Appeal No. 2001-1293 Page 11
Application No. 08/464,271
most “method of treatment” claims wherein the subject to be treated
is said to be “in need of” the drug administered. In such a claim,
creation of the precondition is not required of the one who would
practice the treatment claim. It is respectfully submitted that the
burden of creating a transgenic animal should be relegated to those
who submit claims reciting acts that lead to the production of
transgenic animals.
Appeal Brief, page 9 (emphasis in original).
This argument is not persuasive. Appellants argue, in a nutshell, that the
only manipulative step actually recited in the claim is administering a latent toxin
to a transgenic organism, and therefore that is all that must be enabled by the
specification. However, it is indisputable that practicing the claimed method
requires that the transgenic animal recited in the claims be available for
treatment. Appellants have presented no evidence to show that a “stable” of
appropriate transgenic animals are available in the art, such that they can be
obtained by the skilled artisan without experimentation. Thus, it would appear
from the record that the only way for a person of skill in the art to obtain a
transgenic animal expressing an exogenous converting enzyme, such as that
recited in claim 44, would be to make it following the guidance provided in the
specification. That the claim does not expressly recite the manipulative steps
required to do so is of no importance; those steps are required to practice the
claimed method, even if they are not expressly recited in the claims. In order to
enabled the claimed method, therefore, the specification must enable those
skilled in the art to make the recited transgenic organisms.
Appellants also argue that the specification is enabling “[e]ven if the claims
were to be read as requiring creation of an organism containing a transgene.”
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