Appeal No. 2002-1740
Application No. 08/447,398
suggesting that fractionation is a form of purification methodology. The specification
also suggests that immunogenic components of a vaccine may be directly expressed in
host cells containing directly introduced genetic constructs encoding therefor.
Specification, page 18.
35 U.S.C. § 112, first paragraph
Claims 47-67 and 70 stand rejected under 35 U.S.C. § 112, first paragraph for
lack of enablement as to how to make and use the invention within the scope of the
claims. The examiner relies on Wiegeshaus as evidence of lack of enablement.
Although not explicitly stated in section 112, 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." In re Vaeck, 947 F.2d 488, 495, 20
USPQ2d 1438, 1444 (Fed. Cir. 1991); In re Wands, 858 F.2d 731, 737, 8 USPQ2d
1400, 1404, (Fed. Cir. 1988). Nothing more than objective enablement is required, and
therefore it is irrelevant whether this teaching is provided through broad terminology or
illustrative examples. In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA
1971).
In order to establish a prima facie case of lack of enablement, the examiner has
the initial burden to establish a reasonable basis to question the enablement provided
for the claimed invention. See In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d
1510, 1513 (Fed. Cir. 1993) (examiner must provide a reasonable explanation as to
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