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  • PTAB · Feb 6, 2023 · PGR2021-00103 · APJ Patrick R Scanlon · PGR · Final written decision

    Claims 1–28 were not shown unpatentable on any asserted ground; the Board found the prior art failed to establish key limitations and rejected the enablement and indefiniteness challenges.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “In reply, Petitioner argues that the ’764 patent’s control system is not complex as there are no detailed algorithms, logic, or software. Pet. Reply 4. Instead, the control system merely raises or lowers power of the pumps in accordance with the demand HHP of the job design. Id. (citing Ex. 1036, 97:15–98:18, 98:21–99:25, 100:1–101:25, 102:2–7, 115:4–9, 115:24–116:4, 116:17–22; Ex. 1001, 5:2–6, 6:36–7:7, 10:4–64). According to Petitioner, this “rudimentary control concept” does not necessitate the higher skill level proposed by Patent Owner. Id. Petitioner further notes that Dr. Adnan testifies that “a mechanical engineer who has worked in the industry developing programming and control systems could fall within this definition,” and the person of ordinary skill in the art “is ‘just a specifier.’” Id. (quoting Ex. 2003 ¶ 22; Ex. 1036, 161:21–164:18). Based on our review of the record before us, particularly the ’764 patent’s description and Dr. Adnan’s testimony, we agree with Petitioner that the ordinary level of skill in the art does not require the high level of specialized knowledge of control systems suggested by Patent Owner. Moreover, we find that Petitioner’s stated level of ordinary skill in the art is reasonable because it is consistent with the evidence of record, including the asserted prior art. Accordingly, for the purposes of this Decision, we apply Petitioner’s definition, although our conclusions with respect to obviousness would be the same if we were to apply Patent Owner’s definition.” slip op. at 9

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “Based on the full record, we are not persuaded that Mr. Marscher is unqualified to serve as an expert in this proceeding. As noted above, a person of ordinary skill in the art is not required to have been a fracturing operator. Patent Owner’s proposed definition does not even require experience as a fracturing operator. See PO Resp. 20–21. Furthermore, Mr. Marscher testifies that he has extensive experience developing pumps for fracturing applications. Ex. 2027, 6:24–8:7. Mr. Marscher also testifies that he has experience with control systems relating to pumps and pumps units. Id. at 212:19–23. This testimony, as well as his declaration and curriculum vitae, show that Mr. Marscher has extensive education and experience in relevant fields. Ex. 1003 ¶¶ 8–17; Ex. 1004. Accordingly, we are not persuaded that Mr. Marscher’s qualifications or experience provide reason to discount the weight associated with Mr. Marscher’s testimony.” slip op. at 10

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

      “In its Reply, Petitioner argues that the maximum power output value is the pump unit’s highest HHP output and one of ordinary skill in the art would have understood this value is the pump unit’s output power in intermittent duty. Pet. Reply 2–3 (citing Ex. 1003 ¶¶ 71–72, 123–124; Pet. 9–10; Ex. 1036, 64:17–67:13, 119:17–120:11, 124:7–24, 198:9–200:9, 221:8–222:15). However, even if Petitioner is correct that the “maximum power output value” is near or equivalent to a pump unit’s output power in intermittent duty, we are still not persuaded that the term “maximum intermittent power” should be tied to the “maximum power output value,” in conflict with the definition provided in the Specification. Petitioner also argues that Patent Owner’s proposed construction is indefinite. Pet. Reply 3. For the reasons discussed below (see supra § II.I.1), we determine that Petitioner has not shown by a preponderance of the evidence that the term “maximum intermittent power,” as defined in the Specification, is indefinite. Thus, based on the complete record before us, we maintain our prior construction of “maximum intermittent power” for this Final Written Decision.” slip op. at 13

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

      “3. Additional Terms We determine that we need not expressly construe any other claim terms to resolve the parties’ disputes because doing so would have no effect on the analysis below. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 13

    Patent outcomesUS 10,815,764 not shown unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 10,815,764
  • PTAB · Nov 18, 2020 · PGR2019-00048 · APJ David Cotta · PGR · Final written decision

    Claims 1–13 were not shown unpatentable because the prior art did not establish a reasonable expectation that doses above 300 mg/day of mifepristone could be safely co-administered with a strong CYP3A inhibitor.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “The definition of a POSA that best incorporates both experience with drug-drug interaction and experience treating patients is Petitioner’s proposed multidisciplinary team. Patent Owner does not object to defining the POSA as part of a multidisciplinary team, so long as that team includes a person with experience treating Cushing’s syndrome, which, as discussed above, is appropriate. Tr. 38. Accordingly, we define the POSA as: a multidisciplinary team that includes researchers and clinicians in the field and is able to draw upon not only the individual skills of each team member, but also the specialized skills of others to solve a given problem. The 6 Claim 5 and its dependents are directed to “[a] method of treating symptoms associated with elevated cortisol levels.” Cushing’s syndrome is “caused by excess levels of cortisol.” Ex. 1001, 1:31–33. Accordingly, claim 5 relates to Cushing’s syndrome even if it does not specifically recite that the patient has Cushing’s syndrome. All of the other claims expressly recite Cushing’s syndrome. researchers and clinicians would have an M.D., a Pharm. D., and/or a Ph.D. in pharmacology or a related discipline. The clinician would have at least four years of experience treating patients with Cushing’s syndrome using mifepristone and/or CYP3A inhibitors. The researcher would have at least four years of experience studying drug-drug interactions involving CYP3A inhibitors.” slip op. at 8

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

      “Further, if we were to consider Petitioner’s new argument, we would find that the claims do require safety, as entirely consistent with what both parties unmistakably understood, as evidenced by their patentability arguments throughout the proceeding (until Petitioner’s new argument in its Reply). In this regard, we note that the preambles in the independent claims at issue, i.e., in claims 1, 5, and 10, are necessarily limiting and we consider the scope of the challenged claims as a whole, including preambles, in our patentability analysis. The preamble in claim 1, for example, recites a “method of treating Cushing’s syndrome in a patient who is taking an original once-daily dose of 1200 mg or 900 mg per day of mifepristone.” Ex. 1001, 68:2–16. Claims 5 and 10 contain similar language relating to a patient taking an “original once-daily dose” of 1200 mg or 900 mg per day of mifepristone, although claim 5 is directed to a “method of treating symptoms associated with elevated cortisol levels,” and claim 10 is directed” slip op. at 19

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

      “In addition, when considering the recited methods of treatment (or controlling hyperglycemia) in a patient in the context of the specification, we interpret the recited methods to require administration of drugs in a manner that is safe for a patient. The summary section in the specification of the ’214 patent, for example, states that: concomitant administration of a CYP3A inhibitor such as ketoconazole and a GRM such as mifepristone is believed to be safe for the subject, and to provide the therapeutic benefits of both drugs to the subject, and may allow the reduction in the amount of a GRM, or of a CYP3A inhibitor, administered to the subject; such reduction may reduce the risk of toxic effects of the CYP3A inhibitor concomitantly administered with the GRM. Ex. 1001, 3:50–58 (emphasis added); see id. at 4:4–21. That disclosure, along with many other statements in the specification, clarify that safety and efficiency are important aspects of the recited methods, especially in relation to toxic effects that might preclude treatment in patients. See also id. at 13:1–3 (stating “Applicant discloses herein methods for the safe concomitant administration of both a glucocorticoid receptor modulator (GRM) and steroidogenesis inhibitor to a subject.”), 13:10–23 (same).” slip op. at 20

    • Strike new argumentNew argument disregardedDecided for patent owner

      “Our regulations require the Petition to identify “[h]ow the challenged claim is to be construed” and “[h]ow the construed claim is unpatentable.” 37 C.F.R. § 42.104(b)(3),(4). A reply is not an opportunity to start anew, to fill in gaps or to remedy omissions in a petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1357 (2018) (explaining that “petitioner’s contentions [in a petition] ... define the scope of the litigation all the way from institution through to conclusion.”); see also Patent Trial and Appeal Board Consolidated Trial Practice Guide 73 (Nov. 2019), https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf. We therefore decline to consider Petitioner’s belatedly presented new argument in its Reply that the claims do not require safety. See Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 775 (Fed. Cir. 2018) (concluding that the Board did not abuse its discretion in refusing to consider portions of a reply declaration “rais[ing] a new obviousness argument for [a claim] limitation that could have been made in the petition” but was not); Intelligent Bio-Sys., 821 F.3d at 1369–70 (concluding that the Board did not abuse its discretion in refusing to consider reply brief arguments advocating a “new theory” of unpatentability under 37 C.F.R. § 42.23(b)). Even if we were to consider Petitioner’s new argument regarding claim construction, we would not find it persuasive because Petitioner’s obviousness rationale incorporates an expectation of safety. Irrespective of whether the claims require safety, Petitioner cannot carry its burden to establish that the claimed methods would have been obviousness without establishing that – as posited in the Petition – the POSA would have expected co-administration to be safe.” slip op. at 18

    Patent outcomesUS 10,195,214 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips
    Patents in suitUS 10,195,214
  • PTAB · Oct 10, 2018 · PGR2017-00015 · APJ Kevin W Cherry · PGR · Final written decision

    The Board held claims 1–4 not unpatentable: the obviousness grounds failed to establish the claimed elastic fastener limitation, and claim 3 was not shown indefinite or lacking written-description support.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “We agree with Petitioner and determine that a POSA would have been a person having a general knowledge about, and experience with, expandable containers, including, without limitation, balloons, and at least an associate’s degree in mechanical engineering, or the equivalent. This level of skill is consistent with the types of problems and solutions described in the ’612 patent and cited prior art. For example, the ’612 patent describes a fluid inflatable system that uses elastic valve 20A (e.g., mechanical gasket, O-ring, etc.) for sealing fluid inside multiple containers (e.g., water balloons). See Ex. 1001, 1:22–24, 3:10–16. In any event, none of the issues in this case turn on the definition of a POSA, and the prior art of record provides ample evidence of the level of skill in the art. See In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (finding that the Board of Patent Appeals and Interferences did not err in concluding that the level of ordinary skill was best determined by the references of record); see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he 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”’) (internal citation omitted).” slip op. at 13

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

      “1. Terms Construed in the Institution Decision We construed the term “elastic fastener” in our Decision on Institution, which is set forth in the following table. Inst. Dec. 14. Claim Term Construction in Institution Decision elastic fastener “an elastic element for attaching things together” Neither party disputes the language of this construction. See generally Prelim Resp. 17; Reply. We adopt them for this Final Written Decision. See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1080 (Fed. Cir. 2015) (quoting Rodale Press, Inc. v. FTC, 407 F.2d 1252, 1256–57 (D.C. Cir. 1968)) (“‘an agency may not change theories in midstream without giving respondents reasonable notice of the change’ and ‘the opportunity to present argument under the new theory.’”)” slip op. at 14

    • Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteNot shown unpatentable

      “While the terms “unfilled state” and “filled state” describe the fullness for a container, we do not agree with Petitioner that the claim language requires determining the precise amount of fluid for each state. Section 112(b) requires that we read claim terms in the context of the surrounding claim language, not in isolation. Telebrands, 733 F. App’x at 1020. When we look at the entire claim phrase—“regardless whether the first and second ones of the plurality of containers are in a filled state or an unfilled state”— the plain language is clear that regardless of whether the balloons are in either state, the “at least first and second ones of the plurality of containers are disposed sufficiently close to each other such that they press against each other.” In other words, the exact volume of fluid or water needed to reach a “filled state” does not need to be determined in order to understand the metes and bounds of the claim so as to understand how to avoid infringement. We are further persuaded because this is consistent with the district court’s construction of this term. See Ex. 1023, 19–20.” slip op. at 17

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

      “Based upon our review of the specification, and consideration of the arguments and evidence presented, Petitioner’s position is not persuasive. We agree with Patent Owner that Petitioner has failed to show that the ’612 patent does not provide such adequate guidance to a person of ordinary skill in the art. On its face, Figure 1 of the ’612 patent (reproduced below) shows containers 18 in contact or pressing against one another with the reasonable clarity required by Vas–Cath Inc. Figure 1 of the ’612 patent is reproduced above. Although the ’612 patent describes, as Petitioner notes, that tubes 16 can be different lengths, we are not persuaded that the ’612 patent’s disclosure of an embodiment with different tube lengths detracts from the concurrent disclosure in Figure 1 of an embodiment, where it is difficult to describe containers 18 as being not in contact with each other. Additionally, we agree with Patent Owner that Petitioner has failed to show adequately that a person of ordinary skill would not have understood the ’612 patent as describing the containers in Figure 1 as pressing against one another in an unfilled state. The ’612 patent indicates Figure 1 shows elastic valve 20A in an open configuration when container 18A is attached to tube 16A to allow container 18A to fill with fluid. Ex. 1001, 3:14–18. In this open configuration, container 18A is to be filled with fluid, after which, “it may be removed from tube 16A, whereupon elastic valve 20A closes, thereby closing the neck of container 18A and sealing the fluid inside.” Id. at 3:18–21 (emphasis omitted). The ’612 patent refers to Figure 1 to describe an embodiment where elastic valve 20A is in an open configuration to fill a container that has not been filled (i.e., unfilled) and removed from tube 16A. Thus, we are persuaded that, at least, Figure 1 and this accompanying description of Figure 1 in the ’612 patent provides sufficient written description for the recited limitation that “at least first and second ones of the plurality of containers are disposed sufficiently close to each other such that they press against each other . . . in a filled state or an unfilled state.”” slip op. at 21

    Patent outcomesUS 9,527,612 not shown unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites Graham
    Patents in suitUS 9,527,612

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.