Appeal No. 2001-0870 Page 2
Application No. 08/422,381
determining the values of at least a body mass factor
and a cumulative smoking factor; and
determining the dosage to achieve the target nicotine
serum concentration based on the patient’s measured
nicotine concentration, the body mass factor value, and the
cumulative smoking factor value; or
(ii) for female patients:
determining at least the value of a psychological
dependence factor and age; and
determining the dosage to achieve the target nicotine
serum concentration based on the patient’s measured
nicotine concentration, the psychological dependence factor
value and the age.
The examiner relies on the following references:
Goodman & Gilman’s: The Pharmacological Basis of Therapeutics, 6th Ed.,
pp. 43-48 (1980)
DiPiro et al. (DiPiro), ”Chapter 2/ Drug Delivery and Administration,”
Pharmacotherapy : A Pathophysiologic Approach, pp. 15-17 (1989)
Chan et al. (Chan), ”Pharamacokinetics of a single transdermal dose of nicotine
in healthy smokers,” Journal of Controlled Release, Vol. 14, pp. 145-151 (1990)
Claims 37-46 stand rejected under 35 U.S.C. § 103 as obvious in view of
the combined disclosures of Chan, DiPiro, and Goodman & Gilman.
We reverse.
Background
“[A] number of products have been commercially developed for providing
nicotine replacement while a patient is undergoing smoking cessation . . .,
including gums, transdermal patches, nasal spray, inhalers, lozenges, and the
like.” Specification, page 1. The specification discloses that the dosage of
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