Appeal 2007-0854
Application 10/179,463
Thus, the issue is does the evidence submitted by Appellants
demonstrate unexpected results as to the insulin formulation being claimed
and thus rebut the Examiner’s case of prima facie obviousness.
FACTS
The Examiner rejected claims 5, 7-18, 26, 28-42, 51, 53-64, and 66-74
under 35 U.S.C. § 103(a) as being obvious over Patton in view of Edwards
(Office Action mailed August 11, 2004, 2). 3
The Examiner relies on Patton for teaching the systemic delivery of
insulin to a mammalian host through the inhalation of a dry powder that is
rapidly absorbed through the alveolar regions of the lung (Office Action
dated August 11, 2004, 2). The dry powder containing insulin is prepared
by dissolving insulin in an aqueous buffer to form a solution and then spray
drying the solution to produce substantially amorphous particles (id.).
According to the Examiner, the pharmaceutical carrier, which may be an
amino acid such as glycine, lysine, etc., may be optionally dissolved in the
buffer, typically a citrate buffer such as sodium citrate, to form a
homogenous solution, “wherein spray drying of the solution produces
individual particles comprising insulin, carrier buffer, and any other
compounds which were preset in the solution.” (Id. at 2-3.)
Patton is also cited for teaching that dry powders of insulin that may
be used include amorphous insulin, crystalline insulin, and mixtures thereof
3 Claims 5, 7-18, 26, 28-42, 51, 53-64, and 66-74 also stood rejected under
the judicially created doctrine of obviousness-type double patenting as being
unpatentable over the claims of copending 10/179,463 in view of Patton
(Office Action mailed August 11, 2004, 5). The rejection was withdrawn in
the Answer upon the filing of a terminal disclaimer (Answer 6).
3
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 Next
Last modified: September 9, 2013