- Fujirebio Diagnostics, Inc. v. Quanterix Corp.Institution deniedPTAB · Oct 17, 2025 · IPR2025-01060 · APJ Coke Morgan Stewart · IPR · Director review
The Director granted Quanterix’s request for discretionary denial and denied institution of IPR based on the examiner’s consideration of copying evidence and the holistic assessment.
RulingsDirector review decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“is appropriate because the patent examiner found that the objective indicia of nonobviousness evidence was persuasive in allowing the patent application. DD Req. 13–30. Although Petitioner addresses the sufficiency of Patent Owner’s evidence, Petitioner has not persuasively demonstrated that the Office erred in evaluating this evidence. DD Opp. 21; Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). Rather, Petitioner merely disagrees with the Examiner’s treatment of the evidence without showing material error. DD Opp. 21–26. “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.” See Advanced Bionics, Paper 6 at 9. Under these circumstances, discretionary denial is appropriate.” slip op. at 2
- Other 314aInstitution denied discretionary otherInstitution denied
“Furthermore, to the extent resolution of this issue may require additional evidence regarding objective indicia of nonobviousness, a district court may be the more appropriate venue, as it may allow for more robust discovery. Accordingly, the considerations that favor discretionary denial outweigh those that counsel against it. Although certain arguments are highlighted above, the determination to exercise discretion to deny institution is based on a holistic assessment of all of the evidence and arguments presented. Accordingly, the Petition is denied under 35 U.S.C. § 314(a).” slip op. at 3
- Obviousness (§103) › Objective indicia / secondary considerations › CopyingObjective indicia with nexusDecided for patent owner
“particular, in allowing the challenged patent, the patent examiner stated that Patent Owner provided rebuttal evidence of copying by others sufficient to overcome the obviousness rejection. Ex. 1002, 659–660. The patent examiner explained that “no group prior to the effective filing date had done more than perhaps suggest” using the claimed assay, “while dozens of groups utilized” that assay “after the date of Applicant’s contribution.” Id. at 660. Patent Owner argues that discretionary denial under 35 U.S.C. 325(d) is appropriate because the patent examiner found that the objective indicia of nonobviousness evidence was persuasive in allowing the patent application. DD Req. 13–30. Although Petitioner addresses the sufficiency of Patent Owner’s evidence, Petitioner has not persuasively demonstrated that the Office erred in evaluating this evidence. DD Opp. 21; Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). Rather, Petitioner merely disagrees with the Examiner’s treatment of the evidence without showing material error. DD Opp. 21–26. “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.” See Advanced Bionics, Paper 6 at 9. Under these circumstances, discretionary denial is appropriate.” slip op. at 2
§ 103 obviousnessDiscretionary denialPatents in suitUS 11,275,092 - Skechers U.S.A., Inc. v. Nike, Inc.Institution deniedPTAB · Jun 10, 2025 · IPR2025-00141 · APJ Ken B Barrett · IPR · Institution
The Board denied institution on all challenged claims under §325(d), finding the petition relied on previously presented art and did not show material error by the Office.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“The Board uses a two-part framework in determining whether to exercise its discretion under § 325(d), specifically: (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, Paper 6 at 8.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“single §102 rejection based solely on Nishida.” Pet. § 325(d) Reply 3 (emphasis omitted). Specifically, Petitioner argues that: The examiner seemingly failed to consider how it would have been obvious to combine Nishida (or any other reference of record, such as Orei) with knowledge in the art, including the fact that it was “well known to use double needle-bar raschel machines . . . to knit textile elements simultaneously with surrounding textile structures” (Pet., 37–38), and that simultaneous knitting would be obvious because it would “increase yield and reduce manufacturing steps,” as explained in the Petition and supporting evidence. See Pet., 42–44. Id. (alterations in original); see also id. at 4 (Petitioner arguing that the Examiner clearly erred for “failing to seemingly even consider if it would 10 We quote here, to give context to “otherwise,” both aspects that a petitioner must demonstrate in order to meet its burden. In order to determine whether Petitioner has met its overall burden, we need not and do not reach the issue of whether “the previously presented art [Nishida] teaches the limitations of the challenged claims.” Ecto World, Paper 13 at 6. have been obvious to combine Nishida with other prior art, or to implement Nishida using well-known techniques for simultaneously knitting textile elements and surrounding structures having differing textures.”). We do not find this argument persuasive. The cited portion of the Petition is the contention that Orei—not Nishida—would render obvious claim 1. See Pet. 37–38, 42–44 (Ground 1A). Thus, Petitioner has not shown persuasively that the Examiner erred in not making an obviousness rejection based on Nishida because the disputed limitation was purportedly well-known. Additionally, Petitioner’s support for the assertion that this limitation is well-known is not persuasive. The Petition parenthetically quotes from a source stating that plural “articles . . . can be simultaneously knitted side-by-side,” not that an article (a textile element) and surrounding textile structure are known to be simultaneously knitted. See Pet. 38 (quoting Ex. 1050, 201) (emphasis added); see also Pet. § 325(d) Reply 3 (Petitioner quoting its own argument and characterizing it as a “fact” (“The examiner seemingly failed to consider . . . the fact that it was ‘well known . . . “)).” slip op. at 21
§ 103 obviousnessDiscretionary denialPatents in suitUS 8,266,749 - Neogenomics Laboratories, Inc. v. Natera, Inc.Institution deniedPTAB · Jun 21, 2024 · IPR2024-00346 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution for claims 1–28 under § 325(d), finding the same or substantially the same art had been presented to the Office and no material examination error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“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 Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). “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.” Id. at 8–9. “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 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“III. CONCLUSION Because the same or substantially the same art previously were presented to the Office and Petitioner has not demonstrated that the examiner materially erred when considering the prior art, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’454 patent.10 IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“erred when considering the multiplex-amplification limitation. See Advanced Bionics, 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.”). Under the asserted grounds, Petitioner relies on Forshew as the sole reference to teach this limitation, which is required in all challenged claims. Thus, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’454 patent.” slip op. at 13
§ 103 obviousnessDiscretionary denialPatents in suitUS 11,530,454 - Hugel, Inc. v. Medytox Inc.Institution deniedPTAB · 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 · KSRPatents in suitUS 11,331,598 - Risen (Suzhou) Pharma Tech. Co. Ltd. v. Alzheon, Inc.Institution deniedPTAB · 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 · GrahamPatents in suitUS 11,191,742 - Risen (Suzhou) Pharma Tech. Co. Ltd. v. Alzheon, Inc.Institution deniedPTAB · 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 · GrahamPatents in suitUS 10,471,029 - Google LLC v. Valtrus Innovations LimitedInstitution deniedPTAB · 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 PhillipsPatents in suitUS 6,816,809 - Miltenyi Biomedicine GmbH / Miltenyi Biotec Inc. v. The Trustees Of The University Of PennsylvaniaInstitution deniedPTAB · Oct 11, 2022 · IPR2022-00853 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on all challenged claims under § 325(d), finding substantially the same art had been presented to the Office and no material examination error was shown.
RulingsInstitution decision- Skill levelSkill level board ownOther
“In addressing the level of ordinary skill in the art, Petitioner contends that: A POSA is a person skilled in the art of administering CAR T-cell therapies. The person would possess a relatively high level of skill and have at least an MD, together with several years of experience in administering CAR T-cell therapies. The person would also have experience designing CARs. The POSA would have knowledge of the scientific literature pertaining to immunology, including CARs and methods for utilizing CARs before the priority date. A POSA would also be knowledgeable about laboratory techniques related to engineering and testing the function of CAR T-cells. A POSA would also be knowledgeable about designing clinical trials, including selecting dose ranges, that evaluate CAR T-cell therapies. Pet. 10. Patent Owner does not presently contest this definition. Although Petitioner’s definition generally comports with our understanding of the high level of skill in the art, we are not persuaded all of the asserted qualifications must be embodied in a single person. For example, it seems unduly limiting to require that the person of ordinary skill in the art have “at least an MD” degree, and “be knowledgeable about laboratory techniques related to engineering and testing the function of CAR T-cells,” as Petitioner suggests. Accordingly, we provisionally adopt Petitioner’s definition with the caveat that the asserted qualifications may be shared among multiple individuals working as part of a multidisciplinary team. C. Claim Construction” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notNot reached
“Patent Owner points out that the structure of independent claim 1 here is similar to those addressed in Eli Lilly. Prelim. Resp. 18. And, as in Eli Lilly, the Specification of the ’140 patent underscores the centrality of the method recited in the preamble. Id. (citing Ex. 1001, codes (54), (57), 1:55– 57). Unlike in Eli Lilly, however, the body of independent claim 1 does not recite merely “an effective amount” but “an anti-tumor effective amount” of the composition administered. Petitioner argues that whereas the preambles in Eli Lilly “provide the only metric by which one practicing the claim could determine whether the amount administered is an ‘effective amount,’” the term “anti-tumor effective amount” in independent claim 1 “is well-defined by the specification and provides sufficient guidance for determining effectiveness.” Prelim. Reply 3 (citing Eli Lilly at 1342). On balance, Petitioner appears to have the better argument. Nonetheless, even if we were to construe the treatment language of the preamble to mean “reducing the frequency or severity of at least one sign or symptom of cancer” as Patent Owner proposes, this definition is coextensive with, if not subsumed by, the term “anti-tumor effective amount,” discussed below. As such, the outcome of this proceeding does not turn on whether the preamble is limiting.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“As we understand it response, Patent Owner does not appear to contest that “anti-tumor effect” can comprise a decrease in the number of tumor cells, but argues that the claim term requires “a palpable therapeutic effect,” which is more than “just the death of a single cancer cell or handful of cells.” Prelim. Resp. 19–23; Prelim. Sur-reply 4–5. In support, Patent Owner points to the ’140 patent’s express definition of “[a]n ‘effective amount’” as meaning “an amount which provides a therapeutic or prophylactic benefit.” Pet. 20 (citing Ex. 1001, 13:53–54). Relatedly, we note that the Specification also teaches that a “‘therapeutically effective amount’ includes that amount of a compound that, when administered, is sufficient to prevent development of, or alleviate to some extent, one or more of the signs or symptoms of the disorder or disease being treated.” Ex. 1001, 18:12–15. Patent Owner further contends that “[t]he specification teaches that ‘an antitumor effective amount’ is an amount to be administered that is “determined by a physician” as part of determining ‘[t]he optimal dosage and treatment regime for a particular patient . . . by monitoring the patient for signs of disease and adjusting the treatment accordingly.’” Prelim. Resp. 22 (citing Ex. 1001, 37:53–38:5). Considering the argument and evidence of record, we agree with Patent Owner that one of ordinary skill in the art would understand an “anti- tumor effective amount” as used in claim 1 to require more than the killing of a single tumor cell. Accordingly, we provisionally construe “anti-tumor effective amount” as any amount of CAR T-cells administered to a patient in need of cancer treatment that reduces the frequency or severity of at least one clinically relevant sign or symptom of the disease. To the extent this functional limitation is satisfied, claim 2 indicates that an “anti-tumor effective amount” may be limited to between 104 to 109 CAR T-cells/kg body weight. At this stage of the proceeding, no other term requires construction.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“reasonable expectation of success in light of the unpredictability of cancer therapy and the “uninspiring” results and failures of earlier CAR-T clinical trials. Prelim. Resp. 23–28 (citing e.g., Ex. 2037, 1036; Ex. 2010, 1824– 1825; Ex. 2032, 1250–1251). In support, Patent Owner points to OSI Pharms. as “directly on-point.” Id. at 24 (citing OSI Pharms., LLC v. Apotex Inc., 939 F.3d 1375 (Fed. Cir. 2019)). The claims at issue in OSI Pharms., were structurally similar to those at issue here and directed to a method of treating non-small cell lung cancer (“NSCLC”) in a mammal using a therapeutically effective amount of erlotinib, which had previously been shown to inhibit the epidermal growth factor receptor (“EGFR”) in vitro. 939 F.3d at 1378–79. The court stated: Cancer treatment is highly unpredictable. Even though the EGFR was identified in some cancers as a drug target, the in vitro (i.e., in a test tube) effectiveness of a drug in inhibiting the EGFR turned out to be a poor proxy for how effective that drug actually was in treating cancer in vivo (i.e., in the body). Numerous EGFR inhibitors that showed promising in vitro activity failed for a variety of reasons. Id. at 1377; see also id. at 1386 (“1,630 other new drug compounds that, like erlotinib, targeted NSCLC and were studied in Phase II trials. The failure rate for these compounds was 99.5%”). Against this backdrop, the court reversed the Board over its unsupported reading of the two cited references, finding that: the asserted references do not disclose any data or other information about erlotinib’s efficacy in treating NSCLC. The record does not contain any clinical (human) data or preclinical (animal) data. It does not even include in vitro (test tube) data regarding erlotinib’s effect on NSCLC. Id. at 1384. Considering the promising in vitro data presented in Campana and Jensen, Petitioner here has a somewhat better position than the Appellees in OSI Pharms. At core, Grounds 1 and 2, require us to find a reasonable expectation of success in treating a human cancer based on in vitro experiments, the mere existence of a clinical trial, and absent any of the “clinical (human) data or preclinical (animal) data,” highlighted by the court. See id. Considering the inherent unpredictability of the field and the history of failures of similar technology documented by Patent Owner, we do not find Petitioner’s arguments persuasive. As such, Petitioner has not demonstrated a reasonable likelihood of success in proving that any claim of the ’140 patent is unpatentable under Grounds 1 and 2.” slip op. at 40
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,464,140 - Google LLC v. Ecofactor, Inc.Institution deniedPTAB · Aug 1, 2022 · IPR2022-00535 · APJ Brent M Dougal · IPR · Institution
The Board denied institution for claims 1–17 under § 325(d), finding no material error in the Examiner’s priority determination and Quam essential to every asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“2. Conclusion as to 35 U.S.C. § 325(d) As discussed in detail above, the Quam and Modi references only qualify as prior art that can be used against the ’890 patent if the ’890 patent is not entitled to priority. However, the Petition fails to establish that the Examiner erred in determining that the ’890 patent is entitled to its priority claim. We exercise our discretion to decline to reconsider the issue of priority which has already been addressed by the Office. Thus, the Petition cannot show that Quam and Modi are prior art that can be used against the ’890 patent. As Quam is essential to all grounds in the Petition, we exercise our discretion under 35 U.S.C. § 325(d) to decline to institute.” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“Petitioner’s argument fails to identify any material errors by the Examiner. First, we determine that Petitioner makes no credible argument that one of skill in the art would not understand the ’554 application to teach that weather data is obtained from outside a building or that the Examiner erred in making such a determination. Petitioner acknowledges that the ’554 application teaches data comprising an outside weather condition. Id. at 12– 14. Data of an outside weather condition necessarily ultimately comes from a source outside of a building; otherwise it would not be an “outside” weather condition. Contrary to Petitioner’s argument, the claim does not require that the outside weather condition be transmitted from a source external to the building to the one or more processors through a network connected to the thermostat. See id. at 14. The claim states that the “outside weather condition [is] collected from a source external to the building,” but then only requires that the outside weather condition be received by the one or more processors from a network connected to the thermostat. Thus, how it is collected and how it is received is not linked or required by the claim language. Secondly, Figure 2 relied on by the Applicant shows that the entire system is set-up on a network. Thus, Figure 2 shows “a network connected to the thermostat” as required by the claim and sharing of data comes across the network, such as would occur when a server having a processor retrieves data, such as an outside weather condition, from a storage database on another server in the network. See e.g., Ex. 1005, 46; Ex. 1007, 399 at ¶¶ 81, 84, 406 at ¶ 110, 440–441.” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“qualify as prior art that can be used against the ’890 patent if the ’890 patent is not entitled to priority. However, the Petition fails to establish that the Examiner erred in determining that the ’890 patent is entitled to its priority claim. We exercise our discretion to decline to reconsider the issue of priority which has already been addressed by the Office. Thus, the Petition cannot show that Quam and Modi are prior art that can be used against the ’890 patent. As Quam is essential to all grounds in the Petition, we exercise our discretion under 35 U.S.C. § 325(d) to decline to institute. III. CONCLUSION For the foregoing reasons, we do not institute trial. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 314(a), no inter partes review as to any claim of U.S. Patent 10,584,890 B2 is instituted.” slip op. at 14
§ 112 disclosureDiscretionary denialPatents in suitUS 10,584,890 - Guardant Health, Inc. v. University Of WashingtonInstitution deniedPTAB · Aug 1, 2022 · IPR2022-00449 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because the written-description priority arguments were substantially the same as those considered by the Office, and Petitioner did not show material error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Based on this record, we find Petitioner’s arguments challenging written description support are the same or substantially the same as those considered by the examiner during the prosecution of the ’045 application. 4. Material Error Having found that the condition in the first part of the two-prong framework is satisfied, we next evaluate whether Petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, 8. Based on the current record, we determine Petitioner has not met its burden to show the examiner materially erred.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Not reached
“Specifically, Petitioner argues that the ’785 application lacks written description support for “converting” or “attaching” tags to “circulating DNA molecules,” as recited in independent claims 1 and 20. Id. at 17–30. Patent Owner argues that we should deny institution under § 325(d) “because the Office already found that the specification provides § 112 support for tagging circulating DNA.” Prelim. Resp. 10. For the reasons explained below, we find Patent Owner’s arguments persuasive.5 5 As another basis for its priority arguments, Petitioner contends that the ’785 application does not enable methods for “converting” or “attaching” tags to “circulating DNA molecules.” Pet. 30. Patent Owner asserts that “[t]he Petition gives enablement only cursory treatment.” Prelim. Resp. 36. We agree with Patent Owner. Petitioner disposes of the entire enablement argument in a single seven-line paragraph. See Pet. 30. It provides no meaningful analyses of the factors set forth in In re Wands, 858 F.2d 731,” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“III. CONCLUSION Petitioner’s anticipation and obviousness grounds rest on the priority date of the challenged claims. Because we decline to reconsider Petitioner’s challenge of priority date based on lack of written description support, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’699 patent. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied.” slip op. at 18
§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,689,699
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.