By Kevin E. Noonan —

Pursuant to the Patent Trial and Appeal Board Order issued November 29, 2021, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") on December 17, 2021 filed its Responsive Preliminary Motion No. 1 in Interference No. 106,132 (which names Sigma-Aldrich as Senior Party), asking the Board for benefit of priority to U.S. Provisional Application No. 61/652,086, filed May 25, 2012 ("P1"), or in the alternative either U.S. Provisional Application No. 61/716,256, filed October 19, 2012 ("P2"); U.S. Provisional Application No. 61/757,640, filed January 28, 2013 ("P3"); U.S. Application No. 13/842,859, filed March 15, 2013; U.S. Application No. 14/685,504, filed April 13, 2015; or U.S. Application No. 15/138,604, filed April 26, 2016, pursuant to 37 C.F.R. §§ 41.121(a)(1)(ii) and 41.208(a)(3) and Standing Order ¶ 208.4.1, contingent on the Board granting Sigma-Aldrich's Substantive Preliminary Motion No. 1 to Substitute the Count.

The relationships between the patents and applications in the '132 interference are set forth in this chart (filed in CVC's earlier preliminary motion in Interference No. 106,115):

The significance of the Board granting this motion with regard to the P1 or P2 provisional applications would be that CVC would be Senior Party, with all the presumptions benefits of Senior Party status.

CVC has filed similar motions in earlier Interferences (in the '115 Interference and in Interference No. 106,127) without (at least complete) success (as to the '115 Interference; the Board has not yet ruled on the corresponding motion in the '127 Interference) and in this Interference with regard to the Count as declared.  Unlike in each of these cases, however, CVC seeks priority benefit to the earliest of its priority documents which focuses the argument to what was disclosed therein.  Specifically, the brief references the disclosure for using sgRNA in a pre-assembled ribonucleoprotein complex with Cas9 microinjected into fish embryos, human cells, and fruit fly cells and produce double-stranded breaks at specific target sequences followed by homology-directed repair using endogenous cellular machinery.  Because these functions comprise the elements of CRISPR as recited in the Substitute Count, CVC argues they are entitled to P1's May 26, 2012 priority date (or in the alternative the filing dates of the P2, P3, or other utility applications set forth in the brief).

The brief sets forth the legal requirements for priority benefit (i.e., describing one embodiment falling within the scope of the Count; Falkner v. Inglis, 448 F.3d 1357, 1362 (Fed. Cir. 2006)) as understood by one of ordinary skill in the art (setting forth the characteristics of this entity).  As part of the latter standard, the brief sets forth the level of skill in the art at the priority date, specifically with regard to ZFN- and TALEN-mediated methods for site-specific DNA cleavage in eukaryotic cells, as models for CRISPR-Cas9 mediated cleavage (noting that Sigma-Aldrich's '204 application in interference makes this comparison expressly).  And in addition, the brief notes that those in the field pursuing eukaryotic CRISPR embodiments themselves adapted existing ZFN and TALEN protocols for performing sgRNA comprising CRISPR systems.

In making these arguments, CVC disparages (gently) the Board's decision in the '115 Interference granting their Preliminary Motion No. 1 only in part (i.e., to confer priority benefit to their P3 provisional application only).

The brief then turns to Sigma-Aldrich's Proposed Substitute Count No. 2:

Claim 156:       

[1] A method of cleaving or editing a target DNA molecule or modulating transcription of  at least one gene encoded thereon, the method comprising:
    contacting [in a eukaryotic cell] … a target DNA molecule … with an engineered and/or non-naturally-occurring Type II [CRISPR] system comprising:
    [2] a) a single molecule DNA-targeting RNA comprising
        [3] i) a targeter-RNA …
        [4] ii) an activator-RNA …
        [5] wherein the targeter-RNA and the activator-RNA are covalently linked to one another with intervening nucleotides; and
    [6] b) a Cas9 protein,
    [7] wherein the single molecule DNA-targeting 1 RNA forms a complex with the Cas9 protein, thereby targeting the Cas9 protein to the target DNA molecule,
[8] 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.

Claim 157:

[9] The method of [Elements [1]-[8]], wherein, prior to the contacting step, the method comprises: introducing [the sgRNA and the Cas9] into the eukaryotic cell containing the target DNA molecule …

Claim 164:

[10] The method of [Element [9]], 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.

wherein the bold and bracketed numbers represent the elements in the Proposed Substitute Count that CVC will use to compare its claims to the Count for establishing correspondence therewith.  The brief then sets forth a table of this correspondence between the disclosure and the recited limitations in Sigma-Aldrich's Proposed Substitute Count:

stating "[i]n light of general knowledge in the art and the POSA's high degree of skill, P1 conveys possession of at least one embodiment within the scope of PC2 and all the detail needed to practice it."  The brief then sets forth the details of this correspondence for each of these embodiments as disclosed in the P1 specification (following the same template for this argument regarding the P1 disclosure that CVC had used in similar Motions in other Interferences, for both written description and enablement).  In particular, the brief follows the rubrics of In re Wands to establish enablement, and as CVC has done in earlier interferences the brief sets out post-filing evidence by "independent researchers" showing that the disclosed methods achieved and were adopted for performing CRISPR in eukaryotic cells.  Finally, in this regard (and again reprising earlier arguments) CVC sets forth and rebuts purported "concerns" in the art showing them to have been "unfounded."

The brief then argues that, in the alternative, its P2 and P3 applications are constructive reductions to practice of CRISPR embodiments falling within the scope of Sigma-Aldrich's Proposed Substitute Count ("The same disclosures in P1 are carried forward in P2 and P3"), and further that its '859, '504' and '604 applications provide constructive reductions to practice of CRISPR embodiments falling within the scope of Sigma-Aldrich's Proposed Substitute Count.

The brief concludes with a brief argument that "although not required, those in the field, including the inventors, expected CRISPR-Cas9 to work in eukaryotes" (including "[t]estimony from Luciano Marraffini, Erik Sontheimer, Rodolphe Barrangou, Dana Carroll, Samuel Sternberg, and Jennifer Doudna) and that there is a continuous chain of CVC's involved applications as set forth in the drawing above.

By Kevin E. Noonan —

The Patent Trial and Appeal Board has set February 4th at 1:00 pm EST for the Oral Hearing in the Priority Phase of Interference No. 106,115 between the Broad Institute, Harvard University, and MIT (collectively, "Broad") as Senior Party and the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") as Junior Party.  The hearing will be virtual (by telephone, audio only) and will be available to the public upon request under 37 C.F.R. § 41.124(c).  The Parties will each have 20 minutes for argument, and each party will be able to reserve 5 minutes for rebuttal, with the Junior Party, CVC, arguing first.

The Board's Order, issued January 13th, informs the parties, pursuant to 37 C.F.R. §§ 41.121(b) and 208(b), that:

Each party bears the burden of presenting persuasive arguments and evidence in the motions it files to establish that it is entitled to relief requested in that motion.  . . .  Thus, the written motions and supporting evidence filed by the parties, as well as the corresponding oppositions, replies, and supporting evidence, constitute the "trial" of an interference proceeding.  To that end, trial testimony of witnesses is presented in the proceeding through written declarations and transcripts of cross-examination depositions submitted with the parties' briefs.  Oral argument in an interference serves as means for the Board to question the parties on issues presented in their briefs and for the parties to summarize their arguments and the supporting evidence.  Neither the oral argument nor demonstrative exhibits used during the oral argument will fulfill the requirement that each party must meet its burden in the briefs previously filed.  Neither the oral argument nor demonstrative exhibits constitute evidence (other than possible admissions).  The demonstratives may not introduce new evidence or argument.  Demonstrative exhibits must cite to the location of the evidence in the record.

Regarding public access, interested members of the public can request access by e-mailing the request to PTABHearings@uspto.gov.  The parties can object to access if that objection is provided at least five business days prior to the oral hearing date.