• Darfon Electronics Corp. v. Michael ShipmanInstitution denied
  PTAB · Dec 2, 2022 · IPR2022-01008 · APJ Debra K Stephens · IPR · Institution

  The Board denied institution under § 325(d), finding the asserted art cumulative of art previously presented to the Office and no material Office error shown.

  RulingsInstitution decision

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

    “In evaluating arguments under § 325(d), we use [a] two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner slip op. at 10

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

    “(a) THRESHOLD.—The Director may not authorize an inter partes review to be instituted unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 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)). Petitioner challenges claims 1–20 as unpatentable under 35 U.S.C. § 103 in twelve grounds of unpatentability (Pet. 7). Generally, Patent Owner contends that the Petition should be denied as to all challenged claims (see Prelim. Resp.). We do not reach whether Petitioner has shown a reasonable likelihood of prevailing on at least one claim. For reasons discussed below, we discretionarily deny the Petition under 35 U.S.C. § 325(d).” slip op. at 2

  Discretionary denial
  Patents in suitUS 10,942,581
• 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
• 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
• Hospira, Inc. v. Genentech, Inc.Institution denied
  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
• Hospira, Inc. v. Genentech, Inc.Institution denied
  PTAB · Jul 27, 2017 · IPR2017-00731 · APJ Zhenyu Yang · IPR · Institution

  Institution was denied for claims 1–14: the Baselga ’97 and Baselga ’94 ground was denied under § 325(d), and the Baselga ’96 and Baselga ’94 ground did not meet the reasonable-likelihood threshold.

  RulingsInstitution decision

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

    “In this case, in an office action dated December 7, 1999, the examiner rejected the then-pending claims as anticipated by Baselga ’97. Ex. 1011, vol. 1, 379. In response, the applicant attempted to distinguish over the reference. Id. at 398. The applicant later submitted a declaration by the inventor under 37 C.F.R. §1.131, together with certain evidence, to antedate Baselga ’97. Ex. 1011, vol. 2, 37, 118–47. In an office action dated January 9, 2001, the examiner found that neither the argument nor the declaration was persuasive. Id. at 213–14. As a result, the examiner continued to reject the claims as unpatentable over Baselga ’97. Id. at 212–14. In response, the applicant submitted another declaration by the inventor under 37 C.F.R. §1.131, accompanied by additional evidence, to antedate Baselga ’97. Id. at 230–31, 237–312. Thereafter, the examiner withdrew the rejection based on Baselga ’97, stating that “[t]he declaration filed on 5/07/2001 under 37 CFR 1.131 is sufficient to overcome the Baselga (1997).” Id. at 324. Petitioner does not present additional evidence or persuasive arguments in this proceeding for us to reach a different conclusion with respect to Baselga ’97. Under these circumstances, we exercise our discretion under § 325(d) and decline to institute inter partes review based on the combination of Baselga ’97 and Baselga ’94.” slip op. at 8

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

    “in the absence of an anthracycline derivative.” To account for this limitation, Petitioner argues that (1) the cardiotoxicity of anthracycline derivatives was well known in the prior art; (2) both preclinical and clinical studies employed the combination of an anti-ErbB2 antibody “with paclitaxel or anthracycline, not together;” and (3) Baselga ʼ94 shows that the combination with paclitaxel was superior to the combination with doxorubicin, an anthracycline derivative. Pet. 45–46. Patent Owner counters that Petitioner has not shown an ordinary artisan would have avoided anthracyclines when pursuing the combination therapy of anti- ErbB2 antibody with a taxoid. Prelim. Resp. 52. We agree with Patent Owner. Petitioner is correct that cardiotoxicity of anthracyclines was well known at the time of the ’441 patent invention. See, e.g., Ex. 1033. Yet, Petitioner concedes that “[a]nthracyclines were and remain common first-line chemotherapies for breast cancer.” Pet. 13. Thus, cardiotoxicity does not appear to have motivated an ordinary artisan to avoid anthracyclines in treating breast cancer. slip op. at 9

  • BurdenInstitution denied

    “We acknowledge that Baselga ’94 teaches a pre-clinical study using mice that combined anti-ErbB2 antibody with either paclitaxel or an anthracycline, but not the anti-ErbB2 antibody with both paclitaxel and an anthracycline. Without additional credible evidence5 or persuasive argument, however, this fact is insufficient to suggest that an ordinary artisan would have avoided anthracyclines while pursuing the combination therapy with anti-ErbB2 antibody and a taxoid in a treatment regimen for humans. As a result, based on the current record, we conclude Petitioner has 5 In the concurrently issued decision to institute trial in IPR2017-00737, we conclude that Petitioner has made a sufficient showing regarding the limitation “in the absence of an anthracycline derivative.” IPR2017-00737, Paper 17, 21–23. There, we take into consideration the disclosures of Baselga ’97 and a second prior-art reference. Id. We also find the testimony of Dr. Litton on this issue persuasive. Id. The record in the present proceeding, however, is different. As explained above, Baselga ’97 was removed from consideration as prior art for the two-drug combination treatment recited in the claims of the ’441 patent during prosecution and, as we do not revisit the antedating issue here, it is not part of our analysis. Also, the second prior art reference in IPR2017-00737 is not of record in this proceeding and Petitioner does not present persuasive expert testimony on this issue. not established a reasonable likelihood it would prevail in showing that any challenged claim would have been obvious over the teachings of Baselga ’96 and Baselga ’94.” slip op. at 10

  Discretionary denial
  Patents in suitUS 7,846,441
• Fustibal LLC v. Bayer Healthcare LLCInstitution denied
  PTAB · Feb 8, 2017 · IPR2016-01490 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution because Riedl was repeatedly considered during prosecution and the petition did not show a reasonable likelihood that claims 1–16 were unpatentable.

  RulingsInstitution decision

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

    “§ 314(a); 37 C.F.R. § 42.108. Our discretion on whether to institute is guided, in part, by 35 U.S.C. § 325(d), which states that “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Patent Owner requests that the Board exercise its discretion to deny institution with respect to Ground 1 because Riedl was expressly considered by the Examiner during the prosecution of the ’553 Patent. Prelim. Resp. 7–8. As noted in section I(E), above, in allowing claims 1–16 of the ’533 Patent, the Examiner expressly referred to Riedl as the closest prior art, yet found that it “fails to teach . . . the instant claimed compounds.” Ex. 2006, 913; see also Ex. 2005, 397, 569; Ex. 2006, 855 (same, with respect to similar claims).” slip op. at 11

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

    “As an initial matter, the above argument fails because, as discussed in section I(C)(iii), above, Riedl does not “expressly disclose[] the rografenib compound,” as Petitioner contends. We further agree with Patent Owner’s observation “that the Petition nowhere engages in a ‘lead compound’ analysis” and, at least with respect to Ground 2, “merely assumes—without explanation—that the POSA would select sorafenib for modification.” Prelim. Resp. 22–23. A lead compound comprises “a natural choice for further development efforts” (Altana Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 1008 10 Petitioner provides similar arguments with respect to claims 1–12, 14, and 16. Id. at 22–25. (Fed. Cir. 2009)), i.e., a prior art compound “that would be most promising to modify in order to improve upon its . . . activity and obtain a compound with better activity” (Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007)). “In determining whether a chemist would have selected a prior art compound as a lead, the analysis is guided by evidence of the compound’s pertinent properties.” Otsuka Pharm., 678 F.3d at 1292. “Absent a reason or motivation based on such prior art evidence, mere structural similarity between a prior art compound and the claimed compound does not inform the lead compound selection.” Id. In setting forth Ground 2, Petitioner invokes a person of ordinary skill in the art “who was looking to modify sorafenib.” Prelim. Resp. 22. Neither Petitioner nor Petitioner’s expert address why a skilled artisan reading Riedl would select that compound for further development. Given that Riedl does not highlight any of the vast number of disclosed compounds as having particularly beneficial properties or present any enzymatic or biological data, we also do not discern from this reference why a person of ordinary skill in the art would have selected sorafenib as “a natural choice for further development efforts.”” slip op. at 17

  • Skill levelSkill level petitioner adoptedOther

    “Person of Ordinary Skill in the Art. Petitioner contends that a person of ordinary skill in the art “typically would have a PhD, MD, MS, or another degree relating to pharmaceutical chemistry (e.g. biology, chemistry, medicinal chemistry, medicine, pharmacology, or a closely related discipline), and . . . would have substantial familiarity, training, or experience with pharmaceutical compositions.” Pet. 6. Patent Owner has not challenged Petitioner’s proposed interpretation of a skilled artisan. We adopt Petitioner’s proposed interpretation for purposes of this opinion. See Prelim. Resp. 6 & n.1; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evident from the prior art). B.” slip op. at 6

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “Petitioner (correctly) contends that the ’553 Patent expressly defines the claim term “pharmaceutically acceptable salt” as “‘a relatively non-toxic, inorganic or organic acid addition salt of a compound of the present invention.’” Pet. 7 (quoting Ex. 1001, 9:56–62). Patent Owner does not presently object to this definition. Based on the specification’s express disclosure, we agree that the cited definition applies. See Prelim. Resp. 6 & n.2. The parties agree that all other terms should be accorded their ordinary and customary meaning. Id.; Pet. 6–7. Our reviewing court counsels that only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Accordingly, for purposes of this decision, we determine that no further construction is necessary. C.” slip op. at 7

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR
  Patents in suitUS 8,637,553
• Great West Casualty Company / Bitco General Insurance Corporation et al. v. Intellectual Ventures II LLCInstitution denied
  PTAB · Jun 9, 2016 · IPR2016-00453 · APJ Michael W Kim · IPR · Institution

  The Board denied institution on claims 11–20, exercising discretion under § 314(a) because this was an unjustified serial petition and separately rejecting it under § 325(d).

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied

    “patent, using substantially the same prior art, and filed so long apart that Petitioner received the benefit of having studied Patent Owner’s Preliminary Response in an earlier petition. That is especially so if Petitioner, at the time of filing of the earlier petition was aware of or should have been aware of the prior art references newly cited and applied in the later petition. To that end, Petitioner does not assert that it was unaware of Nazem prior to filing the instant Petition or any earlier petition. The potential inequity based on a petitioner’s filing of serial and similar attacks against the same claims of the same patent, while having the opportunity to adjust litigation positions along the way based on either patent owner’s contentions responding to prior challenges or the Board’s decision on prior challenges, is real and cannot be ignored. This is not to say, however, that multiple petitions against the same claims of the same patent are never permitted. Rather, each case depends on its own facts. We look to and consider, in each case, as we do here, what rationale a petitioner offers for filing multiple petitions and for the time elapsed between those filings. Generally, however, we are unpersuaded that the possibility of an adverse claim construction alone, especially where the possibility of the adverse claim construction was expressly a result of assertions made by a patent owner in the previous proceeding, is sufficient to justify serial petitions.” slip op. at 9

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

    “Emphasis added. As admitted by Petitioner, all of the grounds in the instant Petition and the petition in IPR2015-01706 rely primarily on MyLibrary. Furthermore, the only reference cited additionally in the instant proceeding is Nazem, and Nazem mentions, on multiple occasions, variations of “MyYahoo” or “my.yahoo.com.” Ex. 1047, Figs. 1, 3, 4, 5A, 5B; 2:63-3:2; Appendices A and B. Moreover, Petitioner asserts the following: For example, one such prior art personalized portal, referenced by MyLibrary as an inspiration, was the MyYahoo system, Ex. 1005 at 1, a system described in U.S. Patent No. 5,983,227 to Nazem et al. (issued Nov. 9, 1999) (Ex. 1047). Ex. 1047 at Face, Fig. 5a (“MyYahoo!”). Pet. 21. A person having ordinary skill in the art would have been motivated to add content, such as disclosed in Nazem, to the personalized web pages of MyLibrary because MyYahoo was an inspiration for the system of MyLibrary, thereby suggesting the additional MyYahoo functionality would work well with MyLibrary. Pet. 22. Given these articulated connections between the substance of MyLibrary and Nazem, we have no trouble determining that presenting MyLibrary and Nazem in this proceeding is “the same or substantially the same prior art or arguments” as was presented previously to the Office in IPR2015-01706, with MyLibrary alone.” slip op. at 13

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

    “III. CONCLUSION For the foregoing reasons, we exercise discretion not to institute inter partes review of any of claims 11–20 of the ’177 patent, and also reject the Petition under 35 U.S.C. § 325(d). IV. ORDER It is ORDERED that no trial or inter partes review is instituted for any claim of the ’177 patent on any ground in this proceeding.” slip op. at 14

  Discretionary denial
  Patents in suitUS 7,516,177

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.