- Inari Agriculture, Inc. v. Corteva Agriscience LLCNo claims unpatentablePTAB · Nov 18, 2025 · IPR2024-01014 · APJ Zhenyu Yang · IPR · Final written decision
Petitioner did not show claims 1–8 unpatentable because they are entitled to the 2004 priority date, making Barbour unavailable as prior art.
RulingsFinal written decision- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Entitled to earlier dateDecided for patent owner
“For a claim to a biological material, the enablement requirement of § 112, first paragraph, does not require such assured access to a microorganism deposit as of the filing date; what is required is assurance of access (to the microorganism culture by the public upon issuance of a patent on the application) prior to or during the pendency of the application, so that, upon issuance of a U. S. patent on the application, the public will, in fact, receive something in return for the patent grant. Feldman, 517 F.2d at 1355. Patent Owner has persuaded us that such exception not only applies to a deposit, but also extends to a biological material known and readily available. See 52 Fed. Reg. 34080, 34081. In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art.” slip op. at 15
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable
“In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“would understand that the term “‘flanked by’ permits overlap between the expression cassette and the DNA sequence it is flanked by.” Pet. 24–26. Patent Owner does not propose any claim construction. PO Resp. 6–7. On this record and for purposes of this Decision, we see no need to expressly construe any claim term.” slip op. at 9
Patent outcomesUS 8,901,378 not shown unpatentableClaim construction§ 102 anticipation§ 112 disclosurecites PhillipsPatents in suitUS 8,901,378 - Padagis US LLC v. Neurelis, Inc.InstitutedPTAB · Sep 16, 2025 · IPR2025-00465 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–18 because Petitioner showed a reasonable likelihood of proving claim 1 obvious over Gwozdz and Meezan.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the relevant art. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) secondary considerations (i.e., objective indicia) of nonobviousness when presented.6 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). To show unpatentability based on a combination of teachings, “[a]n obviousness determination [also] requires finding both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” CRFD” slip op. at 7
- 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. 23–24; Ex. 1062 ¶ 20. Patent Owner “does not dispute” Petitioner’s POSA definition at this stage. Prelim. Resp. 18. 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 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“standard used in a civil action before the courts under 35 U.S.C. § 282(b), including construing claim language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only expressly construe terms to the extent needed to resolve the controversy before us. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019).” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“applicant, as part of the bargain with the public, must describe his or her invention so that the public will know what it is and that he or she has truly made the claimed invention.” AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1298 (Fed. Cir. 2014). “[T]he test for sufficiency [of the written description requirement] is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date sought.” Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (explaining that “the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”) (internal quotation marks omitted); see also id. at 1352 (“[A] description that merely renders the invention obvious does not satisfy the requirement.”).” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,241,414 - 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 - PTAB · May 23, 2025 · IPR2025-00195 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on all challenged claims based on the petition’s grounds, finding a reasonable likelihood of success on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Inter partes review may not be instituted unless there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. See 35 U.S.C. § 314(a). For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’998 patent’s challenged claims. We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSA”) at the relevant time “would have had a bachelor’s degree in Electrical Engineering, Mechanical Engineering, or a similar discipline with at least one year of experience with portable electronic devices,” and that “[m]ore education can substitute for practical experience and vice versa.” Pet. 6 (citing Ex. 1003 ¶¶ 23–25). Patent Owner does not at this time dispute Petitioner’s definition of the POSA’s skill level. Prelim. Resp. 14. We apply Petitioner’s proposed POSA level, which appears to be generally consistent with the cited prior art.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“At this time, express claim interpretation is not needed to resolve the controversy. According to Patent Owner, “claim construction is unnecessary at this stage because the prior art fails to invalidate under any reasonable construction of the claims.” Prelim. Resp. 14. Patent Owner does not, however, challenge Petitioner’s contentions under any of Grounds 1–5 that the asserted prior art teaches or suggests the claimed subject matter. Patent Owner’s counterargument at this time is limited to whether the asserted references qualify as prior art. See, e.g., id. at 510 (arguing most of Petitioner’s references (e.g., Downey) “fail to qualify as prior art due to their 9 Unless otherwise stated, emphases appear in the cited paper or evidence. 10 Patent Owner’s Preliminary Response includes an initial unnumbered page and the second page is numbered page “6.” The unnumbered page is, therefore, cited herein as page “5.” according to Patent Owner) or “due to insufficient evidence of public availability (in the case of Ohgi).”). We address this counterargument, which does not turn on a dispute about the meaning of any claim terms, below. See infra Sections III.D and III.G.11 Regarding Petitioner’s contention of “ambiguity” in the phrase “each of the measurements” in claims 1 and 8, Patent Owner states only that “there is no ambiguity.” Prelim. Resp. 14. If Patent Owner believes that either of Petitioner’s suggested “broader” or “narrower” interpretations of the phrase is incorrect, or if Patent Owner wants to propose another interpretation altogether, Patent Owner may address such issues in its Response during trial. And, should it elect to do so, Patent Owner will have the opportunity at trial to explain why the claims do not read on the asserted art under any interpretation advanced by Petitioner or proposed by Patent Owner.” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“sufficient written description support in either the ’315 PCT Application or the ’422 Provisional for a sensing unit that comprises a compass. The ’315 PCT Application (and similarly the ’422 Provisional) describes the sensing unit as “includ[ing] accelerometer means and gyroscope means” and that a processor is adapted to receive from a sensing unit having those features (i.e., an accelerometer and gyroscope) measurements from which data indicative of a training activity can be calculated. See, e.g., Ex. 1005, 5:13–19, 5:30–33; Ex. 1004, 5:2–28, 12:2–31. Patent Owner identifies no express or inherent disclosure of a compass in the priority applications filed before March 11, 2009. It seems all “compass” disclosures were added only when the CIP application that issued as the ’998 patent was filed. Compare, e.g., Ex. 1001, 10:23–29, 50– 59 (new or revised paragraphs adding references to a compass), with Ex. 1005, 14 (no corresponding paragraphs or descriptions of a compass). That a compass might be “compatible” with devices described in the ancestral applications or even provide alleged benefits (e.g., mitigating a swimmer’s “drift” compared to a fixed external reference, as argued by Patent Owner) misses the point. Prelim. Resp. 12–13; Paper 9, 1–2. To obtain the priority benefit of the ancestral applications’ filing dates, those applications must describe the invention of the challenged claims. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997) (explaining that, to claim “the benefit of the filing date of an earlier application under 35 U.S.C. § 120, each application in the chain leading back to the earlier application must comply with the written description requirement of 35 U.S.C. § 112”). And whether it might have been obvious to add a compass is not the proper inquiry. Ariad Pharm., Inc. v. Eli Lilly description that merely renders the invention obvious does not satisfy the [written description] requirement”).” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 7,980,998 - PTAB · Dec 16, 2024 · IPR2024-01014 · APJ Zhenyu Yang · IPR · Institution
The Board instituted inter partes review of claims 1–8 on all asserted grounds, finding a reasonable likelihood that Barbour would render the challenged claims unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Anticipation by or Obviousness over Barbour Petitioner asserts that Barbour anticipates and/or renders obvious all challenged claims. Pet. 6, 41–67. Patent Owner does not dispute these assertions. Barbour is the published 2004 application and shares the same disclosure as the ’378 patent. Based on this record, we find Petitioner’s arguments on anticipation and/or obviousness persuasive. Thus, we determine Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of the challenged claims. We institute inter partes review of all challenged claims on all of the grounds in the Petition.” slip op. at 21
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledDecided for petitioner
“4. Summary In sum, based on the current record, and for purposes of this Decision, Petitioner has shown sufficiently that the disclosure of the 2004 application, by itself, fails to enable POSAs to practice the challenged claims without undue experimentation. In addition, Patent Owner has not shown that TC1507 was “known and readily available to the public” as of the filing date of the 2004 application. Therefore, the 2004 application does not enable the challenged claims, and the challenged claims are not entitled to the 2004 priority date. The earliest possible priority date for the challenged claims is, thus, July 6, 2007, which is the filing date of the 2007 application.” slip op. at 18
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner
“4. Summary In sum, based on the current record, and for purposes of this Decision, Petitioner has shown sufficiently that the disclosure of the 2004 application, by itself, fails to enable POSAs to practice the challenged claims without undue experimentation. In addition, Patent Owner has not shown that TC1507 was “known and readily available to the public” as of the filing date of the 2004 application. Therefore, the 2004 application does not enable the challenged claims, and the challenged claims are not entitled to the 2004 priority date. The earliest possible priority date for the challenged claims is, thus, July 6, 2007, which is the filing date of the 2007 application.” slip op. at 18
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artPrinted publication establishedDecided for petitioner
“Thus, the critical issue is not, as Patent Owner asserts, whether “the same application can be simultaneously enabling and not enabling.” Id. at 32. It is whether TC1507 was “known and readily available” to the public at the relevant time. As explained above, for the priority determination, the relevant time is April 30, 2004, the filing date of the 2004 application. Patent Owner has not produced or pointed to any evidence to show TC1507 corn “readily available” to the public without restrictions as of the filing date of the 2004 application. On the other hand, for prior-art status determination, the relevant time is February 16, 2006, the publication date of Barbour. Petitioner has presented sufficient evidence, which Patent Owner does not challenge, to show that, by 2006, corn harvested from TC1507 plants was “commercially available following the 2003, 2004, and 2005 growing seasons” and “[s]uch corn was sold as a commodity—without any contractual restrictions” Pet. 52 (citing Ex. 1007 ¶ 134). As a result, based on the current record, we find Petitioner has established sufficiently that, as of its publication date in February 2006, Barbour is prior art that would have enabled practice of the subject matter encompassed by the challenged claims.” slip op. at 20
§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 8,901,378 - Marinus Pharmaceuticals, Inc. v. Ovid Therapeutics, Inc.All claims unpatentablePTAB · Aug 1, 2024 · PGR2023-00020 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 22 and 25–31 are unpatentable because the Board found them obvious over Zhang with Saporito P1 and Saporito P2, and not enabled.
RulingsFinal written decision- Skill levelDecided for petitioner
“IV. LEVEL OF ORDINARY SKILL IN THE ART We consider the grounds of unpatentability in view of the” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“3. Analysis We start with the language of claim 22 that recites “the pharmaceutical composition provides improvement to the patient after administration for more than 8 hours.” Claim 22 does not indicate whether this is after the start of administration, after the completion of administration, or after some intermediate point. However, the plain language suggests that recited “improvement” occurs “after” the recited “administration” period. See, e.g., KEYnetik, Inc. v. Samsung Electronics Co., Ltd., 837 F. App’x 786, 792 (Fed. Cir. 2020) (“use of the word ‘after’ in the claim indicates a temporal relationship.”) We therefore turn to the ’817 patent specification for clarification. The ’817 patent repeats the claim language in a number of locations. See, e.g., Ex. 1001, 5:1–2, 5:9–11; 14:21–41; 15:18–19; 24:45–49. The ’817 patent provides definitions of “Improvement” and of “Improvement in next functioning,” but neither of these definitions addresses the timing issue. See id. at 29:57–30:5. The schematic drawing in Figure 2, however, addresses timing, and is reproduced below: “FIG. 2 is a schematic drawing depicting a timeline for an evaluation study of the ability of allopregnanolone, ganaxolone and gaboxadol to block benzodiazepine resistant status epilepticus in rats.” Ex. 1001, 3:48–51. Figure 2 differentiates between a 30 minute administration period, a 120 minute post-drug dosing period during which the animals are observed, and a 24 hour timepoint after which the animals are weighed, consistent with the ’817 patent disclosure that “[a]ll rats are observed and scored for seizure severity for 120 min post drug administration.” Ex. 1001, 35:64–65. This disclosure tends, on balance, to support Patent Owner’s proposed interpretation. Turning to the extrinsic evidence, Dr. Sankar similarly stated whether a patient with SE has sustained any improvement after administration of a drug is typically assessed at a point in time after a full dose is administered, rather than starting the clock after the first administration of only part of the dose. This is because the full dose of the drug is generally required to provide the expected effect.” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“3. Analysis a. Claim 22 It is Petitioner’s burden to show by a preponderance of the evidence that claim 22 of the ’817 patent is unpatentable as anticipated by Zhang, and we find that Petitioner has failed to meet its burden. See 35 U.S.C. § 326(e). We agree with Petitioner, as discussed in our claim interpretation section above, that patients within the scope of claim 22 include animals such as rats, and also that Zhang teaches “[s]eizure disorders that may be treated with the substituted β-cyclodextrin-ganaxolone injectable formulation include status epilepticus.” Ex. 1009 ¶ 70. As to the intravenous administration requirement in claim 21, from which claim 22 depends, we also agree with Petitioner that Zhang teaches embodiments where the “substituted β-cyclodextrin-ganaxolone injectable formulation is administered as an intravenous infusion dose.” Id. ¶ 76. We therefore agree that Zhang teaches intravenous treatment using a ganaxolone formulation in patients with status epilepticus. See, e.g., id. ¶¶ 22, 70, 76. As discussed above, we agree with Patent Owner that claim 22 is properly interpreted to require improvement 8 hours after total administration of the ganaxolone dose. A preponderance of the evidence of record does not support Petitioner’s position that Zhang inherently, and therefore necessarily, provides improvement after administration for more than 8 hours. Even if claim 22 simply required improvement 8 hours after initiation of a ganaxolone dose, we would still conclude that a preponderance of evidence does not support Petitioner’s position. Zhang provides no evidence of improvement at an 8 hour timepoint” slip op. at 29
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia no nexusDecided for petitioner
“disclosure suggesting that treatment with ganaxolone will result in “improvement to the patient after administration for more than 8 hours.” Also, as we discussed above with regard to anticipation, a preponderance of the evidence does not show that Zhang alone would inherently and necessarily result in 8 hour improvement in any particular species of patient after administration of ganaxolone. That conclusion is supported by Petitioner’s own expert, Dr. Rogawski, who stated with regard to the claimed 8 hour improvement that “I think it’s possible that there could be improvement, there might not be improvement. When one is treating a medical condition, there’s always a degree of variability and one doesn’t expect a certain outcome.” Ex. 2015, 155:9–16. Dr. Rogawski therefore acknowledges that improvement at the 8 hour timepoint is not necessarily the natural result of ganaxolone treatment and may not necessarily occur.” slip op. at 41
Patent outcomesUS 11,395,817 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,395,817 - PTAB · Jul 23, 2024 · IPR2024-00669 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–8 and 11, finding a reasonable likelihood of success on at least one claim under the Saadat grounds.
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 ’077 patent’s challenged claims. Also, we decline to deny the Petition on a discretionary basis. Therefore, we institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“As discussed below (Section IV.D), we determine at this stage that Saadat is prior art. There is no argument from Patent Owner that Saadat was presented previously to the Office. Pet. 96 (Petitioner’s unrebutted argument that Saadat was not previously considered by the Examiner). And, beyond the unsuccessful attempt to antedate and, thus, disqualify Saadat as prior art, at this stage of the proceeding Patent Owner offers no argument or evidence to rebut Petitioner’s contention that Saadat anticipates and renders obvious the ’077 patent’s claims under Grounds 1–3. See generally Prelim. Resp. 8–26 (Patent Owner’s priority date arguments). For the above reasons, we find that Patent Owner has not shown that substantially the same prior art or arguments (i.e., Saadat and arguments based thereon) were previously presented to the Office and, thus, Patent Owner has not satisfied step one of Advanced Bionics’ two-step framework. Advanced Bionics, Paper 6 at 8. On this record, even if we accept Patent Owner’s contentions about the Office’s prior consideration of Makower or Fang (art asserted under Grounds 5 and 6), we do not find that § 325(d) is sufficiently implicated based on our determination on the priority issue and Petitioner’s otherwise uncontested argument that the challenged claims are unpatentable over Saadat—issues we discuss in more detail below.” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not propose an alternate definition of the POSA’s qualifications or contest Petitioner’s definition. See generally Prelim. Resp. We apply Petitioner’s proposed POSA level, which appears to be consistent with the level of skill shown in the prior art of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that, “[f]or purposes of this IPR, the Board need not construe any terms.” Pet. 18. Patent Owner similarly does not propose any express claim construction for any of the challenged claims at this time. See generally Prelim. Resp. and based on our review of the record, we determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Realtime Data, 912 F.3d at 1375.” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 11,679,077 - PTAB · Jul 23, 2024 · IPR2024-00279 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted review of claims 1–3, 7, 9, 10, and 17–25 on all petitioned grounds, finding a reasonable likelihood of success on at least one claim.
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 1–3, 7, 9, 10, and 17–25 of the ’675 patent are unpatentable.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Specification of the ’675 patent provides written description support for the challenged claims. The challenged claims are purportedly directed to treating a nasal condition comprising “delivering energy to the target tissue” to reduce mucus secretion or congestion. Ex. 1001, claims 1 and 17. As noted by Petitioner, the ’675 patent Specification does not describe the use to energy to treat a nasal condition in the manner recited in the claims. Pet. 24–25. Rather, the ’675 patent Specification discloses the use of neurotoxins to treat nasal conditions, and, more specifically, that neurotoxins are used to disrupt neural signals in the targeted tissue and, therein, disable mucus secretion by such tissues. Ex. 1001, 3:25–34, 8:18–21, 8:38–60, achieve cell membrane permeabilization or poration and effectuate the delivery of neurotoxin into to target cells. See, e.g., id. at 4:49–51, 8:4–21. Here, we note that the challenged claims do not recite administering neurotoxins, but instead only require the delivery of energy to the target tissue to administer therapy.” slip op. at 16
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedDecided for petitioner
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted
“probe in a nasopharyngeal passage of a patient for the ablation of a posterior nasal nerve. Id. at 30 (citing Ex. 1002 ¶¶ 85–99). Petitioner also contends that “Saadat explains that RF ablation disrupts neural activity to reduce or eliminate rhinitis symptoms, including mucus secretion and congestion.” Id. at 36 (citing Ex. 1003, 3:6–14 (“Ablating [posterior nasal] nerves leads to a decrease in or interruption of parasympathetic nerve signals that contribute to congestion and rhinorrhea in patients with chronic rhinitis (allergic or vasomotor).”), 16:44–51; Ex. 1002 ¶ 103). Patent Owner at this stage does not offer any arguments addressing Petitioner’s substantive showing, which we find sufficient for institution purposes. See generally Prelim. Resp. Rather, Patent Owner contends Saadat is not prior art because the ’675 patent is entitled to rely upon the July 21, 2006, filing date of the ’090 application. Id. at 24. For the reasons discussed above, we determine that the Specification of the ’675 patent fails to provide adequate written description support for the challenged claims, and thus, the challenged claims are entitled to an effective filing date no earlier than October 22, 2019. Saadat is a U.S. patent that issued June 4,” slip op. at 33
§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,610,675 - Platinum Optics Technology, Inc. v. Viavi Solutions Inc.All claims unpatentablePTAB · Apr 11, 2024 · IPR2022-01489 · APJ Sharon Fenick · IPR · Final written decision
Claims 1–19 are unpatentable: Hendrix anticipates them, and the listed combinations also render their respective claims obvious.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“In the Decision on Institution, we adopted a slightly modified version of this definition in which we removed the open-ended term “at least.” Inst. Dec. 10–11. Patent Owner does not address the definition of a POSA. See generally PO Resp. Patent Owner’s declarant Dr. Clemens applies Petitioner’s definition, but does not opine on whether it is correct. Ex. 2001 ¶¶ 22–23. As in the Decision on Institution (Inst. Dec. 10), we apply the same slightly modified version of Petitioner’s definition of the level of ordinary skill in the art that removes the open-ended term “at least.” We determine this level of skill comports with the qualifications a person would have needed to understand and implement the teachings of the ʼ794 patent and the” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“filter comprises “a third set of layers on the second side, whether the third set of layers includes oxygen.” Ex. 1001, 10:41–49. Petitioner argues that the proper construction of this limitation “means that there is a third set of layers on the opposite side of the substrate, whether or not [the layers] include oxygen” – i.e., that the third set of layers do not need to include oxygen. Pet. 7–8. Patent Owner agrees that this is the “literal” reading of the language, but contends that one of ordinary skill in the art “would have appreciated that this language was intended to read ‘wherein’ rather than ‘whether’” and that the claim requires that this set of layers must include oxygen. PO Resp. 24–26 (citing Ex. 2001 ¶¶ 53–55). We agree with Petitioner’s representation that each of the challenges presented either anticipates or renders obvious a third set of layers with oxygen on a second side of a substrate (Pet. 8) and therefore, no claim construction is necessary for this term. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“415 F.3d at 1314): “a first set of layers on the first side, wherein the first set of layers includes silicon and hydrogen” (claim 1) and “a first set of layers including silicon and hydrogen” (claims 9 and 15). Ex. 1001, 10:41–49, 10:65–11:4, 11:17–12:5. As the parties agree, these recitations are broadly worded. See Pet. 14 (describing the recitations of the claims as “broad” and directed to “layers of any material that has both ‘silicon and hydrogen’”); PO Resp. 42 (describing the claims as “simply specifying physical layers including silicon and hydrogen in them”), 44 (describing the disputed terms as “open-ended claiming of layers including hydrogen and silicon”). Despite this broad language, Patent Owner contends that we must read “layers including silicon and hydrogen” in conjunction with other limitations in the claims reciting a “near infrared bandpass filter.” PO Resp. 35–37 (citing Ex. 2001 ¶¶ 65–66). For purposes of our analysis, we limit “layers including silicon and hydrogen” to only materials suitable for NIR bandpass filters, as suggested by Patent Owner. We next examine the rest of the intrinsic evidence. The specification of the ’794 patent does not contain language that generally describes “layers including silicon and hydrogen.” Instead, the specification describes only layers of hydrogenated silicon: its abstract is directed to an “optical filter” that “includes a filter stack formed of hydrogenated silicon layers” (Ex. 1001, code (57)); the technical field of the invention is described as “relat[ing] to optical filters including hydrogenated silicon layers and to sensor systems comprising such optical filters” (id. at 1:20–23); the summary of the invention describes “the present invention” as an optical filter or sensor system “comprising” “a plurality of hydrogenated silicon layers” (id. at 2:57–3:19); and the detailed description begins with a hydrogenated silicon (Si:H) layers” (id. at 4:19–20). The specification only mentions silicon and hydrogen separately with respect to the disclosed sputter-deposition system “used to produce the hydrogenated silicon material.” Id. at 4:35–5:61, 7:10–19. In particular, the specification describes how “cathode 430 includes a silicon target 431, which is sputtered in the presence of hydrogen (H2), as well as an inert gas such as argon, to deposit the hydrogenated silicon material as a layer on the substrate 420.” Id. at 4:44–47. The specification also describes how altering the hydrogen flow rate in the deposition process affects the optical properties of hydrogenated silicon produced by the deposition system. See id. at 5:1–61. But the only end product described from the sputter-deposition process using silicon and hydrogen is hydrogenated silicon. See id. at 4:35–5:61, 7:10–19. As such, the specification does not provide any indication of materials beyond hydrogenated silicon that are within the scope of “layers including silicon and hydrogen.”” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“hydrogen” defines a genus. The test for providing a written description that supports a genus claim is whether the description provides “either a representative number of species falling within the scope of the genus or in the art can ‘visualize or recognize’ the members of the genus.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en banc). “Regarding whether common structural features must exist between a claim and a putative priority disclosure, those features must constitute the near-entirety of the structures being compared.” Regents of the Univ. of Minnesota v. Gilead Scis., Inc., 61 F.4th 1350, 1358 (Fed. Cir. 2023). Yet the patentees only disclosed hydrogenated silicon as a possible species. Indeed, the specification focuses on a singular example of a sputterdeposition system that is used to produce an improved hydrogenated silicon material. See Ex. 1017 ¶¶ 36–38. Patent Owner cites this deposition process as written description support for “the claimed layers containing silicon and hydrogen.” See PO Resp. 44. But this example supports only how to make hydrogenated silicon and does not include any indication about what other materials would be within the scope of the claimed genus. Under these circumstances, the specification’s disclosure of a single species is not an adequate number to show possession of the entire genus of “layers including silicon and hydrogen.” Beyond the disclosure of the sputter-deposition process for producing hydrogenated silicon, Patent Owner does not identify—and we cannot discern—any other examples of a “structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Ariad, 598 F.3d at 1350. This is particularly noteworthy given that undisputed record evidence shows numerous other potential filter materials “including silicon and hydrogen.” See supra § II.D.1.a. In the absence of structural description supporting “layers including silicon and hydrogen,” we determine that an” slip op. at 19
Patent outcomesUS 11,131,794 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites GrahamPatents in suitUS 11,131,794 - PTAB · Dec 19, 2023 · IPR2023-01037 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–29 and all asserted grounds, finding a reasonable 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. § 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. Considering the parties’ arguments and evidence, for reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’283 patent’s challenged claims. We decline to deny the Petition on the basis of discretion under § 325(d). We institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“35 U.S.C. § 325(d). In evaluating whether to deny institution under 325(d), the Board has considered several non-exclusive factors: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination; (d) the extent of the overlap between the arguments made during examination and the manner in which a petitioner relies on the prior art or a patent owner distinguishes the prior art; (e) whether a petitioner has pointed out sufficiently how the Office erred in evaluating the asserted prior art; and (f) the extent to which additional evidence and facts presented in the petition warrant reconsideration of the prior art or arguments. See Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first para.). Factors (a), (b), and (d) relate to whether the art or arguments in the Petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 10 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in the Office’s prior consideration of that art or arguments. Id. Under Advanced Bionics’s two-part framework, we first determine whether the same or substantially the same art or arguments previously were presented to the Office. Id. at 8, 10. If “either condition of [the] first part of Office has been shown. Id. at 8, 10.” slip op. at 68
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing. Petitioner’s proposal could have been more specific, but it is not so lacking that the institution burden is unmet. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in a “relevant discipline,” Petitioner is referring to the technical areas it cited previously, such as protein/enzyme biochemistry. Pet. 18. Petitioner’s definition does not ignore subject matter like “transgenic plants” because it states that the POSA would be able to apply key scientific concepts here (e.g., protein biochemistry, enzyme activity, and substrate selectivity) to such plants. Moreover, although Patent Owner complains about Petitioner’s POSA definition, it does not offer its own or explain why Petitioner’s challenge fails under any alternative definition. At this stage, Patent Owner’s suggestion that Dr. Hausinger lacks relevant expertise or qualifications of at least a POSA is unpersuasive. The ’283 patent relies on Dr. Hausinger’s own prior work. See, e.g., 1002, 18:44–50 (citing Hogan (Ex. 1027)), 50:51–55 (citing Fukumori (Ex. 2001)) (both references co-authored by Dr. Hausinger). Patent Owner also cites Dr. Hausinger’s work as evidencing what “skilled artisans” understood about the claimed and prior art technology, including αKGD dioxygenases, which is a focus of the parties’ arguments. See, e.g., Prelim. Resp. 8 (“Thus, as reflected in Hogan and Hotopp [(co-authored by Dr. Hausinger)], skilled artisans understood the structure-function relationships of Group II αKG-dependent dioxygenases . . . .”); Ex. 1029 (Hotopp 2002)). During prosecution, Dr. Wright’s declaration relied on Dr. Hausinger’s research. See, e.g., Ex. 1008, 462 (Wright I ¶ 13 (citing Hotopp)), 658 (Wright II artisans”)). And, Applicant’s other declarant, Dr. Nair, who testified about the POSA’s perspective at the time of the invention, appears to have academic and prior work history focused on chemistry, biochemistry, and enzymology without significant background in subjects like “controlling weeds” about which Patent Owner questions Dr. Hausinger’s qualifications. See, e.g., Ex. 1008, 590–591.17 Patent Owner will have the chance to cross-examine Dr. Hausinger in this proceeding. If Patent Owner feels we should discount Dr. Hausinger’s testimony due to lack of qualifications, it may raise such argument in trial. For now, we apply Petitioner’s proposed POSA level, with the” slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“C. Claim Construction In inter partes review, we construe claims using the same claim construction standard used to construe claims in a civil action before the courts under 35 U.S.C. § 282(b), including construing claims in accordance with the ordinary and customary meaning as understood by the POSA and the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms that are in controversy and only as needed to resolve the matters in dispute. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). 17 The closest work we see from Dr. Nair related to herbicide resistant transgenic plants is his 2019 paper co-written with the applicant’s employees (e.g., Dr. Wright), which paper appears to be a follow-on investigation into the AAD-1 proteins of the patent. Ex. 1008, 594–595; Ex. 1019, Abstr. proceeding. Pet. 17; Prelim. Resp. 20. It is not apparent at this stage that any terms need further interpretation to resolve the matters in dispute.18” slip op. at 24
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 11,149,283
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.