Interference 102,728
We decline to credit Dr. Falkinham’s opinion that construction of the n=0 DNA
construct using oligonucleotide mutagenesis could not have been accomplished without
undue experimentation in view of the allegedly vague disclosure of the Brake 1
application. Brake acknowledges that the Brake 1 specification does not disclose the
synthesis of a DNA construct wherein the “glu-ala” sequence of the "-factor spacer
sequence has been removed, i.e., the n=0 construct required by Count 1. However, as
we discussed above, it is well established that a specification need not describe that
which is well known in the art. Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d
at 1385, 231 USPQ at 94, 480 U.S. 947 (1986). Moreover, as further discussed
above, the evidence of record indicates that oligonucleotide (site-directed) mutagenesis
was well known in the art by 1982. See Dr. Tekamp-Olson’s Declaration 1, pp. 2-4,
paras. 4-5; Singh Declaration, SR 568, para. 58; Hitzeman Declaration, SR 168-169,
para. 9.28 Thus, we find Dr. Falkinham’s testimony to be inconsistent with the testimony
of three (3) other declarants of record, including, arguably, two of Singh’s declarants.
In addition, we find that although Dr. Falkinham states that the making of an n=0
construct using an oligonucleotide to delete the “glu-ala” sequence of the "-factor
spacer sequence could not have been accomplished without undue experimentation,
the only “difficulty” he discusses is that of screening for an n=0 construct once it has
been made. Thus, we find that Dr. Falkinham’s opinion is based on his concern that
28 The Singh and Brake record will be referred to as SR and BR, respectively,
followed by the appropriate page number. Similarly, the Singh and Brake exhibits will
be referred to as SX and BX, followed by the page number.
38
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