Interference 102,728
under stringent “wash” conditions routine in the art in 1983, “n=0” constructs could have
been identified. Id.; see also Brake Exhibit 28 attached to Paper No. 44.
In paragraph 12 of his declaration Dr. Falkinham argues that the success of the
oligonucleotide mutagenesis technique was unpredictable. Falkinham declaration, p. 4,
para. 12. Dr. Falkinham points to a twelve (12)- page review article by Fritz which is
said to state that “It is therefore not surprising that the conventional protocol typically
gives rise to marker yields of only about 5%,” to support his position. Id.
Here, we agree with Brake that Dr. Falkinham has misinterpreted the referenced
section of the Fritz publication. That is, Dr. Falkinham has interpreted the obtention of
a 5% yield as meaning that oligonucleotide mutagenesis is an unpredictable technique.
However, as pointed out by Drs. Johnson and Tekamp-Olson, the Fritz article is
referring to the efficiency of the procedure, not the predictability. Johnson Declaration,
p. 11, para. 10b, Tekamp-Olson Declaration 2, pp. 7-8, para. 9. Thus, we find that
those skilled in the art would have understood the Fritz publication to mean that for
every 100 colonies screened, five would be positive. Id. Accordingly, since screening
hundreds of colonies was routine in the art in January, 1983, we further find that those
skilled in the art would have reasonably expected 5% of the colonies to be positive. Id.
Finally, Dr. Falkinham urges that the Bal 31 method of making the n=0
constructs described by Dr. Tekamp-Olson (Tekamp-Olson declaration, pp. 3-4,
para. 5b) “would require undue experimentation.” Declaration of Dr. Falkinham, p. 5,
para. 13. According to Dr. Falkinham:
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