Sec.

Subpart F-Extension of Patent Term

1.710 Patents subject to extension of the patent term.

1.720 Conditions for extension of patent term.

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.

Subpart G-Biotechnology Invention Disclosures

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 de

posit.

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.

Sec.

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.

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 CORRESPONDENCE

§ 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 courtesy. 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]

§ 1.5 Identification of application, patent or registration.

(a) No correspondence relating to an application should be filed prior to when notification of the application number is received from the Patent and Trademark Office. When a letter directed to the Patent and Trademark Office concerns a previously filed application for a patent, it must identify on the top page in a conspicuous location, the application number (consisting of the series code and the serial number, e.g., 07/123,456), or the serial number and filing date assigned to that application by the Patent and Trademark Office, or the international application number of the international application. Any correspondence not containing such identification will be returned to the sender where a return address is available. The returned correspondence will be accompanied with a cover letter which will indicate to the sender that if the returned correspondence is resubmitted to the Patent and Trademark Office within two weeks of the mail date on the cover letter, the original date of receipt of the correspondence will be considered by the Patent and Trademark Office as the date of receipt of the correspondence. Applicants may use either the certificate of mailing procedure under § 1.8 or the Express Mail procedure under § 1.10 for resubmissions of returned correspondence if they desire to have the benefit of the date of deposit in the United States Postal Service. If the returned correspondence is not resubmitted within the two-week period, the date of receipt of resubmission will be considered to be the date of receipt of the correspondence. The two-week period to resubmit the returned correspondence will not be extended. If for some reason returned correspondence is resubmitted with proper identification later than two weeks after the return mailing by the Patent and

Trademark Office, the resubmitted correspondence will be accepted but given its date of receipt. In addition to the application number, all letters directed to the Patent and Trademark Office concerning applications for patent should also state "PATENT APPLICATION," the name of the applicant, the title of the invention, the date of filing the same, and if known, the group art unit or other unit within the Patent and Trademark Office responsible for considering the letter and the name of the examiner or other person to which it has been assigned.

(b) When the letter concerns a patent other than for purposes of paying a maintenance fee, it should state the number and date of issue of the patent, the name of the patentee, and the title of the invention. For letters concerning payment of a maintenance fee in a patent, see the provisions of § 1.366(c).

(c) A letter relating to a trademark application should identify it as such and by the name of the applicant and the serial number and filing date of the application. A letter relating to a registered trademark should identify it by the name of the registrant and by the number and date of the certificate.

(d) A letter relating to a reexamination proceeding should identify it as such by the number of the patent undergoing reexamination, the reexamination request control number assigned to such proceeding and, if known, the group art unit and name of the examiner to which it has been assigned.

(e) When a paper concerns an interference, it should state the names of the parties and the number of the interference. The name of the examinerin-chief assigned to the interference (§ 1.610) and the name of the party filing the paper should appear conspicuously on the first page of the paper.

(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 46 FR 29181, May 29, 1981; 49 FR 552, Jan. 4, 1984; 49 FR 48451, Dec. 12, 1984; 53 FR 47807, Nov. 28, 1988]

§ 1.6 Receipt of letters and papers.

(a) Letters and other papers received in the Patent and Trademark Office are stamped with the date of receipt except where such letters and papers are filed in accordance with § 1.10. Any such letters and papers filed in accordance with § 1.10 will be stamped with the date of deposit as "Express Mail" with the United States Postal Service unless the date of deposit is a Saturday, Sunday, or Federal holiday within the District of Columbia in which case the date stamped will be the next succeeding day which is not a Saturday, Sunday, or Federal holiday within the District of Columbia. No papers are received in the Patent and Trademark Office on Saturdays, Sundays or Federal holidays within the District of Columbia.

(b) Mail placed in the Patent and Trademark Office pouch up to midnight on weekdays, excepting Saturdays and federal holidays, by the post office at Washington, D.C., serving the Patent and Trademark Office, is considered as having been received in the Patent and Trademark Office on the day it was so placed in the pouch.

(c) In addition to being mailed or delivered by hand during office hours, letters and other papers may be deposited up to midnight in a box provided at the guard's desk at the lobby of building 3 of the Patent and Trademark Office at Crystal Plaza, Arlington, Virginia and at the main entrance (14th Street) of the Department of Commerce Building, Washington, D.C., on weekdays except Saturdays and Federal holidays, and all papers deposited therein are considered as received in the Patent and Trademark Office on the day of deposit.

(d) If interruptions or emergencies in the United States Postal Service which have been so designated by the Commissioner occur, the Patent and Trademark Office will consider as filed on a particular date in the Office any paper or fee which is: (1) Promptly filed after the ending of the designated interruption or emergency; and (2) Accompanied by a statement indicating that such paper or fee would have been filed on that particular date if it were not for the designated interruption or emergency in the United States

Postal Service. Such statement must be a verified statement if made by a person not registered to practice before the Patent and Trademark Office.

(35 U.S.C. 6, Pub. L. 97-247)

[48 FR 2707, Jan. 20, 1983; 48 FR 4285, Jan. 31, 1983, as amended at 49 FR 552, Jan. 4, 1984]

§ 1.7 Times for taking action: Expiration on Saturday, Sunday or Federal holiday.

Whenever periods of time are specified in this part in days, calendar days are intended. When the day, or the last day fixed by statute or by or under this part for taking any action or paying any fee in the Patent and Trademark Office falls on Saturday, Sunday, or on a Federal holiday within the District of Columbia, the action may be taken, or the fee paid, on the next succeeding day which is not a Saturday, Sunday, or a Federal holiday. See § 1.304 for time for appeal or for commencing civil action.

(35 U.S.C. 6, Pub. L. 97-247)

[48 FR 2707, Jan. 20, 1983; 48 FR 4285, Jan. 31, 1983]

§ 1.8 Certificate of mailing.

(a) Except in the cases enumerated below, papers and fees required to be filed in the Patent and Trademark Office within a set period of time will be considered as being timely filed if:

(1) They are addressed to the Commissioner of Patents and Trademarks, Washington, DC 20231, and deposited with the U.S. Postal Service with sufficient postage as first class mail prior to expiration of the set period: and

(2) They also include a certificate for each paper or fee stating the date of deposit. The person signing the certificate should have reasonable basis to expect that the correspondence would be mailed on or before the date indicated. The actual date of receipt of the paper or fee will be used for all other purposes. This procedure does not apply to the following:

(i) The filing of a national patent application specification and drawing or other papers for the purpose of obtaining an application filing date;

(ii) The filing of trademark applications;

(iii) The filing of agreements between parties to an interference under 35 U.S.C. 135(c);

(iv) The filing of an affidavit showing that a mark is still in use or containing an excuse for nonuse under section 8 (a) or (b) or section 12(c) of the Trademark Act, 15 U.S.C. 1058(a), 1058(b), 1062(c);

(v) The filing of an application for renewal of a mark registration under section 9 of the Trademark Act, 15 U.S.C. 1059;

(vi) The filing of a petition to cancel a registration of a mark under section 14 (a) or (b) of the Trademark Act, 15 U.S.C. 1064(a), 1064(b);

(vii) The filing of an affidavit under section 15, subsection (3) of the Trademark Act, 15 U.S.C. 1065;

(viii) The filing of a notice of election to proceed by civil action in an inter partes proceeding under 35 U.S.C. 141 or section 21(a)(1) of the Trademark Act, 15 U.S.C. 1071(a)(1), in response to another party's appeal to the Court of Appeals for the Federal Circuit;

(ix) The filing of a notice and reasons of appeal under 35 U.S.C. 142 or a notice of appeal under section 21(a)(2) of the Trademark Act, 15 U.S.C. 1071(a)(2);

(x) The filing of a statement under 42 U.S.C. 2182 or 42 U.S.C. 2457(c);

(xi) The filing of international applications for patent and all papers and fees relating thereto;

(xii) The filing of a paper in an interference which an examiner-in-chief orders to be filed by hand or "Express Mail"; and

(xiii) Papers filed in connection with a disciplinary proceeding under part 10 of this subchapter.

(xiv) In an application under section 1(b) of the Trademark Act (15 U.S.C. 1051(b)), the filing of a statement of use under § 2.88 (15 U.S.C. 1051(d)).

(xv) In an application under section 1(b) of the Trademark Act (15 U.S.C. 1051(b)), the filing of a request, under § 2.89 (15 U.S.C. 1051(d)), for an extension of time to file a statement of use under § 2.88 (15 U.S.C. 1051(d)).

(xvi) In an application under section 1(b) of the Trademark Act (15 U.S.C.

1051(b)), the filing of an amendment to allege use in commerce under § 2.76 (15 U.S.C. 1051(c)).

(b) In the event that correspondence or fees are timely filed in accordance with paragraph (a) of this section, but not received in the Patent and Trademark Office, and the application is held to be abandoned or the proceeding dismissed, terminated, or decided with prejudice, the correspondence or fee will be considered timely if the party who forwarded such correspondence or fee (1) informs the Office of the previous mailing of the correspondence or fee promptly after becoming aware of the Office action, (2) supplies an additional copy of the previously mailed correspondence or fee and certificate, and (3) includes a declaration under § 1.68 or § 2.20 which attests on a personal knowledge basis or to the satisfaction of the Commissioner to the previous timely mailing.

(Pub. L. 94-131, 89 Stat. 685; 35 U.S.C. 6, Pub. L. 97-247)

[41 FR 43721, Oct. 4, 1976, as amended at 47 FR 47381, Oct. 26, 1982; 48 FR 2708, Jan. 20, 1983; 49 FR 48451, Dec. 12, 1984; 50 FR 5171, Feb. 6, 1985; 52 FR 20046, May 28, 1987; 54 FR 37588, Sept. 11, 1989]

(a) A national application as used in this chapter means a U.S. national application for patent which was either filed in the Office under 35 U.S.C. 111 or which resulted from an international application after compliance with 35 U.S.C. 371.

(b) An international application as used in this chapter means an international application for patent filed under the Patent Cooperation Treaty prior to entering national processing at the Designated Office stage.

(c) An independent inventor as used in this chapter means any inventor who (1) has not assigned, granted, conveyed, or licensed, and (2) is under no obligation under contract or law to assign, grant, convey, or license, any rights in the invention to any person who could not likewise be classified as an independent inventor if that person had made the invention, or to any concern which would not qualify as a