- 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 · Jun 16, 2020 · IPR2019-01393 · APJ Ryan H Flax · IPR · Rehearing
Granted Sand Revolution II, LLC’s rehearing request and instituted IPR of claims 1, 2, 4, 6–14, and 16–20 on two obviousness grounds.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“As noted in Fintiv, we consider six factors when taking “a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Fintiv, Paper 11 at 6. For the reasons discussed above, the Fintiv factors weigh against invoking our discretion to deny institution. Considering the Fintiv factors as part of a holistic analysis, we are not persuaded that the interests of the efficiency and integrity of the system would be best served by invoking our authority under 35 U.S.C. § 314(a) to deny institution of a potentially meritorious Petition. For the reasons discussed above, we modify our initial decision denying institution. On rehearing, after considering the factors outlined in the precedential order in Fintiv, we decline to deny institution under § 314(a). Accordingly, we grant Petitioner’s Request for Rehearing. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 14
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“demonstrating a reasonable likelihood that it would prevail in showing that claims of the ’740 patent are unpatentable. At this preliminary stage of the proceeding and on the record before us, Petitioner’s case is strong on most challenged claims. Fintiv, Paper 11 at 14–15 (“[I]f the merits of a ground raised in the petition seem particularly strong on the preliminary record, this fact has favored institution.”). Although we recognize the record can change during trial, as discussed in detail below, Petitioner has made a sufficiently persuasive showing, on the record presently before us, that the prior art references cited in the Petition teach or suggest all limitations of most challenged claims. We determine, on this preliminary record, that Petitioner has set forth a reasonably strong case for the obviousness of most challenged claims. Thus, this factor weighs in favor of not exercising discretion to deny institution under 35 U.S.C. § 314(a).” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“system” would have been readily understandable to the skilled artisan on its face, and the combination of these words into the recited phrase does not introduce any different meaning or ambiguity. The fact that the mobile storage module comprises the “integrated actuating system,” as well as the inclusion of the word “integrated” in this disputed term, each supports that such a system is a part of the module; in other words, it is built into the module as proposed by Petitioner. Because the fact that the actuating system is built into the mobile storage module is evident from the claim language itself, defining the claim term expressly to include this concept is unnecessary, as it would be redundant of the term’s plain meaning as understood by the skilled artisan. Nothing in the intrinsic record, or other evidence submitted by Petitioner, is inconsistent with this conclusion. Furthermore, regarding the proposed self-deployment concept, we also conclude it is unnecessary to add this concept to define the claim term in view of the plain meaning of “integrated actuating system.” Per the plain language of the claim term, the system that actuates the mobile storage module, i.e., moves it between a lowered and raised position, is integrated into the mobile storage module. The mobile storage module’s integrated components move, or actuate, the mobile storage module, per the plain meaning of the claim language. Thus, the system that is expressly recited as being a part of the module (integrated), actuates the module; the module actuates itself. Therefore, adding “self-deploying” to specially define the term “integrated actuating system” is unnecessary. Nothing in the intrinsic record is inconsistent with this conclusion. See Ex. 1002, 83–91 (arguing the characteristic of “self-deploying” invokes the inclusion of “an integrated actuating system,” but not the converse). Because Petitioner’s proposed construction of “integrated actuating system” would add unnecessary and undesirable redundancy to the claims, we determine that it is unnecessary to expressly construe this claim term at this stage of the proceedings.” slip op. at 32
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“V. CONCLUSION Petitioner demonstrates a reasonable likelihood of prevailing at trial in demonstrating that claims 1, 2, 4, 6–10, 12–14, and 16–20 of the ’740 patent would have been obvious over the prior art combinations set forth in Grounds 1 and 2. Our decision at this stage derives from our review of the preliminary record before us. This decision does not reflect a final determination on the patentability of the claims. ORDER Accordingly, it is hereby: ORDERED that, Petitioner’s Request for Reconsideration is granted; FURTHER ORDERED that, pursuant to 35 U.S.C. § 314, an inter partes review of claims 1, 2, 4, 6–14, and 16–20 of the ’740 patent, in accordance with Grounds 1 and 2 in the Petition, is hereby instituted; and” slip op. at 56
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 8,944,740 - 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
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.