MPEP Section 2434, Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences

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This document contains Section 2434 ("Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences") 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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2434 Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences

The U.S. Patent and Trademark Office published its policy for the examination of patent applications that claim large numbers of nucleotide sequences in the Official Gazette, 1192 O.G. 68 (November 19, 1996). Nucleotide sequences encoding different proteins are structurally distinct chemical compounds and are unrelated to one another. These sequences are thus deemed to normally constitute independent and distinct inventions within the meaning of 35 U.S.C. 121. Absent evidence to the contrary, each such nucleotide sequence is presumed to represent an independent and distinct invention, subject to a restriction requirement pursuant to 35 U.S.C. 121 and 37 CFR 1.141. In establishing the new policy, the Commissioner has partially waived the requirements of 37 CFR 1.141 and will permit a reasonable number of such nucleotide sequences to be claimed in a single application. Under this policy, in most cases, up to 10 independent and distinct nucleotide sequences will be examined in a single application without restriction.Those sequences which are patentably indistinct from the sequences selected by the applicant will also be examined. Nucleotide sequences encoding the same protein are not considered to be independent and distinct and will continue to be examined together. In some exceptional cases, the complex nature of the claimed material may necessitate that the reasonable number of sequences to be selected be less than 10. In other cases, applicants may petition pursuant to 37 CFR 1.181 for examination of additional nucleotide sequences by providing evidence that the different nucleotide sequences do not cover independent and distinct inventions. For examples of typical nucleotide sequence claims and additional information on the search and examination procedures, see the above cited O.G. Notice. See also MPEP § 803.04.