Appeal No. 2006-0656 Page 3
Application No. 10/086,637
(a) injecting a patient who is to undergo such a procedure with a bispecific
antibody fragment or subfragment with a molecular weight of 85,000 daltons or less,
wherein the bispecific antibody fragment has a first antibody binding site which
specifically binds to an antigen produced or associated with a lesion, and has a second
antibody binding site which specifically binds to a hapten, and permitting the antibody
fragment to accrete at target sites;
(b) injecting a bivalent labeled hapten, which quickly localizes at the target site
and clears through the kidneys; and
(c) detecting the presence of the hapten by close-range detection of elevated
levels of accreted label at the target sites with detection means, within 48 hours of the
first injection, and conducting said procedure.
Discussion
Obviousness
The examiner rejected claims 183, 187-189, 191-193, 196 and 197 under
35 U.S.C. §103 as unpatentable over Goldenberg1 in view of Barbet.2 In addition, the
examiner rejected claim 190 under 35 U.S.C. §103 as unpatentable over Goldenberg
and Barbet, and further in view of Horowitz.3 We consider the examiner’s proposed
combination of Goldenberg and Barbet to be central to both rejections, so we will
discuss the rejections together.
Goldenberg describes “short-range intraoperative or endoscopic tumor
detection,” wherein a patient is injected with a radiolabeled primary antibody which
specifically binds a tumor marker, and a surgically exposed or endoscopically accessed
body cavity is scanned at close range to detect accretion of the labeled antibody
1 Goldenberg, U.S. Patent 4,932,412, issued June 12, 1990
2 Barbet et al., U.S. Patent 5,256,395, issued October 26, 1993
3 Horowitz, U.S. Patent 4,706,652, issued November 17, 1987
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