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  • PTAB · Jan 10, 2023 · IPR2022-01340 · APJ Amee A Shah · IPR · Institution

    The Board denied institution on all challenged claims 1–8 because Petitioner did not show a reasonable likelihood that any claim was obvious over the asserted prior-art combinations.

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

      “there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. 35 U.S.C. § 314. That burden never shifts to the patentee. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). A patent claim is unpatentable under 35 U.S.C. § 103(a) if the” slip op. at 12

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

      “III. ANALYSIS A. DISCRETION TO DENY UNDER 35 U.S.C. § 325(D) Patent Owner argues that we should exercise our discretion under 35 U.S.C. § 325(d) and deny institution because Petitioner presents the same 2 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), amended 35 U.S.C. § 103, effective March 16, 2013. Because the’683patent has an effective filing date after the effective date of the applicable AIA amendments, we refer to the AIA version of § 103. 3 Brugh, U.S. Patent Application Publication No. 2017/0238524, published Aug. 24, 2017 (Ex. 1005, “Brugh”), issued as US Patent No. 9,943,073 B2 on Apr. 17, 2018. 4 ECOLOGICAL AND BEHAVIORAL METHOD FOR THE STUDY OF BATS (Thomas H. Kunz, 1998). EX. 1010. 5 Bird Barrier, Mist Kit Assembly and Use, YouTube (Aug. 19, 2014). Ex. 1009 (“Bird Barrier Video”). 6 Petitioner also submits a screenshot from a Bird Barrier webpage advertising “mist nets” (Ex. 1011), a transcript from the Bird Barrier Video (Ex. 1014), and a “Bird Barrier Product Catalog 2013” (Ex. 1015). or substantially the same prior art or arguments that were previously presented to the Office during the prior prosecution of the ’683 patent. Prelim. Resp. 21–23. As explained in this Decision, we decline to institute review based on the merits of Petitioner’s challenges. Accordingly, we need not and do not determine whether it would be appropriate to discretionarily deny institution under § 325(d).” slip op. at 11

    • Skill levelSkill level board ownOther

      “We decline to adopt either party’s proposed definition. The evidence does not support Petitioner’s proposed definition that a skilled artisan who lacked a formal bachelor’s degree would fail to qualify as a person of ordinary skill in the art if that artisan had several years of experience trapping flying animals. See Pet. 7. Further, the evidence does not support Patent Owner’s proposed definition that a skilled artisan with an advanced degree in wildlife management would fail to qualify as a POSITA simply because his or her experience fell short of “2 years working with animal capture net systems.” See Prelim. Resp. 13. For purposes of this Decision, we adopt a hybrid of Petitioner’s and Patent Owner’s proposed definitions of a POSITA. We find that a POSITA would have had at least either (i) at least a bachelor’s degree in the study of wildlife management or wildlife ecology or (ii) two or more years of field experience trapping flying animals. We find that this level of ordinary skill in the art is consistent with the ’683 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 14

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

      “Figure 2 of the ’683 patent (as shown above in Section II.C) depicts a preferred net set up depicting two perimeter nets 12 “set up around the perimeter of the enclosure 36” and three trapping nets 14, one located proximate to the perimeter and two located in the interior. Ex. 1003, 3:56–57, 4:29–42. Although the ’683 patent does not provide a specific definition for a “perimeter net” and describes that the “perimeter net” is only “preferably . . . set up around the perimeter of the enclosure” (id. at 4:29–30), the term “perimeter” qualifies the term “net” and connotes structure, namely, the location of the “net” in relation to the “structure” recited in the preamble of independent claim 1, i.e., the enclosure. Here, the term “perimeter” before net connotes a relationship between the “structure” of the preamble and the location of the net. In other words, “perimeter” is a meaningful modifier for the location of the net as being at or proximate to the perimeter of the enclosure, i.e., the “structure” recited in the preamble of claim 1. Thus, we agree with Patent Owner and determine that the term “perimeter net” is a net located at or proximate to the perimeter.” slip op. at 17

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 11,064,683
  • PTAB · Jan 10, 2023 · IPR2022-01254 · APJ Amee A Shah · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–17 were obvious over Brugh, Brugh and Kunz, or Bird Barrier Video and Kunz.

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

      “LEGAL STANDARDS B. In an inter partes review, the petitioner has the burden of showing there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. 35 U.S.C. § 314. That burden never shifts to the patentee. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).” slip op. at 12

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached

      “III. ANALYSIS A. DISCRETION TO DENY UNDER 35 U.S.C. §§ 314(A) AND 325(D) Patent Owner argues that we should exercise discretion under 35 U.S.C. § 314(a) and deny institution under Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential). Prelim. Resp. 25–26. Patent Owner also argues that we should exercise our discretion under 35 U.S.C. § 325(d) and deny institution based on prior prosecution of the ’108 patent. Prelim. Resp. 23–25. As explained in this Decision, we decline to institute review based on the merits of Petitioner’s challenges. Accordingly, we need not and do not determine whether it would be appropriate to discretionarily deny institution under § 314(a) or § 325(d).” slip op. at 12

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

      “Patent Owner also argues that we should exercise our discretion under 35 U.S.C. § 325(d) and deny institution based on prior prosecution of the ’108 patent. Prelim. Resp. 23–25. As explained in this Decision, we decline to institute review based on the merits of Petitioner’s challenges. Accordingly, we need not and do not determine whether it would be appropriate to discretionarily deny institution under § 314(a) or § 325(d).” slip op. at 12

    • Skill levelSkill level board ownOther

      “We decline to adopt either party’s proposed definition. The evidence does not support Petitioner’s proposed definition that a skilled artisan who lacked a formal bachelor’s degree would fail to qualify as a person of ordinary skill in the art if that artisan had several years of experience trapping flying animals. See Pet. 6. Further, the evidence does not support Patent Owner’s proposed definition that a skilled artisan with an advanced degree in wildlife management would fail to qualify as a POSITA simply because his or her experience fell short of “2 years working with animal capture net systems.” See Prelim. Resp. 14. For purposes of this Decision, we adopt a hybrid of Petitioner’s and Patent Owner’s proposed definitions of a POSITA. We find that a POSITA would have had at least either (i) at least a bachelor’s degree in the study of wildlife management or wildlife ecology or (ii) two or more years of field experience trapping flying animals. We find that this level of ordinary skill in the art is consistent with the ’108 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 15

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 10,729,108
  • PTAB · Jan 9, 2023 · IPR2022-01200 · APJ Devon Zastrow Newman · IPR · Institution

    The Board denied institution for claims 1–14 under § 325(d), finding the petition relied on substantially the same art and arguments previously presented and did not show material examiner error.

    RulingsInstitution decision
    • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner

      “ApoE4+ patient with AD using tramiprosate over the Caltagirone reference, which disclosed treatment of ApoE4+ “all-comers” (containing at least one ApoE4 allele, either heterozygous or homozygous) with tramiprosate. See, e.g., Ex. 1002, 204–208. When Patent Owner responded to the Examiner by highlighting data (i.e., Figure 8 of the specification giving rise to the ’029 patent) showing a notable increase in cognitive function in patients with two ApoE4 alleles (homozygous) who were administered tramiprosate as compared to the ApoE4 “all-comers” (mixed homozygous/heterozygous population), the Examiner suggested narrowing the pending claims to treatment of ApoE4 homozygotes. Ex. 1002, 342. Patent Owner submitted amended claims requiring selection of patients for treatment who were homozygous for ApoE4, and argued: The presently amended claims . . . select only ApoE4 homozygotes for treatment with tramiprosate or a prodrug thereof, necessarily omitting ApoE4 heterozygotes from such treatment. . . . Caltagirone fails to teach or suggest a patient selection strategy that would limit tramiprosate treatment to patients having two ApoE4 alleles and, in fact, teaches away from such selection. Kong fails to contradict or overcome these deficiencies in Caltagirone. Kong does not refer to any patient selection strategy, much less one that would limit tramiprosate prodrug treatment to ApoE4 homozygotes. The Office's reliance on Kong is solely for its teaching of a tramiprosate prodrug. Thus, the combination of Caltagirone and Kong, taken under the Office’s interpretation, suggests treatment of all ApoE4+ patients with a prodrug of tramiprosate. This falls far short of suggesting the presently claimed patient selection and treatment strategy which selects only ApoE4 homozygotes for treatment and does not treat ApoE4 heterozygotes. Id. at 338–39 (emphasis added). The Examiner acknowledged the” slip op. at 16

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of ordinary skill in the art (“skilled artisan”) at the time of the invention would have had at least an M.D. or Ph.D. degree in a biomedical science or equivalent field. They would also have several years of clinical experience treating and/or conducting clinical trials of drugs for AD patients, or professional experience working in clinical trial design and execution related to drugs for AD or supervising such work. Pet. 19 (citing Ex. 1003 ¶¶ 52–53). Patent Owner does not contest the characterization offered by Petitioner. Prelim. Resp. 14–15. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’029 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 12

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

      “whether the art or arguments presented in the Petition are the same or substantially the same as those previously presented to the Office (Advanced Bionics, Paper 6 at 10). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in its prior consideration of that art or arguments (Advanced Bionics, Paper 6 at 10). Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated a material error by the Office (Advanced Bionics, Paper 6 at 10). “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown” (Advanced Bionics, Paper 6 at 9).” slip op. at 21

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot reached

      “Babic ascertained that “different effects of a drug could be observed in different subpopulations of patients based on ApoE4 carrier status”” and that “drug effects in homozygous carriers could be greater than those in the heterozygous carriers and non-carriers who did not respond to the drug.” Ex. 1003 ¶ 107. As stated, this testimony does not support Petitioner’s contention that an ordinary artisan would have been motivated “to select homozygous ApoE4 carriers for treatment with any drug for which response has been correlated to ApoE4 carrier status.” See Pet. 41 (emphasis added). In particular, we find an insufficient factual basis for Petitioner’s contention that results obtained for galantamine, an acetylcholinesterase inhibitor (Ex. 1003 ¶ 105) would have motivated an ordinary artisan to replace the galantamine taught in Babic with tramiprosate (homotaurine), a GABA receptor agonist that works by a different mechanism (Ex. 1007, 582). We have also considered Dr. Ruffalo’s testimony that the ordinary artisan would have been motivated to replace Babic’s galantamine with tramiprosate as taught in Caltagirone or Val-APS as taught in Kong. Ex. 1003 ¶¶ 276–277. Dr. Ruffalo posits that Babic’s disclosures would have motivated the ordinary artisan to analyze Caltagirone’s data to ascertain if tramiprosate is more effective in homozygotes, and to replace galantamine with tramiprosate or Val-APS as taught in Kong because of their improved safety profiles as compared to galantamine, and because the replacement drugs target the underlying disease and not symptom amelioration as does galantamine. Id. Dr. Ruffalo also posits that the prior art would have imparted the following knowledge to the ordinary artisan: because the effect of tramiprosate was dependent on the required ApoE4 allele, homozygotes having the highest number of ApoE4 allele copies would derive, at the very least, as much benefit as from the drug as the heterozygotes having only one copy of the allele, and most likely the homozygotes would have the greatest therapeutic response to tramiprosate since they have the maximum number of copies of the required allele. Having done this simple assessment, A POSA would conclude that tramiprosate would be expected to exhibit a greater therapeutic effect in homozygotes and thus would have been motivated to treat homozygotes with tramiprosate, including in an oral dosage form as taught by Aisen. Id. Dr. Ruffalo further posits that the skilled artisan would have had a reasonable expectation of success in administering tramiprosate to treat homozygous ApoE4 patients because they “would almost certainly have the greatest response to the drug.” Id. ¶ 286. Patent Owner argues that the Examiner previously examined the issue of whether ApoE4 genotypes in treatment decisions should be considered during prosecution, with respect to Caltagirone, where ApoE4 genotypes were included, and Sleegers (Ex. 1002, 685, 1137), where studies led away from such inclusion. Prelim. Resp. 30–31. We find Sleegers’ disclosure” slip op. at 29

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
    Patents in suitUS 10,471,029
  • PTAB · Jan 9, 2023 · IPR2021-01189 · APJ Hyun J Jung · IPR · Final written decision

    Claims 1–13 were not shown unpatentable because MacDonald was not prior art and the petition failed to establish anticipation or obviousness; the contingent motion to amend was dismissed as moot.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedOther

      “The full record makes clear that the parties do not dispute the portion of Petitioner’s proposed level of ordinary skill regarding education and years of experience. Compare Pet. 14–15, with PO Resp. 3. Patent Owner acknowledges that the analysis does not depend on whether Petitioner’s proposed level of ordinary skill or Patent Owner’s proposal is adopted. See PO Resp. 3–4; Ex. 2003 ¶ 34 (testifying that Patent Owner’s declarant has an understanding of the capabilities of one of ordinary skill in the art irrespective of which proposed skill level is adopted), ¶ 35. The parties’ proposals are consistent with the factors of GPAC, the disclosure of the ’728 patent, and the prior art of record. Ex. 1012 ¶ 71 (testifying that Petitioner’s proposed level of ordinary skill is based on considering the factors of GPAC); Ex. 2003 ¶ 32 (testifying that Patent Owner’s proposed level of ordinary skill is based on the ’728 patent); GPAC, 57 F.3d at 1579. In view of the above, we see no reason to disturb our preliminary determination regarding the level of ordinary skill in the art. Thus, we maintain and reaffirm that one of ordinary skill in the art would have had “(1) a bachelor’s degree in mechanical engineering or a similar field that includes thermal sciences; and (2) at least two years of industrial experience on the design and evaluation of thermal management of electronic systems and heat pipes/TGPs.” Pet. 14–15; Ex. 1012 ¶ 71; Ex. 2003 ¶ 35. We agree with Patent Owner that the analysis would not be affected by adopting Patent Owner’s proposed level of ordinary skill in the art. PO Resp. 3–4; Ex. 2003 ¶ 35.” slip op. at 13

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

      “Petitioner contends that “the ordinary and customary meaning of the term ‘pitch’ in [c]laim 9 encompasses the definition of ‘pitch’ given in [c]laim 1—‘a distance from a center of one microfabricated structure to a center of a next neighboring microfabricated structure.’” Pet. 15. No claim term was interpreted expressly for our Institution Decision. Inst. Dec. 10. Patent Owner does not propose expressly any interpretation for any claim term. See generally PO Resp. Patent Owner, however, states that “claim 1 of the ’728 Patent expressly defines the claimed ‘pitch’ of the microfabricated structures as being ‘a distance from a center of one microfabricated structure to a center of a next neighboring microstructure.’” Id. at 12 (citing Ex. 1001, 14:45–48). Patent Owner notes that “[c]laim 9 does not include this particular definition, but the Board apparently applied the definition of the ‘pitch’ limitation in claim 1 to claim 9, as did Petitioner.” Id. “Patent Owner does not dispute or disagree with this.” Id. Based on the full record and because the parties do not dispute it, we apply the definition of pitch in claim 1 to the recited pitch of claim 9. Also, based on the full record, we determine that no other claim term requires express interpretation. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only 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 14

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateNot shown unpatentable

      “Petitioner appears to be seeking verbatim support, when, as argued by Patent Owner, the Specification does not need to provide exact or verbatim support to meet the written description requirement. See Pet. 20; PO Resp. 32. One of ordinary skill in the art would have immediately discerned that 5–500 microns is well within 2–1500 microns calculated by Petitioner using the parent applications’ claim 2. See Pet. 21–22; PO Resp. 16–17; Ex. 2003 ¶ 47. The numerical differences between the derived and claimed ranges do not address sufficiently why one of ordinary skill in the art would not discern the claimed range. See Pet. 20. As determined above, the disclosure would allow one of ordinary skill in the art to recognize that the claimed “distance from a center of one microfabricated structure to a center of a next neighboring microfabricated structure” has a range of values, such as the 2– 1500 microns calculated by Petitioner. See id. at 22. The numerical differences between the calculated ranges and the claimed ranges alone fail to show that the ordinarily skilled artisan would not have discerned the claimed range of 5–500 microns from the range of 2–1500 microns.” slip op. at 42

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

      “Patent Owner responds that “[b]ecause MacDonald does not qualify as prior art against the claims of the ‘728 Patent, Petitioner has failed to show that the challenged claims of the ‘728 Patent . . . would have been obvious over MacDonald in view of Ding.” PO Resp. 40. No reply arguments are presented specifically for the obviousness challenge. See generally Pet. Reply; PO Sur-reply. For the reasons given above, we agree with Patent Owner that MacDonald is not prior art to the ’728 patent. PO Resp. 39. Accordingly, based on the full record, Petitioner fails to show by a preponderance of the evidence that MacDonald and Ding would have rendered obvious claims 2, 3, and 7.” slip op. at 51

    Patent outcomesUS 10,309,728 not shown unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 10,309,728
  • PTAB · Dec 20, 2022 · IPR2022-01138 · APJ Richard H Marschall · IPR · Institution

    The Board instituted review of claims 1–19 on all petitioned grounds after finding a reasonable likelihood that claims 1 and 7 would have been obvious based on Goss.

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

      “review. See 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2021). Inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the evidence and arguments in the record, we institute inter partes review of the ’397 patent on all challenges set forth in the Petition.” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied

      “We agree with Patent Owner that both House and Goss were at least considered by the Examiner, even if the Examiner never discussed the references or relied on them in any manner. See Ex. 1001, code (56) (listing both House and Goss among the references cited, and identifying Goss as cited by the Examiner). Under these circumstances, we find the first part of the Advanced Bionics framework satisfied because the prior art before the Examiner and the prior art relied on in the Petition include the same prior art references.” slip op. at 10

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot reached

      “Petitioner provides very little argument or evidence in support of its motivation to combine argument in the Petition. See Pet. 46. We note that Petitioner does not explain why a “PHOSITA would understand that there is a rational underpinning to combine” Goss and House or cite to any declarant support for its argument. See id. Based on the limited argument, evidence, and explanation provided by Petitioner, on the current record, we question whether Petitioner establishes sufficiently that one of ordinary skill in the art would have had a reason to modify Goss with the teachings of House. Even if Petitioner fails to establish adequately a motivation to combine the references, that does not end our analysis. A “patent can be obvious in light of a single prior art reference if it would have been obvious to modify that reference to arrive at the patented invention.” Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1361 (Fed. Cir. 2016); see also Game & Tech Co. v. Activision Blizzard Inc., 926 F.3d 1370, 1381 (Fed. Cir. 2019). For the limitations in independent claims 1 and 7, Petitioner does rely on House, but only as an additional reason why the references disclose a limitation in question. See Pet. 46–61 (relying on Goss for every limitation in claims 1, 3–8, 10–16, and 18). Based on our review of the Petition, Petitioner sets forth an analysis based on Goss alone for at least claims 1 and 7, within the context of its second challenge based on Goss and House. See id. Although Petitioner may not need to rely on a combination of Goss and House for the limitations of independent claims 1 and 7, the additional reliance on House may buttress Petitioner’s arguments as to these and other claims. Consequently, the motivation to combine issue may impact whether Petitioner ultimately prevails as to this challenge. The parties may address the motivation to combine issue further during trial.” slip op. at 17

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted

      “adequately that Goss discloses the surface area limitation. We have also reviewed Petitioner’s arguments and evidence as to the remaining limitations of claims 1 and 7. Based on our review of the current record, Petitioner establishes sufficiently that Goss discloses or renders obvious all of the limitations of claims 1 and 7 for the reasons provided by Petitioner. See Pet. 46–51, 53–55. Accordingly, Petitioner establishes a reasonable likelihood that independent claims 1 and 7 would have been obvious based on Goss alone. We have also reviewed Petitioner’s arguments and evidence as to dependent claims 2–6 and 8–19. See Pet. 62–68. Patent Owner does not separately address the dependent claims. Prelim. Resp. 29–36. Because we institute inter partes review as to the independent claims 1 and 7, we also institute inter partes review as to dependent claims 2–6 and 8–19. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). Because Petitioner relies on Goss for every limitation in dependent claims 3–6, 8, 10–16, and 18, the Petition sets forth a challenge based on Goss alone for these claims as well as claims 1 and 7. See Pet. 49–61. These challenges, as well as the challenge to claims 1–19 based on a combination of Goss and House set forth in the Petition, are part of the instituted grounds at issue during the trial. See id. at 46–61; SAS, 138 S.Ct. at 1359–60. We note that Petitioner relies exclusively on House for dependent claims 2, 9, 17, and 19, and any deficiency in Petitioner’s showing as to the motivation to combine Goss and House may impact whether Petitioner can establish the obviousness of those claims, apart from whether House discloses the limitations in question. See Pet. 51, 53, 55, 60–61 (relying on House as disclosing the limitations in dependent claims 2, 9, 17 and 19).” slip op. at 18

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · Graham
    Patents in suitUS 11,026,397
  • PTAB · Dec 5, 2022 · IPR2022-01107 · APJ Richard H Marschall · IPR · Institution

    The Board instituted IPR on claims 1–19, finding a reasonable likelihood that claims 1 and 7 are anticipated by Goss and instituting the remaining asserted grounds as well.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “We agree with Patent Owner that Goss was at least considered by the Examiner, even if the Examiner never discussed the references or relied on it in any manner. See Ex. 1001, code (56) (listing Goss among the references cited). Under these circumstances, we find the first part of the Advanced Bionics satisfied because the prior art before the Examiner and the prior art relied on in the Petition include the same prior art reference.” slip op. at 11

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

      “review. See 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2021). Inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the evidence and arguments in the record, we institute inter partes review of the ’397 patent on all challenges set forth in the Petition.” slip op. at 2

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

      “same claim construction standard that would be used in a civil action under 35 U.S.C. § 282(b), as described in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). See 37 C.F.R. § 42.100(b). Under that standard, we generally give claim terms their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history. See Phillips, 415 F.3d at 1313–14. Although extrinsic evidence, when available, may also be useful when construing claim terms under this standard, extrinsic evidence should be considered in the context of the intrinsic evidence. See id. at 1317–19. Petitioner proposes constructions for the terms “filler material,” “clump strength,” “clumping agent,” and “wetting agent.” Pet. 17. Patent Owner does not dispute Petitioner’s constructions for these terms, but argues that these constructions are unnecessary to resolve any controversy in this proceeding. Prelim. Resp. 12–13. Based on our review of the current record, we agree with Patent Owner that we need not formally construe any claim terms to determine whether to institute an inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (stating that “we need only construe terms ‘that are in controversy, and only 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 7

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person having ordinary skill in the art “would have a bachelor’s degree in chemistry or chemical engineering or an equivalent degree and sufficient work experience in animal litter process development. A bachelor’s degree is not explicitly necessary.” Pet. 4. Petitioner further contends that “[h]ands-on experience in the field of animal litter process development could substitute for possessing a degree if that individual’s experience is in contributing to and/or leading the process development effort rather than following a set of instructions given to them.” Id. at 4–5. Petitioner asserts that such a person “should have familiarity with the process of validating relevant test methods and qualifying analysts as well as familiarity with the composition and chemistry of various clays used in animal litter (including sodium bentonite)” and that such a person “would have gained this familiarity through education, training and/or experience.” Id. Patent Owner does not dispute Petitioner’s proposed definition of the level of ordinary skill in the art, which appears consistent with the record, including the prior art. See Prelim. Resp. 12; GPAC Inc., 57 F.3d at 1579. We adopt the definition of the level of ordinary skill in the art proposed by Petitioner.” slip op. at 7

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips
    Patents in suitUS 11,026,397
  • PTAB · Nov 14, 2022 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Institution

    The Board instituted PGR on claims 1–17 based on all asserted grounds, finding the petition showed they more likely than not lacked written description support and enablement.

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

      “For the reasons explained below, we find that Petitioner has met the threshold showing for post-grant review of claims 1–17 with respect to the first challenge (written description support for the claimed genus). On that basis, we institute post-grant review of all challenged claims. See SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1358 (2018); 37 C.F.R. § 42.208(a) (“When instituting post-grant review, the Board will authorize the review to proceed on all of the challenged claims . . . .”). We address this challenge first, then provide the parties guidance on Petitioner’s second written description challenge (support for carbidopa itself).” slip op. at 19

    • Skill levelSkill level board ownOther

      “Ex. 1006, 1 (citations omitted). Accordingly, when considering the ’507 patent’s purpose, the type of problems encountered in the art, and prior art solutions to those problems, it is clear that with respect to levodopa/carbidopa treatments for Parkinson’s Disease, the pharmaceutical formulation and its resulting pharmacokinetics and patient experience are intertwined, thus supporting a requirement that a person of ordinary skill in the art have knowledge or experience in each of these areas. See, e.g., Indivior Inc. v. Dr. Reddy’s Labs., S.A., 930 F.3d 1325, 1345 (Fed. Cir. 2019) (finding no clear error in district court’s compromise measure of level of ordinary skill in the art as a team comprising different skill sets). In view of the above considerations, we preliminarily find that a person of ordinary skill in the art would be a member of a team that includes person(s) with (a) a Ph.D. in a field related to the development of pharmaceuticals (for example, pharmacology, pharmacokinetics, pharmaceutics, pharmaceutical chemistry, organic chemistry, biochemistry, molecular biology, medicinal chemistry, formulation development, or a related field), or equivalent degree, and 2–4 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, or a B.S. or M.S. degree in a field related to the development of pharmaceuticals, or equivalent degree, and 4–6 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, and (b) a medical degree or equivalent degree with experience in treating patients with Parkinson’s disease. In subsequent briefing, should the parties propose any differences from the team approach articulated above, they should support their proposal and address the impact, if any, of the differences on the pertinent disputes in this proceeding. Any final determination on the level of ordinary skill in the art will be made on the full trial record.” slip op. at 15

    • Expert testimonyPetitioner expert creditedOther

      “Additionally, based on their statements of qualifications and curricula vitae, for purposes of this Decision we find Drs. LeWitt and Sloan qualified to provide technical opinions from the perspective of a person of ordinary skill in the art. Ex. 1003 ¶¶ 1–10, pp. 87–119 (Dr. LeWitt’s statement of qualifications and curriculum vitae); Ex. 1004 ¶¶ 1–11, pp. 45–71 (Dr. Sloan’s statement of qualifications).” slip op. at 16

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

      “We agree with the parties that the express definition provided during prosecution should be adopted. See, e.g., Biotec Biologische Naturverpackungen GmbH v. Biocorp, Inc., 249 F.3d 1341, 1346–47 (Fed. Cir. 2001) (construing claims in accordance with definition provided in declarations submitted during prosecution). Accordingly, we preliminarily construe the term “a compound comprising levodopa” in accordance with the full definition Dr. Okun provided during prosecution, i.e., “any molecule with a levodopa core moiety including levodopa itself, as well as prodrugs, salts, and hydrates of levodopa.”” slip op. at 17

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham
    Patents in suitUS 11,091,507
  • PTAB · Nov 7, 2022 · PGR2022-00037 · APJ Devon Zastrow Newman · PGR · Institution

    The Board denied institution because Petitioner did not show that the patent was eligible for post-grant review; the challenged claims were entitled to the pre-AIA priority date.

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

      “Accordingly, we find that Petitioner has not identified any challenged claim that has an effective filing date on or after March 16, 2013. For this reason, we find that Petitioner has not shown sufficiently that the ’265 patent is eligible for post-grant review. IV. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has not shown that the ’265 patent is eligible for post-grant review. Accordingly, we do not institute a post-grant review. V. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(d), the Petition is denied.” slip op. at 29

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

      “To interpret “stable,” we begin with how the term is used in independent claims 7 and 19. Both terms recite “stable” in relation to the pharmaceutical formulation as a whole by reciting “wherein the formulation is stable.” Ex. 1001, 189:62–190:27. From this, we conclude that the ordinary artisan, as defined above to have a relevant advanced degree and at least two years of experience in development or manufacture of therapeutic protein formulations, would have understood that the components of a “stable” formulation would maintain their integrity and desired function following preparation, including when stored as described. This meaning is supported by the following language in the specification pertaining to the disclosed pharmaceutical compositions: Pharmaceutical compositions according to the present invention are described in further details hereinbelow. In one aspect, the pharmaceutical compositions disclosed herein are physico-chemically stable and maintain the integrity of an antibody comprised in said pharmaceutical composition, for example when stored for 8 weeks at 40° C. as shown hereinbelow. Ex. 1001, 84:20–26. We also note, as Petitioner argued, that the prosecution history supports that the formulation components needed to remain functional during storage, and that Patent Owner cited to formulation integrity after a storage period of 8 weeks at 40° C as evidence of such integrity. Ex. 1004, 7380. As disclosed in the ’265 patent, Examples 9 and 12 measure function and identity of the components following storage to confirm formulation stability.” slip op. at 11

    • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

      “burden of showing that claim 7 or 14 lacks written description support in the priority application, which Petitioner has conceded provides the same support as the ’265 patent specification. In this regard, we agree that the reasoning in Fresenius likewise applies: there is no legal requirement that a patent specification must include test results or working examples demonstrating stability for every possible composition that is covered by the claims. Fresenius at 13, citing Ariad Pharms., 598 F.3d at 1352 (stating that “the written description requirement does not demand either examples or an actual reduction to practice”). Formulations 2 and 3, disclosed in the ’265 patent specification, which Petitioner acknowledges falls within the scope of claims 7 and 14 (Pet. 26–27 (citing Ex. 1002 ¶¶ 134, 135)), were shown to be stable for 8 weeks in a syringe. Moreover, the ordinary artisan was provided with guidance in making such formulations from the teachings of the specification and has additional knowledge from the art. See Ex. 1001, 85:32–94:35. Claims 7 and 14 identify specific structures (risankizumab) and required excipients within a defined pH range, which are stable as confirmed by testing results presented in the specification. Prelim. Resp. 33; Ex. 1001, 94:14–36. On this record, we conclude that the evidence presented does not establish that it is more likely than not that an ordinarily skilled artisan would not have reasonably believed that the inventors of the ’265 patent possessed the claimed subject matter, each limitation of which is demonstrated as supported in the specification. As we have interpreted the claim term “wherein the formulation is stable” to mean “wherein the formulation maintains the functional integrity of the antibody and other components, for example when stored for 8 weeks at 40° C,” the specification supports maintenance of functional integrity as shown by the stability of Formulations 2 and 3, including when stored for a period of time. For this reason, we find that Petitioner has not shown that the ordinary artisan would not have understood the inventors of the ’265 patent possessed the subject matter of claims 7 and 14 as of the filing date of the priority application.” slip op. at 23

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not shown unpatentable

      “We acknowledge that in the Fresenius case, the extensive testing disclosed in that specification supported the ordinary artisan’s ability to formulate stable compounds using such guidance, and that the specification here discloses less testing. See, e.g., Sur-Reply. 8–9. Nevertheless, it is Petitioner’s burden on this issue, and we are not persuaded that the concerns raised by Dr. Klibanov provide sufficient evidence of actual instability to justify institution on this record. See, e.g., Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984) (finding lack of evidence that district court erred in upholding claims as enabled where defendant did not identify inoperable embodiments despite extensive testing). In particular, we are persuaded that, on this record, Petitioner’s lack of evidence of instability of any formulation falling within the limitations of claim 14 indicates that Petitioner has not established sufficiently, for purposes of trial institution, that it is more likely than not that an ordinarily skilled artisan would not have been able to practice the full scope of claim 14 invention based on the teachings of the specification.” slip op. at 28

    Claim construction§ 112 disclosurecites Phillips
    Patents in suitUS 11,078,265
  • PTAB · Sep 14, 2022 · IPR2022-00691 · APJ Richard H Marschall · IPR · Institution

    The Board instituted IPR on claims 1–17, finding a reasonable likelihood of obviousness based on Goss, Winkleman, and House.

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

      “Under these circumstances, we find the first part of the Advanced Bionics framework is not satisfied because the Petition sets forth prior art and arguments that are not the same or substantially the same as that considered by the Examiner during prosecution. Accordingly, we decline to exercise our discretion to deny institution pursuant to 35 U.S.C. §325(d).” slip op. at 8

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

      “review. See 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2021). Inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the evidence and arguments in the record, we institute inter partes review of the ’393 patent on all challenges set forth in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person having ordinary skill in the art (“PHOSITA”) “would have at least a bachelor of science degree in chemistry, mineralogy, geological science, material science, chemical engineering, or mining engineering with at least two to five years of work experience relating to designing specific chemical mixtures including clay or other minerals, particularly absorbents.” Pet. 33 (citing Ex. 1006 ¶ 38). Patent Owner does not dispute Petitioner’s proposed definition of the level of ordinary skill in the art, which appears consistent with the record, including the prior art. See Prelim. Resp. 11; In re GPAC Inc., 57 F.3d at 1579. We adopt the definition of the level of ordinary skill in the art proposed by Petitioner.” slip op. at 9

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionOther

      “Based on our review of the record and the parties’ arguments, we determine that “removably clumpable” in independent claims 1 and 10 refers to a mixture having “a clump strength of ≤ 1.33 using the Standard Drop Method Test” in addition to the other aspects of the “removably clumpable” definition provided in the specification. See Ex. 1001, 5:24–36. This is the same conclusion we reached in IPR2022-00206, which addresses the same issues raised here. See AMCOL, IPR2022-00206, Paper 9, at 9–13. As we noted in that Decision, the paragraph containing the phrase “a clump strength ≤ 1.33 using the Standard Drop Method Test” appears within the “Definitions” section of the specification, and the use of the term “i.e.” just prior to the phrase signals an intent to define the limitation. See id. at 9–10; Ex. 1001, 3:63, 5:24–36.6 We also pointed out that the ’393 patent’s 5 Patent Owner further argues that Petitioner expressly acknowledges the correct definition of “removably clumpable,” but fails to apply it in its proposed construction or apply it to the prior art. Prelim. Resp. 19–21; Surreply 1–3. Petitioner argues that it properly incorporated the narrower definition in its analysis. See Reply 1–3. We address Petitioner’s challenges as to the “removably clumpable” limitation in our discussion of the merits below. 6 Relevant case law supports this interpretation of “i.e.” in the specification. See Edwards Lifesciences LLC v. Cook Inc., 582 F.3d, 1322 1334 (Fed. Cir. 2009) (“As the court correctly reasoned, the specification’s use of ‘i.e.’ signals an intent to define the word to which it refers, . . . and that definition was not limited to the embodiment being discussed.”); Abbott Labs. v. Novopharm Ltd., 323 F.3d 1324, 1327–28, 1330 (Fed. Cir. 2003) (holding that the specification’s use of “i.e.” defined the limitation); SkinMedica, Inc. v. Histogen Inc., 727 F.3d 1187, 1201 (Fed. Cir. 2013) (finding that reading “‘beads (i.e., two-dimensions)’ as definitional comports with the plain language of the specification as a whole and the inventors clearly expressed Example 26, which discloses a clump strength of ≤ 1.33 at the 24-hour mark but clump strengths above 1.33 at the three other time periods, still falls within the scope of the definition of “removably clumpable.” AMCOL, IPR2022-00206, Paper 9 at 11–12. The “definitional paragraph” relied on by Patent Owner notes that “[a] litter material having a clump strength of ≤1.33 using the Standard Drop Method Test (described below) [at] 30 seconds, 1 hour, 12 hours, 24 hours, 36 hours or 72 hours after the clump is formed by exposure to a liquid is removably clumpable.” Ex. 1001, 5:28–33 (emphasis added); Prelim. Resp. 17–18 (referring to “definitional paragraph” that includes this language). Use of the disjunctive “or” in that sentence indicates that a litter having the required clump strength at any of the listed time intervals falls within the scope of “removably clumpable.” Based on the foregoing, we again conclude that “removably clumpable” in independent claims 1 and 10 requires, at a minimum, a mixture having “a clump strength of ≤ 1.33 using the Standard Drop Method Test . . . 30 seconds, 1 hour, 12 hours, 24 hours, 36 hours or 72 hours after the clump is formed.” Ex. 1001, 5:28–32 (emphasis added).” slip op. at 12

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips
    Patents in suitUS 9,439,393
  • PTAB · Sep 1, 2022 · IPR2022-00740 · APJ Michael L Woods · IPR · Institution

    The Board instituted IPR on claims 1–13, 15, and 17–20, finding a reasonable likelihood that at least one challenged claim is unpatentable on the asserted grounds.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

      “discretionary denial. Fintiv, Paper 11 at 5–16. The Director of the USPTO issued, on June 21, 2022, an Interim Procedure regarding the application of Fintiv factors for purposes of determining whether to exercise discretion to deny a petition. Interim Procedure for Discretionary Denials in AIA Post- Grant Proceeding with Parallel District Court Litigation, available at https://www.uspto.gov/sites/default/files/documents/interim_proc_discretion ary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf (“Interim Procedure”). The Interim Procedure states: “[T]he PTAB will not discretionarily deny institution in view of parallel district court litigation where a petitioner presents a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the PTAB.” Interim Procedure at 3. Petitioner stipulates that “if the Board institutes the Petition on the same grounds presented, then it will not seek resolution in the district court of any ground of invalidity raised in the Petition or that could have been raised in the Petition.” Pet. 68; see also Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A) (“Sotera”).” slip op. at 8

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

      “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 has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (addressing in a two part framework the factors presented in Becton, Dickinson & Co. v. B. Braun Melsungen AG, Case IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to § III(C)(5), first paragraph)).” slip op. at 10

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

      “Under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a), we have authority to institute an inter partes review if “the information presented in the petition . . . and any response . . . 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). After considering the Petition, the Preliminary Response, the Reply, the Sur-reply, and the evidence of record, we determine the information presented shows a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the challenged claims of the ’411 patent. Accordingly, we institute an inter partes review of claims 1–13, 15, and 17– 20 of the ’411 patent on the grounds asserted in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “of the invention (“POSITA” or “PHOSITA”) “would have been a person having (i) a Bachelor’s degree in computer science, computer engineering, electrical engineering, or a similar technical field[;] (ii) a working knowledge of computer programming and navigation systems; and (iii) two to four years of experience with location-based systems, user interfaces and databases.” Pet. 4–5 (citing Ex. 1003 ¶ 37). “For the purpose of [the] Preliminary Response only, Patent Owner does not dispute Petitioner’s definition.” Prelim. Resp. 12. For purposes of this Decision, we adopt Petitioner’s assessment of the level of ordinary skill in the art as it is consistent with the ’411 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 12

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 10,197,411

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.