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Junior Party CVC Files Response to Sigma-Aldrich’s Objection to Preliminary Motion No. 4 | McDonnell Boehnen Hulbert & Berghoff LLP

By on May 17, 2022 0

November 19, Junior Party at the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, “CVC”) filed Preliminary Substantive Motion No. 4* in Interference No. 106,132, in which CVC proposed to add U.S. Patent Nos. 10,731,181 and 10,745,716 main party Sigma-Aldrich to the interference and designate claims 1 to 17 of the ‘181 patent and claims 2 to 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 Section 203.2 of the Regulations (“OS”). On February 18, senior party Sigma-Aldrich filed its opposition to this motion and on April 7, CVC filed its reply.

The basis of CVC’s Motion 4 was that these assertions would have been obvious from 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 called “nominal differences” between the number and claims to be named 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 of 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 “very similar claims already implicated in this proceeding under U.S. Application No. 15/456,204 of Sigma.” )(2) and Section ¶ 208.3.1 of the Regulations that claims match count where “the subject matter of count, if treated as prior art, would have anticipated or made obvious the object of [each] claim.” This test is satisfied if additional references are invoked to establish a At first glance case of evidence CVC argued, citing Desjardins versus Wax, Interference No. 105,915, Paper 125, 17-20 (PTAB 21 Jan. 2014). The basis of CVC’s argument that the distinctions set forth above do not make these clams patentably distinct was that these distinctions were in the cited prior art or were otherwise “well known”, the specification setting out the reasons why the Commission has come to this conclusion. Finally, CVC argued that there is no objective clue (or secondary considerations) that would provide the missing distinctions.

Sigma-Aldrich’s opposition argued that CVC failed to apply the proper “two-way test” to determine whether a claim matches an interference count. Sigma-Aldrich cited a decision by 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 against Fujita, 1999 Pat. App. LEXIS 7, *49-50, 53 USPQ2d (BNA) 1234, 1248 (BPAI 16 November 1999). Noting that the patent interference rules were amended in 2004, Sigma-Aldrich sets out the current rules and the illustrated application of those rules in Ledenev v. Adest, 2020 Pat. App. LEXIS 6912, *35-36, Decision on Motions, at 31, 35 (PTAB Mar 25, 2020) (JTM) (proposing to add patents to interference, “[t]The standard to be applied is whether the claim is clearly distinct from the head. . . . [T]it loads placed on mover [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]the 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 implicated patent or application matches the interference number. Sigma-Aldrich further argued in this regard that what CVC stated in its Motion No. 4 is whether the narrower interference count would make the 181 or 716 patent claims obvious. fact was the reverse evaluation, if “the broader rendering of the claim[s] evident the narrower count(short emphasis) according to Sigma-Aldrich. Finally, Sigma-Aldrich argued that CVC’s No. 4 Motion would become moot if the Commission granted its No. 1 Preliminary Motion to Amend Count.

In its response, CVC justified its reliance on one-way analysis for claim matching on 37 CFR § 41.207(b)(2), which CVC says is used by the Board in deciding whether to add a claim. to existing interference, citing Ledenev v. AdestNo. 106,112, document 137, decision on the motions, p. 30 (PTAB March 25, 2020) and Ritzberger versus Durschang, No. 106,012, Paper 210, Decision on Priority and Other Motions, p. 17-25 (PTAB 29 Sept. 2016). Additionally, according to CVC, Sigma-Aldrich relies on outdated interference rules (37 CFR § 1.642 (2004)) and authority relying on those rules, Winter against Fujita. Regarding Sigma-Aldrich’s citation of more current rules, § 41.202(a), § 41.203(a), and § 41.203(d), CVC argues (somewhat oddly) that “[n]o no matter what these rules say, Ledenev and Ritzberger both applied a one way account in relation to the analysis of claims under Rule 41.207(b)(2) when deciding motions to add a patent to interference” (emphasis added), while further indicating that “[t]The analysis of the PTAB in these cases was correct and dictated by the only logical reading of the rules cited by Sigma.” The memorandum goes on to explain for the Board Why the Council’s reasoning was “the only logical reading” of these rules.

Having set out the merits of the one-way test under the rules as the Board interpreted them under Ledenev and Ritzberger, CVC then recounts how, in its motion, it applied the rules to the claims at issue in that motion. Regarding Sigma-Aldrich’s attempt to distinguish these claims with respect 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” count. McKelvey in the interference. And even if the Commission grants Sigma-Aldrich’s Motion No. 1 to substitute count CVC submits that because this replacement count contains the portion of Sigma-Aldrich’s count, these claims would meet the correct one-way test.

Finally, CVC rebuts Sigma-Aldrich’s assertion that this motion would become moot if the Commission granted Sigma-Aldrich’s Motion No. 1 to replace the Chief, saying that if the Commission granted this motion and redeclared interference , these claims should be designated as corresponding to the count ab-initio.

For all these reasons, CVC asks the Commission to grant its request n° 4.

* CVC captioned this as a miscellaneous motion.