Broad Files Opposition to ToolGen Substantive Preliminary Motion No. 1

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On May 20th, ToolGen filed its Substantive Motion No. 1 for benefit of priority in Interference No. 106,126, which names ToolGen as Senior Party and as Junior Party The Broad Institute, the Massachusetts Institute of Technology, and the President and Fellows of Harvard College (collectively, "Broad").  On August 6th, Broad filed its Opposition to this Motion.

As set forth in ToolGen's motion, the Board had granted ToolGen the benefit of its U.S. provisional application, Serial 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 Oct. 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 sets out the basis for ToolGen's claim of priority, setting forth its arguments for satisfaction of the written description and enablement requirements under 35 U.S.C. § 112(a) with regard to two embodiments falling within the scope of the Interference Count.

In its Opposition, Broad asks 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 asserts that ToolGen's motion is premature and "completely irrelevant" at this time.  Broad further asserts 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 on the basis of 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 includes 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 urges the Board to exercise that discretion with regard to ToolGen's Preliminary Motion No. 1.

Broad's brief explicates 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.

One notable feature of Broad's argument is that good portions of it are redacted.  As set forth in associated Motion to permit portions to be redacted, Broad explains that these portions are to be kept confidential at ToolGen's behest and to protect ToolGen's proprietary information obtained from ToolGen's Priority Statement.  According to Broad in its motion to seal, the redacted portions of its Opposition, "Toolgen alleges that the potential harm to the holders of the information would be significant."  Broad's motion to permit redactions, an unusual request and one even less frequently granted under the Rule that proceedings should be open to the public in the public interest, 37 C.F.R. § 42.14, is (understandably) unopposed by ToolGen in view of the benefit it asserts it requires in Broad's unopposed motion and is based on ¶ 4(a)(ii) of the Protective Order entered by the Board in this interference.  Broad also assures the Board that the redactions have been "narrowly tailored" to "minimize the impact on the public."  In this motion, Broad makes the necessary averments, specifically: 1) The information sought to be sealed is truly confidential; 2) A concrete harm would result upon public disclosure; 3) The information is not necessary to understand the issues; and 4) Confidentiality interests outweigh any interest in access.

Nevertheless, even with the redactions, it can be ascertained that Broad argues 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 Oct. 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 with regard to conception of a nucleic acid encoding a particular protein; see, Amgen v. Chugai, Fed. Cir. 1990).

The contingent nature of the events that must arise for ToolGen's Preliminary Motion No. 1 to require the Board to address it, and the intervening determinations that would make this motion moot, according to Broad, provide the basis for Broad's opposition to ToolGen's Preliminary Motion.

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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