• Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution denied
  PTAB · Dec 30, 2022 · IPR2022-01115 · APJ Susan L C Mitchell · IPR · Institution

  The Board denied institution on all grounds because Petitioner did not show a reasonable likelihood of proving the challenged claims obvious, including the claimed tagging efficiency.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented by the parties, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field, and have at least about two years of experience in the use and development of sequencing technologies; or (ii) a Master’s degree in one of the same fields with at least about five years of the same experience.” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Petitioner sets forth a proposed construction for “a number of double- stranded cfDNA molecules that map to the mappable base position,” recited in claim 1. Pet. 18–19. Petitioner asserts that a “POSA [person of ordinary skill in the art] would understand that the number of double-stranded cfDNA molecules that map to the mappable base position will vary, depending on the number of haploid genome equivalents (HGEs) in the sample.” Id. at 19 (citing Ex. 1002 ¶¶ 133–136). Patent Owner does not dispute Petitioner’s construction. Prelim. Resp. 32–33. that it is unnecessary to expressly construe any claim terms for purposes of rendering this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable

    “40–60% tagging efficiency, Petitioner fails to sufficiently explain why a person of ordinary skill in the art would have expected Meyer’s tagging efficiency to apply to Schmitt’s DCS method when used with Narayan’s sequencing of cfDNA. For example, Petitioner fails to address the differences between Meyer’s adapters and Schmitt’s adapters and how those differences affect the tagging efficiency. Meyer’s barcodes comprise “single self-hybridized palindromic oligonucleotides, carrying an Srf I restriction site in the middle (GCCCGGGC), a sequence tag at the 3’ end and the reverse complementary tag sequence at the 5’ end.” Ex. 1005, Fig. 1. Schmitt, on the other hand, teaches a “hybrid method” of tagging that uses a combination of the sheared ends of the DNA fragments and a “shorter n-mer the adaptor.” Ex. 1009 ¶ 38.” slip op. at 14

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,801,063
• Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution denied
  PTAB · Dec 30, 2022 · IPR2022-01116 · APJ Tina E Hulse · IPR · Institution

  The Board denied institution on all challenged claims because Petitioner did not show a reasonable likelihood that the claims were obvious over the asserted prior art.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented by the parties, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we decline to institute an inter partes review of any claim of the ’858 patent on any ground.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field, and have at least about two years of experience in the use and development of sequencing technologies; or (ii) a Master’s degree in one of the same fields with at least about five years of the same experience.” slip op. at 6

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Petitioner sets forth a proposed construction for “a number of double- stranded cfDNA molecules that map to the mappable base position,” recited in claims 22 and 24. Pet. 19. Petitioner asserts that a “POSA would understand that the number of double-stranded cfDNA molecules that map to the mappable base position will vary, depending on the number of haploid genome equivalents (HGEs) in the sample.” Id. (citing Ex. 1002 ¶¶ 133– 136). Patent Owner does not dispute Petitioner’s constructions. Prelim. Resp. 24. that it is unnecessary to expressly construe any claim terms for purposes of rendering this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 7

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

    “40–60% tagging efficiency, Petitioner fails to explain sufficiently why a person of ordinary skill in the art would have expected Meyer’s tagging efficiency to apply to Schmitt’s DCS method when used with Narayan’s sequencing of cfDNA. For example, Petitioner fails to address the differences between Meyer’s adapters and Schmitt’s adapters and how those differences affect the tagging efficiency. Meyer’s barcodes comprise “single self-hybridized palindromic oligonucleotides, carrying an Srf I restriction site in the middle (GCCCGGGC), a sequence tag at the 3’ end and the reverse complementary tag sequence at the 5’ end.” Ex. 1005, Fig. 1. Schmitt, on the other hand, teaches a “hybrid method” of tagging that uses a combination of the sheared ends of the DNA fragments and a “shorter n-mer tag (such as 1 or 2 or 3 or 4 or more degenerate or semi-degenerate bases) in the adaptor.” Ex. 1009 ¶ 38. Moreover, as Patent Owner notes, Petitioner is silent as to how the references’ different starting sample sizes affect tagging efficiency. Prelim. Resp. 37–38. According to the KAPA data sheet submitted by Petitioner, “[t]he proportion of fragmented DNA that is successfully converted to adapter-ligated molecules decreases as input is reduced.” Ex. 1015, 4. The KAPA data sheet states that “[w]hen starting library construction (end repair) with >100 ng fragmented DNA, 15–40% of input DNA is typically recovered as adapter-ligated molecules, whereas the recovery typically ranges from 0.5 to 15% for libraries constructed from 100 pg–100 ng DNA.”” slip op. at 14

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,889,858
• Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution denied
  PTAB · Dec 13, 2022 · IPR2022-01152 · APJ Michael A Valek · IPR · Institution

  The Board denied institution on all challenged claims because Petitioner did not show a reasonable likelihood that Narayan and Schmitt taught or suggested the claimed use of unpaired reads.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented by the parties, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we decline to institute an inter partes review of any claim of the ’221 patent on any ground.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field, and have at least about two years of experience in the use and development of sequencing technologies; or (ii) a Master’s degree in one of the same fields with at least about five years of the same experience. Pet. 19 (citing Ex. 1002 ¶¶ 27–30). Patent Owner does not offer a proposed definition of the level of ordinary skill in the art at this stage of the proceeding. On this record, we adopt Petitioner’s uncontested definition of the level of ordinary skill in the art. We further note that the prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

    “Regarding the phrase “a number of double-stranded cfDNA molecules that map to the mappable base position” in claims 6 and 18, Petitioner contends a “POSA would understand that the number of double-stranded cfDNA molecules that map to the mappable base position will vary, depending on the number of haploid genome equivalents (HGEs) in the sample” and generally be equal to the amount of HGEs. Pet. 20, (citing Ex. 1002 ¶¶ 133–136). Patent Owner does not dispute Petitioner’s understanding, but contends no construction is necessary at this stage. See Prelim. Resp. 30 We agree with Patent Owner that it is unnecessary to expressly construe any claim terms for purposes of rendering this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “The Petition frames Ground 1 as the combination of Schmitt’s DCS with Narayan’s cfDNA. See Pet. 33–36. It relies on Schmitt’s “methods of error correction for NGS by generating duplex consensus sequences (i.e., reducing or tracking redundancy in sequence reads)” as Petitioner’s alleged motivation for that combination. Id. at 33–34; see also id. at 37 (arguing that a POSA would have had a reasonable expectation of success because “the prior art expressly taught that DCS could enhance accuracy when sequencing cfDNA”) (internal quotations omitted). According to Schmitt, the error correction and improved accuracy of DCS results from grouping reads into paired families in order to “capitalize[] on the redundant information stored in double-stranded DNA, thus overcoming technical limitations of prior methods utilizing data from only one of the two strands.” Ex. 1083, 47 (Abstract); see also id. ¶¶ 7, 43. Thus, Petitioner’s theory of unpatentability is inextricably tied to DSC’s use of paired reads, as opposed to unpaired reads, to generate consensus sequences. To the extent Petitioner contends that the collapsing of reads into SSCSs prior to the formation of Schmitt’s double-stranded consensus sequences discloses the use of unpaired reads, such a theory is not sufficiently supported on the current record. The portions of Schmitt the Petition relies on for element 1(e) describe the use of paired families to generate a double-stranded consensus sequence. See Pet. 31–33 (citing Ex. 1083 ¶¶ 13, 60, 68, Fig. 3). For example, Petitioner points to the” slip op. at 16

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,118,221
• Genus PLC v. Inguran, LLCAll claims unpatentable
  PTAB · Dec 8, 2022 · IPR2021-01027 · APJ Ulrike W Jenks · IPR · Final written decision

  Claims 1–5 are unpatentable as obvious over Dekkers, Maxwell, Garner, and Kim; the Board did not reach the alternative obviousness grounds.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Patent Owner agrees with Petitioner’s first portion of the definition, specifically, that a person of ordinary skill in the art would have had at least “an undergraduate or graduate degree in genetics, genomics, and/or animal breeding, along with several years of relevant applied research and/or industry work experience in the same fields, including in swine.” PO Resp. 16. Patent Owner, however, objects to the inclusion of the second portion of Petitioner’s definition because it is “improperly injecting a purported knowledge of the claimed invention into the definition of a” person of ordinary skill in the art. Id. at 17 (citing Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362 (Fed. Cir. 2016); In re Sang Su Lee, 277 F.3d 1338, 1345 (Fed. Cir. 2002)); Sur-reply 2–4. Petitioner responds, that its proposed definition reflects the level of skill in the art as supported by the various cited prior art. Pet. Reply. 5. Having considered the arguments and evidence, we agree with Patent Owner that Petitioner’s definition of one of ordinary skill in the art unnecessarily recites specific knowledge, whereas the art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Accordingly, we agree with Patent Owner and determine that one of ordinary skill in the art is a person having at least “an undergraduate or graduate degree in genetics, genomics, and/or animal breeding, along with several years of relevant applied research and/or industry work experience in the same fields, including in swine” and this definition is reasonably consistent with the ’734 patent and the prior art of record.” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner

    “Having considered the record as a whole, we determine that Petitioner’s position with respect to the interpretation of “genetic nucleus” is reasonably supported within the record. At oral argument, however, Petitioner acknowledged that omitting the language “wherein certain offspring of the herd are used for breeding within the herd” from the claim construction would not change whether the challenged claims read on the applied references. See Tr. 14:6–16:28. Because the additional language proposed by Petitioner is unnecessary in order to resolve the disputed issues in this case, we do not adopt it here. We, therefore, construe “genetic nucleus” as an animal herd comprising one or more lines and positioned at the top of a multi-level pyramidal hierarchy of herds in a commercial herd breeding structure. 2. Remaining Claim Terms We find that it is unnecessary to expressly construe any remaining claim terms for purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). D. Ground 1A: Anticipation of Claims 1–5 by Dekkers, as evidenced by either Maxwell or Garner (claims 1–4), or Kim (claim 5)” slip op. at 13

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “We agree with Patent Owner that in an anticipation challenge under 35 U.S.C. § 102, Petitioner cannot rely upon specific disclosures in Maxwell or Gardner based on the generic reference to these publications cited Dekkers. Merely citing Maxwell or Gardner in association with sorting sperm as discussed in Dekkers is not incorporation by reference with any level of particularity. See PO Resp. 29 (citing Callaway Golf Co. v. Acushnet Co., 576 F.3d 1331, 1346 (Fed. Cir. 2009) (To incorporate matter by reference, “a host document must contain language clearly identifying the subject matter which is incorporated and where it is to be found; a mere reference to another application, or patent, or publication is not an incorporation of anything therein.” (internal quote and citations omitted, emphasis in original)); see also Cook Biotech Inc. v. Acell, Inc., 460 F.3d 1365, 1376 (Fed. Cir. 2006) (“To incorporate material by reference, the host document must identify with detailed particularity what specific material it incorporates and clearly indicate where that material is found in the various documents.”). The disclosure in Dekkers relied on by Petitioner recites: “The technique involves the separation of spermatozoa carrying either X or Y chromosomes (Maxwell et al., 2004; Garner, 2006).” Ex. 1004, 396. We note that Maxwell and Garner are review articles discussing the state of sperm sexting technology generally. See Ex. 1005; Ex. 1006. We agree with Patent Owner that the generic citation to these review articles as set out in Dekkers is not an incorporation by reference of any specific detail from these articles. Unlike the disclosures at issue in Callaway and Cook, Dekkers does not use language such as “reference is made to” (Callaway, 576 F.3d at 1346) or “the disclosure of which is expressly incorporated herein by reference” (Cook, 460 F.3d at 1376) in conjunction with identifying a particular portion of the cited reference that our reviewing court has held to be sufficient to indicate to one of skill in the art that the referenced material is fully incorporated in the host document. Because Dekkers does not incorporate by reference the level of sorting accuracy as required by the claims – at least 80% – the preponderance of evidence of record does not support Petitioner’s position the Dekkers anticipates claims 1–5 of the ’734 patent.” slip op. at 19

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “We find that Petitioner has the better position. Here, Patent Owner is identifying the scope of the invention as the commercial tier at the bottom of the pig production pyramid. However, the scope of the claimed invention is directed to the substantially smaller herd sitting at the top of the commercial pig breeding pyramid. As explained in Teva, “[t]he reasonable-expectationof-success analysis must be tied to the scope of the claimed invention. See Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 966 (Fed. Cir. 2014) (“[F]ailure to consider the appropriate scope of the ... claimed invention in evaluating the reasonable expectation of success ... constitutes a legal error ....”); see also Intelligent Bio-Sys., Inc., 821 F.3d at 1367.” Teva, 18 F.4th at 1381. Above, we construed “genetic nucleus” as an animal herd comprising one or more lines and positioned at the top of a multi-level pyramidal hierarchy in a commercial herd breeding structure. See above II.C.1. The herd at the top of the pyramid comprises far fewer animals than the multiplication and production tiers. See Ex. 1097 ¶¶ 65 (“the relatively smaller herd size of the genetic nucleus (e.g., hundreds or thousands as compared to millions at the production level) makes the use of sexed semen far easier than in vastly larger multiplier and production herds”), 84; Ex. 1096, 36:21–37:4; Ex. 2004, 39:6–22 (millions of animals at the production level). Petitioner contends that sperm sorting combined with lowdose insemination would have been practical for the much smaller herds found at the genetic nucleus. Pet. Reply 21. Both Maxwell and Garner reasonably suggest that deep-uterine insemination (DIU) allows for the use of sex sorted boar sperm. See Ex. 1005, 88; Ex. 1006, 952. Patent Owner admits that the use of sex-selected semen in the laboratory environment works. See PO Resp. 39. Even if the genetic nucleus (i.e. nuclear herd) comprises in excess of 100 or even 1000 animals it is not clear why using artificial insemination in conjunction with sex-selection would not work at the level of the genetic nucleus as argued by Patent Owner. See PO Resp. 39 (“sexed semen has not been implemented outside of a research setting”). Absolute predictability is not necessary to reach an obviousness determination; only a reasonable expectation of success is needed. Pharma Stem Therpeutic, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1360 (2007); In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009); In re O’Farrell, 853 F.2d 894, 903–904 (Fed. Cir. 1988) (“Obviousness does not require absolute predictability of success . . . . For obviousness under § 103, all that is required is a reasonable expectation of success.”). In particular, Dekkers teaches that sorted sperm can be used for artificial insemination. Specifically, acknowledging that “new developments in sperm sexing technology allow for the production of either male or female offspring for sire or dam lines, and this can be very useful for the nucleus and multiplication tiers.” Ex. 1004, 396; Ex. 1002 ¶ 48; see also Ex. 1055, 80 (“The main application by pig producers is for the use of sex-sorting technology in nucleus herds, particularly for producing female lines.”). Here, the evidence supports Petitioner’s contentions that given the” slip op. at 32

  Patent outcomesUS 10,542,734 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,542,734
• Nichia Corporation v. Document Security Systems, Inc.Adverse judgment
  PTAB · Nov 18, 2022 · IPR2018-01165 · APJ Barbara A Benoit · IPR · Adverse judgment

  The Board granted adverse judgment against Patent Owner as to claims 16–19 after their statutory disclaimer and terminated the proceeding.

  RulingsAdverse judgment

  • Adverse judgmentAdverse judgmentGranted

    “Moreover, under 37 § C.F.R. 42.73(b), a “party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include . . . disclaimer of a claim such that the party has no remaining claim in the trial.” The only claims before us on remand have been disclaimed. Accordingly, we construe Patent Owner’s disclaimer to be a request for adverse judgment as to those claims which remain before us, which we now grant.” slip op. at 3

  • RemandOther

    “Written Decision to the United States Court of Appeals for the Federal Circuit. Papers 31, 32. The court issued its decision affirming our findings as to all claims except claims 15–19. Nichia Corp. v. Document Sec. Sys., Inc., Nos. 2020-2261, 2020-2287, 2022 WL 1218036, at *1 (Fed. Cir. Apr. 26, 2022). Specifically, the court reversed our determination that Petitioner had not shown independent claim 15 to be unpatentable and remanded for further proceedings regarding dependent claims 16–19. Id. On June 14, 2022, the court issued the formal mandate. Paper 33. On June 23, 2022, Patent Owner statutorily disclaimed claims 16–19 of the ’087 patent. Thus, claims 16–19 are no longer part of this proceeding and no issues remain for us to consider on remand. See Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc., 933 F.3d 1367, 1373 (Fed. Cir. 2019) (noting that disclaiming claims effectively eliminates those claims from the patent as though the disclaimed claims had never existed (internal quotations and citations omitted)); see also Asetek Danmark A/S v. CoolIT Sys., Inc., IPR2020-00747, Paper 42 at 6 (PTAB Sept. 30, 2021) (determining that a proceeding); cf. 37 C.F.R. § 42.107(e) (“No inter partes review will be instituted based on disclaimed claims.”).” slip op. at 2

  None
  Patents in suitUS 7,524,087
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2022-00298 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach the other instituted grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Having considered the arguments and evidence, we maintain that Petitioners’ definition of one of ordinary skill in the art is reasonable and consistent with the ’338 patent and the prior art of record. On the other hand, we find Patent Owner’s definition to be inappropriately limited to those having “firsthand experience” regarding the diagnosis and treatment of angiogenic eye disorders, as explained by Dr. Do. See Ex. 2051 ¶ 28. While it may be that the claimed methods would be performed an ophthalmologist, a person having ordinary skill in the art need not be limited to those more appropriately considers that knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders, may be possessed by other professionals that are not ophthalmologists. Accordingly, we adopt Petitioners’ definition for purposes of this Decision.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “preamble of method claims 1 and 14, i.e., “[a] method for treating an angiogenic eye disorder in a patient” is limiting. Although we agree with Petitioners that the preamble sets forth “‘a statement of purpose or intended’ use for the claimed dosing regimen,” see Pet. 17, that does not the end our inquiry. As noted in the Institution Decision, the Federal Circuit has explained 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). Rather, as the Federal Circuit reiterated, “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 consider 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)).” slip op. at 17

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “or that the administered doses are “therapeutically effective” separately or cumulatively. Instead, the claimed method focuses on treating an angiogenic eye disorder with a specific compound, i.e., a VEGF antagonist, based on a specific temporal regimen, i.e., sequentially administering an initial dose, followed by a prescribed time frame for secondary and tertiary dose(s). As discussed above, we determined that the preamble limits the claims in terms of requiring the doses of VEGF antagonist administered to be for the purpose of treating an angiogenic eye disorder in a patient. We find that the intrinsic evidence supports finding that it is the administration of the VEGF antagonist to such patient for the purpose of providing an improvement of or beneficial effect on their angiogenic eye disorder that satisfies the “treating” portion of the preamble.” slip op. at 19

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “arguments and the evidence, we find that the Specification expressly defines the terms “initial dose,” “secondary doses,” and “tertiary doses.” The Specification states, 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. Ex. 1001, 3:31–38 (emphasis added). 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 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,” and that “the ‘tertiary doses’ are the doses which are administered after the secondary doses.” Ex. 1001, 3:31–38 (emphasis added). Patent Owner has not directed us to any portion of the Specification or other persuasive evidence that supports adding an efficacy requirement to that definition.” slip op. at 24

  Patent outcomesUS 9,254,338 unpatentable
  Claim construction§ 102 anticipationcites Phillips · Graham
  Patents in suitUS 9,254,338
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2022-00258 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Having considered the arguments and evidence, we maintain that Petitioners’ definition of one of ordinary skill in the art is reasonable and consistent with the ’338 patent and the prior art of record. On the other hand, we find Patent Owner’s definition to be inappropriately limited to those having “firsthand experience” regarding the diagnosis and treatment of angiogenic eye disorders, as explained by Dr. Do. See Ex. 2051 ¶ 28. While it may be that the claimed methods would be performed an ophthalmologist, a person having ordinary skill in the art need not be limited to those more appropriately considers that knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders, may be possessed by other professionals that are not ophthalmologists. Accordingly, we adopt Petitioners’ definition for purposes of this Decision.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “preamble of method claims 1 and 14, i.e., “[a] method for treating an angiogenic eye disorder in a patient” is limiting. Although we agree with Petitioners that the preamble sets forth “‘a statement of purpose or intended’ use for the claimed dosing regimen,” see Pet. 17, that does not the end our inquiry. As noted in the Institution Decision, the Federal Circuit has explained 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). Rather, as the Federal Circuit reiterated, “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 consider 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)). Here, the claims are directed to methods of administering, i.e., using, a VEGF antagonist for an intended purpose of “treating an angiogenic eye disorder in a patient.” See Claims 1 and 14, Ex. 1001, 23:2–3; 24:3–4. The angiogenic eye disorders in patients. See, e.g., id. at 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 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. As the Federal Circuit explained in Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339 (Fed. Cir. 2003), “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 find that such is the case here. 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 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 find that the preambles of method claims 1 and 14 are limiting insofar as they require “treating an angiogenic eye disorder in a patient.”” slip op. at 17

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “We begin by noting that the claims do not recite any dosage amounts or that the administered doses are “therapeutically effective” separately or cumulatively. Instead, the claimed method focuses on treating an angiogenic eye disorder with a specific compound, i.e., a VEGF antagonist, based on a specific temporal regimen, i.e., sequentially administering an initial dose, followed by a prescribed time frame for secondary and tertiary dose(s). As discussed above, we determined that the preamble limits the claims in terms of requiring the doses of VEGF antagonist administered to be for the purpose of treating an angiogenic eye disorder in a patient. We find that the intrinsic evidence supports finding that it is the administration of the VEGF antagonist to such patient for the purpose of providing an improvement of or beneficial effect on their angiogenic eye disorder that satisfies the “treating” portion of the preamble. regarding the “Amount of VEGF Antagonist Administered.” See Ex. 1001, 6:29–7:14. In that discussion, the Specification explains, The amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount. As used herein, the phrase “therapeutically effective amount” means a dose of VEGF antagonist that results in a detectable improvement in one or more symptoms or indicia of an angiogenic eye disorder, or a dose of VEGF antagonist that inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder. Id. at 6:48–55 (emphasis added). That description, along with the absence of the phrase “therapeutically effective” in the claims,11 signals for us the inventors’ intention to not limit the claims to the administration of doses that ultimately prove to be therapeutically effective in a given patient. Instead, the Specification describes administration of VEGF antagonist doses for treating angiogenic eye disorder in a manner that encompasses doses that result in disclosed improvements and benefits, referred to as “therapeutically effective amounts,” and doses that do not. Indeed, as guidance, the Specification discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” without any guarantee that any particular dosage regimen administered within that range of dosage amounts will necessarily be “therapeutically effective,” and without limiting the treatment methods based upon such results. Ex. 1001, 6:55–58 (emphasis added).” slip op. at 19

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “arguments and the evidence, we find that the Specification expressly defines the terms “initial dose,” “secondary doses,” and “tertiary doses.” The Specification states, 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. Ex. 1001, 3:31–38 (emphasis added). 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 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,” and that “the ‘tertiary doses’ are the doses which are administered after the secondary doses.” Ex. 1001, 3:31–38 (emphasis added). Patent Owner has not directed us to any portion of the Specification or other persuasive evidence that supports adding an efficacy requirement to that definition.” slip op. at 24

  Patent outcomesUS 9,254,338 unpatentable
  Claim construction§ 102 anticipationcites Phillips · Graham
  Patents in suitUS 9,254,338
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2021-00881 · APJ Erica A Franklin · IPR · Final written decision

  Petitioners proved claims 1, 3–11, 13, 14, 16–24, and 26 unpatentable as anticipated by Dixon; the Board did not reach the other grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Having considered the arguments and evidence, we maintain that Petitioners’ definition of one of ordinary skill in the art is reasonable and consistent with the ’338 patent and the prior art of record. On the other hand, we find Patent Owner’s definition to be inappropriately limited to those having “firsthand experience” regarding the diagnosis and treatment of angiogenic eye disorders, as explained by Dr. Do. See Ex. 2051 ¶ 28. While it may be that the claimed methods would be performed an ophthalmologist, a person having ordinary skill in the art need not be limited to those more appropriately considers that knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders, may be possessed by other professionals that are not ophthalmologists. Accordingly, we adopt Petitioners’ definition for purposes of this Decision.” slip op. at 10

  • Expert testimonyPetitioner expert creditedOther

    “Insofar as Patent Owner relies on the extrinsic testimony of Drs. Do and Brown for that description, we do not assign that testimony persuasive weight as it lacks sufficient evidentiary support. As discussed above, we find Dr. Do’s testimony at odds with the Specification. In particular, for the reasons discussed above regarding the Specification description of the amount of VEGF antagonist administered to the patient, we find troubling not be a treatment.” Ex. 2051 ¶ 46. Additionally, we find much of her testimony regarding the a so-called “high level of efficacy” based on an asserted existing standard of care for angiogenic eye disorder is supported by little more than evidence relating to FDA approvals for Macugen and Lucentis. Dr. Brown’s testimony cited by Patent Owner to support the asserted efficacy requirement, simply relies on Dr. Do’s testimony without discussing any additional evidentiary support.” slip op. at 22

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “preamble of method claims 1 and 14, i.e., “[a] method for treating an angiogenic eye disorder in a patient” is limiting. Although we agree with Petitioners that the preamble sets forth “‘a statement of purpose or intended’ use for the claimed dosing regimen,” see Pet. 17, that does not the end our inquiry. As noted in the Institution Decision, the Federal Circuit has explained 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). Rather, as the Federal Circuit reiterated, “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 consider 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)).” slip op. at 17

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “We begin by noting that the claims do not recite any dosage amounts or that the administered doses are “therapeutically effective” separately or cumulatively. Instead, the claimed method focuses on treating an angiogenic eye disorder with a specific compound, i.e., a VEGF antagonist, based on a specific temporal regimen, i.e., sequentially administering an initial dose, followed by a prescribed time frame for secondary and tertiary dose(s). As discussed above, we determined that the preamble limits the claims in terms of requiring the doses of VEGF antagonist administered to be for the purpose of treating an angiogenic eye disorder in a patient. We find that the intrinsic evidence supports finding that it is the administration of the VEGF antagonist to such patient for the purpose of providing an improvement of or beneficial effect on their angiogenic eye disorder that satisfies the “treating” portion of the preamble. regarding the “Amount of VEGF Antagonist Administered.” See Ex. 1001, 6:29–7:14. In that discussion, the Specification explains, The amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount. As used herein, the phrase “therapeutically effective amount” means a dose of VEGF antagonist that results in a detectable improvement in one or more symptoms or indicia of an angiogenic eye disorder, or a dose of VEGF antagonist that inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder. Id. at 6:48–55 (emphasis added). That description, along with the absence of the phrase “therapeutically effective” in the claims,11 signals for us the inventors’ intention to not limit the claims to the administration of doses that ultimately prove to be therapeutically effective in a given patient. Instead, the Specification describes administration of VEGF antagonist doses for treating angiogenic eye disorder in a manner that encompasses doses that result in disclosed improvements and benefits, referred to as “therapeutically effective amounts,” and doses that do not. Indeed, as guidance, the Specification discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” without any guarantee that any particular dosage regimen administered within that range of dosage amounts will necessarily be “therapeutically effective,” and without limiting the treatment methods based upon such results. Ex. 1001, 6:55–58 (emphasis added).” slip op. at 19

  Patent outcomesUS 9,254,338 unpatentable
  Claim construction§ 102 anticipationcites Phillips · Graham
  Patents in suitUS 9,254,338
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2022-00257 · APJ John G New · IPR · Final written decision

  Claims 1 and 8–12 are unpatentable: Dixon anticipates claims 1 and 9–12 and claim 8, and the Board also finds the claims obvious over Dixon.

  RulingsFinal written decision

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

    “On February 9, 2022, we instituted an inter partes review in IPR2022- 00257 and granted the motion for joinder with IPR2021-00880, adding Celltrion, Inc. as a petitioner in the instant proceeding. Paper 35. On the same date, we also instituted an inter partes in IPR2022-00301 and likewise granted the motion for joinder with IPR2021-00880, adding Apotex, Inc. as a petitioner in the instant proceeding. Paper 36. We refer to Mylan Pharmaceuticals, Inc., Celltrion, Inc. and Apotex, Inc., collectively, as “Petitioner.”” slip op. at 3

  • ExcludeMotion to exclude, deniedDenied

    “We are not persuaded by Petitioner’s argument that the challenged Exhibits are not authenticated. Federal Rule of Evidence 901 sets a relatively low bar for authentication. See Comcast, 2020 WL 4687062, at *28. Rule 901(a) states: “To satisfy the requirement of authenticating or identifying an item of evidence, the proponent must produce evidence sufficient to support a finding that the item is what the proponent claims it is.” Fed. R. Evid. 901(a). By way of example, Rule 901(b)(1) states that a witness with knowledge can provide authenticating testimony that an item is what it is claimed to be. Fed. R. 901(b)(1).” slip op. at 15

  • Strike new argumentNew argument consideredDenied

    “We deny the motion to exclude the referenced argument in Petitioners’ Reply, as well as the invitation to consider the motion as one to strike the argument. As Patent Owner notes in the motion, Patent Owner raised this issue previously in this proceeding. PO Mot. Exclude 5. At that time, we denied Patent Owner’s request for authorization to file a motion to strike the referenced argument in the Reply. It is improper for Patent Owner to now seek to strike the argument in a motion to exclude. A motion to exclude is not the proper vehicle to address arguments or evidence that a party believes exceeds the proper scope of a reply. See USPTO, Consolidated Trial Practice Guide (2019) at 79, available at: https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf?MURL= (last visited October 27, 2022) (“CTPG”). Moreover, as Petitioners correctly assert, Patent Owner has failed to satisfy the prerequisite for filing a motion to exclude by failing to timely file an objection. See 37 C.F.R. 42.64(b)(1); CTPG 78–79. Patent Owner has not been left without an opportunity to address the Reply argument. When we denied authorization to file a motion to strike, we authorized Patent Owner to file, with its Sur-Reply, a table identifying any portion of the Reply that Patent Owner considers to have exceeded the scope of the Reply. Further, we explained that Patent Owner, alternatively, may address that contention, or the merits of any newly-raised arguments or evidence in its Sur-Reply. Indeed, Patent Owner addressed the issue in its 26 Sur-Reply for our consideration. Thus, Patent Owner had sufficient opportunity to identify in its Sur-Reply its contentions regarding Petitioners’ allegedly inappropriate Reply argument and took advantage of that opportunity. That is sufficient for us to consider the issue and determine whether such argument should be disregarded. See CTPG 80.” slip op. at 26

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We find that Petitioner’s definition is the better definition for purposes of this proceeding. We acknowledge that the claims of the ’069 patent are directed to a “method for treating an angiogenic eye disorder in a patient” 29 and that the actual practice of the method would therefore seem to be limited to those who have the ability to treat patients, i.e., physicians, etc. However, we find Patent Owner’s definition to be unduly limiting. Individuals who are involved in drug development or sub-clinical level testing of drugs for treating eye disorders may be extremely knowledgeable about the development of the treatment of eye disorders and drug development, and able to comprehend and evaluate the teachings of the prior art. See, e.g., Pet. 25. Such individuals might not possess an M.D. degree, but instead possess a Ph.D. in a “biotechnological, or pharmaceutical field,” or a lesser degree with a corresponding increased depth of experience, as suggested by Petitioner. We agree that such individuals should be considered persons of ordinary skill in the art. We also find that Petitioner’s definition is commensurate with the level of skill reflected in the prior art. See, e.g., Exs. 1006, 1010, 1030, 1033; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We consequently adopt Petitioner’s definition of a person of ordinary skill in the art has having an M.D. or Ph.D. or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field, and having practical academic or medical experience in developing treatments 30 for angiogenic eye disorders or treating angiogenic eye disorders including through the use of VEGF antagonists.” slip op. at 29

  Patent outcomesUS 9,669,069 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 9,669,069
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2022-00301 · APJ John G New · IPR · Final written decision

  Claims 1 and 8–12 are unpatentable: Dixon anticipates them, including claim 8 through its disclosure of a comparable VEGF Trap-Eye dosing regimen.

  RulingsFinal written decision

  • Strike new argumentNew argument consideredDenied

    “We deny the motion to exclude the referenced argument in Petitioners’ Reply, as well as the invitation to consider the motion as one to strike the argument. As Patent Owner notes in the motion, Patent Owner raised this issue previously in this proceeding. PO Mot. Exclude 5. At that time, we denied Patent Owner’s request for authorization to file a motion to strike the referenced argument in the Reply. It is improper for Patent Owner to now seek to strike the argument in a motion to exclude. A motion to exclude is not the proper vehicle to address arguments or evidence that a party believes exceeds the proper scope of a reply. See USPTO, Consolidated Trial Practice Guide (2019) at 79, available at: https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf?MURL= (last visited October 27, 2022) (“CTPG”). Moreover, as Petitioners correctly assert, Patent Owner has failed to satisfy the prerequisite for filing a motion to exclude by failing to timely file an objection. See 37 C.F.R. 42.64(b)(1); CTPG 78–79. Patent Owner has not been left without an opportunity to address the Reply argument. When we denied authorization to file a motion to strike, we authorized Patent Owner to file, with its Sur-Reply, a table identifying any portion of the Reply that Patent Owner considers to have exceeded the scope of the Reply. Further, we explained that Patent Owner, alternatively, may address that contention, or the merits of any newly-raised arguments or evidence in its Sur-Reply. Indeed, Patent Owner addressed the issue in its 26 Sur-Reply for our consideration. Thus, Patent Owner had sufficient opportunity to identify in its Sur-Reply its contentions regarding Petitioners’ allegedly inappropriate Reply argument and took advantage of that opportunity. That is sufficient for us to consider the issue and determine whether such argument should be disregarded. See CTPG 80.” slip op. at 26

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We find that Petitioner’s definition is the better definition for purposes of this proceeding. We acknowledge that the claims of the ’069 patent are directed to a “method for treating an angiogenic eye disorder in a patient” 29 and that the actual practice of the method would therefore seem to be limited to those who have the ability to treat patients, i.e., physicians, etc. However, we find Patent Owner’s definition to be unduly limiting. Individuals who are involved in drug development or sub-clinical level testing of drugs for treating eye disorders may be extremely knowledgeable about the development of the treatment of eye disorders and drug development, and able to comprehend and evaluate the teachings of the prior art. See, e.g., Pet. 25. Such individuals might not possess an M.D. degree, but instead possess a Ph.D. in a “biotechnological, or pharmaceutical field,” or a lesser degree with a corresponding increased depth of experience, as suggested by Petitioner. We agree that such individuals should be considered persons of ordinary skill in the art. We also find that Petitioner’s definition is commensurate with the level of skill reflected in the prior art. See, e.g., Exs. 1006, 1010, 1030, 1033; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We consequently adopt Petitioner’s definition of a person of ordinary skill in the art has having an M.D. or Ph.D. or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field, and having practical academic or medical experience in developing treatments 30” slip op. at 29

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Patent Owner does not propose claim construction positions for these terms because construction of these terms is not necessary to resolve the arguments presented in Mylan’s Petition. PO Resp. 8 (citing Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)). We agree that it is unnecessary to construe these claim terms in view of the express definitions set forth in the Specification. DePuy, 469 F.3d at 1014. Because the claim terms are undisputed, we adopt the definition of the claim terms “initial dose,” “secondary dose,” and “tertiary dose” as expressly defined by the Specification of the ’069 patent. Nidec, 868 F.3d at 1017.” slip op. at 32

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundUnpatentable

    “Patent Owner’s arguments are unavailing. The test for whether a reference inherently anticipates a claim is whether a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010) (emphasis added). Patent Owner has made multiple acknowledgements that the VEGF Eye-Trap used in the VIEW 1/VIEW 2 test disclosed by Dixon possessed the amino acid sequence recited in claim 1 of the ’069 patent.” slip op. at 54

  Patent outcomesUS 9,669,069 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 9,669,069

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.