Biological Material That Can Be Made or Isolated Without Undue Experimentation

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USPTO MPEP › Chapter 2400 - Biotechnology › MPEP § 2404.02

This text was captured on Aug 14, 2026. It is a snapshot, not a live feed, so check the official code before relying on it.

Text

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).

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

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