Appeal No. 1999-1355 Page 5
Application No. 08/469,786
The examiner indirectly touches on a few of the Wands factors (Answer, pages 7
and 8), arguing that
[D]isclosure of three functional chimeric antibodies is insufficient evidence
to support the present claims as to all chimeric antibodies prepared from
all non-Ig proteins as being functional.
The specification examples, while differing structurally and functionally,
are not representative of all classes of non-Ig protein moieties nor that
when coupled to an Ig, that the chimeric protein would have retained the
properties of both parts of the chimeric protein . . .
[T]he biological activity [and] function of a protein are greatly dependent
upon its three-dimensional configuration . . . and [ ] even minor changes in
the sequence of a protein may adversely affect its ability to fold properly.
Changes in DNA sequence may alter the ability of a transfected cell to
express, secrete and properly assemble the protein. The present
application disclosure does not disclose nor guide one skilled in the art . . .
as to the parameters that affect and/or effect the predictability of the
retention of biological activity and function for both the non-Ig segment
and the Ig segment of the chimeric protein. The indicia of certainty is not
apparent in the application as filed. Thus, one of skill in the art . . . would
not have been able to predict with certainty or even a priori that
biologically active and functional chimeric antibodies would have been
produced from all expression constructs.
This argument is not persuasive for several reasons. To the extent that the
examiner requires “certainty” to demonstrate enablement, we note that no authority has
been cited in support of this requirement. On the contrary, a requirement for certainty
would be incompatible with any amount of experimentation and therefore incompatible
with the standard of enablement discussed above. Nor is it the function of the claims to
specifically exclude possibly inoperative embodiments - only if the number of
inoperative embodiments becomes significant, and in effect forces one of ordinary skill
in the art to experiment unduly in order to practice the claimed invention, might the
claims be invalid. See Atlas Powder Co. v. E.I. Du Pont De Nemours & Co., 750 F.2d
1569, 1576-77, 224 USPQ 409, 414 (Fed. Cir. 1984).
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