• Lifevac, LLC v. Dcstar Inc.Institution denied
  PTAB · Sep 8, 2025 · IPR2025-00454 · APJ Cynthia M Hardman · IPR · Institution

  The Board denied institution on claims 1–17 because Petitioner did not show a reasonable likelihood that Zhongnan qualifies as prior art under the § 102(b)(1)(B) exception.

  RulingsInstitution decision

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

    “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”)). Petitioner ultimately bears the burden of persuasion to prove unpatentability of each challenged claim by a preponderance of the evidence. 35 U.S.C. § 316(e). This burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The Board may authorize inter partes review if we determine that the information presented in the Petition and Patent Owner’s Preliminary Response shows 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 8

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artDecided for patent owner

    “provides that a disclosure which would otherwise qualify as prior art under AIA 35 U.S.C. 102(a)(1) (patent, printed publication, public use, sale, or other means of public availability) is excepted as prior art if: (1) the disclosure was made one year or less before the effective filing date of the claimed invention; and (2) the subject matter disclosed had been previously publicly disclosed by the inventor, a joint inventor, or another who obtained the subject matter directly or indirectly from the inventor or joint inventor. MPEP § 2153.02 (9th ed. rev. 01.2024 Nov. 2024); see also Sanho, 108 F.4th at 1381. As to point (1), there is no dispute that Zhongnan was published one year or less before the effective filing date of the challenged claims. See, e.g., Ex. 1005, code (43); Pet. 11, 20; Prelim. Resp. 9–10. Thus, we focus on point (2), which requires that IDEAR be previously publicly disclosed by the inventor, and that Zhongnan and IDEAR disclose the same subject matter.” slip op. at 10

  • BurdenDecided for patent owner

    “Our rules require that in determining whether to institute inter partes review, we “take into account a patent owner preliminary response where such a response is filed, including any testimonial evidence.” 37 C.F.R. § 42.108(c) (emphasis added); Prelim. Sur-reply 3. As Patent Owner correctly notes, “the Board routinely weighs declaratory testimony at the institution[] stage and virtually always makes institution decisions without the benefit of cross-examination.” Prelim. Resp. 19–20 (emphasis omitted) (citing LG Elecs. Inc. v. Wi-LAN Inc., IPR2018-00704, Paper 14 at 13–14 (PTAB 2018); Freebit AS v. Bose Corp., IPR2017-01308, Paper 8 at 28 (PTAB 2017)). For example, in LG Electronics and Freebit, the Board denied institution, finding that the patent owner had provided sufficient evidence to antedate the petitioners’ proffered prior art references. See LG Elecs., IPR2018-00704, Paper 14 at 7; Freebit, IPR2017-01308, Paper 8 at 25, 34.10” slip op. at 23

  § 102 anticipation
  Patents in suitUS 11,478,575
• Trove Brands, LLC v. Camelbak Products, LLCInstitution denied
  PTAB · Jul 8, 2025 · IPR2025-00155 · APJ James A Worth · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 3–9, 11–17, or 19 were unpatentable on the asserted obviousness grounds.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 311 and any response filed under [35 U.S.C. §] 313 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) (2018).1 For the reasons set forth below, we determine that Petitioner has not demonstrated that there is a reasonable likelihood that at least one of claims 1, 3–9, 11–17, and 19 of the ’187 patent is unpatentable based on the grounds set forth in the Petition, and we do not institute an inter partes review.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that a person of ordinary skill in the art (“POSITA”) would have had an undergraduate degree in mechanical engineering or equivalent coursework, and a year or more of experience in designing, prototyping, and/or manufacturing fluid containers or similar products. Pet. 19 (citing Ex. 1003 ¶ 29). Petitioner asserts that more work experience may substitute for a lower level of education, and vice versa. Id. Patent Owner admittedly sets forth “a similar, though slightly different, level of ordinary skill”: a bachelor’s degree in mechanical engineering or the equivalent coursework and approximately one year of experience with liquid-containing devices, with more work experience substituting for less education and vice versa. Prelim. Resp. 27 (citing Ex.2001 ¶¶ 60–64). Patent Owner discerns no material difference between the definitions provided by the parties for purposes of the Board’s decision on whether to institute this proceeding. Id. For purposes of this decision, we adopt Petitioner’s proposed level of skill as being consistent with the prior art, although our conclusion on whether to institute would be unchanged under either definition.” slip op. at 10

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner

    “The failure to use the word “means” in a claim element creates a rebuttable presumption that § 112 ¶ 6 does not apply. Williamson v. Citrix Online, 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc). The presumption can be overcome and § 112 ¶ 6 will apply if the challenger demonstrates that the claim term fails to “recite[ ] sufficiently definite structure” or else recites “function without reciting sufficient structure for performing that function. “Construing a means-plus-function claim term is a two-step process.” Id. at 1351. “The [tribunal] must first identify the claimed function.” Id. “Then, the [tribunal] must determine what structure, if any, disclosed in the specification corresponds to the claimed function.” Id. There may be multiple claimed functions, each with disclosed corresponding structure. See id. at 1351–52.” slip op. at 14

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

    “We are persuaded by Patent Owner that the term “automatically” in “to automatically disengage the first and second catch structures” means that it is not just the force applied by the user that disengages the first and second catch structures, but also the bias of the mouthpiece that helps to disengage the first and second catch structures. In the first instance, we agree with Patent Owner that the claim itself recites that, upon actuation, the mouthpiece assembly is “release[d]” to “move via its bias from the stowed configuration to the dispensing configuration.” See Ex. 1001, 21:59–64. This meaning is supported by the Specification which states: “In some examples, the mouthpiece assembly is biased toward the dispensing configuration and thus moves automatically under its bias upon release by the user-release mechanism.” Ex. 1001, 1:64–67. We further agree with Patent Owner that the plain and ordinary meaning of “automatic” is that the user operation alone is not responsible for the action. For example, in one dictionary cited by Petitioner, “automatic” is defined as “2: having a self-acting or self-regulating mechanism.” See Ex. 2007, 1.11 The district court construction is consistent therewith. The district court identified two functions, the first of which is the same as that of the ’028 patent, i.e., “Automatically disengaging the first and second catch structures upon actuation of the user release mechanism and thereby releasing the mouthpiece assembly to move via its bias from the stowed configuration to the dispensing configuration.” See Section II.C.1, supra. In discussing that function, the district court states: “While a user may impart force upon user engagement portion 260 to release the mouthpiece, the bias of the mouthpiece towards the dispensing configuration causes the mouthpiece to move automatically, satisfying the requirements of Claim 1.” Ex. 2002, 16. We conclude that the term “automatically” in “adapted to” slip op. at 17

  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,684,187
• Trove Brands, LLC v. Camelbak Products, LLCInstituted
  PTAB · Jun 6, 2025 · IPR2025-00140 · APJ James A Worth · IPR · Institution

  The Board instituted IPR of claims 1–18 on all petitioned challenges, finding a reasonable likelihood that at least claim 1 is obvious over Nakajima and the knowledge of a person of ordinary skill.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 311 and any response filed under [35 U.S.C. §] 313 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) (2018). For the reasons set forth below, we determine that Petitioner has demonstrated that there is a reasonable likelihood that at least one of claims 1–18 of the ’250 patent is unpatentable, and we institute an inter partes review of claims 1–18 based on the grounds set forth in the Petition.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that a person of ordinary skill in the art (“POSITA”) would have had an undergraduate degree in mechanical engineering or equivalent coursework, and a year or more of experience in designing, prototyping, and/or manufacturing fluid containers or similar products. Pet. 15 (citing Ex. 1002 ¶ 25). Petitioner asserts that more work experience may substitute for a lower level of education, and vice versa. Id. Patent Owner admittedly sets forth “a similar, though slightly different, level of ordinary skill”: a bachelor’s degree in mechanical experience with liquid-containing devices, with more work experience substituting for less education and vice versa. Prelim. Resp. 28 (citing Ex. 2001 ¶ 50). Patent Owner discerns no material difference between the definitions provided by the parties for purposes of the Board’s decision on whether to institute this proceeding. Id. For purposes of this decision, we adopt Petitioner’s proposed level of skill as being consistent with the prior art, although our conclusion on whether to institute would be unchanged under either definition.” slip op. at 9

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

    “For purposes of this decision on institution, we adopt the proffered dictionary definition of “mouthpiece” as “a part (as of an instrument) that goes in the mouth or to which the mouth is applied” (see Ex. 2005), and we construe this as an intended use of this component of the apparatus, because this definition is consistent with the plain and ordinary meaning of the term which is a compound of “mouth” and “piece” and also because this definition is consistent with the Specification. For example, the Specification describes the use of the mouthpiece as follows: “In use, the mouthpiece is adapted to be configured to the dispensing configuration by a user placing the mouthpiece in the user’s mouth and biting upon or otherwise compressing the appropriate portions of sidewalls 92 of the mouthpiece.” Ex. 1001, 8:45–49. We note that, although the Specification refers to bite-actuation of the mouthpiece, for example in the field of the disclosure and certain embodiments (e.g., Ex. 1001, 1:25–27), the independent claims do not require bite-actuation. The Specification identifies the mouthpiece as item 72 (which is depicted, for example, in Figure 25, reproduced supra). Ex. 1001, 3:7‒8. 7 Exhibit 2005 appears to be from an online Merriam-Webster dictionary accessed March 13, 2025. Ex. 2005, 4. At this time, there is no argument in the preliminary record that this definition would have been different before the critical date of the patent.” slip op. at 12

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

    “Although the construction of this limitation may be helpful in deciding the issues of unpatentability, we determine that the construction of this term would benefit from further briefing during the trial phase of this proceeding, and we invite the parties to continue to brief this issue. Therefore, we do not provide a preliminary construction of the term at this time.” slip op. at 14

  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,851,250
• Integrated Dna Technologies, Inc. v. Tecan Genomics, Inc.Instituted
  PTAB · Apr 21, 2025 · IPR2024-01504 · APJ James A Worth · IPR · Institution

  The Board instituted IPR on claims 1–4, 6, 7, 9, and 10 on all petitioned grounds, finding a reasonable likelihood that claim 1 is obvious over Iafrate and Kivioja.

  RulingsInstitution decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “On this preliminary record, we agree with Patent Owner that Petitioner’s asserted level of ordinary skill in the art is higher than warranted when Petitioner argues that a person of ordinary skill “further would have had specific experience with implementing and designing library preparation methods.” Pet. 21–22. However, we disagree with Patent Owner that a POSA only need to “have had experience with DNA sequencing methods” (Prelim. Resp. 8) because an artisan with experience with only pre-NGS sequencing methods would not qualify as a person of ordinary skill. Instead, for purposes of this Decision, we find a person of ordinary skill would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. The person of ordinary skill would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a person of ordinary skill is consistent with the skill level reflected in the disclosures of the ’357 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review.” slip op. at 9

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

    “1. “indexing site” Petitioner argues that the ’357 patent defines “indexing site” as a sample index, specifically, “a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing.” Pet. 23 (citing Ex. 1004, 4:40–44). Patent Owner does not disagree other than to argue that no claim requires construction. The ’357 patent states: An indexing site is a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing. provide a definition for “indexing site,” and we construe the term in accordance therewith.” slip op. at 10

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

    “3. “identifying sequence reads with identical identifier and target sequences as duplicates” Although the parties do not request construction of this limitation, we note that the parties may wish to address the construction of this limitation after institution. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (claims are construed only to the extent necessary the term “duplicates” means that the sequences are identical. We observe that the ’357 patent states: “A duplicate sequencing read can be a sequencing read with the same identifier site and target sequence as another sequencing read in the population of sequencing reads.” Ex. 1004, 4:12–15. The claim does not use the exact wording as the Specification.4” slip op. at 11

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

    “4. “comprising” The parties may address the meaning of the transitional phrase “comprising” and whether the prior art meets the claim if the prior art discloses a method of identifying as duplicates those sequence reads with identical labels and target fragments and, in addition also identifies other sequence reads as duplicates, including sequence reads with some mutations resulting from PCR or SBS error. See Ex. 1079 ¶ 117. On this preliminary record, we construe “comprising” as an open-ended transition that is not limited to the listed steps. See Vivid Techs., Inc., 200 F.3d at 811.” slip op. at 13

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 11,098,357
• Integrated Dna Technologies, Inc. v. Tecan Genomics, Inc.Instituted
  PTAB · Apr 21, 2025 · IPR2024-01502 · APJ James A Worth · IPR · Institution

  Instituted IPR of claims 1–3, 5–11, and 14–17 on all petitioned grounds; the Board found a reasonable likelihood that at least claim 1 was obvious over Iafrate and Kivioja.

  RulingsInstitution decision

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

    “On the record at this stage of the proceeding, we determine that Petitioner has made an adequate showing on claim 1’s preamble language.9 Kivioja discloses that “with the UMI method one can reproducibly detect the number of molecules after different numbers of PCR cycles without normalization.” Ex. 1012, 2–3. Dr. Sims opines that a person of ordinary skill would have understood that Kivioja’s method teaches a method of detecting and removing duplicate sequencing reads, i.e., that Kivioja’s method of counting unique sequences necessarily identifies duplicate reads. See Ex. 1079 ¶ 260. 8 We recognize that the burden remains with Petitioner to prove unpatentability of the challenged claims. See 35 U.S.C. § 316(e). 9 We do not need to decide for purpose of institution whether the preamble is limiting.” slip op. at 20

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “On this preliminary record, we agree with Patent Owner that Petitioner’s asserted level of ordinary skill in the art is higher than warranted when Petitioner argues that a person of ordinary skill “further would have had specific experience with implementing and designing library preparation methods.” Pet. 23. However, we disagree with Patent Owner that a POSA only need to “have had experience with DNA sequencing methods” (Prelim. Resp. 8) because an artisan with experience with only pre-NGS sequencing methods would not qualify as a person of ordinary skill. skill would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. The person of ordinary skill would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a person of ordinary skill is consistent with the skill level reflected in the disclosures of the ’399 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review.” slip op. at 9

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

    “1. “indexing site” Petitioner argues that the ’399 patent defines “indexing site” as a sample index, specifically, “a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing.” Pet. 24 (citing Ex. 1003, 4:34–38). Patent Owner does not disagree other than to argue that no claim term requires construction. The ’399 patent states: An indexing site is a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing. Ex. 1003, 4:34–38. We understand this passage of the ’399 patent to provide a definition for “indexing site,” and we construe the term in accordance therewith. 2. “indexing primer binding site” Petitioner argues that the ’399 patent defines “indexing primer binding site” as the binding site for a primer used to read the indexing site/sample index, specifically, “a nucleotide sequence for binding a primer for an indexing site.” Pet. 24 (citing Ex. 1003, 4:33–34). Patent Owner does not disagree other than to argue that no claim term requires construction. The ’399 patent states: “An indexing primer binding site is a nucleotide sequence for binding a primer for an indexing site.” Ex. 1003, definition for “indexing primer binding site,” and we construe the term in accordance therewith. 3. “identifier site” Petitioner argues that the ’399 patent defines “identifier site” as a molecular tag attached to fragments prior to amplification, specifically, “a nucleic acid sequence that comprises random bases and is used to identify duplicate sequencing reads.” Pet. 25 (citing Ex. 1003, 4:43-45). Petitioner argues that an “identifier site” “can be designed as a set of sequences, or it can be semi-random, or it can be completely random.” Id. (citing Ex. 1003, 4:49–51). Petitioner argues that an “identifier site” can also “be a fixed length, or it can be a variable length.” Id. (citing Ex. 1003, 4:51–54). Patent Owner does not disagree other than to argue that no claim term requires construction. The ’399 patent states: “An identifier site is a nucleic acid sequence that comprises random bases and is used to identify duplicate sequencing reads.” Ex. 1003, 4:43–45. We understand this passage of the ’399 patent to provide a definition for “identifier site,” and we construe the term in accordance therewith. 4. “target sequence primer binding site” Petitioner argues that the ’399 patent defines “target sequence primer binding site” as a binding site for a primer used to read the fragment sequence, specifically, a “nucleotide sequence for binding a primer for a target sequence.” Pet. 25 (citing Ex. 1003, 4:62–65). Petitioner also argues that the ’399 patent expressly discloses that this site can be a standard Illumina sequence compatible with an Illumina primer for an SBS reaction to read the DNA fragment. Id. (citing Ex. 1003, 16:48–51 & SEQ ID No. 3). requires construction. The ’399 patent states: “A target sequence primer binding site nucleotide sequence for binding a primer for a target sequence.” Ex. 1003, 4:62–63. The ’399 patent appears to have a typographical error at this juncture in the Specification because the quoted text is missing a verb (e.g., “is”) and is therefore an incomplete sentence. Based on the context of the surrounding parts of the Specification, we infer that the ’399 patent intended to define “target sequence primer binding site” as a “nucleotide sequence for binding a primer for a target sequence.”” slip op. at 11

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

    “5. “identifying a duplicate sequencing read as the sequencing read comprising the same identifier site and nucleic acid fragment as another sequencing read in the population of sequencing reads” Although the parties do not request construction of this limitation, we note that the parties may wish to address the construction of this limitation after institution. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (claims are construed only to the extent necessary to resolve a dispute). For example, the parties may wish to address whether the “same identifier and nucleic acid fragment” means that the sequences are identical. We observe that the ’399 patent states: “A duplicate sequencing read can be a sequencing read with the same identifier site and target sequence as another sequencing read in the population of sequencing reads.” Ex. 1003, 4:8–11. The claim does not use the exact wording as the Specification.5” slip op. at 13

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 9,546,399
• Bluebird Bio, Inc. v. Sloan Kettering Institute For Cancer ResearchNo claims unpatentable
  PTAB · Apr 22, 2024 · IPR2023-00074 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1, 2, 5–8, 11, and 15 were not shown unpatentable because the cited May references did not sufficiently disclose or guide a skilled artisan to the claimed LCR fragments.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See PO Resp. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’061 patent and the prior art of record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 8

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

    “Petitioner states that “that no term of the ’061 patent requires construction to resolve the challenges in this Petition.” Pet. 25 (citing Ex. 1002 ¶¶ 50–51) (footnote omitted). Patent Owner does not argue for any express claim constructions. See PO Resp. Based upon our review of the current record, we determine that no claim terms require express construction for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 8

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference not prior artNot shown unpatentable

    “represents the inventors’ own work, and thus the May Thesis is not prior art to the ’061 patent. PO Resp. 14–15. The May Thesis is authored by Chad May, who is a listed inventor of the ’061 patent. Id.; Ex. 1004, 3; Ex. 1001, code (75). Thus, the May Thesis represents the work of one of the ’061 inventors and is therefore ineligible as prior art under 35 U.S.C. § 102(a) based on the July 1, 2002 priority date. See, e.g., In re Katz, 687 F.2d 450, 454–455 (CCPA 1982) (a prior publication by inventors or a subset of the inventors does not qualify as prior art under 102(a)). With respect to 35 U.S.C. § 102(b), we find that the May Thesis is ineligible as prior art, even assuming that the Challenged Claims are not entitled to receive benefit of an earlier filing date. Petitioner provides evidence that the May Thesis was publicly available as of November 26, 2001. Pet. 17 (citing Ex. 1036 ¶¶ 1–26; Ex. 1002 ¶ 60). Patent Owner does not dispute that evidence. Based on the undisputed November 26, 2001 public availability date, the May Thesis represents a disclosure less than one year before the asserted effective filing date, i.e., July 1, 2002. Based on that timing and because the disclosure was made by the inventor, the May Thesis is not available as prior art to the Challenged Claims under 35 U.S.C. §102(b).” slip op. at 11

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

    “summarized above, we determine that the May Article fails to disclose the restriction sites surrounding the BstXI and SnaBI HS2-, BamHI and HindIII HS3-, or BamHI and BanII HS4-spanning nucleotide fragments, as required by the challenged claims. According to Petitioner, that limitation is inherently disclosed by the May Article’s description of the lengths of the HS2, HS3, and HS4 fragments in the TNS9 vector and its depiction of those fragments on a map of the LCR. Pet. 28. To support its inherency argument, Petitioner relies on knowledge in the art, i.e., the availability of the entire map of the LCR region, and the availability of restriction enzymes, including BstX1, SnaBI, BamHI, HindIII, and BanII. Id. at 39–40 (citing Kennametal, 780 F.3d at 1381–83). Based on that combined information, Petitioner contends that a POSA would “have been able to map all of the possible restriction sites in the regions flanking the cores of HS2, HS3, and HS4.” Id. Petitioner asserts further that “[g]iven the May Article’s disclosure regarding the size and location of TNS9’s HS2, HS3, and HS4 fragments, a POSA would have placed these fragments onto the restrictionsite map of the LCR” that was available at the time, and would have identified only six possible combinations of restriction enzyme fragments, including the one recited in claim 1. Id. Upon closer inspection, however, we appreciate from the testimony of Petitioner’s declarant, Dr. Bungert, that the process involved in arriving at those six possible combinations is predicated on numerous assumptions guiding a number of exacting steps to be performed in order to achieve the the claimed LCR fragment would have involved the steps of (a) placing fragments that are the disclosed size of the HS2, HS3, and HS4 fragments from the TNS9 vector in the May Article onto the known restriction-site map of the LCR; (b) comparing those fragments to the “‘drawn to scale’ map” in the May Article; and then (c) identifying various fragments and determining which ones are consistent with the May Article’s description and match up with the fragments on the May Article’s drawn to scale map. Ex. 1002 ¶¶ 143–156. To identify the fragments consistent with the May Article’s description, it was necessary for Dr. Bungert to use certain assumptions that exclude unfavorable enzymes, such as using a range of ± 20 bp in order to identify fragments with lengths that are within 20 bp of the fragments reported in the May Article. Id. In view of the number of assumptions and steps required to get from what is disclosed in the May Article to arrive at the alleged “six possible LCRs (i.e., combination of HS2, HS3, and HS4 fragments based on the TNS9 LCR disclosed in the May Article)—including the LCR recited in claim 1,” Ex. 1002 ¶ 156, we do not find that Petitioner has demonstrated that fragments having the restriction sites recited in claim 1 would have been “at once envisaged” by a skilled artisan as argued by Petitioner. Pet. 39–40.” slip op. at 16

  Patent outcomesUS 8,058,061 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,058,061
• Bluebird Bio, Inc. v. Sloan Kettering Institute For Cancer ResearchNo claims unpatentable
  PTAB · Apr 22, 2024 · IPR2023-00070 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1, 10, 19, and 22 were not shown unpatentable because the May Thesis was not prior art and the May Article and May Abstract did not establish the claimed LCR fragments.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See PO Resp. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’179 patent and the prior art of record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 8

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

    “Based upon our review of the current record, we determine that no claim terms require express construction for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 8

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

    “the ’179 patent. Id.; Ex. 1004, 3; Ex. 1001, code (75). Thus, the May Thesis represents the work of one of the ’179 inventors and is therefore ineligible as prior art under 35 U.S.C. § 102(a) for challenged claims 1, 19, and 22. See, e.g., In re Katz, 687 F.2d 450, 454–455 (CCPA 1982) (a prior publication by inventors or a subset of the inventors does not qualify as prior art under 102(a)). With respect to 35 U.S.C. § 102(b), we find that the May Thesis is ineligible as prior art, even assuming that claims 1, 19, and 22 are not entitled to receive benefit of an earlier filing date. Petitioner provides evidence that the May Thesis was publicly available as of November 26, 2001. Pet. 17 (citing Ex. 1036 ¶¶ 1–26; Ex. 1002 ¶ 60). Patent Owner does not dispute that evidence. Based on the undisputed November 26, 2001 public availability date, the May Thesis represents a disclosure less than one year before the asserted effective filing date, i.e., the July 1, 2002, for claims 1, 19, and 22 challenged with this reference. Based on that timing and because the disclosure was made by the inventor, the May Thesis is not available as prior art to challenged claims 1, 19, and 22 under 35 U.S.C. §102(b). Petitioner has not established that the May Thesis is prior art to claims” slip op. at 11

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

    “summarized above, we determine that the May Article fails to disclose the restriction sites surrounding the BstXI and SnaBI HS2-, BamHI and HindIII HS3-, or BamHI and BanII HS4-spanning nucleotide fragments, as required by the challenged claims. According to Petitioner, that limitation is inherently disclosed by the May Article’s description of the lengths of the HS2, HS3, and HS4 fragments in the TNS9 vector and its depiction of those fragments on a map of the LCR. Pet. 28. To support its inherency argument, Petitioner relies on knowledge in the art, i.e., the availability of the entire map of the LCR region, and the availability of restriction enzymes, including BstX1, SnaBI, BamHI, HindIII, and BanII. Id. at 30–31 (citing Kennametal, 780 F.3d at 1381–83). Based on that combined information, Petitioner contends that a POSA would “have been able to map all of the possible restriction sites in the regions flanking the cores of HS2, HS3, and HS4.” Id. Petitioner asserts further that “[g]iven the May Article’s disclosure regarding the size and location of [TNS9’s] HS2, HS3, and HS4 fragments, a POSA would have placed these fragments onto the restrictionsite map of the LCR” that was available at the time, and would have identified only six possible combinations of restriction enzyme fragments, including the one recited in claim 1. Id. Upon closer inspection, however, we appreciate from the testimony of Petitioner’s declarant, Dr. Bungert, that the process involved in arriving at those six possible combinations is predicated on numerous assumptions guiding a number of exacting steps to be performed in order to achieve the claimed LCR fragment. According to Dr. Bungert, the process for making the claimed LCR fragment would have involved the steps of (a) placing fragments that are the disclosed size of the HS2, HS3, and HS4 fragments from the TNS9 vector in the May Article onto the known restriction-site map of the LCR; (b) comparing those fragments to the “‘drawn to scale’ map” in the May Article; and then (c) identifying various fragments and determining which ones are consistent with the May Article’s description and match up with the fragments on the May Article’s drawn to scale map. Ex. 1002 ¶¶ 112–117. To identify the fragments consistent with the May Article’s description, it was necessary for Dr. Bungert to use certain assumptions that exclude unfavorable enzymes such as using a range of ± 20 bp in order to identify fragments with lengths that are within 20 bp of the fragments reported in the May Article. Id. In view of the number of assumptions and steps required to get from what is disclosed in the May Article to arrive at the alleged “six possible LCRs (i.e., combination of HS2, HS3, and HS4 fragments based on the TNS9 LCR disclosed in the May Article)—including the LCR recited in claim 1,” Ex. 1002 ¶ 117, we do not find that Petitioner has demonstrated that fragments having the restriction sites recited in claim 1 would have been “at once envisage[d]” by a skilled artisan as argued by Petitioner. Pet. 30–31.” slip op. at 16

  Patent outcomesUS 7,541,179 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,541,179
• BTC Corporation v. TG Biotech Co., Ltd.No claims unpatentable
  PTAB · Nov 13, 2023 · IPR2022-00998 · APJ Ulrike W Jenks · IPR · Final written decision

  Claims 1–13 were not shown unpatentable under the asserted obviousness grounds; Patent Owner’s motion to strike Exhibit 1038 was granted.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We are not persuaded by Petitioner’s contention that we should disregard Dr. Naumovski’s testimony because she may have taken a leave of absence from work for a couple of years. The record supports that Dr. Naumovski not only meets the requirements of the person of ordinary skill in the art, but also appears to have relevant knowledge with respect to Gynostemma pentaphylum (“GP”) saponins. See Ex. 2015 (Appendix A). related field, and at least two years of experience using techniques for extraction and characterization of plant-based materials.” PO Resp. 11 (citing Ex. 2015 ¶ 74). Because there are more than 400 species of plants that contain saponins, Patent Owner disagrees that a person of ordinary skill in the art would be familiar with the structure and utility of saponins. Id. The level of skill in the art is a reference point for gauging what would have been obvious based on the reference disclosures. See Okajima, 261 F.3d at 1355. In other words, the lens of the level of ordinary skill in the art does not change a prior art’s disclosure, though it may change one’s understanding of what is disclosed. Patent Owner, however, does not explain how its definition provides a reference point that would meaningfully alter the Petition’s assertions of obviousness. For purposes of this decision, we analyze the asserted prior art with respect to the level of skill set forth by Petitioner, but there would be no difference in the outcome of this Decision if we were to apply the level of skill in the art set forth by Patent Owner. C.” slip op. at 13

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “during the full trial, we determine that Petitioner has not shown by a preponderance of the evidence that applying the methods of Kim 460 to the G. pentaphyllum starting material of Razmovski necessarily results in the damulin levels as claimed. We agree with Dr. Naumovski’s explanation that the use of an impure damulin B standard containing a double peak renders the results as shown in Exhibit 1013 unreliable. Ex. 2015 ¶¶ 141–143, 162–173; see Ex. 2007. Dr. Naumovski further explains that the use of an impure standard would require the application of a correction factor, but this correction factor would need to be reassessed as the purity of the standard decreases over time. See Ex. 2015 ¶ 166. As Dr. Naumovski explains that applying a correction factor to the linear regression would result in a shallower slope. Ex. 2015 ¶ 165 (citing 2006, 71:12–73:5; 99:2–9). “Reducing the calibration curve slope increases the amount of damulin B calculated from the experimental extracts.” Ex. 2015 ¶ 165. However, in the Experimental Report-1 the same correction factor for the damulin B standard was used to” slip op. at 41

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “Petitioner requests construction of the terms “an effective amount for improving or treating the metabolic syndrome,” which is found in claims 11–13, as meaning “an amount that produces any measurable amount of improvement in the metabolic syndrome” (Pet. 13–15 (citing Ex. 1003 ¶ 91)) and “[a] pharmaceutical composition for improving and treating a metabolic syndrome, comprising at least one of at least 0.7% damulin A and at least 0.5% damulin B . . . and a pharmacologically acceptable carrier or excipient,” which is found in claim 8, as meaning “a pharmaceutical composition that includes an extract with 0.7% and 0.5% of damulin A and damulin B[, respectively,] along with a carrier or excipient” (id. at 15–16 (citing Ex. 1002, 64–65, 251–52, 280; Ex. 1001, 12:15–67, Table 2)). Patent Owner argues that “constructions are not necessary.” PO Resp. 11–12. We agree with Patent Owner and determine that it is not necessary for purposes of this Decision to construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only terms” slip op. at 15

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

    “Obviousness does not require absolute predictability of success . . . all that is required is a reasonable expectation of success.” In re Droge, 695 F.3d 1334, 1338 (Fed. Cir. 2012) (quoting In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (citing In re O’Farrell, 853 F.2d 894, 903–04 (Fed.Cir.1988)); Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359 (Fed. Cir. 2016) (explaining that the expectation of success issue involves a showing of “a reasonable expectation of achieving what is claimed”) (emphasis added). Here, Petitioner relies on Kim 460 to show that heating ginseng, which contains the ginsenosides Rb1, Rb2, Rc, Rd, Rg3, and Rg5, results in a teaches that ginseng with the higher Rg3 and Rg5 content is 50-fold more potent in their vasodilation studies than the non-treated samples. Razmovski teaches that G. pentaphyllum contains over 100 saponins and eight of those saponins are the same as protoparaxadiol-type ginsenosides Rb1, Rc, Rb3, Rd, F2, Rg3, malonyl-Rb1, and malonyl-Rd that are found in P. ginseng. Ex. 1007, 4. Knowing that G. pentaphyllum also contains ginsenosides Rb1, Rb2, Rc, Rd, Rg3, and Rg5, we find Petitioner’s conclusion that heating a G. pentaphyllum extract that contains these ginsenosides would similarly increase the ginsenoside levels of Rg3 and Rg5 is a reasonable inference from the cited references. Based on the teachings in Kim 460, we agree with Petitioner that it would have been reasonable to expect that the same source material, although derived from a different plant, would behave similarly to heat treatment. See Pet. 24. Because G. pentaphyllum is a less expensive starting material, we also agree with Petitioner that there is sufficient motivation to substitute G. pentaphyllum for ginseng in the methods of Kim 460. slip op. at 29

  Patent outcomesUS 8,357,786 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,357,786
• Eli Lilly And Company v. Teva Pharmaceuticals International GmbHAll claims unpatentable
  PTAB · Sep 25, 2023 · IPR2022-00739 · APJ David Cotta · IPR · Final written decision

  Claims 1–30 are unpatentable as obvious over Sun, Dodick, and Sharma; the Board did not reach the separate Dodick and Sharma ground.

  RulingsFinal written decision

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

    “(iii) Conclusion with respect to Group I patients In sum, we find that the only difference between Sun’s patients who” slip op. at 33

  • Expert testimonyPetitioner expert creditedOther

    “be advantageous as compared to galcanezumab on the basis that galcanezumab is a “less selective agent” than erenumab. Patent Owner and Dr. Grosberg cite Shi 2016 (Ex. 2049) as teaching the “high selectivity” of erenumab for blocking the CGRP complex as compared to “less selective agents,” and use this teaching to imply that galcanezumab is less selective than erenumab. PO Resp. 22; Ex. 2037 ¶ 218. But, as Dr. Hay explains, “[t]he ‘less selective agents’ that Shi 2016 refers to are the small-molecule CGRP receptor antagonists, Gepants, not galcanezumab.” Ex. 1239 ¶ 29. We find Dr. Hay’s testimony on this point persuasive, as it is consistent with Shi 2016. See Ex. 2049, 2 (discussing concerns regarding small molecule CGRP antagonists that have prevented their approval and opining that “[a] monoclonal antibody may be a preferred modality to target the CGRP receptor”). Moreover, Shi 2016 concludes with a discussion of the advantages of the superior selectivity of mAbs as a class. Id. at 8 (discussing advantages of mAbs over small molecule CGRP-receptor antagonists, noting “[i]n addition to high potency and superior selectivity, which may provide the benefit of fewer off-target side effects, monoclonal antibodies provide advantages that make them better suited for preventive treatment compared with small molecules”); Ex. 1239 ¶ 32 (interpreting Shi as teaching that “antibodies as a class have limited off-target effects as compared to small molecules because they bind to fewer biological targets and are therefore considered more specific.”). Accordingly, the evidence of” slip op. at 50

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

    “1. “A subject having refractory migraine” The phrase “a subject having refractory migraine” appears in the preamble to claim 1. Ex. 1002, 173:2–3. The parties agree that the preamble is limiting because it provides context and antecedent basis for terms in the body of the claim. Pet. 12 (“Claim 1’s preamble . . . should be construed as limiting at least because it provides context and antecedent [basis] for the claimed ‘therapeutically effective amount.’”); PO Resp. 9 (“There is no dispute that the preamble ‘[a] method of treating or preventing migraine in a subject having refractory migraine, the method comprising’ is reasons expressed by the parties. Rapoport v. Dement, 254 F.3d 1053, 1059 (Fed. Cir. 2001) (finding that the phrase “treatment of sleep apneas” in the preamble of an interference count was limiting because it provided antecedent basis for the phrase “to a patient in need of such treatment” in the body of the interference count); see also Eli Lilly Co. v. Teva Pharmas Int’l GmbH, 8 F.4th 1331, 1340–41 (Fed. Cir. 2021) (discussing construction of claims directed to “methods of using a composition for a specific purpose,” explaining, “while there is no bright-line rule for determining whether a preamble is limiting, we have generally construed statements of intended purpose in such method claims as limiting”). We turn now to the meaning of the phrase “a subject having refractory migraine.” The parties agree that the ’161 patent expressly defines the phrase “a subject having refractory migraine.” Pet. 13; PO Resp. 9. In this regard, the ’161 patent states: As used herein, refractory migraine patients (or “subject having refractory migraine”) are considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to at least two preventive medications (from a different cluster, defined below). Refractory migraine patients can also be considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to two to four classes of prior preventive medications (from different cluster[s], as defined below), e.g., inadequate response to two classes of prior preventive medications, inadequate response to three classes of prior preventative medications, or an inadequate response to four classes of prior preventative medications. Ex. 1002, 18:61–19:7. Thus, a “subject having refractory migraine” should be construed as: a migraine patient having a documented inadequate least two preventive medications from a different cluster. Id.” slip op. at 8

  • ExcludeMotion to exclude, deniedMixed

    “A. Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 We do not rely on Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 in our Final Written Decision. Accordingly, we dismiss Patent Owner’s Motion as it relates to these exhibits.” slip op. at 107

  Patent outcomesUS 11,028,161 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,028,161
• Eli Lilly And Company v. Teva Pharmaceuticals International GmbHAll claims unpatentable
  PTAB · Sep 25, 2023 · IPR2022-00738 · APJ David Cotta · IPR · Final written decision

  Claims 1–30 are unpatentable as obvious over Sun, Dodick, and Sharma; the Board did not reach the alternative ground.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the problems” slip op. at 6

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “1. “A subject having refractory migraine” The phrase “a subject having refractory migraine” appears in the preamble to claim 1. Ex. 1001, 173:2–3. The parties agree that the preamble is limiting because it provides context and antecedent basis for terms in the body of the claim. Pet. 12 (“Claim 1’s preamble . . . should be construed as limiting at least because it provides context and antecedent [basis] for the claimed ‘therapeutically effective amount.’”); PO Resp. 9 (“There is no dispute that the preamble ‘[a] method of treating or preventing migraine in a subject having refractory migraine, the method comprising’ is limits the claim for the reasons expressed by the parties. Rapoport v. Dement, 254 F.3d 1053, 1059 (Fed. Cir. 2001) (finding that the phrase “treatment of sleep apneas” in the preamble of an interference count was limiting because it provided antecedent basis for the phrase “to a patient in need of such treatment” in the body of the interference count); see also Eli Lilly Co. v. Teva Pharmas Int’l GmbH, 8 F.4th 1331, 1340–41 (Fed. Cir. 2021) (discussing construction of claims directed to “methods of using a composition for a specific purpose,” explaining, “while there is no bright-line rule for determining whether a preamble is limiting, we have generally construed statements of intended purpose in such method claims as limiting”). We turn now to the meaning of the phrase “a subject having refractory migraine.” The parties agree that the ’160 patent expressly defines the phrase “a subject having refractory migraine.” Pet. 13; PO Resp. 9. In this regard, the ’160 patent states: As used herein, refractory migraine patients (or “subject having refractory migraine”) are considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to at least two preventive medications (from a different cluster, defined below). Refractory migraine patients can also be considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to two to four classes of prior preventive medications (from different cluster[s], as defined below), e.g., inadequate response to two classes of prior preventive medications, inadequate response to three classes of prior preventative medications, or an inadequate response to four classes of prior preventative medications. Ex. 1001, 18:59–19:5. Thus, a “subject having refractory migraine” should be construed as: a migraine patient having a documented inadequate least two preventive medications from a different cluster. Id.” slip op. at 8

  • Expert testimonyPatent owner expert discountedDecided for petitioner

    “understand the term “adverse event” to be limited to “serious” events. Ex. 2004, 1; Ex. 1208, 1; Ex. 1209, 6; Ex. 1210, 8. The only evidence to the contrary is the testimony of Dr. Grosberg. Ex. 2037 ¶ 45. Because Dr. Grosberg’s testimony is inconsistent with the evidence he relies upon, we decline to give it substantial weight. We recognize that the Specification of the ’160 patent includes language imposing some degree of severity on the “adverse event.” Specifically, the adverse event must be significant enough to cause treatment to be “interrupted” because the event made the treatment become “intolerable by the patient.” But, we find no support in the record for imposing an additional severity requirement by effectively limiting the term “adverse event” to “serious adverse events.” Accordingly, we decline to construe the term “adverse event” to mean “a serious undesirable experience associated with the use of a treatment” as proposed by Patent Owner. PO Resp. 12. We do not find it necessary to further construe the term “adverse event” to resolve this dispute.” slip op. at 14

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “d) Conclusion regarding Sun’s disclosure of the claimed patients For the reasons discussed supra §§ II.F.1.a–c, we find that Petitioner” slip op. at 40

  Patent outcomesUS 11,028,160 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,028,160

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.