Appeal No. 1997-0661
Application No. 08/257,866
The examiner relies upon Barenholz to teach liposomes of between 0.02 and
0.08 microns in size.
Appellants argue (Brief, page 5) that the “Soloviev reference would not give
one of ordinary skill in the art a reasonable expectation of success for treating
hypertension by the intravenous administration of liposomes.” Reading Soloviev in
its entirety, W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1550, 220
USPQ 303, 311 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984), Soloviev teach
(page 624, column 1) preconstricting thoracic aortic rings to plateau level in vitro
with noradrenaline, and then administering acetylcholine to relax the noradrenaline-
preconstricted ring. Soloviev found (page 625,
figure 2) that administering liposomes can further relax the acetylcholine relaxed
noradrenaline-preconstricted ring. However, Soloviev also teach (page 625,
column 1) that “liposomes administered at plateau level of noradrenaline-induced
contraction caused increased tension development in both [Wistar-Kyoto and
spontaneously hypertensive] strains of rats but never relaxation.”
Appellants note (Reply Brief, page 2) that “[c]laim 1 on appeal requires a
decrease of systolic and diastolic blood pressure of at least 10 percent in the
subject, whereas Soloviev did not measure blood pressure change as a result of
treatment.” Here, we agree with appellants, Soloviev does not provide a
reasonable expectation of success in obtaining a “reduction in both systolic and
diastolic blood pressure of at least 10 percent from said elevated blood pressure”
by administering a suspension of small unilamellar liposomes intravenously, as
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