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2411.04 After a Patent Has Been Granted - 2400 Biotechnology
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.
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