Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving nucleic acid
Reexamination Certificate
2000-07-26
2003-08-26
Huff, Sheela (Department: 1642)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving nucleic acid
C435S007100, C435S007200, C435S007230, C435S007920, C436S063000, C436S064000, C436S501000, C436S503000, C436S504000
Reexamination Certificate
active
06610484
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The field of this invention is methods and systems for detecting breast cancer and breast precancer in humans.
2. Description of the Background Art
For several decades significant members of the medical community dedicated to studying breast cancer have believed and shown that the cytological analysis of cells retrieved from nipple discharge from the breast milk ducts can provide valuable information leading to an identifying patients at risk for breast cancer. Indeed Papanicolaou himself contributed to the genesis of such a possibility of a “Pap” smear for breast cancer by analyzing the cells contained in nipple discharge. See Papanicolaou et al, “Exfoliative Cytology of the Human Mammary Gland and Its Value in the Diagnosis of Cancer and Other Diseases of the Breast” Cancer (1958) March/April 377-409. See also Petrakis, “Physiological, biochemical, and cytological aspects of nipple aspirate fluid”,
Breast Cancer Research and Treatment
1986; 8:7-19; Petrakis, “Studies on the epidemiology and natural history of benign breast disease and breast cancer using nipple aspirate fluid”
Cancer Epidemiology, Biomarkers and Prevention
(January/Febuary 1993) 2:3-10; Petrakis, “Nipple Aspirate Fluid in epidemiological studies of breast disease”,
Epidemiologic Reviews
(1993) 15:188-195. More recently, markers have also been detected in nipple fluid. See Sauter et al, “Nipple aspirate fluid: a promising non-invasive method to identify cellular markers of breast cancer risk”,
British Journal of Cancer
76(4):494-501 (1997). The detection of CEA in fluids obtained by a nipple blot is described in Imayama et al. (1996)
Cancer
78: 1229-1234.
Breast cancer is believed to originate in the lining of a single breast milk duct in the breast; and additionally human breasts are believed to contain from 6 to 9 of these ducts. See Sartorius,
JAMA
224 (6): 823-827 (1973). Sartorius describes use of hair-like single lumen catheters that are inserted into breast ducts using an operating microscope and the ducts were flushed with saline solution as described in Cassels, D Mar. 20, 1973,
The Medical Post,
article entitled “New tests may speed breast cancer detection”. Sartorius et al, Contrast ductography for recognition and localization of benign and malignant breast lesions: an improved technique. pp. 281-300. In: Logan WW, ed.
Breast Carcinoma
New York, Wiley, 1977. After the fluid was infused, the catheter was removed because it was too small to collect the fluid, the breast was squeezed and fluid that oozed onto the nipple surface was removed from the surface by a capillary tube. Similarly, Love and Barsky, “Breast-duct endoscopy to study stages of cancerous breast disease”,
Lancet
348(9033):997-999, 1996 describes cannulating breast ducts with a single lumen catheter and infusing a small amount of saline, removing the catheter and squeezing to collect the fluid that returns on the nipple surface. The use of a rigid 1.2 mm ductscope to identify intraductal papillomas in women with nipple discharge is described in Makita et al (1991)
Breast Cancer Res Treat
18: 179-188. It would be advantageous to develop methods and devices to collect the ductal fluid from within the duct.
Galactography, or contrast ductography has for years located breast ducts based on spontaneous nipple discharge, infused the ducts (using cannulas for this purpose) with contrast dye solutions, and taken x-ray pictures to determine the source of the discharge within the duct. See generally, The Breast: Comprehensive Management of Benign and Malignant Breast Diseases, Bland and Copeland eds. W.B. Saunders Co. Philadelphia Pa. 1991 pages 61-67.
Nuclear matrix proteins are implicated in bladder, colon, prostate, breast and other cancers, and have been put forth by Matritech, Inc (Newton, Mass. 02460) as part of a kit for testing for bladder cancer using body fluid. For testing for breast cancer, a blood test has been developed using antibodies to nuclear matrix proteins (see website for Matritech, Inc. http://www.matritech.com) The blood and body fluid tests are promoted as being capable of early detection of the cancers they seek to identify. In addition, profiles and differential patterns of expression of nuclear matrix proteins have been detected for several different cancers (Fey and Penman 1986, Stuurman 1990, and Getzenberg 1990).
Matritech, Inc. has patented various aspects of proteins and nucleic acids of nuclear matrix proteins as well as kits for testing for their presence in order to identify cancer in U.S. Pat. Nos. 5,965,376, 5,914,238, 5,882,876, 5,858,683, 5,840,503, 5,830,677, 5,783,403, 5,780,596, 5,698,439, 5,686,562, and 5,547,928. Specifically, Matritech has patented claims in U.S. Pat. No. 5,914,238 to a method for diagnosing breast cancer in a patient comprising detecting the presence of a breast cancer-associated protein in a tissue or body fluid obtained from the patient. The breast cancer-associated protein has a molecular weight of about 32,500 or 33,000 Daltons and an isoelectric point of about 6.82, and has a continuous amino acid sequence from several amino acid sequences disclosed in the application. The nuclear matrix protein is detected by polyclonal or monoclonal antibodies or by PCR amplification of an expression product of the target gene. The patient sample in the examples is breast tissue samples, although the possibility of testing blood or body fluid is claimed and mentioned in the specification. Testing breast duct fluid is not described.
SUMMARY OF THE INVENTION
An object of the invention is to identify a patient having breast cancer or breast precancer. In accordance with this object, is provided a method comprising providing a ductal fluid sample from one duct of a breast of a patient, the fluid not mixed with ductal fluid from any other duct of the breast, and examining the ductal fluid sample to determine the presence of a marker comprising a protein, a polypeptide, a peptide, a nucleic acid, a polynucleotide, an mRNA, a small organic molecule, a lipid, a fat, a glycoprotein, a glycopeptide, a carbohydrate, an oligosaccharide, a chromosomal abnormality, a whole cell having a marker molecule, a particle, a secreted molecule, an intracellular molecule, and a complex of a plurality of molecules. In accordance with this object is also provided methods for determining markers which can identify a patient having breast cancer or precancer by examining the ductal fluid sample to determine the presence of a marker comprising RNA, DNA, protein, polypeptide, or peptide form of the marker. The invention also includes a method of identifying a patient having breast cancer or breast precancer, said method comprising providing a ductal fluid sample from one duct of a breast of a patient, said fluid not mixed with ductal fluid from any other duct of the breast, examining the ductal fluid sample to determine the presence of a marker comprising a protein, a polypeptide, a peptide, a nucleic acid, a polynucleotide, an mRNA, a small organic molecule, a lipid, a fat, a glycoprotein, a glycopeptide, a carbohydrate, an oligosaccharide, a chromosomal abnormality, a whole cell having a marker molecule, a particle, a secreted molecule, an intracellular molecule, and a complex of a plurality of molecules; wherein the marker is capable of differentiating between any two of cytological categories consisting of normal, abnormal, hyperplasia, atypia, ductal carcinoma, ductal carcinoma in situ (DCIS), ductal carcinoma in situ—low grade (DCIS-LG), ductal carcinoma in situ—high grade (DCIS-HG), invasive carcinoma, atypical mild changes, atypical marked changes, atypical ductal hyperplasia (ADH), insufficient cellular material for diagnosis, and sufficient cellular material for diagnosis.
Any of the methods can comprise further analyzing the ductal fluid for abnormal cytology. Any of the methods can comprise that the ductal fluid is retrieved by placing a ductal access tool in the duct and infusing fluid into the duct through the tool and retrieving from
Banner & Witcoff , Ltd.
Cytyc Health Corporation
Huff Sheela
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