1346 Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Rules and Regulations 

(NEPA) (42 U.S.C. 4321–4370f), and 

have determined that this action is one 

of a category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves 

establishment of a safety zone and thus, 

is categorically excluded from further 

review under paragraph 34(g) of Figure 

2–1 of the Commandant Instruction. 

Under figure 2–1, paragraph (34)(g), of 

the Instruction, an environmental 

analysis checklist supporting this 

determination and a Categorical 

Exclusion Determination will be 

available in the docket where indicated 

under ADDRESSES. We seek any 

comments or information that may lead 

to the discovery of a significant 

environmental impact from this rule. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C., 1231; 46 U.S.C. 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Pub. L. 107–295, 116 Stat. 2064; Department 

of Homeland Security Delegation No. 0170.1. 

■ 2. Add § 165.T01–1037 to read as 

follows: 

§ 165.T01–1037 Safety Zone: Eastport 

Breakwater Terminal, Eastport, Maine. 

(a) Location. The following area is a 

safety zone: All navigable waters, from 

surface to bottom, within the following 

position(s) 44°54′26′′ N, 066°59′00′′ W, 

44°54′25′′ N, 066°58′54′′ W, 44°54′19′′ N, 

066°58′55′′ W, 44°54′19′′ N, 066°59′01′′ 

W, (NAD). Friar Roads, Eastport, Maine. 

All positions are approximate. 

(b) Enforcement period. This rule will 

be enforced from 3:00 p.m. on December 

11, 2014 to 11:59 p.m. January 30, 2017. 

(c) Notification. Coast Guard Sector 

Northern New England will give actual 

notice to mariners for the purpose of 

enforcement of this temporary safety 

zone. Also, Sector Northern New 

England will notify the public to the 

greatest extent possible of any period in 

which the Coast Guard will suspend 

enforcement of this safety zone. 

(d) Regulations. (1) The general 

regulations contained in § 165.23 apply. 

(2) In accordance with the general 

regulations in § 165.23, entry into or 

movement within this zone is 

prohibited unless authorized by the 

Captain of the Port or his designated 

representatives. 

(3) The ‘‘designated representative’’ is 

any Coast Guard commissioned, 

warrant, or petty officer who has been 

designated by the Captain of the Port to 

act on his behalf. The designated 

representative may be on board a Coast 

Guard vessel, or on board a federal, 

state, or local agency vessel that is 

authorized to act in support of the Coast 

Guard. 

(4) Upon being hailed by a U.S. Coast 

Guard vessel or his designated 

representatives by siren, radio, flashing 

light or other means, the operator of the 

vessel shall proceed as directed. 

(5) Vessel operators desiring to enter 

or operate within this safety zone shall 

contact the Captain of the Port or his 

designated representatives via VHF 

channel 16 to obtain permission to do 

so. 

Dated: December 12, 2014. 

B. S. Gilda, 

Captain, U.S. Coast Guard, Captain of the 

Port, Northern New England. 

[FR Doc. 2015–00184 Filed 1–8–15; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF COMMERCE 

United States Patent and Trademark 

Office 

37 CFR Part 1 

[Docket No.: PTO–P–2014–0023] 

RIN 0651–AC96 

Changes to Patent Term Adjustment in 

View of the Federal Circuit Decision in 

Novartis v. Lee 

AGENCY: United States Patent and 

Trademark Office, Commerce. 

ACTION: Final rule. 

SUMMARY: The United States Patent and 

Trademark Office (Office) is revising the 

rules of practice pertaining to patent 

term adjustment in view of the decision 

by the U.S. Court of Appeals for the 

Federal Circuit (Federal Circuit) in 

Novartis AG v. Lee. The Federal Circuit 

confirmed in Novartis that any time 

consumed by continued examination is 

subtracted in determining the extent to 

which the period of application 

pendency exceeds three years, 

regardless of when the continued 

examination was initiated. The Federal 

Circuit, however, decided that the time 

consumed by continued examination 

does not include the time after a notice 

of allowance, unless the Office actually 

resumes examination of the application 

after allowance. Accordingly, the Office 

is revising the rules of practice to 

provide that the time consumed by 

continued examination does not include 

the time after a notice of allowance, 

unless the applicant files a request for 

continued examination after such 

allowance. The Office also is revising 

the rules of practice to provide that the 

submission of a request for continued 

examination after any notice of 

allowance has been mailed will 

constitute a failure of an applicant to 

engage in reasonable efforts to conclude 

processing or examination of an 

application and thus result in a 

reduction of any period of patent term 

adjustment. The Office is providing an 

exception to this patent term adjustment 

reduction provision for a request for 

continued examination filed solely to 

submit information cited in a patent 

office communication in a counterpart 

application that is submitted to the 

Office within thirty days of receipt of 

the patent office communication. 

Additionally, the Office is clarifying 

what papers may be submitted after a 

notice of allowance without the 

applicant being considered to have 

failed to engage in reasonable efforts to 

conclude processing or examination of 

the application. 

DATES: Effective date: The changes to 37 

CFR 1.703 in this final rule are effective 

on January 9, 2015, and the changes to 

37 CFR 1.704 in this final rule are 

effective on March 10, 2015. 

Applicability date: The changes to 37 

CFR 1.703 in this final rule apply to any 

patent granted before, on, or after 

January 9, 2015. 37 CFR 1.704 as 

adopted in this final rule applies to all 

original applications (other than for a 

design patent) filed on or after May 29, 

2000, and to patents issued on such 

applications, except that 37 CFR 

1.704(c)(12) as adopted in this final rule 

applies only to applications in which a 

request for continued examination 

under 35 U.S.C. 132(b) and 37 CFR 

1.114 is filed on or after March 10, 2015, 

and 37 CFR 1.704(c)(13) as adopted in 

this final rule applies only to patent 

applications filed under 35 U.S.C. 111 

on or after December 18, 2013, and 

international patent applications in 

which the national stage commenced 

under 35 U.S.C. 371 on or after 

December 18, 2013. 

FOR FURTHER INFORMATION CONTACT: Kery 

Fries, Senior Legal Advisor, Office of 

Patent Legal Administration, Office of 

the Deputy Commissioner for Patent 

Examination Policy, at telephone 

number 571–272–7757. 


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Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Rules and Regulations 1347 

SUPPLEMENTARY INFORMATION: Executive 

Summary: Purpose: The Office is 

revising the rules of practice pertaining 

to the patent term adjustment provisions 

of 35 U.S.C. 154(b) in view of the 

decision by the Federal Circuit in 

Novartis, 740 F.3d 593 (Fed. Cir. 2014). 

The Federal Circuit confirmed in 

Novartis that any time consumed by 

continued examination under 35 U.S.C. 

132(b) is subtracted in determining the 

extent to which the period defined in 35 

U.S.C. 154(b)(1)(B) exceeds three years, 

regardless of when the continued 

examination under 35 U.S.C. 132(b) was 

initiated. The Federal Circuit, however, 

decided that the time consumed by 

continued examination under 35 U.S.C. 

132(b) does not include the time after a 

notice of allowance unless the Office 

actually resumes examination of the 

application after allowance. This final 

rule follows the Office’s earlier proposal 

to change the rules of practice in view 

of the Federal Circuit’s decision in 

Novartis. See Changes to Patent Term 

Adjustment in view of the Federal 

Circuit Decision in Novartis v. Lee, 79 

FR 34681 (June 18, 2014) (Novartis 

notice of proposed rulemaking). 

Summary of Major Provisions: The 

Office is revising the rules of practice to 

provide that the time consumed by 

continued examination does not include 

the time after the mailing date of a 

notice of allowance, unless the 

applicant files a request for continued 

examination under 35 U.S.C. 132(b) 

after such allowance. The Office also is 

revising the rules of practice to provide 

that the submission of a request for 

continued examination after any notice 

of allowance has been mailed will 

constitute a failure of an applicant to 

engage in reasonable efforts to conclude 

processing or examination of an 

application and thus result in a 

reduction of any period of patent term 

adjustment. The Office is providing an 

exception to this patent term adjustment 

reduction provision for a request for 

continued examination filed solely to 

submit information cited in a patent 

office communication in a counterpart 

application that is submitted to the 

Office within thirty days of receipt of 

the patent office communication. 

Additionally, the Office is clarifying 

what papers may be submitted after a 

notice of allowance without the 

applicant being considered to have 

failed to engage in reasonable efforts to 

conclude processing or examination of 

the application. 

Costs and Benefits: This rulemaking is 

not economically significant under 

Executive Order 12866 (Sept. 30, 1993). 

Background: Section 532(a) of the 

Uruguay Round Agreements Act or 

URAA (Pub. L. 103–465, 108 Stat. 4809 

(1994)) amended 35 U.S.C. 154 to 

provide that the term of a patent ends 

on the date that is twenty years from the 

filing date of the application, or the 

earliest filing date for which a benefit is 

claimed under 35 U.S.C. 120, 121, or 

365(c). The URAA also contained 

provisions, codified at 35 U.S.C. 154(b), 

for patent term extension due to certain 

examination delays. Under the patent 

term extension provisions of 35 U.S.C. 

154(b) as amended by the URAA, an 

applicant is entitled to patent term 

extension for delays due to interference 

(which has since been replaced by 

derivation), secrecy order, or successful 

appellate review. See 35 U.S.C. 154(b) 

(1995). The Office implemented the 

patent term extension provisions of the 

URAA in a final rule published in April 

of 1995. See Changes to Implement 20- 

Year Patent Term and Provisional 

Applications, 60 FR 20195 (Apr. 25, 

1995) (twenty-year patent term final 

rule). 

The American Inventors Protection 

Act of 1999 or AIPA (Pub. L. 106–113, 

113 Stat. 1501, 1501A–552 through 

1501A–591 (1999)) further amended 35 

U.S.C. 154(b) to include additional 

bases for patent term extension 

(characterized as ‘‘patent term 

adjustment’’ in the AIPA). Original 

utility and plant patents issuing from 

applications filed on or after May 29, 

2000, may be eligible for patent term 

adjustment if issuance of the patent is 

delayed due to one or more of the 

enumerated administrative delays listed 

in 35 U.S.C. 154(b)(1). Specifically, 

under the patent term adjustment 

provisions of 35 U.S.C. 154(b) as 

amended by the AIPA, an applicant is 

entitled to patent term adjustment for 

the following reasons: (1) If the Office 

fails to take certain actions during the 

examination and issue process within 

specified time frames (35 U.S.C. 

154(b)(1)(A)); (2) if the Office fails to 

issue a patent within three years of the 

actual filing date of the application (35 

U.S.C. 154(b)(1)(B)); and (3) for delays 

due to interference (and now 

derivation), secrecy order, or successful 

appellate review (35 U.S.C. 

154(b)(1)(C)). See 35 U.S.C. 154(b)(1). 

The AIPA, however, sets forth a number 

of conditions and limitations on any 

patent term adjustment accrued under 

35 U.S.C. 154(b)(1). Specifically, 35 

U.S.C. 154(b)(2)(C) provides, in part, 

that ‘‘[t]he period of adjustment of the 

term of a patent under [35 U.S.C. 

154(b)(1)] shall be reduced by a period 

equal to the period of time during which 

the applicant failed to engage in 

reasonable efforts to conclude 

prosecution of the application’’ and that 

‘‘[t]he Director shall prescribe 

regulations establishing the 

circumstances that constitute a failure of 

an applicant to engage in reasonable 

efforts to conclude processing or 

examination of an application.’’ 35 

U.S.C. 154(b)(2)(C)(i) and (iii). The 

Office implemented the patent term 

adjustment provisions of 35 U.S.C. 

154(b) as amended by the AIPA, 

including setting forth circumstances 

that constitute a failure of an applicant 

to engage in reasonable efforts to 

conclude processing or examination of 

an application, in a final rule published 

in September of 2000. See Changes to 

Implement Patent Term Adjustment 

Under Twenty-Year Patent Term, 65 FR 

56365 (Sept. 18, 2000) (AIPA patent 

term adjustment final rule). 

In January 2014, the Federal Circuit 

issued a decision in Novartis pertaining 

to the patent term adjustment provisions 

of 35 U.S.C. 154(b), and specifically the 

impact of continued examination under 

35 U.S.C. 132(b) on patent term 

adjustment under the three-year 

pendency provision of 35 U.S.C. 

154(b)(1)(B). The Federal Circuit 

confirmed in Novartis that any time 

consumed by continued examination 

under 35 U.S.C. 132(b) is subtracted in 

determining the extent to which the 

period defined in 35 U.S.C. 154(b)(1)(B) 

exceeds three years, regardless of when 

the continued examination under 35 

U.S.C. 132(b) was initiated. See 740 

F.3d at 601 (‘‘[t]he better reading of the 

language is that the patent term 

adjustment time should be calculated by 

determining the length of the time 

between application and patent 

issuance, then subtracting any 

continued examination time (and other 

time identified in (i), (ii), and (iii) of [35 

U.S.C. 154](b)(1)(B)), and determining 

the extent to which the result exceeds 

three years’’). The Federal Circuit, 

however, decided that the time 

consumed by continued examination 

under 35 U.S.C. 132(b) does not include 

the time after a notice of allowance 

unless the Office actually resumes 

examination of the application after 

allowance. See 740 F.3d at 602 (‘‘[t]he 

common-sense understanding of ‘time 

consumed by continued examination,’ 

35 U.S.C. 154(b)(1)(B)(i), is time up to 

allowance, but not later, unless 

examination on the merits resumes’’). 

Therefore, the Office is revising the 

rules of practice to provide that the time 

consumed by continued examination 

under 35 U.S.C. 132(b) does not include 

the time after the mailing date of a 

notice of allowance, unless the 


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1348 Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Rules and Regulations 

applicant files a request for continued 

examination after such allowance. 

The Office makes the patent term 

adjustment determination indicated in 

the patent by a computer program that 

uses the information recorded in the 

Office’s Patent Application Locating and 

Monitoring (PALM) system (except 

when an applicant requests 

reconsideration pursuant to § 1.705). 

See Changes to Implement Patent Term 

Adjustment Under Twenty-Year Patent 

Term, 65 FR at 56381 (response to 

comment 25). The decision in Novartis 

that the time consumed by continued 

examination under 35 U.S.C. 132(b) 

does not include the time after a notice 

of allowance unless the Office actually 

resumes examination of the application 

after allowance required a modification 

of the Office’s patent term adjustment 

program. The modification of the 

Office’s patent term adjustment program 

required by the decision in Novartis has 

now been completed, and the patent 

term adjustment determinations in 

patents issued on or after October 7, 

2014 are consistent with the Federal 

Circuit decision in Novartis and this 

final rule. The Office calculates the 

patent term adjustment manually when 

an applicant requests reconsideration of 

a patent term adjustment determination 

pursuant to 37 CFR 1.705. The Office 

has been deciding requests for 

reconsideration of a patent term 

adjustment filed pursuant to 37 CFR 

1.705 consistent with the Federal 

Circuit decision in Novartis since 

January 15, 2014 (the date the Federal 

Circuit issued its decision in Novartis). 

Nothing in this final rule shall be 

construed as a waiver of: (1) The 

requirement of 37 CFR 1.705(b) that any 

request for reconsideration of the patent 

term adjustment indicated on the patent 

must be by way of an application for 

patent term adjustment filed no later 

than two months from the date the 

patent was granted (which two-month 

period may be extended under the 

provisions of 37 CFR 1.136(a)), and be 

accompanied by the items specified in 

37 CFR 1.705(b)(1) and (b)(2); or (2) the 

requirement of 35 U.S.C. 154(b)(4) that 

an applicant dissatisfied with the 

Director’s decision on the applicant’s 

request for reconsideration under 35 

U.S.C. 154(b)(3)(B)(ii) shall have 

exclusive remedy by a civil action 

against the Director filed in the United 

States District Court for the Eastern 

District of Virginia within 180 days after 

the date of the Director’s decision on the 

applicant’s request for reconsideration 

under 35 U.S.C. 154(b)(3)(B)(ii). In other 

words, nothing in this final rule excuses 

patentees from having to meet the time 

limitations set forth in 37 CFR 1.705 or 

35 U.S.C. 154(b)(4) in effect at the time 

of the patent’s issuance in order to 

challenge any patent term adjustment 

under 37 CFR 1.702 et seq. regarding the 

issues addressed in this final rule. 

As discussed previously, the patent 

term adjustment statutory provision also 

includes the provision that ‘‘[t]he period 

of adjustment of the term of a patent 

under [35 U.S.C. 154(b)(1)] shall be 

reduced by a period equal to the period 

of time during which the applicant 

failed to engage in reasonable efforts to 

conclude prosecution of the 

application,’’ and that ‘‘[t]he Director 

shall prescribe regulations establishing 

the circumstances that constitute a 

failure of an applicant to engage in 

reasonable efforts to conclude 

processing or examination of an 

application.’’ See 35 U.S.C. 

154(b)(2)(C)(i) and (iii). Under the 

authority provided in 35 U.S.C. 

154(b)(2)(C)(iii), the Office is revising 

the rules of practice to establish that the 

submission of a request for continued 

examination after any notice of 

allowance has been mailed constitutes a 

failure of an applicant to engage in 

reasonable efforts to conclude 

processing or examination of an 

application. This provision has been 

adopted to ensure that an applicant does 

not obtain additional patent term 

adjustment under 35 U.S.C. 154(b)(1)(B) 

for the time after a notice of allowance 

has been mailed as a consequence of 

delaying issuance of the patent by filing 

a request for continued examination 

under 35 U.S.C. 132(b) after a notice of 

allowance has been mailed. 

Discussion of Specific Rules 

The following is a discussion of 

amendments to title 37 of the Code of 

Federal Regulations, Part 1: 

Section 1.703: Section 1.703(b)(1) is 

amended to provide that the time 

consumed by continued examination of 

the application under 35 U.S.C. 132(b) 

is the number of days, if any, in the 

period beginning on the date on which 

any request for continued examination 

of the application under 35 U.S.C. 

132(b) was filed and ending on the date 

of mailing of the notice of allowance 

under 35 U.S.C. 151. If a first request for 

continued examination is filed before a 

notice of allowance has been mailed and 

a second request for continued 

examination is filed after a notice of 

allowance has been mailed, the time 

consumed by continued examination of 

the application under 35 U.S.C. 132(b) 

is the number of days in the period 

beginning on the date on which the first 

request for continued examination was 

filed and ending on the date of mailing 

of the notice of allowance following the 

first request for continued examination, 

plus the number of days in the period 

beginning on the date on which the 

second request for continued 

examination was filed and ending on 

the date of mailing of the notice of 

allowance following the second request 

for continued examination. If a second 

request for continued examination is 

filed without a notice of allowance 

having been mailed between the filing 

of the first and second requests for 

continued examination and a notice of 

allowance is mailed after the second 

request for continued examination, the 

time consumed by continued 

examination of the application under 35 

U.S.C. 132(b) is the number of days in 

the period beginning on the date on 

which the first request for continued 

examination was filed and ending on 

the date of mailing of the notice of 

allowance. 

Section 1.704: Section 1.704(c)(10) is 

amended to change ‘‘other paper’’ to 

‘‘other paper, other than a request for 

continued examination in compliance 

with § 1.114,’’ to clarify that the filing of 

a request for continued examination 

under 35 U.S.C. 132(b) in compliance 

with § 1.114 is treated under 

§ 1.704(c)(12) rather than § 1.704(c)(10). 

Section 1.704(c)(12) is amended to 

include a new provision that establishes 

the submission of a request for 

continued examination under 35 U.S.C. 

132(b) after any notice of allowance 

under 35 U.S.C. 151 has been mailed as 

constituting a failure of an applicant to 

engage in reasonable efforts to conclude 

processing or examination of an 

application, in which case the period of 

adjustment set forth in § 1.703 shall be 

reduced by the number of days, if any, 

beginning on the date of mailing of the 

notice of allowance under 35 U.S.C. 151 

and ending on the date the request for 

continued examination under 35 U.S.C. 

132(b) was filed. As discussed 

previously, this provision has been 

adopted to ensure that an applicant does 

not obtain additional patent term 

adjustment under 35 U.S.C. 154(b)(1)(B) 

for the time after a notice of allowance 

has been mailed as a consequence of 

delaying issuance of the patent by filing 

a request for continued examination 

under 35 U.S.C. 132(b) after a notice of 

allowance has been mailed. Moreover, 

the filing of a request for continued 

examination after the mailing of a notice 

of allowance removes the application 

from the issue process, prevents the 

Office from issuing the patent, and 

requires the Office to determine if the 

submission affects the patentability of 

the application, which adds to the 

pendency of the application in which 

the request for continued examination is 


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Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Rules and Regulations 1349 

filed (as well as other applications since 

examination resources must be diverted 

from other applications to the 

application in which the request for 

continued examination is filed). 

Section 1.704(c)(13) is amended and 

§ 1.704(c)(14) is added to include the 

provisions of §§ 1.704(c)(12) and (c)(13), 

respectively. 

Section 1.704(d) is amended to also 

provide that a request for continued 

examination in compliance with § 1.114 

with submission of only an information 

disclosure statement in compliance with 

§§ 1.97 and 1.98 will not be considered 

a failure to engage in reasonable efforts 

to conclude prosecution (processing or 

examination) of the application under 

§ 1.704(c)(12), if the request for 

continued examination under 35 U.S.C. 

132(b) is accompanied by the statement 

provided for in § 1.704(d). 

The Office has a pilot program that 

reduces the need for processing a 

request for continued examination with 

an information disclosure statement 

filed after payment of the issue fee in 

order for the information disclosure 

statement to be considered by the 

examiner. See Quick Path Information 

Disclosure Statement (QPIDS) Pilot 

Program, 77 FR 27443 (May 10, 2012). 

Applicants are encouraged to use the 

QPIDS program when submitting an 

information disclosure statement after 

payment of the issue fee, but an 

applicant may file a request for 

continued examination with an 

information disclosure statement and 

statement under § 1.704(d) without 

submitting the request for continued 

examination and information disclosure 

statement via the QPIDS program. An 

applicant submitting an information 

disclosure statement filed after payment 

of the issue fee via the QPIDS program 

should also include the statement under 

§ 1.704(d) (if appropriate) with the 

conditional request for continued 

examination submitted in accordance 

with the QPIDS program. 

Comments and Responses to 

Comments: The Office received eight 

written comments from intellectual 

property organizations, industry, a law 

firm, individual patent practitioners, 

and the general public in response to 

the Novartis notice of proposed 

rulemaking. The comments and the 

Office’s responses to those comments 

follow: 

Comment 1: Several comments 

suggest that ‘‘time consumed by 

continued examination of the 

application requested by the applicant 

under section 132(b)’’ under 35 U.S.C. 

154(b)(1)(B)(i) does not include the date 

of mailing of a notice of allowance, 

citing Novartis, 740 F.3d at 601 et seq. 

Response: The Federal Circuit 

decision in Novartis does not 

specifically state whether the date of 

mailing of a notice of allowance is 

considered part of the ‘‘time consumed 

by continued examination of the 

application requested by the applicant 

under section 132(b)’’ within the 

meaning of 35 U.S.C. 154(b)(1)(B)(i). 

The Federal Circuit decision in Novartis 

simply discusses the time period 

‘‘before allowance’’ and the ‘‘time after 

allowance, until issuance.’’ See 

Novartis, 740 F.3d at 602 (‘‘we reject the 

PTO’s view that the time after 

allowance, until issuance, is ‘time 

consumed by continued examination’ ’’ 

and ‘‘ ‘time consumed by continued 

examination’ . . . is time up to 

allowance, but not later’’) (emphasis 

added). The mailing of the notice of 

allowance is the action which concludes 

examination of the application and 

closes prosecution of the application. 

See id. (‘‘ ‘examination’ presumptively 

ends at allowance, when prosecution is 

closed and there is no further 

examination on the merits. . . .’’) 

(emphasis added). Thus, it is 

appropriate to consider the ‘‘time 

consumed by continued examination of 

the application requested by the 

applicant under section 132(b)’’ as 

including the date of mailing of the 

notice of allowance in an application 

that has been allowed after the filing of 

a request for continued examination. 

In addition, treating the period of 

‘‘time consumed by continued 

examination of the application 

requested by the applicant under 

section 132(b)’’ as ending on the date on 

which a notice of allowance is mailed 

(rather than the day before the date on 

which a notice of allowance is mailed) 

is consistent with how the Office treats 

the date on which a patent issues for 

purposes of 35 U.S.C. 154(b)(1)(A)(iv) 

(four months to issue patent term 

adjustment provision) and 154(b)(1)(B) 

(the three-year pendency patent term 

adjustment provision). Specifically, the 

Office treats the four-month period in 35 

U.S.C. 154(b)(1)(A)(iv) and the threeyear period in 35 U.S.C. 154(b)(1)(B) as 

ending on the date the patent issues 

(rather than day before date the patent 

issues), even though the patent has been 

granted and is in force on the date the 

patent issues. 

Comment 2: Several comments 

oppose the provision in proposed 

§ 1.703(b)(1) that if prosecution in the 

application is reopened, the period 

under § 1.702(b) does not include the 

period between the reopening of 

prosecution and the date of mailing of 

a subsequent notice of allowance. The 

comments suggest that the period under 

§ 1.702(b) should include any period of 

post-allowance examination unless the 

reopening of prosecution is in response 

to a request for continued examination, 

or at least that the period of adjustment 

under § 1.702(b) should include any 

period of post-allowance examination 

due to the Office sua sponte reopening 

prosecution. 

Response: Section 1.703(b)(1) as 

adopted in this final rule provides that 

the time consumed by continued 

examination of the application under 35 

U.S.C. 132(b) is the number of days, if 

any, in the period beginning on the date 

on which any request for continued 

examination of the application under 35 

U.S.C. 132(b) was filed and ending on 

the date of mailing of the notice of 

allowance under 35 U.S.C. 151. Thus, 

any period of examination after the 

mailing of a notice of allowance 

resulting from the filing of a subsequent 

request for continued examination 

would be considered ‘‘time consumed 

by continued examination,’’ but a 

period of examination after the mailing 

of a notice of allowance resulting from 

the Office sua sponte reopening 

prosecution would not be considered 

‘‘time consumed by continued 

examination’’ (unless the applicant 

subsequently files a request for 

continued examination). 

Comment 3: One comment suggests 

that there is no basis for treating a 

second or subsequent request for 

continued examination after a notice of 

allowance as ‘‘time consumed by 

continued examination of the 

application requested by the applicant 

under section 132(b),’’ arguing that the 

Novartis court did not consider second 

or third requests for continued 

examination to be continued 

examination. The comment alternatively 

suggests that a second or subsequent 

request for continued examination after 

a notice of allowance should not be 

treated as ‘‘time consumed by continued 

examination of the application 

requested by the applicant under 

section 132(b)’’ unless the request for 

continued examination results in the 

mailing of an Office action under 35 

U.S.C. 132. One comment states that it 

is not clear why ‘‘time consumed by 

continued examination’’ is defined in 

such a way as to include noncontiguous periods of exclusion in 

certain circumstances where 

prosecution is reopened. 

Response: 35 U.S.C. 154(b)(1)(B)(i) 

provides that the period under 35 U.S.C. 

154(b)(1)(B) does not include ‘‘any time 

consumed by continued examination of 

the application requested by the 

applicant under section 132(b)’’ 

(emphasis added). There is no basis for 


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1350 Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Rules and Regulations 

treating a second or subsequent request 

for continued examination differently 

than the first request for continued 

examination with respect to period 

between the filing of the request for 

continued examination and a notice of 

allowance being considered ‘‘time 

consumed by continued examination of 

the application requested by the 

applicant under section 132(b).’’ The 

Federal Circuit decision in Novartis did 

not state that this time ‘‘consumed by 

continued examination of the 

application’’ under 35 U.S.C. 

154(b)(1)(B)(i) includes only the time 

consumed by a first request for 

continued examination, or includes the 

time consumed by a request for 

continued examination only if the 

Office issues an Office action under 35 

U.S.C. 132. 

Treating a second or subsequent 

request for continued examination as 

not being ‘‘time consumed by continued 

examination of the application 

requested by the applicant under 

section 132(b)’’ unless the Office issues 

an Office action under 35 U.S.C. 132 in 

response to the request for continued 

examination would not be consistent 

with the statutory framework of 35 

U.S.C. 131, 132, and 151. 35 U.S.C. 131 

provides for examination of patent 

applications, specifically stating that 

‘‘[t]he Director shall cause an 

examination to be made of the 

application and the alleged new 

invention; and if on such examination it 

appears that the applicant is entitled to 

a patent under the law, the Director 

shall issue a patent therefor.’’ 35 U.S.C. 

131. Thus, examination has two 

possible outcomes: Namely, if ‘‘on such 

examination it appears that the 

applicant is entitled to a patent under 

the law,’’ the Office issues a notice of 

allowance under 35 U.S.C. 151; 

however, if ‘‘on such examination’’ it 

does not appear that the applicant is 

entitled to a patent under the law, the 

Office issues a notice (Office action) 

under 35 U.S.C. 132 specifying the 

reasons why it does not appear that the 

applicant is entitled to a patent under 

the law. See 35 U.S.C. 132(a) 

(‘‘Whenever, on examination, any claim 

for a patent is rejected, or any objection 

or requirement made, the Director shall 

notify the applicant thereof, stating the 

reasons for such rejection, or objection 

or requirement, together with such 

information and references as may be 

useful in judging of the propriety of 

continuing the prosecution of his 

application’’). Thus, the time period 

between a request for continued 

examination and a notice of allowance 

is ‘‘time consumed by continued 

examination of the application 

requested by the applicant under 

section 132(b)’’ regardless of whether 

the Office issues an Office action under 

35 U.S.C. 132. 

Finally, § 1.703(b)(1) as adopted in 

this final rule does not ‘‘define’’ ‘‘time 

consumed by continued examination’’ 

as generally or necessarily including 

non-contiguous periods. The ‘‘time 

consumed by continued examination’’ 

as measured by § 1.703(b)(1) will 

include non-contiguous periods if the 

applicant files a request for continued 

examination after a notice of allowance 

is mailed because the ‘‘time consumed 

by continued examination’’ includes 

non-contiguous periods if the applicant 

files a request for continued 

examination after a notice of allowance 

is mailed. 

Comment 4: One comment questions 

how an application will be treated when 

multiple consecutive notices of 

allowance (e.g., a notice of allowance 

and then a supplemental notice of 

allowance) are mailed. 

Response: The Office issues a notice 

of allowability (PTOL–37) and a notice 

of allowance (PTOL–85) when an 

application is in condition for 

allowance. The Office rarely issues 

multiple consecutive notices of 

allowance (PTOL–85) (e.g., a notice of 

allowance and then a supplemental 

notice of allowance). In the rare 

situation in which the Office issues 

multiple consecutive notices of 

allowance (PTOL–85), the ‘‘time 

consumed by continued examination of 

the application requested by the 

applicant under section 132(b)’’ is the 

number of days, if any, in the period 

beginning on the date on which a 

request for continued examination was 

filed and ending on the date of mailing 

of the first notice of allowance (PTOL– 

85). 

The Office does occasionally mail or 

issue multiple consecutive notices of 

allowability (PTOL–37) (e.g., a notice of 

allowability and then a supplemental 

notice of allowability). In these 

situations, the ‘‘time consumed by 

continued examination of the 

application requested by the applicant 

under section 132(b)’’ is the number of 

days, if any, in the period beginning on 

the date on which a request for 

continued examination was filed and 

ending on the date of mailing of the 

notice of allowance (PTOL–85), 

regardless of whether the notice of 

allowability (PTOL–37) and notice of 

allowance (PTOL–85) are mailed or 

issued on different days, and also 

regardless of whether the Office has 

issued multiple consecutive notices of 

allowability (PTOL–37). 

Comment 5: Several comments 

oppose the provisions of proposed 

§ 1.704(c)(12) stating that applicants 

must file a request for continued 

examination when they become aware 

of prior art after allowance that must be 

submitted to the Office to comply with 

§ 1.56. The comments further state that 

applicants often cannot make the 

statement required by § 1.97(e), and that 

the QPIDS program is a pilot program 

and thus there is no certainty that it will 

continue. One comment further states 

that an applicant who may be able to 

make the statement required by 

§ 1.704(d) does not necessarily have the 

option of filing an information 

disclosure statement after allowance 

without filing a request for continued 

examination, and suggests that the 

Office apply the ‘‘safe harbor’’ provision 

under § 1.704(d) to proposed 

§ 1.704(c)(12). One comment suggests 

that the Office should make the QPIDS 

pilot program permanent, and one 

comment suggests that the Office should 

provide for the filing of an information 

disclosure statement after payment of 

the issue fee without the need for filing 

of a request for continued examination. 

Response: As discussed previously, 

the mailing of a notice of allowance 

under 35 U.S.C. 151 concludes the 

examination process and starts the 

process of preparing the application for 

issuance as a patent. The AIPA patent 

term adjustment final rule defined the 

submission of an amendment under 

§ 1.312 or other paper (which would 

include a request for continued 

examination) after a notice of allowance 

has been given or mailed as a 

circumstance that constitutes a failure of 

an applicant to engage in reasonable 

efforts to conclude processing or 

examination of an application (codified 

in § 1.704(c)(10)) because the 

submission of amendments (or other 

papers) after an application is allowed 

causes substantial interference with the 

patent issue process. See Changes to 

Implement Patent Term Adjustment 

Under Twenty-Year Patent Term, 65 FR 

at 56373 (discussion of § 1.704(c)(10)). 

The filing of a request for continued 

examination after the mailing of a notice 

of allowance removes the application 

from the issue process, prevents the 

Office from issuing the patent, and 

requires the Office to determine if the 

submission affects the patentability of 

the application, which adds to the 

pendency of the application in which 

the request for continued examination is 

filed (as well as other applications since 

examination resources must be diverted 

from other applications to the 

application in which the request for 


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Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Rules and Regulations 1351 

continued examination is filed). As 

further indicated in the AIPA patent 

term adjustment final rule, ‘‘[a]n 

applicant who is engaging in actions or 

inactions that prevent or interfere with 

the Office’s ability to process or 

examine an application cannot 

reasonably be characterized as 

‘engag[ing] in reasonable efforts to 

conclude processing or examination of 

an application’ (35 U.S.C. 

154(b)(2)(C)(i)).’’ See Changes to 

Implement Patent Term Adjustment 

Under Twenty-Year Patent Term, 65 FR 

at 56379 (response to comment 17). 

Therefore, the Office considers it 

appropriate to expressly define the 

filing of a request for continued 

examination after the mailing of any 

notice of allowance as a failure to 

engage in reasonable efforts to conclude 

processing or examination of an 

application. See 35 U.S.C. 

154(b)(2)(C)(iii) (provides for the Office 

to prescribe regulations establishing the 

circumstances that constitute a failure of 

an applicant to engage in reasonable 

efforts to conclude processing or 

examination of an application). 

Nevertheless, the AIPA patent term 

adjustment final rule also indicates that 

the Office considers it appropriate to 

permit applicants to submit information 

cited in a patent office communication 

in a counterpart application to the 

Office without a reduction in patent 

term adjustment if an information 

disclosure statement is submitted to the 

Office within thirty days (not three 

months) of the date the patent office 

communication was received by an 

individual designated in § 1.56(c). See 

Changes to Implement Patent Term 

Adjustment Under Twenty-Year Patent 

Term, 65 FR at 56385 (response to 

comment 36). Section 1.704(d) was thus 

adopted in the AIPA patent term 

adjustment final rule to permit 

applicants to file an information 

disclosure statement promptly without a 

reduction of patent term adjustment. 

See Changes to Implement Patent Term 

Adjustment Under Twenty-Year Patent 

Term, 65 FR at 56373 (discussion of 

§ 1.704(d)). The Office is therefore 

revising § 1.704(d) in this final rule to 

provide that a request for continued 

examination in compliance with § 1.114 

with no submission other than an 

information disclosure statement in 

compliance with §§ 1.97 and 1.98 will 

not be considered a failure to engage in 

reasonable efforts to conclude 

prosecution (processing or examination) 

of the application under § 1.704(c)(12), 

if the request for continued examination 

is accompanied by a statement in 

compliance with § 1.704(d). 

With respect to the suggestions that 

the Office make the QPIDS pilot 

program permanent and provide for the 

filing of an information disclosure 

statement after payment of the issue fee 

without the need for filing of a request 

for continued examination, the Office is 

currently studying the results of the 

QPIDS pilot program and other 

mechanisms for considering information 

disclosure statements submitted after 

payment of the issue fee. 

Comment 6: Several comments state 

that the provisions of proposed 

§ 1.704(c)(12) should apply only when 

there is patent term adjustment under 

35 U.S.C. 154(b)(1)(B) (under the ‘‘B’’ 

provision), and should not apply to 

patent term adjustment under 35 U.S.C. 

154(b)(1)(A) or 154(b)(1)(C) (under the 

‘‘A’’ or ‘‘C’’ provision). One comment 

states that 35 U.S.C. 154(b)(2)(C)(ii) 

applies only to patent term adjustment 

under 35 U.S.C. 154(b)(1)(B), and thus 

applicant delays that may be deducted 

from the total patent term adjustment 

are only those that occur at the same 

time that Office delays would otherwise 

be included in the calculation of patent 

term adjustment. The comment suggests 

that § 1.704(b) should be revised to 

indicate that patent term adjustment is 

not reduced by applicant delays arising 

after the filing of a request for continued 

examination, since 35 U.S.C. 

154(b)(2)(C)(ii) applies only to patent 

term adjustment under 35 U.S.C. 

154(b)(1)(B). 

Response: The current provisions of 

§ 1.704(b) were adopted in the AIPA 

patent term adjustment final rule. See 

Changes to Implement Patent Term 

Adjustment Under Twenty-Year Patent 

Term, 65 FR at 56370–71 and 56393 

(discussion of § 1.704(b) and § 1.704(b)). 

The Office did not propose any 

amendment to § 1.704(b) in the Novartis 

notice of proposed rulemaking. 35 

U.S.C. 154(b)(C)(ii) provides that, with 

respect to adjustments to patent term 

made under 35 U.S.C. 154(b)(1)(B), an 

applicant shall be deemed to have failed 

to engage in reasonable efforts to 

conclude processing or examination of 

an application for the cumulative total 

of any periods of time in excess of three 

months that are taken to respond to a 

notice from the Office making any 

rejection, objection, argument, or other 

request. 35 U.S.C. 154(b)(C)(iii), 

however, further provides that the 

Office shall prescribe regulations 

establishing the circumstances that 

constitute a failure of an applicant to 

engage in reasonable efforts to conclude 

processing or examination of an 

application. Thus, 35 U.S.C. 

154(b)(2)(C)(ii) cannot be considered 

exhaustive of the circumstances for 

which an applicant may be determined 

to have failed to engage in reasonable 

efforts to conclude processing or 

examination of an application. See 

Changes to Implement Patent Term 

Adjustment Under Twenty-Year Patent 

Term, 65 FR at 56381 (response to 

comment 28). Under the authority in 35 

U.S.C. 154(b)(2)(C)(iii), § 1.704(b) as 

adopted in the AIPA patent term 

adjustment final rule established failure 

to respond to a notice from the Office 

making any rejection, objection, 

argument, or other request within three 

months as a failure of an applicant to 

engage in reasonable efforts to conclude 

processing or examination of an 

application with respect to patent term 

adjustment under §§ 1.702(a) through (e) 

(corresponding to the grounds for patent 

term adjustment under 35 U.S.C. 

154(b)(1)(A) through (C)). See Changes 

to Implement Patent Term Adjustment 

Under Twenty-Year Patent Term, 65 FR 

at 56370 (discussion of § 1.704(b)). 

35 U.S.C. 154(b) provides that the 

period of patent term adjustment under 

35 U.S.C. 154(b)(1) ‘‘shall be reduced by 

a period equal to the period of time 

during which the applicant failed to 

engage in reasonable efforts to conclude 

prosecution of the application.’’ See 35 

U.S.C. 154(b)(2)(C)(i). 35 U.S.C. 

154(b)(1)(C)(i) does not require the 

applicant’s action or inaction (that 

amounts to a failure to engage in 

reasonable efforts to conclude 

prosecution of the application) to have 

caused or contributed to patent term 

adjustment for the period of adjustment 

to be reduced due to such action or 

inaction. See Changes to Implement 

Patent Term Adjustment Under TwentyYear Patent Term, 65 FR at 56379 

(response to comment 18). The patent 

term adjustment provisions of 35 U.S.C. 

154(b) create a balanced system 

allowing for patent term adjustment due 

to Office delays for a reasonably diligent 

applicant. Id. Since the public has an 

interest in the technology disclosed and 

covered by a patent being available to 

the public at the earliest possible date, 

it is appropriate to reduce patent term 

adjustment by any period of time during 

which applicant failed to engage in 

reasonable efforts to conclude 

prosecution of the application, 

regardless of whether the applicant’s 

actions or inactions caused or 

contributed to patent term adjustment. 

Id. 

Comment 7: One comment opposes 

the provisions of proposed 

§ 1.704(c)(12) stating that the proposed 

rule undermines the three-month 

statutory period applicant has to review 

the application and pay the issue fee, 

and is inconsistent with the ‘‘deduction 


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1352 Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Rules and Regulations 

free’’ three-month response periods 

permitted in 35 U.S.C. 154(b)(2)(C)(ii). 

Response: 35 U.S.C. 151 provides a 

three-month period for an applicant to 

pay the issue fee (or permit an 

application to become abandoned for 

failure to pay the issue fee). That 

applicants also use this three-month 

period for other purposes does not mean 

that the three-month period in 35 U.S.C. 

151 is designed for those purposes. In 

addition, 35 U.S.C. 154(b)(2)(C)(ii) does 

not provide ‘‘deduction free’’ threemonth response periods, but rather 

defines a failure to reply to any Office 

action or notice within three months as 

a per se failure to engage in reasonable 

efforts to conclude processing or 

examination of an application (subject 

to reinstatement under 35 U.S.C. 

154(b)(3)(C)). See Changes to Implement 

Patent Term Adjustment Under TwentyYear Patent Term, 65 FR at 56389 

(response to comment 51). As discussed 

previously, 35 U.S.C. 154(b)(2)(C)(iii) 

authorizes (or requires) the Office to 

prescribe regulations establishing the 

circumstances that constitute a failure of 

an applicant to engage in reasonable 

efforts to conclude processing or 

examination of an application. In any 

event, a request for continued 

examination is not, strictly speaking, a 

‘‘response’’ to a notice of allowance. See 

35 U.S.C. 151 (‘‘The notice [of 

allowance] shall specify a sum, 

constituting the issue fee and any 

required publication fee, which shall be 

paid within 3 months thereafter. . . . 

Upon payment of this sum, the patent 

may issue, but if payment is not timely 

made, the application shall be regarded 

as abandoned.’’). 

Comment 8: One comment opposing 

the provisions of proposed 

§ 1.704(c)(12) states that proposed 

§ 1.704(c)(12) is unnecessary as multiple 

requests for continued examination are 

filed in only a low percentage of 

applications, and that applicants have a 

‘‘legal right’’ to file multiple requests for 

continued examination. The comment 

further states that proposed 

§ 1.704(c)(12) is unwarranted as it treats 

requests for continued examination filed 

after allowance differently from requests 

for continued examination filed prior to 

allowance. 

Response: Section 1.114 currently 

permits applicants to file multiple 

requests for continued examination and 

requests for continued examination after 

a notice of allowance has been mailed. 

See Request for Continued Examination 

Practice and Changes to Provisional 

Application Practice, 65 FR 50092, 

50095–96 (Aug. 16, 2000) (comparing 

the request for continued examination 

practice as implemented in § 1.114 with 

the transitional procedure in § 1.129(a)). 

There is, however, a distinction between 

permitting an applicant to take an action 

(or engage in an inaction) and treating 

that action or inaction as not being 

failure to engage in reasonable efforts to 

conclude processing or examination of 

an application. See Changes to 

Implement Patent Term Adjustment 

Under Twenty-Year Patent Term, 65 FR 

at 56379 (response to comment 17) (that 

conduct is permitted by the rules of 

practice does not imply that such 

conduct is not a failure to engage in 

reasonable efforts to conclude 

processing or examination of an 

application); see also Changes to 

Implement the Patent Law Treaty, 78 FR 

62368, 62384–85 (Oct. 21, 2013) 

(revising patent term adjustment 

provisions to define delays newly 

permitted by the Patent Law Treaty and 

Patent Law Treaties Implementation Act 

of 2012 (Pub. L. 112–211, 126 Stat. 1527 

(2012)) as a failure to engage in 

reasonable efforts to conclude 

processing or examination of an 

application). In addition, while multiple 

requests for continued examination are 

filed in a relatively low percentage of 

applications, even a low percentage of 

activity represents thousands of 

applications (and patents) in view of the 

number of applications filed in the 

Office each year. In any event, that only 

a few applicants engage in actions or 

inactions that are a failure to engage in 

reasonable efforts to conclude 

processing or examination of an 

application does not justify excusing 

such applicants from the patent term 

adjustment consequences of their 

actions or inactions. 

Finally, requests for continued 

examination filed after allowance are 

treated differently from requests for 

continued examination filed prior to 

allowance because applications in 

which a notice of allowance has been 

mailed are ready to be issued as a patent 

(subject to the applicant paying the 

issue fee in a timely manner). As 

discussed previously, the filing of a 

request for continued examination after 

the mailing of a notice of allowance 

removes the application from the issue 

process and prevents the Office from 

issuing the patent, which adds to the 

pendency of the application as well as 

the pendency of other applications since 

examination resources must be diverted 

from other applications to the 

application in which the request for 

continued examination was filed after a 

notice of allowance was filed. 

Comment 9: One comment opposing 

the provisions of proposed 

§ 1.704(c)(12) states that requests for the 

Office to correct matters in a notice of 

allowability (such as an error in the 

claims or the failure of the Office to 

provide an initialed copy of an 

information disclosure statement) or to 

respond to an amendment under § 1.312 

before payment of the issue fee should 

not be held against applicant if 

applicant files a request for continued 

examination to have such addressed. 

Response: A request for continued 

examination should never be filed 

simply to obtain correction of a notice 

of allowability or a response to an 

amendment under § 1.312. An applicant 

may simply call the examiner to obtain 

the correction (such as a supplemental 

notice of allowability correctly 

indicating the allowed claims or an 

initialed copy of an information 

disclosure statement) or a response to 

the amendment under § 1.312 (or call 

the supervisory patent examiner or 

technology center director if the call to 

the examiner is unavailing). Applicants 

should note that filing an amendment 

under § 1.312 is defined as a failure to 

engage in reasonable efforts to conclude 

prosecution of the application, and will 

result in a reduction of any patent term 

adjustment, under § 1.704(c)(10). 

Comment 10: One comment opposing 

the provisions of proposed 

§ 1.704(c)(12) states that the filing of a 

request for continued examination is 

already a ‘‘reduction’’ from any patent 

term adjustment under 35 U.S.C. 

154(b)(1)(B) (the ‘‘B’’ provision) and 

would now be an additional reduction 

of patent term adjustment under 

§ 1.704(c)(12). 

Response: The provisions of 35 U.S.C. 

154(b)(1)(B)(i) through (iii) are not a 

‘‘reduction’’ of patent term adjustment. 

Rather, 35 U.S.C. 154(b)(1)(B)(i) through 

(iii) simply define periods that are not 

included in determining whether and by 

how much the pendency of an 

application has exceeded the three-year 

period specified in 35 U.S.C. 

154(b)(1)(B). Under §§ 1.703 and 1.704 

as adopted in this final rule, if a request 

for continued examination is filed after 

any notice of allowance was mailed, any 

patent term adjustment would be 

reduced by the number of days in the 

period starting on the day after the date 

of mailing of the notice of allowance 

and ending on the date the request for 

continued examination was filed as 

provided in § 1.704(c)(12), and the 

period between the date the request for 

continued examination was filed and 

the date of mailing of the subsequent 

notice of allowance would not be 

included in determining whether and by 

how much the pendency of an 

application has exceeded the three-year 

period specified in 35 U.S.C. 

154(b)(1)(B). 


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Comment 11: One comment opposing 

the provisions of proposed 

§ 1.704(c)(12) states that proposed 

§ 1.704 is unclear as to how it would 

work if a request for continued 

examination is filed after payment of the 

issue fee. 

Response: If a request for continued 

examination is filed after payment of the 

issue fee, any patent term adjustment 

would be reduced by the number of 

days in the period starting on the day 

after the date of mailing of the notice of 

allowance and ending on the date the 

request for continued examination was 

filed. 

35 U.S.C. 154(b)(1)(A)(iv) provides 

that, subject to the limitations under 35 

U.S.C. 154(b)(2), if the issue of an 

original patent is delayed due to the 

failure of the Office to issue a patent 

within four months after the date on 

which the issue fee was paid under 35 

U.S.C. 151 and all outstanding 

requirements were satisfied, the term of 

the patent shall be extended one day for 

each day after the date on which the 

issue fee was paid and all outstanding 

requirements were satisfied until the 

patent is issued. Thus, the period of 

adjustment under 35 U.S.C. 

154(b)(1)(A)(iv), if any, is ascertained by 

looking back from the issue date to the 

most recent time at which the issue fee 

or another requirement was outstanding, 

determining the succeeding date on 

which the issue fee was paid and all 

outstanding requirements were satisfied, 

and measuring the number of days, if 

any, in the period beginning on the day 

after the date that is four months after 

such date the issue fee was paid and all 

outstanding requirements were satisfied 

and ending on the date a patent was 

issued. Where prosecution in an 

application is reopened after a notice of 

allowance (before or after payment of 

the issue fee), either by the Office sua 

sponte or as the result of an applicant 

filing a request for continued 

examination, the date on which the 

issue fee was paid and all outstanding 

requirements were satisfied is the date 

on which the Issue Fee Transmittal 

Form (PTOL–85(b)) from the ultimate 

notice of allowance under 35 U.S.C. 151 

is returned to the Office (or a later date 

if there remain additional outstanding 

requirements, such as payment of any 

additional fees owed or required 

drawings to be submitted). See Manual 

of Patent Examining Procedure (MPEP) 

2731. The mailing of a notice of 

allowance by the Office subsequent to 

the reopening of prosecution is the 

Office’s indication that the application 

is (again) in condition to be issued as a 

patent, and the applicant’s return of the 

Issue Fee Transmittal Form (PTOL– 

85(b)) is the applicant’s indication or 

confirmation that the applicant wants 

any previously paid issue fee to be 

applied as the issue fee for the patent. 

See MPEP 1306 (’’[i]f an issue fee has 

previously been paid in the application 

as reflected in the Notice of Allowance, 

the return of Part B (Fee(s) Transmittal 

form) will be considered a request to 

reapply the previously paid issue fee 

toward the issue fee that is now due’’). 

Thus, if prosecution in an application is 

reopened after a notice of allowance as 

the result of an applicant filing a request 

for continued examination, the date on 

which the issue fee was paid and all 

outstanding requirements were satisfied 

is the date on which the Issue Fee 

Transmittal Form (PTOL–85(b)) from 

the ultimate notice of allowance under 

35 U.S.C. 151 is returned to the Office 

(or a later date if there remain additional 

outstanding requirements, such as 

payment of any additional fees owed or 

required drawings to be submitted). 

Applicants should note that § 1.114 

does not permit an applicant to file a 

request for continued examination 

under 35 U.S.C. 132(b) after the date the 

issue fee is paid as a matter of right. See 

§ 1.114(a)(1). 

Comment 12: One comment states 

that the date of mailing of a notice of 

allowance should not be included in 

§ 1.704(c)(12) if it is excluded in 

§ 1.703(b)(1). 

Response: Section 1.704(c)(12) as 

adopted in this final rule provides that 

the period of reduction begins on the 

‘‘day after the date’’ of mailing of a 

notice of allowance under 35 U.S.C. 

151. 

Comment 13: One comment questions 

whether the proposed change to § 1.703 

and § 1.704 will be ‘‘retroactive,’’ how 

existing petitions are being treated 

under Novartis, and whether there will 

be any interim procedure to request 

recalculation under Novartis. Several 

comments suggest that the proposed 

change to § 1.704 should only be 

applied prospectively if it is adopted. 

Response: The changes to § 1.703 in 

this final rule apply to any patent 

granted before, on, or after January 9, 

2015. However, nothing in this final 

rule excuses or supersedes the timing 

requirements set forth in § 1.705 

regarding requests for reconsideration of 

patent term adjustment for patents 

granted before, on, or after January 9, 

2015. The Office has been deciding 

requests for reconsideration of a patent 

term adjustment timely filed pursuant to 

§ 1.705 consistent with the Federal 

Circuit decision in Novartis since 

January 15, 2014 (the date the Federal 

Circuit issued its decision in Novartis). 

As discussed in the final rule to 

implement the patent term adjustment 

provisions of the Leahy-Smith America 

Invents Act Technical Corrections Act 

(Pub. L. 112–274, 126 Stat. 2456 (2013)), 

because of the change to the time period 

for requesting reconsideration of a 

patent term adjustment determination 

adopted in that final rule, the Office is 

not adopting ad hoc procedures for 

requesting a patent term adjustment 

recalculation specifically directed to the 

Federal Circuit decision in Novartis. See 

Revisions to Implement the Patent Term 

Adjustment Provisions of the LeahySmith America Invents Act Technical 

Corrections Act, 79 FR 27755, 27759 

(May 15, 2014) (discussion of Federal 

Circuit decision in Novartis). 

The changes to 37 CFR 1.704 in this 

final rule apply only to applications in 

which a request for continued 

examination after a notice of allowance 

is filed on or after March 10, 2015. 

Comment 14: One comment states 

that the Office should amend § 1.704(d) 

to provide a way to submit an 

information disclosure statement 

without any reduction of patent term 

adjustment when the failure to submit 

the information disclosure statement 

within the thirty-day time period 

provided in § 1.704 was unintentional. 

Response: That a delay is 

‘‘unintentional’’ may be an appropriate 

standard for the revival of an abandoned 

application (35 U.S.C. 27) or acceptance 

of a delayed maintenance fee (35 U.S.C. 

41(c)), it is not an appropriate standard 

for the reinstatement of reduced patent 

term adjustment. See 

§ 1.703(c)(2)(defining abandonment of 

an application as a failure to engage in 

reasonable efforts to conclude 

processing or examination of an 

application notwithstanding that an 

application may be revived if the delay 

is shown to have been unintentional). 

Patent term adjustment reduced under 

35 U.S.C. 154(b)(2)(C) may be reinstated 

only if the applicant makes a showing 

that, ‘‘in spite of all due care,’’ the 

applicant was unable to respond within 

the three-month period set forth in 35 

U.S.C. 154(b)(2)(C). See 35 U.S.C. 

154(b)(3)(C). The ‘‘in spite of all due 

care’’ standard in 35 U.S.C. 154(b) is 

significantly more stringent than the 

‘‘unintentional’’ delay standard of 35 

U.S.C. 27 and 41(c). See Changes to 

Implement Patent Term Adjustment 

Under Twenty-Year Patent Term, 65 FR 

at 56389 (response to comment 51) 

(discussing the ‘‘in spite of all due care’’ 

standard of 35 U.S.C. 154(b)(3)(C)). 

Thus, reinstatement of reduced patent 

term adjustment solely on the basis of 

‘‘unintentional’’ delay would not be 

appropriate. 


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1354 Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Rules and Regulations 

Comment 15: One comment questions 

whether the filing of a request for 

continued examination was also 

considered a failure under 

§ 1.703(c)(10). 

Response: The Office has, as a matter 

of practice, not treated the filing of a 

request for continued examination as a 

failure of an applicant to engage in 

reasonable efforts to conclude 

processing or examination of an 

application under § 1.703(c)(10). The 

Office is revising § 1.703(c)(10) in this 

final rule to add ‘‘other than a request 

for continued examination in 

compliance with § 1.114,’’ to clarify that 

the filing of a request for continued 

examination under 35 U.S.C. 132(b) in 

compliance with § 1.114 is treated 

under § 1.704(c)(12) rather than 

§ 1.704(c)(10). 

Comment 16: One comment opposing 

the provisions of proposed 

§ 1.704(c)(12) states that the Federal 

Circuit decision in Novartis does not 

permit the Office to treat applicant 

actions after a notice of allowance as a 

failure of an applicant to engage in 

reasonable efforts to conclude 

processing or examination of an 

application unless the action results in 

the resumption of examination. The 

comment requests that the Office clarify 

what applicant actions after a notice of 

allowance constitute a failure of an 

applicant to engage in reasonable efforts 

to conclude processing or examination 

of an application. 

Response: The regulations setting out 

the circumstances that are considered a 

failure of an applicant to engage in 

reasonable efforts to conclude 

processing or examination of an 

application in § 1.704 are authorized by 

35 U.S.C. 154(b)(2)(C)(iii). See 35 U.S.C. 

154(b)(2)(C)(iii) (‘‘The Director shall 

prescribe regulations establishing the 

circumstances that constitute a failure of 

an applicant to engage in reasonable 

efforts to conclude processing or 

examination of an application’’). The 

provisions of 35 U.S.C. 154(b)(2)(C) and 

§ 1.704(c) were not at issue in Novartis. 

Rather, the provisions of 35 U.S.C. 

154(b)(1)(B) and § 1.703(b) were at issue 

in Novartis. The Federal Circuit in 

Novartis held that the period between 

the mailing of a notice of allowance and 

the issue of the patent was not ‘‘time 

consumed by continued examination of 

the application requested by the 

applicant under section 132(b)’’ under 

35 U.S.C. 154(b)(1)(B)(i), unless action is 

taken to actually resume examination 

after allowance. Novartis, 740 F.3d at 

602. That an action (or inaction) by the 

applicant after the allowance of an 

application does not result in 

examination, and is thus not ‘‘time 

consumed by continued examination of 

the application requested by the 

applicant under section 132(b)’’ under 

35 U.S.C. 154(b)(1)(B)(i), does not imply 

that an action (or inaction) by the 

applicant after the allowance of an 

application cannot be defined in § 1.704 

as a failure of an applicant to engage in 

reasonable efforts to conclude 

processing or examination of an 

application under the authority 

provided in 35 U.S.C. 154(b)(2)(C)(iii). 

Section 1.704(c)(10), as adopted in the 

AIPA patent term adjustment final rule, 

provides that the circumstances 

constituting a ‘‘failure to engage in 

reasonable efforts to conclude 

processing or examination of an 

application’’ include submission of an 

amendment under § 1.312 or other 

paper after a notice of allowance has 

been given or mailed, in which case the 

period of adjustment set forth in § 1.703 

shall be reduced by the lesser of: (1) The 

number of days, if any, beginning on the 

date the amendment under § 1.312 or 

other paper was filed and ending on the 

mailing date of the Office action or 

notice in response to the amendment 

under § 1.312 or such other paper; or (2) 

four months. 

All new patent applications are now 

scanned into the Office’s Image File 

Wrapper (IFW) system, and all 

processing and examination of these 

applications is conducted using 

electronic images instead of the paper 

source documents. This process permits 

multiple employees to view the IFW file 

of an application concurrently, which 

has reduced processing delays in patent 

issuance for certain papers filed after 

the mailing of the notice of allowance. 

In view of the changes that have been 

brought about by the electronic filing 

and processing of patent applications, 

the Office is clarifying what papers may 

be submitted after a notice of allowance 

without the applicant being considered 

to have failed to engage in reasonable 

efforts to conclude processing or 

examination of the application under 

§ 1.704(c)(10). Specifically, the 

submission of the following papers after 

a notice of allowance will not be 

considered a failure to engage in 

reasonable efforts to conclude 

processing of examination of the 

application under § 1.704(c)(10): (1) An 

Issue Fee(s) Transmittal (PTOL–85B); (2) 

a power of attorney; (3) a power to 

inspect; (4) a change of address; (5) a 

change of entity status (micro, small, 

non-small); (6) a response to the 

examiner’s reasons for allowance or a 

request to correct an error or omission 

in the ‘‘Notice of Allowance’’ or ‘‘Notice 

of Allowability’’; (7) status letters; (8) 

requests for a refund; (9) an inventor’s 

oath or declaration; (10) an information 

disclosure statement with a statement in 

compliance with § 1.704(d); (11) the 

resubmission by applicant of 

unlocatable paper(s) previously filed in 

the application (§ 1.251); (12) a request 

for acknowledgment of an information 

disclosure statement in compliance with 

§§ 1.97 and 1.98, provided that the 

applicant had requested that the 

examiner acknowledge the information 

disclosure statement prior to the notice 

of allowance, or the request for 

acknowledgement was applicant’s first 

opportunity to request that the examiner 

acknowledge the information disclosure 

statement; (13) comments on the 

substance of an interview where the 

applicant-initiated interview resulted in 

a notice of allowance; and (14) letters 

related to government interests (e.g., 

those between NASA and the Office). 

The Office previously indicated that 

three types of these papers (written 

status inquiries, requests for refund, an 

inventor’s oath or declaration) were a 

type of after-allowance submission that 

would be considered a failure to engage 

in reasonable efforts to conclude 

processing and examination of the 

application. See Clarification of 37 CFR 

1.704(c)(10) b Reduction of Patent Term 

Adjustment For Certain Types of Papers 

After a Notice of Allowance has been 

Mailed, 1247 Off. Gaz. Pat. Office 111 

(June 26, 2001); see also MPEP section 

2732. The Office no longer considers 

submission of a written (or other type 

of) status inquiry, request for refund, or 

an inventor’s oath or declaration to be 

a failure to engage in reasonable efforts 

to conclude processing and examination 

of the application under § 1.704(c)(10) 

due to the changes that have been 

brought about by the electronic filing 

and processing of patent applications. 

The Office reminds applicants that 

the submission of other types of papers 

after a notice of allowance has been 

given or mailed constitutes a ‘‘failure to 

engage in reasonable efforts to conclude 

processing or examination of an 

application’’ in which case the period of 

adjustment set forth in § 1.703 shall be 

reduced by the lesser of: (1) The number 

of days, if any, beginning on the date the 

amendment under § 1.312 or other 

paper was filed and ending on the 

mailing date of the Office action or 

notice in response to the amendment 

under § 1.312 or such other paper; or (2) 

four months. See § 1.703(c)(10). An 

exemplary listing of such papers 

includes: (1) An amendment under 

§ 1.312; (2) a paper containing a claim 

for priority or benefit or request to 

correct priority or benefit information 

(e.g., a new or supplemental application 

data sheet filed to correct foreign or 


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Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Rules and Regulations 1355 

domestic benefit information); (3) a 

request for a corrected filing receipt; (4) 

a certified copy of a priority document; 

(5) drawings; (6) a letter relating to 

biologic deposits; (7) a request to change 

or correct inventorship; and (8) an 

information disclosure statement not 

accompanied by a statement in 

compliance with § 1.704(d). 

Rulemaking Considerations 

A. Administrative Procedure Act: The 

amendments to 37 CFR 1.703 in this 

rulemaking to provide that the time 

consumed by continued examination 

under 35 U.S.C. 132(b) does not include 

the time after a notice of allowance has 

been mailed, unless the applicant files 

a request for continued examination 

after such allowance, simply 

implements the Federal Circuit’s ruling 

on the provisions of 35 U.S.C. 

154(b)(1)(B)(i) in Novartis that the time 

consumed by continued examination 

under 35 U.S.C. 132(b) does not include 

the time after a notice of allowance has 

been mailed, unless the Office actually 

resumes examination of the application 

after allowance. Therefore, the 

amendment to 37 CFR 1.703 eliminates 

any inconsistency with the Federal 

Circuit’s determination and is simply a 

procedural and/or interpretive rule. See 

Bachow Commc’ns Inc. v. FCC, 237 F.3d 

683, 690 (D.C. Cir. 2001) (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) (rules for handling appeals were 

procedural where they did not change 

the substantive standard for reviewing 

claims); Nat’l Org. of Veterans’ 

Advocates, Inc. v. Sec’y of Veterans 

Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 

2001) (rule that clarifies interpretation 

of a statute is interpretive). 

Accordingly, prior notice and 

opportunity for public comment are not 

required pursuant to 5 U.S.C. 553(b) or 

(c) (or any other law), with respect to 

the change to 37 CFR 1.703. 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)(A)). The Office, however, 

published the change to 37 CFR 1.703 

for comment as it sought the benefit of 

the public’s views on the Office’s 

implementation of the Federal Circuit’s 

interpretation of the provisions of 35 

U.S.C. 154(b)(1)(B)(i) in Novartis. 

Similarly, the change to 37 CFR 1.703, 

as a procedural and/or interpretive rule, 

is not subject to the requirement of 5 

U.S.C. 553(d) and any delayed effective 

date. 

B. Regulatory Flexibility Act: For the 

reasons set forth herein, the Deputy 

General Counsel for General Law of the 

United States Patent and Trademark 

Office has certified to the Chief Counsel 

for Advocacy of the Small Business 

Administration that changes adopted in 

this final rule will not have a significant 

economic impact on a substantial 

number of small entities. See 5 U.S.C. 

605(b). 

The changes to the patent term 

adjustment provisions do not impose 

any additional requirements or fees on 

applicants. The change to 37 CFR 1.703 

simply implements the Federal Circuit’s 

ruling on the provisions of 35 U.S.C. 

154(b)(1)(B)(i) in Novartis and reflects 

how patent term adjustment is now 

calculated. The change to 37 CFR 1.704 

specifies that the submission of a 

request for continued examination 

under 35 U.S.C. 132(b) after any notice 

of allowance under 35 U.S.C. 151 has 

been mailed constitutes a failure of an 

applicant to engage in reasonable efforts 

to conclude processing or examination 

of an application. This change will not 

have a significant economic impact on 

a substantial number of small entities 

because applicants are not entitled to 

patent term adjustment for examination 

delays that result from an applicant’s 

delay in prosecuting the application (35 

U.S.C. 154(b)(2)(C)(i) and 37 CFR 

1.704(a)) and because applicants may 

avoid any consequences from this 

provision simply by refraining from 

filing a request for continued 

examination under 35 U.S.C. 132(b) 

after a notice of allowance under 35 

U.S.C. 151 has been mailed. The Office 

received no public comment on this 

Regulatory Flexibility Act certification, 

or any of the sections under the 

Rulemaking Considerations, in the 

Novartis notice of proposed rulemaking. 

For the foregoing reasons, the changes 

adopted in this final rule 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. 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 on-line 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 effect 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 


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1356 Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Rules and Regulations 

provisions of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (5 U.S.C. 801–808), the United 

States Patent and Trademark Office will 

submit a report containing any final rule 

resulting from this rulemaking and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the 

Government Accountability Office. 

L. Unfunded Mandates Reform Act of 

1995: The changes set forth in this 

rulemaking 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: The 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.) requires that the 

Office consider the impact of paperwork 

and other information collection 

burdens imposed on the public. The 

rules of practice pertaining to patent 

term adjustment and extension have 

been reviewed and approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

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

under OMB control number 0651–0020. 

The changes in this rulemaking would: 

(1) Provide that the time consumed by 

continued examination under 35 U.S.C. 

132(b) does not include the time after a 

notice of allowance, unless the Office 

actually resumes examination of the 

application after allowance; and (2) 

provide that the submission of a request 

for continued examination under 35 

U.S.C. 132(b) after any notice of 

allowance under 35 U.S.C. 151 has been 

mailed constitutes a failure of an 

applicant to engage in reasonable efforts 

to conclude processing or examination 

of an application. 

This rulemaking does not add any 

additional requirements (including 

information collection requirements) or 

fees for patent applicants or patentees. 

Therefore, the Office is not resubmitting 

information collection packages to OMB 

for its review and approval because the 

changes in this rulemaking do not affect 

the information collection requirements 

associated with the information 

collections approved under OMB 

control number 0651–0020 or any other 

information collections. 

Notwithstanding any other provision 

of law, no person is required to respond 

to, nor shall any person be subject to a 

penalty for failure to comply with, a 

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 in 37 CFR Part 1 

Administrative practice and 

procedure, Courts, Freedom of 

information, Inventions and patents, 

Reporting and record keeping 

requirements, Small businesses. 

For the reasons set forth in the 

preamble, 37 CFR part 1 is 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 1.703 is amended by 

revising paragraph (b)(1) to read as 

follows: 

§ 1.703 Period of adjustment of patent 

term due to examination delay. 

* * * * * 

(b) * * * 

(1) The number of days, if any, in the 

period beginning on the date on which 

any request for continued examination 

of the application under 35 U.S.C. 

132(b) was filed and ending on the date 

of mailing of the notice of allowance 

under 35 U.S.C. 151; 

* * * * * 

■ 3. Section 1.704 is amended by 

revising paragraphs (c)(10), (12), and 

(13) and (d)(1) and adding paragraph 

(c)(14) to read as follows: 

§ 1.704 Reduction of period of adjustment 

of patent term. 

* * * * * 

(c) * * * 

(10) Submission of an amendment 

under § 1.312 or other paper, other than 

a request for continued examination in 

compliance with § 1.114, after a notice 

of allowance has been given or mailed, 

in which case the period of adjustment 

set forth in § 1.703 shall be reduced by 

the lesser of: 

(i) The number of days, if any, 

beginning on the date the amendment 

under § 1.312 or other paper was filed 

and ending on the mailing date of the 

Office action or notice in response to the 

amendment under § 1.312 or such other 

paper; or 

(ii) Four months; 

* * * * * 

(12) Submission of a request for 

continued examination under 35 U.S.C. 

132(b) after any notice of allowance 

under 35 U.S.C. 151 has been mailed, in 

which case the period of adjustment set 

forth in § 1.703 shall be reduced by the 

number of days, if any, beginning on the 

day after the date of mailing of the 

notice of allowance under 35 U.S.C. 151 

and ending on the date the request for 

continued examination under 35 U.S.C. 

132(b) was filed; 

(13) Failure to provide an application 

in condition for examination as defined 

in paragraph (f) of this section within 

eight months from either the date on 

which the application was filed under 

35 U.S.C. 111(a) or the date of 

commencement of the national stage 

under 35 U.S.C. 371(b) or (f) in an 

international application, in which case 

the period of adjustment set forth in 

§ 1.703 shall be reduced by the number 

of days, if any, beginning on the day 

after the date that is eight months from 

either the date on which the application 

was filed under 35 U.S.C. 111(a) or the 

date of commencement of the national 

stage under 35 U.S.C. 371(b) or (f) in an 

international application and ending on 

the date the application is in condition 

for examination as defined in paragraph 

(f) of this section; and 

(14) Further prosecution via a 

continuing application, in which case 

the period of adjustment set forth in 

§ 1.703 shall not include any period that 

is prior to the actual filing date of the 

application that resulted in the patent. 

(d)(1) A paper containing only an 

information disclosure statement in 

compliance with §§ 1.97 and 1.98 will 

not be considered a failure to engage in 

reasonable efforts to conclude 

prosecution (processing or examination) 

of the application under paragraphs 

(c)(6), (c)(8), (c)(9), or (c)(10) of this 

section, and a request for continued 

examination in compliance with § 1.114 

with no submission other than an 

information disclosure statement in 

compliance with §§ 1.97 and 1.98 will 

not be considered a failure to engage in 


rljohnson on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Rules and Regulations 1357 

reasonable efforts to conclude 

prosecution (processing or examination) 

of the application under paragraph 

(c)(12) of this section, if the paper or 

request for continued examination is 

accompanied by a statement that each 

item of information contained in the 

information disclosure statement: 

(i) Was first cited in any 

communication from a patent office in 

a counterpart foreign or international 

application or from the Office, and this 

communication was not received by any 

individual designated in § 1.56(c) more 

than thirty days prior to the filing of the 

information disclosure statement; or 

(ii) Is a communication that was 

issued by a patent office in a 

counterpart foreign or international 

application or by the Office, and this 

communication was not received by any 

individual designated in § 1.56(c) more 

than thirty days prior to the filing of the 

information disclosure statement. 

* * * * * 

Dated: December 17, 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. 2015–00061 Filed 1–8–15; 8:45 am] 

BILLING CODE 3510–16–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Parts 17 and 71 

RIN 2900–AN94 

Caregivers Program 

AGENCY: Department of Veterans Affairs. 

ACTION: Final rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) adopts, with changes, the 

interim final rule concerning VA’s 

Program of Comprehensive Assistance 

for Family Caregivers. VA administers 

this program to provide certain medical, 

travel, training, and financial benefits to 

caregivers of certain veterans and 

servicemembers who were seriously 

injured during service on or after 

September 11, 2001. Also addressed in 

this rulemaking is the Program of 

General Caregiver Support Services that 

provides support services to caregivers 

of veterans from all eras who are 

enrolled in the VA health care system. 

Specifically, changes in this final rule 

include a requirement that Veterans be 

notified in writing should a Family 

Caregiver request revocation (to no 

longer be a Family Caregiver), an 

extension of the application timeframe 

from 30 days to 45 days for a Family 

Caregiver, and a change in the stipend 

calculation to ensure that Primary 

Family Caregivers do not experience 

unexpected decreases in stipend 

amounts from year to year. 

DATES: Effective Date: This rule is 

effective on January 9, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Michael Kilmer, Chief Consultant, 

Veterans Health Administration, 810 

Vermont Avenue, Washington, DC 

20420, 202–461–6780. (This is not a 

toll-free number.) 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

I. Purpose of the Final Rule 

This final rule continues to 

implement title I of the Caregivers and 

Veterans Omnibus Health Services Act 

of 2010, Public Law 111–163, which 

was signed into law on May 5, 2010. VA 

has been administering the benefits 

program under this law continuously 

since May 5, 2011, under an interim 

final rule published in the Federal 

Register (76 FR 26148) as well as part 

71 of title 38, Code of Federal 

Regulations (CFR). The purpose of the 

benefits program under this law is to 

provide certain medical, travel, training, 

and financial benefits to caregivers of 

certain veterans and servicemembers 

who were seriously injured in the line 

of duty on or after September 11, 2001. 

Among other things, title I of the law 

established 38 U.S.C. 1720G, which 

requires VA to ‘‘establish a program of 

comprehensive assistance for family 

caregivers of eligible veterans,’’ as well 

as a program of ‘‘general caregiver 

support services’’ for caregivers of 

‘‘veterans who are enrolled in the health 

care system established under [38 U.S.C. 

1705(a)] (including caregivers who do 

not reside with such veterans).’’ 38 

U.S.C. 1720G(a), (b). 

II. Major Provisions 

VA distinguishes between three types 

of caregivers based on the requirements 

of the law: Primary Family Caregivers, 

Secondary Family Caregivers, and 

General Caregivers. A Primary Family 

Caregiver is an individual designated as 

a ‘‘primary provider of personal care 

services’’ for the eligible veteran under 

38 U.S.C. 1720G(a)(7)(A), who the 

veteran specifies on the joint 

application and is approved by VA as 

the primary provider of personal care 

services for the veteran. A Secondary 

Family Caregiver is an individual 

approved as a ‘‘provider of personal care 

services’’ for the eligible veteran under 

38 U.S.C. 1720G(a)(6)(B), and generally 

serves as a back-up to the Primary 

Family Caregiver. General Caregivers are 

‘‘caregivers of covered veterans’’ under 

the program in 38 U.S.C. 1720G(b), and 

provide personal care services to 

covered veterans, but do not meet the 

criteria for designation or approval as a 

Primary or Secondary Family Caregiver. 

In general, caregivers receive the 

following benefits and services: 

• General Caregivers—Education and 

training on caring for an enrolled 

Veteran; use of telehealth technologies; 

counseling and other services under 

§ 71.50; and respite care. 

• Secondary Family Caregivers—All 

benefits and services available to 

General Caregivers; monitoring; veteranspecific instruction and training; 

beneficiary travel under 38 CFR part 70; 

ongoing technical support; and 

counseling. 

• Primary Family Caregivers—All 

benefits and services available to both 

General Caregivers and Secondary 

Family Caregivers; monthly caregiver 

stipend; respite care available for at 

least 30 days per year, and may exceed 

30 days per year if clinically appropriate 

and if requested by the Primary Family 

Caregiver; and health care coverage (if 

they are eligible). 

Some of these benefits are delivered 

directly to veterans, such as monitoring 

the quality of the care provided by 

caregivers to ensure that the veteran is 

able to live in a residential setting 

without unnecessary deterioration of his 

or her disability, and safe from potential 

abuse or neglect. Other benefits are 

delivered directly to the veteran’s 

caregiver, such as a stipend or 

enrollment in the Civilian Health and 

Medical Program of the Department of 

Veterans Affairs (CHAMPVA), which 

provides health coverage for certain 

Primary Family Caregivers. The fact that 

caregiver benefits are offered and 

delivered to both the veteran and his or 

her caregiver makes the benefits 

significantly different from virtually all 

other benefits programs offered through 

the Veterans Health Administration. 

III. Costs and Benefits 

Summary of Costs of the Caregiver 

Program for FY2015 Through FY2017 

In developing the Regulatory Impact 

Analysis (RIA) for this final rule, VA did 

consider different alternative 

approaches on how best to regulate the 

statutory provisions of the law. More 

specifically, VA changed the formula 

and methodology to compute the 

caregiver stipend rate from the interim 

final rule. Individuals designated as the 

eligible Veteran’s primary family 

caregiver are eligible to receive a 

monthly stipend from VA as an 


rljohnson on DSK3VPTVN1PROD with RULES