- 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 - PTAB · Nov 12, 2021 · IPR2021-00843 · APJ Jon B Tornquist · IPR · Institution
The Board instituted IPR on all grounds for claims 1–17, finding a reasonable likelihood that at least one challenged claim would be shown unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). The standard for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the parties’ arguments and evidence, and for the reasons set forth below, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one challenged claim of the ’023 patent. Accordingly, we institute an inter partes review of claims 1–17 of the ’023 patent. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- Skill levelSkill level board ownDecided for petitioner
“For purposes of this Decision, we generally accept Petitioner’s proposed definition of the person of ordinary skill in the art (or ordinarily skilled artisan), which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosures of the ’023 patent; however, we also agree with Patent Owner that such a definition should be flexible enough to include a person with a lesser academic degree and having experience working in the field, such as an engineer with clinical experience in ophthalmic surgery, as well as a medical doctor, such as an ophthalmic surgeon with experience working with medical optics and lasers. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the appropriate level of ordinary skill in the art may be reflected in “the prior art itself”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Such an expanded definition of the person of ordinary skill in the art, including aspects of both parties’ definitions, is appropriate based on our review of the record, which demonstrates individuals having a broad array of scientific degrees that collaborate as a team. We note, however, that our decision to institute trial in this proceeding would not change were we to adopt Patent Owner’s proposed definition.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“On this record, we agree with Patent Owner that the disputed preamble phrase is limiting. “[C]lear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates use of the preamble to define, in part, the claimed invention.” Catalina Mkt’g Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808–09 (Fed. Cir. 2002). Here, the Examiner expressly allowed the claims in view of the Examiner’s Amendment changing “scanning system” to “cataract surgery scanning system,” thereby transforming this portion of the preamble into a limitation. Ex. 1006, 13, 15, 18; see Catalina Mkt’g, 289 F.3d. at 808. Furthermore, contrary to Petitioner’s arguments, the record appears to suggest that there are structural differences between the optical systems of cataract surgery systems on the one hand and corneal surgery systems on the other. See Ex. 2006, 5:30–36; Ex. 2009, 1209–10. Thus, on this record, we are not persuaded that the language added by the Examiner represents merely an intended use for the disclosed system. In view of the foregoing, for purposes of this Decision, we construe the preamble phrase “cataract surgery scanning system” recited in independent claims 1, 8, and 12 to be limiting.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“The ’023 patent explains that a “cataract incision” is an incision created “to allow access for the lens removal instrumentation.” Ex. 1004, 10:17–19. The potential ambiguity in the claim comes, as Petitioner notes, from the fact that the cataract incision of claim 1 “only partially extend[s] through the target tissue,” which would not appear to provide immediate “access to an eye chamber of the patient’s eye.” Pet. 10; Ex. 1004, 10:19– 23, 14:15–21. Although somewhat ambiguous on its face, the prosecution history provides guidance as to how this claim phrase is to be interpreted. Phillips, 415 F.3d at 1317 (“Like the specification, the prosecution history provides evidence of how the PTO and the inventor understood the patent.”). During prosecution, the Applicants explained that the invention allows “straight cataract incisions [to be] made at the correct location,” and that partially penetrating cataract incisions are advantageous because they allow the laser delivery system to be located in an “unsterile field,” with the final penetrating incision to be made “by a physician after a patient has been moved to a sterile field.” Ex. 1006, 52–53. The Applicants then explained that despite the fact that partially penetrating cataract incisions do not fully for the lens removal instruments,” as that term is used in the ’023 patent. Id. at 52 (noting the purpose of “partially penetrating cataract incisions” is “to allow access for lens removal instruments”), 55 (“In short, none of the cited art teaches . . . to deliver the first treatment pattern to the target tissue to form partially penetrating cataract incisions – i.e. incisions that allow access for the lens removal instruments.”). The Examiner agreed with this reasoning. Id. at 15 (agreeing that the prior art did not teach or suggest partially penetrating cataract incisions that provide “access to the eye chamber of the patient’s eye”). Given these disclosures, we agree with Patent Owner that “provides access to an eye chamber of the patient’s eye” in claim 1 means that the partial incision is a starting incision, made in the appropriate shape and location, that allows complete access for lens removal instrumentation when completed, for example, by the surgeon. In view of the foregoing, we construe the claim phrase “cataract incision therein that provides access to an eye chamber of the patient’s eye, the incision . . . only partially extending through the target tissue” to require “a partially penetrating cataract incision that, when completed by the” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,233,023
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.