Application for Patent Term Adjustment; Due Care Showing

[Editor Note:

37 CFR 1.705(b) and

(c)

below include amendments applicable only to patents granted on

or after January 14, 2013. See

37 CFR 1.705 (pre-2013-04-01)

with

respect to patents granted prior to January 14, 2013.]

37 CFR 1.705  Patent term adjustment determination.

*****

(b) Any request for reconsideration of the patent term adjustment

indicated on the patent must be by way of an application for patent term

adjustment filed no later than two months from the date the patent was granted.

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

§ 1.136(a)

.

An application for patent term adjustment under this section must be accompanied

by:

(1) The fee set forth in

§ 1.18(e)

; and

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

(i) The correct patent term adjustment and the basis or

bases under

§ 1.702

for the

adjustment;

(ii) The relevant dates as specified in

§§ 1.703(a) through

(e)

for which an adjustment is sought and the

adjustment as specified in

§ 1.703(f)

to

which the patent is entitled;

(iii) Whether the patent is subject to a terminal

disclaimer and any expiration date specified in the terminal

disclaimer; and

(iv)

(A) Any circumstances during the prosecution of

the application resulting in the patent that constitute a

failure to engage in reasonable efforts to conclude processing

or examination of such application as set forth in

§ 1.704

;

or

(B) That there were no circumstances constituting a

failure to engage in reasonable efforts to conclude processing

or examination of such application as set forth in

§ 1.704

.

circumstances during the prosecution of

the application resulting in the patent that constitute a

failure to engage in reasonable efforts to conclude processing

or examination of such application as set forth in

§ 1.704

;

or

(B) That there were no circumstances constituting a

failure to engage in reasonable efforts to conclude processing

or examination of such application as set forth in

§ 1.704

.

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

adjustment reduced pursuant to

§ 1.704(b)

for failing to

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

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

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

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

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

§ 1.704(b)

must be accompanied by:

(1) The fee set forth in

§ 1.18(f)

; and

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

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

objection, argument, or other request within three months of the date of

mailing of the Office communication notifying the applicant of the

rejection, objection, argument, or other request. The Office shall not grant

any request for reinstatement for more than three additional months for each

reply beyond three months from the date of mailing of the Office

communication notifying the applicant of the rejection, objection, argument,

or other request.

*****

I.

OFFICE PROCEDURE FOR THE TREATMENT OF REQUESTS FOR RECONSIDERATION OF PATENT TERM

ADJUSTMENT

37 CFR

1.705(b)

provides that any request for reconsideration of the

patent term adjustment indicated on the patent must be by way of an application for

patent term adjustment which must filed within two months of the date the patent was

granted and accompanied by the fee set forth in

37 CFR 1.18(e)

and a statement of

the facts involved

ENT OF REQUESTS FOR RECONSIDERATION OF PATENT TERM

ADJUSTMENT

37 CFR

1.705(b)

provides that any request for reconsideration of the

patent term adjustment indicated on the patent must be by way of an application for

patent term adjustment which must filed within two months of the date the patent was

granted and accompanied by the fee set forth in

37 CFR 1.18(e)

and a statement of

the facts involved.

37

CFR 1.705(b)(2)

provides that such statement of facts involved

must specify: (1) the correct patent term adjustment and the basis or bases under

37 CFR

1.702

for the adjustment; (2) the relevant dates as specified in

37 CFR 1.703(a)

through (e)

for which an adjustment is sought and the adjustment

as specified in

37 CFR

1.703(f)

to which the patent is entitled; (3) whether the patent

is subject to a terminal disclaimer and any expiration date specified in the terminal

disclaimer; and (4) any circumstances, if any, during the prosecution of the application

resulting in the patent that constitute a failure to engage in reasonable efforts to

conclude processing or examination of such application as set forth in

37 CFR 1.704

(or a

statement that there were no such circumstances). The two month period set in

37 CFR

1.705(b)

is extendable under

37 CFR 1.136(a)

for up to five

additional months (permitting patentee to request reconsideration of the patent term

adjustment indicated on the patent as late as within seven months after the date the

patent was granted).

The Office will conduct a manual redetermination of

patent term adjustment in response to a request for reconsideration of the patent term

adjustment. The Office makes the patent term adjustment determination indicated in the

patent by a computer program that uses the information recorded in the Office's One

Patent Service Gateway (OPSG) system, except when an applicant requests reconsideration

pursuant to

37 CFR 1.705

. See

Changes

to Implement Patent Term Adjustment Under Twenty-Year Patent Term,

65 FR

56365, 56370, 56380-81 (September 18, 2000) (final rule)

s the patent term adjustment determination indicated in the

patent by a computer program that uses the information recorded in the Office's One

Patent Service Gateway (OPSG) system, except when an applicant requests reconsideration

pursuant to

37 CFR 1.705

. See

Changes

to Implement Patent Term Adjustment Under Twenty-Year Patent Term,

65 FR

56365, 56370, 56380-81 (September 18, 2000) (final rule). The patent term adjustment

provisions of

35

U.S.C. 154(b)

are complex, with numerous types of communications

exchanged between applicants and the Office during the patent application process. Thus,

a manual redetermination of patent term adjustment could result in (1) an amount of

patent term adjustment that is the amount of patent term adjustment requested by the

applicant; (2) the same amount of patent term adjustment as indicated in the patent

(i.e., there being no change); or (3) a different amount of patent term adjustment that

may be higher or lower than the patent term adjustment as indicated in the patent.

If the patent term adjustment redetermination results in

the amount of patent term adjustment requested by the applicant, the Office will issue a

decision granting the request for reconsideration and a certificate of correction that

indicates the revised patent term adjustment. If the patent term adjustment

redetermination results in the same amount of patent term adjustment as indicated in the

patent (i.e., there being no change) and the Office does not require any additional

information to render a decision on the request for reconsideration, the Office will

issue a decision denying the request for reconsideration, and this decision is the

Director's decision on the applicant's request for reconsideration within the meaning of

35 U.S.C.

154(b)(4)

nt term adjustment as indicated in the

patent (i.e., there being no change) and the Office does not require any additional

information to render a decision on the request for reconsideration, the Office will

issue a decision denying the request for reconsideration, and this decision is the

Director's decision on the applicant's request for reconsideration within the meaning of

35 U.S.C.

154(b)(4)

.

If the patent term adjustment redetermination results in

a different amount of patent term adjustment (higher or lower than the patent term

adjustment indicated in the patent), the Office will issue a redetermination of patent

term adjustment that explains how the Office arrived at the different amount of patent

term adjustment. This redetermination of patent term adjustment is not the Director's

decision on the applicant's request for reconsideration within the meaning of

35 U.S.C.

154(b)(4)

, but is simply a new patent term adjustment

determination (e.g., a redetermination). If the Office issues such a redetermination of

patent term adjustment in response to the request for reconsideration, the applicant has

two months from the date of the redetermination to file a renewed request for

reconsideration of the patent term adjustment that addresses the issues included in the

Office's redetermination of patent term adjustment. No additional fee under

37 CFR

1.18(e)

is required. The two-month period to file a renewed

request for reconsideration of patent term adjustment is extendable under

37 CFR

1.136(a)

.

If the patent term adjustment redetermination results in

the same amount of patent term adjustment as indicated in the patent (i.e., there being

no change) but the Office requires additional information to render a decision on the

request for reconsideration of the patent term adjustment, the Office will issue a

requirement for information to obtain the additional information. This requirement for

information is not the Director's decision on the applicant's request for

reconsideration within the meaning of

35 U.S.C

tent (i.e., there being

no change) but the Office requires additional information to render a decision on the

request for reconsideration of the patent term adjustment, the Office will issue a

requirement for information to obtain the additional information. This requirement for

information is not the Director's decision on the applicant's request for

reconsideration within the meaning of

35 U.S.C. 154(b)(4)

. If the Office

issues a requirement for information in response to the request for reconsideration of

the patent term adjustment, the applicant has two months from the date of the

requirement for information to file a renewed request for reconsideration of the patent

term adjustment. The renewed request should supply the required information and no

additional fee is required. This two-month period is extendable under

37 CFR

1.136(a)

.

The Office will again conduct a redetermination of patent

term adjustment in response to any renewed request for reconsideration, which is filed

in response to a redetermination of patent term adjustment and/or a requirement for

information. If this redetermination of patent term adjustment results in the amount of

patent term adjustment requested by the applicant, the Office will issue a decision

granting the request for reconsideration and a certificate of correction that indicates

the revised patent term adjustment. If this redetermination of patent term adjustment

results in the same amount of patent term adjustment as indicated in the previous

redetermination of patent term adjustment or in the patent, the Office will generally

issue a decision denying the request for reconsideration and a certificate of

correction, if necessary, indicating the revised patent term adjustment as the result of

a redetermination of patent term adjustment. The decision denying the request for

reconsideration is the Director's decision on the applicant's request for

reconsideration within the meaning of

35 U.S.C. 154(b)(4)

ice will generally

issue a decision denying the request for reconsideration and a certificate of

correction, if necessary, indicating the revised patent term adjustment as the result of

a redetermination of patent term adjustment. The decision denying the request for

reconsideration is the Director's decision on the applicant's request for

reconsideration within the meaning of

35 U.S.C. 154(b)(4)

. In certain,

limited circumstances, the redetermination may result in another redetermination of

patent term adjustment or requirement for information. In such a case, applicant will be

given another opportunity to file a renewed request for reconsideration as described

above.

Only if the Office issues a decision denying patentee’s

request for reconsideration, then patentee may appeal such decision to the District

Court for the Eastern District of Virginia by filing a civil complaint within 180 days

of the date of the decision on the request for reconsideration of patent term adjustment

(within the meaning of

35 U.S.C. 154(b)(4)

).

Section 1(h)(3) of the AIA Technical Corrections Act

amended

35 U.S.C.

154(b)(4)

to provide that “[a]n applicant dissatisfied with the

Director’s decision on the applicant’s request for reconsideration under paragraph

(3)(B)(ii)

shall have exclusive remedy by a civil action against

the Director filed in the United States District Court for the Eastern District of

Virginia within 180 days after the date the Director’s decision on the applicant’s

request for reconsideration.” The change to

35 U.S.C. 154(b)(4)

clarifies that

ith the

Director’s decision on the applicant’s request for reconsideration under paragraph

(3)(B)(ii)

shall have exclusive remedy by a civil action against

the Director filed in the United States District Court for the Eastern District of

Virginia within 180 days after the date the Director’s decision on the applicant’s

request for reconsideration.” The change to

35 U.S.C. 154(b)(4)

clarifies that

(1) a civil action under

35 U.S.C. 154(b)(4)

is not an

alternative to requesting reconsideration of the patent term adjustment under

35 U.S.C.

154(b)(3)

but is the remedy for an applicant who is dissatisfied

with the Director’s decision on the applicant’s request for reconsideration under

35 U.S.C.

154(b)(3)

; and (2) a civil action provided in

35 U.S.C.

154(b)(4)

is the

exclusive

remedy for an applicant

who is dissatisfied with the Director’s decision on the applicant’s request for

reconsideration. In other words, an applicant that is dissatisfied with the patent term

adjustment determination on the patent must first request reconsideration under

35 U.S.C.

154(b)(3)

and

37 CFR 1.705(b)

. Only after

receiving a decision denying the request for reconsideration, may the applicant file a

civil action, proscribed in

35 U.S.C. 154(b)(4)

, if the

applicant is dissatisfied with the decision on the request for reconsideration. This

statutory change is applicable for all patents that issue on or after January 14, 2013.

For patents that issued prior to January 14, 2013,

35 U.S.C.

154(b)(4)

previously required that patentee commence a civil

action within 180 days of the grant of the patent. Patentee is not entitled to equitable

tolling of the 180-day period to commence the civil action in the district court where

patentee did not lack sufficient facts on which it could sue but instead waited until

another, unrelated party secured a favorable ruling on a legal theory in another court

proceeding. See

Novartis AG v. Lee,

740 F.3d 593, 109 USPQ2d 1385

(Fed. Cir. 2014). It is noted, however, that the U.S

entitled to equitable

tolling of the 180-day period to commence the civil action in the district court where

patentee did not lack sufficient facts on which it could sue but instead waited until

another, unrelated party secured a favorable ruling on a legal theory in another court

proceeding. See

Novartis AG v. Lee,

740 F.3d 593, 109 USPQ2d 1385

(Fed. Cir. 2014). It is noted, however, that the U.S. District Court for the District of

Columbia affirmed a prior decision of the court holding that the 180-day deadline under

35 U.S.C.

154(b)(4)(A)

for filing a lawsuit challenging a PTA determination

was tolled in the circumstances of that case by the patent holders' timely requests for

reconsideration of the PTA determinations set forth in the patents at issue. See

Bristol-Myers Squibb Co. v. Kappos,

891 F. Supp. 2d 135 (D.D.C.

2012) (denying reconsideration of the decision published at 841 F. Supp. 2d 238 (D.D.C.

2012)). Section 1(n) of the AIA Technical Corrections Act provides that amendments made

in section 1(h) shall take effect on January 14, 2013 (the date of enactment) and shall

apply to the proceedings commenced on or after January 14, 2013. Section 1(n) of the

Technical Corrections Act does not limit the applicability of the changes in section

1(h) to applications filed on or after January 14, 2013. Cf. Section 4405(a) of the

American Inventors Protection Act of 1999 (AIPA), Public Law 106-113, 113 Stat. 1501,

1501A-552 through 1501A-591 (limiting the applicability of the patent term adjustment

provisions of the AIPA to applications filed on or after May 29, 2000 (the date that is

six months after the enactment of AIPA)). Patent term adjustment proceedings are not

“commenced” until the Office notifies the applicant of the Office’s patent term

adjustment determination under

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

, which now

occurs when the patent is granted. Accordingly, the changes to

35 U.S.C. 154

in

section 1(h) of the AIA Technical Corrections Act apply to any patent granted on or

after January 14, 2013.

II

he enactment of AIPA)). Patent term adjustment proceedings are not

“commenced” until the Office notifies the applicant of the Office’s patent term

adjustment determination under

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

, which now

occurs when the patent is granted. Accordingly, the changes to

35 U.S.C. 154

in

section 1(h) of the AIA Technical Corrections Act apply to any patent granted on or

after January 14, 2013.

II.

DUE CARE SHOWING

37 CFR

1.705(c)

implements the provisions of

35 U.S.C.

154(b)(3)(C)

and specifically provides that a request for

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

37 CFR

1.704(b)

for failing to reply to a rejection, objection, argument,

or other request within three months of the date of mailing of the Office communication

notifying the applicant of the rejection, objection, argument, or other request must

include: (1) the fee set forth in

37 CFR 1.18(f)

; and (2) a showing to

the satisfaction of the Director that, in spite of all due care, the applicant was

unable to reply to the rejection, objection, argument, or other request within three

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

rejection, objection, argument, or other request.

37 CFR 1.705(c)

also provides that

the Office shall not grant any request for reinstatement for more than three additional

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

communication notifying the applicant of the rejection, objection, argument, or other

request (

35 U.S.C.

154(b)(3)(C)

).

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

and

37 CFR

1.705(c)

also requires that the request for reinstatement be filed

prior to the issuance of the patent. Because

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

requires that

the request be filed prior to the issuance of the patent, the Office will not consider

or act on a request for reinstatement in a paper filed after the patent is issued. For

example, a request for reinstatement cannot be made as part of a request for

reconsideration under

37 CFR 1.705(b)

t for reinstatement be filed

prior to the issuance of the patent. Because

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

requires that

the request be filed prior to the issuance of the patent, the Office will not consider

or act on a request for reinstatement in a paper filed after the patent is issued. For

example, a request for reinstatement cannot be made as part of a request for

reconsideration under

37 CFR 1.705(b)

. Applicants are

aware during the pendency of the application of situations where the reply was filed

more than three months after the Office communication notifying the applicant of the

rejection, objection, argument, or other request. If applicants believe that they can

make the required showing that, in spite of all due care, the applicant was unable to

rely to the rejection, objection, argument or other Office request within three months,

then applicants should file the request for reinstatement promptly and no later than at

least one day prior to the issuance of the patent. Applicants need not review of the

patent term adjustment calculation to establish a request for reinstatement under

37 CFR

1.705(c)

. The Office will not delay issuance of the patent but

will make a decision on the request for reinstatement after the grant of the patent and

if appropriate, issue a certificate of correction to revise the patent term adjustment

determination on the patent.

As noted

supra,

37 CFR

1.705(c)

continues to require that any request for reinstatement

of all or part of the cumulative period of time of an adjustment reduced under

35 U.S.C.

154(b)(2)(C)

, on the basis of a showing that, in spite of all due

care, the applicant was unable to respond within the three-month period, must be filed

prior to the issuance of the patent. Thus, where an applicant is seeking reinstatement

under

35 U.S.C.

154(b)(3)(C)

of patent term adjustment reduced under

35 U.S.C.

154(b)(2)(C)

, the showing required by

35 U.S.C.

154(b)(3)(C)

must be filed prior to the issuance of the patent

a showing that, in spite of all due

care, the applicant was unable to respond within the three-month period, must be filed

prior to the issuance of the patent. Thus, where an applicant is seeking reinstatement

under

35 U.S.C.

154(b)(3)(C)

of patent term adjustment reduced under

35 U.S.C.

154(b)(2)(C)

, the showing required by

35 U.S.C.

154(b)(3)(C)

must be filed prior to the issuance of the patent.

However, where the patentee is not seeking reinstatement under

35 U.S.C.

154(b)(3)(C)

of patent term adjustment reduced under

35 U.S.C.

154(b)(2)(C)

, but is simply contending that the Office's patent

term adjustment determination is in error with respect to the three-month timeframe in

35 U.S.C.

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

(e.g., a reply is filed within the three-month

timeframe in

35 U.S.C.

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

, but the Office's patent term adjustment

determination treats the reply as having been filed outside the three-month period in

35 U.S.C.

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

), any request for reconsideration or review of a

patent term adjustment determination is by way of an application for patent term

adjustment under

37 CFR 1.705(b)

filed no later than

two months from the date the patent was granted (this two-month period being extendable

under the provisions of

37 CFR 1.136(a)

).

Filing a reply outside of three months after an Office action is

per se

a failure to engage in reasonable efforts to conclude

prosecution under

35

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

unless applicant can establish that the

delay was “in spite of all due care.” The provisions of

35 U.S.C. 21(b)

are applicable to the determination of three-month period for reply. If the last day of

the three-month 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 the 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

the three-month 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 the 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.

Supp. 2d 214 (D.D.C. 2011). For example, 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 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.

Accordingly, a request for reinstatement of all or part of the period of adjustment

under

37

CFR 1.705(c)

would not be applicable since applicant would not

have been deemed to reply more than three months from the date of the Office action.

The Office “shall reinstate all or part of the cumulative

period of time of an adjustment reduced under [

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

] if the

applicant… makes a showing that, in spite of all due care, the applicant was unable to

respond within the 3-month period….” See

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

. The “due

care” of a reasonably prudent person standard has been applied in deciding petitions

under the “unavoidable delay” standard of

35 U.S.C. 133

. See

In re

Mattullath,

38 App. D.C. 497, 514-15 (1912) (“the word ‘unavoidable’ … is

applicable to ordinary human affairs, and requires no more or greater care or diligence

than is generally used and observed by prudent and careful men in relation to their most

important business”) (quoting and adopting

Ex parte Pratt,

1887 Dec.

Comm’r Pat. 31, 32-33); see also

Ray v. Lehman,

55 F.3d 606, 609, 34

USPQ2d 1786, 1787 (Fed. Cir

pp. D.C. 497, 514-15 (1912) (“the word ‘unavoidable’ … is

applicable to ordinary human affairs, and requires no more or greater care or diligence

than is generally used and observed by prudent and careful men in relation to their most

important business”) (quoting and adopting

Ex parte Pratt,

1887 Dec.

Comm’r Pat. 31, 32-33); see also

Ray v. Lehman,

55 F.3d 606, 609, 34

USPQ2d 1786, 1787 (Fed. Cir. 1995) (“in determining whether a delay…was unavoidable, one

looks to whether the party…exercised the due care of a reasonably prudent person”).

While the legislative history of the American Inventors Protection Act of 1999 is silent

as to the meaning of the phrase “in spite of all due care,” the phrases “all due care”

and “unable to respond” invoke a higher degree of care than the ordinary due care

standard of

35

U.S.C. 133

, as well as the “reasonable efforts to conclude

processing or examination [or prosecution] of an application” standard of

35 U.S.C.

154(b)(2)(C)(i) and (iii)

. Therefore, applicants should not rely

upon decisions relating to the “unavoidable delay” standard of

35 U.S.C. 133

as controlling in a request to reinstate reduced patent term adjustment on the basis of

a showing that the applicant was unable to respond within the three-month period in

spite of all due care.

Examples

The following are examples of showings that may establish that the

applicant was unable to respond within the three-month period in spite of all due

care:

(A) a showing that the original three-month period was

insufficient to obtain the test data necessary for an affidavit or declaration

under

37 CFR

1.132

that was submitted with a reply filed outside the

original three-month period;

(B) a showing that the applicant was unable to reply within the

original three-month period due to a natural disaster;

(C) a showing that applicant was unable to reply within the

original three-month period because testing was required to reply to an Office

action, and the testing necessarily took longer than three months; or

(D) a showing that the

y filed outside the

original three-month period;

(B) a showing that the applicant was unable to reply within the

original three-month period due to a natural disaster;

(C) a showing that applicant was unable to reply within the

original three-month period because testing was required to reply to an Office

action, and the testing necessarily took longer than three months; or

(D) a showing that the applicant was unable to reply within the

original three-month period due to illness or death of a sole practitioner of

record who was responsible for prosecuting the application.

The patent term adjustment reinstated would be limited to the period

in which the showing establishes that the applicant was acting with all due care to

reply to the Office notice or action, but circumstances (outside applicant’s control)

made applicant unable to reply in spite of such due care. An applicant will not be

able to show that the applicant was unable to reply within the three-month period “in

spite of all due care” if the reply was not filed within the three-month period due

to reasons within the control of applicant or agencies within the applicant’s

control.

Examples of circumstances that would

NOT

establish that

the applicant was unable to respond within the three-month period in spite of all due

care are:

(A) an applicant’s or representative’s preoccupation with other

matters (e.g., an

inter partes

lawsuit or interference) that

is given priority over prosecution of the application;

(B) illness or death of the practitioner in charge of the

application if the practitioner is associated (in a law firm) with other

practitioners (since the other practitioners could have taken action to reply

within the three-month period);

(C) time consumed with communications between the applicant and

the applicant's representative, regardless of whether the applicant resides in

the United States or chooses to communicate with the United States

representative via a foreign representative;

(D) vacation or other non-attention to an application that res

her practitioners could have taken action to reply

within the three-month period);

(C) time consumed with communications between the applicant and

the applicant's representative, regardless of whether the applicant resides in

the United States or chooses to communicate with the United States

representative via a foreign representative;

(D) vacation or other non-attention to an application that results

in a failure to reply within the three-month period;

(E) applicant filing a reply on or near the last day of the

three-month period using first class mail with a certificate of mailing under

37 CFR

1.8

, rather than by electronic filing, Priority Mail

Express

®

under

37 CFR

1.10

or facsimile (if permitted), and the reply is not

received (filed) in the Office until after the three-month period; or

(F) failure of clerical employees of applicant or applicant’s

representative to properly docket the Office action or notice for reply or

perform other tasks necessary for reply within the three-month period.

Rarely is the power of attorney given to a single attorney and often

many attorneys are given power of attorney in an application. An attorney in

litigation, working on an interference or taking a vacation is generally aware of

that fact before the event and should make plans for another to take over the work so

that it is completed and filed in the Office within the three-month period. Thus,

failure to reply within the three-month period in

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

due to

preoccupation with other matters (e.g., an

inter partes

lawsuit or

interference) given priority over the application, or vacation or other non-attention

to an application, cannot be relied upon to show that applicant was unable to reply

“in spite of all due care” under

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

.

III

nth period. Thus,

failure to reply within the three-month period in

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

due to

preoccupation with other matters (e.g., an

inter partes

lawsuit or

interference) given priority over the application, or vacation or other non-attention

to an application, cannot be relied upon to show that applicant was unable to reply

“in spite of all due care” under

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

.

III.

INTERIM PROCEDURE FOR REQUESTING PTA

RECALCULATION WHEN THE OFFICE FAILS TO RECOGNIZE THE TIMELY FILING OF THE SAFE HARBOR

STATEMENT

For safe harbor statements under 37 CFR 1.704(d) filed

before July 17, 2023, the Office has created an interim procedure by which a patentee

can request recalculation of patent term adjustment where the sole reason for contesting

the patent term adjustment determination is the Office’s failure to recognize a timely

filed safe harbor statement accompanying an information disclosure statement. The

interim procedure waives the fee under

37 CFR 1.705(b)(1)

as set forth in

37 CFR

1.18(e)

to file the request for reconsideration. The interim

procedure is not applicable to safe harbor statements filed on or after July 17, 2023,

because the Office updated the patent term adjustment computer program and provided

notice to the public that the computer program had been updated in the final rule

Standardization of the Patent Term Adjustment Statement Regarding

Information Disclosure Statements,

88 FR 39172 (June 15, 2023).

Under the interim procedure, recalculation of patent

term adjustment is requested by submitting form PTO/SB/134 in lieu of the request and

fee set forth in

37 CFR 1.705(b)

. This form, “Request

for Reconsideration of Patent Term Adjustment in View of Safe Harbor Statement Under 37

CFR 1.704(d)”, is available on the USPTO website (

www.uspto.gov

) and is reproduced below.

The form must be filed within the time period set forth in

37 CFR

1.705(b)

, and the Office will not grant any request for

recalculation of the patent term adjustment that is not timely filed

705(b)

. This form, “Request

for Reconsideration of Patent Term Adjustment in View of Safe Harbor Statement Under 37

CFR 1.704(d)”, is available on the USPTO website (

www.uspto.gov

) and is reproduced below.

The form must be filed within the time period set forth in

37 CFR

1.705(b)

, and the Office will not grant any request for

recalculation of the patent term adjustment that is not timely filed. The time period

set forth set forth in

37 CFR 1.705(b)

may be extended

under the provisions of

37 CFR 1.136(a)

. The Office of

Management and Budget (OMB) has determined that, under 5 CFR 1320.3(h), Form PTO/SB/134

does not collect “information” within the meaning of the Paperwork Reduction Act of

1995.

If the request for recalculation is not based solely on

the Office’s failure to recognize a timely filed, compliant safe harbor statement under

37 CFR

1.704(d)

, the patentee must file a request for reconsideration of

the patent term adjustment indicated on the patent under

37 CFR

1.705(b)

with the fee set forth in

37 CFR 1.18(e)

. If

a patentee files both form PTO/SB/134 and a request under

37 CFR

1.705(b)

prior to the Office’s recalculation of patent term

adjustment, the Office will treat both papers together as a request for reconsideration

of the patent term adjustment indicated on the patent under

37 CFR

1.705(b)

and require the fee set forth in

37 CFR

1.18(e)

.

While the Office’s interim procedure waives the fee

under

37

CFR 1.705(b)(1)

as set forth in

37 CFR 1.18(e)

to

file the form PTO/SB/134, it does not waive any extensions of time fees due under

37 CFR

1.705(b)

and

37 CFR 1.136

. In addition, it is

noted that the fee specified in

37 CFR 1.18(e)

is required for a

request for reconsideration under

37 CFR 1.705

, and the Office may

only refund fees paid by mistake or in excess of that required (

35 U.S.C. 42(d)

)

FR 1.705(b)(1)

as set forth in

37 CFR 1.18(e)

to

file the form PTO/SB/134, it does not waive any extensions of time fees due under

37 CFR

1.705(b)

and

37 CFR 1.136

. In addition, it is

noted that the fee specified in

37 CFR 1.18(e)

is required for a

request for reconsideration under

37 CFR 1.705

, and the Office may

only refund fees paid by mistake or in excess of that required (

35 U.S.C. 42(d)

).

Thus, the interim procedure is not a basis for requesting a refund of the fee specified

in

37 CFR

1.18(e)

for any request for reconsideration under

37 CFR

1.705

, including any previously filed request that was solely

based on the Office's error in assessing an applicant delay under

37 CFR

1.704(c)(6)

,

(c)(8)

,

(c)(9)

,

(c)(10)

, or

(c)(12)

for the submission of an information disclosure statement that was accompanied by the

statement under

37 CFR 1.704(d)

.

The Office of Petitions will manually review the request

for recalculation of patent term adjustment filed under the interim procedure.

Specifically, the Office of Petitions will review the accuracy of the patent term

adjustment calculation in view of

37 CFR 1.702

through

1.704

. After the review by the Office of Petitions, the patentee

will be given one opportunity to respond to the recalculation. The response must be

filed by patentee within two months of the date of the recalculation is mailed or given.

No extensions of time will be granted. If patentee responds to the recalculation by

requesting changes to the recalculation based on issues not related to the safe harbor

statement, patentee must comply with the requirements of

37 CFR 1.705(b)(1) and

tunity to respond to the recalculation. The response must be

filed by patentee within two months of the date of the recalculation is mailed or given.

No extensions of time will be granted. If patentee responds to the recalculation by

requesting changes to the recalculation based on issues not related to the safe harbor

statement, patentee must comply with the requirements of

37 CFR 1.705(b)(1) and

(2)

.

If patentee fails to respond to the recalculation and

the Office’s determination of the amount of recalculated patent term adjustment is

different from that printed on the front of the patent, the Office will

sua

sponte

issue a certificate of correction that reflects the recalculated

patent term adjustment. If patentee files a response after the Office’s recalculation

and the Office maintains its recalculation, the Office will issue its decision

confirming its recalculation pursuant to

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

, and this

decision is the Director’s decision under

35 U.S.C. 154(b)(4)

. The Office's

initial recalculation of patent term adjustment under the interim procedure described

above is

not

the Director’s decision under

35 U.S.C.

154(b)(4)

.

A copy of form PTO/SB/134 is reproduced below.

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