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  • PTAB · Sep 9, 2022 · IPR2022-00608 · APJ Jamie T Wisz · IPR · Institution

    The Board instituted review of claims 1–21 on all four § 103 grounds, finding a reasonable likelihood that at least one challenged claim would have been obvious.

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

      “review under 35 U.S.C. § 314, which provides that an inter partes review may be instituted only upon a showing that “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). After considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of all challenged claims of the ’253 patent, based on all of the grounds identified in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); 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”).” slip op. at 2

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

      “On the current record, we do not find that the disclosure of the ’011 provisional application is sufficient to provide written description support for the limitation of “substantially prevent[ing] forward flow.” The ’253 13 patent defines forward flow as “an amount of liquid in the lumen . . . that exits the distal end . . . in the distal direction” and “is defined as greater than 6 microliters of fluid.” Ex. 1001, 38:18–22. While Patent Owner points to disclosure from the ’011 provisional application which describes “a minimal amount of momentum transfer from the fluid column to the stuck clot to unstick the clot sufficiently” and “[t]he exiting movement of fluid [being] limited to a specific volume and/or pressure and is automatically and precisely controlled” to prevent the “possibility of overshooting,” it would not necessarily be apparent to one of ordinary skill in the art that such disclosure is referring to no greater than 6 microliters of fluid. Prelim. Resp. 31–32 (citing Ex. 1003 ¶¶ 16, 138).” slip op. at 13

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner

      “Next, we note that Patent Owner does not appear to contest that Teigen gets priority back to the December 12, 2018, filing date of the ’708 provisional application. See e.g., Prelim. Resp. 25. As discussed above, because we find on the current record that the ’253 patent is only entitled to a priority date of July 18, 2019, Teigen is 35 U.S.C. §§ 102(a)(2) and (d)(2) art to the ’253 patent regardless of whether it can receive priority to the ’804 provisional application. However, we discuss the priority date of Teigen here in order to provide guidance to the parties. The ’804 provisional application discloses pulsated aspiration in which, at times, the valve to the vacuum pump is closed and the valve to the saline injection unit is open in order to more efficiently digest a clot that is 25 large or otherwise difficult to aspirate. Ex. 1008 ¶¶ 65, 69. According to the ’804 provisional, “[s]aline pulsated aspirations provide a ‘dynamic’ aspiration force” because “[i]nstead of aspirating clots with a static (constant) vacuum force, pulsated aspiration introduces an acceleration component to the mass transfer force which can help break up larger clots so that they can better fit in the catheter lumen.” Id. ¶ 64. We agree with Patent Owner that the ’804 provisional does not specifically mention “positive pressure.” We also understand, based on the current record, that a positive pressure could result at the distal end of the catheter when the vacuum pump is turned off and the saline injection unit is open to create an influx of saline into the catheter. However, we acknowledge Patent Owner and Dr. Finol’s contentions that such positive pressure is not necessarily inherent because catheters are somewhat compliant and there are many factors that influence the magnitude of a pressure pulse caused by introducing saline into the catheter. We also acknowledge their argument that such an ambient saline flow may not inherently produce a positive pressure sufficient to overcome the mean arterial pressure. These issues will be better resolved on a complete trial record. But, for the reasons stated above and based on the present record, we treat Teigen as prior art for purposes of this Decision.” slip op. at 25

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner, relying on the testimony of Mr. Brown, contends that a person of ordinary skill in the art (“POSA” or “POSITA”) as of the relevant date would be either: (1) a person with a B.S. in engineering or an equivalent field, with two to four years of academic or industry experience in aspiration embolectomy and thrombectomy or comparable industry experience who would, where necessary or desired, work or consult with others, including a physician, to develop embolectomy or thrombectomy devices; or (2) an interventional neurosurgeon with at least three years of experience developing and/or using medical devices in embolectomy or thrombectomy procedures, and who would, where necessary, work or consult with others, including an engineer, to develop such a medical device. Pet. 16 (citing Ex. 1005 ¶ 48). Petitioner also contends that, “[a] person with less education but more relevant practical experience, or more relevant education but less practical experience, may also meet this standard.” Id. Patent Owner does not address the definition of a POSA in its Preliminary Response.2 See Prelim. Resp.” slip op. at 7

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 10,722,253
  • PTAB · Jun 15, 2022 · PGR2022-00015 · APJ Susan L C Mitchell · PGR · Institution

    Instituted PGR of claims 1–7 on all petition grounds; the Board found claims more likely than not indefinite because the claimed curcumin percentages lacked a clear measurement basis.

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

      “Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] 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; see 37 C.F.R. § 42.4. Upon considering the Petition and the cited evidence, we conclude that Petitioner has satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would comprise an individual with a Ph.D in pharmaceutical sciences, pharmaceutics, chemical engineering, or a related field, or an M.S. or B.S. degree in pharmaceutical sciences, pharmaceutics, chemical engineering, or a related field, with an additional 3–5 years of practical experience in pharmaceutical or nutraceutical product development of characterization.” Pet. 17 (citing Ex. 1019 ¶ 94 (Dr. Amiji Declaration)). Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’970 patent itself, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 8

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

      “Petitioner asserts that the term “about” in relation to the percentages of curcumin I, II, and III in claims 2 and 5 of the ’970 patent “should be given its ordinary meaning of ‘approximately’ rather than a particular numerical range.” Pet. 18. On this record, we agree with Petitioner that “about” generally means “approximately,” but how much this term numerically affects the express boundaries for ranges set forth in the claims that the term “about” modifies is not clarified by the proposed construction. See Ortho-McNeil Pharmas., Inc. v. Caraco Pharma., 476 F.3d 1321, 1326 (Fed. Cir. 2007) (“Although both parties and the district court seem to agree that the term “about” means “approximately,” the parties and the district court disagree over the numerical limits that that term imparts to the limitation “1:5” in this case.”).” slip op. at 10

    • Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteInstituted

      “We agree with Dr. Amiji’s analysis and determine, based on the present record, that Petitioner has established that it is more likely than not that claims 1–7 are indefinite. Claims 1–7 are unclear because these claims do not specify how the percentages of curcumin I, II, or III, are to be measured, but instead only provide raw percentages for each curcumin species. See Ex. 1001, 14:10–49. The Specification of the ’970 patent mentions a weight-by-volume measure for curcumin species for only Examples 6 through 8, but as Dr. Amiji testifies, these Examples are formulated as capsules with optional fillers that may be liquid including water. See id. at 13:15–19, 34–38. The remaining Examples 4 and 5 setting” slip op. at 15

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
    Patents in suitUS 10,945,970

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