Appeal No. 2006-1879 Page 6
Application No. 10/010,114
The invention that must be enabled to satisfy § 112 is the invention defined by
the claims. See CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1338, 68 USPQ2d
1940, 1944 (Fed. Cir. 2003) (“Title 35 does not require that a patent disclosure enable
one of ordinary skill in the art to make and use a perfected, commercially viable
embodiment absent a claim limitation to that effect.”). Thus, when the claims are not
directed to a method that achieves a therapeutically useful result, achieving such a
result is not required for the claims to be enabled.
Here, the claims, as restricted, are directed to a “method for the transfer of a
nucleic acid composition [encoding a therapeutic agent] to cells.” Thus, while the claims
read on gene therapy methods, they do not require producing a clinically effective
therapeutic response. Cf. In re Cortright, 165 F.3d 1353, 49 USPQ2d 1464 (Fed. Cir.
1999) (claims to a method of “treating scalp baldness” could be enabled even if the
method did not produce a full head of hair).
The examiner argues, however, that the specification must teach those skilled in
the art how to use the claimed method to produce a therapeutically useful result
because
the only use disclosed for in vivo delivery is [ ] for therapeutic purposes.
. . . Thus, while the specification enables delivery and expression in cells
in culture or cells in vitro, the method of delivering has no enabled use for
delivery to cells in an animal, patient or subject[;] that is[,] in vivo. There is
no evidence that the method results in sufficient delivery of a nucleic acid
in vivo to offer a therapeutic effect. The specification offers no use for
mere delivery of a therapeutic agent in vivo absent a therapeutic effect.
Examiner’s Answer, page 8. As we understand it, the examiner does not dispute that
the specification enables those skilled in the art to transfer nucleic acids into cells in
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