• 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
• Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution denied
  PTAB · Oct 11, 2022 · IPR2022-00747 · APJ Tina E Hulse · IPR · Institution

  The Board denied institution on all grounds because Petitioner did not show a reasonable likelihood that claims 1–29 were obvious over the cited 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 proposed constructions 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 reached

    “merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 550 U.S. at 418. “[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” Id. Moreover, a person of ordinary skill in the art must have had a reasonable expectation of success of doing so. PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1193 (Fed. Cir. 2014).” slip op. at 11

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,889,858
• Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution denied
  PTAB · Oct 11, 2022 · IPR2022-00746 · APJ Susan L C Mitchell · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–28 would have been obvious over the asserted combinations.

  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

    “Pet. 18 (citing Ex. 1002 ¶¶ 26–29). Patent Owner does not offer a proposed definition of the level of ordinary skill in the art at this stage of the proceeding. See generally Prelim. Resp. 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 neededDecided for patent owner

    “Having considered the parties’ respective arguments, we determine 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

    “We are not persuaded by Petitioner’s arguments. Although Meyer teaches that its particular protocol results in 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 Murtaza’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” slip op. at 13

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 10,801,063
• Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.Institution denied
  PTAB · Sep 15, 2022 · PGR2022-00025 · APJ Susan L C Mitchell · PGR · Institution

  The Board denied institution because Petitioner did not show it was more likely than not that any of claims 1–19 was unpatentable on the asserted grounds.

  RulingsInstitution decision

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

    “Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the Petition and the cited evidence, we conclude that Petitioner has not satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable. Therefore, we deny institution of a post-grant review.1” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would have a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders . . . [and] would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders.” Pet. 26–27 (citing Ex. 1005 ¶ 34 (Dr. Carey Declaration)). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Preliminary Response. Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’201 patent itself, see, e.g., Exs. 1024, 1025, 2003, 2004, 2005, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 7

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

    “The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001[,] col. 42, ll. 12–16.6 This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration [submitted by Patent Owner during prosecution], and is the only definition of a “baseline” in the ’908 patent. See Ex. 1002, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4. Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced by at least 10% from baseline” as meaning “a reduction of at least 10% in the level of ACTH (claim 1) or 17-OHP (claim 11) compared to measurements of ACTH or 17-OHP made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 9

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

    “From mere disclosure of crincerfont, Petitioner asks us to find a particular treatment protocol using this drug and the outcomes of such treatment as taught by non-prior art Auchus 2021 are inherent in the drug itself. Such outcomes of such treatment as is the subject of the challenged claims here may be inherent in a particular treatment regimen using a particular drug, but it is too far of a leap to say that disclosure of the drug itself would render inherent any treatment outcome using any treatment protocol. For the reasons set forth above, we determine that Petitioner has failed to establish that it is more likely than not that Grigoriadis anticipates claim 1 of the ’201 patent. Because the remaining claims challenged in this ground depend either directly or indirectly on claim 1, we similarly conclude that Petitioner has not established a likelihood of prevailing with respect to these dependent claims, claims 2–4, 7–9, 11–15, 18.” slip op. at 19

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 11,007,201
• Osteomed, LLC v. Stryker European Operations Holdings LLCInstitution denied
  PTAB · Aug 12, 2022 · IPR2022-00486 · APJ Hyun J Jung · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing on any challenged claim under the asserted anticipation and 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 [claim] it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016). This burden of persuasion never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The Board may authorize an inter partes review if we determine that the information presented in the Petition shows that there is a reasonable likelihood that Petitioner will prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a). slip op. at 6

  • Skill levelSkill level board ownOther

    “the parties and the Board agreed that “a [person of ordinary skill in the art] at the time of the invention would be an individual having at least a bachelor’s degree in engineering with at least two years of experience in the field, such as experience with the design of surgical implants, or a clinical practitioner with a medical degree and at least two years of experience as an orthopedic surgeon.” Prelim. Resp. 4. Patent Owner contends that “[f]or purposes of consistency, the same level of ordinary skill in the art at the time of the invention should be used here, given the similarities in the technology” and “disagrees with Petitioner’s asserted level of ordinary skill in the art to the extent that it differs from the previously agreed-upon definition.” Id. We decline to adopt a specific formulation regarding the level of ordinary skill in the art, and instead find that the cited references are representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evidenced by the cited references themselves). We need not provide a specific formulation because our analysis of the issues below would be the same regardless of whether we adopted Petitioner’s or Patent Owner’s proposed level of ordinary skill.” slip op. at 8

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

    “Petitioner proposes interpretations for “a body portion” and “a cross- section.” Pet. 4–8. Patent Owner responds that “a body portion” does not need to be construed for determining whether to institute, and that Petitioner’s proposed interpretation for “a cross-section” should be rejected. Prelim. Resp. 5, 6. Because determining whether Petitioner shows a reasonable likelihood of prevailing does not depend on a particular interpretation for any claim term, we determine that no claim term requires express interpretation. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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 9

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

    “The portion of Jackson cited in the Petition does not disclose that its conical shaped distal limb 3 has threads. See Ex. 1004, 6:21–7:2, 8:6–7. Jackson, instead, states expressly that “[t]he surface of the distal conical limb 3 of the device is scored with oblique ridges 5 that lock the limb 3 in place in the intermedullary cavity of a middle phalanx when it is fitted, by manually screwing and impacting it.” Id. at 6:26–28. Jackson goes on to state that “[t]he oblique ridges are similar in structure to the ridges that would be found on a workshop file giving sufficient abrasiveness that it will be fitted securely within the middle phalanx.” Id. at 6:29–31. None of the portions of Jackson that Petitioner relies upon discloses a “threaded end” as recited in the challenged claims. See id. at 6:21–7:2, 8:6–7. To the extent that Petitioner is contending that Jackson’s description of “manually screwing” discloses the presence of threads on limb 3, Jackson makes clear that limb 3 has oblique ridges 5, not threads. See Ex. 1004, 6:26–31. Petitioner’s arguments do not address why one of ordinary skill in the art would understand Jackson to be disclosing threads when Jackson explicitly states that “[t]he oblique ridges are similar in structure to the ridges that would be found on a workshop file.” See Pet. 15; Ex. 1004, 6:29–31. Because this description is not even addressed and Petitioner’s arguments clearly focus on what Jackson discloses, Petitioner has not sufficiently shown that a person of ordinary skill in the art would understand the oblique ridges on Jackson’s limb 3 to be threads. See Pet. 15; Ex. 1002 ¶¶ 78, 79.” slip op. at 12

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,168,074
• Airbus Americas, Inc. v. Harper Engineering CompanyInstitution denied
  PTAB · May 20, 2022 · IPR2022-00195 · APJ James A Tartal · IPR · Institution

  The Board denied institution because the Petition did not show a reasonable likelihood of proving any challenged claim unpatentable on the asserted obviousness grounds.

  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) (2021). 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). Moreover, a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). Upon consideration of the Petition, the Preliminary Response, the Reply, the Sur-reply, and the evidence of record, we conclude that the information does not show a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we do not institute an inter partes review.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “ordinary skill in the art in light of the subject matter of the ’244 patent, which is not limited to “aeronautical” or “aerospace” applications, claims a “stowage bin assembly” and a “hinge assembly,” and expressly refers broadly to “transportation vehicles” as typically including “overhead storage compartments,” identifying “airplanes” only as an “example” of a “transportation vehicle.” Ex. 1001, code (57), 1:12–15, 7:31–8:64. Patent Owner’s argument appears to be no more than a transparent attempt to baselessly suggest that Dr. Codd should be excluded from testifying because he lacks “the proper background or sufficient experience in the field” under Patent Owner’s unreasonable proposed level of ordinary skill. See Prelim. Resp. 17–18. Dr. Dershowitz’s testimony in support of Patent Owner on the level of ordinary skill is not credible because it is inconsistent with the ’244 patent and the asserted art. Ex. 2001 ¶¶ 58–63. For example, Dr. Dershowitz acknowledges that “[h]inges are common to many mechanical systems,” but then suggests “being familiar with hinges in general may not directly apply to the specifics of this invention” without identifying anything “specific” to the ’244 patent that requires the level of skill Dr. Dershowitz endorses. Id. ¶ 62. Dr. Dershowitz suggests “hinges used in storage solutions that are stationary have fewer requirements related to mass and volume and are not subject to the same forces and stresses that are experienced on an aircraft,” however, the challenged claims of the ’244 patent do not preclude “stationary” storage solutions, do not require anything pertaining to “mass and volume,” and are not required to withstand any “forces and stresses” experienced on an aircraft. Dr. Dershowitz’s opinion that “[d]ue to the unique environment and specialized nature of the technology at issue” a person of ordinary skill in the art would have needed “to have an educational background and experience that is specific to the aerospace field” is not supported by the ’244 patent or the asserted art. See id. ¶ 63; see also Ex. 1005 ¶ 2 (Rheaume stating it “relates to a hinge assembly and, more particularly to a hinge assembly for retaining a door of a storage bin”); Ex. 1006 ¶ 2 (Savian stating it “relates generally to overhead storage bin assemblies”); Ex. 1008, 3:24–27 (Frazier stating it discloses “improvements to standard luggage and storage bins commonly found in commercial aircraft as well as other aircraft, buses, passenger vans, and other vehicles”). Dr. Dershowitz’s misapprehension of the appropriate level of ordinary skill in the art is a consideration we apply in weighing his opinion of how a” slip op. at 11

  • Expert testimonyPatent owner expert discountedDecided for patent owner

    “Dr. Dershowitz’s testimony in support of Patent Owner on the level of ordinary skill is not credible because it is inconsistent with the ’244 patent and the asserted art. Ex. 2001 ¶¶ 58–63. For example, Dr. Dershowitz acknowledges that “[h]inges are common to many mechanical systems,” but then suggests “being familiar with hinges in general may not directly apply to the specifics of this invention” without identifying anything “specific” to the ’244 patent that requires the level of skill Dr. Dershowitz endorses. Id. ¶ 62. Dr. Dershowitz suggests “hinges used in storage solutions that are stationary have fewer requirements related to mass and volume and are not subject to the same forces and stresses that are experienced on an aircraft,” however, the challenged claims of the ’244 patent do not preclude “stationary” storage solutions, do not require anything pertaining to “mass and volume,” and are not required to withstand any “forces and stresses” experienced on an aircraft. Dr. Dershowitz’s opinion that “[d]ue to the unique environment and specialized nature of the technology at issue” a person of ordinary skill in the art would have needed “to have an educational background and experience that is specific to the aerospace field” is not supported by the ’244 patent or the asserted art. See id. ¶ 63; see also Ex. 1005 ¶ 2 (Rheaume stating it “relates to a hinge assembly and, more particularly to a hinge assembly for retaining a door of a storage bin”); Ex. 1006 ¶ 2 (Savian stating it “relates generally to overhead storage bin assemblies”); Ex. 1008, 3:24–27 (Frazier stating it discloses “improvements to standard luggage and storage bins commonly found in commercial aircraft as well as other aircraft, buses, passenger vans, and other vehicles”). Dr. Dershowitz’s misapprehension of the appropriate level of ordinary skill in the art is a consideration we apply in weighing his opinion of how a person of ordinary skill in the art would have understood the prior art at issue.” slip op. at 12

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

    “Petitioner contends that no claim terms require construction. Pet. 10 (citing Ex. 1003 ¶¶ 64–66). Patent Owner proposes an express construction for “stowage bin door” and “self-opening mechanism.” Prelim. Resp. 13– 17. We find no claim term requires an express construction in reaching our decision for the reasons below to deny institution of inter partes review. See Vivid Techs., 200 F.3d at 803.” slip op. at 13

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 10,801,244
• Airbus Americas, Inc. v. Harper Engineering CompanyInstitution denied
  PTAB · May 20, 2022 · IPR2022-00192 · APJ James A Tartal · IPR · Institution

  The Board denied institution because the petition did not show a reasonable likelihood that claims 2–6 or 12–17 were unpatentable; claims 1 and 7–11 had been disclaimed.

  RulingsInstitution decision

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

    “obvious over Rheaume and Savian. Pet. 32–51. Each of claims 2–6 and 12–17 requires a “hinge assembly” that includes “a self-opening mechanism.” Ex. 1001, 7:47–8:8, 8:27–64. Petitioner relies only upon Savian as teaching a “self-opening mechanism.” Pet. 32–34, 45. We focus our discussion on the “self-opening mechanism” limitation because it is dispositive and, for the reasons that follow, we determine that Petitioner has not shown sufficiently that Savian teaches this limitation.” slip op. at 21

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

    “More importantly, Petitioner provides no sufficient reasoning and cites no support for construing the required “self-opening mechanism” to be so broad as to include a mechanism that provides “only some damping against gravity to be ‘self-opening.’” Reply 2. We agree with Patent Owner that, contrary to Petitioner’s assertion, a component that only opposes opening is not a “self-opening mechanism.” See Sur-reply 2. In short, as shown by Patent Owner, the plain and ordinary meaning of “self-opening mechanism” in the context of the ’315 patent, as required by claims 2–6 and 12–17, is a mechanism that acts on its own accord to open the stowage bin door. See Prelim. Resp. 16 (citing Ex. 2006). An express construction of any other claim term is not necessary for” slip op. at 15

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

    “obvious over Rheaume and Savian. Pet. 32–51. Each of claims 2–6 and 12–17 requires a “hinge assembly” that includes “a self-opening mechanism.” Ex. 1001, 7:47–8:8, 8:27–64. Petitioner relies only upon Savian as teaching a “self-opening mechanism.” Pet. 32–34, 45. We focus our discussion on the “self-opening mechanism” limitation because it is dispositive and, for the reasons that follow, we determine that Petitioner has not shown sufficiently that Savian teaches this limitation.” slip op. at 21

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

    “9 Patent Owner also argues that we should exercise our discretion under 35 U.S.C. §325(d) to deny institution of inter partes review. Prelim. Resp. 36–46. We deny institution of inter partes review for the reasons provided above and, therefore, do not reach Patent Owner’s arguments regarding discretionary denial.” slip op. at 24

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 10,760,315
• Human Power Of N Company v. Heartbeet LtdInstitution denied
  PTAB · May 16, 2022 · PGR2022-00004 · APJ Devon Zastrow Newman · PGR · Institution

  The Board denied institution on all challenged claims because Petitioner did not show the patent was eligible for post-grant review.

  RulingsInstitution decision

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

    “Determining whether a patent is subject to the first-inventor-to-file provisions of the AIA, and therefore eligible for post-grant review, is straightforward when the patentee filed the application from which the patent issued before March 16, 2013, or when the patentee filed the application on or after March 16, 2013, without any priority claim. The determination is more complex, however, for a patent that issues from a “transition application,” that is, an application filed on or after March 16, 2013, that claims the benefit of an earlier filing date. See MPEP § 2159.04 (9th ed. Rev. 10.2019, June 2020). Entitlement to the benefit of an earlier date under 35 U.S.C. §§ 119, 120, 121, or 365 is premised on disclosure of the claimed invention “in the manner provided by § 112(a) (other than the requirement to disclose the best mode)” in the earlier application. See 35 U.S.C. §§ 119(e), 120. Thus, a patent that issues from a transition application is not available for post-grant review if the claimed subject matter complies with the written description and enablement requirements of § 112(a) for an ancestor application filed prior to March 16, 2013.” slip op. at 9

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “B. Legal Standard The test for written description support is “whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” based on an “objective inquiry into the four corners of the specification.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). If this test fails, the application is not entitled to the benefit of the earlier filing date.” slip op. at 11

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledDecided for patent owner

    “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)). Undue experimentation is analyzed by applying the factors set forth in In re Wands, 858 F.2d 731 (Fed. Cir. 1988).5 Nothing more than objective enablement is required, and therefore it is irrelevant whether this teaching is provided through broad terminology or illustrative examples. In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971); see also In re Howarth, 654 F.2d 103, 105 (CCPA 1981) (“An inventor need not, however, explain every detail since he is speaking to those skilled in the art.”). slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “F. Person of Ordinary Skill in the Art Petitioner proposes that one of ordinary skill in the art would have had “an M.D. degree or a Ph.D. degree in biochemistry, pharmacology, nutrition chemistry, exercise physiology, or kinesiology, and at least two years of 2 This chart repeats the grounds as presented in Petitioner’s chart at Pet. 4. 3 Brunton, An Address on Blood Pressure in Man: Its estimation and indications for treatment, The British Medical Journal, pp. 64-67 (July 10, 1909) (Ex. 1032 “Brunton”). 4 Brunton et al., An Address on Longevity and the Means of Attaining It, The Lancet, Vol. 168, Issue 4342, pp. 1330–1355 (Nov. 17, 1906) (Ex. 1033 “Brunton 2”). post-doctoral research or clinical experience with physiology, biochemistry, or dietary supplements and formulation.” Pet. 13 (citing Ex. 1003 ¶ 21). Patent Owner does not challenge this definition at this time. Prelim. Resp. 7. For purposes of this decision, we apply Petitioner’s proposed definition as it is consistent with the level of skill presented in the ’747 patent and applied art. We also note that the level of ordinary skill in the art at the time of the invention may be reflected in the prior art in this proceeding. 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 6

  Claim construction§ 112 disclosurecites Phillips
  Patents in suitUS 11,083,747

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.