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

This is the Ninth Edition of the MPEP, Revision 08.2017, Last Revised in Januay 2018

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2404.02    Biological Material That Can Be Made or Isolated Without Undue Experimentation [R-08.2012]

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).