Appeal No. 2001-0869 Page 6
Application No. 08/453,347
Appellants argue that “[t]here is no valid reason why gene therapy
inventions should undergo a different or stricter standard of enablement than any
other therapy.” Appeal Brief, page 9. Appellants cite Orkin as disclosing that
“[b]y 1995, more than one hundred federally approved clinical trials were
underway on gene therapy protocols.” Appeal Brief, page 14. Since, Appellants
argue, “the requirements for FDA approval are in fact more stringent than
requirements for enablement,” the federally approved clinical trials provide
evidence that the claimed methods should not be held to be nonenabled simply
because they involve gene therapy. See the Appeal Brief, page 15.
Appellants also argue that the references cited by the examiner do not
provide evidence of nonenablement, because the problems addressed in those
references concerned the clinical success and commercial viability of gene
therapy techniques, considerations that go beyond what is required for
enablement. See the Appeal Brief, pages 17-21. Finally, Appellants argue that
their position is supported by In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed.
Cir. 1995). See the Appeal Brief, pages 30-34.
“When rejecting a claim under the enablement requirement of section 112,
the PTO bears an initial burden of setting forth a reasonable explanation as to
why it believes that the scope of protection provided by that claim is not
adequately enabled by the description of the invention provided in the
specification of the application; this includes, of course, providing sufficient
reasons for doubting any assertions in the specification as to the scope of
enablement. If the PTO meets this burden, the burden then shifts to the
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