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  • PTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision

    Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.

    RulingsFinal written decision
    • Skill levelSkill level board ownOther

      “We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9

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

      “Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10

    • BurdenNot shown unpatentable

      “In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable

      “Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23

    Patent outcomesUS 11,959,109 unpatentable
    Claim construction§ 102 anticipation§ 112 disclosure
    Patents in suitUS 11,959,109
  • PTAB · Sep 8, 2026 · IPR2025-00440 · APJ Tawen Chang · IPR · Final written decision

    Claim 21 is unpatentable as obvious over Mizumura with either the ’498 PCT or McClymont; the Revised Contingent Motion to Amend proposing claim 22 is denied.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “overlap to a significant degree, i.e., a person with a Ph.D. in a discipline related to biological sciences and having had at least two years of work experience. However, the parties’ proposals differ slightly in the specific subjects in which a POSA would have had a doctoral degree, and whether the person’s work experience must have been directly related to horseshoe crab Factor C. As an initial matter, we find that a rigid requirement as to the subject of a POSA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 19; Ex. 1065, 99:14–100:3. with respect to the claims of the ’318 patent would have had a Ph.D. in molecular biology, biochemistry, or a related discipline, and about two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 13

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

      “C. Claim Construction The parties agree that “the terms in claim 21 can be afforded their plain and ordinary meaning for purposes of this proceeding” without further construction. Pet. 19–20; PO Resp. 11. Because express claim construction is not needed to resolve the issues in this case, we need not, and do not, construe expressly any claim term for purposes of this Decision. See 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 14

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

      “Carrying Out the Invention section, that “[t]he Factor C of the present invention is a Factor C derived from a horseshoe crab,” and states later in the same section that “[e]xamples of the horseshoe crab include . . . Limulus polyphemus.” Ex. 1006, 40. However, none of the remaining portions of ’767 application cited by Patent Owner relate directly to L. polyphemus; instead, the remaining portions of ’767 application cited by Patent Owner are directed to other species, in particular the Japanese horseshoe crab T. tridentatus. Further, Patent Owner’s witness, Dr. Schaefer, conceded that the ’767 application does not contain Factor C sequence information for L. polyphemus. See, e.g., Ex. 1067, 44:25–45:23. Although “[n]o length requirement exists for a disclosure to adequately describe an invention,” Falko-Gunter, 448 F.3d at 1365–1366, we are persuaded that a POSA would not, based on the totality of the above disclosures, reasonably understand that the inventors were in possession of the claimed HEK-293 recombinant L. polyphemus Factor C protein, in view of the state of the art as of December 10, 2013. In this regard, we note that adequate written description of a biological molecule, such as a HEK293 recombinant L. polyphemus Factor C protein, requires “more than a mere statement that it is part of the invention and reference to a potential method for isolating it”; instead, what is required is “‘a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” The Regents of the” slip op. at 21

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

      “Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Neither do we see Petitioner’s arguments regarding the December 10, 2013 priority date to be “mutually opposed” as Dr. Schaefer testified. Ex. 1067, 216:4– 24. Instead, we credit evidence of record, including Dr. Jain’s testimony and the February 22, 2018 Mizumura Declaration, that existence of the full sequence would permit a more complete analysis and that such an analysis would provide a POSA with a reasonable expectation that the claimed L. polyphemus recombinant protein would have a residual activity within the claimed range. See, e.g., Ex. 1029, 2–5; Ex. 1010, 48; Ex. 1065, 117:14– 130:24 (explaining that comparison of partial sequences in the Tokunaga 1991 publication showed “difference around the cleavage site” between T. tridentatus and L. polyphemus but comparison of the full sequence revealed that “the catalytic triad of histidine, serine, aspartate . . . to be more similar between Tachypleus and Limulus”). Patent Owner asserts that “Petitioner’s reliance on a statement made by Dr. Mizumura in a declaration submitted during prosecution of the ’767 Application fails to fill the gap in the analysis” regarding reasonable expectation of success, because the declaration “offers no evidence of the percentage of conserved amino acid substitutions that exist to support the conclusion that a POSA would have expected residual activity to be maintained between Tachypleus tridentatus and Limulus polyphemus” PO Resp. 47. However, as noted above, Dr. Mizumura provides an alignment of Factor C proteins from the two different species of horseshoe crab, determines that the similarity between the amino acid sequence is 99.5%, states that the amino acid residues that can undergo N-type sugar chain that L. polyphemus, like T. tridentatus, would also be less susceptible to inhibition by ions. Ex. 1029, 4–5. For the reasons discussed above, we also disagree with Patent Owner’s assertion that Petitioner’s reasonable expectation of success argument is “nothing more than conclusory assertions with no support.” PO Resp. 46. Rather, we find Petitioner has shown, by a preponderance of the evidence, that a POSA would have had reason to combine the teachings of Mizumura and the ’498 PCT, with a reasonable expectation of success in arriving at the Factor C protein recited in claim 21.” slip op. at 38

    Patent outcomesUS 11,236,318 unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 11,236,318
  • PTAB · Dec 10, 2025 · PGR2025-00054 · APJ Ryan H Flax · PGR · Institution

    The Board instituted PGR on claims 1–16 on all four grounds, finding at least one claim more likely than not unpatentable based on obviousness, indefiniteness, or lack of written description.

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

      “institute trial in a post-grant review. We institute a post-grant review only if the information presented in the petition filed under 35 U.S.C. § 321, if unrebutted, shows that it is more likely than not that at least one claim challenged in the petition is unpatentable. 35 U.S.C. § 324. On the existing record, we conclude that Petitioner demonstrates it is more likely than not that Petitioner would prevail in showing that at least one challenged claim of the ’781 patent is unpatentable under a presented ground. See generally Pet. Therefore, we grant institution of post-grant review. Our reasoning is discussed below.” slip op. at 2

    • PTAB / AIA Trials › Real party in interest / privityDecided for petitioner

      “STANDING Petitioner states that it certifies that: (1) the ’781 patent is available for post grant review because its earliest claimed effective filing date is October 9, 2018, and the patent issued less than nine months ago, on December 3, 2024; and (2) Petitioner is not barred or estopped from requesting a post grant review on the grounds in this petition. Pet. 5. This is sufficient. See 35 U.S.C. § 100(note)(A)–(B), § 321; 37 C.F.R. § 42.204(a). Patent Owner does not contest standing. See generally Prelim. Resp. B. REAL PARTIES-IN-INTEREST Petitioner states that “[t]he real parties-in-interest are Petitioner Straumann USA, LLC and its affiliates Institut Straumann AG and JJGC Indústria e Comércio de Materiais Dentários S.A.” Pet. 3. Patent Owner raises no objection and itself identifies “Smart Denture Conversions, LLC is the real party-in-interest.” Paper 4, 2; see generally Prelim. Resp. C.” slip op. at 3

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “At this point, we find little meaningful difference between the two proposed definitions. In fact, neither does Patent Owner’s witness, Mr. Leinsing, who states that his “opinions would not change under either definition.” Ex. 2011 ¶ 42. And, as set forth above, Patent Owner asserts that, for the sake of its present arguments, it matters not which of the two proposed definitions we use for this proceeding. Prelim. Resp. 21. Thus, at this stage, we accept and use Petitioner’s proposed definition of the ordinarily skilled artisan, which, unlike Patent Owner’s, does not implicate reliance on the knowledge of people other than the individual ordinarily skilled artisan. Petitioner’s definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’781 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he prior art itself [may] reflect[] an appropriate level” of ordinary skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). This issue may be further developed at trial by the parties, if desired. C.” slip op. at 19

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

      “same claim construction standard that is used to construe patent claims in a civil action in federal district court thus, by default, we give claim terms their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” 37 C.F.R. § 42.200(b); Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner indicates that None of the claim terms of claims 1–16 need to be construed to determine the patentability issues presented in this petition. The petition applies the ordinary meaning of the claim language as it would be understood by a POSA after reading the ’781 patent. Ex. 1002, ¶130. Petitioner will propose a construction if Patent Owner argues or the Board determines that one is required for any term. Pet. 31 (citing Ex. 1002). And, Patent Owner presents no express position on claim construction at this point. See generally Prelim. Resp. At this stage of the proceeding, we do not expressly construe any claim terms; however, this position is preliminary and we may change it based on the fully developed record at trial.8 D.” slip op. at 19

    Claim construction§ 103 obviousness§ 112 disclosurecites Graham
    Patents in suitUS 12,156,781
  • PTAB · Nov 21, 2025 · IPR2025-00956 · APJ Ryan H Flax · IPR · Institution

    The Board instituted IPR on claims 1–12 under all asserted grounds, finding a reasonable likelihood that at least one claim is unpatentable.

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

      “institute trial in an inter partes review. We institute an inter partes review only if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’ submissions in view of the existing record, we conclude that Petitioner demonstrates a reasonable likelihood it would prevail in showing that at least one challenged claim of the ’992 patent is unpatentable under the presented grounds. See Pet. Therefore, we grant institution of inter partes review. Our reasoning is discussed below. A.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “These two proposed definitions of the ordinarily skilled artisan share many consistencies, for example, the types of degrees and experience such a person would have had, but differ in the number of years of experience. Petitioner proposes the ordinarily skilled artisan would have had at least five years of experience and Patent Owner proposes at least three years (which would necessarily include five years, too). Patent Owner also proposes that the ordinarily skilled artisan would have consulted a dentist, oral surgeon, prosthodontist, or periodontist with experience in dental implants and prosthetics. At this point, we find little meaningful difference between the two proposed definitions. In fact, neither does Patent Owner’s witness, Mr. Leinsing, who states that his “opinions would not change under either definition.” Ex. 2011 ¶ 40. Thus, at this stage, we accept and use Petitioner’s proposed definition of the ordinarily skilled artisan, which, unlike Patent Owner’s, does not implicate reliance on the knowledge of people other than the individual ordinarily skilled artisan. Petitioner’s definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’992 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). This parties may further developed this issue at trial, if desired. C.” slip op. at 13

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

      “The Board interprets claim terms in an inter partes review using the same claim construction standard that is used to construe patent claims in a civil action in federal district court. 37 C.F.R. § 42.100(b). In construing claims, district courts and the Board here, by default, give claim terms their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc).” slip op. at 14

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

      “Here, the first claim limitation at issue is broad, i.e., different thread pattern/profile between a definite and a temporary screw, and the Specification’s and priority applications’ disclosure is narrow and specific, asymmetric buttress style threads in a temporary screw and symmetrical threads in a definite screw (are different). Any apparent predictability in or maturity of the relevant field here must be contrasted with the fact that the Specification, considering the ’992 patent itself or any of the identified priority applications, never once even discusses the (claimed) concept of specifically differing the thread style between a temporary and a definitive screw. Any differences in thread style are not called out by the disclosure, but are described and can be discerned only in relation to the respective threads’ functionality, i.e., Fig. 75’s temporary screw 190 has buttress-style threading so it can be pulled out rather than unscrewed from the abutment; Fig. 9’s definitive screw 75 has male threads that fill the female threads of the abutment 8 for a secure permanent engagement. Ex. 1001, 15:23–30, 21:25–44, 23:3–36; Ex. 1012, 97–98, Figs. 9, 75. And, although it is possible for a single disclosed species to provide written description support for a claimed genus, “a sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350; see also Synthes USA, LLC v. Spinal Kinetics, Inc., 734 F.3d 1332, 1344 (Fed. Cir. 2013). That does not appear to be the case here—the present record does not support that the described asymmetrical buttress, serrated style of different temporary screw threading (relative to that of the definitive screw and regardless of the direction of the threads for rotation) is sufficiently representative of the genus’s “different” thread patterns/profiles. See, e.g., Ex. 1006 (a buttress style thread does not function the same as a buttress reverse or 75º joint profile or rounded, or trapezoidal thread).” slip op. at 30

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · Graham
    Patents in suitUS 11,937,992
  • PTAB · Nov 18, 2025 · IPR2024-01014 · APJ Zhenyu Yang · IPR · Final written decision

    Petitioner did not show claims 1–8 unpatentable because they are entitled to the 2004 priority date, making Barbour unavailable as prior art.

    RulingsFinal written decision
    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Entitled to earlier dateDecided for patent owner

      “For a claim to a biological material, the enablement requirement of § 112, first paragraph, does not require such assured access to a microorganism deposit as of the filing date; what is required is assurance of access (to the microorganism culture by the public upon issuance of a patent on the application) prior to or during the pendency of the application, so that, upon issuance of a U. S. patent on the application, the public will, in fact, receive something in return for the patent grant. Feldman, 517 F.2d at 1355. Patent Owner has persuaded us that such exception not only applies to a deposit, but also extends to a biological material known and readily available. See 52 Fed. Reg. 34080, 34081. In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art.” slip op. at 15

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

      “In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15

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

      “In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15

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

      “would understand that the term “‘flanked by’ permits overlap between the expression cassette and the DNA sequence it is flanked by.” Pet. 24–26. Patent Owner does not propose any claim construction. PO Resp. 6–7. On this record and for purposes of this Decision, we see no need to expressly construe any claim term.” slip op. at 9

    Patent outcomesUS 8,901,378 not shown unpatentable
    Claim construction§ 102 anticipation§ 112 disclosurecites Phillips
    Patents in suitUS 8,901,378
  • PTAB · Nov 6, 2025 · PGR2025-00040 · APJ Kimberly Mcgraw · PGR · Institution

    The Board instituted PGR on claims 1–9, 11–33, and 35–38 on all petition grounds, finding it more likely than not that Hassfjell-Hoff anticipates at least claim 1.

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

      “Under 35 U.S.C. § 324(a), a post-grant review may be instituted only if “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.” Post-grant review is available for patents that issue from applications that at one point contained at least one claim with an effective filing date on or after March 16, 2013. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), §§ 3(n)(1), 6(f)(2)(A). After considering the briefing and the evidence of record, for the reasons set forth below, we determine that Petitioner has shown that the ’437 patent is eligible for post-grant review and that it is more likely than not that at least one challenged claim of the ’437 patent is unpatentable under § 324(a). Accordingly, we institute a post-grant review of all challenged claims of the ’437 patent.” slip op. at 2

    • Adverse judgmentAdverse judgmentOther

      “Here, Patentee Sciencons AS filed a statutory disclaimer of claims 10 and 34 of the ’437 patent. Ex. 2001; Prelim. Resp. 43. Based on our review of Exhibit 2001 and the Office’s public records, we find that the disclaimer of claims 10 and 34 complies with the above-listed requirements of 37 C.F.R. § 1.321(a). Accordingly, we treat claims 10 and 34 as having never been part of the ’437 patent. See Vectra Fitness, Inc. v. TNWK Corp., 162 F.3d 1379, 1383 (Fed. Cir. 1998) (“This court has interpreted the term ‘considered as part of the original patent’ in [35 U.S.C.] § 253 to mean that the patent is treated as though the disclaimed claims never existed.”). Because post-grant review cannot be instituted based on disclaimed claims, claims 10 and 34 are outside the scope of this proceeding. 37 C.F.R. § 42.207(e) (“No post-grant review will be instituted based on disclaimed claims.”); General Elec. Co. v. United Techs. Corp., IPR2017-00491, Paper 9 (PTAB July 6, 2017) (precedential) (denying institution in view of a statutory disclaimer of all the challenged claims). Thus, we confine our analysis in this Decision to claims 1–9, 11–33, and 35– 38, the remaining challenged claims that have not been disclaimed.” slip op. at 6

    • PTAB / AIA Trials › Real party in interest / privityGranted

      “Sciencons AS also states that ARTBIO, Inc. is responsible for defending the ’437 patent in this proceeding and requests that ARTBIO, Inc. be included in the caption for this proceeding.2 Paper 4, 1. ARTBIO, Inc. has signed powers of attorney appointing the same practitioners that were appointed by Sciencons AS to transact all business associated with the instant post-grant review review of the ’437 patent. See Paper 3. To date, no objection has been raised to Patent Owner’s request. Given Sciencons AS’s representation that ARTBIO, Inc. is currently the exclusive licensee of the ’437 patent and is responsible for defending the ’437 patent, we grant Sciencons AS’s unopposed request that ARTBIO, Inc. be included in the caption. For convenience we refer to Sciencons AS and the purported exclusive licensee ARTBIO, Inc. collectively as “Patent Owner.” As stated supra, to the extent any party disputes ARTBIO, Inc.’s right to participate in this proceeding or to be included in the caption, the party shall request authorization to brief the issue within 10 business days of this Decision.” slip op. at 3

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “nuclear chemistry, radiochemistry, or materials science, or a comparable field of study, plus approximately two to three years of professional experience with radioisotope generators, radiopharmaceutical chemistry, nuclear medicine, or other relevant industry experience” and that “[a]dditional graduate education could substitute for professional experience, and significant experience in the field could substitute for formal education.” Pet. 2–3 (citing Ex. 1002 ¶ 33; Ex. 1019 ¶ 27). At this stage of the proceeding, Patent Owner does not dispute Petitioner’s proposed definition nor provide a proposed definition of its own. See generally Prelim. Resp. For the purposes of this Decision, we adopt Petitioner’s undisputed proposed definition of a POSITA.” slip op. at 10

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
    Patents in suitUS 12,249,437
  • PTAB · Oct 14, 2025 · PGR2025-00029 · APJ Kimberly Mcgraw · PGR · Institution

    The Board instituted PGR on claims 1–6 and 8–20 on all asserted grounds, finding it more likely than not that at least one challenged claim is unpatentable.

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

      “After reviewing the parties’ briefs and supporting evidence, we determine that Petitioner has sufficiently shown that Hassfjell-Hoff discloses each element of claim 1. As such, Petitioner’s argument and evidence as set forth above and further discussed below, sufficiently shows that it is more likely than not that claim 1 is anticipated by Hassfjell-Hoff, notwithstanding Patent Owner’s arguments, also addressed below.” slip op. at 16

    • Adverse judgmentAdverse judgmentOther

      “Here, Patentee Sciencons AS filed a statutory disclaimer of claim 7 of the ’603 patent. Ex. 2001. Based on our review of Exhibit 2001 and U.S. Patent and Trademark Office public records, we find that the disclaimer of claim 7 complies with the above-listed requirements of 37 C.F.R. § 1.321(a). Accordingly, we treat claim 7 as having never been part of the ’603 patent. See Vectra Fitness, Inc. v. TNWK Corp., 162 F.3d 1379, 1383 (Fed. Cir. 1998) (“This court has interpreted the term ‘considered as part of the original patent’ in [35 U.S.C.] § 253 to mean that the patent is treated as though the disclaimed claims never existed.”). Because post-grant review cannot be instituted based on disclaimed claims, claim 7 is outside the scope of this proceeding. 37 C.F.R. § 42.207(e) (“No post-grant review will be instituted based on disclaimed claims.”); General Elec. Co. v. United Techs. Corp., IPR2017-00491, Paper 9 (PTAB July 6, 2017) (precedential) (denying institution in view of a statutory disclaimer of all the challenged claims). Thus, we confine our analysis in this Decision to claims 1–6 and 8– 20, the remaining challenged claims that have not been disclaimed.” slip op. at 7

    • PTAB / AIA Trials › Real party in interest / privityGranted

      “Sciencons AS also states that ARTBIO, Inc. is responsible for defending the ’603 patent in this proceeding and requests that ARTBIO, Inc. be included in the caption for this proceeding.2 Paper 4, 1; Paper 7, 1. ARTBIO, Inc. has signed powers of attorney appointing the same practitioners that were appointed by Sciencons AS to transact all business associated with the instant post-grant review proceeding of the ’603 patent. See Papers 3, 4, 7, 8. To date, no objection has been raised to Patent Owner’s request. Given Sciencons AS’s representation that ARTBIO, Inc. is currently the exclusive licensee of the ’603 patent and is responsible for defending the ’603 patent, we grant Sciencons AS’s unopposed request that ARTBIO, Inc. be included in the caption. For convenience we refer to Sciencons AS and the purported exclusive licensee ARTBIO, Inc. collectively as “Patent Owner.” As stated supra, to the extent any party disputes ARTBIO, Inc.’s right to participate in this proceeding or to be included in the caption, the party shall request authorization to brief the issue within 10 business days of this Decision.” slip op. at 3

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person of ordinary skill in the art “would have had a bachelor’s degree in chemistry, chemical engineering, physics, nuclear chemistry, radiochemistry, or materials science, or a comparable field of study, plus approximately two to three years of professional experience with radioisotope generators, or other relevant industry experience” and that “[a]dditional graduate education could substitute for professional experience, and significant experience in the field could substitute for formal education.” Pet. 2–3 (citing Ex. 1002 ¶ 33; Ex. 1017 ¶ 27). At this stage of the proceeding, Patent Owner does not dispute Petitioner’s proposed definition nor provide a proposed definition of its own. See generally Prelim. Resp. For the purposes of this Decision, we adopt Petitioner’s undisputed proposed definition.” slip op. at 10

    § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
    Patents in suitUS 12,125,603
  • PTAB · Oct 10, 2025 · PGR2025-00037 · APJ Kevin W Cherry · PGR · Institution

    The Board denied institution of PGR on claims 1–14 because Petitioner did not show that any challenged claim was more likely than not unpatentable.

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

      “information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates 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(a). For the reasons set forth below, we determine that Petitioner has failed to demonstrate that it is more likely than not that at least one of claims 1–14 of the ’463 patent is unpatentable. Accordingly, we deny institution of a postgrant review of claims 1–14 based on the grounds set forth in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that one of ordinary skill in the art “would have had at least a Bachelor’s degree in electrical engineering, material science, chemical engineering, or an equivalent field, as well as at least 2 to 3 years of academic or industry experience in the recycling or processing of lithiumion batteries. Additional formal education focusing on processing of lithium batteries may substitute for practical experience and additional practical experience can substitute for less education.” Pet. 10–11. Patent Owner does not contest this definition of a person of skill in the art. See Prelim. Resp. 11. For purposes of this Decision, we adopt Petitioner’s assessment of the level of ordinary skill in the art, as, on the present record, it appears consistent with the ’463 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

    • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

      “distinct from “comminute[ion],” Petitioner offers only the testimony of its expert, Mr. Juzkow, who equates Tomioka’s “cutting” with “comminute[ion].” See Ex. 1003 ¶ 121. However, Mr. Juzkow provides insufficient reasoning to support his conclusion, particularly given the intrinsic and extrinsic evidence discussed above. In contrast, Patent Owner’s expert, Mr. Dantam, provides extensive reasoning, supported by citations to other evidence, to support his conclusion that Tomioka’s “dismantling” is not the claimed “comminution.” Thus, we give more weight to Mr. Dantam’s testimony than Mr. Juzkow’s testimony. Weighing this evidence all together, we find that Petitioner has failed to show that it is more likely than not that Tomioka’s teaches the claimed comminution under Petitioner’s first theory.” slip op. at 15

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

      “obvious. Pet. 34–35. However, we agree with Patent Owner that Petitioner has also failed to show that it is more likely than not that Tomioka renders this limitation obvious. See Prelim. Resp. 28–31. To begin with, Petitioner’s contentions lack sufficient reasoning explaining why a person of ordinary skill would have modified Tomioka in the manner proposed. “[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Petitioner merely asserts that a person of ordinary skill in the art could use the roller system in place of the dismantling disclosed for the embodiments in Figures 19 and 20. On this record, we find this bare contention insufficient. actual disclosure of Tomioka. The rollers in Tomioka are used to separate the “battery body” from the “resin package enclosing the battery body,” and Tomioka specifically discloses that this technique is designed to “avoid damaging the battery body.” Ex. 1005 ¶¶ 25, 26, 29; Ex. 2011 ¶¶ 72–73. Thus, there is a significant difference between what Tomioka teaches and what Petitioner proposes to use the roller system to do. In addition, as Patent Owner points out, Tomioka specifically discloses there are risks associated with mechanically crushing battery packs, such as “risk of sparking due to residual voltage if the battery units are damaged in the process.” Ex. 1005 ¶ 5. Although we do not agree with Patent Owner that this amounts to a “teaching away,” see In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994), we do believe that this teaching suggests a trade off that should be weighed in determining whether to make the modification, see Medichem S.A. v. Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). However, Petitioner has failed to account adequately, if at all, for this trade off. Thus, we find that Petitioner has failed to show that it is more likely than not that Tomioka accounts for the claimed “comminuting.”” slip op. at 15

    § 103 obviousness§ 112 disclosurecites Phillips · Graham · Nautilus
    Patents in suitUS 12,119,463
  • PTAB · Sep 16, 2025 · IPR2025-00465 · APJ Timothy G Majors · IPR · Institution

    The Board instituted IPR on claims 1–18 because Petitioner showed a reasonable likelihood of proving claim 1 obvious over Gwozdz and Meezan.

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

      “A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the relevant art. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) secondary considerations (i.e., objective indicia) of nonobviousness when presented.6 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). To show unpatentability based on a combination of teachings, “[a]n obviousness determination [also] requires finding both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” CRFD” slip op. at 7

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “[A POSA] would have been a pharmaceutical scientist, chemist, or biologist involved in the research and development of pharmaceutical formulations and/or delivery, and would have at least a Bachelor’s degree with at least 5 years of experience, or a Master’s, Ph.D. or Pharm.D. degree with several years of experience. In addition, a POSA would have had knowledge of benzodiazepine structure and function, and would further have knowledge and practical experience working with intranasal and transmembrane formulations, including knowledge of the physiology and anatomy of the nasal cavity, with relevant experience in developing intranasal formulations. Pet. 23–24; Ex. 1062 ¶ 20. Patent Owner “does not dispute” Petitioner’s POSA definition at this stage. Prelim. Resp. 18. We apply Petitioner’s proposed POSA definition for this Decision, which definition appears to be generally consistent with the cited prior art.” slip op. at 8

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

      “standard used in a civil action before the courts under 35 U.S.C. § 282(b), including construing claim language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only expressly construe terms to the extent needed to resolve the controversy before us. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019).” slip op. at 8

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

      “applicant, as part of the bargain with the public, must describe his or her invention so that the public will know what it is and that he or she has truly made the claimed invention.” AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1298 (Fed. Cir. 2014). “[T]he test for sufficiency [of the written description requirement] 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 sought.” Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (explaining that “the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”) (internal quotation marks omitted); see also id. at 1352 (“[A] description that merely renders the invention obvious does not satisfy the requirement.”).” slip op. at 25

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 11,241,414
  • PTAB · Sep 16, 2025 · IPR2025-00466 · APJ Timothy G Majors · IPR · Institution

    The Board instituted IPR on claims 1–27 because Petitioner showed a reasonable likelihood of prevailing on at least one claim, including claim 1 over Gwozdz and Meezan.

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

      “Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’786 patent’s challenged claims.1 We institute inter partes review on all challenged claims. SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

      “We find that Petitioner has made a threshold showing that the ’558 Provisional does not provide written description support for claim 1’s pharmaceutical solution consisting of each of the recited elements, including n-dodecyl beta-D-maltoside. It is true that “n-Dodecyl β-D-maltoside” can be found listed in the SIGMA Catalog. Ex. 1026, 316. But Dr. Donovan’s testimony helps put that listing in context. It is merely one among well over 100 ionic and non-ionic detergents listed in the cited six pages of the SIGMA Catalog. See 1026, 316–321; Ex. 1062 ¶ 50. When further considered in the context of paragraphs 150–152 of the ’558 Provisional, which generically suggest that “enhancer” compounds can be used in “some embodiments”—then introducing at least 15 classes of potential enhancers16 including “preferred” lysophospholipids and acyl carnitines—the listing of n-dodecyl beta-D-maltoside among at least 150 biological detergents in the SIGMA Catalog is even more remote. Moreover, although satisfaction of the written description requirement is not limited to what is exemplified in a priority application, none of the ’558 Provisional’s examples use any “enhancer,” much less any detergent, any alkyl glycoside, or n-dodecyl beta-D maltoside in particular. The 16 The ’558 Provisional suggests that whether “a given compound” will function as an “enhancer” in a formulation requires testing. Ex. 1008 ¶ 150 (indicating “an in vivo or good model test” may “determin[e] whether the uptake of the drug is enhanced to a clinically significant degree”). ethanol. See Ex. 1008 ¶¶ 172–174 (Examples 1 and 2). In short, we find no sufficient disclosure of “blaze marks” in the ’558 Provisional that point to the inventors’ possession of a pharmaceutical solution that includes n-dodecyl beta-D-maltoside as claimed. Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326–27 (Fed. Cir. 2000) (analogizing an application’s generic disclosures to a forest of unmarked trees and explaining that, “to satisfy the written description requirement,” there must be “blaze marks directing the skilled artisan to that tree [within the forest that represents the claimed invention]” in the application).” slip op. at 28

    • PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner

      “and applying collateral estoppel to vacate a claim construction in an underlying IPR). In an IPR, “a party seeking to invoke collateral estoppel must show: ‘(1) the issue is identical to one decided in the first action; (2) the issue was actually litigated in the first action; (3) resolution of the issue was essential to a final judgment in the first action; and (4) [the party against whom collateral estoppel is being asserted] had a full and fair opportunity to litigate the issue in the first action.’” Google LLC v. Hammond Development Int’l, Inc., 54 F.4th 1377, 1381 (Fed. Cir. 2022) (quoting In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994)) (alteration in original).14 “It is [also] well established that patent claims need not be identical for collateral estoppel to apply.” Id. at 1381. Instead, “collateral estoppel requires the issues of patentability be identical.” Id. If “the differences between the unadjudicated patent claims and adjudicated patent claims do not materially alter the question of invalidity, collateral estoppel applies.” Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333, 1342–43 (Fed. Cir. 2013) (affirming application of collateral estoppel where claims adjudicated as obvious required a “polymeric” gel whereas similar, unadjudicated claims required a “block copolymer” gel). “Collateral estoppel also applies to common issues in actions involving different but related patents.” Mycogen Plant Sci., Inc. v. Monsanto Co., 252 F.3d 1306, 1310 (Fed. Cir. 2001), vacated on other grounds, 353 U.S. 1109 (2002).” slip op. at 22

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

      “We agree that at least one portion of Gwozdz is not prior art. To establish that the cited disclosures in Gwozdz are prior art, Petitioner must show support for those disclosures in the Gwozdz Provisional. In re Riggs, 131 F.4th 1377, 1384 (Fed. Cir. 2025) (explaining that “the portion of the application relied on . . . as prior art must be supported by the provisional application”). Petitioner did not establish that Gwozdz’s disclosure of “penetration enhancers” finds support in the Gwozdz Provisional. Pet. 22. Conversely, Patent Owner shows that the phrase is absent in the Gwozdz Provisional. Prelim. Resp. 37.20 Based on this record, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the 19 Patent Owner argues this “penetration enhancers” disclosure in Gwozdz is not prior art regardless which of the disputed priority dates (March 28, 2008, or March 27, 2009) one accords to the challenged claims. Prelim. Resp. 33. 20 We also agree that collateral estoppel does not bar Patent Owner from challenging Gwozdz’s prior-art status in this case. Patent Owner’s apparent concession that Gwozdz was prior art during the 451 IPR does not equate to the issue being actually litigated. Prelim. Resp. 34–35; Ex. 1040, 14 (“Patent Owner does not contest that Gwozdz is entitled to this filing date” of the Gwozdz Provisional). Purdue, 767 F. App’x at 922 (determining “[t]he priority date for the Joshi reference . . . cannot be determined based on collateral estoppel” where patentee could have argued, but did not in fact argue, Joshi’s prior-art status in an earlier matter).” slip op. at 35

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 11,793,786
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