- 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 - Neurent Medical Inc. / Neurent Medical Ltd. v. The Foundry, LLCAll claims unpatentablePTAB · Jul 21, 2025 · IPR2024-00280 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1, 2, 5, 8–10, 12, and 14 are unpatentable as obvious over Makower, Fang, and Edwards; the Board did not reach Grounds 1–3.
RulingsFinal written decision- Skill levelSkill level board ownOther
“Based on the record before us, including the types of problems and solutions described in the ’011 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.” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
“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 ’011 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. Accordingly, we do not agree with Patent Owner that we should discount the testimony of Dr. Bu-Saba and we give Dr. Bu-Saba’s testimony appropriate weight in reaching our conclusions here.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“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 claim 9, we address that dispute below including, to the extent necessary, any implicit disagreement about the subject matter encompassed by claim 9.” slip op. at 14
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Petitioner contends that Makower and Fang7 are analogous art to the challenged claims. Pet. 77 (arguing Makower and Fang “are in the same field” and are “reasonably pertinent” to solving problems addressed by the claimed invention); Ex. 1002 ¶ 178. According to Petitioner, Makower and 7 Petitioner argues a POSA had reasons for combining Edwards with Makower and Fang with a reasonable expectation of success (see, e.g., Pet. 74–76, 81–85). We find persuasive Petitioner’s reasoning and evidence on the addition of Edwards, and Patent Owner provides no rebuttal about Edwards. energy to tissue and “each uses RF energy to treat tissue.” Pet. 77 (citing, e.g., Ex. 1005 ¶¶ 1, 43, 132, 164, 187; Ex. 1006, 876–877).” slip op. at 25
Patent outcomesUS 10,894,011 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,894,011 - Neurent Medical Inc. / Neurent Medical Ltd. v. The Foundry, LLCAll claims unpatentablePTAB · Jul 21, 2025 · IPR2024-00279 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–3, 7, 9, 10, and 17–25 are unpatentable as obvious over Makower and Fang; the Board did not reach the other grounds.
RulingsFinal written decision- Skill levelSkill level board ownPetitioner expert creditedDecided for petitioner
“Based on the record before us, including the types of problems and solutions described in the ’675 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 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. In reaching our finding, we note that, although we agree with Petitioner that the ’675 patent discloses delivering neurotoxins to any target, and not just the nose, the claims of the ’675 patent are directed to methods of treating a nasal condition by delivering energy to the nasal cavity. Pet. Reply 30. 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. 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 ’675 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. Accordingly, we do not agree with Patent Owner” slip op. at 12
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Second, we credit the testimony of the experts that, on balance, further confirms that skilled clinicians knew how to manage and remove fluids to the extent necessary. Dr. Bu-Saba testifies that typical steps for RF ablation procedures (even before 2006) included positioning the patient in a seated or slightly reclined position to facilitate the flow of any mucus or fluids away from the nasal cavity, application of topical decongestants, and “[i]n some circumstances,” if mucus or blood was still in the treatment area, “a 11 Nor does Patent Owner identify any disclosure in any other technical literature (either before or after 2006) expressing concerns that electrolytic fluids at the operative site could not be managed and/or would prevent targeted application of RF ablation energy to tissues at that site. See, e.g., Ex. 2003 ¶¶ 91–97 (testifying about the hypothetical “fluid” problem, but identifying no independent recognition of such a problem in any corroborating reference); Ex. 2005 ¶¶ 66–76 (same). visualization of the surgical site.” Ex. 1098 ¶¶ 81–89; Pet. Reply 14–15. Patent Owner’s expert, Dr. Levine, concurs that skilled clinicians knew how to remove mucus and other fluids, testifying that “[i]f [mucus] was obstructing my view” and “[i]f it was this thick . . . I might have to mechanically remove it with forceps, I might have to suction it, I might have to irrigate the nose with a saline solution to wash out the nose.” Ex. 1089 (Levine Tr.), 83:3–84:6 (admitting residual saline could either be swallowed or suctioned out); see also id. at 86:1–16 (testifying a patient may be positioned such that by “[v]irtue of gravity . . . fluid would fall to the bottom”).” slip op. at 33
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“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 claim 22, we address that dispute below including, to the extent necessary, any implicit disagreement about the subject matter encompassed by claim 22.” slip op. at 14
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
Patent outcomesUS 10,610,675 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,610,675 - PTAB · Jul 16, 2025 · PGR2025-00012 · APJ Debra L Dennett · PGR · Institution
Instituted PGR on claims 1–3 based on five grounds; the Board found each ground met the institution threshold on the preliminary record.
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). A post-grant review may also be instituted when “the petition raises a novel or unsettled legal question that is important to other patents or patent applications.” See id. § 324(b). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, and the evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 of the ’201 patent.” slip op. at 2
- Skill levelSkill level board ownOther
“At this stage of the proceedings, neither Petitioner’s nor Patent Owner’s proffered definitions of the level of skill appear appropriate. Petitioner’s proposal requires as little as a bachelor’s degree in organic chemistry and two years of experience as a laboratory technician working on development of molecules with targeted biological activity, and an ambiguous “understanding” of certain processes. Patent Owner’s proposal, other the other hand, requires multiple years of both formal training and actual, practical experience in highly specialized fields that involve detection of optical or radiolabeled compounds and use of molecular imaging techniques such as PET and SPECT. For the purposes of this decision, on the record at this time, we find that a POSA would have had a Ph.D. in chemistry, biochemistry, or a comparable field or an M.D., and at least four years of experience in chemical synthesis of compounds that may be used to target biologically-significant tissues. This definition appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). The parties will have the opportunity to cross-examine Dr. Martin and Dr. VanBrocklin in this proceeding to develop a full record for us to determine the weight that each expert’s testimony should be given. We invite the parties to further brief the definition of a POSA here, and whether we should discount either experts’ testimony due to lack of qualifications.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other
“c) Analysis On the present record, we find that “low molecular weight” is not limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration all concerns metabolomics and metabolites, and we find no reason that even a vague definition of metabolites applies to the claimed compounds. See Ex. 1002, ¶ 102. Moreover, the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’201 patent fall outside of Patent Owner’s proposed definition is persuasive (see id., ¶ 103), as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts’” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically form about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) The Pomper reference (Ex. 1006) also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 2002, ¶ 60; Ex. 1006, ¶ 12. The table giving the molecular weight of a “selection of compounds disclosed by Pomper” (see Ex. 2002, ¶ 62) is not persuasive in defining “low molecular weight,” as it does not explain how those included were “selected” and does not include molecular weights for all of the examples.7 In addition, Patent Owner’s definition does not appear to apply to all claimed compounds.8 7 At least one of the examples (SRV73) not included in the table appears to have a molecular weight well over “about 1,500 Daltons.” 8 See, e.g., claim 113 of Ex. 1006. Patent Owner’s arguments distinguishing “low molecular weight” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“The ’201 patent defines “alkyl” as “a straight (i.e., unbranched) or branched chain, acyclic or cyclic hydrocarbon group, or combination thereof” “ that has “the number of carbon atoms designated (i.e., C1–C10 means one to ten carbons, including 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 carbons)” and “[i]n particular embodiments, the term ‘alkyl’ refers to C1-20 inclusive, including 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20 carbons” “unless otherwise stated.” Ex. 1001, 39:44–58. Although substituents at the R1x position in the claims are limited to “C1-6alkyl,” those at position R3x are not. Ex. 1001, Certif. Corr. Patent Owner’s representation that “Jansen I provides ‘the following definitions’ stating that ‘alkyls groups of this invention comprise from 1 to 6 carbon atoms’” is inaccurate. See Prelim. Resp. 19. In fact, Jansen I states: The term “alkyl” by itself or as part of another substituent refers to a fully saturated hydrocarbon of Formula CxH2x+1 wherein x is a number greater than or equal to 1. Generally, alkyl groups of this invention comprise from 1 to 6 carbon atoms. Alkyl groups may be linear or branched and may be substituted as indicated herein. When a subscript is used herein following a carbon atom, the subscript refers to the number of carbon atoms that the named group may contain. Ex. 1007, 22:16–23 (emphasis added). Neither the ’201 patent nor its incorporation by reference of Jansen I would have conveyed to a POSA that the “(CO)alkyl” of the substituent in the R3x position in the claims is intended to comprise from one to six carbon atoms or is limited to any particular length and size. “(C(O)alkyl,” having no number of carbon atoms designated, means” slip op. at 15
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 11,938,201 - PTAB · Jul 11, 2025 · PGR2025-00009 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1, 2, 6–14, and 16–29, finding the written-description and enablement challenges met the institution threshold; the obviousness challenge did not.
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, 6–14, and 16–29 of the ’035 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 ’035 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.” 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).” slip op. at 15
- 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 ’035 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, on the current record, we find that Petitioner has demonstrated that it is more likely than not that the ’035 patent does not comply with the written description requirement. Similarly, the current record does not appear to provide evidence of possession of the full scope of the claims of the ’035 patent in the ’731 application or any of the subsequent divisional or continuation applications leading to the ’035 patent that claim priority to the ’731 application (which appear to all have similar specifications) for the reasons given above.10 Therefore, the ’035 patent might not receive the benefit of priority to the earlier filed applications, and based on this preliminary determination, is eligible for post-grant review” slip op. at 30
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,123,035 - Trove Brands, LLC v. Camelbak Products, LLCInstitution deniedPTAB · Jul 8, 2025 · IPR2025-00155 · APJ James A Worth · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 3–9, 11–17, or 19 were unpatentable on the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 311 and any response filed under [35 U.S.C. §] 313 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) (2018).1 For the reasons set forth below, we determine that Petitioner has not demonstrated that there is a reasonable likelihood that at least one of claims 1, 3–9, 11–17, and 19 of the ’187 patent is unpatentable based on the grounds set forth in the Petition, and we do not institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art (“POSITA”) would have had an undergraduate degree in mechanical engineering or equivalent coursework, and a year or more of experience in designing, prototyping, and/or manufacturing fluid containers or similar products. Pet. 19 (citing Ex. 1003 ¶ 29). Petitioner asserts that more work experience may substitute for a lower level of education, and vice versa. Id. Patent Owner admittedly sets forth “a similar, though slightly different, level of ordinary skill”: a bachelor’s degree in mechanical engineering or the equivalent coursework and approximately one year of experience with liquid-containing devices, with more work experience substituting for less education and vice versa. Prelim. Resp. 27 (citing Ex.2001 ¶¶ 60–64). Patent Owner discerns no material difference between the definitions provided by the parties for purposes of the Board’s decision on whether to institute this proceeding. Id. For purposes of this decision, we adopt Petitioner’s proposed level of skill as being consistent with the prior art, although our conclusion on whether to institute would be unchanged under either definition.” slip op. at 10
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner
“The failure to use the word “means” in a claim element creates a rebuttable presumption that § 112 ¶ 6 does not apply. Williamson v. Citrix Online, 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc). The presumption can be overcome and § 112 ¶ 6 will apply if the challenger demonstrates that the claim term fails to “recite[ ] sufficiently definite structure” or else recites “function without reciting sufficient structure for performing that function. “Construing a means-plus-function claim term is a two-step process.” Id. at 1351. “The [tribunal] must first identify the claimed function.” Id. “Then, the [tribunal] must determine what structure, if any, disclosed in the specification corresponds to the claimed function.” Id. There may be multiple claimed functions, each with disclosed corresponding structure. See id. at 1351–52.” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We are persuaded by Patent Owner that the term “automatically” in “to automatically disengage the first and second catch structures” means that it is not just the force applied by the user that disengages the first and second catch structures, but also the bias of the mouthpiece that helps to disengage the first and second catch structures. In the first instance, we agree with Patent Owner that the claim itself recites that, upon actuation, the mouthpiece assembly is “release[d]” to “move via its bias from the stowed configuration to the dispensing configuration.” See Ex. 1001, 21:59–64. This meaning is supported by the Specification which states: “In some examples, the mouthpiece assembly is biased toward the dispensing configuration and thus moves automatically under its bias upon release by the user-release mechanism.” Ex. 1001, 1:64–67. We further agree with Patent Owner that the plain and ordinary meaning of “automatic” is that the user operation alone is not responsible for the action. For example, in one dictionary cited by Petitioner, “automatic” is defined as “2: having a self-acting or self-regulating mechanism.” See Ex. 2007, 1.11 The district court construction is consistent therewith. The district court identified two functions, the first of which is the same as that of the ’028 patent, i.e., “Automatically disengaging the first and second catch structures upon actuation of the user release mechanism and thereby releasing the mouthpiece assembly to move via its bias from the stowed configuration to the dispensing configuration.” See Section II.C.1, supra. In discussing that function, the district court states: “While a user may impart force upon user engagement portion 260 to release the mouthpiece, the bias of the mouthpiece towards the dispensing configuration causes the mouthpiece to move automatically, satisfying the requirements of Claim 1.” Ex. 2002, 16. We conclude that the term “automatically” in “adapted to” slip op. at 17
Claim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,684,187 - Gene Company Pty Ltd v. The Trustees Of Columbia University In The City Of New YorkNo claims unpatentablePTAB · Jun 23, 2025 · IPR2024-00313 · APJ Tawen Chang · IPR · Final written decision
Claims 1–54 were not shown unpatentable because Petitioner failed to establish a reasonable expectation of success for the proposed combinations; objective indicia also supported non-obviousness.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“As to the first issue, we agree with Patent Owner that defining the level of skill in view of the solution described in the patent risks improper hindsight. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) 18 (“[T]he level of skill in the art is a . . . lens through which . . . the Board views the prior art and the claimed invention,” which “prevents . . . factfinders from using their own insight or . . . hindsight[] to gauge obviousness.”). We therefore do not include “practical knowledge about . . . the deuterium isotope effect, including the patents and publications discussed [in the Petition],” as part of our definition of a person of ordinary skill in the art.” slip op. at 18
- Expert testimonyPetitioner expert creditedMixed
“person of ordinary skill in the art would employ” in an obviousness analysis, we give some weight to Dr. Guengerich’s testimony. KSR, 550 U.S. at 418; Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 (Fed. Cir. 2013) (explaining that “motivation to combine may be found. . . in . . . the background knowledge, creativity, and common sense of the person of ordinary skill”). Nevertheless, even if we were to agree that an ordinarily skilled artisan would have seen the 1,5-shift in NRPE in Mata’s A2E biosynthetic pathway as a particularly desirable location for intervention, we are not persuaded that such a person would have been motivated to substitute C20 deuterated vitamin A for the vitamin A in Ortho Pharma’s composition and method, because Petitioner has not shown, by a preponderance of evidence, that such an artisan would have reasonably expected the substitution to retard the accumulation of A2E or to treat macular degeneration.” slip op. at 42
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In our Institution Decision, we preliminarily construed the preamble of claim 28 as limiting. Inst. Dec. 30–31. Petitioner did not take issue with our construction, or dispute Patent Owner’s construction of the preambles of claims 1 and 29 as also limiting. After consideration of the full trial record, we maintain our construction of the preamble of claim 28 as limiting for the reasons set forth in our Institution Decision. For similar reasons and the reasons set forth in Patent Owner’s Response, we further construe the preambles of claims 1 and 29 as limiting. See PO Resp. 12–14. We further determine that we do not need to construe any other claim term in order to resolve the controversy between the parties. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 26
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art, at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.” slip op. at 25
Patent outcomesUS RE47,045 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · Graham - PTAB · Jun 11, 2025 · PGR2025-00004 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1–4, 7–19, and 22; it found written-description and enablement challenges likely to succeed, but the obviousness ground insufficient.
RulingsInstitution decision- 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 ’298 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. 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. Patent Owner will have the chance to cross-examine Dr. Hecht and Dr. Park in this proceeding to develop a full record for us to determine the weight that each expert’s testimony should be given. Patent Owner will have further opportunity on a full record to assert that we should discount either experts’ testimony due to lack of appropriate qualifications. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“posttranslational modifications and those that do not contain chemical or posttranslational modifications.” Id. at 44:59–62. The ’298 patent provides an express definition of the term “modified PH20 polypeptide” which refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:15–30 (emphasis added).” slip op. at 14
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Under the second step of the Advanced Bionics framework, we must determine whether Petitioner has demonstrated Examiner error in a manner material to the patentability of the challenged claims. Advanced Bionics, at 10. Becton, Dickinson Factors (c), (e), and (f) inform our analysis at this step. Id. at 8.” slip op. at 21
- 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 1–4, 7–19, and 22 of the ’298 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 12,018,298 - PTAB · Jun 6, 2025 · IPR2025-00140 · APJ James A Worth · IPR · Institution
The Board instituted IPR of claims 1–18 on all petitioned challenges, finding a reasonable likelihood that at least claim 1 is obvious over Nakajima and the knowledge of a person of ordinary skill.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 311 and any response filed under [35 U.S.C. §] 313 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) (2018). For the reasons set forth below, we determine that Petitioner has demonstrated that there is a reasonable likelihood that at least one of claims 1–18 of the ’250 patent is unpatentable, and we institute an inter partes review of claims 1–18 based on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art (“POSITA”) would have had an undergraduate degree in mechanical engineering or equivalent coursework, and a year or more of experience in designing, prototyping, and/or manufacturing fluid containers or similar products. Pet. 15 (citing Ex. 1002 ¶ 25). Petitioner asserts that more work experience may substitute for a lower level of education, and vice versa. Id. Patent Owner admittedly sets forth “a similar, though slightly different, level of ordinary skill”: a bachelor’s degree in mechanical experience with liquid-containing devices, with more work experience substituting for less education and vice versa. Prelim. Resp. 28 (citing Ex. 2001 ¶ 50). Patent Owner discerns no material difference between the definitions provided by the parties for purposes of the Board’s decision on whether to institute this proceeding. Id. For purposes of this decision, we adopt Petitioner’s proposed level of skill as being consistent with the prior art, although our conclusion on whether to institute would be unchanged under either definition.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“For purposes of this decision on institution, we adopt the proffered dictionary definition of “mouthpiece” as “a part (as of an instrument) that goes in the mouth or to which the mouth is applied” (see Ex. 2005), and we construe this as an intended use of this component of the apparatus, because this definition is consistent with the plain and ordinary meaning of the term which is a compound of “mouth” and “piece” and also because this definition is consistent with the Specification. For example, the Specification describes the use of the mouthpiece as follows: “In use, the mouthpiece is adapted to be configured to the dispensing configuration by a user placing the mouthpiece in the user’s mouth and biting upon or otherwise compressing the appropriate portions of sidewalls 92 of the mouthpiece.” Ex. 1001, 8:45–49. We note that, although the Specification refers to bite-actuation of the mouthpiece, for example in the field of the disclosure and certain embodiments (e.g., Ex. 1001, 1:25–27), the independent claims do not require bite-actuation. The Specification identifies the mouthpiece as item 72 (which is depicted, for example, in Figure 25, reproduced supra). Ex. 1001, 3:7‒8. 7 Exhibit 2005 appears to be from an online Merriam-Webster dictionary accessed March 13, 2025. Ex. 2005, 4. At this time, there is no argument in the preliminary record that this definition would have been different before the critical date of the patent.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Although the construction of this limitation may be helpful in deciding the issues of unpatentability, we determine that the construction of this term would benefit from further briefing during the trial phase of this proceeding, and we invite the parties to continue to brief this issue. Therefore, we do not provide a preliminary construction of the term at this time.” slip op. at 14
Claim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,851,250 - PTAB · Jun 2, 2025 · PGR2025-00003 · APJ Jeffrey N Fredman · PGR · Institution
Instituted PGR on claims 1–4 and 8–21 because the Board found a more-likely-than-not showing of written description and enablement failures; the obviousness ground did not meet that threshold.
RulingsInstitution decision- 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 prior art relevant to the ’600 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. 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.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 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. 2001 ¶ 68.4 Indeed, when reproducing the definition from this column of the ’600 patent, Dr. Triggs-Raine does not include any text after the first period, but the ’600 patent text 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, 48:44‒46. On this” slip op. at 13
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“on the ’429 patent, and there is no evidence of record that the Examiner meaningfully considered the relevant disclosures of the ’429 patent. We find unpersuasive Patent Owner’s reliance on the Examiner’s issuance of an office action with a written description rejection over a different issue that also included some double patenting rejections. As to Becton, Dickinson Factor (e), “whether Petitioner has pointed out sufficiently how the [E]xaminer erred in its evaluation of the asserted prior art,” Petitioner provides persuasive evidence of Examiner error. See Pet. 36–39 (citing Ex. 1009, 21–27). We agree with Petitioner that the Examiner overlooked the written description requirement with regard to claim 1. As discussed below, we find that, on the current record, the evidence sufficiently shows that it is more likely than not that the claims fail to comply with the written description requirement. See Section X. We, thus, find that the Examiner erred by either overlooking, or failing to appreciate, the factual underpinning necessary to support a written description for the breadth of an enormous genus claim such as claim 1 of the ’600 patent.” slip op. at 22
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“XIII. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. XIV. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 and 8–21 of the ’600 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 60
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,952,600
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.