Appeal No. 1998-1283
Application No. 08/449,731
Further, it is well settled that patent applicants are not required to disclose every
species encompassed by their claims, even in an unpredictable art. In re Angstadt, 537 F.2d
498, 502-03, 190 USPQ 214, 218 (CCPA 1976). A conclusion of lack of enablement means
that, based on the evidence regarding the above factors, the specification, at the time the
application was filed, would not have taught one skilled in the art how to make and/or use the
full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d
1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
On this record, it does not appear that the examiner disputes that there are tumor
suppressor genes that play a role in the tumorigenesis process (Specification, page 1).
Appellants allege that they have discovered another gene on chromosome 5q which is
named the Adenomatous Polyposis Coli (APC) gene. If this gene is responsible for
expressing a protein which has tumor suppressing activity it follows that the absence of or
modifications of the protein resulting from the expression of the gene could affect the
tumorigenesis activity of the resulting protein. The examiner has not provided any evidence
or pointed to any facts which would reasonably suggest that one skilled in this art could not
readily distinguish between the presence of the complete protein and the absence of the
complete protein in a tissue sample in the manner presently claimed. If we accept that the
protein has the activity urged by the appellants, and the examiner has given us no reason to
doubt appellants' proposition on this score, then the absence of the whole protein while
possibly not absolutely predictable of cancer or the potential of cancer, is at the very least
helpful information which would aid in the diagnosis and/or prognosis of cancer in a patient.
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