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2407    Replacement or Supplement of Deposit [R-08.2012]

37 C.F.R. 1.805   Replacement or supplement of deposit.

  • (a) A depositor, after receiving notice during the pendency of an application for patent, application for reissue patent or reexamination proceeding, that the depository possessing a deposit either cannot furnish samples thereof or can furnish samples thereof but the deposit has become contaminated or has lost its capability to function as described in the specification, shall notify the Office in writing, in each application for patent or patent affected. In such a case, or where the Office otherwise learns, during the pendency of an application for patent, application for reissue patent or reexamination proceeding, that the depository possessing a deposit either cannot furnish samples thereof or can furnish samples thereof but the deposit has become contaminated or has lost its capability to function as described in the specification, the need for making a replacement or supplemental deposit will be governed by the same considerations governing the need for making an original deposit under the provisions set forth in § 1.802(b). A replacement or supplemental deposit made during the pendency of an application for patent shall not be accepted unless it meets the requirements for making an original deposit under these regulations, including the requirement set forth under § 1.804(b). 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 § 1.323 is requested by the patent owner which meets the terms of paragraphs (b) and (c) of this section.
  • (b) A request for certificate of correction under this section shall not be granted unless the certificate identifies:
    • (1) The accession number for the replacement or supplemental deposit;
    • (2) The date of the deposit; and
    • (3) The name and address of the depository.
  • (c) A request for a certificate of correction under this section shall not be granted unless the request is made promptly after the replacement or supplemental deposit has been made and the request:
    • (1) Includes a statement of the reason for making the replacement or supplemental deposit;
    • (2) Includes a statement from a person in a position to corroborate the fact, and stating that the replacement or supplemental deposit is of a biological material which is identical to that originally deposited;
    • (3) Includes a showing that the patent owner acted diligently —
      • (i) In the case of a replacement deposit, in making the deposit after receiving notice that samples could no longer be furnished from an earlier deposit; or
      • (ii) In the case of a supplemental deposit, in making the deposit after receiving notice that the earlier deposit had become contaminated or had lost its capability to function as described in the specification;
    • (4) Includes a statement that the term of the replacement or supplemental deposit expires no earlier than the term of the deposit being replaced or supplemented; and
    • (5) Otherwise establishes compliance with these regulations.
  • (d) A depositor’s failure to replace a deposit, or in the case of a patent, to diligently replace a deposit and promptly thereafter request a certificate of correction which meets the terms of paragraphs (b) and (c) of this section, after being notified that the depository possessing the deposit cannot furnish samples thereof, shall cause the application or patent involved to be treated in any Office proceeding as if no deposit were made.
  • (e) In the event a deposit is replaced according to these regulations, the Office will apply a rebuttable presumption of identity between the original and the replacement deposit where a patent making reference to the deposit is relied upon during any Office proceeding.
  • (f) A replacement or supplemental deposit made during the pendency of an application for patent may be made for any reason.
  • (g) In no case is a replacement or supplemental deposit of a biological material necessary where the biological material, in accordance with § 1.802(b), need not be deposited.
  • (h) No replacement deposit of a biological material is necessary where a depository can furnish samples thereof but the depository for national security, health or environmental safety reasons is unable to provide samples to requesters outside of the jurisdiction where the depository is located.
  • (i) The Office will not recognize in any Office proceeding a replacement deposit of a biological material made by a patent owner where the depository could furnish samples of the deposit being replaced.

37 CFR 1.805 relates to the deposit of a biological material to replace or supplement a previous deposit. The term “replacement” is directed to those situations where one deposit is being substituted for another. An applicant may have greater latitude in replacing a deposit during the pendency of an application than after the patent is granted. Replacement will typically take place where the earlier deposit is no longer viable. The term “supplement” is directed to those situations where the earlier deposit is still viable in the sense that it is alive and capable of replication either directly or indirectly, but has lost a quality (e.g., purity, functionality) it allegedly possessed at the time the application was filed.

2407.01   In a Pending Application [R-08.2012]

37 CFR 1.805(a) relates to the procedure for replacing or supplementing a deposit with respect to a pending application or a patent. An applicant or patent owner is required to notify the Office when it obtains information that the depository possessing a deposit cannot furnish samples of the deposit to satisfy the requirements of 35 U.S.C. 112. 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 or reexamination proceeding, whichever is applicable, as if no deposit existed. 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-08.2012]

A replacement deposit made in connection with an application for reissue patent or a reexamination proceeding or both shall not be accepted unless a certificate of correction is requested which meets the terms of 37 CFR 1.805(b) and 37 CFR 1.805 (c) for replacement deposits. Any correction made to the original patent will be automatically incorporated into the reissued or reexamined patent unless changes are made during examination of the reissue application or reexamination proceeding.

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.

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-08.2012]

Finally, 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.

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Last Modified: 03/27/2014 10:10:34