Following a telephone conference held on August 16th (a transcript of which can be found here) between the Board and representatives of Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") and Senior Party Sigma-Aldrich, the Board issued its Order on September 20th authorizing motions and setting times under 37 C.F.R. §§ 104(c) and 121.

As it had in its Order setting motions and times in related Interference No. 106,133 between Sigma-Aldrich and Junior Party the Broad Institute, Harvard University, and MIT, the Order begins with the Board's rejection of any of these motions being "threshold" motions (as the parties had argued), stating that "[p]atentability over the prior art is not now, and never has been, a 'threshold issue.'"  Further, the Board stated that "a holding during the course of interference that a party's claims are unpatentable over prior art does not necessarily deprive that party of standing on the central issue of an interference—priority," citing  37 C.F.R. § 41.201, noting that a party in an interference having claims deemed unpatentable "may still have a basis to show the opponent is not entitled to a patent because the opponent was not the first to invent the interfering subject matter."  This raises the possibility that the outcome of an interference may be that neither party is entitled to a patent on claims falling within the scope of the Interference Count.

Regarding Junior Part CVC's Motions List, the Board DEFERRED CVC'S Substantive Preliminary Motion No. 1, which CVC characterized as a "threshold" motion, that sought to have a finding of no interference-in-fact based on CVC's allegations that  Sigma-Aldrich's application-in-interference was properly governed under the "first inventor to file" provisions of the Leahy-Smith America Invents Act; the basis for this allegation was that Sigma-Aldrich's application-in-interference "contains or contains at any time" (emphasis in brief) subject matter not entitled to priority to an application filed prior to enactment of the AIA.  The Board considered this not as a motion for no interference-in-fact, as CVC maintained, but rather as a motion for unpatentability and thus agreed to consider granting the motion and hearing CVC's arguments during the priority phase of the interference.

The Board GRANTED CVC leave to file Substantive Preliminary Motion No. 2 under 37 C.F.R. §§ 41.121(a)(1)(ii) and 41.208(a)(3) for benefit of priority to U.S. Provisional Application Nos. 61/652,086, filed May 25, 2012 ("P1"), or 61/716,256, filed October 19, 2012 ("P2").  The Board designated this as CVC SUBSTANTIVE MOTION 1 and also granted CVC's request to extend the page limit for CVC's Motion and Sigma-Aldrich's Opposition to 45 pages.

The Board GRANTED CVC leave to file Substantive Preliminary Motion No. 3 seeking to have the Board deny Sigma-Aldrich benefit of priority to its earliest provisional application, No. 61/734,256, filed December 6, 2012.  The Board designated this as CVC SUBSTANTIVE MOTION 2.

The Board GRANTED CVC leave to file Substantive Preliminary Motion No. 4 seeking the Board to change the Count, including the alternative portion of the Count to recite Sigma-Aldrich's involved claim 33 instead of 31 as declared.  The Board designated this as CVC SUBSTANTIVE MOTION 3.

The Bared DEFERRED CVC's proposed Preliminary Motions 5-7 which sought to file motions under 37 C.F.R. § 41.121(a)(1) for unpatentability of Sigma-Aldrich's claims in this interference.  The Board noted that it would consider authorizing these motions during the priority phase.

The Board GRANTED CVC leave to file proposed Contingent Miscellaneous Motion No. 8 under 37 C.F.R. § 41.121(a)(3), asking the Board to add claims of U.S. Patent Nos. 10,731,181 and 10,745,716, designating this motion as CVC MOTION 4.  The Board DENIED (without prejudice).  The Board DENIED CVC leave to file Contingent Miscellaneous Motion No. 9 under 37 C.F.R. § 41.121(a)(3), asking the Board to add claims in Sigma-Aldrich's U.S. Patent Application Nos. 15/188,927; 15/188,931; 16/943,767; and 17/208,477 to this Interference because these claims had not yet been allowed.

Finally, CVC's request to file a motion under 37 C.F.R. § 41.208(a)(4) seeking judgment based on priority was DEFERRED until the priority phase.

Turning to Sigma-Aldrich's Motions list, the Board GRANTED Sigma-Aldrich leave to file its proposed Preliminary Motion No. 1 under 37 C.F.R. § 41.121(a)(1)(i) to change the Count to Count 2:

Proposed Count 2 (reciting in the alternative claim 31 of Sigma-Aldrich's Application No. 15/456,204 as in the Count as declared):

156.  A method of cleaving or editing a target DNA molecule or modulating transcription of at least one gene encoded thereon, the method comprising:
contacting a target DNA molecule having a target sequence with an engineered and/or non-naturally-occurring Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)—CRISPR associated (Cas) (CRISPR-Cas) system comprising:
    a) a single molecule DNA-targeting RNA comprising
        i) a targeter-RNA that hybridizes with the target sequence, and
        ii) an activator-RNA that hybridizes with the targeter-RNA to form a double-stranded RNA duplex of a protein-binding segment,
wherein the targeter-RNA and the activator-RNA are covalently linked to one another with intervening nucleotides; and
    b) a Cas9 protein,
wherein the single molecule DNA-targeting RNA forms a complex with the Cas9 protein, thereby targeting the Cas9 protein to the target DNA molecule
whereby said target DNA molecule is cleaved or edited or transcription of at least one gene encoded by the target DNA molecule is modulated, and
wherein said contacting occurs in a eukaryotic cell.

157.  The method of Claim 156, wherein, prior to the contacting step, the method comprises:
introducing into the eukaryotic cell containing the target DNA molecule:
    1) the single molecule DNA-targeting RNA, or a DNA molecule comprising a nucleotide sequence that (i) encodes the single molecule DNA targeting RNA and (ii) is operably linked to a regulatory element operable in said eukaryotic cell; and
    2) the Cas9 protein, an RNA molecule comprising a nucleotide sequence encoding the Cas9 protein, or a DNA molecule comprising a nucleotide  sequence that (i) encodes the Cas9 protein and (ii) is operably linked to a regulatory element operable in said eukaryotic cell.

164.  The method of Claim 157, wherein the method comprises creation of a double strand break in the target DNA molecule which is repaired by a homology-directed repair mechanism which incorporates a sequence of a donor polynucleotide into the target DNA molecule, thereby editing the target DNA molecule.

(CVC Application No. 15/947,680)

The Board designated this as SIGMA MOTION 1.

The Board DENIED Sigma-Aldrich leave to file its proposed Contingent Motion No. 2 to deny CVC benefit of Application Nos. 61/757,640, filed Jan. 28, 2013 ("CVC P3"), or 61/765,576, filed Feb. 15, 2013 ("CVC P4"), under 37 C.F.R. § 41.121(a)(1), as "moot ab initio," on the grounds that:

[A] motion to change a count must show why the movant should be accorded any benefit for the proposed count and may overcome the presumption that the opponent is entitled to its earliest accorded benefit date by showing in the motion why the opponent should not be accorded benefit of an earlier application with respect to the proposed count. (See Standing Order 8 ¶ 208.2.)

And thus any arguments in this proposed motion should be presented in SIGMA MOTION 1.

The Board DEFERRED until the priority phase Sigma-Aldrich's proposed Substantive Preliminary Motion No. 3 that CVC's claims were unpatentable.

The Board DISMISSED (as moot) Sigma-Aldrich's request for a Protective Order, instead the Board issuing an ORDER that Sigma-Aldrich could submit a protective order to keep its Priority Statement under seal until the priority phase of the interference, suggesting Sigma-Aldrich use the protective order filed in Interference 106,115 "as reference."

Sigma-Aldrich's request to file a motion under 37 C.F.R. § 41.208(a)(4) seeking judgment based on priority was DEFERRED until the priority phase.

In addition to these Motion requests, Sigma-Aldrich requested that the requirement under 37 C.F.R. § 41.121(d) that the parties file separate statements of material fact be waived; the Board DENIED this request.  The Board GRANTED the parties' request that the deadlines for filing and service be extended to 8:00 pm for filing and 11:00 pm, respectively, for all papers filed and served in the interference.  The Board WAIVED the requirement for sequential exhibit numbers and ORDERED that exhibits could be filed within two business days of the due date for any paper in which they were cited.  The Board also granted Sigma-Aldrich's request that it correct certain typographical errors in the caption.

The Board set out the following briefing schedule, subject to agreement by the parties to change the schedule for TIME PERIODS 1-6.

TIME PERIOD 1 ..........................................................29 October 2021
File motions
File (but serve one business day later) priority statements
TIME PERIOD 2 ........................................................10 December 2021
File responsive motions to motions filed in TIME PERIOD 1
TIME PERIOD 3 ...........................................................21 January 2022
File oppositions to all motions
TIME PERIOD 4 ...............................................................4 March 2022
File all replies
TIME PERIOD 5 ...............................................................15 April 2022
File request for oral argument
File motions to exclude.
File observations
TIME PERIOD 6 ..................................................................6 May 2022
File oppositions to motions to exclude
File response to observations
TIME PERIOD 7 .................................................................20 May 2022
File replies to oppositions to motions to exclude
DEFAULT ORAL ARGUMENT DATE ......................................................TBD