Appeal No. 1999-1231 Page 4
Application No. 08/709,554
paragraph of ' 112, it appears that his conclusion is based on two principle misgivings.
The first concerns the field of gene therapy generally, while the second is more specific
to the claimed invention as it concerns the role of Aglucocorticoids in combination with
gene transfer techniques@ (Examiner=s Answer, page 10).
The examiner cites several references in support of his assertion that, A[a]t the
time of filing, . . . gene therapy [was] in its infancy and [ ] highly unpredictable@ and
Aremains at a very early stage of development.@ Examiner=s Answer, page 8. If we
understand the examiner=s position, it is that the field of gene therapy, generally, will not
be enabled so long as it remains Aexperimental and unpredictable and, . . . unproven for
general treatment.@ Id., page 13. However, this position does not reflect the applicable
legal standard.
In In re Brana, 51 F.3d 1560, 1567, 34 USPQ2d 1436, 1442 (Fed. Cir. 1995), the
court cautioned against confusing Athe requirements under the law for obtaining a
patent with the requirements for obtaining government approval to market a particular
drug for human consumption,@ citing Scott v. Finney, 34 F3d 1058, 1063, 32 USPQ2d
1115, 1120 (Fed. Cir. 1994). The rejection before the court for review in Brana was for
lack of enablement under the first paragraph of 35 U.S.C. ' 112 (although 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):
On the basis of animal studies, and controlled testing in a limited number
of humans (referred to as Phase I testing), the Food and Drug
Administration may authorize Phase II clinical studies. [ ] Authorization for
a Phase II study means that the drug may be administered to a larger
number of humans, but still under strictly supervised conditions. The
purpose of the Phase II study is to determine primarily the safety of the
drug when administered to a larger human population, as well as its
potential efficacy under different dosage regimes. [ ]
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