By Kevin E. Noonan –

The PTAB held an Oral Hearing between Junior Party the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") and Senior Party ToolGen on September 12th, bringing to a close proceedings in the Preliminary Motions phase of Interference No. 106,127.

As a reminder, the parties had filed the following motions at issue at the hearing:

For CVC, Substantive Motion No. 1 for priority benefit to U.S. Provisional Application No. 61/652,086, filed May 25, 2012 ("P1"), U.S. Provisional Application No. 61/716,256, filed October 19, 2012, ("P2"), and U.S. Provisional Application No. 61/757,640, filed January 28, 2013 ("Provisional 3"); Substantive Motion No. 2 to deny ToolGen benefit of priority to U.S. Provisional Application No. 16/717,324, filed October 23, 2012 ("P1"); Substantive Motion No. 3 asking the Patent Trial and Appeal Board to add claims in ToolGen's U.S. Patent No. 10,851,380 to this interference; and Contingent Responsive Motion No. 1 to be accorded benefit of priority to U.S. Patent Application No. 13/842,859, filed March 15, 2013, or in the alternative U.S. Patent Application No. 14/685,504, filed April 7, 2015, or U.S. Patent Application No. 15/138,604, filed April 26, 2016.

ToolGen filed Substantive Motion No. 1 for priority to later-filed U.S. Provisional Appl. No. 61/837,481, filed June 20, 2013 ("P3" or "ToolGen P3"), or alternatively, International Appl. No. PCT/KR2013/009488, filed Oct. 23, 6 2013 ("PCT"), contingent on the Board granting CVC Substantive Motion No. 2 to deny ToolGen benefit of priority to U.S. provisional application, Serial No. 61/717,324, filed October 23, 2012 ("P1"), and Substantive Motion No. 2 to deny CVC priority to its U.S. Provisional Application No. 61/757,640, filed January 28, 2013 ("Provisional 3").

The oral hearing was held before Administrative Patent Judges Sally Gardner Lane, Deborah Katz, and Rachel H. Townsend.  Keith R. Hummel of Cravath, Swaine & Moore LLP argued for CVC, and Anthony M. Insogna 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).

Mr. Hummel began his argument regarding denial of priority to ToolGen's P1 provisional application and grant of priority to CVC's earlier provisional applications P1, P2, and/or P3.  (The significance of these Motions would be that the interference would be redeclared with CVC as Senior Party for the Priority Phase of the interference should the Board grant CVC priority to the P1 or P2 priority document.)  The basis for CVC's Motion No. 2 to deny ToolGen priority benefit to its earliest provisional filing was party admission and judicial estoppel, Mr. Hummel argued.  The grounds for this accusation were that ToolGen had argued codon optimization was required for patentability before the PTAB in an appeal resulting in allowance of ToolGen's application in interference.  ToolGen's P1 priority document did not contain such disclosure, Mr. Hummel argued and ToolGen should be held to its prior arguments here. Mr. Hummel argued that contrary to ToolGen's previous representations ex parte to the Board codon optimization was routine and that it was also untrue that it was unpredictable, arguments that Mr. Hummel asserted ToolGen advanced during prosecution supported by an expert declaration in a strategic decision to obtain a notice of allowance.  "And it worked," he stated, saying that these representations were the reason ToolGen in in the interference (and he was careful to say these arguments were asymmetric and did not apply to CVC).

Judge Katz says this a motion to deny benefit and that CVC's portion of the Count does not require codon optimization.  Mr. Hummel replied that this did not matter because P1 does not disclose codon optimization or how it could be achieved (there being different ways to do it).  He characterized ToolGen's behavior as being akin to "bait and switch" and said it would be unfair to CVC for the Board not to recognize the limitations of ToolGen's P1 priority document with regard to codon optimization.  In response to Judge Katz reminding Mr. Hummel that if this was an argument grounded in written description, that CVC had not made such a motion, and the Count was not limited to CRISPR methods using codon optimized Cas9 proteins, Mr. Hummel returned to his argument that ToolGen had the burden to show that its P1 priority document contained an embodiment having codon optimization, citing (as it had in its brief) In re Alonso, 545 F.3d 1015, 1021 (Fed. Cir. 2008).  Judge Lane asked whether CVC had shown that P1 does not have an embodiment falling within the scope of CVC's side of the Count but Mr. Hummel's response could not maintain that it did not.

Next Mr. Hummel turned to CVC's Motion No. 1 for priority benefit, a motion Mr. Hummel acknowledged was made (and denied) in Interference No. 106,115 but he argued under different circumstances (although the arguments were substantially the same).  CVC's argument came down to the techniques disclosed in these three priority documents would have been expected to be successful by the person of ordinary skill in the art and that CVC should have priority because they were the innovators.

For ToolGen, Mr. Insogna began his argument by saying that CVC bore the burden to show that ToolGen's P1 priority document did not show constructive reduction to practice of an embodiment falling within the scope of the Count (which they have not done).  He challenged CVC's estoppel theory as having no basis in precedent, and that ToolGen had disclosed in its P1 priority document what was practiced within the scope of the Count. He further argued that the case law asserted by CVC (specifically Louis v Okada) did not stand for the estoppel principle CVC was arguing.

Mr. Insogna then turned to CVC's Motion No. 1 for priority, arguing (as Broad had done successfully in the '115 interference) that CVC had not disclosed operative embodiments, based on the fish, human, and fruit fly embodiments shown in the '115 interference to be unsuccessful.  This argument raised a litany of reasons and reasoning, that CVC and anyone paying attention to these interferences has heard before (including statements by Jennifer Doudna regarding the uncertainties of practicing CRISPR successfully in eukaryotic cells).  With regard to the declaration evidence adduced for the first time in this interference (which provided a basis for CVC to distinguish the argument and perhaps the outcome here) Mr. Insogna dismissed it as being outside the scope of the P1, P2, or P3 disclosure and hence not relevant to the issue before the Board.

Mr. Insogna also dismissed as inadmissible hearsay testimony regarding Dr. Marrafini and his role in the CRISPR saga, including that ToolGen had not had the opportunity to depose him.  Mr. Insogna similarly dismissed a new Doudna declaration, because it contained no testimony specifically related to the disclosure in the P1 or P2 applications and relied on e-mails outside the specification.  And with regard to testimony by Dr. Cohen regarding microinjection of CRISPR-Cas9 into cells, while it was recited in the P1 and P2 specification it was not expressly exemplified, and while Dr. Cohen testified that the technique was within the skill in the art, he admitted at deposition that none of his students knew how to do microinjection as disclosed in P1 or P2.  Mr. Insogna further argued that neither P1 nor P2 satisfied the factors set forth in In re Wands regarding enablement.

Mr. Hummel in his rebuttal argument returned to CVC's Motion No. 2 and reiterated CVC's position that the Board must consider "questions of proof and prior representations," which are unique in this interference (without affirmatively ascribing any untruthfulness to ToolGen).  Regarding CVC's Motion No. 1 for priority benefit, Mr. Hummel argued that there is no requirement for a working example and Dr. Cohen's testimony regarding not knowing anyone who could perform microinjection was not dispositive.  He further argued that a priority document does not need actual iteration of embodiments that satisfy the count (which is a somewhat dubious assertion).

Mr. Insogna argued in rebuttal that regarding CVC's P1 application the law is clear that enablement does not lie where a skilled artisan needs to supply elements of the invention, citing Genentech v. Novo Nordisk, 77 F.3d 1364 (Fed. Cir. 1996).

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 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.

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.