Appeal No. 1999-1434
Application No. 08/307,044
administered in multiple doses of about 400 milligrams or
more per dose.
The examiner relies on no references.
Appellants rely on the following reference:
Fogler et al. (Fogler), “Enhanced cytotoxicity against colon carcinoma by
combinations of noncompeting monoclonal antibodies to the 17-1A antigen,”
Cancer Research, Vol. 48, pp. 6303-6308 (1988)
Claims 12-15, 19, 20, 22-24, and 27-34 stand rejected under 35 U.S.C.
§ 112, first paragraph, as unsupported by an enabling disclosure.
We reverse.
Background
The specification discloses that
[t]he tumoricidal activity of the murine monoclonal antibody 17-1A
has been characterized in the nude mouse and in humans. . . .
Several cases have been reported where the administration of Mab
17-1A resulted in a partial or complete regression of metastatic
colorectal or pancreatic car[c]inomas. . . . Generally, the antibody
has been administered as a single administration of 500 µg or less.
Page 1.
The specification discloses a “method of immunotherapy of
gastrointestinal tumors employing multiple, high doses of murine monoclonal
antibody against the gastrointestinal tumor-associated antigen 17-1A.”1 Id. The
dosages used in the claimed method are orders of magnitude higher than the
= 500 µg dosage disclosed to have been known in the art. See the paragraph
bridging pages 1 and 2.
1 The specification refers to both the antigen and a monoclonal antibody as “17-1A.”
2
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