- Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Rehearing grantedPTAB · Aug 10, 2023 · PGR2022-00023 · APJ Jeffrey N Fredman · PGR · Rehearing
On Patent Owner’s rehearing request, the Board held claim 25 unpatentable under § 112(a) because it depends from claim 14, which lacks written description support.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“We therefore agree with Petitioner that we overlooked the correct dependency of claim 25. Claim 25, as a claim dependent from claim 14, lacks written descriptive support because claim 25 fails to cure the absence of descriptive support for claim 14.” slip op. at 4
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“In the Final Written Decision, we determined that claim 14 lacked descriptive support. We noted that Claim 14, in particular, recites a GDC-0199 dosing regimen “compris[ing] a dose of 20 mg per day for one week, a dose of 50 mg per day for one week, a dose of 100 mg per day for one week, a dose of 200 mg of GDC-0199 per day for one week, and a dose of 400 mg per day.” Unlike for claim 1, such disclosure is not found in a single example, but results from picking and choosing three separate selections from column 24. “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 3
§ 112 disclosurePatents in suitUS 10,993,942 - PTAB · Feb 14, 2023 · PGR2021-00030 · APJ Christopher M Kaiser · PGR · Rehearing
The Board granted Petitioner’s third rehearing request and instituted PGR of claims 1–5, 9, and 10, finding the petition presented compelling evidence of unpatentability.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“The Guidance Memo defines “[c]ompelling, meritorious challenges” as “those in which the evidence, if unrebutted in trial, would plainly lead to a conclusion that one or more claims are unpatentable by a preponderance of the evidence.” Guidance Memo 4. The phrase “plainly lead to a conclusion that one or more claims are unpatentable” was further clarified in the Director’s precedential decision in OpenSky Industries, LLC v. VLSI Technology, LLC, as only satisfied when “it is highly likely that the petitioner would prevail with respect to at least one challenged claim.” IPR2021-01064, Paper 102 at 49–50 (PTAB Oct. 3, 2022) (Decision by the Director) (precedential). Thus, a compelling challenge is one “in which the 8 evidence, if unrebutted in trial, would” render it “highly likely that the petitioner would” show “that one or more claims are unpatentable by a preponderance of the evidence.” Id.; Guidance Memo 4.” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitutedInstituted
“one claim is unpatentable and that one of Petitioner’s challenges presents strong merits—are sufficient to show that the likelihood of Petitioner’s success at trial falls within the uncertain bounds of “highly likely.”5 Accordingly, we determine that the Petition “presents compelling evidence of unpatentability” as that phrase is defined in the Guidance Memo and the OpenSky decision. For this reason, we erred by “discretionarily deny[ing] institution in view of [the] parallel district court [proceeding].” Guidance Memo 2. We grant Petitioner’s request for rehearing and do not exercise discretion to deny institution. We acknowledge that instituting review in this proceeding when the district court already has reached its result requires the parties to duplicate the efforts they have put into the district court proceeding and requires us to duplicate the efforts of the district court and its jury. We are not insensitive to the fact that such a situation “can increase, rather than limit, litigation costs,” contrary to what “Congress designed the America Invents Act (AIA) 5 Our determination that Petitioner is “highly likely” to succeed in proving at least one claim unpatentable on at least one ground should not be understood to mean that we have prejudged the outcome of the trial. In particular, under OpenSky and the Guidance Memo, a compelling challenge is one “in which the evidence, if unrebutted in trial, would” render it “highly likely that the petitioner would” show “that one or more claims are unpatentable by a preponderance of the evidence.” OpenSky, IPR2021-01064, Paper 102 at 49–50; Guidance Memo 4. Thus, in making our compelling-challenge determination, we are not permitted to consider any rebuttal evidence that has been entered, let alone any rebuttal evidence that may be entered during the trial. Our final determination will not be so limited and will be made based upon the full arguments and evidence developed during the trial. 11 post-grant proceedings” to accomplish. Guidance Memo 1. But the Guidance Memo is unequivocal: “the PTAB will not rely on the Fintiv factors to discretionarily deny institution in view of parallel district court litigation where a petition presents compelling evidence of unpatentability.” Id. at 2. In the absence of such discretionary denial, we institute trial for the reasons discussed in the Institution Decision. Inst. Dec. 16–41.” slip op. at 11
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“likely” one, are not entirely clear, and this case likely falls somewhere near that boundary. We note first that the standard for instituting trial in a post-grant review requires a showing that “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.” 35 U.S.C. § 324(a). We previously held that this standard had been met in the present case. Inst. Dec. 3. In particular, we determined that Petitioner had made the necessary “threshold showing” as to its arguments that (1) “the claimed subject matter [was] not enabled for the full scope as claimed,” and (2) “Ogitani anticipates at least one of the challenged claims.” Id. at 26, 40. Moreover, “[w]e previously described ‘Petitioner’s argument that the claims lack enablement’ as presenting ‘strong merits.’” Second Denial Dec. 6 (quoting Inst. Dec. 3). slip op. at 9
Discretionary denialPatents in suitUS 10,808,039 - PTAB · Jul 15, 2022 · PGR2021-00030 · APJ Sheridan K Snedden · PGR · Rehearing
Patent Owner’s rehearing request was granted, and institution was denied for all challenged claims based on changed circumstances in the parallel district court proceeding under Fintiv.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“Having considered the parties’ positions and evidence of record, summarized above, we agree with Patent Owner that a rehearing of our prior institution decision is appropriate due to the changed circumstances of: (1) the statutory disclaimer of claims 6–8 of the ’039 patent, (2) Patent Owner’s request for adverse judgment of related proceeding PGR2021-00042, and (3) the additional investment in the parallel proceeding by the district court and the parties, including the completion of a jury trial that resulted in a jury verdict not finding invalidity of the challenged claims. We further agree with Patent Owner that “[c]ontinuing with this proceeding would result in duplicative efforts and potentially conflicting results between the district court and the Board.” Reh’g Req. 9. It is the combination of these changed circumstances, rather than any one of them individually, that compels the result we reach.” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“In considering the parties’ positions and the evidence of record, we note that we have been instructed not to exercise discretion to deny a petition when “the information presented at the institution stage presents a compelling unpatentability challenge.” Guidance Memo 4–5. We previously described “Petitioner’s argument that the claims lack enablement” as presenting “strong merits.” Paper 17, 3. Despite that determination, we believe the record as it stands currently does not “present[] a compelling unpatentability challenge” on the lack-of-enablement issue. Guidance Memo 4–5. The district court already has substantially completed its review of the enablement issue, and a jury has determined that the claims do not lack enablement. Given this new information, we cannot conclude that Petitioner’s enablement case is compelling.” slip op. at 6
- Adverse judgmentOther
Discretionary denialPatents in suitUS 10,808,039 - 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 LLCRehearing grantedPTAB · Nov 10, 2020 · PGR2018-00092 · APJ Sheridan K Snedden · PGR · Rehearing
The Board granted the petitioner’s rehearing request, vacated the final written decision, and will issue a revised decision after overlooking Varenna 2012 in Grounds 5–7.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must (1) “specifically identify all matters the party believes the Board misapprehended or overlooked” and (2) identify the place “where each matter was previously addressed.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768.” slip op. at 2
NonePatents in suitUS 9,820,999 - Dispersive Networks, Inc. v. Nicira, Inc.Rehearing grantedPTAB · Jul 17, 2019 · PGR2018-00063 · APJ Debra K Stephens · PGR · Rehearing
Patent Owner’s rehearing request was granted as to claim 7, which was removed from institution under § 112(b); institution on claims 1–6 and 8–11 remained unchanged.
RulingsRehearing decision- RehearingRehearing, grantedRehearing, deniedGranted in part
“We agree. We erroneously instituted review of claim 7 under 35 U.S.C. § 112(b). We modify our Decision to the extent that we do not institute on claim 7 under 35 U.S.C. § 112(b). That is, we institute a post-grant review of claims 1–6 and 8–11 of the ’815 Patent on the challenge that these claims are indefinite and unpatentable under 35 U.S.C. § 112(b).” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We agree. We erroneously instituted review of claim 7 under 35 U.S.C. § 112(b). We modify our Decision to the extent that we do not institute on claim 7 under 35 U.S.C. § 112(b). That is, we institute a post-grant review of claims 1–6 and 8–11 of the ’815 Patent on the challenge that these claims are indefinite and unpatentable under 35 U.S.C. § 112(b).” slip op. at 10
NonePatents in suitUS 9,722,815 - David’S Bridal, Inc. v. Jenny Yoo Collection, Inc.Rehearing grantedPTAB · Jun 15, 2017 · PGR2016-00041 · APJ Jennifer S Bisk · PGR · Rehearing
Rehearing was granted to consider David’s Bridal’s acquiescence argument but otherwise denied; institution of review of the patent’s sole claim remained denied.
RulingsRehearing decision- RehearingRehearing, grantedRehearing, deniedGranted in part
“DISCUSSION The applicable standard for granting a request for rehearing is abuse of discretion. The requirements are set forth in 37 C.F.R. § 42.71(d), which provides in relevant part: A party dissatisfied with a decision may file a single request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. Petitioner argues that the Board: (1) “misapprehended and overlooked” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“SUMMARY Petitioner, David’s Bridal, Inc., requests rehearing of the Board’s decision (Paper 11) (“Institution Decision”), entered February 22, 2017, denying institution of inter partes review of the sole claim of U.S. Patent D744,723 (Ex. 1002) (“the ’723 patent”). Paper 12 (“Reh’g Req.”). For the reasons that follow, Petitioner’s request is granted to the extent that we address Petitioner’s “acquiescence argument,” but denied in all other respects.” slip op. at 2
None
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.