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  • PTAB · Apr 30, 2020 · IPR2018-00685 · APJ Toni R Scheiner · IPR · Rehearing

    The Board denied rehearing, leaving in place its denial of institution on all challenged claims under § 325(d) for grounds I and II and for failure to establish printed-publication status for ground III.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.”” slip op. at 3

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

      “presented in the petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 at 10 (Feb. 13, 4 2020) (precedential). 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. If the same or substantially the same art or arguments were previously presented to the Office, we then consider whether petitioner has demonstrated the Office erred. Id. In evaluating the Petition and accompanying evidence in light of the Becton, Dickinson factors, we determined that grounds I and II were “based on substantially the same prior art and arguments previously presented to the office,” and that Petitioner had “neither sufficiently pointed out how the Examiner erred, nor provided additional evidence or facts that warrant reconsideration of the Examiner’s decision.” Inst. Dec. 26. Accordingly, we exercised our discretion under 35 U.S.C. §325(d) and denied institution of grounds I and II on that basis.” slip op. at 4

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

      “we determined that the Petition failed to establish a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one claim challenged in the Petition, and declined to institute an inter partes review on any of the three grounds asserted. Specifically, with respect to grounds I and II, we declined to institute pursuant to our discretion under 35 U.S.C. § 325(d). Inst. Dec. 22–26. With respect to ground III, we determined that Petitioner had not met its burden of establishing that the Celgene Press Release was available as a printed publication. Id. at 27–31.” slip op. at 3

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

      “we determined that the Petition failed to establish a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one claim challenged in the Petition, and declined to institute an inter partes review on any of the three grounds asserted. Specifically, with respect to grounds I and II, we declined to institute pursuant to our discretion under 35 U.S.C. § 325(d). Inst. Dec. 22–26. With respect to ground III, we determined that Petitioner had not met its burden of establishing that the Celgene Press Release was available as a printed publication. Id. at 27–31.” slip op. at 3

    § 102 anticipation§ 103 obviousnessDiscretionary denial
    Patents in suitUS 8,741,929
  • PTAB · Jan 31, 2019 · IPR2018-00569 · APJ Kristi L R Sawert · IPR · Rehearing

    The Board denied Hologic’s rehearing request, leaving in place the denial of institution under § 325(d) for claims 1–6.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was 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) (citations omitted).” slip op. at 2

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

      “The Board determined that these factors weighed in favor of denying institution because, inter alia: the Examiner considered the same prior art or prior art cumulative to Petitioner’s prior art during prosecution, id. at 12–13; the Examiner thoroughly considered the patentability of the ’352 patent’s claims over the lengthy period of prosecution, id. at 13–15; Petitioner’s arguments were substantially the same as the findings the Examiner made with respect to prior-art reference Montagnier, which is a strong (if not stronger) reference than the prior art Petitioner asserted in these Petitions for inter partes review, id. at 15–18; Petitioner failed to address §325(d) in the Petition, id. at 18; and Petitioner failed to persuade the Board that the Examiner erred in relying on the unexpected results shown in the Laayoun Declaration, id. at 18–21; see also id. at 21–22 (weighing the factors). As to the final finding, the Board considered Petitioner’s argument that the Laayoun Declaration is not persuasive evidence of non-obviousness because the Declaration compares the claimed invention to Bell’s prior-art primers, rather than Backus’s “closest prior art” primers. Id. at 20–21. The Board explained that Petitioner bears the burden to prove unpatentability in an inter partes review, and had failed, in this case, to provide “some persuasive evidence that the claimed primers would not have been unexpectedly better than Backus’s primers.” Id. at 21. The Board noted that the Examiner was aware of Backus, but nevertheless “accepted Bell as the closest prior art.” Id. The Board “decline[d] to revisit that decision,” because “Petitioner d[id] not persuade us that the Examiner erred in accepting that evidence as showing unexpected results.” Id. at 21–22.” slip op. at 4

    Discretionary denial
    Patents in suitUS 8,697,352
  • PTAB · Jan 31, 2019 · IPR2018-00568 · APJ Kristi L R Sawert · IPR · Rehearing

    The Board denied Hologic’s rehearing request, leaving in place the § 325(d) denial of institution for claims 1–6 because Hologic did not show the Board abused its discretion.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was 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) (citations omitted).” slip op. at 2

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

      “The Board determined that these factors weighed in favor of denying institution because, inter alia: the Examiner considered the same prior art or prior art cumulative to Petitioner’s prior art during prosecution, id. at 12–13; the Examiner thoroughly considered the patentability of the ’352 patent’s claims over the lengthy period of prosecution, id. at 13–15; Petitioner’s arguments were substantially the same as the findings the Examiner made with respect to prior-art reference Montagnier, which is a strong (if not stronger) reference than the prior art Petitioner asserted in these Petitions for inter partes review, id. at 15–18; Petitioner failed to address §325(d) in the Petition, id. at 18; and Petitioner failed to persuade the Board that the Examiner erred in relying on the unexpected results shown in the Laayoun Declaration, id. at 18–21; see also id. at 21–22 (weighing the factors). As to the final finding, the Board considered Petitioner’s argument that the Laayoun Declaration is not persuasive evidence of non-obviousness because the Declaration compares the claimed invention to Bell’s prior-art primers, rather than Backus’s “closest prior art” primers. Id. at 20–21. The Board explained that Petitioner bears the burden to prove unpatentability in an inter partes review, and had failed, in this case, to provide “some persuasive evidence that the claimed primers would not have been unexpectedly better than Backus’s primers.” Id. at 21. The Board noted that the Examiner was aware of Backus, but nevertheless “accepted Bell as the closest prior art.” Id. The Board “decline[d] to revisit that decision,” because “Petitioner d[id] not persuade us that the Examiner erred in accepting that evidence as showing unexpected results.” Id. at 21–22.” slip op. at 4

    • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsDecided for patent owner

      “Here, Petitioner attempted to show that Bell is not the closest prior art by presenting schematics comparing the nucleotide sequences of Backus’s primers to Bell’s primers and repeating Dr. Linnen’s statements that he considered the Backus primer set “closer” to the claimed primer set than the Bell primer set. Pet. 52–54 (citing Ex. 1020 ¶¶ 317–327). But neither Petitioner nor Dr. Linnen attempted to explain—or present any evidence— that Backus’s primers would have achieved the same results as the claimed primers. See Instit. Dec. 21. Put differently, Petitioner’s bare assertions failed to establish a reasonable likelihood that Patentee’s unexpected results would have been any different when compared to Backus. See Kao Corp. v. Unilever U.S., Inc., 441 F.3d 963, 970 (Fed. Cir. 2006) (calling patent challenger Unilever’s argument that patentee Kao’s unexpected results were not compared to the closest prior art “not sustainable”: “Even if we were to conclude that Gangadharan was clearly the closest prior art, Unilever has not demonstrated, or even alleged, that Gangadharan achieved [the unexpected results] reported by Kao. . . . In the absence of such an allegation, any error made by the trial court in using Gueret for its comparison would be harmless.”). Third, we note that Petitioner’s case appears to rely on an overly mechanical application of the “closest prior art.” See Reh’g Req. 6–12. Although unexpected results must be shown to be unexpected compared to the closest prior art, the Federal Circuit has warned against applying that requirement “so rigidly as to require [patentee] to identify and focus on just one prior art product when multiple, similar” products “existed or were described in the prior art.” Tris Pharma, Inc. v. Actavis Labs. FL, Inc., 2019 WL 254418, at *7 (Fed. Cir. Jan. 16, 2019). Thus, as we stated in the Institution Decision, we decline to revisit the Examiner’s decision to accept the Laayoun Declaration absent some persuasive evidence that the claimed primers would not have been unexpectedly better than Backus’s primers. Instit. Dec. 21.” slip op. at 8

    § 103 obviousnessDiscretionary denial
    Patents in suitUS 8,697,352
  • 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
  • PTAB · Jul 2, 2015 · CBM2015-00067 · APJ Michael W Kim · CBM · Institution

    The Board denied institution under § 325(d), finding the challenges substantially repeated those in CBM ’159, including a second attempt to challenge claims 8 and 19.

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

      “the obviousness of claims 8 and 19 in this proceeding, as was set forth in CBM ’159. For example, Petitioner presents almost exactly the same wordfor-word rationale for combining Ondrus II with Bemmel and Dalzell, as was presented for combining Ondrus I with Bemmel and Dalzell in CBM ’159. Pet. 72; CBM ’159, Paper 3 at 38–39. Indeed, the only differences we are able ascertain readily are changes to exhibit citations. In another example, the quotations attributed to Ondrus I and Ondrus II in the relevant portions of the respective claim charts concerning claim 8 are identical. Pet. 42; CBM ’159, Paper 3 at 39. On these facts, the Board, accordingly and unquestionably, has discretion under § 325(d) to deny institution of this ground, “because[ ] the same or substantially the same prior art or arguments previously were presented to the Office.”” slip op. at 8

    Discretionary denial
    Patents in suitUS 8,396,808

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