Appeal No. 1996-2468
Application 08/091,899
35 U.S.C. § 112, first paragraph, unless there is a reason to doubt the objective truth of the
statements contained therein which must be relied on for enabling support. See
In re Marzocchi, 439 F.2d at 224, 169 USPQ at 370 (CCPA 1971). As stated by the court,
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. Otherwise, there would be no need for the
applicant to go to the trouble and expense of supporting his
presumptively accurate disclosure.
The threshold step in resolving this issue is to determine whether the examiner has met his
burden of proof by advancing acceptable reasoning inconsistent with enablement.
It is the examiner’s position that the claims, as written encompass both in vitro and
in vivo methods. The examiner alleges that “the specification does not set forth any use for
the in vitro methods.” Examiner’s Answer, page 8. The examiner admits that the
“specification enables the in vitro administration of IGF-1 to placental tissue and
demonstrates the changes in thromboxane and PGF , [but] the specification does not tell
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how to use the in vitro methods in a patentable manner.” Examiner’s Answer, page 8. The
examiner further argues that the in vitro test results are “deemed to provide information for
further scientific research in this area, particularly in vivo, but do not enable using IGF-I in
vivo to inhibit labor or inhibit placental cell production of thromboxane and PGF in vivo.”
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Examiner’s Answer, page 9. Thus, the examiner appears ultimately to argue that the in
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