2411    Examination Procedures

37 C.F.R. 1.809   Examination procedures.

  • (a) The examiner shall determine pursuant to § 1.104  in each application for patent, application for reissue patent or reexamination proceeding if a deposit is needed, and if needed, if a deposit actually made is acceptable for patent purposes. If a deposit is needed and has not been made or replaced or supplemented in accordance with these regulations, the examiner, where appropriate, shall reject the affected claims under the appropriate provision of 35 U.S.C. 112, explaining why a deposit is needed and/or why a deposit actually made cannot be accepted.
  • (b) The applicant for patent or patent owner shall reply to a rejection under paragraph (a) of this section by—
    • (1) In the case of an applicant for patent, either making an acceptable original, replacement, or supplemental deposit, or assuring the Office in writing that an acceptable deposit will be made; or, in the case of a patent owner, requesting a certificate of correction of the patent which meets the terms of paragraphs (b) and (c) of § 1.805, or
    • (2) Arguing why a deposit is not needed under the circumstances of the application or patent considered and/or why a deposit actually made should be accepted. Other replies to the examiner’s action shall be considered nonresponsive. The rejection will be repeated until either paragraph (b)(1) of this section is satisfied or the examiner is convinced that a deposit is not needed.
  • (c) If an application for patent is otherwise in condition for allowance except for a needed deposit and the Office has received a written assurance that an acceptable deposit will be made, applicant will be notified and given a period of time within which the deposit must be made in order to avoid abandonment. This time period is not extendable under § 1.136(a) or (b) if set forth in a "Notice of Allowability" or in an Office action having a mail date on or after the mail date of a "Notice of Allowability" (see § 1.136(c) ).
  • (d) For each deposit made pursuant to these regulations, the specification shall contain:
    • (1) The accession number for the deposit;
    • (2) The date of the deposit;
    • (3) A description of the deposited biological material sufficient to specifically identify it and to permit examination; and
    • (4) The name and address of the depository.
  • (e) Any amendment required by paragraphs (d)(1), (d)(2) or (d)(4) of this section must be filed before or with the payment of the issue fee (see § 1.312 ).

37 CFR 1.809  sets forth procedures that will be used by the examiner to address a deposit issue. The burden is initially on the Office to establish that access to a biological material is necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112. Once the Office has met this burden, the burden shifts to the applicant or patent owner to demonstrate that access to such biological material either is not necessary, or is already available, or that a deposit of such material will be made in accordance with these regulations.

2411.01   Rejections Based on Deposit Issue

Under 37 CFR 1.809(a), once the examiner has determined that access to a biological material is necessary, and there is no information that would support the conclusion that access is currently available in accordance with these regulations, the examiner should make an appropriate rejection under 35 U.S.C. 112  until such time as a deposit in accordance with these regulations is actually made or a written assurance is received in the patent application that such a deposit will be made upon an indication of allowability of the application. The examiner should clearly indicate the statutory basis for the rejection and the reasons that are relied upon by the examiner to conclude that the application does not comply with some requirement of 35 U.S.C. 112. Although not exhaustive, the following grounds of rejection may be applicable in appropriate circumstances:

    • (A) 35 U.S.C. 112, first paragraph - lack of an enabling disclosure without access to a specific biological material. This ground of rejection should be accompanied by evidence of scientific reasoning to support the conclusion that a person skilled in the art could not make or use the invention defined in and commensurate with the claims without access to the specific biological material.
    • (B) 35 U.S.C. 112, first paragraph - description requirement. This ground of rejection typically arises in the context that the application as filed does not contain a description to support an amendment to the specification or claims. An amendment to the claims that is not described in the application as filed would justify a rejection of the affected claims under 35 U.S.C. 112, first paragraph. If an amendment is made to the application, other than the claims, that is not described in the application as filed, this would justify an objection under 35 U.S.C. 112, first paragraph and/or 35 U.S.C. 132  (prohibition against the introduction of new matter) and a requirement that the amendment be canceled.
    • (C) 35 U.S.C. 112, first paragraph - best mode requirement. This ground of rejection will be rare in the ex parte examination process because it requires (1) a finding by the examiner that, at the time the application was filed, the inventor(s) knew of a specific material that was considered by the inventor(s) to be better than any other, and (2) if a best mode was contemplated at that time, that the inventor(s) concealed the best mode (accidentally or intentionally) by failing to adequately describe that best mode. See Chemcast Corp. v. Arco Industries Corp., 913 F.2d 923, 16 USPQ2d 1033 (Fed. Cir. 1990). The Court of Appeals for the Federal Circuit has at least twice resolved a best mode issue arising in the context of a biotechnology invention in favor of the patentee. See Scripps Clinic and Research Foundation v. Genentech Inc., 927 F.2d 1565, 18 USPQ2d 1001 (Fed. Cir. 1991) with respect to monoclonal antibodies, and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991) with respect to mammalian host cells.
    • (D) 35 U.S.C. 112, second paragraph - indefiniteness. This ground of rejection, as applied to a deposit issue, requires the examiner to provide reasons why the terms in the claims and/or scope of the invention are unclear because of an incomplete or inaccurate description or the absence of a reference to a biological material.
    • (E) 35 U.S.C. 112, second paragraph - claims do not set forth what applicants regard as their invention. This ground of rejection requires the citation of some evidence, not contained in the application as filed, that the claims do not set forth what applicants regard as their invention. In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969). Any disagreement between the content of the application disclosure and the scope of the claims should be addressed under 35 U.S.C. 112, first paragraph. See In re Ehrreich, 590 F.2d 902, 200 USPQ 504 (CCPA 1979).

Where a deposit is required to satisfy 35 U.S.C. 112, a deposit must be made in accordance with these regulations. A deposit accepted in any IDA under the Budapest Treaty shall be accepted for patent purposes if made under conditions which comply with 37 CFR 1.806  and 37 CFR 1.808(a)  concerning term of deposit and permissible conditions on access once the patent is granted.

2411.02   Replies to Rejections Based on Deposit Issue

Once a rejection under 35 U.S.C. 112  has been made by the examiner directed to the absence of access to a biological material, applicant may reply, pursuant to 37 CFR 1.809  (b)(1), by either making an acceptable original or replacement deposit in accordance with these regulations, or assuring the Office in writing that an acceptable deposit will be made on or before the date of payment of the issue fee, or by submitting an argument of why a deposit is not required under the circumstances of the application being considered. Other replies to such a rejection by the examiner shall be considered nonresponsive and may result in abandonment of the application. The rejection will be repeated and made final until the requirements of 37 CFR 1.809(b) (1) are satisfied or the examiner is convinced that a deposit is not required for the claimed subject matter. Once the rejection is made final, the requirements of 37 CFR 1.116  apply to further submissions. The written assurance will be accepted by the Office if it clearly states that an acceptable deposit will be made within the required time and under conditions which satisfy these rules. In the case that an acceptable written assurance has been made by the applicant, the rejection under 35 U.S.C. 112 directed to the absence of access to the biological material should be removed.

2411.03   Application in Condition for Allowance Except for Deposit

As set forth in 37 CFR 1.809(c), in the event that an application for patent is otherwise in condition for allowance except for a required deposit and the Office has received a written assurance that an acceptable deposit will be made, applicant will be notified and given a period of time within which the deposit must be made in order to avoid abandonment. This time period is not extendable under 37 CFR 1.136(a)  or (b) if set forth in a "Notice of Allowability" or in an Office action having a mail date on or after the mail date of a "Notice of Allowability" (see 37 CFR 1.136(c).  Failure to make the needed deposit in accordance with this requirement will be considered a failure to prosecute the application under 35 U.S.C. 133  and result in abandonment of the application.

Once the deposit has been made, information regarding the deposit, such as the name and address of the depository, the accession number and the date of the deposit, that is to be added to the specification must be added by means of filing an amendment under the provisions of 37 CFR 1.312. Such an amendment must be filed before or with the payment of the issue fee. Therefore, applicants need to make any necessary deposit of biological material well prior to payment of the issue fee such that the accession number is received with sufficient time remaining to amend the specification as required by 37 CFR 1.809(d)  on or before the date the issue fee payment is paid. See 37 CFR 1.809(e).

2411.04   After a Patent Has Been Granted

In a proceeding involving a patent, it may not be possible to request a certificate of correction of the patent which meets the terms of 37 CFR 1.805(b)  and 37 CFR 1.805(c). For example, if the patent owner is on notice that samples of an original deposit can no longer be furnished by the depository, failure to diligently make a replacement deposit will preclude grant of a certificate of correction. A replacement deposit subsequently made will not be recognized by the Office nor will a request for certificate of correction, even if made promptly thereafter, be granted. It would also not be possible to request a certificate of correction of the patent which meets the terms of 37 CFR 1.805(b)  and 37 CFR 1.805(c)  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). Whether reissue is available where a biological material necessary for compliance with 35 U.S.C. 112  was known and readily available at the time of issuance of the patent and subsequently ceased to be readily available is problematic. Nevertheless, the rules do not provide for post-issuance original deposits.

Where an applicant for patent has any doubt as to whether access to a biological material specifically identified in the specification is necessary to satisfy 35 U.S.C. 112  or whether such a material, while currently freely available, may become unavailable in the future, the applicant would be well-advised to make a deposit thereof before any patent issues. Similarly, where a patent owner has any doubt whether a deposit referred to in the specification is a biological material necessary to satisfy 35 U.S.C. 112  and, if the material is necessary, whether it is otherwise known and readily available, the patent owner would be well-advised to follow the procedures set forth in 37 CFR 1.805(b)  and 37 CFR 1.805(c)  after receiving the notice specified in those paragraphs.

2411.05   Content of Application with Respect to Deposited Material

37 CFR 1.809(d)  sets forth the requirements for the content of the specification with respect to a deposited biological material. Specifically, the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited biological material sufficient to specifically identify it and to permit examination. The description also must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement. As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.