Appeal No. 1999-1430
Application No. 08/441,893
hybridizes to any DNA encoding one of the disclosed proteins
under moderate or even high stringency conditions.
In response appellants argue (Brief, page 7):
With respect to the breadth of the claims, contrary to
the [e]xaminer’s position, the claims do not encompass ANY
and all mutants, variants, or derivatives of SEQ ID NO:2 and
SEQ ID NO:13. Similarly, the claims do not encompass
potentially thousands of embodiments that deviate from the
natural amino acid sequences. The claims encompass
polypeptides that bind IL-1 and which are encoded by DNA
that hybridizes under specified conditions to the DNA that
encodes SEQ ID NO:2 or SEQ ID NO:13. [Emphasis
removed].
With regard to the quantity of experimentation appellants argue (Brief,
page 8) that:
[T]he [e]xaminer has erroneously maintained that “a practitioner
would have to resort to a substantial amount of undue
experimentation in the form of insertional, deletional and
substitutional mutation analysis …” The CAFC has consistently
held that the test is not merely quantitative, because a considerable
amount of experimentation is permissible, if it is merely routine. …
It is further the law that the disclosure of a large number of
embodiments does not render a claim broader than the enabled
scope as long as undue experimentation is not involved in
determining the embodiments.
…
There is simply no room to conclude that the quantity of
experimentation required to practice this invention is excessive in
view of the above discussion of the claim breadth. One need only
to prepare variants using routine and often automated procedures,
determine whether the degree of homology of the encoding DNA is
sufficient for it to hybridize to DNA that encodes the specified
regions of SEQ ID NO:2 or SEQ ID NO:13 under the recited
conditions, and determine its IL-1 binding characteristics using
known binding methodologies or those described in Example 5 of
the present specification. All methodologies for performing such
tasks are routine and well known in the art and/or disclosed in the
present specification and require no inventive effort or thought.
5
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