CVC Files Reply to Senior Party Sigma-Aldrich's Opposition to CVC's Substantive Preliminary Motion No. 3 in Interference No. 106,132

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP

On November 19th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its Substantive Preliminary Motion No. 3 in Interference No. 106,132 (which names Sigma-Aldrich as Senior Party), asking the Patent Trial and Appeal Board to substitute the Count of the interference pursuant to 37 C.F.R. §§ 41.121(a)(1)(iii) and 41.208(a)(1).  On February 18th, Senior Party Sigma-Aldrich filed its Opposition, and on April 7th CVC filed its Reply.

The basis for CVC's motion was to change the Count to be limited to so-called "single (RNA) molecule guide RNA (sgRNA) species."  CVC argued that substituting this Count is more symmetrical with CVC's portion of the Count and "avoids inconsistency" with the Counts in related interferences (see "CRISPR Battle Joined Again"; "The CRISPR Chronicles: Enter ToolGen"; and "Sigma-Aldrich Joins the CRISPR Interference Fray").

Sigma-Aldrich responded in its Opposition that, contrary to any nebulous (and "self-serving") "inconsistency," what CVC is actually trying to accomplish is to prevent Sigma-Aldrich from asserting its "best proofs" in the interference.  Sigma-Aldrich contended it is the only party in any of the pending interferences -- CVC, ToolGen, and Broad -- having proofs of reducing to practice CRISPR in eukaryotic cells having both single-molecule RNA (sgRNA) and dual-molecule ("dgRNA") RNA species.  CVC's proposed motion on its face and according to its arguments in its Motion No. 3 would change the Count to exclude dual-molecule RNA-comprising eukaryotic CRISPR.  Sigma-Aldrich argues that any concerns CVC asserted regarding "inconsistency" and "the public interest" would be served by the Board granting its own Motion No. 1 (while characterizing CVC's concerns in this regard as being "á la Chicken Little's dire predictions, . . . highly remote and purely speculative at best").  Also raising questions about CVC's "ulterior motives," Sigma-Aldrich contended that CVC's proposed Count would "not []enable CVC to better make out CVC's priority case, but instead [would] hamstring Sigma from making out Sigma's priority case" which "is not a legitimate basis to seek to change the count."  And CVC had not carried its burden in making a showing that they are entitled to the relief sought, Sigma-Aldrich argued, because they have failed to assert the conventional basis for such a motion -- that it would enable CVC to proffer its best proofs in the interference but rather is a "strategic maneuver to try to prejudice Sigma's ability to proffer its proofs of invention."  Sigma-Aldrich also argued that CVC's Motion No. 3 would be moot should the Board grant Sigma-Aldrich's own motion (No. 1) to change the Count.

In its Reply, CVC argues that the Count "should reflect the common invention defining multiple pending, related interferences -- single-guide CRISPR-Cas9 systems useful in eukaryotic cells."  CVC identifies Sigma-Aldrich's portion of the McKelvey Count in this interference as an outlier amongst the CVC portion of the Count (and the Counts in interference with Broad and ToolGen) because it is "not aligned with CVC's half or any other parties' halves."  CVC cites the Board's decision to challenge Sigma-Aldrich's arguments that its disclosure of dgRNA CRISPR species mandates a generic-guide Count, based on the Board's decision in the '115 Interference, citing Regents of the University of California v. The Broad Institute, Int. No. 106,115 Paper 877 (Decision on Motions) at 39:22-40:8 (P.T.A.B. Sept. 10, 2020).  Following Board rules setting out the proper structure of Reply brief in an interference (§ 41.122 and S.O. ¶122.3.2), CVC sets out it responses and rebuttals of each of Sigma-Aldrich's arguments in its Opposition.  For example, to Sigma-Aldrich's argument that CVC's Motion No. 3 will be mooted if the Board grants Sigma-Aldrich's Motion No. 1 to change the Count, CVC argues that the subject of Sigma-Aldrich's Motion No. 1 is different (being directed to "whether or not the scope of the interference is limited to cleavage plus donor integration") than the question here regarding limiting the Count to sgRNA CRISPR embodiments.

CVC also argues that whether to change the scope of the Count in this interference to be consistent with the Counts in related interferences is within the Board's sound discretion, citing Hitzeman v. Rutter, 243 F.3d 1345, 1359 (Fed. Cir. 2001), generally for the principle and In re Vivint, Inc., 14 F.4th 1342, 1351 (Fed. Cir. 2021), specifically in support of this argument.  In this regard, CVC also refutes Sigma-Aldrich's claim that it is the only party in these interferences to assert dgRNA CRISPR species, reminding the Board that Broad asserted similar "best proof" arguments in motions in the '115 interference (which the Board denied; see "PTAB Denies Broad Motion No. 2 to Substitute the Interference Count").  And CVC argues that granting its Motion No. 3 is consistent with fairness and would "limit the inherent prejudice to CVC that results from arbitrarily giving Sigma special treatment" in an interference that "Sigma requested."  CVC also argues that Sigma-Aldrich has not established that its "best proofs" are outside the scope of the CVC's proposed substitute Count, and that "substituting the Count will streamline the issues in the Interference," inter alia, by not "impact[ing]the designation of claims, priority benefit, or patentability over the [prior] art."

For all these reasons CVC asks the Board to grant its Motion No 3.

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