Broad Files Reply to ToolGen Opposition to Broad's Contingent Preliminary Motion No. 2

By Kevin E. Noonan --

On May 28th, Junior Party the Broad Institute, Harvard University and MIT (collectively, "Broad") filed its Preliminary Motion No. 2 in CRISPR Interference No. 106,126 (where ToolGen is the Senior Party), contingent on the Board's grant of Broad's Substantive Preliminary Motion No. 1 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 its Motion No. 2, 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.  In the alternative (i.e., should the Board deny Broad's Substantive Preliminary Motion No. 1), Broad in its Motion No. 2 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, and on September 24th Broad filed its Reply.

In its Opposition, ToolGen asserted several bases for the Board to deny Broad's Motion No. 2.  ToolGen argued that had 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 further contended that "Broad has neither demonstrated that the claims should be added, nor that alternative remedies are unavailable."  ToolGen also argued 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.  With regard to such alternative remedies, ToolGen argued that Broad has not explained why any such remedies would be inadequate, despite the existence of such remedies (for example, asking the Board to declare another interference which could be combined with the current one between the parties).  ToollGen further argued that Broad's Motion No. 2 was unnecessary, because either Broad would prevail under Proposed Count 2 and the claims at issue in this motion would grant, or Broad will not prevail and Broad will be estopped from pursuing them under the principles of interference estoppel.  Finally, ToolGen argued that the motion was unauthorized and exceeded the scope of the Motions List submitted to the Board in this interference.

Broad's Reply begins by disputing ToolGen's contention that SO ¶ 203.2 requires them to show a "compelling reason" why these claims should be added to the Interference should the Board grant Broad's Preliminary Motion No. 1.  All that the Rule requires, according to Broad, is that the claims correspond to the Count, which they do (being directed to "generic" species of CRISPR comprising either dual- or single-molecule guide RNA.  Nevertheless, Broad argues they have provided compelling reasons (including remedying the "unjust structure" of the Interference) and these amount to reasons not "irrelevant" as ToolGen argued in its Opposition according to Broad.  The Reply sets out in detail how Broad's Motion No. 1 addresses the requirements of SO ¶ 203.2, including the basis for their contention that no alternative remedy would suffice to bring Broad "justice" in this interference.

Broad also argues that its Motion was authorized by the Board, including that certain of the claims corresponding to the Count are directed to single-molecule guide RNA (sgRNA) species and others are generic according to Broad's nomenclature, making its case that it was not attempting to mislead the Board (while at the same time making its case that ToolGen had tried to do so in its Opposition).  Broad provides a quotation from the hearing on motions to illustrate the consistency of "its position that the broader eukaryotic invention [encompassing generic guide RNA species] is the proper subject matter of this Interference":

. . . there are claims that Broad has that do not use the terminology 'guide RNA,' and also gets into our second motion, which we have been informed that we have other allowable claims that we—that we could potentially move to be brought in as part of the count being broaden[ed] to encompass those best proofs, because the subject matter on our side includes both the dual molecule and the single molecule . . . [emphasis in brief].

Moreover, Broad asserts that the Board was not unaware or confused about their arguments and the consistency or strategic aim of their motions request.

Finally, Broad dismisses ToolGen's argument that Broad had requested relief from the Board to designate these claims as corresponding to Count 1, saying that while they have not requested this relief they are "unaware of any authority preventing the PTAB at this stage of the Interference from adding allowable claims from applications not currently involved in the Interference if those claims correspond to Count 1; the claims limited to sgRNA configurations can be designated as corresponding to Count 1, if the PTAB believes such a designation is appropriate."

Comments

[Paul Morgan]

Kevin, it would be useful to post a list of all the motions filed, and their decisions, if made, in this Byzantine interference, and the currently set date for a priority trial.

[Kevin E Noonan]

Good idea, Paul - no decisions yet, but briefing on the merits is over. There will be some motions to exclude evidence for the Board to decide, and then a Final Hearing on the Preliminary Motions, followed by a Board decision on those motions.

THEN, there will be a priority phase (because neither party has filed a motion alleging there is no interference in fact, as happened in the '048 interference).

Depending on how the Board comes down on these motions there might be some strategic advantages on one side or the other; the biggest risk for ToolGen is that the Board substitutes the Count to one generic for guide RNA species of CRISPR.

Thanks for the comment