Appeal No. 97-2833
Application 08/236,190
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or induce weight loss. The Benowitz article cited in appellant’s specification (page 8)
teaches that cotinine is the major metabolite of nicotine and is present in the blood of
tobacco smokers in much higher concentrations and remains longer than nicotine after
cessation of smoking (page 604). Benowitz infused the fumarate salt of cotinine into
subjects at a rate of 4 Fg base/kg/min for 60 min (page 605). This amount “was
selected as one which would induce blood concentrations of cotinine in the range of
that achieved by moderately heavy cigarette smokers” (page 605). Benowitz states
that the cotinine infusion “was of a magnitude consistent with the expected reduction in
preexperimental anxiety and tension that we usually see with similar subjects and
paradigms that also include placebo infusions” (page 610). Benowitz concludes that
“at levels to which smokers are generally exposed, cotinine exerts little, if any,
pharmacologic effect” (page 610).
The amount of cotinine infused by Benowitz, i.e., 4 Fg/kg/min for 60 min, which,
Benowitz states, is an amount which would induce blood concentrations of cotinine in
the range of that of persons who smoke cigarettes moderately heavily (page 605), is
240 Fg/kg, which is less than one fourth the minimum amount of nicotine metabolite
recited in appellant’s claims, and Benowitz concludes that the infused amount has little
if any pharmacologic effect (page 610). This reference, therefore, indicates that the
2Neal L. Benowitz et al., “Cotinine disposition and effects”, 34 Clin. Pharmacol.
Ther. 604-11 (1983).
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