- Novartis Pharmaceuticals Corporation v. Shilpa Pharma, Inc.All claims unpatentablePTAB · Sep 29, 2023 · IPR2022-00886 · APJ John G New · IPR · Final written decision
Claims 1–4 are unpatentable under §102 over Mutz; the Board did not reach the §103 Mutz and Gidwani or §102 Gidwani grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that Petitioner Novartis Pharmaceuticals Corporation (“Petitioner”) has established, by a preponderance of the evidence of record, that challenged claims 1–4 of Patent Owner Shilpa Pharma Inc.’s (“Patent Owner”) U.S. Patent No. 9,266,816 B2 (Ex. 1001, the “’816 patent”) are unpatentable. Additionally, because we find that Petitioner has established that claims 1–4 are unpatentable, we dismiss as moot Petitioner’s Motion to Exclude Evidence (Paper 59). Furthermore, for the reasons we set forth below, Patent Owner’s Motion to Exclude Evidence (Paper 48) is dismissed-in-part as moot and denied-in-part. Both parties’ unopposed Motions to Seal are granted. See Papers 31, 33, 39, 40, 42, 46, 52, 56, 57, 60, 62, 68. Finally we deny Petitioner’s Motion for Sanctions against Patent Owner. (Paper 43).” slip op. at 2
- ExcludeMotion to exclude, grantedMixed
“§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that Petitioner Novartis Pharmaceuticals Corporation (“Petitioner”) has established, by a preponderance of the evidence of record, that challenged claims 1–4 of Patent Owner Shilpa Pharma Inc.’s (“Patent Owner”) U.S. Patent No. 9,266,816 B2 (Ex. 1001, the “’816 patent”) are unpatentable. Additionally, because we find that Petitioner has established that claims 1–4 are unpatentable, we dismiss as moot Petitioner’s Motion to Exclude Evidence (Paper 59). Furthermore, for the reasons we set forth below, Patent Owner’s Motion to Exclude Evidence (Paper 48) is dismissed-in-part as moot and denied-in-part. Both parties’ unopposed Motions to Seal are granted. See Papers 31, 33, 39, 40, 42, 46, 52, 56, 57, 60, 62, 68. Finally we deny Petitioner’s Motion for Sanctions against Patent Owner. (Paper 43).” slip op. at 2
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied
“claims, Petitioner’s request that we do so as a sanction against Patent Owner is denied. Furthermore, having reviewed the arguments and evidence presented by Petitioner and Patent Owner, we conclude that the evidence is not sufficiently conclusive to warrant the additional imposition of financial sanctions. We consequently deny Petitioner’ Motion for Sanctions.” slip op. at 82
Patent outcomesUS 9,266,816 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 9,266,816 - PTAB · Sep 22, 2023 · IPR2023-00481 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 17, 19, 20, and 22–27 because Hopewell showed a reasonable likelihood that the claims would have been obvious over Bodor and Stelmasiak.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“5. Analysis: Claim 17 Based on the present record, Petitioner persuades us that it is reasonably likely to prevail in establishing that claim 17 would have been obvious over Bodor and Stelmasiak. We agree with Petitioner’s showing that Bodor teaches or suggests a method for treating MS, including RRMS, by orally administering cladribine tablets over a two-month induction period at a total dose of between 100 mg to 140 mg (equivalent to 1.4–2.0 mg/kg for the average patient) and, thus, satisfies claim 17’s preamble15 and step (i). See, e.g., Pet. 46–51. Bodor also expressly teaches such an” slip op. at 32
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“Because we agree that Bodor and Stelmasiak were presented previously to the Office, we turn to part two of the Advanced Bionics framework—whether there was a material error by the Office.” slip op. at 54
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Analogous artInstituted
“reasonably likely to prevail in establishing that claim 17 would have been obvious over Bodor and Stelmasiak. We agree with Petitioner’s showing that Bodor teaches or suggests a method for treating MS, including RRMS, by orally administering cladribine tablets over a two-month induction period at a total dose of between 100 mg to 140 mg (equivalent to 1.4–2.0 mg/kg for the average patient) and, thus, satisfies claim 17’s preamble15 and step (i). See, e.g., Pet. 46–51. Bodor also expressly teaches such an” slip op. at 32
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“maintenance period” or a secondary cladribine-free period, we find it logical, credible, and consistent with Dr. Miller’s testimony, that a POSA would have understood Bodor to suggest retreatment and that a POSA would know that retreatment is often needed given the chronic, incurable nature of MS. See, e.g., Ex. 1002 ¶¶ 86–87, 100–102 (testifying that a POSA would have thought to readminister cladribine according to Bodor’s initial treatment regimen, disclosed as suitable for MS treatment, and optimize if needed). Moreover, Petitioner provides evidence-backed reasoning supporting why it would have been routine and obvious to “tailor” the dosage, including by starting with a lower dose and “step-wise” increase it until a desired therapeutic effect is achieved. See, e.g., Ex. 1022, 24:1–9;16 Ex. 1002 ¶ 93. The POSA would have also been aware, from at least Stelmasiak, that it’s possible to give lower amounts of cladribine in a maintenance phase versus an induction phase, keeping lymphocyte counts in a suppressed state, and providing therapeutic benefits even over extended periods where no cladribine is administered. Ex. 1013, 5–7 (describing a decrease in relapse rate and EDSS improvements over a twenty-four month study period). That, combined with Bodor’s teachings and an expectation that a lower dose and intermittent cladribine-free periods would help manage 16 See also Ex. 1022, 26:2–8 (teaching that dosages are given with concomitant, continuous clinical evaluations by a skilled practitioner to “determine subsequent therapy” and “evaluating whether to increase, reduce or continue a particular treatment dose”). ¶¶ 50–52, 91, 95, 103. Based on Petitioner’s evidence and reasoning, we find it reasonably likely that a POSA would have found it obvious to modify Bodor’s method to arrive at steps (iii) and (iv) of claim 17. We also find that the preliminary record, on balance, supports Petitioner’s contention that the POSA would have reasonably expected success in modifying the art to arrive at the subject matter of claim 17. Bodor discloses a method for treating MS with administration of oral cladribine and provides further guidance for adjusting the dosage or duration as needed to produce a desired therapeutic result. See, e.g., Ex. 1022, 22:18–22, 23:15–20, 24:1–9. Stelmasiak further evidences efficacy in treating RRMS with cladribine administration, including in oral and parenteral forms. Ex. 1013, 7. And neither Bodor nor Stelmasiak stands alone; as pointed out by Petitioner and Dr. Miller, several studies predating the ’903 patent describe the use of cladribine for treating MS, including RRMS, and such studies inform the POSA’s background knowledge—a necessary consideration in any obviousness analysis. See Pet. 19–21, 44; Ex. 1002 ¶¶ 35–49, 115; Randall Mfg. v. Rea, 733 F.3d 1355, 1362 (Fed. Cir. 2013) (“[T]he knowledge of such an artisan is part of the store of public knowledge that must be consulted when considering whether a claimed invention would have been obvious.”). Indeed, many of these studies are incorporated by reference into Bodor. Ex. 1022, 22:27–23:6 (incorporating, e.g., Romine (Ex. 1031) and Rice (Ex. 1018), after teaching that “various dosage amounts and dosing regimens have been reported in the literature for use in the treatment of multiple sclerosis”). slip op. at 33
§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 8,377,903 - Celltrion, Inc. v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Sep 1, 2023 · IPR2023-00620 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution because claims 1–4 had been statutorily disclaimed.
RulingsInstitution decision- Adverse judgmentAdverse judgmentDenied
“Under 37 C.F.R. § 42.107(e), “patent owner may file a statutory disclaimer under 35 U.S.C. 253(a) in compliance with § 1.321(a) of this chapter, disclaiming one or more claims in the patent” and “[n]o inter partes review will be instituted based on disclaimed claims.” A disclaimer under 35 U.S.C. § 253(a) is “considered as part of the original patent” as of the date on which it is “recorded” in the Office. 35 U.S.C. § 253(a). For a disclaimer to be “recorded” in the Office, the document filed by the Patent Owner must:” slip op. at 2
NonePatents in suitUS 10,406,226 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentablePTAB · Jul 28, 2023 · IPR2022-01515 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2, 5, and 8 as obvious over Foley, and claims 3–4, 6–7 as obvious over Foley and Plosker.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary 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 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75–100 mg daily.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“2. Analysis “A claim is anticipated if each and every element as set forth in the claim is found, either expressly or inherently, in a single prior art reference.” Arbutus Biopharma Corp. v. ModernaTX, Inc., 65 F. 4th 656, 662 (Fed. Cir. 2023). The Federal Circuit explains that “[a]nticipation by inherent disclosure is appropriate only when the reference discloses prior art that must necessarily include the unstated limitation.” Monsanto Tech. LLC v. Inherent anticipation requires “merely that the disclosure of the prior art is sufficient to show that the natural result flowing from the operation as taught in the prior art would result in the claimed product.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. Cir. 2005) (internal quotes omitted).” slip op. at 23
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, Petitioner must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (quotations and citations omitted).” slip op. at 28
Patent outcomesUS 10,828,310 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,828,310 - Nextremity Solutions, Inc. / Zimmer Biomet Holdings, Inc. et al. v. Extremity Medical, LLCAll claims unpatentablePTAB · Jul 26, 2023 · IPR2022-00802 · APJ Jeffrey N Fredman · IPR · Final written decision
Claim 59 is unpatentable as anticipated by Brumfield, Marcus, and Chandran; the motion to amend proposing substitute claim 62 is denied because claim 62 is unpatentable.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We find this argument unpersuasive. As Patent Owner notes, Petitioner’s expert provides a definition of POSITA that is very similar to that recited by Patent Owner in its Motion to Amend, substantively differing only in the number of years of experience of the engineer at issue. This congruity supports the conclusion that the level of ordinary skill in the art may be recognized in the prior art itself. Okajima, 261 F.3d at 1355 (“the absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown’”).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In our Institution Decision, we agreed with Petitioner that the “portion of the preamble reciting ‘for compressing bone’ is not limiting to the claim” and found that other terms did not require construction. Dec. 8–9. We agreed with Petitioner that “[t]he phrase ‘for compressing bone’ merely identifies an intended use.” Pet. 20; Dec. 9. Patent Owner does not dispute this interpretation. See generally PO Resp. We agree with Petitioner that “the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Therefore, having considered the entire record developed during trial, we adhere to the preliminary construction that the limitation “for compressing bone” does not impose a structural limitation on claim 59 and that the other terms do not require construction.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Patent Owner disputes the Petition generally but Patent Owner does not identify any error in Petitioner’s foregoing arguments. Accordingly, we adopt the factual statements regarding the specific teachings of the references as findings of fact. See generally In re NuVasive, 841 F.3d 966, 974 (Fed. Cir. 2016) (explaining that the Board need not make specific findings as to claim limitations that Patent Owner does not dispute are disclosed in the prior art). We have reviewed Petitioner’s analysis and the underlying evidence cited in support and conclude that Petitioner has shown, by a preponderance of the evidence, that the limitations of claim 59 are disclosed by Brumfield.” slip op. at 26
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“For the reasons discussed below, Patent Owner has shown that proposed substitute claim 62 meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. For the reasons discussed below, however, Petitioner has proven by a preponderance of the evidence that proposed substitute claim 62 is unpatentable over prior art. Therefore, we deny Patent Owner’s Revised Motion to Amend.” slip op. at 38
Patent outcomesUS 8,303,589 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 8,303,589 - 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 · GrahamPatents in suitUS 10,130,681 - PTAB · Jul 3, 2023 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Institution
The Board instituted PGR on claims 1–5 and all asserted challenges, finding written description and enablement challenges met the threshold but the Harris–Xing obviousness challenge did not.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“Patent Owner’s argument is unpersuasive because the combination of Harris with Xing is not cumulative of Pavlakis, Harris-2015, and Damsky. Here the combination of Harris with Xing is argued in different ways compared to what was made to the Examiner. Additionally, we agree with Petitioner that Xing discloses information the Examiner indicated were absent from the prior art. See Ex. 1010, 14–15. For example, Xing teaches administering a therapeutically effective amount of an inhibitor of IL-15 or the IL-15 receptor is administered to the subject. Compare id. at 15, with Ex. 1007, 3. Xing also teaches that TM-β1-mediated blockade of CD122 prevented disease development and progression and that inhibiting IFN-γ production downstream of IL-15 through topical administration of JAK inhibitors effectively eliminated existing lesions. Thus, we do not find that the same or substantially the same arguments were presented previously to the Office, nor do we find that the same or substantially the same art was previously presented to the Office. Thus, the first part of the Advanced Bionics framework is not satisfied for Petitioner’s § 103 challenge, and we decline to exercise our discretion under 35 U.S.C. § 325(d) to deny institution of a trial proceeding on this challenge.” slip op. at 12
- Skill levelSkill level petitioner adoptedOther
“At this stage of the proceeding, Patent Owner does not assert a different level of skill in the art at the time of the alleged invention and uses Petitioner’s proposed level of skill. Prelim. Resp. 16. For the purposes of this Decision, we too adopt Petitioner’s level of ordinary skill in the art because it appears consistent with the problems addressed in the ’505 patent and the prior art of record.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther
“Both parties state that express claim construction is unnecessary at this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Prelim. Resp. 17. We agree. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 terms for purposes of institution.” slip op. at 7
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 324 and 37 C.F.R. § 42.4. A post-grant review may not be instituted unless it is determined that “the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324 (2018); see also 37 C.F.R § 42.4(a) (2022) (“The Board institutes the trial on behalf of the Director.”). The “more likely than not” standard requires greater than 50% chance of prevailing. Consolidated Trial Practice Guide 58 (Nov. 2019), available at https://www.uspto.gov/TrialPracticeGuideConsolidated. For the reasons provided below and based on the record before us, we determine Petitioner has demonstrated that it is more likely than not that it would prevail in showing the unpatentability of at least one of the challenged claims. We decline to deny the Petition on a discretionary basis as requested by Patent Owner. Accordingly, we institute a post-grant review of the ’505 patent and all of the asserted challenges to patentability.” slip op. at 2
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,278,505 - Pelican Biothermal, LLC v. Va-Q-Tec AGSome claims unpatentablePTAB · Jun 16, 2023 · PGR2021-00085 · APJ Barry L Grossman · PGR · Final written decision
The Board granted the motion to amend but held amended claim 64 unpatentable as anticipated by NanoCool 98596-type products and obvious over the cited combinations; all other amended claims were not shown unpatentable.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has demonstrated by a preponderance of the evidence that amended claim 64 is unpatentable; FURTHER ORDERED that Patent Owner’s Non-Contingent Motion to Amend is granted for claims 64 and denied for all other amended claims; and” slip op. at 77
- ExcludeMotion to exclude, deniedDenied
“A. Status as Prior Art Is a Substantive Issue, Not an Evidentiary Issue. A motion to exclude is not an appropriate mechanism for challenging the sufficiency of evidence, such as whether a reference qualifies as prior art, or the proper weight that should be afforded an argument. See Flir Systems, Inc. v. Leak Surveys, Inc., IPR2014-00411, Paper 113, 4, 8–9 (PTAB September 3, 2015); PTAB Consol. Trial Practice Guide 79 (Nov. 30 Mr. Zumwalt testifies that other NanoCool products, designated by product number 85430 and 98630, also have the same configuration as the 98830 product and are made by the same process. Thus, “the 98830, 85430, and 98630 products can be collectively referred to as ‘98830-type’ products all having the same relevant design.” Ex. 1030 ¶ 17. 2019) (“A motion to exclude . . . may not be used to challenge the sufficiency of the evidence to prove a particular fact. A motion to exclude is not a vehicle for addressing the weight to be given evidence—arguments regarding weight should appear only in the merits documents.”); Caterpillar Inc. v. Wirtgen Am., Inc., IPR2017-02187, Paper 42,17 (PTAB May 21, 2019) (status as prior art “is a substantive issue, not an evidentiary issue.”) Thus, whether the NanoCool 98830 product is prior art is not the proper basis for Patent Owner’s Motion to Exclude evidence concerning the NanoCool 98830 product.” slip op. at 29
- Skill levelSkill level board ownOther
“Neither Petitioner nor Mr. Harber provide any analysis of the factors pertinent to a determination of the level of ordinary skill, identified above, to support their conclusory statements. We give Mr. Harber’s conclusory testimony minimal probative weight. 37 C.F.R. § 42.64(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Moreover, there is no persuasive evidence to which we have been directed of the need for specific education or experience in biological or chemical technologies related to the claimed containers and inserts.” slip op. at 26
- Expert testimonyPetitioner expert discountedDecided for patent owner
“With regard to the level of ordinary skill in the art, Petitioner asserts that a person of ordinary skill would have had “a bachelor’s degree or higher degree in biological, chemical or mechanical engineering, or related sciences, and at least two to five years of experience in designing and testing ISCs [insulated shipping containers] depending on education level.” Pet. 9 (emphasis added) (citing Ex. 1002 ¶¶ 23–24). Exhibit 1002 is the Declaration testimony of Mr. Paul Haber. Mr. Harber actually states a slightly different level of ordinary skill. Mr. Harber testifies: The hypothetical POSITA would have: (i) at least a bachelor’s degree in biological, chemical or mechanical engineering, or related sciences, and have at least three to five years of experience in designing and testing ISCs [Insulated Shipping Containers][29]. Such a person may also have (ii) a higher level degree, such as a PhD and/or Master’s degree in engineering, or related sciences, and have at least two to three years of experience in designing and testing ISCs. 29 See Ex. 1002 ¶ 23. Ex. 1002 ¶ 24 (emphasis added). Mr. Harber also testifies that “[t]hese descriptions are approximate, and a higher level of education or specific skill might make up for less experience, and vice-versa.” Id.” slip op. at 25
Patent outcomesUS 10,766,685 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,766,685 - Vifor (International) AG v. Biofer S.P.A.Institution deniedPTAB · Apr 24, 2023 · IPR2022-01608 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–16, 19–21, and 23–25 were unpatentable on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“step of reacting a sugar with bromine occurs “in a solution at a pH between 7.0 and 9.0.” Ex. 1001, 16:46–47. A dispositive question arises, on this record, as to whether Petitioner’s information, directed to this pH range limitation, is sufficient to support institution of review. For reasons that follow, we determine that Petitioner’s information is not sufficient and deny the Petition on that basis.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“and 12 and that Stoll suggests a pH range of 7 or greater. Pet. 29–30 and n.7, 39. Those prior art pH ranges overlap or encompass the specified pH range of “between 7.0 and 9.0.” Pet. 38–39 and n.10. Under these circumstances, the burden of production shifts to Patent Owner to come forward with evidence of the criticality of the specified pH range limitation. See id. at 39–40 (quoting E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1008 (Fed. Cir. 2018). Patent Owner meets that burden by directing us to the Marchi Declaration. Resp. 9–12; Ex. 1004, 432–440. That evidence contains experimental results that support Dr. Marchi’s opinion that the claimed method, when performed at a pH of 8, “can be run with equimolar amounts of oxidant without increasing depolymerization,” but when performed at a pH of 10, results in an undesirable “depolymerizing attack on the main chain, even employing only 0.9 equivalents of oxidant.” Ex. 1004, 434–435 (¶ 7). As Patent Owner points out, moreover, the oxidation reaction in each of the examples in Geisser is carried out at a pH of 10. see Prelim. Resp. 26 and n.8 (citing Ex. 1006, Examples 1–8).” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We assess the ground based on anticipation by Geisser in view of the principle that a prior art reference anticipates a patent claim “if it discloses every claim limitation.” In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). The ground based on anticipation by Geisser rests on a conclusory opinion that Geisser’s disclosure of a pH range between 8 and 12 “describes” an oxidation reaction that occurs “at a pH between 7.0 and 9.0.” Pet. 63 (citing Ex. 1002 ¶ 178, which repeats that conclusory opinion verbatim without objective evidence or analysis). It is unclear on this record, and Petitioner does not explain adequately, how or why Geisser anticipates the pH range limitation of claim 1, which is “critical” for reasons explained above in our analysis of the ground based on obviousness over Geisser and Stoll. Ex. 1004, 435 (the Marchi Declaration, ¶ 7). Accordingly, on this record, we determine that Petitioner does not establish a reasonable likelihood of prevailing “with respect to at least [one] of the claims” based on any ground asserted in the Petition. 35 U.S.C. § 314(a).” slip op. at 13
- Skill levelSkill level petitioner adoptedOther
“Petitioner proposes that an ordinarily skilled artisan “would hold an advanced degree, such as an M.S. or doctorate, in chemistry, medicine, pharmacy, or a related degree,” as well as post-graduate experience “in areas of carbohydrate chemistry, synthetic chemistry, medicinal chemistry, inorganic chemistry, and/or metal carbohydrate complexes, or the clinical use of such complexes.” Pet. 16. Patent Owner does not contest Petitioner’s proposed definition in the Preliminary Response. Prelim. Resp. 17–18. Based on the information presented, we find that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect the appropriate level of ordinary skill in the art). To the extent a more precise definition is required, we apply Petitioner’s unopposed proposed definition for purposes of determining whether to institute review because it is consistent with the disclosures of the asserted prior art references.” slip op. at 7
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,759,320 - PTAB · Apr 19, 2023 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted review on all challenged claims and the sole anticipation ground: claims 1–4, 8–14, and 18–26, with a reasonable likelihood of unpatentability except claim 19.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denialInstitutedDenied
“This case differs from other situations where the Board has exercised discretion under § 314(a) to deny institution. For example, we are not presented with a later-filed petition after having considered an earlier-filed petition challenging the same patent. See, e.g., General Plastic Indus. Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19, 6–11, 15–22 (PTAB Sept. 6, 2017) (precedential)). This is the first petition filed against this patent and contains only a single ground. Also, as Petitioner asserts, and Patent Owner does not contest, the Fintiv factors are neutral or favor institution. See Pet. 61–63. Instead, Patent Owner asks us to deny institution because Petitioner” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 6 and 35 U.S.C. § 314, which provides that an 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.” A decision to institute under § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). In addition, if the Board institutes trial, it will “institute on all grounds in the petition.” PTAB Consolidated Trial Practice Guide, 5–6 (Nov. 2019); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Having considered the arguments and evidence presented in the Petition and the Preliminary Response, for the reasons described below, we institute inter partes review.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts A person of ordinary skill in the art (“POSA”) in the field of the patent between 2012 and 2021 would have held an MD with experience in clinical oncology or pharmacology; a PhD in pharmacology, pharmaceutical chemistry, cancer biology, or a related discipline; or a PharmD with experience in clinical oncology. Ex. 1020 ¶ 29. A POSA would also have practical working knowledge of oncology (Ex. 1020 ¶ 29) and experience with the design of studies necessary for drug development. This description is approximate, and additional experience could make up for less education and vice versa. Ex. 1020 ¶ 29. Pet. 15–16. Patent Owner asserts “that a POSA for purposes of the ’087 Patent would have had at least an M.D. and several years of experience treating patients with hematological malignancies (i.e., blood cancers).” Prelim. Resp. 13. Patent Owner asserts “Petitioner’s definition fails to require experience specific to hematological malignancies or blood cancers. Patent Owners’ definition of a POSA, on the other hand, accounts for the claims’ focus on lymphoma and leukemia.” Id. at 14. At this stage in the proceeding, we find that Patent Owner’s analysis more precisely establishes the level of ordinary skill in the art as it directly relates to those deciding prescribing information based on the prior art reference. See Ex. 1011, 2. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 5
- Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateNot entitled to earlier dateMixed
“reasonable likelihood that claims 1 and 9 are not entitled benefit of priority to the ’087 or earlier priority Specifications prior to the publication of the November 2018 Venclexta label. Claim 1, for example, recites a GDC-0199 dosing regimen “compris[ing] a dose of 100 mg of GDC-0199 per day, followed by orally administering to the patient a dose of 200 mg of GDC- 0199 per day, followed by orally administering to the patient a dose of 400 mg of GDC-0199 per day.” This disclosure is not found in a single example, but must be selected from disparate parts of the Specification. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 4 (Fed Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 22
§ 102 anticipation§ 112 disclosureDiscretionary denialPatents in suitUS 11,110,087
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.