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2420 The Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures - the Sequence Rules - 2400 Biotechnology
2420 The Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures - the Sequence Rules
Prior to the effective date (October 1, 1990) and implementation of the sequence rules ( 37 CFR 1.821 through 1.825), applications for patents that included nucleotide or amino acid sequence information posed special problems for the Office. While not related to the disclosure requirements of an invention, problems existed in the presentation, examination and printing of nucleotide and amino acid sequence data that appeared in patent applications because of the lack of uniformity in submission of sequence data to the Office and the impracticality of properly searching and examining sequences submitted in paper form. In summary, the diversity and complexity of nucleotide and amino acid sequence data resulted in searching and analysis difficulties both within the Office and outside the Office, decreased accuracy of search and reproduction and increased costs. These difficulties made the development and implementation of the sequence rules a critical necessity for the Office. As such, the Office amended its regulations to establish a standardized format for descriptions of nucleotide and amino acid sequence data submitted as a part of patent applications, in conjunction with the required submission of that data in computer readable form. The final rules were published in the Federal Register at 55 FR 18230 (May 1, 1990) and in the Official Gazette at 1114 O.G. 29 (May 15, 1990). The sequence rules went into effect on October 1, 1990. The sequence rules were subsequently revised effective July 1, 1998. See 63 FR 29634 (June 1, 1998) and 1121 O.G. 82 (June 23, 1998).
The sequence rules were further revised on September 8, 2000 to allow submissions of the nucleotide and/or amino acid sequences and associated information on compact discs. See 65 FR 54604 (Sept. 8, 2000) and 1238 O.G. 145 (Sept. 19, 2000). See also MPEP § 608.05 and § 2422.03.
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