• Avation Medical, Inc. v. Emkinetics, Inc.All claims unpatentable
  PTAB · Mar 16, 2026 · IPR2024-01378 · APJ John G New · IPR · Final written decision

  Claims 1–10 are unpatentable as anticipated by Svihra or obvious over the asserted combinations; the cited non-patent references qualify as printed publications.

  RulingsFinal written decision

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

    “Legal Standards Anticipation A claim is unpatentable as anticipated under 35 U.S.C. § 102 only when “every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). However, a reference may inherently anticipate if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). The “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.” Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009).” slip op. at 8

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

    “(citing In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)). Of particular relevance to the case presently before us is the VidStream court’s holding that “[w]hen there is an established publisher there is a presumption of public accessibility as of the publication date.” VidStream, 981 F.3d at 1065. Hulu addressed, inter alia, whether certain asserted references were shown to be publicly available and could be considered as prior art. IPR2018-01039, Paper 29 at 8. In Hulu, the Board held that, although testimonial evidence is one way to prove public accessibility, there are also various indicia of publication and other evidence that may be considered as a totality of the evidence to determine if an asserted reference was publicly accessible and prior art. Id. at 18. Facts to be considered in analyzing the issue, other than testimonial evidence, include, for example, whether there is an established publisher, a copyright date/notice, other publication-related dates (impression, printing, etc.), an ISBN number, citations to the reference before (and to a lesser degree, after) the priority date at issue corroborating its availability and/or that the publisher was established. Id. at 19–20 (see Valve Corp. v. Ironburg Inventions Ltd., 8 F.4th 1364, 1374 (Fed. Cir. 2021)). Here, we find the totality of evidence supports the conclusion that Petitioner has made a sufficient showing that Svihra and Amarenco (as well as the other identified non-patent references) were printed publications, and publicly accessible, prior to the ’477 patent’s priority date. We note at the outset that Patent Owner does not allege that any contested reference is fabricated, or a counterfeit document, but only that Petitioner has not set forth sufficient facts establishing that such references were published and available. Resp. 4. Svihra bears sufficient indicia of publication to conclude it was a printed publication and publicly accessible as of 2002. Ex. 1004. First, it appears on its face to be a legitimate scientific journal article; it indicates it was included at pages 480–83 in volume 103 (No. 12) of Bratisl Lek Listy, the Bratislava Medical Journal, which was established in 1921. The article identifies that it was received for publication on May 30, 2002, and accepted for publication on December 9, 2002; and multiple means of contact for the author and publisher are provided. Id. at 480, 483. Each of these indicia supports the contention that Svihra was published and publicly available in 2002. There is no direct evidence that Svihra was publicly accessed as of this date, but the article is cited as a reference in each of Exhibits 1085–1087, which further supports that Svihra was, generally, publicly available to interested individuals of ordinary skill in the art, which further corroborates that it was a published and publicly accessible publication. Having an established publisher also creates a presumption of publication for Svihra, which has not been rebutted by Patent Owner. VidStream, 981 F.3d at 1065.” slip op. at 22

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

    “Petitioner also explains why a person of ordinary skill would have been motivated to combine the cited references, again citing specific disclosures from the references, and the supporting testimony of Dr. Wingeier. See Pet. at 27–28. Based on our review of Petitioner’s arguments and the evidence of record, we determine that Petitioner has established, by a preponderance of the evidence, that the cited references teach or suggest all of the limitations of challenged claim 1, and that Petitioner has established why a person of ordinary skill would have been motivated to combine the references, as proposed, with a reasonable expectation of success, for the reasons advocated by Petitioner with respect to Ground 2.” slip op. at 14

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “engineering, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could substitute for a formal degree and vice versa.” Pet. 14 (citing Ex. 1003 ¶ 21). Patent Owner does not dispute Petitioner’s proposal. See generally Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and the level of skill in the prior art, we adopt Petitioner’s proposed definition and additionally use the term “skilled artisans” to refer to people with such skill at the time the invention was filed.” slip op. at 10

  Patent outcomesUS 9,002,477 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 9,002,477
• Avation Medical, Inc. v. Emkinetics, Inc.All claims unpatentable
  PTAB · Mar 16, 2026 · IPR2024-01375 · APJ John G New · IPR · Final written decision

  Claims 1–13 are unpatentable as obvious under § 103 over Svihra, Mann, and Ponsford, and independently over Amarenco, Mann, and Ponsford.

  RulingsFinal written decision

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

    “Ex. 1001, claim 1. In other words, to effectuate “direct” stimulation of the PTN nerve branch, a practitioner of the ’742 patent must: (1) non-invasively position an electrical stimulator relative to a portion of a patient’s body, such that a branch of a posterior tibial nerve within the first portion of the body is directly targeted by the electrical stimulator; (2) passing a current through the electrical stimulator; and (3) delivering an electrical stimulus from the electrical stimulator to the branch of the posterior tibial nerve such that the branch directly receives the electrical stimulation. Merely “placing electrodes over branches of the PTN” cannot be said, in and of itself, to “directly” target and stimulate the branches, as Petitioner argues.” slip op. at 12

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “of filing “would have had an undergraduate degree in the field of biomedical engineering or a related discipline, such as electrical engineering, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could substitute for a formal degree and vice versa.” Pet. 21 (citing Ex. 1003 ¶¶ 20–21). Patent Owner does not dispute Petitioner’s proposal. See generally Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and prior art, we adopt this definition, and also use the term “skilled artisan” to refer to persons with such skill at the time the invention was filed.” slip op. at 13

  • Expert testimonyPetitioner expert creditedOther
  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “the evidence of record, that a person of ordinary skill in the art would have found it obvious to modify the teachings of Svihra by non-invasively stimulating a nerve branch of the PTN, e.g., the medial or lateral plantar nerves, as taught by Ponsford, to treat OAB/urinary incontinence. A skilled artisan would have understood that the fibers of a given branch of the PTN necessarily constitute a subset of the PTN fibers, stimulation of which is known to be effective in the treatment of OAB/urinary incontinence. See Ex. 1004, 480–481. Just as it was known in the art that stimulation of the much larger sacral nerve, of which the fibers of the PTN form a part, could have beneficial effects in the treatment of incontinence, and that stimulation of the PTN itself could have a similar effect (see Ex. 1084, col. 12, ll. 33–52), so, a skilled artisan could reason, might electrical stimulation of a branch of the PTN exert a similar effect. We also agree that a person of ordinary skill in the art would have been motivated to stimulate a smaller nerve branch of the PTN, rather than the entire PTN itself, so as to minimize undesirable side effects of stimulating the entire PTN, i.e., the recruitment of downstream muscular contraction, as taught by Mann. With respect as to whether a person of ordinary skill in the art would have had a reasonable expectation of success in the treatment of OAB/incontinence via stimulation of a branch of the PTN, rather than the entire PTN itself, we agree with Petitioner that a person of ordinary skill in the art, would understand from Mann that electrical stimulation of the larger, more central sacral nerve could be employed to treat OAB/urinary incontinence, and that a subset of those PTN fibers could be electrically stimulated to achieve a similar effect. See Ex. 1084, col. 12, ll. 33–52. Such a skilled artisan could similarly reason that a subset of those PTN fibers, i.e., a branch of the PTN, particularly major branches such as the plantar nerves, could also be similarly electrically stimulated to treat OAB/urinary incontinence. Although success in such an experiment would not be guaranteed, “only a reasonable expectation of success, not absolute predictability, is necessary for a conclusion of obviousness.” In re Longi, 759 F.2d 887, 897 (Fed. Cir. 1985).” slip op. at 46

  Patent outcomesUS 11,224,742 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,224,742
• Nxtgen Toys, LLC v. Zipstring, LLCAll claims unpatentable
  PTAB · Feb 20, 2026 · IPR2024-01213 · APJ Richard H Marschall · IPR · Final written decision

  Claims 1–4, 12, and 15–17 are unpatentable; substitute claim 27 is allowed, while substitute claims 21–26 and 28 are denied as obvious.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person having ordinary skill in the art at the time of the invention “was typically a person with a bachelor’s degree in mechanical engineering, aerospace engineering, physics, or other science or 6 Patent Owner does not rely on any objective indicia of nonobviousness in this proceeding. engineering based degree that [was] familiar with general principles of mechanics and aerodynamics with at least two years of experience in product design and development in the field of toys or other amusement type devices.” Pet. 32 (citing Ex. 1002 ¶¶ 2–6, 22–26). Patent Owner states that it submitted the following proposal for a POSITA in the related district court litigation: “[a POSITA] would have had at least a B.S. degree in Mechanical Engineering, Electrical Engineering, Aerospace Engineering, Industrial Design, Product Design, or similar field, with at least two years industry experience in one of these fields, and such POSITA would have been familiar with general principles of mechanics, fluid mechanics and aerodynamics.” PO Resp. 4–5. We note that the parties’ proposals overlap considerably, and neither party argues the inadequacy of the other party’s proposal or that any patentability issue in this case turns on the resolution of this issue. We find Petitioner’s definition consistent with the problems and solutions disclosed in the ’774 patent and prior art of record, and adopt it as our own. See, e.g., GPAC, 57 F.3d at 1579 (approving the determination of the level of ordinary skill in the art by appeal to the references of record). We would arrive at the same findings and conclusions in this Decision if we adopted Patent Owner’s proposal.” slip op. at 7

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

    “Id. at 1312–13. Only terms in controversy need be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner contends that no “term requires construction to resolve the invalidity grounds presented in this Petition since the prior art renders claims 1–4, 12, and 15–17 unpatentable under any reasonable interpretation of the claims.” Pet. 7. Patent Owner argues that it “does not believe express claim constructions are necessary during this proceeding because the claims can readily be given their ordinary and customary meaning in the context of the patent at the time it was filed.” PO Resp. 5. Based on the parties’ positions and our view of the record, we need not expressly construe any claim limitations to resolve the issues in this Decision. To the extent that any implicit claim construction issues relate to the issues raised by the parties, we address them in the context of the parties’ patentability arguments below.” slip op. at 9

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

    “string, and that adding Scorch’s slot removes this arguably inconvenient process by allowing insertion and removal of a string without removing and reinstalling any aspects of the housing. See Pet 85–86 (citing Ex. 1002 ¶¶ 174–175; Ex. 1007, 3:30–3:53, 6:03; Ex. 1008, 3:46–4:45); Pet. Reply 18–20 (citing in part Ex. 2002 ¶ 187 (Dr. Janét’s testimony that Wagner’s removal and reinstallation of a cover “may be viewed as an inconvenient process”)). Making insertion and removal of the string easier and quicker provides a notable advantage over Wagner’s existing device. See id. Scorch itself supports this argument and the related expert testimony because it discusses insertion and removal of strings and stated that the slot allows a user to “swap them out really quick.” Ex. 1007, 3:30–53. Petitioner also persuasively argues that a POSITA would know how to add the slot while maintaining the proper operation of the device, such as allowing insertion and removal of the string and avoiding inadvertent exiting of the string from the device. See Pet. 86–87 (citing Ex. 1002 ¶¶ 175–176; Ex. 1007, 4:00–30, Ex. 1008, 2:49–52); Pet. Reply 19, 21 (citing Ex. 1002 ¶¶ 174–176). We find Petitioner’s arguments and reasoning in support of adding Scorch’s slot to Wagner’s housing straightforward and persuasive. Patent Owner’s arguments against the combination do not directly refute Petitioner’s reasoning or cast doubt on Scorch’s statement that its slot enables “quick” insertion and removal of a string—quicker than Wagner’s method that requires removal and replacement of a cover on its housing. See PO Resp. 16–22; PO Sur-reply 14–20; Ex. 2002 ¶ 187 (acknowledging inconvenience of Wagner’s existing process for insertion and removal of a string). Patent Owner suggests that Petitioner’s proposed combination fails to take into consideration certain drawbacks such as the risk of inadvertent string exit from the housing or slot, but Petitioner expressly addresses such concerns in the Petition. See PO Resp. 18 (stating that Scorch’s slotted funnel may allow the string to “shoot out the slot” and that Scorch addresses this by adding “a bent wire” to “prevent the string from coming out the side”); PO Sur-reply 16–17; Pet. 86–87 (arguing that Wagner’s flanges would help to trap the string in place, but if not, Scorch’s additional structures could be used to restring the string and “to further reduce the risk of a string inadvertently exiting” the device). We agree with Petitioner that a POSITA would understand how to incorporate Scorch’s slot without causing inadvertent removal of the string—using structures already present in Wagner and Scorch—and the need to add such unclaimed structurers does not teach away from the combination as Patent Owner suggests. See Pet. 86–87; PO Resp. 22. We also agree with Petitioner that a POSITA would understand how to make minor modifications, if necessary, to allow insertion and removal of the string around Wagner’s flanges. See Pet. Reply 21 (citing Ex. 1002 ¶¶ 174–176).” slip op. at 26

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “refute Petitioner’s reasoning or cast doubt on Scorch’s statement that its slot enables “quick” insertion and removal of a string—quicker than Wagner’s method that requires removal and replacement of a cover on its housing. See PO Resp. 16–22; PO Sur-reply 14–20; Ex. 2002 ¶ 187 (acknowledging inconvenience of Wagner’s existing process for insertion and removal of a string). Patent Owner suggests that Petitioner’s proposed combination fails to take into consideration certain drawbacks such as the risk of inadvertent string exit from the housing or slot, but Petitioner expressly addresses such concerns in the Petition. See PO Resp. 18 (stating that Scorch’s slotted funnel may allow the string to “shoot out the slot” and that Scorch addresses this by adding “a bent wire” to “prevent the string from coming out the side”); PO Sur-reply 16–17; Pet. 86–87 (arguing that Wagner’s flanges would help to trap the string in place, but if not, Scorch’s additional structures could be used to restring the string and “to further reduce the risk of a string inadvertently exiting” the device). We agree with Petitioner that a POSITA would understand how to incorporate Scorch’s slot without causing inadvertent removal of the string—using structures already present in Wagner and Scorch—and the need to add such unclaimed structurers does not teach away from the combination as Patent Owner suggests. See Pet. 86–87; PO Resp. 22. We also agree with Petitioner that a POSITA would understand how to make minor modifications, if necessary, to allow insertion and removal of the string around Wagner’s flanges. See Pet. Reply 21 (citing Ex. 1002 ¶¶ 174–176). At best, Patent Owner’s arguments on this issue establish potential drawbacks in Petitioner’s proposed combination, but drawbacks alone do not defeat Petitioner’s obviousness rationale that includes readily apparent benefits. See Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000) (“The fact that the motivating benefit comes at the expense of another benefit . . . should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another.”); Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine “). In addition, even if Patent Owner were correct that Wagner’s existing design works as well as Petitioner’s proposed combination, given all of the tradeoffs involved, that would not fatally undermine Petitioner’s showing. In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (obviousness does not require that the proposed combination “is the preferred, or most desirable, combination”). On this record, Petitioner’s (and Scorch’s) stated advantages that are achieved when adding Scorch’s slot to Wagner’s housing adequately support Petitioner’s motivation to combine rationale.” slip op. at 26

  Patent outcomesUS 11,674,774 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Nautilus
  Patents in suitUS 11,674,774
• Shenzhen Root Technology Co., Ltd. v. Willow Blossom Holdco LimitedAll claims unpatentable
  PTAB · Feb 18, 2026 · IPR2024-01296 · APJ Barry L Grossman · IPR · Final written decision

  Claims 1–46 are unpatentable as obvious under § 103 over the asserted combinations of Chang, Fang, Yuen, Khalil, Park, and Chen.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that before the effective filing date of the claimed invention a person of ordinary skill in the art (“POSITA”) “would have had at least a bachelor’s degree in mechanical engineering or a similar field and at least two years of experience designing human breast pump equipment” and that “[m]ore education could substitute for experience and vice versa.” Pet. 2 (citing Ex. 1003 ¶¶ 15–18). Mr. Bauer’s cited testimony supports Petitioner’s assertion.” slip op. at 16

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

    “[parent application to the application that matured into the ’380 patent], the Examiner construed the term ‘self-contained, in-bra wearable device’ to mean ‘complete, or having all that is needed, in itself’ and is capable of being worn in a bra.” Pet. 3 (citing Ex. 1005, 2290) (emphasis omitted). According to Petitioner, “PO did not dispute this construction, and Petitioner applies it herein.” Id. Petitioner also states that “[o]ther terms of the Challenged Claims should receive their plain and ordinary meaning, and no formal claim constructions are necessary in this proceeding because ‘claim terms need only be construed to the extent necessary to resolve the controversy.’” Id. (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011); Ex. 1003 ¶¶ 69–70). Again, because Patent Owner did not file a Response, we exercise our discretion and look to Patent Owner’s Preliminary Response. We note that in the Preliminary Response Patent Owner states that “[f]or purposes of this Preliminary Response, no claim terms require construction to resolve the prior art grounds raised in the Petition.” Prelim. Resp. 19. According to specific construction, any such terms should be accorded their plain and ordinary meaning in light of the specification.” Id. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). There are no claim terms in controversy. Accordingly, we need not construe any terms for our analysis.” slip op. at 17

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

    “Petitioner contends (Pet. 17) that a person of ordinary skill in the art “would have been motivated to implement Chang’s breast pump device as suggested by Fang” to achieve four benefits: (1) “to facilitate convenient cleaning and maintenance” (Pet. 19 (citing Ex, 1003 ¶ 102)); (2) “to facilitate more rapid assembly and disassembly (e.g., during use)” (id. at 20–21 (citing Ex. 1003 ¶ 105)); (3) “as a particularly effective and suitable option to generate negative” slip op. at 34

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “a breast pump device having “a diaphragm pump that generates negative air pressure.” Pet. 33; see also id. at 38. Petitioner explains Chang’s pump “generates suction by cyclical compression and decompression of a conduit or flex-tube, and expressly notes that other configurations were known and suitable.” Id. at 17 (citing Ex. 1007 ¶¶ 22, 25, 28, 68, 79, 84–86). Chang, however, does not mention, specifically, that Chang’s pump is a “diaphragm” pump. We note, however, that this claim clause does not state or require any specific type of pump. It merely requires a “pump.” Clause 1[e]/29[e], discussed below, however, does require a “diaphragm” pump. Petitioner here merely lays the foundation for this later clause by asserting that “Fang provides a straightforward suggestion of a diaphragm pump including a diaphragm housing component formed in a wall of the pump housing.” Id. at 18 (citing Ex. 1009 ¶¶ 24–25, Fig. 7; Ex. 1003 ¶ 97). Thus, Petitioner asserts, Fang teaches “an ‘air pump’ in pneumatic connection with the diaphragm that serves to generate negative air pressure,” and Chang teaches “the location of pump components (e.g., ‘motor’ [46]).” Pet. 33 (citing Ex. 1007 ¶¶ 72, 80, Fig, 6A; Ex. 1009 ¶¶ 19, 24). Petitioner then asserts that “the ‘air pump’ components of the combined device are positioned within the pump housing,” and the air pump is powered by Chang’s rechargeable battery. Id. (citing Ex. 1007 ¶¶ 72, 80).” slip op. at 34

  Patent outcomesUS 11,413,380 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,413,380
• Tommy John, Inc. v. Pakage Apparel, Inc.All claims unpatentable
  PTAB · Feb 12, 2026 · IPR2024-01163 · APJ Robert J Silverman · IPR · Final written decision

  The Board held claims 1–13, 15, and 16 unpatentable as obvious under § 103 over the identified combinations of Kitsch, Brocks, and Carrillo.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Accordingly, for purposes of this Decision, we adopt Petitioner’s” slip op. at 12

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

    “21; 4:1:13–22. Accordingly, Kitsch and Brocks have similar goals, with respect to formation of a secure pouch for containing the genitals, for which each reference discloses a distinct technical solution. Thus, a POSITA would have regarded the application of Brocks’ familiar and effective gathering technique to Kitsch’s side panels as a viable approach for improving a supportive pouch, and would have expected such combination of teachings to achieve the structural benefit used in Brocks. See Pet. 25–27 (citing, inter alia, Ex. 1005 ¶¶ 68–72). In other words, a POSITA would have had a reasonable expectation that the combination of Kitsch and Brocks, as discussed above, would result in what is recited in limitation 1[g].” slip op. at 44

  Patent outcomesUS 10,834,974 unpatentable
  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,834,974
• GE Healthcare Ltd. v. The Johns Hopkins UniversityInstituted
  PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution

  The Board instituted post-grant review of claims 1–4 on all four asserted grounds, finding a sufficient preliminary showing of obviousness and lack of enablement.

  RulingsInstitution decision

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

    “V. 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. VI. 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 of the ’233 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 40

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not proffer a description of a POSA. See generally, Prelim. Resp. For the purposes of this decision, on the record at this time, we find that Petitioner’s definition appears consistent with the level of skill shown in the prior art references of record, and apply it herein. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We invite the parties to further address the definition of a POSA during trial should they find it necessary.” slip op. at 7

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “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 from 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 (“[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.”) US-121, of which Dr. Pomper is lead inventor, 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. 1006, ¶ 12. In addition, Patent Owner’s definition does not appear to apply to all compounds claimed in US-121.5” slip op. at 11

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

    “limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration to define “low molecular weight” as a term well accepted in the chemical arts relates to metabolomics and metabolites. See Ex. 1002, 169, (specifically, ¶ 17 of Dr. Pomper’s declaration). Patent Owner admits that Dr. Pomper’s testimony is about molecules that differ from the claimed imaging and radiotherapeutic agents targeting FAP-α, but argues that the testimony is still relevant for purposes of explanation. Prelim Resp. 21. While it may be relevant, the testimony is not persuasive in light of the Specification. We find the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’233 patent fall outside of Patent Owner’s proposed definition persuasive, 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). The cases cited by Patent Owner supporting that a claim term may be construed to exclude embodiments where the prosecution history supports such construction are factually distinguishable from the instant case as they regard instances of specific prosecution history disclaimer, clear prosecution disavowal, or relate to a specific definition of the terms in the Specification for the term being construed. Here, “low molecular weight” is not defined in the Specification, but, as Petitioner argues (see Pet. 21–25) is characterized as “demonstrat[ing] faster pharmacokinetics and a higher specific signal within clinically convenient times after administration” and that it “can be synthesized in radiolabeled form more easily.” Ex.1001, 13:33–50, 14:56– 16:14, 17:9–20. We are persuaded by the testimony of Dr. Zeglis, Petitioner’s declarant, that compounds weighing over 1500 Da may share those same behaviors, along with certain identified B moieties disclosed as embodiments. See Ex. 1003 ¶ 83.” slip op. at 10

  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 12,115,233
• Avation Medical, Inc. v. Emkinetics, Inc.All claims unpatentable
  PTAB · Jan 7, 2026 · PGR2024-00043 · APJ Ryan H Flax · PGR · Final written decision

  Claims 1–39 are unpatentable under Grounds 1–10; Petitioner did not prove lack of enablement under Ground 11, and Patent Owner’s motion to exclude was denied.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “REAL PARTIES-IN-INTEREST Petitioner identifies Avation Medical, Inc. as the real party-in-interest. Pet. x. Patent Owner identifies EMKinetics, Inc. as the real party-in-interest. Paper 5, 1; Paper 6, 1. Neither party contests the other’s assertions on this. C.” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A POSA at the time of the claimed invention would have had an undergraduate degree in the field of biomedical engineering or a related discipline, such as electrical engineering, and at least two years of experience in the design and/or analysis of biomedical devices. Additional work experience could substitute for a formal degree and vice versa. Ex.1003, ¶21. Pet. 20 (citing Ex. 1003). Patent Owner does not contest this proposed definition or offer an alternative. See generally Resp. We accept and use Petitioner’s uncontested definition of the ordinarily skilled artisan, which appears to comport with the level of skill in the art reflected in the prior art of record and the ’943 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may]” slip op. at 19

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

    “same claim construction standard that is used to construe patent claims in a civil action in federal district court. 37 C.F.R. § 42.200(b). In construing claims, district courts and the Board here, by default, give claim terms their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner states that, “no terms require construction for purposes of this Petition.” Pet. 21. Patent Owner presents no express position on claim construction. See generally Resp. We do not expressly construe any claim terms. E.” slip op. at 20

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

    “question, based on factual findings. VidStream, 981 F.3d at 1063–64. Moreover, public accessibility is the touchstone in determining whether a reference is a printed publication and such depends on whether the reference was available to interested, ordinarily skilled persons exercising reasonable diligence, which is determined on a case-by-case basis. Id. at 1065. Particularly pertinent here is that “[w]hen there is an established publisher there is a presumption of public accessibility as of the publication date.” Id. Hulu (which cites VidStream on this issue) concerned, inter alia, whether certain asserted references were shown to be publicly available and could be considered as prior art. Hulu, 2021 WL 487622. Hulu holds that, although testimonial evidence is one way to prove public accessibility, there are also a variety of hallmarks of publication and other evidence that may be considered as a totality of the evidence to determine if an asserted reference was publicly accessible and prior art. Id. at *10–13, 21. Facts to be considered in analyzing the issue, other than testimonial evidence, include, for example, whether there is an established publisher, a copyright date/notice, other publication-related dates (impression, printing, etc.), an ISBN number, citations to the reference before (and to a lesser degree, after) the priority date at issue corroborating its availability and/or that the publisher was established, and whether the reference’s “purpose of publishing . . . was ‘dialogue with an intended audience.’” Id. at *10–21 (citing Valve Corp. v. Ironburg Inventions Ltd., 8 F.4th 1364, 1374 (Fed. Cir. 2021)).” slip op. at 30

  Patent outcomesUS 11,844,943 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · Graham
  Patents in suitUS 11,844,943
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision

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

  RulingsFinal written decision

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

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

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

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

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

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

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

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

  Patent outcomesUS 11,643,462 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,643,462
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 6, 2025 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Final written decision

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

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

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

  • Skill levelSkill level board ownDecided for petitioner

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

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

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

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

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

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

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

    “The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 11–12; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe” slip op. at 7

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

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

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

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

  Patent outcomesUS 11,325,975 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,325,975

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.