Appeal No. 1999-1413
Application 08/176,024
case of lack of enablement, the examiner has the initial burden to establish a reasonable
basis to question the enablement provided for the claimed invention. See In re Wright, 999
F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993) (examiner must provide a
reasonable explanation as to why the scope of protection provided by a claim is not
adequately enabled by the disclosure). See also In re Morehouse, 545 F2d 162, 165, 192
USPQ 29, 32 (CCPA 1976). The threshold step in resolving this issue is to determine
whether the examiner has met his burden of proof by advancing acceptable reasoning
inconsistent with enablement.
Factors to be considered by the examiner 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. In re Wands, 858 F.2d 731, 737, 8 USPQ2d
1400, 1404 (Fed. Cir. 1988).
In the present case, the examiner cites the state of the art and the lack of working
examples involving humans as the factors leading to a conclusion of non-enablement.
Specifically, the examiner argues (Answer, page 6):
6
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