Appeal No. 1998-2107
Application No. 08/137,624
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 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 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.
We find no Wands analysis in this record. Instead, we find only the
examiner’s unsupported conclusion that the terms presented in “claim 59 leave too
much conception to the reader.” It is unclear exactly what the examiner intends by
this phrase. Nevertheless, in the absence of a fact-based statement of a rejection
based upon the relevant legal standards, the examiner has not sustained his initial
burden of establishing a prima facie case of non-enablement.
This board functions as a board of review, not a de novo examination
tribunal. 35 U.S.C. §7(b)(“[t]he Board of Patent Appeals and Interfernces shall …
review adverse decisions of examiners upon application for patents …”). For the
reasons set forth above, the examiner’s rejection set forth in the Answer is not
susceptible to a meaningful review. Rather than spend the resources of the board in
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