On October 14th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier; collectively, "CVC") filed its Substantive Motion No. 1 to be awarded priority benefit to their earlier priority applications: USSN 61/652,086, filed May 25, 2012 (P1); USSN 61/716,256, filed October 19, 2012 (P2); USSN 61/757,640, filed January 28, 2013 (P3); USSN 13/842,859, filed March 15, 2013; USSN 14/685,504, filed April 13, 2015; or USSN 15/138,604, filed April 26, 2016, in Interference No. 106,115 against Senior Party the Broad Institute, Harvard University, and the Massachusetts Institute of Technology.

CVC sets forth in detail the disclosure in its earlier priority applications for at least one embodiment falling within the scope of Count 1 of this interference.  The brief recites the "ground-breaking" nature of their work, stating that the earliest priority document (P1) disclosed "the minimal components required to generate a functional CRISPR-Cas9 DNA-cleavage complex—Cas9, crRNA, and tracrRNA."  In addition, CVC argues that this priority document "disclosed, for the first time, that complexes of Cas9 and a double- or single-molecule DNA-targeting RNA . . . are useful for targeted DNA cleavage and described numerous applications of this gene-editing technology, including modifying target DNA in eukaryotic cells," noting the many accolades bestowed upon CVC's inventors by the scientific community.  CVC further argues that "[t]he CVC inventors immediately understood that the CRISPR-Cas9 DNA-cleavage complex could be used in a variety of different cellular and noncellular settings."  The brief recites (prophetic) Example 1 in the P1 specification, and the (albeit prophetic) application of CRISPR technology to fish, human, and fruit fly cells.

The brief is careful to note that any failure of the P1 specification to show actual reduction to practice is not required to satisfy the requirement for entitlement benefit.  CVC also cautions the Board against any attempt by the Broad to "erroneously to link the issues in this motion to the PTAB's termination of Interference No. 106,048 due to no interference-in-fact," stating that "the legal and factual issues raised here are fundamentally different from those decided in the prior '048 proceeding" based on the PTAB's own prior statements of the grounds for its no interference-in-fact determination.  Rather, according to CVC:

[A person of ordinary skill in the art] reading P1 in light of the state of the art at the time of filing would have understood that the application describes and enables at least one embodiment within the scope of the count.  Moreover, post-filing-date publications report successfully practicing CVC's claimed invention in eukaryotes using the very methods and components that P1 describes.  The Board should therefore accord CVC the benefit of its first provisional application.

What follows is a succinct statement of the Precise Relief Requests (pursuant to PTAB rules) and support in the P1 specification for this relief, recited in the alternative with the other priority documents recited in CVC's request for relief.  The standard, undisputed by the parties, is that to be accorded benefit of priority a prior application must show constructive reduction to practice (CRTP) regarding at least one embodiment falling within the scope of the count, citing Falkner v. Inglis, 448 F.3d 1357, 1362 (Fed. Cir. 2006).  After setting out the legal grounds for CRTP, the brief then applies these rubrics to the disclosure in P1 for subject matter falling within the scope of the interference Count (which CVC argues satisfies these requirements).  Along the way the brief also suggests that "Broad will doubtlessly rely on cherry-picked quotes about whether or not the inventors or experts knew CRISPR would work in eukaryotic cells before testing it," rejecting these anticipated arguments on the ground that CTRP is grounded on what is disclosed in the specification citing Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc); Frazer v. Schlegel, F.3d 1283, 1288 (Fed. Cir. 2007); and Centrak, Inc. v. Sonitor Tech., Inc., 915 F.3d 1360, 1369 (Fed. Cir. 2019).  The relevant P1 disclosure for CVC is that CRISPR is functional "when removed from its natural prokaryotic cellular milieu, which is highly relevant here because it establishes CVC's possession of the necessary and sufficient components for a functional CRISPR-Cas9 DNA-cleavage complex regardless of its environment" (emphasis in brief).

The argument is illustrated by Figures from the P1 application:

And explicit disclosure compared with the elements of the interference Count:

The brief then sets forth specific disclosure related to the elements of the Count (also provided in Appendix 3 entitled "Exemplary Evidence of Constructive Reduction to Practice of Count 1 in the P1 '068 Application"), and CVC further asserts that "[t]he inventors fully grasped the broad utility of such a method as aptly illustrated by the many types of 'target cells of interest' suitable for the methods described in P1, including a variety of eukaryotic cells (elements [1]-[2]) such as a fish, human, and fruit fly cell," noting that "[t]hese features are not merely recited in P1, but diagrammed, discussed, and specifically exemplified showing the inventors' possession" based on express disclosure cited with particularity in the brief (including specifically the prophetic use of CRISPR in fish cells).  CVC presents explicit argument relating to what the skilled worker would understand CVC possessed and would be able to accomplish without undue experimentation with regard to the CRTP requirement for being accorded benefit.  Finally, in this regard, the brief asserts that post-filing evidence (much of it by third parties) further supports a conclusion of constructive reduction to practice in the P1 disclosure:

Within a year of CVC publishing that Cas9 and a [single guide RNA] such as chimera A (or a double-molecule RNA) formed a functional DNA-cleavage complex (Ex. 3202), other researchers used materially the same components and methods disclosed in P1 to practice the fish cell embodiment—objectively confirming that P1 enables making and using the fish cell of E1.  While the studies described below published after P1's May 25, 2012 filing date, post-priority date evidence "may show, for example, that practicing the invention did not require undue experimentation," citing Amgen, Inc. v. Sanofi, 872 F.3d 1367, 1379 (Fed. Cir. 2017); In re Wands, 858 F.2d 731, 739 (Fed. Cir. 1988); In re Hogan, 559 F.2d 595, 605 (Fed. Cir. 1977).

CVC supports its allegations of what the skilled person would understand from the disclosure in the P1 specification by declaration testimony an expert, Dr. Peterson (who eventually will be subject to cross-examination by the Broad in this interference).  Specifically, Dr. Peterson attests extensively to the applicability of CRISPR as set forth in P1 to use in human cells, which CVC asserts is also shown by third-party success in applying CRISPR to human cells, and fruit fly cells.  Thus, CVC asserts "[i]n sum, the great weight of evidence compels a finding that P1 describes and enables each of the fish (E1), human (E2), and fruit fly (E3) cell methods, any one of which, on its own provides a CRTP of Count 1."

The brief then turns on the distinction between what was required for the Broad to prevail (as it did) in the earlier interference and in this one:

Broad's previously asserted arguments wrongly impose a reasonable expectation of success standard (obviousness) on §112, first paragraph, which contains no such standard.  Obviousness "turns on . . . whether the claimed invention would have been obvious in view of the prior art."  Allergan, Inc. v. Sandoz, Inc., 796 F.3d 1293, 1310 (Fed. Cir. 2015) (emphasis in original).  "In contrast, the enablement inquiry turns on whether the skilled artisan, after reading the specification, would be able to make and use the claimed invention without undue experimentation."  Id. (emphasis in original).  Similarly, "[t]he standard for satisfying the written description requirement is whether the disclosure 'allow(s) one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.'"  Alcon, 745 F.3d at 1190 (emphasis added; citation omitted); see also, Ariad, 598 F.3d at 1351.  Any argument to the contrary erroneously conflates obviousness with written description and enablement.

Finally, the brief argues in the alternative that the other applications CVC asserts for priority contain the P1 disclosure relied upon for priority in this brief, and thus for the same reasons (set forth in brief for each reference) CVC is entitled to priority to these applications, based on the "continuous chain" of priority in these CVC applications.