US7879612中Claim 1:
A method for preserving the activity of one or more biologically active molecules in a dried and reconstituted state, comprising: a) depositing the one or more biologically active molecules onto a surface; b) depositing one or more non-sugar organic compatible solutes onto the surface, wherein said one or more non-sugar organic compatible solutes are each selected from the group consisting of: glycine, alanine, serine, proline, sodium glutamate, lysine, aminobutric acid, taurine, amines, betaine, sarcosine, trimethylamine N-oxide, 2-Naphthol, ectoine, hydroxyectoine, glycerine, deoxyribonucleic acid, adenosine monophosphate, PCR primers, spermine, spermidine, polyethyleneimine, polyhystidine, polythymadilic acid, acetyl-L-camitine, and L-citruline; and c) drying the deposited one or more biologically active molecules and the deposited one or more non-sugar organic compatible solutes on the surface, wherein the one or more non-sugar organic compatible solutes preserves the activity of the one or more biologically active molecules in the dried and reconstituted state.
其中说明书中指出,不论是deposit the one or more biologically active molecules 还是one or more non-sugar organic compatible solutes onto the surface,没有先后顺序,可以同时,也可以有先后次序。只是说明书中都是讲都是免疫检测,用抗体在免疫层析测试纸上检测样品中待测物质,且说明书中指出biologically active molecules “refers to any active organic molecule that is part of a living organism, which may be natural, synthetic, or a combination thereof.” 因此按照这种解释,biologically active molecules 应该包括酶,抗体等蛋白质,但说明书中只提及抗体,比如单克隆抗体,多克隆抗体,以及抗体片段,没有提及酶。但是如果,在电化学酶检测的生物传感器中使用了酶和Claim 1列举的one or more biologically active molecule,比如ectoine,起着稳定酶的作用,保持酶在干燥时的活性。两者属于不同的领域,一个是免疫检测领域,一个是电化学酶检测生物传感器领域,是否依然落入US7879612中的Claim 1的保护范围。当然如果按照字面理解,one or more biologically active molecule,比如ectoine,起着稳定酶的作用,而酶的确是一种biologically active molecule,也符合说明书中给出的定义和业界共识。有点迷茫,请大家给点建议啊。 |
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