On November 19th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its Substantive Miscellaneous Motion No. 4 in Interference No. 106,132 (which names Sigma-Aldrich as Senior Party), asking the Patent Trial and Appeal Board to add Sigma-Aldrich's U.S. 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, and 21-22 of the '716 patent as corresponding to the Count, pursuant to 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208(a)(2) and Standing Order ("SO") 203.2.  CVC's substantive argument is 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 identifies what it characterizes as "nominal differences" between the Count and the claims to be designated 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 render these claims patentably distinct from the Count, as evidenced CVC argued by "highly similar claims already being involved in this proceeding as part of Sigma's U.S. Application No. 15/456,204."  These claims satisfy the test set forth under 37 C.F.R. § 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 argues, citing Desjardins v Wax, Interference No. 105,915, Paper 125, 17-20 (P.T.A.B. Jan. 21, 2014).  The basis for CVC's argument that the distinctions set forth above do not render these clams patentably distinct is that these distinctions are found in the cited prior art or were otherwise "well known for year," the brief the setting forth reasons for the Board to reach this conclusion.  Finally, CVC argues there are no objective indicia (or secondary considerations) that would provide the missing distinctions.

The brief then explicates with particularity the disclosures in the cited references which in combination with the limitations in the Count satisfy the requirements for obviousness.  These include 1) disclosure of dual-guide (dgRNA) and single-guide (sgRNA) RNA embodiments of CRISPR in the Jinek 2012 reference; and 2) the use of the nuclear localization signal from SV40 T antigen as the "canonical NLS for targeting proteins to the nucleus" in the prior art, citing references in exhibits.  The brief then subjects each of the claims CVC asks the Board to designate as corresponding to the count to the test established by the Supreme Court in Graham v. John Deere and KSR v. Teleflex  Int'l to support its obviousness argument with regard to those claims.

In addition, the brief sets forth a comparison between the claims CVC asks the Board to designate as corresponding to the Count with Sigma-Aldrich's claims already involved in the interference the inclusion of which the Senior Party has not contested:

Finally, CVC argues that it should prevail against Sigma-Aldrich in this interference based on nothing more than the disclosures in U.S. Provisional Application No. 61/652,086, filed May 25, 2012 ("P1"), and U.S. Provisional Application No. 61/716,256, filed October 19, 2012, ("P2"), the benefit of priority to which CVC argued in its Substantive Preliminary Motion No. 1.