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  • PTAB · Jan 30, 2023 · IPR2022-01319 · APJ Thomas L Giannetti · IPR · Institution

    The Board denied institution for all challenged claims under § 325(d), finding Beyda had been presented to the Office and Microsoft had not shown material Examiner error.

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

      “Here, Petitioner does not dispute Patent Owner’s evidence that Beyda was previously presented to the Office. Ex. 1004, 295. Thus, the first criterion of the Advanced Bionics framework (same art or arguments) is met. Advanced Bionics, Paper 6 at 7–8 (“Previously presented art includes art made of record by the Examiner and art provided to the Office by an applicant, such as on an Information Disclosure Statement (IDS),”). The second inquiry in the Advanced Bionics framework asks whether the Petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8–9. As Patent Owner points out, “although the Petition admits that the Examiner considered Beyda during prosecution, it fails to make any allegation whatsoever that the Examiner erred (let alone erred in a material way) in his consideration of Beyda.” Prelim. Resp. 18. As to Narin, Patent Owner argues that Petitioner “does not offer any explanation” why that reference is not “substantially the same” as art considered by the Examiner, “let alone how or why the Examiner materially erred in considering that art to not be invalidating.” Id. We agree that Petitioner has failed to demonstrate that the Office erred in its evaluation of the cited art. See Advanced Bionics, Paper 6 at 8–9 (“If a condition in the first part of the framework is satisfied and the petitioner fails to make a showing of material error, the Director generally will exercise discretion not to institute inter partes review.”). Here, the Beyda prior art that was before the Examiner during the examination is identical to the art cited here.3 There is no argument or evidence before us that Beyda was concealed from the Examiner. The Examiner ultimately made a determination that the claims were patentable. Ex. 1004, 49, 92. As cautioned by Advanced Bionics, “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Advanced Bionics, Paper 6 at 9. Advanced Bionics goes on to explain the rationale for this rule: “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. Having considered the record presented by Patent Owner and the absence of any substantive showing from Petitioner, we are not persuaded of material Examiner error. Petitioner’s assertion that the prior art references in the Petition “were not substantively considered during the prosecution of the ’139 Patent, or in the prior CBM challenge,” without further explanation, is insufficient. In summary, applying the two-part framework of Advanced Bionics, we are persuaded to deny the Petition under 35 U.S.C § 325(d).” slip op. at 10

    Discretionary denial
    Patents in suitUS 8,671,139
  • PTAB · 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
  • PTAB · 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 denial
    Patents in suitUS 10,584,890
  • 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
  • PTAB · Apr 14, 2022 · IPR2022-00003 · APJ Juliet Mitchell Dirba · IPR · Institution

    The Board denied institution of review of claims 1–15, 23–28, 32, 43–51, and 97 under § 325(d) because substantially the same art or arguments were previously presented and Petitioner showed no material Office error.

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

      “(1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” slip op. at 7

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

      “We may institute an inter partes review if the information presented in the Petition and the Preliminary Response shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims. See 35 U.S.C. § 314. However, the Board has discretion to deny a petition even if a petitioner meets that threshold. See, e.g., 35 U.S.C. § 325(d); Cuozzo Speed Techs., LLC v. Lee, 579 U.S. 261, 273 (2016) (“[T]he agency’s decision to deny a petition is a matter committed to the Patent Office’s discretion.”).” slip op. at 2

    Discretionary denial
    Patents in suitUS 7,630,358
  • PTAB · Mar 2, 2022 · IPR2021-01484 · APJ Robert A Pollock · IPR · Institution

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

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

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

    • Skill levelSkill level patent owner adoptedOther

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

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

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

    Claim constructionDiscretionary denialcites Graham
    Patents in suitUS 9,765,342
  • PTAB · 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
  • 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
  • PTAB · Mar 14, 2019 · IPR2018-01280 · APJ Scott B Howard · IPR · Rehearing

    The Board denied Apple’s rehearing request, leaving in place the denial of institution because it had not overlooked or misapprehended material facts about Brown or the prosecution history.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “a panel will review the decision for an abuse of discretion.” The party requesting rehearing has the burden of showing that the decision from which rehearing is sought should be modified and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d).” slip op. at 2

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

      “Dec. 8–9 (emphasis added). Similarly, when weighting the Becton factors, we explicitly found that although the Examiner originally rejected the claims based on Brown, “[f]ollowing an amendment to the claims adding the prompting step along with arguments by the applicant explaining why Brown did not teach that new limitation, the Examiner shifted to new references and no longer relied on Brown.” Id. at 14 (citing Ex. 1002, 142– 149, 156–168, 178–181). In other words, twice we explicitly acknowledged what Petitioner now argues we overlooked.” slip op. at 5

    • Strike new argumentNew argument disregardedOther

      “For the reasons explained above, we are not persuaded that we misapprehended or overlooked any material facts. Moreover, Petitioner never explicitly nor implicitly addressed the Becton factors in the Petition, and new arguments are not permitted in a request for rehearing absent exceptional circumstances, of which none have been identified here.” slip op. at 8

    Discretionary denial
    Patents in suitUS 7,844,037
  • PTAB · Jul 27, 2017 · IPR2017-00739 · APJ Robert A Pollock · IPR · Institution

    The Board denied institution on claims 1–11 and 14–17 under § 325(d), finding the priority issue and Nabholtz ground had been considered during prosecution.

    RulingsInstitution decision
    • BurdenDecided for patent owner

      “Prelim. Resp. 10–11; see also id. 11, n.3 (arguing that Applicant demonstrated support for a three-part combination comprising a “further therapeutic agent”). Having considered the Specification of the ’649 Application and the arguments raised during prosecution, as discussed section II(B), above, Petitioner has not presented any further evidence in this proceeding that would persuade us to reach a conclusion different from the Examiner’s position that the challenged claims are adequately disclosed in the priority document.” slip op. at 14

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateDecided for patent owner

      “established priority for those claims based upon the parent application’s specific disclosure of using growth inhibitory agents as part of the present invention. (Ex. 1119-5 at 179 (citing Ex. 1121 at 20 (16:11- 24), 39 (35:6-14), 41 (37:9-18).) Based upon that disclosure, the examiner agreed that the claims reciting a combination with “a further growth inhibitory agent” were supported by, and thus entitled to priority to, the parent applications. (Ex. 1119-5 at 41; id. at 292-93; Ex. 1119- 6 at 245.) Prelim. Resp. 10–11; see also id. 11, n.3 (arguing that Applicant demonstrated support for a three-part combination comprising a “further therapeutic agent”). Having considered the Specification of the ’649 Application and the arguments raised during prosecution, as discussed section II(B), above, Petitioner has not presented any further evidence in this proceeding that would persuade us to reach a conclusion different from the Examiner’s position that the challenged claims are adequately disclosed in the priority document.” slip op. at 14

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledDecided for patent owner

      “combination are needed to demonstrate that they can be usefully combined,’” flatly contradicts Patent Owner’s position that the ’649 Application and ’346 Provisional Application adequately disclose the claimed invention. Pet. 17–18 (citing Ex. 1119-5, 308–09). We do not find Petitioner’s argument persuasive. As an initial matter, Petition fails to address the “Wands” factors in its enablement analysis. See In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).” slip op. at 15

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

      “As discussed in section II(B), above, the Examiner considered fully the written description and enablement issues underlying Applicant’s claim to priority in allowing the claims to issue, and Petitioner has not presented new evidence or arguments that would convince us that the Examiner’s determination was unreasonable. The Examiner’s decision to withdraw the rejection under 35 U.S.C. § 102(b) over Nabholtz was expressly predicated on that priority determination, which removed Nabholtz as prior art. In Ground I of this Petition, Petitioner also asserts that the claims are unpatentable under § 102(b) over Nabholtz, thus raising “the same or substantially the same prior art or arguments previously [] presented to the Office” as contemplated under 35 U.S.C. § 325(d). Under the circumstances of this case, we exercise our discretion under § 325(d) and decline to institute inter partes review based on Ground I.” slip op. at 18

    § 102 anticipation§ 112 disclosureDiscretionary denial
    Patents in suitUS 7,892,549
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