• Neogenomics Laboratories, Inc. v. Natera, Inc.Institution denied
  PTAB · 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 denial
  Patents in suitUS 11,530,454
• Sandoz Inc. v. Acerta Pharma B.V.Institution denied
  PTAB · Aug 7, 2023 · IPR2023-00478 · APJ Ulrike W Jenks · IPR · Institution

  The Board denied institution of review of claims 8–12, 19, and 20 under § 325(d), finding the asserted art substantially the same as art previously presented and no material Office error.

  RulingsInstitution decision

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

    “we agree with Patent Owner that, because Barf is nearly identical to Barf-PCT in its disclosure – Barf is “substantially the same art” as Barf-PCT, which was previously presented to the Office. Advanced Bionics, 8.” slip op. at 15

  • PTAB / AIA Trials › Motions to amend / substitute claimsDenied

    “for a certificate of correction is meritorious; instead, we are tasked with simply assessing whether there is a sufficient basis to support Patent Owner’s position. If so, it is up to the Director to decide whether to exercise the authority under § 255 and issue a certificate of correction. We have reviewed the arguments in the Motion and conclude that “there is a sufficient basis supporting Patent Owner’s position that the mistake may be correctable.” Honeywell, 939 F.3d at 1349. However, because as discussed above (see supra Section III), we deny institution here pursuant to our discretion under Section 325(d), we find that whether Barf is or is not prior art is immaterial to this proceeding and Patent Owner’s request and any certificate of correction here is moot. Therefore, we deny as moot the Motion for leave to file a Certificate of Correction.” slip op. at 22

  Discretionary denial
  Patents in suitUS 10,272,083
• Miltenyi Biomedicine GmbH / Miltenyi Biotec Inc. v. The Trustees Of The University Of PennsylvaniaInstitution denied
  PTAB · 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 · Graham
  Patents in suitUS 9,464,140
• Boehringer Ingelheim Animal Health USA Inc. v. Kansas State University Research FoundationInstitution denied
  PTAB · Jul 15, 2022 · PGR2022-00021 · APJ Sheridan K Snedden · PGR · Institution

  The Board denied institution on Grounds 1–5 under § 325(d) and found Ground 6 had not shown any challenged claim more likely than not unpatentable.

  RulingsInstitution decision

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

    “met (e.g., substantially the same art is presented), we move to part two of the framework, asking “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of [the] challenged claims.” Id. at 8. Factors (c), (e), and (f) of Becton, Dickinson fall within part two of the framework. Id. at 10 (“[F]actors (c), (e), and (f) relate to whether the petitioner has demonstrated material error by the Office.”). Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated error. Id. at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise his discretion not to institute.” Id. at 8–9. “At bottom, this [§ 325(d)] framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9 (“If reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.”).” slip op. at 15

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

    “specific citations to evaluate its assertions, Petitioner does not direct our attention to any portion of the Nordgren Declaration providing information on why the partial sequences disclosed by the references teach or suggest the claimed 90% sequence homology. Pet. 76, 79 (citing Ex. 1026 at VII.C, ¶¶ 247–269). For example, Dr. Nordgren’s assertion “a POSITA would anticipate natural genetic variation of PorkNW2/USA/2009 ORF2 would bring it within the scope of the Claim 1 genera” is not supported by substantial evidence. Ex. 1026 ¶ 256. Claim 1, for example, recites a PCV3 protein and does not recite partial proteins. Without knowing what portion of complete proteins are disclosed by the references, we are not persuaded that a person of ordinary skill in the art would have been able to predict the variation expected among a group of complete proteins to arrive at the claimed subject matter as is implied by Petitioner. Petitioner’s conclusory statements are insufficient to support a legal conclusion of obviousness. And while we agree with Petitioner that the protein sequences disclosed in the cited references do not necessarily have to be designated as PCV3 sequences, we determine that Petitioner has failed to meet its burden to demonstrate that any of the PCV3 deposit references teach or suggest the recited sequences within the claimed range. Pet. 79. Therefore, Petitioner has not met its burden in showing that every claimed element is taught by its cited references, and we need not reach Petitioner’s argument on motivation to combine. Accordingly, we determine that Petitioner fails to carry its burden to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable based on Petitioner’s Ground 6.” slip op. at 25

  • Skill levelSkill level petitioner adoptedOther

    “A person of ordinary skill in the art (or “POSITA”) in the field of the ’274 Patent in the October 2015 to October 2019 timeframe would have held a Doctorate in Veterinary Medicine (D.V.M.) or equivalent, or a Ph.D. or equivalent in immunology, vaccinology, virology, molecular biology, animal science, and/or husbandry, or a closely related field. A POSITA would also have practical knowledge of immunology, including how vaccine candidates are first identified and then subsequently developed. The knowledge may come from the POSITA’s own experience, or it may come through research or work collaborations with other experienced individuals in the medical, pharmaceutical, or biotech industry, e.g., as members of a research team or group. Pet. 16 (citing Ex. 1026 ¶ 34). Absent opposition from Patent Owner, we adopt Petitioner’s definition because it is consistent with the level of ordinary skill in the art reflected by the prior art in this proceeding. 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 11

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

    “The Board applies the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(b) (2019). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner contends that it “does not believe any term of the ’274 Patent needs to be construed in this proceeding.” Pet. 29. We agree and independently determine that it is unnecessary to expressly construe any claim term for purposes of rendering this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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 11

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 10,954,274
• Janssen Biotech, Inc. v. The United States Of America, As Represented By The Secretary, Department Of Health & Human ServicesInstitution denied
  PTAB · Mar 2, 2022 · IPR2021-01484 · APJ Robert A Pollock · IPR · Institution

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

  RulingsInstitution decision

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

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

  • Skill levelSkill level patent owner adoptedOther

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

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

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

  Claim constructionDiscretionary denialcites Graham
  Patents in suitUS 9,765,342
• Atrium Medical Corporation v. Bard Peripheral Vascular, Inc.Institution denied
  PTAB · Jan 20, 2022 · IPR2021-01200 · APJ James A Tartal · IPR · Institution

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

  RulingsInstitution decision

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

    “Section 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 claims. Advanced Bionics, Paper 6 at 8.” slip op. at 20

  • Expert testimonyPetitioner expert discountedOther

    “Pet. vi. Although both citations above refer to “Herts” as an author, it is apparent that the citations to the two articles provide different article titles, different publications, and different publication dates. Accordingly, Petitioner’s assertion that “Bardport specifically identifies Herts as ‘on the subject’ of, and ‘of help’ regarding, the use of power injectors with Bard’s venous access port assembly,” is incorrect, because the article Petitioner relies on as Herts is not the article cited in Bardport authored by “Herts.” See Pet. 22 (citing Ex. 1012, 27–28; Ex. 1038, 1–2). Mr. Leschinsky’s testimony regarding Bardport on this point is likewise incorrect. See Ex. 1003 ¶ 94. Mr. Leschinsky states that “[i]t is my opinion that a [person of ordinary skill in the art] would have been motivated to combine the 9 The identical question and answer appears on multiple pages of Exhibit 1012. See Ex. 1012, 21–22, 27–28, 33–34. teachings of Herts . . . because Bardport itself acknowledges Herts’ findings,” and “in response to a ‘frequently asked question’ titled ‘[c]an catheters be used in the Radiology Department with the Power Injector?’ Bardport cites to Herts.” Id. (citing Ex. 1012, 21–22). As explained above, Bardport does not cite to Herts, the reference relied upon by Petitioner, but instead refers to a different article identifying “Herts” as the author.” slip op. at 14

  Discretionary denial
  Patents in suitUS 7,947,022
• Atrium Medical Corporation v. Bard Peripheral Vascular, Inc.Institution denied
  PTAB · Jan 20, 2022 · IPR2021-01199 · APJ James A Tartal · IPR · Institution

  The Board denied institution on all challenged claims and grounds under § 325(d), finding the art previously presented to the Office and no material Office error.

  RulingsInstitution decision

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

    “Section 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 claims. Advanced Bionics, Paper 6 at 8.” slip op. at 20

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

    “review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . 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 that the petitioner raises “the same or substantially the same prior art or arguments previously presented to the Office,” for example, during patent examination or” slip op. at 2

  • Expert testimonyPetitioner expert discountedOther

    “See Pet. 54 (citing Ex. 1012, 27–28; Ex. 1038, 2). Mr. Leschinsky’s testimony regarding Bardport on this point is likewise incorrect. See Ex. 1003 ¶ 100. Mr. Leschinsky states that “[i]t is my opinion that a [person of ordinary skill in the art] would have been motivated to combine the teachings of Herts . . . because Bardport itself acknowledges Herts’ findings,” and “in response to a ‘frequently asked question’ titled ‘[c]an catheters be used in the Radiology Department with the Power Injector?’ Bardport cites to Herts.” Id. (citing Ex. 1012, 21–22). As explained above, Bardport does not cite to Herts, the reference relied upon by Petitioner, but instead refers to a different article identifying “Herts” as the author.” slip op. at 15

  Discretionary denial
  Patents in suitUS 7,785,302
• Atrium Medical Corporation v. Bard Peripheral Vasulcar, Inc.Institution denied
  PTAB · Jan 10, 2022 · IPR2021-01197 · APJ Ryan H Flax · IPR · Institution

  The Board denied institution of IPR challenging claims 8, 9, and 11 under § 325(d), finding the same art had been presented before and no material Office error was shown.

  RulingsInstitution decision

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

    “In evaluating the exercise of discretion to deny institution under Section 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 claims. Advanced Bionics, Paper 6 at 8.” slip op. at 18

  • Expert testimonyOther

    “5 It is specifically this portion of Melsky that Petitioner cites as teaching a power-injectable access port, as claimed. See Pet. 27, 31, 36; see also Ex. 1003 ¶¶ 66, 70, 74 (analyzing Melsky and concluding it teaches a power injectable port, as claimed). We note that Melsky never expressly mentions a power injectable port. See generally Ex. 1008. Petitioner’s witness relies on Melsky’s disclosure that its port can withstand pressures of 200 psi or more as inherently disclosing a power injectable port; however, the witness merely concludes this without citation to supporting evidence. This is meager evidence of an alleged inherent disclosure intended to be a foundation of Petitioner’s challenges in this proceeding. “Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a); see TQ Delta, LLC v. CISCO Sys., Inc., 942 F.3d 1352, 1358–59 (Fed. Cir. 2019) (“conclusory expert testimony is inadequate to support an obviousness determination on substantial evidence review.”).” slip op. at 16

  Discretionary denial
  Patents in suitUS 7,959,615
• Boragen, Inc. v. Syngenta Participations AGRehearing denied
  PTAB · Aug 10, 2020 · IPR2020-00124 · APJ Timothy G Majors · IPR · Rehearing

  The Board denied Boragen’s rehearing request and left in place the denial of institution under § 325(d), finding no abuse of discretion.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “whether to institute trial for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be found if there was an erroneous interpretation of law, a factual finding not supported by substantial evidence, or an unreasonable judgment in weighing relevant factors. 37 C.F.R. § 42.71(c); Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); The Arnold Partnership v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). The rehearing request “must specifically identify all matters the [requesting] party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id.” slip op. at 2

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

    “Petitioner contends the Board “failed to exercise its discretion under 325(d)” (Req. 2), but this is plainly inconsistent with the Decision, because we did exercise discretion under § 325(d) and denied the Petition because it was based on substantially the same prior art as already considered by the Office. See Dec. 6–35 (analyzing, inter alia, the asserted prior art, the prosecution history, declarant testimony, and the precedential Becton, Dickinson factors under a framework explained further in Advanced Bionics, in route to denial under § 325(d)).1 Petitioner continues, arguing the Board “improperly” slip op. at 3

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “expert” may opine on the unpatentability of the challenged claims generally represents one factor that we account for in exercising our discretion under § 325(d) (e.g., insofar as it may comprise “additional evidence” addressing prior art that the Office may have already considered). Becton, Dickinson at 17–18. It is not, however, a super-factor that overrides others in the manner urged by Petitioner that would, in effect, require we institute inter partes review so long as the challenge is accompanied by “new” testimony slip op. at 4

  • PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied

    “precedential after the Petition was filed, and requests “additional briefing to directly address the Advanced Bionics factors” if this Request is denied. Req. 1 n.1. Petitioner’s request for additional briefing is denied. Additional briefing is unnecessary because the arguments and evidence already submitted by the parties is sufficient for us to make a determination based on the two-part framework in Advanced Bionics. Furthermore, we have reviewed the arguments based on Advanced Bionics submitted by Petitioner on rehearing and do not find them persuasive. Req. 8–10 (“Petitioner highlights such errors herewith separately under the guidelines set forth in Advanced Bionics”). Moreover, Advanced Bionics became precedential six weeks before we denied institution in this case, where discretionary denial” slip op. at 10

  Discretionary denial
  Patents in suitUS 10,130,096
• Boragen, Inc. v. Syngenta Participations AGInstitution denied
  PTAB · May 5, 2020 · IPR2020-00124 · APJ Timothy G Majors · IPR · Institution

  The Board denied institution of IPR on claims 1–12 under § 325(d), finding the asserted prior art and arguments were substantially the same as those considered during prosecution and no material error was shown.

  RulingsInstitution decision

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

    “Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated error. Advanced Bionics at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise his discretion not to institute inter partes review.” Id. at 8–9 (“If a condition in the first part of the framework [i.e., substantially same art or arguments] 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”). “At bottom, this [§ 325(d)] framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 14 9. On the question of material error, “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Id.” slip op. at 14

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

    “Under 35 U.S.C. § 314(a), an inter partes may not be instituted unless the Petition “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.” Upon considering the arguments and evidence, we deny review of the Petition on a discretionary basis under 35 U.S.C. § 325(d). Thus, for reasons further explained below, we do not institute inter partes review of claims 1–12 of the ’096 patent.” slip op. at 2

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

    “Petitioner makes the same points about Kohn here. According to Petitioner, Kohn teaches “compounds with an oxaborole core structure could be used as fungicides to treat plants and seeds.” Pet. 26–27; see also id. at 42–43 (block quoting, with apparent approval, the Examiner’s findings about Kohn in combination with Austin). Like the Examiner, Petitioner cites Kohn’s teaching of the use of “boroxarophenanthrenes” as fungicides, and the application of such fungicides in effective amounts on vegetative hosts. Pet. 46 (claim chart, citing Kohn’s teachings). Indeed, Petitioner expressly invokes the reasons offered by the Examiner during prosecution as motivating the combination of Austin and Kohn. Pet. 44 (“For all the reasons discussed above and in the prosecution history, a POSITA would have been motivated to combine the teachings of Austin and Kohn with a reasonable expectation of success.”).14 14 In fact, the only reasons that are expressly offered in the Petition for combining Austin and Kohn come from the Examiner. Pet. 42–49 (Ground 2). Petitioner’s assertion that the declaration submitted during prosecution was “misleading” is not a reason for combining Austin and Kohn. Pet. 43–44. Nor do vague citations to testimony of Petitioner’s declarants, without any adequate explanation in the Petition itself, suffice to demonstrate persuasive reasons for combining the art. Id.; see also id. at 23 (asserting vaguely in a section titled “Overview of Grounds” that “[a] POSITA would also be motivated to combine Austin and Kohn to arrive at the claimed invention”) (citing Ex. 1003 ¶ 82; Ex. 1018 ¶¶ 63–65, 82–85). Even the cited testimony here is unpersuasive. For example, Dr. Hall’s cited testimony merely repeats that a skilled person “would have been motivated to combine Austin and Kohn with a reasonable expectation of success.” Ex. 1003 ¶ 82; Ex. 1018 ¶¶ 63–65 (conclusory opinion about an alleged “structure similar to that of a benzoxaborole compound” in Kohn), ¶¶ 82–85” slip op. at 19

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “14 In fact, the only reasons that are expressly offered in the Petition for combining Austin and Kohn come from the Examiner. Pet. 42–49 (Ground 2). Petitioner’s assertion that the declaration submitted during prosecution was “misleading” is not a reason for combining Austin and Kohn. Pet. 43–44. Nor do vague citations to testimony of Petitioner’s declarants, without any adequate explanation in the Petition itself, suffice to demonstrate persuasive reasons for combining the art. Id.; see also id. at 23 (asserting vaguely in a section titled “Overview of Grounds” that “[a] POSITA would also be motivated to combine Austin and Kohn to arrive at the claimed invention”) (citing Ex. 1003 ¶ 82; Ex. 1018 ¶¶ 63–65, 82–85). Even the cited testimony here is unpersuasive. For example, Dr. Hall’s cited testimony merely repeats that a skilled person “would have been motivated to combine Austin and Kohn with a reasonable expectation of success.” Ex. 1003 ¶ 82; Ex. 1018 ¶¶ 63–65 (conclusory opinion about an alleged “structure similar to that of a benzoxaborole compound” in Kohn), ¶¶ 82–85” slip op. at 19

  § 103 obviousnessDiscretionary denial
  Patents in suitUS 10,130,096

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.