Appeal No. 2002-1740
Application No. 08/447,398
why the scope of protection provided by a claim is not adequately enabled by the
disclosure). See also In re Morehouse, 545 F2d 162, 192 USPQ 29 (CCPA 1976).
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. (footnote omitted). In re
Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404, (Fed. Cir. 1988). 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.
The examiner finds the claimed invention is “enabling for immunizing a guinea
pig host susceptible to disease caused by Mycobacterium tuberculosis comprising
purified extracellular proteins from Mycobacterium tuberculosis”, but “does not
reasonably provide enablement for immunizing all other mammalian hosts susceptible
to disease caused by any pathogen from the genus Mycobacterium using purified
extracellular proteins from any other species of Mycobacterium.” Answer, page 4.
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