Interference 102,728
9. We find the following testimony by Dr. Tekamp-Olson credible:
3. Based upon my review of the Brake 1 patent application it clearly
discloses Saccharomyces "-factor constructs for secretory expression of
heterologous genes which constructs lack a dipeptidylaminopeptidase A (“DPAP
A”) site. This is disclosed in Brake 1 on page 3, line 33 to page 4, line 14; and in
the claims page 16, lines 22 and 32. In particular, the fact that “n” can be zero in
the formulae tells me (as well as those of ordinary skill as of 1983), that the
DPAP A site is optional and can be deleted. Tekamp-Olson declaration, p. 2,
para. 3.
10. Brake argued that one skilled in the art would have been able to make
and use the n=0 construct disclosed in the ‘325 Application using the well-known
technique of site-directed mutagenesis (a.k.a. in vitro or oligonucleotide mutagenesis),
at the time the application was filed. Paper No. 15, pp. 10-12.
11. Brake relied, inter alia, on the declaration testimony of Dr. Patricia
Tekamp-Olson (para. 5a) to establish that the site-directed mutagenesis technique was
available and known to those skilled in the art by January, 1983. Paper No. 15, pp. 11-
12.
12. Dr. Tekamp-Olson credibly states:
5. For example, such constructs could have been made using in vitro
mutagenesis, a technique extensively used by January 1983 to modify DNA.
This technique could have been performed on the construct exemplified in the
Brake 1 application. The in vitro mutagenesis procedure disclosed in Brake 2
was available in January 1983. It would have been apparent to one of ordinary
skill in January 1983 to apply the technique to the material disclosed in Brake 1
to produce a construct of the count, namely a construct lacking the DPAP A site.
a. To perform in vitro mutagenesis on the construct py"EGF-21 or
according to the Brake 1, pYEGF-8 disclosed in Brake 1 it would have been
apparent and within the level of ordinary skill in 1983 to (1) digest the construct
with BamHI; (2) subclone the BamHI digest into an M13 vector; (3) mutagenized
[sic, mutagenize] the M13 vector with a primer lacking the DPAP A site; (4)
screen the mutagenized M13 vector with the primer to isolate a clone lacking the
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