Appeal No. 2002-0870 Page 4
Application No. 09/208,206
With respect to the guidance provided by the specification, the examiner does
not appear to question the ability of one skilled in the art to follow the protocol disclosed
in the specification. Nor, apparently, does the examiner appear to question whether
that protocol would have enabled one skilled in the art to obtain naturally occurring
polypeptides found in humans that have a 90% sequence identity to SEQ ID NO:2. We
accept, for the sake of argument, that it would be iterative and time consuming to
identify naturally occurring polypeptides found in humans that have a 90% sequence
identity to SEQ ID NO:2, but undue experimentation has little to do with the quantity of
experimentation; it is much more a function of the amount of guidance or direction
provided. As explained in PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558,
1564, 37 USPQ2d 1618, 1623 (Fed. Cir. 1996):
[T]he question of undue experimentation is a matter of degree. The fact
that some experimentation is necessary does not preclude enablement;
what is required is that the amount of experimentation “must not be unduly
extensive.” Atlas Powder Co. v. E.I. DuPont de Nemours & Co., 750 F.2d
1569, 1576, 224 USPQ 409, 413 (Fed. Cir. 1984). The Patent and
Trademark Office Board of Appeals summarized the point well when it
stated:
The test is not merely quantitative, since a considerable
amount of experimentation is permissible, if it is merely
routine, or if the specification in question provides a
reasonable amount of guidance with respect to the direction
in which the experimentation should proceed to enable the
determination of how to practice a desired embodiment of
the invention claimed.
Ex parte Jackson, 217 USPQ 804, 807 (1982).
Further, to the extent the examiner requires the specification to “provide
enablement for all naturally occurring polypeptides found in humans that have 90%
sequence identity to SEQ ID NO:2” (Answer, page 3, emphasis added), we note that no
authority has been cited in support of this requirement. On the contrary, “appellants are
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