PTAB Grants Broad Motion No. 4 for Priority Benefit to U.S. Provisional Application No. 61/736,527

By Kevin E. Noonan --

In the Patent Trial and Appeal Board's decision on motions issued September 10th in Interference No. 106,115 (see "PTAB Decides Parties' Motions in CRISPR Interference") between Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") and Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC"), the Board granted Broad's Motion No. 4 for priority benefit to U.S. Provisional Application No. 61/736,527.  As a result, Broad will remain Senior Party during the Priority Phase of the interference.

Broad in its substantive Motion No. 4 argued that it had satisfied the standard for priority to USSN 61/736,527 to Zhang (termed "Zhang B1" in the motion).  The following diagram, showing the interrelatedness of the various Broad patents and applications in the interference, illustrates the basis of Broad's priority claim:

The Board in its Decision on Motions pursuant to 37 C.F.R. § 41.125(a) set forth a recapitulation of Broad's arguments, in sum that Zhang B1 "provides working examples and embodiments that meet each and every limitation of both halves of Count 1" and thus evinces to the skilled worker possession of an embodiment within the scope of the Count.  The Board in its Decision cited (and provided as an illustration) what it deemed to be successful practice of CRISPR-Cas9 in eukaryotic cells by reference to Figure 1D:

with the understanding that:

Figure 1D depicts a nuclease assay for SpCas9 mediated insertions and deletions wherein different combinations of four components of a CRISPR-Cas system are tested in each lane.  Bands indicating a 367 bp and a 317 bp product are present in the lanes that include Cas9, tracrRNA, and EXM1-target spacer, but not in the lanes that are missing either tracrRNA or EXM1-target spacer.

The Board also sets forth CVC's arguments in opposition, specifically that the priority document was non-enabling for the invention set forth in the interference Count because it relies exclusively on a 'chimeric guide RNA' that a [person of ordinary skill in the art or] POSA could not have made and used in a cell without undue experimentation."  This argument focuses (as the Broad did in its brief and the Board does in its Decision) on "Embodiment 17" (E17), wherein a chimeric guide RNA is expressed by a cell comprising both U and T bases:

In its Decision, the Board was convinced by Broad's evidence, particularly by expert testimony, that the skilled worker would have interpreted the "T's" in the sequence to be "U's."  Broad argued that describing Figure 2A as an RNA would have supported that interpretation (despite the contra designation as a "Chimeric guide RNA") and further states that Figures 12B and 8 would support this interpretation.  Further, the Board credited Broad's argument that the skilled worker would recognize that the disclosed vector would naturally produce the guide RNA having U's instead of T's:

The Board criticized CVC's arguments on several points.  For example, the Decision states that while CVC argued that the Examiner in related applications recognized the disparity regarding U's and T's comprising the chimeric guide RNA but noted that 'in the Examiner's requirement for correction CVC highlights, the Examiner only required Broad to include sequence identification numbers, not correction of the actual sequence and that "CVC does not direct us to any comment by the Examiner regarding the sequence in Figure 2A or to any rejection based on lack of enablement because of it."  And specifically with regard to this argument, the Board voiced its agreement with Broad's witness that the skilled worker would have understood that the illustrated T's would have been produced as U's in the RNA produced in a eukaryotic cell.  (Nor, the Board notes, has there been any correction of the corresponding scientific paper, Cong et al., 2013, "Multiplex Genome Engineering Using CRISPR/Cas Systems," Science 339: 819–23, in the record, supporting the view that the skilled worker's understanding would be consistent with Broad's argument and expert testimony.)

The Decision concludes on this issue that "[b]ecause Broad has persuaded us that Zhang B1 provides a constructive reduction to practice of an embodiment of Count 1, we are persuaded that Broad should be accorded its filing date."  Accordingly, the Board granted Broad Motion No 4.

As a consequence, Broad will remain the Senior Party in this interference.

The remainder of the Board's Decision with regard to CVC's motions will be discussed in future posts.

Comments

[Atari Man]

Nobel committee seems to have reached its own conclusion in this matter...

[Kevin E Noonan]

Fortunately a different standard but I admit I was surprised it wasn't three . . .