Appeal No. 2002-1631 Page 3
Application No. 08/213,433
jun deletion mutant would need to be administered to [a] mammal . . . , [t]he nucleic
acid would then need to reach [ ] tumor cells, be translated into the mutant c-jun
phosphoprotein in sufficient quantities to complex with other components to form a
mutant AP-1 . . . incapable of binding to the AP-1 element in the promoter sequence, or
. . . inducing transcription.” Answer, pages 2 and 3.
DISCUSSION
“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 required is ‘undue.’” In re Vaeck, 947 F.2d 488, 495, 20
USPQ2d 1438, 1444 (Fed. Cir. 1991) (emphasis in original).
A number of factors are relevant to whether undue experimentation would be
required to practice the claimed invention, including “(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 at 737, 8 USPQ2d at
1404 (Fed. Cir. 1988).
Following a thorough analysis in keeping with that outlined in In re Wands, the
examiner rejected the claims under the first paragraph of 35 U.S.C. § 112, concluding
that “[t]he claims are not enabled because the specification fails to provide guidance as
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