- 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 - Intel Corporation v. Tela Innovations, Inc.All claims unpatentablePTAB · Mar 10, 2021 · IPR2019-01637 · APJ Kristina M Kalan · IPR · Final written decision
Claims 1–11, 15, 18, 20, and 22–24 are unpatentable as obvious over Becker and Greenway; the claims are not entitled to the earlier priority dates.
RulingsFinal written decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We instituted an inter partes review of claims 1–11, 15, 18, 20, and 22–24 of the ’335 patent on the ground of unpatentability alleged in the Petition. Paper 16 (“Dec.”). After institution of trial, Patent Owner filed a Patent Owner Response. Paper 28 (“PO Resp.”). Petitioner filed a Reply. Paper 35 (“Reply”). Patent Owner filed a Sur-Reply. Paper 38 (“Sur- Reply”). An oral hearing was held on December 9, 2020, and a transcript of the hearing is included in the record. Paper 45 (“Tr.”).” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Neither party argues that the outcome of this case would differ based on our adoption of any particular definition of one of ordinary skill in the art. On this record, we find that the differences in the parties’ contentions as to the level of ordinary skill are not consequential, in part because the levels of skill set forth by both Petitioner and Patent Owner are based on a Bachelor’s degree in Electrical Engineering and a length and type of experience that overlap. Accordingly, we adopt Patent Owner’s definition, which overlaps that set forth by Petitioner, particularly regarding a Bachelor’s degree in Electrical Engineering, with five years of experience in semiconductor layout technology and integrated circuit design, and because it is consistent with the cited prior art. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that “specific findings on the level of skill in the art . . . [are not required] ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown’” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). 37 C.F.R. § 42.100(b) (2019). Under Phillips, claim terms are afforded “their ordinary and customary meaning.” Phillips, 415 F.3d at 1312. “[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Id. at 1313. Only terms that are in controversy need to be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner notes that there are disputed claim terms in the NDCA Action—namely, the terms “gate electrode,” “gate structure(s),” and “contact structure(s)”—but asserts that Becker and Greenway render the challenged claims obvious under any of the proposed constructions. Pet. 31–32. In light of this, Petitioner states that the Board does not need to construe any claim term in order to evaluate the asserted prior art. Id. Patent Owner provides the district court’s construction of the claim terms “gate electrode,” “gate structure(s),” and “contact structure(s)” in the NDCA Action, stating that Patent Owner “applies the District Court constructions” of these claim terms. PO Resp. 21–22. Patent Owner, however, does not expressly argue for those constructions, and states that “Petitioner’s obviousness arguments fail regardless of whether any of the above claims constructions are adopted by the Board.” Id. at 22. On the full record now before us, we determine it is not necessary to construe any claim term expressly to resolve the parties’ dispute. Vivid Techs., 200 F.3d at 803; Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in an inter partes review).” slip op. at 13
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Application and 2007 Original Application, Patent Owner does not disagree that the smallest gate pitch mentioned therein is 360nm (0.36 μm). Ex. 1005, 8, 9 11; Ex. 1007, 30–31; Pet. 20; PO Resp. passim. Petitioner has reasonably established that the claimed range of less than or equal to about 193nm would extend, at its lower bound, to the single-digit nanometer range. Reply 4–5 (citing Ex. 1061, 329:10–21). The disclosures relied on by Patent Owner in the 2006 Provisional Application and the 2007 Original Application do not support the entire range of gate pitches from 193nm down to the lower bound of the single-digit nanometer range. Pet. 15, 19; compare Ex. 1005, 8, 11 (teaching a gate pitch of 360nm), Ex. 1007, 30–31 (teaching a gate pitch of 360nm) with Ex. 1008, 21–24 (requiring a gate pitch of less than or equal to about 193nm). This does not show possession of the entire range down to the single-digit nanometer range. See Lukach, 442 F.2d at 969. Regarding feature size, the smallest actual feature size mentioned in the 2006 Provisional Application and 2007 Original Application is 65nm. Ex. 1005, 5 (“65nm sized features”); Ex. 1007, 10 (“65 nm sized features”). Figure 1 of the 2006 Provisional Application, titled “Lithography Trends,” emphasizes that Patent Owner did not have possession of smaller gate pitches or feature sizes at the time of that application, but rather, that a 45nm feature size would be expected to be achieved in about 2012. Ex. 1005, Fig. 1; see Lukach, 442 F.2d at 969. We find that the disclosures of the 2006 Provisional Application and the 2007 Original Application do not show possession of the 45nm feature size. Looking next at Patent Owner’s “scalability” theory, we do not agree that the 2006 Provisional Application or 2007 Original Application would inform one of ordinary skill in the art that Patent Owner had possession of the claimed 193nm gate pitch ranges or 45nm feature sizes, or anything smaller, at the time of the 2006 Provisional Application or the 2007 Original Application. In order for Patent Owner to prevail on its argument that the 2006 Provisional Application and the 2007 Original Application support the disclosure of a sub-193nm gate pitch range or 45nm features, the disclosures of those applications must convey with reasonable clarity to one skilled in the art that the inventors possessed the invention claimed in the 2015 Application. See Ariad Pharms., 598 F.3d at 1351. We do not agree that the aspirational language in the 2006 Provisional Application demonstrates that the inventors had possession of the claimed range of gate pitches from 193nm down to the single-digit nanometer range, or possession of 45nm-sized features. Rather, the language of the 2006 Provisional Application describes a layout methodology, but fails to expressly teach scaling down to the gate pitches specified in the 2015 Application or explain to one of ordinary skill in the art how to do so. Even though “scaling” is a mathematical possibility, as argued by Patent Owner, that possibility does not equate to possession of the scaled-down structure itself. At the time of the 2006 Provisional Application and the 2007 Original Application, feature sizes were only “approaching” 45nm (Ex. 1005, 4; Ex. 1007, 3) or “expected to soon approach sizes as small as 45 nm” (Ex. 1007, 10). This language is, in effect, an acknowledgment that 45nm feature sizes were not yet a reality. Further, nothing in the 2006 Provisional Application shows how to make a 45nm feature, or how one of ordinary skill in the art could have made this happen in the 2006/2007 time frame. Similarly, Dr. Khatri’s scaling formula based on “simple geometry” that Patent Owner proposes to apply to the gate pitches and feature sizes identified in the 2006 Provisional Application is not found in that application. See generally Ex. 1005. The application’s use of “Moore’s Law as a crystal ball to predict future reductions in chip dimensions is not the same as inventing a chip with reduced chip dimensions, including reduced gate pitches down to unfathomable single-digit nanometer pitches.” Reply 6. The evidence demonstrates that scaling down feature sizes and gate pitches is not a simple function of time or a mere application of Moore’s Law, but the result of technological innovation that was not in the possession of the inventors at the time of the 2006 Provisional Application or 2007 Original Application. See Ex. 1061, 341:2–9; Ex. 1077, 1283:21–1284:3 (ITC hearing transcript). Thus, we do not agree that, by virtue of Patent Owner’s proposed “scalability” theory, the inventors conveyed with reasonable clarity to one skilled in the art that the inventors possessed the invention claimed in the 2015 Application at the time of the 2006 Provisional Application or 2007 Original Application.” slip op. at 26
Patent outcomesUS 10,141,335 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,141,335 - 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.