Appeal No. 2000-1783 Page 4
Application No. 08/817,719
agent to CD23 other than anti-CD23 antibodies to treat autoimmune diseases.@ Id.
AThe 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, 1444 (Fed. Cir. 1991) (emphasis in original).1 Nevertheless, A[w]hen rejecting a
claim under the enablement requirement of section 112,@ it is well settled that Athe PTO
bears an initial burden of setting forth a reasonable explanation as to why it believes
that the scope of protection provided by that claim is not adequately enabled by the
description of the invention provided in the specification of the application; this includes,
of course, providing sufficient reasons for doubting any assertions in the specification
as to the scope of enablement.@ In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510,
1513 (Fed. Cir. 1993).
1
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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