Interference No. 102,700
The Office Action also draws the conclusion that
the presence of amidated peptides in a particular
tissue is synonymous with high levels of alpha-
amidating enzyme. This is not true. For example,
rat anterior pituitary tissue contains high alpha-
amidating activity but no known substrates [Eipper
et al., PNAS 80, 5144-5148 (1983)]. Rat posterior
pituitary tissue contains amidated peptides
(oxytocin and vasopressin) but has very little
alpha-amidating activity [Eipper et al., Endo 116,
2497-2504 (1985)]. Therefore, until individual
tissues are tested for alpha-amidating activity, the
presence or potential levels of the enzyme can not
be anticipated. In fact, Applicants had to screen
large numbers of tumors prior to identifying a tumor
series with high levels of amidating enzyme
activity; many of them were found to be unreliable
or useless as enzyme sources. [OR-231]
According to Gilligan, the foregoing statement relates to
difficulties encountered in developing the invention prior to
the filing date; and Gilligan insists that those difficulties
dissipated once the purification technique described in
Gilligan's specification was developed. However, as we see
it, Gilligan's statements are tantamount to an admission that
identifying sources of PAM enzyme was unpredictable at the
time the Gilligan application was filed. Gilligan has adduced
no evidence that the identification of particular sources for
the enzyme became more predictable as a result of Gilligan's
development of a purification technique for extracting the
enzyme from an identified source. Rather, by Gilligan's own
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