CVC Files Reply to ToolGen’s Opposition to CVC’s Responsive Motion No. 1 | McDonnell Boehnen Hulbert & Berghoff LLP

On June 11th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, “CVC”) filed its Responsive Preliminary Motion No. 1 in Interference No. 106,127 to be accorded benefit of priority to U.S. Patent Application No. 13/842,859, filed March 15, 2013, or in the alternative U.S. Patent Application No. 14/685,504, filed April 7, 2015, or U.S. Patent Application No. 15/138,604, filed April 26, 2016, pursuant to 37 C.F.R. §§ 41.121(a)(2) and 41.208(a)(3) and Standing Order ¶ 208.4.1.  CVC filed this motion contingent on the Board granting Senior Party ToolGen’s Substantive Preliminary Motion No. 2 to deny CVC priority benefit to U.S. Provisional Application No. 16/757,640, filed January 28, 2013 (“P3”).  On July 15th, Toolgen filed its Opposition, and on August 27th CVC filed its Reply.

ToolGen’s Substantive Preliminary Motion No. 2 challenged CVC’s entitlement to priority benefit to the P3 provisional in this interference on the grounds that it did not disclose “successful cleavage of DNA within eukaryotic cells, nor does it otherwise show a constructive reduction to practice of an embodiment within Count 1.”  In its Responsive Motion, CVC sought to establish its entitlement to later-filed applications, to retain its best priority position against ToolGen (CVC itself has filed its Preliminary Motion No. 2 to deny ToolGen of the priority benefit to its earliest application, U.S. Provisional Application No. 16/717,324, filed October 23, 2012).  In its Responsive Motion, CVC argued entitlement to the ‘859 application as a matter of law because it is the earliest application having an identical specification to CVC’s applications-in-interference and CVC argues that it therefore is entitled to a presumption that this application provides a constructive reduction to practice thereby, citing Transco Prod. Inc. v. Performance Contracting, Inc., 38 F.3d 551, 556–57 (Fed. Cir. 1994).  CVC’s alternative priority claims were based on the common specification shared by all these applications, comprising “a string of continuation applications [that] thus provide[s] the same disclosure as the involved applications.”  CVC provided the following table of comparison evidence of what is disclosed in the specification of the ‘859 application with each element of the Count:

Specifically, CVC argued that Examples 4, 5, and 7 set forth a constructive reduction to practice of an embodiment falling within the scope of the Interference Count.

ToolGen disagreed, arguing in its Opposition that CVC failed to carry its burden of showing the constructive reduction to practice it alleged.  As an initial matter, ToolGen cited CVC’s argument that the disclosure in the three non-provisional applications here has been continuously disclosed in earlier provisional applications (U.S. Provisional Application No. 61/652,086, filed May 25, 2012 (“P1”), U.S. Provisional Application No. 61/716,256, filed October 19, 2012, (“P2”), and U.S. Provisional Application No. 61/757,640, filed January 28, 2013 (“P3”), priority to which CVC asked the Board to accord benefit in its Substantive Preliminary Motion No. 1 (opposed by ToolGen separately).  ToolGen understandably repeated (in brief) its principal argument in that Opposition, that CVC had not shown that CRISPR-mediated DNA cleavage in eukaryotic cells would have been a matter of routine and predictable experimentation, based inter alia on the Board’s decisions in Interference No 105,048 (and Federal Circuit affirmance thereof; Regents of Univ. of California v. Broad Inst., Inc., 903 F.3d 1286, 1291–92 (Fed. Cir. 2018)) and Interference No. 106,115 to the contrary.  And ToolGen, as it has done in its own Preliminary Motion No. 2 to deny priority benefit, argued that the Board erred in granted CVC priority benefit to its P3 provisional application (U.S. Provisional Application No. 61/757,640, filed January 28, 2013) in the ‘115 Interference because it did not consider ToolGen’s arguments that CVC had not satisfied the constructive reduction to practice requirement for this provisional (again, briefly recounting their earlier arguments here).  ToolGen thus made its first argument on the backs of its earlier arguments with regard to the P1, P2, and P3 priority documents, because if CVC was not entitled to priority to them then the Board should not grant CVC priority benefit to the three non-provisional applications at issue here in the face of CVC’s representations that the disclosure in Examples 4, 5, and 7 was the same in these non-provisional applications and the earlier-filed provisional applications.  ToolGen supported these arguments by applying them to each of these Examples to illustrate what it considered to be their flaws that precluded CVC from entitlement to priority benefit.

CVC’s Reply focuses on having the Board grant priority to the ‘859 application even if its claims for priority benefit to all the earlier applications have been denied.  The basis for this claim is that the ‘859 application contains disclosures regarding eukaryotic CRISPR embodiments that appear in all the other, later-filed applications in this interference and thus CVC is entitled to priority benefit under 35 U.S.C. § 120 and precedent, citing Transco Prods. 6 Inc. v. Performance Contracting, Inc., 38 F.3d 551, 556 (Fed. Cir. 1994).  CVC bootstraps ToolGen’s failure to challenge specification support in later-filed applications (inter alia, its involved Application No. 15/981,807) as an admission that the disclosure in the ‘859 application is similarly sufficient, based on its assertion that the disclosures (at least with respect to Examples 4, 5, and 7) are the same, citing Dreyfus v. Lilienfeld, 49 F.2d 1062, 1064 (C.C.P.A. 1931), and Renz v. Jacob, 326 F.2d 792, 799 (C.C.P.A. 1964).

On the merits, CVC sets forth its case regarding what is disclosed in the ‘859 application as the basis for its priority claim.  In doing so, CVC distinguishes the Board’s basis for denying priority to earlier applications (specifically in the ‘048 and ‘115 Interferences) because it asserts that “the evidence supporting this motion involves additional disclosures, including at least the ‘859 application’s Examples 4, 5, and 7, which were not at issue in the ‘048 or ‘115 interferences, as well as different expert testimony and a later state of the art, March 15, 2013—by which time numerous peer-reviewed publications had reported using sgRNA CRISPR-Cas9 in eukaryotic cells.”  CVC characterizes ToolGen’s arguments are requiring actual (as opposed to constructive) reduction to practice, which is generally not required, citing Falkner v. Inglis, 448 F.3d 1357, 1362 (Fed. Cir. 2006).  Regardless, CVC argues that ToolGen is wrong in asserting any deficiencies in its disclosure of eukaryotic CRISPR falling within the scope of Count 1, which errors it then explicates in its brief.

Specifically, CVC argues that ToolGen is wrong at least with regard the human cell experiments set forth in Example 4 (and alleging that ToolGen’s expert Dr. Tuchi agreed), enumerating the eight specific elements of the Count and where in the Example they were satisfied.  CVC’s brief faults ToolGen for applying an incorrect legal theory, specifically that the ‘859 application would need to provide “definitive evidence that CRISPR-Cas9 modulates transcription of at least one gene encoded by the target DNA molecule in eukaryotic cells” (emphasis in brief).  CVC cites Faulkner and In re Borkowski, 422 F.2d 904, 908 (C.C.P.A. 1970), for the principle that there is no need to show specific working examples to satisfy constructive reduction to practice.  CVC’s brief faults ToolGen’s expert witness for a variety of blunders in his analyses and consideration of the prior art (including positions CVC contends are contradicted by the ‘859 application), and accordingly urges that his testimony be given no weight.  And CVC argues that reassertion of arguments regarding its P1-P3 provisional applications here against the ‘859 application are mere illustrations of the consistency of ToolGen’s errors it makes in supporting its Opposition.

The focus of the parties’ arguments is at the nexus of where a constructive reduction to practice in an unpredictable art meets the requirement that a skilled artisan would recognize by that disclosure that an inventor has possession of the disclosed invention, described in such a way that a person of ordinary skill in the art would be able to practice a claim throughout its full scope without undue experimentation.  In an interference context these principles apply to an application receiving priority benefit adequately discloses at least one embodiment of an invention falling within the scope of the interference Count, which ultimately is what the Board will need to decide in determining the priority question regarding the ‘859 application.

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