Appeal No. 1998-0667 Page 7
Application No. 081280,306
The portions of the references relied upon by the examiner in the Answer in
support of his case for the most part express concerns regarding possible problems
which may have to be overcome in order for gene therapy to be useful in a clinical
setting. For example, the examiner states at page 5 of the Answer, "Wagner states that
while oligos [oligonucleotides] 'show great promise', development of delivery systems is
essential. Wagner concludes that 'critical evaluation of antisense [oligos]
-...should eventuallv lead to the development of improved methods in antisense
therapy for human diseases.[']" In like manner, the examiner relies upon Stull at page 5
of the Answer for the proposition that "[nlucleic acid drugs must overcome several
formidable obstacles before they can be widely applied as therapeutics."
From ,these and other statements in the Answer, it is our belief that the examiner
is of the opinion that gene therapy will not be enabled until it is clinically ava~lableto
humans. However, this is not the legal standard to be applied.
As explained in In re Brana, 51 F.3d 1560, 1567, 34 USPQ2d 1436, 1442 (Fed.
Cir. 1995), the USPTO should not confuse "the requirements under the law for
obtaining a patent with the requirements for obtaining government approval to market a
particular drug for human consumption," citinq Scott v. Finnev, 34 F.3d 1058, 1063, 32
USPQ2d 1 11 5, 1 120 (Fed. Cir. 1994). The rejection before the court for review in
Brana was under 35 U.S.C. § 112, first paragraph (enablement). However, the court
discussed the issues raised in the appeal in the context of both enablement and the
utility requirement of 35 U.S.C. § 101. The court went on to state in Brana, 51 F.3d at
1568, 34 USPQ2d at 1442-43:
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