Appeal No. 2001-1907 Page 5
Application No. 08/694,315
histamine activated immunoglobulin has a therapeutic effect in he numerous
diseases and conditions encompassed by the claims.” Id. at page 5.
The burden is on the examiner to set forth a prima facie case of
unpatentability. See In re Alton, 76 F.3d 1168, 1175, 37 USPQ2d 1578, 1581
(Fed. Cir. 1996). “[A] specification disclosure which contains a teaching of the
manner and process of making and using the invention in terms which
correspond in scope to those used in describing and defining the subject matter
sought to be patented must be taken as in compliance with the enabling
requirement of the first paragraph of § 112 unless there is reason to doubt the
objective truth of the statements contained therein which must be relied on for
enabling support.” In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369
(CCPA 1971) (emphasis in original). “[It] is incumbent upon the Patent Office,
whenever a rejection on this basis is made, to explain why it doubts the truth or
accuracy of any statement in a supporting disclosure and to back up assertions
of its own with acceptable evidence or reasoning which is inconsistent with the
contested statement.” Id. at 224, 169 USPQ at 370. Here, the examiner has not
provided “acceptable evidence or reasoning which is inconsistent” with the
specification, and therefore has not met the initial burden of showing
nonenablement.
In this case, one issue that the rejection focuses on is the alleged
unpredictability of the therapeutic use of antibodies. That discussion, however,
is very generic, and does not specifically address the claims at issue. Moreover,
it ignores the data presented in the specification In addition, merely because the
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