Appeal 2007-1152
Application 10/660,924
USPQ2d 1115, 1120 (Fed. Cir. 1994) (“Testing for the full
safety and effectiveness of a prosthetic device is more properly
left to the Food and Drug Administration (FDA). Title 35 does
not demand that such human testing occur within the confines
of Patent and Trademark Office (PTO) proceedings.”).
(Brana, at 1567, 34 USPQ2d at1442.) We see no reason why enablement of
a method claim whose scope includes humans should likewise require
human testing. Thus, in view of Brana, we conclude that animal models can
be used to establish enablement under § 112, first paragraph of a method
claim.
The relevant standard is rather whether the scope of the claims bears
“a reasonable correlation to the scope of enablement provided by the
specification to persons of ordinary skill in the art.” In re Fisher, 427 F.2d
833, 839, 166 USPQ 18, 24 (CCPA 1970). See also Invitrogen Corp. v.
Clontech Laboratories Inc., 429 F.3d 1052, 1071, 77 USPQ2d 1161, 1173-
1174 (Fed. Cir. 2005). In this case where an animal model serves as the
enablement for the claimed method, the proper question is whether it
reasonably correlates with the method for which patent protection is sought.
On this point, the Examiner has provided no evidence that results obtained
with streptozotocin-induced diabetes in C57B6 mice, as described in the
Specification, do not reasonably correlate with the scope of claim 2.
In contrast, Appellant has provided post-filing evidence, that together with
Atkinson’s teaching about the acceptability of NOD mouse as a model for
diabetes, establishes by the preponderance of the evidence that the
Specification as filed is, in fact, enabling. See In re Oetiker, 977 F.2d 1443,
1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“[P]atentability is
determined on the totality of the record, by a preponderance of the
evidence.”).
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