US4556558A
Expired / Lapsed
US
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Treatment of factor VIII concentrate to minimize the affect of undesirable microorganisms
Assignee: Cedars-Sinai Medical Center
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Filing: 1984-06-26
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Granted: 1985-12-03
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Expires: 2004-06-26
Abstract
Abstract The invention is directed to treating blood clotting Factor VIII products to minimize the presence of undesirable microorganisms involving process steps of drying and heating of the product. In addition the invention is directed to products obtained by the process.
Inventors
- 👤 Alan Rubinstein
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-05 10:01
CPC Classifications
C; C12; C12N; C12N9/00; C12N9/14; C12N9/48; C12N9/50; C12N9/64; C12N9/6421; C12N9/6424; C12N9/644; A; A61; A61L; A61L2/00; A61L2/02; A61L2/04; C07; C07K; C07K14/00; C07K14/435; C07K14/745; C07K14/755; C12Y; C12Y304/00; C12Y304/21; C12Y304/21022; A61L2103/00; A61L2103/05; A61L2103/09
Claims Analysis
Total Claims: 19
Claim 1
Independent Claim
96 words
A method of treating human blood clotting Factor VIII concentrate in order to minimize the effect of undesirable virus microorganisms present in said human blood clotting Factor VIII concentrate, said method comprising the steps of: lyophilizing said human blood clotting Factor VIII concentrate; heating said lyophilized human blood clotting Factor VIII concentrate at a predetermined temperature of at least about 60° C. for a period of time sufficient to minimize the effect of any undesirable virus microorganisms present in said human blood clotting Factor VIII concentrate, said heating generally decreasing as said predetermined temperature is increased.
Claim 2
Independent Claim
96 words
A method of treating human blood clotting Factor VIII concentrate in order to minimize the effect of undesirable virus microorganisms present in said human blood clotting Factor VIII concentrate, said method comprising the steps of: lyophilizing said human blood clotting Factor VIII concentrate; heating said lyophilized human blood clotting Factor VIII concentrate at a predetermined temperature of at least about 60° C. for a period of time sufficient to minimize the effect of any undesirable virus microorganisms present in said human blood clotting Factor VIII concentrate, said heating generally decreasing as said predetermined temperature is increased.
Claim 3
Dependent Claim
19 words
The method claimed in claim 1 wherein said predetermined temperature is between about 60° C. and about 100° C.
Claim 4
Dependent Claim
19 words
The method claimed in claim 1 wherein said predetermined temperature is between about 100° C. and about 125° C.
Claim 5
Independent Claim
96 words
A method of treating human blood clotting Factor VIII concentrate in order to minimize the effect of undesirable virus microorganisms present in said human blood clotting Factor VIII concentrate, said method comprising the steps of: dehydrating said human blood clotting Factor VIII concentrate; heating said dehydrated human blood clotting Factor VIII concentrate at a predetermined temperature of at least about 60° C. for a period of time sufficient to minimize the effect of any undesirable virus microorganisms present in said human blood clotting Factor VIII concentrate, said heating generally decreasing as said predetermined temperature is increased.
Claim 6
Independent Claim
96 words
A method of treating human blood clotting Factor VIII concentrate in order to minimize the effect of undesirable virus microorganisms present in said human blood clotting Factor VIII concentrate, said method comprising the steps of: dehydrating said human blood clotting Factor VIII concentrate; heating said dehydrated human blood clotting Factor VIII concentrate at a predetermined temperature of at least about 60° C. for a period of time sufficient to minimize the effect of any undesirable virus microorganisms present in said human blood clotting Factor VIII concentrate, said heating generally decreasing as said predetermined temperature is increased.
Claim 7
Independent Claim
84 words
A method of treating human blood clotting Factor VIII concentrate in order to minimize the effect of AIDS virus microorganisms present in said blood clotting Factor VIII concentrate, said method comprising the steps of: lyophilizing said blood clotting Factor VIII concentrate; heating said blood clotting Factor VIII concentrate for a predetermined period of time at a predetermined temperature of at least about 60° to inactivate AIDS microorganisms in said blood clotting Factor VIII concentrate said heating time generally decreasing as said temperature is increased.
Claim 8
Independent Claim
84 words
A method of treating human blood clotting Factor VIII concentrate in order to minimize the effect of AIDS virus microorganisms present in said blood clotting Factor VIII concentrate, said method comprising the steps of: lyophilizing said blood clotting Factor VIII concentrate; heating said blood clotting Factor VIII concentrate for a predetermined period of time at a predetermined temperature of at least about 60° to inactivate AIDS microorganisms in said blood clotting Factor VIII concentrate said heating time generally decreasing as said temperature is increased.
Claim 9
Independent Claim
85 words
A method of treating human blood clotting Factor VIII concentrate in order to minimize the effect of CMV virus microorganisms present in said blood clotting Factor VIII concentrate, said method comprising the steps of: lyophilizing said blood clotting Factor VIII concentrate; heating said blood clotting Factor VIII concentrate for a predetermined period of time at a predetermined temperature of at least about 60° C. to inactivate CMV microorganisms in said blood clotting Factor VIII concentrate, said heating time generally decreasing as said temperature is increased.
Claim 10
Independent Claim
85 words
A method of treating human blood clotting Factor VIII concentrate in order to minimize the effect of CMV virus microorganisms present in said blood clotting Factor VIII concentrate, said method comprising the steps of: lyophilizing said blood clotting Factor VIII concentrate; heating said blood clotting Factor VIII concentrate for a predetermined period of time at a predetermined temperature of at least about 60° C. to inactivate CMV microorganisms in said blood clotting Factor VIII concentrate, said heating time generally decreasing as said temperature is increased.
Claim 11
Independent Claim
85 words
A method of treating human blood clotting Factor VIII concentrate in order to minimize the effect of Epstein-Barr virus microorganisms present in said blood clotting Factor VIII concentrate, said method comprising the steps of: lyophilizing said blood clotting Factor VIII concentrate; heating said blood clotting Factor VIII concentrate for a predetermined period of time at a predetermined temperature of at least about 60° C. to inactivate Epstein-Barr microorganisms in said blood clotting Factor VIII concentrate, said heating time generally decreasing as said temperature is increased.
Claim 12
Independent Claim
85 words
A method of treating human blood clotting Factor VIII concentrate in order to minimize the effect of Epstein-Barr virus microorganisms present in said blood clotting Factor VIII concentrate, said method comprising the steps of: lyophilizing said blood clotting Factor VIII concentrate; heating said blood clotting Factor VIII concentrate for a predetermined period of time at a predetermined temperature of at least about 60° C. to inactivate Epstein-Barr microorganisms in said blood clotting Factor VIII concentrate, said heating time generally decreasing as said temperature is increased.
Claim 13
Independent Claim
133 words
A method of treating blood clotting Factor VIII concentrate in order to minimize the effect of undesirable virus microorganisms present in said blood clotting Factor VIII concentrate, said method comprising the steps of: lyophilizing said blood clotting Factor VIII concentrate; heating said blood clotting Factor VIII concentrate for a predetermined period of time at a predetermined temperature of at least about 60° C. to inactivate any undesirable microorganisms in said blood clotting Factor VIII concentrate, said heating time generally decreasing as said temperature is increased; and reconstituting the heated lyophilized blood clotting Factor VIII by increasing the moisture content thereof to a predetermined level irrespective of the amount of moisture removed when lyophilizing the blood clotting Factor VIII, said predetermined level being sufficient to completely solubilize the heated, lyophilized blood clotting Factor VIII.
Claim 14
Independent Claim
133 words
A method of treating blood clotting Factor VIII concentrate in order to minimize the effect of undesirable virus microorganisms present in said blood clotting Factor VIII concentrate, said method comprising the steps of: lyophilizing said blood clotting Factor VIII concentrate; heating said blood clotting Factor VIII concentrate for a predetermined period of time at a predetermined temperature of at least about 60° C. to inactivate any undesirable microorganisms in said blood clotting Factor VIII concentrate, said heating time generally decreasing as said temperature is increased; and reconstituting the heated lyophilized blood clotting Factor VIII by increasing the moisture content thereof to a predetermined level irrespective of the amount of moisture removed when lyophilizing the blood clotting Factor VIII, said predetermined level being sufficient to completely solubilize the heated, lyophilized blood clotting Factor VIII.
Claim 15
Dependent Claim
61 words
A human blood clotting Factor VIII concentrate, said human blood clotting Factor VIII concentrate having been treated to minimize the effect of undesirable virus microorganisms by lyophilizing said human blood clotting Factor VIII concentrate followed by heating at a predetermined temperature of at least about 60° C. for a period time sufficient to minimize the effect of any undesirable virus microorganisms.
Claim 16
Dependent Claim
61 words
A human blood clotting Factor VIII concentrate, said human blood clotting Factor VIII concentrate having been treated to minimize the effect of undesirable virus microorganisms by lyophilizing said human blood clotting Factor VIII concentrate followed by heating at a predetermined temperature of at least about 60° C. for a period time sufficient to minimize the effect of any undesirable virus microorganisms.
Claim 17
Dependent Claim
22 words
The human blood clotting Factor VIII concentrate claimed in claim 9 wherein said undesirable virus microorganisms are further defined as AIDS virus.
Claim 18
Dependent Claim
22 words
The human blood clotting Factor VIII concentrate claimed in claim 9 wherein said undesirable virus microorganisms are further defined as CMV virus.
Claim 19
Dependent Claim
22 words
The human blood clotting Factor VIII concentrate claimed in claim 9 wherein said undesirable virus microorganisms are further defined as Epstein-Barr virus.
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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) | 1988-12-02 | 1989-06-03 | 1989-12-03 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1992-12-02 | 1993-06-03 | 1993-12-03 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1996-12-02 | 1997-06-03 | 1997-12-03 | $7700.00 | Window Closed / Lapsed |