Appeal No. 2003-0919 Page 5
Application No. 09/463,097
formula I according to claim 1 or of a pharmaceutically acceptable salt of
such a compound having at least one salt-forming group.
Under the provisions 35 U.S.C. § 282, a patent shall be presumed valid; and each claim
of a patent shall be presumed valid independently of the validity of other claims.
Accordingly, claims 21 and 22 of U.S. Patent No. 5,521,184 (the Zimmermann patent),
shall be presumed valid. We may presume, therefore, that claims 21 and 22 are based
on an enabling disclosure; and that the specification of the Zimmermann patent teaches
any person skilled in the art how to use a compound of formula I, or a pharmaceutically
acceptable salt thereof, in a pharmaceutical composition for treating tumours or in a
method of treating warm-blooded animals suffering from a tumoral disease. In claim 23,
Zimmermann recites imatinib, a specific compound within the scope of formula I, or a
pharmaceutically acceptable salt thereof. In light of 35 U.S.C. § 282, therefore, we may
presume that the specification of the Zimmermann patent teaches any person skilled in
the art how to use imatinib, or a pharmaceutically acceptable salt thereof, in a
pharmaceutical composition for treating tumours or in a method of treating warm-
blooded animals suffering from a tumoral disease. On these facts, we disagree that the
examiner has set forth adequate reasons or evidence to doubt the objective truth of
statements in applicants' specification that an effective amount of the $-crystal form of
imatinib mesylate may be administered to a patient as the manipulative step in a
method for treating tumour disease in a patient.
The rejection under 35 U.S.C. § 112, first paragraph, is reversed.
Sections 102(b)/103(a)
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