• Ascentcare Dental Product, Inc. v. Solmetex, LLCInstitution denied
  PTAB · Dec 23, 2025 · IPR2025-01104 · APJ James A Tartal · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood of proving any challenged claim obvious over the asserted prior-art combinations.

  RulingsInstitution decision

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

    “review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2025). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon institution of inter partes review, the review proceeds “on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a). Based on our consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that the information does not demonstrate a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we” slip op. at 2

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “the ’329 patent was filed would have had “at least a B.S. degree in mechanical engineering or a related field with at least two years’ experience designing dental devices” and that “[l]ess work experience may be compensated by a higher level of education, such as a master’s degree, and vice versa.” Pet. 32. Patent Owner contends that Petitioner’s definition is overly narrow and argues that “[n]othing in the claims of the ’329 Patent requires experience designing ‘dental devices.’” Prelim. Resp. 19. According to Patent Owner, “the claims are directed to the structural components of a dental isolation mouthpiece, and an individual with a mechanical engineering degree and experience designing medical devices would be a [person of ordinary skill in the art] for purposes of the ’329 Patent.” Id. (citing Ex. 2030 ¶ 83). We adopt Patent Owner’s proposed level of skill for purposes of this Decision. We determine that this level of ordinary skill in the art—i.e., an individual with a mechanical engineering degree and experience designing medical devices—is consistent with the level of technical understanding and competence reflected in the ’329 patent Specification and the asserted prior art references, based on our review of the current record. Moreover, our determination in this Decision would be the same were we to adopt Petitioner’s proposed level of ordinary skill in the art.” slip op. at 8

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

    “Patent Owner asserted “[p]lain and ordinary meaning” for “a plurality of protrusions” in claims 9 and 30, whereas Petitioner proposed “an internal structure attached to the second wall that prevents the collapse of the first and second wall during suction.” Prelim. Resp. 20 (citing Ex. 2039). Here, Patent Owner argues that “protrusion” should be construed to mean “a structure attached to the second wall but not the first wall,” with respect to claims 1, 9, and 30, and to mean “a structure attached to the first wall but not the second wall,” with respect to claim 21. Id. at 24. Patent Owner also argues that structure attached to both the first wall and the second wall is inconsistent with “the plain and ordinary meaning of ‘protrusions’ in light of the specification.” Id. at 21 (citing Ex. 2030 ¶¶ 111–112). We address Patent Owner’s arguments in the context of our analysis of Petitioner’s contentions below.” slip op. at 11

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

    “combination deficient. Petitioner argues that Park’s walls are “likely to collapse under the suction force,” based not on Park, but on Baughan, which states that “discs” in Baughan are used to prevent the “flexible sleeve” of Baughan from collapsing. Pet. 89. (citing Ex. 1007, 3:46–48). Petitioner reasons that because Park uses silicone, a flexible material, Park’s walls must also collapse like Baughan. Id. (citing Ex. 1006 ¶¶ 32, 34). Petitioner, however, directs us to no disclosure in Park to suggest that the material used in Park or the arrangement of Park would collapse in the same manner as Baughan. Indeed, if Park’s mouthpiece collapses as Petitioner speculates, it would appear likely to render Park inoperable. See Ex. 2030 ¶ 205. Additionally, Petitioner recognizes that in Park “the sidewalls and the insertion part 111 would help resist this collapsing force,” and states that in Park it “is unclear whether the mouth prop 100 includes a spine or other rigid structure running through the middle of the mouth prop 100.” Pet. 89– 90. Thus, whether Park is susceptible to collapse is, at best, unknown. See Prelim. Resp. 48 (asserting that a person of ordinary skill would have known “that silicone can have varying degrees of hardness, tensile strength, and elasticity such that Park’s mouthpiece would not necessarily collapse under suction”) (citing Ex. 2030 ¶¶ 189–90; Ex. 2036; Ex. 2037). Even assuming, as Petitioner asserts, that “additional anti-collapsing structure would assist at the weakest areas of the tongue retractor” in Park, Petitioner offers insufficient reasoning for why a person of ordinary skill would have turned to Baughan and modified the structure taught by Baughan to instead conform to what is recited in claim 1. Petitioner’s suggestion that “common sense” would have led a person of ordinary skill in the art to modify the structures of Baughan to solve a problem with collapse in Park that Park does not suggest was a problem is likewise unpersuasive and insufficient. Pet. 93 (further asserting that “it was well known in the art how to make projections on a flat surface”). Petitioner’s reliance on Johnson as generically teaching that protrusions can be on flat surfaces does not supply a reason why a person of ordinary skill in the art would have made the proposed modifications outside of improper hindsight. See also Prelim. Resp. 58, 59 (arguing that the projections in Johnson are on a semicircular surface, not on a flat surface as Petitioner asserts) (citing Ex. 1008 Figs. 4, 5). Based on the evidence and arguments presented, we determine that Petitioner fails to show sufficiently for purposes of instituting inter partes review that the asserted combination of Park, Baughan, and Johnson, or in further combination with Zheng, teaches “protrusions protruding from an interior surface” of one wall of the mouthpiece “towards” an opposing wall of the mouthpiece, as required by claim 1, or that a person of ordinary skill in the art would have had reason to combine the asserted references in the manner alleged by Petitioner.” slip op. at 28

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 12,011,329
• MPL Brands NV, Inc. v. Buzzballz, LLCAll claims unpatentable
  PTAB · Dec 16, 2025 · IPR2024-01098 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1–6 are unpatentable as anticipated by or obvious over Kick and as obvious over Ackermann and Kaminski, with or without Hutchinson.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(sometimes abbreviated herein as “POSITA”) would have had “(i) an associate’s or bachelor’s degree in mechanical, industrial or manufacturing engineering and (ii) at least two to three years of practical experience with designing or manufacturing mechanical products, such as food or beverage packaging. A POSITA could substitute additional education for industry experience and vice versa.” Pet. 15 (citing Ex. 1002 (Delson Decl.) ¶ 14).” slip op. at 12

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

    “Petitioner asserts that no claim term requires an express construction. See Pet. 15. We agree and find it unnecessary to construe any claim term to resolve the issues in this case. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 13

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedDecided for petitioner

    “is no earlier than the February 25, 2020, filing date of the ’195 application. Petitioner demonstrates by a preponderance of the evidence that the volume limitations recited in independent claim 1 and dependent claims 2 and 6 lack adequate written description support in the ’934 application as filed. See Pet. 10–11. The specification, figures, and claims of the ’934 application as originally filed do not disclose any volume limitations. See Ex. 1004 (’934 prosecution history), 1–17. Instead, the volume limitations recited in the challenged claims find their first support in Figure 7, which was filed over one month after the ’934 application was filed. Compare id. at 1–17, with id. at 34–56. The addition of new matter during prosecution of a patent application is prohibited. See 35 U.S.C. § 132(a) (“No amendment shall introduce new matter into the disclosure of the invention.”); see also 37 C.F.R. § 1.121(f); Manual of Patent Examining Procedure § 608.04. Therefore, we agree with Petitioner that “the new matter improperly added during the prosecution of the ’934 application cannot be considered part of the disclosure of the original, April 19, 2010 application and/or relied upon for claiming priority in subsequent applications.” Pet. 9.” slip op. at 20

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

    “obvious over Kick. Pet. 16–41. Kick published with the additional figures and disclosure the applicant submitted during prosecution of the ’934 application, and its detailed description and figures are the same as or similar to that of the ’904 patent. See id. at 16; compare Ex. 1007 (Kick), with Ex. 1001. Petitioner compares Kick to each limitation of the challenged claims. See Pet. 16–41. Based on the record before us, we find that Kick teaches or suggests each of the limitations of the challenged claims, for the reasons discussed in the Petition. See id. Accordingly, we determine that Petitioner has established by a preponderance of the evidence that Kick renders claims 1–6 of the ’904 patent unpatentable as anticipated and as obvious.” slip op. at 22

  Patent outcomesUS 11,738,904 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,738,904
• Ascentcare Dental Product, Inc. v. Solmetex, LLCInstitution denied
  PTAB · Dec 12, 2025 · IPR2025-01175 · APJ James A Tartal · IPR · Institution

  The Board denied institution because Petitioner did not sufficiently show the patent was eligible for IPR when it filed the petition less than two months after issuance.

  RulingsInstitution decision

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

    “We determine that Petitioner cannot credibly certify that the ’418 patent is available for inter partes review, based on a claim of priority on the face of the ’418 patent to the ’939 provisional application filed prior to the effective date of the AIA, where, as here, Petitioner contradictorily contends in the Petition that the ’939 provisional application “does not support all claim limitations” of the ’418 patent.4 Id. If Petitioner’s allegation that claims of the ’418 patent are not supported by the ’939 provisional application is correct, then the ’418 patent would be a post- AIA patent for which a petition may not be filed earlier than 9 months after the ’418 patent issued. See 35 U.S.C. § 311(c). Thus, based on the arguments and evidence presented by Petitioner, Petitioner fails to show that the ’418 patent is eligible for inter partes review when Petitioner filed the Petition less than two months after the ’418 patent issued. 35 U.S.C. § 311(c), 37 C.F.R. § 42.102(a)(1). We, therefore, deny the Petition. IV. CONCLUSION For the foregoing reasons, we find that Petitioner has not shown sufficiently that the Petition complies with 35 U.S.C. § 311(c) and, therefore, deny the Petition.” slip op. at 10

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportNot reached

    “review when the Petition was filed “because the ’418 Patent claims priority to December 7, 2012 and is therefore,” not a post-AIA patent. Pet. 17 (emphasis added). Contrary to Petitioner’s assertion, the ’418 patent is a post-AIA patent if any claim of the ’418 patent does not have priority to the ’939 provisional application, regardless of whether, on its face, the ’418 patent “claims priority” to an application filed prior to the effective date of the AIA. See In re NTP, Inc., 654 F.3d 1268, 1276–77 (Fed. Cir. 2011) (“[A] patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority.”).” slip op. at 9

  § 102 anticipation
  Patents in suitUS 12,290,418
• Merck Sharp & Dohme LLC v. Halozyme, Inc.Instituted
  PTAB · Nov 19, 2025 · PGR2025-00053 · APJ Susan L C Mitchell · PGR · Institution

  The Board instituted PGR on claims 1–3 and 5–15, finding written-description and enablement challenges more likely than not to succeed, but not the obviousness challenge.

  RulingsInstitution decision

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

    “We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate 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). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 and 5– 15 of the ’773 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’773 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Pet. 7. We have adjusted the claims challenged to only those that remain in effect following Patent Owner’s disclaimer. See Ex. 2003. 3 US 7,767,429 B2, issued Aug. 3, 2010 (the “’429 patent”; Ex. 1005). 4 Chao et al., Structure of Human Hyaluronidase-1, a Hyaluronan Hydrolyzing Enzyme Involved in Tumor Growth and Angiogenesis, 46 Biochemistry 6911–6920 (2007) (Ex. 1006). Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 16–17. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 8

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

    “refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:8–22 (emphasis added). On this record, however, we find that the definition of “modified PH20 polypeptide” permits amino acid replacements in the PH20 polypeptide but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:13–15. Indeed, while some of the language in the above paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:8–22. This distinction demonstrates that hyaluronidase activity is not an optional feature of a non-limiting example, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’773 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional).” slip op. at 13

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

    “We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post-grant review. See 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 14

  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 12,195,773
• Merck Sharp & Dohme LLC v. Halozyme, Inc.Instituted
  PTAB · Nov 19, 2025 · PGR2025-00050 · APJ Susan L C Mitchell · PGR · Institution

  The Board instituted PGR on claims 1–3 and 6–10 because Petitioner showed they were more likely than not to lack written-description support and enablement.

  RulingsInstitution decision

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

    “We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate 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). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 and 6– 10 of the ’791 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’791 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 20. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

    “refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:4–18 (emphasis added). On this record, we find that the definition of “modified PH20 polypeptide” permits amino acid replacements in the PH20 polypeptide but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:9–11. Indeed, while some of the language in the above paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:4–18. This distinction demonstrates that hyaluronidase activity is not an optional feature, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’791 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional). Thus, the evidence of record shows the ’791 patent recognizes a broad understanding of a “modified PH20 polypeptide” as encompassing PH20 sequences from a variety of different mammalian species, with or without precursor or signal sequences, with or without post-translational modifications, and with up to 150 amino acid replacements. The express definition of “modified PH20 polypeptide” in the ’791 patent permits up to 150 amino acid replacements but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:9–11. That is, the provided definition of “modified PH20 polypeptide” in the ’791 patent expressly requires some hyaluronidase activity. On the current record, we therefore adopt the definition for “modified PH20 polypeptide” as recited in the ’791 patent to encompass polypeptides with some hyaluronidase activity. We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post-grant review. See 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 12

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateInstituted

    “As we noted, on the current record claim 1 is reasonably interpreted to encompass PH20 polypeptides with some hyaluronidase activity. But even if we were to find that immunization using PH20 polypeptide as a contraceptive antigen serves to satisfy the utility requirement for the instant claims, there is a similar concern as to whether modified PH20 polypeptides with significant differences from the native protein as encompassed by claim 1 would maintain the antigenic determinants necessary to function as contraceptives. See Ex. 1003 ¶ 122. That the modified PH20 polypeptides would be homogenous in function is contradicted both by evidence in the ’791 patent itself and by Dr. Hecht and Dr. Parker. The ’791 patent discloses synthesis of 6,753 single amino acid mutations in residues 1‒447 of SEQ ID NO: 3. See Ex. 1001, 199:15–200:34. The ’791 patent teaches that just under 10% of these mutations, i.e. over 600, “exhibit activity that is increased compared to wildtype.” Id. at 233:1–2. Appendix A of Dr. Hecht’s Declaration shows 3,380 of these mutations were inactive, or 57.13%. See Ex. 1003, Appendix A-1, 171. Thus, the ’791 patent evidences that even when only a single mutation is made in the PH20 polypeptide, that single mutation is more likely than not to alter the structure in such a way as to inactivate the hyaluronidase activity found in the native PH20 polypeptide. On this record, Dr. Hecht persuasively demonstrates that when the full scope of claim 1 is addressed, which includes not just single mutations in the PH20 polypeptide, but also multiple mutations, there is no expectation of structural homogeneity, stating that “[i]ntroducing multiple amino acid changes simultaneously . . . could prevent the folding of sequences into secondary structures and structural motifs and can destabilize those structures if they do form.” Ex. 1003 ¶ 59. Dr. Hecht notes that claim 1 allows “up to 21 changes, with each additional change (except at position 309) being to any of 19 alternative amino acids. But the up to 21 changes also can be at any of 433 different positions.” Id. ¶ 129. Dr. Park calculates that the number of distinct polypeptides that meet the claimed criteria “is extremely large by all accounts, ranging from 1049 to 1060 distinct polypeptides.” See Ex. 1004 ¶ 161. Dr. Hecht characterizes the number of possible mutations as “astronomical in size.” Ex. 1003 ¶ 134.” slip op. at 20

  Claim construction§ 112 disclosure
  Patents in suitUS 12,077,791
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–30 are unpatentable: claims 1–2, 4–7, 9–12, 14–17, and 19–30 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious over the cited combinations.

  RulingsFinal written decision

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

    “We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having cancer to determine that the patient’s cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 10

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artDecided for petitioner

    “Patent Owner does not direct us to evidence that it attempted to file any patent application before the publication date of the MSI-H clinical study and was denied an earlier filing date. Contrary to Patent Owner’s argument that it could not file a patent application without results from the MSI-H clinical study, we note that the inventors filed a provisional patent application on November 13, 2014, which, although also filed more than a year after the publication of the MSI-H clinical study, disclosed no clinical results or data. Ex. 1001, cover; Ex. 1030, 1. After considering the parties’ arguments, we are not persuaded by Patent Owner’s assertion that the inventors could not have filed an earlier application to at least attempt to secure a priority date before the MSI-H clinical study was publicly available. an earlier filing date. Instead, we are persuaded by Petitioner’s argument that because the MSI-H clinical study was published before the inventors filed an application to protect their patent rights the MSI-H clinical study is prior art for the information it discloses. Accordingly, we proceed to analyze Petitioner’s contentions in Ground 1.” slip op. at 24

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

    “the genus disclosed in the MSI Study Record and does not argue or provide evidence to show that one of ordinary skill in the art could have envisaged each species within that genus. PO Resp. 11–14. We are not persuaded that either the size of the genus in the MSI Study Record or whether one of ordinary skill in the art would have been able to envisage every species within it is dispositive of whether the MSI Study Record anticipates claim 1, where one of ordinary skill in the art would have known that specific cancers recited in claim 1 would be included in the MSI Study Record. As Petitioner argues, claim 1 requires that “a patient…selected from the group consisting of [the listed cancers]” be tested and treated. Pet. Reply 10 (emphasis original). Claim 1 does not require that the patient have each and every one of the sixteen listed cancers to anticipate the claim. Rather, claim 1 requires testing a sample from “a patient” with one of the recited types of cancer and treating the patient. See Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) (“When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.”).” slip op. at 31

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “In contrast, the testimony of Patent Owner’s witness, Dr. Goldberg, supports Petitioner’s argument of the knowledge in the art at the time, wherein Dr. Goldberg testifies that “[w]hile many clinical oncologists were aware that patients with Lynch Syndrome had a defect in DNA mismatch repair, they associated MSI testing with young onset colorectal and endometrial cancer and patients with a family history of colorectal and/or endometrial cancer.” Ex. 2090 ¶ 79. Similarly, during his deposition, Dr. Goldberg also agreed that endometrial, gastric, and small-bowel cancers would come to mind when he saw a reference to MSI-high non-colorectal cancer. See Ex. 1243, 115:5–116:22 (Q. And so does endometrial cancer come to mind when you see reference to MSI-high non-colorectal cancers? . . . A. Yes. Q. As . . . a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does gastric cancer come to mind? . . . A. comes to mind. So the answer is yes. Q. As a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does small bowel cancer come to mind? . . . A. Yes.”). Patent Owner does not direct us to other evidence contradicting Petitioner’s argument that MSI-H was known to occur in endometrial, small bowel, and gastric cancer. Pet. 18.” slip op. at 30

  Patent outcomesUS 11,643,462 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,643,462
• MPL Brands NV, Inc. v. Buzzballz, LLCAll claims unpatentable
  PTAB · Nov 17, 2025 · PGR2024-00035 · APJ Cynthia M Hardman · PGR · Final written decision

  Claims 1–20 are unpatentable as obvious over the cited prior art, based on the Board’s findings across the four asserted grounds.

  RulingsFinal written decision

  • Skill levelOther

    “II. ANALYSIS A. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art” slip op. at 12

  • Expert testimonyPatent owner expert discountedDecided for patent owner

    “person or designer of ordinary skill in the art. See Reply 7; Ex. 2001 ¶ 5. Patent Owner asserts that Mr. Kirkpatrick’s testimony is nevertheless relevant because it “informs the opinion of expert witnesses who do qualify as POSITAs” (i.e., Dr. Rojas). PO Resp. 4–5. But the level of ordinary skill in the art as defined here does not mention patents or patent drawings, and Patent Owner has not explained why or in what capacity a person of ordinary skill in the art would have consulted with a patent illustrator.15 For these reasons, we accord no weight to Mr. Kirkpatrick’s opinions on how a person of ordinary skill in the art would have viewed the figures. See” slip op. at 26

  • BurdenFwd all claims unpatentableUnpatentable

    “Petitioner has the burden of proving unpatentability of the challenged claims by a preponderance of the evidence. 35 U.S.C. § 326(e). Having reviewed the parties’ arguments and cited evidence, for the reasons we discuss below, we find that Petitioner has demonstrated by a preponderance of the evidence that claims 1–20 are unpatentable as obvious over the cited prior art.” slip op. at 2

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

    “For the above reasons, and after considering Patent Owner’s” slip op. at 47

  Patent outcomesUS 11,932,441 unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,932,441
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 6, 2025 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–7 are unpatentable: claims 1–3 and 5–7 are anticipated by the MSI-H Study Record, and claim 4 is obvious over the MSI-H Study Record and other cited references.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “On balance, we find Petitioner’s evidence more persuasive of what one of ordinary skill in the art would have understood from the MSI-H Study Record. We find Dr. Neugut’s and Dr. Oberstein’s testimony, and Dr. Lonberg’s lack of clear testimony to the contrary, persuasive as to this issue. In addition, we are not persuaded by the case law cited by Patent Owner regarding inherent anticipation. See PO Resp. 6–7. Rather, we agree with Petitioner that the correct inquiry is whether the skilled artisan would have understood that all limitations are disclosed in the prior art. See Pet. 34–35; Pet. Reply 12–13. In light of the cited testimony, we are persuaded that Petitioner has met its burden of proving that a skilled artisan would reasonably have understood or inferred that the limitation for a patient having received a prior cancer therapy drug to treat the tumor was disclosed in the MSI-Study Record. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSI-H Study Record, not what it inherently discloses. Contra PO Resp. 6–9.” slip op. at 22

  • Skill levelSkill level board ownDecided for petitioner

    “In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’974 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

  Patent outcomesUS 11,325,974 unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,325,974
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 4, 2025 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–4, 6–10, and 12–15 are unpatentable, principally because the MSI-H Study Record anticipates them.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Pet. 12 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Thus, Petitioner and Patent Owner characterize one of ordinary skill in the art differently. Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects.” slip op. at 8

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

    “The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 11–12; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. 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)). We construe” slip op. at 7

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

    “record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’975 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not inherently anticipate where it failed to mention specific vitamin deficiencies, instead merely inviting further experimentation to find associations with metabolic perturbations). requirement, efficacy is inherent in carrying out the claim steps,” referring to a claimed method of treating or preventing stroke, which was held to be anticipated by the publication of a proposed study. 677 F.3d at 1381. Patent Owner attempts to distinguish the size and apparent surety of the study in Montgomery from the MSR. PO Resp. 15. But because we find that the MSR teaches performing the steps recited in claim 1 for the purpose of determining and treating MSI-H cancer, we are persuaded that the MSR inherently discloses the results of selection of patients and administration of the drug treatment recited in those steps. See Bristol-Myers, 246 F.3d at 1376. Whether or not the MSR could have provided results or was sufficient for full regulatory approval does not change that the MSR teaches Patent Owner’s claimed steps. We have no reason to doubt that the disclosure in the MSR of the steps recited in claim 1 produces the efficacy element required in claim 1, whether or not this efficacy was disclosed in the MSR or was known when it was published. See Mehl/Biophile, 192 F.3d at 1366 (“Where, as here, the result is a necessary consequence of what was deliberately intended, it is of no import that the article’s authors did not appreciate the results.”).” slip op. at 21

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “use that does not qualify as prior art. PO Resp. 18–25. Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. Id. at 18 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998). According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). PO Resp. 19–25. For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. Id. at 20–22. Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. Id. at 21. Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” Id. at 23. sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024).” slip op. at 24

  Patent outcomesUS 11,325,975 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,325,975
• Clearcorrect Operating, LLC v. Align Technology Inc.Instituted
  PTAB · Oct 30, 2025 · IPR2025-00817 · APJ Kevin F Turner · IPR · Institution

  The Board instituted IPR on claims 1–20, finding a reasonable likelihood of success on the Boerjes-Geng and Boerjes-Geng-Babayoff obviousness grounds.

  RulingsInstitution decision

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

    “On this record, we determine that Petitioner has developed this ground sufficiently to meet the reasonable likelihood standard for institution. Having determined that Petitioner has met its burden as to its Ground 2 arguments, and because the Board must institute on all grounds or none, SAS Institute Inc. v. Iancu, 584 U.S. 357, 364–65 (2018) and 37 C.F.R. § 42.108(a), we institute trial in on all grounds presented in this proceeding. Nevertheless, we address the additional grounds below.” slip op. at 24

  • Skill levelSkill level petitioner adoptedOther

    “Pet. 16 (citing Ex. 1003 ¶¶ 27–30). At this stage, Patent Owner does not dispute Petitioner’s proposal or offer an alternative proposal. See generally Prelim. Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 9

  • Prior constructionPrior construction adoptedDecided for petitioner

    “The parties indicate that in the co-pending litigation in the District Court for the Western District of Texas (see supra Section I.B), the Court provided preliminary constructions of two specific claim limitations. Pet. 16–17; Prelim. Resp. 8. Patent Owner adds that “district court subsequently adopted these constructions in its final claim construction order.” Prelim. Resp. 8 (citing Ex. 2001). We determine that the constructed limitations do not impact the analysis below, but nonetheless, we adopt this those constructions for purposes of this Decision.” slip op. at 9

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

    “identify areas that need replacing, such as ‘a margin line’ to be removed, ‘areas of poor margin preparation,’ and ‘holes or areas of incomplete scan[s],’” and that the user can identify regions of a prepared tooth surface requiring additional preparations and “supplemental scanning” (Pet. 32 (citing Ex. 1004 ¶¶ 189, 193, 196)), Boerjes is silent with respect to replacing at least a portion of the removed surface portion of the model using the received second scan data of the patient’s teeth, per claim 1. Boerjes certainly contemplates the re-scanning of the dentition, but does not assert partial insertion of new data into an existing 3D model. Even under the “comprising” language of claim 1, for example, the complete replacement of a 3D model cannot teach or suggest “replacing at least a portion of the removed surface portion” without repudiating the language of the claim by making a portion be the entire model. Even if, as Petitioner asserts, “removing portions of a virtual model has been a well-known and routine technique in 3D modeling,” and the “process of replacing a user-identified portion would have been well within the skills of a POSITA” (Pet. 35), the disclosure of Boerjes does not teach or suggest such processes. Although Boerjes allows for the possibility that portions of a model can be identified as needing replacement or supplementation, it does not disclose the partial replacement required by the instant, independent claims. Boerjes’s actual disclosure details that supplemental scanning is used to compensate for an inadequate scan, but not disclosed to be used to stitch together before-and-after models that have undergone an intervening physical change. slip op. at 18

  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 10,791,936

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.