Appeal No. 2006-1879 Page 7
Application No. 10/010,114
vivo, but she argues that transferring a nucleic acid encoding a therapeutic protein does
not produce a useful result unless it confers a therapeutic benefit.
The examiner’s reasoning highlights the incorporation into § 112 of the utility
requirement of 35 U.S.C. § 101: to be enabled, a claimed method must be disclosed
sufficiently to allow those skilled in the art to carry out the recited steps and, in addition,
the result of the claimed method must have a specific and substantial utility. See In re
Fisher, 421 F.3d 1365, 1378, 76 USPQ2d 1225, 1235 (Fed. Cir. 2005) (“It is well
established that the enablement requirement of § 112 incorporates the utility
requirement of § 101.”); In re Kirk, 376 F.2d 936, 942, 153 USPQ 48, 53 (CCPA 1967)
(“[S]urely Congress intended § 112 to pre-suppose full satisfaction of the requirements
of § 101. Necessarily, compliance with § 112 requires a description of how to use
presently useful inventions, otherwise an applicant would anomalously be required to
teach how to use a useless invention.”).
The examiner’s reasoning is logical but we do not agree that it applies to the
instant claims. The specification describes experiments in which exogenous DNA was
transferred, using the claimed method, to muscle cells and liver cells in vivo. See pages
77-78. The examiner has not disputed the accuracy of these working examples, but
points out that the transferred DNAs did not encode therapeutic proteins and the
specification does not describe therapeutically effective gene therapy.
The examiner has cited several references to show that clinical application of
gene therapy faced many hurdles in 1994. The examiner has characterized the
references as showing that delivering therapeutic genes to cells in vivo and ensuring
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