Appeal No. 2001-1705 Page 4
Application No. 08/616,141
provided through broad terminology or illustrative examples.” In re Marzocchi,
439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971). As set forth in In re
Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993):
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.
As the examiner recognizes (Answer, page 5), “[c]laim 31 recites
dissociation of the macrocycle from the compound after internalization inside the
cells.” As we understand the examiner’s position, since “page 6, lines 9-12 [of
the specification], provides support for internalization of the complex within cells,
but not for dissociation of the complex”, the specification fails to enable the
claimed invention.
Lines 9-12, on page 6 of appellants’ specification state “the compound to
be delivered is ionically bound to the macrocyclic compound until it and the
bound nucleic acids are internalized in the targeted cells [emphasis added].”
According to appellants (Reply Brief, page 3), “[t]he critical term in this passage
[is] – ‘until’ ….” This language, absent factual evidence to the contrary, is
sufficient to objectively enable the claimed invention. Marzocchi.
What is missing from the examiner’s rejection is factual evidence
disputing appellants’ objectively enabled specification. It is the examiner’s
burden to make out a case of non-enablement. In our opinion, the examiner has
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