Appeal No. 1997-2122
Application 08/310,902
In the first full paragraph of the right-hand column of 331, Conrad indicates that
at the time of that work the surface accessible IgE receptors found on rat
basophilic leukemia cells and rat mast cells were found to be associated with a
second polypeptide termed “J component.” Conrad explains that the surface
labeling used in their study would not be expected to detect a human
J equivalent and that the identification of a human J equivalent “probably awaits
the development of a human cell line bearing the high-affinity IgE receptor.” It is
of interest to note the discussion in the paragraph bridging pages 331-32 of
Conrad that the cells used in that study may have two distinct types of IgE
receptors, i.e., one which binds both human IgE and rodent IgE with high-affinity
and a second which showed high-affinity binding only for human IgE.
Conrad describes the polypeptide which is characterized as a human IgE
receptor which binds human IgE with high-affinity. It is not clear from Conrad
whether that isolated polypeptide is “essentially free of the J- and K-subunits of
the human FcERI” as required by claim 3 on appeal. Under these
circumstances, it is reasonable to shift the burden to appellants to establish
whether the procedures described in Conrad for isolating the IgE receptor result
in obtention of the I-subunit to the essential exclusion of the J- and K- subunits.
As set forth in In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA
1977):
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