- Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentablePTAB · Mar 25, 2026 · IPR2024-01498 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–19 are unpatentable as obvious over the Lesniak- and Native-based grounds; the Squatch and Sturgis ground fails because Squatch was not shown to be a printed publication.
RulingsFinal written decision- BurdenDecided for patent owner
“We agree with Patent Owner that Petitioner has not shown sufficiently that Squatch is a printed publication. As described above, Petitioner relies on Squatch as a “website excerpt” placed on its site at the relevant time, but has not produced a screen shot of the website to show that it ever existed. See Ex. 1059. Petitioner provides internal documents that purport to describe what would have been on Dr. Squatch’s website at the relevant time, but falls short of establishing what was on the website for the interested consumer to view. Thus, we determine that this ground fails.” slip op. at 55
- Skill levelSkill level petitioner adoptedDecided for petitioner
“or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 17 (citing Ex. 1002 ¶¶ 26–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications at this stage of the proceeding. PO Resp. 10. We adopt and apply Petitioner’s proposed definition of a POSA, which is consistent with the level of skill reflected in the asserted prior art. See e.g., Exs. 1003, 1004.” slip op. at 8
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Pet. Reply 6–7 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a secondary wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that Lesniak teaches how to make stable compositions by including a secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Id. Ex. 1086 ¶ 7; see also Pet. Reply 6 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32). Having considered the parties’ positions and evidence of record, summarized above, we determine that Lesniak provides sufficient disclosure to enable a person of ordinary skill in the art to formulate deodorant stick within the parameters of claim 1.” slip op. at 25
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Patent Owner asserts that the preamble of independent claims 1, 16, and 19 reciting “a deodorant stick” is limiting as it provides antecedent basis for the recitation of “said deodorant stick being free of an aluminum salt” for each independent claim. PO Resp. 7–10. Patent Owner also points to dependent claims 6–9 as relying on the preamble reciting “a deodorant stick” as antecedent basis for claim elements. Id. at 9. We agree. Petitioner does not argue to the contrary. See, e.g., Pet. 19 (arguing that Lesniak discloses a deodorant stick in the form of an antiperspirant stick).” slip op. at 8
Patent outcomesUS 11,844,752 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,844,752 - Avation Medical, Inc. v. Emkinetics, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 9,002,477 - Avation Medical, Inc. v. Emkinetics, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,224,742 - PTAB · Sep 19, 2025 · PGR2025-00025 · APJ Kimberly Mcgraw · PGR · Institution
The Board instituted PGR on claims 1–19 and all asserted grounds, finding it more likely than not that claim 1 is anticipated by the Gatorade Label.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“if “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Post-grant review is available for patents that issue from applications that at one point contained at least one claim with an effective filing date on or after March 16, 2013. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), §§ 3(n)(1), 6(f)(2)(A). After considering the briefing and the evidence of record, for the reasons set forth below, we determine that Petitioner has shown that the ’422 Patent is eligible for post-grant review and has shown it is more likely than not that at least one challenged claim of the ’422 Patent is unpatentable under § 324(a). Accordingly, we institute a post-grant review of the challenged claims of the ’422 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art “would possess at least (1) a Bachelor’s degree in chemistry or a related field, with (2) five years of experience in material identification and characterization using multiple analytical methods and field sampling, or equivalent research or professional experience.” Pet. 12 (citing Ex. 1014 ¶ 24). Patent Owner does not dispute Petitioner’s definition for one of ordinary skill in the art nor provide a proposed definition of its own. See generally Prelim. Resp. For the purposes of this Decision, we adopt Petitioner’s undisputed proposal regarding the level of one of ordinary skill in the art.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner
“336. The applicant explained that not all combinations of shrink films and light blocking materials are recyclable. Id. at 335. The applicant explained that films can be compatible with PET recycling in two ways, (1) the film can float in water and be separated from PET that sinks in water or (2) the PET films crystallize and “can be recovered with the PET stream.” Id. at 336 (citing “A Resource Document by the Association of Plastic Recyclers (APR)”) (found at Ex. 1002, 323–332) (emphasis omitted). The applicant explained that “removing the label before or during the recycling process is not evidence of the recyclability of the label” and that “[r]emoving the label during the recycling process is not equivalent to actually recycling the label.” Id. at 335. As such, a POSITA reading the prosecution history would understand that a label is not recyclable with a PET container, as recited by the independent claims, by removing the label from the PET recycle stream before or during the recycling process.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“To determine how a person skill in the art would determine if a shrink label is “recyclable” as recited in the independent claims, we look to how the Specification of the ’422 Patent describes or defines recyclable shrink labels. For example, the ’422 Patent states that PET shrink films are generally considered recyclable if no inks are retained on the film after a caustic wash cycle typically used in PET reclaiming processes. Ex. 1001, 6:61–65. The ’422 Patent further states that labels are fully recyclable if the polymers used are clear, preferably clear PET, and the labels include inks that can be washed off in a “typical PET recycling wash (caustic wash).” Id. at 11:44– 49; see also id. at 11:49–54 (describing embodiments in which the labels are free or substantially free of inks that cannot be washed off in a caustic wash or where the labels are free or substantially free of color plastics that cannot be recycled). The ’422 Patent further discusses “industry standards” for determining whether various embodiments of shrink labels are recyclable. See, e.g., id. at 11:29–53. For example, the Specification states that the “Association for Plastic Recyclers (APR) Critical Guidance Protocol for Clear PET Articles with Labels and Closures (PET-CG-02)” (Ex. 1005) can certify that a film is fully recyclable with a container or bottle. Id. at 11:34– 38. Additionally, the Specification states that labels “are recyclable according to the Evaluation of the Near Infrared (NIR) Sorting Potential of a Whole Plastic Article (SORT-B-01)” (Ex. 1010) and/or the “Evaluation of Sorting Potential for Plastic Articles Utilizing Metal, Metalized, or Metallic Printed Components (SORT-B-03)” (Ex. 1011). Ex. 1001, 11:39–44. The ’422 Patent further states that embodiments of the labels “are fully recyclable. For example, the labels may include inks that can be washed off in a typical PET recycling wash (caustic wash) and the polymers” are preferably clear PET. Id. at 11:44–48. The ’422 Patent thus provides various descriptions or standards to determine the recyclability of shrink labels. For the purposes of addressing the anticipation and obviousness grounds, we determine that any of these standards can be used to determine if a shrink label is “recyclable.” We note that our construction is preliminary and is based on the present record. We invite the parties to further the address the construction of “wherein the recyclable shrink label is recyclable with a PET container” during trial.” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 11,961,422 - Zhuhai Cosmx Battery Co., Ltd. v. Ninge Amperex Technology LimitedInstitution deniedPTAB · Aug 20, 2025 · IPR2025-00385 · APJ Debra L Dennett · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–10 were anticipated by Nishikawa or obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review under 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least [one] of the claims challenged in the petition.” For the reasons set forth below, upon considering the Petition and Preliminary Response, we determine that Petitioner has not established a reasonable likelihood of prevailing with respect to at least one challenged claim. Accordingly, we deny the Petition and decline to institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedOther
“Petitioner contends that A person of ordinary skill in the relevant art would typically hold an advanced degree in chemistry, material science, and/or a related discipline, and have at least two years of experience with designing and/or fabricating battery separators or have an equivalent level of education, training, and experience. Pet. 5. Patent Owner “adopts the definition proposed by Petitioner” for the purposes of the Preliminary Response. Prelim. Resp. 22. In light of the record before us, and for purposes of this Decision, we adopt Petitioner’s unopposed definition because it is consistent with the specification. We note that neither party indicated that the result would change under any different definition.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Absolute plastic deformation rate” and “relative plastic deformation rate” are the only claim terms disputed in this proceeding, and are clearly defined in the Specification and in claim 1. See Spec. 4:22–27, 4:47–54; 25:31–37. Because we determine that claim construction is not necessary to decide whether to institute, we do not expressly construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the context of an inter partes review). slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Petitioner’s arguments are unconvincing. Petitioner points to nothing in Nishikawa that allows a POSITA to determine L2 (defined as “a length of 4 Tensile strength is measured as force per units area, such as MPa or psi. One MPa equals one N/mm2. Nishikawa Table 1 discloses tensile strength in N/cm. Ex. 1004 Table 1. Petitioner makes calculations to convert the reported N/cm into N/m2 and then to GPa, but provides no explanation for why tensile strength is reported in N/cm or how it was measured. See Pet. 31. the porous substrate after the porous substrate is stretched to breakage and docked along the fracture caused by the breakage and flattened”) or L2 – L0. See generally Pet., Ex. 1004. Petitioner and its expert, Dr. Pecht, fail to adequately explain why tensile strength divided by Young’s modulus is “a proxy for L1 – L2” or why such a proxy is sufficient to disclose the limitation as stated. Instead, we are required to rely on “approximations” and “estimates” with insufficient explanation of why such they are appropriate or adequate. See Pet. 26, 30, 32; see also Ex. 1003 ¶¶ 97, 105–108, 111.” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,964,927 - PTAB · Apr 11, 2025 · IPR2024-01498 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–19, finding a reasonable likelihood of unpatentability on multiple obviousness grounds, while declining institution under Ground 9 at the preliminary merits stage.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “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). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–19 of the ’752 patent is unpatentable.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“summarized above, we determine that Petitioner has established a reasonable likelihood of prevailing in showing that claims 1 and 4–14 are obvious over the combination of Native and Bianchi ’254. In particular, we are persuaded by Petitioner that the combination of Native and Bianchi ’254 discloses a deodorant stick comprising each element of claims 1 and 4–14. Pet. 41–50. We also find that Petitioner has shown sufficiently on the record before us that a person of ordinary skill in the art would have had a reasonable expectation of success to implement Bianchi ’254’s hardness range in Native’s formula. Here, we credit Dr. Michniak-Kohn’s testimony that a person of ordinary skill in the art would have understood how to adjust hardness using the structurants in a deodorant composition. Ex. 1002 ¶ 41, 191–192.” slip op. at 20
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“biased testimony from an employee” and the Petition therefore lacks sufficient evidence to establish the images provided in the Squatch declaration as containing prior art printed publication material. Id. at 27–28 (citing Finnigan Corp. v. ITC, 180 F.3d 1354, 1366 (Fed. Cir. 1999) (“[T]he law has long looked with disfavor upon invalidating patents on the basis of mere testimonial evidence absent other evidence that corroborates that testimony.”); Nobel Biocare Services AG v. Instradent USA, Inc., 903 F.3d 1365, 1377-78 (Fed. Cir. 2018) (“corroboration is required of any witness whose testimony alone is asserted to invalidate a patent, regardless of his or her level of interest.”). 3. Discussion Having considered the parties’ positions and evidence of record, summarized above, we find Patent Owner to have, at this stage of the proceeding, the better position.. Accordingly, we determine that there is insufficient evidence to indicate a reasonable likelihood that Petitioner will prevail in establishing that that claims 15–19 would have been obvious over the combination of Squatch and Sturgis for the reasons set forth in the Preliminary Response and summarized above. However, we will make our final determination on these issues on the full record developed during this proceeding. See Hulu LLC v. Sound View Innovations, LLC, IPR2018- 01039, Paper 29, 11 (PTAB Dec. 20, 2019) (precedential) (“To prevail in a final written decision in an inter partes review, the petitioner bears the burden of establishing by a preponderance of the evidence that a particular document is a printed publication.”).” slip op. at 30
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“35 U.S.C. § 325(d). Prelim. Resp. 29–38. In determining whether to deny institution under § 325(d), we use the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential). The Becton, Dickinson factors provide useful insight into how to apply the framework under 35 U.S.C. § 325(d). Id. at 9 (referencing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, 17– 18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph)).” slip op. at 32
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,844,752 - PTAB · Mar 18, 2025 · IPR2024-01378 · APJ Jason W Melvin · IPR · Institution
The Board instituted inter partes review of claims 1–10 on all petitioned grounds, finding a reasonable likelihood that at least one claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). “When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a) (2021).” slip op. at 2
- BurdenInstituted
“In sum, Patent Owner asserts that the precise teachings of the asserted secondary references do not amount to detecting electrical conduction through the posterior tibial nerve. That argument does not consider that Petitioner relies on a combination in which Svihra’s approach is modified by the secondary references such that Svihra’s stimulation of the PTN is detected and used to automatically control the stimulation parameters. Pet. 21–28. As discussed, we view the references’ disclosures as supporting Petitioner’s contentions. f. Summary We conclude that Petitioner has identified sufficient reason that skilled artisans would have modified Svihra’s approach to incorporate the systems and techniques of Mann, DiLorenzo, Gerber, and Bourget, and that the asserted combination renders obvious claim 1’s limitations. Accordingly, this ground supports institution.” slip op. at 30
- 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. 14 (citing Ex. 1003 ¶ 21). Patent Owner does not dispute Petitioner’s proposal. See generally Prelim. 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 it and use “skilled artisans” to refer to people with such skill at the time the invention was filed.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner argues that “no terms require construction for purposes of this Petition.” Pet. 14. Patent Owner does not contest Petitioner’s argument. See generally Prelim. Resp. We agree and do not expressly construe any terms at this stage. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). Should either party believe that a position taken during trial depends on a particular claim construction, we encourage the party to explain that dependence and why its asserted construction is correct.” slip op. at 10
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 9,002,477 - PTAB · Mar 18, 2025 · IPR2024-01375 · APJ Jason W Melvin · IPR · Institution
The Board instituted IPR of claims 1–13 based on both §103 grounds, finding a reasonable likelihood that the asserted combinations render at least one challenged claim unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“35 U.S.C. § 325(d) because Amarenco and Mann previously were presented to the Office during prosecution of the ’742 patent. See Prelim. Resp. 17–18. According to Patent Owner, Petitioner has identified additional references that “supposedly teach[] only some of what was missing—stimulation of a branch of the posterior tibial nerve but not to treat overactive bladder or incontinence.” Id. at 18. Patent Owner’s argument is flawed for two reasons. First, neither Svihra nor Ponsford were previously presented to the Office. Because Patent Owner does not argue that we should deny institution of Petitioner’s Svihra-based ground under § 325(d), and because that ground relies on a combination of art not previously presented, Patent Owner’s § 325(d) argument is unpersuasive. In that regard, we determine that even if we were to conclude the Amarenco-based ground warranted discretionary denial, the Svihra-based ground would not be subject to such denial and may alone justify institution. See USPTO, SAS Q&As (June 5, 2018) at D1.11 Additionally, for the Amarenco-based ground, Petitioner relies on a combination including prior art that was not previously presented, and Patent Owner does not show that additional prior art is cumulative to art presented during prosecution. We determine that Petitioner’s Amarenco-based ground 11 Available at: https://www.uspto.gov/sites/default/files/documents/ sas_qas_20180605.pdf is not substantially the same as one previously presented to the Office. Thus, we decline to discretionarily deny institution under § 325(d).” slip op. at 8
- 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 Prelim. 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 it, and use “skilled artisans” to refer to people with such skill at the time the invention was filed.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner argues that “no terms require construction for purposes of this Petition.” Pet. 22. Patent Owner does not contest Petitioner’s position. See generally Prelim. Resp. We agree and do not expressly construe any terms at this stage. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 9
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“It has long been recognized that the touchstone as to whether an asserted reference qualifies as prior art is public accessibility. See In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986). “[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential).” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,224,742 - PTAB · Jan 29, 2025 · PGR2024-00043 · APJ John G New · PGR · Institution
The Board instituted PGR on all challenged claims, finding a sufficient likelihood that claims are anticipated or obvious under Grounds 1–10; it found Ground 11’s enablement challenge insufficient.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 324, the Board “may not authorize a post-grant review to be instituted unless … the information presented in the petition … if such information is not rebutted would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” For the reasons we explain below, we institute post-grant review of the ’943 patent.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“asserted reference qualifies as prior art is public accessibility. See In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986). “[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential).” slip op. at 15
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner
“priority benefit of the ’720 provisional application (at top center). See Ex. 1001, code (60) (listing “provisional application No. 5,995,873, filed on Oct. 2, 2006”). However, simply to claim the priority benefit of an earlier application is not necessarily to receive it. See In re NTP, Inc., 654 F.3d 1268, 1276 (Fed. Cir. 2011) (holding that “a patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority.… Rather, for a patent’s claims to be entitled to an earlier priority date, the patentee must demonstrate that the claims meet the requirements of 35 U.S.C. § 120.”). As the diagram shows (and as we have verified), the ’529 application was a continuation-in-part of the preceding ’329 application. See Ex. 1001, code (63). However, the ’529 application was abandoned on February 10, 2016 (See Ex. 1052), and the succeeding application, U.S. Patent Application Ser. No. 15,474,875 (the “’875 application”) which is listed in the ’943 patent as being a continuation-in-part of the ’529 application, was not filed until March 30, 2017. See Ex. 1001, code (63) (stating that “said application No. 15/474,875 is a continuation-in-part of application No. 12/508,529”). Put simply, the ’875 application was not filed until over a year after the ’529 application was abandoned. As 35 U.S.C. § 120 states, in relevant part: An application for patent for an invention disclosed in the manner provided by section 112(a) (other than the requirement to disclose the best mode) in an application previously filed in the United States, or as provided by section 363 or 385, which names an inventor or joint inventor in the previously filed application shall have the same effect, as to such invention, as though filed on the date of the prior application, if filed before the patenting or abandonment of or termination of proceedings on the first application or on an application similarly entitled to the benefit of the filing date of the first application and if it contains or is amended to contain a specific reference to the earlier filed application. (emphasis added). In other words, if there is a “break in the chain” of priority caused by the abandonment or termination of an application claiming priority prior to filing of a subsequent application, the subsequent application loses the priority benefit of the abandoned or terminated application, as well as the priority benefit of all applications that antedate that abandoned or terminated application. Such is the case presently before us. Based on the current record, we are persuaded that the abandonment of the ’529 application prior to filing of the continuation-in-part ’875 application broke the priority chain leading to the ’720 provisional application, and the ’943 patent cannot, therefore, claim the priority benefit of the ’720 provisional application’s October 2, 2006 filing date. Consequently, the earliest date of which the ’943 patent could possibly claim the priority benefit is that of U.S. Patent Provisional Application Ser. No. 61/403,680 (the “’680 provisional application”) (located at the top of the left branch of the “family tree” depicted above), which has a filing date of September 20, 2010. See Ex. 1001, code (60). Burnett (i.e., the ’329 application) was filed on October 2, 2007 and thus antedates the ’680 provisional application. Consequently, Patent Owner’s argument fails based on the current record, and Burnett is prior art to the ’943 patent.” slip op. at 55
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Patent Owner’s request that we exercise our discretion under § 325(d) is not tenable. In deciding whether to exercise our discretion under § 325(d) in situations where only some of the challenges fall within its scope, we evaluate the challenges and determine whether § 325(d) is sufficiently implicated that its statutory purpose would be undermined by instituting on all challenges. If so, the panel will evaluate whether the entire petition should be denied.” See USPTO, SAS Q&As (June 5, 2018) at D1, available at: https://www.uspto.gov/sites/default/files/ documents/ sas_qas_20180605.pdf; see also Kansas State Univ. Res. Found., PGR2022- 00021, Paper 11 at 7–8 & n.3 (Vidal Feb. 24, 2023) (holding that “the Board will further evaluate … whether § 325(d) is sufficiently implicated that its statutory purpose would be undermined by instituting review on all challenges presented in the Petition”). We having instituted post grant review based at least upon claim 1 of Ground 1 of the Petition. Even if the panel agreed with Patent Owner that Grounds 5–8 present “the same or substantially the same prior art or arguments” previously presented to the Office, § 325(d) would not be “sufficiently implicated” due to the 7 other asserted grounds. We therefore do not proceed with the § 325(d) analysis established in Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) and decline to exercise our discretion to deny the petition on that basis.” slip op. at 41
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites Phillips · KSRPatents in suitUS 11,844,943 - Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentablePTAB · Nov 26, 2024 · PGR2021-00088 · APJ John G New · PGR · Final written decision
Claims 1–25 are unpatentable because the ’908 patent lacks written description support under § 112(a); the Board did not reach Grounds 1–3 or 5.
RulingsFinal written decision- ExcludeMotion to exclude, deniedMixed
“To the extent that Dr. Dobs has admitted that she is “not comfortable with chemical terminology”; “could not answer questions regarding the chemical structures in the prior art articles”; “did not know whether CRF1 receptor antagonists contained the structural features she deemed ‘essential’ in her Declaration”; and “agreed that tildacerfont has structurally unique features” (see Ex. 1038, 52–53, 125–126, 126–128, 128–130), we will weigh her testimony regarding those matters accordingly. However, for the reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 19 and 80–91 of Exhibit 2014 is denied.” slip op. at 10
- Strike new argumentOther
“Analysis Patent Owner’s Exhibits 2020–2026 play no part in our reasoning and were not relied upon by the Board in reaching our Decision. Petitioner’s Motion to strike Exhibits 2020–2026 is therefore dismissed as moot.” slip op. at 23
- Skill levelSkill level petitioner adoptedDecided for petitioner
“typically possess a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders. Pet. 60 (citing Ex. 1005 ¶ 34). Petitioner argues that such a person of ordinary skill would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders. Id. Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because we find Petitioner’s definition to be consistent with the demonstrable level of skill in the art (see, e.g., Exs. 1009, 1025, 2003, 2004, 2005), and in the absence of a different proposed definition of the level of skill in the art by Patent Owner, we adopt Petitioner’s definition.” slip op. at 26
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“For these reasons, we do not find persuasive the testimony of Patent Owner’s expert, Dr. Dobs, that: By describing adjustments of dosing protocols to achieve at least a 10% reduction from baseline, and describing this use of tildacerfont as just one embodiment of the claimed use of the entire well-known, well-characterized, and discrete class, the specification reasonably conveyed to a POSA that the invention extended to the particularly claimed use of the entire recited class. Ex. 2014 ¶ 87. On the contrary, far from being a “well-known, well-characterized, and discrete class” the prior art teaches a heterogeneous assembly of different classes of small molecule CRF1 receptor antagonists (Type I, Type II, and “atypical”) displaying a very considerable variety of structures, both in terms of the core pharmacophore (e.g., monocyclic, bicyclic, tricyclic, phenolic, cyclohexyl amide, etc.) as well as in the various side groups. Moreover, the challenged claims recite only “a CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof,” the scope of which also encompasses the much larger (and, according to Williams) much more effective large-molecule (peptide) CRF1 receptor antagonists, about which the Specification is entirely silent. See Ex. 1029, Abstr., 1065.” slip op. at 56
Patent outcomesUS 10,849,908 unpatentable§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,849,908
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.