By Kevin E. Noonan --
The Patent Trial and Appeal Board held an Oral Hearing between Junior Party the Broad Institute, Harvard University and MIT (collectively, "Broad") and Senior Party ToolGen on September 12th, bringing to a close proceedings in the Preliminary Motions phase of Interference No. 106,126.
As a reminder, the parties had filed the following motions at issue at the hearing:
For Broad, Substantive Motion No. 1 to change the Count (a motion similar to the motion denied in Interference No. 106,115); Contingent Motion No. 2 to add U.S. Application Nos. 15/160,710 (having allowable claims 1, 40, and 41) and 15/430,260 (allowable claims 74, 94, and 95); and Substantive Motion No. 3 to de-designate Broad claims as not corresponding to either Count 1 or proposed Count 2.
ToolGen had a single motion at issue in this interference, Substantive Motion No. 1 for priority to later-filed U.S. Provisional Appl. No. 61/837,481, filed June 20, 2013 ("P3" or "ToolGen 5 P3"), or alternatively, International Appl. No. PCT/KR2013/009488, filed Oct. 23, 2013 ("PCT").
The oral hearing was held before Administrative Patent Judges Sally Gardner Lane, Deborah Katz, and Rachel H. Townsend. Raymond N. Nimrod of Quinn Emanuel Urquhart & Sullivan LLP argued for Broad, and Timothy J. Heverin of Jones Day argued for ToolGen. Generally of course the parties made their arguments consistent with their briefs but colloquy with the Board was informative (in this regard Judge Townsend had no questions for the parties).
Junior Party's counsel, Mr. Nimrod, went first and began with Broad Motion No. 1 to change the Count. The basis was that Broad had evidence that would support priority to a "generic" CRISPR RNA count, i.e., one encompassing both single molecule (sgRNA) and dual molecule (dgRNA) CRISPR guide RNA species; the current Count is limited to sgRNA species. Judge Katz asked if sgRNA and dgRNA were the same invention and when Mr. Nimrod responded "Yes" the Judge asked him for his evidence and argument for this principle? Mr. Nimrod asserted having the benefit of a presumption that this is the case and cited the decision in Interference No. 104,733.
The argument then turned to Broad Motion No. 3 to designate Broad claims as not corresponding to either Count. Judge Lane says the test for claim correspondence is a one-way test which is different than the test for same patentable invention (a two-way test) and noted that cases Mr. Nimrod seemed to rely upon arose before the new interference rules were promulgated and thus these cases may not bind the Board. Judge Lane also asked about Broad's burden as moving party and Mr. Nimrod cited the rule about substituting a count (Rule 208(c)(2)). The Judge also mentioned fairness, if the Count is broadened beyond scope of ToolGen's claims, saying "fairness goes both ways." Mr. Nimrod countered that it is unfair to Broad to lose generic claims based on the current Count and noted that during prosecution ToolGen had claims corresponding to generic CRISPR claims and cancelled them (suggesting implicitly that this was a strategic ploy by ToolGen).
Before finishing, Mr. Nimrod spoke about Motion 2 and mentioned the outcome of the '115 interference.
Mr. Insogna began his argument directed to Broad's Motion No. 1, reminding the panel that Broad's burden was to show proposed Count 2 is necessary and proper, which requires a showing that the Count is directed to a single patentable invention, that Broad's proffer be adequate, that the proposed Count not be excessively broad and that it is patentable over the prior art. Mr. Insogna objected to Mr. Nimrod's assertion of Rule 208(c)(2), saying that there is not proof of the single patentable invention (citing the two-way test and raising a "battle of the citations" with Mr. Nimrod). Mr. Insogna asserted that Broad erred by trying to have sgRNA in one half of proposed Count 2 and generic RNA in the other, but then failed to show that these were the same patentable invention. "It's Broad's motion and thus Broad's burden" was the thrust of Mr. Insogna's argument. He also argued that the presumption Mr. Nimrod asserted under the '733 Interference was new argument that the Board should not consider. In response to Judge Lane's inquiry, Mr. Insogna stated there was no presumption upon which Broad could rely, mentioning there was no such presumption in prior interference rules under 37 C.F.R. § 1.600 et seq rules and cited Rule 207(c)(2) that there is a difference between claim correspondence and separate patentability. Broad relied on the one-way test in its Reply brief and Mr. Insogna says they are wrong.
Judge Katz then asked about Mr. Nimrod's unfairness argument, that Count 1 was too narrow and Broad's generic claims were put in jeopardy. Mr. Insogna says Broad cited no authority for its position and that the Board had held in prior interferences that it disagreed that a party is entitled to a Count as broad as the broadest patentable claim corresponding to the Count. Mr. Insogna then noted that of the 480 Broad claims designated as corresponding to Count 1 only 11 claimed generic (dgRNA) embodiments of CRISPR. Mr. Insogna also mentioned that the Board had rejected Broad's position in the '115 Interference regarding the propriety of substituting a Count that broadly recited a generic RNA CRISPR invention. Mr. Insogna stated that Count 1 better covers these 480 claims. He further argued that the Motion makes no argument under Rule 207(b)(2) to de-designate claims and that in Broad's Motion 3 there was no Rule 207(b)(2) analysis on patentability. Mr. Insogna asserted that under circumstances (such as these) where a party doesn't make an argument under the proper standard it would be unfair for them to be heard on that argument.
Mr. Insogna finished his principal argument by stating ToolGen relies on their briefing with regard to proffers of evidence. Specifically with regard to Broad's Exhibit 2454 he argued that the Exhibit was undated and unexplained and that an NIH declaration contradicted that this is sgRNA and not dgRNA. He also noted that some of Broad's evidence showed cleavage but not editing and that Broad did not establish patentability of embodiments raised in Broad's Reply brief.
Mr. Nimrod in rebuttal directed the Board's attention to page 2, line 17 of its Reply brief in support of its arguments before the Board. He reiterated his unfairness argument based on the Count encompassing but one generic RNA CRISPR claim being enough due to the effects of interference estoppel. Judge Katz asked whether, should Broad lose could they pursue generic RNA CRISPR claims? Mr. Nimrod distinguished the Board's decision on separate patentability in Interference No. 105,048 and that a decision on Count 1 would no resolve the issue. He also mentioned evidence of dgRNA in the 2011-2012 timeframe (relying on specific slides in his presentation) and a January 2012 grant proposal. In response to Judge Lane's question of whether the proposed Count was unnecessarily broad, Mr. Nimrod did not challenge ToolGen's distinction between cleavage and editing.
Mr. Insogna's rebuttal argued that Broad improperly relied on several arguments made first in its Reply brief. He also warned the Board that Broad was attempting to shift the burden of providing evidence to support its Motion No. 1 to ToolGen and that the "explained expansions" of scope were broader that the purported proofs.
(Somewhat curiously both parties had another "sur-rebuttal" opportunity limited to about a sentence or two but these were without apparent substantive effect.)
While it is never easy (nor prudent) to attempt to read the judicial tea leaves after oral argument it is certainly the case that Mr. Nimrod and Broad had a "hotter" bench than Mr. Insogna and ToolGen. If the Board is inclined to follow its decisions in the earlier '115 interference, they will deny Broad's Motion No. 1 and with it Contingent Motion No. 2 and Motion No. 3. The fate of ToolGen's sole motion, regarding priority to later-filed provisional applications, is less certain but also less significant.
A decision can be expected any time in the next several months, absent settlement. Thereafter, the parties will enter the Priority phase of the interference when they will proffer their evidence of conception and diligence to reduction to practice (constructive or actual).
A transcript of the hearing will be made public for anyone wishing to hear the argument directly and more thoroughly than could be presented here.
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