On December 3rd, Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) filed its Contingent Preliminary Motion No. 2 in Interference No. 106,133 (which names Sigma-Aldrich as Senior Party), asking the Patent Trial and Appeal Board to add claims 52-54 of Broad Application No. 16/177,403 to the interference, pursuant to the provisions of 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208 and Standing Order ¶ 203.2.  The motion is contingent on the Board granting Broad's Substantive Preliminary Motion No. 1 to substitute the Count.

These claims recite a CRISPR method in eukaryotic cells that cleaves both strands and repairs the break by integration of a template polynucleotide.  Claim 52 is generic with regard to the guide RNA species, comprising dual-molecule and single-molecule (sgRNA) species:

52.  A method comprising: introducing into, or expressing in, a eukaryotic cell having a DNA molecule,
    (I) a Cas9 protein or one or more nucleotide sequences encoding the Cas9 protein,
    (II) an RNA or one or more nucleotide sequences encoding the RNA, the RNA comprising:
        (a) a first RNA comprising a first ribonucleotide sequence and a second ribonucleotide sequence, and
        (b) a second RNA, and
    (III) a template polynucleotide,
    wherein, the second RNA forms an RNA duplex with the second ribonucleotide sequence, and wherein, in the eukaryotic cell, the first ribonucleotide sequence directs the Cas9 protein to a target sequence of the DNA molecule, whereby the Cas9 cleaves both strands of the DNA molecule and the cleavage is repaired by integration of the template polynucleotide into  the DNA molecule in the eukaryotic cell.

Claim 53 (dual molecule RNA species) and claim 54 (single-molecule RNA species) recite the two alternative species.  These claims were deemed allowable by the U.S. Patent and Trademark Office Examiner on November 15, 2021.

The brief sets forth the four requirements for adding a claim to an interference:

(1) Identify the application or patent to be added;

(2) Certify that a complete copy of the application file for the application or patent has been served on all opponents except if it belongs to the opponent or if the Office has posted it electronically;

(3) Indicate which claims of the patent or application should be designated as corresponding to the count and show how the claims correspond to the count(s);

and

(4) Explain whether there are alternative remedies; if so, why alternative remedies are not adequate; and what attempts, if any, have been made to have the examiner recommend declaration of another interference.

Except for reiterating the grounds/bases for the Board to substitute the Count as declared for Proposed Substitute Count 3 (set forth more thoroughly in Broad's Substantive Preliminary Motion No. 1), the remainder of the brief sets out Broad's compliance with these four provisions of Rule 203.2.