—it runs afoul of the “consisting essentially of” transitional phrase
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`in the claimed methods. This is so regardless of whether the medicated eyedrops
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`were specifically administered to “reduce redness” when used in their window of
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`effectiveness. See EX-1024 at 115-118.
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`Petitioner has not met its burden with respect to the
`“consisting essentially of” transitional phrase
`Separate and apart from all of the reasons Petitioner’s arguments have failed
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`as discussed in Section II.B above and in detail in Patent Owner’s papers,
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`Petitioner’s arguments have significant failures with respect to the “consisting
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`essentially of” claim element, as evidenced by its arguments with respect to Example
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`1 of the ’553 patent.
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`Indeed, while Slayback initially took the position that “no other drugs,
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`compositions, or steps are identified for reducing eye redness” in Example 1 of the
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`’553 patent, (see, e.g., Petition at 50), testimony from Petitioner’s expert Dr. Sher
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`confirms that Example 1 fails to meet the “consisting essentially of” element. Dr.
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`Sher’s testimony confirmed that a POSA would have understood that Example 1 of
`
`the ’553 patent was incomplete as written and that there were gaps to fill, if he were
`
`to practice the prior art example. Specifically, Dr. Sher revealed at his deposition
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`13
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`Case IPR2022-00142
`Patent Owner’s Opening Brief Addressing the Board’s Questions
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`that a POSA reading Example 1 would have immediately recognized that it would
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`be malpractice, and contrary to best practices, to perform radial keratotomy without
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`ocularly administering other drugs. EX-2213 at 22:24-23:13.
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`In this regard, Dr. Sher admitted that the other drugs typically administered to
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`patients as part of the eye drop dosing protocol in radial keratotomy procedures
`
`include anesthetics, as well as drugs that can impact the development and reduction
`
`of redness, such as anti-inflammatory agents (e.g., steroids and NSAIDs) and
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`antibiotics. EX-2213 at 18:10-22 (NSAIDs, including diclofenac and ketorolac, are
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`administered pre- and post-operatively), 18:23-19:25 (steroids can be used pre- and
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`post-operatively to reduce inflammation and redness), 20:3-21:8 (antibiotics can be
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`used pre- and post-operatively), 22:24-23:13 (anesthetics are used pre-operatively)
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`41:17-42:4 (admitting that prophylactic administration of antibiotics could prevent
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`redness associated with infections).
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`Thus, despite the lack of explicit “identification” of other drugs, compositions,
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`or steps in Example 1 of the ’553 patent (see Petition at 34), a POSA would have
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`recognized that they would have been present if a POSA were to practice the
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`example.
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`Petitioner’s own prior art references further confirm this. Norden (EX-1006)
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`and Aslanides 2006 (EX-1103), which are directed to LASIK—a procedure which
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`Petitioner went through great lengths to argue is a similar corneal refractive surgery
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`Case IPR2022-00142
`Patent Owner’s Opening Brief Addressing the Board’s Questions
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`that replaced radial keratotomy—confirms the same eye drop dosing protocol.
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`Norden discloses administering diclofenac (NSAID) pre-operatively and ofloxacin
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`(antibiotic) pre- and post-operatively. EX-1006 at 4-5. Aslanides 2006 discloses
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`intra-operative administration of prednisolone acetate (a steroid), and post-operative
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`administration of sodium flurbiprofen (NSAID) and tobramycin (antibiotic). EX-
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`1103 at 2.
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`Thus, focusing on the “consisting essentially of” element, Example 1 of the
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`’553 patent fails to anticipate because other drugs would have been dosed with
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`0.03% brimonidine, and some would have affected redness development, as Dr. Sher
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`admitted. This means that Example 1 does not teach or even suggest administering
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`brimonidine alone to a patient with eye redness. It also means that Example 1 not
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`only could but likely would be practiced in a way that yields a result lacking the
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`“consisting essentially of’ element, thereby destroying Petitioner’s anticipation
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`position. See Glaxo, 52 F.3d at 1047-48; Bettcher, 661 F.3d at 639; Perricone, 432
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`F.3d at 1376-79.
`
`Date: March 20, 2023
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`Respectfully submitted,
`
`
`
`
`
`
`
`/Bryan C. Diner/
`By:
`Bryan C. Diner, Reg. No. 32,409
`Justin J. Hasford, Reg. No. 62,180
`Caitlin E. O’Connell, Reg. No. 73,934
`Christina Ji-Hye Yang, Reg. No. 79,103
`
`
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`Case IPR2022-00142
`Patent Owner’s Opening Brief Addressing the Board’s Questions
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`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Patent Owner’s
`
`
`
`Opening Brief Addressing the Board’s Questions was served electronically via
`
`email on March 20, 2023, in its entirety on the following:
`
`Linnea P. Cipriano
`Goodwin Proctor LLP
`620 Eight Avenue
`New York, NY 10018
`lcipriano@goodwinlaw.com
`
`Louis H. Weinstein
`Patrick G. Pollard
`Windels Marx Lane & Mittendorf, LLC
`1 Giralda Farms
`Madison, NJ 07940
`lweinstein@windelsmarx.com
`ppollard@windelsmarx.com
`
`Robert Frederickson III
`Goodwin Proctor LLP
`100 Northern Avenue
`Boston, MA 02210
`rfrederickson@goodwinlaw.com
`
`Petitioner has consented to service by electronic mail.
`
`
`
`
`
`
`
`
`
`/Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER LLP
`
`Dated: March 20, 2023
`
`
`
`
`
`
`
`
`
`
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