By Kevin E. Noonan —

On May 28th, Junior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") filed its Substantive Preliminary Motion No. 1 in CRISPR Interference No. 106,126, where ToolGen is the Senior Party.  On August 6th, ToolGen filed its Opposition and on September 24th Broad filed its Reply.

Broad's Motion sought to substitute the Count; Broad's Proposed Count 2 is shown in comparison to the Count in the interference as declared below:

Broad's argument (the consequences of which are discussed below) was that their "best proofs" are better represented in Proposed Count 2, which encompasses dual-molecule guide RNA CRISPR embodiments rather than being limited to single-molecule guide RNA (sgRNA) species.

ToolGen argued in its Opposition that the Board should deny Broad's motion first, because Broad has neither established nor argued that dual-and single-molecule eukaryotic CRISPR is the same patentable invention, and second, that Broad's proposed Count 2 "does not define the common claimed subject matter [because] all of ToolGen's involved claims are limited to single-molecule RNA" species (emphasis in brief).  As to the first argument, ToolGen contended that there is a distinction to be made between Broad's position that dual- and single-molecule CRISPR embodiments are "alternative approaches" to eukaryotic CRISPR and that they are the same invention, which ToolGen asserted they are.  Presciently, ToolGen argued that "Broad cannot attempt to make that showing for the first time in its reply," citing Nau v. Ohuchida, Int. No. 104,258, 9 Paper 57, at *4 (B.P.A.I. 1999), regarding making the argument that a dual-molecule eukaryotic CRISPR system would be prima facie obvious over single-molecule embodiments, under Spine v. Biedermann Motech GmbH, 684 F. 18 Supp. 2d 68, 89 (D.D.C. 2010).  And in this regard ToolGen argued that Broad had not established that Broad has best proofs that would be best adjudged for priority under Proposed Count 2.

ToolGen also argued that proposed Count 2 is broader than the common claimed invention between the parties because, as instituted by the Board, existing Count 1 is limited to single-molecule RNA embodiments of eukaryotic CRISPR and that common claimed subject matter is what defines an interference, citing Beech Aircraft Corp. v. Edo Corp., 990 F.2d 1237, 1248–49, and Louis v. Okada, 59 22 U.S.P.Q.2d 1073, 2001 WL 775529 at*4 (B.P.A.I. 2001).

In its Reply, Broad sets forth clearly its strategic focus in making its Preliminary Motion No. 1 and the consequences of the Board granting the motion.  According to Broad's brief:

Broad's proffered best proofs are—as ToolGen's expert now admits—directed to dual3 molecule RNA work.  These proofs underlie, inter alia, Broad's generic molecule RNA claims at issue in this Interference.  Accordingly, the PTAB should adopt Proposed Count 2, a Count broad enough to include Broad's best proofs.  See Grose v. Plank, 15 U.S.P.Q.2d 1338, 1341 (B.P.A.I. 1990) (allowing a party to rely on its best proofs of priority "is an accepted reason in interference practice for granting" a motion to modify the count).

Broad illustrates these "best proofs" by two examples from the record.  The first comes from Inventor Zhang's January 12, 2012 NIH grant application describing this vector to be used in practicing eukaryotic CRISPR:

(It should be remembered that grant applications, unlike patent applications, are under no burden of showing that a proposed research plan has been used, successfully or otherwise, and that many research proposals describe work to be performed using the monies applied for in the grant.)

The second example of best proofs also comes from that grant proposal, this one showing the expected products of the vector disclosed in the previous figure:

Broad's brief argues that under interference practice a party is permitted to move (and the Board can grant such a motion) to change the Count under circumstances where their best proofs are better accommodated by the changed Count.  Many of Broad's arguments intended to counter ToolGen's opposition recite the absence of a rule against substituting the Count in this instance.  For example, Broad argues that:

The rules do not require a proposed count to be directed to the same patentable invention as the original count.  See Board Rule 41.208(c)(2).  None of the cases cited by ToolGen at 2:6-18 require a showing that the proposed count is the same patentable invention as the original one.  Indeed, the Standing Order, consistent with the cited cases, contradicts ToolGen's position—it does not recite any rule that a proposed count must be directed to the same patentable invention as the original count.  Paper 2 at ¶ 208.

Broad counters ToolGen's citation of Theeuwes v. Bogentoft, 2 U.S.P.Q.2d (BNA) 1378, 1379 (Comm'r Pat. & Trademarks December 11, 1986) for what is required to show that Proposed Count 2 is the same invention by asserting that "claimed generic RNA genus of Proposed Count 2 would be anticipated by the Count 1 species claim limited to single-molecule RNA."  Indeed, the fact that Proposed Count 2 recites CRISPR generically as regards the nature of the guide RNA is the major theme of their Reply, Broad stating that "even if the proposed count needed to be directed to the same patentable invention as the original count, the relevant question would be whether a generic RNA genus is directed to the same invention as the single-molecule RNA species" because "it is"; Broad supports this argument by the Board's designating their generic CRISPR claims as corresponding to Count 1 in the Declaration (which designation ToolGen has adopted in its Opposition to Broad's Preliminary Motion No. 3 to have these claims de-designated).

The Reply also notes that the manuscript for the scientific paper that was ultimately published as the Le Cong et al. 2013 reference was submitted in October 5, 2012, which antedates (for the purposes of Broad's Motion) the earliest filing date according by the Board to ToolGen in its Interference Declaration, which Broad contends are relevant under Byrn v. Aronhime, Patent Interference 105,384 (McK), Paper 64, at 11:17 (P.T.A.B. Sept. 20, 2006).

Outside these substantive arguments, Broad's brief sets forth its procedural justifications under the Rules and relevant case law that would permit the Board to grant its motion.  And Broad argues that ToolGen is asking the Board to unfairly consider priority to its generic guide RNA-encompassing CRISPR claims in this interference while not permitting its "best proofs" regarding species outside the scope of Interference Count 1.  Finally, the Reply sets forth specific rebuttals to ToolGen's arguments with regard to correspondence between Broad's claims and Proposed Count 2 regarding vector delivery, SaCas9, the use of two or more nuclear localization signals (NLS), and Cas9 fusion to heterologous protein domains.

The Board's consideration of Broad's Preliminary Motion No. 1 raises an interesting possibility.  If it is indeed the case that eukaryotic CRISPR was only (and could only) be achieved using single guide RNA embodiments (as CVC has argued in this and its pending interference with Broad (No. 106,115); see "CVC Files Motion in Opposition to Broad Priority Motion") then Broad has fashioned a way to provide its "best proofs" with regard to dual-molecule CRISPR embodiments to establish an earlier conception date even though those embodiments would not have satisfied the enablement requirement for the claimed CRISPR methods.  Interestingly, in its priority motion in the '115 interference, Broad asserted an earliest reduction-to-practice date of July 20, 2012 (wherein that embodiment involved the use of sgRNA in eukaryotic CRISPR).  While this may reflect merely a parsimonious approach towards asserting just enough to satisfy what was required to have an earlier priority fate than CVC in that interference, CVC had asserted an earlier conception date (March 2012) that Broad's purported best proofs" would antedate.  While there is nothing untoward about Broad asking the Board to change the Count to accommodate these proofs, it does raise the possibility that the arcane mechanisms of interference practice could result in what can conservatively be called an anomalous result.