- 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 - 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 - Geosys-Intl, Inc. v. Farmers Edge Precision Consulting Inc.Rehearing grantedPTAB · Nov 22, 2016 · IPR2015-00711 · APJ James T Moore · IPR · Rehearing
Rehearing was granted, and claim 25 was held unpatentable as obvious over Hauwiller, the Background of the ’867 patent, and Shibusawa.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“After considering the arguments in the Request for Rehearing and reconsidering the evidence of record, we agree with Petitioner that the reasoning in our Final Decision misapprehended what is required by claim 25. Claim 25 does not require satellite imaging to create a map of soil electrical conductivity. Applying this corrected understanding of claim 25, we also now agree that Petitioner established by a preponderance of the evidence that claim 25 would have been obvious in view of Hauwiller, the Background of the ’867 patent, and Shibusawa.” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentableUnpatentable
“Applying this corrected understanding of claim 25, we also now agree that Petitioner established by a preponderance of the evidence that claim 25 would have been obvious in view of Hauwiller, the Background of the ’867 patent, and Shibusawa. As summarized above, Petitioner presented evidence that Shibusawa discloses a map of measurements of soil electrical conductivity, and that combining Shibusawa’s teachings with Hauwiller’s system would have been obvious because electrical conductivity testing is a relatively efficient method for determining soil properties. Pet. 45–46; Ex. 1004, 20:11–16, 23:14–17; Ex. 1009 ¶ 80. As Petitioner points out, the subject matter recited in claim 25 is similar to that of claims 7 and 14, and we determined in our Final Decision that Petitioner’s contentions regarding the obviousness of those claims were persuasive. See Req. Reh’g 5; Dec. 39–40.” slip op. at 5
§ 103 obviousnessPatents in suitUS 7,343,867 - Geosys-Intl, Inc. v. Farmers Edge Precision Consulting Inc.Rehearing grantedPTAB · Nov 22, 2016 · IPR2015-00709 · APJ Timothy J Goodson · IPR · Rehearing
Rehearing granted; claim 25 held unpatentable as obvious over Hauwiller, the Background of the ’912 patent, and Shibusawa.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“was based on a misapprehension of what is required by claim 25. Req. Reh’g 6. Specifically, Petitioner argues that claim 25 does not require satellite imaging to create a map of soil electrical conductivity. Id. at 1. Petitioner points out that claim 25 requires that the soil electrical conductivity map is used for the calculation of the “site-specific measures of the soil nutrient existing in the field.” Id. at 2. Claim 15 requires that the map of site-specific field characteristic data generated using a satellite image of the agricultural field is used in the calculation of the map of “site-specific soil nutrient amount needed to produce at each site a maximum possible crop yield.” Ex. 1001, 12:7–12. In other words, the map of soil electrical conductivity recited in claim 25 is used in the first calculating step of claim 15, not the second calculating step that uses a map generated through satellite imaging. After considering the arguments in the Request for Rehearing and reconsidering the evidence of record, we agree with Petitioner that the reasoning in our Final Decision misapprehended what is required by claim 25. Claim 25 does not require satellite imaging to create a map of soil electrical conductivity. Applying this corrected understanding of claim 25, we also agree that Petitioner established by a preponderance of the evidence that claim 25 would have been obvious in view of Hauwiller, the Background of the ’912 patent, and Shibusawa. As summarized above, Petitioner presented evidence that Shibusawa discloses a map of measurements of soil electrical conductivity, and that combining Shibusawa’s teachings with Hauwiller’s system would have been obvious because electrical conductivity testing is a relatively efficient method for determining soil properties. Pet. 47; Ex. 1004, 20:11–16, 23:14–17; Ex. 1009 ¶ 80. As Petitioner points out, the subject matter recited in claim 25 is similar to that of claims 7 and 14, and we determined in our Final Decision that Petitioner’s contentions regarding the obviousness of those claims were persuasive. See Req. Reh’g 5–6; Dec. 34.” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“reconsidering the evidence of record, we agree with Petitioner that the reasoning in our Final Decision misapprehended what is required by claim 25. Claim 25 does not require satellite imaging to create a map of soil electrical conductivity. Applying this corrected understanding of claim 25, we also agree that Petitioner established by a preponderance of the evidence that claim 25 would have been obvious in view of Hauwiller, the Background of the ’912 patent, and Shibusawa. As summarized above, Petitioner presented evidence that Shibusawa discloses a map of measurements of soil electrical conductivity, and that combining Shibusawa’s teachings with Hauwiller’s system would have been obvious because electrical conductivity testing is a relatively efficient method for determining soil properties. Pet. 47; Ex. 1004, 20:11–16, 23:14–17; Ex. 1009 ¶ 80. As Petitioner points out, the subject matter recited in claim 25 is similar to that of claims 7 and 14, and we determined in our Final Decision that Petitioner’s contentions regarding the obviousness of those claims were persuasive. See Req. Reh’g 5–6; Dec. 34.” slip op. at 4
§ 103 obviousnessPatents in suitUS 7,171,912 - Merial Limited v. VirbacRehearing grantedPTAB · Apr 15, 2015 · IPR2014-01279 · APJ Fred E Mckelvey · IPR · Rehearing
Rehearing was granted and review instituted on claims 1–15 under § 103 over Huet ’333 combined with Saito and over Huet ’333 combined with Sirinyan.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“We agree with Petitioner that we overlooked the significance of that portion of Huet ʼ333 indicating that use of a cosolvent is optional. Upon consideration of the Petition for Rehearing1 and the Response, we grant the Petition for Rehearing and order institution of an inter partes review.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“solvent must include any C1-C4 alcohol. The cosolvent, which can be absolute ethanol, isopropanol, or methanol (Ex. 1005, 6:19–20), is optional (Ex. 1005, 10:45).” slip op. at 11
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“We recognize in circumstances similar to those present in this case that it often is questioned why one skilled in the art would “pick and choose” particular ingredients (solvents and crystallization inhibitors in this case) where a reference describes several alternatives. There is an answer. First, the entire disclosure of Huet ʼ333 is in the public domain. One skilled in the art should be free to use any combination described by Huet ʼ333 in proportions that Huet ʼ333 characterizes as being within the skill of the art. Claim 1 of the ’799 patent presumptively removes from that public domain a portion of what is described by Huet ʼ333. Absent some unexpected result obtained by the subgenus of claim 1 of the ʼ799 patent vis-à-vis the broader genus described by Huet ʼ333, it is likely that the subject matter of claim 1 of the ʼ799 patent would have been obvious within the meaning of 35 U.S.C. § 103(a). Patent Owner, in responding on the merits, is free to present evidence of unexpected results.” slip op. at 11
§ 103 obviousnessPatents in suitUS 8,501,799
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.