Appeal No. 1997-2751
Application No. 08/159,096
505, right-hand column (“The reason for this finding is unknown, since
mineralization rates are not increased nor has this dose level been previously
shown to increase activation frequency or appositional rate.”). Therefore, this
finding would not have led those skilled in the art to expect similar results from
treatment of fractures with other diphosphonates, such as those recited in the
instant claims.
As stated in In re Wright, 999 F.2d. 1557, 1561, 27 USPQ2d 1510, 1513
(Fed. Cir. 1993):
[w]hen 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. If the PTO meets this burden, the burden then shifts to
the applicant to provide suitable proofs indicating that the
specification is indeed enabling.
Factors that bear on whether claims are adequately enabled include:
(1) the quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of
working examples, (4) the nature of the invention, (5) the state of
the prior art, (6) the relative skill of those in the art, (7) the
predictability or unpredictability of the art, and (8) the breadth of the
claims.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
After reviewing all of the evidence in the record in light of the Wands
factors, we conclude that the specification does not enable practice of the full
scope of the claimed invention without undue experimentation. In particular, we
note that the invention is of a nature which contradicts accepted scientific
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