Appeal No. 2001-0870 Page 5
Application No. 08/422,381
they do teach, nor do they provide a reasonable expectation of success. Appeal
Brief, pages 12-14.
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial
burden of presenting a prima facie case of obviousness. Only if that burden is
met, does the burden of coming forward with evidence or argument shift to the
applicant.” In re Rijckaert, 9 F.3d 1531, 1532, 28 USPQ2d 1955, 1956 (Fed. Cir.
1993). The test of obviousness is “whether the teachings of the prior art, taken
as a whole, would have made obvious the claimed invention.” In re Gorman, 933
F.2d 982, 986, 18 USPQ2d 1885, 1888 (Fed. Cir. 1991).
In this case, we agree with Appellant that the examiner has not
established a prima facie case of obviousness. The references cited by the
examiner disclose that nicotine patches were known in the art (Chan), and that
the effective dose of a therapeutic drug would depend on a number of factors,
including “disease state,” “sex,” and “age” (DiPiro, page 16), as well as “body
size and composition” and “physiological variables” generally (Goodman &
Gilman, page 43). However, none of the references discuss factors to consider
in optimizing the dosage of nicotine specifically. In fact, none of the references
even recognize a need to optimize nicotine dosages, let alone suggest using the
factors recited in the claims to do so. The claimed method requires considering
specific factors, which vary depending on the sex of the patient, in order to
calculate an individualized dosage. The examiner has pointed to nothing in the
references that would have led those of skill in the art to consider specifically the
Page: Previous 1 2 3 4 5 6 7 8 Next
Last modified: November 3, 2007