63036 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Rules and Regulations 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, Medical 

devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for 21 CFR 

part 866 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

■ 2. Section 866.3373 is added to 

subpart D to read as follows: 

§ 866.3373 Nucleic acid-based in vitro 

diagnostic devices for the detection of 

Mycobacterium tuberculosis complex (MTBcomplex) and the genetic mutations 

associated with MTB-complex antibiotic 

resistance in respiratory specimens. 

(a) Identification. Nucleic acid-based 

in vitro diagnostic devices for the 

detection of Mycobacterium 

tuberculosis complex (MTB-complex) 

and the genetic mutations associated 

with MTB-complex antibiotic resistance 

in respiratory specimens are qualitative 

nucleic acid-based devices that detect 

the presence of MTB-complexassociated nucleic acid sequences in 

respiratory samples. These devices are 

intended to aid in the diagnosis of 

pulmonary tuberculosis and the 

selection of an initial treatment regimen 

when used in conjunction with clinical 

findings and other laboratory results. 

These devices do not provide 

confirmation of antibiotic susceptibility 

since other mechanisms of resistance 

may exist that may be associated with 

a lack of clinical response to treatment 

other than those detected by the device. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The FDA document entitled ‘‘Class 

II Special Controls Guideline: Nucleic 

Acid-Based In Vitro Diagnostic Devices 

for the Detection of Mycobacterium 

tuberculosis Complex and Genetic 

Mutations Associated with Antibiotic 

Resistance in Respiratory Specimens,’’ 

which addresses the mitigation of risks 

specific to the detection of MTBcomplex. For availability of the 

document, see § 866.1(e). 

(2) The following items, which 

address the mitigation of risks specific 

to the detection of the genetic mutations 

associated with antibiotic resistance of 

MTB-complex: 

(i) The device must include an 

external positive assay control as 

appropriate. Acceptable positive assay 

controls include MTB-complex isolates 

containing one or more antibioticresistance associated target sequences 

detected by the device. 

(ii) The device must include internal 

controls as appropriate. An acceptable 

internal control may include human 

nucleic acid co-extracted with MTBcomplex containing nucleic acid 

sequences associated with antibiotic 

resistance and primers amplifying 

human housekeeping genes (e.g., 

RNaseP, b-actin). 

(iii) The device’s intended use must 

include a description of the scope of 

antibiotic resistance targeted by the 

assay, i.e., the specific drugs and/or 

drug classes. 

(iv) The specific performance 

characteristics section of the device’s 

labeling must include information 

regarding the specificity of the assay 

oligonucleotides for detecting mutations 

associated with antibiotic resistance of 

MTB-complex, and any information 

indicating the potential for non-specific 

binding (e.g., BLAST search). 

(v) In demonstrating device 

performance you must perform: 

(A) Pre-analytical studies that 

evaluate: 

(1) Frozen samples. If there is use of 

any frozen samples in the device 

performance studies, or if there is a 

device claim for the use of frozen 

samples for testing, the effect of freezing 

samples prior to testing and the effect of 

multiple freeze/thaw cycles on both 

antibiotic susceptible and antibiotic 

resistant strains of MTB-complex. 

(2) Nucleic acid extraction methods. 

Extraction methods must parallel those 

used in devices for the detection of 

MTB-complex nucleic acid and confirm 

that the detection of the genetic 

mutations associated with antibiotic 

resistance is not affected. 

(B) Analytical studies that analyze: 

(1) Limit of Detection. Limit of 

Detection must be determined in the 

most challenging matrix (e.g., sputum) 

claimed for use with the device. The 

Limit of Detection must be determined 

using both antibiotic susceptible and 

antibiotic resistant strains of MTBcomplex. The antibiotic resistant strains 

must be those with well characterized 

genetic mutations associated with 

antibiotic resistance. 

(2) Analytical Reactivity (Inclusivity). 

Testing must be conducted to evaluate 

the ability of the device to detect genetic 

mutations associated with antibiotic 

resistance in a diversity of MTBcomplex strains. Isolates used in testing 

must be well characterized. Isolate 

strain characterization must be 

determined using standardized 

reference methods recognized by a 

reputable scientific body and 

appropriate to the strain lineage. 

(3) Within-Laboratory (Repeatability) 

Precision Testing. Within-laboratory 

precision studies, if appropriate, must 

include at least one antibiotic resistant 

and one antibiotic susceptible strain of 

MTB-complex. 

(4) Between Laboratory 

Reproducibility Testing. The protocol 

for the reproducibility study may vary 

slightly depending on the assay format; 

however, the panel must include at least 

one antibiotic resistant and one 

antibiotic susceptible strain of MTBcomplex. 

(C) Clinical Studies. Clinical 

performance of the device must be 

established by conducting prospective 

clinical studies that include subjects 

with culture confirmed active 

tuberculosis. Studies must attempt to 

enroll subjects at risk for antibioticresistant MTB-complex; however, it may 

be necessary to include supplemental 

antibiotic resistant retrospective and 

contrived samples. Clinical studies must 

compare device results to both 

phenotypic drug susceptibility testing 

and genotypic reference methods. The 

genotypic reference method must be a 

polymerase chain reaction based 

method that uses primers different from 

those in the experimental device and 

confirmed by bidirectional sequencing. 

Dated: October 15, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25049 Filed 10–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF COMMERCE 

United States Patent and Trademark 

Office 

37 CFR Parts 1, 2, 7, 11, 41, and 42 

[Docket No.: PTO–P–2014–0045] 

RIN 0651–AC98 

Renaming of Express Mail® to Priority 

Mail Express®

AGENCY: United States Patent and 

Trademark Office, Commerce. 

ACTION: Final rule. 

SUMMARY: The United States Patent and 

Trademark (Office) is revising the rules 

of practice to change the phrase Express 

Mail or EXPRESS MAIL® to Priority 

Mail Express® due to the United States 

Postal Service (USPS) renaming Express 

Mail® to Priority Mail Express® on July 

28, 2013, and to make other changes to 

conform the nomenclature used in the 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Rules and Regulations 63037 

rules of practice to the current 

nomenclature used by the USPS. 

DATES: Effective Date: The changes in 

this final rule are effective on October 

22, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Eugenia A. Jones, Senior Legal Advisor, 

at (571) 272–7727, or Erin M. Harriman, 

Legal Advisor, at (571) 272–7747; or by 

mail addressed to: United States Patent 

and Trademark Office, Mail Stop 

Comments-Patents, Commissioner for 

Patents, P.O. Box 1450, Alexandria, VA 

22313–1450, marked to the attention of 

Eugenia A. Jones. 

SUPPLEMENTARY INFORMATION: 

Executive Summary: Purpose: 

Effective July 28, 2013, the USPS 

changed the name of Express Mail® to 

Priority Mail Express®. Accordingly, the 

Office is revising the rules of practice to 

conform the nomenclature used in the 

rules of practice to the current 

nomenclature used by the USPS. 

More specifically, the Office is 

changing the phrase Express Mail or 

EXPRESS MAIL® to Priority Mail 

Express® in 37 CFR 1.5, 1.6, 1.10, 2.119, 

2.195, 2.198, 7.4, 11.35, 11.41, 11.42, 

11.51, 41.106, 42.6, 42.105, 42.205, and 

42.406. In addition, the USPS has 

updated the Priority Mail Express®

mailing label. The mailing label now 

has a ‘‘date accepted’’ field rather than 

a ‘‘date-in’’ field, which was previously 

used on the Express Mail® mailing 

label. The Office is revising 37 CFR 

1.10, 2.198, and 41.106 accordingly. 

All characteristics of the Priority Mail 

Express® service are the same as those 

of the former Express Mail® service, 

although the mailing labels differ. The 

modifications to the rules are purely 

changes in terminology resulting from 

the renaming implemented by the USPS 

on July 28, 2013. There is no substantive 

change in practice before the Office as 

a result of these rule changes. Thus, 

parties still cannot use a foreign or 

international mail service (such as the 

newly renamed Priority Mail Express 

International®) or other forms of U.S. 

mail, such as certified mail, to obtain 

the benefit under 37 CFR 1.10 and 

2.198. The procedure in 37 CFR 1.10 

and 2.198 is limited to correspondence 

deposited in Priority Mail Express® Post 

Office to Addressee service of the USPS. 

The changes in this final rule are 

effective on the date of publication in 

the Federal Register. Papers submitted 

prior to the effective date containing 

language pertaining to Express Mail®

and the mailing label ‘‘date-in’’ field 

will be accepted by the Office. Papers 

submitted after the effective date 

containing language pertaining to 

Express Mail® and the mailing label 

‘‘date-in’’ field will be accepted by the 

Office. Although the new terminology 

should be used, papers submitted using 

the former language of Express Mail®

and ‘‘date-in’’ will be presumed by the 

Office to mean Priority Mail Express®

and ‘‘date accepted’’ after the effective 

date. The Office is in the process of 

updating its patent application 

transmittal forms (e.g., PTO/AIA/15, 

PTO/AIA/18, PTO/AIA/19, PTO/AIA/

50, PTO/SB/16, PTO/SB/29) to change 

the reference Express Mail® Label No. to 

Priority Mail Express® Label No. 

Costs and Benefits: This rulemaking is 

not economically significant under 

Executive Order 12866 (Sept. 30, 1993). 

Background: Effective July 28, 2013, 

the USPS changed the name of Express 

Mail® to Priority Mail Express®. This 

final rule revises the rules of practice to 

change the phrase Express Mail to 

Priority Mail Express® and to make 

other changes to conform the 

nomenclature used in the rules of 

practice to the current nomenclature 

used by the USPS. 

Discussion of Specific Rules 

The following is a discussion of 

amendments to Title 37 of the Code of 

Federal Regulations, Parts 1, 2, 7, 11, 41, 

and 42. 

37 CFR Part 1 

Section 1.5: Section 1.5(a) is amended 

to change ‘‘Express Mail procedure’’ to 

‘‘Priority Mail Express® procedure.’’ 

Section 1.6: Section 1.6(a) is amended 

to change ‘‘Express Mail date of 

deposit’’ to ‘‘Priority Mail Express® date 

of deposit.’’ Section 1.6(a)(2) is 

amended to change ‘‘Express Mail’’ to 

‘‘Priority Mail Express®.’’ 

Section 1.10: Section 1.10 is amended 

to change ‘‘Express Mail’’ to ‘‘Priority 

Mail Express®’’ and to change ‘‘date-in’’ 

or ‘‘date in’’ to ‘‘date accepted.’’ In 

particular, 37 CFR 1.10(a)(1), (c), (d), 

(d)(3), (e), (e)(3), (g), and (h) are 

amended to change ‘‘Express Mail Post 

Office to Addressee’’ to ‘‘Priority Mail 

Express® Post Office to Addressee’’ and 

37 CFR 1.10(a)(2), (b), (c), (c)(2), (c)(3), 

(d), (d)(2), (e)(2)–(4), (f), (g), (g)(2)–(4), 

(h), (h)(2)–(4), (i), (i)(1), and (i)(3) are 

amended to change ‘‘Express Mail’’ to 

‘‘Priority Mail Express®.’’ In addition, 

37 CFR 1.10(a)(2), (b), (c), (c)(3), (d), 

(e)(3), and (g)(3) are amended to change 

‘‘date-in’’ or ‘‘date in’’ to ‘‘date 

accepted.’’ 

37 CFR Part 2 

Section 2.119: Section 2.119(b)(4) is 

amended to change ‘‘Express Mail Post 

Office to Addressee’’ to ‘‘Priority Mail 

Express® Post Office to Addressee’’ and 

37 CFR 2.119(c) is amended to change 

‘‘Express Mail’’ to ‘‘Priority Mail 

Express®.’’ 

Section 2.195: Sections 2.195(a), 

(a)(4), (e)(2)(iii), and (e)(3) are amended 

to change ‘‘Express Mail’’ to ‘‘Priority 

Mail Express®,’’ and 37 CFR 2.195(e)(1) 

is amended to change ‘‘Express Mail 

Post Office to Addressee’’ to ‘‘Priority 

Mail Express® Post Office to 

Addressee.’’ 

Section 2.198: Section 2.198 is 

amended to change ‘‘Express Mail’’ to 

‘‘Priority Mail Express®’’ and to change 

‘‘date in’’ or ‘‘date-in’’ to ‘‘date 

accepted.’’ In particular, 37 CFR 

2.198(a)(1), (c), (d), (d)(3), (e), and (e)(3) 

are amended to change ‘‘Express Mail 

Post Office to Addressee’’ to ‘‘Priority 

Mail Express® Post Office to Addressee’’ 

and 37 CFR 2.198(a)(1), (a)(2), (b), (c), 

(c)(2), (c)(3), (d), (d)(2), (e)(2)–(4), and (f) 

are amended to change ‘‘Express Mail’’ 

to ‘‘Priority Mail Express®.’’ In addition, 

37 CFR 2.198(a)(2), (b), (c), (c)(3), (d), 

and (e)(3) are amended to change ‘‘date 

in’’ or ‘‘date-in’’ to ‘‘date accepted.’’ 

37 CFR Part 7 

Section 7.4: Section 7.4(b)(1) is 

amended to change ‘‘Express Mail’’ to 

‘‘Priority Mail Express®.’’ 

37 CFR Part 11 

Section 11.35: Section 11.35(a)(2) is 

amended to change ‘‘Express Mail’’ to 

‘‘Priority Mail Express®.’’ 

Section 11.41: Section 11.41(b) is 

amended to change ‘‘Express Mail’’ to 

‘‘Priority Mail Express®.’’ 

Section 11.42: Sections 11.42(a)(2), 

(b)(2), (c)(2), and (e) are amended to 

change ‘‘Express Mail’’ to ‘‘Priority Mail 

Express®.’’ 

Section 11.51: Section 11.51(a) is 

amended to change ‘‘Express Mail’’ to 

‘‘Priority Mail Express®.’’ 

37 CFR Part 41 

Section 41.106: Section 41.106(d)(1) is 

amended to change each occurrence of 

‘‘EXPRESS MAIL®’’ to ‘‘Priority Mail 

Express®’’ and to change ‘‘date-in’’ to 

‘‘date accepted.’’ 

37 CFR Part 42 

Section 42.6: Section 42.6(e)(1) is 

amended to change each occurrence of 

‘‘EXPRESS MAIL®’’ to ‘‘Priority Mail 

Express®.’’ 

Section 42.105: Section 42.105(b) is 

amended to change each occurrence of 

‘‘EXPRESS MAIL®’’ to ‘‘Priority Mail 

Express®.’’ 

Section 42.205: Section 42.205(b) is 

amended to change each occurrence of 

‘‘EXPRESS MAIL®’’ to ‘‘Priority Mail 

Express®.’’ 

Section 42.406: Section 42.406(b) is 

amended to change each occurrence of 


tkelley on DSK3SPTVN1PROD with RULES
63038 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Rules and Regulations 

‘‘EXPRESS MAIL®’’ to ‘‘Priority Mail 

Express®.’’ 

Rulemaking Considerations 

A. Administrative Procedure Act: This 

rulemaking revises the rules of practice 

to change the phrase Express Mail or 

EXPRESS MAIL® to Priority Mail 

Express® due to the United States Postal 

Service (USPS) renaming Express Mail®

to Priority Mail Express® on July 28, 

2013, and to make other changes to 

conform the nomenclature used in the 

rules of practice to the current 

nomenclature used by the USPS. 

Therefore, the changes in this 

rulemaking involve rules of agency 

practice and procedure and/or 

interpretive rules. See Bachow 

Commc’ns Inc. v. F.C.C., 237 F.3d 683, 

690 (D.C. Cir. 2001) (stating that rules 

governing an application process are 

procedural under the Administrative 

Procedure Act); Inova Alexandria Hosp. 

v. Shalala, 244 F.3d 342, 350 (4th Cir. 

2001) (holding that rules for handling 

appeals were procedural where they did 

not change the substantive standard for 

reviewing claims). 

Accordingly, prior notice and 

opportunity for public comment were 

not required pursuant to 5 U.S.C. 553(b) 

or (c) (or any other law). See Cooper 

Techs. Co. v. Dudas, 536 F.3d 1330, 

1336–37 (Fed. Cir. 2008) (stating that 5 

U.S.C. 553, and thus 35 U.S.C. 

2(b)(2)(B), does not require notice and 

comment rulemaking for ‘‘interpretative 

rules, general statements of policy, or 

rules of agency organization, procedure, 

or practice’’ (quoting 5 U.S.C. 

553(b)(3)(A))). 

B. Regulatory Flexibility Act: As prior 

notice and an opportunity for public 

comment are not required pursuant to 5 

U.S.C. 553 or any other law, neither a 

regulatory flexibility analysis nor a 

certification under the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.) is 

required. See 5 U.S.C. 603. Further, this 

rulemaking only revises nomenclature 

to be consistent with the current 

nomenclature used by the USPS, and 

therefore the changes in this rulemaking 

will not have a significant economic 

impact on a substantial number of small 

entities. 

C. Executive Order 12866 (Regulatory 

Planning and Review): This rulemaking 

has been determined to be not 

significant for purposes of Executive 

Order 12866 (Sept. 30, 1993). 

D. Executive Order 13563 (Improving 

Regulation and Regulatory Review): The 

Office has complied with Executive 

Order 13563 (Jan. 18, 2011). 

Specifically, the Office has, to the extent 

feasible and applicable: (1) Made a 

reasoned determination that the benefits 

justify the costs of the rule; (2) tailored 

the rule to impose the least burden on 

society consistent with obtaining the 

regulatory objectives; (3) selected a 

regulatory approach that maximizes net 

benefits; (4) specified performance 

objectives; (5) identified and assessed 

available alternatives; (6) involved the 

public in an open exchange of 

information and perspectives among 

experts in relevant disciplines, affected 

stakeholders in the private sector, and 

the public as a whole, and provided online access to the rulemaking docket; (7) 

attempted to promote coordination, 

simplification, and harmonization 

across government agencies and 

identified goals designed to promote 

innovation; (8) considered approaches 

that reduce burdens and maintain 

flexibility and freedom of choice for the 

public; and (9) ensured the objectivity of 

scientific and technological information 

and processes. 

E. Executive Order 13132 

(Federalism): This rulemaking does not 

contain policies with federalism 

implications sufficient to warrant 

preparation of a Federalism Assessment 

under Executive Order 13132 (Aug. 4, 

1999). 

F. Executive Order 13175 (Tribal 

Consultation): This rulemaking will not: 

(1) Have substantial direct effects on one 

or more Indian tribes; (2) impose 

substantial direct compliance costs on 

Indian tribal governments; or (3) 

preempt tribal law. Therefore, a tribal 

summary impact statement is not 

required under Executive Order 13175 

(Nov. 6, 2000). 

G. Executive Order 13211 (Energy 

Effects): This rulemaking is not a 

significant energy action under 

Executive Order 13211 because this 

rulemaking is not likely to have a 

significant adverse effect on the supply, 

distribution, or use of energy. Therefore, 

a Statement of Energy Effects is not 

required under Executive Order 13211 

(May 18, 2001). 

H. Executive Order 12988 (Civil 

Justice Reform): This rulemaking meets 

applicable standards to minimize 

litigation, eliminate ambiguity, and 

reduce burden as set forth in sections 

3(a) and 3(b)(2) of Executive Order 

12988 (Feb. 5, 1996). 

I. Executive Order 13045 (Protection 

of Children): This rulemaking does not 

concern an environmental risk to health 

or safety that may disproportionately 

affect children under Executive Order 

13045 (Apr. 21, 1997). 

J. Executive Order 12630 (Taking of 

Private Property): This rulemaking will 

not affect a taking of private property or 

otherwise have taking implications 

under Executive Order 12630 (Mar. 15, 

1988). 

K. Congressional Review Act: Under 

the Congressional Review Act 

provisions of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (5 U.S.C. 801 et seq.), prior to 

issuing any final rule, the United States 

Patent and Trademark Office will 

submit a report containing the final rule 

and other required information to the 

United States Senate, the United States 

House of Representatives, and the 

Comptroller General of the Government 

Accountability Office. The changes in 

this document are not expected to result 

in an annual effect on the economy of 

100 million dollars or more, a major 

increase in costs or prices, or significant 

adverse effects on competition, 

employment, investment, productivity, 

innovation, or the ability of United 

States-based enterprises to compete 

with foreign-based enterprises in 

domestic and export markets. Therefore, 

this document is not expected to result 

in a ‘‘major rule’’ as defined in 5 U.S.C. 

804(2). 

L. Unfunded Mandates Reform Act of 

1995: The changes set forth in this 

document do not involve a Federal 

intergovernmental mandate that will 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

of 100 million dollars (as adjusted) or 

more in any one year, or a Federal 

private sector mandate that will result 

in the expenditure by the private sector 

of 100 million dollars (as adjusted) or 

more in any one year, and will not 

significantly or uniquely affect small 

governments. Therefore, no actions are 

necessary under the provisions of the 

Unfunded Mandates Reform Act of 

1995. See 2 U.S.C. 1501 et seq. 

M. National Environmental Policy 

Act: This rulemaking will not have any 

effect on the quality of the environment 

and is thus categorically excluded from 

review under the National 

Environmental Policy Act of 1969. See 

42 U.S.C. 4321 et seq. 

N. National Technology Transfer and 

Advancement Act: The requirements of 

section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) are not 

applicable because this rulemaking does 

not contain provisions which involve 

the use of technical standards. 

O. Paperwork Reduction Act: This 

rulemaking does not contain any 

information collection requirements 

under the Paperwork Reduction Act of 

1995 (44 U.S.C. 3501 et seq.). 

Notwithstanding any other provision 

of law, no person is required to respond 

to, nor shall a person be subject to a 

penalty for failure to comply with, a 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Rules and Regulations 63039 

collection of information subject to the 

requirements of the Paperwork 

Reduction Act unless that collection of 

information displays a currently valid 

OMB control number. 

List of Subjects 

37 CFR Part 1 

Administrative practice and 

procedure, Courts, Freedom of 

information, Inventions and patents, 

Reporting and recordkeeping 

requirements, Small businesses. 

37 CFR Part 2 

Administrative practice and 

procedure, Courts, Lawyers, 

Trademarks. 

37 CFR Part 7 

Administrative practice and 

procedure, Trademarks. 

37 CFR Part 11 

Administrative practice and 

procedure, Inventions and patents, 

Lawyers, Reporting and recordkeeping 

requirements. 

37 CFR Part 41 

Administrative practice and 

procedure, Inventions and patents, 

Lawyers. 

37 CFR Part 42 

Administrative practice and 

procedure, Inventions and patents, 

Lawyers. 

For the reasons set forth in the 

preamble, 37 CFR parts 1, 2, 7, 11, 41, 

and 42 are amended as follows: 

PART 1—RULES OF PRACTICE IN 

PATENT CASES 

■ 1. The authority citation for 37 CFR 

Part 1 continues to read as follows: 

Authority: 35 U.S.C. 2(b)(2), unless 

otherwise noted. 

■ 2. Section 1.5 is amended by revising 

paragraph (a) to read as follows: 

§ 1.5 Identification of patent, patent 

application, or patent-related proceeding. 

(a) No correspondence relating to an 

application should be filed prior to 

receipt of the application number 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 Priority 

Mail Express® 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 the 

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. In 

addition to the application number, all 

letters directed to the Patent and 

Trademark Office concerning 

applications for patent should also state 

the name of the first listed inventor, 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. 

* * * * * 

■ 3. Section 1.6 is amended by revising 

the introductory text of paragraph (a) 

and revising paragraph (a)(2) to read as 

follows: 

§ 1.6 Receipt of correspondence. 

(a) Date of receipt and Priority Mail 

Express® date of deposit. 

Correspondence received in the Patent 

and Trademark Office is stamped with 

the date of receipt except as follows: 

* * * * * 

(2) Correspondence filed in 

accordance with § 1.10 will be stamped 

with the date of deposit as Priority Mail 

Express® with the United States Postal 

Service. 

* * * * * 

■ 4. Section 1.10 is revised to read as 

follows: 

§ 1.10 Filing of correspondence by Priority 

Mail Express®. 

(a)(1) Any correspondence received 

by the U.S. Patent and Trademark Office 

(USPTO) that was delivered by the 

Priority Mail Express® Post Office to 

Addressee service of the United States 

Postal Service (USPS) will be 

considered filed with the USPTO on the 

date of deposit with the USPS. 

(2) The date of deposit with USPS is 

shown by the ‘‘date accepted’’ on the 

Priority Mail Express® label or other 

official USPS notation. If the USPS 

deposit date cannot be determined, the 

correspondence will be accorded the 

USPTO receipt date as the filing date. 

See § 1.6(a). 

(b) Correspondence should be 

deposited directly with an employee of 

the USPS to ensure that the person 

depositing the correspondence receives 

a legible copy of the Priority Mail 

Express® mailing label with the ‘‘date 

accepted’’ clearly marked. Persons 

dealing indirectly with the employees of 

the USPS (such as by deposit in a 

Priority Mail Express® drop box) do so 

at the risk of not receiving a copy of the 

Priority Mail Express® mailing label 

with the desired ‘‘date accepted’’ clearly 

marked. The paper(s) or fee(s) that 

constitute the correspondence should 

also include the Priority Mail Express®

mailing label number thereon. See 

paragraphs (c), (d) and (e) of this 

section. 

(c) Any person filing correspondence 

under this section that was received by 

the Office and delivered by the Priority 

Mail Express® Post Office to Addressee 

service of the USPS, who can show that 

there is a discrepancy between the filing 

date accorded by the Office to the 

correspondence and the date of deposit 

as shown by the ‘‘date accepted’’ on the 

Priority Mail Express® mailing label or 

other official USPS notation, may 

petition the Director to accord the 

correspondence a filing date as of the 

‘‘date accepted’’ on the Priority Mail 

Express® mailing label or other official 

USPS notation, provided that: 

(1) The petition is filed promptly after 

the person becomes aware that the 

Office has accorded, or will accord, a 

filing date other than the USPS deposit 

date; 

(2) The number of the Priority Mail 

Express® mailing label was placed on 

the paper(s) or fee(s) that constitute the 

correspondence prior to the original 

mailing by Priority Mail Express®; and 

(3) The petition includes a true copy 

of the Priority Mail Express® mailing 

label showing the ‘‘date accepted,’’ and 

of any other official notation by the 

USPS relied upon to show the date of 

deposit. 


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(d) Any person filing correspondence 

under this section that was received by 

the Office and delivered by the Priority 

Mail Express® Post Office to Addressee 

service of the USPS, who can show that 

the ‘‘date accepted’’ on the Priority Mail 

Express® mailing label or other official 

notation entered by the USPS was 

incorrectly entered or omitted by the 

USPS, may petition the Director to 

accord the correspondence a filing date 

as of the date the correspondence is 

shown to have been deposited with the 

USPS, provided that: 

(1) The petition is filed promptly after 

the person becomes aware that the 

Office has accorded, or will accord, a 

filing date based upon an incorrect entry 

by the USPS; 

(2) The number of the Priority Mail 

Express® mailing label was placed on 

the paper(s) or fee(s) that constitute the 

correspondence prior to the original 

mailing by Priority Mail Express®; and 

(3) The petition includes a showing 

which establishes, to the satisfaction of 

the Director, that the requested filing 

date was the date the correspondence 

was deposited in the Priority Mail 

Express® Post Office to Addressee 

service prior to the last scheduled 

pickup for that day. Any showing 

pursuant to this paragraph must be 

corroborated by evidence from the USPS 

or that came into being after deposit and 

within one business day of the deposit 

of the correspondence in the Priority 

Mail Express® Post Office to Addressee 

service of the USPS. 

(e) Any person mailing 

correspondence addressed as set out in 

§ 1.1(a) to the Office with sufficient 

postage utilizing the Priority Mail 

Express® Post Office to Addressee 

service of the USPS but not received by 

the Office, may petition the Director to 

consider such correspondence filed in 

the Office on the USPS deposit date, 

provided that: 

(1) The petition is filed promptly after 

the person becomes aware that the 

Office has no evidence of receipt of the 

correspondence; 

(2) The number of the Priority Mail 

Express® mailing label was placed on 

the paper(s) or fee(s) that constitute the 

correspondence prior to the original 

mailing by Priority Mail Express®; 

(3) The petition includes a copy of the 

originally deposited paper(s) or fee(s) 

that constitute the correspondence 

showing the number of the Priority Mail 

Express® mailing label thereon, a copy 

of any returned postcard receipt, a copy 

of the Priority Mail Express® mailing 

label showing the ‘‘date accepted,’’ a 

copy of any other official notation by 

the USPS relied upon to show the date 

of deposit, and, if the requested filing 

date is a date other than the ‘‘date 

accepted’’ on the Priority Mail Express®

mailing label or other official notation 

entered by the USPS, a showing 

pursuant to paragraph (d)(3) of this 

section that the requested filing date 

was the date the correspondence was 

deposited in the Priority Mail Express®

Post Office to Addressee service prior to 

the last scheduled pickup for that day; 

and 

(4) The petition includes a statement 

which establishes, to the satisfaction of 

the Director, the original deposit of the 

correspondence and that the copies of 

the correspondence, the copy of the 

Priority Mail Express® mailing label, the 

copy of any returned postcard receipt, 

and any official notation entered by the 

USPS are true copies of the originally 

mailed correspondence, original Priority 

Mail Express® mailing label, returned 

postcard receipt, and official notation 

entered by the USPS. 

(f) The Office may require additional 

evidence to determine if the 

correspondence was deposited as 

Priority Mail Express® with the USPS 

on the date in question. 

(g) Any person who mails 

correspondence addressed as set out in 

§ 1.1(a) to the Office with sufficient 

postage utilizing the Priority Mail 

Express® Post Office to Addressee 

service of the USPS, but has the 

correspondence returned by the USPS 

due to an interruption or emergency in 

Priority Mail Express® service, may 

petition the Director to consider such 

correspondence as filed on a particular 

date in the Office, provided that: 

(1) The petition is filed promptly after 

the person becomes aware of the return 

of the correspondence; 

(2) The number of the Priority Mail 

Express® mailing label was placed on 

the paper(s) or fee(s) that constitute the 

correspondence prior to the original 

mailing by Priority Mail Express®; 

(3) The petition includes the original 

correspondence or a copy of the original 

correspondence showing the number of 

the Priority Mail Express® mailing label 

thereon and a copy of the Priority Mail 

Express® mailing label showing the 

‘‘date accepted’’; and 

(4) The petition includes a statement 

which establishes, to the satisfaction of 

the Director, the original deposit of the 

correspondence and that the 

correspondence or copy of the 

correspondence is the original 

correspondence or a true copy of the 

correspondence originally deposited 

with the USPS on the requested filing 

date. The Office may require additional 

evidence to determine if the 

correspondence was returned by the 

USPS due to an interruption or 

emergency in Priority Mail Express®

service. 

(h) Any person who attempts to mail 

correspondence addressed as set out in 

§ 1.1(a) to the Office with sufficient 

postage utilizing the Priority Mail 

Express® Post Office to Addressee 

service of the USPS, but has the 

correspondence refused by an employee 

of the USPS due to an interruption or 

emergency in Priority Mail Express®

service, may petition the Director to 

consider such correspondence as filed 

on a particular date in the Office, 

provided that: 

(1) The petition is filed promptly after 

the person becomes aware of the refusal 

of the correspondence; 

(2) The number of the Priority Mail 

Express® mailing label was placed on 

the paper(s) or fee(s) that constitute the 

correspondence prior to the attempted 

mailing by Priority Mail Express®; 

(3) The petition includes the original 

correspondence or a copy of the original 

correspondence showing the number of 

the Priority Mail Express® mailing label 

thereon; and 

(4) The petition includes a statement 

by the person who originally attempted 

to deposit the correspondence with the 

USPS which establishes, to the 

satisfaction of the Director, the original 

attempt to deposit the correspondence 

and that the correspondence or copy of 

the correspondence is the original 

correspondence or a true copy of the 

correspondence originally attempted to 

be deposited with the USPS on the 

requested filing date. The Office may 

require additional evidence to 

determine if the correspondence was 

refused by an employee of the USPS due 

to an interruption or emergency in 

Priority Mail Express® service. 

(i) Any person attempting to file 

correspondence under this section that 

was unable to be deposited with the 

USPS due to an interruption or 

emergency in Priority Mail Express®

service which has been so designated by 

the Director, may petition the Director 

to consider such correspondence as 

filed on a particular date in the Office, 

provided that: 

(1) The petition is filed in a manner 

designated by the Director promptly 

after the person becomes aware of the 

designated interruption or emergency in 

Priority Mail Express® service; 

(2) The petition includes the original 

correspondence or a copy of the original 

correspondence; and 

(3) The petition includes a statement 

which establishes, to the satisfaction of 

the Director, that the correspondence 

would have been deposited with the 

USPS but for the designated 

interruption or emergency in Priority 


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Mail Express® service, and that the 

correspondence or copy of the 

correspondence is the original 

correspondence or a true copy of the 

correspondence originally attempted to 

be deposited with the USPS on the 

requested filing date. 

PART 2—RULES OF PRACTICE IN 

TRADEMARK CASES 

■ 5. The authority citation for 37 CFR 

part 2 continues to read as follows: 

Authority: 15 U.S.C. 1123; 35 U.S.C. 2, 

unless otherwise noted. 

■ 6. Section 2.119 is amended by 

revising paragraphs (b)(4) and (c) to read 

as follows: 

§ 2.119 Service and signing of papers. 

* * * * * 

(b) * * * 

(4) Transmission by the Priority Mail 

Express® Post Office to Addressee 

service of the United States Postal 

Service or by first-class mail, which may 

also be certified or registered; 

* * * * * 

(c) When service is made by first-class 

mail, Priority Mail Express®, or 

overnight courier, the date of mailing or 

of delivery to the overnight courier will 

be considered the date of service. 

Whenever a party is required to take 

some action within a prescribed period 

after the service of a paper upon the 

party by another party and the paper is 

served by first-class mail, Priority Mail 

Express®, or overnight courier, 5 days 

shall be added to the prescribed period. 

* * * * * 

■ 7. Section 2.195 is revised to read as 

follows: 

§ 2.195 Receipt of trademark 

correspondence. 

(a) Date of receipt and Priority Mail 

Express® date of deposit. Trademark 

correspondence received in the Office is 

given a filing date as of the date of 

receipt except as follows: 

(1) The Office is not open for the 

filing of correspondence on any day that 

is a Saturday, Sunday, or Federal 

holiday within the District of Columbia. 

Except for correspondence transmitted 

electronically under paragraph (a)(2) of 

this section or transmitted by facsimile 

under paragraph (a)(3) of this section, 

no correspondence is received in the 

Office on Saturdays, Sundays, or 

Federal holidays within the District of 

Columbia. 

(2) Trademark-related correspondence 

transmitted electronically will be given 

a filing date as of the date on which the 

Office receives the transmission. 

(3) Correspondence transmitted by 

facsimile will be given a filing date as 

of the date on which the complete 

transmission is received in the Office 

unless that date is a Saturday, Sunday, 

or Federal holiday within the District of 

Columbia, in which case the filing date 

will be the next succeeding day that is 

not a Saturday, Sunday, or Federal 

holiday within the District of Columbia. 

(4) Correspondence filed in 

accordance with § 2.198 will be given a 

filing date as of the date of deposit as 

Priority Mail Express® with the United 

States Postal Service. 

(b) Correspondence delivered by 

hand. Correspondence may be delivered 

by hand during hours the Office is open 

to receive correspondence. 

(c) Facsimile transmission. Except in 

the cases enumerated in paragraph (d) of 

this section, correspondence, including 

authorizations to charge a deposit 

account, may be transmitted by 

facsimile. The receipt date accorded to 

the correspondence will be the date on 

which the complete transmission is 

received in the Office, unless that date 

is a Saturday, Sunday, or Federal 

holiday within the District of Columbia. 

See § 2.196. To facilitate proper 

processing, each transmission session 

should be limited to correspondence to 

be filed in a single application, 

registration or proceeding before the 

Office. The application serial number, 

registration number, or proceeding 

number should be entered as a part of 

the sender’s identification on a facsimile 

cover sheet. 

(d) Facsimile transmissions are not 

permitted and if submitted, will not be 

accorded a date of receipt, in the 

following situations: 

(1) Applications for registration of 

marks; 

(2) Drawings submitted under § 2.51, 

§ 2.52, § 2.72, or § 2.173; 

(3) Correspondence to be filed with 

the Trademark Trial and Appeal Board, 

except notices of ex parte appeal; 

(4) Requests for cancellation or 

amendment of a registration under 

section 7(e) of the Trademark Act; and 

certificates of registration surrendered 

for cancellation or amendment under 

section 7(e) of the Trademark Act; and 

(5) Madrid-related correspondence 

submitted under § 7.11, § 7.21, § 7.14, 

§ 7.23, § 7.24, or § 7.31. 

(e) Interruptions in U.S. Postal 

Service. (1) If the Director designates a 

postal service interruption or emergency 

within the meaning of 35 U.S.C. 21(a), 

any person attempting to file 

correspondence by Priority Mail 

Express® Post Office to Addressee 

service who was unable to deposit the 

correspondence with the United States 

Postal Service due to the interruption or 

emergency may petition the Director to 

consider such correspondence as filed 

on a particular date in the Office. 

(2) The petition must: 

(i) Be filed promptly after the ending 

of the designated interruption or 

emergency; 

(ii) Include the original 

correspondence or a copy of the original 

correspondence; and 

(iii) Include a statement that the 

correspondence would have been 

deposited with the United States Postal 

Service on the requested filing date but 

for the designated interruption or 

emergency in Priority Mail Express®

service; and that the correspondence 

attached to the petition is the original 

correspondence or a true copy of the 

correspondence originally attempted to 

be deposited as Priority Mail Express®

on the requested filing date. 

(3) Paragraphs (e)(1) and (e)(2) of this 

section do not apply to correspondence 

that is excluded from the Priority Mail 

Express® procedure pursuant to 

§ 2.198(a)(1). 

■ 8. Section 2.198 is revised to read as 

follows: 

§ 2.198 Filing of correspondence by 

Priority Mail Express®. 

(a)(1) Except for documents listed in 

paragraphs (a)(1)(i) through (vii) of this 

section, any correspondence received by 

the Office that was delivered by the 

Priority Mail Express® Post Office to 

Addressee service of the United States 

Postal Service (USPS) will be 

considered filed with the Office on the 

date of deposit with the USPS. The 

Priority Mail Express® procedure does 

not apply to: 

(i) Applications for registration of 

marks; 

(ii) Amendments to allege use under 

section 1(c) of the Act; 

(iii) Statements of use under section 

1(d) of the Act; 

(iv) Requests for extension of time to 

file a statement of use under section 1(d) 

of the Act; 

(v) Affidavits of continued use under 

section 8 of the Act; 

(vi) Renewal requests under section 9 

of the Act; and 

(vii) Requests to change or correct 

addresses. 

(2) The date of deposit with USPS is 

shown by the ‘‘date accepted’’ on the 

Priority Mail Express® label or other 

official USPS notation. If the USPS 

deposit date cannot be determined, the 

correspondence will be accorded the 

date of receipt in the Office as the filing 

date. 

(b) Correspondence should be 

deposited directly with an employee of 

the USPS to ensure that the person 

depositing the correspondence receives 


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a legible copy of the Priority Mail 

Express® mailing label with the ‘‘date 

accepted’’ clearly marked. Persons 

dealing indirectly with the employees of 

the USPS (such as by deposit in a 

Priority Mail Express® drop box) do so 

at the risk of not receiving a copy of the 

Priority Mail Express® mailing label 

with the desired ‘‘date accepted’’ clearly 

marked. The paper(s) or fee(s) that 

constitute the correspondence should 

also include the Priority Mail Express®

mailing label number thereon. See 

paragraphs (c), (d) and (e) of this 

section. 

(c) Any person filing correspondence 

under this section that was received by 

the Office and delivered by the Priority 

Mail Express® Post Office to Addressee 

service of the USPS, who can show that 

there is a discrepancy between the filing 

date accorded by the Office to the 

correspondence and the date of deposit 

as shown by the ‘‘date accepted’’ on the 

Priority Mail Express® mailing label or 

other official USPS notation, may 

petition the Director to accord the 

correspondence a filing date as of the 

‘‘date accepted’’ on the Priority Mail 

Express® mailing label or other official 

USPS notation, provided that: 

(1) The petition is filed within two 

months after the person becomes aware 

that the Office has accorded, or will 

accord, a filing date other than the USPS 

deposit date; 

(2) The number of the Priority Mail 

Express® mailing label was placed on 

the paper(s) or fee(s) that constitute the 

correspondence prior to the original 

mailing; and 

(3) The petition includes a true copy 

of the Priority Mail Express® mailing 

label showing the ‘‘date accepted,’’ and 

of any other official notation by the 

USPS relied upon to show the date of 

deposit. 

(d) Any person filing correspondence 

under this section that was received by 

the Office and delivered by the Priority 

Mail Express® Post Office to Addressee 

service of the USPS, who can show that 

the ‘‘date accepted’’ on the Priority Mail 

Express® mailing label or other official 

notation entered by the USPS was 

incorrectly entered or omitted by the 

USPS, may petition the Director to 

accord the correspondence a filing date 

as of the date the correspondence is 

shown to have been deposited with the 

USPS, provided that: 

(1) The petition is filed within two 

months after the person becomes aware 

that the Office has accorded, or will 

accord, a filing date based upon an 

incorrect entry by the USPS; 

(2) The number of the Priority Mail 

Express® mailing label was placed on 

the paper(s) or fee(s) prior to the original 

mailing; and 

(3) The petition includes a showing 

that establishes, to the satisfaction of the 

Director, that the correspondence was 

deposited in the Priority Mail Express®

Post Office to Addressee service prior to 

the last scheduled pickup on the 

requested filing date. Any showing 

pursuant to this paragraph must be 

corroborated by evidence from the USPS 

or evidence that came into being within 

one business day after the deposit of the 

correspondence in the Priority Mail 

Express® Post Office to Addressee 

service of the USPS. 

(e) If correspondence is properly 

addressed to the Office pursuant to 

§ 2.190 and deposited with sufficient 

postage in the Priority Mail Express®

Post Office to Addressee service of the 

USPS, but not received by the Office, 

the party who mailed the 

correspondence may petition the 

Director to consider such 

correspondence filed in the Office on 

the USPS deposit date, provided that: 

(1) The petition is filed within two 

months after the person becomes aware 

that the Office has no evidence of 

receipt of the correspondence; 

(2) The number of the Priority Mail 

Express® mailing label was placed on 

the paper(s) or fee(s) prior to the original 

mailing; 

(3) The petition includes a copy of the 

originally deposited paper(s) or fee(s) 

showing the number of the Priority Mail 

Express® mailing label thereon, a copy 

of any returned postcard receipt, a copy 

of the Priority Mail Express® mailing 

label showing the ‘‘date accepted,’’ a 

copy of any other official notation by 

the USPS relied upon to show the date 

of deposit, and, if the requested filing 

date is a date other than the ‘‘date 

accepted’’ on the Priority Mail Express®

mailing label or other official notation 

entered by the USPS, a showing 

pursuant to paragraph (d)(3) of this 

section that the correspondence was 

deposited in the Priority Mail Express®

Post Office to Addressee service prior to 

the last scheduled pickup on the 

requested filing date; and 

(4) The petition includes a statement 

that establishes, to the satisfaction of the 

Director, the original deposit of the 

correspondence and that the copies of 

the correspondence, the copy of the 

Priority Mail Express® mailing label, the 

copy of any returned postcard receipt, 

and any official notation entered by the 

USPS are true copies of the originally 

mailed correspondence, original Priority 

Mail Express® mailing label, returned 

postcard receipt, and official notation 

entered by the USPS. 

(f) The Office may require additional 

evidence to determine whether the 

correspondence was deposited as 

Priority Mail Express® with the USPS 

on the date in question. 

PART 7—RULES OF PRACTICE IN 

FILINGS PURSUANT TO THE 

PROTOCOL RELATING TO THE 

MADRID AGREEMENT CONCERNING 

THE INTERNATIONAL REGISTRATION 

OF MARKS 

■ 9. The authority citation for 37 CFR 

part 7 continues to read as follows: 

Authority: 15 U.S.C. 1123, 35 U.S.C. 2, 

unless otherwise noted. 

■ 10. Section 7.4 is amended by revising 

paragraph (b)(1) to read as follows: 

§ 7.4 Receipt of correspondence. 

* * * * * 

(b) * * * 

(1) International applications under 

§ 7.11, subsequent designations under 

§ 7.21, requests to record changes in the 

International Register under § 7.23 and 

§ 7.24, and petitions to the Director to 

review an action of the Office’s Madrid 

Processing Unit, when filed by mail, 

will be accorded the date of receipt in 

the Office, unless they are sent by 

Priority Mail Express® pursuant to 

§ 2.198, in which case they will be 

accorded the date of deposit with the 

United States Postal Service. 

* * * * * 

PART 11—REPRESENTATION OF 

OTHERS BEFORE THE UNITED 

STATES PATENT AND TRADEMARK 

OFFICE 

■ 11. The authority citation for 37 CFR 

part 11 continues to read as follows: 

Authority: 5 U.S.C. 500, 15 U.S.C. 1123, 35 

U.S.C. 2(b)(2), 32, 41. 

■ 12. Section 11.35 is amended by 

revising the introductory text of 

paragraph (a)(2) to read as follows: 

§ 11.35 Service of complaint. 

(a) * * * 

(2) By mailing a copy of the complaint 

by Priority Mail Express®, first-class 

mail, or any delivery service that 

provides ability to confirm delivery or 

attempted delivery to: 

* * * * * 

■ 13. Section 11.41 is amended by 

revising paragraph (b) to read as follows: 

§ 11.41 Filing of papers. 

* * * * * 

(b) All papers filed after entry of an 

initial decision by the hearing officer 

shall be filed with the USPTO Director. 

A copy of the paper shall be served on 


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the OED Director. The hearing officer or 

the OED Director may provide for filing 

papers and other matters by hand, by 

Priority Mail Express®, or by other 

means. 

■ 14. Section 11.42 is revised to read as 

follows: 

§ 11.42 Service of papers. 

(a) All papers other than a complaint 

shall be served on a respondent who is 

represented by an attorney by: 

(1) Delivering a copy of the paper to 

the office of the attorney; or 

(2) Mailing a copy of the paper by 

first-class mail, Priority Mail Express®, 

or other delivery service to the attorney 

at the address provided by the attorney 

under § 11.40(a)(1); or 

(3) Any other method mutually 

agreeable to the attorney and a 

representative for the OED Director. 

(b) All papers other than a complaint 

shall be served on a respondent who is 

not represented by an attorney by: 

(1) Delivering a copy of the paper to 

the respondent; or 

(2) Mailing a copy of the paper by 

first-class mail, Priority Mail Express®, 

or other delivery service to the 

respondent at the address to which a 

complaint may be served or such other 

address as may be designated in writing 

by the respondent; or 

(3) Any other method mutually 

agreeable to the respondent and a 

representative for the OED Director. 

(c) A respondent shall serve on the 

representative for the OED Director one 

copy of each paper filed with the 

hearing officer or the OED Director. A 

paper may be served on the 

representative for the OED Director by: 

(1) Delivering a copy of the paper to 

the representative; or 

(2) Mailing a copy of the paper by 

first-class mail, Priority Mail Express®, 

or other delivery service to an address 

designated in writing by the 

representative; or 

(3) Any other method mutually 

agreeable to the respondent and the 

representative. 

(d) Each paper filed in a disciplinary 

proceeding shall contain therein a 

certificate of service indicating: 

(1) The date on which service was 

made; and 

(2) The method by which service was 

made. 

(e) The hearing officer or the USPTO 

Director may require that a paper be 

served by hand or by Priority Mail 

Express®. 

(f) Service by mail is completed when 

the paper mailed in the United States is 

placed into the custody of the U.S. 

Postal Service. 

■ 15. Section 11.51 is amended by 

revising paragraph (a) to read as follows: 

§ 11.51 Depositions. 

(a) Depositions for use at the hearing 

in lieu of personal appearance of a 

witness before the hearing officer may 

be taken by respondent or the OED 

Director upon a showing of good cause 

and with the approval of, and under 

such conditions as may be deemed 

appropriate by, the hearing officer. 

Depositions may be taken upon oral or 

written questions, upon not less than 

ten days’ written notice to the other 

party, before any officer authorized to 

administer an oath or affirmation in the 

place where the deposition is to be 

taken. The parties may waive the 

requirement of ten days’ notice and 

depositions may then be taken of a 

witness at a time and place mutually 

agreed to by the parties. When a 

deposition is taken upon written 

questions, copies of the written 

questions will be served upon the other 

party with the notice, and copies of any 

written cross-questions will be served 

by hand or Priority Mail Express® not 

less than five days before the date of the 

taking of the deposition unless the 

parties mutually agree otherwise. A 

party on whose behalf a deposition is 

taken shall file a copy of a transcript of 

the deposition signed by a court reporter 

with the hearing officer and shall serve 

one copy upon the opposing party. 

Expenses for a court reporter and 

preparing, serving, and filing 

depositions shall be borne by the party 

at whose instance the deposition is 

taken. Depositions may not be taken to 

obtain discovery, except as provided for 

in paragraph (b) of this section. 

* * * * * 

PART 41—PRACTICE BEFORE THE 

PATENT TRIAL AND APPEAL BOARD 

■ 16. The authority citation for 37 CFR 

part 41 continues to read as follows: 

Authority: 35 U.S.C. 2(b)(2), 3(a)(2)(A), 21, 

23, 32, 41, 134, 135, and Public Law 112–29. 

■ 17. Section 41.106 is amended by 

revising paragraphs (d)(1) and (e)(3) to 

read as follows: 

§ 41.106 Filing and service. 

* * * * * 

(d) Specific filing forms—(1) Filing by 

mail. A paper filed using the Priority 

Mail Express® service of the United 

States Postal Service will be deemed to 

be filed as of ‘‘date accepted’’ on the 

Priority Mail Express® mailing label; 

otherwise, mail will be deemed to be 

filed as of the stamped date of receipt 

at the Board. 

* * * * * 

(e) * * * 

(3) Service must be by Priority Mail 

Express® or by means at least as fast and 

reliable as Priority Mail Express®. 

Electronic service is not permitted 

without Board authorization. 

* * * * * 

PART 42—TRIAL PRACTICE BEFORE 

THE PATENT TRIAL AND APPEAL 

BOARD 

■ 18. The authority citation for 37 CFR 

part 42 continues to read as follows: 

Authority: 35 U.S.C. 2(b)(2), 6, 21, 23, 41, 

135, 311, 312, 316, 321–326 and Public Law 

112–29. 

■ 19. Section 42.6 is amended by 

revising paragraph (e)(1) to read as 

follows: 

§ 42.6 Filing of documents, including 

exhibits; service. 

* * * * * 

(e) * * * 

(1) Electronic or other mode. Service 

may be made electronically upon 

agreement of the parties. Otherwise, 

service may be by Priority Mail 

Express® or by means at least as fast and 

reliable as Priority Mail Express®. 

* * * * * 

■ 20. Section 42.105 is amended by 

revising paragraph (b) to read as follows: 

§ 42.105 Service of petition. 

* * * * * 

(b) Upon agreement of the parties, 

service may be made electronically. 

Service may be by Priority Mail 

Express® or by means at least as fast and 

reliable as Priority Mail Express®. 

Personal service is not required. 

■ 21. Section 42.205 is amended by 

revising paragraph (b) to read as follows: 

§ 42.205 Service of petition. 

* * * * * 

(b) Upon agreement of the parties, 

service may be made electronically. 

Service may be by Priority Mail 

Express® or by means at least as fast and 

reliable as Priority Mail Express®. 

Personal service is not required. 

■ 22. Section 42.406 is amended by 

revising paragraph (b) to read as follows: 

§ 42.406 Service of petition. 

* * * * * 

(b) Upon agreement of the parties, 

service may be made electronically. 

Service may be by Priority Mail 

Express® or by means at least as fast and 

reliable as Priority Mail Express®. 

Personal service is not required. 


tkelley on DSK3SPTVN1PROD with RULES
63044 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Rules and Regulations 

Dated: October 10, 2014. 

Michelle K. Lee, 

Deputy Under Secretary of Commerce for 

Intellectual Property and Deputy Director of 

the United States Patent and Trademark 

Office. 

[FR Doc. 2014–24891 Filed 10–21–14; 8:45 am] 

BILLING CODE 3510–16–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R07–OAR–2014–0500; FRL–9918–11– 

Region 7] 

Approval and Promulgation of 

Implementation Plans; State of 

Kansas; Infrastructure SIP 

Requirements for the 2010 Nitrogen 

Dioxide National Ambient Air Quality 

Standard 

AGENCY: Environmental Protection 

Agency. 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is taking final action to 

approve elements of a State 

Implementation Plan (SIP) submission 

from the State of Kansas addressing the 

applicable requirements of Clean Air 

Act (CAA) section 110 for the 2010 

National Ambient Air Quality Standards 

(NAAQS) for Nitrogen Dioxide (NO2), 

which requires that each state adopt and 

submit a SIP to support implementation, 

maintenance, and enforcement of each 

new or revised NAAQS promulgated by 

EPA. These SIPs are commonly referred 

to as ‘‘infrastructure’’ SIPs. The 

infrastructure requirements are designed 

to ensure that the structural components 

of each state’s air quality management 

program are adequate to meet the state’s 

responsibilities under the CAA. 

DATES: This final rule is effective 

November 21, 2014. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. EPA–R07–OAR–2014–0500. All 

documents in the electronic docket are 

listed in the http://www.regulations.gov 

index. Although listed in the index, 

some information is not publicly 

available, i.e., CBI or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically at http://

www.regulations.gov or in hard copy at 

U.S. Environmental Protection Agency, 

Region 7, 11201 Renner Boulevard, 

Lenexa, Kansas 66219 from 8:00 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The interested 

persons wanting to examine these 

documents should make an 

appointment with the office at least 24 

hours in advance. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Lachala Kemp, Air Planning and 

Development Branch, U.S. 

Environmental Protection Agency, 

Region 7, 11201 Renner Boulevard, 

Lenexa, KS 66219; telephone number: 

(913) 551–7214; fax number: (913) 551– 

7065; email address: kemp.lachala@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, the terms 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ refer to EPA. This 

section provides additional information 

by addressing the following: 

I. Background 

II. Summary of SIP Revision 

III. Final Action 

IV. Statutory and Executive Order Review 

I. Background 

On August 28, 2014, (79 FR 51277), 

EPA published a notice of proposed 

rulemaking (NPR) for the State of 

Kansas. The NPR proposed approval of 

Kansas’ submission that provides the 

basic elements specified in section 

110(a)(2) of the CAA, or portions 

thereof, necessary to implement, 

maintain, and enforce the 2010 NO2

NAAQS. 

II. Summary of SIP Revision 

On March 19, 2013, and May 9, 2013, 

EPA received SIP submissions from the 

state of Kansas that address the 

infrastructure elements specified in 

section 110(a)(2) for the 2010 NO2

NAAQS. The submissions addressed the 

following infrastructure elements of 

section 110(a)(2): (A), (B), (C), (D), (E), 

(F), (G), (H), (J), (K), (L), and (M). 

Specific requirements of section 

110(a)(2) of the CAA and the rationale 

for EPA’s proposed action to approve 

the SIP submission are explained in the 

NPR and will not be restated here. No 

public comments were received on the 

NPR. 

III. Final Action 

EPA is approving Kansas’ 

submissions which provides the basic 

program elements specified in section 

110(a)(2)(A), (B), (C), (D), (E), (F), (G), 

(H), (J), (K), (L), and (M) of the CAA, or 

portions thereof, necessary to 

implement, maintain, and enforce the 

2010 NO2 NAAQS, as a revision to the 

Kansas SIP. This action is being taken 

under section 110 of the CAA. As 

discussed in each applicable section of 

the NPR, EPA is not acting on section 

110(a)(2)(I)—Nonattainment Area Plan 

or Plan Revisions Under Part D, and on 

the visibility protection portion of 

section 110(a)(2)(J). 

IV. Statutory and Executive Order 

Review 

Under the CAA the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

Act and applicable Federal regulations. 

42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, 

EPA’s role is to approve state choices, 

provided that they meet the criteria of 

the CAA. Accordingly, this action 

merely approves state law as meeting 

Federal requirements and does not 

impose additional requirements beyond 

those imposed by state law. For that 

reason, this action: 

• Is not a ‘‘significant regulatory 

action’’ under the terms of Executive 

Order 12866 (58 FR 51735, October 4, 

1993) and is therefore not subject to 

review under Executive Orders 12866 

and 13563 (76 FR 3821, January 21, 

2011). 

• does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• is not subject to requirements of 

section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 


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