Appeal No. 2001-0407 Page 13
Application No. 08/460,215
company has no direct bearing on the issue of whether administering DNA
encoding PKD1 would be expected to effectively treat APKD.
Appellants’ Supplemental Brief (Paper No. 22) also cited several papers
that were published before January 31, 1995: references 12, 13, 18, and 19.
According to Appellants, reference 12 shows “methods for treating brain tumors
with gene therapy,” reference 13 “discloses methods for in vivo gene transfer
throughout mouse skeletal, [sic] and cardiac muscles,” while references 18 and
19 show “that at or about the time the instant application was submitted, human
gene therapy clinical trials were being approved[,] demonstrating the numerous
successes being achieved in gene therapy.” Supplemental Brief, page 2. In a
similar vein, Appellants cite Zabner (reference 10 attached to the Appeal Brief),
as evidence that “treatment of an autosomal recessive disease, cystic fibrosis,
was efficacious.” Appeal Brief, page 6.
Neither Zabner nor the references cited in Appellants’ Supplemental Brief
support enablement. The references relate to gene therapy of cystic fibrosis,
brain tumors, and cancer, and gene transfer into mouse muscles, but not to a
method of treating APKD by administering a wild-type PKD1 gene. The issue
here is not whether gene therapy in general is enabled; the issue is whether the
claimed method of treating APKD is enabled. Whether the methods discussed in
the cited references are enabled is simply not probative of the issue in this case.
It is not clear, e.g., why a purportedly successful method of treating a recessively
1994. The instant claims therefore have an effective filing date under 35 U.S.C. § 120 of either
January 31, 1995 or October 12, 1994.
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