Appeal No. 2005-0902 Page 8
Application No. 09/529,053
Hammer also teaches that combination therapy for HIV provides several advantages
over treatment with a single antiviral drug. See page s2, paragraph bridging the
columns.
In view of these teachings, it would have been obvious to a person of ordinary
skill in the art, at the time the invention of claim 22 was made, to administer leflunomide
at 3 to 50 mg per day to a patient having an HIV infection, in combination with one of
the other antiretroviral agents described by Hammer (e.g., zidovudine in Figure 2).
Motivation to do so is provided by Hammer, who teaches that treating HIV infection with
a combination of antiviral agents is expected “(1) to provide additive or synergistic
antiviral activity; (2) to modulate, and hopefully prevent, the emergence of resistance;
(3) to minimize toxicity; and (4) to provide drug activity in different cellular and body
compartments.” We therefore agree with the examiner that the teachings of Weithmann
and Hammer would have made obvious the invention of claim 22.
Appellants argue that
[c]laim 23 is directed to co-administration of leflunomide products with a
pyrimidine. Leflunomide products inhibit dihydroorotate dehydrogenase, a
key enzyme in the biosynthesis of pyrimidines. Appellants disclose and
claim the co-administration of leflunomide products with a pyrimidine, “in
order to reduce its [the leflunomide products’] potential toxicity while
maintaining its therapeutic effectiveness.” (Pages 20-21 of the
Application)[.]
Neither Weithmann nor Hammer have any discussion of co-administering
a pyrimidine with leflunomide (or with any anti-viral agent) to stimulate
DNA synthesis. Rather, the various nucleoside analogue reverse
transcriptase inhibitors . . . are taught to prevent, as opposed to facilitate,
DNA synthesis. Since Hammer teaches the opposite effect of that stated
by the Appellants, one of ordinary skill in the art would not have combined
Hammer with Weithmann.
Appeal Brief, page 9 (alterations in original).
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