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2401 Introduction - 2400 Biotechnology
2401 Introduction
This chapter provides guidance on the practices and procedures for implementation of the deposit rules ( 37 CFR 1.801 - 1.809) and the sequence rules ( 37 CFR 1.821 - 1.825). The final rule for deposits of biological materials for patent purposes was published in the Federal Register, 54 FR 34864 (August 22, 1989) and in the Official Gazette, 1106 O.G. 37 (September 12, 1989). The deposit rules went into effect on January 1, 1990. Revised deposit rules were published in the Federal Register at 66 FR 21090 (April 27, 2001) and in the Official Gazette at 1246 O.G. 104 (May 22, 2001) and went into effect on May 29, 2001. The final rule for the requirements for patent applications containing nucleotide sequence and/or amino acid sequence disclosures was published in the Federal Register, 55 FR 18230 (May 1, 1990) and in the Official Gazette, 1114 O.G. 29 (May 15, 1990) and went into effect on October 1, 1990. Revised sequence rules were published in the Federal Register at 63 FR 29620 (June 1, 1998) and in the Official Gazette at 1121 O.G. 82 (June 23, 1998) and went into effect on July 1, 1998.
Further revisions to the sequence rules were published in the Federal Register at 65 FR 54604 (September 8, 2000) and in the Official Gazette at 1238 O.G. 145 (September 19, 2000) and went into effect on September 8, 2000.
Additional information regarding the development of the deposit rules can be obtained in the text of the draft policy statement, published in BNA's Patent, Trademark and Copyright Journal, 32 PTCJ 781 at 76, 90 (May 22, 1986), the advanced notice of proposed rulemaking, published in the Federal Register, 52 FR 34080 (September 9, 1987), and in the Official Gazette, 1082 O.G. 47 (September 29, 1987) and in the notice of proposed rulemaking, published in the Federal Register, 53 FR 39420 (October 6, 1988), and in the Official Gazette, 1095 O.G. 47 (October 25, 1988). Additional information regarding the development of the sequence rules can be obtained in the text of the notice of proposed rulemaking, published in the Federal Register, 54 FR 18671 (May 2, 1989) and in the Official Gazette, 1102 O.G. 34 (May 16, 1989).
See MPEP § 803.04 and § 1850 for restriction and unity of invention practice respectively in patent applications claiming independent and distinct nucleotide sequences. See also MPEP § 2434.
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