Appeal No. 1999-1430
Application No. 08/441,893
Appellants further argue (Brief, page 10) that “the [e]xaminer [has not]
backed up his own assertions with acceptable evidence and reasoning that
refutes [a]ppellants showing that methods for preparing variant DNA and
polypeptides and methods for testing the variant molecules are within the
ordinary skill of those in this art.” We agree. It is the examiner who bears the
initial burden of providing reasons why a supporting disclosure does not enable a
claim. In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971).
In this case, the rejection under 35 U.S.C. §112, first paragraph, is more of a
series of conclusions by the examiner than a fact-based, reasoned explanation
as to why a person skilled in the art would not be able to make and use the
claimed invention throughout its scope without undue experimentation.
Here, the examiner did not perform the fact-finding needed in order to
reach a proper conclusion that it would require undue experimentation, to
practice the full scope of appellants’ claimed invention. The enablement
requirement of 35 U.S.C. or § 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)). Whether making or using the invention would have required
undue experimentation, and thus whether the disclosure is enabling, is a legal
conclusion based on several underlying factual inquiries. See In re Wands,
858 F.2d 731, 735, 736-37, 8 USPQ2d 1400, 1402, 1404 (Fed. Cir. 1988). As
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