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  • PTAB · Jan 29, 2025 · IPR2024-01174 · APJ Susan L C Mitchell · IPR · Institution

    The Board instituted IPR on claims 1–8 and 10–23, finding a reasonable likelihood that claims 1, 3, 4, and 8 are unpatentable, including over Lesniak-based grounds.

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

      “We determine that the first part of the Advanced Bionics framework is satisfied. Although the Examiner did not specifically apply Lesniak, Phinney, or Sturgis to the grounds of rejection for ’706 patent application, the Examiner considered these references as evidenced on the face of the ’706 patent indicating these were cited references, as well as by the Information Disclosure Statement that listed these three references. See Ex. 1001, code (56); Ex. 2001, 287, 297, 304. Various combinations of these references are asserted in six of the nine grounds before us in this proceeding. Therefore, we determine that same or substantially the same art previously was presented to the Office.” slip op. at 13

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

      “summarized above, we determine that the information presented in the Petition establishes that Petitioner has shown sufficiently a reasonable likelihood of succeeding with respect to at least claims 1, 3, 4, and 8 challenged in Grounds I through IV.2 We are persuaded, based on the current record, that persons of ordinary skill in the art would have been motivated to make the different combinations of Lesniak, Phinney, Lamb, Bianchi ’518, Bianchi ’254 and Anconi for Grounds I through IV to arrive at the deodorant stick of at least claims 1, 3, 4, and 8 with a reasonable expectation of success. Below, we discuss how Petitioner has shown a reasonable likelihood of success that the teachings of Lesniak for claim 1 and the various combinations of Grounds II through IV would render obvious claims 3, 4, and 8, representative claims for these grounds.” slip op. at 30

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

      “rational motivation to combine, supported by Dr. Michniak-Kohn’s testimony, stating that Lesniak and Phinney are in the same field of endeavor as the ’706 patent—personal care compositions, including deodorant and/or antiperspirant sticks, that contain known antimicrobials and focus on the use of natural ingredients. Pet. 25 (citing Ex. 1001, Abstract, 1:26–44, 14:32– 60; 17:58–12, 18:65–26:36; Ex. 1003, Abstract, Title, 1:16–35, 3:39, 4:22, 4:61–67; 5:5–31, 8:43–46, 9:45, 10:27–33; Ex. 1004, Abstract, Title, 1:5–9, 5:52–60, 6:1–34, 8:40–44; Ex. 1002 ¶ 80). Petitioner points to Phinney’s teaching that that “’a mixture of the hydroxides of zinc and magnesium could provide long lasting protection against odour due to perspiration,’” versus using zinc oxide alone, which was less effective “due to insolubility and low hydrolysis rate to a hydroxide form that could show some activity.” Pet. 25–26 (citing Ex. 1004, 1:12–22, 2:33–37; 5:64–66, 5:48–49; Ex. 1002 ¶ 82); see Ex. 1002 ¶ 77.” slip op. at 32

    • Expert testimonyPetitioner expert creditedOther

      “Dr. Michniak-Kohn testifies that “a POSA would have been motivated to incorporate magnesium hydroxide into Lesniak’s composition following Phinney’s guidance, as this combination would improve odor protection while maintaining the ‘natural’ composition intended by Lesniak.” Ex. 1002 ¶ 77. Dr. Michniak-Kohn also testifies that “a POSA would have appreciated that deodorant compositions could be formed through various combinations of known ingredients, such as antimicrobials, as simple design choices.” Id. ¶ 79. We credit Dr. Michniak-Kohn’s testimony here as supported by the record before us at this stage of the proceeding. On the record before us, we determine that Petitioner has shown sufficiently a reason to combine the teachings of Lesniak and Phinney to arrive at claim 3.” slip op. at 33

    § 103 obviousnessDiscretionary denialcites Graham
    Patents in suitUS 11,497,706
  • PTAB · Jan 27, 2025 · IPR2024-01105 · APJ Sheridan K Snedden · IPR · Institution

    Instituted review of claims 1–15 based on all six asserted grounds after finding a reasonable likelihood that at least one challenged claim is unpatentable.

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

      “We determine that the first part of the Advanced Bionics framework is satisfied. While the Examiner did not specifically apply Lesniak to the grounds of rejection for the ’542 application, the Examiner was aware of Lesniak during its prosecution as evidenced by the fact that Lesniak appears on an IDS signed by the Examiner, which is not disputed by Petitioner. Prelim. Resp. 11–15; Ex. 2001, 79; Pet. 21. We turn to whether Petitioner demonstrates that the Office erred in a manner material to the patentability of the challenged claims when it considered Lesniak. 2. Whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims Under the second part of the Advanced Bionics framework, we consider “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Advanced Bionics, Paper 6, 8. “An example of a material error may include misapprehending or overlooking specific teachings of the relevant prior art where those teachings impact patentability of the challenged claims.” Id. at 8 n.9. We evaluate Becton, Dickinson factors (c), (e), and (f) to determine whether Petitioner has demonstrated material error. Id. at 10. Those factors are:” slip op. at 10

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

      “To institute an inter partes review, we must determine that the information presented in the Petition shows “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) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–15 of the ’915 patent is unpatentable.” slip op. at 2

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

      “35 U.S.C. § 103 as obvious over the combination of Lesniak and Phinney. Claims 2 and 10 depend from claim 1 and further require that the antimicrobial to be selected from, among other things, magnesium carbonate and magnesium hydroxide. Ex. 1001, 15:44–46, 16:1–14, 16:29–30. Petitioner concedes that Lesniak does not expressly teach the use of magnesium hydroxide. Pet. 34. However, Petitioner asserts that, in view of Phinney, a POSA would have found it obvious to add magnesium hydroxide to the composition of Lesniak. Id. Phinney states that metal oxides, such as zinc oxide, are not particularly efficacious antimicrobials in deodorants when used alone and describes using magnesium hydroxide as an antimicrobial in a deodorant stick in combination with zinc oxide. Id., 35. adequately articulate a reason why a POSA would combine Lesniak and Phinney. Prelim. Resp. 16–18. Having considered the parties’ positions and evidence of record, we determine that Petitioner has shown a reasonable likelihood that claims 2 and 10 of the ’915 patent are unpatentable as obvious over the combination of Lesniak and Phinney. At this stage in the proceedings, we disagree with Patent Owner that Petitioner has not articulated an adequate motivation to combine Lesniak and Phinney. Petitioner has articulated a clear motivation to combine these two references. Pet. 35. Specifically, Petitioner asserts that “[b]oth Lesniak and Phinney are directed to deodorants with ‘natural ingredients”’ and “[b]oth describe using known antimicrobials” and “[b]ecause Lesniak teaches using zinc oxide (a known antimicrobial) and Phinney teaches that using magnesium hydroxide in combination with zinc oxide improves antimicrobial properties, a POSA would have had a reason to follow Phinney’s teaching and add magnesium hydroxide to Lesniak’s composition.” Pet. 35.” slip op. at 22

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 27 (citing Ex. 1002 ¶¶ 26–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. Prelim. Resp. 7. For this Decision, we adopt and apply Petitioner’s proposal above, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 7

    § 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 10,966,915
  • PTAB · Jan 23, 2025 · IPR2024-01104 · APJ Sheridan K Snedden · IPR · Institution

    The Board instituted IPR on claims 1–18 based on all petitioned grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

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

      “consider “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Advanced Bionics, Paper 6, 8. “An example of a material error may include misapprehending or overlooking specific teachings of the relevant prior art where those teachings impact patentability of the challenged claims.” Id., 8 n.9. We evaluate Becton, Dickinson factors (c), (e), and (f) to determine whether Petitioner has demonstrated material error. Id., 10. Those factors are: (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; . . . (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, Paper 8 at 17–18.” slip op. at 11

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

      “summarized above, we are persuaded, based on the current record, that persons of ordinary skill in the art would have been motivated to combine Lesniak, Phinney, and Bianchi ’518 to arrive at the deodorant stick of at least claim 1 with a reasonable expectation of success for the reasons stated in the Petition. Pet. 24–37. In particular, we are persuaded by Petitioner that Lesniak teaches natural anhydrous personal care compositions, including a deodorant stick in the form of an antiperspirant stick. Pet. 24 (citing Ex. 1003, 1:16–35, 4:22, 5:5–32, 10: 27, 10:32–33). Lesniak explains that such compositions include at least one antimicrobial (i.e., zinc oxide) and a where the compositions are free of an aluminum salt. Id., 24–25. While Petitioner concedes that Lesniak does not expressly teach that its compositions include magnesium hydroxide, for that element, Petitioner combines Phinney disclosure for using magnesium hydroxide as an antimicrobial in a deodorant stick. Id., 25–26 (citing Ex. 1004, 2:33–37). And Petitioner provides a reason to combine Lesniak and Phinney, noting that “[b]oth Lesniak and Phinney are directed to deodorants with ‘natural ingredients’ and both describe the use of known antimicrobials”. Id., 26–27 (citing to Ex. 1003, 4:61–5:31, 9:45, 10:27, 10:31–33, 3:39–4:21, 8:31–9:59; Ex. 1004, 1:5–9, 1:15–19, 5:52–67, 6:31–34, 8:40–44). Petitioner concludes that “a POSA would have been motivated to incorporate magnesium hydroxide into Lesniak’s composition following Phinney’s guidance, as this combination would improve odor protection while maintaining the ‘natural’ composition intended by Lesniak.” Pet. 27; Ex. 1002 ¶ 62 (same). Petitioner also concedes that Lesniak also does not expressly teach hardness as measured by penetration within an ASTM-D 1321 needle test, but that Bianchi ’518 discloses a hardness range by needle penetration. Id at 26–28. By combining these references of record in the manner proposed by the Petitioner, we are persuaded on the record before us that those of ordinary skill in the art would combine the teachings of Lesniak, Phinney, and Bianci ’518 to meet each limitation of claim 1 for the reasons set forth in the Petition. See e.g. id., 27 (“a POSA would have known that hardness was an ‘important physical parameter affecting consumer acceptance,’ and would have looked to achieve hardness levels that were taught in the field to achieve consumer acceptance”); see also Ex. 1002 ¶¶ 63–64 (same). Patent” slip op. at 21

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted

      “summarized above, we are persuaded, based on the current record, that persons of ordinary skill in the art would have been motivated to combine Lesniak, Phinney, and Bianchi ’518 to arrive at the deodorant stick of at least claim 1 with a reasonable expectation of success for the reasons stated in the Petition. Pet. 24–37. In particular, we are persuaded by Petitioner that Lesniak teaches natural anhydrous personal care compositions, including a deodorant stick in the form of an antiperspirant stick. Pet. 24 (citing Ex. 1003, 1:16–35, 4:22, 5:5–32, 10: 27, 10:32–33). Lesniak explains that such compositions include at least one antimicrobial (i.e., zinc oxide) and a where the compositions are free of an aluminum salt. Id., 24–25. While Petitioner concedes that Lesniak does not expressly teach that its compositions include magnesium hydroxide, for that element, Petitioner combines Phinney disclosure for using magnesium hydroxide as an antimicrobial in a deodorant stick. Id., 25–26 (citing Ex. 1004, 2:33–37). And Petitioner provides a reason to combine Lesniak and Phinney, noting that “[b]oth Lesniak and Phinney are directed to deodorants with ‘natural ingredients’ and both describe the use of known antimicrobials”. Id., 26–27 (citing to Ex. 1003, 4:61–5:31, 9:45, 10:27, 10:31–33, 3:39–4:21, 8:31–9:59; Ex. 1004, 1:5–9, 1:15–19, 5:52–67, 6:31–34, 8:40–44). Petitioner concludes that “a POSA would have been motivated to incorporate magnesium hydroxide into Lesniak’s composition following Phinney’s guidance, as this combination would improve odor protection while maintaining the ‘natural’ composition intended by Lesniak.” Pet. 27; Ex. 1002 ¶ 62 (same). Petitioner also concedes that Lesniak also does not expressly teach hardness as measured by penetration within an ASTM-D 1321 needle test, but that Bianchi ’518 discloses a hardness range by needle penetration. Id at 26–28. By combining these references of record in the manner proposed by the Petitioner, we are persuaded on the record before us that those of ordinary skill in the art would combine the teachings of Lesniak, Phinney, and Bianci ’518 to meet each limitation of claim 1 for the reasons set forth in the Petition. See e.g. id., 27 (“a POSA would have known that hardness was an ‘important physical parameter affecting consumer acceptance,’ and would have looked to achieve hardness levels that were taught in the field to achieve consumer acceptance”); see also Ex. 1002 ¶¶ 63–64 (same). Patent” slip op. at 21

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 24 (citing Ex. 1002, ¶¶ 26–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. Prelim. Resp. 8. For this Decision, we adopt and apply Petitioner’s proposal above, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 7

    Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 11,540,999
  • PTAB · Sep 23, 2024 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Institution

    The Board instituted IPR on claims 1, 6–11, 13–20, 22–24, and 26–28 on all petitioned grounds, finding a reasonable likelihood of success and declining discretionary denial.

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

      “the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 11

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

      “the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 11

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “Petitioner contends that the MSI-H Study Record is prior art under 35 U.S.C. § 102(a) and is not covered by an exception under 35 U.S.C. § 102(b). Pet. 8. The parties agree that the MSI-H Study Record was publicly available by June 12, 2013. Id. at 7; Prelim. Resp. 19 (“JHU submitted the MSI-H Study Record on June 10, 2013, and it was posted on clinicaltrials.gov on approximately June 12, 2013”).” slip op. at 16

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

      “summarized above, we determine that the information presented in the Petition establishes that Petitioner has a reasonable likelihood of prevailing in showing that claim 1 would have been obvious in view of the MSI-H Study Record. We are persuaded that the MSI-H Study Record discloses the limitations of claim 1. Pet. 16–24. We are further persuaded that a person of ordinary skill in the art would have been motivated to modify the MSI-H Study Record with Pernot and Benson to benefit from the improved outcomes in treating MSI-H colorectal patients with the drug therapeutic. Id. at 41–44. We are also persuaded that a person of ordinary skill would have been motivated to test patients to determine their MSI-H status as such testing was routine in the art. Id. at 44–45. We are also persuaded that a person of ordinary skill would have been motivated to combine the teachings of the MSI-H Study Record and Benson to treat patients with metastatic and advanced disease. Id. at 46–47.” slip op. at 27

    § 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 10,934,356
  • PTAB · Nov 17, 2023 · IPR2023-00884 · APJ Ryan H Flax · IPR · Institution

    The Board instituted IPR of claims 1–30 on every asserted ground, finding a reasonable likelihood that at least one challenged claim is unpatentable.

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

      “institute trial in an inter partes review. We may institute an inter partes review if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that 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. After reviewing the parties’ submissions in view of the preliminary record, we conclude Petitioner demonstrates a reasonable likelihood it would prevail in showing that at least one challenged claim of the ’572 patent is unpatentable under the presented grounds. Therefore, we grant institution of inter partes review. We note that there are disputed issues in this proceeding under 35 U.S.C. § 325(d) and § 314(a) concerning discretionary denial; however, we determine institution should be not be denied. See Pet. 63–68; Prelim. Resp. 49–62. Our reasoning is discussed below.” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

      “1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits.” slip op. at 67

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

      “We agree with Petitioner that the Examiner committed error in failing to make any rejections over the references asserted here. As noted above, certain of Petitioner’s grounds for unpatentability present compelling merits and had the Examiner correctly evaluated the asserted references, a rejection under § 102 or § 103 would have been made. Accordingly, we determine that Petitioner demonstrates that the Office erred in a manner material to the patentability of the challenged claims. 3. Summary For the reasons discussed above, we decline to exercise our discretion under § 325(d) to deny the Petition.” slip op. at 77

    Discretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 11,253,572
  • PTAB · Oct 13, 2023 · IPR2023-00876 · APJ Michael J Fitzpatrick · IPR · Institution

    Instituted IPR on claims 1–6; the Board found a reasonable likelihood that claim 1 would be unpatentable as obvious over Linnarsson and McCloskey.

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

      “In sum, on the record presented, it appears that Petitioner is correct in stating that “no arguments were made during examination with respect to McCloskey or any similar reference disclosing an oligonucleotide with two tags.” Pet. 70 (underlining added).” slip op. at 16

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

      “4. Conclusion as to Claim 1 There is a reasonable likelihood that Petitioner would prevail in proving that claim 1 is unpatentable on this ground.” slip op. at 23

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

      “The Petition states that “Petitioner does not believe that any terms require explicit construction in view of the prior art being presented.” Pet. 36. Despite this stated position, Petitioner proposes constructions for “multiplex-identifier (MID)” and “providing a sample.” Id. Patent Owner, for its part, states that it “agrees that at this time, solely for purposes of an institution decision on the Petition, no terms require explicit construction.” Prelim. Resp. 45. On the record before us, and for purposes of institution, we find there is no need to provide an express construction of any claim term.” slip op. at 6

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Pet. 21–22 (citations omitted). At this stage of the proceeding, Patent Owner does not dispute the level of skill proposed by Petitioner. Because Petitioner’s formulation of the level of ordinary skill in the art appears consistent with the disclosure of the ’981 patent and the asserted prior art, and because there is no argument to the contrary at this stage of the proceeding, we apply Petitioner’s formulation in our analysis below.” slip op. at 7

    Claim construction§ 103 obviousnessDiscretionary denialcites Graham
    Patents in suitUS 10,155,981
  • PTAB · Jul 31, 2023 · PGR2023-00017 · APJ Zhenyu Yang · PGR · Institution

    Instituted PGR on claims 1–10 and all asserted grounds because the Board found it more likely than not that Tobler anticipates and renders obvious at least claim 1.

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

      “We review the Petition under 35 U.S.C. § 324, which provides that a post-grant review may not be instituted unless “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). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 324(a). Accordingly, we institute a post-grant review of all challenged claims based on all grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PTAB Consolidated Trial Practice Guide (“Practice Guide”),1 5–6 (Nov. 2019).” slip op. at 2

    • Other 314aInstitution denied discretionary otherDenied

      “We disagree. It is unclear which aspect of the Petition that Patent Owner takes issue with. If it is the “multitudinous grounds” presented in the Petition, Patent Owner points to no authority that permits us to deny institution merely because a petition presents numerous grounds. In any event, on the facts of this case, we do not view eight grounds asserted in the Petition to be excessive.6 To the extent Patent Owner urges that we should deny institution because Petitioner’s grounds are “futil[e],” we understand that to be an argument on the merits, and not related to our discretion. See Prelim. 6 The Petition presents five grounds. See generally Pet. We agree with Patent Owner, however, the ground based on Tobler, in fact, encompasses three grounds, and the ground based on De Oliveira, in fact, encompasses two grounds. See Prelim. Resp. 2. Resp. 45. As explained below, we find Petitioner has established that it is more likely than not that claims 1–10 of the ’727 patent are unpatentable over Tobler. See infra Section II.D.2. Because the grounds based on Tobler apply to all challenged claims,7 at least these grounds are not, as Patent Owner asserts, futile. Thus, we decline to exercise discretion to deny the Petition under § 324(a).” slip op. at 6

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

      “review, we “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.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. 7 The cases Patent Owner cites do not support its argument on discretionary denial under § 324(a). See Prelim. Resp. 45–46. In those cases, the Board exercised discretion to deny institution because the petitions only met the threshold requirement for institution with regard to a small percentage of the challenged claims. See Chevron Oronite Co. LLC v. Infineum USA L.P., IPR2018-00923, Paper 9, 11 (PTAB Nov. 7, 2018) (stating “instituting a trial with respect to all twenty claims based on evidence and arguments directed to dependent claims 3 and 4 is not an efficient use of the Board’s time and resources”); Deeper, UAB v. Vexilar, Inc., IPR2018-01310, Paper 7, 2 (PTAB Jan. 24, 2019) (denying institution because the petitioner only “demonstrated a reasonable likelihood of prevailing with respect to only two of twenty-three challenged claims as to only one of four asserted grounds of unpatentability”). MED-EL Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). The parties agree that, during prosecution, the relevant disclosure in Tobler was before the Examiner in U.S. Patent Application Publication 2010/0216640, which was cited in an Information Disclosure Statement (“IDS”). Pet. 12; Prelim. Resp. 46. In other words, the first prong of the Advanced Bionics analysis is satisfied. Thus, we must determine whether Petitioner has shown a material error by the Office. We find Petitioner has met its burden on this issue.” slip op. at 7

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

      “The parties agree that, for purposes of this Decision, all claim terms should be given their plain and ordinary meaning. Pet. 18; Prelim. Resp. 13. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address the construction of any claim term.” slip op. at 9

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 11,445,727
  • PTAB · Jul 19, 2023 · IPR2023-00442 · APJ John G New · IPR · Institution

    The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claim 1 is obvious over Dixon, CATT, MACTEL, and PIER.

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

      “Under 35 U.S.C. § 314, the Board “may not authorize an inter partes review to be instituted unless … 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.” Upon consideration of the Petition, Preliminary Response, Reply, Sur-Reply, and the evidence of record, we determine that the evidence presented demonstrates a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’681 patent. We therefore institute inter partes review.” slip op. at 2

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

      “deny a Petitioner successive attacks on the claims of a single patent, and profiting from those prior attempts by altering a petition’s strategy in response to Patent Owner’s and the Board’s responses. General Plastic, Paper 19 at 9–10. Patent Owner is quite correct, however, that, under Valve Corp., we can consider the relationship between different parties bringing successive challenges to a given patent. Valve Corp., Paper 11, at 2, 9. However, the facts of the present Petition render this present situation readily distinguishable from the facts in Valve Corp. In Valve Corp., we found that the parties bringing successive challenges to the patent-in-suit were “named as co-defendants in that lawsuit and were accused of infringing the ’934 patent based on [co-defendant] HTC’s VIVE devices that incorporate Valve’s technology.” Valve Corp., Paper 11, at 9–10. Furthermore, in that litigation, Valve represented that “HTC’s VIVE devices incorporate certain Valve technologies under a technology license from Valve,” and that “Valve employees did provide HTC with technical assistance during the development of the accused VIVE devices.” Id. at 10. The Board consequently concluded that “there is a significant relationship between Valve and HTC with respect to Patent Owner’s assertion of the ’934 patent. The complete overlap in the challenged claims and the significant relationship between Valve and HTC favor denying institution.” Id. No such facts obtain in the present instance. Petitioner is not a co- defendant with Mylan in the district court infringement action, Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 1:22-cv-00061-TSK (N.D.W. Va.).11 There is no credible evidence of record that Petitioner and Mylan, potential business competitors, have developed any significant relationship, as in Valve Corp. Petitioner has joined the -01226 inter partes review as a “silent” slip op. at 44

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted

      “skill in the art would have been motivated to adopt the exclusion criteria when administering aflibercept via intravitreal injection to minimize the risks of intravitreal infection and complications such as endophthalmitis and that adoption of these criteria reflected basic safety precautions developed to address the risks associated with intravitreal injections generally, regardless of the specific anti-VEGF agent injected. See Pet. 48–52. Petitioner has shown sufficient support on the record before us for such a view. Patent Owner also argues that Petitioner: (1) has not shown motivation to modify the exclusion criteria of PIER by adding the third exclusion criterion; and (2) has not shown motivation to modify the exclusion criteria of CATT and/or MACTEL. We disagree. We have explained above why we conclude that a person of ordinary skill in the art would have found exclusion criterion three to be obvious over not CATT and MACTEL individually and together. See KSR, 550 U.S. at 416. Moreover, Petitioner has, as we have also explained, asserted a persuasive reason why a skilled artisan would have been motivated to adopt the teachings of MACTEL and CATT to reduce the risk of intravitreal infection subsequent to injection of a VEGF receptor antagonist, such as aflibercept. Furthermore, Petitioner has persuasively argued that a person of ordinary skill in the art would also have had a reasonable expectation of success in adopting the exclusion criteria to the studies disclosed by Dixon, viz., that a person of ordinary skill in the art would therefore have reasonably expected that the exclusion criteria developed for prior art VEGF receptor antagonists could be successfully applied to aflibercept. Pet. 53 (citing Ex. 1002 ¶¶ 156–158).” slip op. at 39

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner disagrees with Petitioner’s definition of a person of ordinary skill in the art, arguing that the skilled artisan is an ophthalmologist experienced in treating angiogenic eye disorders, including with VEGF antagonists. Prelim. Resp. 11. Patent Owner acknowledges, however, that the parties’ differing definitions of a person of ordinary skill in the art do not affect any argument presented with respect to our present Decision to Institute. Id. As we explain below, with the exception of the exclusion criteria, claim 1 of the ’681 patent is identical to claim 1 of the ’388 patent in the -00881 IPR. We again determine that our definition of a person of ordinary skill in the art is reasonable and consistent with the prior art of record at this stage of the proceeding. For the purposes of this decision, and for the sake of consistency, we adopt our prior definition, quoted above, as the definition of a person of ordinary skill in the art.” slip op. at 10

    § 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 10,130,681
  • PTAB · Feb 8, 2023 · IPR2022-01400 · APJ Michael A Valek · IPR · Institution

    The Board instituted IPR on claims 1–29 on all asserted grounds, finding a reasonable likelihood of unpatentability for at least one claim.

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

      “Nevertheless, based on its showing in Ground 1, we determine that Petitioner has sufficiently demonstrated a material error during the examination of claim 1. Claim 1 and its dependent claims were allowed shortly after Patent Owner’s amendment to recite a range of barcode combinations n between 2 and 100,000*z in element 1(b). This suggests the Examiner determined that Salk and Schmitt ’188 did not disclose or suggest the recited range. As explained below, however, the record at this stage of the proceeding supports Petitioner’s argument that the number of barcode 10 The “Schmitt” referenced in the ’652 IPR decision is U.S. Patent No. 9,752,188 (“Schmitt ’188”). Ex. 1074, 3 n. 2. Schmitt ’188 claims priority to the international application publication (i.e., WO2013/142,389) referred to as “Schmitt” in this proceeding. Ex. 2008, code (87). combinations for Schmitt’s 3-mer hybrid tag embodiment falls within the recited range regardless of the value of z. See infra § III.E.1. To the extent the Examiner did not appreciate the relevance of the “hybrid method using a combination of sheared ends and shorter n-mer tags (such as 1 or 2 or 3 or 4 or more degenerate or semi-degenerate bases)” taught in Salk and Schmitt ’188 to claim element 1(b), this constitutes material error. Ex. 2012 9:20–24; Ex. 1083 ¶ 30. Moreover, the Petition presents additional evidence regarding element 1(b), e.g., Ex. 1002 ¶ 166, that warrants reconsideration of Schmitt in this proceeding.” slip op. at 10

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

      “Considering the arguments and evidence of record, we determine that the Petition demonstrates “a reasonable likelihood that [P]etitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Accordingly, we institute an inter partes review.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “(i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field, and have at least about two years of experience in the use and development of sequencing technologies; or (ii) a Master’s degree in one of the same fields with at least about five years of the same experience. Pet. 18 (citing Ex. 1002 ¶¶ 27–30). Patent Owner does not offer a proposed definition of the level of ordinary skill in the art at this stage of the proceeding. On this record, we adopt Petitioner’s uncontested definition of the level of ordinary skill in the art. We further note that the 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) (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 13

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

      “As explained below and based on the current record, Petitioner has shown sufficiently for institution that Schmitt discloses the use of barcodes having a number of different combinations that falls within the recited range regardless of the value of z. For this reason, it is unnecessary to expressly construe “z” or any other aspect of element 1(b) to decide the issues presented in the Petition. To the extent Patent Owner disagrees, it will have the opportunity to address this issue at trial. Neither party refers to any other claim term in the claim construction sections of their papers. See Pet. 18–19; Prelim. Resp. 19. We agree 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 14

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 11,149,306
  • PTAB · Jan 11, 2023 · IPR2022-01225 · APJ John G New · IPR · Institution

    The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claim 1 is anticipated by Dixon because the exclusion criteria likely lack patentable weight.

    RulingsInstitution decision
    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

      “Decision. See Ex. 3001, 12–23. In the -00881 Decision, challenged claim 1 of US 9,254,338 B2 (the “’338 patent”) recited preamble language identical to that recited in claim 1 of the ’681 patent, viz., “a method for treating an angiogenic eye disorder in a patient.” See Ex. 1001 col. 21, ll. 40–41; Ex. 3001, 7. The Board found that this preamble was limiting upon the remainder of the claim. Ex. 3001, 18. Specifically, the Board found that: Here, the claims are directed to methods of administering, i.e., using, a VEGF antagonist for an intended purpose of “treating an angiogenic eye disorder in a patient.” The Specification repeatedly characterizes the method as one for treating angiogenic eye disorders in patients. Apart from the preamble, the independent claims do not elsewhere recite or indicate any other use for the method steps comprising the administration of a VEGF antagonist. Thus, we determine that the preamble sets forth the essence of the invention—treating an angiogenic eye disorder in a patient. Additionally, we find that the preamble provides antecedent basis for claim terms “the patient” recited in the body of each independent claim, and “angiogenic eye disorders” recited in dependent claims 6, 7, 18, and 20. Indeed, without the preamble, it would be unclear to whom the doses of VEGF are administered. Thus, … in view of the evidence of record, namely, the claim language and the written description of the ’338 patent, we find that the preambles of method claims 1 and 14 are limiting insofar as they require “treating an angiogenic eye disorder in a patient.” Id. at 17–18 (citations omitted). We adopt this same reasoning here and find, for the purposes of this Decision, that the preamble of claim 1 reciting “[a] method for treating an angiogenic eye disorder in a patient” is limiting upon the claims.” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

      “[W]hen the Specification explains that “[t]he amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount,” and discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” we find that a POSA would have understood that any dosage amount within that range administered according to the invention may, in some cases, result in a detectable improvement in “one or more symptoms or indicia of an angiogenic eye disorder,” or be one that “inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder,” or it may not. In either event, the VEGF antagonist would have been administered for the purpose of treating the eye disorder. In other words, the method of treating the patient with the eye disorder is performed upon administration of the VEGF antagonist to the patient for the purpose of achieving an improvement or beneficial effect in the eye disorder, regardless whether the dosage amount administered actually achieves that intended result. Id. at 21–22 (citation omitted). Furthermore, the Board found that: Patent Owner’s proposes that the claims require not only achieving a therapeutically effective result, but more specifically, achieving a “high level of efficacy that was noninferior to the standard of care by the time the patent was filed in 2011.” In the Sur-reply, Patent Owner describes a “highly effective treatment for angiogenic eye disorders” as “one that is on par to Lucentis or off-label Avastin and can produce visual acuity gains, not just slow vision losses.” The Specification refers to “a high level of efficacy” in one instance, i.e., in the “Background” section. The Specification does not describe there, or elsewhere that “treating,” in the context of the claims or in the art, requires achieving a “high level of efficacy” or providing results “on par to Lucentis or off-label Avastin.” Id. at 22 (citations omitted). We adopt the same reasoning here, and find that, for the purposes of this Decision, the evidence of record and the Specification support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to such patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder, but does not require a “high level of efficacy,” as proposed by Patent Owner. See Ex. 3001, 22.” slip op. at 10

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

      “construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses “secondary doses” are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001 col. 3, ll. 36–44. We do not find persuasive Patent Owner’s argument that the definition of these terms require a high, or otherwise defined, degree of efficacy. As we stated in the -00881 Decision: Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist.” Ex. 3001, 25 (emphasis added). We see no need or reason to upend this construction now and, for the purposes of this Decision, we adopt Petitioner’s proposed definition of the claim terms “initial dose,” “secondary doses,” and “tertiary doses” as the express definition provided by the ’681 Specification.” slip op. at 13

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

      “Claim(s) 35 U.S.C. § Reference(s)/Basis Challenged 4 1, 3–11, 13, 14, 103 Dixon alone or in view of 16–24, 26 Papadopoulos5 and/or Wiegand6 5 1, 3–11, 13, 14, 103 Dixon in combination 16–24, 26 with Rosenfeld-20067, and if necessary, Papadopoulos patent and/or Wiegand 6 1, 3–11, 13, 14, 103 Dixon in combination 16–24, 26 with Heimann-2007, and if necessary, Papadopoulos and/or Wiegand” slip op. at 5

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips
    Patents in suitUS 10,130,681
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