Appeal No. 1997-2385
Application No. 08/271,571
It is well settled that the examiner bears the initial burden of providing reasons why a
supporting disclosure does not enable a claim. In re Marzocchi, 439 F. 2d 220, 223, 169
USPQ 367, 369 (CCPA 1971). It has long been held that "[t]o be enabling, the
specification of a patent must teach those skilled in the art how to make and use the full
scope of the claimed invention without 'undue experimentation.' " Genentech, Inc. v. Novo
Nordisk, A/S, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997) (quoting
from In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)).
Further, in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) the
court stated that
Factors to be considered in determining whether a disclosure would require
undue experimentation have been summarized by the board in Ex parte
Forman [230 USPQ 546, 547 (Bd. Pat. App. Int. 1986)]. They 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. [Footnote omitted.]
These factors are neither mandatory nor cumulative. Enzo Biochem Inc. v. Calgene Inc.,
188 F.2d 1362, 1371, 52 USPQ2d 1129, 1136 (Fed. Cir. 1999).
Here, the examiner argues that the "[d]etermination of the denaturation temperature
of the therapeutic active ingredient and the plant enzymes are not enabled by the
specification" (Answer, p. 4) because "nowhere in the specification is found how one of
ordinary skill would know which enzymes are found in the plant of interest nor how to
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