Appeal No. 1997-3122
Application No. 08/082,848
is quite limited given the breadth of the claims, and on the whole, insufficient to enable the
breadth of claimed invention without undue experimentation; in particular, the specification
is insufficient to establish “that the in vitro system used is predictive of in vivo
administration . . . [or] representative . . . of neurotoxicity in Huntington’s disease,
Alzheimer’s disease, or Parkinson’s disease.” Examiner’s Answer, pages 6 and 7.
“The first paragraph of 35 U.S.C. § 112 requires, inter alia, that the specification of
a patent enable any person skilled in the art to which it pertains to make and use the
claimed invention. Although the statute does not say so, enablement requires that the
specification teach those in the art to make and use the invention without ‘undue
experimentation.’ In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir.
1988). That some experimentation may be required is not fatal; the issue is whether the
amount of experimentation is ‘undue.’” In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438,
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1444 (Fed. Cir. 1991) (emphasis in original). Nevertheless, “[w]hen rejecting a claim
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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 (BdPatAppInt 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).
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