Meanwhile . . . ToolGen Files Substantive Motion No. 1 in Interference with CVC

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP

Lest we forget, there are two other interferences proceeding before the Patent Trial and Appeal Board, one of which (Interference No. 106,127) names ToolGen as Senior Party and as Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC").  In March, the PTAB granted leave for the parties to file Preliminary Motions and on May 20th, ToolGen filed its Substantive Motion No. 1 for benefit of priority.

As set forth in ToolGen's motion, the Board had granted ToolGen the benefit of its U.S. provisional application, Serial No. 61/717,324, filed October 23, 2012 ("P1"), resulting in ToolGen having an earlier priority date than either CVC or Junior Party in related Interference No 106,126, the Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad").  ToolGen submitted this motion to be accorded benefit of priority to two later-filed, related applications:  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, 6 2013 ("PCT").  ToolGen in its motion explains that it is submitting this motion contingent on the Board granting CVC Substantive Motion No. 2, which attacks ToolGen's entitlement to priority to the P1 priority document (said motion being the subject of a later post).  The brief sets out graphically the relationship of these priority documents:

Image 1
The brief then sets out the basis for ToolGen's claim of priority, setting forth its arguments for satisfaction of the written description and enablement requirements under 35 U.S.C. § 112(a) with regard to two embodiments falling within the scope of the Interference Count.  ToolGen specifically illustrates satisfaction of that alternative language of the Count that recites claim 18 (dependent on claim 15) of Broad's U.S. Patent No. 8,697,359, the brief annotating the limitation recited therein to facilitate identification of ToolGen's disclosure corresponding thereto:

[1] An engineered, programmable, non-naturally occurring Type II CRISPR-Cas system comprising
[2] a Cas9 protein and
[3] at least one guide RNA that targets and hybridizes to a target sequence of a DNA molecule in a eukaryotic cell,
[4] wherein the DNA molecule encodes and the eukaryotic cell expresses at least one gene product and
[5] the Cas9 protein cleaves the DNA molecules,
[6] whereby expression of the at least one gene product is altered; and,
[7] wherein the Cas9 protein and the guide RNA do not naturally occur together;
[8] wherein the guide RNAs comprise a guide sequence fused to a tracr sequence.

The brief takes pains to recite satisfaction of each element with reference to Examples 3 and 4 of the P3 (PCT) priority document, noting that one such embodiment (designated 3-1) comprise a Foxn1-specific sgRNA and a Cas9 mRNA, while embodiment 3-2 comprises the same sgRNA and recombinant Cas9 protein.  And in each case, the Examples illustrate CRISPR-mediated cleavage and editing of the target Foxn1 DNA in mouse embryos expressed in the resultant genetically engineered mice.  The CRISPR-Cas9 complex is illustrated in the brief by this drawing:

Image 2
wherein "target DNA [is] in the green box, DNA-targeting sequence of crRNA [is] in the blue box, crRNA:tracrRNA duplex linked together by a -GAAA- loop [is] in the red box, remaining tracrRNA portion shown with brown underline, Cas9 protein with label shown with purple underline depicted as a shaded oval, which is in complex with sgRNA and cleaves the target sequence in the target DNA."

The brief also notes the portions of the P3 priority document showing such CRISPR-Cas9 complexes successfully cleaved and edited the target Foxn1 DNA.

The brief argues that this extensive disclosure in the P3 priority document "provides abundant working examples and considerable guidance to a [person of ordinary skill in the art] to make and use CRISPR/Cas9 in eukaryotic cells."

ToolGen also notes that the P3 priority document shares the same specification with U.S. Application No. 14/685,510, to which the Board has recognized ToolGen's entitlement to priority.  Accordingly, ToolGen argues that the skilled worker would recognize that the PCT application enables at least one embodiment falling within the Count and that as a result this disclosure constitutes a constructive reduction to practice of the Count.  While the brief focuses in most detail on the disclosure of Example 3 (if only because disclosure of only one embodiment falling within the scope of the Count is needed), the brief also sets forth an assessment of how what is disclosed in Example 4 also satisfies the requirement as a constructive reduction to practice of embodiments falling within the scope of the Count.

The brief concludes by noting that "PCT provides additional disclosures, such as examples of Cas9 sequences that are codon optimized and contain an NLS tag, to further illustrate various embodiments of the Count" and thus provides ToolGen's constructive reduction to practice for yet additional embodiments falling within the scope of the Count.

ToolGen has filed an identical motion as its Substantive Motion No. 1 in related interference No. 106,126 naming Broad as Junior Party.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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