Appeal No. 2001-1293 Page 9
Application No. 08/464,271
The state of the prior art does not appear to contribute significantly to the
enabling scope of the disclosure. Mullen discusses “metabolic suicide genes”
which appear to meet the criteria recited in the claims. However, Mullen was
published in 1994, while the instant application claims an effective filing date at
least as early as 1990. Thus, Mullen’s disclosure does not appear to reflect the
state of the art as of the relevant date. See Hybritech, Inc. v. Monoclonal
Antibodies, Inc., 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed. Cir. 1987)
(“Enablement . . . is determined as of the filing date of the patent application.”).
In addition, Mullen identifies only three metabolic suicide gene systems,
one of which is the HSV-TK system. The other systems discussed by Mullen are
the cytosine deaminase system and the varicella thymidine kinase system. With
one exception, the references cited by Mullen with respect to these other enzyme
systems were all published after 1990. The only exception concerns a “non-
genetic” approach of coupling cytosine deaminase enzyme to a tumor-specific
antibody; an approach very different from the claimed method. Thus, the prior art
of record does not reflect that other DNAs encoding enzymes meeting the
limitations of the instant claims were known in the art as of the application’s
effective filing date.
The examiner has provided evidence that expression of transgenes was
unpredictable. See the Examiner’s Answer, pages 5 and 6. This evidence is
relevant here, where no other genes encompassed by the claims have been
exemplified, or even identified. The examiner’s evidence shows that the
disclosed success with HSV-TK in mice would not have been viewed by those in
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