- 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 · Aug 12, 2025 · IPR2025-00405 · APJ Debra L Dennett · IPR · Institution
The Board instituted IPR on claims 1–6 and 12–26 because Petitioner showed a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2025). 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, Preliminary Response, and the evidence of record as presently developed, we determine that Petitioner has established a reasonable likelihood of prevailing with respect to at least one challenged claim. Accordingly, we grant the Petition and institute an inter partes review.” slip op. at 2
- BurdenNot reached
“3. Analysis On the preliminary record, we agree with Patent Owner that Petitioner fails to demonstrate that it meets the threshold showing under 35 U.S.C. § 314(a) for institution of trial with respect to Grounds 4C, 5C, and 6C.” slip op. at 91
Nonecites Phillips · KSR · GrahamPatents in suitUS 11,769,910 - Solus Advanced Materials Co., Ltd. v. SK Nexilis Co., Ltd.Institution deniedPTAB · May 19, 2025 · IPR2025-00005 · APJ John G New · IPR · Institution
The Board denied institution on all grounds, finding no reasonable likelihood that claims 1–4 were obvious because Petitioner did not show a reasonable expectation of success in combining the cited references.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“Analysis The burden of proving the unpatentability of the challenged claims rests with (and is borne at all times by) Petitioner. 35 U.S.C. §§ 314(a), 316(e); see also In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016). To satisfy this burden, Petitioner must “articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness”; “mere conclusory statements” will not suffice. Magnum Tools, 829 F.3d at 1380. Indeed, “[i]t is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Furthermore, “[a]n obviousness determination requires finding that a person of ordinary skill in the art would have been motivated to combine or modify the teachings in the prior art and would have had a reasonable expectation of success in doing so.” See Regents of the Univ. of Cal. v. Broad Inst., Inc., 903 F.3d 1286, 1291 (Fed. Cir. 2018). We have consistently denied institution of inter partes review in cases in which the petitioner fails to meet its burden of demonstrating a reasonable likelihood of success at trial with respect to the latter requirement. See NJOY, LLC v. JUUL Labs., Inc., IPR2024-00536, Paper 17 (PTAB Aug. 12, 2024) (denying institution where petitioner did not show a reasonable expectation of success in combining the asserted references); see also Honeywell Int’l Inc. v. DSM IP Assets, B.V., IPR2024-00493, Paper 7 (PTAB Aug. 21, 2024). We conclude that, in this instance, Petitioner fails to meet its burden of showing that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the references.” slip op. at 32
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“As an initial matter, we note that, of the 44 specimens tested by Ye, as revealed in Ye’s Table II, only a single specimen, specimen 15, meets the required TC ratios recited in challenged claim 1 of the ’541 patent. Furthermore, none of the references cited by Petitioner teach, or even remotely suggest, the four requisite TC ratios recited by challenged claim 1. We find Petitioner’s argument that a person of ordinary skill in the art would have been motivated to exclusively select Ye’s sample 15, out of the remaining 43, to which to apply the teachings of Hara and Otsuka concerning the requisite tensile strength and weight deviation ranges in the hope of arriving at the claimed invention, is implausible. Indeed, only the ’541 patent, among all of the evidence of record, that actually mentions the required texture coefficient ratios recited in challenged claim 1. Petitioner provides no convincing argument as to why a skilled artisan would have selected sample 15 for combination with Hara and Otsuka. Rather, Petitioner’s argument appears to be based upon impermissible hindsight reconstruction. However: Any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper. In re McLaughlin, 443 F.2d 1392, 1395 (C.C.P.A. 1971). Accordingly, Petitioner’s failure to suggest a reason as to why a person of ordinary skill in the art would have been motivated to select that single specimen, without knowledge of the specific TC ratios disclosed by the ’541 patent argues against Petitioner’s contention that the claims are obvious.” slip op. at 47
- PTAB / AIA Trials › Discretionary denialNot reached
“Discretionary Denial of Institution under 35 U.S.C. §§ 314(a) and 325(d) Because we deny institution of inter partes review on the merits, we do not reach the parties’ arguments in this respect.” slip op. at 58
§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 9,457,541 - Solus Advanced Materials Co, Ltd. v. SK Nexilis Co., Ltd.Institution deniedPTAB · Apr 22, 2025 · IPR2024-01460 · APJ Jon B Tornquist · IPR · Institution
The Board denied institution of review of claims 1–11 because the Fintiv factors, including the early trial date and close merits case, favored discretionary denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied fintivInstitution denied
“whether to institute an inter partes review. Applying the standard set forth in 35 U.S.C. § 314(a), we may not institute an inter partes review unless the information presented in the petition “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.” Institution of inter partes review, however, is discretionary. See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is permitted, but never compelled, to institute an IPR proceeding.”). For the reasons stated below, we exercise our discretion not to institute an inter partes review. A. Real Parties-in-Interest” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“Board’s projected statutory deadline to issue a final written decision. Fintiv, Paper 11 at 9. “If the court’s trial date is at or around the same time as the projected statutory deadline . . . the decision whether to institute will likely implicate other factors.” Id. Conversely, “[i]f the court’s trial date is earlier than the projected statutory deadline,” this has generally weighed “in favor of exercising authority to deny institution.” Id.” slip op. at 15
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“Petition under 35 U.S.C. § 325(d) because the same or substantially the same art and arguments were before the Examiner during prosecution and Petitioner’s has not demonstrated that the Examiner erred in a material manner when allowing the claims. Pet. 17–18. Given our discretionary denial of the Petition in view of the Fintiv factors, we do not address Petitioner’s further arguments with respect to § 325(d).” slip op. at 32
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner applies Petitioner’s recited level of ordinary skill in the art for purposes of its Preliminary Response. Prelim. Resp. 4. Upon review of the parties’ arguments and the prior art of record, we adopt Petitioner’s unopposed definition of the ordinarily skilled artisan for purposes of this decision as it appears consistent with the disclosures of the ’090 patent and the prior art of record. C. Claim Construction” slip op. at 9
§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,480,090 - Penumbra, Inc. v. Rapidpulse, Inc.InstitutedPTAB · Feb 21, 2025 · IPR2024-01261 · APJ Jamie T Wisz · IPR · Institution
Instituted IPR of claims 1–20 on all petitioned grounds after finding a reasonable likelihood that the challenged claims would have been obvious over the cited combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), the Board “may not authorize an inter partes review to be instituted unless . . . the information 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.” After considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1–20 of the ’402 patent, based on all of the grounds identified in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner, relying on the testimony of Mr. Brown, contends that a person of ordinary skill in the art (“POSA” or “POSITA”) as of the relevant date would be either: (1) a person with a B.S. in engineering or an equivalent field, with two-four years of academic or industry experience in aspiration embolectomy and thrombectomy or comparable industry experience who would, where appropriate, work or consult with others, including a physician, to develop embolectomy or thrombectomy devices; or (2) an interventional neurosurgeon with at least three years of experience developing and/or using medical devices in embolectomy or thrombectomy procedures, and who would, where appropriate, work or consult with others, including an engineer, to develop such a medical device. Pet. 11 (citing Ex. 1005 ¶ 48). Petitioner also contends that, “[a] person with less education but more relevant practical experience, or more relevant education but less practical experience, may also meet this standard.” Id. Patent Owner states that for purposes of its Preliminary Response, it accepts Petitioner’s proposed definition of POSA, but “reserves the right to propose its own description of a POSA if the Board institutes review.” Prelim. Resp. 8 n.3. For purposes of this Decision, we adopt Petitioner’s characterization because it is consistent with the level of skill in the art at the time of the invention as reflected by the ’402 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Petitioner provides a proposed construction for the term “[limited/limiting] to a positive amount of exit flow” recited in claims 3, 4, 13, and 15, as “the maximum permitted amount of positive exit flow in the distal direction, including no exit flow.” Pet. 15–16. Patent Owner asserts that “Petitioner’s proposed construction of ‘a positive amount of exit flow’ as ‘including no exit flow’ is plainly wrong.” Prelim. Resp. 9 (citing Pet. 15–16). Patent Owner also asserts that to the extent Petitioner “view[s] the claim term ‘flow in and out’ as encompassing only flow in or no flow at all, that would be plainly wrong too.” Id. Having evaluated the arguments and evidence before us on this record, we determine that construction of “[limited/limiting] to a positive amount of exit flow” is not necessary for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). Turning to a different claim term, we note that neither party provided an explicit construction for the limitation in claim 1 of “control[ling] fluid address the proper claim construction for this term and to specifically discuss what is encompassed by “flow . . . out from the distal end.” We note that in the related cases (IPR2021-01466 and IPR2022-00608), we construed the term, “forward flow” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters of fluid.” Ex. 2007, 15; Ex. 2011, 13–14. Upon review of the parties’ arguments and the evidence of record, we determine that no terms require express construction for purposes of this Decision. See Nidec Motor Corp, 868 F.3d at 1017.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“c) Analysis On the current record, we are persuaded that Petitioner has demonstrated a reasonable likelihood that the subject matter of claim 1 would have been obvious over the combined disclosures of Yang and Mullins. First, Patent Owner asserts that Yang does not disclose the limitation of “a controller . . . to control fluid flow in and out from the distal end.” Prelim. Resp. 21– 32. On the current record, we agree with Patent Owner that introducing a positive pressure pulse such as through the water hammer effect does not necessarily mean that there will be an overall distal end. See Ex. 2001 ¶¶ 53–54; Ex. 2005 ¶ 60; Ex. 2007, 51 n.12. This is especially true if an overall vacuum state is maintained in the catheter. See Ex. 2001 ¶ 56; Ex. 2007, 43; Ex. 2010, 125:11–18. Further, on the current record, we credit the testimony of Patent Owner’s declarant, Mr. Culbert, that to have flow out of the catheter’s distal end when it is in a patient, the pressure in the catheter needs to exceed mean arterial pressure. See Ex. 2001 ¶ 59; Ex. 2010, 126:15–21. Therefore, on the current record, we agree with Patent Owner that Yang may not explicitly disclose flow out from the distal end of the catheter. Whether Yang alone renders this limitation obvious may be explored further on a full trial record; however, because this limitation appears to be taught by Mullins and Petitioner has shown on this record that a POSA would have been motivated to combine the disclosures of Yang and Mullins, we are sufficiently persuaded that Petitioner has met its burden to show a reasonable likelihood that this limitation is rendered obvious by the combined disclosures of Yang and Mullins.” slip op. at 18
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,406,402 - Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentablePTAB · Nov 27, 2024 · PGR2022-00025 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1–19 are unpatentable because the ’201 patent lacks written description support for the claimed genus of CRF1 receptor antagonists under § 112(a).
RulingsFinal written decision- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“[A] sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1350 (citing Regents, 119 F.3d at 1568–69). Moreover, “an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Id. (citing Regents, 119 F.3d at 1568 (quoting Fiers, 984 F.2d at 1171)). Furthermore, “functional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. (citing Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001))). “[M]erely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id.” slip op. at 42
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would have 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 . . . [and] would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders.” Pet. 26–27 (citing Ex. 1005 ¶ 34 (Dr. Carey Declaration)). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’201 patent itself, see, e.g., Exs. 1024, 1025, 2003, 2004, 2005, we apply Petitioner’s proposed level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art). C.” slip op. at 22
- 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 an A4 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 ¶ 82. 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. Furthermore, despite Dr. Dobs’ testimony that “[t]he [prior art] references explain the typical CRF1 antagonist consists of a core nitrogen heterocycle with an aryl substituent adjacent to the core nitrogen atom and a branched alkyl group attached at the opposite end of the core,” Dr. Dobs also acknowledged that the “atypical CRF1 receptors depicted in Figures 11 and 12 of Williams had different structures, and lacked the nitrogen heterocyclic core.” Ex. 1042, 127:9–14, 130:13–131:16; see also Ex. 2014 ¶ 83. Additionally, Petitioner’s expert, Dr. Cutler, testified, by way of example, in his Reply Declaration that two of the ‘“first-generation CRF1 antagonists’ identified in Figure 1 of the Williams article do not fall within the Figure 2 structure Dr. Dobs relies upon.” Ex. 1047 ¶ 93. Indeed, with respect to the alleged core pharmacophore that Dr. Dobs” slip op. at 54
- ExcludeMotion to exclude, deniedMixed
“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. 1042, 52–53, 125–126, 126–128, 128–130) goes to the weight that we assign to such testimony, but we do not find that such testimony, in light of Dr. Dobs’ extensive qualifications as an endocrinologist set forth above, deems Dr. Dobs unqualified to testify concerning the written description issue in this proceeding. For these reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 20 and 75–87 of Exhibit 2014 is denied.” slip op. at 11
Patent outcomesUS 11,007,201 unpatentable§ 112 disclosurecites PhillipsPatents in suitUS 11,007,201 - 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 - Shanghai Hongene Biotech Corp. v. Chemgenes Corp.All claims unpatentablePTAB · Oct 17, 2024 · IPR2023-00875 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1 and 2 are unpatentable because the ’696 patent anticipates each claim.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“The parties’ proposed definitions of the level of ordinary skill, although different facially, are similar substantively. For example, both parties argue that a POSA would have high levels of skill, with advanced degrees and/or extensive work experience in organic chemistry.3 See Pet. 16; PO Resp. 21. In addition, Petitioner contends that a POSA would have had experience in the development of oligonucleotide building blocks. Pet. 16. Similarly, Patent Owner asserts that a POSA would have had education” slip op. at 8
- Expert testimonyPetitioner expert creditedDecided for patent owner
“have significant background in P(III) chemistry. Id. at 19; Sur-reply 12–13. According to Patent Owner, Dr. Baran published only about a dozen papers that relate to oligonucleotide synthesis, and the focus of those papers appears to be on P(V) chemistry, which is fundamentally different from P(III) chemistry. PO Resp. 19–20; Sur-reply 12–13. Although it does not challenge Dr. Baran’s qualification to provide opinion in this proceeding, Patent Owner asserts that “Dr. Baran’s lack of experience in P(III) synthesis[] should be strongly considered” in our evaluation of the weight of Dr. Baran’s testimony. Sur-reply 13. Patent Owner’s argument that Dr. Baran is principally experienced in P(V) chemistry presupposes that experience indicates an ignorance of P(III) chemistry. We do not find this position consistent with the breadth of Dr. Baran’s experience as indicated by his Curriculum Vitae. See Ex. 1003, 50–105. We weigh the testimonies of both Dr. Baran and Dr. Hrdlicka, against the cumulative weight of the evidence of record in assessing their credibility and probative value.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“To show anticipation under 35 U.S.C. § 102, each and every claim element, arranged as in the claim, must be disclosed in a single piece of prior art. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008). For a claim directed to a genus, if a prior art reference discloses a species falling within the claimed genus, the species anticipates the genus. In re Slayter, 276 F.2d 408, 411 (CCPA 1960); see also Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298 (Fed. Cir. 2009) (stating that when a claim 2 US Patent No. 5,869,696, issued Feb. 9, 1999 (Ex. 1014, “the ’696 patent”). element is written in Markush form, “the entire element is disclosed by the prior art if one alternative in the Markush group is in the prior art”).” slip op. at 6
- PTAB / AIA Trials › Motions to amend / substitute claimsOther
“Resp.”) and a Motion to Amend Claims (Paper 11, “MTA”). In the MTA, Patent Owner proposed to replace claims 1 and 2 with substitute claims 4 and 5. MTA 1–2. Petitioner filed an Opposition to Patent Owner’s MTA (Paper 13) and a Reply to Patent Owner’s Response (Paper 14, “Reply”). After we entered Preliminary Guidance on Patent Owner’s Motion to Amend (Paper 15), Patent Owner requested authorization to withdraw its MTA (Ex. 3003). We granted that request. Paper 17. Thereafter, Patent Owner filed a Sur-reply to Petitioner’s Reply (Paper 20, “Sur-reply”).1” slip op. at 2
Patent outcomesUS 8,309,707 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 8,309,707
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.