Appeal No.2001-1258 Page 6
Application No. 08/413,805
legend. Hussey reported that expression in insect cells allowed purification of
milligram quantities (i.e., large amounts) of soluble CD4. See page 78 (abstract),
see also the legend to Figure 2 (“Yields were routinely 1-2 mg secreted T4ex1 or
T4ex2 proteins per litre SF9 cells.”).
The examiner concluded that it would have been obvious, in view of the
combined teachings of Szala, Bumol, Johnson, and Hussey, to recombinantly
produce a soluble variant of GA733-2 consisting of the first 265 amino acids
(SEQ ID NO: 2), i.e., a soluble variant consisting of the signal sequence and the
extracellular domain but deleted for the transmembrane domain and cytoplasmic
domain. The examiner pointed to Szala’s disclosure of the need for large
quantities of the GA733-2 antigen as motivation to produce the soluble GA733-2
variant in a baculovirus/insect cell expression system, which is shown by
Johnson and Hussey to efficiently produce recombinant proteins. The examiner
acknowledged that the soluble GA733-2 variant disclosed by Bumol was also
deleted for the signal sequence and propeptide, but pointed to Johnson and
Hussey as evidence that such deletions would have been recognized as
unnecessary for expressing a soluble GA733-2 variant in eukaryotic cells such as
insect cells. Thus, the examiner concluded that the polypeptide of claim 1 would
have been prima facie obvious.
With respect to claim 4, the examiner concluded that it would have been
obvious “to produce pharmaceutically acceptable compositions with adjuvants or
pharmaceutically acceptable carriers in order to immunize animals or raise
antibodies or produce antisera as suggested by both Szala et al. and
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