- 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 - Incyte Corporation v. Concert Pharmaceuticals, Inc.Rehearing grantedPTAB · Apr 9, 2018 · IPR2017-01256 · APJ Tina E Hulse · IPR · Rehearing
The Board granted Incyte’s rehearing request and instituted review of claims 1–15 on Ground 3, finding it had applied overly restrictive standards for lead compound analysis and combining references.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, 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. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if an unreasonable judgment is made in weighing relevant factors. In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). Having considered the Request for Rehearing, the current record, and our Decision denying institution, we are persuaded that we applied an overly restrictive standard for the lead compound analysis and for the reason to combine the cited references. See Reh’g Req. 2–12. Accordingly, we grant Petitioner’s Request for Rehearing and concurrently issue a decision granting institution on Ground 3. Paper 14.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Having considered the Request for Rehearing, the current record, and our Decision denying institution, we are persuaded that we applied an overly restrictive standard for the lead compound analysis and for the reason to combine the cited references. See Reh’g Req. 2–12. Accordingly, we grant Petitioner’s Request for Rehearing and concurrently issue a decision granting institution on Ground 3. Paper 14.” slip op. at 3
NonePatents in suitUS 9,249,149 - 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 - Micron Technology, Inc. v. MLC Intellectual Property, LLCRehearing grantedPTAB · Mar 31, 2016 · IPR2015-00504 · APJ Kevin F Turner · IPR · Rehearing
The Board granted rehearing only as to addressing the request’s assertions and otherwise denied rehearing, leaving the denial of institution for claims 1, 9, 10, 12, 30, 42, and 45 over Kitamura in place.
RulingsRehearing decision- RehearingRehearing, grantedRehearing, deniedGranted in part
“II. ANALYSIS When rehearing a decision on institution, the Board will review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“Dr. Baker goes on to further interpret Kitamura (id. at ¶¶ 75–79), citing additional references (Exs. 1012, 1013), but those additional references do not form part of the obviousness ground, and are not cited in the Petition. We further note Petitioner may rely on expert testimony to interpret patents and printed publications, but may not rely on such testimony as a substitute for a patent or printed publication. See 35 U.S.C. § 311(b). We remain persuaded that Dr. Baker does not interpret Kitamura’s D/A conversion circuit as requiring the selection of an analog signal, but rather indicates that only as a possible interpretation of Kitamura. As we stated in the Decision, Dr. Baker’s discussion makes clear how the output voltages could be set, but he does not testify that it must employ his discussed methods. Dec. 10.” slip op. at 6
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Ex. 1003 ¶ 74 (citing Exhibit 1004 at 21:27-31). We were not persuaded that Dr. Baker is testifying as to how the circuit must perform, only how it could perform. 5 Dr. Baker goes on to further interpret Kitamura (id. at ¶¶ 75–79), citing additional references (Exs. 1012, 1013), but those additional references do not form part of the obviousness ground, and are not cited in the Petition. We further note Petitioner may rely on expert testimony to interpret patents and printed publications, but may not rely on such testimony as a substitute for a patent or printed publication. See 35 U.S.C. § 311(b). We remain persuaded that Dr. Baker does not interpret Kitamura’s D/A conversion circuit as requiring the selection of an analog signal, but rather indicates that only as a possible interpretation of Kitamura. As we stated in the Decision, Dr. Baker’s discussion makes clear how the output voltages could be set, but he does not testify that it must employ his discussed methods. Dec. 10. Petitioner also argues that we mischaracterized what aspects Dr. Baker relied upon in making his assessment. Reh’g Req. 8–9. Petitioner continues that Dr. Baker cites to Kitamura’s explicit disclosure, as well as corroborating his explanation with citations to textbook knowledge, but that we failed to credit the same. Id. at 8. We do not agree. We fully reviewed all of Dr. Baker’s testimony and corroborating citations, but we were not persuaded that Kitamura’s D/A conversion circuit must function as Dr. Baker suggests it could function. In other words, we do not doubt Dr. Baker’s facts; we are only unpersuaded that Dr. Baker’s testimony states sufficiently that Kitamura’s D/A conversion circuit must select among specific analog reference voltages.” slip op. at 5
§ 103 obviousnessPatents in suitUS 5,764,571 - Biomarin Pharmaceutical Inc. v. Duke UniversityRehearing grantedPTAB · Jul 14, 2015 · IPR2013-00535 · APJ Sheridan K Snedden · IPR · Rehearing
The Board granted rehearing but again held claim 19 unpatentable as obvious over Reuser ’771, Van Hove 1997, and Brady.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“In relation to Patent Owner’s contentions in this regard, we grant a rehearing to reconsider the teachings of Brady in relation to “Day 1.” Taking a closer look at the reference as a whole, we see that Brady discloses, in the paragraph discussed above, that “[t]he effort to immunosuppress the patient was initiated on July 26, 1993.” Ex. 1012, 3. Reading the entire paragraph, it is clear that July 26, 1993, corresponds to “Day 1” as presented in Table 1, i.e., the first day that the patient received both an immunosuppressant and enzyme therapy. Id. Earlier in the reference, Brady states that the “patient was admitted to NIH for periodic evaluation on January 21, 1992, 6 months after the initiation of enzyme replacement therapy.” Id. at 2 (under the heading “Clinical Course”). The reference also states that “[o]n March 19, 1993, 1 day after routine intravenous infusion of Ceredase, the patient experienced severe pain in his left shoulder . . . .” Id. Thus, we are persuaded by Patent Owner’s contentions that Brady does not disclose administering immunosuppressant prior to any and all administration of hGAA, as required by claim 19. Req. Reh’g 6. Accordingly, we now reconsider the arguments and evidence, including the aspects of Brady discussed above, and address the question of whether claim 19 is obvious over the combination of Reuser ’771, Van Hove 1997, and Brady.” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“We agree with Patent Owner that Brady does not teach prophylactically administering an immunosuppressant under our construction of claim 19. We determine, however, that the preponderance of evidence shows that the prophylactic administration of an immunosuppressant would have been a predictable variation of the use of immunosuppressant disclosed in Brady. Brady teaches administering the immunosuppressant in an “effort to immunosuppress the patient” and to reduce neutralizing antibodies in the individual. Ex. 1012, 3 (including sections titled “Intervention” and “Reduction of Neutralizing Antibody Titer”). Dr. Pastores testifies that administration of foreign protein could lead to an immune response (Pastores Dec. ¶ 94), such as the adverse immune response seen in Brady, and that hypersensitivity to replacement enzyme may be addressed by pretreatment with antihistamines or widely used immunosuppressants such as corticosteroids (Dr. Pastores ¶ 95 (citing Ex 1011, 130)).” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
§ 103 obviousnesscites KSRPatents in suitUS 7,056,712 - 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 - Target Corporation v. Destination Maternity CorporationRehearing grantedPTAB · Feb 12, 2015 · IPR2014-00509 · APJ Lora M Green · IPR · Rehearing
The Board granted Target’s request for rehearing of the denial of institution, for the reasons given in the related IPR2014-00508 decision.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“our Decision Denying Joinder of the instant proceeding with IPR2013-00533 (Paper 18), as well as our Decision Denying Institution of Inter Partes Review (Paper 19). Paper 20 (“Request for Rehearing”). Patent Owner, Destination Maternity Corporation, was authorized to file an Opposition (Paper 22), to which Petitioner was authorized to file a Reply (Paper 23). For the reasons discussed in the Decision Granting Petitioner’s Request for Rehearing in related IPR2014-00508 (Paper 28), we grant the Request for Rehearing.” 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.