ToolGen Files Opposition to Broad Contingent Preliminary Motion No. 2 to Add Claims Corresponding to the Count

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP

On May 28th, Junior Party the Broad Institute, Harvard University and MIT (collectively, "Broad") filed its Contingent Preliminary Motion No. 2 in CRISPR Interference No. 106,126 (where ToolGen is the Senior Party), pursuant to 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208(a)(2) and Standing Order ("SO") 203.2.  This motion is contingent on the Board's grant of Broad's Substantive Preliminary Motion No. 1.  In that motion, Broad asked the Board to substitute (in part) a new Count No. 2 in place of Count 1 in the '126 Interference as instituted (see "Broad Files Substantive Preliminary Motion No. 1 in CRISPR Interference").

In this motion, Broad asked the Board to add their U.S. Application Nos. 15/160,710 (having allowable claims 1, 40, and 41) and 15/430,260 (allowable claims 74, 94, and 95) to the Interference and designate the allowable claims as corresponding to Proposed Count 2.  Consistent with their arguments in Motion No. 1, Broad contended that these claims recite "generic" limitations with regard to the RNA components of CRISPR, i.e., both dual-molecule and single-molecule guide RNA.  In the alternative (i.e., should the Board deny Broad's Substantive Preliminary Motion No. 1), Broad in this motion asked the Board to designate claim 1 of the '710 application and claim 95 of the '260 application as corresponding to current Count 1.

On August 6th, ToolGen filed its Opposition to Broad's Contingent Preliminary Motion No. 2.  ToolGen first asserts that it has shown (in its Opposition to Broad Preliminary Motion No. 1) that Broad's motion to substitute the Count should be denied (in which case this motion would become moot).  ToolGen also contends that "Broad has neither demonstrated that the claims should be added, nor that alternative remedies are unavailable," also providing a basis for the Board to deny this motion.  ToolGen focuses on Broad's arguments in its motion that "proceeding with Count 1 would be unfair [to Broad]," because (logically) should the Board reach this motion on the merits it would have had to grant Broad Motion No.1 and any "unfairness" would have been resolved ("Count 1 would no longer exist for Broad to complain about").  Some of the basis for this argument is also procedural, to the extent that Broad makes these unfairness arguments in Motion No. 2 they are duplicative of the same arguments in its Motion No. 1.

Substantively, ToolGen argues that Broad has not borne its burden under 37 C.F.R. § 41.208(b) and SO ¶ 203.2 showing why these claims should be added to this Interference and why alternative remedies are unavailing or inadequate.  Instead, according to ToolGen, Broad merely shows how these claims correspond to the "Broad half" of Proposed Count 2.  ToolGen argues:

"One cannot broaden the scope of a count just for the sake of doing so.  Likewise, one cannot simply add claims for the sake of designating more claims without offering a compelling reason" under 37 C.F.R. § 41.208(b) as provided by Louis v. Okada, 59 U.S.P.Q.2d 1073 (B.P.A.I. 2001) (precedential) to the effect that the scope of a count should be changed only when there is a "compelling reason" for doing so.

According to ToolGen, Broad has failed to make a showing of such a compelling reason.

ToolGen also argues the motion is not necessary, because either Broad will prevail under Proposed Count 2 and the claims at issue in this motion will grant, or Broad will not prevail and Broad will be estopped from pursuing them under the principles of interference estoppel.  In neither case, according to ToolGen, will these claims have any effect on the priority determination made in this Interference.

Turning to alternative remedies, ToolGen argues that Broad has not explained why any such remedies would be inadequate, merely relying on its arguments of unfairness.  Alternatives exist, according to ToolGen, but Broad neither acknowledges them nor explains why they would be inadequate.  For example, ToolGen challenges Broad for not satisfying requirement (4) of SO ¶ 203.2, requesting the examiner to declare another interference (which the Board could then combine with this one).  Nor does Broad inform the Board (and ToolGen) if it has taken these steps in ex parte prosecution.

ToolGen also argues that the Board did not authorize what ToolGen characterizes as Broad's "request for relief" of adding claim 41 of the '710 Application and claim 95 of the '260 Application as corresponding to Count 1 should the Board refuse to substitute Proposed Count 2 as Broad requested in its Preliminary Motion No. 1.

Finally, ToolGen contends that Broad's motion exceeds the scope of the Motions List submitted to the Board in this interference because it contends in its motion that claims 40 and 41 of the '710 application and claims 95 and 96 of the '260 application are "generic as to the RNA configuration."  This is not how Broad characterized these claims in its Motions List, ToolGen asserting that Broad characterized all six claims in these two applications as being generic and that the Board relied upon these characterizations. Consequently:

Because the Board relied on Broad's prior characterization (F12), the Board's authorization is also limited to the Broad's initial characterization of the claims as generic.  Broad may not now expand its arguments to urge that claims 40, 41, 94 and 95 are limited to single- or dual-molecule RNA.  In doing so, Broad exceeds the scope of its authorization for Motion 2.  Accordingly, for this additional reason, the Board should dismiss or deny Broad's request to add claims 40, 41, 94 20 and 95.

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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