On Monday, the Patent Trial and Appeal Board (PTAB) heard oral argument (remotely) from Senior Party the Broad Institute (and its partners as Senior Party, Harvard University and MIT) and Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") on the substantive motions filed in the Motions Phase of Interference No. 106,115.
The Broad had four substantive motions to be decided by the Board: Broad's Substantive Motion No. 1, requesting the Board to find (as it had in the earlier, 105,048 interference between these parties) that there was no interference-in-fact; Substantive Motion No. 2 to Substitute the Count; Broad's Substantive Motion No. 3 to de-designate claims as not corresponding to Count 1; and Broad's Substantive Motion No. 4 for priority to U.S. Provisional Application No. 61/736,527.
CVC for its part filed only two motions to be decided by the Board: CVC's Motion No. 1 was to be accorded the benefit of priority to three earlier-filed provisional applications for Count 1 of the Interference as declared; and CVC's Responsive Contingent Motion No. 2 was to be accorded the benefit of priority to three earlier-filed provisional applications contingent on the PTAB granting the Broad's Motion No. 2 to Substitute the Count of the interference.
The hearing began at 10:30 am Monday morning with Raymond Nimrod from Quinn Emanuel arguing for Senior Party the Broad et al. and Eldora Ellison from Sterne Kessler arguing for CVC. Administrative Patent Judge Katz presided, joined by Judges Lane and Moore. Despite the number of motions before the Board, the panel imposed the conventional time limits on the parties of 20 minutes for argument. Senior Party reserved 3 minutes for rebuttal while Junior Party split its time evenly, to be able to provide its arguments for benefit of priority and then to rebut Broad's arguments in opposition.
The Broad went first, summarily mentioning its Substantive Motion No. 1 (with regard to slides 38-44 of its demonstrative exhibits) that the Board should reach the same conclusion here that it had in the '048 interference, that there is no interference-in-fact based on the same analysis and decision reached by the Board and affirmed by the Federal Circuit.
Turning to CVC's motions for priority benefit, Mr. Nimrod argued that the Board's earlier fact-finding in the '048 interference was not only relevant and dispositive but bound the Board to reach the same conclusion. That conclusion was that CVC's specification was not enabling for the practice of CRISPR in eukaryotic cells and the prior art did not provide routine methods that would have permitted the skilled worker to practice CRISPR in eukaryotic cells. Mr. Nimrod maintained that CVC's arguments in its motions contradicted those earlier Board findings and that specifically CVC's expert, Dr. Peterson (who did not testify in the '048 interference) advanced arguments opposite to the Board's earlier findings of fact and provided no additional information or data that rebutted those earlier Board findings.
Mr. Nimrod attempted to address what he termed CVC's five arguments (and succeeded in addressing the first four of them):
1. That the Board's earlier fact finding was not applicable because reduction to practice was not determined in the '048 interference. Senior Party argued that the Supreme Court in B&B Hardware Inc. v. Hargis Industries, Inc. held that issue preclusion precludes this argument ("we cannot relitigate this issue" and "CVC is simply wrong about that"). Mr. Nimrod also argued that CVC's argument was a repudiation of the PTAB's fact-finding in the '048 interference.
2. That CVC's second argument (which he termed their "second excuse"), that neither priority document (termed P1 and P2 in the interference, corresponding to USSN 61/652,086, filed May 25, 2012, and USSN 61/716,256, filed October 19, 2012, respectively) was considered in the '048 interference, was unavailing because there was nothing disclosed in these applications that had not been disclosed in CVC's Jinek 2012 reference and thus the factual bases for the Board's earlier decision remained sound and applied in this interference. Mr. Nimrod asserted that CVC's expert admitted to this. Mr. Nimrod took this occasion to tell the Board that the mere assemblage of broad categories of prior art methods did not change the state of the prior art and "compelled" the Board to deny CVC's motions for priority benefit.
3. That CVC's third argument ("excuse"), that the facts and bases for determining non-obviousness in the '048 interference were not relevant to the issue before the Board here, satisfaction of the written description requirement under Section 112(a), was contrary to the Federal Circuit's decision in Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., which Mr. Nimrod quoted as saying that "a description that does not render a claimed invention obvious is not sufficiently described that invention for purposes of Section 112, paragraph 1."
4. CVC's fourth "excuse" is a purported bright line rule that experimental evidence is not required to show adequate written description, which Mr. Nimrod asserted is a fact-specific inquiry. Satisfaction of the requirement is dependent on many factors, the most [important] of which is unpredictability. (In the heat of argument it appears Mr. Nimrod was discussing enablement here.) He cited Novozymes A/S v. DuPont Nutrition Biosciences APS, which Mr. Nimrod argued stands for the proposition that to show possession the patentee needs to actually make embodiments of the claimed invention. He attempted to rebut CVC's assertion of Alcon Research Ltd. v. Barr Laboratories Inc. in favor of its position by citing Nuvopharm v. Dr. Reddy's Labs (a case nicely relevant to the tension that can exist, and here Senior Party argues does exist in CVC's arguments, between the lack of reasonable expectation of success in asserting non-obviousness versus the ability of the skilled worker to rely on what is known in the art to supplement what is expressly disclosed in a specification).
Having permitted counsel to argue for the full amount of Senior Party's time, Judge Katz asked the first question, which was where in Broad's motions was it shown which claims encompass "dual molecule" CRISPR embodiments and which are limited to single-molecule embodiments (Mr. Nimrod ultimately referenced the panel to its Substantive Motion No. 2 at page 28). This colloquy ended Senior Party's argument.
Counsel Ellison argued for CVC, and she addressed the benefit motions just argued by Broad's counsel. Her argument was simple: the disclosure of the P1 application satisfies the requirement for constructive reduction to practice and thus for priority benefit. CVC's strongest argument is that several groups used the same methods and techniques disclosed in P1 (which, as admitted by Broad in its argument, were the same as those disclosed in the Jinek 2012 scientific journal reference) to practice CRISPR in eukaryotic cells (although counsel missed the opportunity to press home CVC's best equitable argument, that Broad merely copied CVC's invention in eukaryotic cells and thus should not be entitled to priority in the interference). CVC counsel argued that Broad is wrong about priority depending on the existence of a working example and deftly distinguishes the differences in case law between what is required to satisfy Sections 103 and 112(a). Specifically, Counsel Ellison argued that what was required was not a simple reasonable expectation of success, but rather the factors as set forth in In re Wands. And she was careful to link these arguments with the availability of post-filing date evidence to show enablement.
APJ Katz then asked about the significance of using fish cells as showing use of CRISPR in eukaryotic cells, which might have provided an opportunity to state that these cells are relatively easy to use and provide clear evidence of successful genetic manipulation. Although counsel mentioned microinjection as one feature, her argument was grounded more on how using these cells were well known. Counsel then yielded to Broad counsel's rebuttal before continuing her argument regarding Broad's motions.
In his rebuttal. Mr. Nimrod disputed CVC's characterization of the Novozymes case again, and termed post-2012 work by others to be "hindsight" that is irrelevant to the skilled worker's expectations in 2012. He reiterated his arguments regarding the primacy of the expectation of success prong, and stated that CVC is limited by its earlier arguments in the '048 interference. Finally, and for the first time (and perhaps as a way to anticipate similar arguments from CVC), Mr. Nimrod implied that it was only after discussing eukaryotic CRISPR with Broad scientists that CVC's scientists understood how to adapt CRISPR to the eukaryotic environment.
In her rebuttal, Counsel Ellison addressed the (ir)relevance of the Board's earlier '048 interference decision to the questions before the Board in this interference. She addressed and attempted to rebut Broad's estoppel arguments and distinguish the Supreme Court's B&B Hardware decision relying on the differences in facts relevant to the issues here versus the issues in the earlier interference. She stated that there is no authority that would permit the Board to avoid the priority issues in this interference, and reminded the Board of the history of serial interferences (i.e., that having decided one interference between parties having multiple patents and applications does not prelude the Board from decided additional interferences). Counsel referenced CVC's arguments regarding Rule 127 to rebut Broad's "failure to move" argument with regard to the earlier interference, reminding the Board that this principle applies only to losing parties and, insofar as the earlier interference was resolved on the grounds of there being no interference-in-fact, CVC was not a loser in that interference. CVC's counsel then argued that the Broad had established no basis for changing the Count in its Substantive Motion No. 2 and the Board should not make "changes for changes' sake."
Judge Katz then asked about the significance, as a claim interpretation question, of the Broad's claim 1 in its patent in interference seeming to encompass both dual and single molecule embodiments, based on express recitation of single molecule embodiments in a dependent claim. Counsel Ellison argued in response that claim differentiation is not a rule, and that fused RNAs were but one way of making single molecule RNAs according to intrinsic evidence. This response initially led to a difficult question from Judge Katz (asking how else such a molecule could be made), but Counsel recovered in arguing that it was for Broad to explain this point, referencing Broad's express definition in their specification. She reminded the Board that all Broad's claims were directed to single-molecule embodiments, and that the existence of a dependent claim that does not further limit the scope of the independent claim interpreted in light of the Broad's specification is merely invalid under Section 112(d).
Counsel Ellison's final argument related to Broad's Substantive Motion No. 4, and the issue that this application disclosed RNA comprising both uracil and thymidine residues, and thus did not enable what was claimed. Judge Katz did ask about CVCs expert's "admission" that he did not read this (initially) to be inoperative, but Counsel countered by mentioning Broad's reliance in this regard to "Molecular Biology for Dummies."
The only remarkable aspect of this argument is that Judge Katz was the only active questioner; it is foolhardy to attempt to read the judicial tea leaves based on the "limited" questions from the panel. A decision should be issued in the next several months.
