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.