Trials@uspto.gov
`571-272-7822
`
`Paper 21
`Date: November 10, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`IPR2021-00881
`Patent 9,254,338 B2
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, JOHN G. NEW, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper 21
`Date: November 10, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`IPR2021-00881
`Patent 9,254,338 B2
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, JOHN G. NEW, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`
`IPR2021-00881
`Patent 9,254,338 B2
`
`INTRODUCTION
`I.
`Mylan Pharmaceuticals, Inc. (“Petitioner”) filed a Petition requesting
`an inter partes review of claims 1, 3–11, 13, 14, 16–24, and 26 of
`U.S. Patent No. 9,254,338 B2 (Ex. 1001, “the ’338 patent”). Paper 1
`(“Petition” or “Pet.”). Regeneron Pharmaceuticals, Inc. (“Patent Owner”)
`filed a Preliminary Response to the Petition. Paper 10 (“Prelim. Resp.”).
`With our authorization, Paper 13, Petitioner filed a Reply to the Preliminary
`Response, and Patent Owner filed a Sur-reply to address further issues
`involving 35 U.S.C. § 325(d). Paper 16 (“Reply”); Paper 19 (“Sur-reply”).
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314 (2018). Upon considering the parties’ arguments
`and evidence, we determine that Petitioner has demonstrated a reasonable
`likelihood that it would prevail in showing the unpatentability of at least one
`claim challenged in the Petition. Accordingly, we institute an inter partes
`review of claims 1, 3–11, 13, 14, 16–24, and 26 of the ’338 patent.
`Real Parties in Interest
`A.
`Petitioner identifies itself, Viatris Inc., Mylan Inc., Momenta
`Pharmaceuticals, Inc., Janssen Research & Development LLC, and Johnson
`& Johnson as the real parties-in-interest. Pet. 3, Paper 18 (Petitioner’s
`Amended Mandatory Notices). Patent Owner identifies itself as the real
`party-in-interest. Paper 5, 2.
`Related Proceedings
`B.
`Petitioner and Patent Owner identify Mylan Pharms. Inc. v.
`Regeneron Pharms., Inc., IPR2021-00880 (PTAB May 5, 2021) (“the -880
`petition”) as a related matter. Pet. 3; Paper 5, 2. The -880 petition
`challenges claims of U.S. Patent No. 9,669,069 B2 (“the ’069 patent”). The
`parties further identify Chengdu Kanghong Biotechnol. Co. v. Regeneron
`
`2
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`IPR2021-00881
`Patent 9,254,338 B2
`Pharms., Inc., PGR2021-00035 (petition dismissed and proceeding
`terminated, Paper 8 (PTAB June 25, 2021)) challenging the claims of
`U.S. Patent No. 10,828,345 B2 (“the ’345 patent”), which is related to the
`’338 patent and the ’069 patent. Pet. 4; Paper 5, 2.
`Petitioner identifies additional patents and patent applications that
`claim priority to the ’338 patent, namely: U.S. Patent Nos. 10,130,681 B2,
`10,857,205 B2, 10,828,345 B2, and 10,888,601 B2; and U.S. Application
`Serial Nos. 17/072,417, 17/112,063, and 17/112,404. Pet. 4.
`The ’338 Patent
`C.
`The ’338 patent relates to methods for treating angiogenic eye
`disorders. Ex. 1001, 1:63–64. Angiogenic eye disorders include age-related
`macular degeneration (“AMD”) and diabetic macular edema (“DME”). Id.
`at 1:24–34. According to the Specification, “[r]elease of vascular
`endothelial growth factor (VEGF) contributes to increased vascular
`permeability in the eye and inappropriate new vessel growth. Thus,
`inhibiting the angiogenic-promoting properties of VEGF appears to be an
`effective strategy for treating angiogenic eye disorders.” Id. at 1:44–48.
`The Specification describes inhibiting the angiogenic-promoting
`properties of VEGF by administering a VEGF antagonist. Id. at 4:37–42.
`VEGF antagonists may include “VEGF receptor-based chimeric
`molecule(s), (also referred to herein as a ‘VEGF-Trap’ or ‘VEGFT’). An
`exemplary VEGF antagonist . . . is a multimeric VEGF-binding protein
`comprising two or more VEGF receptor-based chimeric molecules referred
`to herein as ‘VEGFR1R2-FcΔC1(a)’ or ‘aflibercept.’” Id. at 2:30–37.
`“VEGFR1R2-FcΔC1(a) comprises three components: (1) a VEGFR1
`component comprising amino acids 27 to 129 of SEQ ID NO:2; (2) a
`VEGFR2 component comprising amino acids 130 to 231 of SEQ ID NO:2;
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`Patent 9,254,338 B2
`and (3) a multimerization component [] comprising amino acids 232 to 457
`of SEQ ID NO:2.” Id. at 4:58–5:3 (citing U.S. Patent No. 7,396,664 B2).
`The Specification discloses that, despite the known methods for
`treating eye disorders using VEGF antagonists, “there remains a need in the
`art for new administration regimens for angiogenic eye disorders, especially
`those which allow for less frequent dosing while maintaining a high level of
`efficacy.” Id. at 1:53–61. The Specification discloses that
`[t]he present inventors have surprisingly discovered that
`beneficial therapeutic effects can be achieved in patients
`suffering from angiogenic eye disorders by administering a
`VEGF antagonist to a patient at a frequency of once every 8 or
`more weeks, especially when such doses are preceded by about
`three doses administered to the patient at a frequency of about 2
`to 4 weeks.
`Id. at 2:3–10. The Specification describes this dosing regimen as
`sequentially administering initial, secondary, and tertiary doses. See id. at
`1:62–2:3. The Specification refers to “sequentially administering” as “each
`dose of VEGF antagonist is administered to the patient at a different point in
`time, e.g., on different days separated by a predetermined interval (e.g.,
`hours, days, weeks or months).” Id. at 3:22–26. The Specification refers to
`the “initial dose” as “the dose which is administered at the beginning of the
`treatment regimen;” the “secondary doses” as “the doses which are
`administered after the initial dose;” and the “tertiary doses” as “the doses
`which are administered after the secondary doses.” Id. at 3:31–38.
`
`Illustrative Claims
`D.
`Petitioner challenges claims 1, 3–11, 13, 14, 16–24, and 26 of the
`’338 patent. Claims 1 and 14, the only independent claims, are set forth
`below and are illustrative of the claimed subject matter.
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`Patent 9,254,338 B2
`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
`VEGFR2 component comprising amino acids 130–231 of
`SEQ ID NO:2; and (3) a multimerization component
`comprising amino acids 232–457of SEQ ID NO:2.
`Ex. 1001, 23:2–18.
`14. 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 VEGFR1R2-FcΔC1(a)
`encoded by the nucleic acid sequence of SEQ ID NO:1.
`Id. at 24:2–15.
`
`Asserted Grounds of Unpatentability
`E.
`Petitioner asserts that claims 1, 3–11, 13, 14, 16–24, and 26 are
`unpatentable on the following grounds:
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`Patent 9,254,338 B2
`Claims 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
`
`1, 3–11, 13, 14, 16–24, 26
`
`1, 3–11, 13, 14, 16–24, 26
`
`1, 3–11, 13, 14, 16–24, 26
`
`
`32 U.S.C. § Reference(s)
`102
`Dixon1
`
`102
`
`102
`
`102
`
`102
`
`103
`
`Adis2
`
`Regeneron 20083
`
`NCT-7954
`
`NCT-3775
`
`Dixon, Papadopoulos, 6 Dix7
`
`Petitioner also relies upon the Declarations of Thomas Albini M.D.
`(Ex. 1002), and Mary Gerritsen Ph.D. (Ex. 1003). In the Preliminary
`Response, Patent Owner relies on the Declaration of Diana V. Do, M.D.
`(Ex. 2001).
`
`
`1 James A. Dixon et al., “VEGF Trap-Eye for the treatment of neovascular
`age-related macular degeneration,” 18(10) Expert Opin. Investig. Drugs
`1573–1580 (2009) (Ex. 1006, “Dixon”)).
`2 Adis Data Information BV, “Aflibercept,” 9(4) Drugs R&D 261–269
`(2008) (Ex. 1007, “Adis”).
`3 Press Release, Regeneron, “Bayer and Regeneron Dose First Patient in
`Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular
`Degeneration” (May 8, 2008) (Ex. 1013, “Regeneron 2008”).
`4 Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of
`Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)
`(VIEW1), NCT00509795, ClinicalTrials.gov (Apr. 28, 2009),
`https://clinicaltrials.gov/ct2/show/NCT00509795 (Ex. 1014, “NCT-795”).
`5 VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD
`(VIEW2), NCT00637377, ClinicalTrials.gov (Mar. 17, 2008),
`https://clinicaltrials.gov/ct2/show/NCT00637377 (Ex. 1015, “NCT-377”).
`6 Papadopoulos et al., US 7,374,758 B1, issued May 20, 2008, (Ex. 1010,
`“Papadopoulos”).
`7 Dix et al., US 8,110,546 B2, issued Feb. 7, 2012 (Ex. 1033, “Dix”).
`
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`II. ANALYSIS
`A. Discretionary Denial under 35 U.S.C. § 325(d)
`Patent Owner asserts that we should deny the Petition under 35 U.S.C.
`§ 325(d). Prelim. Resp. 9–17. We have discretion to deny review when “the
`same or substantially the same prior art or arguments previously were
`presented to the Office.” 35 U.S.C. § 325(d). In that respect, § 325(d)
`provides that the Director may elect not to institute a proceeding if the
`challenge to the patent is based on matters previously presented to the
`Office. 8 Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte
`GmbH, IPR2019-01469, Paper 6 at 7 (PTAB Feb. 13, 2020) (precedential)
`(“Advanced Bionics”).
`In evaluating matters under § 325(d), the Board uses the following
`two-part framework: (1) determining whether the same or substantially the
`same art previously was presented to the Office or whether the same or
`substantially the same arguments previously were presented to the Office;
`and (2) if either condition of the first part of the framework is satisfied,
`determining whether the petitioner has demonstrated that the Office erred in
`a manner material to the patentability of challenged claims. Advanced
`Bionics at 8.
`In applying the two-part framework, we consider several nonexclusive
`factors, including:
`(a) the similarities and material differences between the asserted art
`and the prior art involved during examination;
`
`
`8 The Board institutes trial on behalf of the Director. 37 C.F.R. § 42.4(a);
`Advanced Bionics, Paper 6 at 7 n.7.
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`(b) the cumulative nature of the asserted art and the prior art evaluated
`during examination;
`(c) the extent to which the asserted art was evaluated during
`examination, including whether the prior art was the basis for rejection;
`(d) the extent of the overlap between the arguments made during
`examination and the manner in which petitioner relies on the prior art or
`patent owner distinguishes the prior art;
`(e) whether petitioner has pointed out sufficiently how the examiner
`erred in its evaluation of the asserted prior art; and
`(f) the extent to which additional evidence and facts presented in the
`petition warrant reconsideration of the prior art or arguments. Becton,
`Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at
`17–18 (PTAB Dec. 15, 2017) (precedential as to Section III.C.5, first
`paragraph) (“Becton, Dickinson”).
`Factors (a), (b), and (d) of the Becton, Dickinson factors relate to
`whether the art or arguments presented in the Petition are the same or
`substantially the same as those previously presented to the Office. Advanced
`Bionics at 10. Factors (c), (e), and (f) “relate to whether the petitioner has
`demonstrated a material error by the Office” in its prior consideration of that
`art or arguments. Id. Only if the same or substantially the same art or
`arguments were previously presented to the Office do we then consider
`whether petitioner has demonstrated a material error by the Office. Id.
`“[T]his framework reflects a commitment to defer to previous Office
`evaluations of the evidence of record unless material error is shown.”
`Id. at 9.
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`Part One of the § 325(d) Analysis
`1.
`We first consider whether Petitioner asserts the same or substantially
`the same art or arguments that previously were presented to the Office.
`Advanced Bionics, Paper 6 at 8. Patent Owner asserts that Petitioner relies
`on substantially the same art that was already considered by the Examiner
`during prosecution of the ’338 patent. Prelim. Resp. 9. In particular, Patent
`Owner asserts that its VIEW1/2 dosing regimens, which form the basis of
`Petitioner’s unpatentability challenges, “were before the Examiner and
`considered during prosecution of the ’338 Patent.” Id. In support of that
`contention, Patent Owner asserts that “[o]n October 18, 2013, [applicant]
`Regeneron presented a September 28, 2008, Regeneron Press Release
`(‘9/28/2008 Press Release’) to the Office in an IDS, which was marked
`considered by the Examiner.” Id. (citing Ex. 1017, 60 and 277). Patent
`Owner asserts that “[t]he 9/28/2008 Press Release discloses the same
`VIEW1/2 prospective dosing regimen that Petitioner relies on in Grounds 1–
`5 of its Petition.” Id. (citing Ex. 2007, 1). Specifically, Patent Owner
`asserts that each reference relied on for the five separate anticipation
`challenges, i.e., Dixon, Adis, Regeneron May 2008, NCT-795, and NCT-
`377, “are essentially identical to the disclosure of the 9/28/08 Press
`Release.” Id. at 12. To illustrate that point, Patent Owner provides the
`following table identifying the dosing regimen disclosed in each of those
`references:
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`Id. at 13. Patent Owner’s table includes five columns setting forth the
`disclosed dosing regimen for VEGF Trap-Eye or aflibercept. Id. According
`to Patent Owner, because the asserted references for these grounds are
`cumulative of the 9/28/08 Press Release provided to the Examiner in the IDS
`during the prosecution of the ’338 patent, the Petition asserts substantially
`the same prior art that was previously presented to the Office. Id.
`As for Petitioner’s obviousness ground, Patent Owner asserts that “the
`9/28/08 Press Release” also discloses the same CLEAR-IT 2 clinical trial
`results as Dixon, which Petitioner relies upon to show a reasonable
`expectation of success. Id. at 14 (citing Pet. 64; Ex. 2007, 1; Ex. 1006,
`1576). Patent Owner further asserts that the same teachings of the secondary
`references, Papadopoulos and Dix, were provided to the Office in an IDS
`listing Daly. 9 Id. at 15 (citing Ex. 1017, 66, 112). Patent Owner asserts that
`
`9 Daly et al., US 2006/0058234 A1, published Mar. 16, 2006 (Ex. 2009,
`“Daly”).
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`Daly “contains the same amino acid sequence that Petitioner identifies as the
`VEGF Trap-Eye sequence in” Papadopoulos and Dix. See id. at 15 (citing
`Ex. 2009, SEQ ID NO:7; Ex. 1010, Figs. 24A–C; Ex. 1033, SEQ ID NO:3).
`Therefore, Patent Owner asserts that substantially the same prior art relied
`upon by Petitioner for the obviousness ground was also previously presented
`to the Office. Id.
`Petitioner contends that neither the same nor substantially the same art
`or arguments were previously considered by the Office during the
`prosecution of the ’338 patent. Reply 2. Specifically, Petitioner asserts that
`the document, Exhibit 2007, that Patent Owner refers to as the “9/28/2008
`Press Release,” is actually “a 2012 (i.e., post-art) printout of a ‘Thomson
`Reuters’ website.” Id. at 5. 10 Petitioner asserts that the actual 9/28/2008
`press release, Ex. 1056, was not applied against the claims or discussed by
`the Examiner during prosecution of the ’338 patent. Id. Therefore,
`according to Petitioner, the Thomson Reuters document,
`Ex. 2007, listed on the IDS, “is post-art and thus is not, and cannot be, the
`‘same or substantially the same prior art.’” Id. at 7 (citing 35 U.S.C.
`§325(d)).
`Petitioner asserts also that its grounds rely on additional disclosures
`not in the Thomson Reuters document. Id. Specifically, Petitioner asserts
`that “Dixon discusses Lucentis extended dosing regimens and the problems
`with monthly intravitreal injections”; “Adis and Dixon disclose that VEGF
`Trap-Eye is aflibercept”; and “Regeneron (8-May-2008) includes efficacy
`
`
`10 Petitioner refers to a priority date of January 2011 for the ’338 patent. Id.
`at 5 n.5.
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`endpoints for the VIEW trials and PO/inventor statements about the claimed
`regimens.” Id. at 7 (citing Ex. 1006, 1573, 1574, 1577; Ex. 1007, 261;
`Ex. 1013). Additionally, Petitioner contends that the secondary references
`cited in the obviousness challenge (Ground 6) were not presented to the
`Examiner and include non-cumulative disclosures. Id. at 7–8.
`Further, Petitioner asserts that its reliance on Dr. Albini’s opinions
`and analysis in the Petition also weigh against § 325(d) denial. Id. at 9.
`In Patent Owner’s Sur-reply, Patent Owner asserts that “[t]he IDS
`clearly identifies the title of the press release, the source as Thomas [sic]
`Reuters Integrity, and the date as September 28, 2008.” Sur-reply 2 (citing
`Ex. 1017, 60). According to Patent Owner, “[n]othing on the IDS suggests a
`2012 date. Rather, the IDS and the face of the ’338 Patent report the
`document’s date as September 28, 2008.” Id. Additionally, Patent Owner
`asserts that Exhibit 2007 “identifies the ‘Reference’ as ‘Regeneron
`Pharmaceuticals Press Release 2008, September 28’ and the ‘Title’ as
`‘VEGF Trap-Eye final phase II results in age-related macular degeneration
`presented at 2008 Retina Society Meeting.” Id. at 3. According to Patent
`Owner, that information makes clear that the press release was available on
`September 28, 2008. Id. Patent Owner notes also that the footer of the
`Thomson Reuters Integrity printout indicates that it was obtained from a
`Thomson website in 2012. Id.
`Patent Owner does not disagree with Petitioner’s assertion that the
`actual press release includes disclosures not found in Exhibit 2007. Id. at 5.
`Instead, Patent Owner asserts those differences are not relevant, as the issue
`is whether Exhibit 2007 contains substantially the same disclosures as
`Petitioner’s cited art. Id. In terms of the differences between Exhibit 2007
`and Petitioner’s cited art, Patent Owner contends that Petitioner does not
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`rely on the additional disclosures in its cited art for the anticipation grounds.
`Id. Patent Owner asserts that Petitioner also does not rely on Dixon’s
`discussion about problems with monthly dosing of Lucentis. Id.
`Additionally, Patent Owner asserts that Petitioner’s reliance on Dixon and
`Adis as disclosing that VEGF Trap-Eye is aflibercept “rests on the flawed
`premise that these terms are synonymous.” Id. at 5–6.
`According to Patent Owner, Petitioner’s secondary references,
`Papadopoulos and Dix, relied upon in the obviousness challenge, are also
`substantially the same as what was presented to the Office during the ’338
`prosecution. Id. In particular, Patent Owner asserts that Daly, which was
`presented to the Office, expressly incorporates by reference the entirety of
`Papadopoulos. Id. Additionally, Patent Owner asserts that Dix is
`cumulative of Daly, inasmuch as Petitioner relies upon Dix for the
`obviousness ground. Id.
`To begin, we find that Patent Owner has shown persuasively that,
`during the prosecution of the ’338 patent, the Examiner was presented with
`the information disclosed in the 2008 Press Release for “VEGF Trap-Eye
`final phase II results in age-related macular degeneration presented at 2008
`Retina Society Meeting.” Applicant included the Thomson Reuters
`description of the press release on the IDS, Ex. 1017, 60–61, along with the
`submission of the Thomson Reuters publication, Ex. 2007, referenced
`therein. The Thomson Reuters publication expressly identified the press
`release by name and date as the “Reference” for the information described in
`the publication, as well as by the title of the press release. Ex. 2007.
`Importantly, the Thomson Reuters publication also provided a summary
`description of the contents of the press release, in a form that resembles an
`abstract. The contents of the Thomson Reuters publication provides the
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`information from the 2008 press release that describes the same dosing
`regimen for VEGF Trap-Eye as each of the cited references relied upon by
`Petitioner for its anticipation and obviousness challenges.
`However, Patent Owner has not shown that the Office was presented
`with the additional information disclosed in Petitioner’s cited art that
`Petitioner relies upon for its claim challenges. In particular, Petitioner relies
`upon a teaching in Dixon that “VEGF Trap-Eye and aflibercept (the
`oncology product) have the same molecular structure.” Pet. 40 (citing
`Ex. 1006, 1575). Petitioner relies, in part, on that teaching to reach the
`limitations in the challenged claims reciting characteristics of the VEGF
`antagonist. Id. We note that the Thomson Reuters publication includes the
`term “[a]flibercept,” but it does not discuss or describe it as having the same
`molecular structure as VEGF Trap-Eye. Instead, the term is presented with
`a parenthetical number next to it, i.e., “Aflibercept (303153),” without any
`further mention or explanation. Ex. 2007.
`Patent Owner has not adequately accounted for the additional teaching
`in Dixon that “VEGF Trap-Eye and aflibercept have the same molecular
`structure” by merely asserting that Petitioner’s reliance on that teaching in
`Dixon “rests on the flawed premise that these terms are synonymous.”
`Sur-reply 5–6. The additional teaching in Dixon, relied upon by Petitioner
`to reach a claim limitation, is sufficient, under Part One of the § 325(d)
`analysis, to distinguish the Dixon ground presented by Petitioner here from
`what was before the Office during prosecution.
`Thus, we do not find that Dixon is cumulative to the information
`presented to the Office in the Thomson Reuters publication. For the same
`reasons, we find that Adis is not cumulative to the information presented to
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`the Office in the Thomson Reuters publication, as Petitioner similarly relies
`on a disclosure in Adis that VEGF Trap-Eye is aflibercept. Pet. Reply 7.
`Because we determine that the same or substantially the same prior art
`or arguments previously were not presented to the Office, we need not
`proceed to step two of the Advanced Bionics framework.
`Conclusion
`2.
`Based on the foregoing analysis, we decline to exercise our discretion
`to deny the Petition under § 325 (d).
`Person of Ordinary Skill in the Art
`B.
`The level of skill in the art is a factual determination that provides a
`primary guarantee of objectivity in an obviousness analysis. Al-Site Corp. v.
`VSI Int’l Inc., 174 F.3d 1308, 1323 (Fed. Cir. 1999) (citing Graham v. John
`Deere Co., 383 U.S. 1, 17–18 (1966)); Ryko Mfg. Co. v. Nu-Star, Inc.,
`950 F.2d 714, 718 (Fed. Cir. 1991)).
`Petitioner asserts that a person of ordinary skill in the art at the time of
`the invention would have had
`(1) knowledge regarding the diagnosis and treatment of
`angiogenic eye disorders, including
`the administration of
`therapies to treat said disorders; and (2) the ability to understand
`results and findings presented or published by others in the field,
`including the publications discussed herein. Typically, such a
`person would have an advanced degree, such as an M.D. or Ph.D.
`(or equivalent, or less education but considerable professional
`experience in the medical, biotechnological, or pharmaceutical
`field), with practical academic or medical experience in
`(i) developing treatments for angiogenic eye disorders (such as
`AMD), including through the use of VEGF antagonists, or
`(ii) treating of same, including through the use of VEGF
`antagonists.
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`Pet. 22 (citing Ex. 1002 ¶¶ 26–28; Ex. 1003 ¶¶ 20–24). Patent Owner does
`not address Petitioner’s description of the level of ordinary skill in the art, or
`propose its own description, in the Preliminary Response.
`Because Petitioner’s definition of one of ordinary skill in the art is
`reasonable and consistent with the ’338 patent and the prior art of record, we
`adopt Petitioner’s definition for purposes of this Decision.
`C. 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).
`37 C.F.R. § 100(b) (2019). 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) (quoting Vitronics Corp.
`v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). “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).
`Petitioner proposes constructions for several claim terms. See Pet.
`11–22. In the following discussion, we address those proposed
`constructions and Patent Owner’s challenges to them.
`“A method for treating an angiogenic eye disorder in a patient”
`1.
`Petitioner asserts that “[t]he ‘method for treating’ preamble of
`independent claims 1 and 14 is ‘merely a statement of purpose or intended’
`use for the claimed dosing regimen and is non-limiting.” Pet. 17 (citing
`Bristol-Myers Squibb Co. v. Ben Venue Lab’ys, Inc., 246 F.3d 1368, 1375
`
`16
`
`
`
`IPR2021-00881
`Patent 9,254,338 B2
`(Fed. Cir. 2001)). Petitioner further asserts that the preamble provides no
`antecedent basis for any other claim element, nor results in a manipulative
`difference in the steps of the claims. Id. at 20 (citing In Re: Copaxone
`Consol. Cases, 906 F.3d 1013, 1023 (Fed. Cir. 2018)).
`Petitioner asserts that even if the Board determines that the preamble
`is limiting, the plain and ordinary meaning of the “method of treating an
`angiogenic eye disorder” does not require a therapeutically effective
`treatment. Id. at 20. Rather, Petitioner asserts that the plain and ordinary
`meaning requires “administering a therapeutic to a patient, without a specific
`degree of efficacy required.” Id. at 20–21 (citing, Ex. 1002 ¶ 43).
`Patent Owner disagrees with Petitioner’s proposed construction.
`Prelim. Resp. 32–37. Patent Owner asserts that the preamble is limiting
`because it “sets forth the essence of the invention.” Id. at 32 (citing
`Ex. 1001, Abstract, 2:3–22). According to Patent Owner, the Specification
`confirms “that treatment of an angiogenic eye disorder is the entire purpose
`of the claimed invention.” Id. at 33 (citing Ex. 1001, 1:18–21, 63–66, 3:19–
`20, 7:15–19). Patent Owner asserts that the preamble provides utility to the
`claims and “makes clear that the recited dosing regimen must treat a patient
`with an angiogenic eye disorder.” Id. at 34 (bolding omitted).
`Additionally, Patent Owner asserts that the preamble is limiting
`because it provides an antecedent basis for “the patient” recited in the bodies
`of the independent claims and “angiogenic eye disorders” in dependent
`claims 6, 7, 18, and 20. Id. at 34–35. Patent Owner asserts that “[w]ithout
`the preamble, it would be unclear who is receiving sequentially administered
`doses, i.e., being treated for an angiogenic eye disorder.” Id. at 35 (bolding
`omitted).
`
`17
`
`
`
`IPR2021-00881
`Patent 9,254,338 B2
`Further, Patent Owner contends that the result of a limiting preamble
`is “that the recited method steps produce an effective method of treatment.”
`Id. at 36. Patent Owner further asserts that “the method steps of the body of
`the claim that require administering an initial dose and one or more
`secondary doses must result in efficacy, which is maintained with the
`‘tertiary dose(s).’” Id.
`Having considered the arguments and the evidence, we find, based on
`the current record, that the preamble reciting “[a] method for treating an
`angiogenic eye disorder in a patient” is limiting. Although we agree with
`Petitioner that the preamble sets forth “‘a statement of purpose or intended’
`use for the claimed dosing regimen,” the Federal Circuit has recently
`articulated that its case law does not support a “binary distinction between
`statements of mere intended purpose on the one hand and limiting preambles
`on the other.” Eli Lilly and Company v. Teva Pharms. Int’l GmbH, 8 F.4th
`1331, 1340 (Fed. Cir. 2021). Indeed, the Federal Circuit reiterated that
`“there is no ‘litmus test’ for determining whether a preamble is limiting.”
`Id. (citing Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006)
`and Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808
`(Fed. Cir. 2002)). As the Court instructed, we determine whether to treat a
`preamble as a claim limitation based upon “the facts [in this] case in light of
`the claim as a whole and the invention described in the patent.” Id. (quoting
`Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003)).
`With that said, the Court explained that “while there is no bright-line rule, it
`is instructive that this court has not hesitated to hold preambles limiting
`when they state an intended purpose for methods of using a compound.” Id.
`at 1342.
`
`18
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`IPR2021-00881
`Patent 9,254,338 B2
`Here, the claims are directed to methods of administering, i.e., using,
`a VEGF antagonist for the specific purpose of treating an angiogenic eye
`disorder in a patient. The Specification repeatedly characterizes the method
`as one that is useful for treating angiogenic eye disorders in patients. See
`Ex. 1001, 1: 18–20, 63–66, 2:23–27; 3:19–20; 5:11–13. Apart from the
`preamble, the independent claims do not elsewhere recite or indicate the
`usefulness of the method steps. Thus, we agree with Patent Owner that the
`preamble sets forth the essence of the invention. Prelim. Resp. 32. In
`Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d
`1339 (Fed. Cir. 2003), the Federal Circuit explained that “preamble language
`will limit the claim if it recites not merely a context in which the invention
`may be used, but the essence of the invention without which performance of
`the recited steps is nothing but an academic exercise,” and that this principle
`frequently holds true for method claims. Id. at 1345 (citing Griffin v.
`Bertina, 285 F.3d 1029, 1033 (Fed. Cir. 2002)).
`We also agree with Patent Owner that the preamble provides
`antecedent basis for claim terms “the patient” recited in the body of each
`independent claims, and “angiogenic eye disorders” recited in dependent
`claims 6, 7, 18, and 20. Prelim. Resp. 34–35. As Patent Owner asserts,
`without the preamble, it would be unclear to whom the doses of VEGF are
`administered. See id. at 35.
`Thus, in view of Federal Circuit case law regarding statements of
`intended purpose in claims directed to method of using compositions, and in
`view of the evidence of record, namely, the claim language and the written
`description of the ’338 patent, we preliminarily find that the preambles of
`claims 1 and 14 are limiting.
`
`19
`
`
`
`IPR2021-00881
`Patent 9,254,338 B2
`
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