Top of Notices Top of Notices   (207)  December 26, 2023 US PATENT AND TRADEMARK OFFICE Print This Notice 1517 CNOG  736 

Biotechnology Referenced Items (206, 207, 208, 209, 210, 211, 212)
(207)    Changes to Requirements for Seed Deposits at American Type Culture
          Collection and Advanced Notice of Change to Manual of
                        Patent Examining Procedure

   Biological material that may be deposited for purposes of utility
applications under 35 U.S.C. § 101 includes plant seeds. Even though the
deposit of biological material is not applicable to patent applications
submitted under the Plant Patent Act (35 U.S.C. §§ 161-164), utility
applications directed to plants must meet the requirements of
35 U.S.C. § 112. In order to ensure compliance with 35 U.S.C. § 112 for
patents for utility plant inventions, the deposit of inventive seeds may
supplement the disclosure in the specification to provide an adequate
written description of the invention and to enable those skilled in the art
to make and use the claimed invention. A deposit must comply with the
biological deposit rules (37 CFR 1.801 through 1.809) to be relied upon to
meet the requirements of 35 U.S.C. § 112.

   Currently, there are seven Budapest Treaty International Depositary
Authorities (IDAs) that accept seeds for deposit. Of those seven, the
American Type Culture Collection (ATCC), which is one of the largest IDAs,
has recently updated its requirements regarding the number of seeds for

   In the past, ATCC required 2,500 seeds for deposit. These 2,500 seeds
were to be packaged in 25 packets of 100 seeds. Distribution analysis of
deposited seeds to requesters by ATCC revealed that, at most, four seed
packets had been requested of any seed deposit. Most common requests
involved one or two packets of seeds. As a result, effective January 1,
2019, ATCC reduced the number of seeds required for patent seed deposits to
25 packets of 25 seeds for deposit, for a total of 625 seeds.

   The biological deposit rules require that should there be requests that
exceed the availability of a deposited material, the depositor must replace
or supplement the deposited material. Additionally, should the biological
deposit no longer be viable or become contaminated, the depositor would be
required to supplement or replace the biological deposit. A depositor's
failure to replace a deposit causes the application or patent involved to
be treated in any Office proceeding as if no deposit were made. See
37 CFR 1.805.

   With these safeguards already in place as per the biological deposit
rules, and because the biological deposit rules do not require a minimum
number of seeds, the USPTO is amending the Manual of Patent Examining
Procedure at § 2403.02 to indicate that so long as the number of seeds
deposited complies with the requirements of the IDA where the deposit is
made, the USPTO would consider such a compliant submission as satisfying
the rules under 37 CFR 1.801 through 1.809. It should be noted, however,
that although a deposit of 625 seeds is compliant for submission to ATCC,
other IDAs may have different minimum requirements. Accordingly, any
depositor should confirm that the number submitted to a specific IDA
complies with that IDA's requirements for seed deposits.

   Questions about this announcement may be directed to Mary C. Till,
Senior Legal Advisor, Office of Patent Legal Administration, 571-272-7755.
Comments may be directed to the Patent Practice mailbox at Electronic mailbox inquiries typically are
returned within one business day.

March 1, 2019                                                  ANDREI IANCU
                  Under Secretary of Commerce for Intellectual Property and
                  Director of the United States Patent and Trademark Office

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