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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 exten

sion of patent term. 1.760 Interim extension of patent term

under 35 U.S.C. 156(e)(2). 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. 1.790 Interim extension of patent term

under 35 U.S.C. 156(d)(5). 1.791 Termination of interim extension

granted prior to regulatory approval of a product for commercial marketing or use.

1.825 Amendments to or replacement of se

quence listing and computer readable

copy thereof. APPENDIX A TO SUBPART G OF PART 1-SAM

PLE SEQUENCE LISTING APPENDIX B TO SUBPART G OF PART 1-HEAD

INGS FOR INFORMATION ITEMS IN $1.823 AUTHORITY: 35 U.S.C. 6 and 23, unless otherwise noted.

SOURCE: 24 FR 10332, Dec. 22, 1959, unless otherwise noted.

EDITORIAL NOTE: In Patent and Trademark Office publications and usage the part number is omitted from the numbers of $81.1 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

Subpart G-Biotechnology Invention

Disclosures

DEPOSIT OF BIOLOGICAL MATERIAL 1.801 Biological material. 1.802 Need or Opportunity to make a de

posit. 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.

81.1 All communications to be ad

dressed 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, DC 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

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 ap

plication papers. 1.824 Form and Format for nucleotide and

or amino acid sequence submissions in computer readable form.

alleged oral promise, stipulation, or understanding in relation to which there is disagreement or doubt.

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.”

(i) The filing of all provisional applications and any communications relating thereto should be additionally marked “Box Provisional Patent Application."

$ 1.3 Business to be conducted with de

corum 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.

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; 60 FR 20220, Apr. 25, 1995)

81.4 Nature of correspondence and

signature requirements. (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, $81.710 to 1.785; and of trademark applications $82.11 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

8 1.2 Business to be transacted in writ

ing. 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

or

answering letters dealing with different subjects.

(d) Each piece of correspondence, except as provided in paragraphs (e) and (f) of this section, filed in a patent or trademark application, reexamination proceeding, patent or trademark interference proceeding, patent file or trademark registration file, trademark opposition proceeding, trademark cancellation proceeding, trademark concurrent use proceeding, which requires a person's signature, must either:

(1) Be an original, that is, have an original signature personally signed in permanent ink by that person; or

(2) Be a copy, such as a photocopy or facsimile transmission ($1.6(d)), of an original. In the event that a copy of the original is filed, the original should be retained as evidence of authenticity. If a question of authenticity arises, the Patent and Trademark Office may require submission of the original.

(e) Correspondence requiring a person's signature and relating to registration to practice before the Patent and Trademark Office in patent cases, enrollment and disciplinary investigations, or disciplinary proceedings must be submitted with an original signature personally signed in permanent ink by that person.

(f) When a document that is required by statute to be certified must be filed, a copy, including a photocopy or facsimile transmission of the certification is not acceptable. (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; 58 FR 54501, Oct. 22, 1993) $ 1.5 Identification of application, pat

ent 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 or Transmission 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 concern- which the complete transmission is reing payment of a maintenance fee in a ceived in the Patent and Trademark patent, see the provisions of $1.366(c). Office unless that date is a Saturday,

(c) A letter relating to a trademark Sunday, or Federal holiday within the application should identify it as such District of Columbia, in which case the and by the name of the applicant and date stamped will be the next succeedthe serial number and filing date of the ing day which is not a Saturday, Sunapplication. A letter relating to a reg- day, or Federal holiday within the Disistered trademark should identify it by trict of Columbia. the name of the registrant and by the (b) Patent and Trademark Office Post number and date of the certificate.

Office pouch. Mail placed in the Patent (d) A letter relating to a reexamina- and Trademark Office pouch up to midtion proceeding should identify it as

night on any day, except Saturdays, such by the number of the patent un- Sundays and Federal holidays within dergoing reexamination, the reexam- the District of Columbia, by the post ination request control number as- office at Washington, DC, serving the signed to such proceeding and, if Patent and Trademark Office, is conknown, the group art unit and name of

sidered as having been received in the the examiner to which it has been as

Patent and Trademark Office on the signed.

day it was so placed in the pouch by (e) When a paper concerns an inter

the U.S. Postal Service. ference, it should state the names of

(c) Correspondence delivered by hand. the parties and the number of the in

In addition to being mailed, corterference. The name of the examiner

respondence may be delivered by hand in-chief assigned to the interference

during hours the Office is open to re(81.610) and the name of the party fil

ceive correspondence. ing the paper should appear conspicu

(d) Facsimile transmission. Except in ously on the first page of the paper. the cases enumerated below, cor(Pub. L. 94-131, 89 Stat. 686; 35 U.S.C. 6, Pub. respondence, including authorizations L. 97–247)

to charge a deposit account, may be [24 FR 10332, Doc. 22, 1959, as amended at 46

transmitted by facsimile. The receipt FR 29181, May 29, 1981; 49 FR 562, Jan. 4, 1984;

date accorded to the correspondence 49 FR 48461, Dec. 12, 1984; 53 FR 47807, Nov. 28, will be the date on which the complete 1988; 58 FR 54501, Oct. 22, 1993)

transmission is received in the Patent

and Trademark Office, unless that date $ 1.6 Receipt of correspondence.

is a Saturday, Sunday, or Federal holi(a) Date of receipt and Express Mail day within the District of Columbia. date of deposit. Correspondence received See $1.6(a)(3). To facilitate proper procin the Patent and Trademark Office is essing, each transmission session stamped with the date of receipt except should be limited to correspondence to as follows:

be filed in a single application or other (1) No correspondence is received in proceeding before the Patent and the Patent and Trademark Office on Trademark Office. The application Saturdays, Sundays or Federal holi- number of a patent or trademark applidays within the District of Columbia; cation, the control number of a reex

(2) Correspondence filed in accord- amination proceeding, the interference ance with $1.10 will be stamped with number of an interference proceeding, the date of deposit as “Express Mail” the patent number of a patent, or the with the United States Postal Service registration number of a trademark unless the date of deposit is a Satur- should be entered as a part of the sendday, Sunday, or Federal holiday within er's identification on a facsimile cover the District of Columbia in which case sheet. Facsimile transmissions are not the date stamped will be the next suc- permitted and if submitted, will not be ceeding day which is not a Saturday, accorded a date of receipt, in the folSunday, or Federal holiday within the lowing situations: District of Columbia;

(1) Correspondence as specified in (3) Correspondence transmitted by $1.4(e), requiring an original signature; facsimile to the Patent and Trademark (2) Certified documents as specified Office will be stamped with the date on in $1.4(f);

or

(3) Correspondence which cannot receive the benefit of the certificate of mailing or transmission as specified in $1.8 (a)(2)(1)(A) through (D) and (F); 1.8 (a)(2)(11)(A) and (D); and 1.8 (a)(2)(iii)(A);

(4) Drawings submitted under $81.81, 1.83 through 1.85, 1.152, 1.165, 1.174, 1.437, 2.51, 2.52, or 2.72;

(5) A request for reexamination under $1.510;

(6) Correspondence to be filed in a patent application subject to a secrecy order under $85.1 through 5.8 of this chapter and directly related to the secrecy order content of the application;

(7) Requests for cancellation amendment of a registration under section 7(e) of the Trademark Act, 15 U.S.C. 1057(e); and certificates of registration surrendered for cancellation or amendment under section 7(e) of the Trademark Act, 15 U.S.C. 1057(e);

(8) Correspondence to be filed with the Trademark Trial and Appeal Board, except the notice of ex parte appeal;

(9) Correspondence to be filed in an interference proceeding which consists of a preliminary statement under $1.621; a transcript of a deposition under $1.676 or of interrogatories, cross-interrogatories, or recorded answers under $1.684(c); or an evidentiary record and exhibits under $1.653.

(e) Interruptions in U.S. Postal Service. 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 correspondence which is:

(1) Promptly filed after the ending of the designated interruption or emergency; and

(2) Accompanied by a statement indicating that such correspondence 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 other than a practitioner as defined in $10.1(r) of this chapter.

81.7 Times for taking action: Expira.

tion on Saturday, Sunday or Fed

eral 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)

81.8 Certificate of mailing or trans

mission. (a) Except in the cases enumerated in paragraph (a)(2) of this section, correspondence required to be filed in the Patent and Trademark Office within a set period of time will be considered as being timely filed if the procedure described in this section is followed. The actual date of receipt will be used for all other purposes.

(1) Correspondence will be considered as being timely filed if:

(i) The correspondence is mailed or transmitted prior to expiration of the set period of time by being:

(A) Deposited with the U.S. Postal Service with sufficient postage as first class mail addressed to the Commissioner of Patents and Trademarks, Washington, DC 20231; or

(B) Transmitted by facsimile to the Patent and Trademark Office in accordance with $1.6(d); and

(ii) The correspondence includes a certificate for each piece of correspondence stating the date of deposit or transmission. The person signing the certificate should have reasonable basis to expect that the correspondence would be mailed or transmitted on or before the date indicated.

(2) The procedure described in paragraph (a)(1) of this section does not apply to, and no benefit will be given to a Certificate of Mailing or Transmission on the following:

(58 FR 54501, Oct. 22, 1993; 58 FR 64154, Dec. 6, 1993)

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