Appeal No. 2001-0121 Page 5
Application No. 08/212,185
form or the phosphotyrisone itself (as anti-phosphotyrosine
antibodies are well known in the art).
On reflection, it is our opinion that the examiner failed to provide the
evidence necessary to meet her burden of establishing a prima facie case of
non-enablement. Instead, we agree with appellants argument (Brief, bridging
sentence, pages 12-13) that “[a]ppellants are not required to teach how to isolate
and characterize all of the receptor recognition factors that the method can be
performed on …, but rather are only required to enable the claimed methodology
such that it can be used on any given receptor recognition factor.”
The enablement requirement of 35 U.S.C. § 112, first paragraph, requires
that the patent specification enable “those skilled in the art to make and use the
full scope of the claimed invention without ‘undue experimentation.’” Genentech,
Inc. v. Novo Nordisk. A/S, 108 F.3d at 1365, 42 USPQ2d at 1004 (quoting In re
Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)).
Whether the disclosure is enabling, is a legal conclusion based on several
underlying factual inquiries. To assist the fact finder in meeting his initial burden
of setting forth a reasonable explanation as to why he believes the scope of the
claimed invention is not adequately enabled by the description, our appellate
reviewing court has outlined a number of factors that should be considered. As
set forth in In re Wands, 858 F.2d 731, 735, 736-37, 8 USPQ2d 1400, 1402,
1404 (Fed. Cir. 1988), the factors to be considered in determining whether a
claimed invention is enabled throughout its scope without undue experimentation
include the quantity of experimentation necessary, the amount of direction or
guidance presented, the presence or absence of working examples, the nature
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