Trials@uspto.gov
`571.272.7822
`
`Paper 13
`Entered: November 17, 2023
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2023-00884
`Patent 11,253,572 B2
`____________
`
`Before SUSAN L. C. MITCHELL, ROBERT A. POLLOCK, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`Biocon Exhibit 1066 Page 1
`
`
`571.272.7822
`
`Paper 13
`Entered: November 17, 2023
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2023-00884
`Patent 11,253,572 B2
`____________
`
`Before SUSAN L. C. MITCHELL, ROBERT A. POLLOCK, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`Biocon Exhibit 1066 Page 1
`
`
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`IPR2023-00884
`Patent 11,253,572 B2
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`INTRODUCTION
`I.
`Regeneron Pharmaceuticals, Inc. (“Patent Owner”) is the owner of
`U.S. Patent 11,253,572 B2 (“the ’572 patent”). Paper 5, 1. On April 27,
`2023, Samsung Bioepis Co., Ltd. (“Petitioner”) filed a Petition for inter
`partes review challenging the patentability of claims 1–30 (all claims) of the
`’572 patent. Paper 2, 1 (“Pet.”). On August 25, 2023, Patent Owner filed a
`Preliminary Response to the Petition. Paper 7 (“Prelim. Resp.”). With our
`authorization (see Ex. 3001), Petitioner filed a Reply to the Preliminary
`Response to address the issue of the priority date to be accorded the ’572
`patent as it relates to asserted references, and Patent Owner filed a respective
`Sur-Reply.
`Under 37 C.F.R. § 42.4(a), we have authority to determine whether to
`institute trial in an inter partes review. We may institute an inter partes
`review if the information presented in the petition filed under 35 U.S.C.
`§ 311, and any preliminary response filed under § 313, shows that there is a
`reasonable likelihood that Petitioner would prevail with respect to at least
`one of the claims challenged in the petition. 35 U.S.C. § 314.
`After reviewing the parties’ submissions in view of the preliminary
`record, we conclude Petitioner demonstrates a reasonable likelihood it would
`prevail in showing that at least one challenged claim of the ’572 patent is
`unpatentable under the presented grounds. Therefore, we grant institution of
`inter partes review. We note that there are disputed issues in this
`proceeding under 35 U.S.C. § 325(d) and § 314(a) concerning discretionary
`denial; however, we determine institution should be not be denied. See Pet.
`63–68; Prelim. Resp. 49–62. Our reasoning is discussed below.
`
`2
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`A.
`
`REAL PARTIES-IN-INTEREST
`Each party identifies only itself as a real party-in-interest. Pet. 6;
`Paper 3, 1.
`B.
`RELATED MATTERS
`Petitioner identifies the following regarding related matters:
`IPR2022-01524 concerning the ’572 patent (institution denied);
`IPR2021-00881 concerning U.S. Patent 9,254,338; IPR2021-00880
`concerning U.S. Patent 9,669,069; IPR2022-01225 concerning U.S. Patent
`10,130,681; IPR2023-00442 also concerning U.S. Patent 10,130,681;
`IPR2022-01226 concerning U.S. Patent 10,888,601, to which
`IPR2023-00566 is joined; IPR2023-00739 also concerning U.S. Patent
`10,888,601; Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals
`Inc., NDWV-1-22-cv-00061 (NDWV); and United States v. Regeneron
`Pharms., Inc., No. 1:20-cv-11217-FDS (D. Mass.).
`Patent Owner identifies the same matters and adds: IPR2023-00532
`also concerning U.S. Patent 10,130,681; IPR2022-00257 and
`IPR2022-00301 joined with IPR2021-00880; IPR2022-00258 and
`IPR2022-00298 joined with IPR2021-00881; PGR2021-00035 concerning
`U.S. Patent 10,828,345; and appeals to the U.S. Court of Appeals for the
`Federal Circuit (“Fed. Cir.” or “Federal Circuit”) from the Board’s final
`decisions in IPR2021-00880 and IPR2021-00881 in Regeneron
`Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., No. 2023-1395, and
`Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., No. 2023-
`1396. Paper 3, 1–2.
`Regarding the above-noted district court litigation, Regeneron
`Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., NDWV-1-22-cv-
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`00061, the evidence of record indicates, inter alia: (1) Petitioner is not a
`party to this litigation; (2) on April 19, 2023, the District Court entered an
`Order on Claim Construction (discussed infra Section II.B); (3) on April 27,
`2023, Patent Owner expressly stipulated to, inter alia, the invalidity of the
`’572 patent’s claims 1–5, 8–11, 14, and 26–28, reserving rights to appeal;
`and (4) a bench trial was held and all briefing, closing arguments, and post-
`trial briefing is concluded. Ex. 1063 (Order on Claim Construction);
`Ex. 2003 (Bench Trial Transcript); Ex. 2031 (Stipulation); Ex. 2032 (post-
`trial brief); Prelim. Resp. 10–12. Patent Owner states that the parties now
`“await the [D]istrict [C]ourt’s judgment,” and “[a]n expedited appeal is
`likely to follow.” Prelim. Resp. 11–12 (citing Ex. 2031; Ex. 2033; Ex. 2034,
`20:11–19).
`THE ’572 PATENT
`C.
`The ’572 patent issued on February 22, 2022, from U.S. Application
`17/352,892, which was filed on June 21, 2021. Ex. 1001, codes (45), (21),
`(22). The ’572 patent ultimately indicates priority to U.S. Provisional
`Application 61/432,245, filed on January 13, 2011. Id. at code (60), 1:7–29.
`However, priority is an issue raised by the parties in this proceeding and we
`discuss the matter below at Section II.C.
`The ’572 patent’s abstract states:
`The present invention provides methods for treating angiogenic
`eye disorders by sequentially administering multiple doses of a
`VEGF antagonist to a patient. The methods of the present
`invention include the administration of multiple doses of a
`VEGF antagonist to a patient at a frequency of once every 8 or
`more weeks. The methods of the present invention are useful
`for the treatment of angiogenic eye disorders such as age related
`macular degeneration, diabetic retinopathy, diabetic macular
`
`4
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`edema, central retinal vein occlusion, branch retinal vein
`occlusion, and corneal neovascularization.
`Id. at Abstract.
`As background, the ’572 patent states that “[r]elease of vascular
`endothelial growth factor (VEGF) contributes to increased vascular
`permeability in the eye and inappropriate new vessel growth,” and
`“inhibiting the angiogenic-promoting properties of VEGF appears to be an
`effective strategy for treating angiogenic eye disorders.” Id. at 1:60–65. As
`further background, the ’572 patent identifies that “FDA-approved
`treatments of angiogenic eye disorders such as AMD and CRVO include the
`administration of an anti-VEGF antibody called ranibizumab (Lucentis®,
`Genentech, Inc.) on a monthly basis by intravitreal injection.” Id. at 1:66–
`2:2. The ’572 patent indicates that its invention is a response to the need for
`“new administration regimes” of “less frequent dosing while maintaining a
`high level of efficacy.” Id. at 2:6–9.
`In summarizing its invention, the ’572 patent states:
`The 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. Thus, according to the methods of the present
`invention, each secondary dose of VEGF antagonist is
`administered 2 to 4 weeks after the immediately preceding
`dose, and each tertiary dose is administered at least 8 weeks
`after the immediately preceding dose.
`Id. at 2:22–33. The ’572 patent defines certain terms relevant to the above
`passage. The Specification states, for example, that “the VEGF antagonist
`comprises one or more VEGF receptor-based chimeric molecule(s), (also
`
`5
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`referred to herein as a ‘VEGF-Trap’ or ‘VEGFT’),” and that an exemplary
`VEGF antagonist includes “aflibercept,” marketed as “EYLEA” by
`Regeneron Pharmaceuticals, Inc. and approved by the FDA in November
`2011, at a dose of 2 mg via intravitreal injection every 4 weeks for three
`months and then every 8 weeks. Id. at 2:47–67.
`Regarding a dosing regimen, the ’572 patent further defines the terms
`(ultimately used in the claims) “initial dose, “secondary doses,” and “tertiary
`doses” as follows:
`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.
`Id. at 3:51–58. As discussed below at Section II.B.1, we interpret these
`terms in accordance with these express definitions in the Specification.
`The ’572 patent describes a series of Examples detailing clinical trials
`conducted to validate the VEGFT drug and the dosing regimen. Id. at 8:12–
`18:3. Example 4 details two “Phase III Clinical Trials of the Efficacy,
`Safety, and Tolerability of Repeated Doses of Intravitreal VEGFT in
`Subjects with Neovascular Age-Related Macular Degeneration” (AMD)
`(Study 1 and Study 2), which employed a dosing regimen for aflibercept
`comprising an initial 2 mg dose, followed by two 4-week doses, and then
`additional doses every 8-weeks through the end of the 52-week study (the
`“2Q8” regimen). Id. at 9:29–14:30. The results of this and other regimens
`were compared to subjects administered 0.5 mg ranibizumab every 4 weeks
`(the “RQ4” regimen) by assessing patients’ visual acuity based on a Best
`Corrected Visual Acuity (BCVA) test, which is based on the ability to
`identify letters. Id. at 9:35–10:7. This disclosure describes the inclusion
`
`6
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`criteria and exclusion criteria for the participating patients. Id. at 10:50–
`12:22.
`Results of the Example 4 clinical trials are described in TABLE 1,
`which we reproduce below:
`
`
`
`Id. at 13:9–27. According to the ’572 patent, these results showed that the
`VEGFT therapies usually maintained or improved visual acuity in patients
`and were not inferior to the ranibizumab treatment based on similar criteria.
`Id. at 13:28–38.
`As Example 5, the ’572 patent describes a Phase 2 clinical trial using
`the same drug, also administered at 2 mg doses and, in one arm of the trial,
`at a regimen of three initial doses every four weeks followed by doses every
`eight weeks, but treating patients with diabetic macular edema (DME). Id.
`
`7
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`at 14:32–15:5. The ’572 patent describes that visual acuity in this trial was
`maintained or improved for all VEGFT study groups. Id.
`The ’572 patent concludes with 30 claims, of which claims 1, 15, 26,
`and 29 are independent claims. Ex. 1001, 23:2–25:5. Claim 1 is illustrative:
`1. A method of treating an angiogenic eye disorder in a
`patient in need thereof comprising sequentially administering to
`the patient by intravitreal injection a single initial dose of 2 mg
`of aflibercept, followed by one or more secondary doses of
`2 mg of aflibercept, followed by one or more tertiary doses of
`2 mg of aflibercept;
`wherein each secondary dose is administered
`approximately 4 weeks following the immediately
`preceding dose; and
`wherein each tertiary dose is administered
`approximately 8 weeks following the immediately
`preceding dose;
`wherein the patient achieves a gain in visual acuity
`within 52 weeks following the initial dose.
`Ex. 1001, 23:2–14.
`Independent claim 15 is similar to claim 1 in reciting the same drug,
`dose, and dosing regimen, but is directed to “treating diabetic macular
`edema” (DME) and does not include any language directed to results. Id. at
`23:53–64.
`Independent claim 26 is also similar to claim 1 in reciting the same
`drug, dose, and regimen, but adds that the method treats “age related
`macular degeneration” (AMD) and that “the method is as effective in
`achieving a gain in visual acuity as monthly administration of 0.5 mg of
`ranibizumab by intravitreal injection in human subjects with age-related
`macular degeneration at 52 weeks following the initial dose.” Id. at 24:26–
`44.
`
`8
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`Independent claim 29is also similar to claim 1, and is essentially the
`
`same as claim 26, but differs in requiring effectiveness in “maintaining
`
`visual acuity”rather than a gain therein. Jd. at 24:50—67.
`
`D.
`
`ASSERTED GROUNDS FOR UNPATENTABILITY
`
`Petitioner asserts the following groundsfor the unpatentability of
`
`claims 1—30 ofthe ’572 patent:
`
`Claims Challenged|35 U.S.C.§!|_Reference(s)/Basis
`2009 PR? or Dec. 2010
`
`| 1020)|ppindal
`1-5, SI,16, 17,
`102(a)
`Dec. 2010 PR
`
`Nov. 2010 PR*
`
`! The parties contest thepriority date to be accorded the ’572 patent;
`however, as explained herein, we agree with Patent Ownerthat all claims
`should be accordedat least a January 21, 2011, priority date, which is before
`the AIA revisionsto 35 U.S.C. §§ 102 and 103 took effect on March 16,
`2013. 35U.S.C. § 100 (note). Therefore, pre-AIA § 102 and § 103 apply.
`
`? Regeneron, Enrollment Completed in Regeneron and Bayer HealthCare
`Phase 3 Studies ofVEGF Trap-Eyein Neovascular Age-Related Macular
`Degeneration (Wet AMD)(Sept. 14, 2009) (Ex. 1005, “2009 PR”).
`3 Regeneron, Regeneron andBayerReport Positive Results for VEGF Trap-
`Eye in Phase 3 Study in Central Retinal Vein Occlusion (CRVO)and in
`Phase 2 Study in Diabetic Macular Edema(DME) (Dec. 20, 2010)
`(Ex. 1006, “Dec. 2010 PR”).
`
`4 Regeneron, Bayer andRegeneron Report Positive Top-Line Results of
`TwoPhase 3 Studies with VEGF Trap-Eyein Wet Age-related Macular
`Degeneration (Nov. 22, 2010) (Ex. 1007, “Nov. 2010 PR”).
`
`Biocon Exhibit 1066 Page 9
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`Biocon Exhibit 1066 Page 9
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`16, 17, 20, 21
`
`6, 7, 12, 13
`
`CATT, ?° PIER, =
`
`103(a)
`
`103(a)
`
`103(a)
`
`Claims Challenged|35 U.S.C. §! Reference(s)/Basis
`
`1-5, 8-11, 26-30
`Dixon,* 2006 PR®
`2009 PR, 2007 ARVO,”
`Dixon, 2010 ARVO®
`Dixon, Hecht,’ 2006
`PR. Dec. 2010 PR
`Dec. 2010 PR, Hecht,
`2009 PR, 2007 ARVO,
`Dixon, 2010 ARVO
`Dixon, Dec. 2010 PR,
`
`18, 19, 22, 23
`
`Po
`
`> James A. Dixonet5JamesA.Dixonetal.J, VEGFTrap-Eyeforthetreatmentofneovascular
`age-related macular degeneration, 18(10) EXPERT OPIN. INVESTIG. DRUGS
`1573-80 (2009) (Ex. 1009, “Dixon”).
`° Regeneron Phamm., Regeneron Reports Positive Phase 1 Data for the
`VEGFTrap in Age-Related Macular Degeneration, Prelimmary results show
`improvements in vision and retinal swelling, VEGF Trap waswell tolerated
`at all dose levels, Companyalso announcesinitiation ofphase2 trial (May1,
`2006) (Ex. 1027, “2006 PR”).
`7D.V. Do et al., ARVO Annual MeetingAbstract, Results ofa PhaseI Study
`ofIntravitreal VEGFTrap in Subjects with Diabetic Macular Edema: The
`CLEAR-ITDMEStudy, 48 Investigative Ophthalmology & Visual Sci. 1430
`(May 2007) (Ex. 1030, “2007 ARVO’).
`8 J.C. Major, Jr. & D.M. Brown, ARVO AnnualMeeting Abstract, DA
`VINCI: DME and VEGFTrap-Eye:Investigation ofClinicalImpact: Phase
`2 Study in Patients with Diabetic Macular Edema (DME), 51 Investigative
`Ophthalmology & Visual Sci. 6426 (April 2010) (Ex. 1010, “2010 ARVO’).
`
`° Gerald Hecht, PhD, OphthalmicPreparations, in I] REMINGTON: THE
`SCIENCE AND PRACTICE OF PHARMACY,19" ed., Ch. 89, 1563-76 (Alfonso
`R. Gennaro ed., 1995) (Ex. 1016, “Hecht’).
`
`10 CATTand PIERreferto clinical trials conceming ranibizumab and
`bevacizumab,andare describedin the Petition as encompassing Exhibits
`1020-1026.
`
`11 WO 2006/047325 A] (publishedMay 4, 2006) (Ex. 1017, “Shams”).
`
`10
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`Claims Challenged|35 U.S.C. §! Reference(s)/Basis
`
`poEman 2010 1-5, 8-11, 26-30
`
`1-5, 8-11, 26-30
`
`2009 PR
`
`See Pet. 11-13.
`
`In support ofthese grounds for unpatentability Petitioner submits,
`
`inter alia, the Declaration ofEdward Chaum, MD. Ex. 1002. Patent Owner
`
`submits, inter alia, the Declaration ofRichard Manning, PhD, both in
`
`public-redacted form andin confidential-sealed form. Ex. 2001. In the
`
`absenceofevidenceto the contrary, we find on the record before us that
`
`Drs. Chaum and Manningare competentto testify on the subject matter of
`
`their declarations. See Ex. 1002 §§] S—13, 22—25; Ex. 1003; Ex. 1003; Ex.
`
`2001 §| 1-11, CV (at pages 139-150). Dr. Manning indicates he was
`
`retainedby Patent Ownerto “testify concerning commercial success,” a
`
`topic about which wefind no argumentin the Preliminary Response. Ex.
`
`2001 § 9; see generally Prelim. Resp.
`
`II. DISCUSSION
`
`Patent Ownerdescribes Petitioner as taking a “kitchen sink approach”
`
`to the asserted unpatentability grounds, which we understand to be an
`
`argumentthat Petitioner is overly inclusive. Prelim. Resp. 20. As listedand
`
`summarized above andin the Petition, Petitioner has expressly numbered
`
`eleven separate grounds for its unpatentability challenges. See supra Section
`
`LD; see also Pet. 11-13. However, depending upon how oneinterprets
`
`12 Michael J. Elman et al., Randomized Trial Evaluating Ranibizumab Plus
`Promptor Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic
`Macular Edema, 1 17(6) OPHTHALMOLOGY 1064—77 (June 2010) (Ex. 1018,
`“Elman 2010”).
`
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`Petitioner’s challenges, there are potentially many more asserted
`unpatentability grounds because the Petition includes prior art assertions in
`the alternative (e.g., anticipation by one reference or another) and reference
`combinations in the alternative (e.g., obviousness over one reference
`individually or in view of another or several others) and, more than once,
`includes “and/or” conjunctions when listing proposed reference
`combinations asserted against claims (e.g., obviousness over one reference
`in view of one or several others and/or another reference, or references, on
`occasion merely incorporated by reference from other grounds).
`By statute, petitions for inter partes review are required to identify
`“with particularity, each claim challenged, the grounds on which the
`challenge to each claim is based, and the evidence that supports the grounds
`for the challenge to each claim.” 35 U.S.C. § 312(a)(3); see also 37 C.F.R.
`§ 42.104(b) (specifying necessary elements of a petition). Consistent with
`such requirements, the Board’s Trial Practice Guide advises that petitioners
`should “avoid submitting a repository of all the information that a judge
`could possibly consider, and instead focus on concise, well-organized, easy-
`to-follow arguments supported by readily identifiable evidence of record.”
`Consolidated Trial Practice Guide (Nov. 2019), at 39 (“CTPG”).13
`The particularity requirement is “of the utmost importance” because a
`detailed and clear explanation of the challenge at the outset is necessary to
`complete the trial within the statutorily prescribed time frame. Intelligent
`Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359,1369 (Fed. Cir.
`2016). Moreover, as explained in Adaptics, the “all-or-nothing” nature of
`
`
`13 Available at www.uspto.gov/sites/default/files/documents/tpgnov.pdf.
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`12
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`institution decisions following SAS Institute Inc. v. Iancu, 138 S.Ct. 1348
`(2018), 14 gives heightened importance to the statutory requirement for
`particularity in an IPR petition. Adaptics Limited v. Perfect Co., IPR2018-
`01596, Paper 20, at 17–18 (PTAB Mar. 6, 2019) (informative) (quoting SAS
`Q&As (June 5, 2018), at Part D, Question D2).15
`The petition at issue in Adaptics asserted ten prior art references
`against nine patent claims in five grounds, two of which were for
`anticipation and three for obviousness. Id. at 2, 6, 8–9. The three numbered
`obviousness grounds, however, relied on “up to ten references connected by
`the conjunction ‘and/or,’” which made the challenge unclear and resulted in
`“a multiplicity of grounds” that were “voluminous and excessive.” Id. at
`18–21. Accordingly, the Board denied institution because the petition’s
`“lack of particularity . . . result[ed] in voluminous and excessive grounds.”
`Id. at 18, 24.
`Following Adaptics, the Board has consistently denied petitions that
`asserted inordinately large numbers of ambiguous grounds. See, e.g.,
`EnergySource Minerals, LLC v. TerraLithium LLC, IPR2019-01607, Paper
`10 (PTAB May 4, 2020) (denying institution where the use of “and/or” in
`listing the references applied under obviousness grounds in the petition led
`to voluminous, excessive, and ambiguous grounds); Sinjimoru v. Geneze
`
`
`14 See SAS, 138 S.Ct. at 1355 (holding that under § 314, the Board has “a
`binary choice—either institute review or don’t”); see also CTPG at 64 (“In
`instituting a trial, the Board will either (1) institute as to all claims
`challenged in the petition and on all grounds in the petition, or (2) institute
`on no claims and deny institution.”).
`15 Available at www.uspto.gov/sites/default/files/documents/
`sas_qas_20180605.pdf.
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`13
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`Innovation Inc., IPR2021-00493, Paper 8 (PTAB July 28, 2021) (denying
`institution where the petition purported to present 32 grounds, but, because
`many of those grounds asserted multiple statutory bases and multiple
`combinations of references, the petition actually advanced 205 different
`grounds); Playtika Ltd. and Playtika Holding Corp. v. NexRF Corp.,
`IPR2021-00952, Paper 14, at 11, 12 (PTAB Nov. 6, 2021) (denying
`institution where the petition “challenges ten claims by combining eight
`references in various permutations to arrive at 96 grounds” and where the
`grounds are unclear because petitioner “lumps together the discussion of
`large numbers of grounds under a single heading” thereby obscuring the
`specific arguments advanced); IPR2023-00738, Uber Technologies, Inc. et
`al. v. Surgetech, LLC, Paper 8 (PTAB Oct. 23, 2023) (denying institution
`where the petition lumped together multiple grounds into a single claim
`chart that identified every prior art reference teaching any claim element
`and, arguably, asserted thousands of possible unpatentability grounds).
`The Petition here poses some of the same challenges found to be a
`reason to deny institution in other cases before the Board. As noted above,
`there are potentially many more than the eleven numbered grounds asserted
`for unpatentability and the style and wording of some of Petitioner’s grounds
`suggest a questionable ambiguity in the Petition. Despite this potential
`infirmity, however, we find good reasons to institute trial here.
`First, as discussed in detail below, we find that certain of Petitioner’s
`grounds present compelling merits for the unpatentability of at least some
`challenged claims.
`Second, and importantly, Patent Owner identifies Petitioner’s “kitchen
`sink approach,” but does not argue that this should be a basis for denying
`
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`institution. See generally Prelim. Resp. If Patent Owner does not anticipate
`it will be overly burdened in presenting a full defense against the challenges
`in the Petition, we will likewise undertake entering a final decision in this
`matter.
`Therefore, we interpret Petitioner’s grounds in a manner so that we
`may reasonably deal with each and all of the unpatentability challenges. We
`will follow Petitioner’s express listing of grounds and include thereunder,
`respectively, any and all references listed under each numbered ground. For
`any proposed combination of prior art listed in the Petition’s summary of
`Grounds of Challenge we interpret the asserted prior art combination to
`include every reference listed under the numbered obviousness ground. For
`example, under Petitioner’s Ground V (5), we interpret the proposed
`combination of references to include 2009 PR, 2007 ARVO, Dixon, and
`2010 ARVO because each is listed under this Ground. If, under our final
`analysis in view of a complete trial record, certain references are found to be
`unnecessary to render a final decision on a challenge of unpatentability, or if
`certain references are shown to not be prior art (as presently asserted by
`Patent Owner), we will so note it in our final decision, as necessary.
`Any other manner of interpreting Petitioner’s obviousness grounds
`would render the Petition overly ambiguous and too unwieldy to institute
`trial. If, upon considering this and our analysis in this Institution Decision,
`Petitioner determines that certain grounds for unpatentability are no longer
`necessary to its case or do not require a final decision, we encourage
`Petitioner to expressly abandon such challenges at trial.
`
`15
`
`Biocon Exhibit 1066 Page 15
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`
`A.
`
`LEVEL OF ORDINARY SKILL IN THE ART
`In determining the level of ordinary skill in the art, we consider the
`types 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 Accs., Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir.
`1986).
`Petitioner asserts that the level of ordinary skill in the art should be
`defined here consistent with related IPR2021-00881 concerning U.S. Patent
`9,254,338 and IPR2022-01226 concerning U.S. Patent 10,888,601, as
`follows:
`A POSA here would have: (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.
`Pet. 16–17 (citing Ex. 1002 ¶¶ 22–25). This is also consistent with the
`proposed and adopted definition in IPR2022-01524. Patent Owner expressly
`adopts this proposed definition of the ordinarily skilled artisan for the
`purposes of this proceeding (at this point). Prelim. Resp. 13.16
`
`16 The parties use the acronym “POSA” to refer to the ordinarily skilled
`artisan. Prelim. Resp. 13; see also Pet. 40 (for example).
`
`16
`
`Biocon Exhibit 1066 Page 16
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`
`
`For the purposes of this Decision, we accept Petitioner’s proposed
`definition of the person of ordinary skill in the art (or ordinarily skilled
`artisan), which appears to be consistent with the level of skill in the art
`reflected in the prior art of record and the disclosure of the ’572 patent. See
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art
`itself [may] reflect[]” evidence of the ordinary level of skill in the art)
`(quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,
`163 (Fed. Cir. 1985)).
`B. CLAIM CONSTRUCTION
`The Board interprets claim terms in an inter partes review using the
`same claim construction standard used to construe claims in a civil action in
`federal district court. 37 C.F.R. § 42.100(b). In construing claims, district
`courts and the Board here, by default, give claim terms their ordinary and
`customary meaning, which is “the meaning that the term would have to a
`person of ordinary skill in the art in question at the time of the invention.”
`Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc).
`Should claim terms require express construction, sources for claim
`interpretation include “the words of the claims themselves, the remainder of
`the specification, the prosecution history[, i.e., the intrinsic evidence], and
`extrinsic evidence concerning relevant scientific principles, the meaning of
`technical terms, and the state of the art.” Id. at 1314 (quoting Innova/Pure
`Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed.
`Cir. 2004)). “[T]he claims themselves [may] provide substantial guidance as
`to the meaning of particular claim terms.” Id. However, the claims “do not
`stand alone,” but are part of “‘a fully integrated written instrument’ . . .
`consisting principally of a specification that concludes with the claims,” and,
`
`17
`
`Biocon Exhibit 1066 Page 17
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`
`therefore, the claims are “read in view of the specification.” Id. at 1315
`(quoting Markman v. Westview Insts., Inc., 52 F.3d 967, 978–79 (Fed. Cir.
`1995) (en banc)). Any special definition for a claim term must be set forth
`in the specification “with reasonable clarity, deliberateness, and precision.”
`In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Without such a special
`definition, however, limitations may not be read from the specification into
`the claims. In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993).
`“[W]e need only construe terms ‘that are in controversy, and only to
`the extent necessary to resolve the controversy.’” Nidec Motor Corp. v.
`Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
`(quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999)).
`“initial dose,” “secondary doses,” and “tertiary doses”
`1.
`Although neither party requests such express interpretation, for the
`sake of consistency with our decision denying institution in IPR2022-01524,
`we repeat the following interpretations for claim language expressly defined
`in the ’572 patent’s Specification.
`One or all of the terms “initial dose,” “secondary doses,” and “tertiary
`doses,” are included in every claim. See Ex. 1001, 23:1–25:5 (claims). The
`’572 patent expressly defines the claim terms “initial dose,” “secondary
`doses,” and “tertiary doses,” in its Specification, 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
`
`18
`
`Biocon Exhibit 1066 Page 18
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`
`
`all contain the same amount of VEGF antagonist, but will
`generally differ from one another in terms of frequency of
`administration. In certain embodiments, however, the amount
`of VEGF antagonist contained in the initial, secondary and/or
`tertiary doses will vary from one another (e.g., adjusted up or
`down as appropriate) during the course of treatment.
`Pet. 16 (quoting Ex. 1001, 3:51–65; citing Ex. 1002 ¶ 62).
`“When the specification explains and defines a term used in the
`claims, without ambiguity or incompleteness, there is no need to search
`further for the meaning of the term.” Multiform Dessicants Inc. v. Medzam
`Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998).
`The Specification of the ’572 patent expressly and unequivocally
`defines the claim terms “initial dose,” “secondary doses,” and “tertiary
`doses,” as set forth in the quote above, as meaning, respectively, (1) the dose
`which is administered at the beginning of the treatment regimen; (2) the
`doses administered after the initial dose; and (3) the doses administered
`after the secondary doses. We interpret these terms consistent with the
`Specification’s definitions.
`Preambles: “A method of treating . . .”
`2.
`There are three claim terms addressed by the parties for claim
`construction, the first of which concerns the preambles of independent
`claims 1, 15, 26, and 29, each of which recites “[a] method of treating . . .” a
`disorder “in a patient in need”––“an angiogenic eye disorder” in claim 1,
`“diabetic macular edema” or DME in claim 15, and “age related macular
`degeneration” or AMD in claims 26 and 29 (although in claim 29 a hyphen
`is included between age and related
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