Appeal 2007-0860
Application 10/148,535
“[i]n children with symptom[s] of disruptive behavior disorder
(ADHD/conduct disorder) and a mood disorder (principally bipolar
disorder), is there a differential improvement of their hyperactive or
inattention symptoms that is meaningful diagnostically or clinically to
[methylphenidate] or lithium treatment?” (Id. at 263). Seven psychiatrically
hospitalized children made up the study population (id.), and patients were
given placebo, methylphenidate alone, lithium alone, and a combination of
methylphenidate and lithium (id. at 264). Carlson reports that “[s]everal
children had problems with increasing irritability and depressive symptoms
during the stay, and reports of even worse behavior in the late afternoons
and evenings on [methylphenidate] alone,” concluding that
“[methylphenidate] may have worsened certain affective symptoms
(depression and irritability) in some children without significantly improving
target symptoms.” (Id. at 268-269.) The reference does note, however, that
in “the behavioral arena [i.e., ADHD], at least in this sample, lithium does
not block MPH effects, it may enhance them.” (Id. at 269.)
From our reading of the reference, at best, Carlson seems to suggest
that methylphenidate is effective in treating some components of ADHD in
patients that may have both ADHD and bipolar disorder. That reading,
however, is tempered by the statement that methylphenidate may have
worsened certain affective symptoms (depression and irritability) in some
children without significantly improving the target symptoms of the ADHD.
Again, contrary to the findings of the Examiner, we can find no teaching in
Carlson that bipolar disorder may be treated with methylphenidate, or even a
combination of methylphenidate and lithium. Thus, while there may be
some association between bipolar disorder and ADHD, we cannot dismiss
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