Appeal No. 1998-2195
Application No. 08/277,241
concentration, and [despite the fact] that “exact mathematical
relationships” are not known between any hormone and its
regulatory peptide.
Appeal Brief, page 30. Appellants have provided an excerpt from a laboratory
medicine textbook to support their assertions concerning the state of the art.
The examiner bears the burden of establishing that the claimed invention
is not enabled by the specification. See In re Wright, 999 F.2d 1557, 1561-62, 27
USPQ2d 1510, 1513 (Fed. Cir. 1993):
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.
See also In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA 1971):
[It] is incumbent upon the Patent Office, whenever a rejection on
this basis is made, to explain why it doubts the truth or accuracy of
any statement in a supporting disclosure and to back up assertions
of its own with acceptable evidence or reasoning which is
inconsistent with the contested statement. Otherwise, there would
be no need for the applicant to go to the trouble and expense of
supporting his presumptively accurate disclosure.
In this case, we conclude that the examiner has not met her burden of
providing acceptable evidence or reasoning to establish that the claimed method
is not enabled by the specification. It is true, as the examiner points out, that the
specification does not disclose a normal range of DIP levels. Thus, those skilled
in the art would have been required to perform some experimentation, in order to
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