- Grünenthal GmbH v. Antecip Bioventures II LLCRehearing deniedPTAB · Mar 26, 2020 · PGR2018-00001 · APJ Grace Karaffa Obermann · PGR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving claims 3–30 unpatentable for lack of enablement because the specification does not guide an artisan to practice their full scope without undue experimentation.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Upon request for rehearing, we review our decision for an abuse of discretion. 37 C.F.R. § 42.71(c). “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). “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.” Id. Based on an application of those principles, we deny the Request for Rehearing.” slip op. at 2
- Expert testimonyOther
“zolendronic acid dosage forms could achieve bioavailabilities as high as 1.1% to “a belie[f] in ‘fairies.’” Req. Reh’g 2 (quoting Dec. 14; Ex. 2014, 137:21–138:8). That testimony represents a small fraction of the totality of evidence that undergirds our finding that an ordinarily skilled artisan generally would have expected that attaining a human bioavailability for zolendronic acid above 1% required an enhancer. See Dec. 12–21 (citing substantial evidence for that proposition). Even if we set aside the testimony misattributed to Dr. Wargin, substantial evidence supports that finding.” slip op. at 3
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“unenhanced dosage form of zoledronic acid disclosed in Aronhime or Exhibit 2026 would have attained a bioavailability that falls within the scope of the challenged claims. The key is whether an ordinarily skilled artisan, reading the disclosure of the ’268 Patent, would have been equipped to practice the full scope of the claimed invention. We did not overlook or misapprehend Exhibit 2026. We correctly determined that, in this unpredictable field of pharmaceutical formulation, an ordinarily skilled artisan would have required direction (lacking in the Specification or the prior art) explaining how to prepare dosage forms that meet the full range of bioavailabilities embraced by the challenged claims, including the specified high endpoint human bioavailability of about 4%. See, e.g., Dec. 11–12 (citing undisputed evidence of unpredictable nature of the field of invention (Ex. 1005 ¶ 60)).” slip op. at 7
§ 112 disclosurePatents in suitUS 9,539,268 - Grünenthal GmbH v. Antecip Bioventures II LLCAll claims unpatentablePTAB · Jun 22, 2018 · PGR2017-00008 · APJ Sheridan K Snedden · PGR · Final written decision
Claims 1–17 are unpatentable under § 112(a) for lack of written description because the claimed dosing regimen is not supported by the specification.
RulingsFinal written decision- Skill levelSkill level board ownOther
“with regard to claim 17. Nonetheless, we are not persuaded by Petitioner’s contentions. Rather, we find that the ’239 patent contains a sufficient written description of an oral dosage form containing “at least 10% zoledronic acid.” The specification describes a full panoply of zoledronic acid concentrations. Liquid compositions may contain “about 10% (w/v) to about 15% (w/v), about 15% (w/v) to about 20% (w/v), about 20% (w/v) to about 30% (w/v), about 30% (w/v) to about 40% (w/v), or about 40% (w/v) to about 50% (w/v) of zoledronic acid.” Ex. 1003, 10:25–28. Solid dosage forms may contain “at least about 10% (w/w), at least about 20% (w/w) . . .” up to “at least about 80% [w/w]” zoledronic acid. Id. at 10:30–32. Solid dosage forms also are described as containing zoledronic acid in ranges beginning from “about 10% (w/w) to about 30% (w/w), about 10% (w/w) to about 20% (w/w) . . .” all the way up to a range of “about 80% (w/w) to about 90% (w/w).” Id. at 10:32–39. The breadth of zoledronic acid concentration ranges disclosed is more comprehensive than, and therefore distinguishable from, the more limited concentration ranges disclosed in Wertheim (claimed range of “at least 35%” not supported by disclosure of 25% to 60% range disclosed in priority application). In short, we determine that a person of ordinary skill in the art – a medical doctor with experience treating CRPS – would have recognized that the “inventor invented what is claimed” and did not overreach in claiming “at least 10% zoledronic acid” in an orally administered dosage form for treating CRPS. See University of Rochester, 358 F.3d at 928 (Fed. Cir. 2004).” slip op. at 21
- Expert testimonyOther
“Unocal or Wertheim where the specification clearly allowed persons of ordinary skill in the art to recognize the claimed invention despite the absence of literal support. In Unocal, the original disclosure explicitly described the effects of altering the variables, explicitly described the claimed endpoints as preferred, or explicitly recited them in an original claim. Moreover, persuasive expert testimony was offered to support the finding that the specification reasonably conveyed to one skilled in the relevant art that the inventor possessed the later claimed invention. Unocal, 208 F.3d at 993, 998–99. In Wertheim, the CCPA held that the specification supported the claimed range of 35–60% where the specification described the range of 25–60% along with specific embodiments of 36% and 50%. 541 F.2d at 264–65. In this case, the ’239 patent specification does not clearly allow persons of ordinary skill in the art to recognize the “about 80 mg” endpoint as part of invention described in the ’239 patent. There is no disclosure of “about 80 mg” as a preferred endpoint, no disclosure of a specific embodiment including a dose of 80 mg, nor any other description suggesting the importance or criticality of the “about 80 mg” endpoint.” slip op. at 16
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateWritten description adequateMixed
“In this case, the ’239 patent specification does not clearly allow persons of ordinary skill in the art to recognize the “about 80 mg” endpoint as part of invention described in the ’239 patent. There is no disclosure of “about 80 mg” as a preferred endpoint, no disclosure of a specific embodiment including a dose of 80 mg, nor any other description suggesting the importance or criticality of the “about 80 mg” endpoint.” slip op. at 16
Patent outcomesUS 9,283,239 unpatentable§ 112 disclosurePatents in suitUS 9,283,239 - Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratory, Inc. v. Helsinn Healthcare S.A.Institution deniedPTAB · Aug 17, 2016 · PGR2016-00008 · APJ Toni R Scheiner · PGR · Institution
The Board denied institution because Petitioner did not show that claims 1–19 lacked written-description support or violated the AIA on-sale bar.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“35 U.S.C. § 324(c); 37 C.F.R. § 42.4(a). The standard is set forth in § 324(a), which provides that a post-grant review shall 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, we determine that Petitioner has failed to demonstrate that it is more likely than” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“The written description requirement is satisfied when the specification “set[s] forth enough detail to allow a person of ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what 7 Patent Owner additionally provides Appendix A to the Preliminary Response. Appendix A purportedly maps the requirements of claims 1–19 to the specification. 11 is claimed.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 928 (Fed. Cir. 2004). Here, it is undisputed that the specification describes formulations comprising the same ingredients, in the same amounts, concentrations, and combinations required by the challenged claims. Given this disclosure, one of ordinary skill in the art could hardly fail to recognize a description of the claimed formulations in the specification, whether or not the claims recite that the formulations are stable.” slip op. at 11
- Novelty / Anticipation (§102) › Prior-art status of a reference › On-sale bar (Pfaff, Helsinn)Not shown unpatentableNot shown unpatentable
“A person shall be entitled to a patent unless—(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention . . . . As an AIA first-inventor-to-file patent, the ’942 patent is subject to AIA § 102(a)(1). Thus, the dispositive issue in this case is whether § 102(a)(1) requires a public sale or offer for sale of the claimed invention to trigger the on-sale bar.” slip op. at 18
§ 102 anticipation§ 112 disclosurePatents in suitUS 9,173,942 - Bioactive Laboratories v. BTG International Inc.Rehearing deniedPTAB · Aug 2, 2016 · IPR2015-01305 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied BioActive Laboratories’ rehearing request, leaving institution denied for claims 1–22 because the ’352 patent was not shown to be prior art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ANALYSIS When considering a request for rehearing, the Board reviews its decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The party requesting rehearing bears the burden of showing that the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“After reviewing the arguments and evidence presented in the Petition, however, we were not persuaded that Petitioner had shown that the ’352 patent fails to provide proper written description support or enablement for the claims of the ’414 patent. Accordingly, we were not persuaded that the ’352 patent is prior art to the claims of the ’414 patent and declined to institute an inter partes review on grounds based on the ’352 patent. Dec. 10–11.” slip op. at 3
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedNot shown unpatentable
“anticipated by, and claims 8 and 19 are unpatentable over U.S. Patent No. 4,489,352 (Ex. 1004, “the ’352 patent”). Petitioner acknowledged that the ’352 patent “is listed in the priority chain on the face of the ’414 patent” (Pet. 5), and that the specifications of the ’352 patent and the ’414 patent are identical (id. at 29), but argued that: [T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“[T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2
Claim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 8,048,414
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.