• Risen (Suzhou) Pharma Tech. Co. Ltd. v. Alzheon, Inc.Institution denied
  PTAB · Jan 13, 2023 · PGR2022-00051 · APJ Jamie T Wisz · PGR · Institution

  The Board denied institution on all challenged claims, finding no reasonable likelihood of unpatentability under §§ 101 and 112(a), and denying Grounds 4–6 under § 325(d).

  RulingsInstitution decision

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

    “unless . . . the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence, we determine that the information presented fails to demonstrate it is more likely than not that at least one of the challenged claims of the ’742 patent is unpatentable for ineligibility, lack of written description, or non-enablement. We also exercise our discretion to deny institution of post-grant review under 35 U.S.C. § 325(d). slip op. at 2

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

    “tramiprosate “showed a significant overall treatment effect” in “an APOE4+ sub-group,” including APOE4 homozygotes; “therapeutic interventions applied earlier in the course of AD more likely might achieve the goal of disease modification;” and that “AD would be optimally treated before significant cognitive impairment, during its pre-symptomatic or pre-clinical stages …”) (emphases removed). Accordingly, Caltagirone was previously presented to the Office and we also find that Caltagirone’s disclosures are substantially similar to, or cumulative of, other references previously considered by the Examiner.” slip op. at 49

  • Adverse judgmentAdverse judgmentOther

    “D. Statutory Disclaimer After the filing of the Petition in this proceeding, Patent Owner filed a statutory disclaimer, disclaiming claims 9 and 11–15 of the ’742 patent, effective October 7, 2022. Prelim. Resp. 12; Ex. 2001, 1. “No post-grant review will be instituted based on disclaimed claims.” 37 C.F.R. § 42.207(e). We do not analyze the validity of claims 9 and 11–15 based on Petitioner’s challenges (e.g., Grounds 2 and 3) because these claims have been statutorily disclaimed.” slip op. at 5

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “at least an M.D. or Ph.D. degree in a biomedical science or equivalent field. They would also have several years of clinical experience treating and/or conducting clinical trials of drugs for AD patients, or professional experience working in clinical trial design and execution related to drugs for AD or supervising such work. Pet. 14–15 (citing Ex. 1003 ¶ 62) (internal citation omitted). Patent Owner does not contest the characterization offered by Petitioner. Prelim. Resp. 12–13. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’742 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 9

  Claim construction§ 101 eligibility§ 112 disclosureDiscretionary denialcites Alice · Mayo · Graham
  Patents in suitUS 11,191,742
• 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
• Johnson & Johnson Surgical Vision, Inc. v. Alcon, Inc.Institution denied
  PTAB · Nov 9, 2021 · IPR2021-00899 · APJ Grace Karaffa Obermann · IPR · Institution

  The Board denied institution of IPR on claims 1–17 under § 325(d), finding substantially the same art or arguments had been presented to the Office and no material examination error was shown.

  RulingsInstitution decision

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

    “discretion and deny a petition as authorized under Section 325(d). First, we consider whether the same or substantially the same prior art or arguments previously were presented to the Office. If either condition is satisfied, we assess whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of the challenged claims. Advanced Bionics, Paper 6 at 8. A non-exclusive list of factors, set forth in Becton, Dickinson and Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph), guides our application of that two-part framework. Advanced Bionics, Paper 6 at 9. Those factors include: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; (d) the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art; (e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and (f) the extent to which additional evidence and facts presented in the Petition warrant reconsideration of the prior art or arguments. Becton, Paper 8 at 17–18. “If, after review of factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office.” Advanced Bionics, Paper 6 at 10.” slip op. at 19

  • Skill levelSkill level petitioner adoptedOther

    “Based on the information presented, we find the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art). To the extent a more precise definition is required, we adopt Petitioner’s definition because, on this record, it appears consistent with the disclosures of the asserted prior art and the written description of the invention provided in the ’036 patent. Pet. 17 (Petitioner’s asserted definition of the ordinarily skilled artisan); see Prelim. Resp. 20 (reciting that definition without adopting it or proposing an alternative definition).” slip op. at 17

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

    “We construe terms in controversy only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Neither party proposes an express construction for any claim term. See Pet. 17; Prelim. Resp. 61–62. We find no claim term requires express construction in order to resolve whether to exercise our discretion and deny the Petition under Section 325(d). We discuss the scope of certain claim terms as necessary to our analysis of that issue, however, which we turn to in the next section.” slip op. at 18

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

    “factual determination that provides a primary guarantee of objectivity in an obviousness analysis. Al-Site Corp. v. VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966); Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991)). In this Decision, we assess the asserted obviousness grounds only to the extent necessary to resolve Patent Owner’s request that we exercise our discretion and deny the Petition under Section 325(d).” slip op. at 17

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 9,849,036
• Volkswagen Group Of America, Inc. v. Stratosaudio, Inc.Institution denied
  PTAB · Oct 25, 2021 · IPR2021-00718 · APJ Hyun J Jung · IPR · Institution

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

  RulingsInstitution decision

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

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

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

    “v. Avid Tech, Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he [Office] is permitted, but never compelled, to institute an [inter partes review] proceeding.”). Pursuant to 35 U.S.C. § 325(d), in determining whether to institute an inter partes review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” In evaluating the exercise of discretion to deny institution under § 325(d), the Board uses the following two-part framework: (1) determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential). In applying the two-part framework, we consider several non- exclusive factors, including: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; (d) the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art; (e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and (f) the extent to which additional evidence and facts presented in the Petition warrant reconsideration of the prior art or arguments. Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to Section III.C.5, first paragraph) (“Becton, Dickinson”). Factors (a), (b), and (d) of the Becton, Dickinson factors relate to whether the art or arguments presented in the Petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, Paper 6 at 10. Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in its prior consideration of that art or arguments. Id. Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated a material error by the Office. Id. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 19

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

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

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

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

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 9,584,843
• Triplet Therapeutics, Inc. v. Board Of Supervisors Of Louisiana State University And Agricultural And Mechanical CollegeInstitution denied
  PTAB · Sep 8, 2021 · PGR2021-00059 · APJ Devon Zastrow Newman · PGR · Institution

  The Board denied institution on claims 1–15: grounds 2–5 lacked a supported reason to combine, and ground 1 repeated arguments considered by the Office.

  RulingsInstitution decision

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

    “We have the authority and discretion to determine whether to institute a post grant review. 35 U.S.C. § 324; 37 C.F.R. § 42.4(a) (2021). We may not institute a post-grant review unless “the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). After considering the briefing and the evidence of record, we conclude that Petitioner has failed to establish a reasonable likelihood of prevailing in demonstrating that the challenged claims are unpatentable over the cited prior art in asserted grounds 2–5. With regard to ground 1, Petitioner’s written description ground, we determine that Petitioner’s arguments are substantially the same as those previously presented to and considered by the Office, and we exercise our discretion under 35 U.S.C. § 325(d) and decline to institute post-grant review of the ’542 patent on that ground alone.” slip op. at 2

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

    “We agree with Patent Owner that Petitioner’s arguments regarding whether the ’542 patent provides § 112 written description support for the challenged claims are substantially the same as those considered by the Examiner during the prosecution of the ’542 patent. As set forth above, the Examiner repeatedly rejected the pending claims because (1) the claims were overly broad in light of the guidance provided in the specification that was limited to the working examples specific to exon 7 of a gene encoding a MLH3 subunit (Ex. 1006, 623–24); (2) the claims did not enable the oligonucleotides to “hybridize[] to a complementary target nucleic acid sequence of a gene or gene product to modulate the expression of a component of a mismatch repair (MMR) complex” based on the disclosure of the specification, which was limited to the working examples (id.); and (3) the claims did not enable a pharmaceutical composition of the recited nucleotide base length range for the entire scope of the claims based on the disclosure of the specification, which was limited to the working examples (id. at 1183–84). The rejections were based on a broad reading of the claims as interpreted by the ordinarily skilled artisan, and required analysis of whether there is sufficient support in the specification for the entire scope of the claims. Applicant overcame these issues by narrowing the claims until the Examiner agreed that the support present was sufficient.” slip op. at 36

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not found

    “We agree with Patent Owner that Petitioner’s allegations regarding the skilled artisan’s reasons to combine are conclusory and insufficiently supported by evidence. Petitioner cites Dr. Wood’s testimony to explain why the skilled artisan would have understood that Fuselier’s suggestion to “switch[] isoforms of MLH3” could be accomplished by manipulating pre-mRNA splicing to delete exon 7. Petitioner’s discussion on pages 59–60 quotes phrases from Dr. Wood’s referenced testimony, see Ex. 1002, ¶¶ 213–216, but the rationale appearing in the Petition merely comprises repetitive generalized statements akin to “Morcos is a powerful tool that can accomplish what Fuselier suggested.” See Pet. 59–60. Dr. Wood’s underlying testimony lacks key explanation as to the understanding of the ordinary artisan at the time of the invention. What Petitioner has not provided, as Patent Owner argues, are the reasons 1) why Fuselier’s suggestion to “switch[] isoforms” would have led the artisan to pursue deletion of exon 7; and 2) why the artisan would have selected Morcos’ time. See Prelim. Resp. 55–56.” slip op. at 19

  • Skill levelSkill level petitioner adoptedOther

    “invention in the field of antisense technology “would have had knowledge of the scientific literature and have skills relating to approaches for utilizing synthetic oligonucleotides to manipulate gene expression” and “have been well-experienced in laboratory techniques and strategies for designing and making SSOs, conducting in vitro and in vivo testing, and application of SSOs in research.” Pet. 18 (citing Ex. 1002 ¶¶ 30, 31). Petitioner adds that the artisan “would have had knowledge of laboratory techniques and strategies in creating nuclease-resistant SSOs, and using such SSOs to manipulate gene expression to force expression of selected isoforms of a M.D. or a Ph.D. in physiological science, biochemistry, molecular biology, chemistry, or a related discipline, with at least five years of experience in SSOs design and manipulation” and may have “worked as part of a multidisciplinary team” to permit input by others on the team with specialized skills to assist in solving problems. Id. Patent Owner does not contest the skill level provided by Petitioner for the purpose of deciding institution (Prelim. Resp. 4), and we adopt it as reasonably consistent with the level of skill represented by the ’542 patent and the art of record.” slip op. at 8

  Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 10,669,542
• Universal Imaging Industries, LLC v. Lexmark International, Inc.Institution denied
  PTAB · Feb 27, 2020 · IPR2019-01383 · APJ Justin T Arbes · IPR · Institution

  The Board denied institution of IPR on claims 1–22, finding the Adkins ground warranted denial under § 325(d) and the other obviousness grounds lacked a reasonable likelihood of success.

  RulingsInstitution decision

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

    “As we explain in detail below, Petitioner has not demonstrated a reasonable likelihood of prevailing on its other asserted grounds of unpatentability. Because each of Petitioner’s grounds should be denied, either for an inadequate showing on the merits or pursuant to our discretion under § 325(d), we exercise our discretion to deny the Petition under §§ 314(a) and 325(d).” slip op. at 21

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

    “Weighing each of the factors, we conclude that the circumstances of this case, on the record presented, warrant exercise of our discretion to deny institution based on § 325(d). Patent Owner identified the Adkins application as “related” to the ’079 patent, made statements in the Specification attempting to distinguish the ’079 patent’s invention from Adkins, and cited the ’021 patent in an IDS. Further, the Examiner already was familiar with Adkins given that the same Examiner examined both the ’021 patent and the ’079 patent. We infer from these circumstances that the Examiner considered the substance of Adkins and Patent Owner’s statements regarding the disclosure of Adkins and problems with its approach, despite the lack of an express rejection over Adkins. Petitioner has not presented a convincing case that the Examiner erred in allowing the claims of the ’079 patent and Dr. Direen’s testimony does not provide persuasive support for Petitioner’s arguments.” slip op. at 20

  • BurdenNot shown unpatentable

    “limitation that the plurality of address change requests occurs “substantially immediately following a predetermined event.”6 Prelim. Resp. 42. We agree. In its analysis of claim 7, Petitioner does not identify any “event” at all or explain how such an event would be “predetermined” or why the alleged address change requests in Mayer or I2C Spec would occur “substantially immediately following” such an event. See Pet. 21–24. Indeed, the “substantially immediately following a predetermined event” claim language does not even appear in Petitioner’s arguments. See id. 6 Patent Owner makes a number of other arguments regarding the asserted combinations with I2C Spec in its Preliminary Response, including that Petitioner has not shown sufficiently that I2C Spec is a prior art printed publication under 35 U.S.C. § 102(b). See Prelim. Resp. 26–30, 36–37, 43–48. We need not reach these issues, however, because Petitioner has not shown a reasonable likelihood of prevailing on the asserted grounds for the reasons explained herein. Although Petitioner does not identify a “predetermined event” in its Petition, Dr. Direen appears to opine that a “power-on reset process” would trigger the plurality of address change requests. Ex. 1002, App. 1002-A, 14. Dr. Direen states that “[i]t is well understood in the electronic industry and by [persons of ordinary skill in the art] that complex devices such as a microprocessor or I2C slave device will go through a power-on reset process to ensure internal states are at known states. This is inherent device operation.” Id. Dr. Direen, however, cites no support for this opinion and does not explain in any detail what a power-on reset process would entail or why a plurality of address change requests in either Mayer or I2C Spec would occur “substantially immediately following” a power-on reset process. See id. Moreover, to the extent Dr. Direen bases his opinion on inherency, Petitioner does not assert that theory in its Petition.7 See Pet. 21–24. Petitioner has not shown sufficiently that Mayer and I2C Spec teach a “dynamic address generator” wherein “substantially immediately following a predetermined event and in a continual series of a plurality of address change requests received by the interface and corresponding acknowledgements sent thereby in reply, for each address change request received the dynamic address generator generates a new component address,” as recited in claim 7.” slip op. at 24

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Relevant to factor (f), Petitioner offers the testimony of Dr. Direen, which was not available to the Examiner. However, Dr. Direen’s testimony is entitled to little weight because it consists primarily of quotations from Adkins, many of which are not cited in the Petition, and an unsupported inherency theory that is not argued in the Petition. See, e.g., Ex. 1002, App. 1002-C, 11–16 (testimony for claim 7). See 37 C.F.R. §§ 42.6(a)(3) (“Arguments must not be incorporated by reference from one document into another document.”), 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Thus, Dr. Direen’s testimony does not provide persuasive evidentiary support for Petitioner’s arguments regarding Adkins. This factor is, at most, neutral.” slip op. at 20

  Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 8,850,079
• Universal Imaging Industries, LLC v. Lexmark International, Inc.Institution denied
  PTAB · Feb 3, 2020 · IPR2019-01369 · APJ Justin T Arbes · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing on any challenged claim, and § 325(d) also supported denying the claim 10 grounds based solely on Schön and Robb or …

  RulingsInstitution decision

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

    “each of its elements was, independently, known in the prior art.” KSR, 550 U.S. at 418. An obviousness determination requires finding “both ‘that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367–68 (Fed. Cir. 2016) (citation omitted); see KSR, 550 U.S. at 418 (for an obviousness analysis, “it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does”). “Although the KSR test is flexible, the Board ‘must still be careful not to allow hindsight reconstruction of references . . . without any explanation as to how or why the references would be combined to produce the claimed invention.’” TriVascular, Inc. v. Samuels, 812 F.3d 1056, 1066 (Fed. Cir. 2016) (citation omitted). Further, an assertion of obviousness “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal 3 Additionally, secondary considerations, such as “commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented. As indicia of obviousness or nonobviousness, these inquiries may have relevancy.” Graham, 383 U.S. at 17–18. Neither party, however, has presented any such evidence for us to consider. conclusion of obviousness.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)); accord In re NuVasive, Inc., 842 F.3d 1376, 1383 (Fed. Cir. 2016) (stating that “‘conclusory statements’” amount to an “insufficient articulation[] of motivation to combine”; “instead, the finding must be supported by a ‘reasoned explanation’” (citation omitted)); In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016) (“To satisfy its burden of proving obviousness, a petitioner cannot employ mere conclusory statements. The petitioner must instead articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.”).” slip op. at 9

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

    “institute an inter partes review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” In evaluating whether to exercise our discretion when the same or substantially the same prior art or arguments previously were presented to the Office under section 325(d), we have weighed some common non-exclusive factors, such as: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; (d) the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art; (e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and (f) the extent to which additional evidence and facts presented in the Petition warrant reconsideration of the prior art or arguments. Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to Section III.C.5, first paragraph) (“Becton, Dickinson”).” slip op. at 37

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “the ’657 patent would have had “a bachelor’s degree in electrical and/or computer engineering with training and one or more years of experience in embedded systems including both hardware and embedded software design,” as well as “a working understanding of communication on an electronics bus.” Pet. 8 (citing Ex. 1002 ¶¶ 25–28). Patent Owner argues that an ordinarily skilled artisan would have had “a bachelor’s degree in electrical and/or computer engineering with one or more years of work experience in printer design, including hardware and/or embedded software design for printer applications.” Prelim. Resp. 7–8 (citing Ex. 2001 ¶¶ 29–33). The parties’ proposed definitions differ in that Petitioner’s definition requires experience with “embedded systems” and “communication on an electronics bus,” whereas Patent Owner’s definition more specifically requires experience with “printer design.” The Specification of the ’657 patent states that the disclosure relates to “master and slave devices communicating on a shared bus,” and specifically, “addressing schemes to provide security to the system.” Ex. 1001, col. 1, ll. 15–19. The claims of the ’657 patent similarly each recite “slave circuitry” for communicating as a “slave device” and an “address generator” generating plural addresses. Based on the record presented, including our review of the ’657 patent and the types of problems and solutions described in the ’657 patent and cited prior art, we agree with and apply Petitioner’s proposed definition of the level of ordinary skill in the art for purposes of this Decision.” slip op. at 10

  • Expert testimonyPatent owner expert creditedOther

    “combine Schön with I2C Spec. Prelim. Resp. 50–54. In particular, Patent Owner argues that Schön already discloses an address format, and neither Schön, I2C Spec, nor the Petition identifies any disadvantages with Schön’s address format that would have been improved by I2C Spec’s address format. Id. at 52. Patent Owner argues that Petitioner does not explain why an ordinarily skilled artisan would have replaced Schön’s exemplary 8-bit address format, which allows for up to 256 addresses, with I2C Spec’s 7-bit address format with a limited number of variable bits, allowing fewer addresses to be generated in response to an address generation command. Id. at 52–53. Dr. Folkins’s testimony supports Patent Owner’s arguments. See Ex. 2001 ¶¶ 101, 105‒113. In particular, Dr. Folkins testifies that replacing Schön’s addressing scheme with I2C Spec’s addressing would limit the flexibility of Schön’s addressing. Id. ¶¶ 105‒107. Dr. Folkins further testifies that I2C Spec’s addressing scheme would have caused inefficiencies in Schön’s system because a smaller pool of addresses would lead to more duplicate addresses, causing additional cycles of address generation. Id. ¶¶ 108‒111. We credit Dr. Folkins’s uncontroverted testimony. We recognize that, according to our rules, we “will take into account a patent owner preliminary response where such a response is filed, including any testimonial evidence, but a genuine issue of material fact created by such testimonial evidence will be viewed in the light most favorable to the petitioner solely for purposes of deciding whether to institute an inter partes review.” 37 C.F.R. § 42.108(c). However, in this case, Dr. Folkins’s testimony does not implicate a genuine issue of material fact. Petitioner does not provide any argument or cite to any testimony regarding the advantages or disadvantages of using I2C Spec’s addressing scheme in place of Schön’s. See Pet. 15‒21. Petitioner merely asserts, without further explanation, that Schön teaches “generating slave addresses,” I2C Spec teaches one “addressing format[],” and a person of ordinary skill in the art would have been motivated to use the latter. Id. at 16. Dr. Direen’s testimony regarding combining the teachings of Schön and I2C Spec also makes no mention of advantages or disadvantages of replacing Schön’s addressing scheme with I2C Spec’s addressing scheme. See Ex. 1002, App. 1002-A, 7 (concluding that “[i]t would be natural for a [person of ordinary skill in the art] to combine the teaching of the I2C standard with [Schön’s] teachings as they both relate to similar computer bus systems,” without addressing advantages or disadvantages of the addressing schemes).” slip op. at 18

  Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 8,386,657
• Nitro Fluids, L.L.C. v. Cameron International CorporationRehearing denied
  PTAB · Oct 15, 2019 · IPR2019-00804 · APJ Jon B Tornquist · IPR · Rehearing

  The Board denied the rehearing request and maintained denial of institution for claims 1–15 under § 325(d) based on Kajaria and Guidry.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. STANDARD FOR REHEARING Pursuant to 37 C.F.R. § 42.71(d): A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The 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. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion exists where a “decision [i]s based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988).” slip op. at 2

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

    “Dickinson & Co. v. B. Braun Melsungen AG, Case IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential in relevant part) and determined that the balance of these factors favored denial of the Petition under 35 U.S.C. § 325(d). Dec. 11–23. As part of this analysis, we determined that: Kajaria was previously presented to the office during prosecution and was the basis for a rejection by the Examiner; Petitioner and the Examiner relied on the same disclosures of Kajaria to support their arguments; Petitioner did not sufficiently point out how the Examiner erred in his evaluation of Kajaria; and the declaration testimony of Mr. Ely did not warrant reconsideration of the prior art previously analyzed by the Examiner. Id. at 12–22.” slip op. at 3

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Other

    “fracturing tree, wherein the single outlet is coupled to the fracturing tree by a single fluid conduit that is the only fluid conduit connecting the skid apparatus in fluid communication with the well at which the one fracturing tree is positioned. Ex. 1001, 7:6–30.” slip op. at 3

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

    “obviousness ground relies solely on modification of distribution modules 42. Req. Reh’g 14. According to Petitioner, the Petition specifically alleges that “it would have been obvious to modify any module, including specifically module 40, to use a single manifold, to support only a single valve group, for delivery of fluid to a single well, via a single fluid conduit.” Id. (citing Pet. 35–42, 49–52, 56–57; Ex. 1002 ¶¶ 92, 96, 99, 102, 103, 122, 124–126, 128, 138). We did not misunderstand or misapprehend this argument; indeed, we noted its logical appeal. Dec. 21 n.10. We instead declined to credit the inference underpinning this argument, i.e., that a single-manifold embodiment would use a single fluid conduit, because the only reference of record having a single distribution module coupled to a single manifold had two fluid conduits extending from the distribution module to the well. Id. Accordingly, we are not persuaded that we misunderstood or overlooked Petitioner’s obviousness arguments.” slip op. at 11

  § 102 anticipation§ 103 obviousnessDiscretionary denial
  Patents in suitUS 9,903,190
• Apotex Inc. / Apotex Corp. v. Celgene CorporationInstitution denied
  PTAB · Sep 27, 2018 · IPR2018-00685 · APJ Toni R Scheiner · IPR · Institution

  The Board denied institution: the obviousness grounds repeated substantially the same art and arguments considered in prosecution, and the press release was not shown to be a printed publication.

  RulingsInstitution decision

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

    “As discussed above in Section D2, the Examiner was ultimately persuaded that Applicant’s evidence of unexpected results—i.e., the overall response rate elicited by lenalidomide in pretreated mantle cell lymphoma patients—outweighed the evidence supporting his initial determination that it would have been prima facie obvious for one of ordinary skill in the art to use lenalidomide to treat mantle cell lymphoma given the combined teachings of Zeldis, Damaj, Wilson, and Kaufmann. Ex. 2007, 81–82.” slip op. at 24

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

    “As we have determined that Petitioner has not established that Celgene Press Release is available as a prior art printed publication, Petitioner has not shown a reasonable likelihood of prevailing in its assertion that the subject matter of claims 1–4, 8, 9, 15, and 20 of the ’929 patent is anticipated by the Celgene Press Release. Accordingly, we do not institute an inter partes review of claims 1–4, 8, 9, 15, and 20 of the ’929 patent on the ground of anticipation by the Celgene Press Release.” slip op. at 31

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable

    “A reference will be considered publicly accessible if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting Kyocera, 545 F.3d at 1350). A party seeking to introduce a reference “should produce sufficient proof of its dissemination or that it has otherwise been available and accessible to persons concerned with the art to which the document relates and thus most likely to avail themselves of its contents.” In re Wyer, 655 F.2d 221, 227 (CCPA 1981) (quoting Philips Elec. & Pharm. Indus. Corp. v. Thermal & Elecs. Indus., Inc., 450 F.2d 1164, 1171 (3d Cir. 1971)). As explained by the Federal Circuit, a “determination of whether a reference is a ‘printed publication’ under 35 U.S.C. § 102(b) involves a case-by-case 28 inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). slip op. at 28

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsNot reached

    “support patentability.” Id. Paragraph 109 of Dr. Thirman’s Declaration is nearly identical to the above passage from the Petition. Following the summary of those prior art teachings, Dr. Thirman asserts “[t]hus, the alleged unexpected properties would have been expected” (Ex. 1002 ¶ 110), but provides no further evidentiary support for the proposition that the results obtained by treating relapsed and/or refractory MCL with lenalidomide would have been expected. Again, during prosecution, the Examiner maintained that the combined prior art (Zeldis, Damaj, Wilson, and Kaufmann) would have given one of ordinary skill in the art a reason to use lenalidomide to treat patients with relapsed and/or refractory mantle cell lymphoma, but concluded that the evidence of obviousness was outweighed by Applicant’s evidence of unexpected results—namely, a 28% overall response rate in patients with relapsed and/or refractory mantle cell lymphoma. Although Drach—given its particular focus on treating mantle cell lymphoma—is stronger evidence than Damaj, Wilson, and Kaufmann that one of ordinary skill in the art would have had a reason to treat MCL patients with lenalidomide, Drach is no more informative as to expected results than the references the Examiner relied on in making out a prima facie case of obviousness, i.e., Damaj, Wilson, and Kaufmann. Essentially, Petitioner and Dr. Thirman disagree with the Examiner’s conclusion that, on balance, the subject matter of the challenged claims would not have been obvious, in light of the level of response in patients 25 with relapsed and/or refractory MCL (as described in Dr. Zhang’s Declaration and the underlying Goy reference), despite one of ordinary skill in the art having had a reason to administer lenalidomide to treat MCL.” slip op. at 25

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denial
  Patents in suitUS 8,741,929

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.