Interference 102,728
fragment encoding epidermal growth factor (EGF), demonstrates the unpredictability of
modifying the pYEGF-8 construct described in the Brake 1 specification using the
techniques of oligonucleotide mutagenesis or Bal 31 digestion described in Dr.
Tekamp-Olson’s declaration (attached to Brake Motion 2, Paper No. 15). That is, Dr.
Falkinham does not explain how the spontaneous deletion of two amino acids in a DNA
fragment encoding EGF demonstrates the unpredictability of making the “n=0” DNA
construct described in Brake 1 which requires the deletion of four amino acids from the
" factor spacer sequence using a different technique; i.e., either the oligonucleotide
mutagenesis or Bal 31 digestion technique.
Singh still further argues that the early DNA mutagenesis techniques would have
required undue experimentation by those skilled in the art. Paper No. 30, p. 14. Singh
relies on paragraphs eleven (11) through thirteen (13) of Dr. Falkinham’s declaration for
support. Id. We find this argument to be unconvincing.
Turning first to paragraph 11 of the declaration, we find that Dr. Falkinham
states:
11. It is my opinion that the construction of the n=0 construct using
oligonucleotide mutagenesis could not have been accomplished without undue
experimentation based upon the vague disclosure of the Brake application.
Brake contends that an oligonucleotide could be employed to make the deletion
of the Glu-Ala sequences and to screen for potential mutants. However, this
oligonucleotide would bind to both the n$1 and the n=0 constructs. Therefore,
one who attempted to use this oligonucleotide to identify mutants (i.e., the n=0
construct) would have to know how to modify the hybridization conditions to
distinguish the binding to the starting n$1 construct and the n=0 construct.
Brake does not provide any disclosure or suggestion of these conditions
[emphases added].
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