Appeal 2007-1820
Application 10/659,408
marker of airway inflammation”), 534 (“Functional importance of exhaled
NO”), and 535 (“There is now persuasive evidence that levels of NO are
increased in association with airway inflammation and are decreased with
anti-inflammatory therapy”).
6. A study is described by Kharitonov in which patients with asthma
“showed a progressive reduction in exhaled NO down to normal levels after
3 weeks of therapy” with inhaled budesonide (Kharitonov, at 535, col. 2).
7. Kharitonov states that “[b]ecause exhaled NO is reduced by anti-
inflammatory treatments, it may be of use in monitoring whether therapy is
adequate” (Kharitonov, at 536, col. 1).
8. The NO measurements can “be performed repeatedly” (Kharitonov, at
536, col. 1).
9. “However, the measurement is not specific, and exhaled NO is increased
in inflammation due to asthma, bronchiectasis . . . , and respiratory tract
infections. . . . This means that absolute values are less important than serial
measurements in individual patients” (Kharitonov, at 536, col. 1).
Analysis
The Examiner contends:
It would have been obvious . . . to combine the teachings of
Moilanen and Kharitonov, because both references teach the
utility of monitoring exhaled nitric oxide levels as a metric to
evaluate anti-inflammatory treatment. . . . It would have been
apparent to a skilled artisan that one would use the curve for
exhaled nitric oxide (NO) of healthy patients provided by
Moilanen as a baseline to ascertain the effectiveness of
treatment because the achievement of normative exhaled nitric
oxide levels is obviously a goal of these therapeutic methods. It
would have been apparent that a skilled artisan would use a
patient’s initial eNO measurements as a baseline [claim 18, step
5
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