1.730 Applicant for extension of patent term. 1.740 Application for extension of patent term. 1.741 Filing date of application. 1.750 Determination of eligibility for extension of patent term. 1.760 Interim extension of patent term. 1.765 Duty of disclosure in patent term ex tension proceedings. 1.770 Express withdrawal of application for extension of patent term. 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. 1.776 Calculation of patent term extension for a food additive or color additive. 1.777 Calculation of patent term extension for a medical device. 1.778 Calculation of patent term extension for an animal drug product. 1.779 Calculation of patent term extension for a veterinary biological product. 1.780 Certificate of extension of patent term. 1.785 Multiple applications for extension of term of the same patent or of differ- Subpart G-Biotechnology Invention DEPOSIT OF BIOLOGICAL MATERIAL 1.801 Biological material. 1.802 Need or Opportunity to make a deposit. 1.803 Acceptable depository. 1.804 Time of making an original deposit. 1.805 Replacement or supplement of deposit. 1.806 Term of deposit. 1.807 Viability of deposit. 1.808 Furnishing of samples. 1.809 Examination procedures. APPLICATION DISCLOSURES CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCES 1.821 Nucleotide and/or amino acid sequence disclosures in patent applications. 1.822 Symbols and format to be used for nucleotide and/or amino acid sequence data. 1.823 Requirements for nucleotide and/or amino acid sequences as part of the application papers. 1.824 Form and Format for nucleotide and/or amino acid sequence submissions in computer readable form. 1.825 Amendments to or replacement of sequence listing and computer readable copy thereof. APPENDIX A TO SUBPART G-SAMPLE SEQUENCE LISTING APPENDIX B TO SUBPART G-HEADINGS FOR INFORMATION ITEMS IN § 1.823 AUTHORITY: 35 U.S.C. 6 unless otherwise noted. AUTHORITY: 35 U.S.C. 6, unless otherwise noted. SOURCE: 24 FR 10332, Dec. 22, 1959, as amended at 54 FR 34880, Aug. 22, 1989; 55 FR 18245, May 1, 1990. EDITORIAL NOTE: In Patent and Trademark Office publications and usage the part number is omitted from the numbers of §§ 1.1 to 1.352 and the numbers to the right of the decimal point correspond with the respective rule numbers. Subpart A-General Provisions GENERAL INFORMATION AND § 1.1 All communications to be addressed to Commissioner of Patents and Trademarks. (a) All letters and other communications intended for the Patent and Trademark Office must be addressed to "Commissioner of Patents and Trademarks," Washington, D.C. 20231. When appropriate, a letter should also be marked for the attention of a particular officer or individual. (b) Letters and other communications relating to international applications during the international stage and prior to the assignment of a national serial number should be additionally marked "Box PCT." (c) Requests for reexamination should be additionally marked "Box Reexam." (d) Payments of maintenance fees in patents and other communications relating thereto should be additionally marked "Box M. Fee." (e) Communications relating to interferences and applications or patents involved in an interference should be additionally marked "BOX INTERFERENCE." (f) All applications for extension of patent term and any communications relating thereto intended for the Patent and Trademark Office should be additionally marked "Box Patent Ext." When appropriate, the communication should also be marked to the attention of a particular individual, as where a decision has been rendered. (g) All communications relating to pending litigation which are required by the Federal Rules of Civil or Appellate Procedure or by a rule or order of a court to be served on the Solicitor shall be hand-delivered to the Office of the Solicitor or shall be mailed to: Office of the Solicitor, P.O. Box 15667, Arlington, Virginia 22215 or such other address as may be designated in writing in the litigation. All other communications to the Office of the Solicitor should be addressed to: Box 8, Commissioner of Patents and Trademarks, Washington, DC 20231. Any communication which does not involve pending litigation which is received at P.O. Box 15667 will not be filed in the Office but will be returned. See §§ 1.302(c) and 2.145(b)(3) for filing a notice of appeal to the U.S. Court of Appeals for the Federal Circuit. (h) In applications under section 1(b) of the Trademark Act, 15 U.S.C. 1051(b), all statements of use filed under section 1(d) of the Act, and requests for extensions of time therefor, should be additionally marked "Box ITU." NOTE: Sections 1.1 to 1.26 are applicable to trademark cases as well as to national and international patent cases except for provisions specifically directed to patent cases. See § 1.9 for definitions of “national application" and "international application." (Pub. L. 94-131, 89 Stat. 685) [46 FR 29181, May 29, 1981, as amended at 49 FR 34724, Aug. 31, 1984; 49 FR 48451, Dec. 12, 1984; 52 FR 9394, Mar. 24, 1987; 53 FR 16413, May 9, 1988; 54 FR 37588, Sept. 11, 1989] § 1.2 Business to be transacted in writing. All business with the Patent and Trademark Office should be transacted in writing. The personal attendance of applicants or their attorneys or agents at the Patent and Trademark Office is unnecessary. The action of the Patent and Trademark Office will be based exclusively on the written record in the Office. No attention will be paid to any alleged oral promise, stipulation, or understanding in relation to which there is disagreement or doubt. § 1.3 Business to be conducted with decorum and courtesy. Applicants and their attorneys or agents are required to conduct their business with the Patent and Trademark Office with decorum and courte sy. Papers presented in violation of this requirement will be submitted to the Commissioner and will be returned by his direct order. Complaints against examiners and other employees must be made in communications separate from other papers. § 1.4 Nature of correspondence. (a) Correspondence with the Patent and Trademark Office comprises: (1) Correspondence relating to services and facilities of the Office, such as general inquiries, requests for publications supplied by the Office, orders for printed copies of patents or trademark registrations, orders for copies of records, transmission of assignments for recording, and the like, and (2) Correspondence in and relating to a particular application or other proceeding in the Office. See particularly the rules relating to the filing, processing, or other proceedings of national applications in Subpart B, §§ 1.31 to 1.378; of international applications in Subpart C, §§ 1.401 to 1.499; of reexamination of patents in Subpart D, §§ 1.501 to 1.570; of interferences in Subpart E; §§ 1.601 to 1.690; of extension of patent term in Subpart F, §§ 1.710 to 1.785; and of trademark applications §§ 2.11 to 2.189. (b) Since each application file should be complete in itself, a separate copy of every paper to be filed in an application should be furnished for each application to which the paper pertains, even though the contents of the papers filed in two or more applications may be identical. (c) Since different matters may be considered by different branches or sections of the Patent and Trademark Office, each distinct subject, inquiry or order should be contained in a separate letter to avoid confusion and delay in answering letters dealing with different subjects. (Pub. L. 94-131, 89 Stat. 685; 35 U.S.C. 6, Pub. L. 97-247) [24 FR 10332, Dec. 22, 1959, as amended at 48 FR 2707, Jan. 20, 1982; 49 FR 48451, Dec. 12, 1984; 53 FR 47807, Nov. 28, 1988] 1.730 Applicant for extension of patent term. 1.740 Application for extension of patent term. 1.741 Filing date of application. 1.750 Determination of eligibility for extension of patent term. 1.760 Interim extension of patent term. 1.765 Duty of disclosure in patent term ex tension proceedings. 1.770 Express withdrawal of application for extension of patent term. 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. 1.776 Calculation of patent term extension for a food additive or color additive. 1.777 Calculation of patent term extension for a medical device. 1.778 Calculation of patent term extension for an animal drug product. 1.779 Calculation of patent term extension for a veterinary biological product. 1.780 Certificate of extension of patent term. 1.785 Multiple applications for extension of term of the same patent or of different patents for the same regulatory review period for a product. 1.806 Term of deposit. 1.807 Viability of deposit. 1.808 Furnishing of samples. 1.809 Examination procedures. APPLICATION Disclosures CONTAINING NUCLEOTIDE AND/OR AMINO Acid SequeNCES 1.821 Nucleotide and/or amino acid sequence disclosures in patent applications. 1.822 Symbols and format to be used for nucleotide and/or amino acid sequence data. 1.823 Requirements for nucleotide and/or amino acid sequences as part of the application papers. 1.824 Form and Format for nucleotide and/or amino acid sequence submissions in computer readable form. 1.825 Amendments to or replacement of sequence listing and computer readable copy thereof. APPENDIX A TO SUBPART G-SAMPLE SEQUENCE LISTING APPENDIX B TO SUBPART G-HEADINGS FOR INFORMATION ITEMS IN § 1.823 AUTHORITY: 35 U.S.C. 6 unless otherwise noted. AUTHORITY: 35 U.S.C. 6, unless otherwise noted. SOURCE: 24 FR 10332, Dec. 22, 1959, as amended at 54 FR 34880, Aug. 22, 1989; 55 FR 18245, May 1, 1990. EDITORIAL NOTE: In Patent and Trademark Office publications and usage the part number is omitted from the numbers of §§ 1.1 to 1.352 and the numbers to the right of the decimal point correspond with the respective rule numbers. Subpart A-General Provisions GENERAL INFORMATION AND § 1.1 All communications to be addressed to Commissioner of Patents and Trademarks. (a) All letters and other communications intended for the Patent and Trademark Office must be addressed to "Commissioner of Patents and Trademarks," Washington, D.C. 20231. When appropriate, a letter should also be marked for the attention of a particular officer or individual. (b) Letters and other communications relating to international applications during the international stage and prior to the assignment of a national serial number should be additionally marked “Box PCT." (c) Requests for reexamination should be additionally marked "Box Reexam." (d) Payments of maintenance fees in patents and other communications relating thereto should be additionally marked "Box M. Fee." (e) Communications relating to interferences and applications or patents involved in an interference should be additionally marked "BOX INTERFERENCE." (f) All applications for extension of patent term and any communications relating thereto intended for the Patent and Trademark Office should be additionally marked "Box Patent Ext." When appropriate, the communication should also be marked to the attention of a particular individual, as where a decision has been rendered. (g) All communications relating to pending litigation which are required by the Federal Rules of Civil or Appellate Procedure or by a rule or order of a court to be served on the Solicitor shall be hand-delivered to the Office of the Solicitor or shall be mailed to: Office of the Solicitor, P.O. Box 15667, Arlington, Virginia 22215 or such other address as may be designated in writing in the litigation. All other communications to the Office of the Solicitor should be addressed to: Box 8, Commissioner of Patents and Trademarks, Washington, DC 20231. Any communication which does not involve pending litigation which is received at P.O. Box 15667 will not be filed in the Office but will be returned. See §§ 1.302(c) and 2.145(b)(3) for filing a notice of appeal to the U.S. Court of Appeals for the Federal Circuit. (h) In applications under section 1(b) of the Trademark Act, 15 U.S.C. 1051(b), all statements of use filed under section 1(d) of the Act, and requests for extensions of time therefor, should be additionally marked "Box ITU." NOTE: Sections 1.1 to 1.26 are applicable to trademark cases as well as to national and international patent cases except for provisions specifically directed to patent cases. See § 1.9 for definitions of "national application" and "international application." (Pub. L. 94-131, 89 Stat. 685) [46 FR 29181, May 29, 1981, as amended at 49 FR 34724, Aug. 31, 1984; 49 FR 48451, Dec. 12, 1984; 52 FR 9394, Mar. 24, 1987; 53 FR 16413, May 9, 1988; 54 FR 37588, Sept. 11, 1989] § 1.2 Business to be transacted in writing. All business with the Patent and Trademark Office should be transacted in writing. The personal attendance of applicants or their attorneys or agents at the Patent and Trademark Office is unnecessary. The action of the Patent and Trademark Office will be based exclusively on the written record in the Office. No attention will be paid to any alleged oral promise, stipulation, or understanding in relation to which there is disagreement or doubt. § 1.3 Business to be conducted with decorum and courtesy. Applicants and their attorneys or agents are required to conduct their business with the Patent and Trademark Office with decorum and courte sy. Papers presented in violation of this requirement will be submitted to the Commissioner and will be returned by his direct order. Complaints against examiners and other employees must be made in communications separate from other papers. § 1.4 Nature of correspondence. (a) Correspondence with the Patent and Trademark Office comprises: (1) Correspondence relating to services and facilities of the Office, such as general inquiries, requests for publications supplied by the Office, orders for printed copies of patents or trademark registrations, orders for copies of records, transmission of assignments for recording, and the like, and (2) Correspondence in and relating to a particular application or other proceeding in the Office. See particularly the rules relating to the filing, processing, or other proceedings of national applications in Subpart B, §§ 1.31 to 1.378; of international applications in Subpart C, §§ 1.401 to 1.499; of reexamination of patents in Subpart D, §§ 1.501 to 1.570; of interferences in Subpart E; §§ 1.601 to 1.690; of extension of patent term in Subpart F, 88 1.710 to 1.785; and of trademark applications §§ 2.11 to 2.189. (b) Since each application file should be complete in itself, a separate copy of every paper to be filed in an application should be furnished for each application to which the paper pertains, even though the contents of the papers filed in two or more applications may be identical. (c) Since different matters may be considered by different branches or sections of the Patent and Trademark Office, each distinct subject, inquiry or order should be contained in a separate letter to avoid confusion and delay in answering letters dealing with different subjects. (Pub. L. 94-131, 89 Stat. 685; 35 U.S.C. 6, Pub. L. 97-247) [24 FR 10332, Dec. 22, 1959, as amended at 48 FR 2707, Jan. 20, 1982; 49 FR 48451, Dec. 12, 1984; 53 FR 47807, Nov. 28, 1988] 1.730 Applicant for extension of patent term. 1.740 Application for extension of patent term. 1.741 Filing date of application. 1.750 Determination of eligibility for extension of patent term. 1.760 Interim extension of patent term. 1.765 Duty of disclosure in patent term ex tension proceedings. 1.770 Express withdrawal of application for extension of patent term. 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. 1.776 Calculation of patent term extension for a food additive or color additive. 1.777 Calculation of patent term extension for a medical device. 1.778 Calculation of patent term extension for an animal drug product. 1.779 Calculation of patent term extension for a veterinary biological product. 1.780 Certificate of extension of patent term. 1.785 Multiple applications for extension of term of the same patent or of differ- Subpart G-Biotechnology Invention DEPOSIT OF BIOLOGICAL MATERIAL 1.801 Biological material. 1.802 Need or Opportunity to make a deposit. 1.803 Acceptable depository. 1.804 Time of making an original deposit. 1.805 Replacement or supplement of deposit. 1.806 Term of deposit. 1.807 Viability of deposit. 1.808 Furnishing of samples. 1.809 Examination procedures. APPLICATION Disclosures CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCES 1.821 Nucleotide and/or amino acid sequence disclosures in patent applications. 1.822 Symbols and format to be used for nucleotide and/or amino acid sequence data. 1.823 Requirements for nucleotide and/or amino acid sequences as part of the application papers. 1.824 Form and Format for nucleotide and/or amino acid sequence submissions in computer readable form. 1.825 Amendments to or replacement of sequence listing and computer readable copy thereof. APPENDIX A TO SUBPART G-SAMPLE SEQUENCE LISTING APPENDIX B TO SUBPART G-HEADINGS FOR INFORMATION ITEMS IN § 1.823 AUTHORITY: 35 U.S.C. 6 unless otherwise noted. AUTHORITY: 35 U.S.C. 6, unless otherwise noted. SOURCE: 24 FR 10332, Dec. 22, 1959, as amended at 54 FR 34880, Aug. 22, 1989; 55 FR 18245, May 1, 1990. EDITORIAL NOTE: In Patent and Trademark Office publications and usage the part number is omitted from the numbers of §§ 1.1 to 1.352 and the numbers to the right of the decimal point correspond with the respective rule numbers. Subpart A-General Provisions GENERAL INFORMATION AND § 1.1 All communications to be addressed to Commissioner of Patents and Trademarks. (a) All letters and other communications intended for the Patent and Trademark Office must be addressed to "Commissioner of Patents and Trademarks," Washington, D.C. 20231. When appropriate, a letter should also be marked for the attention of a particular officer or individual. (b) Letters and other communications relating to international applications during the international stage and prior to the assignment of a national serial number should be additionally marked "Box PCT." (c) Requests for reexamination should be additionally marked "Box Reexam." (d) Payments of maintenance fees in patents and other communications relating thereto should be additionally marked "Box M. Fee." (e) Communications relating to interferences and applications or patents involved in an interference should be additionally marked "BOX INTERFERENCE." (f) All applications for extension of patent term and any communications relating thereto intended for the Patent and Trademark Office should be additionally marked "Box Patent Ext." When appropriate, the communication should also be marked to the attention of a particular individual, as where a decision has been rendered. (g) All communications relating to pending litigation which are required by the Federal Rules of Civil or Appellate Procedure or by a rule or order of |