Appeal No. 95-3461
Application 08/056,076
Claim 15 is illustrative of the subject matter on appeal and reads as follows:
15. A transdermal patch comprising a laminated composite of:
a backing layer and
a sustained release drug formulation layer comprising a matrix of:
(a) a continuous hydrophobic polymer phase;
(b) a particulate phase dispersed in the continuous polymer phase comprised of:
(I) a hydrated inorganic silicate;
(ii) a water-soluble drug at least partly dissolved in the aqueous phase of (I);
and
(c) a dispersing agent for dispersing (a) in (b), wherein the particular phase defines
at least a portion of the surface area of the matrix and provides a diffusion pathway for the
drug in the matrix;
wherein the continuous hydrophobic polymer phase is a pressure sensitive
adhesive; and
wherein the drug constitutes about 1% to 20% by weight of the matrix and the
inorganic silicate (unhydrated) constitutes about 2% to 20% by weight of the matrix.
The references relied upon by the examiner are:
Cleary et al. (Cleary) 4,906,463 Mar. 6, 1990
Johnson et al. (Johnson) 5,071,645 Dec. 10, 1991
Kon et al. (Kon) 5,166,341 Nov. 24, 1992
Claims 15 and 29 through 41 stand rejected under 35 U.S.C. § 103. As evidence
of obviousness, the examiner relies upon Cleary, Johnson, and Kon. We reverse.
Discussion
The initial burden of establishing reasons for unpatentability rests on the examiner.
In re Oetiker, 977 F.2d 1443, 1446, 24 USPQ2d 1443, 1445 (Fed. Cir. 1992). Where, as
here, a conclusion of obviousness is premised upon a combination of references, the
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