Appeal No. 95-4692
Application 08/141,316
specification does not describe the characterization of any
microbial enzymes which are derived from the claimed
microorganisms and which are capable of catalyzing the
hydroxylation of compactin or analogues thereof. Nor does the
specification describe the characterization of any enzymes
having the structure of said microbial enzymes and which are
capable of catalyzing the claimed hydroxylation reaction. In
considering whether it would require undue experimentation for
those skilled in the art to “make and use” the claimed method,
the examiner should consider such facts in light of the
various factors set forth by the court in In re Wands, supra.
For example, what was the state of the art at the time the
application was filed? Was the hydroxylation of compactin and
analogs thereof well known in the art? Was this a known and
well characterized pathway at the time the application was
filed? Were the enzyme(s) involved known and characterized?
How much guidance does the specifi-cation provide as to the
isolation and characterization of such enzyme(s)? How many
working examples of the claimed enzyme(s) does the
specification provide? Is the structure of the claimed
enzyme(s) predictable based on the teachings of the specifi-
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