Appeal No. 94-1775
Application 07/488,513
patentability of any claim pending in this application. If so, the examiner should issue an
appropriate Office action setting forth all appropriate rejections.
REJECTION UNDER 35 U.S.C. § 103 PREMISED UPON CHANG
1. Claim 18
Claim 18 is directed to a method for producing proteins with hirudin activity which
comprises culturing under appropriate nutrient conditions yeast cells which have been
transformed with a specified hybrid vector. In relevant part, claim 18 requires that 90% or
more of the proteins with hirudin activity are secreted into the culture medium.
Assuming without deciding that the references relied upon by the examiner would
have suggested the construction and use of yeast cells transformed with the hybrid vector
required by claim 1 on appeal, the rejection before us still cannot be sustained. According
to pages 3-6 of the Examiner’s Answer, the examiner’s position in regard to the required
level of secretion of proteins with hirudin activity is:
[a]ny differences between the amount of protein product secreted using the
method of the instant invention, and that of Chang et al. is considered to be
expected, since such variability was well known at the time of the invention,
as has been pointed out by the applicant in previous arguments and in the
Declaration of Dr. Hinnen, submitted 8/9/90, Paper No. 16, and appended to
the Brief.
While the record of this application may support the proposition that transformed
yeasts will secret heterologous proteins in a variable amount, that does not in and of itself
support the finding which needs to be made under these circumstances, i.e., whether the
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