Appeal No. 1997-2510
Application No. 07/868,539
When rejecting a claim under the enablement requirement of
section 112, the PTO bears an initial burden of setting forth a
reasonable explanation as to why it believes that the scope of
protection provided by that claim is not adequately enabled by the
description of the invention provided in the specification of the
application; this includes, of course, providing sufficient reasons for
doubting any assertions in the specification as to the scope of
enablement.
With regard to the examiner’s burden of setting forth a reasonable explanation
as to why he believes the specification does not enable the claimed invention,
we note that determining 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 also recommend that the examiner review Enzo Biochem, Inc. v.
Calgene, Inc., 188 F.3d 1362, 52 USPQ2d 1129 (Fed. Cir. 1999). Therein, the
court provided a model analysis of enablement issues and illustrated the type of
fact finding which is needed before one is in a proper position to determine
whether a given claim is enabled or non-enabled.
II. Utility:
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