Appeal No. 2001-0562 Page 6
Application No. 08/460,478
conclusion that ‘one of skill in the art would not expect the adenovirus to reach
cells of the CNS” in an effective quantity.
Whether the disclosure is enabling, is a legal conclusion based on several
underlying factual inquiries. See In re Wands, 858 F.2d 731, 735, 736-37, 8
USPQ2d 1400, 1402, 1404 (Fed. Cir. 1988). As set forth in Wands, the factors
to be considered in determining whether a claimed invention is enabled
throughout its scope without undue experimentation include the quantity of
experimentation necessary, the amount of direction or guidance presented, the
presence or absence of working examples, the nature of the invention, the state
of the prior art, the relative skill of those in the art, the predictability or
unpredictability of the art, and the breadth of the claims.
We find no analysis of the Wands factors by the examiner. Instead, we
find only the examiner’s unsupported conclusions as to why the specification
does not enable the claimed invention. We remind the examiner that nothing
more than objective enablement is required, and therefore it is irrelevant whether
this teaching is provided through broad terminology or illustrative examples. In
re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971). In the
absence of a fact-based statement of a rejection based upon the relevant legal
standards, the examiner has not sustained his initial burden of establishing a
prima facie case of non-enablement. In our opinion, the examiner failed to
provide the evidence necessary to support the rejection of claims 81, 82 and 85-
102 under 35 U.S.C. §112, first paragraph. Accordingly, we reverse the rejection
of claims 81, 82 and 85-102 under 35 U.S.C. §112, first paragraph.
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