Appeal No. 1998-2010
Application No. 08/542,861
assurance that the tests presented in the specification for inhibition of HIV proteases, or
other undisclosed retroviral proteases are art-accepted predictors of in vivo effectiveness
in man or other non-murine hosts. Answer, page 7. It is suggested that, in view of the
state of the art of retroviral inhibition and the persistent difficulty in treating viral infections,
such as AIDS, that more than screening tests are need to support the method claims
directed to in vivo use.
In this regard, the examiner relies on Kayegama for its disclosure that the ability to
inhibit HIV protease is only a starting point in developing potential drugs for treating HIV
infections and not in itself an indicator of useful drugs. Answer, page 7. The examiner
suggests that compound and composition claims are not commensurate in scope with the
examples listed in Table 12.
It is well settled that the examiner bears the initial burden of providing reasons why a
supporting disclosure does not enable a claim. In re Marzocchi, 439 F. 2d 220, 223, 169
USPQ 367, 369 (CCPA 1971). It has long been held that "[t]o be enabling, the
specification of a patent must teach those skilled in the art how to make and use the
full scope of the claimed invention without 'undue experimentation.' " Genentech, Inc. v.
Novo Nordisk, A/S, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997)
(quoting from In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir.
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