Junior Party CVC Files Reply to Sigma-Aldrich’s Opposition to Its Preliminary Motion No. 4

By Kevin E. Noonan —

On November 19th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, “CVC”) filed Substantive Preliminary Motion No. 4* in Interference No. 106,132, wherein CVC moved to add Senior Party Sigma-Aldrich’s US Patent Nos. 10,731,181 and 10,745,716 to the interference and designate claims 1-17 of the ‘181 patent and claims 2-4, 11, 14, 21, and 22 of the ‘716 patent as corresponding to the Count, pursuant to 37 CFR §§ 41.121) a)(1)(i) and 41.208(a)(2) and Standing Order (“SO”) 203.2. On February 18th, Senior Party Sigma-Aldrich filed its Opposition to this Motion and on April 7th CVC filed its Reply.

The basis for CVC’s Motion No. 4 was that these claims would have been obvious over Count 1 and the Jinek 2012 reference (Jinek et al., 2012, “A Programmable Dual-RNA–Guided DNA Endonuclease in Adaptive Bacterial Immunity,” Science 337 (6096): 816-21) in light of the Krebber 2000 reference (Krebber and Silver, 2000, “Directing Proteins to Nucleus by Fusion to Nuclear Localization Signal Tags,” Methods in Enzymology 327: 283-96) or the Lange 2007 reference (Lange, 2007, “Classical Nuclear Localization Signals: Definition, Function, and Interaction with Importin α,” J. Biol. Chem. 282(8): 5101–05. CVC identified what it is characterized as only “nominal differences” between the Count and the claims to be defined in these two patents as “the recitation of the well-established Cas9 protein (from S. pyogenes), a well-known nuclear localization signal (a C-terminal SV40 NLS), and the natural and previously disclosed location for the DNA-targeting region (at the 5′ end of the guide RNA).” None of these differences rendered these Claims patentably distinct from the Count, CVC argued, as evidenced by “highly similar claims already being involved in this proceeding as part of Sigma’s US Application No. 15/456,204.” These claims satisfy the test set forth under 37 CFR § 41.207(b)(2) and Standing Order ¶ 208.3.1 that claims correspond to the Count where “the subject matter of the count, if treated as prior art , would have anticipated or rendered obvious the subject matter of [each] claim.” This test is satisfied if additional references are relied upon to make out a prima facie case of obviousness CVC argued, citing Desjardins v Wax, Interference No. 105,915, Paper 125, 17-20 (PTAB Jan. 21, 2014). The basis for CVC’s argument that the distinctions set forth above do not render these clams patentably distinct was that these distinctions are found in the cited prior art or were otherwise “well known,” the brief setting forth reasons for the Board to reach this conclusion. Finally, CVC argued there are no objective indicia (or secondary considerations) that would provide the missing distinctions.

Sigma-Aldrich’s Opposition contended that CVC failed to apply the proper “two-way test” for determining whether a claims to an interference Count. Sigma-Aldrich cited a decision from the PTAB’s predecessor, the Board of Patent Appeals and Interferences, for the definition of “the same patentable invention” as requiring a “two-way obviousness test,” citing Winter v. Fujita, 1999 Pat. App. LEXIS 7, *49-50, 53 USPQ2d (BNA) 1234, 1248 (BPAI Nov. 16, 1999). Noting that the rules for patent interferences were changed in 2004, Sigma-Aldrich sets forth the current rules and illustrated application of these rules in Ledenev v. Adest, 2020 Pat. App. LEXIS 6912, *35-36, Decision on Motions, at 31, 35 (PTAB Mar. 25, 2020) (JTM) (in moving to add patents to an interference,”[t]he standard to be applied is whether the claim is patentably distinct from the Count . . . . [T]he placed burden upon movant [is] to compare the claims to the count in the required two-way analysis.”). Sigma-Aldrich also noted (in a footnote) in this regard that “[t]he authority cited by CVC [37 C.F.R. § 41.207(b)(2) (“Claim correspondence”); Standing Order 208.3.1 (“Claim correspondence”)] is directed to the analysis of whether a claim of an already involved patent or application corresponds to the interference count.” Such a one-way test would be appropriate, Sigma-Aldrich argued, only for showing claim correspondence to an interference Count for claims of an already-involved patent or application. Sigma-Aldrich further argued in this regard that what CVC set forth in its Motion No. 4 is whether the narrower interference Count would render obvious the ‘181 or ‘716 patent claims. was the converse assessment, whether “the broader claim render[s] obvious the narrower count(emphasis in brief) according to Sigma-Aldrich. Finally, Sigma-Aldrich contended that CVC’s Motion No. 4 would become moot should the Board grant its Preliminary Motion No. 1 to change the Count.

In its Reply, CVC justified its reliance on the one-way analysis for claim correspondence on 37 CFR § 41.207(b)(2), which CVC contends is used by the Board in deciding to add a claim to an existing interference, citing Ledenev v. Adest, No. 106,112, Paper 137, Decision on Motions, at 30 (PTAB Mar. 25, 2020) and Ritzberger v. Durschang, No. 106,012, Paper 210, Decision on Priority and Other Motions, at 17-25 (PTAB Sept. 29, 2016). Moreover, according to CVC, Sigma-Aldrich relies on outdated interference rules (37 CFR § 1.642 (2004)) and authority relying on those rules, Winter v. Fujita. With regard to Sigma-Aldrich’s citation of more current rules, § 41.202(a), § 41.203(a), and § 41.203(d), CVC argues (somewhat curiously) that “[n]o matter what these rules state, Ledenev and Ritzberger both applied a one-way count vs. claim analysis under Rule 41.207(b)(2) when deciding motions to add a patent to an interference” (emphasis added), albeit further stating that “[t]he PTAB’s analysis in these cases was correct and dictated by the only logical reading of the rules Sigma cites.” The brief goes on to explicate for the Board why the Board’s reasoning was “the only logical reading” of these rules.

Having set forth the propriety of the one-way test under the rules as the Board construed them under Ledenev and Ritzberger, CVC then recounts how in its motion it applied the rules to the claims at issue in this motion. Regarding Sigma-Aldrich’s attempt to distinguish these claims with regard to “Element 13” CVC argues that Sigma-Aldrich admits that this element is limited to HDR, which is found as a limitation in its “half” of the McKelvey Count in the interference. And even if the Board grants Sigma-Aldrich’s Motion No. 1 to substitute the Count CVC argues that because this substitute count contains Sigma-Aldrich’s portion of the count these claims would satisfy the proper, one-way test.

Finally, CVC rebuts Sigma-Aldrich’s assertion that this motion would become moot should the Board grant Sigma-Aldrich’s Motion No. 1 to substitute the Count, by saying that the Board grant that motion and redeclare the interference these claims should be designated as corresponding to the Count ab initio.

For all these reasons CVC asks the Board to grant its Motion No. 4.

* CVC captioned this as a Miscellaneous Motion.

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