Appeal No. 2001-0288 Page 2
Application No. 08/277,031
a yeast NADPH-P450 reductase, wherein said yeast
NADPH-P450 reductase is optionally in the form of a fused
enzyme with each of said human cytochrome P450
molecular species, or reacting the chemical compound with
cell free extracts of the yeast cells; and
(b) analyzing the resulting metabolite to determine the safety of
the compound.
6. A method according to claim 1, wherein the recombinant yeast
cells further produce at least one additional human cytochrome
P450 molecular species selected from a group of human
cytochrome P450 2A6, P450 2C19 and P450 2D6.
8. An artificial fused enzyme, which comprises human cytochrome
P450 3A4 and yeast NADPH-P450 reductase.
10. A method of determining in vitro the potential human metabolite of
a chemical compound, which comprises:
(a) reacting the chemical compound with recombinant yeast
cells that produce human cytochrome P450 molecular
species P450 1A2, P450 2C9, P450 2E1 and P450 3A4 and
a yeast NADPH-P450 reductase, wherein said yeast
NADPH-P450 reductase is optionally in the form of a fused
enzyme with each of said human cytochrome P450
molecular species, or reacting the chemical compound with
cell free extracts of the yeast cells; and
(b) identifying the resulting metabolite.
The references relied upon by the examiner are:
Yabusaki et al. (Yabusaki) 5,114,8521 May 19, 1992
Crespi et al. (Crespi) WO 92/07085 Apr. 30, 1992
Wolf et al. (Wolf) WO 92/14817 Sep. 3, 1992
Yasumori et al. (Yasumori ‘87), “Nucleotide sequence of a human liver
cytochrome P-450 related to the rat male specific form,” J. Biochemistry, Vol.
102, pp. 1075-1082 (1987)
1 We note the Final Rejection (Paper No. 27, mailed September 14, 1998), and Brief (Paper No.
29, received December, 9, 1998), rely on Yabusaki et al., United States Patent No. 5,436,159
(‘159) and not United States Patent No. 5,114,852 (‘852). It appears that the examiner’s
reference to ‘852 in the Answer is a typographical error. Furthermore, we note that ‘852 is a
continuation of ‘159 and therefore both patents have identical disclosures. Therefore, to the
extent the examiner’s reliance on ‘852 is in error, we find the error harmless.
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