Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Amino acid sequence disclosed in whole or in part; or...
Reexamination Certificate
1999-06-08
2002-07-09
Scheiner, Laurie (Department: 1648)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Amino acid sequence disclosed in whole or in part; or...
C424S204100, C435S005000, C435S007100, C435S069100
Reexamination Certificate
active
06416761
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of Art
Hantaviruses
Hantaviruses are a group of at least 19 diverse agents. They occur worldwide in rodent hosts and cause either (1) no known human disease; (2) hemorrhagic fever with renal syndrome, HFRS, or (3) Hantavirus pulmonary syndrome (HPS) when transmitted to man. The following is a compilation of currently recognized types; there is not universal agreement among workers in the field as to the degree to which each is clearly distinct from each other:
Virus
Abbreviation
Synonyms
Host
Distribution of Host
Disease
Hantaan
HTN
A. agrarius
Central & E Asia, Central & E Europe
HFRS
Seoul
SEO
Baltimore rat
R. norvegicus, R.
Worldwide; commensal rat hosts
HFRS
virus; many others
rattus
Dobrava/Belgrade
DOB
BEL
A. flavicollis
Asia Minor Europe, Palestine
HFRS
Puumala
PUU
C. glareolus
Russia, Europe, Asia Minor
HFRS
Sin Nombre
SN
Four Corners;
P. maniculatus
Throughout US, W Canada
HPS
Muerto Canyon;
Convict Creek
Black Creek Canal
BCC
S. hispidus
SE US to Peru
HPS
Muleshoe
MULE
S. hispidus
W. Texas
unknown
Monongahela
MON
P. maniculatus
Appalachians, W. Va. to New York
unknown
New York
NY
SI-1
P. leucopus
NE US, SE Canada
HPS
Bayou
BAY
O. palustris
SE US, Kansas to New Jersey
HPS
Thottapalayam
TPM
S. murinus
Africa, India, SE Asia
unknown
Tula
TUL
M. arvalis
Russia, Europe, Asia Minor
unknown
Thai
THAI
B. indica
SE Asia, India
unknown
Prospect Hill
PH
M. pennsylvanicus
N, E US, Canada, Alaska
unknown
Bloodland Lake
BLLL
PVV
M. ochrogaster
Midwestern, E US, S Canada
unknown
Khabarovsk
KBR
M. fortis
E Russia
unknown
Isla Vista
ILV
CMMV
M. californicus
California, Oregon, Mexico
unknown
El Moro Canyon
ELMC
HMV-1
R. megalotis
W US, Mexico, SW Canada
unknown
Rio Segundo
RIOS
HMV-2
R. mexicanus
?
Mexico, Costa Rica, Ecuador
unknown
Rio Mamoré
RM
Oligoryzomysmicrotis
Bollvia, Brazil, Paraguay, Peru,
unknown
Argentina
Since there are so many distinct species of Hantaviruses, there is no single test or single reagent that allows the diagnosis of all hantavirus infection. In each case, the best reagents for detection of antibodies to a given hantavirus are those which are based upon the hantavirus species that actually caused the infection. The nucleocapsid (N) protein is the portion of each hantavirus that is most strongly immunogenic, and the standard for diagnosis of Hantaviruses has increasingly been to rely upon the expression of homologous N protein in bacteria or other microbial expression system to generate high concentrations of recombinant-expressed antigen. Classical methods of viral antibody detection have depended upon the growth of the virus in culture, with use of the viral antigens from infected cultures in immunologic detection, but these methods are increasingly falling out of favor for a variety of technical and practical reasons.
2. Discussion of Related Art
Specific diagnostic tests are available for several previously-described Hantaviruses. For Hantaviruses in general, antibody tests are much preferred over direct detection of infectious viral particles, viral genomic RNA, or viral antigens because of the inherently superior stability, sensitivity, specificity, and ease of transfer of antibody assay technologies. The following modalities are in common use (C) or are under development or research use (D) for the following Hantaviruses:
High density particle
Virus
agglutination
IFA*
ELISA**
Western blot
Hantaan
C
C
C
D
Seoul
C
C
C
D
Puumala
C
C
C
C/D
Sln Nombre
D
C
C
Dobrava
D
D
*IFA, immunofluorescence assay
**ELISA, enzyme-linked immunosorbent assay. Both native (cultured virus) and recombinant-expressed antigens are used.
Because none of the prototype Hantaviruses listed above occurs in rodents with distribution in South America, it is virtually certain that human Hantavirus disease in South America is due to novel virus(es) that will be detected in a less-than-optimal manner by tests that utilize antigens derived from prototype species. These virus(es) are almost certainly associated with indigenous rodents of the subfamily Sigmodontinae, family Muridae, because the clinical disease that has been noted in Brazilian, Argentinean, and Paraguayan patents is closely similar to those diseases caused by North American Hantaviruses of sigmodontine rodents. Detection of Hantavirus infection in South America has relied most heavily upon cross-reactivity between the prototypic sigmodontine rodent-borne Hantavirus Sin Nombre (Four Corners) virus (SNV) and the South American virus(es).
SUMMARY OF THE DISCLOSURE
The invention provides a molecular clone encoding and expressing the complete nucleotide protein of Rio Mamoré virus. The RMV N protein includes antigenically active domains useful in immunoassays for detecting South American Hantavirus infection, and in vaccines.
REFERENCES:
patent: 5837441 (1998-11-01), Hjelle et al.
LeDuc, James W., et al., “Isolation of a Hantaan-Related Virus from Brazilian rats and Serologic Evidence of Its Widespread Distribution in South America,”Am. J. of Tropical Med and Hygiene,vol. 34, No. 4, (Jul. 1985).
Lopez, Nora, et al., “Genetic Identification of a New Hantavirus Causing Severe Pulmonary Syndrome in Argentina,”Virologyvol. 220. pp 223-226 (Mar. 1996).
Jenison, S., et al., 1994, “Characterization of human antibody responses to four corners hantavirus infections among patients with hantavirus pulmonary syndrome”, J. Virol. 68(5):3000-6.
Hjelle Brian L.
Torrez-Martinez Norah
Morgan, Lewis & Bockius, L.L.P.
Parkin Jeffrey S.
Scheiner Laurie
Science & Technology Corporation @UNM
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