Appeal No. 2001-2497 Page 5
Application No. 08/855,744
agents which are highly toxic occurs after being administered
separately. Furthermore, all of the species being administered
such as the binding molecules, remover substances, and the
therapeutic agents are immunogenic and would appear to hinder
long term administrations. Therefore, in the absence of further
guidelines, it would be undue experimentation to determine the
conditions in which bifunctional binding molecules with which
remover and which therapeutic agents would be operable as
broadly claimed in the instant application.
Paper No. 5, pages 4-5.2 As we understand it, the examiner’s reasoning is that
the claimed method encompasses inoperative embodiments and undue
experimentation would have been required to determine what embodiments
within the scope of the claims are and are not operable.
The examiner bears the initial burden of establishing nonenablement. See
In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)
(“[T]he 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.”).
That burden is not met by a bare assertion that a claimed method has not
been shown to work. “Section 112 does not require that a specification convince
persons skilled in the art that the assertions therein are correct.” In re
2 Paper No. 5 includes an additional basis of nonenablement: “The specification improperly
incorporates the essential material required to make and use the claimed invention.” Page 4,
lines 25-27. This basis, however, was apparently withdrawn in the next Office action. See Paper
No. 10 (mailed Jan. 13, 1993), page 3: “[C]laims 1-3 . . . remain rejected under 35 U.S.C. §112,
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