Claims for Patent: 7,396,644

Summary for Patent: 7,396,644

Title:	Method of diagnosing and treating dentinogenesis imperfecta type II by using dentin sialophosphoprotein gene and coded product thereof
Abstract:	The invention has disclosed a method for diagnosis of dentinogenesis imperfecta type II (DGI-II) and/or dentinogenesis imperfecta type II with deafness (DGI-II with deafness). Said method comprises the steps of detecting the DSPP gene, transcript and/or protein in said subject and comparing it with the normal DSPP gene, transcript and/or protein to determine whether there is any variation, wherein said variation indicates that the possibility of suffering DGI-II and/or DGI-II with deafness in said subject is higher than the normal population. The present invention also discloses the method and pharmaceutical composition for treating DGI-II and/or DGI-II with deafness.
Inventor(s):	Kong; Xiangyin (Shanghai, CN), Xiao; Shangxi (Shanghai, CN), Zhao; Guoping (Shanghai, CN), Yu; Chuan (Shanghai, CN), Hu; Landian (Shanghai, CN)
Assignee:	Shanghai Institutes of Biological Science, Chinese Academy of Science (Shanghai, CN)
Application Number:	10/363,798
Patent Claims:	1. A method for determining the susceptibility of dentinogenesis imperfecta type II (DGI-II) and/or DGI-II with deafness in a human subject comprising the steps of: detecting the dentin sialophosphoprotein (DSPP) gene or transcript in said subject and comparing it with the wild-type DSPP gene or transcript thereof to determine whether there is any difference between the DSPP gene or transcript in said subject and the wild-type DSPP gene or transcript, wherein the wild-type gene comprises a nucleotide sequence of SEQ ID NO:1 and the wild-type transcript comprises nucleotides 7-98, 2359-2437, 3577-3660, 3794-4780, and 5257-8201 of SEQ ID NO: 1, wherein said difference comprises a G.fwdarw.T mutation at position 1 of Exon 3 or a G.fwdarw.A mutation at position 1 of Intron 3, and wherein said G.fwdarw.T mutation at position 1 of Exon 3 indicates an increased likelihood of suffering DGI-II in said subject and said G.fwdarw.A mutation at position 1 of Intron 3 indicates an increased likelihood of suffering DGI-II with deafness in said subject. 2. The method of claim 1 wherein the DSPP gene in said subject is detected, and compared with the nucleotide sequence of the wild-type DSPP to determine the difference. 3. A method of detecting dentinogenesis imperfecta type II (DGI-II) and/or DGI-II with deafness in a human subject, comprising: detecting a dentin sialophosphoprotein (DSPP) gene or transcript in said subject and comparing it with a wild-type DSPP gene or transcript to determine whether there is any difference between the DSPP gene or transcript in said subject and the wild-type DSPP gene or transcript, wherein the wild-type gene comprises a nucleotide sequence of SEQ ID NO: 1 and the wild-type transcript comprises nucleotides 7-98, 2359-2437, 3577-3660, 3794-4780, and 5257-8201 of SEQ ID NO: 1, wherein said difference comprises a G.fwdarw.T mutation at position 1 of Exon 3 or a G.fwdarw.A mutation at position 1 of Intron 3, and wherein said G.fwdarw.T mutation at position 1 of Exon 3 indicates DGI-II and said G.fwdarw.A mutation at position 1 of Intron 3 indicates DGI-II with deafness. 4. The method of claim 3, wherein the DSPP gene or transcript is detected with a primer or probe. 5. The method of claim 4, wherein the primer or probe detects a difference selected from the group consisting of: in position 1 of Exon 3, G1.fwdarw.T1; and in position 1 of Intron 3, G1.fwdarw.A1.

Details for Patent 7,396,644

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		2020-09-05
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2020-09-05
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2020-09-05