Appeal No. 95-2851
Application 08/012,379
appellant’s claims and is sufficient to reduce or eliminate symptoms of tobacco
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withdrawal syndrome. 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 produced a significant reduction in the desire to smoke (page
607) but also states that this reduction “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 achieved by moderately heavy cigarette smokers (page 605), is 240
Fg/kg, which is less than one fourth the minimum amount of nicotine metabolite recited
3Neal L. Benowitz et al., “Cotinine disposition and effects”, 34 Clin. Pharmacol.
Ther. 604-11 (1983).
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