Appeal 2007-1154
Application 09/367,950
(Answer 3). The Examiner finds that “[t]he claims encompass prevention of
a complex cell[ular] autoimmune disorder in humans which has potentially
many different causes (i.e. many different allergen[s] or combination[s] of
allergens). Each of which may or may not be addressed by the
administration of the claimed composition” (Answer 4-5). According to the
Examiner, the prevention of an acute episode of asthma in a human with the
claimed compounds is unpredictable, “the state of the art with regard to
prevention of . . . [acute asthmatic attack] is underdeveloped[,]” and the
working examples provided in Appellant’s Specification do not address the
“prevention of an acute episode of asthma” (Answer 5). Based on this
reasoning, the Examiner concludes that “it would require undue,
unpredictable experimentation to practice the claimed invention to prevent
the development of an acute episode of asthma in a subject by administration
of the claimed composition” (Answer 6).
In response, Appellant asserts that the prevention of acute episodes of
asthma is disclosed in the [S]pecification at page 3, lines 7-19,
Acute asthma attacks may occur on an irregular basis
when exposed to an agent e.g., during the pollen season,
a virus infection, cold air, perfumes or any other agent(s)
triggering an asthma attack in the patient . . . We
contemplate preventive use when the patient expects to
encounter asthma inducing conditions e.g. intends to take
exercise or go into smoky conditions.
This “preventive use” is accomplished by simply using the
formoterol/budesonide composition that is taught throughout
the [S]pecification (the same composition as for treatment),
delivered via inhalation in the manner that is taught throughout
the [S]pecification (the same delivery method as for treatment),
but where the timing of the administration is at a point before
4
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 Next
Last modified: September 9, 2013