Appeal 2007-1152
Application 10/660,924
process can be used to prevent certain diseases, such as Type I diabetes
(Spec. 10: 12-17).
Claims 2-9 are pending and appealed (Supp. Appeal Br.1 2). Claims
2-9 stand rejected under 35 U.S.C. § 112, first paragraph, as lacking
enablement (Answer 4) and also for lacking written description (Answer 8).
We select claim 2, the only independent claim on appeal, as
representative of the claims. It reads as follows:
2. A method of preventing onset of Type I diabetes in a
mammal predisposed to Type I diabetes, comprising implanting
a dose of insulin-producing cells encapsulated in a biologically-
compatible membrane into an implantation site in said mammal
prior to onset of Type I diabetes, wherein said dose is at least
one order of magnitude less than that necessary to achieve
normoglycemia in a mammal of the same species.
DISCUSSION
Enablement rejection
“To be enabling, the specification of a patent must teach those skilled
in the art how to make and use the full scope of the claimed invention
without ‘undue experimentation.’” Genentech, Inc. v. Novo Nordisk, A/S,
108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997) (quoting In
re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)).
“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
1 “Supp. Appeal Br.” is a reference to the Supplemental Appeal Brief which
is date stamped Jul. 19, 2006.
2
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