Appeal No. 1997-0496 Page 4
Application No. 08/387,935
The Rejection under §§ 102(b) and 103
“[T]he examiner bears the initial burden, on review of the prior art or on any other
ground, of presenting a prima facie case of unpatentability.” See In re Oetiker, 977 F.2d
1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). The examiner relies upon a
reference to Horstmann to reject the claimed subject matter and establish a prima facie
case of unpatentability. The basic premise of the rejection is that the primary reference to
Horstmann discloses a multilayer transdermal therapeutic system, wherein the medicament
layer is essentially the same as the claimed barrier layer. See Answer, page 5. In addition,
Horstmann teaches, a barrier layer, an adhesive layer and contemplates alternative
arrangement of layers. See Answer page 6 and 7.
We find that the multilayer transdermal therapeutic system of Horstmann is taught in
Figure 1. The first layer is a backing layer (11). Adjacent to the backing layer is a layer with
a matrix having an active substance present, such as a medicament of the claimed subject
matter (12). Adjacent to the active substance containing layer is a barrier layer, which
controls the access of liquids (13). Atop the barrier layer is a removable protective layer
(16). The matrix containing layer includes, in addition to the medicament, a hydrophobic
phase including polyisobutylene, polymers of styrene and unsaturated hydrocarbon resins
and water swellable hydrophilic materials, which includes cellulose and its derivatives. See
column 3, line 67 through column 4, line 16 and Example 1.
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