• Nexus Pharmaceuticals, LLC v. Exela Pharma Sciences, LLCInstitution denied
  PTAB · 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 denial
  Patents in suitUS 11,642,370
• Parse Biosciences, Inc. v. 10x Genomics, Inc.Institution denied
  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
• Hugel, Inc. v. Medytox Inc.Institution denied
  PTAB · Aug 28, 2023 · IPR2023-00604 · APJ Jo-Anne M Kokoski · IPR · Institution

  The Board denied institution: Ground 1 did not show claims 1–9 likely obvious over Jung and Ton; it denied Ground 2 under § 325(d).

  RulingsInstitution decision

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

    “Petitioner “has the burden from the outset to show with particularity why the patent it challenges is unpatentable.” Harmonic, Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016); see also SAS Inst., Inc. v. Iancu, 138 S.Ct. 1348, 1355 (2018) (“in an inter partes review, the petitioner is the master of its complaint”). A petition for inter partes review must identify how the challenged claims are unpatentable, and must specify where each element of the claim is found in the relied-upon prior art. 37 C.F.R. § 42.104(b); see also 35 U.S.C. § 312(a)(3) (a petition must identify, “with particularity, each claim challenged, the grounds on which the challenge to each claim is based, and the evidence that supports the grounds for the challenge to each claim”). A petition must also include “a detailed explanation of the significance of the evidence including material facts, and the governing laws, rules, and precedent.” 37 C.F.R. § 42.22(a)(2). What is missing from both the Petition and the supporting testimony is an adequate explanation of how or why a POSA would have understood that Jung teaches the isolation of a botulinum toxin type A macro complex in particular, when Jung is silent as to the form of the toxin being produced. In this case, it is not enough to simply cite evidence; an explanation of the significance of that evidence is necessary. Based on our review of the record, we find that there is insufficient explanation and insufficient supporting evidence that Jung teaches isolating a botulinum toxin type A macro complex. Petitioner’s statements, and Dr. Bates’s testimony, that Jung teaches isolating a botulinum toxin, and that botulinum toxins “naturally comprise[] a complex with a variety of non-toxic proteins bound thereto” that can be intermediate, large, or macro in size, are conclusory because they do not explain why the form of toxin ultimately isolated in Jung is a macro complex. Therefore, Petitioner does not sufficiently show that the combination of Jung and Ton discloses “[a] method of isolating a botulinum toxin type A macro complex from a botulinum containing solution” or “separating the botulinum toxin type A macro complex from the cation exchange chromatography medium” as required by claim 1 of the ’598 patent.” slip op. at 13

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

    “the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” The Board uses a two-part framework for evaluating arguments under § 325(d): (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. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). In applying this framework, we consider the Becton, Dickinson10 factors that address discretion to deny institution when a petition presents the same or substantially the same prior art or arguments previously presented to the Office, including:” slip op. at 17

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

    “To support a conclusion of obviousness when combining the teachings of multiple references, an articulated reason with some rational underpinning to combine the known elements in the fashion claimed must be provided. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007); see also In re Magnum Oil Tools, Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (It is the petitioner’s “burden to demonstrate both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention[s], and that the skilled artisan would have had a reasonable expectation of success in doing so.” (citation and internal quotation marks omitted)). Here, the Petition lacks an adequate explanation as to why a POSA reading Kim ’741 would have looked to Jung for its teachings regarding anion exchange chromatography, and how a POSA would have combined the teachings of Kim ’741 and Jung in the manner claimed. Because we are not persuaded that Petitioner sufficiently establishes a motivation to combine Kim ’741 and Jung with respect to the anion exchange chromatography limitation of claim 1, we are not persuaded that Petitioner’s alternative assertion of Jung for this limitation warrants reconsideration of the prior art and arguments previously considered by the Office. Accordingly, we find that the Examiner’s failure to consider Jung in combination with Kim ’741 with respect to the anion exchange chromatography limitation of claim 1 is not an error that weighs in favor of institution.” slip op. at 29

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “the graduate degree.” Pet. 17 (citing Ex. 1021 ¶ 22). Patent Owner states that, for purposes of its Preliminary Response, it does not challenge Petitioner’s proposed definition of a POSA. Prelim. Resp. 20. For purposes of this Decision, and based on the current record, we adopt the uncontested assessment offered by Petitioner.” slip op. at 6

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR
  Patents in suitUS 11,331,598
• LG Electronics Inc. / LG Electronics USA, Inc. v. Image Processing Technologies, LLCInstitution denied
  PTAB · May 11, 2023 · IPR2023-00104 · APJ Barbara A Benoit · IPR · Institution

  The Board denied institution on claim 1, finding the petition presented the same or substantially the same art or arguments previously considered by the Office.

  RulingsInstitution decision

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

    “under 35 U.S.C. § 325(d) to deny institution of an inter partes review. See 37 C.F.R. § 42.4(a) (The Director delegated her authority to determine whether trial should be instituted to the Board.). Section 325(d) of Title 35 of the United States Code states, in relevant part: “In determining whether to institute or order a proceeding under this chapter, chapter 30, or chapter 31, 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.” We use a two-part framework for evaluating arguments under § 325(d): (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.” slip op. at 12

  • Prior constructionPrior construction adoptedDecided for petitioner

    “applied the construction of “the [at least two] calculation units being configured to form a histogram representative of the parameter” (the “common parameter” limitation) as meaning “the histogram calculation units being configured to each form a histogram representative of at least one common parameter.” Ex. 1005 (IPR 336 Final Written Decision), 12– 14; see Ex. 1006 (IPR 1189 Decision Denying Institution), 9; Ex. 1007 (Reexam 056 Decision finding claim 1 patentable), 8.” slip op. at 11

  Claim constructionDiscretionary denialcites Phillips · Graham
  Patents in suitUS 6,959,293
• Risen (Suzhou) Pharma Tech. Co. Ltd. v. Alzheon, Inc.Institution denied
  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
• Risen (Suzhou) Pharma Tech. Co. Ltd. v. Alzheon, Inc.Institution denied
  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
• Alarm.Com, Inc. v. Vivint, Inc.Institution denied
  PTAB · Nov 1, 2022 · IPR2022-00728 · APJ Charles J Boudreau · IPR · Institution

  The Board denied institution on all challenged claims under § 325(d), finding substantially the same art had been presented during prosecution and no material Office error was shown.

  RulingsInstitution decision

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

    “GMBH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”), the Board applied a two-part framework in considering whether to exercise discretion to deny institution under § 325(d): “(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.” Advanced Bionics, Paper 6 at 8.” slip op. at 17

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

    “After considering the Petition and associated evidence, we exercise” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Based on our review of the record at this stage, we find that Petitioner’s proposal is consistent with the level of skill reflected in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007) (listing the type of problems encountered in the art, prior art solutions to those problems, and the sophistication of the technology as factors that may be considered in determining the level of ordinary skill in the art). See also 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”). Accordingly, for purposes of this decision and to the extent necessary, we adopt Petitioner’s definition of the person of ordinary skill in the art.” slip op. at 12

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Petitioner does not propose constructions for any claim terms. See Pet. 6 (citing 37 C.F.R. § 42.100(b)). On this record, we determine that no terms or phrases in the claims require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 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 constructionDiscretionary denial
  Patents in suitUS 9,349,262
• Volkswagen Group Of America, Inc. v. Stratosaudio, Inc.Institution denied
  PTAB · Nov 12, 2021 · IPR2021-00717 · APJ Kevin C Trock · IPR · Institution

  The Board denied institution on all challenged claims: Grounds 1–3, 6, and 7 failed the institution threshold, and Grounds 4 and 5 were denied under § 325(d).

  RulingsInstitution decision

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

    “the list of cited references of the ’203 Patent. Ex. 1001, 2; Ex. 1002, 430. Because the same reference was cited during prosecution, there is no material difference between Christensen and the prior art involved during examination. Given these facts, we need not further evaluate factor (b), whether Christensen is cumulative, nor factor (d), the extent of overlap in arguments regarding Christensen. Thus, we find that the same reference was previously presented to the Office, and we move on to the second part of the Advanced Bionics framework.” slip op. at 11

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

    “unless the information presented in the Petition and any response thereto shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Taking into account Patent Owner’s Preliminary Response, we conclude that the Petition does not establish there is a reasonable likelihood Petitioner would prevail in establishing at least one of Challenged Claims of the ’203 Patent as unpatentable under certain grounds presented in the Petition, and that the remaining asserted grounds should be denied pursuant to our delegated discretion under 35 U.S.C. § 325(d). Accordingly, we do not institute an inter partes review as to any of the challenged claims of the ’203 Patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that “[a] person of ordinary skill in the art (‘POSITA’) would have had at least a B.S. in computer science, electrical engineering, or a related field, and three years of experience working in the communications- or Internet-related industries” and that “[m]ore education or skill might make up for less experience, and vice-versa.” C. Pet. 5 (citing Ex. 1003 ¶ 43). Patent Owner does not dispute this level of skill. See generally Prelim. Resp. Petitioner’s description of the level of ordinary skill appears to be generally consistent with the subject matter of the ’203 Patent. For purposes of this Decision, we adopt Petitioner’s assessment of the level of ordinary skill.” slip op. at 14

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

    “We are not persuaded by Petitioner that the recited database system should be given no patentable weight. The Federal Circuit explains that [p]roduct-by-process claims are not specifically discussed in the patent statute. The practice and governing law have developed in response to the need to enable an applicant to claim an otherwise patentable product that resists definition by other than the process by which it is made. For this reason, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985). With respect to patentability, “[i]f the product in a product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” Id. The Federal Circuit has clearly stated that “[i]n determining validity of a product-by-process claim, the focus is on the product and not the process of making it.” Purdue Pharma, 811 F.3d at 1354 (quoting Greenliant Sys., Inc. v. Xicor LLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012)). “That is because of the . . . longstanding rule that an old product is not patentable even if it is made by a new process.” Id. Generally, therefore, the recited process steps in a product-by-process claim are not accorded patentable weight. See In re Nordt Development Co., LLC, 881 F.3d 1371, 1375 (Fed. Cir. 2018) (“[T]he Board typically will not accord patentable weight to a process limitation in a product-by-process claim.”) (citing Thorpe, 777 F.2d at 697).” slip op. at 18

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 8,200,203
• Johnson & Johnson Surgical Vision, Inc. v. Alcon, Inc.Institution denied
  PTAB · Nov 9, 2021 · IPR2021-00898 · APJ Grace Karaffa Obermann · IPR · Institution

  The Board denied institution under § 325(d), finding the petition relied on substantially the same art or arguments previously presented to the Office and failed to show material examination error.

  RulingsInstitution decision

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

    “discretion and deny a petition as authorized under Section 325(d). First, we consider whether the same or substantially the same prior art or arguments previously were presented to the Office. If either condition is satisfied, we assess whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of the challenged claims. Advanced Bionics, Paper 6 at 8. A non-exclusive list of factors, set forth in Becton, Dickinson and Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph), guides our application of that two-part framework. Advanced Bionics, Paper 6 at 9. Those 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, Paper 8 at 17–18. “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, Paper 6 at 10.” slip op. at 19

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

    “The Board may not institute an inter partes review unless the information presented “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). The Board has discretion to deny a request for institution when the information presented shows a petitioner raises “the same or substantially the same prior art or arguments previously presented to the Office,” for example, during patent examination. 35 U.S.C. § 325(d).” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Based on the information presented, we find the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art). To the extent a more precise definition is required, we adopt Petitioner’s definition because, on this record, it appears consistent with the disclosures of the asserted prior art and the written description of the invention provided in the ’913 patent. Pet. 16 (Petitioner’s asserted definition of the ordinarily skilled artisan); see Prelim. Resp. 18 (reciting that definition without adopting it or proposing an alternative definition).” slip op. at 17

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “We construe terms in controversy only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Neither party proposes an express construction for any claim term. See Pet. 17; Prelim. Resp. 59–60. We find no claim term requires express construction in order to resolve whether to exercise our discretion and deny the Petition under Section 325(d). We discuss the scope of certain claim terms as necessary to our analysis of that issue, however, which we turn to in the next section.” slip op. at 18

  Claim constructionDiscretionary denialcites Phillips · Graham
  Patents in suitUS 9,622,913
• Volkswagen Group Of America, Inc. v. Stratosaudio, Inc.Institution denied
  PTAB · Oct 25, 2021 · IPR2021-00718 · APJ Hyun J Jung · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood of success on the Levy grounds and § 325(d) warranted denial of the Christensen ground.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 314, an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and Preliminary Response and for the reasons explained below, we do not institute an inter partes review of claims 10, 11, 13, and 15 of the ’843 patent.” slip op. at 2

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

    “v. Avid Tech, Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he [Office] is permitted, but never compelled, to institute an [inter partes review] proceeding.”). Pursuant to 35 U.S.C. § 325(d), in determining whether to institute an inter partes 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.” In evaluating the exercise of discretion to deny institution under § 325(d), the Board uses the following two-part framework: (1) determining 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, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential). In applying the two-part framework, we consider several non- exclusive factors, including: (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 & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to Section III.C.5, first paragraph) (“Becton, Dickinson”). Factors (a), (b), and (d) of the Becton, Dickinson factors relate to 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. Id. 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. Id. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 19

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentable

    “Based on our review of Petitioner’s relied-upon portions of Levy, Levy uses an extracted identifier, such as a broadcaster ID, and “context information” to identify an audio object. Ex. 1005 ¶¶ 15, 56. Thus, if we accepted Petitioner’s position that obtaining Levy’s “object identifier” discloses “acquir[ing] encoded third party data associated with the reception of the specific instance of the media segment in the electronic transmission,” Petitioner does not explain sufficiently how context information that is extracted and forwarded with the broadcaster ID to obtain the “object identifier” can disclose “generat[ing] data that enables the unique identification of the specific instance of acquisition of the encoded third party data.” See Pet. 57–60; Ex. 1003 ¶¶ 181–194. Petitioner does not identifier” can be acquired and generated in the manner argued by Petitioner. See Pet. 57–60; Ex. 1003 ¶¶ 181–194; see also Prelim. Resp. 36–37 (contending that Petitioner’s anticipation challenges lack particularity). As argued by Patent Owner, claim 10 requires that “generat[ing] data that enables the unique identification of the specific instance of acquisition of the encoded third party data” occur either after or at the same time as “acquir[ing] encoded third party data associated with the reception of the specific instance of the media segment in the electronic transmission.” Ex. 1001, 36:28–33. Claim 10 recites a “specific instance of acquisition of the encoded third party data” that apparently refers to the earlier-recited “acquire encoded third party data associated with the reception of the specific instance of the media segment in the electronic transmission,” and Petitioner does not address the interpretation of “acquisition” in view of the previously recited “acquire.” See Pet. 9–10, 57–60. Additionally, Petitioner’s declarant testimony does not explain further the arguments or evidence presented in the Petition and does not provide additional evidence beyond that cited in the Petition. See Ex. 1003 ¶¶ 181–194. Thus, for the reasons above, Petitioner fails to show that Levy discloses all the limitations of independent claim 10. 3. Dependent Claims 11, 13, and 15 Petitioner argues that Levy anticipates dependent claims 11, 13, and 15 with citations to the record. Pet. 65–69. Petitioner’s arguments and relied upon evidence for these claims do not remedy the deficiencies discussed above for independent claim 10. that Levy discloses all the limitations of dependent claims 11, 13, and 15 and, therefore, fails to show that Levy anticipates these claims.” slip op. at 16

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentable

    “4. Asserted Obviousness in view of Levy and Finley Petitioner argues that: [t]o the extent . . . that Levy does not anticipate the Challenged Claims because Levy does not disclose the complete details of the claimed database (in other words, that the difference between each claim as a whole and the prior art as a whole is the explicit recitation of the claimed database), it would have been obvious to store the object ID lookup information or purchase transaction tracking information. Pet. 69 (citing Ex. 1003 ¶ 227); see also id. (contending that Levy teaches storing a transaction log in a log file of a database). Petitioner’s arguments that Levy and Finley would have rendered obvious claims 10, 11, 13, and 15 do not further address the limitations we discussed above for claim 10, and Petitioner’s proposed modification of Levy in view of Finley does not remedy the deficiencies of Petitioner’s arguments that Levy discloses all the limitations of claim 10. Thus, for the reasons discussed above for claim 10, Petitioner fails to show that Levy and Finley teach or suggest all the limitations of claims 10, 11, 13, and 15 and, therefore, fails to show that Levy and Finley would have rendered obvious these claims. 5. Petitioner Fails to Show a Reasonable Likelihood of Prevailing As discussed above, Petitioner’s arguments and evidence fail to show that Levy anticipates claims 10, 11, 13, and 15 and fail to show that Levy and Finley would have rendered obvious these claims. Petitioner, therefore, fails to show a reasonable likelihood of prevailing in its challenges based on Levy.” slip op. at 18

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 9,584,843

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.