Appeal No. 2003-0984 Page 2
Application No. 09/418,825
20. A method comprising:
supplying a patch as defined in claim 1; and
impregnating said patch with said liquid before or after applying the patch to the
skin.
The references relied on by the examiner are:
Katz et al. (Katz) 5,028,435 Jul. 2, 1991
Petersen et al. (Petersen) 5,156,846 Oct. 20, 1992
Claims 1-3, 5, 7-21, 23-26 and 28-30 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Katz and Petersen.
We reverse this rejection.
DISCUSSION
The claims on appeal are directed to transdermal delivery patches and methods
of using them. Each of the claims requires, at a minimum, a patch comprising a liquid
permeable matrix having dry adhesive properties and containing at least one active
agent unsuitable for migrating through the matrix without the addition of liquid to the
patch, wherein the matrix is attached on one face to a porous backing capable of
containing a liquid.
Katz describes systems (devices) and methods for rate-controlled drug delivery.
The systems include transdermal patches comprising “a matrix layer having a backing”
and a “means for securing the system to the skin, such as a tape or adhesive layer;” the
matrix layer contains the drug and “a chemical penetration enhancer which promotes
transport of the drug across [the] skin” (column 2, lines 44-55). “[A]t least a portion of
either the drug or the chemical penetration enhancer (or both) will be contained within a
plurality of polymeric particles dispersed within the matrix layer . . . which entrap and
release the drug and/or enhancer into the matrix at a preselected rate” (column 2, lines
58-65). Katz’s “suitable backing materials will generally be thin, flexible films or fabrics
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