ToolGen Responds to Broad Opposition to ToolGen Preliminary Motion # 1 | McDonnell Boehnen Hulbert & Berghoff LLP

On May 20, Senior Party ToolGen filed its Substantial Request No. 1 to benefit from the priority of US Provisional Application No. 61 / 837,481, filed on June 20, 2013 (“P3” or “ToolGen 5 P3”), or alternatively , International Application No. PCT / KR2013 / 009488, filed October 23, 2013 (“PCT”). The Junior Party, the Broad Institute, Harvard University and the Massachusetts Institute of Technology (collectively, “Broad”) filed their opposition to this motion, and on September 24, ToolGen filed its reply.

As indicated in ToolGen’s request, the Council had granted ToolGen the benefit of its US provisional application No. 61/717 324, filed on October 23, 2012 (“P1”), which means that ToolGen has an earlier priority date to that of Broad. ToolGen submitted this request to benefit from the priority of two related applications filed subsequently: US Provisional Application No. 61/837 481, filed June 20, 2013 (“P3” or “ToolGen 5 P3”), or, failing that, International Application No. PCT / KR2013 / 009488, filed October 23, 2013 (“PCT”). In his motion, ToolGen explains that he is submitting this motion subject to the Board granting CVC’s substantive motion # 2, which attacks ToolGen’s right to priority over the P1 priority document in the interference n ° 106 127. The brief presents graphically the relationship between these priority documents:

The brief then set out the basis for ToolGen’s priority claim, in particular its arguments for meeting the written description and clearance requirements under 35 USC § 112 (a) regarding two embodiments. falling within the scope of the interference count.

In his opposition, Broad asked the board to postpone consideration of ToolGen’s motion, rightly pointing out that Broad (unlike CVC in the ‘127 interference) has not contested ToolGen’s priority benefit over its provisional P1 application. As a result, Broad asserted that ToolGen’s motion is premature and “totally irrelevant” at this time. Broad further asserted that this motion could “potentially” become relevant “only if multiple contingencies in this proceeding and others – which may or may not occur – actually occur.” These include in particular:

1) the PTAB notes that ToolGen is not entitled to the benefit of its P1 application in the ongoing 127 interference,

2) Broad application and granted leave to file a motion here challenging ToolGen’s benefit to P1 based on the estoppel of this determination in interference 127, and

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

Broad’s rationale included that Council would consider this motion under these circumstances would be a “waste of judicial resources” as well as an inappropriate advisory opinion. The Interference Rules provide that the Board has the discretion to defer consideration of motions under 37 CFR § 41.125 as applied in Berman vs. Housey, 291 F.3d 1345, 1352 (Fed. Cir. 2002). Broad urged the board to exercise this discretion regarding ToolGen’s preliminary motion # 1. consideration of it.

Broad argued that priority should be either US Provisional Application No. 61 / 837,481, filed June 20, 2013 (“P3” or “ToolGen P3”), or International Application No. PCT / KR2013 / 009488, filed on 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 takes precedence in the ‘115 interference. This argument also resonates in representations made by ToolGen during prosecution about what was necessary to provide a skilled worker with a reasonable expectation of success:

On the contrary, the only thing which would have alleviated the unpredictability of the art and the concerns of those skilled in the art at that time would have been the actual demonstration of a Cas9 type II system successfully introducing site-specific double-stranded breaks into a target nucleic acid sequence in a eukaryotic cell, e.g., mammal . . . [emphasis in brief].

Here, Broad resurrects an argument made in Interference # 106115, that eukaryotic CRISPR is an invention for which the design can only be demonstrated by successful reduction in practice (under a theory of “simultaneous design and reduction at the practice ”first enunciated thirty years ago regarding the design of a nucleic acid encoding a particular protein; see Amgen vs. Chugai, Fed. Cir. 1990).

In its reply, ToolGen boldly asks the Board to reject rather than postpone its Preliminary Motion # 1 if the Board rejects CVC’s Preliminary Motion # 1 in Interference # 106.126 in co-proceeding to deny ToolGen the priority benefit of its US provisional application No. 1. 61/717 324, filed October 23, 2012 (“P1”). In addition, ToolGen raises the procedural requirement that decisions on motions must be decided before the start of the priority phase. And finally, ToolGen argues that if the contingency arises and the board grants CVC’s motion and denies ToolGen the priority benefit of its P1 provisional request, the board should grant its preliminary motion # 1 because Broad’s opposition was procedural and not substantive.

With respect to the many eventualities that Broad identifies in its opposition, ToolGen submits that Broad did not file a motion or make an argument to deny ToolGen the benefit of the priority of its P1 application. And at this point, Broad should not be allowed to benefit from the fact that the Board deferred the issue of priority benefits until the priority phase has begun, as this would be procedurally inappropriate according to ToolGen, relying on 37 CFR § 41.121 (a) (1), Standing Order at 6: 22-24 and Hmm. Genome Scis., Inc. v. Genentech, Inc., 589 F. Supp. 2d 512, 514 (D. Del. 2008), rejected 368 F. App’x 116 (Fed. Cir. 2009). And to the extent that any eventuality resulting in the loss of ToolGen’s priority benefit in favor of the P1 application, ToolGen argues, its preliminary motion No. 1 has not been considered on the merits in opposition from Broad and therefore his motion n ° 1 is unopposed.

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