Appeal No. 2006-0656 Page 4
Application No. 10/086,637
(Goldenberg, column 2, lines 6-16). “[D]iscrimination between tumor and non-tumor
tissue is enhanced” (id., column 1, lines 63-64) by injecting a “contrast or subtraction
agent radiolabeled with a radioisotope emitting at an energy which is separately
detectable from the primary antibody label” (id., column 2, lines 19-21) and an
“unlabeled second antibody which specifically binds the primary antibody or the labeling
moiety thereof . . . in an amount sufficient to reduce the circulating level of the primary
antibody label by at least about 10-85%” (id., lines 49-56). Finally, Goldenberg teaches
that “[t]he antibody used as the primary imaging agent . . . may be whole IgG, IgA, IgD,
IgE, IgM and the like, or a fragment such as, e.g., F(ab’)2, F(ab)2, Fab’, Fab or the like”
(id., column 6, lines 50-54).
Barbet describes an immunodiagnostic method comprising “intravenous injection
of a suitable dose of [a] dual specificity conjugate, together with, or followed . . . by,
injection of [a] radioactive affinity enhancement probe . . . to allow detection of [ ] target
cells by [an] imaging device” (Barbet, column 8, lines 51-57). The dual specificity
conjugate is trivalent (at least), with two or more binding sites specific for antigen(s)
expressed on the surface of the target cells, plus at least one hapten specific binding
site (id., column 5, lines 1-12). The dual specificity conjugate preferably comprises
“F(ab’)2 fragments of about 100,000 Da, or Fab or Fab’ fragments of about 50,000 Da”
(id., column 6, lines 32-35), and may be, for example, “an F(ab’)2 recognizing a cell
membrane target antigen, coupled to an Fab’ recognizing [a] hapten” (id., column 5,
lines 9-11). “[T]he affinity enhancement probe comprises at least two hapten groups
and one or several effector groups” (id., column 4, lines 49-50). According to Barbet,
the affinity enhancement probe has a “definite tropism towards cell-bound, as opposed
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