Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving virus or bacteriophage
Reexamination Certificate
1996-02-28
2001-07-31
Stucker, Jeffrey (Department: 1648)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving virus or bacteriophage
C435S006120, C435S007100, C435S007200, C435S007500, C435S007600, C435S007800, C435S007900, C435S007920, C435S091330, C435S961000, C435S968000, C435S974000, C436S525000, C436S526000, C436S529000, C436S531000, C436S532000, C436S534000
Reexamination Certificate
active
06268123
ABSTRACT:
I. FIELD OF THE INVENTION
The present invention relates to the detection and identification of retroviruses. More specifically, the invention relates to processes for the direct detection of retroviruses in biological samples. The processes are characterized by the structure-specific extraction of retrovirus particles and a subsequent analysis and detection of retrovirus-specific enzymatic reactions. The processes of the invention have broad application in the diagnosis of retroviral infection and virological research.
II. BACKGROUND
Presently, the routine detection of retroviruses in biological samples is only made indirectly by structure-specific (i.e., non-functional) analysis, namely via the detection of viral-specific antibodies and/or individual components (antigens, RNA proviral DNA). Examples of such detection methods are anti-HIV antibody tests, HIV-p24 antigen tests, and HIV-PCR detection test. Holodniy et al., 1991,
J. Infect. Dis.
163:862-866; Henrard et al, 1992,
AIDS Res. Hum. Retrovir.
8:47-52. This type of analysis is based on a structure-specific molecular interaction between antibody and antigen or PCR primer and proviral DNA. Since it is not testing for viral function, it does not establish the presence of biological intact and functional retroviral particles. Furthermore, this type of analysis does not detect all stages of a viral infection, e.g., the phase in which the infection has already taken place, but antibodies have not yet been generated. These factors can cause both false positive or false negative results.
Accordingly, there is a need for the direct and also functional detection of retroviruses in biological samples. This need is further underscored by the medical and socio-political significance of retroviruses, presently lead by the greatest medical challenge, AIDS, and by an observable increasing tendency and role of retroviruses in animal and human disease (leukemia, auto-immune diseases, cancer, etc.). In addition, the transmissibility of retroviruses by infection poses a serious challenge on the transfusion and transplantation medicine, calling for reliable detection of viral contamination, both for lymph, saliva, sperm or blood samples, and for organs, skin, bone marrow, etc., to be transplanted. The same problem of viral contamination and infection also applies to the use of pharmaceutical preparations and other pharmaceutical/biotechnological or genetechnological preparations with biological origin for treating diseases in human beings and animals, as well as in basic medical research. A prerequisite for a solution to the above-mentioned problems is the direct detection of functional retroviruses by means of a simple, reliable and sensitive method.
Prior to the present invention, the direct and biologically functional detection of retroviruses was only possible in individual cases. It was labor and time intensive, involving the infection of cells using purified virus preparations or cell culture supernatants. Quantitative, simple and reliable routine methods have not existed prior to this invention. This is due to the complex composition of biological samples (blood, organ extracts, etc.) which contain proteins, enzymes, vitamins, lipids, sugars and various inhibitors. They hinder or render impossible the direct and functional detection of retrovirus.
The process of the present invention provides for the routine, direct and biochemically functional detection of retrovirus in biological samples.
III. SUMMARY OF THE INVENTION
The present invention relates to the detection and identification of retroviruses. In particular, the invention relates to processes for the direct detection of retroviruses in biological samples.
More specifically, the retrovirus particles are extracted based on their structure-specific characteristics. Subsequently, the presence of functional retrovirus is identified by analysis and detection retrovirus-specific functional reactions. For example, retrovirus-specific ligands may be employed for extraction, and retrovirus-specific enzymes may be employed for the subsequent functional analysis.
The processes of the invention have broad application in diagnosis of retroviral infection and virological research.
REFERENCES:
patent: 5077192 (1991-12-01), Liang et al.
patent: 5534406 (1996-07-01), Liang et al.
patent: 93/07259 (1993-04-01), None
Faff et al. “Retrovirus-Like Particles from the Human T47D Cell Line are Related to Mouse Mammary Tumour Virus and are of Human Endogenous Origin”The Journal of General Virology,vol. 73, part 5(May 1992), pp. 1087-1097.*
Eberle and Seibl, 1992 “A New Method For Measuring Reverse Transcriptase Activity By ELISA,”J. Virol. Meth.40:347-356.
Faff et al., 1989, “Microassay of Reverse Transcriptase In Microtiterplates,”Methods in Mol. and Cell. Biol.1:67-72.
Faff et al., 1993, “Large Scale Production And Purification Of Human Retrovirus-Like Particles Related To The Mouse Mammary Tumor Virus”FEMS Microbiology Letters109:289-296.
Gallo, 1991, “Ein Krebsvirus Wird Entdeckt: Das Erste Menschliche Retrovirus,”Die Jagd Nach Dem Virus ed, S. Fischer,pp. 144-165.
Henrard et al., 1992, “A Sensitive Viral Capture Assay For Detection Of Plasma Viremia In HIV-Infected Individuals,”AIDS Res. Hum. Retrovir.8:47-52.
Holodniy et al., 1991, “Detection And Quantification Of Human Immunodeficiency Virus RNA In Patient Serum By Use Of The Polymerase Chain Reaction,”J. Infect. Dis.163:862-866.
Kurth et al., 1993, “Entdeckung Von Viren Im Meschlichen Erbgut,”Spektrum der Wissenschaft9:15-17.
Pennie & Edmonds LLP
Retro-Tech GmbH
Stucker Jeffrey
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