Appeal No. 1997-4145
Application No. 08/361,328
upon the disclosure in the specification, i.e., whether it would take undue
experimentation to reasonably and predictably obtain stretched DNAs of the specifically
claimed lengths.
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 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997) (quoting In
re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)); see also In
re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (“[T]he scope of the
claims must bear a reasonable correlation to the scope of enablement provided by the
specification to persons of ordinary skill in the art.”). Whether making and using the
invention would have required undue experimentation, and thus whether the disclosure
is enabling, is a legal conclusion based upon several underlying factual inquiries. See
In re Wands, 858 F.2d 731, 735, 736-37, 8 USPQ2d 1400, 1402, 1404 (Fed. Cir. 1988).
As set forth in Wands, 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 of the invention, the state of
the prior art, the relative skill of those in the art, the predictability or unpredictability of
the art, and the breadth of the claims.
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