- 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 - L’Oréal USA, Inc. v. Liqwd, Inc.Institution deniedPTAB · Jul 19, 2017 · PGR2017-00011 · APJ Christopher M Kaiser · PGR · Institution
The Board denied institution of PGR on claims 1–10 because Petitioner did not show that any claim was more likely than not unpatentable under § 112.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 324(c); 37 C.F.R. § 42.4(a). The standard for instituting a post-grant review is set forth in 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless the Director determines . . . it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.”” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed patent owner constructionDecided for patent owner
“Moreover, “[a]pplicants can define . . . claim scope during prosecution,” just as they can in a patent specification. Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1343 (Fed. Cir. 2015). Here, during prosecution of the ’419 patent, the applicant stated that “[t]he term ‘hair coloring agent’ refers to a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.” Ex. 1005, 7. To define specific terms used to describe an invention, the applicant need only set out the definition “with reasonable clarity, deliberateness, and precision,” “so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). On the present record, the definition of the term “hair coloring agent” set out in the prosecution history of the ’419 patent is sufficiently clear, deliberate, and precise to give a person of ordinary skill in the art notice that the term is used in the ’419 patent in a manner that does not include substances other than “colorant[s] or pigment[s] that [are] customarily used in hair care products,” even if those other substances might be described as “hair coloring agents” outside the context of the ’419 patent. Ex. 1005, 7. Accordingly, we should give effect to that definition. Because Patent Owner’s proposed construction of “wherein the mixture does not contain a hair coloring agent” gives effect to the prosecution history’s definition of “hair coloring agent,” we adopt Patent Owner’s proposed construction for purposes of the present decision. Thus, on the present record, and for purposes of the present decision, we construe “wherein the mixture does not contain a hair coloring agent” as “wherein the mixture applied to the hair does not have a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.”” slip op. at 6
- Disclosure Requirements (§112) › Definiteness (Nautilus)Not shown unpatentable
“to determine the scope of the claims. As discussed above, however, we interpret “wherein the mixture does not contain a hair coloring agent” as “wherein the mixture applied to the hair does not have a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.” We have not been directed to evidence of record that a person of ordinary skill in the art would have considered a bleaching agent to be “a colorant or pigment.” Pet. 7 (describing bleaching as a “process[] that destroy[s] pigment to change hair color,” as opposed to a “process[] that deposit[s] dyes, pigments, or other substances onto the hair to change hair color”); Ex. 1006 ¶¶ 14–15 (contrasting “dyeing,” meaning “processes that alter or change hair color by depositing dyes, pigments, or other substances onto the hair,” with “bleaching,” meaning “the application of an oxidizing agent to hair to destroy the natural or artificial pigment”). Accordingly, on the present record, we are not persuaded that Petitioner has shown that it is more likely than not that claims 1–10 of the ’419 patent are indefinite.” slip op. at 10
- Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable
“wherein the mixture does not contain a hair coloring agent.” Pet. 36–39; Prelim. Resp. 39–40. If “a hair coloring agent” encompasses bleaching agents, then the claims all require a bleaching formulation and simultaneously exclude a bleaching agent, a scope that Petitioner argues is not described in the specification of the ’419 patent. As discussed above, however, we interpret “wherein the mixture does not contain a hair coloring agent” as “wherein the mixture applied to the hair does not have a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.” We have not been directed to evidence of record that a person of ordinary skill in the art would have considered a bleaching agent to be “a colorant or pigment.” Pet. 7 (describing bleaching as a “process[] that destroy[s] pigment to change hair color,” as opposed to a “process[] that deposit[s] dyes, pigments, or other substances onto the hair to change hair color”); Ex. 1006 ¶¶ 14–15 (contrasting “dyeing,” meaning “processes that alter or change hair color by depositing dyes, pigments, or other substances onto the hair,” with “bleaching,” meaning “the application of an oxidizing agent to hair to destroy the natural or artificial pigment”). Accordingly, on the present record, we are not persuaded that Petitioner has shown it is more likely than not that claims 1–10 of the ’419 patent lack written description support. slip op. at 12
Claim construction§ 112 disclosurePatents in suitUS 9,498,419 - 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 - Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratory, Inc. v. Helsinn Healthcare S.A.Institution deniedPTAB · Aug 17, 2016 · PGR2016-00007 · APJ Toni R Scheiner · PGR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–6, 10, and 11 were unpatentable as obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“persuaded that Petitioner has shown sufficiently that one of ordinary skill in the art would have had a reason to formulate palonosetron as required by the claims, particularly at a concentration of 0.05 mg/mL. First, Eglen does not discuss the concentration of its formulations at all. Even assuming one of ordinary skill in the art could ascertain the concentration of Eglen’s formulations by making inferences about the dosage volumes, the result would be discrete concentrations—not a range. Petitioner has not shown that any of Eglen’s purported concentrations correspond to the claimed 0.05 mg/mL concentration.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayDecided for patent owner
“We agree with Patent Owner that a person of ordinary skill in the art would have considered Tang to be relevant to a “palonosetron development project.” Prelim. Resp. 33. Moreover, we are not persuaded by Petitioner’s argument that because the challenged claims “[do] not require administration to a human of any dose to reduce the likelihood of postoperative nausea and vomiting,” “Tang is not a teaching away from the alleged invention as actually claimed.” Pet. 18. We need not determine whether Tang actually teaches away from the claimed formulations—it is enough that we agree with Patent Owner that Tang would not have led a person of ordinary skill in the art to expect that a solution of palonosetron at a concentration of 0.05 mg/mL would be effective in treating emesis. Id. at 39 (citing Ex. 1008, 466). If anything, Tang would have suggested amounts and concentrations still higher than the highest dose and concentration evaluated by Tang.” slip op. at 21
§ 103 obviousnessPatents in suitUS 9,173,942 - PTAB · Nov 24, 2014 · PGR2014-00010 · APJ Jon B Tornquist · PGR · Order
The Board granted the parties’ joint motion and terminated PGR2014-00010 without a final decision; it also granted confidential treatment of the settlement agreement.
RulingsOther- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted
“Patent Owner’s preliminary response is not yet due. On November 20, 2014, the parties filed a joint motion to terminate the proceeding (Paper 7) and a copy of their written settlement agreement (Ex. 2001). Along with the motion to terminate, the parties also filed a joint motion to treat the settlement agreement as business confidential information and keep it separate from the file of U.S. Patent No. 8,598,219 (“the ’219 patent”) pursuant to 35 U.S.C. § 327(b) and 37 C.F.R § 42.74(c). Paper 8, 1.” slip op. at 2
NonePatents in suitUS 8,598,219
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.