Appeal No. 95-3732
Application 08/172,110
We have carefully considered the record before us,4 and based thereon, find that we cannot
sustain the examiner’s ground of rejection of the appealed claims under 35 U.S.C. § 112, first
paragraph, enablement, for the reason that “the specification is inadequate to support the assertion that
any aminopyridine will treat any disease of the anterior horn cells” (answer, page 2; see also pages 3-4)
. It is well settled that under § 112, first paragraph, the examiner has the burden of providing a
reasonable explanation, supported by the record as a whole, why the assertions as to the scope of
objective enablement set forth in the specification are in doubt, including reasons why the description of
the invention in the specification would not have enabled one of ordinary skill in this art to practice the
claimed invention without undue experimentation, in order to establish a prima facie case under the
enablement requirement of the first paragraph of § 112. In re Wright, 999 F.2d 1557, 1561, 27
USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404
(Fed. Cir. 1988); In re Marzocchi, 439 F.2d 220, 223-24, 169 USPQ 367, 369-70 (CCPA 1971).
We reverse this ground of rejection because the examiner has not sustained her burden of
establishing a prima facie case under § 112, first paragraph, enablement. Even though the examiner
has withdrawn the ground of rejection of the appealed claims under 35 U.S.C. § 101 on the basis that
the “instant method is credible for the treatment of a disease of the anterior horn cells and thereby for
increasing motor strength” (answer, page 2), she has advanced a contrary position with respect to §
112, first paragraph, enablement, in contending that it would be “unpredictable” to treat a human having
a disease of the anterior horn cells with an aminopyridine in order to increase his/her motor strength
because of the treatment of another disease of the anterior horn cells with an aminopyridine where the
motor strength of the human was increased (answer, page 4). The examiner predicates her position on
the theory that the nine aminopyridines encompassed by appealed claim 1 are not “pharmacologically
equivalent,” citing pharmacological differences between 3,4-diaminopyridine and 4-aminopyridine and
the “questioned” “potential usefulness of 3,4-diaminopyridine in the treatment of multiple sclerosis” as
set forth in Bever et al (answer, page 3), from which the examiner concludes that “each aminopyridine
of the formula of claim 1 would not necessarily provide appropriate therapy for any disease of the
4 We refer to the examiner’s answer and to appellants’ principal and reply briefs for a complete
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