Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving virus or bacteriophage
Reexamination Certificate
1994-06-20
2002-06-18
Scheiner, Laurie (Department: 1648)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving virus or bacteriophage
C435S007100, C424S187100, C424S207100, C422S067000
Reexamination Certificate
active
06406841
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to an isolate of human T-cell lymphotropic virus type II (“HTLV-II”) referred to as “NRA.” More particularly, the invention relates to compositions derived from the NRA provirus, and to the use of such compositions in assays and kits to detect HTLV infection.
BACKGROUND OF THE INVENTION
Human T-cell lymphotropic virus type I (“HTLV-I”) has been established as the etiologic agent of two diseases, adult T-cell leukemia (“ATL”) [Poiesz et al.,
Proc. Natl. Acad. Sci. USA,
77:7415-7419 (1980); Uchiyama et al.,
Blood,
50:481-492 (1977)] and a neurologic disorder known either as HTLV-associated myelopathy (“HAM”) [Tsujimoto et al.,
Mol. Biol. Med.,
5:29-42 (1988)] or tropical spastic paraparesis (“TSP”) [Gessain et al.,
Lancet,
II:407-409 (1985)].
Genetic analysis of HTLV-I genomes has been performed. [Ratner et al.,
AIDS Res. and Human Retroviruses,
7:923-941 (1991); Goodenow et al.,
J. Acquired Immune Defic. Syndr.,
2:344-352 (1989); Gray et al.,
Virology,
177:391-395 (1990)]. Genetic diversity within the HTLV-I genome has been reported to be associated with the geographical origin of the isolate. [Gessain et al.,
J. Virol.,
66:2288-2295 (1992); Sherman et al.,
J. Virol,
66:2556-2563 (1992)].
Another type of human lymphotropic virus, HTLV-II, has been identified among approximately half of the U.S. blood donors with anti-HTLV reactivity [Hjelle et al.,
Blood,
76:450-454 (1990); Lee et al.,
Lancet,
337:1435-1439 (1991)], and a high risk association has been reported in intravenous drug users (“IVDU”) from New Orleans [Lee et al.,
Science,
244:471-475 (1989)], New York City [Robert-Guroff et al.,
JAMA,
255:3133-3137 (1986); Ehrlich et al.,
Blood,
74:1658-1664 (1989)], the United Kingdom [Tedder et al.,
Lancet,
11:125-128 (1984)], and Italy [Zella et al.,
Lancet,
336:575-576 (1990)]. HAM/TSP-like myelopathy has also been described in one patient coinfected with HIV-1 and HTLV-II [Berger et al.,
Neurology,
41:85-87 (1991)] and in several additional HTLV-II infected individuals. [Hjelle et al.,
Lancet,
339:645-646 (1992); Rosenblatt et al.,
AIDS,
6:1151-1158 (1992)].
HTLV-II was first identified in a patient (“Mo”) with a T-cell variant hairy cell leukemia. [Saxon et al.,
Ann. Intern. Med.,
88:323-326 (1978); Kalyanaraman et al.,
Science,
218:571-573 (1982)]. A “Mo” cell line was established from the spleen cells of that patient, and the Mo provirus was characterized. [Chen et al.,
Nature,
305:502-505 (1983)]. U.S. Pat. No. 4,438,032 to Golde et al. further describes the Mo T-lymphoblast cell line and the proteinaceous products produced by that cell line. The nucleotide sequence of the Mo provirus has also been determined. [Shimotohno et al.,
Proc. Natl. Acad. Sci. USA,
82:3101-3105 (1985)].
In 1986, Rosenblatt et al. reported the second isolation of HTLV-II in a patient (“NRA”) with an atypical hairy cell leukemia. [Rosenblatt et al.,
New Engl. J. Med.,
315:372-377 (1986)]. Cell lines, NRA, NRA-P, NRA-WM 2, and NRA-SH were established and restriction enzyme analysis of the new HTLV-II isolate was performed. The data from the genetic analysis of the NRA isolate showed that the genomes of HTLV-II
Mo
and HTLV-II
NRA
are not identical. [Id]. Rosenblatt et al.,
Blood,
71:363-369 (1988), later reported in a follow-up analysis of the NRA patient's HTLV infection that the patient had two coexistent lymphoproliferative disorders of distinct T and B cell origin.
Recently, Hall et al. and Dube et al. have described and compared various HTLV-II isolates. Based on partial sequencing of the gp21e envelope region and restriction mapping of several HTLV-II isolates from intravenous drug users, Hall et al. have proposed that HTLV-II
Mo
and HTLV-II
NRA
are two different HTLV-II subtypes. [Hall et al.,
J. Virol.,
66:2456-2463 (1992)]. Particularly, Hall et al. describe HTLV-II
Mo
as being subtype A and HTLV-II
NRA
as being subtype B.
Dube et al.,
J. Virol.,
67:1175-1184 (1993) have also investigated the heterogeneity of HTLV-II in different patients residing in the Western hemisphere. Dube et al. report that at least two genetically distinct HTLV-II strains are present in the Western hemisphere. Based on the data obtained in the study, Dube et al. suggest that HTLV-II isolates introduced into the New World were more heterogeneous than the HTLV-I strains.
Various compositions and assays for detecting HTLV-I infection have been described. [See, for example, WO 85/01803 to Slamon, published Mar. 27, 1986]. The Abbott Laboratories' HTLV-I EIA is a commercially available kit assaying for HTLV-I antibodies. The kit employs HTLV-I viral lysate-coated beads. There is also commercially available from Cambridge Technologies a kit assaying for HTLV-I antibodies. That kit employs HTLV-I viral lysate and recombinant gp21E protein attached to microtiter plate wells.
Compositions and assays for detecting and/or differentiating HTLV-I and HTLV-II infection have also been described. [See, for example, co-owned and co-pending U.S. patent application Ser. No. 08/170,063, filed Dec. 20, 1993; WO 90/10231 to Blomberg, published Mar. 5, 1990; WO 90/15820 to Vahlne, published Dec. 27, 1990; Lal et al.,
J. Infectious Diseases,
163:41-46 (January 1991)].
To Applicants' knowledge, prior to the filing of the present application the NRA provirus and NRA infected cell lines were not publicly available. Moreover, Applicants are not aware of any publications reporting the use of the presently disclosed NRA compositions in assays or kits to detect HTLV infection.
SUMMARY OF THE INVENTION
One embodiment of the invention is directed to various DNA sequences derived from HTLV-II
NRA
provirus. More particularly, there is provided:
a DNA sequence coding the genome of HTLV-II
NRA
provirus;
a DNA sequence coding for the HTLV-II
NRA
gag region and for gag p19, p24, and p15;
a DNA sequence coding for the HTLV-II
NRA
pol region;
a DNA sequence coding for the HTLV-II
NRA
env region and for env p21e;
a DNA sequence coding for the HTLV-II
NRA
tax region; and
a DNA sequence coding for the HTLV-II
NRA
rex region. Amino acid sequences corresponding to the respective DNA sequences are also provided.
Another embodiment of the invention is directed to HTLV-II
NRA
compositions, including polypeptides and proteins coded by the sequences disclosed in the present application, purified HTLV-II
NRA
viral lysate, purified HTLV-II
NRA
, and tissue culture grown cells infected with HTLV-II
NRA
.
Another embodiment of the invention is directed to methods and assays for detecting anti-HTLV antibodies in a test sample.
A further embodiment of the invention is directed to kits for detecting anti-HTLV antibodies in a test sample.
REFERENCES:
patent: 4228237 (1980-10-01), Hevey et al.
patent: 4438032 (1984-03-01), Golde et al.
patent: 4683195 (1987-07-01), Mullis et al.
patent: 4683202 (1987-07-01), Mullis
patent: 5039604 (1991-08-01), Papsidero et al.
patent: 5041385 (1991-08-01), Kingsman et al.
patent: 5378805 (1995-01-01), Lal
patent: A320308 (1989-06-01), None
patent: A336731 (1989-10-01), None
patent: 8601834 (1986-03-01), None
patent: 8909835 (1989-10-01), None
patent: 8912696 (1989-12-01), None
patent: 9010231 (1990-09-01), None
patent: 9015820 (1990-12-01), None
patent: 9204046 (1992-03-01), None
patent: 9301316 (1993-01-01), None
Harlow et al., 1988, Antibodies: A Laboratory Manual. Cold Spring Harbor Laboratory, p. 179.*
Cockerell et al., 1991, Infectious Transmission of Human T-Cell Lymphotropic Virus Type II in Rabbits, Blood, 78(6):1532-1537.*
Harlow, E. and D. Lane, 1988, “Immunoblotting”, in Antibodies: A Laboratory Manual, Harlow, E. and D. Lane, eds., Cold Spring Harbor Laboratory, pp. 496 and 497.*
Barker et al.,Plant Mol. Bio., 2:335-350 (1983).
Berger et al.,Neurology, 41:85-87 (1991).
Berneman et al.,P
Buytendorp Mark H.
Chan Emerson W.
Chen Irvin S. Y.
Edwards Michelle
Golde David W.
Abbott Laboratories
Casuto Dianne
Danckers Andreas M.
Parkin Jeffrey S.
Scheiner Laurie
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