Senior Party Toolgen and Junior Parties The Broad Institute, Massachusetts Institute of Technology, and Harvard University (collectively, "Broad") in Interference No. 106,126 and University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") in Interference No. 106,127 each filed Lists of Proposed Motions that the Board considered today and responsive thereto will issue its rulings shortly (see "The CRISPR Chronicles: Enter Toolgen"). The CVC list will be the subject of this post.
CVC's list contains six proposed motions and in some respects mirrors the motions filed in on-going Interference No. 106,115 against Broad (see "CRISPR Interference Parties Propose Motions"). CVC Motion No. 1 under 37 C.F.R. §§ 41.121(a)(1)(ii) and 41.208(a)(3) seeks to be awarded priority to their first-filed priority applications (specifically, in the alternative either the P1 or P2 applications), as set forth in this diagram:
As shown in the diagram, all of CVC's applications having allowable claims that have formed the jurisdictional basis for this interference depend on the four provisional applications designated P1 through P4, and have an earliest priority date of May 25, 2012. Given their status as the discoverers of CRISPR (for which Jennifer Doudna and Emmanuelle Charpentier received the 2020 Nobel Prize in Physiology and Medicine), it is unsurprising that CVC has the earliest priority date. Whether this is enough to constitute a constructive reduction to practice is the issue in the 106,048 Interference; CVC is careful to argue that "no estoppel or prior decision of the PTAB weighs against authorizing this motion" and "[t]he PTAB's Decision on Motions in Interference No. 106,115 is not final, as it is still subject to review by the Federal Circuit," citing Vardon Golf Co. v. Karsten Manufacturing Corp., 294 F.3d 1330 (Fed. Cir. 2002). In addition, CVC notes that the Count in this interference is not the same as the Count in the '048 Interference. CVC also requests that the Board increase the page limits for its brief to 55 pages, and exclude claim charts from that limit, "[d]ue to the complexity of the issues and extensive evidentiary record implicated by this Motion."
CVC Motion No. 2 seeks to have the Board deny the benefit of Toolgen's priority application, U.S. Provisional Application No. 61/717,324, filed October 12, 2012. This proposed motion is devoid of any further asserted bases for the Board to grant leave to file this motion, stating merely that "CVC should be given the opportunity to develop its arguments in full."
CVC Motion No. 3 under 37 C.F.R. § 41.121(a)(3) and Standing Order, ¶ 203.2, seeks to have the Board add Toolgen's U.S. Patent No. 10,851,380 to this interference. The grounds for this motion is that the '380 patent contains at least one claim within the scope of the Count, specifically that recites "methods of introducing a site-specific, double-stranded break at a target nucleic acid sequence in a eukaryotic cell, the method comprising introducing a chimeric guide RNA (i.e., a single guide RNA) and Cas9 into the eukaryotic cell." In the alternative, CVC asks the Board to add the '380 patent to this interference sua sponte.
CVC's Motion No. 4 under 37 C.F.R. § 41.121(a)(1) is for judgment that Toolgen's involved claims corresponding to the Count are unpatentable. CVC contends that Toolgen's involved claims are invalid under 35 U.S.C. § 102 over CVC's U.S. Patent Application Publication No. 2014/0068797, which claims the benefit of priority to the P1 provisional application illustrated above. Specifically, CVC notes that "ToolGen added a codon-optimization limitation to overcome an anticipation rejection over the '797 publication" and CVC's P1 and P2 priority applications disclose codon optimization. Presciently addressing the expected response to this argument, that as Broad has contended in the '048 and '115 Interferences that CVC's P1 and P2 provisional applications do not disclose eukaryotic CRISPR embodiments, CVC's brief notes that "[an] anticipatory reference need not demonstrate utility," citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005). And CVC argues that "[b]ecause the requirements for an anticipatory reference differ from the written description requirement to support a constructive reduction of practice of a count, the Board's Decision on Motions in the '115 interference between CVC and the Broad Institute does not control here." Finally, CVC argues that the Board authorizing its Motion No. 4 would be consistent with 37 C.F.R. § 41.1(b) "to secure the just, speedy, and inexpensive resolution of every proceeding before the Board" and inter alia that "ToolGen aggressively sought this interference via petition and ex parte prosecution, which included inaccurate characterizations of what CVC's P1 and P2 disclose, including incorrect statements regarding the necessity of codon optimization and NLSs for functionality in eukaryotes." As with Motion No. 3, CVC asks the Board to increase the page limit to 40 pages and to exclude claim charts from this number.
CVC's Motion No. 5 (contingent) is for judgment that Toolgen's claims are unpatentable under 35 U.S.C. §§ 102 or 103 over Sigma's U.S. Application Publication No. 2016/0298138, which claims priority to its first provisional application filed October 23, 2012, should the Board grant CVC's Motion No. 2 that Toolgen's application in interference is not to be entitled to priority its U.S. Provisional Application No. 61/717,324, filed October 12, 2012.
Finally, CVC's Motion No. 6 under 37 C.F.R. § 41.208(a)(4) seeks judgment based on priority.
The Board having set February 4th as the date for a teleconference with each set of parties jointly, the Board's Order notifying the parties as to which motions they are authorized to file and which have been deferred or denied is expected within the week. During the call, the parties were able to inform the Board more specifically of the bases for their motions, provide a proffer if the Board needs additional evidence or information, and provide opposing parties the opportunity to give the Board their views. With the Order on which motions are permitted the Board will also set a briefing schedule. All these events will be the subject of future posts.
* As a reminder, an interference proceeds in two stages. The first stage involves the parties presenting motions that can modify the count, have certain claims declared outside the scope of the count (or vice versa), seek to establish an earlier priority date, and ask for a finding that their opponents' claims are invalid under any of the provisions of the patent statute. If these motions are not decided in a way that would disqualify one or both parties, then the interference will move to a second stage, where in each Interference the Junior Party (CVC, in the '126 Interference and CVC in the '127 Interference) will present its proofs of conception and reduction to practice and the Senior Party Toolgen will be permitted to oppose and/or present its own priority evidence. The Senior Party is under no obligation to present proofs earlier than its earliest filing date unless the Junior Party evinces evidence of (at least) earlier conception. In practice, the parties can both be expected to submit their priority evidence.
