`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SLA YBACK PHARMA LLC,
`
`Petitioner,
`
`V.
`
`EYE THERAPIES, LLC,
`
`Patent Owner.
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`
`
`
`PATENT OWNER'S NOTICE OF APPEAL
`
`• I
`
`
`
`Case No. IPR2022-00142
`
`Pursuant to 35 U.S.C. §§ 141(c) and 319 and 37 C.F.R. § 90.2(a), Patent
`
`Owner Eye Therapies LLC ("Eye Therapies") hereby provides notice that it appeals
`
`to the United States Court of Appeals for the Federal Circuit from the Final Written
`
`Decision in Inter Partes Review IPR2022-00142, entered on May 15, 2023, (Paper
`
`77 (Ex. A)), and from all underlying orders, decisions, rulings, and opinions relating
`
`to U.S. Patent No. 8,293,742 ("the '742 patent") set forth in Inter Partes Review
`
`IPR2022-00142.
`
`In accordance with 37 C.F.R. § 90.2(a)(3)(ii), the issues on appeal include,
`
`but are not limited to, whether the Patent Trial and Appeal Board of the United States
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`Patent and Trademark Office ("the Board") erred in determining that claims 1-6 of
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`the '742 patent are unpatentable under 35 U.S.C. § 103, including, without
`
`limitation:
`
`•
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`the Board's determination that claims 1-6 of the '742 patent would have
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`been obvious under 35 U.S.C. § 103 over the instituted ground III (the
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`2
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`
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`combination of Gil1, Norden2, Dean3, Alphagan® Label 19984 and Federal
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`Case No. IPR2022-00142
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`Register5);
`
`•
`
`•
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`the Board's construction of claim limitations set forth in claims 1-6 of the
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`'742 patent;
`
`the Board's consideration of Patent Owner's evidence, including objective
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`indicia of non-obviousness; and
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`• all other issues decided adversely to Patent Owner in any order, decision,
`
`ruling, or opinion by the Board in this proceeding.
`
`Pursuant to 35 U.S.C. § 142 and 37 C.F.R. § 90.2(a), this Notice is being filed
`
`with the Director of the United States Patent and Trademark Office, and a copy of
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`this Notice is being concurrently filed with the Board. In addition, a copy of this
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`Notice and the required docketing fees are being filed with the Clerk's Office for the
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`United States Court of Appeals for the Federal Circuit via CM/ECF.
`
`1 U.S. Patent No. 6,294,553 (EX-1004, "Gil").
`2 Norden, Richard A. "Effect of Prophylactic Brimonidine or Bleeding
`Complications and Flap Adherence after Laser in Situ Keratomileusis." Journal of
`Refractive Surgery, vol. 18, no. 4, 2002, pp. 468-471 (EX-1006, "Norden").
`3 U.S. Patent No. 6,242,442 (EX-1007, "Dean").
`4 "Alphagan® (brimonidine tartrate ophthalmic solution) 0.2%." Physicians' Desk
`Reference, 52th ed., Medical Economics Company, Inc., 1998, p. 487 (EX-1008,
`"Alphagan® Label 1998").
`5 53 Fed. Reg. 7076-7093 (Mar. 4, 1988) (EX-1009, "Federal Register").
`
`3
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`
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`Case No. IPR2022-00142
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`Dated: July 14, 2023
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`Respectfully submitted,
`
`/Bryan C. Diner/
`Bryan C. Diner, Reg. No. 32,409
`Counsel for the Patent Owner
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`4
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`
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`Case No. IPR2022-00142
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`CERTIFICATE OF SERVICE
`
`I hereby certify that on this 14th of July, 2023, a copy of this PATENT
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`OWNER'S NOTICE OF APPEAL was filed and served via the Board's P-TACT
`
`system, and a copy was also filed by hand with the Director of the United States
`
`Patent and Trademark Office, at the following address:
`
`Director of the United States Patent and
`Trademark Office
`c/o Office of the General Counsel, 10B20
`Madison Building East
`600 Dulany Street
`Alexandria, VA 22314
`
`I also hereby certify that on this 14th of July, 2023, a copy of this PATENT
`
`OWNER'S NOTICE OF APPEAL and the filing fee, were filed with the Clerk's
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`Office of the United States Court of Appeals for the Federal Circuit, via CM/ECF.
`
`I also hereby certify that on this 14th of July, 2023, a true and correct copy of
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`this PATENT OWNER'S NOTICE OF APPEAL was served via email on counsel
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`of record for the Petitioner at the following:
`
`Linnea P. Cipriano
`Goodwin Proctor LLP
`620 Eight A venue
`New York, NY 10018
`lcipriano@goodwinlaw.com
`
`Louis H. Weinstein
`Patrick G. Pollard
`
`
`
`Case No. IPR2022-00142
`
`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
`
`The Petitioner has consented to service by electronic mail.
`
`Date: July 14, 2023
`
`Respectfully submitted,
`
`/Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`2
`
`
`
`EXHIBIT A
`EXHIBIT A
`
`
`
`Trials@uspto.gov
`571-272-7822
`
`Paper 77
`Date: May 15, 2023
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PA TENT TRIAL AND APPEAL BOARD
`
`SLA YBACK PHARMA LLC,
`Petitioner,
`
`V.
`
`EYE THERAPIES, LLC,
`Patent Owner.
`
`IPR2022-00142
`Patent 8,293,742 B2
`
`Before TINA E. HULSE, ROBERT A. POLLOCK, and RYAN H. FLAX,
`Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 US.C. § 318(a)
`
`
`
`IPR2022-00142
`Patent 8,293,742 B2
`
`INTRODUCTION
`I.
`Slayback Pharma, LLC ("Petitioner") filed a Petition requesting inter
`partes review of claims 1-6 of U.S. Patent No. 8,293,742 B2 (Ex. 1001,
`"the '742 patent"), owned by Eye Therapies, LLC ("Patent Owner").
`Paper 2 ("Pet."). Upon considering the Petition, Preliminary Response
`(Paper 7), Petitioner's Reply to Patent Owner's Preliminary Response
`(Paper 10), and Patent Owner's Sur-Reply (Paper 12), on May 18, 2022, we
`instituted an inter partes review of the challenged claims of the '742 patent.
`Paper 13 ("Dec. Inst." or "Institution Decision").
`Patent Owner then filed a Response to the Petition (Paper 30,
`"PO Resp."), Petitioner filed a Reply (Paper 43, "Pet. Reply"), and Patent
`Owner filed a Sur-reply (Paper 59, "PO Sur-reply").
`Petitioner also filed a Motion to Exclude Evidence (Paper 57), to
`which Patent Owner filed an Opposition (Paper 62), and Petitioner filed a
`Reply (Paper 64).
`An oral hearing was held on February 27, 2023. A portion of the
`hearing was closed so the parties could discuss confidential information filed
`under seal. A transcript of the public portion of the hearing has been entered
`in the record. Paper 75. A transcript of the closed portion of the hearing has
`been entered separately. Paper 74.
`After the hearing, the Board requested supplemental briefing on two
`issues: (1) whether the preamble of the claims should be construed as limited
`to a statement of the intentional purpose for which the method must be
`performed and, if so, what impact that construction has on inherent
`anticipation; and (2) what impact the transitional phrase "consisting
`essentially of' has on the claims and whether there is a temporal and intent
`aspect to the term. See Paper 69. Both parties submitted opening briefs
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`2
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`IPR2022-00142
`Patent 8,293,742 B2
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`(Paper 70, "PO Supp. Br."; Paper 71, "Pet. Supp. Br.") and both parties
`submitted simultaneous responses to those briefs (Paper 73, "Pet. Reply
`Supp.- Br."; Paper 72, "PO Reply Supp. Br.").
`We have authority under 35 U.S.C. § 6. We issue this Final Written
`Decision under 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons
`that follow, we determine Petitioner has shown by a preponderance of the
`evidence that claims 1--6 of the '742 patent are unpatentable.
`A. Real Parties-in-Interest
`Petitioner identifies itself, Slayback Pharma India LLP, Dr. Reddy's
`Laboratories S.A., and Dr. Reddy's Laboratories, Inc. as the real parties-in
`interest. Paper 24, 1. Patent Owner identifies itself, Bausch & Lomb, Inc.,
`and Bausch & Lomb Ireland Limited as the real parties-in-interest. Paper 4,
`2.
`
`B. Related Proceedings
`Petitioner states that the '742 patent has been asserted in the following
`cases: Bausch & Lomb, Inc. v. Slayback Pharma LLC, 3:21-cv-16766
`(D.N.J.); Bausch & Lomb, Inc. v. Lupin Ltd., 3:22-cv-00534 (D.N.J.).
`Paper 24, 1. Patent Owner states that the '742 patent has also been asserted
`in Bausch & Lomb, Inc. v. Harrow Health, Inc., 3:21-cv-19252 (D.N.J.).
`Paper 4, 2.
`
`C. The '742 Patent
`The '742 patent is entitled "Preferential Vasoconstriction
`Compositions and Methods of Use." Ex. 1001, code (54). The '742 patent
`application was filed on July 27, 2009, and claims priority to a series of
`provisional applications, the earliest of which was filed on August 1, 2008.
`Id., codes (22), 60). Thus, the earliest possible effective filing date of the
`'742 patent claims is August 1, 2008. Pet. 14.
`
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`IPR2022-00142
`Patent 8,293,742 B2
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`The '742 patent relates to compositions and methods for preferential
`vasoconstriction of smaller blood vessels relative to larger blood vessels.
`Ex. I 001, Abstract. According to the Specification, dilation of small blood
`vessels causes undesirable events, including surface hemorrhage and
`hyperemia (i.e., eye redness) following Lasik surgery, eye redness, and nasal
`congestion. Id. at I :6-11.
`Adrenergic receptors, which are divided into a-1 ( or a-1 or alpha-I),
`a-2, and �-adrenergic receptor types, are involved in a variety of
`physiological functions, including functions of the cardiovascular and
`central nervous systems. Id. at 1:12-19. Agonists of a-2 adrenergic
`receptors are used in the treatment of hypertension, glaucoma, spasticity, and
`cancer pain. Id. at I :25-29. Brimonidine is an example of a known
`compound having selective a-2 agonist activity. Id. at I :48--49. According
`to the Specification, "[i]t is a known property of all a[lpha] adrenergic
`receptor agonists, including brimonidine, to cause vasoconstriction." Id. at
`I :61---63. The Specification notes, however, that "known formulations of
`brimonidine and other known a-2 adrenergic receptor agonists are associated
`with a high incidence of rebound hyperemia, 1 or other side effects, in
`clinical use." Id. at I :63---66.
`Moreover, the Specification states that commercially available general
`alpha agonists for topical ophthalmic use have high alpha- I receptor agonist
`activity and are known to cause rebound hyperemia and medicamentosa (i.e.,
`a potentially prolonged inflammatory state that can last for several weeks or
`
`1 The '742 patent states that "[r]ebound hyperemia refers to induced
`vasodilation (instead of intended vasoconstriction) occurring, often with a
`lag time, after an application or, more typically, repeated applications of
`vasoconstrictors." Ex. 1001, 4:30-34.
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`4
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`IPR2022-00142
`Patent 8,293,742 B2
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`months even after stopping the medication). Id at 2:8-13, 26-28. Thus,
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`clinical use of such a-1 receptor agonists are typically limited to several
`
`hours or days, even though users with more chronic conditions, like dry eye
`
`and allergic conjunctivitis, may require longer-term use. Id at 2:14-21.
`
`-
`
`The Specification explains that "there is a need for new methods and
`
`formulations that would provide safe and long term vasoconstriction with
`
`reduced or minimized side effects, such as rebound hyperemia." Id at 2:30-
`
`33.
`
`Accordingly, the Specification states that "[o]ne of the key discoveries
`
`of the present invention lies in using low doses of highly selective a-2
`
`adrenergic receptor agonists to achieve vasoconstriction with significantly
`
`reduced hyperemia." Id at 2: 3 8-41.
`
`D. Illustrative Claim
`
`Petitioner challenges claims 1-6 of the '742 patent. Claims 1 and 3
`
`are the only independent claims and are reproduced below.
`
`1. A method for reducing eye redness consisting essentially
`of administering brimonidine to a patient having an ocular
`condition, wherein brimonidine is present at a concentration
`between about 0.001 % weight by volume and about 0.05%
`weight by volume.
`
`3. A method for reducing eye redness consisting essentially
`of topically administering to a patient having an ocular
`condition a composition consisting essentially of brimonidine
`into ocular tissue, wherein pH of said composition is between
`about 5.5 and about 6.5, wherein said brimonidine
`concentration is between about 0.001 % and about 0.025%
`. weight by volume and wherein said composition is formulated
`as an ocular drop.
`
`Ex. 1001, 22:17-22, 26-32.
`
`5
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`IPR2022-00142
`Patent 8,293,742 B2
`
`Claim 2 depends from claim 1 and further recites a concentration of
`brimonidine "between about 0.001 % to about 0.025% weight by volume."
`Id. at 22:23-25. Claim 4 depends from claim 3 and further recites topically
`administering the composition "within about 24 hours after a Lasik surgery
`on said patient." Id. at 22:33-35. And claims 5 and 6 depend from claims 1
`and 3, respectively, and further recite that the ocular condition is "chronic
`red eye." Id. at 22:36-39.
`E. The Asserted Grounds of Unpatentability
`Petitioner asserts that claims 1-6 of the '742 patent are unpatentable
`on the following grounds:
`Claim(s) Challen2ed
`1 -2
`1 -2
`1-6
`
`
`Reference(s )/Basis
`Gil3
`102
`Walters4
`102
`Gil, Norden 5, Dean 6,
`103
`Alphagan7, and Federal
`Register8
`
`35 u.s.c. §2
`
`2 Because the claims at issue have an effective filing date before March 16,
`2013, the effective date of the applicable provisions of the Leahy Smith
`America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) ("AIA"), we
`apply the pre-AIA versions of 35 U.S.C. §§ 102 and 103(a) in this Decision.
`3 Gil et al., US 6,294,553 Bl, issued Sept. 25, 2001 (Ex. 1004, "Gil").
`4 Walters et al., A Pilot Study of the Efficacy and Safety of AGN 190342-LF
`0. 02% and 0. 08% in Patients with Elevated lntraocular Pressure, 32 Assoc.
`RES. VISION & OPHTHALM0L. 988 (1991) (Ex. 1005, "Walters").
`5 R.A. Norden, Effect of Prophylactic Brimonidine or Bleeding
`Complications and Flap Adherence after Laser in Situ Keratomileusis. 18 J.
`REFRACTIVE SURG. 468-71 (2002) (Ex. 1006, "Norden").
`6 Dean et al., US 6,242,442 Bl, issued June 5, 2001 (Ex. 1007, "Dean").
`7 ALP HAGAN® (brimonidine tartrate ophthalmic solution) 0.2%.
`Physicians' Desk Reference, 52th ed., Medical Economics Company, Inc.,
`487 (1998) (Ex. 1008, "Alphagan").
`8 53 Fed. Reg. 7076-7093 (Mar. 4, 1988) (Ex. 1009, "Federal Register").
`
`6
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`IPR2022-00142
`Patent 8,293,742 B2
`
`Petitioner relies upon the Declarations of Neal A. Sher, M.D., FACS
`(Exs. 1002 and 1049), Paul A. Laskar, Ph.D. (Exs. 1003 and 1048), and Ivan
`T. Hofmann (Ex. 1047). Patent Owner relies on the Declarations of Robert
`J. Noecker, MD, MBA (Ex. 2020), Robert 0. Williams, III, Ph.D.
`(Ex. 2021), Stephen G. Davies, D. Phil. (Ex. 2022), John Ferris (Ex. 2023),
`and John C. Jarosz (Ex. 2024).
`II. ANALYSIS
`Petitioner bears the burden of proving unpatentability of the
`challenged claims, and that burden of persuasion never shifts to Patent
`Owner. Dynamic Drinkware, LLC v. Nat'! Graphics, Inc.; 800 F.3d 1375,
`1378 (Fed. Cir. 2015). To prevail, Petitioner must prove unpatentability by
`a preponderance of the evidence.9 See 35 U.S.C. § 316(e); 37 C.F.R.
`§ 42.l(d) (2019).
`
`A. Person of Ordinary Skill in the Art
`In determining the level of ordinary skill in the art, we consider the
`type of problems encountered in the art, the prior art solutions to those
`problems, the rapidity with which innovations are made, the sophistication
`of the technology, and the educational level of active workers in the field.
`Custom Accessories, Inc. v. Jeffrey-Allan Indus. , Inc., 807 F.2d 955, 962
`(Fed. Cir. 1986).
`Petitioner contends that a person of ordinary skill in the art ("POSA")
`would have been a composite person (or team) that included a medical
`doctor and a pharmaceutical formulator. Pet. 15 (citing Ex. 1002, 26;
`Ex. 1003 , 29). Petitioner asserts that the medical doctor would have been
`
`9 Although we find certain of Patent Owner's arguments not persuasive, this
`should never be taken as an indication that we have assigned Patent Owner
`the burden of proof on patentability.
`
`7
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`IPR2022-00142
`Patent 8,293,742 B2
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`an ophthalmologist with at least three to four years of experience in LASIK
`surgery, clinical trials and U.S. FDA regulation of eye products, and had
`experience in the use of topical brimonidine and apraclonidine and topical
`vasoconstrictors such as naphazoline and tetrahydrozoline. Id. ( citing
`Ex. 1002 , 26). Petitioner contends that the pharmaceutical formulator
`would have had a doctoral degree in pharmaceutics, or a related degree, and
`at least three to five years of experience developing eye drop formulations
`for clinical trial and regulatory approval. Id. (citing Ex. 1003, 29).
`In our Institution Decision, we noted that Patent Owner did not
`contest Petitioner's definition and adopted Petitioner's definition as
`reasonable. Dec. Inst. 14. In its Response, Patent Owner states that a POSA
`"may be represented by a team of individuals with experience and various
`skills relating to eye care, including, inter alia, the medical and
`pharmaceutical arts." PO Resp. 7. Patent Owner further asserts that a
`POSA would have had access to team members with experience in
`chemistry, designing and formulating ophthalmic formulations, and/or in
`administering such formulations to treat ocular conditions obtained by some
`combination of education and work experience. Id. at 7-8 ( citing Ex. 2020
`, 29; Ex. 2021, 33; Ex. 2022, 19). Patent Owner notes that Petitioner's
`definition of a formulator POSA goes beyond the level of a person of
`ordinary skill, and that a formulator POSA would have had a Bachelor's
`degree in pharmaceutics or a related discipline with about three to five years
`of work experience in this area, or a comparable level of education and
`training, such as a Ph.D. with one or two years of experience in this area. Id.
`at 8 (citing Ex. 2020, 28; Ex. 2021 , 32).
`Although the parties disagree as to the specific qualifications of a
`person of ordinary skill in the art, the parties' experts agree that their
`
`8
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`Patent 8,293,742 B2
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`opinions would not change regardless of which definition is applied. See
`Ex. 1049, 6 (Sher); Ex. 2020, 28 (Noecker); Ex. 2021, 34 (Williams);
`Ex. 2022 , 23 (Davies).
`Both parties' proposed definitions and the prior art of record indicate
`a high level of skill in the relevant art. Because the parties' respective
`experts agree that any dispute as to the level of ordinary skill in the art is not
`material to their opinions, we adopt Patent Owner's definition as consistent
`with the prior art's demonstration of the level of ordinary skill in the art at
`the time of the invention. See Ex. 2020 ,, 28-31; see also Okajima v.
`Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific
`findings regarding ordinary skill level are not required ''where the prior art
`itself reflects an appropriate level and a need for testimony is not shown"
`(quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,
`163 (Fed. Cir. 1985))).
`
`B. Claim Construction
`In an inter partes review, the Board applies the same claim
`construction standard that would be used to construe the claim in a civil
`action under 35 U.S.C. § 282(b). 37 C.F.R. § l00(b) (2021). Under that
`standard, claim terms "are generally given their ordinary and customary
`meaning" as understood by a person of ordinary skill in the art at the time of
`the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir.
`2005) (en bane). "In determining the meaning of the disputed claim
`limitation, we look principally to the intrinsic evidence of record, examining
`the claim language itself, the written description, and the prosecution
`history, if in evidence." DePuy Spine, Inc. v. Medtronic Sofamor Danek,
`Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips, 415 F.3d at
`1312-17). Extrinsic evidence is "less significant than the intrinsic record in
`
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`determining 'the legally operative meaning of claim language."' Phillips,
`415 F.3d at 1317.
`
`1.
`Preamble
`The claims of the '742 patent each recite as their preamble "[a]
`method for reducing eye redness." Ex. 1001, 22:17-39. Both parties agree
`that the preamble of the claims is limiting. PO Supp. Br. 3-6; Pet. Supp.
`Br. 2-3. The parties disagree, however, on what the preamble means.
`Petitioner asserts that the preamble "limits only [sic] the claims to the
`condition to be treated-eye redness." Pet. Supp. Br. 3. Moreover,
`Petitioner asserts that there is no efficacy requirement in the claims, and, at
`most, the claims require that the composition be administered "with the
`intent to reduce redness." Pet. Reply 7-8.
`Patent Owner disagrees, asserting that the preamble requires actual
`reduction in a patient's ocular hyperemia. PO Supp. Br. 3.
`As an initial matter, we agree with the parties that the preamble of the
`claims is limiting. "Whether to treat a preamble as a claim limitation is
`determined on the facts of each case in light of the claim as a whole and the
`invention described in the patent." Storage Tech. Corp. v. Cisco Sys., Inc.,
`329 F.3d 823, 831 (Fed. Cir. 2003). The Federal Circuit "has not hesitated
`to hold preambles limiting when they state an intended purpose for methods
`of using a compound." Eli Lilly & Co. v. Teva Pharms. Int '/ GmbH, 8 F.4th
`1331, 1342 (Fed. Cir. 2021). And where, as here, the claims are directed to
`methods of using a composition for a specific purpose (i.e., reducing eye
`redness), and the method comprises a single step of administering that
`composition, the Federal Circuit "has generally construed statements of
`intended purpose in such method claims as limiting." Id at 1340.
`
`10
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`IPR2022-00142
`Patent 8,293,742 B2
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`As for whether the preamble requires actual reduction in redness, we
`agree with Petitioner that it does not and find Eli Lilly to be instructive. In
`Eli Lilly, the preambles of the claims recite a "method for reducing incidence
`of or treating at least one vasomotor symptom in an individual" and a
`"method for treating headache in an individual." 8 F.4th at 1335. There, the
`Federal Circuit held that the preambles "are not merely statements of effect
`but rather statements of the intentional purpose for which the methods must
`be performed." Id. at 1342. Thus, the Federal Circuit did not require proof
`of actual clinical results from performing the claimed method, even though
`the claims also recited an "effective amount." Id. The Federal Circuit held
`that because the specification defined an "effective amount" as an "an
`amount sufficient to effect beneficial or desired results" and provided
`examples of such results in the context of prophylactic or therapeutic uses,
`the claims "encompass a clinical result, [but] they do not require such a
`result." Id.
`Here, similarly, the '742 patent claims simply recite administering the
`brimonidine composition ( at a concentration range) and do not recite any
`efficacy requirement, nor even the "effective amount" of note in the Eli Lilly
`claims. But, like Lilly and as explained below, the "ocular conditions" of the
`claims encompass prophylactic reduction of hemorrhage and hyperemia in
`addition to therapeutic uses. See Ex. 1001, 12:13-19. We, therefore, find
`the claims here do not require actual redness reduction and, thus, no clinical
`result is required to satisfy the claimed method.
`Thus, having considered the arguments and evidence presented at
`trial, we determine that the preamble of the claims is limiting and requires
`that the claimed brimonidine composition be administered with the
`
`1 1
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`Patent 8,293,742 B2
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`intentional purpose of reducing eye redness, whether or not eye redness is
`actually reduced.
`
`"consisting essentially of'
`2.
`Independent claims 1 and 3 recite the transition phrase "consisting
`essentially of." Ex. 1001, 22: 17-1 8, 25-26. That transition phrase has a
`distinct meaning in patent law and serves as a middle ground between
`closed-ended claims that use the phrase "consisting of' and open-ended
`claims that use the phrase "comprising." AK Steel Corp. v. Sollac & Ugine,
`344 F.3d 1 234, 1239 (Fed. Cir. 2003). As such, the use of "consisting
`essentially of' "signals that the invention necessarily includes the listed
`ingredients [but] is open to unlisted ingredients that do not materially affect
`the basic and novel properties of the invention." PPG Indus. v. Guardian
`Indus. Corp., 156 F.3d 1351, 1354 (Fed. Cir. 1998). The Federal Circuit has
`instructed that determining the bounds of the basic and novel properties of
`an invention is a claim construction issue. HZNP Meds. LLC v. Actavis
`Labs. UT, Inc., 940 F.3d 680, 694-95 (Fed. Cir. 2019).
`Petitioner asserts that the allegedly novel aspect of the claimed
`invention is brimonidine's ability to reduce eye redness at low doses, but
`does not exclude administration of other drugs. Pet. Supp. Br. 9-10 ( citing
`Ex. 1001, 2:38-4 1 (stating "[o]ne of the key discoveries of the present
`invention lies in using low doses of [brimonidine] to achieve
`vasoconstriction with significantly reduced hyperemia")). Patent Owner, on
`the other hand, argues that one of the basic and novel characteristics of the
`claimed methods is "administering brimonidine at the claimed
`concentrations as the sole drug." PO Supp. Br. 1 1 ( citing Ex. 1024, 1 15).
`Thus, the parties dispute whether the scope of the claims includes the use of
`additional drugs along with low-dose brimonidine.
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`Petitioner notes that the Specification states that "[o]ne of the key
`discoveries of the present invention lies in using low doses of [brimonidine]
`to achieve vasoconstriction with significantly reduced hyperemia." Pet.
`Supp. Br. 10 (quoting Ex. 1001, 2:38-41). Petitioner also notes that the
`Specification does not exclude administration of other drugs with
`brimonidine, as evidenced by an entire section titled "Combination
`Treatments." Id. (citing Ex. 1001, 15:35-16:43). Thus, in one embodiment,
`the Specification teaches a composition comprising a selective a-2
`adrenergic receptor agonist and a histamine antagonist. Id. ( citing Ex. 1001,
`16:2-10).
`Patent Owner, on the other hand, relies heavily on the prosecution
`history of the '742 patent. During prosecution, the claims recited "[a]
`method for inducing preferential vasoconstriction of smaller blood vessels
`relative to larger blood vessels comprising" administering a selective a-2
`adrenergic receptor agonist. Ex. 1024, 111. The examiner rejected the
`claims over Dean, which teaches administering brimonidine with
`brinzolamide to treat ocular diseases associated with compromised blood
`flow. PO Supp. Br. 11 (citing Ex. 1007, 2:22-29, 2:51-57, claim 2). To
`overcome the rejection, the patentee amended the claims to change the
`transitional phrase from "comprising" to "consisting essentially of' and
`noted that in Dean, ''the administration of brimonidine alone is not sufficient
`to treat an ocular condition." Id. at 11-12 (citing Ex. 1024, 116). The
`patentee explained that the claimed methods "do not include administering
`other active agents." Id. (citing Ex. 1024, 124, 116-17, 120) (emphasis
`omitted). Patent Owner contends that the '742 patent Specification's
`teaching of embodiments that include other active drugs is not inconsistent
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`with its construction, because that is subject matter that is not claimed in the
`'742 patent. PO Reply Supp. Br. 8.
`We find Petitioner has the better position. We agree that the
`Specification sets forth the basic and novel property of the invention as a
`"key discover[y ]" in the use of "low doses of [brimonidine] to achieve
`vasoconstriction with significantly reduced hyperemia." Ex. 1001, 2 :39-41.
`During prosecution, the patentee asserted that "[ o ]ne of the basic and novel
`
`characteristics of the presently claimed methods is that they do not require
`( emphasis added) in addition to
`the use of any other active ingredients
`
`
`brimonidine." Ex. 1024, 115; see also id. at 144 ( examiner stating same in
`Reasons for Allowance). But, unlike Patent Owner, we do not read the
`prosecution history as prohibiting the use of any other active ingredients
`besides brimonidine. To do so would construe the semi-open-ended
`transition phrase "consisting essentially of' to have the same scope as the
`closed transition phrase "consisting of." AK Steel, 344 F.3d at 1239.
`Rather, under the proper scope of the claims and consistent with the
`prosecution history, the claimed methods cannot include additional active
`ingredients that are required to perform the method. Ex. 1024, 144 (stating
`in the Reasons for Allowance that the claimed methods "do not require the
`use of any other active ingredients in addition to brimonidine") ( emphasis
`omitted). As the patentee explained, "[t]he administration of brimonidine in
`the methods of Dean is a necessary but insufficient part of the taught
`methods; the other necessary part of the method is the administration of
`another active agent, i.e., brinzolamide." Id. at 117 (emphasis added). In
`other words, the scope of the claims does not include additional active
`ingredients that are necessary to achieve "vasoconstriction with significantly
`reduced hyperemia." See Ex. 1001, 2:39-41. Where brimonidine achieves
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`vasoconstriction with reduced hyperemia on its own, we find the "consisting
`essentially of' transition phrase does not preclude the use of additional
`active agents, even if those agents may also cause some degree of
`vasoconstriction.
`We find Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (Fed. Cir. 2009),
`to be instructive. There, the claims recited a method for sanitizing fowl
`using an aqueous peracetic acid (PAA) solution "which consists essentially
`of . . . peracetic acid." Id. at 1342. The patentee argued that the transition
`phrase "consists essentially of' limited the claim scope to compositions
`containing PAA as the sole antimicrobial agent. Id. at 1343. The Federal
`Circuit disagreed, noting that the specification includes examples of
`compositions that contain agents other than PAA that are considered
`antimicrobial agents, even if they were not expressly identified as such. Id.;
`see also Kim v. Earthgrains Co., No. 01 C 3895, 2010 WL 625220, at *4
`(N.D. Ill. Feb. 18, 2010) (stating Ecolab "suggests that additional active
`ingredients which improve the performance of the basic claim formula, but
`do not otherwise change its function, do not materially alter the 'basic and
`novel' characteristics of the invention"), aff'd 451 F. App'x 922 (Fed. Cir.
`2011).
`Applying Ecolab here, because the Specification states that low-dose
`brimonidine alone can significantly reduce hyperemia, if there are additional
`agents beyond low-dose brimonidine administered to a patient that may also
`reduce eye redness ( e.g., anti-inflammatory agents like steroids or pain
`medication), those additional agents would not materially affect the basic
`and novel characteristics of the invention.
`Thus, having considered the arguments and evidence presented at
`trial, we determine that the transitional phrase "consisting essentially of'
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`does not preclude the use of additional active agents that may also cause
`
`vasoconstriction and reduction of hyperemia along with low-dose
`
`brimonidine.
`
`"about 0. 025% "
`3.
`Claims 2 and 3 of the '742 patent recite brimonidine "at a
`
`concentration between about 0.001 % to about 0.025% weight by volume."
`
`Ex. 1001, 22:22-24, 29-30. Petitioner asserts that "about 0.025%" includes
`
`0.03% weight by volume (Pet. 31), whereas Patent Owner asserts that "about
`
`0.025%" means "0.025% plus or minus 10%" (PO Resp. 35). In our
`
`Institution Decision, we construed "about 0.025%" as including "0.03%."
`
`Dec. Inst. 12. Having considered the parties' respective arguments and
`
`evidence presented at trial, we maintain that Petitioner has the better
`
`position.
`
`"When 'about' is used as part of a numeric range, the use of the word
`
`'about' avoids a strict numerical boundary to the specified parameter."
`Cohesive Techs., Inc. v. Waters Corp., 543 F.3d 1351, 1368 (Fed. Cir. 2008)
`(internal quotes omitted). To interpret the range in its technologic and
`
`stylistic context, we must consider how the term is used in the patent
`specification, the prosecution history, and other claims. Central Admixture
`Pharm. Svcs., Inc. v. Advanced Cardiac Solutions, P.C. , 482 F.3d 1347,
`1355 (Fed. Cir. 2007). The range depends on what a person having ordinary
`skill in the art would reasonably consider "about" to encompass. See
`Monsanto Tech. LLC v. E.I. DuPont de Nemours