By Kevin E. Noonan --
On March 23rd Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") filed its Reply to Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") Motion No. 4 in Opposition to Broad's Substantive Motion No. 4 for priority to U.S. Provisional Application No. 61/736,527.
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 this:
According to Broad, 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.
In its Opposition, CVC argued that Broad's disclosure was not enabled 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) on "Embodiment 17" (E17), wherein a chimeric guide RNA is expressed by a cell comprising both U and T bases:
According to CVC, there is no evidence that a chimeric guide RNA could be made inside a cell wherein T bases are incorporated using an RNA polymerase at specific positions, and thus embodiments comprising such chimeric guide RNA would not have been enabled as of the December 12, 2012 filing date of the Zhang B1 provisional application.
In its Reply, Broad argues that the skilled worker would have interpreted the "T's" in the sequence to be "U's" (a difficult argument to sustain, in view of the plethora of U bases in the diagram). Broad argues 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. The brief is on firmer ground in arguing that the skilled worker would recognize that the disclosed vector would naturally produce the guide RNA having U's instead of T's:
And (backtracking a bit) Broad then argues that reciting these T's was a "typo" that no one ever complained about.
Secondarily, the brief argues that even if Figure 2A did not enable the E17 example, the disclosure in Figure 12B (which contained U's instead of T's) did so:
As a third line of argument, the brief states that the skilled worker would know how to make a chimeric guide RNA comprising T bases as shown in Figure 2A. Finally, the brief argues that CVC's assertion that a Certificate of Correction would not be proper is not relevant to its Motion (but, of course, could be should Broad file such a Certificate) and that anything arising after 2012 is also not relevant to the issue before the Board but in any event is not contrary to its argument that Figure 2A contains a typo.
Turning to the specific arguments asserted by Broad in its response, there are three. First, Broad argues that Figure 2A consistently describes what is depicted as being an "RNA molecule" (emphasis in brief). Thus, according to Broad, the skilled worker would recognize that the T's depicted in the Figure should be (or would be) U's, stating (somewhat disingenuously) "to the extent he or she even noticed there were two 'Ts' instead of "U" bases." The brief cites CVC's understanding in the earlier interference (No. 106,048) as considering the T's in Figure 2A to be U's, but except for attempting to attack CVC's credibility (calling it "CVC's 180-degree shift") does not effectively rebut CVC's argument in this interference (although its argument that throughout all the other proceedings concerning these patents and the presence of this Figure in Broad's Cong 2013 Science publication this issue has not arisen does have some persuasive punch). The brief also cites Microbiology for Dummies in support of its argument that the skilled worker would have appreciated the explicit disclosure in Figure 2A to be a "typo."
Second, Broad argues that the disclosure of Figures 12B and 8 remedy any deficiencies in Figure 2A (under the principle of the totality of the disclosure), because those Figures do not recite T's instead of U's ("the typos" according to the brief) and are related to the same example of eukaryotic applications of CRISPR (termed E17). The brief reproduces Paragraph [00176] of the Zhang B1 provisional application in illustration of this argument:
And third, even these "typos" do not thwart enablement, because the skilled worker "would know" how to make a chimeric RNA comprising T's instead of U's (although that knowledge is not expressly disclosed in the Zhang B1 provisional but rather is in the prior art, presumably).
Importantly, Broad sets forth an argument that it has not waived this issue by not raising it in its opening brief, which has some justice in light of Broad's argument that this issue has not arisen In any of the prior proceedings (before the Patent Office and elsewhere) nor in any scientific or academic contexts, saying "Broad was not required to respond in advance to every potential argument CVC may make for lack of benefit, no matter how far-fetched . . . ."
Finally, while relying on these arguments, Broad contends that the continued prosecution post-2012 of applications containing Figure 2A reciting T's instead of U's is irrelevant to the issue before the Board, because these applications were not available to the skilled worker in 2012. Broad gets more traction in pointing out that an example cited by CVC of the PTO requiring correction of a Figure in later application corresponding to Figure 2A in the Zhang B1 application was not related to the presence of T's in a purported RNA molecule but rather a formality regarding the presence of sequence ID numbers. And the designation in the sequence listing that what was depicted in Figure 2A as a "Combined DNA/RNA molecule" as constituting a Broad admission was effectively countered by Broad noting that this designation was mandated by PTO sequence listing rules.
Of all the papers filed so far in this interference, in some ways Broad Motion No.4, CVC's Opposition and Broad's Reply pose some of the more interesting questions for the Board to decide, particularly because of the effect that decision could have on which party is the Senior Party and entitled to all the benefits of Senior Party status.
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