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Title: |
US6221622:
Method and kit for obtaining fluids and cellular material from breast ducts
[ Derwent Title ]
>> View Certificate of Correction for this publication

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Country: |
US United States of America

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Inventor: |
Love, Susan M.; Pacific Palisades, CA

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Assignee: |
The Regents of the University of California, Oakland, CA
other patents from UNIVERSITY OF CALIFORNIA, THE REGENTS OF (599425) (approx. 4,840)
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Published / Filed: |
2001-04-24
/ 1998-04-28

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Application Number: |
US1998000067661

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IPC Code: |
Advanced:
A61B 10/00;
A61B 10/02;
A61K 49/00;
G01N 33/48;
Core:
more...
IPC-7:
A61M 1/00;
A61M 29/00;
G01N 33/561;
G01N 33/574;

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ECLA Code: |
A61B10/00L;

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U.S. Class: |
Current:
435/007.23;
119/014.19;
435/007.21;
604/028;
604/030;
604/035;
604/104;
Original:
435/007.23;
435/007.21;
604/028;
604/030;
604/035;
604/104;
119/014.19;

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Field of Search: |
435/7.1,7.23
604/028,30,35,104
119/14.19

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Government Interest: |
This invention was made with Government support under contract DAMD17-96-C-6117. The government has certain rights in this invention.

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Priority Number: |
| 1998-04-28 |
US1998000067661 |

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Abstract: |
Methods, kits, and apparatus for obtaining cellular, chemical, and other materials from breast ducts are described. A single milk duct is accessed and washed with a washing fluid to obtain marker materials from the lining the duct. The washing fluid is then collected, and the marker materials in the washing fluid identified and analyzed. Usually, the washing fluid is introduced using a syringe through a lumen of a dual-lumen catheter. The ductal volume is filled with the washing fluid and excess fluid flows outwardly through a second lumen of the dual-lumen catheter, from which it is collected.

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Attorney, Agent or Firm: |
Gates & Cooper ;

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Primary / Asst. Examiners: |
Burke, Julie; Sun-Hoffman, Lin

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Maintenance Status: |
CC Certificate of Correction issued View Certificate of Correction

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INPADOC Legal Status: |
Show legal status actions
Family Legal Status Report

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Designated Country: |
AE AL AM AP AZ BA BB BG BR BY CA CN CU CZ EA EE GD GE GH GM HR HU ID IL IN IS AT BE CH CY DE DK ES FI FR GB GR IE

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Family: |
Show 29 known family members

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First Claim:
Show all 33 claims |
What is claimed is:
1. A method of assessing the likelihood of a cancer in the cellular lining of a breast duct, said method comprising:
- (a) locating at least one of the ductal orifices on a nipple of the breast;
- (b) introducing a catheter having at least two lumens through one of the ductal orifices and into the ductal passage;
- (c) introducing a washing fluid through a lumen into the ductal passage;
- (d) collecting the washing fluid from the ductal passage through a lumen of the catheter while the catheter is within the ductal passage, wherein the material in the collected fluid include epithelial cells; and
- (e) examining the morphology of the epithelial cells in the collected fluid to determine if they are atypical in order to assess the likelihood of a cancer present in the cellular lining of the duct.

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Background / Summary: |
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Drawing Descriptions: |
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Description: |
Show description

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Forward References: |
Show 25 U.S. patent(s) that reference this one

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Foreign References: |

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Other Abstract Info: |
DERABS C2000-013362

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Other References: |
Barsky et al., "Pathologic analysis of breast duct endoscoped mastectomies" Laboratory Investigation, Modern Pathology, Annual Meeting Abstracts (1996) p. 15A, abstract No. 67.
Fabian et al., "Prevalence of abnormal biomarkers in fine needle breast aspirates in a high risk population: Potential for use in risk prediction" Proc. Ann. Meet. Am. Assoc. Cancer Res. (1993) 34:A1556.
Imayama et al., "Presence of elevated carcinoembryonic antigen on absorbent disks applied to nipple area of breast carcinoma patients" Cancer (1996) 78(6) :1229-1234.
Lewis, "Technique probes breast ducts for cancer cells" Biophotonics International (May/Jun. 1997) pp. 27-28.
Love, "Breast duct endoscopy: A pilot study of a potential technique for evaluating intraductal disease" 15th Annual San Antonio Breast Cancer Symposium, San Antonio, TX (1996) p. 180, abstract No. 197.
Love and Barsky, "Breast-duct endoscopy to study stages of cancerous breast disease" The Lancet (1996) 348:997-999.
Makita et al., "Duct endoscopy and endoscopic biopsy in the evaluation of nipple discharge" Breast Cancer Research and Treatment (1991) 18:179-187.
Okazaki et al., "Fiberoptic ductoscopy of the breast: A new diagnostic procedure for nipple discharge" Jpn. J. Clin. Oncol. (1991) 21(3):188-193.
Petrakis, "Physiologic, biochemical, and cytologic 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 & Prevention (Jan./Feb. 1993) 2:3-10.
Petrakis, "Nipple aspirate fluid in epidemiologic studies of breast disease" Epidemiologic Reviews (1993) 15:188-195.
Sartorius et al., "Contrast ductography for recognition and localization of benign and malignant breast lesions: An improved technique" Logan, W., ed., Breast Carcinoma, New York, Wiley, (1977) pp. 281-300.
Sartorius, "The biochemistry of breast cyst fluids and duct secretions" Breast Cancer Research and Treatment (1995) 35:255-266.
Wrensch et al., "Breast fluid cholesterol and cholesterol β-epoxide concentrations in women with benign breast disease" Cancer Res. (1989) 49:2168-2174.
Wrensch et al., "Factors associated with obtaining nipple aspirate fluid: Analysis of 1428 women and literature review" Breast Cancer Research and Treatment (1990) 15:39-51.
Wrensch et al., "Breast cancer incidence in women with abnormal cytology in nipple aspirates of breast fluid" Am. J. Epidemiol. (1992) 135(2):130-141.
Love et al., The Lancet. 348:997-999, 1996.*
Akira Okazaki, "Diagnosis of Nonpalpable Breast Cancer By Ductoscopy: Comparison of Imaging and Histological Findings", Nyugan no Rinsho (Clinical Breast Cancer) 4(4):587-594 (1989).
Claude Feige, "Dynamic Morpho-Cyto-Echography and the Echographic Galactoscopy Endo-Ductal Sample Intrinsic and Extrinsic Markers in the Detection of Breast Cancers", Ultrasound in Med. & Biol., vol. 14, Sup. 1, pp. 97-108, 1982.
Jeffrey A. Fisher, "Our Medical Future: Breathroughs in Health and Longevity by the Year 2000 and Beyond", Copyright 1992, book published by Pocket Books, New York, NY, U.S.A., pp. 136-141.
Raul A. Leborgne, "The Breast in Roentgen Diagnosis", Impressora Uruguaya S.A.--Juncal[51], Montevideo (Uruguay), 1953.
Carol J. Fabian et al., "Biomarker and Cytologic Abnormalities in Women at High and Low Risk for Breast Cancer", Journal of Cellular Biochemistry, 17G:153-160 (1993).
M. Falardeau et al., "Selective Galactophorectomy for Mono-Orificial Nipple Discharge Without Associated Mass: Technique and Results. Apropos of seventy-three cases", Database Medline `Online`, US National Library of Medicine, Bethesda, Maryland, USA, (Abstract) and [Annales De Chirurgie, (1991) 45(9)796-801, Journal code: 50E. ISSN: 0003-3944].
C. Feige, "Dynamic Morpho-cyto-echography and the Echographic Galactoscopy Endo-ductal sample. Intrinsic and Extrinsic Markers in the Detection of Breast Cancers", Database Medline `Online`, US National Library of Medicine, Bethesda, Maryland, USA, (Abstract) AN=8904507 and ["Ultrasound in Medicine and Biology", (1998) 14 Suppl 1 97-108. Journal Code: WNE.ISSN: 0301-5629, United Kingdom
M. F. Hou et al., "A Simple Method of Duct Cannulation and Localization for Galactography Before Excision in Patients with Nipple Discharge", Radiology, (May 1995), 195(2) 568-9, Journal Code: QSH.ISSN: 0033-8419., XP002091599, United States.
Tomoaki Katamine et al., "Determination of Cancer-associated Antigens in Body Fluid Secreted from Nipple" Chemical Abstracts, vol. 114, No. 9, Mar. 4, 1991, 2pp, and JP 02 280061 A (Mochida Pharmaceutical Co., Ltd., Japan).
S. Naran et al., "Cytologic Diagnosis of Papillary Carcinoma of the Breast in Needle Aspirates", Database Medline Online, US National Library of Medicine, Bethesda, Maryland, US, an=88242405, Database Accession No. 88242405 XP002114398 (Abstract) and [Diagnostic Cytopathology, (Mar. 1988) 4(1) 33-7
F. A. Weaver et al., "Management of Postoperative Lymphatic Leaks by Use of Isosulphan Blue '3!", Database EMBASE `Online`, Elsevier Science Publishers, Amsterdam, Netherlands, Database Accession No. 91353868, XP002114397 (Abstract) and [Journal of Vascular Surgery, (1991) 14/4 (566-567)
Margaret Wrensch, et al., "Breast Cancer Risk Associated with Abnormal Cytology in Nipple Aspirates of Breast Fluid and Prior History of Breast Biopsy", American Journal of Epidemiology, vol. 137, No. 8, 1993, pp. 829-833.
Akira Okazaki et al., "Relationship Between Cytologic Results and the Extent of Intraductal Spread in Nonpalpable Breast Cancers with Nipple Discharge", Tumor Res., 31, pp. 89-97, 1996.

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Continuity Data: |
| Application Number | Filed | Notes |
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US1998000067661 | 1998-04-28 | is a
related to the prior publication |
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US20020160431A1 issued 2002-10-31 Methods for performing medical procedures within a breast duct
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US1998000153564 | 1998-09-15 | is a
continuation in part of |
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US2000000740561
| 2000-12-19 |
(pending)
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US20010001059A1 issued 2001-05-10 Method and kit for obtaining fluids and cellular material from breast ducts
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US1997000931786 | | is a
continuation in part of |
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US2000000740561
| 2000-12-19 |
(abandoned)
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US20010001059A1 issued 2001-05-10 Method and kit for obtaining fluids and cellular material from breast ducts
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US2002000175022 | 2002-06-19 | is a
continuation in part of |
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US1998000153564
| 1998-09-15 |
(pending)
[presumed granted]
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US6455027 issued 2002-09-24 Methods and kits for identifying ductal orifices in a nipple
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US2002000099439 | 2002-03-15 | is a
continuation in part of |
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US1998000153564
| 1998-09-15 |
(pending)
[presumed granted]
|
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US6455027 issued 2002-09-24 Methods and kits for identifying ductal orifices in a nipple
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|
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US2002000099439 | | is a
continuation in part of |
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US1998000153564
| 1998-09-15 |
|
| |
US6455027 issued 2002-09-24 Methods and kits for identifying ductal orifices in a nipple
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|
|
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US2000000740561 | 2000-12-19 | is a
continuation of |
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>US1998000067661<
| 1998-04-28 |
(pending)
[presumed granted]
|
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US6221622 issued 2001-04-24 Method and kit for obtaining fluids and cellular material from breast ducts
|
|
|
|
US2000000740561 | 2000-12-19 | is a
continuation of |
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>US1998000067661<
| 1998-04-28 |
(granted)
|
| |
US6221622 issued 2001-04-24 Method and kit for obtaining fluids and cellular material from breast ducts
|
|
|
|
US2000000740561 | | is a
continuation of |
|
>US1998000067661<
| 1998-04-28 |
|
| |
US6221622 issued 2001-04-24 Method and kit for obtaining fluids and cellular material from breast ducts
|
|
|
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US1999000301058 | 1999-04-28 | is a
continuation in part of |
|
>US1998000067661<
| 1998-04-28 |
(granted)
|
| |
US6221622 issued 2001-04-24 Method and kit for obtaining fluids and cellular material from breast ducts
|
|
|
|
US1998000153564 | 1998-09-15 | is a
continuation in part of |
|
US1997000931786
| 1997-09-16 |
(granted)
|
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US6168779 issued 2001-01-02 Methods and kits for identifying ductal orifices
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|
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US1998000153564 | | is a
continuation in part of |
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US1997000931786
| 1997-09-16 |
|
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US6168779 issued 2001-01-02 Methods and kits for identifying ductal orifices
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