Appeal No. 2002-1251 Page 8
Application No. 08/459,340
therapeutically. Instead of providing an analysis tailored to the specific facts of
this case, the examiner seems to reason as follows:
(1) Based on the state of the art, any method of using ribozymes
therapeutically would have been considered nonenabled;
(2) The ribozyme-containing compositions claimed here are intended to
be used therapeutically;
(3) Therefore, the specification cannot have enabled those skilled in the
art to use the claimed compositions.
This approach to the enablement analysis is improper. “Whether undue
experimentation is needed is not a single, simple factual determination, but rather
is a conclusion reached by weighing many factual considerations.” In re Wands,
858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). There are no per se
rules of patentability. See In re Ochiai, 71 F.3d 1565, 1572, 37 USPQ2d 1127,
1133 (Fed. Cir. 1995). Just as in the § 103 context, the use of per se rules, while
undoubtedly less laborious than a searching analysis of the claimed invention,
flouts § 112 and the case law applying it. The conclusion of enablement or
nonenablement must rest on an individualized analysis of the invention as
claimed, including all its limitations, in light of the guidance provided by the
specification and the prior art. See Wands, 858 F.2d at 737, 8 USPQ2d at 1404.
In addition to the lack of individualized analysis, the examiner’s rejection
also suffers from lack of evidentiary support. The only evidence the examiner
cites in the statement of the rejection is an article by Branch. He characterizes
Branch as teaching that “delivery of ribozymes in vivo is a highly unpredictable
endeavor.” Examiner’s Answer, page 4. This characterization is not entirely
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