Chemistry: molecular biology and microbiology – Micro-organism – tissue cell culture or enzyme using process... – Recombinant dna technique included in method of making a...
Reexamination Certificate
2001-03-26
2004-09-07
Ungar, Susan (Department: 1642)
Chemistry: molecular biology and microbiology
Micro-organism, tissue cell culture or enzyme using process...
Recombinant dna technique included in method of making a...
C435S252300, C435S320100, C435S325000, C536S023100, C536S023500
Reexamination Certificate
active
06787335
ABSTRACT:
FIELD OF THE INVENTION
This invention relates, in part, to newly identified polynucleotides and polypeptides encoded thereby, as well as methods for producing and using these polynucleotides and polypeptides. Antibodies which are immunospecific for these polypeptides are also described. Expression of the newly identified polynucleotides and levels of the polypeptides encoded thereby are upregulated in or specific to mammary gland cancer tissue. These new polynucleotides and polypeptides, referred to herein as Mammary Gland Cancer Specific Genes or MSGs are believed to be useful in assays for detecting, diagnosing, monitoring, staging, prognosticating, imaging and treating cancers, particularly mammary gland cancer.
BACKGROUND OF THE INVENTION
It is estimated that one out of every nine women in America will develop mammary gland cancer sometime during her life based on a lifespan of 85 years. Annually, over 180,000 women in the United States are diagnosed with mammary gland cancer and approximately 46,000 die from this disease. Every woman is at risk for mammary gland cancer. However, a woman's chances of developing this cancer increase as she grows older; 80 percent of all cancers are found in women over the age of 50. There are also several risk factors that can increase a woman's chances of developing mammary gland cancer. These include a family history of mammary gland cancer, having no children or the first child after the age of 30, and an early start of menstruation. However, more than 70 percent of women who develop mammary gland cancer have no known risk factors. Less than 10 percent of mammary gland cancer cases are thought to be related to the BRCA1 gene discovered in 1994. Researchers are now investigating the role of other factors such as nutrition, alcohol, exercise, smoking, and oral contraceptives in development of this gynecologic cancer. Mammograms, or special x-rays of the breast, can detect more than 90 percent of all cancers.
Procedures used for detecting, diagnosing, monitoring, staging, and prognosticating mammary gland cancer are of critical importance to the outcome of the patient. Patients diagnosed early generally have a much greater five-year survival rate as compared to the survival rate for patients diagnosed with distant metastasized mammary gland cancer. New diagnostic methods which are more sensitive and specific for detecting early mammary gland cancer are clearly needed.
Cancer patients are closely monitored following initial therapy and during adjuvant therapy to determine response to therapy and to detect persistent or recurrent disease or metastasis. Thus, there is also clearly a need for cancer markers which are more sensitive and specific in detecting mammary gland cancer recurrence.
Another important step in managing mammary gland cancer is to determine the stage of the patient's disease. Stage determination has potential prognostic value and provides criteria for designing optimal therapy. Generally, pathological staging of cancer is preferable over clinical staging because the former gives a more accurate prognosis. However, clinical staging would be preferred were it at least as accurate as pathological staging because it does not depend on an invasive procedure to obtain tissue for pathological evaluation. Staging of cancer would be improved by detecting new markers in cells, tissues or bodily fluids which could differentiate between different stages of invasion.
The present invention relates to newly identified polynucleotides and polypeptides encoded thereby which are referred to herein as Mammary Gland Cancer Specific Genes or MSGs, as well as antibodies which are immunospecific for the polypeptides. The present invention also relates to methods for use of these MSGs in detecting, diagnosing, monitoring, staging, prognosticating, imaging and treating mammary gland cancer. For purposes of the present invention, MSG refers, among other things, to native protein expressed by the gene comprising a polynucleotide sequence of SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20. By MSG it is also meant herein polynucleotides which, due to degeneracy in genetic coding, comprise variations in nucleotide sequence as compared to SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20, but which still encode the same protein. In the alternative, what is meant by MSG as used herein, means the native mRNA encoded by the gene comprising the polynucleotide sequence of SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20, or a polynucleotide which is capable of hybridizing under stringent conditions to the antisense sequence of SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20.
Other objects, features, advantages and aspects of the present invention will become apparent to those of skill in the art from the following description. It should be understood, however, that the following description and the specific examples, while indicating preferred embodiments of the invention are given by way of illustration only. Various changes and modifications within the spirit and scope of the disclosed invention will become readily apparent to those skilled in the art from reading the following description and from reading the other parts of the present disclosure.
SUMMARY OF THE INVENTION
Toward these ends, and others, it is an object of the present invention to provide isolated polynucleotide sequences comprising SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20; fragments or portions of such sequences which contain at least 15 contiguous nucleobases of SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20; nucleic acid sequences which, due to degeneracy in genetic coding, comprise variations in polynucleotide sequence as compared to SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20, but which still encode the same protein; and nucleic acid sequences which are capable of hybridizing under stringent conditions to the antisense sequence of SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20. The present invention further relates to isolated polypeptides encoded by the above-described polynucleotides. These polynucleotides and/or the polypeptides encoded thereby are referred to generally herein as Mammary Gland Cancer Specific Genes or MSGs.
It is another object of the present invention to provide vectors containing the MSG polynucleotides and host cells for expression and recovery of the MSG polypeptides encoded thereby.
It is another object of the present invention to provide antibodies which are immunospecific for MSG polypeptides.
It is another object of the present invention to provide tools for detection of MSGs. Such tools include, but are not limited to, antisense oligonucleotides which specifically hybridize with the MSGs and antibodies which are immunospecific for the MSGs.
It is another object of the present invention to provide a method for diagnosing the presence of mammary gland cancer by analyzing for changes in levels of MSG in cells, tissues or bodily fluids compared with levels of MSG in preferably the same cells, tissues, or bodily fluid type of a normal human control, wherein a change in levels of MSG in the patient versus the normal human control is associated with mammary gland cancer.
Further provided is a method of diagnosing metastatic cancer in a patient having mammary gland cancer which is not known to have metastasized by identifying a human patient suspected of having mammary gland cancer that has metastasized; analyzing a sample of cells, tissues, or bodily fluid from such patient for MSG; comparing the MSG levels in such cells, tissues, or bodily fluid with levels of MSG in preferably the same cells, tissues, or bodily fluid type of a normal human control, wherein an increase in MSG levels in the patient versus the normal human control is associated with mammary gland can
Cafferkey Robert
Hu Ping
Recipon Herve
Salceda Susana
Davis Minh-Tam
diaDexus, Inc.
Licata & Tyrrell P.C.
Ungar Susan
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