- PTAB · Aug 17, 2023 · PGR2023-00020 · APJ Jeffrey N Fredman · PGR · Institution
Instituted PGR on claims 22 and 25–31; the Board found a reasonable likelihood of success on anticipation over Zhang and obviousness grounds for claim 22.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Feb. 13, 2020) (“Advanced Bionics”) (precedential), we further apply the following two-step framework in determining whether discretionary denial under § 325(d) is appropriate: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Becton, Dickinson Factors (a), (b), and (d) relate to the first step, and Becton, Dickinson Factors (c), (e), and (f) relate to the second step. Id. Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated error. Advanced Bionics, at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise [her] discretion not to institute inter partes review.” Id. at 8–9 (“If a condition in the first part of the framework [i.e., substantially same art or arguments] is satisfied and the petitioner fails to make a showing of material error, the Director generally will exercise discretion not to institute inter partes review.”). “At bottom, this [§ 325(d)] framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9. An “example of a material error” could be “misapprehending or overlooking specific teachings of the relevant prior art where those teachings impact patentability of the challenged claims.” Id. at 8 n.9” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . 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(a) (2018). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, and the evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 22 and 25–31 of the ’817 patent.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“We find that on the present record, the evidence more likely than not supports Petitioner’s claim interpretation which is based on the express definition of the term “patient” in the ’817 patent specification. That express definition states: “‘Patient’ and ‘subject’ are used interchangeably herein and include, but not limited to, primates such as humans, canines, porcine, ungulates, rodents, poultry, and avian.” Ex. 1001, 32:65–67.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundInstituted
“We appreciate Patent Owner’s point that for a reference to anticipate without disclosing the relevant feature of the claimed invention, it is required that the “missing characteristic is necessarily present . . . in the single anticipating reference.” Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003). In this case, Zhang demonstrates that ganaxolone continues to improve status epilepticus in rats for 5+ hours, supporting the inherency position. Moreover, the ’817 patent’s Specification shows that 10 and 20 mg/kg ganaxolone doses that bracket the 12 and 15 mg/kg ganaxolone doses tested by Zhang, result in improved 24-hour survival relative to lower doses. See Ex. 1001, Fig. 4; Ex. 1009, 21 ¶ 117. This evidence further supports Petitioner’s inherency position because it shows that doses bracketing those recited in Zhang provide continued improvement to patients for periods exceeding 8 hours. “Extrinsic evidence can be used to demonstrate what is ‘necessarily present’ in a prior art embodiment even if the extrinsic evidence is not itself prior art.” Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329 (Fed. Cir. 2020). As to the issue of whether Zhang’s teaching to treat with multiple doses also teaches “improvement to the patient after administration for more than 8 hours” as required by claim 22, on this record we find that Petitioner’s position is more persuasive. Claim 22 does not distinguish between a single administration event or multiple administrations, and therefore is reasonably interpreted as broadly open to both single administration and multiple administrations. This understanding is consistent with the ’817 patent, which teaches that “[g]anaxolone or a pharmaceutically acceptable salt thereof can be administered, e.g., once daily, twice daily, three times daily, or four times daily.” Ex. 1001, 8:35–37. Zhang teaches “[d]osing schedules in which the substituted β-cyclodextrin-ganaxolone injectable formulation is injected every 1 hr, 2 hrs, 4 hrs, 6 hrs, 8 hrs, 12 hrs, or 24 hours are included herein.” Ex. 1009, 13 ¶ 74. We agree with Petitioner that, on this record, Zhang directly demonstrates that where doses are administered every 1, 2, or 4 hours, the ganaxolone would have been expected to necessarily result in improvement in status epilepticus treatment over more than 8 hours based on the five hour efficacy results reported in Zhang. See Ex. 1009, 25 ¶ 135.9” slip op. at 27
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 11,395,817 - PTAB · Feb 8, 2022 · PGR2021-00102 · APJ Patrick R Scanlon · PGR · Institution
The Board instituted PGR on claims 1–28 on all asserted grounds, finding a sufficient likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 324(a), a post-grant review may not be instituted “unless . . . the information presented in the petition . . . , 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.” After considering the Petition and Patent Owner’s Preliminary Response, as well as all supporting evidence, we determine that Petitioner has satisfied the burden under 35 U.S.C. § 324(a) to show that it is more likely than not that at least one of the challenged claims is unpatentable.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“These arguments are not persuasive, however, because Patent Owner does not explain adequately how the disclosures of Oehring and Shampine are cumulative of the disclosure of Mu. In this case, the mere fact that 8 We note that Exhibit 2007 does not have ¶ 95 cited by Patent Owner. not mean necessarily that the references are cumulative of Mu. For instance, Petitioner relies on Mu for allegedly disclosing several claim limitations including “receiving a demand hydraulic horse power (HHP) signal,” “the first output power being in a selected range of a maximum continuous power (MCP) level,” and “the second output power . . . being in a selected range of the MCP level to a maximum intermittent power (MIP) level.” Pet. 19–41. Patent Owner does not direct us to any disclosure in Oehring or Shampine that are cumulative of these alleged teachings in Mu. Accordingly, we do not agree with Patent Owner that either of Oehring or Shampine is cumulative of Mu. As such, we determine that Petitioner’s reliance on Mu does not involve the same or substantially the same art or arguments previously presented to the Office, and the first part of the Advanced Bionics framework is not satisfied with respect to Mu. And although Crowe is cited in the ’459 patent (see Ex. 1001, code (56)), Petitioner’s reliance on Crowe is minimal. The ground based on Mu and Crowe, thus, does not implicate § 325(d).” slip op. at 8
- Skill levelOther
“This dispute presents a factual issue best decided on a complete record. Accordingly, for purposes of the Decision, we determine that no express finding is necessary, and that the level of ordinary skill in the art is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). We note, however, that our obviousness analysis in this Decision would not differ if we adopted either Petitioner’s or Patent Owner’s definition.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionTerm construed board ownOther
“We agree with Patent Owner that Petitioner has not explained sufficiently what a “maximum power output value” means in the context of the ’459 patent. Nor has Petitioner explained sufficiently why “maximum intermittent power” should be tied to the “maximum power output value.” In contrast, Patent Owner’s proposed construction is supported by the Specification, although we do not agree with the last clause of the construction because the references to “typical” values do not assist in understanding the claim language. Accordingly, for purposes of this Decision, we preliminarily construe “maximum intermittent power” to mean “an elevated operating output level that the pump unit may operate intermittently throughout its operating life without excessive damage to the pump unit.”” slip op. at 14
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · Graham · NautilusPatents in suitUS 10,907,459
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.