Appeal No. 2004-2208
Application No. 10/158,988
We cannot agree. Like any other rejection, the initial
burden of establishing a prima facie case of unpatentability
based on non-enablement under 35 U.S.C. § 112, ¶1, rests on the
examiner. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443,
1444 (Fed. Cir. 1992).
“Although not explicitly stated in section 112, to be
enabling, the specification of a patent must teach those skilled
in the art how to make and use the full scope of the claimed
invention without ‘undue experimentation.’”2 In re Wright, 999
F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). As long
as “undue experimentation” is not involved, a specification
would comply with the enablement requirement of the statute even
if a reasonable amount of routine experimentation is necessary
to practice the claimed invention. Enzo Biochem Inc. v.
Calgene, 188 F.3d 1362, 1371, 52 USPQ2d 1129, 1135 (Fed. Cir.
2 The question of whether making and using the invention
would have required “undue experimentation” depends on several
underlying factual inquiries 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 731, 735, 736-37,
8 USPQ2d 1400, 1402, 1404 (Fed. Cir. 1988).
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