Appeal No. 2001-0407 Page 14
Application No. 08/460,215
inherited disease like cystic fibrosis would have led those skilled in the art to
expect success in treating a dominantly inherited disease like APKD.
Appellants also argue that “it has been suggested that APKD requires ‘2-
hits’ for disease progression to occur.” Appeal Brief, page 5. Appellants cite two
references that, they assert, provide “findings [that] suggest to one of skill in the
art that a method involving gene therapy is an attractive method for treating this
disease.” Id., pages 5-6.
This argument is also unpersuasive. All of the references cited by
Appellants to support a two-mutation model of APKD, and by extension the
attractiveness of a gene therapy treatment, were all published after the effective
filing date of the instant application. Therefore, the references cannot be said to
show that the claimed method was enabled as of its filing date. The rejection of
claims 37-39 for nonenablement is affirmed.
B. Composition claims
Claim 45 is directed to a composition comprising the DNA of SEQ ID
NO:1, its complement, or fragments thereof, together with a pharmaceutically
acceptable carrier. The composition is recited to be “for treating cyst formation
associated with APKD.” The examiner rejected the composition claims as
nonenabled, on the basis that “the method of using the composition is not
considered to be enabled; therefore, the composition claims are not enabled.”
Examiner’s Answer, page 11.
Appellants argue that the present application is related to application
08/323,443, which issued as U.S. Patent 5,654,170 (Appeal Brief, page 6), and
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