Appeal No. 1998-1283
Application No. 08/449,731
Claim Interpretation
Claim 19 is directed to a method to aid in the diagnosis or prognosis of a neoplastic
tissue of a human comprising detecting somatic alternations of the wild-type Adenomatous
Polyposis Coli (APC) protein in a tumor tissue isolated from a human using immunoblotting.
Claim 20 is directed to a similar method wherein the detection is by immunocytochemistry.
Claim 52 is directed to a method of aiding in the detection of genetic predisposition to
cancer in a human comprising detecting a germline alteration of wild-type APC protein in a
human sample selected from blood and fetal tissue, wherein the alteration of the protein is
detected by immunoblotting. Claim 53 is directed to a method similar to that of claim 52
except that the detection is by immunocytochemistry. Claim 64 is directed to a method to aid
in the diagnosis or prognosis of a neoplastic tissue of a human comprising detecting somatic
alteration of wild-type APC protein in a tumor tissue isolated from a human. We read the
claims as being directed to a method which aids in the diagnosis and prognosis of a
neoplastic condition or a predisposition to cancer and not, necessarily, to require that the
data, resulting from the method, give a direct correlation or relationship to the underlying
condition. Thus, any method involving the detection of somatic alterations of wild-type APC
protein tissue which assists, in any way, in the diagnosis, prognosis, or detection of a
predisposition to cancer would fall within the scope of the claims on appeal.
The rejection under 35 U.S.C. § 112, first paragraph
Claims 19, 20, 52, 53, and 64 stand rejected under 35 U.S.C. § 112, first paragraph,
as being based on a disclosure which does not enable one skilled in this art to practice the
claimed invention without undue experimentation. The examiner explains the basis of the
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