Trials@uspto.gov
`571-272-7822
`
` Paper 21
`Date: January 11, 2023
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________________________
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`________________________________________
`IPR2022-01225
`Patent 10,130,681 B2
`________________________________________
`
`Before JOHN G. NEW, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`NEW, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
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`I. INTRODUCTION
`Petitioner Mylan Pharmaceuticals Inc. (“Petitioner”) has filed a
`Petition (Paper 2, “Pet.”) seeking inter partes review of claims 1, 3–11, 13,
`14, 16–24, and 26 of US Patent 10,130,681 B2 (Ex. 1001, the “’681
`patent”). Patent Owner Regeneron Pharmaceuticals, Inc. (“Patent Owner”)
`timely filed a Preliminary Response. Paper 14 (“Prelim. Resp.”). With our
`authorization (see Paper 16 at 1), Petitioner filed a Reply to the Preliminary
`Response (Paper 16 (“Reply”)), and Patent Owner filed a Sur-Reply. Paper
`18 (“Sur-Reply”).
`Under 35 U.S.C. § 314, the Board “may not authorize an inter partes
`review to be instituted unless … the information presented in the petition
`… and any response … shows that there is a reasonable likelihood that the
`petitioner would prevail with respect to at least 1 of the claims challenged in
`the petition.” Upon consideration of the Petition, Preliminary Response,
`Reply, Sur-Reply, and the evidence of record, we determine that the
`evidence presented demonstrates a reasonable likelihood that Petitioner
`would prevail in establishing the unpatentability of at least one challenged
`claim of the ’681 patent.
`
`
`A.
`
`II. BACKGROUND
`Real Parties-in-Interest
`Petitioner identifies Viatris Inc., Mylan Inc., Mylan Pharmaceuticals
`Inc., Momenta Pharmaceuticals, Inc., Janssen Research & Development
`LLC, and Johnson & Johnson as the real parties-in-interest. Paper 8 at 1.
`Patent Owner identifies Regeneron Pharmaceuticals, Inc. as the real party-
`in-interest. Paper 5 at 1.
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`Related Matters
`B.
`Petitioner and Patent Owner identify Mylan Pharms. Inc. v.
`
`Regeneron Pharms., Inc., IPR2021-00880, IPR2021-00881, IPR2022-01226
`(PTAB), and Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 1:22-cv-
`00061-TSK (N.D.W. Va.). as related matters. Paper 5 at 1; Paper 6 at 1.
`Patent Owner also identifies Chengdu Kanghong Biotechnology Co. v.
`Regeneron Pharms., Inc., PGR2021-00035 (PTAB) (proceeding terminated).
`Paper 5 at 2–3. Petitioner further identifies the following as judicial or
`administrative matters that would affect, or be affected by, a decision in this
`proceeding: Apotex Inc. v. Regeneron Pharmaceuticals, Inc., No. IPR2022-
`01524 (PTAB), United States v. Regeneron Pharms., Inc., No. 1:20-cv-
`11217-FDS (D. Mass.), and Horizon Healthcare Servs., Inc. v. Regeneron
`Pharms., Inc., No. 1:22-cv-10493-FDS (D. Mass.). Paper 6 at 1–2.
`Petitioner also identifies additional patents and patent applications that
`claim priority to the ’681 patent, namely: US 9,254,338 B2; US 9,669,069
`B2; US 10,857,205 B2; US 10,828,345 B2; US 10,888,601 B2; and US
`11,253,572 B2; and US Appl. Ser. Nos. 17/072,417; 17/112,063;
`17/112,404; 17/350,958; and 17/740,744. Paper 6 at 2.
`Of particular relevance to our decision in this proceeding is the Final
`Written Decision entered in IPR2021-00881 on November 9, 2022. See IPR
`2021-00881, Paper 94 (the “-00881 Decision” Ex. 3001). Both the ’681
`patent and US 9,254,338 B2 (the “’338 patent”) in IPR2021-00881 share a
`common Specification. See generally, Ex. 1001, IPR2021-00881, Ex. 1001.
`In the -00881 Decision, the panel found that the challenged claims were
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`unpatentable on at least one of the same grounds asserted against the
`challenged claims in the present Petition. See generally Ex. 3001.
`
`C.
`
`
`
`
`The Asserted Grounds of Unpatentability
`Petitioner contends that claims 1, 3–11, 13, 14, 16–24, and 26 of the
`’681 patent are unpatentable, based upon the following grounds:
`
`
`Ground
`
`1
`
`1
`
`3
`
`Claim(s)
`Challenged
`1, 3–11, 13, 14,
`16–24, 26
`1, 3–11, 13, 14,
`16–24, 26
`1, 3–11, 13, 14,
`16–24, 26
`
`35 U.S.C. §
`
`Reference(s)/Basis
`
`1021
`
`102
`
`102
`
`Dixon2
`
`Adis3
`
`Regeneron 20084
`
`                                                            
`1 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112–29, 125
`Stat. 284 (2011), amended 35 U.S.C. §§ 102 and 103, effective March 16,
`2013. Because the application from which the ’601 patent issued has an
`effective filing date after that date, the AIA versions of §§ 102 and 103
`apply.
`2 J.A. Dixon et al., VEGF Trap-Eye for the Treatment of Neovascular Age-
`Related Macular Degeneration, 18(10) EXPERT OPIN. INVESTIG. DRUGS
`1573–80(2009) (“Dixon”) Ex. 1006.
`3 Adis R&D Profile, Aflibercept: AVE 0005, AVE 005, AVE0005, VEGF
`Trap – Regeneron, VEGF Trap (R1R2), VEGF Trap-Eye, 9(4) DRUGS R D
`261–269 (2008) (“Adis”) Ex. 2007.
`4 Press Release, Regeneron and Bayer HealthCare Announce Encouraging
`32-Week Follow-Up Results from a Phase 2 Study of VEGF Trap-Eye in
`Age-Related Macular Degeneration, April 28, 2008 (“Regeneron 2008”)
`Ex. 1012.
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`
`Ground
`
`
`
`
`35 U.S.C. §
`
`Reference(s)/Basis
`
`Claim(s)
`Challenged
`1, 3–11, 13, 14,
`16–24, 26
`
`1, 3–11, 13, 14,
`16–24, 26
`
`4
`
`5
`
`6
`
`103
`
`103
`
`Dixon alone or in view of
`Papadopoulos5 and/or
`Wiegand6
`Dixon in combination
`with Rosenfeld-20067, and
`if necessary,
`Papadopoulos patent
`and/or Wiegand
`Dixon in combination
`with Heimann-2007, and
`if necessary,
`Papadopoulos and/or
`Wiegand
`
`1, 3–11, 13, 14,
`16–24, 26
`
`103
`
`
`
`Petitioner also relies upon the Declarations of Dr. Thomas A. Albini
`(the “Albini Declaration,” Ex. 1002) and Dr. Mary Gerritsen (the “Gerritsen
`Declaration,” Ex. 1003). Patent Owner relies upon the Declaration of Dr.
`Diana V. Do (the “Do Declaration,” Ex. 2001).
`
`
`                                                            
`5 Papadopoulos et al. (US 7,374,758 B2, May 20, 2008) (“Papadopoulos”)
`Ex. 1010.
`6 Wiegand et al. (US 7,531,173 B2, May 12, 2009) (“Wiegand”) Ex. 1007.
`7 P.J. Rosenfeld et al., Ranibizumab for Neovascular Age-Related Macular
`Degeneration, 355 (14) N. ENGL. J. MED. 1419–31; Suppl. App’x 1–17
`(2006) (“Rosenfeld”) Ex. 1058.
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`D.
`
`
`
`
`The ’681 Patent
`The ’681 patent is directed to methods for treating angiogenic eye
`disorders by sequentially administering multiple doses of a vascular
`epithelial growth factor (“VEGF”) antagonist to a patient. Ex. 1001, Abstr.
`These methods include the administration of multiple doses of a VEGF
`antagonist to a patient at a frequency of once every 8 or more weeks, and are
`useful for the treatment of angiogenic eye disorders such as, inter alia, age
`related macular degeneration. Id.
`In an exemplary embodiment, a single “initial dose” of VEGF
`antagonist (“VEGFT”) is administered at the beginning of the treatment
`regimen (i.e., at “week 0”), two “secondary doses” are administered at
`weeks 4 and 8, respectively, and at least six “tertiary doses” are administered
`once every 8 weeks thereafter (i.e., at weeks 16, 24, 32, 40, 48, 56, etc.). Ex.
`1001 col. 2, ll. 56–62.
`
`E.
`
`Representative Claim
`Claim 1 is representative of the challenged claims, and recites:
`1. A method for treating an angiogenic eye disorder in a patient,
`said method comprising sequentially administering to the patient a
`single initial dose of a VEGF antagonist, followed by one or more
`secondary doses of the VEGF antagonist, followed by one or more
`tertiary doses of the VEGF antagonist;
`wherein each secondary dose is administered 2 to 4 weeks after
`the immediately preceding dose; and
`wherein each tertiary dose is administered at least 8 weeks after
`the immediately preceding dose;
`wherein the VEGF antagonist is a VEGF receptor-based
`chimeric molecule comprising (1) a VEGFR1 component
`comprising amino acids 27 to 129 of SEQ ID NO:2; (2) a
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`VEGFR2 component comprising amino acids 130-231 of
`SEQ ID NO:2; and (3) a multimerization component
`comprising amino acids 232-457 of SEQ ID NO:2;
`wherein exclusion criteria for the patient include all of:
`(1) active intraocular inflammation;
`(2) active ocular or periocular infection;
`(3) any ocular or periocular infection within the last 2
`weeks.
`Ex. 1001, col. 21, ll. 40–63.
`
`Priority History of the ’681 Patent
`F.
`The ’681 patent issued from U.S. Application Ser. No. 15/471,506
`
`(the “’506 application”) filed on March 28, 2017, and claims the priority
`benefit of, inter alia, US Provisional Application Ser. No. 61/432,245,
`which was filed on Jan. 13, 2011. Ex. 1001, code (60).
`The claims of the ’681 patent, including challenged claims 1, 3–11,
`13, 14, 16–24, and 26, were allowed on July 26, 2018, and the patent issued
`on November 20, 2018. Ex. 1017, 509; Ex. 1001, code (45).
`
`
`III. ANALYSIS
`
`A.
`
`Claim Construction
`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). See
`37 C.F.R. § 100(b) (2020). 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 banc). “In determining the
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`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 determining ‘the legally operative meaning of
`claim language.’” Phillips, 415 F.3d at 1317 (quoting C.R. Bard, Inc. v. U.S.
`Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004)).
`Petitioner initially argues that the language of the preamble reciting “a
`method for treating” is not limiting upon the claims. Pet. 17–20. Petitioner
`additionally proposes constructions for the claim terms “initial dose,”
`“secondary dose,” and “tertiary dose.” Id. at 24–25. Finally, Petitioner
`argues that the limitation reciting “wherein exclusion criteria for the patient
`include all of….” (the “exclusion criteria”) are not entitled to patentable
`weight under the printed matter doctrine. Id. at 25–28.
`Patent Owner disagrees, arguing that not only is the preamble limiting
`and requires “treating,” but that the recited “method for treating” requires “a
`high level of efficacy.” Prelim. Resp. 21–30. Patent Owner further
`contends that the recited “initial,” “secondary,” and “tertiary dose”
`limitations similarly require achieving and maintaining a high level of
`efficacy. Id. at 30–37. Finally, Patent Owner argues that the printed matter
`doctrine is inapplicable to the “exclusion criteria” limitation and that this
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`limitation is limiting upon the claims. Id. at 38–44. We address each of
`these arguments in turn.
`
`1.
`
`Preamble
`Petitioner argues the preamble is not limiting upon the claims.
`Pet. 17–18. Petitioner argues that: (1) the preamble is merely a statement of
`intended purpose and, therefore, not a limitation; and (2) the preamble
`provides no antecedent basis for any other claim element, and that any
`argument that “the patient” and “angiogenic eye disorder” claim terms find
`their respective meaning in the preamble is meritless. Id. at 20.
`Alternatively, argues Petitioner, if the preamble is limiting, it should be
`given its plain and ordinary meaning, which does not require any specific
`efficacy requirement. Id. at 20–23.
`Patent Owner responds that: (1) the preamble is limiting and requires
`“treating”; (2) the recited “method for treating” requires a high level of
`efficacy; and (3) the intrinsic record supports a high level of efficacy.
`Prelim Resp. 21–30.
`These same arguments were argued and addressed in the prior -00881
`Decision. See Ex. 3001, 12–23. In the -00881 Decision, challenged claim 1
`of US 9,254,338 B2 (the “’338 patent”) recited preamble language identical
`to that recited in claim 1 of the ’681 patent, viz., “a method for treating an
`angiogenic eye disorder in a patient.” See Ex. 1001 col. 21, ll. 40–41;
`Ex. 3001, 7. The Board found that this preamble was limiting upon the
`remainder of the claim. Ex. 3001, 18. Specifically, the Board found that:
`Here, the claims are directed to methods of administering, i.e.,
`using, a VEGF antagonist for an intended purpose of “treating an
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`angiogenic eye disorder in a patient.” The Specification
`repeatedly characterizes the method as one for treating
`angiogenic eye disorders in patients. Apart from the preamble,
`the independent claims do not elsewhere recite or indicate any
`other use for the method steps comprising the administration of
`a VEGF antagonist. Thus, we determine that the preamble sets
`forth the essence of the invention—treating an angiogenic eye
`disorder in a patient.
`Additionally, we find that the preamble provides antecedent
`basis for claim terms “the patient” recited in the body of each
`independent claim, and “angiogenic eye disorders” recited in
`dependent claims 6, 7, 18, and 20. Indeed, without the preamble,
`it would be unclear to whom the doses of VEGF are
`administered.
`Thus, … in view of the evidence of record, namely, the claim
`language and the written description of the ’338 patent, we find
`that the preambles of method claims 1 and 14 are limiting insofar
`as they require “treating an angiogenic eye disorder in a patient.”
`Id. at 17–18 (citations omitted). We adopt this same reasoning here and
`find, for the purposes of this Decision, that the preamble of claim 1 reciting
`“[a] method for treating an angiogenic eye disorder in a patient” is limiting
`upon the claims.
`
`We do not find persuasive, however, Patent Owner’s argument that
`the preamble’s recitation of a “method for treating” requires a high level of
`efficacy. In the -00881 Decision, the Board rejected Patent Owner’s similar
`argument because it required improperly importing limitations into the
`claims. See Ex. 3001, 22. Specifically, the Board found that:
`[W]hen the Specification explains that “[t]he amount of VEGF
`antagonist administered to the patient in each dose is, in most
`cases, a therapeutically effective amount,” and discloses that “a
`therapeutically effective amount can be from about 0.05 mg to
`about 5 mg,” we find that a POSA would have understood that
`any dosage amount within that range administered according to
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`the invention may, in some cases, result in a detectable
`improvement in “one or more symptoms or indicia of an
`angiogenic eye disorder,” or be one that “inhibits, prevents,
`lessens or delays the progression of an angiogenic eye disorder,”
`or it may not. In either event, the VEGF antagonist would have
`been administered for the purpose of treating the eye disorder. In
`other words, the method of treating the patient with the eye
`disorder is performed upon administration of the VEGF
`antagonist to the patient for the purpose of achieving an
`improvement or beneficial effect in the eye disorder, regardless
`whether the dosage amount administered actually achieves that
`intended result.
`Id. at 21–22 (citation omitted). Furthermore, the Board found that:
`Patent Owner’s proposes that the claims require not only
`achieving a
`therapeutically effective
`result, but more
`specifically, achieving a “high level of efficacy that was
`noninferior to the standard of care by the time the patent was filed
`in 2011.” In the Sur-reply, Patent Owner describes a “highly
`effective treatment for angiogenic eye disorders” as “one that is
`on par to Lucentis or off-label Avastin and can produce visual
`acuity gains, not just slow vision losses.” The Specification
`refers to “a high level of efficacy” in one instance, i.e., in the
`“Background” section. The Specification does not describe there,
`or elsewhere that “treating,” in the context of the claims or in the
`art, requires achieving a “high level of efficacy” or providing
`results “on par to Lucentis or off-label Avastin.”
`Id. at 22 (citations omitted).
`
`We adopt the same reasoning here, and find that, for the purposes of
`this Decision, the evidence of record and the Specification support
`construing the preamble’s recitation of a “method for treating a patient with
`an angiogenic eye disorder” as meaning administering a compound, i.e., the
`recited VEGF antagonist, to such patient for the purpose of improving or
`providing a beneficial effect in their angiogenic eye disorder, but does not
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`require a “high level of efficacy,” as proposed by Patent Owner. See Ex.
`3001, 22.
`
`2.
`
`“Initial dose,” “Secondary Dose,” and “Tertiary Dose”
`Petitioner next contends that a person of ordinary skill in the art would
`understand each of these claim terms as expressly defined in the ’681
`patent’s Specification. Pet. 24. The Specification defines the claim terms as
`follows:
`The terms “initial dose,” “secondary doses,” and “tertiary doses,”
`refer to the temporal sequence of administration of the VEGF
`antagonist Thus, the “initial dose” is the dose which is
`administered at the beginning of the treatment regimen (also
`referred to as the “baseline dose”) ; the “secondary doses” are the
`doses which are administered after the initial dose; and the
`“tertiary doses” are the doses which are administered after the
`secondary doses. The initial, secondary, and tertiary doses may
`all contain the same amount of dosing regimens, but will
`generally differ from one another in terms of frequency of
`administration.
`Ex. 1001 col. 3 ll. 34–44. Petitioner also notes that the Specification further
`explains that “the immediately preceding dose” means “in a sequence of
`multiple administrations, the dose of VEGF antagonist which is
`administered to a patient prior to the administration of the very next dose in
`the sequence with no intervening doses.” Pet. 24 (citing Ex. 1001 col. 3,
`ll. 54–59; Ex. 1002, ¶¶ 44–45).
`
`Patent Owner responds that the claim terms “initial,” “secondary,”
`and “tertiary dose” again require achieving and maintaining a high level of
`efficacy. Prelim. Resp. 30. According to Patent Owner, if these claim terms
`implied only a temporal sequence, the challenged claims would encompass
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`administering ineffective doses of VEGF antagonist—e.g., infinitesimal
`quantities that are incapable of achieving any efficacy. This would be an
`incongruous interpretation of claims directed to a “method for treating”
`angiogenic eye disorders. Id.
`
`Furthermore, argues Patent Owner, when the claims are considered as
`a whole, it is evident that the dosing regimen recited in the claims—i.e., less
`frequent “tertiary dose(s)” following more frequent “initial” and
`“secondary” doses—must actually “treat[]” the angiogenic eye disorder for
`which the VEGF antagonist is being administered, and such treatment must
`be comparable in efficacy to standard-of-care Lucentis and off-label
`Avastin. Prelim. Resp. 32.
`
`We are persuaded that Petitioner proposes the more correct
`construction of the claim terms “initial dose,” “secondary dose,” and
`“tertiary dose.” Petitioner proposes adoption of the definitions expressly set
`forth in the Specification of the ’681 patent, viz., that the initial dose is the
`dose “administered at the beginning of the treatment regimen,” and is
`followed by the secondary doses “secondary doses” are “administered after
`the initial dose,” and the tertiary doses are “administered after the secondary
`doses” and may be distinguished from the secondary doses “in terms of
`frequency of administration.” Ex. 1001 col. 3, ll. 36–44.
`
`We do not find persuasive Patent Owner’s argument that the
`definition of these terms require a high, or otherwise defined, degree of
`efficacy. As we stated in the -00881 Decision:
`Based on those express definitions in the Specification, we do
`not find cause to construe the terms differently. In particular, we
`do not find that the Specification requires the “tertiary doses” to
`maintain any efficacy gain achieved after the initial and
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`secondary doses, or that the term suggests any specific level of
`efficacy. The Specification unequivocally states that “[t]he
`terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer
`to the temporal sequence of administration of the VEGF
`antagonist.”
`Ex. 3001, 25 (emphasis added). We see no need or reason to upend this
`construction now and, for the purposes of this Decision, we adopt
`Petitioner’s proposed definition of the claim terms “initial dose,” “secondary
`doses,” and “tertiary doses” as the express definition provided by the ’681
`Specification.
`
`3.
`
`The exclusion criteria
`The exclusion criteria limitation of challenged claim 1 recites:
`[W]herein exclusion criteria for the patient include all of:
`(1) active intraocular inflammation;
`(2) active ocular or periocular infection;
`(3) any ocular or periocular infection within the last 2
`weeks.
`Ex. 1001 col. 21, ll. 58–62. Petitioner argues that the “exclusion criteria”
`are entitled to no patentable weight under the printed matter doctrine.
`Pet. 25.
`Petitioner next points to the two-part analysis set forth in Praxair
`Distrib., Inc. v. Mallinckrodt Hosp. Prods. IP Ltd., 890 F.3d 1024, 1032
`(Fed. Cir. 2018). Under this analysis we first determine whether the claim
`limitation in question is directed to printed matter. i.e., “if it claims the
`content of information.” Praxair, 890 F.3d 1032 (citing In re DiStefano,
`808 F.3d 845, 848 (Fed. Cir. 2015). In the second step, we determine
`whether the printed matter is functionally related to its “substrate,” i.e.,
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`whether the printed material is “interrelated with the rest of the claim.” Id.
`Printed matter that is functionally related to its substrate is given patentable
`weight. Id. (citing DiStefano, 808 F.3d at 850).
`Petitioner first argues that the exclusion criteria (i.e., preexisting
`conditions) represent informational content regarding the patient. Pet. 26.
`Petitioner argues that the challenged claims recite no active step of applying
`(or assessing the patient for) the exclusion criteria and consequently is
`“informational content” constituting a “mental step/printed material
`element.” Id. at 27. Petitioner asserts that, even if application of the
`“exclusion criteria” could be inferred, the challenged claims do not dictate
`that any procedural step be taken, or that any alteration be made to the
`claimed dosing regimen. Id.
`Turning to the second step of the Praxair analysis, Petitioner contends
`that there is no functional relationship between the exclusion criteria and the
`rest of the claim (i.e., the operative steps of administering a VEGF
`antagonist to treat an angiogenic eye disorder). Pet. 27. Specifically,
`Petitioner argues that neither the presence nor absence of any exclusion
`criteria dictates any changes to the actual claimed dosing steps—i.e., the
`operative steps remain the same. Id. Therefore, argues Petitioner, because
`the “exclusion criteria” are “directed to mental steps” that “attempt to
`capture informational content,” and lack a functional relationship to the
`other steps of the claimed treatment method, the exclusion criteria should be
`“considered printed matter lacking patentable weight.” Id. (quoting Praxair,
`890 F.3d at 1033).
`Patent Owner responds that, in the -00881 Decision, the Board
`determined that the substantially identical preamble is a positive limitation
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`because it defines (in part) who is treated (a patient with an angiogenic eye
`disorder). Prelim. Resp. 39 (citing Ex. 3001, 16–19 (finding that the
`preamble “method of treating an angiogenic eye disorder” is limiting)).
`Patent Owner argues that the “wherein” clause of the exclusion criteria
`limitation further limits who may be treated with the claimed method—not
`only must the patient suffer from an angiogenic eye disorder, but also must
`not meet any of the recited exclusion criteria. Id. Therefore, contends
`Patent Owner, the exclusion criteria serve to limit the population of patients
`on whom the claimed method may be performed. Id. at 39–40.
`Patent Owner asserts that it is well-established that claim terms
`defining the population of patients to be treated with a claimed method are
`limiting. Prelim. Resp. 40 (citing e.g., Rapoport v. Dement, 254 F.3d 1053,
`1058–60 (Fed. Cir. 2001); Braintree Labs., Inc. v. Novel Labs., Inc., 749
`F.3d 1349, 1356–57 (Fed. Cir. 2014); Jansen v. Rexall Sundown, Inc., 342
`F.3d 1329, 1333–34 (Fed. Cir. 2003); GlaxoSmithKline LLC v. Fibrogen,
`Inc., IPR2016-01318, 2017 WL 379248, *3 (PTAB Jan. 11, 2017); also
`citing Praxair, 890 F.3d at 1035). According to Patent Owner, claim
`limitations that define the treated patient population also define how (i.e.,
`upon whom) the treatment steps are performed, and that if one were to
`ignore the exclusion criteria when practicing the claimed method steps, a
`different (broader) group of patients would be treated. Id. Consequently,
`argues Patent Owner, the exclusion clause of the challenged claims modify
`and further specify the “patient” of the preamble. Id. at 41.
`Turning to the two-part analysis of Praxair, Patent Owner argues that
`the exclusion criteria are not directed to any communication of information
`(printed or otherwise) so as to “claim[] the content of information,” and
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`therefore do not meet the first step one of the printed matter inquiry. Prelim
`Resp. 41 (quoting Praxair, 890 F.3d at 1031–32). Patent Owner notes that,
`in Praxair, the claims at issue held to contain printed matter were expressly
`directed to “providing information” or a “recommendation” to the medical
`provider, which the medical provider was free to ignore. Prelim. Resp. 42
`(citing Praxair, 890 F.3d at 1028–30). To the contrary, Patent Owner
`argues, in the present proceeding, nothing in the challenged claims is
`directed to the mere provision of information, and there is consequently no
`“ineligible information” in the claims to begin with. Id. (citing Praxair, 890
`F.3d at 1033).
`Turning to the second step of the Praxair test, Patent Owner contends
`that the exclusion criteria define the patient population to be treated, and so
`are a limitation with patentable weight. Prelim. Resp. 42. Patent Owner
`analogizes the challenged claims to claim 9 in Praxair, which the court
`found did not comprise unpatentable printed matter, because it further
`required the medical provider to take a specific action—discontinuing
`treatment—as a result of the recommendation limitation. Id. (citing Praxair,
`890 F.3d at 1035). Consequently, Patent Owner points out, the printed
`matter of claim 9 was functionally related to body of the claim and had
`patentable weight. Id. Similarly, argues Patent Owner, the present
`challenged claims require the recited administering steps to be performed
`only on patients who do not meet the exclusion criteria, creating a functional
`relationship with the rest of the claim. Id. at 43.
`We are persuaded that, for the purpose of this Decision, Petitioner has
`the better position. In Praxair, our reviewing court has held that the printed
`matter doctrine does not apply only to literal printed matter, but, rather, is
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`applicable when a claim limitation “claims the content of information.”
`Praxair, 890 F.3d at 1032 (quoting In re DiStefano, 808 F.3d 845, 848 (Fed.
`Cir. 2015)). “Claim limitations directed to the content of information and
`lacking a requisite functional relationship are not entitled to patentable
`weight because such information is not patent eligible subject matter under
`35 U.S.C. § 101.” Id. (citing AstraZeneca LP v. Apotex, Inc., 633 F.3d
`1042, 1064 (Fed. Cir. 2010)).
`If a claim limitation is directed to printed matter, the next step in the
`Praxair analysis is to determine whether the printed matter is functionally
`related to its “substrate.” Praxair, 890 F.3d at 1032. Printed matter that is
`functionally related to its substrate is given patentable weight. Id. (citing
`DiStefano, 808 F.3d at 850). However, “[w]here the printed matter is not
`functionally related to the substrate, the printed matter will not distinguish
`the invention from the prior art in terms of patentability.” Id. (quoting In re
`Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)).
`In the case presently before us, there is little question that the
`exclusion criteria are directed to informational content. Specifically, the
`limitation in question expressly states that the “exclusion criteria for the
`patient include all of: (1) active intraocular inflammation; (2) active ocular
`or periocular infection; (3) any ocular or periocular infection within the last
`2 weeks.” This list of conditions relays direct information to the practitioner
`of the patent as to the nature of the exclusion criteria, much in the manner of
`the listing of contraindications included with the packaging of any other
`drug. The exclusion criteria are certainly analogous to the claim 1 in
`Praxair, in which the practitioner of the claimed “method of providing
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`pharmaceutically acceptable nitric oxide gas” included providing
`information [to the medical provider]
`[T]hat, in patients with preexisting left ventricular dysfunction,
`inhaled nitric oxide may increase pulmonary capillary wedge
`pressure (PCWP), leading to pulmonary edema, the information
`of (ii) being sufficient to cause a medical provider considering
`inhaled nitric oxide treatment for a plurality of neonatal patients
`who (a) are suffering from a condition for which inhaled nitric
`oxide is indicated, and (b) have pre-existing left ventricular
`dysfunction, to elect to avoid treating one or more of the plurality
`of patients with inhaled nitric oxide in order to avoid putting the
`one or more patients at risk of pulmonary edema.
`Praxair, 890 F.3d at 1028–29. These limitations of claim 1 of Praxair
`(quoted above) and the exclusion criteria of the present challenged claims
`both provide information to the practitioner of the respective claimed
`methods concerning criteria to assess risks that may be incurred when
`practicing the method with a patient.
`However, we do not find that the exclusion criteria of the challenged
`claims are functionally related to the rest of the claim. The claims do not
`expressly recite any positive step to be performed (or a negative step not to
`be performed) should a patient meet the exclusion criteria. Patent Owner
`attempts to distinguish the challenged claims from those of Praxair by
`arguing that the latter claims “were expressly directed to ‘providing
`information’ or a ‘recommendation’” to the medical provider, which the
`m