Interference 102,728
13. Brake also alleged that a second method, using Bal 31 nuclease, could be
used to make the n=0 construct. This method is also very unpredictable due to
the following difficulties: (1) the need to closely monitor the Bal 31 reaction, as
the reaction rate of this enzyme is high; (2) the need to isolate, purify and ligate
the fragments resulting from this digestion to a suitable vector for sequencing to
identify the desired construct; and (3) the fact that only a fraction of the DNA
molecules in the reaction mixture at any one time will have blunt ends that are
suitable for ligation. Therefore, without any disclosure of the appropriate
conditions and manipulations, this method would require undue experimentation.
Falkinham declaration, para. 13.
Even if we assume, arguendo, that Dr. Falkinham is correct that the Bal 31
procedure is unpredictable, we agree with Brake that this was presented as an
alternative technique to the site-directed mutagenesis method initially described by
Dr. Tekamp-Olson. Tekamp-Olson declaration, pp. 3-4, para. 5(b). Accordingly, since
both Brake’s declarant, Dr. Tekamp-Olson, and Singh’s declarants, Drs. Singh and
Hitzeman, agree that site-directed mutagenesis was an established technique in the art
by 1982, we need not reach the merits of the Bal 31 procedure argument.
4. Singh’s Brief, Paper No. 151
As discussed above, we are returning Singh’s briefs on the issues of written
description and enablement, filed November 3, 2000, for failure to comply with
37 C.F.R. § 1.655(a) and (b). Here, we will consider only those § 112 issues which
were properly raised in Singh’s original brief (Paper No. 151), filed April 8, 1996.
Turning to Singh’s arguments set forth therein, we find the following.
a. Written description
It is readily apparent from the Opposition to Brake’s Motion (2) (Paper No. 30),
attached as Appendix 2, that Singh did not raise any arguments with respect to written
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