ToolGen Reply to Broad Opposition to ToolGen Preliminary Motion No. 1

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On May 20th, Senior Party ToolGen filed its Substantive Motion No. 1 for benefit of priority to U.S. Provisional Application No. 61/837,481, filed June 20, 2013 ("P3" or "ToolGen 5 P3"), or alternatively, International Application No. PCT/KR2013/009488, filed October 23, 2013 ("PCT").  Junior Party the Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") filed its Opposition to this motion, and on September 24th ToolGen filed its Reply.

As set forth in ToolGen's motion, the Board had granted ToolGen the benefit of its U.S. Provisional Application No. 61/717,324, filed October 23, 2012 ("P1"), resulting in ToolGen having an earlier priority date than Broad.  ToolGen submitted this motion to be accorded benefit of priority to two later-filed, related applications:  U.S. Provisional Application No. 61/837,481, filed June 20, 2013 ("P3" or "ToolGen 5 P3"), or alternatively, International Application No. PCT/KR2013/009488, filed October 23, 2013 ("PCT").  In its motion, ToolGen explains that it is submitting this motion contingent on the Board granting CVC's Substantive Motion No. 2, which attacks ToolGen's entitlement to priority to the P1 priority document in Interference No. 106,127.  The brief sets out graphically the relationship of these priority documents:

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The brief then set out the basis for ToolGen's claim of priority, specifically its arguments for satisfaction of the written description and enablement requirements under 35 U.S.C. § 112(a) regarding two embodiments falling within the scope of the Interference Count.

In its Opposition, Broad asked the Board to defer consideration of ToolGen's Motion, properly pointing out that Broad (unlike CVC in the '127 Interference) has not challenged ToolGen's benefit of priority to its P1 provisional application.  Accordingly, Broad asserted that ToolGen's motion is premature and "completely irrelevant" at this time.  Broad further asserted that this motion may "potentially" become relevant "only if multiple contingencies in this and other proceedings—that may or may not ever come to pass—do actually arise."  These include that:

1) the PTAB finds ToolGen is not entitled to the benefit of its P1 application in the co-pending 127 Interference,

2) Broad requests and is granted permission to file a motion here challenging ToolGen's benefit to P1 based on estoppel from that determination in the 127 Interference, and

3) the PTAB grants Broad's motion, depriving ToolGen here of benefit of its P1.

Broad's justification included that the Board considering this motion under these circumstances would be "waste of judicial resources" as well as improperly constituting an advisory opinion.  The interference rules provide that the Board has discretion to defer consideration of motions under 37 C.F.R. § 41.125 as applied in Berman v. Housey, 291 F.3d 1345, 1352 (Fed. Cir. 2002).  Broad urged the Board to exercise that discretion regarding ToolGen's Preliminary Motion No. 1.  Broad's brief explicated in further detail the contingent nature of the circumstances needing to arise for ToolGen's motion to be timely, in support of its opposition and request for the Board to defer consideration thereof.

Broad argued that priority to either of ToolGen's U.S. Provisional Application No. 61/837,481, filed June 20, 2013 ("P3" or "ToolGen P3"), or alternatively, International Application No. PCT/KR2013/009488, filed October 23, 2013 ("PCT"), would never be relevant because "ToolGen will be unable to beat Broad's dates of [conception and reduction to practice]" if Broad is granted priority in the '115 Interference.  This argument also sounds in representations made by ToolGen during prosecution regarding what was needed to provide a skilled worker with a reasonable expectation of success:

Rather, the only thing that would have alleviated the unpredictability in the art and allayed the concerns of one of ordinary skill at this time would have been the actual demonstration of a Type II Cas9 system successfully introducing site-specific double-stranded breaks in a target nucleic acid sequence within a eukaryotic, e.g., mammalian, cell . . . [emphasis in brief].

Here, Broad resurrects an argument made in Interference No. 106,115, that eukaryotic CRISPR is an invention for which conception can only be shown by successful reduction to practice (under a theory of "simultaneous conception and reduction to practice" first enunciated thirty years ago regarding conception of a nucleic acid encoding a particular protein; see Amgen v. Chugai, Fed. Cir. 1990).

In its Reply, ToolGen boldly asks the Board to dismiss rather than defer its Preliminary Motion No. 1 should the Board deny CVC's Preliminary Motion No. 1 in co-pending Interference No. 106,126 to deny ToolGen priority benefit to its U.S. Provisional Application No. 61/717,324, filed October 23, 2012 ("P1").  In addition, ToolGen raises the procedural requirement that decisions on Motions must be decided prior to initiation of the Priority Phase.  And finally, ToolGen argues that should the contingency arise and the Board grant CVC's motion and deny ToolGen priority benefit to its P1 provisional application the Board should grant its Preliminary Motion No. 1 because Broad's opposition was procedural in nature and not on the merits.

Regarding the many contingencies Broad identifies in its Opposition, ToolGen argues that Broad has not brought a motion or advanced an argument to deny ToolGen the benefit of priority to its P1 application.  And at this point Broad should not be permitted to benefit from the Board deferring the priority benefit issue until after the priority phase has begun because that would be procedurally improper according to ToolGen, relying on 37 C.F.R. § 41.121(a)(1), the Standing Order at 6:22-24 and Hum. Genome Scis., Inc. v. Genentech, Inc., 589 F. Supp. 2d 512, 514 (D. Del. 2008), dismissed 368 F. App'x 116 (Fed. Cir. 2009).  And to the extent any contingency resulting in ToolGen's loss of priority benefit to the P1 application should arise, ToolGen argues, its Preliminary Motion No. 1 was not addressed on the merits in Broad's Opposition and thus its Motion No. 1 is unopposed.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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