Appeal No. 2006-0624 Page 13
Application No. 10/096,127
improvement in SLE symptoms is observed preliminarily, followed by an
exacerbation of the symptoms.” Appeal Brief, page 18. According to appellants,
that their
attempt and eventual failure at treating SLE provides further
evidence that the treatment of autoimmune diseases is in no way
predictable and success cannot be guaranteed without clinical
affirmation of a hypothesis. Appellants have over 30 years of
experience in the field of autoimmune diseases and the
involvement of cytokines in these diseases. However, despite
extensive experience in human clinical trials, even Appellants
disclosed premature results regarding the treatment of SLE with
antibodies to gamma interferon, underscoring the fact that even
with such experience and numerous human clinical trials under
their belts, anti-cytokine therapy for autoimmune diseases offers no
reasonable expectation of success.
Id.
Appellants’ arguments are not found to be convincing because we find
that the references as combined do provide a reasonable expectation of success
of treating the autoimmune disease psoriasis with antibodies if IFN gamma, as all
that is required is a reasonable expectation of success, not absolute predictability
of success. See In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed.
Cir. 1988). Ashkenazi I and Ashkenazi II teach that IFN-gamma exacerbates
psoriasis and that another auto-immune disease, Crohn’s disease may be
treated with antibodies to IFN gamma, and Levinson teaches that Crohn’s
disease and psoriasis are TH1 related disorders, and thus the ordinary artisan
would have reasonably expected that the successful therapy of Crohn’s disease
as taught by the Ashkenazi references would also be expected in another TH1-
related autoimmune disease, such as psoriasis.
Page: Previous 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Next
Last modified: November 3, 2007