On January 9th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its motion in opposition to Senior Party the Broad Institute (joined by Harvard University and MIT) Substantive Motion No. 4 asking the Patent Trial and Appeal Board (PTAB) for priority to U.S. Provisional Application No. 61/736,527 to Zhang (termed "Zhang B1" in the motion), pursuant to 37 C.F.R. § 41.121(a)(1)(ii) and § 41.208(a)(3) and Standing Order ¶ 208.4.1.

The Broad's brief began by setting forth the standard for obtaining the relief requested:  "a party need only show a constructive reduction to practice—an enabled written description—of a single species within the count," citing Hunt v. Treppschuh, 523 F.2d 1386, 1389 (CCPA 1975); Weil v. Fritz, 572 F.2d 856, 865 n.16 (CCPA 1978); and Falkner v. Inglis, 448 F.3d 1357, 1362 (Fed. Cir. 2006).  According to the Broad, Zhang B1 "provides working examples and embodiments that meet each and every limitation of both halves of Count 1" and thus evinces to the skilled worker possession of an embodiment within the scope of the Count.

CVC's argument in opposition is succinct:  the basis for the Broad's constructive reduction to practice "relies exclusively on a 'chimeric guide RNA' that a [person of ordinary skill in the art or] POSA could not have made and used in a cell without undue experimentation."  This argument focuses (as the Broad did in its brief) on "Embodiment 17" (E17), wherein a chimeric guide RNA is expressed by a cell comprising both U and T bases:

But there is no evidence that a chimeric guide RNA could be made inside a cell wherein T bases are incorporated using an RNA polymerase at specific positions, and thus embodiments of comprising such chimeric guide RNA would not have been enabled as of the December 12, 2012 filing date of the Zhang B1 provisional application.

The brief sets forth an explication of the technical and scientific basis for their non-enablement argument, particularly the biology behind RNA production using RNA polymerase III.  CVC's brief further asserts that it is the Broad's burden to show that the Zhang B1 provisional application enables at least one embodiment of a claim that corresponds to the Count, under 37 C.F.R. 41.201, Falkner v. Inglis, 448 F.3d 1357, 1363 (Fed. Cir. 2006) and In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988); in the interference context Fontijn v. Okamoto, 518 F.2d 610, 617 (CCPA 1975), and Yasuko Kawai v. Metlesics, 480 F.2d 880 (CCPA 1973).  CVC argues that the Broad relied in its brief solely on the E17 embodiment, which comprises a chimeric guide RNA comprising T residues as set forth above.  In view of the brief's technical arguments, CVC's position is that the Broad cannot satisfy enablement for E17 embodiment for the Zhang B1 provisional application and thus the Board should deny the motion.  The brief further argues that the Broad cannot assert that the presence of T instead of U residues was an error (e.g., a typographical error that could be corrected by a Certificate of Correction). According to CVC's brief, "[c]orrection is only permissible where 'the correction is not subject to reasonable debate . . . .'" citing Novo Indust. V. Micro Molds Corp., 350 F.3d 1348, 1357 (Fed. Cir. 2003), and moreover the Broad is prohibited from making changes that "are radical in their nature and constitute a departure from the invention originally disclosed," citing In re Oda, 443 F.2d. 1200, 1204 (CCPA 1971).  CVC's brief argues that any such correction would be "subject to reasonable debate" and would constitute changes that would constitute a departure from the invention originally disclosed."  Under the circumstances before the Board in this instance, CVC argues that the Board should deny the Broad's Substantive Motion No. 4.