Appeal No. 2004-2035
Application 09/978,763
70%, respectively, reduction in neointimal hyperplasia, while in Example 13, the result after
2-3 µg/day of paclitaxel over 56 days was 60%, compared to the uncoated stent (id.).
We further find that the experimentation disclosed as specification Comparative Example
14 was not preformed by appellants and in fact comprises the experiments and results reported
by a third party based on an undescribed coil stent coated with an undescribed “biocompatible
polymeric coating incorporating 175-200 µg of TAXOL® and exhibiting in vitro release kinetics
of 0.75 µg/day for the first thirty days,” which “stents were placed in porcine coronary arteries”
(specification, pages 43-44). Appellants state in the specification, that “the results obtained with
a coil stent and paclitaxel (placed in a porcine coronary artery) show a neointimal hyperplasia
reduction of only 40%” as calculated by appellants, and such result is compared only with
specification Example 11 (page 44). Similarly, in specification Comparative Example 15, the
experimentation and results “of another study” by the same third party using low-dose and high-
dose TAXOL® in an unspecified polymer coated on unspecified coil stents, with no indication
of in vitro release kinetics and even the manner of testing as “coated coronary stents,” is reported
with appellants calculating the results as 30% and 39%, respectively, and comparing the result to
specification Examples 11-13 (pages 45-46). Appellants acknowledge that “TAXOL® is a
commercially available form of paclitaxel” (id., page 18).
It is well settled that the burden of establishing the practical significance of data in the
record with respect to unexpected results rests with appellants, which burden is not carried by
mere arguments of counsel. See generally, In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d
1362, 1365-66 (Fed. Cir. 1997); In re Merck, 800 F.2d 1091, 1099, 231 USPQ 375, 381 (Fed.
Cir. 1986); In re Longi, 759 F.2d 887, 897, 225 USPQ 645, 651-52 (Fed. Cir. 1985); In re
Lindner, 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA 1972); In re Klosak, 455 F.2d 1077,
1080, 173 USPQ 14, 16 (CCPA 1972); In re D’Ancicco, 439 F.2d 1244, 1248, 169 USPQ 303,
306 (1971). In our view, appellants have not carried this burden.
It is immediate apparent on mere inspection of the stents and the coatings thereon as
disclosed for the Examples and Comparative Examples in the written description in appellants’
specification that the proposed comparisons of appellants’ Examples 11-13 with the third party’s
Comparative Examples 14 and 15 do not constitute direct, “side-by-side” comparisons of
embodiments of the claimed invention encompassed by appealed claim 75, which is a patterned
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