Appeal No. 1997-3221
Application No. 08/249,241
because Birnbaumer teaches that, as was appreciated in the art,
receptor agonists or antagonists which are candidate human
therapeutics should be assayed with human receptor systems. The
artisan would reasonably have expected a human homolog having
structural and functional properties similar to GluR5-2 to exist
because Puckett teaches that a gene family similar to the GluR gene
family in rat will be present in humans; moreover, Puckett exemplifies
one clone which exhibits “extreme conservation” of sequence
compared to the most closely related rat cDNA. The artisan would
reasonably have expected the properties of the human GluR5 gene
product to be qualitatively the same as those observed for the rat
receptor, including the ability to bind to and respond to kainate, as
evidenced by Sommer [‘92]. The artisan would also have expected,
however, that although qualitatively similar, such properties would
likely not be identical because Birnbaumer teaches, as was known in
the art, that species-specific variations in the quantitative
pharmacological properties are to be expected when comparing
homologous gene products. The artisan would have expected to find
one or two cDNAs homologous to the rat GluR5-2 in a human cDNA
library because of the recognized diploid nature of the human
genome: the copies of the gene inherited from different parents could
be identical or different. The artisan would have expected that each of
the two alleles would be closely related to the rat cDNA. The routineer
would have entertained a reasonable expectation of success in
isolating and identifying the desired clone(s) because of Heinemann,
Bettler [‘90], and Sommer [‘92] describe several characteristic
properties of the receptor (sequence, tissue distribution, functional
response in Xenopus and HEK cells, etc.). The practice of the assays
disclosed by Heinemann would necessarily involve the assessment of
binding between the candidate (ant)agonists and the receptor protein
or would alternatively have involved the measurement of phenomena
(e.g., potentiation of electrophysiological properties) which the artisan
would have expected to correlate with such binding. The claimed
invention would have been prima facie obvious as a whole at the time
it was made.
While the claims on appeal are drawn to “[a] method of assaying” it is
obviously key to the examiner’s rejection that a cDNA encoding the EAA3a, 3b, 3c
or 3d receptor must be first successfully isolated. Once isolated the cDNA is used
to engineer a cell to express the receptor, and then the claimed method can be
performed.
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