- PTAB · Oct 1, 2025 · PGR2025-00033 · APJ Michael A Valek · PGR · Institution
The Board instituted PGR on claims 1, 2, and 6–29 based on the written-description and enablement grounds; it found the obviousness ground did not meet the institution threshold.
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 in view of the current record, we determine that Petitioner has shown it is more likely than not that claims 1, 2 and 6–29 of the ’652 patent are unpatentable and therefore institute post-grant review for the reasons articulated below.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing because Patent Owner’s proffered definition of a POSA is too restrictive. Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’652 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. 15–16. 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. Moreover, Patent Owner fails to persuasively explain why Petitioner’s definition that includes a person with expertise in other enzymes is insufficient. Even if we were to apply Patent Owner’s POSA definition, it is not clear on the record before us that Petitioner’s experts lack relevant expertise or qualifications of at least a POSA.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided 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 48:41–54 (emphasis added). Based on this express definition, the current record does not support the interpretation proffered by Patent Owner and Dr. Triggs-Raine that the “term ‘modified PH20 polypeptide,’. . . has a purely structural meaning in the context of the specification.” Prelim Resp. 21 (citing Ex. 2055 ¶ 68). Patent Owner and its declarant rely on a truncated version of the definition above that omits the text after the first period because, in their view, that text “is not part of the express definition of ‘modified PH20 polypeptide’” and “merely describes an upper limit for the number of modifications possibly allowing a modified PH20 polypeptide to exhibit enzymatic activity.” Ex. 2055 ¶¶ 67, 77–78 (emphasis in original). On this record, we disagree. We find that this text is part of the definition of “modified PH20 polypeptide” because it continues to detail specific elements required of that term, i.e., a requirement that modifications in the PH20 polypeptide are permitted “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 48:47–49 (emphasis added); see Ex. 2055 ¶ 67 (acknowledging that a “patent’s definition controls,” but referring, without adequate explanation, to the second sentence of the definition paragraph as “a non-limiting example”). Indeed, while some of the language in the definitional 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, 48:41–56. This distinction demonstrates that hyaluronidase activity is not an optional feature of a non-limiting example as Patent Owner posits, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’652 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 16
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateInstituted
“On the current record, the evidence shows it is more likely than not that the claims of the ’652 patent fail to satisfy the written description requirement because they “recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim’s functional boundaries— leaving it to the pharmaceutical industry to complete an unfinished invention.” Ariad, 598 F.3d at 1353. Accordingly, Petitioner has demonstrated that it is more likely than not that there is insufficient written description for the challenged claims. Similarly, the current record does not appear to provide evidence of possession of the full scope of the claims of the ’652 patent in the ’731 application or any of the subsequent divisional or continuation applications leading to the ’652 patent that claim priority to the ’731 application (which appear to all have similar specifications) for the reasons given above.11 Therefore, the challenged claims of the ’652 patent do not receive the benefit of priority from the earlier filed applications, and based on this preliminary determination, the ’652 patent is eligible for post-grant review because the 11 We do not agree with Patent Owner that Petitioner only evaluates description and enablement as of 2011, rather than as of the 2012 filing date of the ’731 application. See, e.g., Prelim. Resp. 1, 11–12, 32. Instead, we agree with Petitioner that it “did not restrict the § 112(a) analysis to December 2011;” rather Petitioner stated that “the claims are not entitled to the ‘December 28, 2012’ benefit date of the ’731 Application, while ‘the obviousness grounds use’ the December 2011 priority date being claimed.” Prelim. Reply 5–6 (citing Pet. 5–6, 15–16). effective filing date is no earlier than the ’652 patent’s actual filing date of December 12, 2022. See Ex. 1001, code (22).” slip op. at 32
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,049,652 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 18, 2025 · IPR2024-00625 · APJ Deborah Katz · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–4 and 6–8 are anticipated by MSR, and claim 5 is obvious over MSR with the additional marker-testing teachings of Chapelle.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“In an anticipation analysis, the dispositive question is whether a skilled artisan would ‘reasonably understand or infer’ from a prior art reference that every claim limitation is disclosed in that single reference.” Acoustic Tech., Inc. v. Itron Networked Sols., Inc., 949 F.3d 1366, 1373 (Fed. Cir. 2020). Extrinsic evidence, such as declarations and depositions may be considered when it is used to explain, but not expand, the meaning of a reference. See In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (holding that the depositions and declarations of skilled workers were properly used to show what those skilled in the art would have known about the prior art). Although Patent Owner argues that a missing element cannot be filled by what an ordinarily skilled artisan would have envisioned, Petitioner’s argument is based on what one of ordinary skill in the art would have understood from what the MSR expressly teaches. (See Pet. 20 (“Indeed, prior art concerning the MSI-H Study indicates that the physicians understood postings on clinicaltrials.gov indicated that patients had ‘metastatic tumors.’ (EX1049, 444; see also EX1050, S4; EX1003, ¶62.)”).) Unlike the facts of Nidec, where a missing signal could have been envisioned but was not present, we are persuaded by the evidence Petitioner presents that those of ordinary skill in the art understood the MSR express disclosure to include patients with unresectable or metastatic tumors because references referring to the study underlying the MSR discuss the inclusion of patients with metastatic tumors in the study. Even if Dr. Neugut’s reasoning that the reference to “measurable” disease in the MSR would have indicated patients having metastatic cancer is flawed, we are persuaded by Petitioner’s evidence of publications referring to the MSR as a study of metastatic colorectal cancer, and we are further persuaded that one of ordinary skill in the art would have understood the MSR to disclose treating patients having metastatic colorectal cancer with pembrolizumab. (See Ex. 1049, 444, Ex. 1050, S4.) Patent Owner does not address this evidence. Instead, Patent Owner acknowledges that “the MSR discloses treating cancer patients that could be within the claimed subset,” but argues that the MSR does not inherently anticipate results later obtained by treating only patients within the claimed subset. (See Pet. Sur- Reply 5–6.) We are persuaded, though, that Petitioner’s challenge is based on what one of ordinary skill in the art would have understood from the MSR (that patients who had an unresectable or metastatic tumor were selected), not on what is inherent to the disclosure of the MSR. We are persuaded that one of ordinary skill in the art at the time would have understood the MSR to teach selecting a patient “who has an unresectable or metastatic,” as required in claim 1. c) Element 1.2: “microsatellite instability-high (MSI-H) or mismatch slip op. at 14
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Patent Owner argues further that the MSR discloses an experimental use that does not qualify as prior art. (See PO Resp. 16–23.) Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. (See id. at 16 (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 Eng'g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). (See PO Resp. 17–23.) 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. (See PO Resp. 18–20.) 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. (See id. at 19–20.) 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 21.) In City of Elizabeth, the Supreme Court was concerned that “[i]t is 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). After considering the parties’ arguments and evidence, we are” slip op. at 24
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“In order to show that objective evidence renders the method of claim 5 non-obvious, Patent Owner must show a nexus between the subject matter recited in claim 5 and the evidence of non-obviousness. See Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (“to be accorded substantial weight in the obviousness analysis, the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention. . . . Ultimately, ‘[t]he patentee bears the burden of showing that a nexus exists.’” (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988), WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)). Patent Owner argues that there is a nexus between the development and commercialization of pembrolizumab and the patented method of treatment recited in the challenged claims, citing, inter alia, the package insert for Keytruda® (pembrolizumab), but Patent Owner does not direct us to evidence of a nexus to MSI-H or MMR deficient tumors that exhibit instability in the microsatellite markers recited in claim 5 and the unexpected results, commercial success, or other objective measures of non-obviousness flowing from these additional limitations. (See PO Resp. 50–63 (citing Ex. 2129, Ex. 2072 ¶ 190, Ex. 2090 ¶¶ 82–92).) Patent Owner directs us only to evidence regarding determining MSI-H status and then using Keytruda® to treat MSI-H cancer patients, which we determine to be anticipated by the MSR. (See PO Resp. 60.) When evidence of a “secondary consideration [] is exclusively related” slip op. at 34
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“(Ex. 1001, 26:19–28.) In Grounds 3 and 5, Petitioner argues, relying on Dr. Neugut’s testimony, that Chapelle teaches standard methods of testing whether a tumor is MSI-H, including determining whether the patient’s tumor exhibits instability in a microsatellite marker, such as BAT-25 or BAT-26. (See Pet. 42 (citing Ex. 1007, 3380, 3383; Ex. 1003 ¶ 107).) For example, Chapelle states that “‘a standard test’ using a ‘[p]anel consisting of … BAT26, BAT25’ has ‘stood the test of time.’” (Ex. 1007 at 3382.) Dr. Neugut testifies that one of ordinary skill in the art would have been motivated to treat a patient with an unresectable or metastatic MSI-H dMMR tumor, wherein the tumor exhibits instability in the BAT-25 and BAT-26 microsatellite marker, and would have expected success in doing so, in light of the teachings of Chapelle. (See Ex. 1003 ¶¶ 105–108.) We find that the record as recounted above supports Petitioner’s challenges of claim 5 in Grounds 3 and 5.” slip op. at 31
Patent outcomesUS 11,339,219 unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,339,219 - Commscope Technologies LLC v. Belden Canada UlcAdverse judgmentPTAB · Sep 8, 2025 · IPR2024-01382 · APJ Kimberly Mcgraw · IPR · Adverse judgment
The Board granted Patent Owner’s withdrawal of its motion to amend and entered adverse judgment against all challenged claims after their statutory disclaimer, terminating the IPR.
RulingsAdverse judgment- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“In view of the facts presented, including that no decision as to the patentability of the proposed substitute claims has yet been made and Petitioner does not oppose the withdrawal, we grant Patent Owner’s Motion to Withdraw its Motion to Amend.” slip op. at 2
- Adverse judgmentAdverse judgmentGranted
“Under our rules, a party may request adverse judgment against itself at any time during a proceeding, including by disclaiming all claims involved in a trial. 37 C.F.R. §42.73(b). Because Patent Owner’s request to withdraw its Motion to Amend has been granted and Patent Owner has disclaimed all Challenged Claims such that no claims remain in the trial, we grant Patent Owner’s Motion to Terminate by Adverse Judgment.” slip op. at 3
NonePatents in suitUS 11,740,423 - Commscope Technologies LLC v. Belden Canada UlcAdverse judgmentPTAB · Sep 8, 2025 · IPR2024-01228 · APJ Kimberly Mcgraw · IPR · Adverse judgment
The Board granted Patent Owner’s withdrawal of its motion to amend and entered adverse judgment on the disclaimed challenged claims, terminating the IPR.
RulingsAdverse judgment- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“In view of the facts presented, including that no decision as to the patentability of the proposed substitute claims has yet been made and Petitioner does not oppose the withdrawal, we grant Patent Owner’s Motion to Withdraw its Motion to Amend.” slip op. at 2
- Adverse judgmentAdverse judgmentGranted
“Under our rules, a party may request adverse judgment against itself at any time during a proceeding, including by disclaiming all claims involved in a trial. 37 C.F.R. §42.73(b). Because Patent Owner’s request to withdraw its Motion to Amend has been granted and Patent Owner has disclaimed all Challenged Claims such that no claims remain in the trial, we grant Patent Owner’s Motion to Terminate by Adverse Judgment.” slip op. at 3
NonePatents in suitUS 11,656,422 - Commscope Technologies LLC v. Belden Canada UlcAdverse judgmentPTAB · Sep 8, 2025 · IPR2024-01227 · APJ Christopher M Kaiser · IPR · Adverse judgment
The Board granted Patent Owner’s withdrawal of its motion to amend and entered adverse judgment after it disclaimed challenged claims 1–5 and 8–13, terminating the IPR.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Under our rules, a party may request adverse judgment against itself at any time during a proceeding, including by disclaiming all claims involved in a trial. 37 C.F.R. §42.73(b). Because Patent Owner’s request to withdraw its Motion to Amend has been granted and Patent Owner has disclaimed all Challenged Claims such that no claims remain in the trial, we grant Patent Owner’s Motion to Terminate by Adverse Judgment.” slip op. at 3
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“In view of the facts presented, including that no decision as to the patentability of the proposed substitute claims has yet been made and Petitioner does not oppose the withdrawal, we grant Patent Owner’s Motion to Withdraw its Motion to Amend.” slip op. at 2
NonePatents in suitUS 11,435,542 - Commscope Technologies LLC v. Belden Canada UlcAdverse judgmentPTAB · Sep 8, 2025 · IPR2024-01218 · APJ Kimberly Mcgraw · IPR · Adverse judgment
The Board granted Patent Owner’s request for adverse judgment after it disclaimed challenged claims 1–5 and 8–13, terminating the inter partes review.
RulingsAdverse judgment- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“In view of the facts presented, including that no decision as to the patentability of the proposed substitute claims has yet been made and Petitioner does not oppose the withdrawal, we grant Patent Owner’s Motion to Withdraw its Motion to Amend.” slip op. at 2
- Adverse judgmentAdverse judgmentGranted
“Under our rules, a party may request adverse judgment against itself at any time during a proceeding, including by disclaiming all claims involved in a trial. 37 C.F.R. §42.73(b). Because Patent Owner’s request to withdraw its Motion to Amend has been granted and Patent Owner has disclaimed all Challenged Claims such that no claims remain in the trial, we grant Patent Owner’s Motion to Terminate by Adverse Judgment.” slip op. at 3
NonePatents in suitUS 10,795,107 - PTAB · Sep 8, 2025 · PGR2025-00017 · APJ Jeffrey N Fredman · PGR · Institution
The Board instituted PGR on claims 1, 2, 6–15, and 17–30 based on written-description and enablement challenges; it found the obviousness challenge insufficient at this stage.
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, Preliminary Response, Reply, Sur-Reply, 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, 2, 6–15, and 17–30 of the ’520 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing because Patent Owner’s proffered definition of a POSA is too restrictive. Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’520 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 be an expert in hyaluronidases. See Pet. 15–16. 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. Moreover, Patent Owner fails to persuasively explain why Petitioner’s definition that includes a person with expertise in other enzymes is insufficient. Even if we were to apply Patent Owner’s POSA definition, it is not clear on the record before us that Petitioner’s experts lack relevant expertise or qualifications of at least a POSA.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided 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 48:38–53 (emphasis added). Based on this express definition, the current record does not support the interpretation of Dr. Triggs-Raine that the “term ‘modified PH20 polypeptide,’ therefore, has a purely structural meaning in the context of the specification.” Ex. 2055 ¶ 68. Indeed, when reproducing the definition from this column of the ’520 patent, Dr. Triggs-Raine does not include any text after the first period, stating that “is not part of the express definition of ‘modified PH20 polypeptide’” and “merely describes an upper limit for the number of modifications possibly allowing a modified PH20 polypeptide to exhibit enzymatic activity.” Ex. 2055 ¶¶ 67, 77–78. On this record, however, we find that this text is part of the definition of “modified PH20 polypeptide” because it continues to detail specific elements required including a requirement that replacements in the PH20 polypeptide are permitted “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 48:44–47; see Ex. 2055 ¶ 67 (stating a “patent’s definition controls”). And Dr. Triggs-Raine states “the modified PH20 polypeptides have multiple credible uses, including ‘therapeutic uses of modified PH20 polypeptides that have the ability to degrade hyaluronan.’” Ex. 2055 ¶ 115.7 That is, Dr. Triggs-Raine recognizes hyaluronidase as the primary utility for the modified PH20 polypeptides recited in claim 1.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateInstituted
“Thus, the ’520 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 “21-42 changes, with each additional change (except at position 324) being to 1 of 19 other amino acids. But the up to 21-42 changes also can be at any of between 430 and 465 (or, in the case of the broadest claims, 474) different positions depending on which unmodified PH20 sequence is used.” Id. ¶ 120. Dr. Park calculates that “95% sequence identity to PH201-465 means that the protein can have 23 total changes,” and that where one of those changes is one of five choices at position 324 as required by claim 1, the number of possible PH20 polypeptides with twenty-two additional changes is “extremely large by all accounts, ranging from 1059 to 10112.” See” slip op. at 27
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,110,520 - Sarepta Therapeutics, Inc. v. The Trustees Of The University Of PennsylvaniaNo claims unpatentablePTAB · Aug 20, 2025 · IPR2024-00580 · APJ Susan L C Mitchell · IPR · Final written decision
The Board held claim 8 not shown unpatentable under each of three §103 grounds because Petitioner failed to establish motivation to combine the references with a reasonable expectation of success.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In addressing the level of ordinary skill in the art, Petitioner contends that a person of ordinary skill in the art (“POSA” or “POSITA”) would have had at least a Ph.D. in biochemistry, molecular biology, or a related field and between one and four years of post-doctoral experience in the field of gene therapy. Alternatively, a POSA would have had at least a Master’s or Bachelor’s Degree in biochemistry, molecular biology, or a related field, with a corresponding number of additional years of experience in the field of gene therapy. Pet. 12 (citing Ex. 1005 ¶¶ 111–115). Patent Owner states that it does not challenge Petitioner’s definition. PO Resp. 10. On this complete record, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’274 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence 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)).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that the ’274 patent “does not specify a particular program or set of program parameters that should be used to align sequences and calculate percent identity for purposes of determining whether a particular test sequence falls within the scope of the claims.” Pet. 21. Petitioner asserts that it analyzed the percent identity claim elements, as Patent Owner did in the parallel District Court litigation, Penn-II, “using the Clustal program at default settings to generate amino acid sequence alignments and calculate percent identity values.” Id. at 21–22. Petitioner, however, does not ask for any particular construction of any claim term. See id. Patent Owner states that it “does not challenge Petitioner’s articulation of the lack of a need for claim construction.” PO Resp. 10. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 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., 200 F.3d at 803)).” slip op. at 12
- Expert testimonyPatent owner expert creditedDecided for patent owner
“According to the import of the complete recitation of paragraph 250 of the ’772 Publication set forth above that Petitioner relies upon for the motivation to improve efficient gene transfer in liver, AAV8 already fulfills this need. See Tr. 28:15–18. We do not read the ’772 Publication as calling for a search for a more efficient variant to improve efficient gene transfer in liver. We credit Dr. Samulski’s testimony that supports this view of the teachings of the ’772 Publication. Dr. Samulski testifies: Additionally, when the inventors compared AAV8’s expression in the liver against new serotypes AAVrh2, AAVrh10, AAVrh13, and AAVrh21, they found that AAV8 remained superior: EX1007, ¶ 253. Notably, AAV8 was shown to have over fifty percent (50%) greater expression in liver than AAVrh10. As I discuss more below, a skilled artisan in 2005 would not have expected a single amino acid substitution to significantly alter tropism in order to target to a different tissue. Thus, in my opinion, in 2005, a skilled artisan with the goal of targeting the liver would have selected the best known vector for delivery to liver at that time—AAV8. Ex. 2027 ¶ 42. We also agree with Dr. Samulski’s opinion that a POSA would have selected the best vector for liver, AAV8, instead of modifying another vector to increase tropism to liver. Dr. Samulski testifies: In my opinion, a skilled artisan in 2005 would not have looked solely to modify a vector to try to improve tropism to a particular tissue. As discussed throughout this declaration, changing tropism is difficult to predict, and a skilled artisan would not have had a reasonable expectation that changes could be made to improve or alter tropism. A skilled artisan would also have been concerned that changes, even small ones, could negatively impact other properties of the capsid protein. Therefore, rather than seek to modify a vector, a skilled artisan” slip op. at 29
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“The ’772 Publication, however, does not indicate as Petitioner asserts that a new variant is necessary to improve the efficiency of gene transfer to liver; the ’772 Publication indicates that AAV8 fulfills that need. See Ex. 1007 ¶ 250. In the paragraph that Petitioner relies upon for the alleged need to improve the efficiency of gene transfer to the liver, the ’772 Publication states in full: The tropism of each new vector is favorable for in vivo applications. AAV2/7 vectors appear to transduce skeletal muscle as efficiently as AAV2/1, which is the serotype that confers the highest level of transduction in skeletal muscle of the primate AAVs tested to date. Importantly, AAV2/8 provides a substantial advantage over the other serotypes in terms of efficiency of gene transfer to liver that until now has been relatively disappointing in terms of the numbers of hapatocytes stably transduced. AAV2/8 consistently achieved a 10 to 100-fold improvement in gene transfer efficiency as compared to the other vectors. The basis for the improved efficiency of AAV2/8 is unclear, although it presumably is due to uptake via a different receptor that is more active on the basolateral surface of hepatocytes. This improved efficiency will be quite useful in the development of liver-directed gene transfer where the number of transduced cells is critical, such as in urea cycle disorders and familial hypercholesterolemia. Id. (citations omitted) (emphasis added). According to the import of the complete recitation of paragraph 250 of the ’772 Publication set forth above that Petitioner relies upon for the motivation to improve efficient gene transfer in liver, AAV8 already fulfills this need. See Tr. 28:15–18. We do not read the ’772 Publication as calling for a search for a more efficient variant to improve efficient gene transfer in liver. We credit Dr. Samulski’s testimony that supports this view of the teachings of the ’772 Publication. Dr. Samulski testifies: Additionally, when the inventors compared AAV8’s expression in the liver against new serotypes AAVrh2, AAVrh10, AAVrh13, and AAVrh21, they found that AAV8 remained superior:” slip op. at 28
Patent outcomesUS 11,680,274 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,680,274 - Luminex International Co., Ltd. / Menard, Inc. v. Signify Holdings B.V.Some claims unpatentablePTAB · Aug 13, 2025 · IPR2024-01469 · APJ Steven M Amundson · IPR · Final written decision
Claims 1–7, 9–15, and 18–20 are unpatentable; claims 8, 16, and 17 are not determined unpatentable under the asserted prior-art grounds.
RulingsFinal written decision- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“G. Analysis 1. REAL PARTY IN INTEREST Based on the record before us and for the reasons explained below, we disagree with Patent Owner that Menard is a “real party in interest” under § 315(b). See Resp. 77–82; Sur-reply 27–28. First, the circumstances here differ materially from the circumstances in Ventex. There, two agreements defined the relationship between Ventex (the petitioner and manufacturer of Heatwave fabric) and Seirus (the alleged real party in interest and purchaser of Heatwave fabric). Ventex, IPR2017- 00651, Paper 152 at 7 & n.8. First, a 2013 Supplier Agreement “prevented Ventex from selling to Seirus competitors” and included an indemnity provision requiring Ventex to indemnify Seirus for losses arising from Ventex’s failure to perform certain obligations. Id. at 7, 14. Second, a 2016 Exclusive Manufacturing Agreement provided that Ventex would manufacture the Heatwave fabric only for Seirus in exchange for Seirus’s payment of an exclusivity fee. Id. at 7. Columbia (the patent owner) accused Seirus products incorporating the Heatwave fabric of infringing the patent at issue, and Columbia served Seirus with a complaint alleging patent infringement in 2014 more than two years before Ventex filed a petition in 2017. Id. at 5, 7. When determining that Seirus was a “real party in interest” under § 315(b), the Board reasoned that “Ventex and Seirus had a specially structured, preexisting, and well established business relationship with one another, including indemnification and exclusivity arrangements.” Ventex, IPR2017-00651, Paper 152 at 10; see id. at 12. Additionally, the Board noted that certain evidence “suggest[ed] that” slip op. at 32
- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“G. Analysis 1. REAL PARTY IN INTEREST Based on the record before us and for the reasons explained below, we disagree with Patent Owner that Menard is a “real party in interest” under § 315(b). See Resp. 77–82; Sur-reply 27–28. First, the circumstances here differ materially from the circumstances in Ventex. There, two agreements defined the relationship between Ventex (the petitioner and manufacturer of Heatwave fabric) and Seirus (the alleged real party in interest and purchaser of Heatwave fabric). Ventex, IPR2017- 00651, Paper 152 at 7 & n.8. First, a 2013 Supplier Agreement “prevented Ventex from selling to Seirus competitors” and included an indemnity provision requiring Ventex to indemnify Seirus for losses arising from Ventex’s failure to perform certain obligations. Id. at 7, 14. Second, a 2016 Exclusive Manufacturing Agreement provided that Ventex would manufacture the Heatwave fabric only for Seirus in exchange for Seirus’s payment of an exclusivity fee. Id. at 7. Columbia (the patent owner) accused Seirus products incorporating the Heatwave fabric of infringing the patent at issue, and Columbia served Seirus with a complaint alleging patent infringement in 2014 more than two years before Ventex filed a petition in 2017. Id. at 5, 7. When determining that Seirus was a “real party in interest” under § 315(b), the Board reasoned that “Ventex and Seirus had a specially structured, preexisting, and well established business relationship with one another, including indemnification and exclusivity arrangements.” Ventex, IPR2017-00651, Paper 152 at 10; see id. at 12. Additionally, the Board noted that certain evidence “suggest[ed] that” slip op. at 32
- Skill levelOther
“C. Level of Ordinary Skill in the Art Factors pertinent to determining the level of ordinary skill in the art include (1) the educational level of the inventor; (2) the type of problems encountered in the art; (3) prior-art solutions to those problems; (4) the rapidity with which innovations are made; (5) the sophistication of the technology; and (6) the educational level of workers active in the field. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–97 (Fed. Cir. 1983). Not all factors may exist in every case, and one or more of these or other factors may predominate in a particular case. Id. These factors are not exhaustive, but merely a guide to determining the level of ordinary skill in the art. Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). Moreover, the prior art itself may reflect an appropriate skill level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Petitioner asserts that a person of ordinary skill in the art at the ’336 patent’s effective filing date would have had “a bachelor’s degree in mechanical engineering, electrical engineering, optics, or physics with at least three years of experience working in the design of LED lights or lighting fixtures; a master’s degree in one of the above disciplines with at least two years of experience; or equivalent experience.” Pet. 14 (citing Ex. 1004 ¶¶ 26–29). Dr. Eden’s testimony supports Petitioner’s assertion. See Ex. 1004 ¶¶ 27–28. Patent Owner “adopts for purposes of this proceeding only” Petitioner’s description of an ordinarily skilled artisan. Resp. 10 (citing Pet. 14). We adopt Petitioner’s description of an ordinarily skilled artisan because it comports with the technology and claims of the ’336 patent as” slip op. at 40
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia no nexusDecided for petitioner
“Alleged Objective Indicia of Nonobviousness (i) General Principles Before reaching a conclusion about obviousness, we consider evidence concerning objective indicia of nonobviousness. See Apple, 839 F.3d at 1048. For such evidence to have substantial weight, “its proponent must establish a nexus between the evidence and the merits of the claimed invention.” ClassCo, Inc. v. Apple, Inc., 838 F.3d 1214, 1220 (Fed. Cir. 2016); see Ancora Techs., Inc. v. Roku, Inc., 140 F.4th 1351, 1361 (Fed. Cir. 2025) (noting that the Board did not err by requiring “a nexus to the challenged claims as opposed to the patent as a whole”). “[T]here is no nexus unless the evidence presented is ‘reasonably commensurate with the scope of the claims.’” ClassCo, 838 F.3d at 1220 (quoting Rambus Inc. v. Rea, 731 F.3d 1248, 1257 (Fed. Cir. 2013)). The patentee “bears the burden of showing that a nexus exists.” WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999). A rebuttable presumption of nexus arises “when the patentee shows that the asserted objective evidence is tied to a specific product and that product ‘embodies the claimed features, and is coextensive with them.’” Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (quoting Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018)). Whether a rebuttable presumption of nexus arises “turns on the nature of the claims and the specific facts.” Teva Pharms. Int’l GmbH v. Eli Lilly & Co., 8 F.4th 1349, 1362 (Fed. Cir. 2021). The presumption analysis should consider the unclaimed features in the product tied to the objective evidence to assess their significance and impact on the correspondence between the patented invention and the product. Quanergy Sys., Inc. v. Velodyne Lidar USA, Inc., 24 F.4th 1406, 1418 (Fed. Cir. 2022). When, “for example, the patented invention is only a small component of the product tied to the objective evidence, there is no presumption of nexus.” Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1333 (Fed. Cir. 2019). Absent a presumption of nexus, the patentee may prove nexus by” slip op. at 76
Patent outcomesUS 10,299,336 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,299,336 - Luminex International Co., Ltd. / Menard, Inc. v. Signify Holdings B.V.Some claims unpatentablePTAB · Aug 13, 2025 · IPR2024-00101 · APJ Steven M Amundson · IPR · Final written decision
Claims 1–7, 9–15, and 18–20 are unpatentable; claims 8, 16, and 17 are not shown unpatentable under the asserted grounds.
RulingsFinal written decision- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for patent ownerDecided for patent owner
“G. Analysis 1. REAL PARTY IN INTEREST Based on the record before us and for the reasons explained below, we” slip op. at 32
- PTAB / AIA Trials › §315(b) time barDecided for patent owner
“III. WHETHER THE PETITION IS TIME BARRED The parties dispute whether the Petition is time barred based on a” slip op. at 18
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“vacated the panel’s decision denying institution. Paper 12, 6. Among other things, the Director determined based on a “review of the current record” that (1) Menard is not a real party in interest in this proceeding and (2) Menard is not a privy of Petitioner. Id. at 5. Further, the Director remanded the case to the panel and instructed the panel “to determine whether the Petition presents a reasonable likelihood of prevailing with respect to at least one of the challenged claims under 35 U.S.C. § 314(a), and to determine whether to institute inter partes review accordingly.” Id. at 5–6.” slip op. at 3
- BurdenMixed
“U.S. Patent No. 10,299,336 B2 (“the ’336 patent”) (Exhibit 1001). For the reasons explained below, a preponderance of the evidence shows that claims 1–7, 9–15, and 18–20 in the ’336 patent are unpatentable and does not show that claims 8, 16, and 17 are unpatentable. See 35 U.S.C. § 316(e) (2024).” slip op. at 2
Patent outcomesUS 10,299,336 mixed§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,299,336
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.