- 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 - 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 - Hospira, Inc. v. Genentech, Inc.Rehearing grantedPTAB · Oct 26, 2017 · IPR2017-00731 · APJ Zhenyu Yang · IPR · Rehearing
The Board granted Hospira’s rehearing request and instituted review of claims 1–14 for obviousness over Baselga ’94 and Baselga ’96.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“recites “in the absence of an anthracycline derivative.” In the Petition and the Preliminary Response, neither party proposed a construction for that term. Patent Owner, however, argues that “[e]ven if a person of ordinary skill would have chosen to combine an anti-ErbB2 antibody and a taxoid, there is no reason an ordinarily skilled artisan would have avoided anthracyclines as part of that treatment.” Prelim. Resp. 52 (emphasis added). In our Decision denying institution, we agreed with Patent Owner, stating that evidence of the record is “insufficient to suggest that an ordinary artisan would have avoided anthracyclines while pursuing the combination therapy with anti-ErbB2 antibody and a taxoid in a treatment regimen for humans.” Dec. 10 (emphasis added). In its Request for Rehearing, Petitioner contends that we erred in interpreting the limitation “in the absence of an anthracycline derivative” as requiring “avoidance” of an anthracycline derivative. Reh’g Req. 6. According to Petitioner, this term “is a negative limitation that is satisfied by anti-ErbB2 antibody–paclitaxel combinations that do not include an [anthracycline] derivative.” Id. at 5. After reconsidering the current record, we find Petitioner’s argument persuasive. In particular, because Baselga ’94 suggests a therapeutic composition consisting of an anti-ErbB2 antibody and paclitaxel, and does not suggest that doxorubicin must necessarily be included as part of the same treatment regimen, we are persuaded that the reference satisfies the limitation “in the absence of an anthracycline derivative.” Cf. Upsher-Smith Labs., Inc. v. Pamlab, L.L.C., 412 F.3d 1319, 1322 (Fed. Cir. 2005) (concluding the prior art anticipates a claim requiring a composition “essentially free of antioxidants,” because the prior art teaches “optional inclusion” of antioxidants, “despite no express teaching to exclude the antioxidants”).” slip op. at 17
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In sum, Petitioner has presented sufficient evidence, for purposes of instituting trial, to show that in considering prior therapy received, an ordinary artisan would have been motivated to treat patients with ErbB2- overexpressing breast cancer by administering a combination of an anti- ErbB2 antibody and a taxoid, and “in the absence of an anthracycline derivative.”” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner, however, points to other evidence to show that prior art teaches an ordinary artisan to combine an anti-ErbB2 antibody with a taxoid. Specifically, Petitioner refers to Baselga ʼ94 for teaching that, in mouse xenografts, “individual treatment with either anti-HER2 4D5 or paclitaxel alone resulted in 35% growth inhibition whereas the combination ‘resulted in a major antitumor activity with 93% inhibition of growth’ without increasing toxicity.” Id. at 45 (citing Ex. 1005 at 4). Similarly, Baselga ’96, citing Baselga ’94, teaches that “[i]n preclinical studies, both in vitro and in xenografts, rhuMAb HER2 markedly potentiated the antitumor effects of several chemotherapeutic agents, including … paclitaxel without increasing their toxicity.” Id. at 44 (quoting Ex. 1004, 15). Based on these teachings, we are persuaded that an ordinary artisan would have had a reason to treat HER2-positive breast cancer patients with a combination of rhuMAb HER2 and a taxoid.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“Patent Owner argues that Exhibit 2029, which states that “breast cancers that overexpress p185 [i.e., HER2] will not respond well to Taxol,” teaches away from the claimed combination therapy. Prelim. Resp. 51 (citing Ex. 2029,5 1362). We are not persuaded on this record. In an obviousness inquiry, we must analyze the prior art as a whole, and not individually. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (explaining that the question is “whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination”). Other evidence of record shows paclitaxel had been approved for treating breast cancer (see, e.g., Ex. 1025, 10), demonstrates synergy of paclitaxel and an anti-ErbB2 antibody in human breast cancer xenografts (see, e.g., Ex. 1005, 4; Ex. 1004, 15), and suggests clinical trials of the combination therapy (see, e.g., Ex. 1005, 4; Ex. 1004, 15). Weighing all evidence of record, we are not persuaded that prior art as a whole teaches away from combining paclitaxel and an anti-ErbB2 antibody in treating HER2-positive cancers.” slip op. at 14
Claim construction§ 103 obviousnessPatents in suitUS 7,846,441 - Sure-Fire Electrical Corporation v. Yongjiang Yin And Shenzhen El Lighting Co. Ltd.Rehearing grantedPTAB · Jun 1, 2015 · IPR2014-01448 · APJ Debra K Stephens · IPR · Rehearing
Rehearing was granted for claims 1 and 7 under § 103 over He and Korodi, and denied for the He and Currie ground.
RulingsRehearing decision- RehearingRehearing, grantedRehearing, deniedGranted in part
“Therefore, we conclude that we did not abuse our discretion in declining to institute an inter partes review based the combination of He and Currie. Accordingly, we do not institute an inter partes review based on this ground. III. CONCLUSION For the foregoing reasons, on rehearing, based on our review of the record before us, we determine Petitioner has demonstrated a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the combination of He and Korodi. Therefore, we modify our Decision to institute an inter partes review of claims 1 and 7 for obviousness over He and Korodi. We determine, however, that we did not abuse our discretion in declining to institute review on the asserted ground based on He and Currie, and rehearing is denied as to that ground. At this stage in the proceeding, we have not made a final determination with respect to the patentability of the challenged claims, including the claim construction.” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“a reasonable likelihood that an ordinarily skilled artisan would have been motivated to combine the teachings of He and Korodi. Specifically, we determine, based on the current record, Petitioner has articulated reasoning with a rational underpinning as to why an ordinarily skilled artisan would have been motivated to combine the teachings. “‘[T]here must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness’ . . . [H]owever, the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). We credit Dr. Horenstein’s testimony that an ordinarily skilled artisan would have found it obvious simply to replace the aluminum core wire in He with a power cord as taught by Korodi. Ex. 1008 ¶¶ 99, 102. We additionally are persuaded, on the record before us, that the combination of He and Korodi unites old elements with no change in their respective functions. See KSR, 550 U.S. at 415–16. To be nonobvious, an improvement must be “more than the predictable use of prior art elements according to their established functions.” Id. at 417. Indeed, we credit Dr. Horenstein’s testimony that replacing the aluminum core wire in He for the power cord in Korodi would have been a merger of familiar elements according to their established functions, known methods, and predictable results. Ex. 1008 ¶ 103.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundOther
“Based on the record before us, we are persuaded Petitioner has shown a reasonable likelihood that an ordinarily skilled artisan would have been motivated to combine the teachings of He and Korodi. Specifically, we determine, based on the current record, Petitioner has articulated reasoning with a rational underpinning as to why an ordinarily skilled artisan would have been motivated to combine the teachings. “‘[T]here must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness’ . . . [H]owever, the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). We credit Dr. Horenstein’s testimony that an ordinarily skilled artisan would have found it obvious simply to replace the aluminum core wire in He with a power cord as taught by Korodi. Ex. 1008 ¶¶ 99, 102. We additionally are persuaded, on the record before us, that the combination of He and Korodi unites old elements with no change in their respective functions. See KSR, 550 U.S. at 415–16. To be nonobvious, an improvement must be “more than the predictable use of prior art elements according to their established functions.” Id. at 417. Indeed, we credit Dr. Horenstein’s testimony that replacing the aluminum core wire in He for the power cord in Korodi would have been a merger of familiar elements according to their established functions, known methods, and predictable results. Ex. 1008 ¶ 103. Accordingly, based on the record before us, we are persuaded the combination of He and Korodi is a proper combination.” slip op. at 10
- Burden
“With regard to the asserted ground of unpatentability of claims 1 and 7 for obviousness over He and Currie, Petitioner does not explain adequately the relative strengths or weaknesses of this ground and the grounds on which we have instituted. See Cisco Systems, Inc. v. Constellation Tech. LLC, Case IPR2014-01180, slip op. at 29–30 (PTAB Feb. 8, 2015) (Paper 8). The Currie reference has a filing date of September 24, 2004 and an issuance date of October 17, 2006. Thus, the Currie reference would not be prior art if Patent Owner were successful in establishing a conception date “at least as early as April 2004” and diligence from conception to reduction to practice. See Prelim. Resp. 11. Accordingly, the arguments presented in Petitioner’s Request for Rehearing do not apply to the combination of He and Currie. Therefore, we conclude that we did not abuse our discretion in declining to institute an inter partes review based the combination of He and Currie. Accordingly, we do not institute an inter partes review based on this ground.” slip op. at 11
§ 103 obviousnesscites KSRPatents in suitUS 7,671,279
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.