2410.01 Conditions of Deposit [R-07.2015]

37 CFR 1.808 requires that the deposit of biological material be made under two conditions:

• (A) access to the deposit will be available during pendency of the patent application making reference to the deposit to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C. 122, and
• (B) with one exception, that all restrictions imposed by the depositor on the availability to the public of the deposited biological material be irrevocably removed upon the granting of the patent.

The one exception that is permitted is specified in 37 CFR 1.808(b) which permits the depositor to contract with the depository to require that samples of a deposited biological material shall be furnished only if a request for a sample, during the term of the patent, meets any one or all of the three conditions specified in this paragraph. These conditions are:

• (A) the request is in writing or other tangible form and dated; and/or
• (B) the request contains the name and address of the requesting party and the accession number of the deposit; and/or
• (C) the request is communicated in writing by the depository to the depositor along with the date on which the sample was furnished and the name and address of the party to whom the sample was furnished.

It should be noted that this exception to the general rule that all restrictions will be removed must be strictly followed and that no variations of this explicit exception will be accepted as meeting the conditions of this section. Although this exception is consistent with the provisions in the Budapest Treaty and its implementing regulations (Rule 11.4), other conditions on accessibility are permitted under the Budapest Treaty as prescribed by national law. Consequently, the mere indication that a deposit has been made and accepted under conditions prescribed by the Budapest Treaty would satisfy all conditions of these regulations except the requirement that all restrictions on access be removed on grant of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).

2410.02 Certification of Statement of Availability of Deposit [R-01.2024]

Since the mere description of a deposit or identity of a deposit in a patent specification is not necessarily an indication that a requirement for deposit was made or that a deposit which complies with these rules has been made, accessibility to a deposited material referenced in a patent may depend on the satisfaction of conditions not apparent on the face of the patent. For these reasons, and upon request made to the U.S. Patent and Trademark Office, the Office will certify whether a deposit has been stated to have been made under conditions which make it available to the public as of the issue date of the patent grant provided the request is made to a Director of Technology Center (TC) 1600, and contains the following information:

• (A) the name and address of the depository;
• (B) the accession number given to the deposit;
• (C) the patent number and issue date of the patent referring to the deposit; and
• (D) the name and address of the requesting party.

Persons requesting a certificate of statement of availability of deposit should contact the TC 1600 Director's office directly, and should not submit a request via the examiner of record.

The Office will not certify whether a deposit has been made under conditions which would make it available to the public until the issuance of a U.S. Patent referencing the deposit. For example, a request for such certification will not be considered where the request is filed with regard to a deposit referenced in an international application filed under the PCT, in an international application that entered the U.S. national stage, or any other U.S. national application, that has not yet issued as a patent.

See also MPEP § 2404.01.

For those deposits made pursuant to the Budapest Treaty, the World Intellectual Property Organization provides a form (Form BP-12) for requesting a certification of legal entitlement to receive samples of deposited microorganisms pursuant to Rule 11.3(a) of the Regulations under the Budapest Treaty. The form is available at www.wipo.int/budapest/en/guide/.