- 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 - PTAB · Sep 23, 2025 · IPR2025-00270 · APJ Bach V Hoang · IPR · Institution
The Board instituted IPR on claims 1–13, 15, 18, 20, 21, and 27 on all asserted grounds, finding a reasonable likelihood that claim 13 is obvious over Rohall and Schiavone.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“presented in the petition . . . and any response . . . 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). Having reviewed the parties’ papers and the evidence of record, we determine that Petitioner has shown a reasonable likelihood it would prevail in establishing the unpatentability of at least one challenged claim. Accordingly, we institute an inter partes review on all challenged claims and on all grounds raised in the Petition. See 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner asserts a person of ordinary skill in the art in May 2004 would have had a working knowledge of the telecommunications and networking art that is pertinent to the [’911 patent]. A POSITA would have had a bachelor’s degree in electrical engineering, computer science, computer engineering, or an equivalent, and two years of relevant experience involving computer science fundamentals, including pointers, data structures, object-oriented programming, database principles, internet-based communication technologies and electronic mail systems that is pertinent to the [’911 patent]. Lack of professional experience can be remedied by additional education, and vice versa Pet. 3 (citing Ex. 1003 ¶ 22). Patent Owner asserts a person of ordinary skill in the relevant art — computer science — would have at least a bachelor’s degree in electrical or computer science/engineering, or a related field, with at least two years of experience in the design or implementation of content management and analysis systems or a master[’s] degree in electrical or computer science/engineering, or a related field, with at least one year of experience in the design or implementation of content management and analysis systems. A higher level of education or skill can make up for less experience, and vice versa. Prelim. Resp. 17 (citing Ex. 2002 ¶ 14). For purposes of this Decision, we adopt Petitioner’s proposed level of skill, as articulated above. Petitioner’s proposed definition generally teachings of the ’911 patent and the asserted prior art. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the prior art itself may reflect an appropriate level of skill in the art). This definition is also supported by the testimony of Dr. Black.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“relational references” require using a relational model (or that they are a relational model) and, for purposes of this decision, we adopt Petitioner’s proffered construction. The relevant portion of claim 1 recites “a message container containing relational references pointing to a plurality of sent submessages stored externally to the message container in the message database.” Ex. 1001, 15:56–59. That express language does not recite a relational model, let alone that “relational references” connote required use of a relational model. Instead, the language supports Petitioner’s interpretation that “relational references” are pointers that point to related messages because the claim states that the “relational references” perform the task of “pointing to a plurality of sent submessages.” Although Patent Owner asserts that “pointers pointing” would be redundant (Prelim. Sur-reply 3), we disagree. In addition to being different parts of speech, i.e., a pointer is a noun and pointing is a verb defining what the noun is doing, the claim does not merely recite “relational references pointing.” Rather, Petitioner’s proposed construction outlines what the “relational references” include, i.e., “pointers,” and claim 1 further limits what the “relational references” are “pointing to,” i.e., “to a plurality of sent submessages.” Prelim. Resp. 9. Further, the Specification supports adopting Petitioner’s construction over Patent Owner’s. The Specification does not state that “relational references” require the use of, or are, a relational model, as Patent Owner argues. Rather, any discussion of “relational references” in the Specification describes them as message components that refer to content or other data, e.g., a pointer. Ex. 1001, 3:6–16 (“a message is a container having relational references to content and/or audit data”); see id. at 1:67–2:2, 4:61–64, slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“We agree with Petitioner that the ordinarily skilled artisan would have been motivated to combine Rohall and Schiavone because Schiavone provides reasons to apply its techniques to email systems such as Rohall’s. Schiavone describes a need for “ensuring compliance of e-mail messages with applicable standards and/or laws and/or otherwise determining appropriateness of a message for an intended recipient,” especially because there is “a patchwork of local, federal and international laws.” Ex. 1006 ¶ 6. Schiavone also states that filtering emails, e.g., to remove spam, is beneficial. Id. ¶¶ 1–2. As Schiavone describes problems in email systems, adequately shows that the ordinarily skilled artisan would have been motivated to combine Rohall and Schiavone. See KSR, 550 U.S. 401 (a reference which teaches, suggests, or motivates its combination may “identify a reason that would have prompted a person of ordinary skill in the art to combine the elements”).” slip op. at 17
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 8,073,911 - 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 - 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 - PTAB · Aug 29, 2025 · IPR2025-00479 · APJ Justin T Arbes · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–20 were obvious over Erskine, Scherzer, or Scherzer and Gillett.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“III. CONCLUSION Based on the arguments and evidence presented by the parties, we conclude that Petitioner has not demonstrated a reasonable likelihood of prevailing with respect to at least one claim of the ’634 patent challenged in the Petition. Therefore, we do not institute an inter partes review. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied and no inter partes review is instituted.” slip op. at 25
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner argues that at the time of the ’634 patent (July 2018), a person of ordinary skill in the art would have had “a bachelor’s degree in electrical engineering, computer science, computer engineering, or a similar major with at least two years of experience in the field; or a master’s degree with specialization in the field,” where “[a] person with less education but more relevant practical experience may also meet this standard.” Pet. 7 (citing Ex. 1003 ¶¶ 12–13). Petitioner further argues that a person of ordinary skill in the art would have had knowledge of “[d]esigning and using systems that include endpoint devices (e.g., client devices) and servers for establishing network connections and data transfer,” “[r]ecognizing and applying the client-server architecture,” and “[u]sing and applying concepts from known telecommunication and networking frameworks, protocols and standards, including TCP/IP, IEEE 802.11, VoIP, cellular systems and other known frameworks and standards.” Id. (citing Ex. 1003 ¶ 14). Patent Owner does not address the level of ordinary skill in the art in its Preliminary Response. Based on the record presented, including our review of the ’634 patent and the types of problems and solutions described in the ’634 patent and cited prior art, we agree with Petitioner’s definition and apply it for purposes of this Decision. See, e.g., Ex. 1001, col. 1, ll. 4–29 (describing in the “Background” section of the ’634 patent a “network connection between two endpoints” and known methods of reaching “full effective bandwidth capacity” in a network).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Interpretation We interpret each challenged claim using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b), including construing the claim in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. 37 C.F.R. § 42.100(b). Petitioner notes that it proposed a construction for the claim term “geographical area” in the district court case, but states that it “do[es] not believe proposing a construction for the term is necessary in this proceeding because the relied upon teachings of the prior art references are consistent with examples of ‘geographical area’ included in the ’634 patent [S]pecification.” Pet. 8. Patent Owner argues that “[t]he Board need not engage in express claim construction at this stage of the proceeding.” Prelim. Resp. 5. We conclude that no express interpretation of any claim term is necessary to determine whether to institute an inter partes review in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe [a particular claim limitation] where the construction is not ‘material to the . . . dispute.’” (citation omitted) (emphasis added)).” slip op. at 9
- BurdenNot shown unpatentable
“Petitioner has not shown sufficiently that Erskine teaches or suggests the second requirement of limitation [1c], i.e., “initiating the next network connection . . . with a transmission bandwidth based on the parameter values for the past network connection.” Petitioner’s theory is that (1) the QoS parameters in Erskine are for a “past” connection from one zone to another, (2) the sliding maximum interzone bandwidth is “based on” the QoS parameters, and (3) a new call only proceeds if the transmission bandwidth needed for the call added to the current bandwidth being used over the interzone link is less than the sliding maximum interzone bandwidth, so Erskine therefore teaches a call with a transmission bandwidth determined “based on” the sliding maximum interzone bandwidth (which in turn is determined “based on” the QoS parameters). See Pet. 27–28; Ex. 1003 ¶¶ 59–60 (similar testimony from Dr. Crovella). As Patent Owner points out, however, Erskine only makes “a binary, accept/reject decision as to whether to allow a new call to proceed based on a comparison between the bandwidth needed for the call and a predetermined ‘sliding maximum interzone bandwidth value.’” See Prelim. Resp. 6–7. Specifically, the additional bandwidth that would be needed for the call is added to the current bandwidth being used on the interzone link; if the sum of those values is less than the sliding maximum interzone bandwidth for the link, the call “proceeds”; otherwise, it is “blocked.” Ex. 1004, col. 4, ll. 36–40, col. 6, l. 55–col. 7, l. 10, col. 8, ll. 36–43, col. 9, ll. 9–26, col. 10, ll. 23–25 (the sum is compared to the sliding maximum interzone bandwidth “to determine whether enough bandwidth is available to proceed with the new call”), Fig. 3 (steps 308, 310, and 312). Erskine repeatedly refers to the bandwidth for the new call as the amount of bandwidth that is “necessary” or “required” to handle the call. See, e.g., id. at col. 1, ll. 43–57 (“an amount of bandwidth necessary to handle the new call”), col. 6, ll. 61–64 (“the additional bandwidth required (of the new call)”), col. 8, ll. 36–40 (“the bandwidth necessary for the new call”), col. 9, ll. 16–21 (“the anticipated additional bandwidth necessary for the new call”), 54–56 (“the bandwidth amount the new call will utilize (if connected)”), col. 10, ll. 21–23 (same), 41–43 (same), col. 12, ll. 1–2 (“an amount of bandwidth necessary to handle the new call”). It is that value—determined prior to the addition and comparison to the sliding maximum interzone bandwidth—that will be used for the new call if it is allowed to “proceed[].” Id. at col. 6, ll. 64–67 (if the sum is less than the sliding maximum interzone bandwidth, the call “proceeds” and “the QoS table is updated with the additional bandwidth used by that call”). Erskine does not describe the transmission bandwidth for the new call as being based on any parameter values for a past network connection, but rather as “whatever bandwidth the system determined is necessary for the additional call.” See Prelim. Resp. 8–9. In other words, the transmission bandwidth needed for a new call is predetermined and independent of whatever the sliding maximum interzone bandwidth is currently. See id.” slip op. at 15
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,944,634 - Aylo Freesites Ltd v. Wellcomemat, LLCAll claims unpatentablePTAB · Aug 26, 2025 · IPR2024-00710 · APJ Brian P Murphy · IPR · Final written decision
Claims 13–15 and 17–20 are unpatentable: claims 13–15 and 20 as anticipated by Fegan, claim 17 as obvious over Fegan and Sull, and claims 13–14 and 17–20 as obvious over Vasilevsky and Logan.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“afforded experts in forming opinions in reliance on hypotheticals and “presentation of data to the expert outside of court and other than by his own perception,” i.e., hearsay. Id. (Adv. Comm. Notes). And where a court acts as fact finder, rather than a jury, the danger of unfair prejudice to the objecting party is substantially diminished. See Science Applications Int’l Corp. v. United States, 175 Fed. Cl. 389, 395 (2025) (“bench trials limit the ‘concern for juror confusion or potential prejudice’”) (citations omitted). The Board, sitting as a non-jury tribunal with administrative expertise, is well-positioned to determine and assign appropriate weight to evidence presented, as we have done in the present case. See Gnosis S.p.A. v. S. Alabama Med. Sci. Found., Case IPR2013-00118, slip op. at 43 (PTAB June 20, 2014) (Paper 64); see also Donnelly, 123 F.2d at 224 (“One who is capable of ruling accurately upon the admissibility of evidence is equally capable of sifting it accurately after it has been received.”). In rendering our Decision, we have assigned appropriate weight to Exhibit 2022 in view of the entire record before us. For the reasons given above, we deny Petitioner’s motion to exclude Exhibit 2022.” slip op. at 78
Patent outcomesUS 8,307,286 unpatentableNonecites KSRPatents in suitUS 8,307,286 - 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 - PTAB · Aug 13, 2025 · IPR2025-00430 · APJ Bach V Hoang · IPR · Institution
The Board instituted IPR on claims 1–3, 5–9, 13–15, 18, 19, and 22 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over Rose.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“j) Conclusion as to Claim 1 For the reasons discussed above, and based on Petitioner’s contentions and evidence, summarized above, we are persuaded, on this record, that Petitioner shows a reasonable likelihood of prevailing in demonstrating that claim 1 would have been obvious over Rose. 3. Institution of Inter Partes Review Because we are persuaded that Petitioner has shown a reasonable likelihood of prevailing in demonstrating that the subject matter of claim 1 would have been obvious over Rose, we institute an inter partes review of all claims and all challenges raised in the Petition. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 365 (2018) (stating 35 U.S.C. § 314 “simply requires [the Director] to decide whether the petitioner is likely to succeed on ‘at least 1’ claim. Once that single claim threshold is satisfied, it doesn’t matter whether the petitioner is likely to prevail on any additional claims; the Director need not even consider any other claim before instituting review”); 37 C.F.R. § 42.108(a).” slip op. at 26
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s description is more restrictive than that of Petitioner because it requires the POSITA to have more experience or education in the relevant field. Based on the current record and for the purposes of this Decision, we adopt Petitioner’s proposed level of skill. Petitioner’s proposed definition generally comports with the level of skill necessary to understand and implement the teachings of the ’271 Patent and the asserted prior art. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the prior art itself may reflect an appropriate level of skill in the art). Although we adopt Petitioner’s definition of a person of ordinary skill in the art, our determination regarding Petitioner’s challenge does not turn on the differences between Petitioner’s and Patent Owner’s definitions, and our conclusions would be the same under either definition.” slip op. at 8
- Expert testimonyPatent owner expert creditedDecided for patent owner
“Furthermore, the computer program module limitations are undisputedly coupled with respectively recited functions. See Pet. 11–16 (identifying corresponding functions for each recited module). Dr. Kahn testifies that the POSITA would understand the recited functions can be performed by existing or off-the-shelf systems and that the functions recited explain how to engineer, build, or implement the modules using known and available techniques. Ex. 2001 ¶¶ 25–35. For institution purposes, we credit Dr. Khan’s testimony and determine that a POSITA would have understood the module limitations connote structure. See Dyfan, LLC v. Target Corp., 28 F.4th 1360, 1369 (Fed. Cir. 2022) (“[B]ecause the recited functions can be performed by conventional off-the-shelf software, a person of ordinary skill in the art would have understood the alleged means-plus-function ‘code’ limitations in the asserted claims to connote structure.”) (citing Zeroclick, LLC v. Apple Inc., 891 F.3d 1003, 1008 (Fed. Cir. 2018)); WSOU Invs. LLC v. Google LLC, No. 2022-1063, 2023 WL 6889033, at *5 (Fed. Cir. Oct. 19, 2023) (“‘[C]omputer program code,’ when combined with a description of what the code is intended to accomplish, convey definite structure to the ordinarily skilled artisan.”). Accordingly, for institution purposes, we conclude that the computer program module limitations recited in claims 1 and 6 are not written in means-plus-function format because they would have connoted sufficiently definite structure to persons of ordinary skill in the art.” slip op. at 11
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) does not applyDecided for patent owner
“Id. 48:19–51. That language suggests that the module limitations are software instructions or code because the modules are defined as “computer program modules” or “computer program instructions.” Id. at 47:32, 48:20– 21. Moreover, the claims recite that the modules are stored in a computerreadable storage medium and are instructions to be executed by a processor, further suggesting the modules are software instructions or code. Id. at 47:30–32, 48:16–21. The testimony of Dr. Kahn, which we credit for institution purposes, supports that understanding; Dr. Kahn states a POSITA would understand that “‘computer program modules’ stored on a ‘computerreadable storage medium’ refers to software instructions or code.” Ex. 2001 ¶ 24. Furthermore, the computer program module limitations are undisputedly coupled with respectively recited functions. See Pet. 11–16 (identifying corresponding functions for each recited module). Dr. Kahn testifies that the POSITA would understand the recited functions can be performed by existing or off-the-shelf systems and that the functions recited explain how to engineer, build, or implement the modules using known and available techniques. Ex. 2001 ¶¶ 25–35. For institution purposes, we credit Dr. Khan’s testimony and determine that a POSITA would have understood the module limitations connote structure. See Dyfan, LLC v. Target Corp., 28 F.4th 1360, 1369 (Fed. Cir. 2022) (“[B]ecause the recited functions can be performed by conventional off-the-shelf software, a person of ordinary skill in the art would have understood the alleged means-plus-function ‘code’ limitations in the asserted claims to connote structure.”) (citing Zeroclick, LLC v. Apple Inc., 891 F.3d 1003, 1008 (Fed. Cir. 2018)); WSOU Invs. LLC v. Google LLC, No. 2022-1063, 2023 WL 6889033, at *5 (Fed. Cir. Oct. 19, 2023) (“‘[C]omputer program code,’ when combined with a description of what the code is intended to accomplish, convey definite structure to the ordinarily skilled artisan.”). Accordingly, for institution purposes, we conclude that the computer program module limitations recited in claims 1 and 6 are not written in means-plus-function format because they would have connoted sufficiently definite structure to persons of ordinary skill in the art.” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 7,716,217 - Ceva Santé Animale S.A. / Egg-Chick Automated Technologies S.A.S et al. v. Targan, Inc.Some claims unpatentablePTAB · Jul 24, 2025 · IPR2024-00595 · APJ Brian P Murphy · IPR · Final written decision
Claims 1–15 are unpatentable as obvious over the asserted §103 grounds; Petitioner did not show claims 16–18 unpatentable because the angled-conveyor combination lacked a supported rationale.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). “These factors are not exhaustive but are 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). There is uncontested evidence in the record before us, including the ’124 patent, the Gershman, Pierre, Yavnai, Tao, and Goodwin references, and the background and qualifications of both sides expert witnesses that reflect the knowledge and experience of a POSITA, including knowledge of systems for assessing and transporting poultry in an industrial setting. Patent Owner’s proposed skill level overlaps with Petitioner’s proposed skill level, and any differences would not alter the outcome of this proceeding. Therefore, we adopt Patent Owner’s proposed skill level with two modifications. A POSITA also could have a Bachelor of Science degree in Animal Science or similar discipline, and a POSITA would be familiar with techniques for assessing and transporting poultry in an industrial setting, such as visual and/or anatomical characteristics of a chick.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther
“Therefore, we find that Applicant distinguished Tao from “an unrestrained chick” because in Tao’s automated system a chick is restrained—the chick is held in place—by a retainer unit on a moving platform, whereas in Applicant’s claimed system a chick is not held in place on a moving platform. We further conclude that Applicant’s reason for distinguishing the claimed invention over Tao informs the claim construction even if the “prosecution history statements do not rise to the level of unmistakable disavowal . . . .” Personalized Media, 952 F.3d at 1345 (Fed. Cir. 2020). In view of the ’124 patent claims, specification, and prosecution history, we determine “an unrestrained chick” is a chick not held in place on the moving platform and free to open its wings.” slip op. at 19
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed
“For the reasons given below, we find the Petition has established that Gershman discloses and teaches “a moving platform to support an unrestrained chick of a particular breed” by a preponderance of the evidence.” slip op. at 29
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“to determine a characteristic [of the chick] . . . [that] manifests in one of two or more possible states, e.g., sex (male vs. female), health (healthy vs. unhealthy), genetic mutation (present vs. not present).” Reply 13 (citing Ex. 1004, 3). The recitation of a generic “database of images” does not distinguish limitation [1.4] from the asserted combination of Gershman-Pierre, particularly in view of Pierre’s disclosure of “a computerized processing process is implemented in order to compare the captured images to reference images,” as asserted in the Petition. Ex. 1004, 3 (emphasis added); see Pet. 23–24 (citing Ex. 1003, 2–5; Ex. 1004, 3, 5). Thus, we find that storage of Pierre’s reference images of male and female wing feathers in a database used for comparison in Gershman’s computerized digital chick image processing system would have been obvious to a POSITA and satisfies limitation [1.4].19 We agree with Petitioner that it would have been obvious and well within the skill level of a POSITA—someone with a Bachelor of Science degree in agricultural, industrial, or electrical engineering and two years of experience in industrial poultry sexing and/or image processing (Resp. 20)—to store reference images as taught by Pierre in a “computerized processing” database. The rationale argued by Petitioner, to organize the collection of reference images for comparison to determine whether the characteristic of interest was present, finds direct support in Gershman and Pierre. Both references disclose comparing digital images of a chick’s wing feathers to reference data (Gershman) or reference images (Pierre) of male and female chick wing patterns. Pet. 23–24; Reply 12–13. Storing digital reference images in a database for comparison to captured digital images is, moreover, a basic and straightforward task in any computerized image processing” slip op. at 44
Patent outcomesUS 10,806,124 mixedClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,806,124 - Neurent Medical Inc. / Neurent Medical Ltd. v. The Foundry, LLCAll claims unpatentablePTAB · Jul 21, 2025 · IPR2024-00669 · APJ Timothy G Majors · IPR · Final written decision
Claims 1–8 and 11 are unpatentable as obvious over Makower, Fang, and Edwards, with claim 4 also obvious over those references and Stern; the Board did not reach Grounds 1–4.
RulingsFinal written decision- Skill levelSkill level board ownOther
“Based on the record before us, including the types of problems and solutions described in the ’077 patent and the cited prior art, we find a POSA would have had (1) a Doctor of Medicine (M.D.) or at least a bachelor of science degree in biomedical engineering or a related discipline, (2) at least three years of experience in the clinical use, design, development, and/or testing of medical devices that deliver energy to tissue, and 3) knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. Less work experience may be compensated by a higher level of education, and vice versa. 11 Patent Owner suggests a POSA’s ability to “learn about” the nasal anatomy invokes the wrong standard because a POSA “must have the necessary background at the time of the invention.” PO Sur-reply 27. We agree in part with Patent Owner; the hypothetical POSA is presumed to possess the requisite skill at the time of the invention. Nevertheless, as it concerns an engineer with extensive experience designing and developing RF ablation devices (like Dr. Martin), we see no basis to conclude that such person may not become familiar with the features of the nose through review of the literature and/or consultation with clinicians. Ex. 1098 ¶ 44 (testifying a person with device design experience could learn about the relevant nasal anatomy and apply their skill to problems or solutions for that area by reviewing the relevant literature). Moreover, that Dr. Martin may not have had personal experience designing devices for the nose prior to 2006 does not mean that he cannot testify from a POSA’s perspective. Osseo Imaging, LLC v. Planmeca USA, Inc., 116 F.4th 1335, 1341 (Fed. Cir. 2024) (“An expert need not have acquired the skill level prior to the time of the invention to be able to testify from the vantage point of a person of ordinary skill in the art” because “an expert can acquire the necessary skill level later and develop an understanding of what a [POSA] knew at the time of the invention”) (emphasis omitted). Petitioner that the ’077 patent discloses delivering neurotoxins to any target, and not just the nose, the claims of the ’077 patent are directed to methods of treating a nasal condition by delivering energy to the nasal cavity. Pet. Reply 32. Thus, to fill a gap between Petitioner’s POSA definition and the scope of the challenged claims, we add to Petitioner’s definition the requirement for knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. We additionally add that a POSA’s educational background may include a bachelor of science degree in biomedical engineering or related discipline to reflect the nature of the field of invention. Nonetheless, we also note that our analysis and conclusions herein would not change even under Petitioner’s proposed skill level for a POSA. We do not agree with Patent Owner that prior experience designing or developing nasal medical devices is required for a POSA. PO Resp. 19–20. A definition inclusive of the clinical use, design, development, and/or testing of nasal medical devices that deliver energy to tissue is consistent with the skill level reflected in the disclosures of the ’077 patent and prior art. Consequently, we disagree with Patent Owner that Dr. Bu-Saba fails to qualify as a POSA because he lacks experience specific to designing medical devices. PO Resp. 19 n.4. We also disagree that Dr. Martin’s testimony should be discounted for a lack of first-hand experience designing RF ablation devices specific for the nose (which experience Patent Owner’s engineer expert also lacks). Id. As Dr. Martin’s testimony concerns certain issues in dispute (i.e., use of bipolar electrodes), we find Dr. Martin is qualified and his testimony helpful in resolving those disputes. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010) (explaining And, even if there may be gaps in Dr. Martin’s experience or knowledge about the nasal anatomy, such gaps are filled by Dr. Bu-Saba’s extensive clinical expertise and testimony of record. Accordingly, we do not agree with Patent Owner that we should discount the testimony of Dr. Bu-Saba or Dr. Martin; we give their testimony appropriate weight in reaching our conclusions here.” slip op. at 15
- Expert testimonyPetitioner expert creditedOther
“We do not agree with Patent Owner that prior experience designing or developing nasal medical devices is required for a POSA. PO Resp. 19–20. A definition inclusive of the clinical use, design, development, and/or testing of nasal medical devices that deliver energy to tissue is consistent with the skill level reflected in the disclosures of the ’077 patent and prior art. Consequently, we disagree with Patent Owner that Dr. Bu-Saba fails to qualify as a POSA because he lacks experience specific to designing medical devices. PO Resp. 19 n.4. We also disagree that Dr. Martin’s testimony should be discounted for a lack of first-hand experience designing RF ablation devices specific for the nose (which experience Patent Owner’s engineer expert also lacks). Id. As Dr. Martin’s testimony concerns certain issues in dispute (i.e., use of bipolar electrodes), we find Dr. Martin is qualified and his testimony helpful in resolving those disputes. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010) (explaining And, even if there may be gaps in Dr. Martin’s experience or knowledge about the nasal anatomy, such gaps are filled by Dr. Bu-Saba’s extensive clinical expertise and testimony of record. Accordingly, we do not agree with Patent Owner that we should discount the testimony of Dr. Bu-Saba or Dr. Martin; we give their testimony appropriate weight in reaching our conclusions here.” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“construction standard used to construe claims in a civil action before the courts under 35 U.S.C. § 282(b), including construing claims’ language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms that are in controversy and only to the extent needed to resolve the dispute. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019); U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997) (holding claim construction is for “resolution of disputed meanings”). Petitioner contends that, “[f]or purposes of this IPR, the Board need not construe any terms.” Pet. 18. Patent Owner responds that “the Board need not construe any terms to determine Petitioners have failed to carry their burden in this proceeding.” PO Resp. 20. On the record before us, we conclude that the claims need not be expressly construed to resolve the dispute before us. Insofar as the parties dispute the mapping of the prior art to dependent claims 4 and 7, we address that dispute below including, to the extent necessary, any implicit disagreement about the subject matter encompassed by those claims.” slip op. at 17
- BurdenFwd all claims unpatentableUnpatentable
“For all the reasons above, we determine that the evidence supports Petitioner’s contention that a POSA would have reasonably expected success in combining the prior art to arrive at the subject matter of claim 1.” slip op. at 44
Patent outcomesUS 11,679,077 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,679,077
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.