Appeal No. 2004-2035
Application 09/978,763
The examiner finds, and we agree, that Berg is directed to stents coated with a polymer
matrix containing a drug that are used to treat injuries to blood vessels, including restenosis,
which is a well known cellular proliferative disease as acknowledged by appellants
(specification, page 28; appealed claim 94), by “sustained release of the drug to vascular tissue”
(e.g., col. 1, ll. 5-16, and col. 2, ll. 13-21). Berg would have taught one of ordinary skill in the
art that the polymer matrix “slows the administration of the drug following implantation,”
wherein “[t]he amount of drug to be included on the stent can be readily controlled by applying
multiple thin coats” of drug-polymer matrix, and “the rate at which the drug is delivered can be
controlled by the selection of an appropriate . . . polymer and by the ratio of drug to polymer”
(e.g., col. 2, ll. 30-67). The stent can be, among others, patterned as disclosed by Palmaz; the
polymer can be, among others, “polyvinyl aromatics, such as polystyrene;” and the drug can be,
among others, an antimitotic agent, such as, among others, methotrexate (e.g., col. 2, ll. 55-62,
col. 3, ll. 32-35, col. 4, ll. 56-64, and col. 5, lines 19-39).
Thus, Berg provides substantial evidence supporting the examiner’s position because one
of ordinary skill in this art routinely following the direction therein to use patterned stents coated
with layers of a polyvinyl aromatic polymer matrix containing an antimitotic drug for slow and
measured release in-vivo to treat proliferative diseases in vessels would have routinely arrived at
the claimed invention encompassed by claim 75, as we have interpreted this claim above,
without recourse to appellants’ disclosure. See generally, Merck & Co., Inc. v. Biocraft Labs.,
Inc., 874 F.2d 804, 807, 10 USPQ2d 1843, 1845-46 (Fed. Cir. 1989) (“That the ‘813 patent
discloses a multitude of effective combinations does not render any particular formulation less
obvious. This is especially true because the claimed composition is used for the identical
purpose. [Citations omitted.]”); In re Lemin, 332 F.2d 839, 841, 141 USPQ 814, 815-16 (CCPA
1964) (“Generally speaking there is nothing unobvious in choosing ‘some’ among ‘many’
indiscriminately.”). Indeed, Berg would have reasonably suggested to one of ordinary skill in
the art that the amount of drug released in a desired time frame can be readily determined and
controlled by, among others, “varying the ratio of drug to polymer in the multiple layers” (e.g.,
col. 2, ll. 62-67). Thus, this person routinely working within the teachings of Berg would have
reasonably arrived at a workable or optimum time frame to suite his or her desires in this respect,
including the time frame of at least seven days to prevent or inhibit undesired cellular
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