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  • PTAB · Mar 25, 2025 · IPR2024-01416 · APJ Devon Zastrow Newman · IPR · Institution

    The Board denied institution on claims 1–20 under §325(d), finding the challenges relied on previously presented or cumulative art and Petitioner failed to show material Examiner error.

    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 13

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied

      “III. CONCLUSION Taking a holistic view of the totality of the information presented, we determine that the challenges set forth in the Petition are based on the same or substantially the same prior art or arguments previously presented to the Examiner. Moreover, Petitioner does not direct us to information sufficient to establish a material Examiner error. Accordingly, we exercise our discretion under Section 325(d) and do not institute an inter partes review. 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 1–20 of the ’967 patent is denied, and no trial is instituted.” slip op. at 28

    Discretionary denial
    Patents in suitUS 9,798,967
  • PTAB · Dec 19, 2023 · IPR2023-01033 · APJ Sheridan K Snedden · IPR · Institution

    The Board denied institution of IPR challenging claims 1–30, finding substantially the same art had been presented to the Office and no material error was shown under § 325(d).

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

      “the following 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 [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, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential). The Becton, Dickinson factors provide useful insight into how to apply the framework under 35 U.S.C. § 325(d). Id. at 9 (referencing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, 17– 18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph)).” slip op. at 12

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

      “presented to the Office, and (2) Petitioner has not demonstrated that the Office erred. We therefore conclude that it is appropriate to exercise discretion under 35 U.S.C. § 325(d) to deny the Petition. III. CONCLUSION For the foregoing reasons, we exercise discretion under 35 U.S.C. § 325(d) to deny institution of an inter partes review. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 21

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

      “enzyme complex” and “nucleic acid insert element.” Pet. 21. Patent Owner, for its part, states that “[n]o terms require construction for considering institution.” Prelim. Resp. 18. We determine that neither of the two limitations identified by Petitioner requires an express construction for purposes of this Decision. It bears mentioning, however, that the ’357 patent states that “[t]he insertional enzyme can be a transposase.” Ex. 1001, 3:47–48. There is no dispute that Grunenwald discloses the use of a transposase and, thus, an insertional enzyme complex. See Pet. 16 (citing Ex. 1003 ¶¶ 17, 93–94, 162); Prelim. Resp. 13 (“Grunenwald further defines ‘transposase’ to mean ‘an enzyme that is capable of forming a functional complex . . . and catalyzing insertion or transposition of the transposon end-containing composition into the double-stranded target DNA with which it is incubated in an in vitro transposition reaction.” (citing Ex. 1003 ¶ 93)).” slip op. at 6

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

      “express construction of the term “chromatin.” The ’357 patent itself provides a definition, stating: The term “chromatin,” as used herein, refers to a complex of molecules including proteins and polynucleotides (e.g. DNA, RNA), as found in a nucleus of a eukaryotic cell. Chromatin is composed in part of histone proteins that form nucleosomes, genomic DNA, and other DNA binding proteins (e.g., transcription factors) that are generally bound to the genomic DNA. Ex. 1001, 12:61–67. This is the meaning that we apply in this Decision.” slip op. at 6

    Claim constructionDiscretionary denial
    Patents in suitUS 10,738,357
  • 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 · Mar 2, 2022 · IPR2021-01484 · APJ Robert A Pollock · IPR · Institution

    The Board denied institution of IPR challenging claims 1–9, 13, 17, and 19 as obvious over Milone and Kalled under § 103, exercising discretion under § 325(d).

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

      “Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 at 8–10 (Feb. 13, 2020) (“Advanced Bionics”) (precedential), the Board addresses § 325(d) applying a “two-part framework.” In the first part of the framework, we ask whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments 8 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated. 22 previously were presented to the Office. Advanced Bionics at 8. Factors (a), (b), and (d) of Becton, Dickinson come into play under this first part of the framework. Id. at 8–10. If either condition of the framework’s first part is met (e.g., substantially the same art is presented), we move to part two of the framework, asking “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of [the] challenged claims.” Id. at 8. Factors (c), (e), and (f) of Becton, Dickinson fall within part two of the framework. Id. at 10 (“[F]actors (c), (e), and (f) relate to whether the petitioner has demonstrated material error by the Office.”). 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 error. Advanced Bionics at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise his discretion not to institute inter partes review.” Id. at 8–9. “At bottom, this [§ 325(d)] framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9 (“If 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.”). B.” slip op. at 22

    • Skill levelSkill level patent owner adoptedOther

      “Patent Owner does not dispute Petitioner’s proposed definition, but states that the person of ordinary skill in the art would “[t]ypically” . . . have had an M.D. or a Ph.D. in immunology, biochemistry, cell biology, molecular biology, or a related discipline, with at least two years of experience in conducting laboratory research on chimeric T cell receptors.” Prelim. Resp. 44 (citing Ex. 2001 ¶ 20). According to Patent Owner, the ordinarily skilled artisan “would have had knowledge of the scientific literature and have skills relating to chimeric T cell receptors and methods of using such receptors” and “may have worked as part of a multidisciplinary team” and been able to draw on the specialized skills of, for example, an immunologist, and/or a clinical oncologist. See id. at 43–44. Considering the record before us, both parties present reasonable definitions of one of ordinary skill in the art. For the purpose of this proceeding, we consider one of ordinary skill in the art as having had an M.D. or a Ph.D. in immunology, biochemistry, cell biology, molecular biology, or a related discipline, with at least two years of experience in conducting laboratory research on chimeric T cell receptors and/or the use of CAR-T immunotherapy. Consistent with Patent Owner’s proposed definition, the ordinarily skilled artisan may have worked as part of a 20 multidisciplinary team and been able to draw on the specialized skills of, for example, an immunologist, and/or a clinical oncologist.” slip op. at 20

    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for patent owner

      “We do not find Petitioner’s argument persuasive for the reasons set forth on pages 34–40 of the Preliminary Response. Most particularly, we note that the phrase “[a] chimeric antigen receptor (CAR)” occurs solely in the preamble of independent claim 24. Terms in a preamble, however, are not generally construed as limiting. See Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). More specifically, “when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention,” the preamble is not considered a limitation. Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). In the present case, we find it plausible—if not likely—that the Examiner gave no weight to the terms in the preamble of claim 24 such that the remaining language did not expressly or implicitly require either a 32 transmembrane domain, or a “T-cell activation moiety” specific to CAR constructs. The Examiner appears to have recognized, however, that CAR constructs differ from Kalled’s antibodies at least in having a transmembrane domain as expressly recited in claims 29 and 30. See Ex. 2005, 605, 745–749 (allowing amended claims). This view is underscored by the Examiner’s decision not to reject claims 34 and 38 as anticipated by Kalled. See Ex. 2005, 604. Notably, claims 34 and 38 recite SEQ ID Nos 4–12, each of which encodes a complete CAR construct and, thus, implicitly includes a transmembrane domain. See id. at 589 (claiming a CAR comprising the amino acid sequence of SEQ ID Nos: 4–12 (claim 34) or a nucleic acid encoding the same (claim 38)); Ex. 1001, 9:49–53; Ex. 2001 ¶ 92.12” slip op. at 32

    Claim constructionDiscretionary denialcites Graham
    Patents in suitUS 9,765,342
  • PTAB · Feb 8, 2022 · IPR2021-01379 · APJ Barry L Grossman · IPR · Institution

    The Board denied institution of IPR for claims 3–7, 9, 10, 13, and 15–23 under § 325(d), finding the same or substantially the same art or arguments had previously been presented to the Office.

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

      “and Nobuyuki[] are the same or substantially the same as art previously considered by the Office, in either original prosecution or during reexamination.” Prelim. Resp. 30. Patent Owner asserts that the first part of the Advanced Bionics two-part framework for determining if denial of institution under § 325(d) is proper is satisfied. We agree, based on our analysis above. Specifically, we determine that under Becton, Dickinson factors (a), (b), and (d), the same or substantially the same art or arguments previously were presented to the Office. Turning to the second part of the Advanced Bionics framework, Petitioner also argues that the “Examiner erred in a manner material to patentability by adopting a narrow construction of ‘one or more clamps variably positionable on the dual track rail and footing grid’ that is inconsistent with the term’s plain and ordinary meaning.” Pet. 19. We disagree. We discussed the Board’s appeal decision in the previous section of this Decision. The Board affirmed the entirety of the RAN decision by the Reexamination Examiner, including construction of the phrase Petitioner argues was construed in error. We are not persuaded that Petitioner has met its burden to show error. Thus, under Becton, Dickinson factors (c), (e), and (f), Petitioner has not demonstrated a material error by the Office.” slip op. at 41

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

      “Accordingly, based on our analysis of the Becton, Dickinson factors and the guidelines in Advanced Bionics, we exercise our discretion and deny institution under 35 U.S.C. § 325(d) because the same or substantially the same prior art or arguments previously were presented to the Office. III. CONCLUSION Taking into consideration the arguments in the Petition, the Preliminary Response, and the evidence of record, we exercise our discretion and deny institution of an inter partes review under 35 U.S.C. § 325(d).” slip op. at 42

    • BurdenDecided for patent owner

      “Petitioner also argues that the “Examiner erred in a manner material to patentability by adopting a narrow construction of ‘one or more clamps variably positionable on the dual track rail and footing grid’ that is inconsistent with the term’s plain and ordinary meaning.” Pet. 19. We disagree. We discussed the Board’s appeal decision in the previous section of this Decision. The Board affirmed the entirety of the RAN decision by the Reexamination Examiner, including construction of the phrase Petitioner argues was construed in error. We are not persuaded that Petitioner has met its burden to show error. Thus, under Becton, Dickinson factors (c), (e), and (f), Petitioner has not demonstrated a material error by the Office.” slip op. at 41

    Discretionary denial
    Patents in suitUS 7,434,362
  • PTAB · Sep 8, 2021 · PGR2021-00059 · APJ Devon Zastrow Newman · PGR · Institution

    The Board denied institution on claims 1–15: grounds 2–5 lacked a supported reason to combine, and ground 1 repeated arguments considered by the Office.

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

      “We have the authority and discretion to determine whether to institute a post grant review. 35 U.S.C. § 324; 37 C.F.R. § 42.4(a) (2021). We may not institute a post-grant review 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.” 35 U.S.C. § 324(a). After considering the briefing and the evidence of record, we conclude that Petitioner has failed to establish a reasonable likelihood of prevailing in demonstrating that the challenged claims are unpatentable over the cited prior art in asserted grounds 2–5. With regard to ground 1, Petitioner’s written description ground, we determine that Petitioner’s arguments are substantially the same as those previously presented to and considered by the Office, and we exercise our discretion under 35 U.S.C. § 325(d) and decline to institute post-grant review of the ’542 patent on that ground alone.” slip op. at 2

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

      “We agree with Patent Owner that Petitioner’s arguments regarding whether the ’542 patent provides § 112 written description support for the challenged claims are substantially the same as those considered by the Examiner during the prosecution of the ’542 patent. As set forth above, the Examiner repeatedly rejected the pending claims because (1) the claims were overly broad in light of the guidance provided in the specification that was limited to the working examples specific to exon 7 of a gene encoding a MLH3 subunit (Ex. 1006, 623–24); (2) the claims did not enable the oligonucleotides to “hybridize[] to a complementary target nucleic acid sequence of a gene or gene product to modulate the expression of a component of a mismatch repair (MMR) complex” based on the disclosure of the specification, which was limited to the working examples (id.); and (3) the claims did not enable a pharmaceutical composition of the recited nucleotide base length range for the entire scope of the claims based on the disclosure of the specification, which was limited to the working examples (id. at 1183–84). The rejections were based on a broad reading of the claims as interpreted by the ordinarily skilled artisan, and required analysis of whether there is sufficient support in the specification for the entire scope of the claims. Applicant overcame these issues by narrowing the claims until the Examiner agreed that the support present was sufficient.” slip op. at 36

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not found

      “We agree with Patent Owner that Petitioner’s allegations regarding the skilled artisan’s reasons to combine are conclusory and insufficiently supported by evidence. Petitioner cites Dr. Wood’s testimony to explain why the skilled artisan would have understood that Fuselier’s suggestion to “switch[] isoforms of MLH3” could be accomplished by manipulating pre-mRNA splicing to delete exon 7. Petitioner’s discussion on pages 59–60 quotes phrases from Dr. Wood’s referenced testimony, see Ex. 1002, ¶¶ 213–216, but the rationale appearing in the Petition merely comprises repetitive generalized statements akin to “Morcos is a powerful tool that can accomplish what Fuselier suggested.” See Pet. 59–60. Dr. Wood’s underlying testimony lacks key explanation as to the understanding of the ordinary artisan at the time of the invention. What Petitioner has not provided, as Patent Owner argues, are the reasons 1) why Fuselier’s suggestion to “switch[] isoforms” would have led the artisan to pursue deletion of exon 7; and 2) why the artisan would have selected Morcos’ time. See Prelim. Resp. 55–56.” slip op. at 19

    • Skill levelSkill level petitioner adoptedOther

      “invention in the field of antisense technology “would have had knowledge of the scientific literature and have skills relating to approaches for utilizing synthetic oligonucleotides to manipulate gene expression” and “have been well-experienced in laboratory techniques and strategies for designing and making SSOs, conducting in vitro and in vivo testing, and application of SSOs in research.” Pet. 18 (citing Ex. 1002 ¶¶ 30, 31). Petitioner adds that the artisan “would have had knowledge of laboratory techniques and strategies in creating nuclease-resistant SSOs, and using such SSOs to manipulate gene expression to force expression of selected isoforms of a M.D. or a Ph.D. in physiological science, biochemistry, molecular biology, chemistry, or a related discipline, with at least five years of experience in SSOs design and manipulation” and may have “worked as part of a multidisciplinary team” to permit input by others on the team with specialized skills to assist in solving problems. Id. Patent Owner does not contest the skill level provided by Petitioner for the purpose of deciding institution (Prelim. Resp. 4), and we adopt it as reasonably consistent with the level of skill represented by the ’542 patent and the art of record.” slip op. at 8

    Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 10,669,542
  • PTAB · Apr 3, 2020 · IPR2019-00840 · APJ Bart A Gerstenblith · IPR · Rehearing

    The Board denied Microsoft’s rehearing request, leaving institution denied because it did not show error in the Board’s § 325(d) analysis.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “decision should be modified. 37 C.F.R. § 42.71(d). “The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c).” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for patent owner

      “Petitioner did not argue, in the Petition, that FIPA97 was released as individual parts. Petitioner’s Rehearing Request (page 8) cites to the Petition at page 20 and Exhibit 1054. Page 20 of the Petition, however, contains Petitioner’s argument that FIPA97 was made publicly available as a single document, as discussed above. It does not include any argument or suggestion that FIPA97 was released as individual parts. Additionally, Exhibit 1054 is not cited on page 20 of the Petition in the discussion of FIPA97 nor does it appear that Exhibit 1054 was cited anywhere in the Petition. Thus, because Petitioner did not argue, in the Petition, that FIPA97 was released as individual parts, we could not have overlooked that argument. Petitioner’s contention of error in our determination that FIPA97 was involved during examination of the ’128 patent application is premised upon finding that FIPA97 existed as individual parts. Because Petitioner fails to demonstrate that we overlooked an argument that was not made, we are not persuaded of error.” slip op. at 4

    Discretionary denial
    Patents in suitUS 7,036,128
  • PTAB · Apr 3, 2020 · IPR2019-00838 · APJ Bart A Gerstenblith · IPR · Rehearing

    The Board denied Microsoft’s rehearing request, leaving institution denied under § 325(d) because Microsoft did not show the Board overlooked arguments made in the petition.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “II. ANALYSIS A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). “The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c).” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for patent owner

      “and the prior art relied upon in Petitioner’s challenges to the ’128 patent, Petitioner did not address 35 U.S.C. § 325(d) in the Petition (Paper 1). Instead, Petitioner made two critical representations—(1) that the Examiner of the ’128 patent “did not have FIPA97 before him, or any other FIPA reference for that matter” (Pet. 1) and (2) that despite there being seven “Parts” to FIPA97, “FIPA97 was made publicly available as a single document” and was “developed and published as a single, integrated work.” Pet. 20 (citing Ex. 1055 (FIPA97 Table of Contents for Parts 1–7)); Ex. 1026, 5 (Foundation for Intelligent Physical Agents, “Resolution of Munich meeting”). In the Petition (Paper 1), Petitioner never contended that FIPA97 was published or available as separate and distinct parts, such that access to one part might not mean access to each other part. Rather, Petitioner’s sole statement regarding separate parts was that it filed FIPA97 as seven separate exhibits “due to its size and numbering schedule.” Id. at 20. Accordingly, on the record presented, we agreed with Petitioner’s representation and we found that FIPA97 (Exs. 1006–1012) constitutes a single document, which we then found was involved during examination of the ’128 patent application. Inst. Dec. 15.” slip op. at 3

    Discretionary denial
    Patents in suitUS 7,036,128
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