MPEP Section 2404.02, Biological Material That Can Be Made or Isolated Without Undue Experimentation

Executive summary:

This document contains Section 2404.02 ("Biological Material That Can Be Made or Isolated Without Undue Experimentation") of the Manual of Patent Examining Procedure (the "M.P.E.P."), Eighth Edition, Eighth Revision (July 2010). This page was last updated in January 2011. You may return to the section index to find a particular section. Alternatively, you may search the MPEP using the search box that appears on the left side of every page of BitLaw--you may restrict your search to the MPEP on the search results page.

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2404.02 Biological Material That Can Be Made or Isolated Without Undue Experimentation

Applicant may show that a deposit is not necessary even though specific biological materials are required to practice the invention if those biological materials can be made or isolated without undue experimentation. Deposits may be required to support the claims if an isolation procedure requires undue experimentation to obtain the desired biological material. Ex Parte Jackson, 217 USPQ 804 (Bd. App. 1982). No deposit is required, however, where the required biological materials can be obtained from publicly available material with only routine experimentation and a reliable screening test. Tabuchi v. Nubel, 559 F.2d 1183, 194 USPQ 521 (CCPA 1977); Ex Parte Hata, 6 USPQ2d 1652 (Bd. Pat. App. & Int. 1987).