• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations LLCInstitution denied
  PTAB · Jan 9, 2024 · IPR2023-01151 · APJ Timothy G Majors · IPR · Institution

  The Board denied institution on all asserted grounds because Petitioner did not show a reasonable likelihood that any challenged, undisclaimed claim was unpatentable.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless the Petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For reasons discussed below, we do not institute review of claims 2, 9, 17, and 18 of the ’834 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner proposes that the person of ordinary skill in the art (“POSA”) in November 2012 “would have been an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses. This [POSA] would, where necessary, work with a medical device engineer to experiment with or manufacture a prosthetic heart valve.” Pet. 21 (citing Ex. 1003 ¶ 49). Patent Owner does not expressly contest Petitioner’s proposed definition. For this Decision, we apply Petitioner’s proposed POSA level, which appears to be consistent with the level of skill shown in the prior art of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). This POSA level is also consistent with the level the Board applied in earlier decisions involving the same parties and related patents. See, e.g., Ex. 2124, 11; Ex. 1120, 11–12.” slip op. at 16

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “during prosecution. Pet. 18, 99. According to Petitioner, Spenser II never describes its compressible material as including “tightly knitted fibers” and a POSA would, instead, have understood Spenser II’s compressible material as comprising “loose, porous materials.” Pet. 18, 99. We agree with Petitioner that the phrases “tightly knitted” and “tightly knitted fibers” do not appear in Spenser II. At the same time, neither does Spenser II describe its compressible material as being “loose” and “porous.” Notably, in prior proceedings before the Board, Petitioner’s declarant Dr. Buller testified that Spenser II’s compressible material “includes a plurality of PET fibers on the inward-facing surface of the compressible material” (i.e., the “base layer” and alleged “second plurality” of fibers here; Paper 9, 5), that is “sufficiently dense to prevent blood from leaking through the cloth/fabric.” Ex. 2128 ¶ 222; see also Ex. 2122, 20:2–22:18 (testifying that “nonporous” as used in the Specification means “that fluid would not pass through it” and such fluid includes “all components of blood”). We find that Dr. Buller’s description of Spenser II as having a dense, blood impermeable base layer is, on balance, more consistent with applicant’s characterization of Spenser II as having an arrangement of “tightly-knitted fibers”—even if some imagined or microscopic spaces between fibers might still exist in a base layer. Ex. 2128 ¶ 222; see also Ex. 2002 (Brecker testimony) ¶¶ 42–45 (testifying, inter alia, that the description of a “tight fitted outer seal is . . . consistent with Spenser II’s Figure 22” and “knitted” is consistent with Buller’s testimony describing Spenser II’s compressible material as “velour-like woven or knitted” PET (citing Ex. 1003 ¶ 162; Ex. 2134 ¶ 56). We are, thus, unpersuaded on this record that applicant mischaracterized Spenser II.” slip op. at 38

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

    “Altogether, the parties’ alleged “plain meaning” yet otherwise undefined interpretation of the “spacing” limitations leaves the Board with insufficient clarity about what the claimed “spacing” means in the affirmative. Paper 9, 3 (arguing “plain meaning”); Paper 11, 3 (arguing applicant’s arguments are in “full harmony with the plain meaning”). The intrinsic evidence is minimally helpful: the Specification does not use the term “spacing” in relation to the positioning of adjacent fibers; the drawings might be helpful but neither party proposes a specific construction that is reliant on them.15 The prosecution history provides clues, but portions of the prosecution record are arguably confounding. The applicant distinguished 15 For example, Dr. Brecker, in support of Patent Owner’s argument, identifies several of the patent drawings and testifies that, “as is particularly clear in Figure 13 (but also present elsewhere), there are gaps and spaces between the fibers that extend to the frame” and then proceeds to testify that prior art, like Spenser II’s compressible material, “bears no resemblance” to the “exemplary” spacings identified in prosecution. See, e.g., Ex. 2002 ¶¶ 42–43. Dr. Brecker’s articulation of a “spacing” does not seem to add anything meaningful beyond the language of the claim as written. And, simply comparing the patent drawings to the prior art drawings presumes a sort of “know-it when you see it” interpretation—it is not an affirmative construction for a “spacing” as claimed. the claimed “spacings” from “tightly knitted fibers.” Ex. 1002, 1001. At what point, however, does a cloth of “tightly knitted fibers” qualify as more “loosely defined” and come within the scope of the claimed “spacing?”16 Id. The applicant also described the “spacing” in semi-functional terms based on “advantages” provided by the claim feature. See, e.g., id. (asserting, e.g., that the spacing permits “expansion and contraction” with “lesser rigidity”); see also id. at 1133, 1140 (asserting, e.g., “reduce[d] restrictions” and avoidance of “restrained valve foreshortening” with the then-claimed “openings”). It is not, however, evident where the Specification supports such “advantages”—no citations were given in prosecution. And, in prosecution of related applications, applicant argued, for example, that “[w]hile all fibers have some degree of being spaced-apart, the construction from Applicant’s claimed invention clearly requires some level more spacing.” Ex. 1149, 13–14 (assertion differences over “Dehdashtian” (alias to Spenser II)) (emphasis added). On this record, what would suffice as “some level more spacing” is unclear. Id.” slip op. at 39

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,337,834
• Uber Technologies, Inc. v. Surgetech LLCInstitution denied
  PTAB · Oct 23, 2023 · IPR2023-00738 · APJ Ryan H Flax · IPR · Institution

  The Board denied institution on claims 1–6 because the Petition failed to identify its numerous, ambiguous obviousness grounds with the particularity required by § 312(a)(3).

  RulingsInstitution decision

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

    “An inter partes review may be instituted if the information presented by the petitioner in the petition, in view of the patent owner’s preliminary response and the preliminary record, shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314.” slip op. at 12

  • BurdenDenied

    “to the issue of thousands of asserted combinations of art. Patent Owner argues, and we agree, that Petitioner presents in the Petition “a single, omnibus claim chart that cites to numerous pages of prior art without any substantive explanation describing how those quotations are relevant or how they should be combined” and “exacerbates this confusion by citing to Dr. Regan’s seven-hundred seventy-eight page expert report, which, despite its length, is equally conclusory.” Prelim. Resp. 11–12. Moreover, by citing “dozens of disparate passages from Jacob” in regard to a single limitation, along with “numerous citations to multiple prior art references,” the Petition fails to “identify how the prior art teachings should be combined in the grounds of a petition.” Id. at 18–19. In sum, rather than present its challenges with particularity, the Petition simply reproduces large excerpts from multiple references, while improperly incorporating by reference hundreds of pages from an expert declaration that frequently includes conclusory assertions. See generally Pet.; Ex. 1003. Accordingly, we find that the Petition falls short of the requirement that it present “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). In our view, the large number of ambiguous grounds is far out of proportion with the number of claims and the complexity of the issues involved. This excessiveness indicates that it would impose an undue burden for Patent Owner to respond to and for the Board to resolve all of the grounds asserted in the Petition.” slip op. at 21

  • Skill levelSkill level petitioner adoptedOther

    “Petitioner asserts: POSITA would at minimum have a bachelor’s degree in software/computer/electrical engineering, computer science, or industrial engineering and management with at least two years’ experience in inventory and pricing management, including with respect to systems for dynamically managing inventory and pricing of transportation services or other types of inventory, or the equivalent. Additional graduate education could substitute for professional experience, or significant inventory and pricing management experience could substitute for formal education. EX1003, ¶17. POSITA are presumed knowledgeable of all relevant art, and would thus have been familiar with each reference cited herein and its full teachings. Pet. 14–15. Patent Owner applies this same definition. Prelim. Resp. 10. 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 ’047 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.” slip op. at 9

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

    “Petitioner proposes a construction for the claim language “receiving . . . in real time.” Pet. 13–14. Patent Owner does not argue for any specific claim constructions. See generally Prelim. Resp. “[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)). We determine that, here, no construction of any claim term is necessary for purposes of rendering this Decision. See Nidec Motor Corp., 868 F.3d at 1017. C. LEGAL STANDARDS CONCERNING INSTITUTION AND” slip op. at 11

  Claim constructionDiscretionary denialcites Phillips
  Patents in suitUS 11,475,047
• Uber Technologies, Inc. v. Surgetech LLCInstitution denied
  PTAB · Oct 12, 2023 · IPR2023-00735 · APJ James A Tartal · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing and failed to identify its grounds and supporting evidence with particularity.

  RulingsInstitution decision

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

    “review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Even when that standard is satisfied, however, the Board has discretion to deny institution.4” slip op. at 2

  • BurdenDenied

    “Accordingly, we find that the Petition falls short of the requirement that it present “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). In our view, the large number of grounds is far out of proportion with the number of claims and the complexity of the issues involved. This excessiveness indicates that it would impose an undue burden for Patent Owner to respond to and for the Board to resolve all of the grounds asserted in the Petition. Moreover, in addition to the number of grounds asserted, Petitioner’s arguments in support of those grounds are unclear and impossible to discern. Petitioner does not separately discuss each individual ground, but instead lumps together the discussion of all grounds under a single heading. This grouping together of multiple grounds obscures the specific arguments advanced and the claims challenged in each individual ground. Moreover, we agree with Patent Owner that Petitioner does not adequately explain these multiple-reference combinations, or why ordinarily skilled artisans would be motivated to combine them in the manner recited. In these circumstances, we determine that denial is appropriate because the Petition asserts voluminous and excessive grounds and fails to identify them with the requisite particularity. See Microsoft Corp. v. FG SRC, LLC, 860 Fed. Appx. 708, 713 (Fed. Cir. 2021) (“It is not the Board’s job to cobble together assertions from different sections of a petition or citations of various exhibits in order to infer every possible permutation of a petitioner’s arguments. Arguments in a petition must be made with particularity, not opacity”). We further determine that Petitioner fails to” slip op. at 20

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends a person of ordinary skill in the art “would at minimum have a bachelor’s degree in software/computer/electrical engineering, computer science, or industrial engineering and management including with respect to systems for dynamically managing inventory and pricing of transportation services or other types of inventory, or the equivalent.” Pet. 16. Petitioner also contends “[a]dditional graduate education could substitute for professional experience, or significant inventory and pricing management experience could substitute for formal education.” Id. (citing Ex. 1003 ¶¶ 17–18). Patent Owner does not dispute the level of ordinary skill identified by Petitioner. See Prelim. Resp. 10. For purposes of this Decision, we apply Petitioner’s proposed level of skill because, on the current record, it is consistent with the level of skill at the time of the claimed invention reflected by the ’598 patent and the cited prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “In sum, rather than present its challenges with particularity, the Petition simply reproduces large excerpts from multiple references while improperly incorporating by reference hundreds of pages from an expert declaration that frequently includes conclusory assertions. See, e.g., Ex 1003 ¶¶ 162, 188, 201, 226, 227, 240, 250, 264, 274, 282, 292, 302, 309, 318, 326, 332, 341, 363, 384, 387, 416, 428, 444, 456, 458, 476, 495, 504, 511, 521, 535, 633, 641 (stating in substantially similar terms that it “would have been routine to make such an implementation choice,” and “clear it results with a reasonable expectation of success”). Accordingly, we find that the Petition falls short of the requirement that it present “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). In our view, the large number of grounds is far out of proportion with the number of claims and the complexity of the issues involved. This excessiveness indicates that it would impose an undue burden for Patent Owner to respond to and for the Board to resolve all of the grounds asserted in the Petition. Moreover, in addition to the number of grounds asserted, Petitioner’s arguments in support of those grounds are unclear and impossible to discern. Petitioner does not separately discuss each individual ground, but instead lumps together the discussion of all grounds under a single heading. This grouping together of multiple grounds obscures the specific arguments advanced and the claims challenged in each individual ground. Moreover, we agree with Patent Owner that Petitioner does not adequately explain these multiple-reference combinations, or why ordinarily skilled artisans would be motivated to combine them in the manner recited.” slip op. at 19

  Claim constructionDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 11,334,598
• Uber Technologies, Inc. v. Surgetech LLCInstitution denied
  PTAB · Oct 6, 2023 · IPR2023-00737 · APJ Michael L Woods · IPR · Institution

  Denied institution of IPR for claims 1–10 because the petition lacked particularity and failed to show a reasonable likelihood that any challenged claim was unpatentable.

  RulingsInstitution decision

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

    “We agree with Patent Owner. Petitioner’s citations to Dr. Regan’s testimony, as well as to Jacob, Tamura, and Kono, fail to show a reasonable likelihood that the cited art satisfies that the steps recited in limitations 9(g) and 9(h) are performed “based on the query,” as required in limitation 9(f). Petitioner’s treatment of these limitations lacks sufficient substantive analysis. See Pet. 60–62.” slip op. at 17

  • BurdenDenied

    “1. Petitioner fails to clearly map how the claim limitations are mapped to the prior art, and “simply combines the references together in a single, omnibus chart, with no delineation between grounds.” Id. at 9. 2. The Petition fails to identify how the references are being combined. Id. at 14. 3. Petitioner’s motivations to combine are deficient, as Petitioner simply relies on boilerplate language without “address[ing] the combination of any specific teachings in the prior art, let alone explain why a POSITA would have understood such combinations.” Id. at 20. We agree with Patent Owner. Petitioner has a duty 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 Playtika Ltd. V. NexRF Corp., IPR2021- 00952, Paper 14 (denying institution based on discretionary factors and lack of sufficient particularity). The importance of this requirement has been stressed by our reviewing court. See Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016). (“It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’”). Our Rules further require that the Petition must identify “specific portions of the evidence that support the challenge” (37 C.F.R. § 42.104(b)(5)) and that each petition must include “[a] full statement of the reasons for the relief requested, including a detailed explanation of the significance of the evidence including material facts, and the governing law, rules, and precedent” (id. § 42.22(a)(2)). Our Practice Guide also instructs that “parties 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.” Patent Trial and Appeal Board Consolidated Trial Practice Guide, available at https://www.uspto.gov/TrialPracticeGuideConsolidated (Nov. 14, 2019), at 39.2 The Petition falls short of these requirements. Rather than present its challenges in a concise and understandable” slip op. at 10

  • Skill levelSkill level board ownOther

    “would at minimum have a bachelor’s degree in software/computer/electrical engineering, computer science, or industrial engineering and management with at least two years’ experience in inventory and pricing management, including with respect to systems for dynamically managing inventory and pricing of inventory, or the equivalent. Additional graduate education could substitute for professional experience, or significant inventory and pricing management experience could substitute for formal education. Pet. 10; see also Prelim. Resp. 7 (“This is the same level of skill agreed to by the parties in the litigation. Patent Owner applies this definition for purposes of this Preliminary Response.”). For purposes of this Decision, we adopt the parties’ assessment of the level of ordinary skill in the art. We find that their assessment is consistent with the ’999 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningNo construction neededOther

    “Rather, the parties do not propose competing constructions for any term. Compare Pet. 8–9, with Prelim. Resp. 42–45. For purposes of this Decision, we give the claims their plain and ordinary meaning, and we need not and do not expressly construe any term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (stating that “we need only construe terms ‘that are in controversy, and only 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 10

  Claim constructionDiscretionary denialcites Phillips
  Patents in suitUS 11,360,999
• Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution denied
  PTAB · Oct 2, 2023 · IPR2023-00723 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution on claims 1–6 because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted obviousness grounds.

  RulingsInstitution decision

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

    “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence (1966). In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, a party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (internal quotations omitted). slip op. at 9

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. See Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. Id. at 7–8 (citing Ex. 1020 ¶ 27; Ex. 1022 ¶ 27; Ex. 1024 ¶ 21; Ex. 1026 ¶¶ 25–26). 13 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’343 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as 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)). C. Claim Construction” slip op. at 11

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

    “We interpret a claim “using 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. § 42.100(b) (2020). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Moreover, “the specification ‘is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.’” In re Abbott 13 We need not consider Petitioner’s similar alternative definitions. See id. at 8–9. v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc)). The parties contend that no claim term requires construction. Pet. 13. Prelim. Resp. 15. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only 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. Overview of Asserted References” slip op. at 12

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “On the record before us, however, Dr. Flatt’s assessment of the relative benefit one of ordinary skill in the art would have accorded the higher Ki of mono-substituted compound 3 as compared to the “much longer plasma half-life” of Dong’s bi-substituted compounds is at odds with Dong’s selection of bi-substituted compound 4 for clinical trials. See Ex. 1013, 670– 671 (Table 1). We are also skeptical of Dr. Flatt’s assertion that one of ordinary skill in the art would have recognized that Dong’s substitution of Aib for alanine at position 8 “would complement and work synergistically with liraglutide’s [other] properties,” including the fatty acylation of Lys26. See Ex. 1020 ¶ 181. In this respect, Patent Owner notes that, unlike liraglutide, Dong’s GLP-1 analogs were not acylated, whereas Knudsen 2001 counseled against N-terminal modifications in the context of acylation. Prelim. Resp. 28–30, 46 (citing Ex. 1011, 680–681). In addressing such combinations, Knudsen 2001 states, for example, that “Desamino His7 represents one of the more potent suggestions to a modification giving metabolic stability (81 ). Nevertheless, as seen when comparing 19 (687 pM) to 5 [liraglutide] (68 pM), considerably more potent compounds could be obtained by not modifying the N-terminus when a combination with acylation was desired.” Id. at 680. As such, we are unpersuaded on the record before us that one of ordinary skill in the art would have had a reasonable expectation that the Aib8 modification would be beneficial or otherwise “complement and work synergistically with” the acylated Lys26 of liraglutide or semaglutide. See Ex. 1020 ¶ 181.” slip op. at 30

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 8,129,343
• Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution denied
  PTAB · Oct 2, 2023 · IPR2023-00722 · APJ Robert A Pollock · IPR · Institution

  Institution was denied for claims 1, 2, 4–11, 13, and 15 because Petitioner did not show a reasonable likelihood of proving them obvious under any of the three grounds.

  RulingsInstitution decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, with at least two years of experience in developing therapeutic peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. ¶ 24).14 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’122 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as 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)).” slip op. at 14

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

    “The parties contend that no claim term requires construction. Pet. 16. Prelim. Resp. 16. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our 14 We need not consider Petitioner’s similar, but alternative, definitions. See id. at 8–9. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only 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 15

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

    “For the reasons provided below, we determine Petitioner has not satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has not demonstrated a reasonable likelihood that at least one claim of the ’122 patent is unpatentable, we do not institute an inter partes review on the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).1” slip op. at 2

  • BurdenNot shown unpatentable

    “Considering the record before us, Petitioner has not shown sufficiently that one of ordinary skill in the art would be motivated to make the required modification with a reasonable expectation of success. (4) Hindsight and Reasonable Expectation of Success One of ordinary skill in the art seeking to modify liraglutide would need undertake at least four discrete steps to arrive at semaglutide—some of which entail multiple options and decision points (e.g., the selection and placement of di-AEEA, and whether to replace, or add to, the existing γ-glu linker). As discussed above, we find Petitioner’s justification for these individual steps problematic. Taken as whole, and considering the vast number of modifications suggested in the art—and indeed, the large number of amino acids suggested as cites for modification—Petitioner has failed to meet its burden of demonstrating why a skilled artisan would have been motivated to make all of the identified substitutions and no others. See e.g., Ex. 1010, 4130 (Figure 3) (identifying amino acids available for derivatization (Ser18, Gln23, Lys26, Glu27, Lys34, and Arg36) or modification (Ala8)); Ex. 1011, 680–681 (identifying desamino His7 as “one of the more potent suggestions to a modification giving metabolic stability,”); Ex. 1012 at, e.g., 9:21-19:59; 192:30–60 (Table 1), 193:35–46 (disclosing numerous GLP-1 analogs, including those with greater half-lives or potency than liraglutide, and teaching that each could be further modified, including with amino acid substitutions and/or acylation at multiple positions, numerous the fatty and amino acids); Ex. 1013, 670–671 (disclosing that GLP-1 analogs bearing modifications at both positions 8 and 35 maintain efficacy but “have much longer plasma half-life than mono-substituted compounds”).” slip op. at 43

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 8,536,122
• Celltrion, Inc. v. Regeneron Pharmaceuticals, Inc.Institution denied
  PTAB · Sep 1, 2023 · IPR2023-00620 · APJ Susan L C Mitchell · IPR · Institution

  The Board denied institution because claims 1–4 had been statutorily disclaimed.

  RulingsInstitution decision

  • Adverse judgmentAdverse judgmentDenied

    “Under 37 C.F.R. § 42.107(e), “patent owner may file a statutory disclaimer under 35 U.S.C. 253(a) in compliance with § 1.321(a) of this chapter, disclaiming one or more claims in the patent” and “[n]o inter partes review will be instituted based on disclaimed claims.” A disclaimer under 35 U.S.C. § 253(a) is “considered as part of the original patent” as of the date on which it is “recorded” in the Office. 35 U.S.C. § 253(a). For a disclaimer to be “recorded” in the Office, the document filed by the Patent Owner must:” slip op. at 2

  None
  Patents in suitUS 10,406,226
• Sandoz Inc. v. Acerta Pharma B.V.Institution denied
  PTAB · Aug 7, 2023 · IPR2023-00478 · APJ Ulrike W Jenks · IPR · Institution

  The Board denied institution of review of claims 8–12, 19, and 20 under § 325(d), finding the asserted art substantially the same as art previously presented and no material Office error.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

    “we agree with Patent Owner that, because Barf is nearly identical to Barf-PCT in its disclosure – Barf is “substantially the same art” as Barf-PCT, which was previously presented to the Office. Advanced Bionics, 8.” slip op. at 15

  • PTAB / AIA Trials › Motions to amend / substitute claimsDenied

    “for a certificate of correction is meritorious; instead, we are tasked with simply assessing whether there is a sufficient basis to support Patent Owner’s position. If so, it is up to the Director to decide whether to exercise the authority under § 255 and issue a certificate of correction. We have reviewed the arguments in the Motion and conclude that “there is a sufficient basis supporting Patent Owner’s position that the mistake may be correctable.” Honeywell, 939 F.3d at 1349. However, because as discussed above (see supra Section III), we deny institution here pursuant to our discretion under Section 325(d), we find that whether Barf is or is not prior art is immaterial to this proceeding and Patent Owner’s request and any certificate of correction here is moot. Therefore, we deny as moot the Motion for leave to file a Certificate of Correction.” slip op. at 22

  Discretionary denial
  Patents in suitUS 10,272,083
• Takeda Vaccines, Inc. v. Valneva Austria GmbHInstitution denied
  PTAB · Jun 9, 2023 · IPR2023-00354 · APJ Wesley B Derrick · IPR · Institution

  The Board denied institution because the Patent Owner disclaimed all challenged claims before institution; it declined to enter adverse judgment.

  RulingsInstitution decision

  • Adverse judgmentDecided for patent owner

    “Patent Owner’s statutory disclaimer of the challenged claims, Petitioner correctly notes that the Federal Circuit in Arthrex, Inc. v. Smith & Nephew, Inc., 880 F.3d 1345 (Fed. Cir. 2018), construed Rule 42.73(b) as permitting the Board to enter adverse judgment when a patent owner cancels all challenged claims prior to institution. Paper 6, 2‒3; Arthrex, 880 F.3d at 1350. Neither Arthrex nor Rule 42.73(b), while permitting us to do so, requires us to enter adverse judgment. In the present instance, and consistent with 35 U.S.C. § 253(a), Arthrex, Rule 42.107(e) and the Board’s precedential General Electric decision, we determine that a denial of institution is sufficient to dispose of this case. We acknowledge Petitioner’s request to treat the terminal disclaimer as a request for adverse judgment (see Ex. 3003), but determine that denying institution without entering adverse judgment against the Patent Owner is consistent with § 253(a), Rule 42.107(e), and General Electric, where there are no pending claims for us to consider following disclaimer of all challenged claims prior to institution of trial.” slip op. at 4

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

    “disclaiming all challenged claims of the ’681 patent, and paid the requisite fees. See Ex. 3002; see also 35 U.S.C. § 253(a) (providing that a patentee may disclaim); 37 C.F.R. § 1.321 (setting forth requirements for statutory disclaimer). In particular, based on our review of Ex. 3002 and Patent Office public records, we are satisfied that a disclaimer of the challenged claims of the ’681 patent under 35 U.S.C. § 253(a) has been recorded in the Office as of March 21, 2023. See Vectra Fitness, Inc. v. TNWK Corp., 162 F.3d 1379, 1382 (Fed. Cir. 1998) (holding that a disclaimer filed under immediately “recorded” on the date the Office receives the disclaimer without any requirements of further action). Accordingly, we deny institution of the requested inter partes review. See 37 C.F.R. § 42.107(e) (“No inter partes review will be instituted based on disclaimed claims.”); see also General Elec. Co. v. United Techs. Corp., IPR2017-00491, Paper 9 (PTAB July 6, 2017) (precedential) (“General Electric”) (denying institution of inter partes review under 37 C.F.R. § 42.107(e) based on disclaimer).” slip op. at 3

  None
  Patents in suitUS 11,219,681
• Apotex Inc. v. Regeneron Pharmaceuticals, Inc.Institution denied
  PTAB · Mar 10, 2023 · IPR2022-01524 · APJ Ryan H Flax · IPR · Institution

  Institution denied because Petitioner did not show a reasonable likelihood that claims 1–14 and 26–30 were unpatentable over the asserted anticipation and obviousness grounds.

  RulingsInstitution decision

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

    “APPLICABLE LEGAL STANDARDS “In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). An inter partes review may be instituted if the information presented by Petitioner in the Petition, in view of Patent Owner’s Preliminary Response and the preliminary record, 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.” slip op. at 19

  • BurdenDecided for patent owner

    “As an initial matter, we find Petitioner has insufficiently addressed the issue of inherent anticipation by Dixon (or any other prior art) and has done so in a merely conclusory manner. There is no dispute that Dixon (as well as the other asserted prior art) discloses angiogenic eye disorder treatment using the same drug (aflibercept), at the same dose (2 mg), administered in the same way (intravitreal injection), and administered at the same dosing regimen (an initial, a secondary, and a tertiary dose), as required by all challenged claims. See generally Pet.; Prelim. Resp. Petitioner relies on these facts, and the results of a phase 2 clinical trial that followed a different dosing protocol (one not claimed) to establish that the results limitations of claims 1, 26, and 29 are inherent to the phase 3 clinical trials (VIEW 1 and 2) with a dosing regimen that is claimed. See Pet. 38–39. Petitioner calls the claimed results limitations mere newly discovered results of a known process. Id. (citing Montgomery, 677 F.3d at 1381). As Patent Owner identifies, it is not so simple. The evidence of the results of the VIEW 1 and 2 trials itself (found in the ’572 patent) shows that some, but not all, patients treated with the claimed dosing regimen achieved “a gain in visual acuity” as recited by claim 1, “a gain in visual acuity” that is “as effective” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 26, or “maintaining visual acuity” “as effective[ly]” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 29. See Ex. 1001, 13:5–38 (Table 1). As Patent Owner points out, the ’572 patent’s described studies 1 and 2, when following the claimed dosing regimen (2Q8), were not always effective treatments––achieving mere maintenance (as opposed to improvement or “gains”) of vision 95.1% and 95.6% (respectively) of the time. Id.; see Prelim. Resp. 34–37 (citing Ex. 1001, 13:8–27; Ex. 1014, 4, 6; Ex. 1030, 9; Ex. 2021 ¶¶ 109–111; Ex. 2022). Thus, the evidence shows that, although most would, about 4–5% of patients (or, possibly, an even higher number based on Patent Owner’s cited evidence––Ex. 1030, 9) would not see the gains in visual acuity required by claims 1 and 26 or the maintenance in visual acuity required by claim 29. It is well established that “[i]nherency . . . may not be established by probabilities or possibilities” and “[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re. Oelrich, 666 F.2d 578, 581 (CCPA 1981) (quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939)). Here, the evidence shows that the claimed results limitations may typically flow from the claimed method, but not necessarily.” slip op. at 33

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

    “Relating to the claim construction, the Federal Circuit found that patent at issue was “clear” that the tissue fibrosis, recited by the claim as arrested or regressed by the otherwise recited treatment, was not the same as and did not necessarily accompany the symptom of erectile disfunction (taught in and the focus of the relied-upon prior art), although the former (fibrosis) may frequently result in the latter (disfunction). Id. at 1059. The Federal Circuit held that the “arresting or regressing” clause was more than a mere statement of intended result, but was a limitation carrying patentable weight because the phrase was drafted as a part of a separate step of the method rather than of the preamble, the “arresting or regressing” language demanded efficacy, and the efficacy was linked to specific treatment minimum duration and dosage. Id. at 1060–61. The patients exhibiting these two issues were not necessarily the same. In part because the Board did not consider the arresting/regressing result limitation in its unpatentability analysis, the Federal Circuit agreed with the patent owner that the Board’s findings were insufficient. Id. at 1064, 1067. The Federal Circuit found that that prior art reference relied upon in the Board’s decision for teaching the claimed treatment, and also relied upon to link the condition of fibrosis with the symptom of erectile dysfunction, did not teach treating a population of patients suffering from erectile dysfunction only because of a fibrosis condition and, even though such patients may have had fibrosis, it was not certain; and further found that other cited prior art did not make certain a link between fibrosis and such dysfunction. Id. at 1065–66. This, the Federal Circuit found, was error. We find in agreement with Patent Owner that the results limitations of the challenged claims are limitations and must be given patentable weight for the same reasons arresting or regressing a tissue fibrosis was a limitation in Los Angeles Biomed. Similarly, here the claims are directed to expressly required results of the administration of aflibercept to patients at 2 mg at an initial dose, in at least one secondary dose 4 weeks later, and in at least one tertiary dose 8 weeks later. Therefore, we find that in claim 1, “wherein the patient achieves a gain in visual acuity within 52 weeks following the initial dose,” is a limitation. Further, in claim 26, “wherein 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,” is a limitation. And, in claim 29, “wherein the method is as effective in maintaining 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,” is a limitation.” slip op. at 17

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “A prior art reference without express reference to a claim limitation may anticipate by inherency. See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002). “Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claimed limitations, it anticipates.” Id. (quoting MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999)).” slip op. at 20

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,253,572

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.