Appeal No. 2004-1660 Page 2
Application No. 10/071,247
The present invention provides simple and efficient methods for
incorporating the F-18 [(fluorine-18)] radionuclide into peptide-containing
targeting vectors, such as proteins, antibodies, antibody fragments and
receptor-targeted peptides . . . mak[ing] such targeting vectors available
for routine clinical positron emission tomography.
Of all nucleophiles present on peptides, only the free thiol group can be
rapidly alkylated at neutral pH and moderate temperature. The present
invention takes advantage of this unique property of free thiol groups, and
provides methods for labeling thiol-containing peptides with F-18.
Specification, page 4.
[A]ny thiol-containing peptide [can be labeled] . . .
Peptides that originally do not comprise a free thiol group can be labeled
. . . by first modifying the peptide to add a free thiol group by methods
known to those skilled in the art . . .
Id., pages 5-6.
[A] peptide that has been radiolabeled with F-18 as described above is
delivered to a targeted tissue using a bispecific antibody (bsMAb) . . .
containing at least one arm that is specific to the targeted tissue and at
least one other arm that is specific to the F-18 labeled peptide . . .
[T]he bsMAb . . . is administered to a patient and allowed to localize to the
targeted tissue. Some time later (after the unbound bsMAb . . . is allowed
to clear), the F-18-labeled peptide . . . is administered to the patient.
Since at least one of the arms of the bsMAb . . . is specific to the F-18-
labeled peptide . . . , the F-18-labeled peptide is also localized to the
target. After the unbound F-18-labeled peptide . . . is allowed to clear, the
target is then visualized by routine clinical positron emission tomography.
Id., pages 3-4.
DISCUSSION
The examiner rejected claims 9-12 and 16-20 under 35 U.S.C. § 112, first
paragraph, as lacking both enablement and adequate written description in the
specification for anything other than methods requiring “specific F-18 labeled peptide[s]
such as the ones recited [on page 4 of the specification]” (Answer, page 3).
Enablement
“The first paragraph of 35 U.S.C. § 112 requires, inter alia, that the specification
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