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Comparisons with Chinese Practice. 1993/2001 Examination Guidelines – 4.1, Chapter 10 of Part 2 (“Sufficiency of Disclosure”) For an application for a chemical product invention, the use and technical effect of the product shall be sufficiently disclosed. 2006/2010
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Comparisons with Chinese Practice • 1993/2001 Examination Guidelines – 4.1, Chapter 10 of Part 2 (“Sufficiency of Disclosure”) • For an application for a chemical product invention, the use and technical effect of the product shall be sufficiently disclosed. • 2006/2010 • For an application for a chemical product invention, the use and/or technical effect of the product shall be completely disclosed. • US (1991) • “there must be sufficient disclosure, either through illustrative examples or terminology, to teach those of ordinary skill how to make and use the invention as broadly as it is claimed.” (In Re Vaeck, 1991)
中国及中美专利审查指南比较分析 • 1993/2001 审查指南– 第二部分第十章4.1 节 (“公开的充分性”) • 化学产品发明的专利申请,应充分披露该产品的使用方法和技术效果。 • 2006/2010 • 化学产品发明的专利申请,应完整的披露该产品的使用方法和/或技术效果。 • 美国(1991) • “[说明书]应通过示范性实施例或专业语言充分披露指导普通技术人员如何制造和使用该宽泛的权利要求所涵盖的发明.” (In Re Vaeck, 1991)
Comparisons with Chinese Practice • For a new pharmaceutical compound… • 1993 - The effective amount, method of application or method of formulation shall be described to such an extent that a person skilled in the art can carry it out. • 2001/2006/2010: There should be qualitative or quantitative laboratory test data (including animal test) or clinical test sufficient to prove that the technical solution can achieve the forecasted technical solution or effect. • US/1991: There must be sufficient disclosure, either through illustrative examples or terminology, to teach those of ordinary skill how to make and how to use the invention as broadly as it is claimed. In Re Vaeck (1991).
中国及中美专利审查指南比较分析 • 对于一个新药品化合物… • 1993 – 对有效剂量,施用方法或剂型配方法应描述得使相关技术人员能使用。 • 2001/2006/2010: 应有充分的定性或定量的实验室试验数据(包括动物试验)或临床试验来证实技术解决方案能达到预期的结果或效果。 • 美国(1991) • “[说明书]应通过示范性实施例或专业语言充分披露指导普通技术人员如何制造和使用该宽泛的权利要求所涵盖的发明.” (In Re Vaeck, 1991)
Comparisons with Chinese Practice • 1993: Prerequisite for supplementing use and effect after the filing date [is]…it must be a use or effect that has been implied in the original specification so that a person skilled in the art is able to deduce directly; or it is use that can be deduced directly from the prior art. • 2001: Prerequisite for supplementing use and effect after the filing date [is]…it must be a use or effect that has been implied in the original specification so that a person skilled in the art is able to deduce directly; or it is use that cane be deduced directly from the prior art. • Any embodiment submitted after the filing date can only be used as a reference by the examiner for assessing novelty, inventiveness, and practical applicability. • 2006/2010: Embodiment and experimental data submitted after the filing date shall not be taken into consideration. • US/1971 Post-filing evidence "can be used to substantiate any doubts as to the asserted utility since this pertains to the accuracy of a statement already in the specification." In re Marzocchi (CCPA 1971)
中国及中美专利审查指南比较分析 • 1993: 在申请日之后递交方法和效果的补充说明的前提是该方法和效果已隐含于原始说明中使得本领域技术人员能直接实施;或者该使用能直接根据先有技术而实施。 • 2001:在申请日之后递交方法和效果的补充说明的前提是该方法和效果已隐含于原始说明中使得本领域技术人员能直接实施;或者该使用能直接根据先有技术而实施。 • 2001:任何在申请日之后递交的披露内容只能用于参考材料使检察员能评估[所称发明的]新颖性,创造性和实用性 • 2006/2010:任何在申请日之后递交的披露内容和试验数据不应予以考虑。 • 美国(1971 ) • 申请日之后提交的证据“可用于消除对说明书中所陈述的实用性之疑问”In re Marzocchi (CCPA 1971)