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Patent US5258907A successfully refreshed from Google Patents.
US5258907A
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US
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Method and apparatus for detecting down syndrome by non-invasive maternal blood screening
Assignee: PerkinElmer Singapore Pte Ltd
•
Filing: 1991-05-31
•
Granted: 1993-11-02
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Expires: 2011-05-31
Abstract
Abstract A method and apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome. The method comprises measuring the pregnant woman's maternal blood levels of the free beta subunit of human chorionic gonadotropin. The level of free beta subunit of human chorionic gonadotropin individually or with other marker may be compared to reference data. A computerized apparatus for making the determination preferably using a probability density function generated from a set of reference data by a linear discriminant analysis procedure is disclosed.
Inventors
- 👤 James N. Macri
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-28 20:26
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/74; G01N33/76; Y; Y10; Y10S; Y10S436/00; Y10S436/815; Y10S436/817; Y10S436/818
Claims Analysis
Total Claims: 68
Claim 1
Independent Claim
110 words
Apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal serum level of free beta human chorionic gonadotropin, and computer means for calculating a set of normative data and for incorporating said measurement of said level of said free beta human chorionic gonadotropin and said pregnant woman's gestational age into a probability density function, thereby comparing said pregnant woman's level of said free beta and said pregnant woman's gestational age to the set of normative data, to determine said pregnant 52589447.001 woman's risk of carrying a fetus with Down syndrome.
Claim 2
Dependent Claim
110 words
Apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal serum level of free beta human chorionic gonadotropin, and computer means for calculating a set of normative data and for incorporating said measurement of said level of said free beta human chorionic gonadotropin and said pregnant woman's gestational age into a probability density function, thereby comparing said pregnant woman's level of said free beta and said pregnant woman's gestational age to the set of normative data, to determine said pregnant 52589447.001 woman's risk of carrying a fetus with Down syndrome.
Claim 3
Dependent Claim
27 words
The apparatus recited in claim 1, wherein said computer means generates said probability density function from the set of normative data by a linear discriminant analysis procedure.
Claim 4
Dependent Claim
101 words
The apparatus of claim 1, further comprising: means adapted for receiving a measurement of said pregnant woman's maternal serum level of intact human chorionic gonadotropin molecule and further wherein said computer means comprises means for incorporating said measurement of said level of said intact human chorionic gonadotropin molecule into said probability density function, thereby comparing said pregnant woman's level of intact human chorionic gonadotropin molecule and said pregnant woman's level of free beta human chorionic gonadotropin and said pregnant woman's gestational age to the set of normative data to determine said pregnant woman's risk of carrying a fetus with Down syndrome.
Claim 5
Dependent Claim
25 words
The apparatus recited in claim 3, wherein said probability density function is generated from the set of normative data by a linear discriminant analysis procedure.
Claim 6
Dependent Claim
117 words
The apparatus of claim 3, further comprising means adapted for receiving said pregnant woman's maternal serum level of alpha-feto protein and said pregnant woman's maternal serum level of unconjugated estriol and wherein said computer means further comprise means for incorporating said measurements of said level of said alpha-feto protein and said measurement of said level of said unconjugated estriol into said probability density function, thereby comparing said pregnant woman's level of alpha-feto protein, said pregnant woman's level of unconjugated estriol and said pregnant woman's level of said intact human chorionic gonadotropin molecule and said pregnant woman's gestational age to the set of normative data to determine said pregnant woman's risk of carrying a fetus with Down syndrome.
Claim 7
Dependent Claim
27 words
The apparatus recited in claim 5, wherein said computer means generates said probability density function from the set of normative data by a linear discriminant analysis procedure.
Claim 8
Dependent Claim
109 words
The apparatus recited in claim 5 wherein said computer means comprises means for incorporating a ratio of said measurement of said level of said free beta human chorionic gonadotropin to said measurement of said level of said intact human chorionic gonadotropin molecule into said probability density function thereby comparing said ration, said pregnant woman's level of alpha-fetoprotein, said pregnant woman's level of unconjugated estriol said pregnant woman's level of said intact human chorionic gonadotropin molecule, said level of said free beta human chorionic gonadotropin and said pregnant woman's gestational age to the set of normative data to determine said pregnant woman's risk of carrying a fetus with Down syndrome.
Claim 9
Dependent Claim
27 words
The apparatus recited in claim 7 wherein said computer mean generates said probability density function from the set of normative data by a linear discriminant analysis procedure.
Claim 10
Dependent Claim
131 words
The apparatus recited in claim 3, further comprising: means adapted for receiving a measurement of said pregnant woman's maternal serum level of alpha-fetoprotein and wherein said computer means comprises means for incorporating said measurement of said level of said alpha-fetoprotein and a ratio of said measurement of said level of said free beta human chorionic gonadotropin to said measurement of said level of said intact human chorionic gonadotropin into said probability density function thereby comparing said ratio, said pregnant woman's level of alpha-fetoprotein, said pregnant woman's level of said free beta human chorionic gonadotropin and said pregnant woman's level of said intact human chorionic gonadotropin molecule and said pregnant woman's gestational age to the set of normative data to determine said pregnant woman's risk of carrying a fetus with Down syndrome.
Claim 11
Dependent Claim
27 words
The apparatus recited in claim 9 wherein said computer means generates said probability density function from the set of normative data by a linear discriminant analysis procedure.
Claim 12
Dependent Claim
118 words
Apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal blood level of free beta human chorionic gonadotropin, and computer means for calculating a set of reference data and for incorporating the log of said measurement of said level of said free beta subunit of human chorionic gonadotropin and said pregnant woman's gestational age into a probability density function, thereby comparing the log of said pregnant woman's level of said free beta subunit and said pregnant woman's gestational age to the set of reference data, to determine said pregnant woman's risk of carrying a fetus with Down syndrome.
Claim 13
Dependent Claim
118 words
Apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal blood level of free beta human chorionic gonadotropin, and computer means for calculating a set of reference data and for incorporating the log of said measurement of said level of said free beta subunit of human chorionic gonadotropin and said pregnant woman's gestational age into a probability density function, thereby comparing the log of said pregnant woman's level of said free beta subunit and said pregnant woman's gestational age to the set of reference data, to determine said pregnant woman's risk of carrying a fetus with Down syndrome.
Claim 14
Dependent Claim
26 words
The method of claim 11 wherein said computer means generates said probability density function from a set or reference data by a linear discriminant analysis procedure.
Claim 15
Dependent Claim
98 words
The apparatus recited in claim 12 further comprising: means adapted for receiving a measurement of said pregnant woman's maternal blood level of alpha-feto protein and wherein said computer means comprises means for incorporating the log of said measurement of said level of alpha-feto protein into said probability density function, thereby comparing the log of said pregnant woman's level of alpha-fetoprotein and the log of said pregnant woman's level of free-beta human corionic gonadotropin and said pregnant woman's gestational age to the set of reference data to determine said pregnant woman's risk of carrying a fetus with Down syndrome.
Claim 16
Dependent Claim
27 words
The apparatus recited in claim 13 wherein said computer means generates said probability density function from the set of reference data by a linear discriminant analysis procedure.
Claim 17
Dependent Claim
70 words
Apparatus for determining if a pregnant woman is at an increased risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal blood level of the protein subunit of the free beta human chorionic gonadotropin and computer means to compare the measurement of the level of the protein subunit of the free beta subunit of human chorionic gonadotropin to reference data.
Claim 18
Dependent Claim
70 words
Apparatus for determining if a pregnant woman is at an increased risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal blood level of the protein subunit of the free beta human chorionic gonadotropin and computer means to compare the measurement of the level of the protein subunit of the free beta subunit of human chorionic gonadotropin to reference data.
Claim 19
Dependent Claim
65 words
Apparatus for determining if a pregnant woman is at an increased risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal blood level of the carbohydrate the free beta chorionic gonadotropin and computer means for comparing the measurement of the level of the carbohydrate subunit of the free beta human chorionic gonadotropin to reference data.
Claim 20
Dependent Claim
65 words
Apparatus for determining if a pregnant woman is at an increased risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal blood level of the carbohydrate the free beta chorionic gonadotropin and computer means for comparing the measurement of the level of the carbohydrate subunit of the free beta human chorionic gonadotropin to reference data.
Claim 21
Dependent Claim
80 words
Apparatus for determining if a pregnant woman is at an increased risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal blood level of a portion of the free beta human chorionic gonadotropin located about at the junction of the carbohydrate and the protein portions of the free beta subunit of human chorionic gonadotropin and computer means for comparing the measurement of the level of the portion to reference data.
Claim 22
Dependent Claim
80 words
Apparatus for determining if a pregnant woman is at an increased risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal blood level of a portion of the free beta human chorionic gonadotropin located about at the junction of the carbohydrate and the protein portions of the free beta subunit of human chorionic gonadotropin and computer means for comparing the measurement of the level of the portion to reference data.
Claim 23
Dependent Claim
62 words
Apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal serum level of free beta human chorionic gonadotropin and computer means for comparing the measurement of the level of free beta subunit of human chorionic gonadotropin to a set of reference data.
Claim 24
Dependent Claim
62 words
Apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal serum level of free beta human chorionic gonadotropin and computer means for comparing the measurement of the level of free beta subunit of human chorionic gonadotropin to a set of reference data.
Claim 25
Dependent Claim
55 words
The apparatus recited in claim 18 wherein the means for comparing the measurement of the level of free beta human chorionic gonadotropin to the set of reference data further comprises means for comparing the log of the measurement of the level of free beta subunit of human chorionic gonadotropin to the set of reference data.
Claim 26
Dependent Claim
52 words
The apparatus recited in claim 19 wherein the means for comparing the log of the measurement of the level of free beta to the set of reference data further comprises means for incorporating the log of the measurement of the level of free beta human chorionic gonadotropin into a probability density function.
Claim 27
Dependent Claim
27 words
The apparatus recited in claim 20, wherein said computer means generates said probability density function from a set of reference data by a linear discriminant analysis procedure.
Claim 28
Dependent Claim
41 words
The apparatus recited in claim 19 wherein said computer means further comprises means for comparing the log of the measurement of the level of free beta human chorionic gonadotropin and the pregnant woman's gestational age to the set of reference data.
Claim 29
Dependent Claim
72 words
The apparatus recited in claim 22 wherein the means for comparing the log of the measurement of the level of the free beta human chorionic gonadotropin and the pregnant woman's gestational age to the set of reference data further comprises means for incorporating the multiple of the gestational age specific median of the log of the measurement of the level of the free beta human chorionic gonadotropin into a probability density function.
Claim 30
Dependent Claim
25 words
The apparatus recited in claim 23 wherein said probability density function is generated from the set of reference data by a linear discriminant analysis procedure.
Claim 31
Dependent Claim
69 words
The apparatus recited in claim 19 further comprising means adapted for receiving a measurement of the pregnant woman's maternal serum level of alpha-feto protein and wherein said computer means comprises means for comparing the log of the measurement of the level of free beta subunit of human chorionic gonadotropin and the log of the measurement of the maternal serum level of alpha-feto protein to the set of reference data.
Claim 32
Dependent Claim
83 words
The apparatus recited in claim 25 wherein the means for comparing the log of the measurement of the level of free beta human chorionic gonadotropin and the log of the measurement of the maternal serum level of alpha-feto protein to the set of reference data further comprises means for incorporating the log of the measurement of the level of free beta human chorionic gonadotropin and the log of the measurement of the maternal serum level of alpha-feto protein into a probability density function.
Claim 33
Dependent Claim
26 words
The apparatus recited in claim 26 wherein said computer means generates said probability density function from the set of reference data by a linear discriminant analysis
Claim 34
Dependent Claim
54 words
The apparatus recited in claim 25 wherein said computer means further comprises means for comparing the log of the measurement of the level of free beta human chorionic gonadotropin, the log of the measurement of the maternal serum level of alpha-feto protein and the pregnant woman's gestational age to the set of reference data.
Claim 35
Dependent Claim
93 words
The apparatus recited in claim 28 wherein the means for comparing the log of the measurement of the level of free beta human chorionic gonadotropin, the log of the measurement of the maternal serum level of alpha-feto protein and the pregnant woman's gestational age to the set of reference data further comprises means for incorporating the log of the measurement of the level of free beta human chorionic gonadotropin, the log of the measurement of the maternal serum level of alpha-feto protein and the pregnant woman's gestational age into a probability density function.
Claim 36
Dependent Claim
27 words
The apparatus recited in claim 29 wherein said computer means generates said probability density function from the set of reference data by a linear discriminant analysis procedure.
Claim 37
Dependent Claim
34 words
The apparatus recited in claim 18 further comprising means for comparing the measurement of the level of the free beta chorionic gonadotropin and the pregnant woman's gestational age to the set of reference data.
Claim 38
Dependent Claim
60 words
The apparatus recited in claim 18 wherein the means for comparing the measurement of the level of the free beta human chorionic gonadotropin to the set of reference data further comprises means for comparing the multiple of the gestational age specific median of the measurement of the level of the free beta human chorionic gonadotropin to the set of reference.
Claim 39
Dependent Claim
60 words
The apparatus recited in claim 32, wherein the means for comparing the measurement of the level of the free beta human chorionic gonadotropin to the st of reference data further comprises means for incorporating the multiple of the gestational age specific median of the measurement of the level of the free beta human chorionic gonadotropin into a probability density function.
Claim 40
Dependent Claim
27 words
The apparatus recited in claim 33 wherein the computer means generates the probability density function from the set of reference data by a linear discriminant analysis procedure.
Claim 41
Dependent Claim
62 words
The apparatus recited in claim 18 further comprising means adapted for receiving a measurement of the pregnant woman's maternal serum level of alpha-feto protein and wherein the computer means comprises means for comparing the measurement of the level of the free beta human chorionic gonadotropin and the measurement of the maternal serum level of alpha-feto protein to the set of reference data.
Claim 42
Dependent Claim
73 words
The apparatus recited in claim 35 wherein the means for comparing the measurement of the level of the free beta human chorionic gonadotropin and the measurement of the maternal serum level of alpha-feto protein to the set of reference data further comprises means for incorporating the measurement of the level of the free beta human chorionic gonadotropin and the measurement of the maternal serum level of alpha-feto protein into a probability density function.
Claim 43
Dependent Claim
27 words
The apparatus recited in claim 36 wherein said computer means generates said probability density function from the set of reference data by a linear discriminant analysis procedure.
Claim 44
Dependent Claim
48 words
The apparatus recited in claim 35 wherein said computer means comprises means for comparing the measurement of the level of the free beta human chorionic gonadotropin, the measurement of the maternal serum level of alpha-feto protein and the pregnant woman's gestational age to the set of reference data.
Claim 45
Dependent Claim
85 words
The apparatus recited in claim 38 wherein the means for comparing the measurement of the level of the free beta human chorionic gonadotropin, the measurement of the maternal serum level of alpha-feto protein and the pregnant woman's gestational age to the set of reference data further comprises means for incorporating the measurement of the level of the free beta subunit of human chorionic gonadotropin, the measurement of the maternal serum level of alpha-feto protein and the pregnant woman's gestational age into a probability density function.
Claim 46
Dependent Claim
27 words
The apparatus recited in claim 39, wherein said computer means generates said probability density function from the set of reference data by a linear discriminant analysis procedure.
Claim 47
Dependent Claim
82 words
The apparatus recited in claim 35 wherein the means for comparing the measurement of the level of the free beta human chorionic gonadotropin and the measurement of the maternal serum level of alpha-feto protein to the set of reference data further comprises means for incorporating the measurement of the level of the free beta human chorionic gonadotropin and the multiple of the gestational age specific median of the measurement of the maternal serum level of alpha-feto protein into a probability density function.
Claim 48
Dependent Claim
85 words
The apparatus recited in claim 41 wherein the means for comparing the measurement of the level of the free beta human chorionic gonadotropin and the measurement of the maternal serum level of alpha-feto protein to the set of reference data further comprises means for incorporating the measurement of the level of the free beta human chorionic gonadotropin and the log of the multiple of the gestational age specific median of the measurement of the maternal serum level of alpha-feto protein into a probability density function.
Claim 49
Dependent Claim
97 words
The apparatus recited in claim 35 wherein the means for comparing the measurement of the level of the free beta human chorionic gonadotropin and the measurement of the maternal serum level of alpha-feto protein to the set of reference data further comprises means for incorporating the log of the multiple of the gestational age specific median of the measurement of the level of the free beta human chorionic gonadotropin and the log of the multiple of the gestational age specific median of the measurement of the maternal serum level of alpha-feto protein into a probability density function.
Claim 50
Dependent Claim
92 words
The apparatus recited in claim 35 wherein the means for comparing the measurement of the level of the free beta human chorionic gonadotropin and the measurement of the maternal serum level of alpha-feto protein to the set of reference data further comprises means for comparing the multiple of the gestational age specific median of the measurement of the level of the free beta human chorionic gonadotropin and the multiple of the gestational age specific median of the measurement of the maternal serum level of alpha-feto protein to a set of reference data.
Claim 51
Dependent Claim
98 words
The apparatus recited in claim 44 wherein the means for comparing the measurement of the level of the free beta human chorionic gonadotropin and the measurement of the maternal serum level of alpha-feto protein to the set of reference data further comprises means for comparing the log of the multiple of the gestational age specific median of the measurement of the level of the free beta human chorionic gonadotropin and the log of the multiple of the gestational age specific median of the measurement of the maternal serum level of alpha-feto protein to the set of reference data.
Claim 52
Dependent Claim
29 words
The apparatus recited in claim 18 wherein the free beta human chorionic gonadotropin is produced by at least one of seven genes encoding the free beta human chorionic gonadotropin.
Claim 53
Dependent Claim
50 words
Apparatus comprising: means adapted for receiving a measurement of a pregnant woman's maternal blood level of the free beta human chorionic gonadotropin and computer means for comparing the measurement of the level of the free beta human chorionic gonadotropin to a set of reference data to determine fetal chromosomal abnormalities.
Claim 54
Dependent Claim
50 words
Apparatus comprising: means adapted for receiving a measurement of a pregnant woman's maternal blood level of the free beta human chorionic gonadotropin and computer means for comparing the measurement of the level of the free beta human chorionic gonadotropin to a set of reference data to determine fetal chromosomal abnormalities.
Claim 55
Dependent Claim
76 words
Apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal serum level of a free beta human chorionic gonadotropin produced by at least one of seven genes encoding the free beta human chorionic gonadotropin, and computer means for comparing the measurement of the level of free beta human chorionic gonadotropin to a set of reference data.
Claim 56
Dependent Claim
76 words
Apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal serum level of a free beta human chorionic gonadotropin produced by at least one of seven genes encoding the free beta human chorionic gonadotropin, and computer means for comparing the measurement of the level of free beta human chorionic gonadotropin to a set of reference data.
Claim 57
Dependent Claim
56 words
Apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal serum level of a free beta human chorionic gonadotropin and computer means for comparing said level to a set of reference data to calculate the risk.
Claim 58
Dependent Claim
56 words
Apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement of a pregnant woman's maternal serum level of a free beta human chorionic gonadotropin and computer means for comparing said level to a set of reference data to calculate the risk.
Claim 59
Dependent Claim
73 words
Apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement or a pregnant woman's maternal serum level of a free beta human chorionic gonadotropin produced by at least one of seven genes encoding the free beta subunit of human chorionic gonadotropin and computer means for comparing said level to a set of reference data to calculate the risk.
Claim 60
Dependent Claim
73 words
Apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome comprising: means adapted for receiving a measurement or a pregnant woman's maternal serum level of a free beta human chorionic gonadotropin produced by at least one of seven genes encoding the free beta subunit of human chorionic gonadotropin and computer means for comparing said level to a set of reference data to calculate the risk.
Claim 61
Dependent Claim
58 words
Apparatus for determining if a pregnant woman is at a significant risk of carrying a fetus with Down syndrome comprising means adapted for receiving the pregnant woman's maternal blood level of an analyte using an assay for a free beta hCG and computer means for comparing said level to a set of reference data to calculate the risk.
Claim 62
Dependent Claim
58 words
Apparatus for determining if a pregnant woman is at a significant risk of carrying a fetus with Down syndrome comprising means adapted for receiving the pregnant woman's maternal blood level of an analyte using an assay for a free beta hCG and computer means for comparing said level to a set of reference data to calculate the risk.
Claim 63
Dependent Claim
18 words
The apparatus recited in claim 51 wherein the assay comprises an enzyme linked immunosorbent assay for free beta-hCG.
Claim 64
Dependent Claim
15 words
The method of claim 51 wherein the assay comprises a one step free beta-hCG assay.
Claim 65
Dependent Claim
28 words
The method of claim 53 further comprising computer means for comparing said level of said analyte and the pregnant woman's gestational age to a set of reference data.
Claim 66
Independent Claim
82 words
A method for determining if a pregnant woman is at a significant risk of carrying a fetus with Down syndrome comprising: measuring the pregnant woman's maternal blood level of an analyte using an assay for a free beta subunit of hCG and comparing said level of said analyte to a set of reference data to calculate the risk wherein computer means are utilized for comparing said level of said analyte and the pregnant woman's gestational age to a set of reference data.
Claim 67
Independent Claim
82 words
A method for determining if a pregnant woman is at a significant risk of carrying a fetus with Down syndrome comprising: measuring the pregnant woman's maternal blood level of an analyte using an assay for a free beta subunit of hCG and comparing said level of said analyte to a set of reference data to calculate the risk wherein computer means are utilized for comparing said level of said analyte and the pregnant woman's gestational age to a set of reference data.
Claim 68
Dependent Claim
33 words
The method of claim 55 wherein said computer means compare the log of said level of said analyte and the log of said pregnant woman's gestational age to a set of reference data.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1996-11-01 | 1997-05-03 | 1997-11-02 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2000-11-01 | 2001-05-03 | 2001-11-02 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2004-11-01 | 2005-05-03 | 2005-11-02 | $7700.00 | Window Closed / Lapsed |