Appeal No. 2001-1905 Page 3
Application No. 08/245,827
When rejecting a claim under the enablement requirement of
section 112, the PTO bears an initial burden of setting forth a
reasonable explanation as to why it believes that the scope of
protection provided by that claim is not adequately enabled by the
description of the invention provided in the specification of the
application; this includes, of course, providing sufficient reasons for
doubting any assertions in the specification as to the scope of
enablement.
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.
The Answer addresses the Wands factors, however in our opinion, the
examiner’s rationale is merely a rambling accumulation of conclusions.
Therefore, for the reasons discussed infra, we find that the examiner failed to
meet his burden of establishing a prima facie case of non-enablement.
According to the examiner (Answer, page 4):
The sole description of the invention contemplating
[the] use of glutathione consists of two sentences on page 8
of the specification:
“[a]pplicants [sic] have also discovered that both
reduced and oxidized glutathione (0.5-10mM) can protect
against toxicity mediated at NMDA receptors by a
mechanism not related to the site of oxidation discussed
above. Thus glutathione can be used in vivo or in vitro as
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