Reduction of Period of Adjustment of Patent Term

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USPTO MPEP › Chapter 2700 - Patent Terms, Adjustments, and Extensions › MPEP § 2732

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Text

[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

(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

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 a

notice of appeal filed prior to September 17, 2012, see

37 CFR 1.704(c)(11)

(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 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.

see

37 CFR 1.704(c)(11)

(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 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.

(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.

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

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

U.S.C. 111(b)

to a nonprovisional application under

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

U.S.C. 132

or notice of allowance under

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

.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 (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

U.S.C. 132

or a notice of allowance under

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

U.S.C. 132

or a notice of allowance under

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

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 an 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)

than thirty days prior to the filing of the information disclosure

statement.

(2) The thirty-day period set forth in paragraph

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)

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)

(c)

), the search fee (§

1.16(k)

(m)

), the

examination fee (§

1.16(o)

(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.

37 CFR

1.704

implements the provisions of

35 U.S.C.

154(b)(2)(C)

which 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

(processing or examination) of the application,” and specifies certain circumstances as

constituting a failure of an applicant to engage in reasonable efforts to conclude

processing or examination of an application. Further,

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

gives the

Office the authority 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.”

35 U.S.C

stances as

constituting a failure of an applicant to engage in reasonable efforts to conclude

processing or examination of an application. Further,

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

gives the

Office the authority 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.”

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

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.

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. 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,

35 U.S.C.

154(b)(2)(C)(i)

provides that patent term adjustment is reduced 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.

37 CFR 1.704(a)

37 CFR

1.704(a)

implements the provisions of

35 U.S.C.

154(b)(2)(C)(i)

and sets forth that the period of adjustment 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 (i.e., processing or examination)

of an application.

inactions caused or contributed to patent term adjustment.

37 CFR 1.704(a)

37 CFR

1.704(a)

implements the provisions of

35 U.S.C.

154(b)(2)(C)(i)

and sets forth that the period of adjustment 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 (i.e., processing or examination)

of an application.

II.

37 CFR 1.705(b)

37 CFR

1.704(b)

provides that with respect to the ground for adjustments

set forth in

37 CFR

1.702(a) through (e)

, and in particular

37 CFR 1.702(b)

an applicant shall be deemed to have failed to engage in reasonable efforts to conclude

prosecution 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. A Notice of Omitted Items in

a Nonprovisional Application, however, is not a notice or action by the Office making a

rejection, objection, argument, or other request within the meaning of

35 U.S.C.

154(b)(2)(C)(ii)

37 CFR 1.704(b)

, since the Office

does not require a reply to that notice to continue the processing and examination of an

application.

37 CFR

1.704(b)

indicates that 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 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. As discussed above, a reply

is considered filed on the date of its actual receipt in the Office as defined by

37 CFR

1.6

, and the date indicated on any certificate of mailing or

transmission under

CFR 1.8

will not be taken into account for patent term adjustment

purposes

notifying the applicant of the rejection, objection, argument,

or other request and ending on the date the reply was filed. As discussed above, a reply

is considered filed on the date of its actual receipt in the Office as defined by

37 CFR

1.6

, and the date indicated on any certificate of mailing or

transmission under

CFR 1.8

will not be taken into account for patent term adjustment

purposes.

The three-month period in

37 CFR 1.704(b)

applies to the

Office notices and letters issued as part of the pre-examination processing of an

application (except a Notice of Omitted Items in a Nonprovisional Application as

discussed above). These notices include: (1) a Notice of Incomplete Nonprovisional

Application (except as to any period prior to the filing date ultimately accorded to the

application); (2) a Notice to File Missing Parts of Non-Provisional Application; (3) an

Informational Notice to Applicant; (4) a Notice to File Corrected Application Papers

Filing Date Granted; or (5) a Notice to Comply with Requirements for Patent Applications

Containing Nucleotide and/or Amino Acid Sequence Disclosures.

In addition, the three-month period in

35 U.S.C.

154(b)(2)(C)(ii)

and

37 CFR 1.704(b)

applies regardless

of the period for reply set in the Office action or notice. For example, if an Office

action sets a two-month period for reply (restriction requirement), the applicant may

obtain a one-month extension of time under

37 CFR 1.136(a)

before being subject

to a reduction of patent term adjustment under

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

and

37 CFR

1.704(b)

. If, however, an Office action sets a six-month period

for reply, as is commonly set in applications subject to secrecy orders (see

MPEP §

130

), the applicant is subject to a reduction of patent term

adjustment under

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

and

37 CFR 1.704(b)

if the applicant

does not reply to the Office action within three months, notwithstanding that a reply

may be timely filed six months after the mailing date of the Office action

month period

for reply, as is commonly set in applications subject to secrecy orders (see

MPEP §

130

), the applicant is subject to a reduction of patent term

adjustment under

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

and

37 CFR 1.704(b)

if the applicant

does not reply to the Office action within three months, notwithstanding that a reply

may be timely filed six months after the mailing date of the Office action. If the last

day of the three-month time period from the Office communication notifying the applicant

of the rejection, objection, argument, or other request falls on a Saturday, Sunday, or

federal holiday within the District of Columbia, then action, may be taken, or fee paid,

on the next succeeding secular or business day without loss of any patent term

adjustment under

37 CFR 1.704(b)

. See

ArQule

v. Kappos,

793 F.Supp2d 214 (D.D.C. 2011). For example, no reduction in

patent term adjustment would occur if an applicant’s three-month reply time period

expires on a Saturday and the applicant files a reply that is received by the Office on

the following Monday, which is not a federal holiday within the District of Columbia. In

this case, any patent term adjustment would not be reduced under

37 CFR

1.704(b)

because the reply was received on Monday, the next

succeeding secular or business day after the expiration of the three-month reply time.

If applicant files the reply on Tuesday, then any patent term adjustment for the patent

issuing from the application would be reduced under

37 CFR

1.704(b)

by one day.

A reply under

37 CFR 1.116

to an Office action

containing a final rejection must cancel or appeal each rejected claim and comply with

all patentability requirements and objections as to form for each allowed claim. See

37 CFR

1.113(c)

. “

Section 1.703(a)

is in fact entirely

consistent with our and the Patent Office's reading of ‘reply’ in

1.704(b)

d be reduced under

37 CFR

1.704(b)

by one day.

A reply under

37 CFR 1.116

to an Office action

containing a final rejection must cancel or appeal each rejected claim and comply with

all patentability requirements and objections as to form for each allowed claim. See

37 CFR

1.113(c)

. “

Section 1.703(a)

is in fact entirely

consistent with our and the Patent Office's reading of ‘reply’ in

1.704(b)

. The specific reference to a ‘reply in compliance with

1.113(c)

’ in

§ 1.703(a)

reflects the Patent

Office's recognition that Office actions in response to replies to final Office actions

and Office actions in response to replies to non-final Office actions represent two

different situations, both of which may separately give rise to agency delay.”

Intra-Cellular Therapies, Inc. v. Iancu,

938 F.3d 1371, 1384, 2019

USPQ2d 350004 (Fed. Cir. 2019). Accordingly, an applicant can only stop the three-month

clock under

37 CFR 1.704(b)

by filing a

compliant reply under

37 CFR 1.113(c)

, appealing the final rejection, or filing a

request for continued examination. For example, the Office mailed a final rejection on

October 10, 2017. On January 8, 2018, applicant filed a reply under

37 CFR 1.116

that

would result in the allowance of only some of the pending claims. In other words, the

remaining claims would still be in the rejected status even if the January 8, 2018

amendment was entered into the record. On January 17, 2018, the Office mailed an

advisory action that informed applicant that the January 8, 2018 amendment failed to

overcome all of the rejections of record. On February 5, 2018, applicant filed a Notice

of Appeal. In this case, applicant would have a PTA reduction under

37 CFR

1.704(b)

for the period beginning on January 11, 2018 (the day

after three months from the mailing date of the final rejection) and ending on February

5, 2018 (the day the notice of appeal was filed).

III

uary 8, 2018 amendment failed to

overcome all of the rejections of record. On February 5, 2018, applicant filed a Notice

of Appeal. In this case, applicant would have a PTA reduction under

37 CFR

1.704(b)

for the period beginning on January 11, 2018 (the day

after three months from the mailing date of the final rejection) and ending on February

5, 2018 (the day the notice of appeal was filed).

III.

37 CFR 1.704(c)

37 CFR

1.704(c)

establishes further circumstances that constitute a

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

examination of an application.

37 CFR 1.704(c)(1) through (c)(13)

set forth actions or inactions by an applicant that interfere with the Office’s ability

to process or examine an application (and, thus, are circumstances that constitute a

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

examination of an application), as well as the period by which a period of adjustment

set forth in

37 CFR

1.703

shall be reduced if an applicant engages in any of the

enumerated actions or inactions.

37 CFR 1.704(c)

requires that an

applicant refrain from engaging in actions or inactions that prevent or interfere with

the Office’s ability to process or examine an application. An 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)

). A reduction of patent term adjustment under

35 U.S.C.

154(b)(2)(C)

must be equal to the period of time during which the

applicant failed to engage in reasonable efforts to conclude prosecution of the

application.

Supernus Pharm., Inc. v. Iancu,

913 F.3d 1351, 129

USPQ2d 1240 (Fed. Cir. 2019).

37 CFR 1.704(c)(1)

through 1.704(c)(14)

address situations that occur with sufficient

frequency to warrant being specifically provided for in the rules of practice

(b)(2)(C)

must be equal to the period of time during which the

applicant failed to engage in reasonable efforts to conclude prosecution of the

application.

Supernus Pharm., Inc. v. Iancu,

913 F.3d 1351, 129

USPQ2d 1240 (Fed. Cir. 2019).

37 CFR 1.704(c)(1)

through 1.704(c)(14)

address situations that occur with sufficient

frequency to warrant being specifically provided for in the rules of practice. These

situations do not represent an exhaustive list of actions or inactions that interfere

with the Office’s ability to process or examine an application, since there are a myriad

of actions or inactions that occur infrequently but will interfere with the Office’s

ability to process or examine an application (e.g., applicant files and persists in

requesting reconsideration of a meritless petition under

37 CFR 1.10

;

parties to an interference obtain an extension for purposes of settlement negotiations

which do not result in settlement of the interference; and when the scope of the

broadest claim in the application at the time an application is placed in condition for

allowance is substantially the same as suggested or allowed by the examiner more than

six months earlier than the date the application was placed in condition for allowance).

Thus, the actions or inactions set forth in

37 CFR 1.704(c)

are exemplary

circumstances that constitute a failure of an applicant to engage in reasonable efforts

to conclude processing or examination of an application. The Office may also reduce a

period of adjustment provided in

37 CFR 1.703

on the basis of conduct

that interferes with the Office’s ability to process or examine an application under the

authority provided in

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

, even if such conduct is not

specifically addressed in

37 CFR 1.704(c)

to engage in reasonable efforts

to conclude processing or examination of an application. The Office may also reduce a

period of adjustment provided in

37 CFR 1.703

on the basis of conduct

that interferes with the Office’s ability to process or examine an application under the

authority provided in

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

, even if such conduct is not

specifically addressed in

37 CFR 1.704(c)

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)(6), (c)(9), and (c)(10)

were substantively 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). 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, as discussed

below, if requested by the patentee.

37 CFR 1.704(c)(1) –

Suspension of Action

37 CFR

1.704(c)(1)

establishes suspension of action under

37 CFR

1.103

at the applicant’s request as a circumstance that

constitutes a failure of an applicant to engage in reasonable efforts to conclude

processing or examination of an application. Obviously, if action is suspended at the

applicant’s request, the Office is precluded from processing or examining the

application as a result of an action by the applicant

stablishes suspension of action under

37 CFR

1.103

at the applicant’s request as a circumstance that

constitutes a failure of an applicant to engage in reasonable efforts to conclude

processing or examination of an application. Obviously, if action is suspended at the

applicant’s request, the Office is precluded from processing or examining the

application as a result of an action by the applicant.

37 CFR

1.704(c)(1)

also provides that in such a 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 date a request for suspension of action

under

37 CFR

1.103

was filed and ending on the date of the termination of

the suspension.

37 CFR 1.704(c)(2) – Deferral

of Issuance

37 CFR

1.704(c)(2)

establishes deferral of issuance of a patent under

37 CFR

1.314

as a circumstance that constitutes a failure of an

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

application. Obviously, if issuance of the patent is deferred under

37 CFR 1.314

the Office is precluded from issuing the application as a result of an action by the

applicant. When a petition under

37 CFR 1.314

is granted, the

petition decision generally states that the application will be held for a period of

a month to await the filing of a paper. At the end of the period, the application is

returned to the issue process without a further communication from the Office to the

applicant. For applications in which a notice of allowance was mailed on or after

July 16, 2020,

CFR 1.704(c)(2)

provides that in such a 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 date a request for deferral of issuance

of a patent under

37 CFR 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

was mailed on or after

July 16, 2020,

CFR 1.704(c)(2)

provides that in such a 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 date a request for deferral of issuance

of a patent under

37 CFR 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. To

request termination of the deferral, the applicant should file a petition under

37 CFR

1.182

to request termination of the deferral of the issuance of

the patent, and therefore, end the period of reduction under

37 CFR

1.704(c)(2)

prior to the issuance of the patent. For all other

applications, the period of adjustment shall be reduced by the number of days, if

any, beginning on the date a request for deferral of issuance of a patent under

37 CFR

1.314

was filed and ending on the issue date of the patent.

37 CFR 1.704(c)(3) –

Abandonment or Late Payment of the Issue Fee

37 CFR

1.704(c)(3)

establishes abandonment of the application or late

payment of the issue fee as a circumstance that constitutes a failure of an applicant

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

application. Obviously, if the application is abandoned (either by failure to

prosecute or late payment of the issue fee), the Office is precluded from processing

or examining the application as a result of an action or inaction by the applicant.

For applications in which a notice of allowance was mailed on or after July 16, 2020,

37 CFR

1.704(c)(3)

provides that in such a 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 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

lowance was mailed on or after July 16, 2020,

37 CFR

1.704(c)(3)

provides that in such a 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 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. For all other

applications, the period of adjustment shall be reduced by the number of days, if

any, beginning on the date of abandonment or the date after the date the issue fee

was due, and ending on the earlier of: (1) the date of mailing of the decision

reviving the application or accepting late payment of the issue fee; or (2) the date

that is four months after the date the grantable petition to revive the application

or accept late payment of the issue fee was filed. The phrase “earlier of… [t]he date

that is four months after the date the grantable petition to revive the application

or accept late payment of the issue fee was filed” is to place a cap (measured from

the filing date of the grantable petition) on the reduction if the Office does not

act on (grant) the grantable petition to revive within four months of the date it was

filed.

37 CFR 1.704(c)(4) – Petition

to Withdraw Holding of Abandonment or Revive

Application

37 CFR

1.704(c)(4)

establishes failure to file a petition to withdraw

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

of mailing of a notice of abandonment as a circumstance that constitutes a failure of

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

an application

to Withdraw Holding of Abandonment or Revive

Application

37 CFR

1.704(c)(4)

establishes failure to file a petition to withdraw

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

of mailing of a notice of abandonment as a circumstance that constitutes a failure of

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

an application. Any applicant who considers an application to have been improperly

held abandoned (the reduction in

37 CFR 1.704(c)(3)

is applicable

to the revival of an application properly held abandoned) is expected to file a

petition to withdraw the holding of abandonment (or to revive the application) within

two months from the date of mailing of a notice of abandonment. See

MPEP §

711.03(c)

, subsection I.

37 CFR

1.704(c)(4)

provides that in such a 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 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.

If a petition to withdraw the holding of abandonment is granted,

the Office’s OPSG system records should be checked to ensure that the correct term

adjustment determination is made. Applicants are encouraged to check the Office’s

OPSG system records for their applications through the USPTO patent electronic filing

system (see

MPEP §

2733

). For example, if applicant shows in the petition that

a reply was filed in the Office on March 2, but the March 2 reply was never matched

with the file, when the petition to withdraw the holding of abandonment is granted,

the receipt of a paper on March 2 should be recorded on the Office’s OPSG system

records. If the papers or dates are recorded incorrectly, applicant should contact

the examiner, the examiner’s supervisor or the Technology Center customer service

representative to have the entry corrected

h 2 reply was never matched

with the file, when the petition to withdraw the holding of abandonment is granted,

the receipt of a paper on March 2 should be recorded on the Office’s OPSG system

records. If the papers or dates are recorded incorrectly, applicant should contact

the examiner, the examiner’s supervisor or the Technology Center customer service

representative to have the entry corrected. If an applicant receives a Notice of

Abandonment and does not request that the holding of abandonment be withdrawn within

two months of the date of mailing of the notice, the applicant has failed to engage

in reasonable efforts to conclude prosecution and any patent term adjustment will be

reduced pursuant to

37 CFR 1.704(c)(4)

37 CFR 1.704(c)(5) –

Conversion of a Provisional Application

37 CFR

1.704(c)(5)

establishes 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)

; (see

MPEP

§ 201.04

)) as a circumstance that constitutes a failure of

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

an application. Conversion of a provisional application to a nonprovisional

application will require the Office to reprocess the application (as a nonprovisional

application) up to one year after the filing date that will be accorded to such

nonprovisional application as a result of an action by the applicant.

37 CFR

1.704(c)(5)

provides that in such a 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 date the application was filed under

35 U.S.C.

111(b)

and ending on the date a request in compliance with

37 CFR

1.53(c)(3)

to convert the provisional application into a

nonprovisional application was filed.

n action by the applicant.

37 CFR

1.704(c)(5)

provides that in such a 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 date the application was filed under

35 U.S.C.

111(b)

and ending on the date a request in compliance with

37 CFR

1.53(c)(3)

to convert the provisional application into a

nonprovisional application was filed.

37 CFR 1.704(c)(6) –

Submission of Preliminary Amendment or Paper

37 CFR

1.704(c)(6)

establishes 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 a notice of allowance under

35 U.S.C. 151

that requires the mailing of a supplemental Office action or notice of allowance as a

circumstance that constitutes a failure of an applicant to engage in reasonable

efforts to conclude processing or examination of an application. If the submission of

a preliminary amendment or other paper requires the Office to issue a supplemental

Office action or notice of allowance, the submission of that preliminary amendment or

other paper has interfered with the processing and examination of an application. For

applications in which a notice of allowance was mailed on or after July 16, 2020,

37 CFR

1.704(c)(6)

provides that in such a 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 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

th in

37 CFR 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. For all other

applications, the period of adjustment shall be reduced by the lesser of the number

of days, if any, beginning on the day after the mailing date of the original Office

action or notice of allowance and ending on the date of mailing of the supplemental

Office action or notice of allowance or four months. The phrase “lesser of… or [f]our

months” is to provide a four-month cap for a reduction under

37 CFR

1.704(c)(6)

if the Office takes longer than four months to

issue a supplemental Office action or notice of allowance.

37 CFR 1.704(c)(7) –

Submission of a Reply with an Omission

37 CFR

1.704(c)(7)

establishes submission of a reply having an

omission (e.g.,

CFR 1.135(c)

) as a circumstance that constitutes a failure of

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

an application. Submitting a reply having an omission requires the Office to issue an

action under

37 CFR

1.135(c)

and await and process the applicant’s reply to the

action under

37 CFR

1.135(c)

before the initial reply (as corrected) can be treated

on its merits. In addition,

37 CFR 1.704(c)(7)

provides that

in such a 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

the reply having an omission was filed and ending on the date that the reply or other

paper correcting the omission was filed

1.135(c)

before the initial reply (as corrected) can be treated

on its merits. In addition,

37 CFR 1.704(c)(7)

provides that

in such a 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

the reply having an omission was filed and ending on the date that the reply or other

paper correcting the omission was filed. The reference to

37 CFR 1.135(c)

is parenthetical because

37 CFR 1.704(c)(7)

is not limited

to Office actions under

37 CFR 1.135(c)

but applies also

when the Office issues any action or notice indicating that a reply has an omission

which must be corrected: for example, (1) a decision on a petition under

37 CFR

1.47

dismissing the petition as lacking an item necessary to

grant the petition; or (2) a notice indicating that the computer readable sequence

listing submitted in an application filed on or after July 1, 2022, in reply to a

previous notice relating to the requirements for patent applications containing

nucleotide and/or amino acid sequence disclosures, does not comply with

37 CFR

1.831

et seq.

The filing of a non-compliant appeal brief, however, will

not be deemed an omission under

37 CFR 1.704(c)(7)

if the notice

of appeal was filed on or after September 17, 2012. This situation is covered under

37 CFR 1.704(c)(11)

37 CFR 1.704(c)(8) –

Submission of a Supplemental Reply or Paper

37 CFR

1.704(c)(8)

establishes submission of a supplemental reply or

other paper after a reply has been filed as a circumstance that constitutes a failure

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

of an application. The submission of a supplemental reply or other paper (e.g., an

information disclosure statement (IDS) or petition) after an initial reply was filed

requires the Office to restart consideration of the initial reply in view of the

supplemental reply or other paper, which will result in a delay in the Office’s

response to the initial reply

rts to conclude processing or examination

of an application. The submission of a supplemental reply or other paper (e.g., an

information disclosure statement (IDS) or petition) after an initial reply was filed

requires the Office to restart consideration of the initial reply in view of the

supplemental reply or other paper, which will result in a delay in the Office’s

response to the initial reply. The submission of an information disclosure statement

that is filed after a reply to a restriction requirement (and prior to the subsequent

Office action and without a safe harbor statement under

37 CFR

1.704(d)

) is an applicant delay. See

Gilead Sciences

Inc. v. Lee,

778 F.3d 1341, 113 USPQ2d 1837 (Fed. Cir. 2015). Similarly,

the filing of an information disclosure statement after a request for continued

examination (RCE) but prior to a subsequent Office action is deemed an applicant

delay under

37 CFR 1.704(c)(8)

37 CFR

1.704(c)(8)

does not apply to a supplemental reply or other

paper that was expressly requested by the examiner. In addition, the Office cannot

reduce patent term adjustment in the rare situation for “a period of time during

which there is no identifiable effort in which the applicant could have engaged to

conclude prosecution.”

Supernus Pharm., Inc. v. Iancu,

913 F.3d

1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019) (the court found applicant delay for the

period between the filing of the RCE and the issuance of European Patent Office

communication, which was the basis for the later-filed Information Disclosure

Statement, is not a permissible reduction in patent term adjustment because there is

no identifiable effort in which the applicant could have engaged to conclude

prosecution during this time period.)

) (the court found applicant delay for the

period between the filing of the RCE and the issuance of European Patent Office

communication, which was the basis for the later-filed Information Disclosure

Statement, is not a permissible reduction in patent term adjustment because there is

no identifiable effort in which the applicant could have engaged to conclude

prosecution during this time period.). If applicant believes that the Office has

reduced the patent term adjustment for a period of time during which there is no

identifiable effort in which the applicant could have engaged to conclude

prosecution, a timely request for reconsideration in compliance with

CFR 1.705(b)

may be filed to request correction of the patent

term adjustment determination.

If an amendment is requested by an examiner, the

examiner will have the paper processed so that it is included as part of an interview

summary or examiner’s amendment and not a separate paper for One Patent Service

Gateway (OPSG) to flag in the patent term adjustment calculation.

37 CFR

1.704(c)(8)

also provides that in such a 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 the initial reply was

filed and ending on the date that the supplemental reply or such other paper was

filed.

Applicant’s submission of an information disclosure

statement pursuant to

37 CFR 1.97(c)

or an amendment

under

37 CFR

41.33

after a notice of appeal has been filed but prior to

jurisdiction passing to the Patent Trial and Appeal Board is deemed an applicant

delay under

37 CFR 1.704(c)(8)

. Under

37 CFR

1.97(c)

, an applicant who submits an information disclosure

statement meeting the requirements of

37 CFR 1.97

and

1.98

will have

such submission considered by the examiner if it is accompanied by a statement under

37 CFR

1.97(e)

and the fee under

37 CFR

1.17(p)

. Moreover, the Office may admit an amendment after

notice of appeal if it meets the applicable requirements in

37 CFR 41.33(a)

and

7 CFR

1.97(c)

, an applicant who submits an information disclosure

statement meeting the requirements of

37 CFR 1.97

and

1.98

will have

such submission considered by the examiner if it is accompanied by a statement under

37 CFR

1.97(e)

and the fee under

37 CFR

1.17(p)

. Moreover, the Office may admit an amendment after

notice of appeal if it meets the applicable requirements in

37 CFR 41.33(a)

and

(b)

for consideration. Because the treatment of these papers

may delay the Board taking jurisdiction of the application, the Office will treat

such papers similarly to how the Office treats a supplemental reply under this

provision, in that the papers will be considered as a circumstance that constitutes a

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

examination of an application.

37 CFR 1.704(c)(9) –

Submission of an Amendment or Paper after Board or Court

Decision

37 CFR

1.704(c)(9)

establishes submission of an amendment or other

paper (other than a statement under

37 CFR 41.50(c)

) in an

application after a decision by the Patent Trial and Appeal Board (other than a

decision containing a rejection under

37 CFR 41.50(b)

) or a federal

court 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 supplemental notice of

allowance as a circumstance that constitutes a failure of an applicant to engage in

reasonable efforts to conclude processing or examination of an application. The

submission of an amendment or other paper (e.g., IDS or petition) in an application

after a Board decision or court decision requires the Office to restart consideration

of the application in view of the amendment or other paper, which will result in a

delay in the Office’s taking action on the application

to engage in

reasonable efforts to conclude processing or examination of an application. The

submission of an amendment or other paper (e.g., IDS or petition) in an application

after a Board decision or court decision requires the Office to restart consideration

of the application in view of the amendment or other paper, which will result in a

delay in the Office’s taking action on the application. For applications in which a

notice of allowance was mailed on or after July 16, 2020,

37 CFR

1.704(c)(9)

provides that in such a 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 the decision by

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

amendment or other paper was filed. For all other applications, the period of

adjustment shall be reduced by the lesser of the number of days, if any, beginning on

the day after the mailing date of the original Office action or notice of allowance

and ending on the mailing date of the supplemental Office action or notice of

allowance or four months. The phrase “lesser of…or [f]our months” is to provide a

four-month cap for a reduction under

37 CFR 1.704(c)(9)

if the Office

takes longer than four months to issue a supplemental Office action or notice of

allowance. If the amendment is requested by an examiner, the examiner will have the

paper processed so that it is included as part of an interview summary or examiner’s

amendment and not a separate paper for OPSG to flag in the patent term adjustment

calculation.

or a reduction under

37 CFR 1.704(c)(9)

if the Office

takes longer than four months to issue a supplemental Office action or notice of

allowance. If the amendment is requested by an examiner, the examiner will have the

paper processed so that it is included as part of an interview summary or examiner’s

amendment and not a separate paper for OPSG to flag in the patent term adjustment

calculation.

37 CFR 1.704(c)(10) –

Submission of an Amendment or Paper after Notice of

Allowance

37 CFR

1.704(c)(10)

establishes submission of an amendment under

37 CFR

1.312

or other paper, other than a request for continued

examination in compliance with

37 CFR 1.114

, 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. Effective March 10, 2015,

37 CFR

1.704(c)(10)

was 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

37 CFR 1.114

treated under

37 CFR 1.704(c)(12)

rather than

37 CFR

1.704(c)(10)

. See the final rule

Changes to Patent

Term Adjustment in view of the Federal Circuit Decision in Novartis v.

Lee,

80 FR 1346 (January 9, 2015). Prior to March 10, 2015, the

submission of a request for continued examination after the mailing date of a notice

of allowance was not considered an applicant delay under

37 CFR

1.704

. The submission of amendments (or other papers) after an

application is allowed may cause substantial interference with the patent issue

process. Certain papers filed after allowance are not considered to be a failure to

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

ailing date of a notice

of allowance was not considered an applicant delay under

37 CFR

1.704

. The submission of amendments (or other papers) after an

application is allowed may cause substantial interference with the patent issue

process. Certain papers filed after allowance are not considered to be a failure to

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

See

Clarification of

37 CFR 1.704(c)(10)

–

Reduction of Patent Term Adjustment for Certain Types of Papers Filed After a

Notice of Allowance has been Mailed,

1247 OG 111 (June 26, 2001). For

applications in which a notice of allowance was mailed on or after July 16, 2020,

37 CFR

1.704(c)(10)

provides that in such a 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 amendment under

37 CFR 1.312

or other paper was

filed, except for an amendment under

37 CFR 1.312

or other paper that

was expressly requested by the Office as further discussed below. For all other

applications, the period of adjustment shall be reduced by the lesser of: (1) the

number of days, if any, beginning on the date the amendment under

37 CFR 1.312

other paper was filed and ending on the mailing date of the Office action or notice

in response to the amendment under

37 CFR 1.312

or such other paper;

or (2) four months. The phrase “lesser of …or [f]our months” is to provide a

four-month cap for a reduction under

37 CFR 1.704(c)(10)

if the Office

takes longer than four months to issue an Office action or notice in response to the

amendment under

CFR 1.312

or other paper. If the Office does not mail a

response to the paper that triggered the delay under this provision and the patent

issues in less than four months, then the applicant delay under this provision will

end on the date of the patent issuance

37 CFR 1.704(c)(10)

if the Office

takes longer than four months to issue an Office action or notice in response to the

amendment under

CFR 1.312

or other paper. If the Office does not mail a

response to the paper that triggered the delay under this provision and the patent

issues in less than four months, then the applicant delay under this provision will

end on the date of the patent issuance. The Office will treat the issuance of the

patent as the response to the paper that triggered the delay.

For any application having a notice of allowance

mailed on or after July 16, 2020,

37 CFR 1.704(c)(10)

is also

amended to exclude ‘‘an amendment under

§ 1.312

or other paper expressly

requested by the Office’’ from the amendments under

37 CFR 1.312

other papers filed after a notice of allowance that will result in a reduction of

patent term adjustment under

37 CFR 1.704(c)(10)

. Thus, an

amendment under

CFR 1.312

or other paper not expressly requested by the Office

(i.e., a ‘‘voluntary’’ amendment under

37 CFR 1.312

or other paper)

after the notice of allowance will result in a reduction of patent term adjustment

under

37 CFR 1.704(c)(10)

. An amendment under

37 CFR 1.312

other paper going beyond what was requested by the Office (i.e., including material

not expressly requested by the Office in addition to what was requested by the USPTO)

would not be considered “an amendment under

§ 1.312

or other paper expressly

requested by the Office” under

37 CFR 1.704(c)(10)

. In addition,

the phrase ‘‘expressly requested by the Office’’ requires a specific request in an

Office action or notice, or in an Examiner’s Interview Summary (form PTOL– 413/413B),

for the amendment under

37 CFR 1.312

or other paper

to what was requested by the USPTO)

would not be considered “an amendment under

§ 1.312

or other paper expressly

requested by the Office” under

37 CFR 1.704(c)(10)

. In addition,

the phrase ‘‘expressly requested by the Office’’ requires a specific request in an

Office action or notice, or in an Examiner’s Interview Summary (form PTOL– 413/413B),

for the amendment under

37 CFR 1.312

or other paper. For

example, generic language in an Office action or notice, such as a statement in a

notice of allowability containing an examiner’s amendment indicating that if the

changes and/or additions are unacceptable to applicant, an amendment may be filed as

provided by

37 CFR

1.312

(see

MPEP § 1302.04

), is not a basis for

considering an amendment under

37 CFR 1.312

to be ‘‘expressly

requested by the Office’’ within the meaning of

37 CFR

1.704(c)(10)

. Similarly, the provisions of

37 CFR

1.56

1.97

and

1.98

are not a

basis for considering an information disclosure statement including information that

has come to the attention of the applicant after a notice of allowance has been given

or mailed to be a paper ‘‘expressly requested by the Office’’ within the meaning of

CFR 1.704(c)(10)

. An information disclosure statement in

compliance with

CFR 1.97

and

1.98

, however, will not be

considered a failure to engage in reasonable efforts to conclude prosecution of the

application under

37 CFR 1.704(c)(10)

(or

CFR 1.704(c)(6), (8), or (9)

) if the information disclosure

statement is accompanied by a statement under

37 CFR

1.704(d)

. Finally, an amendment under

37 CFR 1.312

other paper expressly requested by the Office not filed within three months from the

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

will result in a reduction of patent term adjustment under

37 CFR

1.704(b)

In the final rule

Changes to Patent Term

Adjustment in view of the Federal Circuit Decision in Novartis v. Lee,

80 FR 1346 (January 9, 2015), the Office revised policies regarding

37 CFR

1.704(c)(10)

not filed within three months from the

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

will result in a reduction of patent term adjustment under

37 CFR

1.704(b)

In the final rule

Changes to Patent Term

Adjustment in view of the Federal Circuit Decision in Novartis v. Lee,

80 FR 1346 (January 9, 2015), the Office revised policies regarding

37 CFR

1.704(c)(10)

. The revised policy does not consider the

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

37 CFR

1.704(c)(10)

due to the changes that have been brought about by

the electronic filing and processing of patent applications.

The submission of the following papers after a “Notice

of Allowance” is

not

considered a failure to engage in reasonable

efforts to conclude processing or examination of an application: (1) Fee(s)

Transmittal (PTOL-85B); (2) power of attorney; (3) power to inspect; (4) change of

address; (5) change of status (micro/small/not small entity status); (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

37 CFR

1.704(d)

; (11) the resubmission by applicant of unlocatable

paper(s) previously filed in the application (

37 CFR 1.251

); (12) a request for

acknowledgment of an information disclosure statement in compliance with

37 CFR

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 i

rmation disclosure statement in compliance with

37 CFR

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).

Under

37 CFR 1.704(c)(10)

, papers that

will be

considered a failure to engage in reasonable efforts to

conclude processing or examination of an application include: (1) an amendment under

37 CFR

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 priority or domestic benefit

information); (3) a request for a corrected filing receipt; (4) a certified copy of a

priority document; (5) drawings; (6) a letter related 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

37 CFR

1.704(d)

37 CFR 1.704(c)(11) – Failure

to Timely File an Appeal Brief

Effective for applications in which a notice of appeal

was filed on or after September 17, 2012,

37 CFR

1.704(c)(11)

establishes that failure to file an appeal brief

in compliance with

37 CFR 41.37

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

37 CFR 41.31

is a circumstance

that constitutes a failure to engage in reasonable efforts to conclude processing or

examination of the application

September 17, 2012,

37 CFR

1.704(c)(11)

establishes that failure to file an appeal brief

in compliance with

37 CFR 41.37

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

37 CFR 41.31

is a circumstance

that constitutes a failure to engage in reasonable efforts to conclude processing or

examination of the application. It is noted that although the appeal brief is due

within two months of the filing of the notice of appeal under

37 CFR 41.37

37 CFR 1.704(c)(11)

provides

three months before any patent term adjustment under

37 CFR

1.703

will be reduced for the late submission of an appeal

brief. If applicant files a non-compliant appeal brief and thereafter files a

compliant appeal brief, the period of time from the filing of a non-compliant appeal

brief to the filing of the compliant appeal brief will not be considered a failure to

engage in reasonable efforts to conclude processing or examination of the application

under

37 CFR 1.704(c)(8)

. However, if the compliant appeal brief is

filed more than three months from the date on which the notice of appeal was filed,

the provisions of

37 CFR 1.704(c)(11)

may result in

reduction of any patent term adjustment under

37 CFR

1.703

37 CFR

1.704(c)(11)

provides that the period of adjustment set forth

CFR 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 the notice of

appeal to the Patent Trial and Appeal Board was filed and ending on the date an

appeal brief in compliance with

37 CFR 41.37

or a request for

continued examination in compliance with

37 CFR 1.114

was filed

ides that the period of adjustment set forth

CFR 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 the notice of

appeal to the Patent Trial and Appeal Board was filed and ending on the date an

appeal brief in compliance with

37 CFR 41.37

or a request for

continued examination in compliance with

37 CFR 1.114

was filed.

If the Office reopens prosecution of the application

more than three months after the filing of the notice of appeal but prior to the

submission of a compliant appeal brief, the Office will not deem the period of time

from the day after three months from the filing of the notice of appeal to the date

the Office reopens prosecution to be an applicant delay under

37 CFR

1.704(c)(11)

. In addition, the Office’s reopening of

prosecution after appeal will not be considered as vacating any previous response

that potentially increases patent term adjustment under

35 U.S.C.

154(b)(1)(A)(i)

through

(iv)

. As discussed above, the

change to

37 CFR 1.704(c)(11)

is applicable

to any applications that includes an appeal brief in which the notice of appeal was

filed on or after September 17, 2012.

37 CFR 1.704(c)(12) – Filing

of a Request for Continued Examination after Notice of

Allowance

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 provide 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

ng 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

the final rule

Changes to Patent Term Adjustment in view of the Federal

Circuit Decision in Novartis v. Lee,

80 FR 1346 (January 9, 2015). This

provision ensures 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 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). “An 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)

ngaging 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 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

37 CFR 1.56(c)

. Accordingly,

CFR 1.704(d)

was revised to provide 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

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 is

accompanied by a statement in compliance with

37 CFR

1.704(d)

iance with

37 CFR 1.114

with no submission

other than an information disclosure statement in compliance with

37 CFR 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

37 CFR

1.704(c)(12)

, if the request for continued examination is

accompanied by a statement in compliance with

37 CFR

1.704(d)

Effective for applications in which a request for

continued examination was filed on or after March 10, 2015, if such 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

e 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

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

. 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)

amination, 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

37 CFR 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

37 CFR

1.114(a)(1)

Effective March 10, 2015, the provisions in

37 CFR

1.704(c)(12)

and

37 CFR 1.704(c)(13)

were

relabeled as

37 CFR 1.704(c)(13)

and

37 CFR

1.704(c)(14)

, respectively. See the final rule

Changes

to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v.

Lee,

80 FR 1346 (January 9, 2015).

37 CFR 1.704(c)(13) – Failure

to Timely Provide an Examination Ready Application

For applications filed under

35 U.S.C.

111(a)

on or after December 18, 2013 and international patent

applications in which the national stage was commenced under

35 U.S.C. 371

on or after December 18, 2013,

37 CFR 1.704(c)(13)

establishes

that the circumstances that constitute a failure of the applicant to engage in

reasonable efforts to conclude processing or examination of an application also

include the failure to provide an application in condition for examination within

eight months from 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.

Section

1.704(c)(13)

does not require that applications be in condition

for examination on filing (or commencement of national stage in an international

application) in order for an applicant to avoid a reduction of patent term

adjustment

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.

Section

1.704(c)(13)

does not require that applications be in condition

for examination on filing (or commencement of national stage in an international

application) in order for an applicant to avoid a reduction of patent term

adjustment.

37 CFR

1.704(c)(13)

establishes that where there is a failure to

provide an application in condition for examination within eight months from 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, 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 that is eight months from 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.

37 CFR 1.704(c)(14) –

Prosecution via a Continuing Application

37 CFR

1.704(c)(14)

(which was formerly

37 CFR

1.704(c)(11)

(c)(12)

, and

(c)(13)

) establishes further prosecution via a continuing

application as a circumstance that constitutes a failure of an applicant to engage in

reasonable efforts to conclude processing or examination of an application.

Currently, a continuing application may be used to: (1) obtain further examination of

an invention disclosed and claimed in the prior application (continuation

application); (2) obtain examination (for the first time) of an invention disclosed

but not claimed or not elected for examination in the prior application (divisional

application); or (3) obtain examination of an invention neither disclosed nor claimed

in the prior application (continuation-in-part application). The provisions of

35 U.S.C

sclosed and claimed in the prior application (continuation

application); (2) obtain examination (for the first time) of an invention disclosed

but not claimed or not elected for examination in the prior application (divisional

application); or (3) obtain examination of an invention neither disclosed nor claimed

in the prior application (continuation-in-part application). The provisions of

35 U.S.C.

132(b)

and

37 CFR 1.114

permit an applicant

to obtain further or continued examination of an invention disclosed and claimed in

an application, which renders it unnecessary for an applicant whose application is

eligible for patent term adjustment under

35 U.S.C. 154(b)

to file a

continuing application to obtain further examination of an invention disclosed and

claimed in an application. If an applicant is filing a continuing application to

obtain examination (for the first time) of an invention disclosed but not claimed or

not elected for examination in the prior application or an invention neither

disclosed nor claimed in the prior application, it is not appropriate for that

applicant to obtain any benefit in the continuing application for examination delays

that might have occurred in the prior application. See

Mohsenzadeh v.

Lee,

790 F.3d 1377, 115 USPQ2d 1483 (Fed. Cir. 2015) where the district

court upheld the Office’s position that patent term adjustment does not carry over to

a continuing or divisional application. Thus, the Office has established further

prosecution via a continuing application as a circumstance that constitutes a failure

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

of an application, in that the period of adjustment set forth in

37 CFR 1.703

shall not include any period that is prior to the actual filing date of the

application that resulted in the patent

the Office has established further

prosecution via a continuing application as a circumstance that constitutes a failure

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

of an application, in that the period of adjustment set forth in

37 CFR 1.703

shall not include any period that is prior to the actual filing date of the

application that resulted in the patent. Thus, if the application that resulted in

the patent is a continuing application (including a CPA), the period of adjustment

set forth in

37 CFR

1.703

(if any) will not include any period that is prior to the

actual filing date of the application (in the case of a CPA, the filing date of the

request for a CPA) that resulted in the patent.

A CPA under

37 CFR 1.53(d)

filed on or after

May 29, 2000 and before July 14, 2003 is entitled to the patent term adjustment

provisions of

U.S.C. 154(b)

as amended by section 4402 of the American

Inventors Protection Act of 1999 (CPAs can only be filed in design patent

applications on or after July 14, 2003, and design applications are not entitled to

PTA). The period of patent term adjustment set forth in

37 CFR 1.703

(if any), however, will not include any period that is prior to the filing date of

the request for that CPA.

Delays before the filing date of an application are not relevant to

whether an application is entitled to patent term adjustment. Patent term adjustment

will not be reduced by applicant actions or inactions (that amount to a failure to

engage in reasonable efforts to conclude processing or examination of the

application) occurring in a prior (or other) application.

IV.

37 CFR 1.704(d)

37 CFR

1.704(d)

provides that a paper containing only an information

disclosure statement in compliance with

37 CFR 1.97

and

1.98

will not be

considered (result in a reduction) under

37 CFR 1.704(c)(6)

1.704(c)(8)

1.704(c)(9)

, or

1.704(c)(10)

if it

is accompanied by a statement that each item of information:

of the

application) occurring in a prior (or other) application.

IV.

37 CFR 1.704(d)

37 CFR

1.704(d)

provides that a paper containing only an information

disclosure statement in compliance with

37 CFR 1.97

and

1.98

will not be

considered (result in a reduction) under

37 CFR 1.704(c)(6)

1.704(c)(8)

1.704(c)(9)

, or

1.704(c)(10)

if it

is accompanied by a statement that each item of information:

(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 an individual designated in

37 CFR

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

37 CFR

1.56(c)

more than thirty days prior to the filing of the

information disclosure statement.

Effective March 10, 2015,

37 CFR

1.704(d)(1)

was amended to also provide 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

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)

. See the final rule

Changes to Patent Term

Adjustment in view of the Federal Circuit Decision in Novartis v. Lee,

FR 1346 (January 9, 2015)

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)

. See the final rule

Changes to Patent Term

Adjustment in view of the Federal Circuit Decision in Novartis v. Lee,

FR 1346 (January 9, 2015). Thus, unless the information disclosure statement is

accompanied by a safe harbor statement in compliance with

37 CFR

1.704(d)

37 CFR 1.704

provides for a

reduction of any patent term adjustment if an information disclosure statement (1) is

filed after a notice of allowance or after an initial reply by the applicant; or (2) is

filed as a preliminary paper or paper after a decision by the Board or federal court

that requires the USPTO to issue a supplemental Office action. Similarly, unless the

submission for a request for continued examination after a notice of allowance has been

mailed is solely an information disclosure statement and it is accompanied by a safe

harbor statement in compliance with

37 CFR 1.704(d)

37 CFR

1.704

provides for a reduction of any patent term adjustment if a

request for continued examination is filed after the mailing of a notice of

allowance.

37 CFR 1.704(d)(1)

requires that the information disclosure statement “is accompanied by” the safe harbor

statement. In other words, the safe harbor statement must be filed concurrently with

(therefore, on the same date as) the information disclosure statement according to

37 CFR 1.704(d)(1)

However, the Office has provided a procedure for applicants to seek a waiver using a

37 CFR

1.183

petition to allow for a late-filed statement under

37 CFR

1.704

re statement “is accompanied by” the safe harbor

statement. In other words, the safe harbor statement must be filed concurrently with

(therefore, on the same date as) the information disclosure statement according to

37 CFR 1.704(d)(1)

However, the Office has provided a procedure for applicants to seek a waiver using a

37 CFR

1.183

petition to allow for a late-filed statement under

37 CFR

1.704

. If an applicant submits an information disclosure statement

within the 30-day period set forth in

37 CFR 1.704(d)(1)

but

does not include a statement under

37 CFR 1.704

with the information

disclosure statement (therefore, not filed on the same date), the applicant should

consider filing a request for reconsideration of the patent term adjustment indicated on

the patent (

37 CFR 1.705(b)

), along with a

statement under

37 CFR 1.704(d)

(if not previously

filed) and petition under

37 CFR 1.183

(along with the fee

under

37 CFR

1.17(f)

) requesting that the Office consider the statement under

37 CFR

1.704(d)

when making the patent term adjustment determination.

Applicants should keep in mind that a petition under

37 CFR 1.183

may only be used to

request acceptance of the late-filed statement under

37 CFR

1.704(d)

. Under no circumstances will an information disclosure

statement filed more than 30 days from the applicable communication under

37 CFR 1.704(d)(1)(i)

(ii)

be treated as filed within the

“safe harbor” of

37 CFR 1.704(d)

. In addition, the

30-day period in

37 CFR 1.704(d)(1)

is not

extendable. See

37 CFR 1.704(d)(2)

In order to aid the Office in recognizing when a

compliant safe harbor statement under

37 CFR 1.704(d)

has been filed with

an information disclosure statement, the Office has created a form PTO/SB/133 “Patent

Term Adjustment Statement under 37 CFR 1.704(d)” for applicant’s use when submitting the

information disclosure statement

iod in

37 CFR 1.704(d)(1)

is not

extendable. See

37 CFR 1.704(d)(2)

In order to aid the Office in recognizing when a

compliant safe harbor statement under

37 CFR 1.704(d)

has been filed with

an information disclosure statement, the Office has created a form PTO/SB/133 “Patent

Term Adjustment Statement under 37 CFR 1.704(d)” for applicant’s use when submitting the

information disclosure statement. The Office has also updated the patent term adjustment

computer program to recognize that form PTO/SB/133 has been filed concurrently with

(therefore, on the same date as) the information disclosure statement using document

code PTA.IDS. When form PTO/SB/133 is recognized, the patent term adjustment computer

program will perform the patent term calculation by taking into account that applicant

filed a compliant safe harbor statement under

37 CFR

1.704(d)

Use of form PTO/SB/133 was not required for safe harbor

statements filed before July 17, 2023. However, safe harbor statements under

37 CFR

1.704(d)

filed on or after July 17, 2023, must be submitted on

form PTO/SB/133 using the document code PTA.IDS. See

37 CFR

1.704(d)(3)

. The form is available on the USPTO’s website at

(

www.uspto.gov/PatentForms

) and is reproduced below at the end of

this section. The Office of Management and Budget (OMB) has determined that, under 5 CFR

1320.3(h), form PTO/SB/133 does not collect “information” within the meaning of the

Paperwork Reduction Act of 1995.

While the Office encourages the filing of correspondence

via the USPTO patent electronic filing system, the inclusion of document code PTA.IDS on

the form PTO/SB/133 satisfies the “using the appropriate document code (PTA.IDS)”

requirement of

37 CFR 1.704(d)(3)

for statements

under

CFR 1.704(d)

not submitted via the USPTO patent electronic filing

system. Applicants may no longer use the document code PTA.IDS, which is specific to

form PTO/SB/133, on or after July 17, 2023, unless they are using form PTO/SB/133

of document code PTA.IDS on

the form PTO/SB/133 satisfies the “using the appropriate document code (PTA.IDS)”

requirement of

37 CFR 1.704(d)(3)

for statements

under

CFR 1.704(d)

not submitted via the USPTO patent electronic filing

system. Applicants may no longer use the document code PTA.IDS, which is specific to

form PTO/SB/133, on or after July 17, 2023, unless they are using form PTO/SB/133.

Applicants filing a statement under

37 CFR 1.704(d)

on or after July 17,

2023, without form PTO/SB/133 may only use document code IDS for submission of an

information disclosure statement. If a statement under

37 CFR

1.704(d)

is not filed using form PTO/SB/133 or does not use

document code PTA.IDS, the application will be treated as if no safe harbor statement

under

CFR 1.704(d)

had been filed unless a request for reconsideration

of patent term adjustment, in compliance with

37 CFR

1.705(b)

, is filed establishing that the information disclosure

statement was accompanied by a safe harbor statement.

Applicants who submit form PTO/SB/133 with an

information disclosure statement and use document code PTA.IDS will be considered to be

making a proper safe harbor statement, and the filing will be reflected in the file

record. Applicants may not alter the pre-printed text of form PTO/SB/133. The

presentation to the Office (whether by signing, filing, submitting, or later advocating)

of form PTO/SB/133, whether by a practitioner or non-practitioner, constitutes a

certification under

CFR 11.18(b)

that the existing text and any certification

statements on the form have not been altered. See

37 CFR

1.704(d)(3)

. Also, the use of document code PTA.IDS on or after

July 17, 2023, which is specifically for form PTO/SB/133, is a representation that the

applicant is filing form PTO/SB/133 with no alterations to the text of the form

on-practitioner, constitutes a

certification under

CFR 11.18(b)

that the existing text and any certification

statements on the form have not been altered. See

37 CFR

1.704(d)(3)

. Also, the use of document code PTA.IDS on or after

July 17, 2023, which is specifically for form PTO/SB/133, is a representation that the

applicant is filing form PTO/SB/133 with no alterations to the text of the form. As a

result of using the form PTO/SB/133 and document code PTA.IDS with a submission of an

information disclosure statement, the Office’s computer program will take the safe

harbor statement into account when patent term adjustment is calculated, thereby

eliminating the need to file a request for reconsideration of patent term adjustment

under

CFR 1.705(b)

for this matter.

The provision in

37 CFR

1.704(d)

will permit applicants to submit information first cited

in any communication from a patent office in a counterpart foreign or international

application or from the Office in another application without a reduction in patent term

adjustment if an information disclosure statement is promptly (within thirty days of

receipt of the first communication) submitted to the Office. Specifically, information

first cited in any communication from a foreign patent office or this Office and

received by an individual designated in

37 CFR 1.56(c)

more than thirty days

before the filing of the information disclosure statement is not entitled to the safe

harbor provision, even if the same information is once again cited by another foreign

patent office or this Office within thirty days prior to the filing of the information

disclosure statement in the Office. This is because the applicant was aware of the

information more than thirty days before the filing of the information disclosure

statement, yet did not submit that information. The term “any” in “any communication”

was used in

37 CFR 1.704(d)(1)(i)

to make the

distinction clear

atent office or this Office within thirty days prior to the filing of the information

disclosure statement in the Office. This is because the applicant was aware of the

information more than thirty days before the filing of the information disclosure

statement, yet did not submit that information. The term “any” in “any communication”

was used in

37 CFR 1.704(d)(1)(i)

to make the

distinction clear. This provision also permits an applicant to submit communications

that were issued by a patent office in a counterpart foreign or international

application or by the Office that were not received by any individual designated in

37 CFR

1.56(c)

more than thirty days prior to the filing of the

information disclosure statement to avoid a reduction in any patent term adjustment. See

37 CFR 1.704(d)(1)(ii)

Compliance with the statement requirement of

37 CFR

1.704(d)

does not substitute for compliance with any relevant

requirement of

37 CFR

1.97

1.98

37 CFR

1.704(d)(2)

also provides that this thirty-day period is not

extendable.

The determination of when the thirty day period in

37 CFR 1.704(d)(1)(i)

(ii)

begins to run is dependent on

the role of each entity involved in the prosecution of the U.S. and foreign

applications, and the role that each plays (if any) vis-à-vis the application being

examined by the USPTO. The inventors, the assignee and the U.S. patent counsel are all

individuals designated in

37 CFR 1.56(c)

. The issue is whether

the foreign patent counsel is also an individual designated in

37 CFR

1.56(c)

37 CFR

1.56(c)

provides that individuals associated with the filing or

prosecution of a patent application within the meaning of

37 CFR 1.56

are:

1. Each inventor named in the application;

2. Each attorney or agent who prepares or prosecutes

the application; and

3. Every other person who is substantively involved in

the preparation or prosecution of the application and who is associated with the

inventor, with the assignee or with anyone to whom there is an obligation to

assign the application

lication within the meaning of

37 CFR 1.56

are:

1. Each inventor named in the application;

2. Each attorney or agent who prepares or prosecutes

the application; and

3. Every other person who is substantively involved in

the preparation or prosecution of the application and who is associated with the

inventor, with the assignee or with anyone to whom there is an obligation to

assign the application.

Based on these elements of

37 CFR

1.56(c)

, the following three examples provide guidance in regard to

the discussed situations.

Example A:

An applicant based in Chicago, Illinois, directs U.S.

counsel to prepare, file and prosecute an application in the United States Patent and

Trademark Office (USPTO). The U.S. counsel subsequently sends the application to

foreign counsel for filing and prosecution in foreign jurisdictions. The U.S. counsel

directs foreign counsel to provide copies of all communications from the foreign

office (by fax or overnight mail) within seven days of receipt thereof, and expressly

reserves all decision-making authority as to prosecution of the U.S. and foreign

applications.

On January 5, 2002, a foreign counsel in Germany

receives a communication from the European Patent Office (EPO) that includes a list

of citations of patents. On January 8, the foreign counsel, pursuant to the standing

instructions of U.S. counsel, sends by overnight mail, a copy of the communication

from the EPO. The document is received by U.S. counsel on January 12, 2002. On

January 30, the U.S. counsel reviews the document and discovers a previously uncited

patent. A copy of the patent and an IDS is then prepared and filed by the U.S.

counsel, which was received at the USPTO on February 11, 2002.

Answer to Example A:

The thirty-day period would be calculated from January

12, 2002. As such, the IDS received on February 11, 2002 would be filed within the

thirty-day period in

37 CFR 1.704(d)

, and thus would

not result in a reduction of any patent term adjustment pursuant to

37 CFR

1.704(c)(6)

(c)(8)

(c)(9)

, or

ed by the U.S.

counsel, which was received at the USPTO on February 11, 2002.

Answer to Example A:

The thirty-day period would be calculated from January

12, 2002. As such, the IDS received on February 11, 2002 would be filed within the

thirty-day period in

37 CFR 1.704(d)

, and thus would

not result in a reduction of any patent term adjustment pursuant to

37 CFR

1.704(c)(6)

(c)(8)

(c)(9)

, or

(c)(10)

In this example, the foreign counsel has no

substantive role in the prosecution of the U.S. application. The explicitly defined

role of the foreign counsel relative to the U.S. counsel in combination with the

practice in the described fact pattern removes any potential doubt as to the role of

the foreign counsel. For these reasons, the foreign counsel is not deemed a person

who is substantially involved in the U.S. application under

37 CFR

1.56(c)

Example B:

An applicant based in Paris, France, directs French

counsel to prepare, file and prosecute an application in the European Patent Office

(EPO). The EPO application is then sent to U.S. counsel by French counsel to be

reviewed, edited, and prepared for filing in the United States Patent and Trademark

Office (USPTO). The U.S. counsel works with the French counsel to review the edited

application, and then files the application at the USPTO. The review and editing of

the U.S. application filed at the USPTO also leads the French counsel to amend its

EPO application.

On January 5, 2002, the French counsel receives a

search report from the European Patent Office that includes a list of six patents. On

January 20, 2002, the U.S. counsel receives from French counsel (by overnight mail) a

copy of the communication from the EPO and suggests that the U.S. counsel review the

search report and “take appropriate action.” On January 25, 2002, the French counsel

provides a copy of the search report to the applicant. On January 30, 2002, the U.S.

counsel reviews the document and discovers a previously uncited patent

2002, the U.S. counsel receives from French counsel (by overnight mail) a

copy of the communication from the EPO and suggests that the U.S. counsel review the

search report and “take appropriate action.” On January 25, 2002, the French counsel

provides a copy of the search report to the applicant. On January 30, 2002, the U.S.

counsel reviews the document and discovers a previously uncited patent. A copy of the

patent and an IDS is then prepared and filed by the U.S. counsel, which is received

at the USPTO on February 14, 2002

Answer to Example B:

The thirty-day period would be calculated from

January 5, 2002

. As such, the submission of the IDS would not be

received within the thirty-day window in

37 CFR

1.704(d)

, and thus could result in a reduction of any patent

term pursuant to

37 CFR 1.704(c)(6)

(c)(8)

(c)(9)

, or

(c)(10)

In this example, the USPTO would consider the French

counsel to have been a party within the meaning of

37 CFR

1.56(c)

. The French counsel, based on the above facts, played a

substantive role in the preparation and prosecution of the U.S. application (e.g.,

the French counsel drafted the original application, worked with U.S. counsel to edit

the application and subsequently amended the EPO application based on the work

product produced with U.S. counsel).

Example C:

An applicant based in Chicago, Illinois, hires U.S.

counsel to prepare an application suitable for filing in the United States Patent and

Trademark Office (USPTO) and the European Patent Office (EPO). The U.S. counsel

engages a German attorney to assist in the review and editing of the application to

take account of issues relevant to EPO practice. The U.S. counsel then reviews the

edited application, approves the changes, and files it at the USPTO. The U.S. counsel

then directs the German attorney to file the application in the EPO. During

prosecution of the U.S. case, the U.S. counsel receives an Office action citing three

patents.

On December 1, 2001, the U.S

d editing of the application to

take account of issues relevant to EPO practice. The U.S. counsel then reviews the

edited application, approves the changes, and files it at the USPTO. The U.S. counsel

then directs the German attorney to file the application in the EPO. During

prosecution of the U.S. case, the U.S. counsel receives an Office action citing three

patents.

On December 1, 2001, the U.S. counsel sends the three

patents to the German attorney for review and appropriate action. On January 5, 2002,

the German attorney receives a search report from the EPO that cites the three

previously cited patents, plus a fourth patent, which are all designated as “X”

references. On January 15, 2002, the German attorney reviews the fourth patent and

compares it to the three patents cited in the U.S. prosecution. The German attorney

concludes that the fourth patent is duplicative of one of the three patents, and

takes no further action.

On March 1, 2002, during a routine status inquiry, the

U.S. counsel is informed of the citation of the fourth patent by the EPO and the

decision of the German attorney that the information in the newly cited patent was

duplicative of the three patents previously cited by the USPTO. The U.S. counsel also

obtains copies of the newly cited patent on this date. On March 5, 2002, the U.S.

counsel files an IDS containing the newly cited patent, which is received at the

USPTO on the same date.

Answer to Example C:

The thirty-day period would be calculated from January

5, 2002. As such, the submission of the IDS would be determined to have not been

received within the thirty-day period in

37 CFR

1.704(d)

, and thus could result in a reduction of any patent

term pursuant to

37 CFR 1.704(c)(6)

(c)(8)

(c)(9)

, or

g the newly cited patent, which is received at the

USPTO on the same date.

Answer to Example C:

The thirty-day period would be calculated from January

5, 2002. As such, the submission of the IDS would be determined to have not been

received within the thirty-day period in

37 CFR

1.704(d)

, and thus could result in a reduction of any patent

term pursuant to

37 CFR 1.704(c)(6)

(c)(8)

(c)(9)

, or

(c)(10)

In this example, the USPTO would consider the

participation of the German attorney in the prosecution and decision-making as to the

relevance of the newly cited art vis-à-vis the previously cited three patents to be a

substantive participation in the U.S. prosecution. As such, the German attorney would

be considered by the USPTO to be a party covered by

37 CFR

1.56(c)

. Accordingly, evaluation of compliance with

CFR 1.704(d)

would consider the date that the foreign counsel

first learned of the fourth patent (i.e., the newly cited reference).

37 CFR 1.704(e)

37 CFR

1.704(e)

provides that a submission of a request under

37 CFR

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

37 CFR 1.704(c)(10)

. The Office will

not deem such a failure to engage in reasonable efforts to conclude processing or

examination of the application under

37 CFR 1.704(c)(10)

because the

statute expressly requires that all such requests be filed prior to the issuance of the

patent. See

35 U.S.C.

154(b)(3)(C)

VI.

37 CFR 1.704(f)

defines what is meant

by “condition for examination” for purposes of

37 CFR 1.704(c)(13)

. Specifically,

37 CFR

1.704(f)

defines that an application filed under

35 U.S.C

examination of the application under

37 CFR 1.704(c)(10)

because the

statute expressly requires that all such requests be filed prior to the issuance of the

patent. See

35 U.S.C.

154(b)(3)(C)

VI.

37 CFR 1.704(f)

defines what is meant

by “condition for examination” for purposes of

37 CFR 1.704(c)(13)

. Specifically,

37 CFR

1.704(f)

defines that 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 (

37 CFR 1.72(b)

and has papers in compliance with

37 CFR 1.52

, drawings (if any) in

compliance with

37 CFR

1.84

, any English translation required by

37 CFR 1.52(d)

37 CFR

1.57(a)

, a “Sequence Listing” incompliance with

37 CFR 1.821

through

1.825

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

with

37 CFR

1.831

through

1.835

(if applicable), an inventor's

oath or declaration or an application data sheet containing the information specified in

37 CFR

1.63(b)

, the basic filing fee (

37 CFR 1.16(a)

(c)

), the search

fee (

37 CFR

1.16(k)

(m)

), the examination fee

(

37 CFR

1.16(o)

(q)

), any certified copy of the

previously filed application required by

37 CFR 1.57(a)

, and any application

size fee required by the Office under

37 CFR 1.16(s)

37 CFR

1.704(f)

also provides that an international application is in

condition for examination when the application has entered the national stage as defined

37 CFR

1.491(b)

, and includes a specification, including at least one

claim and an abstract (

37 CFR 1.72(b)

), and has papers in compliance with

37 CFR

1.52

, drawings (if any) in compliance with

37 CFR 1.84

, a

“Sequence Listing” in compliance with

37 CFR 1.821

through

1.825

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

with

37 CFR

1.831

through

1.835

(if applicable), an inventor's

oath or declaration or an application data sheet containing the information specified

37 CFR

1.63(b)

, the search fee (

37 CFR 1.492(b)

), the examination

fee (

37 CFR

1.492(c)

), and any app

nce with

37 CFR 1.84

, a

“Sequence Listing” in compliance with

37 CFR 1.821

through

1.825

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

with

37 CFR

1.831

through

1.835

(if applicable), an inventor's

oath or declaration or an application data sheet containing the information specified

37 CFR

1.63(b)

, the search fee (

37 CFR 1.492(b)

), the examination

fee (

37 CFR

1.492(c)

), and any application size fee required by the Office

under

37 CFR

1.492(j)

37 CFR 1.704(f)

also provides that

an application shall be considered as having papers in compliance with

37 CFR 1.52

drawings (if any) in compliance with

37 CFR 1.84

, and a “Sequence

Listing” in compliance with

37 CFR 1.821

through

1.825

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

with

37 CFR

1.831

through

1.835

(if applicable) for purposes

37 CFR

1.704(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.

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This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.