- Apotex Inc. / Apotex Corp. v. Celgene CorporationInstitution deniedPTAB · Sep 27, 2018 · IPR2018-00685 · APJ Toni R Scheiner · IPR · Institution
The Board denied institution: the obviousness grounds repeated substantially the same art and arguments considered in prosecution, and the press release was not shown to be a printed publication.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“As discussed above in Section D2, the Examiner was ultimately persuaded that Applicant’s evidence of unexpected results—i.e., the overall response rate elicited by lenalidomide in pretreated mantle cell lymphoma patients—outweighed the evidence supporting his initial determination that it would have been prima facie obvious for one of ordinary skill in the art to use lenalidomide to treat mantle cell lymphoma given the combined teachings of Zeldis, Damaj, Wilson, and Kaufmann. Ex. 2007, 81–82.” slip op. at 24
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As we have determined that Petitioner has not established that Celgene Press Release is available as a prior art printed publication, Petitioner has not shown a reasonable likelihood of prevailing in its assertion that the subject matter of claims 1–4, 8, 9, 15, and 20 of the ’929 patent is anticipated by the Celgene Press Release. Accordingly, we do not institute an inter partes review of claims 1–4, 8, 9, 15, and 20 of the ’929 patent on the ground of anticipation by the Celgene Press Release.” slip op. at 31
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“A reference will be considered publicly accessible if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting Kyocera, 545 F.3d at 1350). A party seeking to introduce a reference “should produce sufficient proof of its dissemination or that it has otherwise been available and accessible to persons concerned with the art to which the document relates and thus most likely to avail themselves of its contents.” In re Wyer, 655 F.2d 221, 227 (CCPA 1981) (quoting Philips Elec. & Pharm. Indus. Corp. v. Thermal & Elecs. Indus., Inc., 450 F.2d 1164, 1171 (3d Cir. 1971)). As explained by the Federal Circuit, a “determination of whether a reference is a ‘printed publication’ under 35 U.S.C. § 102(b) involves a case-by-case 28 inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). slip op. at 28
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsNot reached
“support patentability.” Id. Paragraph 109 of Dr. Thirman’s Declaration is nearly identical to the above passage from the Petition. Following the summary of those prior art teachings, Dr. Thirman asserts “[t]hus, the alleged unexpected properties would have been expected” (Ex. 1002 ¶ 110), but provides no further evidentiary support for the proposition that the results obtained by treating relapsed and/or refractory MCL with lenalidomide would have been expected. Again, during prosecution, the Examiner maintained that the combined prior art (Zeldis, Damaj, Wilson, and Kaufmann) would have given one of ordinary skill in the art a reason to use lenalidomide to treat patients with relapsed and/or refractory mantle cell lymphoma, but concluded that the evidence of obviousness was outweighed by Applicant’s evidence of unexpected results—namely, a 28% overall response rate in patients with relapsed and/or refractory mantle cell lymphoma. Although Drach—given its particular focus on treating mantle cell lymphoma—is stronger evidence than Damaj, Wilson, and Kaufmann that one of ordinary skill in the art would have had a reason to treat MCL patients with lenalidomide, Drach is no more informative as to expected results than the references the Examiner relied on in making out a prima facie case of obviousness, i.e., Damaj, Wilson, and Kaufmann. Essentially, Petitioner and Dr. Thirman disagree with the Examiner’s conclusion that, on balance, the subject matter of the challenged claims would not have been obvious, in light of the level of response in patients 25 with relapsed and/or refractory MCL (as described in Dr. Zhang’s Declaration and the underlying Goy reference), despite one of ordinary skill in the art having had a reason to administer lenalidomide to treat MCL.” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 8,741,929 - 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.