Appeal No. 2006-0352 Παγε 3
Application No. 09/929,546
prodrug . . . [and] [t]he prodrug activator is conjugated with a second biological agent
. . . preferably one which binds to a non-competing site” on PSMA. “Whether two
biological agents bind to competing or non-competing binding sites can be determined
by conventional competitive binding assays” (id., pages 32-33). For example, “[a]
competition study was carried out to determine whether J591, J533, E99, and J415
detected the same or different antigenic sites (epitopes) of [PSMA]” (id., page 42). “The
results indicated that J591, J533, and E99 each interfere, compete, or block binding of
one another but do not block binding of J415 and vice versa” (id., page 43).
DISCUSSION
According to the examiner, “the specification [ ] provides a written description and
indicates possession of a genus of antibodies that bind to the extracellular domain of
PSMA and four species of such monoclonal antibodies, or species of the genus, e.g.
E99, J591, J415, or J533[,]” but does not provide descriptive support for “a subgenus of
antibodies that ‘compete for binding’ to E99, J591, J415, or J533” (Answer, pages 3-4).
Consequently, the examiner has allowed claims 58-69, which require antibodies that
bind the extracellular domain of PSMA, or which require monoclonal antibodies E99,
J591, J415, or J533 in particular, but has rejected claims 72, 73, 84-111 and 113, which
require antibodies that compete with E99, J591, J415, or J533, under 35 U.S.C. § 112,
first paragraph.
Claims 58, 67 and 68 are representative of subject matter allowed by the
examiner:
58. A method for treating non-prostate cancer in a subject comprising:
providing an antibody or antigen binding portion thereof which binds to the
extracellular domain of prostate specific membrane antigen; and
administering the antibody or antigen binding portion thereof to a subject in need
of treatment under conditions effective to treat non-prostate cancer.
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