Appeal No. 2001-0661 5
Application No. 08/480,232
In light of the above, it is apparent to us that the term “rigid” as used within the
context of appellants’ disclosed invention cannot properly be considered to have
essentially any value, as proposed by the examiner, but instead requires a certain
minimum degree of flexural rigidity or stiffness. More particularly, the degree of stiffness
required is such that a delivery device of such overall flexural rigidity would peel or pull
away from the skin as a result of normal body movement and thereby cause injury or
discomfort for the wearer as a result of normal body movement.
Turning to Sibalis, the “Background” section of the specification explains that prior
to the Sibalis invention, there were no transdermal drug applicators constructed “to
compensate for one’s movement and skin stretch so as to preclude loosening” (column 3,
lines 4-8). Accordingly, one of the objectives of Sibalis is to provide a transdermal drug
applicator of very shallow layered construction that overcomes this deficiency in the prior
art (column 1, lines 26-39). The first layer is a microporous or semipermeable membrane
22 through which the medicament migrates to be deposited on the skin. The second layer
consists of a “flexible pad, pouch or other type reservoir 24” containing the drug to be
administered (column 5, lines 13-15). The next layer above the reservoir 24 is an
extended contact 26 which is “preferably body-conformable, to permit applicator 10 . . . to
be curved or bent to conform to the shaped surface of the skin” (column 5, 37-40). Next, a
battery 28 is provided, which may be a “very thin, flexible sheet[ ]” (column 6, line 8)
whose selection depends on such factors as “the degree of conformability desired”
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