Appeal No. 1995-2772
Application 08/001,063
desthiobiotin synthetase (also called desthiobiotin synthase), and 7-keto-8-
aminopelargonic acid synthetase (also called 7-keto-8-aminopelargonic acid synthase).”
Specification, p. 2; see also, Fisher, col. 3, lines 4-6. Prior art investigators demonstrated
that biotin could be produced in a biotin retention-deficient E. coli host cell by transforming
said E. coli host cell with a plasmid comprising the DNA encoding the biotin gene cluster
4
bioA, bioB, bioF, bioC and bioD. Fisher, the abstract, and Examples 1, 2 and 5 through
7. Furthermore, at the time of the present invention, we find that the applied prior art
establishes that the complete nucleotide sequence of the E. coli bioH gene and the amino
acid sequence of the protein which it encodes were known. O’Regan, p. 8004. It was also
understood that the E. coli bioH gene product was an essential component of the biotin
biosynthetic pathway. Fisher, col. 3, lines 14-15. However, what was not known or
understood in the art at the time of the present invention was the function of the E. coli bioH
gene product or the role it played in the biotin biosynthetic pathway. Specification, para.
bridging pp. 2-3; Fisher, col. 3, lines 9-14; O’Regan, p. 8004, lines 1-3.
Accordingly, the issue which must be resolved is whether at the time of the invention
would a hypothetical person having ordinary skill in this art have performed this seemingly
obvious task of expressing the E. coli bioH gene in a host cell and would it have been
4We note that Fisher has two examples which are denominated Example 5. We
refer to the second Example 5 which is in col. 8.
7
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