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  • PTAB · 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 denial
    Patents in suitUS 9,486,361
  • PTAB · 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 denial
    Patents in suitUS 9,370,443
  • PTAB · Feb 2, 2023 · IPR2022-01287 · APJ Kevin C Trock · IPR · Institution

    The Board denied institution on claims 1–6 under § 325(d), finding substantially the same prior art had been presented and no material Office error was shown.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

      “cumulative to at least Kijima and Tani, as well as Petitioner’s cumulative use of Sawanobori, Silver, and Teranishi, we find that part one of the Advanced Bionics framework is met. Other Board decisions have reached the same conclusion given circumstances similar to this case. See, e.g., Samsung Elecs. Co. v. Power2B, Inc., IPR2021-01190, Paper 11 at 15–17 (PTAB Jan. 6, 2022).” slip op. at 22

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Not reached

      “partes review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). Under 35 U.S.C. § 314(a), we may not authorize an inter partes review unless the information in the 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.”” slip op. at 2

    Discretionary denial
    Patents in suitUS 8,059,177
  • PTAB · 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 denial
    Patents in suitUS 8,671,139
  • PTAB · Jan 13, 2023 · PGR2022-00051 · APJ Jamie T Wisz · PGR · Institution

    The Board denied institution on all challenged claims, finding no reasonable likelihood of unpatentability under §§ 101 and 112(a), and denying Grounds 4–6 under § 325(d).

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “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.” Upon considering the arguments and evidence, we determine that the information presented fails to demonstrate it is more likely than not that at least one of the challenged claims of the ’742 patent is unpatentable for ineligibility, lack of written description, or non-enablement. We also exercise our discretion to deny institution of post-grant review under 35 U.S.C. § 325(d). slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

      “tramiprosate “showed a significant overall treatment effect” in “an APOE4+ sub-group,” including APOE4 homozygotes; “therapeutic interventions applied earlier in the course of AD more likely might achieve the goal of disease modification;” and that “AD would be optimally treated before significant cognitive impairment, during its pre-symptomatic or pre-clinical stages …”) (emphases removed). Accordingly, Caltagirone was previously presented to the Office and we also find that Caltagirone’s disclosures are substantially similar to, or cumulative of, other references previously considered by the Examiner.” slip op. at 49

    • Adverse judgmentAdverse judgmentOther

      “D. Statutory Disclaimer After the filing of the Petition in this proceeding, Patent Owner filed a statutory disclaimer, disclaiming claims 9 and 11–15 of the ’742 patent, effective October 7, 2022. Prelim. Resp. 12; Ex. 2001, 1. “No post-grant review will be instituted based on disclaimed claims.” 37 C.F.R. § 42.207(e). We do not analyze the validity of claims 9 and 11–15 based on Petitioner’s challenges (e.g., Grounds 2 and 3) because these claims have been statutorily disclaimed.” slip op. at 5

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “at least an M.D. or Ph.D. degree in a biomedical science or equivalent field. They would also have several years of clinical experience treating and/or conducting clinical trials of drugs for AD patients, or professional experience working in clinical trial design and execution related to drugs for AD or supervising such work. Pet. 14–15 (citing Ex. 1003 ¶ 62) (internal citation omitted). Patent Owner does not contest the characterization offered by Petitioner. Prelim. Resp. 12–13. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’742 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 9

    Claim construction§ 101 eligibility§ 112 disclosureDiscretionary denialcites Alice · Mayo · Graham
    Patents in suitUS 11,191,742
  • PTAB · Jan 12, 2023 · PGR2022-00048 · APJ James A Tartal · PGR · Institution

    The Board denied institution under § 325(d), finding the same or substantially the same art had been presented to the Office and Petitioner showed no material Office error.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

      “previously presented to the Office under our framework for evaluating discretionary denial under Section 325(d), we next consider whether Petitioner “has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Advanced Bionics, Paper 6 at 8; see also id. at 8–9 (further explaining that if “petitioner fails to make a showing of material error,” generally discretion will be exercised to deny institution of review). In the second part of our framework, we consider (i) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; (ii) whether Petitioner has pointed out sufficiently how the Examiner erred in evaluating the asserted prior art; and (iii) the extent to which additional evidence and facts presented in the Petition warrant reconsideration of the prior art. See id. at 9 n.10, 10– 11 (citing factors (c), (e), and (f) of Becton, Dickinson). For the reasons that follow, we find that Petitioner does not demonstrate an error material to patentability.” slip op. at 13

    Discretionary denial
    Patents in suitUS 11,160,367
  • PTAB · Jan 9, 2023 · IPR2022-01200 · APJ Devon Zastrow Newman · IPR · Institution

    The Board denied institution for claims 1–14 under § 325(d), finding the petition relied on substantially the same art and arguments previously presented and did not show material examiner error.

    RulingsInstitution decision
    • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner

      “ApoE4+ patient with AD using tramiprosate over the Caltagirone reference, which disclosed treatment of ApoE4+ “all-comers” (containing at least one ApoE4 allele, either heterozygous or homozygous) with tramiprosate. See, e.g., Ex. 1002, 204–208. When Patent Owner responded to the Examiner by highlighting data (i.e., Figure 8 of the specification giving rise to the ’029 patent) showing a notable increase in cognitive function in patients with two ApoE4 alleles (homozygous) who were administered tramiprosate as compared to the ApoE4 “all-comers” (mixed homozygous/heterozygous population), the Examiner suggested narrowing the pending claims to treatment of ApoE4 homozygotes. Ex. 1002, 342. Patent Owner submitted amended claims requiring selection of patients for treatment who were homozygous for ApoE4, and argued: The presently amended claims . . . select only ApoE4 homozygotes for treatment with tramiprosate or a prodrug thereof, necessarily omitting ApoE4 heterozygotes from such treatment. . . . Caltagirone fails to teach or suggest a patient selection strategy that would limit tramiprosate treatment to patients having two ApoE4 alleles and, in fact, teaches away from such selection. Kong fails to contradict or overcome these deficiencies in Caltagirone. Kong does not refer to any patient selection strategy, much less one that would limit tramiprosate prodrug treatment to ApoE4 homozygotes. The Office's reliance on Kong is solely for its teaching of a tramiprosate prodrug. Thus, the combination of Caltagirone and Kong, taken under the Office’s interpretation, suggests treatment of all ApoE4+ patients with a prodrug of tramiprosate. This falls far short of suggesting the presently claimed patient selection and treatment strategy which selects only ApoE4 homozygotes for treatment and does not treat ApoE4 heterozygotes. Id. at 338–39 (emphasis added). The Examiner acknowledged the” slip op. at 16

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of ordinary skill in the art (“skilled artisan”) at the time of the invention would have had at least an M.D. or Ph.D. degree in a biomedical science or equivalent field. They would also have several years of clinical experience treating and/or conducting clinical trials of drugs for AD patients, or professional experience working in clinical trial design and execution related to drugs for AD or supervising such work. Pet. 19 (citing Ex. 1003 ¶¶ 52–53). Patent Owner does not contest the characterization offered by Petitioner. Prelim. Resp. 14–15. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’029 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 12

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

      “whether the art or arguments presented in the Petition are the same or substantially the same as those previously presented to the Office (Advanced Bionics, Paper 6 at 10). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in its prior consideration of that art or arguments (Advanced Bionics, Paper 6 at 10). Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated a material error by the Office (Advanced Bionics, Paper 6 at 10). “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown” (Advanced Bionics, Paper 6 at 9).” slip op. at 21

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot reached

      “Babic ascertained that “different effects of a drug could be observed in different subpopulations of patients based on ApoE4 carrier status”” and that “drug effects in homozygous carriers could be greater than those in the heterozygous carriers and non-carriers who did not respond to the drug.” Ex. 1003 ¶ 107. As stated, this testimony does not support Petitioner’s contention that an ordinary artisan would have been motivated “to select homozygous ApoE4 carriers for treatment with any drug for which response has been correlated to ApoE4 carrier status.” See Pet. 41 (emphasis added). In particular, we find an insufficient factual basis for Petitioner’s contention that results obtained for galantamine, an acetylcholinesterase inhibitor (Ex. 1003 ¶ 105) would have motivated an ordinary artisan to replace the galantamine taught in Babic with tramiprosate (homotaurine), a GABA receptor agonist that works by a different mechanism (Ex. 1007, 582). We have also considered Dr. Ruffalo’s testimony that the ordinary artisan would have been motivated to replace Babic’s galantamine with tramiprosate as taught in Caltagirone or Val-APS as taught in Kong. Ex. 1003 ¶¶ 276–277. Dr. Ruffalo posits that Babic’s disclosures would have motivated the ordinary artisan to analyze Caltagirone’s data to ascertain if tramiprosate is more effective in homozygotes, and to replace galantamine with tramiprosate or Val-APS as taught in Kong because of their improved safety profiles as compared to galantamine, and because the replacement drugs target the underlying disease and not symptom amelioration as does galantamine. Id. Dr. Ruffalo also posits that the prior art would have imparted the following knowledge to the ordinary artisan: because the effect of tramiprosate was dependent on the required ApoE4 allele, homozygotes having the highest number of ApoE4 allele copies would derive, at the very least, as much benefit as from the drug as the heterozygotes having only one copy of the allele, and most likely the homozygotes would have the greatest therapeutic response to tramiprosate since they have the maximum number of copies of the required allele. Having done this simple assessment, A POSA would conclude that tramiprosate would be expected to exhibit a greater therapeutic effect in homozygotes and thus would have been motivated to treat homozygotes with tramiprosate, including in an oral dosage form as taught by Aisen. Id. Dr. Ruffalo further posits that the skilled artisan would have had a reasonable expectation of success in administering tramiprosate to treat homozygous ApoE4 patients because they “would almost certainly have the greatest response to the drug.” Id. ¶ 286. Patent Owner argues that the Examiner previously examined the issue of whether ApoE4 genotypes in treatment decisions should be considered during prosecution, with respect to Caltagirone, where ApoE4 genotypes were included, and Sleegers (Ex. 1002, 685, 1137), where studies led away from such inclusion. Prelim. Resp. 30–31. We find Sleegers’ disclosure” slip op. at 29

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
    Patents in suitUS 10,471,029
  • PTAB · Jan 3, 2023 · IPR2022-01197 · APJ Sheldon M Mcgee · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing on the Ogawa grounds and § 325(d) barred the Vea grounds.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied

      “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The findings and conclusions set forth in this Decision are provided for the exclusive purpose of explaining our determination that Petitioner has not met that standard on this record. slip op. at 7

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

      “framework set forth under Advanced Bionics, LLC v. Med-El Electromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 7 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). Under that framework, we must first determine whether the same or substantially the same art or arguments previously were presented to the Office. If so, we must then determine whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of the challenged claims. Id. at 8.” slip op. at 21

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “On this record, we determine that the level of ordinary skill is reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (specific findings on the ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163–64 (Fed. Cir. 1985))). A more specific definition is not necessary for purposes of deciding whether to institute review. To the extent a more specific definition is required, however, we adopt Petitioner’s proposed definition because, on this record, it is consistent with the disclosures of the asserted prior art references.” slip op. at 10

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “12 Dr. Madisetti’s testimony here is entitled to little to no weight as it merely parrots the Petition. 37 C.F.R. § 42.65(a).” slip op. at 19

    § 103 obviousnessDiscretionary denialcites Phillips
    Patents in suitUS 6,816,809
  • PTAB · Dec 2, 2022 · IPR2022-01008 · APJ Debra K Stephens · IPR · Institution

    The Board denied institution under § 325(d), finding the asserted art cumulative of art previously presented to the Office and no material Office error shown.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

      “In evaluating arguments under § 325(d), we use [a] two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner slip op. at 10

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Not reached

      “(a) THRESHOLD.—The Director may not authorize an inter partes review to be instituted unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition (35 U.S.C. § 314(a)). Petitioner challenges claims 1–20 as unpatentable under 35 U.S.C. § 103 in twelve grounds of unpatentability (Pet. 7). Generally, Patent Owner contends that the Petition should be denied as to all challenged claims (see Prelim. Resp.). We do not reach whether Petitioner has shown a reasonable likelihood of prevailing on at least one claim. For reasons discussed below, we discretionarily deny the Petition under 35 U.S.C. § 325(d).” slip op. at 2

    Discretionary denial
    Patents in suitUS 10,942,581
  • Eyenovia, Inc. v. Sydnexis.Institution denied
    PTAB · 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 denial
    Patents in suitUS 9,421,199

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.