2407.01 In a Pending Application [R-07.2015]

Pursuant to 37 CFR 1.805(a), an applicant is required to notify the Office when it obtains information that the depository possessing a deposit referenced in an application cannot furnish samples of the deposit. When the Office is so informed or otherwise becomes aware that samples of the deposited material cannot be furnished by the depository, the examiner will treat the application as if no deposit existed. A replacement or supplemental deposit must be made if access to the deposited material is necessary to satisfy the requirements for patentability under 35 U.S.C. 112. A replacement or supplemental deposit will be accepted if it meets all the requirements for making an original deposit.

It should be noted that in a pending application, an applicant need not replace the identical material previously deposited, but may make an original deposit of a biological material which is specifically identified and described in the application as filed. Whether this alternative deposit will meet the requirements of 35 U.S.C. 112 with respect to the claimed subject matter must be resolved by the examiner on a case-by-case basis. The conditions in 37 CFR 1.802(b) and 37 CFR 1.804(b) must be satisfied.

2407.02 After a Patent Has Issued [R-07.2015]

A patent owner is required to notify the Office when it obtains information that a depository possessing a deposit referenced in a patent cannot furnish samples of the deposit. Failure to diligently replace the deposit and promptly thereafter request a certificate of correction which meets the terms of 37 CFR 1.805(b) and 37 CFR 1.805(c) will cause the patent involved to be treated in any Office proceeding as if no deposit were made.

A replacement or supplemental deposit made in connection with a patent, whether or not made during the pendency of an application for reissue patent or a reexamination proceeding or both, shall not be accepted unless a certificate of correction under 37 CFR 1.323 is requested which meets the terms of 37 CFR 1.805(b) and 37 CFR 1.805(c) for replacement or supplemental deposits. See MPEP § 1411.01 for including changes that were made by a certificate of correction to the original patent grant in a reissue application, and MPEP § 2219 for including a copy of any certificate of correction to the original patent grant as part of a request for ex parte reexamination.

37 CFR 1.805(b) and 37 CFR 1.805(c) specify the procedures that a patent owner may follow to ensure that a patent contains the appropriate information about a deposited biological material in the event that a replacement or supplemental deposit is made after the patent is granted. 37 CFR 1.805(b) describes the information which must be contained in the certificate of correction, whereas 37 CFR 1.805(c) describes the information which must be provided in the request to make the correction.

A request for a certificate of correction of a patent under 37 CFR 1.805(b) and 37 CFR 1.805(c) will not be granted where no original deposit was made before or during the pendency of the application which matured into the patent. A patent defective because of lack of a necessary deposit is necessarily fatally defective for failure to comply with the first paragraph of 35 U.S.C. 112. Reissue is not available in such cases. See In re Hay, 534 F.2d 917, 189 USPQ 790 (CCPA 1976).

2407.03 Failure to Replace [R-08.2012]

37 CFR 1.805(d) sets forth the Office position that the failure to make a replacement deposit in a case pending before the Office, for example a reissue or reexamination proceeding, where a deposit is considered to be necessary to satisfy the requirements of 35 U.S.C. 112, shall cause the application or patent involved to be treated in any Office proceeding as if no deposit were made. The provisions of 37 CFR 1.805(g) indicate that a replacement need not be made where, at the point in time when replacement would otherwise be necessary, access to the necessary biological material was otherwise available. For example, a replacement deposit would not be required under the circumstances where access to the necessary biological material was established through commercial suppliers.

2407.04 Treatment of Replacement [R-08.2012]

37 CFR 1.805(e) indicates that the Office will apply a rebuttable presumption of identity between the replacement deposit and an original deposit where a patent making reference to the deposit is relied on during any Office proceeding. This means that where a replacement deposit is permitted and made, the examiner will assume that the same material as described in the patent is accessible from the identified depository unless evidence to the contrary comes to the attention of the Office.

An applicant for patent may make a replacement deposit during the pendency of the application for any reason. The provisions of 37 CFR 1.805(f) recognize that since an original deposit may be made during the pendency of the application subject to the conditions of 37 CFR 1.809, a replacement deposit logically cannot be held to any higher standard or any further requirements.

2407.05 Exemption From Replacement [R-08.2012]

The provisions of 37 CFR 1.805(h) indicate that a replacement deposit is not required even though the depository cannot furnish samples, under certain conditions, to those requesting a sample outside of the jurisdiction where the depository is located. The conditions are specified in this paragraph as being limited to national security, health or environmental safety reasons. See also Article 5 of the Budapest Treaty.

2407.06 Replacement May Not Be Recognized [R-07.2015]

37 CFR 1.805(i) indicates that the Office will not recognize in any Office proceeding a replacement deposit made by the patent owner where the depository could furnish samples of the original deposit being replaced. The best evidence of what was originally deposited should not be lost through destruction or replacement if made in association with an existing patent. A supplemental deposit may be accepted in an Office proceeding, however, depending on the circumstances in each case.