Appeal No. 1995-2772
Application 08/001,063
dispositive issue here is whether it would have been obvious to a person of ordinary skill in
the art that the transformation of a host cell with an E. coli bioH gene and the expression of
the gene therein, would result in the production of a recombinant cell capable of producing
more biotin than a host cell not transformed with said gene and would said person have
had a “reasonable expectation of success” in producing such a recombinant cell? In re
Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991); In re O’Farrell, 853
F.2d 894, 903-04, 2 USPQ2d 1673, 1681 (Fed. Cir. 1988).
The prior art relied upon by the examiner establishes that (i) the biotin biosynthetic
pathway was partially characterized, and (ii) the starting materials and the methods used
for transforming host cells and expressing heterologous gene products therein, were well
known at the time of the present invention. For example, as discussed above, it was
known in the art that in E. coli the biotin synthetic pathway involved at least six (6) enzymes
which are encoded by the bioA, bioB, bioF, bioC, bioD and bioH genes. Fisher, col. 3,
lines 2-4. The E. coli bioA, bioB, bioD and bioF genes were characterized and were
known to encode “7, 8-diaminopelargonic acid aminotransferase (also called 7, 8-
diaminopelargonic acid synthase), biotin synthetase (also called biotin synthase),
3(...continued)
should have taken a step back and re-evaluated the relevance of Gloeckler after claim 44
was amended to its present form. Now, we find that the reference only obfuscates the
relevant issues in this case.
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