Appeal No. 2001-1970 Page 10
Application No. 08/260,190
First, we agree with Appellants that a therapeutic method need not be
ready for clinical application in order to be enabled. See In re Brana, 51 F.3d
1560, 1567, 34 USPQ2d 1436, 1442 (Fed. Cir. 1995): “Usefulness in patent law,
and in particular in the context of pharmaceutical inventions, necessarily includes
the expectation of further research and development. The stage at which an
invention in this field becomes useful is well before it is ready to be administered
to humans.”3 The references cited by the examiner seem to focus on the clinical
application of antisense therapeutics. For example, the examiner cited Stull’s
statement that “nucleic acid drugs must overcome several formidable obstacles
before they can be widely used as therapeutics.” Examiner’s Answer, page 9.
The examiner also cited Wagner as providing “evidence that antisense was . . .
unpredictable at the time the invention was made.” Examiner’s Answer, page 9.4
While the references cited by the examiner provide evidence that
antisense therapy, in general, was not ready for broad clinical application in the
early 1990s, such evidence is not enough to show nonenablement. What is
needed is evidence or sound scientific reasoning that undue experimentation
would have been required to carry out the claimed methods. The claims are
3 Although the Brana court referred to “usefulness,” the rejection on appeal was based on 35
U.S.C. § 112, first paragraph. See 51 F.3d at 1564, 34 USPQ2d at 1439.
4 The examiner appears to have evaluated the enablement of the claims as of 1992, based on the
filing date of the grandparent application of the present application. However, according to
Appellants, the present application is a continuation-in-part of 08/188,093, filed Dec. 30, 1993,
which was a continuation-in-part of 07/964,589, filed Oct. 21, 1992. Since the present application
does not have the same disclosure as the earlier-filed applications, it is not necessarily entitled to
§ 120 benefit based on those earlier applications. However, the claims have not been rejected
over intervening art, so we need not consider whether the instant claims are entitled to § 120
benefit. We will limit our analysis to whether the claims on appeal would have been enabled by
the disclosure of the present application, in light of the state of the art as of this application’s 1994
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