Applications Filed on or After May 29, 2000; Grounds for Adjustment

35 U.S.C. 154

Contents and term of patent; provisional rights.

*****

(b) ADJUSTMENT OF PATENT TERM.—

(1) PATENT TERM GUARANTEES.—

(A) GUARANTEE OF PROMPT PATENT AND TRADEMARK OFFICE

RESPONSES.— Subject to the limitations under paragraph (2), if the

issue of an original patent is delayed due to the failure of the

Patent and Trademark Office to—

(i) provide at least one of the notifications under

section 132

or a notice of allowance under

section

151

of this title not later than 14 months

after—

(I) the date on which an application was

filed under

section

111(a)

; or

(II) the date of commencement of the national

stage under

section

371

in an international

application;

(ii) respond to a reply under

section

132

, or to an appeal taken under

section 134

,

within 4 months after the date on which the reply was filed or

the appeal was taken;

(iii) act on an application within 4 months after the

date of a decision by the Patent Trial and Appeal Board under

section 134

or

135

or a

decision by a Federal court under

section

141

,

145

, or

146

in a

case in which allowable claims remain in the application; or

(iv) issue a patent within 4 months after the date

on which the issue fee was paid under

section

151

and all outstanding requirements were

satisfied,

the term of the patent shall be

extended 1 day for each day after the end of the period specified in

clause (i), (ii), (iii), or (iv), as the case may be, until the action

described in such clause is taken.

(B) GUARANTEE OF NO MORE THAN 3-YEAR APPLICATION

PENDENCY.— Subject to the limitations under paragraph (2), if the

issue of an original patent is delayed due to the failure of the

United States Patent and Trademark Office to issue a patent within

3 years after the actual filing date of the application under

section 111(a)

in

the United States, or, in the case of an international application,

the date of commencement of the national stage under

section

371

in the international application, not

including—

if the

issue of an original patent is delayed due to the failure of the

United States Patent and Trademark Office to issue a patent within

3 years after the actual filing date of the application under

section 111(a)

in

the United States, or, in the case of an international application,

the date of commencement of the national stage under

section

371

in the international application, not

including—

(i) any time consumed by continued examination of

the application requested by the applicant under

section

132(b)

;

(ii) any time consumed by a proceeding under

section

135(a)

, any time consumed by the

imposition of an order under

section 181

,

or any time consumed by appellate review by the Patent Trial and

Appeal Board or by a Federal court; or

(iii) any delay in the processing of the application

by the United States Patent and Trademark Office requested by

the applicant except as permitted by paragraph (3)(C),

the term of the patent shall be

extended 1 day for each day after the end of that 3-year period until

the patent is issued.

(C) GUARANTEE OF ADJUSTMENTS FOR DELAYS DUE TO DERIVATION

PROCEEDINGS, SECRECY ORDERS, AND APPEALS.— Subject to the limitations

under paragraph (2), if the issue of an original patent is delayed due

to—

(i) a proceeding under

section

135(a)

;

(ii) the imposition of an order under

section 181

;

or

(iii) appellate review by the Patent Trial and Appeal

Board or by a Federal court in a case in which the patent was

issued under a decision in the review reversing an adverse

determination of patentability, the term of the patent shall be

extended 1 day for each day of the pendency of the proceeding,

order, or review, as the case may be.

(a)

;

(ii) the imposition of an order under

section 181

;

or

(iii) appellate review by the Patent Trial and Appeal

Board or by a Federal court in a case in which the patent was

issued under a decision in the review reversing an adverse

determination of patentability, the term of the patent shall be

extended 1 day for each day of the pendency of the proceeding,

order, or review, as the case may be.

(2) LIMITATIONS.—

(A) IN GENERAL.— To the extent that periods of delay

attributable to grounds specified in paragraph (1) overlap, the period

of any adjustment granted under this subsection shall not exceed the

actual number of days the issuance of the patent was delayed.

(B) DISCLAIMED TERM.— No patent the term of which has

been disclaimed beyond a specified date may be adjusted under this

section beyond the expiration date specified in the disclaimer.

(C) REDUCTION OF PERIOD OF ADJUSTMENT.—

(i) The period of adjustment of the term of a

patent under paragraph (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.

(ii) With respect to adjustments to patent term made

under the authority of paragraph (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 3 months

that are taken to respond to a notice from the Office making any

rejection, objection, argument, or other request, measuring such

3-month period from the date the notice was given or mailed to

the applicant.

(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.

o respond to a notice from the Office making any

rejection, objection, argument, or other request, measuring such

3-month period from the date the notice was given or mailed to

the applicant.

(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.

(3) PROCEDURES FOR PATENT TERM ADJUSTMENT DETERMINATION.—

(A) The Director shall prescribe regulations establishing

procedures for the application for and determination of patent term

adjustments under this subsection.

(B) Under the procedures established under subparagraph

(A), the Director shall—

(i) make a determination of the period of any

patent term adjustment under this subsection, and shall transmit

a notice of that determination no later than the date of

issuance of the patent; and

(ii) provide the applicant one opportunity to

request reconsideration of any patent term adjustment

determination made by the Director.

(C) The Director shall reinstate all or part of the

cumulative period of time of an adjustment under paragraph (2)(C) if

the applicant, prior to the issuance of the patent, makes a showing

that, in spite of all due care, the applicant was unable to respond

within the 3-month period, but in no case shall more than three

additional months for each such response beyond the original 3-month

period be reinstated.

(D) The Director shall proceed to grant the patent after

completion of the Director’s determination of a patent term adjustment

under the procedures established under this subsection,

notwithstanding any appeal taken by the applicant of such

determination.

3-month period, but in no case shall more than three

additional months for each such response beyond the original 3-month

period be reinstated.

(D) The Director shall proceed to grant the patent after

completion of the Director’s determination of a patent term adjustment

under the procedures established under this subsection,

notwithstanding any appeal taken by the applicant of such

determination.

(4) APPEAL OF PATENT TERM ADJUSTMENT DETERMINATION.—

(A) An applicant dissatisfied with the Director’s

decision on the applicant’s request for reconsideration under

paragraph (3)(B)(ii) shall have the 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.

Chapter 7 of title 5, United States Code, shall apply to such action.

Any final judgment resulting in a change to the period of adjustment

of the patent term shall be served on the Director, and the Director

shall thereafter alter the term of the patent to reflect such

change.

(B) The determination of a patent term adjustment under

this subsection shall not be subject to appeal or challenge by a third

party prior to the grant of the patent.

*****

I.

37 CFR 1.702 - GROUNDS FOR

ADJUSTMENT

[Editor Note: The provision of

37 CFR

1.702(a)(1)

, as reproduced below, was effective on April 1,

2013 and applies to patent applications granted on or after January 14,

2013.]

37 CFR 1.702  Grounds for adjustment of patent term due to examination delay under the

Patent Term Guarantee Act of 1999 (original applications, other than designs, filed

on or after May 29, 2000).

- GROUNDS FOR

ADJUSTMENT

[Editor Note: The provision of

37 CFR

1.702(a)(1)

, as reproduced below, was effective on April 1,

2013 and applies to patent applications granted on or after January 14,

2013.]

37 CFR 1.702  Grounds for adjustment of patent term due to examination delay under the

Patent Term Guarantee Act of 1999 (original applications, other than designs, filed

on or after May 29, 2000).

(a)

Failure to take certain actions within specified time

frames.

Subject to the provisions of

35 U.S.C. 154(b)

and this

subpart, the term of an original patent shall be adjusted if the issuance of

the patent was delayed due to the failure of the Office to:

(1) Mail at least one of a notification under

35

U.S.C. 132

or a notice of allowance under

35 U.S.C. 151

not later than fourteen months after

the date on which the application was filed under

35 U.S.C.

111(a)

or the date the national stage commenced

under

35 U.S.C. 371(b)

or

(f)

in an international application;

(2) Respond to a reply under

35 U.S.C.

132

or to an appeal taken under

35 U.S.C.

134

not later than four months after the date on

which the reply was filed or the appeal was taken;

(3) Act on an application not later than four months after

the date of a decision by the Patent Trial And Appeal Board under

35

U.S.C. 134

or

135

or a decision by

a Federal court under

35 U.S.C. 141

,

145

, or

146

where at least

one allowable claim remains in the application; or

(4) Issue a patent not later than four months after the date

on which the issue fee was paid under

35 U.S.C. 151

and all

outstanding requirements were satisfied.

(b)

Three-year pendency.

Subject to the provisions of

35 U.S.C. 154(b)

and this

subpart, the term of an original patent shall be adjusted if the issuance of

the patent was delayed due to the failure of the Office to issue a patent

within three years after the date on which the application was filed under

35 U.S.C.

111(a)

or the national stage commenced under

35 U.S.C.

371(b)

or

nts were satisfied.

(b)

Three-year pendency.

Subject to the provisions of

35 U.S.C. 154(b)

and this

subpart, the term of an original patent shall be adjusted if the issuance of

the patent was delayed due to the failure of the Office to issue a patent

within three years after the date on which the application was filed under

35 U.S.C.

111(a)

or the national stage commenced under

35 U.S.C.

371(b)

or

(f)

in an international

application, but not including:

(1) Any time consumed by continued examination of the

application under

35 U.S.C. 132(b)

;

(2) Any time consumed by an interference or derivation

proceeding under

35 U.S.C. 135(a)

;

(3) Any time consumed by the imposition of a secrecy order

under

35 U.S.C. 181

;

(4) Any time consumed by review by the Patent Trial and

Appeal Board or a Federal court; or

(5) Any delay in the processing of the application by the

Office that was requested by the applicant.

(c)

Delays caused by interference and derivation proceedings.

Subject to the provisions of

35 U.S.C. 154(b)

and this

subpart, the term of an original patent shall be adjusted if the issuance of

the patent was delayed due to interference or derivation proceedings under

35 U.S.C.

135(a)

.

(d)

Delays caused by secrecy order.

Subject to the provisions of

35 U.S.C.

154(b)

and this subpart, the term of an original patent

shall be adjusted if the issuance of the patent was delayed due to the

application being placed under a secrecy order under

35 U.S.C.

181

.

hall be adjusted if the issuance of

the patent was delayed due to interference or derivation proceedings under

35 U.S.C.

135(a)

.

(d)

Delays caused by secrecy order.

Subject to the provisions of

35 U.S.C.

154(b)

and this subpart, the term of an original patent

shall be adjusted if the issuance of the patent was delayed due to the

application being placed under a secrecy order under

35 U.S.C.

181

.

(e)

Delays caused by successful appellate review.

Subject to the

provisions of

35 U.S.C. 154(b)

and this subpart, the term of an

original patent shall be adjusted if the issuance of the patent was delayed due

to review by the Patent Trial and Appeal Board under

35 U.S.C.

134

or by a Federal court under

35 U.S.C.

141

or

145

, if the patent was

issued under a decision in the review reversing an adverse determination of

patentability. If an application is remanded by a panel of the Patent Trial and

Appeal Board and the remand is the last action by a panel of the Patent Trial

and Appeal Board prior to the mailing of a notice of allowance under

35 U.S.C.

151

in the application, the remand shall be considered a

decision by the Patent Trial and Appeal Board as that phrase is used in

35 U.S.C.

154(b)(1)(A)(iii)

, a decision in the review reversing an

adverse determination of patentability as that phrase is used in

35 U.S.C.

154(b)(1)(C)(iii)

, and a final decision in favor of the

applicant under

§ 1.703(e)

. A remand by a

panel of the Patent Trial and Appeal Board shall not be considered a decision

in the review reversing an adverse determination of patentability as provided

in this paragraph if there is filed a request for continued examination under

35 U.S.C.

132(b)

that was not first preceded by the mailing, after

such remand, of at least one of an action under

35 U.S.C.

132

or a notice of allowance under

35 U.S.C.

151

.

the Patent Trial and Appeal Board shall not be considered a decision

in the review reversing an adverse determination of patentability as provided

in this paragraph if there is filed a request for continued examination under

35 U.S.C.

132(b)

that was not first preceded by the mailing, after

such remand, of at least one of an action under

35 U.S.C.

132

or a notice of allowance under

35 U.S.C.

151

.

(f) The provisions of this section and

§§ 1.703

through

1.705

apply only to original applications, except

applications for a design patent, filed on or after May 29, 2000, and patents

issued on such applications.

35 U.S.C.

154(b)

, was amended effective May 29, 2000, and further amended by

Public Law 112-29, enacted on September 16, 2011, known as the Leahy-Smith America

Invents Act (AIA) and by Public Law 112-274, enacted on January 14, 2013, known as the

AIA Technical Corrections Act. All references to

35 U.S.C. 154(b)

hereinafter are to

35 U.S.C.

154(b)

, as amended effective May 29, 2000 and as further amended

by Public Laws 112-29 and 112-274.

37 CFR 1.702

-

1.705

implement the provisions of

35 U.S.C. 154(b)

and apply to

utility and plant patent applications filed on or after May 29, 2000.

Due to various effective dates of changes to the

provisions of

37 CFR 1.702

-

1.705

, there are several versions currently in place. For example,

there is a version of

37 CFR 1.702

that applies only to

patents granted on or after January 14, 2013 and another version that applies to patents

granted prior to January 14, 2013. For another example, there is a version of the

provisions of

37 CFR 1.703(b)(4)

and

rious effective dates of changes to the

provisions of

37 CFR 1.702

-

1.705

, there are several versions currently in place. For example,

there is a version of

37 CFR 1.702

that applies only to

patents granted on or after January 14, 2013 and another version that applies to patents

granted prior to January 14, 2013. For another example, there is a version of the

provisions of

37 CFR 1.703(b)(4)

and

(e)

that are only applicable to applications and patents in which

a notice of allowance issued on or after September 17, 2012. Office personnel need to

carefully consider the effective date provisions in the regulations in order to

determine which version to apply to the particular application or patent under

consideration.

37 CFR

1.702

sets forth the bases for patent term adjustment under

35 U.S.C.

154(b)(1)

.

37 CFR

1.702(a)

indicates that a patent is entitled to patent term

adjustment if the Office fails to perform certain acts of examination within specified

time frames (

35 U.S.C.

154(b)(1)(A)

).

Effective September 16, 2012, the Board of Patent Appeals

and Interferences has been redesignated the Patent Trial and Appeal Board. Accordingly,

37 CFR

1.702(a)(3)

has been amended to reflect the redesignation of the

patent appeal board.

For applications in which a patent was granted on or

after January 14, 2013,

37 CFR 1.702(a)(1)

provides patent

term adjustment if the Office fails to mail either a notification under

35 U.S.C.

132

or notice of allowance under

35 U.S.C. 151

not

later than 14 months after the date on which the application was filed under

35 U.S.C.

111(a)

or the date the national stage commenced under

35 U.S.C.

371(b)

or

pplications in which a patent was granted on or

after January 14, 2013,

37 CFR 1.702(a)(1)

provides patent

term adjustment if the Office fails to mail either a notification under

35 U.S.C.

132

or notice of allowance under

35 U.S.C. 151

not

later than 14 months after the date on which the application was filed under

35 U.S.C.

111(a)

or the date the national stage commenced under

35 U.S.C.

371(b)

or

(f)

in an international application.

For applications filed on or after May 29, 2000 in which the patent was granted prior to

January 14, 2013, the fourteen month measurement in international applications is based

upon the date that the application fulfilled the requirements of

35 U.S.C. 371

and

not the date the national stage commenced. See

37 CFR 1.702(a)(1)

(pre-2013-04-01)

.

37 CFR

1.702(b)

indicates that a patent is entitled to patent term

adjustment if, subject to a number of limitations, 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)

). In the case of an international application, the

phrase “actual filing date of the application in the United States” means the date the

national stage commenced under

35 U.S.C. 371(b)

or

(f)

. See

Changes to Implement Patent Term Adjustment

Under Twenty-Year Patent Term,

65 FR 56366, 56382-84, (September 18, 2000),

1239 OG 14, 28-30 (October 3, 2000). On January 14, 2013, section 1(h)(1)(B) of the AIA

Technical Corrections Act amended

35 U.S.C

e

phrase “actual filing date of the application in the United States” means the date the

national stage commenced under

35 U.S.C. 371(b)

or

(f)

. See

Changes to Implement Patent Term Adjustment

Under Twenty-Year Patent Term,

65 FR 56366, 56382-84, (September 18, 2000),

1239 OG 14, 28-30 (October 3, 2000). On January 14, 2013, section 1(h)(1)(B) of the AIA

Technical Corrections Act amended

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

to change

“the actual filing date of the application in the United States” to “the actual filing

date of the application under

section 111(a)

in the United States,

or, in the case of an international application, the date of commencement of the

national stage under

section 371

in the international application.” The clarification

of the meaning of the phrase “actual filing date of the application in the United

States” did not require a change to the language of

37 CFR

1.702(b)

because the Office had interpreted, by regulation, the

language of the former 35 U.S.C. 154(b)(1)(B) to have the same meaning as the current

35 U.S.C.

154(b)(1)(B)

, as discussed above. See

Changes to

Implement Patent Term Adjustment Under Twenty-Year Patent Term,

65 FR

56366, 56382-84, (September 18, 2000), 1239 OG 14, 28-30 (October 3, 2000). See also

Revisions to Patent Term Adjustment,

78 FR 19416, 19417 (April 1,

2013), 1389 OG 224 (April 23, 2013).

Effective on September 16, 2012,

37 CFR

1.702(b)(2)

was amended to reflect the statutory change in section

3(i) of the AIA that replaced interference proceedings with derivation proceedings for

some applications. In addition, section 3(j) of the AIA redesignated the title “Board of

Patent Appeals and Interferences” as “Patent Trial and Appeal Board” in

35 U.S.C.

134

,

145

,

146

,

154

, and

305

. Accordingly,

37 CFR

1.702(b)(4)

was amended to reflect the redesignation of the title

of the Board. See

Changes to Implement Miscellaneous Post Patent Provisions of

the Leahy-Smith America Invents Act,

77 FR 46615 (August 6, 2012)

tion 3(j) of the AIA redesignated the title “Board of

Patent Appeals and Interferences” as “Patent Trial and Appeal Board” in

35 U.S.C.

134

,

145

,

146

,

154

, and

305

. Accordingly,

37 CFR

1.702(b)(4)

was amended to reflect the redesignation of the title

of the Board. See

Changes to Implement Miscellaneous Post Patent Provisions of

the Leahy-Smith America Invents Act,

77 FR 46615 (August 6, 2012).

37 CFR

1.702(c)

also indicates that a patent is entitled to patent term

adjustment if the issuance of the patent was delayed by an interference proceeding

(

35 U.S.C.

154(b)(1)(C)(i)

). Effective September 16, 2012,

37 CFR 1.702(c)

was amended to reflect the statutory change in section 3(i) of the AIA that replaced

interference proceedings with derivation proceedings for certain applications.

Specifically,

37 CFR 1.702(c)

added derivation

proceedings to the guarantees of adjustment for Office delays. In addition, section 3(j)

of the AIA redesignated the title “Board of Patent Appeals and Interferences” as “Patent

Trial and Appeal Board” in

35 U.S.C. 134

,

145

,

146

,

154

, and

305

.

37 CFR

1.702(d)

indicates that a patent is entitled to patent term

adjustment if the issuance of the patent was delayed by the application being placed

under a secrecy order under

35 U.S.C. 181

(

35 U.S.C.

154(b)(1)(C)(ii)

).

37 CFR 1.702(e)

indicates that a

patent is entitled to patent term adjustment if the issuance of the patent was delayed

by successful appellate review under

35 U.S.C. 134

,

141

, or

145

(

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

).

Effective May 24, 2004,

37 CFR 1.702(e)

was amended to

indicate that certain remands by the Board of Patent Appeals and Interferences shall be

considered “a decision in the review reversing an adverse determination of

patentability” for patent term adjustment purposes. Effective September 16, 2012,

37 CFR

1.702(e)

was amended to implemented section (3)(j) of the AIA by

redesignating the title “Board of Patent Appeals and Interferences” as “Patent Trial and

Appeal Board”

in remands by the Board of Patent Appeals and Interferences shall be

considered “a decision in the review reversing an adverse determination of

patentability” for patent term adjustment purposes. Effective September 16, 2012,

37 CFR

1.702(e)

was amended to implemented section (3)(j) of the AIA by

redesignating the title “Board of Patent Appeals and Interferences” as “Patent Trial and

Appeal Board”.

37 CFR

1.702(f)

provides that the provisions of

37 CFR 1.702

through

1.705

apply only to original (i.e., non-reissue) applications,

except applications for design patents, filed on or after May 29, 2000, and patents

issued on such applications. The term ‘‘original application’’ includes a continuing

application (continuation, divisional, or continuation-in-part, whether the application

is filed under

37

CFR 1.53(b)

or as a continued prosecution application under

37 CFR

1.53(d)

) and an international application under

35 U.S.C. 363

which has entered the national stage. See

Cooper Techs. Co. v. Dudas,

536 F.3d 1330, 87 USPQ2d 1705 (Fed. Cir. 2008). In particular, since a continued

prosecution application (CPA) filed under

37 CFR 1.53(d)

is a new (continuing)

application, a CPA filed on or after May 29, 2000, and before July 14, 2003, is entitled

to the benefits of the patent term adjustment provisions of

35 U.S.C. 154(b)

and

37 CFR

1.702

through

1.705

. Since a request for continued

examination (RCE) filed under

35 U.S.C. 132(b)

and

37 CFR

1.114

is

not

a new application (it is a submission in

a previously filed application), filing an RCE in an application filed before May 29,

2000, does

not

cause that application to be entitled to the benefits of the

patent term adjustment provisions of

35 U.S.C. 154(b)

and

37 CFR

1.702

through

1.705.

In regard to international

applications, such an application must have an international filing date on or after May

29, 2000 in order for the provisions of

37 CFR 1.702

through

1.705

to apply. The date on which an international application

fulfills the requirements of

35 U.S.C

o be entitled to the benefits of the

patent term adjustment provisions of

35 U.S.C. 154(b)

and

37 CFR

1.702

through

1.705.

In regard to international

applications, such an application must have an international filing date on or after May

29, 2000 in order for the provisions of

37 CFR 1.702

through

1.705

to apply. The date on which an international application

fulfills the requirements of

35 U.S.C. 371

(e.g., enters the

national stage) is not the filing date of the international application. See

35 U.S.C.

363

. The term “design patents” includes patents issued from design

applications filed under

35 U.S.C. 111

and international

design applications filed under

35 U.S.C. 385

.

II.

37 CFR 1.703 - PERIOD OF

ADJUSTMENT

[Editor Note:

37 CFR

1.703(a)(1)

, as reproduced below, includes amendments

applicable only to patents granted on or after January 14, 2013 and

37 CFR 1.703(b)(4)

and (e)

, as reproduced below, include amendments applicable

only to applications and patents in which a notice of allowance issued on or after

September 17, 2012. See

37 CFR 1.703 (2012-09-17 thru

2013-03-31)

or

37 CFR 1.703 (pre-2012-09-17)

for

paragraph (a)(1) applicable to patents granted before January 14, 2013. See

37

CFR 1.703 (pre-2012-09-17)

for paragraphs (b)(4) and (e) that

apply if the notice of allowance was issued before September 17, 2012.]

37 CFR 1.703  Period of adjustment of patent term due to examination delay.

(a) The period of adjustment under

§

1.702(a)

is the sum of the following periods:

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

the day after the date that is fourteen months after the date on which

the application was filed under

35 U.S.C. 111(a)

the

date the national stage commenced under

35 U.S.C.

371(b)

or

7 CFR 1.703  Period of adjustment of patent term due to examination delay.

(a) The period of adjustment under

§

1.702(a)

is the sum of the following periods:

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

the day after the date that is fourteen months after the date on which

the application was filed under

35 U.S.C. 111(a)

the

date the national stage commenced under

35 U.S.C.

371(b)

or

(f)

in an

international application and ending on the date of mailing of either an

action under

35 U.S.C. 132

, or a

notice of allowance under

35 U.S.C. 151

,

whichever occurs first;

(2) The number of days, if any, in the period beginning on

the day after the date that is four months after the date a reply under

§

1.111

was filed and ending on the date of mailing

of either an action under

35 U.S.C. 132

, or a

notice of allowance under

35 U.S.C. 151

,

whichever occurs first;

(3) The number of days, if any, in the period beginning on

the day after the date that is four months after the date a reply in

compliance with

§ 1.113(c)

was filed

and ending on the date of mailing of either an action under

35

U.S.C. 132

, or a notice of allowance under

35

U.S.C. 151

, whichever occurs first;

(4) The number of days, if any, in the period beginning on

the day after the date that is four months after the date an appeal brief

in compliance with

§ 41.37

was filed and

ending on the date of mailing of any of an examiner’s answer under

§

41.39

, an action under

35 U.S.C.

132

, or a notice of allowance under

35 U.S.C. 151

, whichever occurs first;

(5) The number of days, if any, in the period beginning on

the day after the date that is four months after the date of a final

decision by the Patent Trial and Appeal Board or by a Federal court in an

appeal under

35 U.S.C. 141

or a

civil action under

35 U.S.C. 145

or

146

where at least one allowable claim remains in

the application and ending on the date of mailing of either an action

under

35 U.S.C. 132

or a notice of allowance under

35

U.S.C. 151

, whichever occurs first; and

at is four months after the date of a final

decision by the Patent Trial and Appeal Board or by a Federal court in an

appeal under

35 U.S.C. 141

or a

civil action under

35 U.S.C. 145

or

146

where at least one allowable claim remains in

the application and ending on the date of mailing of either an action

under

35 U.S.C. 132

or a notice of allowance under

35

U.S.C. 151

, whichever occurs first; and

(6) The number of days, if any, in the period beginning on

the day after the date that is four months after the date the issue fee

was paid and all outstanding requirements were satisfied and ending on

the date a patent was issued.

(b) The period of adjustment under

§

1.702(b)

is the number of days, if any, in the period

beginning on the day after the date that is three years after the date on which

the application was filed under

35 U.S.C. 111(a)

or the

national stage commenced under

35 U.S.C. 371(b) or (f)

in

an international application and ending on the date a patent was issued, but

not including the sum of the following periods:

(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

;

(2)

(i) The number of days, if any, in the period

beginning on the date an interference or derivation proceeding was

instituted to involve the application in the interference or

derivation proceeding under

35

U.S.C. 135(a)

and ending on the date that the

interference or derivation proceeding was terminated with respect

to the application; and

(ii) The number of days, if any, in the period

beginning on the date prosecution in the application was suspended

by the Office due to interference or derivation proceedings under

35 U.S.C.

135(a)

not involving the application and

ending on the date of the termination of the suspension;

(3)

the date that the

interference or derivation proceeding was terminated with respect

to the application; and

(ii) The number of days, if any, in the period

beginning on the date prosecution in the application was suspended

by the Office due to interference or derivation proceedings under

35 U.S.C.

135(a)

not involving the application and

ending on the date of the termination of the suspension;

(3)

(i) The number of days, if any, the application was

maintained in a sealed condition under

35 U.S.C.

181

;

(ii) The number of days, if any, in the period

beginning on the date of mailing of an examiner's answer under

§ 41.39

in the

application under secrecy order and ending on the date the secrecy

order was removed;

(iii) The number of days, if any, in the period

beginning on the date applicant was notified that an interference

or derivation proceeding under

35

U.S.C. 135(a)

would be instituted but for the

secrecy order and ending on the date the secrecy order was removed;

and

(iv) The number of days, if any, in the period

beginning on the date of notification under

§

5.3(c)

of this chapter and ending on the date

of mailing of the notice of allowance under

35 U.S.C.

151

; and,

(4) The number of days, if any, in the period beginning on

the date on which jurisdiction over the application passes to the Patent

Trial and Appeal Board under

§ 41.35(a)

of this

chapter and ending on the date that jurisdiction by the Patent Trial and

Appeal Board ends under

§ 41.35(b)

of this

chapter or the date of the last decision by a Federal court in an appeal

under

35 U.S.C. 141

or

civil action under

35 U.S.C. 145

,

whichever is later.

beginning on

the date on which jurisdiction over the application passes to the Patent

Trial and Appeal Board under

§ 41.35(a)

of this

chapter and ending on the date that jurisdiction by the Patent Trial and

Appeal Board ends under

§ 41.35(b)

of this

chapter or the date of the last decision by a Federal court in an appeal

under

35 U.S.C. 141

or

civil action under

35 U.S.C. 145

,

whichever is later.

(c) The period of adjustment under

§

1.702(c)

is the sum of the following periods, to the

extent that the periods are not overlapping:

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

the date an interference or derivation proceeding was instituted to

involve the application in the interference or derivation proceeding

under

35 U.S.C. 135(a)

and

ending on the date that the interference or derivation proceeding was

terminated with respect to the application; and

(2) The number of days, if any, in the period beginning on

the date prosecution in the application was suspended by the Office due

to interference or derivation proceedings under

35 U.S.C.

135(a)

not involving the application and ending on

the date of the termination of the suspension.

(d) The period of adjustment under

§

1.702(d)

is the sum of the following periods, to the

extent that the periods are not overlapping:

(1) The number of days, if any, the application was

maintained in a sealed condition under

35 U.S.C.

181

;

(2) The number of days, if any, in the period beginning on

the date of mailing of an examiner’s answer under

§

41.39

in the application under secrecy order and

ending on the date the secrecy order was removed;

(3) The number of days, if any, in the period beginning on

the date applicant was notified that an interference or derivation

proceeding under

35 U.S.C. 135(a)

would be instituted but for the secrecy order and ending on the date the

secrecy order was removed; and

iling of an examiner’s answer under

§

41.39

in the application under secrecy order and

ending on the date the secrecy order was removed;

(3) The number of days, if any, in the period beginning on

the date applicant was notified that an interference or derivation

proceeding under

35 U.S.C. 135(a)

would be instituted but for the secrecy order and ending on the date the

secrecy order was removed; and

(4) The number of days, if any, in the period beginning on

the date of notification under

§ 5.3(c)

of this

chapter and ending on the date of mailing of the notice of allowance

under

35 U.S.C. 151

.

(e) The period of adjustment under

§

1.702(e)

is the sum of the number of days, if any, in the

period beginning on the date on which jurisdiction over the application passes

to the Patent Trial and Appeal Board under

§

41.45(a)

of this chapter and ending on the date of a

final decision in favor of applicant by the Patent Trial and Appeal Board or a

Federal court in an appeal under

35 U.S.C. 141

or a civil

action under

35 U.S.C. 145

.

(f) The adjustment will run from the expiration date of the patent

as set forth in

35 U.S.C. 154(a)(2)

. To the

extent that periods of delay attributable to the grounds specified in

§

1.702

overlap, the period of adjustment granted under

this section shall not exceed the actual number of days the issuance of the

patent was delayed. The term of a patent entitled to adjustment under

§

1.702

and this section shall be adjusted for the sum of

the periods calculated under paragraphs (a) through (e) of this section, to the

extent that such periods are not overlapping, less the sum of the periods

calculated under

§ 1.704

. The date indicated

on any certificate of mailing or transmission under

§ 1.8

shall not be taken into account in this calculation.

nt entitled to adjustment under

§

1.702

and this section shall be adjusted for the sum of

the periods calculated under paragraphs (a) through (e) of this section, to the

extent that such periods are not overlapping, less the sum of the periods

calculated under

§ 1.704

. The date indicated

on any certificate of mailing or transmission under

§ 1.8

shall not be taken into account in this calculation.

(g) No patent, the term of which has been disclaimed beyond a

specified date, shall be adjusted under

§ 1.702

and this section

beyond the expiration date specified in the disclaimer.

37 CFR

1.703

specifies the period of adjustment if a patent is entitled

to patent term adjustment under

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

and

37 CFR

1.702

. See

MPEP § 2731

for more information.

On September 16, 2012,

37 CFR

1.703

was amended to reflect the statutory change in section 3(i)

of the AIA that replaced interference proceedings with derivation proceedings for

certain applications. See AIA section 3(n).

37 CFR

1.702(c)

added derivation proceedings to the guarantees of

adjustment for Office delays. In addition, section 3(j) of the AIA redesignated the

“Board of Patent Appeals and Interferences” as “Patent Trial and Appeal Board” in

35 U.S.C.

134

,

145

,

146

,

154

, and

305

.

37 CFR

1.703(a)(5)

was amended to reflect the change to the title of the

Patent Board and

37 CFR 1.703(b)(2)

,

(b)(3)

,

(c)(1)

, and

(d)(3)

were amended to reflect the addition of derivation

proceedings to the rules providing patent term adjustment for Office delay.

Effective September 17, 2012, any application that

receives a notice of allowance on or after such date and issues as a patent, is entitled

to patent term adjustment under

37 CFR 1.702(e)

for the sum of the

number of days, if any, in the period beginning on the date on which jurisdiction passes

to the Patent Trial and Appeal Board and ends on the date of a final decision in favor

of applicant by the Patent Trial and Appeal Board or a federal court in an appeal under

35 U.S.C

ce on or after such date and issues as a patent, is entitled

to patent term adjustment under

37 CFR 1.702(e)

for the sum of the

number of days, if any, in the period beginning on the date on which jurisdiction passes

to the Patent Trial and Appeal Board and ends on the date of a final decision in favor

of applicant by the Patent Trial and Appeal Board or a federal court in an appeal under

35 U.S.C.

141

or a civil action under

35 U.S.C. 145

. See

Revisions of Patent Term Adjustment Provisions Relating to Appellate

Review,

77 FR 49354 (August 16, 2012).

Effective September 17, 2012, any application that

receives a notice of allowance on or after such date and issues as a patent, the three

year delay under

37 CFR 1.703(b)

does not include the

number of days, if any, in the period beginning on the date which jurisdiction passes to

the Patent Trial and Appeal Board under

37 CFR 41.35(a)

to the date that the

jurisdiction of the Patent Trial and Appeal Board ends under

37 CFR 41.35(b)

or

the date of the last decision by the federal court in an appeal under

35 U.S.C. 141

or civil action under

35 U.S.C. 145

.

The Office will also apply the changes to

37 CFR

1.703

in any timely patent term adjustment reconsideration

proceeding that is initiated on or after September 17, 2012. To allow patentees to take

advantage of changes to this provision relating to appellate review, the Office will

consider any of the following timely-filed proceedings to be an eligible "patent term

adjustment reconsideration proceeding" if initiated on or after September 17, 2012:

(1) reconsideration proceedings initiated pursuant to a

remand from a timely filed civil action in federal court;

(2) reconsideration proceedings initiated pursuant to a

timely request for reconsideration of the patent term adjustment indicated in the

patent under

37 CFR 1.705(d)

(2012) in

which the patentee argues that the change to

37 CFR

1.703

in this final rule is applicable to their patent;

and

) reconsideration proceedings initiated pursuant to a

remand from a timely filed civil action in federal court;

(2) reconsideration proceedings initiated pursuant to a

timely request for reconsideration of the patent term adjustment indicated in the

patent under

37 CFR 1.705(d)

(2012) in

which the patentee argues that the change to

37 CFR

1.703

in this final rule is applicable to their patent;

and

(3) reconsideration proceedings initiated pursuant to a

request for reconsideration that seeks reconsideration of the Office’s decision

under

37 CFR 1.705(d)

(2012)

regarding patent term adjustment under the Office’s former interpretation of the

appellate review language of

35 U.S.C. 154(b)(1)(B)(ii)

and

(C)(iii)

, if such request is filed within two months of the

date of the decision for which reconsideration is requested. See

37 CFR

1.181(f)

.

For applications in which the patent was granted on or

after January 14, 2013,

37 CFR 1.703(a)(1)

provides patent

term adjustment if the Office fails to mail at least one of a notification under

35 U.S.C.

132

or a notice of allowance under

35 U.S.C. 151

not

later than 14 months after the date on which the application was filed under

35 U.S.C.

111(a)

or the date the national stage commenced under

35 U.S.C.

371(b)

or

(f)

in an international application.

For applications filed on or after May 29, 2000 in which the patent was granted prior to

January 14, 2013, the fourteen month measurement in international applications is based

upon the date that application fulfilled the requirements of

35 U.S.C. 371

and

not the date the national stage commenced.

Effective January 9, 2015,

37 CFR

1.703(b)(1)

was 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

ive January 9, 2015,

37 CFR

1.703(b)(1)

was 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

.

This change is effective for any patent granted before, on, or after January 9, 2015.

See

MPEP §

2731

for more information. See also

Novartis AG v.

Lee,

740 F.3d 593, 109 USPQ2d 1385 (Fed. Cir. 2014).

III.

37 CFR 1.704 - REDUCTION OF

ADJUSTMENT

[Editor Note:

37 CFR

1.704(d)(3)

only applies for statements under

37 CFR

1.704(d)

filed on or after July 17, 2023.

37 CFR

1.704(c)(2)-(4), (c)(6), and (c)(9)-(10)

, as reproduced below,

include changes applicable only to original utility and plant patents issuing from

applications filed on or after May 29, 2000, in which a notice of allowance was

mailed on or after July 16, 2020. For 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10)

in effect for applications filed on or after May 29, 2000, in which there was no

notice of allowance mailed on or after July 16, 2020, see 37 CFR 1.704 (2015‑03‑10

thru 2020‑07‑15).

37 CFR 1.704(c)(12)

, as

reproduced below, include changes applicable only to applications in which a request

for continued examination under

35 U.S.C. 132(b)

and

37 CFR

1.114

was filed on or after March 10, 2015. In addition,

37 CFR

1.704(c)(11)

,

(c)(13)

, and

May 29, 2000, in which there was no

notice of allowance mailed on or after July 16, 2020, see 37 CFR 1.704 (2015‑03‑10

thru 2020‑07‑15).

37 CFR 1.704(c)(12)

, as

reproduced below, include changes applicable only to applications in which a request

for continued examination under

35 U.S.C. 132(b)

and

37 CFR

1.114

was filed on or after March 10, 2015. In addition,

37 CFR

1.704(c)(11)

,

(c)(13)

, and

(c)(14)

, as reproduced below, include changes applicable only

to patent applications filed under

35 U.S.C. 111

on or after

December 18, 2013, and to international patent applications in which the national

stage commenced under

35 U.S.C. 371

on or after

December 18, 2013. For

37 CFR 1.704(c)(11) and (c)(12)

in effect for applications filed before (and international applications in which the

national stage commenced before) December 18, 2013, and in which a notice of appeal

was filed on or after September 17, 2012, see

37 CFR 1.704

(2012-09-17 thru 2013-12-17)

. For

37 CFR

1.704(c)(11)

in effect for applications in which there was no

notice of appeal filed on or after September 17, 2012, see

37 CFR 1.704

(pre-2012-09-17)

.

37 CFR

1.704(e)

below includes changes applicable only to applications

in which a notice of allowance was mailed on or after April 1, 2013. For 37 CFR

1.704(e) in effect for applications in which no notice of allowance was mailed on or

after April 1, 2013, see

37 CFR 1.704(e)

(pre-2013-03-31)

.]

37 CFR 1.704  Reduction of period of adjustment of patent term.

(a) The period of adjustment of the term of a patent under

§§ 1.703(a) through (e)

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 (processing or examination) of the

application.

ter April 1, 2013, see

37 CFR 1.704(e)

(pre-2013-03-31)

.]

37 CFR 1.704  Reduction of period of adjustment of patent term.

(a) The period of adjustment of the term of a patent under

§§ 1.703(a) through (e)

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 (processing or examination) of the

application.

(b) With respect to the grounds for adjustment set forth in

§§

1.702(a) through (e)

, and in particular the ground of

adjustment set forth in

§ 1.702(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 reply to any notice

or action by the Office making any rejection, objection, argument, or other

request, measuring such three-month period from the date the notice or action

was mailed or given to the applicant, 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 three months after the date of

mailing or transmission of the Office communication notifying the applicant of

the rejection, objection, argument, or other request and ending on the date the

reply was filed. The period, or shortened statutory period, for reply that is

set in the Office action or notice has no effect on the three-month period set

forth in this paragraph.

e day after the date that is three months after the date of

mailing or transmission of the Office communication notifying the applicant of

the rejection, objection, argument, or other request and ending on the date the

reply was filed. The period, or shortened statutory period, for reply that is

set in the Office action or notice has no effect on the three-month period set

forth in this paragraph.

(c) Circumstances that constitute a failure of the applicant to

engage in reasonable efforts to conclude processing or examination of an

application also include the following circumstances, which will result in the

following reduction of the period of adjustment set forth in

§ 1.703

to the extent that the periods are not overlapping:

(1) Suspension of action under

§

1.103

at the applicant’s request, 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 a request

for suspension of action under

§ 1.103

was filed and

ending on the date of the termination of the suspension;

(2) Deferral of issuance of a patent under

§

1.314

, 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 a request

for deferral of issuance of a patent under

§

1.314

was filed and ending on the earlier of the

date a request to terminate the deferral was filed or the date the patent

was issued;

(3) Abandonment of the application or late payment of the

issue fee, 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 abandonment or the day after the date the

issue fee was due and ending on the date the grantable petition to revive

the application or accept late payment of the issue fee was filed;

ent

was issued;

(3) Abandonment of the application or late payment of the

issue fee, 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 abandonment or the day after the date the

issue fee was due and ending on the date the grantable petition to revive

the application or accept late payment of the issue fee was filed;

(4) Failure to file a petition to withdraw the holding of

abandonment or to revive an application within two months from the date

of mailing of a notice of abandonment, 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 two months from the date of mailing of a notice of abandonment and

ending on the date a petition to withdraw the holding of abandonment or

to revive the application was filed;

(5) Conversion of a provisional application under

35 U.S.C. 111(b)

to a nonprovisional application

under

35 U.S.C. 111(a)

pursuant to

35 U.S.C.

111(b)(5)

, 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 the

application was filed under

35 U.S.C. 111(b)

and

ending on the date a request in compliance with

§

1.53(c)(3)

to convert the provisional application

into a nonprovisional application was filed;

(6) Submission of a preliminary amendment or other

preliminary paper less than one month before the mailing of an Office

action under

35 U.S.C. 132

or

notice of allowance under

35 U.S.C. 151

that

requires the mailing of a supplemental Office action or notice of

allowance, 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

hat

requires the mailing of a supplemental Office action or notice of

allowance, 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 preliminary amendment or other preliminary paper was

filed;

(7) Submission of a reply having an omission

(

§

1.135(c)

), 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 the reply having an omission was filed and ending on the date that

the reply or other paper correcting the omission was filed;

(8) Submission of a supplemental reply or other paper, other

than a supplemental reply or other paper expressly requested by the

examiner, after a reply has been filed, 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 the initial reply was filed and ending on the date that the

supplemental reply or other such paper was filed;

(9) Submission of an amendment or other paper after a

decision by the Patent Trial and Appeal Board, other than a decision

designated as containing a new ground of rejection under

§

41.50(b)

of this title or statement under

§

41.50(c)

of this title, or a decision by a Federal

court, less than one month before the mailing of an Office action under

35

U.S.C. 132

or a notice of allowance under

35 U.S.C

) Submission of an amendment or other paper after a

decision by the Patent Trial and Appeal Board, other than a decision

designated as containing a new ground of rejection under

§

41.50(b)

of this title or statement under

§

41.50(c)

of this title, or a decision by a Federal

court, less than one month before the mailing of an Office action under

35

U.S.C. 132

or a notice of allowance under

35 U.S.C. 151

that requires the mailing of a

supplemental Office action or supplemental notice of allowance, 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 the decision by the Patent

Trial and Appeal Board or by a Federal court and ending on date the

amendment or other paper was filed;

(10) Submission of an amendment under

§ 1.312

or other paper, other than an amendment

under

§

1.312

or other paper expressly requested by the

Office or 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 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 amendment under

§

1.312

or other paper was filed;

(11) Failure to file an appeal brief in

compliance with

§ 41.37

of this

chapter within three months from the date on which a notice of appeal to

the Patent Trial and Appeal Board was filed under

35 U.S.C.

134

and

§ 41.31

of this

chapter, 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 three months from the date on which a notice of appeal to the Patent

Trial and Appeal Board was filed under

35 U.S.C.

134

and

§ 41.31

of this

chapter, and ending on the date an appeal brief in compliance with

§

41.37

of this chapter or a request for continued

examination in compliance with

§ 1.114

was

filed;

1.703

shall be

reduced by the number of days, if any, beginning on the day after the

date three months from the date on which a notice of appeal to the Patent

Trial and Appeal Board was filed under

35 U.S.C.

134

and

§ 41.31

of this

chapter, and ending on the date an appeal brief in compliance with

§

41.37

of this chapter or a request for continued

examination in compliance with

§ 1.114

was

filed;

(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.

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 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.

(2) The thirty-day period set forth in

paragraph (d)(1) of this section is not extendable.

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.

(2) The thirty-day period set forth in

paragraph (d)(1) of this section is not extendable.

(3) The statement under paragraph (d)(1) of

this section must be submitted on the Office form (PTO/SB/133) provided

for such a patent term adjustment statement using the appropriate

document code (PTA.IDS). Otherwise, the paper or request for continued

examination will be treated as not accompanied by a statement under

paragraph (d)(1) of this section unless an application for patent term

adjustment, in compliance with

§

1.705(b)

, is filed, establishing that the paper or

request for continued examination was accompanied by a statement in

compliance with paragraph (d)(1) of this section. No changes to

statements on this Office form may be made. The presentation to the

Office (whether by signing, filing, submitting, or later advocating) of

this form, whether by a practitioner or non-practitioner, constitutes a

certification under

§ 11.18(b)

of this

chapter that the existing text and any certification statements on this

form have not been altered.

(e) The submission of a request under

§

1.705(c)

for reinstatement of reduced patent term

adjustment will not be considered a failure to engage in reasonable efforts to

conclude prosecution (processing or examination) of the application under

paragraph (c)(10) of this section.

der

§ 11.18(b)

of this

chapter that the existing text and any certification statements on this

form have not been altered.

(e) The submission of a request under

§

1.705(c)

for reinstatement of reduced patent term

adjustment will not be considered a failure to engage in reasonable efforts to

conclude prosecution (processing or examination) of the application under

paragraph (c)(10) of this section.

(f) An application filed under

35 U.S.C.

111(a)

is in condition for examination when it includes a

specification, including at least one claim and an abstract (§

1.72(b)

), and has papers in compliance with §

1.52

, drawings (if any) in compliance with §

1.84

, any English translation required by §

1.52(d)

or §

1.57(a)

, a “Sequence

Listing” in compliance with §§

1.821

through

1.825

(if applicable), a “Sequence Listing XML” in

compliance with §§

1.831

through

1.835

(if applicable), an inventor’s oath or declaration

or an application data sheet containing the information specified in §

1.63(b)

, the basic filing fee (§

1.16(a)

or

(c)

), the search fee (§

1.16(k)

or

(m)

), the examination fee (§

1.16(o)

or

(q)

), any certified copy of the previously filed

application required by §

1.57(a)

, and any

application size fee required by the Office under §

1.16(s)

.

An international application is in condition for examination when it has

entered the national stage as defined in §

1.491(b)

, and includes a specification, including at

least one claim and an abstract (§

1.72(b)

), and has papers in

compliance with §

1.52

, drawings (if any) in

compliance with §

1.84

, a “Sequence Listing”

in compliance with §§

1.821

through

1.825

(if applicable), a “Sequence Listing XML” in

compliance with §§

1.831

through

1.835

(if applicable), an inventor’s oath or declaration

or an application data sheet containing the information specified in §

1.63(b)

, the search fee (§

1.492(b)

), the examination fee (§

1.492(c)

), and any application size fee required by the

Office under §

1.492(j)

isting”

in compliance with §§

1.821

through

1.825

(if applicable), a “Sequence Listing XML” in

compliance with §§

1.831

through

1.835

(if applicable), an inventor’s oath or declaration

or an application data sheet containing the information specified in §

1.63(b)

, the search fee (§

1.492(b)

), the examination fee (§

1.492(c)

), and any application size fee required by the

Office under §

1.492(j)

. An application

shall be considered as having papers in compliance with §

1.52

,

drawings (if any) in compliance with §

1.84

, and a “Sequence

Listing” in compliance with §§

1.821

through

1.825

(if applicable), or a “Sequence Listing XML” in

compliance with §§

1.831

through

1.835

(if applicable), for purposes of this paragraph

(f) on the filing date of the latest reply (if any) correcting the papers,

drawings, “Sequence Listing,” or “Sequence Listing XML” that is prior to the

date of mailing of either an action under

35 U.S.C. 132

or a notice

of allowance under

35 U.S.C. 151

, whichever

occurs first.

Section 1.704 implements the provisions of

35 U.S.C.

154(b)(2)(C)

.

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

specifies

certain circumstances as constituting a failure of an applicant to engage in reasonable

efforts to conclude processing or examination of an application and also provides for

the Office to prescribe regulations establishing circumstances that constitute a failure

of an applicant to engage in reasonable efforts to conclude processing or examination of

an application. For more information, see

MPEP § 2732

.

Section 3(j) of the AIA redesignated the title “Board of

Patent Appeals and Interferences” as “Patent Trial and Appeal Board” in

35 U.S.C.

134

,

145

,

146

,

154

, and

305

. Effective September 16, 2012,

37 CFR

1.704(c)(9)

was amended to reflect the change to the title of the

Board

in reasonable efforts to conclude processing or examination of

an application. For more information, see

MPEP § 2732

.

Section 3(j) of the AIA redesignated the title “Board of

Patent Appeals and Interferences” as “Patent Trial and Appeal Board” in

35 U.S.C.

134

,

145

,

146

,

154

, and

305

. Effective September 16, 2012,

37 CFR

1.704(c)(9)

was amended to reflect the change to the title of the

Board.

Effective December 1, 2011,

37 CFR

1.704(d)

was amended to allow the diligent applicant to avoid

patent term adjustment reduction for an information disclosure statement (IDS)

submission that results from a communication from the Office if submitted within 30 days

of receipt of the communication by any individual designated in

37 CFR

1.56(c)

. See

Revision of Patent Term Adjustment Provisions

Relating to Information Disclosure Statements,

76 FR 74700 (December 1,

2011). Previously, this section only allowed a diligent applicant to avoid patent term

adjustment reduction if the IDS was cited as a result from a foreign patent Office.

Effective March 10, 2015,

37 CFR 1.704(d)(1)

provides that a

request for continued examination in compliance with

37 CFR 1.114

with no submission

other than an information disclosure statement in compliance with

37 CFR 1.97

and

37 CFR

1.98

will not be considered a failure to engage in reasonable

efforts to conclude prosecution (processing or examination) of the application under

37 CFR

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

37 CFR

1.704(d)

.

37 CFR 1.704(d)

statements filed on

or after July 17, 2023, must be submitted on the Office form PTO/SB/133, “Patent Term

Adjustment Statement Under 37 CFR 1.704(d),” using the document code PTA.IDS. See

37 CFR

1.704(d)(3)

. For statements not submitted via the USPTO patent

electronic filing system, inclusion of the document code PTA.IDS on the form PTO/SB/133

satisfies the requirement to use the document code

d)

statements filed on

or after July 17, 2023, must be submitted on the Office form PTO/SB/133, “Patent Term

Adjustment Statement Under 37 CFR 1.704(d),” using the document code PTA.IDS. See

37 CFR

1.704(d)(3)

. For statements not submitted via the USPTO patent

electronic filing system, inclusion of the document code PTA.IDS on the form PTO/SB/133

satisfies the requirement to use the document code. Otherwise, the application will be

treated as if no

37 CFR 1.704(d)

statement had been

filed unless a request for reconsideration of the patent term adjustment, in compliance

with

37

CFR 1.705(b)

, is filed establishing that the IDS was accompanied

by a

37

CFR 1.704(d)

statement.

Effective September 17, 2012,

37 CFR

1.704(c)(11)

was amended to provide that failure to file an appeal

brief in compliance with

37 CFR 41.37

within three months

from the date that the notice of appeal was filed would constitute a failure to engage

in reasonable efforts to conclude processing or examination of the application. The

amended rule is applicable with respect to the filing of an appeal brief in any

application (other than design or reissue applications) in which the notice of appeal is

filed on or after September 17, 2012.

Prior to September 17, 2012,

37 CFR

1.704(c)(11)

contained a provision that further prosecution via a

continuing application is a circumstance constituting a failure of an applicant to

engage in reasonable efforts to conclude processing or examination of an application.

Effective September 17, 2012, this provision previously labeled as

37 CFR 1.704(c)(11)

was labelled

37 CFR 1.704(c)(12)

. Effective

December 18, 2013, this same provision was amended to be located in

37 CFR

1.704(c)(13)

, and a new provision regarding the failure to provide

an application in condition for examination, as defined in

37 CFR

1.704(f)

, was added as

37 CFR 1.704(c)(12)

. Effective March

10, 2015, the same provision formerly labelled as

37 CFR

1.704(c)(13)

is now labelled as

37 CFR

1.704(c)(14)

(c)(12)

. Effective

December 18, 2013, this same provision was amended to be located in

37 CFR

1.704(c)(13)

, and a new provision regarding the failure to provide

an application in condition for examination, as defined in

37 CFR

1.704(f)

, was added as

37 CFR 1.704(c)(12)

. Effective March

10, 2015, the same provision formerly labelled as

37 CFR

1.704(c)(13)

is now labelled as

37 CFR

1.704(c)(14)

.

Effective for applications filed under

35 U.S.C.

111

on or after December 18, 2013 and international applications

in which the national stage was commenced under

35 U.S.C. 371

on or after December

18, 2013, several changes to

37 CFR 1.704

were made.

37 CFR 1.704(c)(11)

was modified to

delete the “and” at the end of the paragraph because it is no longer the penultimate

paragraph of

37 CFR 1.704

. On December 18, 2013,

37 CFR

1.704(c)(12)

was added to provide for a reduction in any earned

patent term adjustment in the situation in which an application is not in condition for

examination within eight months from when an application under

35 U.S.C.

111

was filed or when an international application commenced the

national stage under

35 U.S.C. 371(b) or (f)

. Effective March 10, 2015, this provision

was amended to be labelled as

37 CFR 1.704(c)(13)

. On December 18,

2013,

37

CFR 1.704(f)

was added to define when an application is “in

condition for examination” for purposes of

37 CFR 1.704(c)(13)

.

37 CFR

1.704(f)

was amended in the final rule

Standard for

Presentation of Nucleotide and Amino Acid Sequence Listings Using eXtensible Markup

Language (XML) in Patent Applications To Implement WIPO Standard ST.26; Incorporation

by Reference,

87 FR 30806 (May 20, 2022) and this amendment is effective

for all applications filed before, on, or after July 1, 2022.

Effective for applications in which a request for continued

examination was filed on or after March 10, 2015,

37 CFR

1.704(c)(12)

was amended to include a new provision that

establishes the submission of a request for continued examination under

35 U.S.C

orporation

by Reference,

87 FR 30806 (May 20, 2022) and this amendment is effective

for all applications filed before, on, or after July 1, 2022.

Effective for applications in which a request for continued

examination was filed on or after March 10, 2015,

37 CFR

1.704(c)(12)

was 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

37 CFR 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. See

MPEP § 2732

for more

information.

Effective for applications in which a notice of allowance

was mailed on or after July 16, 2020,

37 CFR 1.704(c)(2), (c)(3), (c)(4), (c)(6), (c)(9), and

(c)(10)

were amended in the final rule

Patent Term

Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm.,

Inc. v. Iancu,

85 FR 36335 (June 16, 2020). These paragraphs, as amended,

were revised to state the period of reduction is equal to “the period from the beginning

to the end of the applicant’s failure to engage in reasonable efforts to conclude

prosecution” and that the reduction cannot exceed the period of time during which an

applicant failed to engage in reasonable efforts.

Supernus Pharm., Inc. v.

Iancu,

913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019). Specifically,

37 CFR

1.704(c)(2)

was amended to end the reduction for applicant delay

on the earlier of the date a request to terminate the deferral was filed or the date the

patent was issued

nd that the reduction cannot exceed the period of time during which an

applicant failed to engage in reasonable efforts.

Supernus Pharm., Inc. v.

Iancu,

913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019). Specifically,

37 CFR

1.704(c)(2)

was amended to end the reduction for applicant delay

on the earlier of the date a request to terminate the deferral was filed or the date the

patent was issued.

37 CFR 1.704(c)(3)

was amended to

end the reduction for applicant delay on the date the grantable petition to revive the

application or accept late payment of the issue fee was filed.

37 CFR

1.704(c)(6)

was amended to begin the reduction for applicant delay

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 to end the reduction for applicant delay on the date the

preliminary amendment or other preliminary paper was filed.

37 CFR

1.704(c)(9)

was amended to begin the reduction for applicant delay

on the day after the date of the decision by the Patent Trial and Appeal Board or by a

Federal court and to end the reduction for applicant delay on date the amendment or

other paper was filed.

37 CFR 1.704(c)(10)

was amended to

begin the reduction for applicant delay on the day after the mailing date of the notice

of allowance under

35

U.S.C. 151

and to end the reduction for applicant delay on the

date the amendment under

37 CFR 1.312

or other paper was

filed.

37

CFR 1.704(c)(10)

was further amended to provide that if the

amendment under

37 CFR

1.312

or other paper expressly requested by the Office, such an

amendment or paper will not result in a reduction of patent term adjustment under

37 CFR

1.704(c)(10)

. If the amendment under

37 CFR 1.312

or

other paper was paper expressly requested by the Office, applicant will have three

months to file a reply without the filing resulting in an applicant delay under

37 CFR

1.704(b)

under

37 CFR

1.312

or other paper expressly requested by the Office, such an

amendment or paper will not result in a reduction of patent term adjustment under

37 CFR

1.704(c)(10)

. If the amendment under

37 CFR 1.312

or

other paper was paper expressly requested by the Office, applicant will have three

months to file a reply without the filing resulting in an applicant delay under

37 CFR

1.704(b)

.

The Office will decide any timely request for

reconsideration in compliance with

37 CFR 1.705(b)

of a patent term

adjustment determination in applications or patents eligible for patent term adjustment

in which a notice of allowance mailed prior to July 16, 2020, consistent with the

changes in the final rule discussed above, if requested by the patentee.

37 CFR 1.704(c)

was also amended to

change ‘‘mailing date’’ to ‘‘date of mailing’’ throughout for consistency with the other

regulations pertaining to AIPA patent term adjustment (

37 CFR

1.702

through

37 CFR 1.705

) and URAA patent term

extension (

37 CFR

1.701

). This conforming change was the only amendment to

37 CFR

1.704(c)(4)

. As background, the USPTO has been issuing Office

actions and notices through the Electronic Office Action Program since June of 2009 for

patent applicants choosing this form of notification. See

Electronic Office

Action,

1343 OG 45 (June 2, 2009). The term ‘‘date of mailing’’ as used in

the regulations pertaining to AIPA patent term adjustment and URAA patent term extension

means the mailroom/notification date indicated on the form PTOL–90 accompanying the

Office action or notice communication. See

Electronic Office Action,

1343 OG at 46 (‘‘The mailroom/notification date will also be considered the date of

mailing of the correspondence for all other purposes (e.g., 37 CFR 1.71(g)(2),1.97(b),

1.701 through 1.705).” ).

IV.

37 CFR 1.705 - DETERMINATION OF PATENT

TERM ADJUSTMENT

[Editor Note:

37 CFR

1.705

, as reproduced below, include amendments applicable only

to patents granted on or after January 14, 2013

ice Action,

1343 OG at 46 (‘‘The mailroom/notification date will also be considered the date of

mailing of the correspondence for all other purposes (e.g., 37 CFR 1.71(g)(2),1.97(b),

1.701 through 1.705).” ).

IV.

37 CFR 1.705 - DETERMINATION OF PATENT

TERM ADJUSTMENT

[Editor Note:

37 CFR

1.705

, as reproduced below, include amendments applicable only

to patents granted on or after January 14, 2013. See

37 CFR 1.705(a)-(f)

(pre-2013-04-01)

in effect with respect to applications

granted prior to January 14, 2013.]

37 CFR 1.705  Patent term adjustment determination

(a) The patent will include notification of any patent term

adjustment under

35 U.S.C. 154(b)

.

(b) 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.

This two-month period may be extended under the provisions of

§

1.136(a)

. An application for patent term adjustment under

this section must be accompanied by:

(1) The fee set forth in

§ 1.18(e)

; and

(2) A statement of the facts involved, specifying:

(i) The correct patent term adjustment and the basis

or bases under

§ 1.702

for the

adjustment;

(ii) The relevant dates as specified in

§§ 1.703(a) through

(e)

for which an adjustment is sought and the

adjustment as specified in

§ 1.703(f)

to

which the patent is entitled;

(iii) Whether the patent is subject to a terminal

disclaimer and any expiration date specified in the terminal

disclaimer; and

(iv)

(A) Any circumstances during the prosecution of

the application resulting in the patent that constitute a

failure to engage in reasonable efforts to conclude

processing or examination of such application as set forth in

§ 1.704

;

or

(B) That there were no circumstances

constituting a failure to engage in reasonable efforts to

conclude processing or examination of such application as set

forth in

§ 1.704

.

circumstances during the prosecution of

the application resulting in the patent that constitute a

failure to engage in reasonable efforts to conclude

processing or examination of such application as set forth in

§ 1.704

;

or

(B) That there were no circumstances

constituting a failure to engage in reasonable efforts to

conclude processing or examination of such application as set

forth in

§ 1.704

.

(c) Any requests for reinstatement of all or part of the period of

adjustment reduced pursuant to

§ 1.704(b)

for failing to

reply to a rejection, objection, argument, or other request within three months

of the date of mailing of the Office communication notifying the applicant of

the rejection, objection, argument, or other request be filed prior to the

issuance of the patent. This time period is not extendable. Any request for

reinstatement of all or part of the period of adjustment reduced pursuant to

§ 1.704(b)

must also be

accompanied by:

(1) The fee set forth in

§ 1.18(f)

; and

(2) A showing to the satisfaction of the Director that, in

spite of all due care, the applicant was unable to reply to the

rejection, objection, argument, or other request within three months of

the date of mailing of the Office communication notifying the applicant

of the rejection, objection, argument, or other request. The Office shall

not grant any request for reinstatement for more than three additional

months for each reply beyond three months from the date of mailing of the

Office communication notifying the applicant of the rejection, objection,

argument, or other request.

nths of

the date of mailing of the Office communication notifying the applicant

of the rejection, objection, argument, or other request. The Office shall

not grant any request for reinstatement for more than three additional

months for each reply beyond three months from the date of mailing of the

Office communication notifying the applicant of the rejection, objection,

argument, or other request.

(d) No submission or petition on behalf of a third party

concerning patent term adjustment under

35 U.S.C. 154(b)

will be

considered by the Office. Any such submission or petition will be returned to

the third party, or otherwise disposed of, at the convenience of the Office.

Section 1.705

implements the

provisions of

35

U.S.C. 154(b)(3) and (b)(4)(B)

. See

MPEP § 2733

for more

information on the patent term adjustment determination under

37 CFR

1.705(a)

and

MPEP § 2734

for more information on

requests for reconsideration under

37 CFR 1.705(b)

and the due care

showing under

37 CFR 1.705(c)

.

Any patent granted on or after January 14, 2013, is

subject to amended

37 CFR 1.705

.

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