Appeal No. 2001-0407 Page 8
Application No. 08/460,215
“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
applicant to provide suitable proofs indicating that the specification is indeed
enabling.” In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed.
Cir. 1993).
In this case, the examiner has met his initial burden of setting out a
reasonable explanation of why the specification does not adequately enable
those skilled in the art to practice the claimed method. We find particularly
persuasive the examiner’s observation that APKD is inherited in a dominant
fashion, suggesting that it is not caused simply by decreased expression of
functional protein. That is, the specification discloses that “APKD exhibits a
transmission pattern typical of autosomal dominant inheritance.” Page 2. A
pattern of autosomal dominant inheritance indicates that the mutant copy of the
gene is dominant over the wild-type copy; i.e., the disease will occur when a copy
of the mutant gene is present, even if a copy of the wild-type gene is also
present. See, e.g., Figure 1 of Grabow, which shows that the children of an
individual with APKD are 50% likely to have APKD themselves.
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