Appeal 2007-1633
Application 09/480,236
Enablement is a question of law, based on underlying findings of fact.
See, e.g., In re Wands, 858 F.2d 731, 735, 8 USPQ2d 1400, 1402
(Fed. Cir. 1988). “When rejecting a claim under the enablement
requirement of section 112, the PTO bears an initial burden of setting forth a
reasonable explanation as to why it believes that the scope of protection
provided by that claim is not adequately enabled by the description of the
invention provided in the specification of the application.” In re Wright, 999
F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
“[T]o be enabling, the specification . . . must teach those skilled in the
art how to make and use the full scope of the claimed invention without
‘undue experimentation.’” Wright, 999 F.2d at 1561, 27 USPQ2d at 1513
(emphasis added), quoted in Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d
1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997). Thus, “there must be
sufficient disclosure, either through illustrative examples or terminology, to
teach those of ordinary skill how to make and how to use the invention as
broadly as it is claimed.” In re Vaeck, 947 F.2d 488, 496 & n. 23, 20
USPQ2d 1438, 1445 & n. 23 (Fed. Cir. 1991), quoted in Enzo Biochem, Inc.
v. Calgene, Inc., 188 F.3d 1362, 1372, 52 USPQ2d 1129, 1138 (Fed. Cir.
1999).
On reflection, we find that there is no dispute on this record that single
amino acid changes in the variable region of an antibody can affect antigen
binding. We also find that Appellants’ Specification fails to provide a
description of the methodology useful in determining whether a CD3-
binding domain is at least about 90% as effective on a molar basis in
competing with UCHT-1 for binding to human CD3. Accordingly, we are
compelled to agree with the Examiner that Appellants’ Specification fails to
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