- PTAB · Apr 7, 2022 · PGR2021-00042 · APJ Sheridan K Snedden · PGR · Rehearing
The Board granted rehearing, reversed its discretionary denial, and instituted PGR on claims 6–8 based on the threshold showing of likely lack of enablement and anticipation.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“We agree with Petitioner that a rehearing of our prior decision to deny institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“35 U.S.C. § 324(a) provides that a post-grant review may not be instituted “unless the Director determines 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.” After considering the Petition and the Preliminary Response, and the evidence cited therein, we determine that Petitioner has shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. Therefore, we grant institution of a post-grant review.” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“For purposes of this Decision, we accept Petitioner’s proposed definition, which is supported by Dr. Lambert’s testimony (Ex. 1002 ¶ 20) and is consistent with the scope and content of the ’039 patent and the asserted prior art.” slip op. at 17
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,808,039 - PTAB · Apr 7, 2022 · PGR2021-00030 · APJ Sheridan K Snedden · PGR · Rehearing
Granted Petitioner’s rehearing request and instituted PGR on claims 1–5, 9, and 10 based on the more-likely-than-not enablement showing and efficiency considerations.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“3. Analysis “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366. Having considered the parties’ positions and evidence of record, summarized above, we determine that Petitioner has established that it is more likely than not that claims 1–5, 9, and 10 of the ’039 patent lack enablement. In particular, we are persuaded based on the record at this stage of the proceeding that the Specification does not enable the full scope of the claims. The Specification focuses on dolastatin/auristatin derivatives and does not describe novel ADCs having non-dolastatin/auristatin derivative drug moieties. Ex. 1001, Abstract. For example, the Specification states that “there is a clear need in the art for dolastatin/auristatin derivatives having significantly lower toxicity, yet useful therapeutic efficiency [sic]” and purports that “[t]hese and other limitations and problems of the past are addressed by the present invention.” Id. at 4:25–29 (emphasis added). Moreover, each embodiment, example, figure, and assay disclosed in the Specification appears to use a drug moiety that is a dolastatin/auristatin derivative. See, e.g., Ex. 1001, Abstract, 4:22–29, 50:56–52:30, 71:19–22, 131:23–48, Figs. 1–19, Examples 2–16. Claim 1, however, recites ADCs” slip op. at 24
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Instituted
“skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366.” slip op. at 24
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,808,039 - Grünenthal GmbH v. Antecip Bioventures II LLCAll claims unpatentablePTAB · Jul 28, 2020 · PGR2019-00026 · APJ Grace Karaffa Obermann · PGR · Final written decision
Claims 1–30 are unpatentable as obvious over Harden and one or more of Varenna 2011, Gatti, and Muratore; the written-description challenge fails.
RulingsFinal written decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“INTRODUCTION A. Background Grünenthal GmbH (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting a post-grant review of claims 1–30 of U.S. Patent No. 9,931,352 B2 (Ex. 1001, “the ’352 patent”). Antecip Bioventures II LLC (“Patent Owner”) did not file a Preliminary Response. We instituted review of all challenged claims on each of the grounds asserted in the Petition. Paper 6 (“Dec. Inst.”).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingOther
“regardless of whether the preambles are limiting. Even if the preambles are limiting, their scope is so broad as to be hardly different from no limitation at all. The specification of the ’352 patent defines “treating” as “includ[ing] any kind of treatment activity, including the diagnosis, cure, mitigation, or prevention of disease in man or other animals, or any activity that otherwise affects the structure or any function of the body of man or other animals.” Ex. 1001, 7:43–47. This definition exhibits “reasonable clarity, deliberateness, and precision” and is “‘set out . . . within the patent disclosure’ so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (quoting Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387–88 (Fed. Cir. 1992)). Accordingly, we give effect to this definition of “treating.” Under the definition of “treating” in the specification of the ’352 patent, “[a] method of treating” hyperalgesia (claim 1) or edema (claim 17) “associated with complex regional pain syndrome” means a method of diagnosing, curing, mitigating, or preventing that condition associated with complex regional pain syndrome, or otherwise affecting the structure or any function of the body of someone suffering from the condition associated with complex regional pain syndrome. To the extent that this requires carrying out the method on a patient suffering from hyperalgesia (claim 1) or edema (claim 17) associated with complex regional pain syndrome, this is already part of the method recited in the body of the claims, Ex. 1001, 90:39–43, 91:23–27, so the preambles provide no additional limitation. To the extent that the preambles require some particular result to be brought about, that result could be the diagnosis, cure, mitigation, or prevention of the symptom in question, or it could be any effect at all on the structure or any function of the patient’s body. Thus, even when construed as limiting, the preambles provide little, if any, further restriction on the scope of the challenged claims beyond that set forth in the body of the claims. Moreover, as discussed below with respect to the asserted grounds of obviousness, Petitioner directs us to evidence that the prior art teaches or suggests the subject matter of the preambles, even when those preambles are construed as limiting in accordance with the meaning of “treating” provided in the specification.8 Thus, whether or not we treat the preambles as limiting, the outcome does not change. Given this circumstance, we treat the preambles of the challenged claims as limiting, and assign them a meaning consistent with the specification’s definition of “treating.”” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Petitioner’s asserted references provides data showing that administering neridronic acid improves the symptoms of CRPS. PO Resp. 18–19. But “[o]bviousness does not require absolute predictability of success. . . . [A]ll that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903–904 (Fed. Cir. 1988). It is sufficient that Varenna 2011, Gatti, and Muratore would have informed the ordinarily skilled artisan that successful treatment of CRPS and its symptoms was likely; there is no requirement that Petitioner show that the prior art taught that success was certain.” slip op. at 15
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“qualifies as a printed publication under 35 U.S.C. § 102. PO Resp. 4–17; PO Sur-Reply 14–21. “To qualify as a printed publication, a reference ‘must have been sufficiently accessible to the public interested in the art.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989)). “A reference will be considered publicly accessible if it was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Id. (quoting Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed. Cir. 2008)) (internal quotation marks omitted). Thus, there are two ways to show that a reference was sufficiently accessible: show it was disseminated or show it was “otherwise made available to the extent that” interested people of ordinary skill in the art could have located it after exercising reasonable diligence. Id. Here, according to Petitioner, the asserted references “are articles published in periodical journals by an identified and reputable publisher.” Reply 3.11 Petitioner argues that the references were “disseminated on the[ir] stated publication date[s].” Id. at 5. We agree.” slip op. at 18
Patent outcomesUS 9,931,352 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurePatents in suitUS 9,931,352
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.