Appeal No. 95-2851
Application 08/012,379
that use of nicotine and nicotine agonists and antagonists for the treatment of tobacco
withdrawal syndrome was known in the art, and that appellant admits at pages 4-7 of
the specification that nicotine was known to metabolize in vivo (answer, page 6).
Because nicotine metabolizes in vivo, the examiner argues, administering nicotine by
methods including smoking provides an amount of nicotine metabolites which is
effective to reduce or eliminate symptoms of tobacco withdrawal syndrome as recited in
appellant’s claims (answer, pages 8-10). The examiner relies upon Borzelleca for
further motivation to use metabolites of nicotine for treating tobacco withdrawal
syndrome (answer, page 7). This reference teaches that isolation of nicotine
metabolites makes possible the investigation of the role of metabolites of nicotine in
controlling or limiting the response to nicotine (page 313). Borzelleca discloses that in
a reported preliminary study of anesthetized dogs, several nicotine metabolites
produced depression, and high dosages produced death (page 314). Borzelleca
reports that in his studies, (-)-cotinine produced depression in most mice and
hyperexcitability in a few (page 316). We find in this reference no indication that
nicotine metabolites are effective for reducing or eliminating the symptoms of tobacco
withdrawal syndrome.
The examiner’s argument is not well taken because the examiner has provided
no evidence or convincing reasoning which shows that the amount of cotinine produced
by metabolism of nicotine ingested during smoking is within the range recited in
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