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35 USC § 101 Utility Guidelines - Training Manual

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과학기술과 인문사회

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2095/08/22


The U.S. Patent and Trademark Office(PTO) has set forth a workable outline for analyzing applications for compliance with the written description requirements. There appear to be significant deficiencies, however, in analyzing the proper relationship of the preamble, transition phrase, and claim body to determinations of genus versus species claims. This determination is particularly critical to the application of the open-ended transition phrase "comprising" to claims involving nucleic acids and amino acids. A number of examples are presented to clarify this relationship. Due to the highly controversial nature of Expressed Sequence Tag(EST) applications related to its potentially devastating impact on the biotechnology community and the relevancy of these written description considerations to the patentability of EST claims employing "comprising" language, the NIH requests that this issue be addressed specifically in the final guidelines.
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