Chemistry: natural resins or derivatives; peptides or proteins; – Proteins – i.e. – more than 100 amino acid residues
Reexamination Certificate
1995-03-22
2001-06-05
Minnifield, Nita (Department: 1645)
Chemistry: natural resins or derivatives; peptides or proteins;
Proteins, i.e., more than 100 amino acid residues
C530S333000, C530S300000, C530S403000, C530S395000, C530S413000, C530S416000, C530S417000, C424S186100, C424S204100, C424S230100, C424S093200, C435S320100, C435S069100, C435S069300, C435S071100, C435S071200, C435S091100, C435S173300
Reexamination Certificate
active
06242567
ABSTRACT:
This invention relates to methods of diagnosing and preventing human cytomegalovirus infection. It also relates to probes used in diagnosing human cytomagalovirus and to medicines such as vaccines for preventing human cytomegalovirus.
Human cytomegalovirus is a member of the herpes virus group and is a relatively common form of disease. For example, approximately ten percent (10%) of all newborn infants carry human cytomegalovirus. Some of these newborn infants suffer congenital birth defects. Other newborn infants carry cytomegalovirus for some time before they actually show symptoms of the disease. People infected with the disease often suffer impairment of some of their vital organs, including the salivary glands, brain, kidney, liver and lungs, as a result of the effects of the disease. Furthermore, human cytomegalovirus is associated with a wide spectrum of classical syndromes including mononucleosis and interstitial pneumonia. Human cytomegalovirus also has an oncogenic potential and a possible association with certain types of malignancy including Karposi's sarcoma.
Since human cytomegalovirus is relatively common in people, a considerable effort has been made to isolate the disease and to diagnose the disease in patients. Attempts have also been made to prepare a medicine, such as a vaccine, which can be administered to a patient to prevent the disease. In spite of such efforts, no satisfactory method has been developed to isolate, diagnose or treat the disease.
This invention relates to methods of using DNA fragments coding for the a major late 64 Kilodalton protein of human cytomegalovirus (HCMVgp64) to diagnose and prevent the disease. The invention also relates to probes formed from DNA fragments coding for this 64K protein of human cytomegalovirus for use in diagnosing cytomegalovirus in human patients. The invention also relates to vaccines formed from matrix proteins such as HCMVgp64 of human cytomegalovirus for use in preventing the disease. The probes and vaccines can be manufactured simply and reliably and can be applied by technicians to patients to obtain reliable results.
In one embodiment of the invention, a probe is capable of hybridizing to a gene fragment coding for an amino acid sequence of HCMVgp64 protein of human cytomegalovirus. The probe has a sequence of at least seventeen (17) to seven hundred twenty-one (721) nucleotides. The probe may be labelled as by radioactivity. The probe is used to screen DNA fragments constituting a subgenomic library of human cytomegalovirus DNA to obtain DNA fragments coding for the HCMVgp64 of human cytomegalovirus.
The DNA fragments coding for the HCMVgp64 of human cytomegalovirus may be hybridized to whole DNA or to DNA fragments of the DNA of an individual having human cytomegalovirus. The DNA fragments may be formed by digesting the human cytomegalovirus DNA with a restriction endonuclease such as one of the restriction endonucleases EcoRI, BamHI, XbaI, HindIII and PstI. During the “dot-blot” screening procedure, the DNA fragments coding for the HCMVgp64 protein of human cytomegalovirus hybridizes to the DNA of HCMV. As a result of such hybridization, the identity of human cytomegalovirus may be established. This particular DNA fragment may have a map location of approximately 0.50 to 0.51 units in the human cytomegalovirus genome. It may have a sequence of about seven hundred twenty-one (721) nucleotides.
The major late protein of human cytomegalovirus (HCMVgp64) also reacts with T-lymphocytes in an individual after natural infection of that individual with human cytomegalovirus. Thus, the HCMVgp64 protein may be used as a vaccine to treat patients having human cytomegalovirus.
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Clark Brian R.
Pande Hema
Riggs Arthur D.
Zaia John A.
City of Hope
Minnifield Nita
Rothwell Figg Ernst & Manbeck
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