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reasonable basis for questioning the enablement of the claims
on appeal.
The specification contains several working examples
demonstrating production of active, heterodimeric human,
bovine, porcine, and equine LH, FSH and CG, and various
methods were used to obtain cDNA encoding the required "- and
$-subunits (specification, pages 9 through 57). For example,
cDNA encoding the $-subunit of porcine FSH was identified by
screening a cDNA library with synthetic probes corresponding
to portions of the mature protein sequence (specification,
page 31). In addition, clones encoding the $-subunits of
equine LH and FSH were found by screening with bovine LH$ cDNA
and bovine FSH$ cDNA, respectively (specification, pages 34
and 38). The specification indicates that the same strategies
can be used to produce biologically active TSH (specification,
pages 2 and 59).
According to the examiner, the specification is not
enabling for production of biologically active TSH, primarily
because “[t]he specification discloses reproducible methods
for obtaining DNA sequences encoding both subunits of LH, FSH
and CG, and the "-subunit of TSH” but “does not disclose a
reproducible source for the TSH$ DNA sequences” (Examiner’s
5
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Last modified: November 3, 2007