- Fustibal LLC v. Bayer Healthcare LLCInstitution deniedPTAB · Feb 8, 2017 · IPR2016-01490 · APJ Robert A Pollock · IPR · Institution
The Board denied institution because Riedl was repeatedly considered during prosecution and the petition did not show a reasonable likelihood that claims 1–16 were unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“§ 314(a); 37 C.F.R. § 42.108. Our discretion on whether to institute is guided, in part, by 35 U.S.C. § 325(d), which states that “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Patent Owner requests that the Board exercise its discretion to deny institution with respect to Ground 1 because Riedl was expressly considered by the Examiner during the prosecution of the ’553 Patent. Prelim. Resp. 7–8. As noted in section I(E), above, in allowing claims 1–16 of the ’533 Patent, the Examiner expressly referred to Riedl as the closest prior art, yet found that it “fails to teach . . . the instant claimed compounds.” Ex. 2006, 913; see also Ex. 2005, 397, 569; Ex. 2006, 855 (same, with respect to similar claims).” slip op. at 11
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As an initial matter, the above argument fails because, as discussed in section I(C)(iii), above, Riedl does not “expressly disclose[] the rografenib compound,” as Petitioner contends. We further agree with Patent Owner’s observation “that the Petition nowhere engages in a ‘lead compound’ analysis” and, at least with respect to Ground 2, “merely assumes—without explanation—that the POSA would select sorafenib for modification.” Prelim. Resp. 22–23. A lead compound comprises “a natural choice for further development efforts” (Altana Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 1008 10 Petitioner provides similar arguments with respect to claims 1–12, 14, and 16. Id. at 22–25. (Fed. Cir. 2009)), i.e., a prior art compound “that would be most promising to modify in order to improve upon its . . . activity and obtain a compound with better activity” (Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007)). “In determining whether a chemist would have selected a prior art compound as a lead, the analysis is guided by evidence of the compound’s pertinent properties.” Otsuka Pharm., 678 F.3d at 1292. “Absent a reason or motivation based on such prior art evidence, mere structural similarity between a prior art compound and the claimed compound does not inform the lead compound selection.” Id. In setting forth Ground 2, Petitioner invokes a person of ordinary skill in the art “who was looking to modify sorafenib.” Prelim. Resp. 22. Neither Petitioner nor Petitioner’s expert address why a skilled artisan reading Riedl would select that compound for further development. Given that Riedl does not highlight any of the vast number of disclosed compounds as having particularly beneficial properties or present any enzymatic or biological data, we also do not discern from this reference why a person of ordinary skill in the art would have selected sorafenib as “a natural choice for further development efforts.”” slip op. at 17
- Skill levelSkill level petitioner adoptedOther
“Person of Ordinary Skill in the Art. Petitioner contends that a person of ordinary skill in the art “typically would have a PhD, MD, MS, or another degree relating to pharmaceutical chemistry (e.g. biology, chemistry, medicinal chemistry, medicine, pharmacology, or a closely related discipline), and . . . would have substantial familiarity, training, or experience with pharmaceutical compositions.” Pet. 6. Patent Owner has not challenged Petitioner’s proposed interpretation of a skilled artisan. We adopt Petitioner’s proposed interpretation for purposes of this opinion. See Prelim. Resp. 6 & n.1; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evident from the prior art). B.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“Petitioner (correctly) contends that the ’553 Patent expressly defines the claim term “pharmaceutically acceptable salt” as “‘a relatively non-toxic, inorganic or organic acid addition salt of a compound of the present invention.’” Pet. 7 (quoting Ex. 1001, 9:56–62). Patent Owner does not presently object to this definition. Based on the specification’s express disclosure, we agree that the cited definition applies. See Prelim. Resp. 6 & n.2. The parties agree that all other terms should be accorded their ordinary and customary meaning. Id.; Pet. 6–7. Our reviewing court counsels that only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Accordingly, for purposes of this decision, we determine that no further construction is necessary. C.” slip op. at 7
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 8,637,553 - PTAB · Jul 1, 2016 · IPR2016-00379 · APJ Tina E Hulse · IPR · Institution
The Board denied institution for claims 1–6 under § 325(d), finding substantially the same prior art and arguments had been presented during prosecution.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“the Petition under § 325(d) because Petitioner’s obviousness challenge is based on (i) the same primary reference addressed during prosecution, including by the Board in an appeal; and (ii) the same arguments regarding that primary reference and how it allegedly would have been modified. Prelim. Resp. 56–60. Upon reviewing the Petition, Preliminary Response, and the prosecution history of the ’040 patent, we agree. During prosecution, the examiner rejected the claims as obvious over Van Lommen. Here, Petitioner also relies primarily on Van Lommen to argue the claims are obvious. We, therefore, find that substantially the same prior art was previously presented to the Office. We also find that substantially the same arguments were previously presented to the Office, including to the Board. Petitioner argues that a person of ordinary skill in the art would have selected Compound 84 of Van Lommen as a base compound for investigation and would have been motivated to stereochemically separate the stereoisomers of Compound 84 using the chromatography techniques disclosed in the secondary prior art references. Pet. 33. As Patent Owner notes, however, the examiner repeatedly stated that “the skilled artisan would have seen optical isomer separation as a routine procedure leading to the compounds claimed herein.” Prelim. Resp. 57 (citing Ex. 1002, 48, 73, 88, 113). Thus, Petitioner asserts substantially the same argument that the examiner asserted during prosecution.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The claims recite a composition “consisting of” the claimed compound. The parties agree that the transitional phrase “consisting of” is a term of art in patent law that “closes” the claim and excludes other elements, steps, or ingredients not specified in the claim. Pet. 29–30; Prelim. Resp. 23. 4 Armstrong et al., Separation of Drug Stereoisomers by the Formation of β- Cyclodextrin Inclusion Complexes, 232 SCIENCE 1132–35 (1986) (Ex. 1007). expected impurities or additional components or steps that are unrelated to the invention. Conoco, Inc. v. Energy & Envtl. Int’l, L.C., 460 F.3d 1349, 1360 (Fed. Cir. 2006). Accordingly, we determine that the term “consisting of” does not exclude the presence of ordinary expected impurities or the presence of additional components that are unrelated to the invention.” slip op. at 5
- Obviousness (§103) › Objective indicia / secondary considerationsOther
“concluding the applicants’ evidence of unexpected results sufficient, and implicitly finding a sufficient nexus between the evidence and the claimed invention. See In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (“For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.”) (quoting Wyers v. Master Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010)). Finally, Petitioner argues that it has submitted “ample evidence” that the compounds of claims 1 and 2 would be the intended and expected result of combining the asserted references, and that claims 3–6 would not be an unexpected result of the suggested combination. Pet. 56 (citing Ex. 1050 ¶¶ 50, 56, 66, 73, 74, 81, 93, 106; Ex. 1052 ¶¶ 60–68, 93, 100). But Petitioner’s cited evidence relates to how a person of ordinary skill in the art would have considered separating and studying the stereoisomers of compound 84 to be ordinary and routine. See, e.g., Ex. 1050 ¶ 73 (“A POSITA at the time would have had an expectation that this stereochemical resolution could be easily achieved using known and commercially available techniques, without undue experimentation.”); Ex. 1052 ¶ 93 (“[I]t is my opinion that a POSITA at the time of the ’040 Patent’s priority date, would have been motivated to carry out standard new-drug investigation on each of the purified stereochemical forms in order to determine the effectiveness of each stereochemical form, to determine whether the drug could be administered as a racemic mixture or whether a purified enantiomer was required, to determine the interactions between stereoisomers if administered together, and to determine the effective amounts of each compound necessary for treatment of hypertension.”). The Board, however, assumed examiner established a prima facie case of obviousness. Ex. 1002, 199. Nevertheless, the Board still found the unexpected results evidence presented by the applicants to be sufficient. Finally, although the prior panel expressly set forth the deficiencies in the examiner’s position with respect to the evidence of unexpected results, the Petition is silent as to those deficiencies. In particular, Petitioner has not offered sufficient evidence to show why an ordinary artisan “would have expected the RSSS stereoisomer to have such [potentiating] properties” or to show “that the potentiating property, described in the declaration, is insignificant.” See Ex. 1002, 200. Because Petitioner has not addressed these issues, we are not inclined to reconsider the Board’s prior decision. Accordingly, under the facts and circumstances of this case, we find that readjudicating substantially the same prior art and arguments as those presented during prosecution would not be an efficient use of Board resources.” slip op. at 11
Claim construction§ 103 obviousnessDiscretionary denialPatents in suitUS 6,545,040
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.