Appeal No. 2000-0600 Page 4
Application No. 08/642,268
DISCUSSION
THE REJECTIONS UNDER 35 U.S.C. § 112, FIRST PARAGRAPH:
Claims 1, 2, 5-11, and 13-19:
The examiner finds (Answer, page 5) appellants “provide no reasonable
assurance that [the] piperazion,[ ]piperidino species having ‘het’ at R2 and/or R3 will
all share the requisite profile of activity needed to be operative for practicing the
invention.” According to the examiner (id.) while certain in vitro tests are disclosed
on pages 4-5 of the specification it has “not been shown if a variety of hetero rings
at R2,[ ]R3 have been tested or just one or two of the working examples directed to
a much narrower scope- ie.[ ]piperidino,[ ]pyridyl,[ ]thienyl and furyl in the R3 group.”
We note that the examiner provides no evidence to support her position,
instead, the examiner simply concludes that the specification is not sufficient to
support the claimed invention. With reference to In re Marzocchi, 439 F.2d 220,
224, 169 USPQ 367, 370 (CCPA 1971), appellants argue (Brief, page 6) “that the
burden of proof on this issue has been prematurely shifted to [a]ppellants.” We
agree with appellants.
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
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