Appeal No. 2001-0869 Page 9
Application No. 08/453,347
51 F.3d at 1568, 34 USPQ2d at 1442 (“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 trials. . . .
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 . . .
as well as its potential efficacy under different dosage regimens.”).
In this case, we have no fact-based explanation from the examiner
focused on the claimed method, as opposed to gene therapy as a general field,
to establish that the instant claims are nonenabled. In addition, it is well-
established that the amount of experimentation that is considered “undue” varies
from one field to another. See, e.g., Wands, 858 F.2d at 737, 8 USPQ2d at 1404
(factors relating to undue experimentation include quantity of experimentation
necessary, nature of the invention, and relative skill of those in the art). In this
case, the evidence shows that “[m]ore than 100 clinical protocols for gene
therapy ha[d] been reviewed and approved” by the NIH as of 1995. Orkin, page
12. See also Anderson, page 128, and Blau, page 1206 (summarizing clinical
trials approved as of 1995).
Orkin states that these protocols were not intended to establish efficacy
(page 13), but these references show that those of skill in the art of gene therapy
regularly applied therapeutic techniques to human patients, despite the problems
remaining to be overcome before the techniques could be widely applied
clinically. Thus, the gene therapy protocols cited by Orkin, Anderson, and Blau
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