By Kevin E. Noonan –
On September 28, 2022, the Patent Trial and Appeal Board denied all preliminary motions by Junior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") and Senior Party ToolGen in Interference No. 106,126.
On the same day, the Board suspended further proceedings in this interference (and in Interference No. 106,127 between Junior Party the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") and Senior Party ToolGen) "in the interest of not wasting resources" (see "PTAB Suspends ToolGen Interferences"), reasoning foreshadowed in the first portion of its Decison on motions which notes that the Board's judgment in the '115 Interference is binding for the purposes of this interference even though the decision is on appeal. But because the Federal Circuit has not overturned the Board's earlier judgment the panel continues (again "in the interests of efficiency") in preparation for the now-suspended priority phase of this interference.
As a reminder, the parties had filed the following motions:
• 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) should the Board grant Motion No. 1; 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 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 P3"), or alternatively, International Appl. No. PCT/KR2013/009488, filed Oct. 23, 2013 ("PCT").
With regard to Junior Party's Motion No. 1 (to change the Count), the Board held that Broad had not satisfied its burden of proof at least because Broad's proposed Count No. 2 included changes other than merely broadening the count to include dual-guide RNA (dgRNA) as well as single-guide RNA (sgRNA), to which the count was limited in the interference as declared. First, the Board agreed with ToolGen that Broad's proposed Count No. 2 added the words "or edited" to the portion of the Count that states "the guide sequence directs the Cas9 to the target sequence, whereby the DNA molecule is cleaved or edited in the eukaryotic cell" (emphasis in opinion). Second, the Board agreed with ToolGen that Broad's proposed Count No. 2 deleted the phrase "expression of at least one gene product is altered" from Broad's portion of the MacKelvey count in the interference. ToolGen argued that changes rendered proposed Count No. 2 "excessively broad" but while the Board did not indicate agreement with this characterization it held that Broad had not adequately explained why these changes were necessary as part of its burden in asserting its motion No. 1, the Board stating it would not make changes "for change's sake," citing Louis v. Okada, 59 U.S.P.Q.2d 1073, 1076 (BPAI 2001).
"Nevertheless," the Board stated, the decision addresses Broad's arguments in support of its Motion No. 1. Despite basing its several arguments on the characteristic of Proposed Count 2 to encompass dgRNA as well as sgRNA, the Board stated that Broad had failed to show any ToolGen claims that are broader than sgRNA embodiments. The Board disregarded Broad's arguments that ToolGen is pursuing dgRNA-reciting claims because such "ToolGen claims have not been allowed and are not involved in the current interference." The Board recognized that "Broad's argument is that because its own claims and proofs are outside the scope of Count 1, the count is too narrow" (emphasis in opinion), and that "this is unjust because it puts Broad's generic RNA invention at risk, while excluding Broad's best proofs, which are based on dual-molecule RNA systems." The Board turns on their head Broad's arguments that ToolGen would not be prejudiced because its claims do not recite dgRNA-containing eukaryotic CRISPR embodiments by saying that "Broad fails to explain why it would be just to put ToolGen's involved claims, limited to a single-molecule system, at risk with proofs to a dual-molecule system, unless both are the same patentable invention." Ultimately the Board's decision is based on the Broad failing to show "why the single- and dual-molecule CRISPR-Cas9 systems should be included in one count." And the Board was not persuaded by Broad's citation of authority regarding the permissibility for a party to broaden a count to include its "best proofs," first noting that none of this authority is binding and then distinguishing each case Broad relied upon, including Grose v. Plank, 15 USPQ2d 1338, 1342 (BPAI 1990); Kondo v. Martel, 220 USPQ 47, 49 (BPAI 1983); and Nelson v. Drabek, 212 U.S.P.Q. 98 (Comm'r 1979). The upshot of this criticism is that Broad has not, in the Board's view, "cite[d] support, precedential or non-precedential, that a count should be broadened to include more than one patentable invention for the purpose of allowing a party to present its best proofs," citing the Board's precedential decision in Lee v. Mcintyre, 55 USPQ2d 1137, 1142 (BPAI 2000), that "there is no per se rule that the count ultimately must be as broad as the broadest patent claim corresponding to the count." And because under the "presumption" rules the Board sees as governing the interference (that a claim corresponds to the count when it would be anticipated or obvious if the count is considered to be prior art) "a species count may anticipate a genus claim," and "designation of claim correspondence to the count thus does not equate to a presumption that the scope of the count is equal to the full scope of the designated claims. In short, there is no presumption here that the species count is the same patentable invention as any genus claims designated as corresponding to the count."
In addition, the Board, asserts, Broad "fails to meet its burden in Motion 1 because it fails to present argument or direct us to evidence that the dual-molecule and single-molecule CRISPR-Cas9 systems are the same patentable invention" and alternatively "Broad fails to present argument or direct us to evidence that the dual-molecule and single-molecule CRISPR-Cas9 systems are separately patentable." The Board also faulted Broad for failing to be thorough in its arguments regarding "common or separate patentability of the dual- and single-molecule CRISPR-Cas 9 systems," nor did Broad argue that either of the two systems are obvious over the other according to the opinion nor show evidence related to whether one species of CRISPR was obvious over the other. These errors led to the Broad leaving it to the Board to make the determination, rather than bearing its burden to do so, in the Board's opinion, thus failing to satisfy the requirements of 37 C.F.R. § 41.208(b).
Under these circumstances, Broad failed to convince the Board to grant Motion No. 1, the opinion stating that their denial was "not because we are persuaded of any specific relationship between a single-molecule and a double-molecule RNA configuration, but because we are not persuaded of any such relationship" (emphasis in opinion). The Board suggests that Broad had two choices: one, to show dual- and single-molecule CRISPR were the same patentable invention (which they did not do) or to move to add a separate count to the interference directed to dual-molecule CRISPR embodiments (which Broad chose not to do)(because, of course, Broad wanted the interference to have a single count encompassing both dual- and single-molecule CRISPR for which its assertion of proofs of earlier invention of dual-molecule CRISPR would garner priority to claims for both species).
The Board responded to Broad's unfairness arguments by stating that Broad failed to adduce evidence that Proposed Count 2 does not encompass more than one patentable invention. In this regard, the opinion notes that Broad's Motion No. 3 asks the Board to designate claims not limited to single-molecule CRISPR as not corresponding to Count 1 (i.e., claims directed to dual-molecule CRISPR and so-called "generic" claims not limited to one or the other species of gRNA), again on putative fairness grounds. Here again the Board states that Broad did not present evidence or argument on obviousness and instead "argues for relief that would involve contradictory reasoning — in Motion 1 that the single- and dual molecule CRISPR-Cas9 systems are the same patentable invention and in Motion 3 that a 'non-limited' CRISPR-Cas9 system is separately patentable from a single-molecule CRISPR-Cas9 system — without directing us to evidence in either context." For the Board, "fairness of the proceeding to both parties depends on whether the single-molecule and dual-molecule systems are the same patentable invention or are separately patentable" — and Broad has not convinced the Board of either proposition.
The Board specifically disagreed with Broad's contention that "the relevant question would be whether a generic RNA genus is directed to the same invention as the single-molecule RNA species" (emphasis in opinion), stating that the "relevant question" is the scope of Proposed Count 2 — something on which the Board accuses the Broad of not taking a position.
Accordingly, the Board held that Broad failed to meet its burden under 37 C.F.R. § 41.208(b) and denied the motion.
Turning to Broad Motion No. 2, a contingent motion designating certain claims of Application Nos. 15/160,710 and 15/430,260, the Board dismissed this motion as moot in view of its decision regarding Broad Motion No. 1. And regarding Broad's contention that if the Board denied its Motion No. 1 it should designate claim 41 of the '710 application and claim 95 of the '260 application as corresponding to Count 1, the Board declined the invitation because Broad had not asked for leave to file a motion to have additional claims designated as corresponding to Count 1.
Returning to Broad Motion No. 3, the Board states that Broad was required in order to prevail to show that the claims it seeks to have designated as not corresponding to Count 1 be neither anticipated not obvious by the subject matter of the Count (under circumstances where features of the claimed CRISPR system, such as being capable of cleaving DNA and altering gene expression in eukaryotic cells, are presumed under 37 C.F.R. § 41.207(b)(2) to be taught in the art). The Board opinion first finds estoppel arising from the Board's decision in the '115 interference regarding SaCas9, a CRISPR-Cas9 system with multiple nuclear localization signals, and claims not limited to an RNA configuration. The Board in that interference decided claims reciting each of these limitations corresponded to the count, which included claim 18 of Broad patent No. 9,697,359 (as does the Count in this interference). The Board in this opinion states that it "decline[s] to decide these issues again under the doctrine of issue preclusion," not due to any position ToolGen has taken but because "[a] party who has litigated an issue and lost should be bound by that decision and cannot demand that the issue be decided over again," citing Mother's Restaurant, Inc. v. Mama's Pizza, Inc., 723 F.2d 1566, 1569 (Fed. Cir. 1983), and that the circumstances here satisfied the requirements of A.B. Dick Co. v. Burroughs Corp., 713 F.2d 700, 702 (Fed. Cir. 1983). Nevertheless, the Board reviewed (and rejected) Broad's arguments regarding the patentable distinctness of claims to CRISPR encompassing generic RNA species, despite the fact that these claims satisfy the requirements of 37 C.F.R. § 41.207(b)(2) due to unfairness in considering this "a per se rule that must be rigidly applied." This outcome was once again based on the Board's conclusion that Broad failed to argue or present facts supporting this distinction, because (referencing ToolGen's arguments) "even if Broad is correct that at least some of its claims are 'generic' as to RNA configuration, a count directed to species — single molecule RNA configuration — would anticipate these claims, if treated as prior art." Relying on the presumption that under the declaration of interference these claims correspond to Count 1, the Board denied Broad Motion No. 3 because "Broad fails to argue or direct us to evidence to the contrary," nor did it support its "inequity" arguments with evidence that single- and dual-molecule RNA CRISPR species are the same invention (and thus that a finding based on earlier invention of single-molecule species would preclude separate priority to dual-molecule CRISPR species), and rejects Broad's citation of rulemaking involving 37 C.F.R. § 41.207(b)(2) based on a distinction between genus and species grounds because, inter alia, Broad did not seek leave to file a motion to add a genus count to the interference.
With regard to claims reciting SaCas9, the Board states that Broad had argued and failed to persuade regarding claims reciting this aspect in the '115 Interference. Regardless of whether issue preclusion would properly prevent Broad from reasserting these arguments, the Board finds these claims to correspond to the Count on the same basis as it had in the '115 Interference and found unpersuasive evidence of commercial success, expert testimony, and citations to scientific literature adduced in support of Motion No. 3 in this interference. The Board reached the same conclusion on similar grounds with regard to claims reciting two or more nuclear localization signals, finding Broad had not convinced them that such claims do not correspond to Count 1. After a long disquisition of the parties' arguments regarding vector delivery of CRISPR components the Board concluded that "we are not persuaded that one of ordinary skill in the art would have considered Broad's involved claims limited to vector delivery to be non-obvious over the subject matter of Count 1 treated as prior art." And finally, the Board states that Broad failed to rely on persuasive evidence that chimeric Cas9 species or fusion with protein or heterologous domains would not be obvious over the count considered to be prior art. On these bases, the Board denied Broad's Motion No. 3.
With regard to ToolGen's Motion No. 1 the Board held this was moot because it was contingent on the Board granting Broad's Motion No.1, and dismissed ToolGen's miscellaneous motion to exclude evidence because it had denied Broad's Motion Nos. 1 and 3.
The interference thus remains in the same posture between the parties as it was when declared, and the parties must await the outcome of CVC's appeal in the '115 Interference. Unless the Supreme Court deigns to review the Federal Circuit's judgment (which is very unlikely regardless of the substance of that judgment), the suspension will not be lifted until sometime next spring, if it is — a decision reversing the Board's awarding priority to Broad should dissolve this interference in ToolGen's favor, the ultimate question of priority thus being the province of the '127 Interference between CVC and ToolGen.
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