Appeal 2007-1820
Application 10/659,408
It is undisputed that the prior art teaches that the levels of exhaled NO
may be used to monitor the efficacy of anti-inflammatory treatment (FF 1,
7). In view of Kharitonov’s teaching about the value of serial and repeated
measurements (FF 8, 9), it is our strong opinion that it would have been
obvious to use an individual baseline to assess drug efficacy and determine
whether the treatment regime should be modified based on changes in it as
recited in steps (b) through (d) of claim 18.
The cited prior art does not disclose the claimed “measurement
frequency of at least three times per week over a period of at least seven
days” and using deviations of less or more than “5 ppb or more based on an
exhalation rate of 50 mL/sec” (“trends”) to determine when to modify
treatment as recited in steps (c) and (d) of claim 18.
However, we agree with the Examiner that “achievement of normative
exhaled nitric oxide levels is . . . a goal of these therapeutic methods,” thus
making it obvious to make repeated measurements over time to determine
the efficacy of therapy. Moilanen explicitly states that its method can be
used to “follow-up drug treatment” (FF 4) and Kharitonov describes the
“progressive reduction in exhaled NO” (FF 6), both indicating that the NO
levels are measured over time. Choosing the particular intervals when to
measure NO, such as “at least three times per week over a period of at least
seven days” or “for at least five days” as recited in steps (b) and (d),
respectively, of claim 18, appears to be nothing more than routine
optimization of a known results-effective variable. “[I]t is not inventive to
discover the optimum or workable ranges by routine experimentation.” In re
Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See also In re
Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (C.C.P.A. 1980)
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