US4756907A
Expired / Lapsed
US
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Active/passive immunization of the internal female reproductive organs
Assignee: Alkermes Controlled Therapeutics Inc II
•
Filing: 1986-01-24
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Granted: 1988-07-12
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Expires: 2006-01-24
Abstract
Abstract Antibody or antigen containing microparticles for the active or passive immunization of the internal female reproductive organs, comprising: microparticles of an antigen or antibody incorporated in a matrix material which is biocompatible and biologically degradable, said microparticles capable of being transported after deposition in the vagina by the natural transport mechanism of the internal female reproductive organs across the cervix into the uterus.
Inventors
- 👤 Lee R. Beck
- 👤 Charles F. Flowers, Jr.
- 👤 Donald R. Cowsar
- 👤 Albert C. Tanquary
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 02:04
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/56; A61K39/00; A61K9/00; A61K9/0012; A61K9/0034; A61K9/0036; A61K9/14; A61K9/16; A61K9/1605; A61K9/1617; A61K9/1629; A61K9/1641; A61K9/1647; C; C07; C07K; C07K16/00; C12; C12N; C12N11/00; C12N11/02; C12N11/04; A61K38/00
Claims Analysis
Total Claims: 68
Claim 1
Independent Claim
151 words
A method of duplicating the menstrual cycle of a host female while administering an antibody or antigen to the internal female reproductive organs, comprising: depositing estrogen containing microparticles in the vagina where estrogen is steadily released thereby duplicating days 1 to 14 of the estrogenic phase of the menstrual cycle and rendering the cervix increasingly capable of microparticle transport; depositing progestin containing microparticles in the vagina where said progestin is released after day 1 to day 28 of said menstrual cycle, thereby duplicating the progestational phase of said cycle; and depositing microparticles containing said antigen or antibody in the vagina in time sufficient for the maximum transport of said antibody or antigen containing microparticles between days 12 and 16 of said cycle across the cervix into the uterus and fallopian tubes where said antigen or antibody is released so as to elicit an antibody response or passive immunization within the uterus.
Claim 2
Independent Claim
151 words
A method of duplicating the menstrual cycle of a host female while administering an antibody or antigen to the internal female reproductive organs, comprising: depositing estrogen containing microparticles in the vagina where estrogen is steadily released thereby duplicating days 1 to 14 of the estrogenic phase of the menstrual cycle and rendering the cervix increasingly capable of microparticle transport; depositing progestin containing microparticles in the vagina where said progestin is released after day 1 to day 28 of said menstrual cycle, thereby duplicating the progestational phase of said cycle; and depositing microparticles containing said antigen or antibody in the vagina in time sufficient for the maximum transport of said antibody or antigen containing microparticles between days 12 and 16 of said cycle across the cervix into the uterus and fallopian tubes where said antigen or antibody is released so as to elicit an antibody response or passive immunization within the uterus.
Claim 3
Dependent Claim
23 words
The method of claim 1, wherein said microparticles are of a monolithic structure in which said antigen is dispersed throughout a matrix material.
Claim 4
Dependent Claim
24 words
The method of claim 1, wherein said microparticles are of a layered structure comprising a core of said antigen surrounded by a matrix material.
Claim 5
Dependent Claim
32 words
The method of claim 1, wherein said microparticles are of a layered structure comprising a core of said antigen dispersed in a matrix material surrounded by said matrix material free of antigen.
Claim 6
Dependent Claim
31 words
The method of claim 1, wherein said antigen induces a contraceptive response and is derived from the blastocyst, the ovum, sperm, is a non-hormonal placental antigen or is a trophobactic hormone.
Claim 7
Dependent Claim
15 words
The method of claim 1, wherein said estrogen is estradiol and said progestin is progesterone.
Claim 8
Dependent Claim
39 words
The method of claim 1, wherein said estrogen is released from said microparticles at a rate of 0.1 to 1 mg per day and wherein said progestin is released at a rate of 0.5 and 2 mg per day.
Claim 9
Dependent Claim
47 words
The method of claim 1, wherein said estrogen and antigen or antibody are both incorporated in said microparticles structured such that the microparticles have a core containing antigen or antibody in a matrix material and an outer shell of matrix material throughout which is dispersed said estrogen.
Claim 10
Dependent Claim
96 words
The method of claim 1, wherein said estrogen and antibody or antigen containing microparticles are dispersed in the vagina such that estrogen is steadily released from said outer shell of said microparticles during the estrogenic phase of said menstrual cycle thereby stimulating the cervix to convey said antigen or antibody containing microparticles across the cervix into the uterus, said antigen or antibody being released from said microparticles as the cores thereof are exposed by deterioration of said shell, and thereafter said progestin containing microparticles are deposited in the vagina for the progestational phase of said cycle.
Claim 11
Dependent Claim
45 words
The method of claim 1, wherein said estrogen, progestin and antibody or antigen are each administered separately in microparticles containing the same, each of said microparticles being of a monolithic structure throughout the matrix material of which antibody or antigen, estrogen and progestin are dispersed.
Claim 12
Dependent Claim
74 words
Antigen containing microparticles for the active immunization of the internal female reproductive organs, which comprises: microparticles containing an amount of antigen sufficient to elicit an antibody response incorporated in a matrix material which is biocompatible and biologically degradable, said microparticles capable of being transported after deposition in the vagina by the natural mechanism of the internal female reproductive organs across the cervix into the uterus wherein an antibody response is elicited within the uterus.
Claim 13
Dependent Claim
74 words
Antigen containing microparticles for the active immunization of the internal female reproductive organs, which comprises: microparticles containing an amount of antigen sufficient to elicit an antibody response incorporated in a matrix material which is biocompatible and biologically degradable, said microparticles capable of being transported after deposition in the vagina by the natural mechanism of the internal female reproductive organs across the cervix into the uterus wherein an antibody response is elicited within the uterus.
Claim 14
Dependent Claim
15 words
The microparticles of claim 11, wherein said microparticles further contain a menstrual cycle regulatory hormone.
Claim 15
Dependent Claim
15 words
The microparticles of claim 12, wherein said menstrual cycle regulatory hormone is estradiol or progesterone.
Claim 16
Dependent Claim
18 words
The microparticles of claim 11, wherein said microparticles are of a size ranging from 20 to 70 μm.
Claim 17
Dependent Claim
21 words
The microparticles of claim 11, wherein said matrix material is polylactic acid, polyglycolic acid, or copolymers of glycolic and lactic acids.
Claim 18
Dependent Claim
23 words
The microparticles of claims 11 and 12, wherein said microparticles have a monolithic structure in which antigen is dispersed throughout the matrix material.
Claim 19
Dependent Claim
26 words
The microparticles of claim 13, wherein said microparticles comprise a core of antigen surrounded by a shell of matrix material containing a menstrual cycle regulatory hormone.
Claim 20
Dependent Claim
20 words
The microparticles of claim 11, wherein said microparticles comprise a core of antigen surrounded by a shell of matrix material.
Claim 21
Dependent Claim
20 words
The microparticles of claim 11, wherein said microparticles contain from 10 wt. % to 60 wt. % of said antigen.
Claim 22
Dependent Claim
16 words
The microparticles of claim 11, wherein said antigen is derived from a bacterial or viral pathogen.
Claim 23
Dependent Claim
102 words
The microparticles of claim 11, wherein said antigen is derived from a bacterial pathogen selected from the group consisting of Neisseria gonorrhea, Mycobacterium tuberculosis, Candida albicans, Candida tropicalis, Trichomonas vaginalis, Haemophilus vaginalis, Group B Streptococcus ecoli, Microplasma hominis, Hemophilus ducreyi, Granuloma inguinale, Lymphopathia venereum, Treponema pallidum, Brucella abortus, Brucella melitensis, Brucella suis, Brucella canis, Campylobacter fetus, Campylobacter fetus intestinalis, Leptospira pomona, Listeria monocytogenes, Brucella ovis, Chlamydia psittaci, Trichomonas foetus, Toxoplasma gondii, Escherichia coli, Actinobacillus equuli, Salmonella abortus ovis, Salmonella abortus equi, Pseudomonas aeruginosa, Corynebacterium equi, Corynebacterium pyogenes, Actinobaccilus seminis, Mycoplasma bovigenitalium, Aspergillus fumigatus, Absidia ramosa, Trypanosoma equiperdum, Babesia caballi, and Clostridium tetani.
Claim 24
Dependent Claim
39 words
The microparticles of claim 11, wherein said antigen is derived from a viral pathogen selected from the group consisting of Equine herpes virus 1, Equine arteritis virus, IBR-IBP virus, BVD-MB virus, and Herpes virus (humonis, types 1 and 2).
Claim 25
Dependent Claim
58 words
The microparticles of claim 11, wherein said antigen is an enzyme selected from the group consisting of ribonuclease, neuramidinase, trypsin, glycogen phosphorylase, sperm lactic dehydrogenase, sperm hyaluronidase, adenosinetriphosphatase, alkaline phosphatase, alkaline phosphatase esterase, amino peptidase, trypsin chymotrypsin, amylase, muramidase, acrosomal proteinase, diesterase, glutamic acid dehydrogenase, succinic acid dehydrogenase, beta-glycophosphatase, lipase, ATP-ase alpha peptate gamma-glutamylotrans peptidase, sterol-3-beta-ol-dehydrogenase, and DPN-di-aprorase.
Claim 26
Dependent Claim
26 words
The microparticles of claim 11, wherein said antigen is a hormone selected from the group consisting of human chorionic gonadotrophin, human placental lactogen, estradiol and progesterone.
Claim 27
Dependent Claim
32 words
The microparticles of claim 11, wherein said antigen induces a contraceptive response and is derived from the blastocyst, the ovum, or sperm; is a non-hormonal placental antigen or is a trophoblastic hormone.
Claim 28
Dependent Claim
27 words
The microparticles of claim 11, wherein said microparticles are formulated in a composition as a suppository, cream, jelly, foam or a liquid with a pharmaceutically acceptable excipient.
Claim 29
Dependent Claim
71 words
Antibody containing microparticles for the passive immunization of the internal female reproductive organs, which comprises: microparticles containing a biologically effective amount of an antibody incorporated in a matrix material which is biocompatible and biologically degradable, said microparticles capable of being transported after deposition in the vagina by the natural transport mechanism of the internal female reproductive organs across the cervix into the uterus wherein passive immunization is effected within the uterus.
Claim 30
Dependent Claim
71 words
Antibody containing microparticles for the passive immunization of the internal female reproductive organs, which comprises: microparticles containing a biologically effective amount of an antibody incorporated in a matrix material which is biocompatible and biologically degradable, said microparticles capable of being transported after deposition in the vagina by the natural transport mechanism of the internal female reproductive organs across the cervix into the uterus wherein passive immunization is effected within the uterus.
Claim 31
Dependent Claim
21 words
The microparticles of claim 27, wherein said microparticles further contain a menstrual cycle regulatory hormone which stimulates said natural transport mechanism.
Claim 32
Dependent Claim
12 words
The microparticles of claim 28, wherein said hormone is estradiol or progesterone.
Claim 33
Dependent Claim
18 words
The microparticles of claim 27, wherein said microparticles are of a size ranging from 20 to 70 μm.
Claim 34
Dependent Claim
21 words
The microparticles of claim 27, wherein said matrix material is polylactic acid, polyglycolic acid or copolymers of glycolic and lactic acids.
Claim 35
Dependent Claim
22 words
The microparticles of claim 27, wherein said microparticles are of a monolithic structure in which antibody is dispersed throughout the matrix material.
Claim 36
Dependent Claim
26 words
The microparticles of claim 28, wherein said microparticles comprise a core of antibody surrounded by a shell of matrix material containing dispersed menstrual cycle regulatory hormone.
Claim 37
Dependent Claim
20 words
The microparticles of claim 27, wherein said microparticles comprise a core of antibody surrounded by a shell of matrix material.
Claim 38
Dependent Claim
20 words
The microparticles of claim 27, wherein said microparticles contain from 10 wt. % to 60 wt. % of said antibody.
Claim 39
Dependent Claim
21 words
The microparticles of claim 27, wherein said antibody is one which responds to an antigen from a viral or bacterial pathogen.
Claim 40
Dependent Claim
22 words
The microparticles of claim 27, wherein said antibody is one which responds to a bacterial antigen from a bacterium of claim 21.
Claim 41
Dependent Claim
22 words
The microparticles of claim 27, wherein said antibody is one which responds to a viral antigen from or virus of claim 22.
Claim 42
Dependent Claim
19 words
The microparticles of claim 27, wherein said antibody is one which responds to an enzyme antigen of claim 23.
Claim 43
Dependent Claim
18 words
The microparticles of claim 27, wherein said antibody is one which responds to a hormone of claim 24.
Claim 44
Dependent Claim
22 words
The microparticles of claim 27, wherein said antibody is one which responds to an antigen derived from the source of claim 25.
Claim 45
Dependent Claim
26 words
The microparticles of claim 27, wherein said microparticles are formulated in a composition as suppository, cream, jelly, foam or a liquid with a pharmaceutically acceptable excipient.
Claim 46
Independent Claim
59 words
A method of passively immunizing the internal female reproductive organs, comprising: depositing microparticles containing an antibody in the vagina; and allowing the natural transport mechanism of said organs to convey said microparticles across the cervix into the uterus and fallopian tubes, whereby said antibody is released by said microparticles so as to elict a passive immunization within the uterus.
Claim 47
Independent Claim
59 words
A method of passively immunizing the internal female reproductive organs, comprising: depositing microparticles containing an antibody in the vagina; and allowing the natural transport mechanism of said organs to convey said microparticles across the cervix into the uterus and fallopian tubes, whereby said antibody is released by said microparticles so as to elict a passive immunization within the uterus.
Claim 48
Dependent Claim
23 words
The method of claim 43, wherein said microparticles are of a monolithic structure in which said antibody is dispersed throughout the matrix material.
Claim 49
Dependent Claim
24 words
The method of claim 43, wherein said microparticles are of a layered structure comprising a core of said antibody surrounded by a matrix material.
Claim 50
Dependent Claim
32 words
The method of claim 43, wherein said microparticles are of a layered structure comprising a core of said antibody dispersed in a matrix material surrounded by said matrix material free of antibody.
Claim 51
Dependent Claim
18 words
The method of claim 43, wherein said microparticles are of a size ranging from 20 to 70 μm.
Claim 52
Dependent Claim
17 words
The method of claim 43, wherein said matrix material is polylactic acid, polyglycolic acid or mixtures thereof.
Claim 53
Dependent Claim
19 words
The method of claim 43, wherein said antibody is responsive to a challenge from a bacterial or viral antigen.
Claim 54
Independent Claim
82 words
A method of passively immunizing the internal female reproductive organs, comprising: depositing microparticles containing an antibody and a menstrual cycle regulatory hormone in the vagina; stimulating the natural transport mechanism of said internal reproductive organs by absorption of said hormone released from said microparticles; and allowing said transport mechanism to convey said microparticles across the cervix into the uterus and fallopian tubes by sperm surrogate forces, whereby said antibody is released from said microparticles so as to elicit immunization within the uterus.
Claim 55
Independent Claim
82 words
A method of passively immunizing the internal female reproductive organs, comprising: depositing microparticles containing an antibody and a menstrual cycle regulatory hormone in the vagina; stimulating the natural transport mechanism of said internal reproductive organs by absorption of said hormone released from said microparticles; and allowing said transport mechanism to convey said microparticles across the cervix into the uterus and fallopian tubes by sperm surrogate forces, whereby said antibody is released from said microparticles so as to elicit immunization within the uterus.
Claim 56
Dependent Claim
29 words
The method of claim 50, wherein said microparticles are of a monolithic structure in which said hormone and said antibody are dispersed throughout the matrix material of said microparticles.
Claim 57
Dependent Claim
17 words
The method of claim 50, wherein said menstrual cycle regulatory hormone is a progestin or an estrogen.
Claim 58
Dependent Claim
15 words
The method of claim 52, wherein said estrogen is estradiol and said progestin is progesterone.
Claim 59
Dependent Claim
43 words
The method of claim 50, wherein said menstrual cycle regulatory hormone and said antibody are incorporated in separate microparticle populations, said microparticles having a monolithic structure in which said antibody and said hormone are dispersed throughout the matrix material of the respective microparticles.
Claim 60
Dependent Claim
21 words
The method of claim 50, wherein said antibody is responsive to a challenge by an antigen of bacterial or viral origin.
Claim 61
Independent Claim
95 words
A method of eliciting an active immunization response of the internal female reproductive organs, comprising: depositing microparticles containing an antigen and a menstrual cycle regulatory hormone in the vagina; stimulating the natural transport mechanism of said internal reproductive organs by absorption of said hormone released from said microparticles; and allowing said transport mechanism to convey said microparticles across the cervix into the uterus and fallopian tubes by sperm surrogate forces, whereby said antigen is discharged from said microparticles by diffusion from or deterioration of said microparticles wherein an antibody response is elicited within the uterus.
Claim 62
Independent Claim
95 words
A method of eliciting an active immunization response of the internal female reproductive organs, comprising: depositing microparticles containing an antigen and a menstrual cycle regulatory hormone in the vagina; stimulating the natural transport mechanism of said internal reproductive organs by absorption of said hormone released from said microparticles; and allowing said transport mechanism to convey said microparticles across the cervix into the uterus and fallopian tubes by sperm surrogate forces, whereby said antigen is discharged from said microparticles by diffusion from or deterioration of said microparticles wherein an antibody response is elicited within the uterus.
Claim 63
Dependent Claim
29 words
The method of claim 52, wherein said microparticles are of a monolithic structure in which said hormone and said antigen are dispersed throughout the matrix material of said microparticles.
Claim 64
Dependent Claim
17 words
The method of claim 52, wherein said menstrual cycle regulatory hormone is a progestin or an estrogen.
Claim 65
Dependent Claim
15 words
The method of claim 52, wherein said estrogen is estradiol and said progestin is progesterone.
Claim 66
Dependent Claim
43 words
The method of claim 52, wherein said menstrual cycle regulatory hormone and said antigen are incorporated in separate microparticle populations, said microparticles having a monolithic structure in which said antigen and said hormone are dispersed throughout the matrix material of the respective microparticles.
Claim 67
Dependent Claim
14 words
The method of claim 56, wherein said antigen is of viral or bacterial origin.
Claim 68
Dependent Claim
34 words
The method of claim 56, wherein said antigen induces a contraceptive response by said organs and is derived from the blastocyst, the ovum, sperm, is a non-hormonal placental antigen or is a trophoblastic hormone.
References Cited (Backward Citations)
US4585651A
Cited
US4389330A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 1991-07-12 | 1992-01-11 | 1992-07-12 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1995-07-12 | 1996-01-11 | 1996-07-12 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1999-07-12 | 2000-01-11 | 2000-07-12 | $7700.00 | Window Closed / Lapsed |