- Padagis US LLC v. Neurelis, Inc.InstitutedPTAB · Sep 16, 2025 · IPR2025-00466 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–27 because Petitioner showed a reasonable likelihood of prevailing on at least one claim, including claim 1 over Gwozdz and Meezan.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’786 patent’s challenged claims.1 We institute inter partes review on all challenged claims. SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“We find that Petitioner has made a threshold showing that the ’558 Provisional does not provide written description support for claim 1’s pharmaceutical solution consisting of each of the recited elements, including n-dodecyl beta-D-maltoside. It is true that “n-Dodecyl β-D-maltoside” can be found listed in the SIGMA Catalog. Ex. 1026, 316. But Dr. Donovan’s testimony helps put that listing in context. It is merely one among well over 100 ionic and non-ionic detergents listed in the cited six pages of the SIGMA Catalog. See 1026, 316–321; Ex. 1062 ¶ 50. When further considered in the context of paragraphs 150–152 of the ’558 Provisional, which generically suggest that “enhancer” compounds can be used in “some embodiments”—then introducing at least 15 classes of potential enhancers16 including “preferred” lysophospholipids and acyl carnitines—the listing of n-dodecyl beta-D-maltoside among at least 150 biological detergents in the SIGMA Catalog is even more remote. Moreover, although satisfaction of the written description requirement is not limited to what is exemplified in a priority application, none of the ’558 Provisional’s examples use any “enhancer,” much less any detergent, any alkyl glycoside, or n-dodecyl beta-D maltoside in particular. The 16 The ’558 Provisional suggests that whether “a given compound” will function as an “enhancer” in a formulation requires testing. Ex. 1008 ¶ 150 (indicating “an in vivo or good model test” may “determin[e] whether the uptake of the drug is enhanced to a clinically significant degree”). ethanol. See Ex. 1008 ¶¶ 172–174 (Examples 1 and 2). In short, we find no sufficient disclosure of “blaze marks” in the ’558 Provisional that point to the inventors’ possession of a pharmaceutical solution that includes n-dodecyl beta-D-maltoside as claimed. Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326–27 (Fed. Cir. 2000) (analogizing an application’s generic disclosures to a forest of unmarked trees and explaining that, “to satisfy the written description requirement,” there must be “blaze marks directing the skilled artisan to that tree [within the forest that represents the claimed invention]” in the application).” slip op. at 28
- PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner
“and applying collateral estoppel to vacate a claim construction in an underlying IPR). In an IPR, “a party seeking to invoke collateral estoppel must show: ‘(1) the issue is identical to one decided in the first action; (2) the issue was actually litigated in the first action; (3) resolution of the issue was essential to a final judgment in the first action; and (4) [the party against whom collateral estoppel is being asserted] had a full and fair opportunity to litigate the issue in the first action.’” Google LLC v. Hammond Development Int’l, Inc., 54 F.4th 1377, 1381 (Fed. Cir. 2022) (quoting In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994)) (alteration in original).14 “It is [also] well established that patent claims need not be identical for collateral estoppel to apply.” Id. at 1381. Instead, “collateral estoppel requires the issues of patentability be identical.” Id. If “the differences between the unadjudicated patent claims and adjudicated patent claims do not materially alter the question of invalidity, collateral estoppel applies.” Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333, 1342–43 (Fed. Cir. 2013) (affirming application of collateral estoppel where claims adjudicated as obvious required a “polymeric” gel whereas similar, unadjudicated claims required a “block copolymer” gel). “Collateral estoppel also applies to common issues in actions involving different but related patents.” Mycogen Plant Sci., Inc. v. Monsanto Co., 252 F.3d 1306, 1310 (Fed. Cir. 2001), vacated on other grounds, 353 U.S. 1109 (2002).” slip op. at 22
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artReference not prior artMixed
“We agree that at least one portion of Gwozdz is not prior art. To establish that the cited disclosures in Gwozdz are prior art, Petitioner must show support for those disclosures in the Gwozdz Provisional. In re Riggs, 131 F.4th 1377, 1384 (Fed. Cir. 2025) (explaining that “the portion of the application relied on . . . as prior art must be supported by the provisional application”). Petitioner did not establish that Gwozdz’s disclosure of “penetration enhancers” finds support in the Gwozdz Provisional. Pet. 22. Conversely, Patent Owner shows that the phrase is absent in the Gwozdz Provisional. Prelim. Resp. 37.20 Based on this record, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the 19 Patent Owner argues this “penetration enhancers” disclosure in Gwozdz is not prior art regardless which of the disputed priority dates (March 28, 2008, or March 27, 2009) one accords to the challenged claims. Prelim. Resp. 33. 20 We also agree that collateral estoppel does not bar Patent Owner from challenging Gwozdz’s prior-art status in this case. Patent Owner’s apparent concession that Gwozdz was prior art during the 451 IPR does not equate to the issue being actually litigated. Prelim. Resp. 34–35; Ex. 1040, 14 (“Patent Owner does not contest that Gwozdz is entitled to this filing date” of the Gwozdz Provisional). Purdue, 767 F. App’x at 922 (determining “[t]he priority date for the Joshi reference . . . cannot be determined based on collateral estoppel” where patentee could have argued, but did not in fact argue, Joshi’s prior-art status in an earlier matter).” slip op. at 35
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,793,786 - Padagis US LLC v. Neurelis, Inc.InstitutedPTAB · Sep 16, 2025 · IPR2025-00464 · APJ Annette R Reimers · IPR · Institution
The Board instituted IPR on claims 1–22, finding a reasonable likelihood that claim 1 would have been obvious over Gwozdz and Meezan.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“3. Conclusion For the reasons discussed above and based on the present record, we find that Petitioner has made an adequate threshold showing that the issues presented in this Petition are substantially the same as the issues the Board previously considered in IPR2019-00451 and that Gwozdz’s effective date is March 28, 2008. We therefore determine that Petitioner has shown that it is reasonably likely to prevail in establishing that at least claim 1 would have been obvious over Gwozdz and Meezan. IV. CONCLUSION Petitioner has shown a reasonable likelihood that it will prevail in establishing the unpatentability of at least one of the claims challenged in the Petition. We institute trial on all challenged claims under the grounds raised in the Petition. PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed.” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“[A POSA] would have been a pharmaceutical scientist, chemist, or biologist involved in the research and development of pharmaceutical formulations and/or delivery, and would have at least a Bachelor’s degree with at least 5 years of experience, or a Master’s, Ph.D. or Pharm.D. degree with several years of experience. In addition, a POSA would have had knowledge of benzodiazepine structure and function, and would further have knowledge and practical experience working with intranasal and transmembrane formulations, including knowledge of the physiology and anatomy of the nasal cavity, with relevant experience in developing intranasal formulations. Pet. 23; Ex. 1062 ¶ 20. Patent Owner “does not dispute” Petitioner’s POSA definition at this stage. Prelim. Resp. 16. We apply Petitioner’s proposed POSA definition for this Decision, which definition appears to be generally consistent with the cited prior art.” slip op. at 6
- PTAB / AIA Trials › §315(e) estoppelMixed
“As the Board’s decision in the 451 IPR explicitly found written description inadequate for the “alkyl glycoside” limitation in the ’558 Provisional, which is the same issue raised here for the ’546 patent, Petitioner has shown that issue was actually litigated and decided in the 451 IPR. Where the same issue is actually litigated and decided as part of a final adjudication in an earlier action, the test for invoking collateral estoppel in a later action is met. On this record and for the reasons above, we are persuaded that collateral estoppel bars Patent Owner from arguing the challenged claims are entitled to the priority date of the ’558 Provisional.” slip op. at 14
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedMixed
“We agree that at least one portion of Gwozdz is not prior art. To establish that the cited disclosures in Gwozdz are prior art, Petitioner must show support for those disclosures in the Gwozdz Provisional. In re Riggs, 131 F.4th 1377, 1384 (Fed. Cir. 2025) (explaining that “the portion of the application relied on . . . as prior art must be supported by the provisional application”). Petitioner did not establish that Gwozdz’s disclosure of “penetration enhancers” finds support in the Gwozdz Provisional. Pet. 22. Conversely, Patent Owner shows that the phrase is absent in the Gwozdz 9 Patent Owner argues that as the ’546 Patent claims priority to the ’439 Application, the “penetration enhancers” disclosure in Gwozdz is not prior art because Gwozdz and the ’439 Application were filed on the same day (March 27, 2009). Prelim. Resp. 21–22. 10 Patent Owner argues that the passage in Gwozdz concerning “penetration enhancers” is relevant solely to “a pharmaceutical composition for injection,” not for intranasal administration as required by the ’546 Patent. Prelim. Resp. 22. First, as noted above, based on the record presented, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the challenged claims. Second, we disagree, however, that Gwozdz’s non-prior art mention of penetration enhancers is relevant solely to a pharmaceutical composition for injection as argued by Patent Owner. Gwozdz discloses that “[the] pharmaceutical compositions of the present invention” can be administered by a number of “nonlimiting” routes including intranasal administration. See Ex. 1009, 9:2–11. Provisional. Prelim. Resp. 20–21. Based on this record, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the challenged claims. The phrase cannot, therefore, be used to establish a motivation to combine the asserted references.” slip op. at 18
§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,895,546 - PTAB · Sep 6, 2024 · IPR2024-00430 · APJ Jon M Jurgovan · IPR · Institution
The Board instituted IPR on claims 1–24 on all asserted grounds, finding a reasonable likelihood of prevailing on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in a petition and the preliminary 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.” Upon consideration of the Petition and Preliminary Response, and accompanying exhibits and evidence, we determine Petitioner has established a reasonable likelihood that it would prevail with respect to at least one challenged claim in the inter partes review. Therefore, we grant institution of an inter partes review as to all of the challenged claims of the ’690 patent on all challenges in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A POSITA6 would have had a bachelor’s degree in electrical engineering, computer engineering, or a similar discipline, and three to four years of experience working in signal processing and/or communication systems/networks. Additional education may substitute for experience, and significant work experience may substitute for formal education. Pet. 6 (citing Ex. 1002 ¶¶ 115–120). Patent Owner does not dispute Petitioner’s proposed level of skill in the art, which is consistent with the prior art references asserted by Petitioner. Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001) (stating that the applied prior art may reflect an appropriate level of skill). For this stage of the proceeding, we agree with and will use Petitioner’s proposed level for this Decision.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Since the parties apply what they contend is the plain and ordinary meaning of the claim terms in their briefs, and have stipulated in the Cox case that the plain and ordinary meaning applies, and Patent Owner argues that the district court’s construction in the Charter case is the plain and ordinary meaning, there is no controversy concerning claim terms that we need to resolve in this Decision. Pet. 6; Prelim. Resp. 10; Ex. 1005, 104–105; Ex. 2001, 2. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). At this stage of the proceeding, therefore, we apply the plain and ordinary meaning to the claim terms consistent with their ordinary and customary meaning under 37 C.F.R. § 42.100(b). We note, however, that Patent Owner seems to consider the court’s construction in the Charter case to require that the claimed “probe” must be of a type that can be compared with a reference signal. Prelim. Resp. 10. We question whether all of the different types of probes mentioned and claimed in the ’690 patent would require comparison with a reference signal. See, e.g., Ex. 1001, 2:7–19. However, this is a matter best resolved, if necessary, on a full record at trial.” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableUnpatentableMixed
“Prelim. Resp. 23 (citing Ex. 1013, 37) (annotated in red by Patent Owner). IEEE-802.16’s Table 5 shows that the CID is a field of a generic MAC header. Petitioner does not show sufficiently that the CID, located in the header, specifies content payload of a MAC message, as required by limitation 1A. Petitioner alternatively relies on IEEE-802.16’s ranging code index that it contends is another example of data that is in a ranging request parameter and is used for the ranging response payload. Pet. 15 (citing Ex. 1013, 49–51, 204–213, 576–579, 665–66; Ex. 1002 ¶ 149). Patent Owner asserts that the portions of IEEE-802.16 that Petitioner cites do not disclose that the ranging code index is sent as part of a ranging request message. Prelim. Resp. 25. Although the parts of IEEE-802.16 that Petitioner cites disclose that the ranging code index is sent from the SS to the BS and is included in a ranging response (Ex. 1013, 49–51, 204–213, 576–579, 665–66), the cited parts do not disclose that the SS sends the ranging code index to the BS in a ranging request. Consequently, Petitioner has not established that IEEE- 802.16 anticipates a ranging code index that is a parameter of a ranging request specifying the content payload of the ranging response corresponding to limitation 1A. For the foregoing reasons, on this record, we determine that Petitioner has not shown a reasonable likelihood to prevail in showing that claim 1 is anticipated by IEEE 802.16.” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 8,284,690 - PTAB · Feb 8, 2022 · PGR2021-00102 · APJ Patrick R Scanlon · PGR · Institution
The Board instituted PGR on claims 1–28 on all asserted grounds, finding a sufficient likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 324(a), a post-grant review may not 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.” After considering the Petition and Patent Owner’s Preliminary Response, as well as all supporting evidence, we determine that Petitioner has satisfied the burden under 35 U.S.C. § 324(a) to show that it is more likely than not that at least one of the challenged claims is unpatentable.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“These arguments are not persuasive, however, because Patent Owner does not explain adequately how the disclosures of Oehring and Shampine are cumulative of the disclosure of Mu. In this case, the mere fact that 8 We note that Exhibit 2007 does not have ¶ 95 cited by Patent Owner. not mean necessarily that the references are cumulative of Mu. For instance, Petitioner relies on Mu for allegedly disclosing several claim limitations including “receiving a demand hydraulic horse power (HHP) signal,” “the first output power being in a selected range of a maximum continuous power (MCP) level,” and “the second output power . . . being in a selected range of the MCP level to a maximum intermittent power (MIP) level.” Pet. 19–41. Patent Owner does not direct us to any disclosure in Oehring or Shampine that are cumulative of these alleged teachings in Mu. Accordingly, we do not agree with Patent Owner that either of Oehring or Shampine is cumulative of Mu. As such, we determine that Petitioner’s reliance on Mu does not involve the same or substantially the same art or arguments previously presented to the Office, and the first part of the Advanced Bionics framework is not satisfied with respect to Mu. And although Crowe is cited in the ’459 patent (see Ex. 1001, code (56)), Petitioner’s reliance on Crowe is minimal. The ground based on Mu and Crowe, thus, does not implicate § 325(d).” slip op. at 8
- Skill levelOther
“This dispute presents a factual issue best decided on a complete record. Accordingly, for purposes of the Decision, we determine that no express finding is necessary, and that the level of ordinary skill in the art is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). We note, however, that our obviousness analysis in this Decision would not differ if we adopted either Petitioner’s or Patent Owner’s definition.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionTerm construed board ownOther
“We agree with Patent Owner that Petitioner has not explained sufficiently what a “maximum power output value” means in the context of the ’459 patent. Nor has Petitioner explained sufficiently why “maximum intermittent power” should be tied to the “maximum power output value.” In contrast, Patent Owner’s proposed construction is supported by the Specification, although we do not agree with the last clause of the construction because the references to “typical” values do not assist in understanding the claim language. Accordingly, for purposes of this Decision, we preliminarily construe “maximum intermittent power” to mean “an elevated operating output level that the pump unit may operate intermittently throughout its operating life without excessive damage to the pump unit.”” slip op. at 14
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · Graham · NautilusPatents in suitUS 10,907,459
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.