- Nexus Pharmaceuticals, LLC v. Exela Pharma Sciences, LLCInstitution deniedPTAB · Aug 8, 2024 · PGR2024-00016 · APJ Ulrike W Jenks · PGR · Institution
The Board denied institution of PGR on claims 1–30 under § 325(d), finding substantially the same art or arguments had been presented to the Office and no material error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“Under 35 U.S.C. § 324(a), a post-grant review may be instituted only if “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Post-grant review is available for patents that issue from applications that at one point contained at least one claim with an effective filing date on or after March 16, 2013. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), §§ 3(n)(1), 6(f)(2)(A). After considering the briefing and the evidence of record, for the reasons set forth below, we exercise discretion to deny institution under § 325(d). Accordingly, we do not institute a post-grant review of the challenged claims of the ’370 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.”3 Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). We consider several non-exclusive factors as set forth in Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (Dec. 15, 2017) (precedential as to § III.C.5, first paragraph) (“Becton, Dickinson”), which “provide useful insight into how to apply the 3 The Board institutes trial on behalf of the Director. 37 C.F.R. § 42.4(a). framework” under § 325(d). Advanced Bionics, 9. These non-exclusive factors include: (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, including whether the prior art was the basis for rejection; (d) the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art; (e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of 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. Becton, Dickinson, 17–18 (formatting added). “If, after review of factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office.” Advanced Bionics, 10.” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art: would have had an advanced degree like a Ph.D. or equivalent in chemistry, biochemistry, pharmaceutics, pharmacy, or a related pharmaceutical field, with at least two years of experience in pharmaceutical formulation development, analysis, optimization and manufacturing, including experiences with processes and techniques for minimizing impurities in, and improving the stability of, pharmaceutical drug products during manufacture and storage. Pet. 27 (citing Ex. 1003 ¶ 24). Petitioner also states that one of ordinary skill in the art “may also have lesser levels of education but more years of experience” and “[a] multi-disciplinary team consisting of individuals with different skills and experience could also suffice.” Id. Patent Owner argues that: A person of ordinary skill in the art has attained a Pharm. D., or M.S. or Ph.D. in chemistry, chemical engineering, or a related field; has three or more years of experience in developing aqueous drug formulations; and has access to other scientists to collaborate and consult with on, for example, characterizing the drug formulation, manufacture of the drug formulation, and clinical use and effect of the drug formulation.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Because this Decision declining to institute trial does not necessitate the application of any express claim construction, we need not construe any terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 8
Claim constructionDiscretionary denialPatents in suitUS 11,642,370 - Ivantis, Inc. / Alcon Research, LLC et al. v. Sight Sciences, Inc.Institution deniedPTAB · Mar 27, 2023 · IPR2022-01533 · APJ Ulrike W Jenks · IPR · Institution
The Board denied institution of review of claims 1, 2, 5, 7, 8, 10, 11, 15, 18, 21, 23, 32, 33, 36, 38, 39, 41, 42, 46, 49, 52, 54, 63, 65, 68–70, 73, 77, …
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“(1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Id. at 8.” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached
“6 Patent Owner presents an alternative basis for denying institution under 35 U.S.C. § 314(a) based on Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) and the Director’s Memo re Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (“Vidal Memo”), at 4 (June 21, 2022). Prelim Resp. 76–81. Because we deny institution based on 35 U.S.C. § 325(d) need not separately reach a conclusion based on Fintiv in this decision.” slip op. at 9
Discretionary denialPatents in suitUS 8,287,482 - Ivantis, Inc. / Alcon Research, LLC et al. v. Sight Sciences, Inc.Institution deniedPTAB · Mar 27, 2023 · IPR2022-01530 · APJ Ulrike W Jenks · IPR · Institution
The Board denied institution of IPR for claims 1–3, 6–9, 12, 13, 15, and 17–20 under § 325(d), finding the art or arguments substantially similar to those previously considered and no material examiner error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“4. Summary Considering the above Becton Dickson factors as they are incorporated into the two-part Advanced Bionic framework, we find that the factors weigh in favor of exercising our discretion and denying institution under § 325(d). The asserted art is either the same as, or cumulative to, the prior art that Examiner has already considered during prosecution of the ’742 patent and its parent application. Further, the arguments Petitioner Examiner during prosecution. Thus, we deny institution under § 325(d). III. CONCLUSION Because the same or substantially the same art previously were presented to the Office and Petitioner has not demonstrated that Examiner materially erred when considering the prior art, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’742 patent.” slip op. at 29
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached
“A. Discretion Under 35 U.S.C. 325 (d) We first consider Patent Owner’s request that we deny institution7 under 35 U.S.C. § 325(d). Prelim. Resp. 9–52. Patent Owner contends that Petitioner’s alleged prior art was presented previously to Examiner during prosecution of the ’742 patent and its parent applications. Id. In the Patent Owner Response, Patent Owner provides a patent family tree, reproduced below. The patent family tree shows that “[t]he ’443 is a parent and the ’789 is a grandparent of the ’742” patent. Prelim. Resp. 8. Patent Owner argues that the same “Primary Examiner . . . examined all patents in this family. (See 7 Patent Owner presents an alternative basis for denying institution under 35 U.S.C. § 314(a) based on Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) and the Director’s Memo re Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (“Vidal Memo”), at 4 (June 21, 2022). Prelim Resp. 76–81. Because we deny institution based on 35 U.S.C. § 325(d) need not separately reach a conclusion based on Fintiv in this decision.” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“III. CONCLUSION Because the same or substantially the same art previously were presented to the Office and Petitioner has not demonstrated that Examiner materially erred when considering the prior art, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’742 patent. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner’s request for an inter partes review, pursuant to 35 U.S.C. § 314(a), of claims 1–3, 6–9, 12, 13, 15, and 17–20 of the ’742 patent is denied, and no trial is instituted.” slip op. at 30
Discretionary denialPatents in suitUS 10,314,742 - Ivantis, Inc. / Alcon Research, LLC et al. v. Sight Sciences, Inc.Institution deniedPTAB · Mar 22, 2023 · IPR2022-01540 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution of IPR on claims 1–3 and 5–9 under § 325(d), finding substantially the same art had been presented and no material error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced” slip op. at 5
Discretionary denialPatents in suitUS 9,486,361 - Ivantis, Inc. / Alcon Research, LLC et al. v. Sight Sciences, Inc.Institution deniedPTAB · Mar 21, 2023 · IPR2022-01529 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution of IPR on claims 1, 8, 11, 12, 21, 23, 24, 27, 42, 43, 46, 52, 54–59, 70, and 71 under § 325(d) because the art was previously considered or cumulative …
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“(1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics at 8.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“B. Summary Considering the above Becton Dickson factors as they are incorporated into the two-part Advanced Bionic framework, we find that the factors weigh in favor of exercising our discretion and denying institution under § 325(d). The asserted art is either the same as, or cumulative to, the prior art that Examiner has already considered during prosecution of the ’443 patent and its related applications, and Petitioner has not shown material error by the Office. Thus, we deny institution under § 325(d). Taking account of the information presented in the Petition, Preliminary Response, Reply, Sur-Reply, and the evidence of record, we exercise our discretion under § 325(d) and deny institution. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner’s request for an inter partes review, pursuant to 35 U.S.C. § 314(a), of claims 1, 8, 11, 12, 21, 23, 24, 27, 42, 43, 46, 52, 54–59, 70, and 71 of the ’443 patent is denied, and no trial is instituted.” slip op. at 20
Discretionary denialPatents in suitUS 9,370,443 - Microsoft Corporation v. Almondnet, Inc.Institution deniedPTAB · Jan 30, 2023 · IPR2022-01319 · APJ Thomas L Giannetti · IPR · Institution
The Board denied institution for all challenged claims under § 325(d), finding Beyda had been presented to the Office and Microsoft had not shown material Examiner error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Here, Petitioner does not dispute Patent Owner’s evidence that Beyda was previously presented to the Office. Ex. 1004, 295. Thus, the first criterion of the Advanced Bionics framework (same art or arguments) is met. Advanced Bionics, Paper 6 at 7–8 (“Previously presented art includes art made of record by the Examiner and art provided to the Office by an applicant, such as on an Information Disclosure Statement (IDS),”). The second inquiry in the Advanced Bionics framework asks whether the Petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8–9. As Patent Owner points out, “although the Petition admits that the Examiner considered Beyda during prosecution, it fails to make any allegation whatsoever that the Examiner erred (let alone erred in a material way) in his consideration of Beyda.” Prelim. Resp. 18. As to Narin, Patent Owner argues that Petitioner “does not offer any explanation” why that reference is not “substantially the same” as art considered by the Examiner, “let alone how or why the Examiner materially erred in considering that art to not be invalidating.” Id. We agree that Petitioner has failed to demonstrate that the Office erred in its evaluation of the cited art. See Advanced Bionics, Paper 6 at 8–9 (“If a condition in the first part of the framework is satisfied and the petitioner fails to make a showing of material error, the Director generally will exercise discretion not to institute inter partes review.”). Here, the Beyda prior art that was before the Examiner during the examination is identical to the art cited here.3 There is no argument or evidence before us that Beyda was concealed from the Examiner. The Examiner ultimately made a determination that the claims were patentable. Ex. 1004, 49, 92. As cautioned by Advanced Bionics, “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Advanced Bionics, Paper 6 at 9. Advanced Bionics goes on to explain the rationale for this rule: “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. Having considered the record presented by Patent Owner and the absence of any substantive showing from Petitioner, we are not persuaded of material Examiner error. Petitioner’s assertion that the prior art references in the Petition “were not substantively considered during the prosecution of the ’139 Patent, or in the prior CBM challenge,” without further explanation, is insufficient. In summary, applying the two-part framework of Advanced Bionics, we are persuaded to deny the Petition under 35 U.S.C § 325(d).” slip op. at 10
Discretionary denialPatents in suitUS 8,671,139 - Eyenovia, Inc. v. Sydnexis.Institution deniedPTAB · Nov 8, 2022 · IPR2022-00963 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution of IPR on claims 1–27 under § 325(d), finding substantially the same art and arguments had been presented to the Office and no material error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“substantially the same as those previously presented to the Office. Advanced Bionics, 8–10. “If, after review of factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office,” then we advance to the second part of the analysis to determine “whether the petitioner has demonstrated a material error by the Office” in view of factors (c), (e), and (f). Id. Advanced Bionics instructs that “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Id. at 9–10.” slip op. at 10
Discretionary denialPatents in suitUS 9,421,199 - Eyenovia, Inc. v. Sydnexis.Institution deniedPTAB · Nov 7, 2022 · IPR2022-00965 · APJ Michael A Valek · IPR · Institution
The Board denied institution on claims 1–20 under § 325(d), finding substantially the same art and arguments had been considered during prosecution and no material Office error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“For these reasons, we determine that both the art and the arguments presented in the Petition are substantially the same as those previously presented to the Examiner.” slip op. at 21
Discretionary denialPatents in suitUS 10,076,515 - Eyenovia, Inc. v. Sydnexis.Institution deniedPTAB · Nov 7, 2022 · IPR2022-00964 · APJ Michael A Valek · IPR · Institution
The Board denied institution of inter partes review of claims 1–19 under § 325(d), finding the art and arguments substantially similar to those previously presented and no material Office error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“We again determine that Patent Owner has the better position. As explained above, the Examiner considered substantially the same art during prosecution. Although there was no rejection issued over the particular references cited in the Petition, those references were either before the Examiner (Siegel) or are cumulative of references (Chua & Tan and Lund) before the Examiner. There is no evidence that suggests the Examiner overlooked the most pertinent teachings in the art presented during prosecution. Indeed, the Teva rejection presented substantially the same arguments as the grounds in the Petition, including Patent Owner’s argument that there was “insufficient rationale to combine Teva and other references to produce a D2O-based formulation in which atropine is the monotherapeutic agent because atropine and its derivatives are specifically recognized as stable in ordinary water.” Ex. 2003, 69, 87–88. The Examiner credited this argument by withdrawing the Teva rejection and allowing the ’447 patent. Thus, we do not agree with Petitioner’s argument that the Examiner failed to consider whether it would have been “obvious to improve low-concentration atropine with D2O as a monotherapy for treating myopia.” See Pet. 63.” slip op. at 22
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“D. Conclusion Based on the foregoing, we determine that the circumstances of this case warrant the exercise of discretion under 35 U.S.C. § 325(d) and therefore deny institution. ORDER After due consideration of the record before us, and for the foregoing reasons, it is: ORDERED that the Petition is denied, and no inter partes review is instituted.” slip op. at 25
Discretionary denialPatents in suitUS 9,770,447 - Eyenovia, Inc. v. Sydnexis.Institution deniedPTAB · Nov 7, 2022 · IPR2022-00966 · APJ Jamie T Wisz · IPR · Institution
The Board denied institution of inter partes review of claims 1–13, 15–27, and 29–30 under § 325(d), finding substantially the same art and arguments had been presented to the Office and no material error shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“For these reasons, we determine that both the art and the arguments presented in the Petition are substantially the same as those previously presented to the Examiner.” slip op. at 20
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“D. Conclusion Based on the foregoing, we determine that the circumstances of this case warrant the exercise of discretion under 35 U.S.C. § 325(d) and therefore deny institution. ORDER After due consideration of the record before us, and for the foregoing reasons, it is: ORDERED that the Petition is denied, and no inter partes review is instituted.” slip op. at 26
Discretionary denialPatents in suitUS 10,201,534
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.