Appeal No. 2001-1970 Page 12
Application No. 08/260,190
In this case, the evidence shows that the FDA had approved several
clinical trials of antisense drugs by 1994. For example, Reynolds disclosed that
“the first approval from the Food and Drug Administration to test an antisense
drug on patients” came in January 1992. See page 288, left-hand column. Wu-
Pong reported that, in 1994, “several ON [oligonucleotide] drug candidates are
currently being tested in clinical trials.” Page 110 (citing Alper, “Oligonucleotides
Surge into Clinical Trials,” Bio/Technology, Vol. 11, p. 1225 (1993)). Wagner,
also in 1994, stated that “[c]linical trials are now in progress to evaluate the
therapeutic potential of antisense ODNs [oligodeoxynucleotides] in several
human diseases, including myologenous leukaemia, and infection by human
immunodeficiency virus-1, cytomegalovirus (CMV) and human papillomavirus.”
Page 333, left-hand column (citing references published in 1993 and 1994).
The approval by the FDA of clinical trials before and contemporaneous
with the filing date of the instant application provides evidence that those skilled
in the art of antisense methods regularly applied therapeutic techniques to
human patients, despite the problems remaining to be overcome before the
techniques could be widely applied clinically. Thus, the antisense protocols cited
by Reynolds, Wu-Pong, and Wagner provide evidence that those practicing
antisense techniques would not have considered the obstacles cited by the
examiner to be a barrier to applying antisense therapies in human patients, and
therefore, that those obstacles would not have been considered to be a source of
undue experimentation in this field. There is no evidence in the record that the
claimed antisense-based methods would have been likely to involve excessive
Page: Previous 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Next
Last modified: November 3, 2007