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Last Updated: March 29, 2024

Claims for Patent: 5,998,141


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Summary for Patent: 5,998,141
Title: Intronic and polymorphic SR-BI nucleic acids and uses therefor
Abstract:The present invention is based at least in part on the discovery of the genomic structure of the human SR-BI gene and on the identification of polymorphic regions within the gene. Accordingly, the invention provides nucleic acids having a nucleotide sequence of an allelic variant of an SR-BI gene and nucleic acids having an SR-BI intronic sequence. The invention also provides methods for identifying specific alleles of polymorphic regions of an SR-BI gene, methods for determining whether a subject has or is at risk of developing a disease which is associated with a specific allele of a polymorphic region of an SR-BI gene, and kits for performing such methods.
Inventor(s): Acton; Susan Laurene (Lexington, MA)
Assignee: Millennium Pharmaceuticals, Inc. (Cambridge, MA)
Application Number:08/890,980
Patent Claims:1. An isolated nucleic acid comprising an intronic sequence of an SR-BI gene as shown in FIG. 2 or any of SEQ ID Nos. 5-16 and 18-40.

2. An isolated nucleic acid of claim 1 comprising an intron/exon border.

3. An isolated nucleic acid, which is capable of hybridizing under a stringency of 0.2.times. sodium chloride sodium citrate (SSC) at 50.degree. C., followed by a wash of 2.0.times. SSC at 50.degree. C. to an intronic sequence of the nucleic acid of claim 1.

4. An isolated nucleic acid of claim 1, further comprising at least a portion of an exon.

5. An isolated nucleic acid of claim 1, comprising from about 15 to about 30 nucleotides.

6. An isolated nucleic acid of claim 1, comprising at least about 31 nucleotides.

7. An isolated nucleic acid of claim 5, comprising a nucleotide sequence selected from the group consisting of SEQ ID NO. 41 to SEQ ID NO. 64, SEQ ID NO. 83, and SEQ ID NO.84.

8. An isolated nucleic acid of claim 1, which is single stranded.

9. An isolated nucleic acid of claim 1, which further comprises a label.

10. An isolated nucleic acid, comprising an allelic variant of a polymorphic region of an SR-BI gene, which allelic variant differs from the allelic variant set forth in SEQ ID NO. 1 or 3.

11. An isolated nucleic acid of claim 10, wherein the polymorphic region is located in an exon.

12. An isolated nucleic acid of claim 11, wherein the exon is exon 8.

13. An isolated nucleic acid of claim 12, wherein the allelic variant comprises a nucleotide sequence set forth in SEQ ID NO. 65.

14. An isolated nucleic acid of claim 10, wherein the polymorphic region is located in an intron.

15. An isolated nucleic acid of claim 14, wherein the intron is intron 5.

16. An isolated nucleic acid of claim 15, wherein the allelic variant comprises a nucleotide sequence set forth in SEQ ID NO. 66.

17. An isolated intronic nucleic acid sequence of a genomic DNA sequence comprising an SR-BI gene, wherein the intronic nucleic acid sequence comprises a nucleotide sequence of any of SEQ ID NO. 18-40.

18. A kit for amplifying and/or for determining the molecular structure of, at least a portion of an SR-BI gene, comprising a probe or primer which is capable of hybridizing to an SR-BI intronic sequence as shown in FIG. 2 or any of SEQ ID Nos. 5-16 and 18-40 and instructions for use.

19. A kit of claim 18, wherein the probe or primer is capable of hybridizing to a nucleic acid comprising an intron/exon border of an SR-BI gene as shown in FIG. 2 or any of SEQ ID Nos. 5-16 and 18-40.

20. A kit of claim 18, wherein the probe or primer is capable of hybridizing to an allelic variant of a polymorphic region of an SR-BI gene, and wherein the allelic variant differs from the allelic variant set forth in SEQ ID NO. 1 or 3.

21. A kit of claim 20, wherein the polymorphic region is located in an exon.

22. A kit of claim 21, wherein the exon is exon 8.

23. A kit of claim 22, wherein the allelic variant of a polymorphic region has a nucleotide sequence set forth in SEQ ID NO. 65.

24. A kit of claim 20, wherein the polymorphic region is located in an intron.

25. A kit of claim 24, wherein the intron is intron 5.

26. A kit of claim 25, wherein the allelic variant of a polymorphic region has a nucleotide sequence set forth in SEQ ID NO. 66.

27. A kit of claim 18, further comprising a second probe or primer.

28. A kit of claim 18, wherein the probe or primer has a nucleotide sequence from about 15 to about 30 nucleotides.

29. A kit of claim 28, wherein the probe or primer comprises a nucleotide sequence selected from the group consisting of nucleic acids having a nucleotide sequence set forth in SEQ ID Nos. 41-64, SEQ ID Nos. 67-82, and SEQ ID Nos 83-84.

30. A kit of claim 29, wherein the kit has two primers selected from the group consisting of nucleic acids having a nucleotide sequence set forth in SEQ ID Nos. 41-64 and SEQ ID Nos. 83-84.

31. A kit of claim 18, wherein the probe or primer is a single stranded nucleic acid.

32. A kit of claim 18, wherein the probe or primer is labeled.

33. A method for determining the identity of an allele of a human SR-BI gene in a nucleic acid obtained from a subject, comprising contacting a sample nucleic acid comprising the allele with a probe or primer having a sequence which is complementary to a human SR-BI gene sequence, to thereby determine the identity of the allele, wherein the probe or primer is capable of hybridizing to an SR-BI intron as shown in FIG. 2 or any of SEQ ID Nos. 5-16 and 18-40.

34. A method of claim 33, wherein the probe or primer is capable of hybridizing to an allelic variant of a polymorphic region, and wherein the allelic variant differs from the allelic variant set forth in SEQ ID NO. 1 or 3.

35. A method of claim 33, wherein determining the the identity of the allele comprises determining the identity of at least one nucleotide of a polymorphic region.

36. A method of claim 33, wherein determining the identity of the allele consists of determining the nucleotide content of a polymorphic region.

37. A method of claim 36, wherein determining the nucleotide content comprises sequencing the nucleotide sequence.

38. A method of claim 33, wherein determining the identity of the allele comprises performing a restriction enzyme site analysis.

39. A method of claim 33, wherein determining the identity of the allele is carried out by single-stranded conformation polymorphism.

40. A method of claim 33, wherein determining the identity of the allele is carried out by allele specific hybridization.

41. A method of claim 33, wherein determining the identity of the allele is carried out by primer specific extension.

42. A method of claim 33, wherein determining the identity of the allele is carried out by an oligonucleotide ligation assay.

43. A method of claim 33, wherein the probe or primer has a nucleotide sequence from about 15 to about 30 nucleotides.

44. A method of claim 43, wherein the probe or primer is selected from the group consisting of nucleic acids having a nucleotide sequence set forth in SEQ ID Nos. 41-65.

45. A method of claim 44, wherein the method comprises hybridizing the sample nucleic acid with two primers selected from the group consisting of nucleic acids having a nucleotide sequence set forth in SEQ ID Nos. 41-64 and SEQ ID Nos. 83-84.

46. A method of claim 33, wherein the probe or primer is a single stranded nucleic acid.

47. A method of claim 33, wherein the probe or primer is labeled.

48. A method of claim 33, wherein the probe or primer is capable of hybridizing to an intron/exon border of an SR-BI gene.

49. A method for selecting the appropriate drug to administer to an individual having a disease or condition which is associated with a specific allele of an SR-=BI gene, comprising determining whether the specific allele is present in a nucleic acid sample of the individual and selecting the appropriate drug if the specific allele is present.

50. A method of claim 49, wherein the disease or condition is abnormal lipid metabolism, inappropriate lipid levels, a cardiovascular disease, atherosclerosis) gallstone formation, or an abnormal body mass index.

51. A method of claim 49, wherein the allele contains a thymidine at position 41 of exon 8 as shown in SEQ ID No. 65.

52. A method of claim 49, wherein the allele contains a thymidine at position 54 of intron 5 as shown in SEQ ID No. 66.

Details for Patent 5,998,141

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Corp. INTRON A interferon alfa-2b For Injection 103132 06/04/1986 ⤷  Try a Trial 2039-02-26
Merck Sharp & Dohme Corp. INTRON A interferon alfa-2b For Injection 103132 ⤷  Try a Trial 2039-02-26
Merck Sharp & Dohme Corp. INTRON A interferon alfa-2b Injection 103132 ⤷  Try a Trial 2039-02-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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