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  • PTAB · Nov 19, 2025 · IPR2025-00946 · APJ Christopher G Paulraj · IPR · Institution

    The Board instituted inter partes review on all challenged claims and grounds after finding a reasonable likelihood that claims 2 and 4 would have been obvious over Herrstedt and Bös.

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

      “review. 35 U.S.C. § 314; 37 C.F.R. §42.4(a). We may not institute an inter partes review “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a).” slip op. at 2

    • PTAB / AIA Trials › Discretionary denialNot reached

      “II. DISCUSSION A. Discretionary Denial Patent Owner filed a request for discretionary denial of institution. Paper 8. Petitioner opposed. Paper 9. The Acting Director denied the discretionary denial request. Paper 12 (September 19, 2025). Accordingly, we proceed with our analysis of the merits of Petitioner’s patentability challenges and do not address the discretionary denial arguments presented by the parties.” slip op. at 8

    • Skill levelOther

      “At this stage, we need not resolve the parties’ dispute with regard to the requisite level of skill in the art, as our analysis would be the same under either party’s definition of a POSA. We note, however, that Petitioner’s definition seems to be overly broad insofar as it would only require the POSA to be skilled in one of several broad fields, including “statistics” and “medical policy and decision making,” that do not directly relate to the Owner that the POSA needs specific clinical experience in the field of oncology. The claimed subject matter relates to the treatment of a side-effect associated with cancer therapy (CINV), and not the cancer itself. We also recognize that the prior art and the ’357 patent itself reflect the level of skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error where the prior art itself reflects an appropriate level and a need for testimony is not shown.”). We further find, based on the present record, that both parties’ experts are qualified to testify from the perspective of a POSA in this proceeding. See Ex. 1009 ¶¶ 1–7 (Dr. Peroutka’s qualifications); Ex. 2068 ¶¶ 8–15 (Dr. Navari’s qualifications); Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm'n, 22 F.4th 1369, 1377 (Fed. Cir. 2022) (“[T]o be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at a minimum possess ordinary skill in the art.”). Even if some specific experience with regard to the treatment of CINV is required, Dr. Peroutka appears to have published in that field. See, e.g., Ex. 1020 at 10, (publication 16: article on “Combination antiemetics” in Cancer Treatment Reports); id. at 11 (publication 37: article on “Neurotransmitter receptor binding studies predict antiemetic efficacy and side effects” in Cancer Treatment Reports); id. at 13 (publication 51: article on “Chemotherapeutic agents do not interact with neurotransmitter receptors” in Cancer Chemotherapy and Pharmacology).” slip op. at 9

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

      “that could be combined with dexamethasone and/or palonosetron to treat emesis. Nonetheless, based on Bös’s identification of netupitant (compound Ib) as a “potent and selective” NK1 antagonist with “valuable therapeutic properties,” the present record supports Petitioner’s argument that the POSA would have been motivated to replace aprepitant with netupitant in the compounds disclosed therein have utility in the treatment of emesis, and that neutpitant in particular “is a potent antagonist of NK1 induced behaviors in Gerbil and blocks emesis in Ferrets and suncus murinus with similar potency.” Id. at 19:26–30. Bös further indicates that netupitant has a high affinity for the NK1 receptor and a prolonged half-life. Id. at 18:44–48, 19:31–38. In view of these properties, we find a POSA would have had good reason to consider netupitant as a potential replacement for aprepitant in the treatment of CINV. Bös also teaches that the daily dosage can be adjusted between 10 to 1000 mg per person, or above that upper limit when necessary, and that the effective amount can be fitted to the individual requirements in each particular case. Id. at 42:5–11. As with palonosetron, given the significant half-life of netupitant, and its administration via the circulatory system, we find that a POSA would also have been motivated to adjust the dose of netupitant to an amount that induces “blood levels” effective to treat CINV.” slip op. at 28

    § 103 obviousnessDiscretionary denialcites KSR
    Patents in suitUS 9,186,357
  • 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 3, 2025 · PGR2025-00043 · APJ Sheridan K Snedden · PGR · Institution

    Instituted PGR of claims 1–44 on all asserted grounds after 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

      “post-grant review may not be instituted “unless . . . the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has demonstrated that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. A. Real Parties-in-Interest” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “would be “someone with a graduate degree in organic chemistry, medicinal chemistry, pharmaceutical chemistry, or a related field, and four to six years of experience in the synthesis, purification, analysis, design, and/or formulation of pharmaceutical compounds and derivatives.” Pet. 7 (citing Ex. 1034 ¶ 21; Ex. 1033 ¶ 25). Petitioner also asserts that a person of ordinary skill in the art “would have worked with a team of professionals with training in related disciplines, such as pharmacology, pharmacokinetics, formulation, drug discovery and/or drug development as of the date of the claimed inventions.” Id. at 7–8.” slip op. at 10

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

      “Patent Owner attempts to distinguish the scope of the claims between the related ’334 patent and ’391 patent, where the claims of the ’334 patent recite a “an endoxifen composition encapsulated in an enteric capsule.” Prelim. Resp. 11. Patent Owner contrasts this with the scope of the claims of the ’391 patent and contends that the challenged claims are directed to “the underlying composition itself, where the enteric material is an ingredient of the composition combined with the endoxifen.” Id. To support its contentions, Patent Owner attempts to apply the doctrine of claim differentiation across patents, noting that [t]he related ’334 describes a composition where the enteric requirement is not part of the composition, reciting “[a]n oral formulation comprising an endoxifen composition encapsulated in an enteric capsule.” EX2014, cl.1. In other words, the enteric aspect of the ’334 claims is not part of the composition itself. In contrast, the ’391 requires “[a] composition comprising an endoxifen and an enteric material.”” slip op. at 12

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

      “distinguish the preamble language reciting “[a] composition comprising an endoxifen and an enteric material” from Ahmad. Prelim. Resp. 13–16. Specifically, Patent Owner contends that Petitioner’s arguments rely on Ahmad’s alleged disclosure of endoxifen encapsulated in enteric-coated capsules. Id. at 14. For example, Patent Owner contends that “every portion of Ahmad relied upon by Petitioner describes a ‘composition containing endoxifen’ that can then be coated with a separate external ‘enteric coating.’” Id. at 15. Patent Owner further contends that these disclosures fail to disclose an enteric material that is a component (with endoxifen) of the composition itself. At most, these disclosures purport to describe (1) a pharmaceutical composition of endoxifen (2) encapsulating the finished composition in a separate external enteric coating. See EX1003, 18:27-29 (“Enteric coating of capsules filled with composition art.”). Prelim. Resp. 15. Patent Owner therefore concludes that “Petitioner identifies no teaching in Ahmad that the enteric material is a component of the endoxifen composition, as claimed.” Id. at 16. Based on our preliminary construction of the term, “[a] composition comprising an endoxifen and an enteric material” discussed above, and, having considered the arguments and evidence presented by the parties at this stage of the proceeding, summarized above, we find that Petitioner has shown it is more likely than not that Ahmad discloses each limitation of claims 1 and 32 for the reasons stated in the Petition, which we adopt for purposes of this Decision. See Pet. 19–25; Ex. 1003, 2:24–40, 3:55–61, 8:47–63, 9:1–20, 11:17–23, 12:14–17, 18:19–29, 19:27–30; Ex. 1033 ¶¶ 54– 64. Accordingly, we find Petitioner has shown that it is more likely than not that claims 1 and 32 are anticipated by Ahmad.” slip op. at 16

    Claim construction§ 102 anticipationcites Phillips
    Patents in suitUS 12,071,391
  • PTAB · Nov 3, 2025 · IPR2025-00799 · APJ Sheridan K Snedden · IPR · Institution

    The Board instituted IPR on claims 1–21, finding a reasonable likelihood that claims 1–6, 16, 18, and 21 are anticipated by Liu.

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

      “To institute an inter partes review, we must determine that the information presented in the Petition shows “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). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented in the Petition and Preliminary Response, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least 1 of the challenged claims of the ’151 patent is unpatentable.” slip op. at 2

    • PTAB / AIA Trials › §315(e) estoppelNot reached

      “On the current record, we tend to agree with Patent Owner that the issues presented in this proceeding concern Liu’s alleged inherency and the Form I or XRPD limitations recited in the challenged claims, which are obviousness grounds asserted in PGR2023-00043. Prelim. Resp. 35. That said, the parties are invited to address the issue of whether collateral estoppel applies in this proceeding based on the Final Written Decision of PGR2023- 00043 during trial. Regardless of whether collateral estoppel applies, however, we determine for the reasons below that Petitioner shows a reasonable likelihood of prevailing in its challenge that at least 1 of the challenged claims of the ’151 patent is unpatentable.” slip op. at 3

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

      “Petitioner states that “all terms should be given their plain and ordinary meaning.” Pet. 10. Patent Owner does not propose construction of any terms. See generally Prelim. Resp. Having considered the parties’ positions and evidence of record, we determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 8

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “H. Level of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art (“POSA”) would be “someone with a graduate degree in organic chemistry, material science, medicinal chemistry, pharmaceutical chemistry, or a related field, and four to six years of experience in the synthesis, purification, analysis, design, and/or formulation of pharmaceutical compounds and derivatives.” Pet. 9. Petitioner also asserts that a person of ordinary skill in the art “would have worked with a team of professionals with training in related disciplines, such as pharmacology, pharmacokinetics, formulation, drug discovery Patent Owner does not dispute Petitioner’s definition of a person of ordinary skill in the art. See generally Prelim. Resp. We adopt Petitioner’s definition as it is consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). To the extent the parties dispute the level of ordinary skill and its impact on the analysis of the challenged claims, we encourage the parties to address this issue further during trial.” slip op. at 8

    Claim construction§ 102 anticipation
    Patents in suitUS 11,261,151
  • PTAB · Nov 3, 2025 · IPR2025-00827 · APJ Barry L Grossman · IPR · Institution

    The Board instituted IPR on claims 1–5, 7–14, 16–19, 22–26, and 28–32, finding a reasonable likelihood that Renisch anticipates at least one challenged claim.

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

      “We have considered Patent Owner’s arguments, but, on this record, are not persuaded. We recognize that Dr. Sonka provides a different opinion than Petitioner and Dr. Rosen. Dr. Sonka testifies that in his opinion “the distinctions between Renisch and claim 1 go beyond terminology.” Ex. 2014 ¶ 79. At this stage, in the absence of a full record, we need not record, it appears that Renisch discloses the elements of limitation [1(c)] at paragraphs 26–31, where it discloses obtaining a scanned 3D image of a fuller anatomy, i.e., a segmentation map, and then using a segmentation unit (76) to define the boundaries of anatomical structures of interest within that fuller anatomy, i.e., creating a plurality of segmentation masks, using a library, models, clustering, edge detection, region growing, neural networks, and/or an atlas of normal anatomical structures, and then identifying hot spots of interest within those anatomical structures of interest, and identifying organs with lesions and those without. Ex. 1005 ¶¶ 26–31. Based on the record before us and the specific disclosures in Renisch, as discussed in this Decision, we determine that Petitioner has met the “reasonable likelihood” standard necessary to institute an inter partes review proceeding. Although we address only Ground A and claims 1 and 10 herein for the purposes of institution, as noted above, we will address all asserted grounds and challenged claims in any final decision.” slip op. at 20

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

      “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We do not perceive a need to construe any claim limitation at this time. This, however, does not preclude the parties from arguing proposed constructions of the claims during trial. Indeed, the parties are hereby given notice that any disputed claim construction, in general, should be addressed at trial and, if so, should be addressed clearly in a designated section of briefing rather than relegated to arguments on the merits of patentability. Claim construction, if necessary, will be determined at the close of the evidentiary record and after any hearing. slip op. at 15

    • BurdenDecided for petitioner

      “Compliance with the Particularity Requirements of 35 U.S.C. § 312(a)(3) Patent Owner asserts that the Petition fails to meet the particularity requirements of 35 U.S.C. § 312(a)(3). Prelim. Resp. 18–26. According to Patent Owner, “Petitioner’s excessive internal cross-referencing impermissibly forces the Board and Patent Owner to piece together scattered portions of the Petition (and exhibits).” Id. at 26. Patent Owner concludes that “the Petition fails to adequately map the references to the claim elements with particularity.” Id. We disagree. Using claims 1 and 10 as an example, Petitioner asserts: Claim 10 recites a “system for automatically processing 3D images” that is substantively identical to the “method for automatically processing 3D images” recited in claim 1, addressed above. Whereas claim 1 (the method claim) recites a series of steps, each performed “by a processor,” claim 10 (the system claim) recites a “processor” with stored instructions that perform the same steps recited in claim 1. Similarly, dependent claims 11–14, 16, and 26 are substantively identical to dependent claims 2–5, 7, and 19. Pet. 41–42. Claims 1 and 10 contain similar elements and limitations. Petitioner’s reference, for example, in the Petition’s analysis of claim 10, back to the analysis of claim 1 concerning nearly identical elements and limitations (id. at 42) is a matter of efficiency and is sufficiently clear for us to determine the basis for Petitioner’s challenges. We determine that the Petition does not violate the statutory requirement for particularity.” slip op. at 16

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

      “We have considered Patent Owner’s arguments, but, on this record, are not persuaded. We recognize that Dr. Sonka provides a different opinion than Petitioner and Dr. Rosen. Dr. Sonka testifies that in his opinion “the distinctions between Renisch and claim 1 go beyond terminology.” Ex. 2014 ¶ 79. At this stage, in the absence of a full record, we need not record, it appears that Renisch discloses the elements of limitation [1(c)] at paragraphs 26–31, where it discloses obtaining a scanned 3D image of a fuller anatomy, i.e., a segmentation map, and then using a segmentation unit (76) to define the boundaries of anatomical structures of interest within that fuller anatomy, i.e., creating a plurality of segmentation masks, using a library, models, clustering, edge detection, region growing, neural networks, and/or an atlas of normal anatomical structures, and then identifying hot spots of interest within those anatomical structures of interest, and identifying organs with lesions and those without. Ex. 1005 ¶¶ 26–31. Based on the record before us and the specific disclosures in Renisch, as discussed in this Decision, we determine that Petitioner has met the “reasonable likelihood” standard necessary to institute an inter partes review proceeding. Although we address only Ground A and claims 1 and 10 herein for the purposes of institution, as noted above, we will address all asserted grounds and challenged claims in any final decision.” slip op. at 20

    Claim construction§ 102 anticipationDiscretionary denialcites Phillips
    Patents in suitUS 11,941,817
  • PTAB · Oct 16, 2025 · IPR2025-00776 · APJ John G New · IPR · Institution

    Instituted review of claims 9, 11, 32–58, 60–62, and 64–67 on all remaining petition grounds, after finding a reasonable likelihood that claim 9 is unpatentable over Thomas and Faucette.

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

      “For the reasons set forth below, we determine that Petitioner has demonstrated that there is a reasonable likelihood that at least one of claims 9, 11, 32–58, 60–62, and 64–67 of the ’802 patent is unpatentable, and we on the Grounds set forth in the Petition.” slip op. at 2

    • Settled expectationsOther

      “Patent Owner also filed a Request with the Acting Director of the USPTO seeking discretionary denial of institution of inter partes review (Paper 6, the “Request”). Petitioner subsequently filed a brief opposing Patent Owner’s Request (Paper 8). On September 3, 2025, the Acting Director denied Patent Owner’s Request for discretionary denial of institution of inter partes review and referred the case to the panel for an institution decision on the merits (Paper 11).” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of ordinary skill would have an M.D. or a Ph.D. degree in virology, immunology, and vaccinology, and at least 3 years of experience in one or more of the research, design, development, and testing of antiviral vaccines. Pet. 17. Petitioner asserts that a person of ordinary skill may be part of a multidisciplinary team having such experience. Id. (citing Ex. 1002 ¶ 81). Patent Owner does not dispute the level of skill asserted by Petitioner.” slip op. at 9

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

      “Neither party requests construction of any claim terms. Petitioner asserts that all claim terms should be given their ordinary and customary meaning, and Patent Owner does not disagree. See Pet. 17. Accordingly, we find, for the purposes of this Decision, that no terms of the challenged claims requires construction beyond the ordinary and customary meaning of the terms, as understood by a person of ordinary skill in the art at the time of the invention. Phillips, 415 F.3d at 1312–13; see also Vivid Techs., Inc. v. construes claims only to the extent necessary to resolve a dispute).” slip op. at 10

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
    Patents in suitUS 11,730,802
  • PTAB · Oct 14, 2025 · IPR2025-00685 · APJ John G New · IPR · Institution

    The Board instituted IPR on claims 1–23 and all petitioned grounds, finding a reasonable likelihood that the claims are obvious over Wei and Liu.

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

      “Summary Based upon the record as presently developed, we conclude that Petitioner has met its burden of showing a reasonable likelihood of showing at trial that at least claim 1 of the ’370 patent is obvious over the cited prior art. Because we determine that Petitioner has demonstrated a reasonable likelihood of success at trial in showing that at least one claim is unpatentable on at least one of the stated Grounds, we institute inter partes review of all challenged claims of the ’370 patent, based on all of the remaining grounds identified in the Petition. See 37 C.F.R. § 42.208(a); SAS Inst., Inc. v. Iancu, 584 U.S. 357, 371 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 44

    • Skill levelSkill level board ownOther

      “appears to be generally consistent with the level of skill presented in the cited prior art. See generally, e.g., Exs. 1005–1008; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reflect an appropriate level of skill in the art). However, at this point we reject the portion of Petitioner’s proposed definition that includes having “access to other individuals with that knowledge and experience,” as not reflecting the individual level of skill of a given skilled artisan. See, e.g., Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (holding that “[t]he person of ordinary skill is a hypothetical person who is presumed to be aware of all the pertinent prior art. The actual inventor’s skill is not determinative”) (emphasis added, footnotes omitted). Consequently, and for the purposes of this Decision, we adopt Petitioner’s proposed definition as defining a person of ordinary skill in the art as a person who would have had “a Ph.D. in immunology, molecular biology, cellular biology, or a similar field, or an M.D. with similar experience, and would further have had at least five years of experience with antibodies and antibody engineering.”” slip op. at 6

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

      “Petitioner states that no term of the challenged claims requires construction to resolve the challenges in this Petition. Pet. 32. Patent Owner does not contest Petitioner’s assertion. See generally Prelim. Resp. We find, for the purposes of this Decision, that no terms of the challenged claims require construction beyond the ordinary and customary meaning of the terms, as understood by a person of ordinary skill in the art at the time of the invention. Phillips, 415 F.3d at 1312–13.” slip op. at 7

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

      “We find, based upon the present record and for the purposes of this Decision, that Petitioner has sufficiently established that a person of ordinary skill in the art would have been motivated to combine the teachings of Wei and Liu to determine the activity and suitability of Liu’s humanized anti- EGFR antibodies in an ADC. We acknowledge that Liu is silent regarding the pH selectivity or tissue preference of its binding affinity, but Patent Owner points to no prior art reference that would have informed a skilled artisan upon this point or that would have discouraged a person of ordinary skill in the art from combining the references. See fn.7, supra. And, even if a skilled artisan might have recognized that Liu’s humanized cetuximab might have been potentially problematic if it failed to show pH-selective activity like Wei’s Y104D, the mere fact that some disadvantage may come with an advantage when combining prior art does not foreclose their combination under § 103. Medichem, S.A. v. Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). In the instance of Liu’s humanized anti-EGFR antibody, a person of ordinary skill in the art would have recognized that its advantages (enhanced activity against tumor cells compared to chimeric cetuximab, thus requiring smaller dosages) could balance or outweigh its possible disadvantages (e.g., possible activity against non-tumor cells). Furthermore, it is in the nature of scientific research to continue to try new substitutions in drug therapy, even if a promising candidate has been discovered. As the Supreme Court stated in KSR: When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. 550 U.S. at 421.” slip op. at 39

    Claim construction§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 10,792,370
  • PTAB · Oct 7, 2025 · IPR2025-00677 · APJ Ryan H Flax · IPR · Institution

    Instituted review of claims 1–7, 10, 13, 16, 18, and 19 on all four anticipation grounds because the Petition showed a reasonable likelihood of prevailing.

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

      “Under 37 C.F.R. § 42.4(a), we have authority to determine whether to institute trial in an inter partes review. We may institute an inter partes review 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 ’811 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

      “ORDINARY LEVEL OF SKILL IN THE ART Petitioner contends: As of the effective priority date of the ‘811 patent, a person of ordinary skill in the relevant field at the time would be familiar with the pre-existing point of sale and network-based technologies as above, for example in Section I.D. above as well as the “BACKGROUND OF THE INVENTION” portion of the ‘811 patent specification. Ex. 1001, col. 1, l. 21 – col. 5, l. 10. This person would include someone who has, through education or practical experience, at least 2-3 years of experience in software engineering, such as the development of data sets, database management, and networking integration for dynamic content generation and network-based distribution. Pet. 10. Patent Owner states, “[f]or the purposes of this Preliminary Response only, Patent Owner applies Petitioner’s definition of a person of ordinary skill in the art. See Petition, p. 10.” Prelim. Resp. 14. We accept and use Petitioner’s proposed, and unopposed, definition of the ordinarily skilled artisan. It appears to comport with the level of skill in the art reflected in the prior art of record and the ’811 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)). C.” slip op. at 10

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

      “The claim language does little to identify any meaning of “point-of- sale interface.” Looking to the ’811 patent’s written description, it never uses the term “point-of-sale interface,” but it states “moder[n] Point-of-Sale (POS) systems . . . capture rich details around their customers’ purchasing activity.” Ex. 1001, 1:52–54. The Specification further states that “[t]he transaction data may be stored locally to a point-of-sale (“POS”) device or to a remote location, such as a cloud service provider.” Id. at 2:23–25. Regarding the associated term “interface,” the written description states, “[i]n general, as used herein, an interface is a component of computer executable instructions stored in a tangible, non-transitory medium and executed by processor 12 to present a display of information related to the interface allowing someone to view and/or interact with the presented information.” Id. at 4:32–37. We are pointed to and find nothing in the ’811 patent’s prosecution history that sheds any further light on the meaning of this language. See Pet. 12–14; Prelim. Resp. 12–13; Ex. 1003. Based on the intrinsic record, we find that the ’811 patent describes a point-of-sale as being local to a transaction, e.g., a sale/purchase of a product” slip op. at 14

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

      “At this point in the proceeding, we do not agree with Patent Owner that the recited survey module must be autonomous, self-contained, or a web-container package. As discussed above, we preliminarily interpret this term to mean software code for displaying a survey question. We find no support in the current record to add to this definition any additional requirements related to autonomy, self-containment, or a web-based context for the survey module. The Petition (at 19) points to Douglas as teaching the claimed survey module, i.e., in Douglas, software sent to the customer for taking a product survey on the display of the customer’s computer device. Douglas teaches, in response to a customer providing a survey trigger (e.g., purchase data signals), a survey generator creates a transaction-specific survey (e.g., “Was the item you found too expensive?”) and transmits it to the customer’s device (e.g., a mobile phone with a touchscreen); the survey is interactive; and the customer touches or clicks their device’s screen to respond to the survey questions. Ex. 1007 ¶¶ 34–35. Moreover, Douglas also discloses that its survey “interact[s] with the customer using one or more software applications on customer device 106,” which may be, e.g., a computer or mobile phone, further, “[t]he one or more software applications may be provided by survey system 101, or merchant 107, or a third party,” and finally, “[t]he one or more software applications may be web-based applications and/or native mobile applications installed on the customer device 106.” Id. ¶¶ 18–20; see also Prelim. Resp. 35 (conceding as much). Thus, Douglas appears to disclose a survey system where a survey server responds to a triggering survey token created by a merchant and sent by a customer, that connects the customer with a particular purchase, by creating a purchase-specific survey question and sending it to a customer’s electronic device, where the survey question is displayed on a web-browser by software, and the customer’s survey answers may then spur the system to generate and follow up with additional questions. See Ex. 1007 ¶¶ 18–20, 27–29, 33–39. This appears to include the claimed survey module at issue. As for Patent Owner’s argument that the recited survey module must” slip op. at 31

    Claim construction§ 102 anticipationcites Phillips
    Patents in suitUS 10,430,811
  • PTAB · Oct 1, 2025 · PGR2024-00028 · APJ Jeffrey N Fredman · PGR · Final written decision

    Claims 1–10 are unpatentable as obvious over Fogarty and Chengod; the Board found that combination sufficient for every challenged claim.

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

      “7. Conclusion Based on the entirety of the record, we determine that a person of” slip op. at 13

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

      “3. Analysis In our claim construction analysis “[w]e begin, as we often do, with” slip op. at 18

    • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed board ownOther

      “the feature of the solid wire being “secured at a proximal-most end thereof within the proximal hub” was added during prosecution to overcome a rejection. Ex. 1002, 573-580. The prior art was distinguished because its guidewire “is configured to be steered and manipulated through the blood vessel, and subsequently removed, and, therefore, cannot be secured at a proximal end thereof to the luer hub 310.” Id., 578-79 (emphasis added). Accordingly, the prosecution history further demonstrates “secured” was not intended to cover removable attachment.” slip op. at 35

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

      “2. Patent Owner’s Arguments Concerning Claim 1 and Our Analysis a. Reasonable Expectation of Success in modifying catheters to less than 6 Fr Patent Owner asserts “Petitioner has failed to perform a proper obviousness analysis by not adequately demonstrating a reasonable expectation of success in modifying Fogarty.” PO Resp. 35. Patent Owner asserts “the category of ‘Fogarty catheters’ is broad and diverse” and “Dr. Resnick admits he has no idea whether Chengod’s or Deaton’s catheters have interior constructions similar to that of the cited Fogarty reference.” Id. at 35‒36 (citing Ex. 2002, 52:16‒57:1). Patent Owner asserts that Petitioner has therefore not demonstrated that a PHOSITA would have a reasonable expectation of success in modifying the particular catheter taught by the cited Fogarty patent (Ex. 1004) to the claimed size when considering the shaft has a spring coil and braid in addition to the outer tube and lumen. Id. Petitioner responds “(1) Fogarty did not indicate the catheter’s size; (2) Fogarty catheters smaller than 6 Fr were known and disclosed in Chengod (and Deaton); and (3) sizing Fogarty’s catheter less than 6 Fr would work (i.e., reasonable expectation of success) because it did work.” Pet. Reply 19. Petitioner asserts that Yassinzadeh “shows a catheter that is less than 6 Fr and that includes a similar spring coil construction as found in the Fogarty patent” where the “dilator 150 has a diameter of either 5 Fr or 6 Fr.” Id. at 19‒20 (citing Ex. 1033 ¶¶ 86‒97 (“Yassinzadeh”)). Petitioner asserts that Yassinzadeh’s “analogous construction being less than 6 Fr confirms a PHOSITA would have a reasonable expectation of success in sizing the catheter in Fogarty (Ex-1004) less than 6 Fr.” Id. at 20 (citing Ex. 1034 ¶ 97). Patent Owner responds “Petitioner fails to specify what” slip op. at 53

    Patent outcomesUS 11,857,737 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,857,737
  • PTAB · Sep 26, 2025 · IPR2025-00605 · APJ Tawen Chang · IPR · Institution

    The Board instituted IPR on claims 1–7 and all petitioned grounds, finding a reasonable likelihood that claim 1 is anticipated by Desjarlais or Moore or obvious over Lazar alone.

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

      “SAS, 138 S. Ct. at 1356. Thus, because we determine, based on the arguments and evidence on the present record, that there is a reasonable likelihood Petitioner would prevail with respect to claim 1, we institute an inter partes review of all challenged claims under each Ground presented in the Petition. Id.; see also 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.”). III. CONCLUSION For the reasons provided above, we find that Petitioner has demonstrated a reasonable likelihood of showing at trial that at least one of the challenged claims of the ’859 patent is unpatentable under at least one ground. Accordingly, we institute inter partes review of all challenged claims based on all the Grounds presented in the Petition.” slip op. at 49

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

      “As Petitioner points out, the cited disclosure in the ’935 provisional does not “mention[] positions 364 and 368 together as a pair of positions for potential mutations on two chains.” Pet. 28 (citing Ex. 1002 ¶¶ 109–19). Although Patent Owner is correct that examples or actual reduction to practice are not required for adequate written description and “[a] specification may . . . contain a written description of a broadly claimed 34 invention without describing all species that [the] claim encompasses,” Prelim. Resp. 15 (quoting Ariad Pharms., 598 F.3d at 1352 and Cordis Corp. v. Medtronic AVE Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003)), the ’935 provisional must still “reasonably convey[] to those skilled in the art that the inventor[s] had possession of the claimed subject matter” as of the relevant date. Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 127 F.4th 896, 914 (Fed. Cir. 2025); Ariad, 598 F.3d at 1351. In this case, Table A of the ’935 provisional discloses a list of CH3 domain interface residues and identifies, for each interface residue in heavy chain A, the contacting residue in the corresponding chain B. Ex. 1030, 17, Table A. Table A does not, however, describe any particular substitutions or pairs of substitutions that should be made to the CH3 domains. See, e.g., Pet. 28 (citing Ex. 1002 ¶¶ 109–119). Table 7 of the ’935 provisional does identify specific amino acid substitutions in CH3 domains, including substitutions resulting in a positively charged residue at position 364 (e.g., S364K) and a negatively charged residue (e.g., L368D) at position 368. Ex. 1030, 52, Table 7. Patent Owner argues that this table “discloses specific positions for ‘identification of novel charge pair mutants.’” Prelim. Resp. 13 (citing Ex. 2010 ¶ 48). As Petitioner points out, however, while Example 13 of the ’935 provisional relates to identification of novel charge pair mutants, Table 7 itself was only a “first step” in this identification process. Ex. 1030, 51:6–17. In this step, “many interface contact residues in the IgG CH3 domain were scanned one by one or in groups for substitutions that would result in repulsion of 35 identical heavy chains” so that identified substitutions can then be used to generate antibodies “by engineering matched pairs of CH3 residues in one or more IgG heavy chains – CH3 regions” in follow up experiments. Id. Accordingly, Table 7 does not appear to describe heterodimer combinations, such as those that would result from a pairing of chains with different substitutions. Pet. 29–30 (citing, e.g., Ex. 1002 ¶¶ 111–118). As Petitioner further points out, the follow up experiments testing the matched pairs of CH3 residues did not include paired substitutions at positions 364 and 368. Id. at 29–31. Patent Owner points to disclosure in the ’935 provisional describing, as a distinguishing feature of its invention, the substitution of non-charged or neutral amino acids in wildtype CH3 with charged residues, which according to the ’935 provisional has the “advantage that at least one additional charge-charge interaction in the CH3 interface is created.” Prelim. Resp. 12 (citing, e.g., Ex. 2010 ¶¶ 42–48). For the same reasons discussed above, Petitioner has sufficiently established, for purposes of institution, that such disclosure would not reasonably convey to an ordinarily skilled artisan that the inventors had possession of the entire genus of heterodimeric antibodies comprising CH3 domains wherein a non-charged amino acid is replaced with a charged residue so as to create an additional charge-charge interaction in the CH3 interface. In this regard, we also note that “a description that merely renders the invention obvious does not satisfy the [written description] requirement.” Ariad, 598 F.3d at 1352.” slip op. at 34

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner

      “adequately describes a heterodimeric antibody comprising the recited charged residues at the recited positions of the CH3 domains, i.e., “a positively charged amino residue at position 364” at a first CH3 domain and “a negatively charged amino acid residue at position 368” of the second CH3 domain. Having considered the evidence of record at this preliminary stage of the proceeding, and for the reasons set forth below, we are persuaded that Petitioner has shown sufficiently, for purposes of institution, that the ’935 provisional does not provide adequate written description support for claim 1 of the ’859 patent and that, accordingly, Desjarlais and Moore qualify as prior art to that claim. As Petitioner points out, the cited disclosure in the ’935 provisional does not “mention[] positions 364 and 368 together as a pair of positions for potential mutations on two chains.” Pet. 28 (citing Ex. 1002 ¶¶ 109–19). Although Patent Owner is correct that examples or actual reduction to practice are not required for adequate written description and “[a] specification may . . . contain a written description of a broadly claimed 34 invention without describing all species that [the] claim encompasses,” Prelim. Resp. 15 (quoting Ariad Pharms., 598 F.3d at 1352 and Cordis Corp. v. Medtronic AVE Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003)), the ’935 provisional must still “reasonably convey[] to those skilled in the art that the inventor[s] had possession of the claimed subject matter” as of the relevant date. Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 127 F.4th 896, 914 (Fed. Cir. 2025); Ariad, 598 F.3d at 1351.” slip op. at 34

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

      “The ’859 patent does not provide an explicit definition of “immunoglobulin class.” Nevertheless, we do not construe that term to require “two heavy chains with four domains, VH, CH1, CH2, and CH3, and two Fab arms.” As an initial matter, the Specification teaches that antibodies include, 16 e.g., IgE and IgM — which have an additional CH4 domain in their heavy chains — as well as functional derivatives and/or fragments of known antibody isotypes. Ex. 1001, 11:44–48. Patent Owner’s proposed construction, which limits antibodies to those having two Fab arms and “two heavy chains with four domains, VH, CH1, CH2, and CH3,” excludes these embodiments and cannot be correct. Moreover, the ’859 patent defines antibody as containing “one or more domains” that bind an epitope on an antigen. Ex. 1001, 11:39–44. Thus, an antibody does not require two Fab arms as in a native immunoglobulin molecule.12 The ’859 patent also describes a preferred embodiment as “Ig-like molecules.” Id. at 11:49–52. Thus, we look to the definition of “Ig-like molecule” in the ’859 patent, i.e., “a proteinaceous molecule that possesses at least one immunoglobulin (Ig) domain,” to inform our understanding of the phrase “immunoglobulin class of proteins.” Ex. 1001, 11:4–6. Accordingly, we further construe “immunoglobulin class of proteins” to mean proteinaceous molecules comprising at least one domain that is derived from or shares sequence homology with an immunoglobulin domain.” slip op. at 16

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 11,926,859

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.