[Federal Register Volume 79, Number 94 (Thursday, May 15, 2014)]
[Rules and Regulations]
[Pages 27755-27761]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11131]



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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

37 CFR Part 1

[Docket No.: PTO-P-2013-0006]
RIN 0651-AC84


Revisions To Implement the Patent Term Adjustment Provisions of 
the Leahy-Smith America Invents Act Technical Corrections Act

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Final rule.

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SUMMARY: Section 1(h) of the Act to correct and improve certain 
provisions of the Leahy-Smith America Invents Act and title 35, United 
States Code (AIA Technical Corrections Act) revised the patent law 
provisions pertaining to patent term adjustment. Section 1(h) of the 
AIA Technical Corrections Act revised the date from which the fourteen-
month patent term adjustment period is measured, and clarified the date 
from which the three-year patent term adjustment period is measured, 
with respect to international applications filed under the Patent 
Cooperation Treaty. Under section 1(h) of the AIA Technical Corrections 
Act, the fourteen-month patent term adjustment period and the three-
year patent term adjustment period is measured from the same date: the 
date on which an application was filed under 35 U.S.C. 111(a) in an 
application under 35 U.S.C. 111; or the date of commencement of the 
national stage under 35 U.S.C. 371 in an international application. 
Section 1(h) of the AIA Technical Corrections Act also revised the 
provisions for notifying applicants of patent term adjustment 
determinations and revised the time period for requesting 
reconsideration and judicial review of the Office's patent term 
adjustment determinations and decisions. The United States Patent and 
Trademark Office (Office) published an interim rule on April 1, 2013 
(patent term adjustment interim rule), amending the rules of practice 
to implement the changes to the patent term adjustment provisions in 
section 1(h) of the AIA Technical Corrections Act. This final rule 
adopts as final the amendments to the rules of practice originally set 
forth in the patent term adjustment interim rule. The Office is further 
providing an optional procedure for requesting a recalculation of 
patent term adjustment, as an alternative to the petition and fee 
otherwise required to request reconsideration of a patent term 
adjustment determination, for patents issued between January 14, 2013 
(the date of enactment of the AIA Technical Corrections Act) and May 
20, 2014 (patents issued on or after this date will have patent term 
adjustment determinations consistent with the AIA Technical Corrections 
Act) that resulted directly from international applications. The Office 
is providing this optional procedure for requesting a recalculation of 
patent term adjustment because the Office has experienced a significant 
delay in modifying the computer program used to calculate patent term 
adjustment with respect to the changes resulting from the AIA Technical 
Corrections Act.

DATES: 
    Effective Date: This final rule is effective on May 15, 2014. The 
interim rule, published April 1, 2013, at 78 FR 19416, was effective on 
April 1, 2013.
    Applicability Date: The amendments to 37 CFR 1.702, 1.703, and 
1.705 apply to any patent granted on or after January 14, 2013. The 
amendment to 37 CFR 1.704 applies to any application in which a notice 
of allowance was mailed on or after April 1, 2013.
    The optional procedure for requesting a patent term adjustment 
recalculation applies only to patents issued between January 14, 2013, 
and May 20, 2014, that resulted directly from international 
applications, and the request must be filed no later than July 31, 
2014.

FOR FURTHER INFORMATION CONTACT: Kery A. Fries, Senior Legal Advisor, 
Office of Patent Legal Administration, Office of the Deputy 
Commissioner for Patent Examination Policy, at (571) 272-7757.

SUPPLEMENTARY INFORMATION: 
    Executive Summary: Purpose: Section 1(h) of the AIA Technical 
Corrections Act revised the patent term adjustment provisions of 35 
U.S.C. 154(b). The AIA Technical Corrections Act revised the date from 
which the fourteen-month period in 35 U.S.C. 154(b)(1)(A)(i)(II), and 
clarified the date from which the three-year period in 35 U.S.C. 
154(b)(1)(B), are measured with respect to international applications. 
Section 1(h) of the AIA Technical Corrections Act also revised the 
provisions in 35 U.S.C. 154(b)(3) and (b)(4) for notifying applicants 
of patent term adjustment determinations and for requesting 
reconsideration and judicial review of the Office's patent term 
adjustment determinations and decisions.
    Summary of Major Provisions: The Office published an interim rule 
on April 1, 2013, amending the rules of practice to implement the 
changes to the patent term adjustment provisions in section 1(h) of the 
AIA Technical Corrections Act.
    This final rule specifically adopts as final the amendment to the 
rules of practice originally set forth in the patent term adjustment 
interim rule specifying that the fourteen-month period in 35 U.S.C. 
154(b)(1)(A)(i) is measured from the date of commencement of the 
national stage under 35 U.S.C. 371 in an international application for 
consistency with the change to 35 U.S.C. 154(b)(1)(A)(i)(II) in section 
1(h) of the AIA Technical Corrections Act. The change to 35 U.S.C. 
154(b)(1)(B) did not require a change to the rules of practice, as the 
current rules of practice interpret the phrase ``actual filing date of 
the application in the United States'' in former 35 U.S.C. 154(b)(1)(B) 
as meaning the date of commencement of the national stage under 35 
U.S.C. 371 in an international application.
    This final rule also adopts as final the amendment to the rules of 
practice originally set forth in the patent term adjustment interim 
rule relating to reconsideration of a patent term adjustment 
determination. This change provides that the two-month period for 
requesting reconsideration of the patent term adjustment indicated on 
the patent may be extended by an additional five months, and thus 
permits a patentee to request reconsideration of the patent term 
adjustment indicated on the patent as late as seven months after the 
date the patent was granted.
    The Office is further providing an optional procedure for 
requesting a recalculation of patent term adjustment, as an alternative 
to the petition and fee otherwise required to request reconsideration 
of a patent term adjustment determination, for patents issued between 
January 14, 2013, and May 20, 2014, that resulted directly from 
international applications. The Office is providing this optional 
procedure for requesting a recalculation of patent term adjustment 
because the Office has experienced a significant delay in modifying the 
computer program used to calculate patent term adjustment with respect 
to the changes in the AIA Technical Corrections Act.
    Costs and Benefits: This rulemaking is not economically significant 
under Executive Order 12866 (Sept. 30, 1993).
    Background: The AIA Technical Corrections Act was enacted on 
January 14, 2013. See Pub. L. 112-274, 126 Stat. 2456 (2013). Section 
1(h) of the AIA Technical Corrections Act revised the patent term 
adjustment provisions of 35 U.S.C. 154(b). See 126 Stat. at 2457.
    Section 1(h)(1)(A) of the AIA Technical Corrections Act amended 35 
U.S.C. 154(b)(1)(A)(i)(II) to change ``the

[[Page 27756]]

date on which an international application fulfilled the requirements 
of section 371'' to ``the date of commencement of the national stage 
under section 371 in an international application.'' See id. Under 
former 35 U.S.C. 154(b)(1)(A)(i)(II), the fourteen-month period in 35 
U.S.C. 154(b)(1)(A)(i) was measured from ``the date on which an 
international application fulfilled the requirements of section 371 of 
this title,'' and an international application does not fulfill the 
requirements of 35 U.S.C. 371 until the applicant files (inter alia) 
the inventor's oath or declaration (35 U.S.C. 371(c)(4) and MPEP Sec.  
1893.03(b)). See Changes to Implement the Inventor's Oath or 
Declaration Provisions of the Leahy-Smith America Invents Act, 77 FR 
48776, 48780 (Aug. 14, 2012). Thus, under section 1(h)(1)(A) of the AIA 
Technical Corrections Act, the fourteen-month period in 35 U.S.C. 
154(b)(1)(A)(i) is measured from: (1) The date on which an application 
was filed under 35 U.S.C. 111(a); or (2) the date of commencement of 
the national stage under 35 U.S.C. 371 in an international application.
    Section 1(h)(1)(B) of the AIA Technical Corrections Act amended 35 
U.S.C. 154(b)(1)(B) to change ``the actual filing date of the 
application in the United States'' to ``the actual filing date of the 
application under section 111(a) in the United States or, in the case 
of an international application, the date of commencement of the 
national stage under section 371 in the international application.'' 
See 126 Stat. at 2457. Thus, under section 1(h)(1)(B) of the AIA 
Technical Corrections Act, the three-year period in 35 U.S.C. 
154(b)(1)(B) is measured from: (1) The actual filing date of the 
application under 35 U.S.C. 111(a) in the United States; or (2) in the 
case of an international application, the date of commencement of the 
national stage under 35 U.S.C. 371 in the international application.
    The change to 35 U.S.C. 154(b)(1)(A)(i)(II) required a modification 
in Office practice, as the date of commencement of the national stage 
under 35 U.S.C. 371 is not always the date on which an international 
application fulfilled the requirements of 35 U.S.C. 371. However, the 
change to 35 U.S.C. 154(b)(1)(B) did not require a modification in 
Office practice, because since the patent term adjustment provisions of 
35 U.S.C. 154(b) were implemented in September 2000, the Office has 
interpreted the phrase ``actual filing date of the application in the 
United States'' in former 35 U.S.C. 154(b)(1)(B) as the date of 
commencement of the national stage under 35 U.S.C. 371 in an 
international application. See Changes to Implement Patent Term 
Adjustment Under Twenty-Year Patent Term, 65 FR 56365, 56382-84 (Sept. 
18, 2000) (explaining why the phrase ``actual filing date of the 
application in the United States'' in 35 U.S.C. 154(b)(1)(B) must mean 
the date the national stage commenced under 35 U.S.C. 371(b) or (f) in 
the case of an international application). The change to 35 U.S.C. 
154(b)(1)(A)(i)(II) and (b)(1)(B) in section 1(h)(1) of the AIA 
Technical Corrections Act means that the fourteen-month period in 35 
U.S.C. 154(b)(1)(A)(i) and the three-year period in 35 U.S.C. 
154(b)(1)(B) will be measured from the same date: (1) The date on which 
an application was filed under 35 U.S.C. 111(a) in an application under 
35 U.S.C. 111; or (2) the date of commencement of the national stage 
under 35 U.S.C. 371 in an international application.
    Section 1(h)(2) of the AIA Technical Corrections Act amended 35 
U.S.C. 154(b)(3)(B)(i) to change ``shall transmit a notice of that 
[patent term adjustment] determination with the written notice of 
allowance of the application under section 151'' to ``shall transmit a 
notice of that [patent term adjustment] determination no later than the 
date of issuance of the patent.'' See 126 Stat. at 2457. This change 
eliminated the need for the Office to provide an initial patent term 
adjustment determination with the notice of allowance and before the 
patent term adjustment under 35 U.S.C. 154(b)(1)(A)(iv) and 
154(b)(1)(B) is known. See Changes to Implement Patent Term Adjustment 
Under Twenty-Year Patent Term, 65 FR 56365, 56374 (explaining that a 
two-part process is required because the Office is obliged under 35 
U.S.C. 154(b)(3) to provide a patent term adjustment determination 
before the issue date and thus before the patent term adjustment is 
known).
    Section 1(h)(3) of the AIA Technical Corrections Act amended 35 
U.S.C. 154(b)(4) to change ``[a]n applicant dissatisfied with a 
determination made by the Director under paragraph (3) shall have 
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 grant of the patent'' to ``[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 of the Director's decision on the applicant's request 
for reconsideration.'' See 126 Stat. at 2457. This change to 35 U.S.C. 
154(b)(4) clarified that: (1) A civil action under 35 U.S.C. 154(b)(4) 
is not an alternative to requesting reconsideration of a patent term 
adjustment under 35 U.S.C. 154(b)(3), but instead is the remedy for an 
applicant who is dissatisfied with the Director's decision on the 
applicant's request for reconsideration; and (2) a civil action under 
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.
    Section 1(n) of the AIA Technical Corrections Act provided that 
amendments made by the AIA Technical Corrections Act shall take effect 
on January 14, 2013 (the date of enactment of the AIA Technical 
Corrections Act), and shall apply to proceedings commenced on or after 
January 14, 2013. See 126 Stat. at 2459. Section 1(n) of the AIA 
Technical Corrections Act did 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), Pub. L. 106-113, 113 Stat. 1501, 1501A-552 through 1501A-
591 (1999) (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 date of enactment of the AIPA). 
Patent term adjustment proceedings are not ``commenced'' until the 
Office notifies the applicant of the Office's patent term adjustment 
under 35 U.S.C. 154(b)(3), which now occurs when the patent is granted. 
Therefore, the changes to 35 U.S.C. 154 in section 1(h) of section 1(n) 
of the AIA Technical Corrections Act apply to any patent granted on or 
after January 14, 2013.

Discussion of Specific Rules

    The Office published an interim rule on April 1, 2013, revising 
Sec. Sec.  1.702, 1.703, 1.704, and 1.705 to implement the changes to 
the patent term adjustment provisions in section 1(h) of the AIA 
Technical Corrections Act. See Revisions to Patent Term Adjustment, 78 
FR 19416 (Apr. 1, 2013). This final rule adopts as final the amendments 
to Sec. Sec.  1.702, 1.703, 1.704, and 1.705 originally set forth in 
the patent term adjustment interim rule. The following is a discussion 
of the amendments to Title 37 of the Code of Federal Regulations, Part 
1, in the patent term adjustment interim rule.
    Section 1.702: The patent term adjustment interim rule amended 
Sec.  1.702(a)(1) to measure the fourteen-month period from the date of

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commencement of the national stage under 35 U.S.C. 371(b) or (f) in an 
international application. With this amendment, Sec.  1.702(a)(1)(i) 
states that a ground for potential patent term adjustment is the 
failure of the Office to: ``Mail at least one of a notification under 
35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151 not later 
than fourteen months after the date on which the application was filed 
under 35 U.S.C. 111(a) or the date the national stage commenced under 
35 U.S.C. 371(b) or (f) in an international application.''
    The patent term adjustment interim rule amended Sec.  1.702(b) to 
change the paragraph heading to ``Three-year pendency.'' No further 
change to Sec.  1.702(b) was necessary, as the Office has interpreted 
the phrase ``actual filing date of the application in the United 
States'' in former 35 U.S.C. 154(b)(1)(B) as the date of commencement 
of the national stage under 35 U.S.C. 371 in an international 
application since the patent term adjustment provisions of 35 U.S.C. 
154(b) were implemented in September 2000 (as discussed previously).
    Section 1.703: The patent term adjustment interim rule amended 
Sec.  1.703(a)(1) to measure the fourteen-month period from the date of 
commencement of the national stage under 35 U.S.C. 371(b) or (f) in an 
international application. With this amendment, Sec.  1.703(a)(1)(i) 
states that the applicable time period is: ``The number of days, if 
any, in the period beginning on the day after the date that is fourteen 
months after the date on which the application was filed under 35 
U.S.C. 111(a) or the date the national stage commenced under 35 U.S.C. 
371(b) or (f) in an international application and ending on the date of 
mailing of either an action under 35 U.S.C. 132, or a notice of 
allowance under 35 U.S.C. 151, whichever occurs first.''
    No change to Sec.  1.703(b) was necessary, as the Office has 
interpreted the phrase ``actual filing date of the application in the 
United States'' in former 35 U.S.C. 154(b)(1)(B) as the date of 
commencement of the national stage under 35 U.S.C. 371 in an 
international application since the patent term adjustment provisions 
of 35 U.S.C. 154(b) were implemented in September 2000 (as discussed 
previously).
    Section 1.704: The patent term adjustment interim rule amends Sec.  
1.704(c) to remove the reference to an application for patent term 
adjustment under Sec.  1.705. With this amendment, Sec.  1.705 no 
longer provides for a request for reconsideration of the patent term 
adjustment indicated in the notice of allowance (as 35 U.S.C. 154(b)(3) 
no longer requires a patent term adjustment with the notice of 
allowance).
    35 U.S.C. 154(b)(3)(C) (implemented in Sec.  1.705(c)) provides for 
reinstatement of all or part of the period of adjustment reduced 
pursuant to 35 U.S.C. 154(b)(2)(C) if the applicant makes a showing 
``prior to the issuance of the patent'' that, in spite of all due care, 
the applicant was unable to respond within the three-month period. 
Section 1.704(e) thus continues to provide that the submission of a 
request under Sec.  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 Sec.  1.704(c)(10).
    Section 1.705: The patent term adjustment interim rule amended 
1.705(a) to provide that the patent will include notification of any 
patent term adjustment under 35 U.S.C. 154(b). This change was due to 
the change to 35 U.S.C. 154(b)(3) to no longer require notice of a 
patent term adjustment with the notice of allowance. The Office plans 
to continue to provide an indication of the patent term adjustment with 
the issue notification, but the patent term adjustment under 35 U.S.C. 
154(b) indicated on the patent is the ``official'' notification of the 
Office's patent term adjustment determination. The Office will 
discontinue providing an indication of the patent term adjustment with 
the notice of allowance under 35 U.S.C. 151.
    The patent term adjustment interim rule amended 1.705(b) to provide 
that the two-month period for requesting reconsideration of the patent 
term adjustment indicated on the patent may be extended by as many as 
five months under the provisions of Sec.  1.136(a). This permits an 
applicant to request reconsideration of the patent term adjustment 
indicated on the patent as late as seven months after the date the 
patent was granted. Section 1.705(b) no longer provides for a request 
for reconsideration of the Office's patent term adjustment 
determination prior to the grant of a patent.
    The patent term adjustment interim rule amended Sec.  1.705(c) to 
provide that any request for reinstatement of all or part of the period 
of adjustment reduced pursuant to Sec.  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 
be filed prior to the issuance of the patent, and that this time period 
is not extendable. 35 U.S.C. 154(b)(3)(C) requires that such a showing 
be made ``prior to the issuance of the patent,'' and thus the Office 
cannot permit the showing provided for in 35 U.S.C. 154(b)(3)(C) and 
Sec.  1.705(c) to be submitted with a request for reconsideration of 
the Office's patent term adjustment determination under Sec.  1.705(b).
    The patent term adjustment interim rule removed the former 
provisions of Sec. Sec.  1.705(d) and (e) in view of the changes to 
Sec.  1.705(b).
    Office Procedure for the Treatment of Requests for Reconsideration 
of Patent Term Adjustment: 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 
Patent Application Locating and Monitoring (PALM) system, except when 
an applicant requests reconsideration pursuant to Sec.  1.705. See 
Changes to Implement Patent Term Adjustment Under Twenty-Year Patent 
Term, 65 FR 56365, 56370, 56380-81 (Sept. 18, 2000) (final rule). The 
PALM system was not originally designed for the purpose of calculating 
patent term adjustment as provided in 35 U.S.C. 154(b). 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 an amount of patent term 
adjustment that is the amount of patent term adjustment requested by 
the applicant, the same amount of patent term adjustment as indicated 
in the patent (i.e., there being no change), or 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 indicating 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

[[Page 27758]]

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. If the Office issues such a redetermination 
of patent term adjustment in response to the request for 
reconsideration of the patent term adjustment, the applicant has two 
months from the date of the redetermination of patent term adjustment 
to file a renewed request for reconsideration of the patent term 
adjustment (no additional fee required) that addresses the issues 
included in the Office's redetermination of patent term adjustment. 
This two-month period is extendable under Sec.  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. 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 
supplying the required information (no additional fee required). This 
two-month period is extendable under Sec.  1.136(a).
    The Office will again conduct a redetermination of patent term 
adjustment in response to any renewed request for reconsideration in 
response to a redetermination of patent term adjustment or in response 
to 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 
indicating 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 issue a decision denying 
the request for reconsideration (unless it is necessary to issue 
another redetermination of patent term adjustment or requirement for 
information) and a certificate of correction if necessary indicating 
the revised patent term adjustment as the result of a redetermination 
of patent term adjustment, and 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).
    Optional Procedure For Seeking a Revised Patent Term Adjustment 
Calculation. As discussed previously, the Office makes patent term 
adjustment determinations by a computer program that uses the 
information recorded in the Office's PALM system, except when an 
applicant requests reconsideration pursuant to Sec.  1.705. See Changes 
to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 
FR 56365, 56370, 56380-81 (Sept. 18, 2000) (final rule). The Office has 
experienced a significant delay in modifying the computer program used 
to calculate patent term adjustment with respect to measuring the 
fourteen-month patent term adjustment period from the date of 
commencement of the national stage under 35 U.S.C. 371 in international 
applications (the change to 35 U.S.C. 154(b)(1)(B) with respect to 
measuring the three-year patent term adjustment period from the date of 
commencement of the national stage under 35 U.S.C. 371 in international 
applications did not require a change to the computer program used to 
calculate patent term adjustment since the Office interpreted the 
phrase ``actual filing date of the application in the United States'' 
in former 35 U.S.C. 154(b)(1)(B) as meaning the date of commencement of 
the national stage under 35 U.S.C. 371 in an international 
application). This software modification was completed in April of 
2014, and patent term adjustment determinations for patents issued on 
or after May 20, 2014, will be consistent with the changes to the 
patent term adjustment provisions in the AIA Technical Corrections Act.
    Due to the significant delay in modifying the computer program the 
Office uses to calculate patent term adjustments with respect to this 
change in the AIA Technical Corrections Act, the Office is providing an 
optional procedure for patentees to request a recalculation of their 
patent term adjustment without a fee as an alternative to the petition 
and fee otherwise required to request reconsideration of a patent term 
adjustment determination. The Office is specifically providing an 
optional procedure under which patentees seeking revised patent term 
adjustment calculations for patents issued between January 14, 2013, 
and May 20, 2014, that resulted directly from international 
applications (i.e., applications that have entered the national stage 
under 35 U.S.C. 371) may request that the Office recalculate the patent 
term adjustment without a request for reconsideration under Sec.  
1.705(b) or a fee. The procedure set forth in this final rule is not 
applicable to patents that resulted from applications under 35 U.S.C. 
111(a), including bypass continuations of international applications or 
continuations of international applications that entered the national 
stage under 35 U.S.C. 371. Any request for recalculation of patent term 
adjustment under the procedure set forth in this final rule must be 
filed no later than July 31, 2014.
    The Office is providing a Request for Recalculation of Patent Term 
Adjustment form (PTO/SB/132) for use in making such a request. The 
Request for Recalculation of Patent Term Adjustment form (PTO/SB/132) 
is available on the Office's Internet Web site at http://www.uspto.gov/forms/index.jsp. As discussed previously, this procedure and Request 
for Recalculation of Patent Term Adjustment form (PTO/SB/132) are 
applicable only for patents issued between January 14, 2013, and May 
20, 2014, that resulted directly from an international application, and 
must be filed no later than July 31, 2014.
    The fee specified in Sec.  1.18(e) and any fee for a petition under 
Sec.  1.136(a) required for a timely request for reconsideration under 
Sec.  1.705 (Sec.  1.705(b)(1)) is not a fee paid by mistake or in 
excess of that required, and the Office may only refund fees paid by 
mistake or in excess of that required (35 U.S.C. 42(d)). Therefore, the 
procedure set forth in this final rule is not a basis for requesting a 
refund of the fee specified in Sec.  1.18(e) or the fee necessary for 
any petition under Sec.  1.136(a) for any request for reconsideration 
under Sec.  1.705, including any previously filed request that was 
solely based on the Office's alleged error

[[Page 27759]]

pertaining to the fourteen-month patent term adjustment period.
    Applicants seeking a revised patent term adjustment in a patent 
issued after May 20, 2014, must file a request for reconsideration 
under Sec.  1.705(b) that complies with the requirements of Sec. Sec.  
1.705(b)(1) and (b)(2) within two months of the date the patent issued.
    To the extent that the procedures adopted under the authority of 35 
U.S.C. 2(b)(2) and 154(b)(3) require that any request for 
reconsideration of the patent term adjustment indicated in the patent 
must be filed within two months of the date the patent issued and 
include the information required by Sec.  1.705(b)(2) and the fee 
required by Sec.  1.18(e), these requirements are hereby sua sponte 
waived for patents that meet all of the following criteria: (1) The 
patent issued between January 14, 2013, and May 20, 2014; (2) the 
patent resulted directly from an international application that has 
entered the national stage under 35 U.S.C. 371; and (3) the Request for 
Recalculation of the Patent Term Adjustment form (PTO/SB/132) is filed 
no later than July 31, 2014. See Sec.  1.183. This waiver does not 
apply to patents issued on or after May 20, 2014, and does not apply to 
requests that the Office recalculate the patent term adjustment for 
alleged errors other than those identified in this final rule.
    A request for recalculation of patent term adjustment under the 
optional procedure to request a recalculation of patent term adjustment 
set forth in this final rule is not a request for reconsideration 
within the meaning of 35 U.S.C. 154(b)(3), and a recalculation of 
patent term adjustment under the optional procedure set forth in this 
final rule is not the Director's decision on an applicant's request for 
reconsideration within the meaning of 35 U.S.C. 154(b)(3) and (b)(4). 
Rather, a recalculation of patent term adjustment under the optional 
procedure set forth in this final rule is simply a new patent term 
adjustment determination under 35 U.S.C. 154(b)(3). Any request for 
reconsideration under 35 U.S.C. 154(b)(3) and Sec.  1.705 of a new 
patent term adjustment determination done under the optional procedure 
set forth in this final rule must comply with the requirements of 
Sec. Sec.  1.705(b)(1) and (b)(2) and be filed no later than two months 
from the date of the new patent term adjustment determination resulting 
from the recalculation of patent term adjustment. This two-month time 
period may be extended under the provisions of Sec.  1.136(a).
    Nothing in this final rule shall be construed as a waiver of the 
requirement of 35 U.S.C. 154(b)(4) that an applicant dissatisfied with 
the Director's decision on the applicant's request for reconsideration 
under 35 U.S.C. 154(b)(3)(B)(ii) shall have exclusive remedy by a civil 
action against the Director filed in the United States District Court 
for the Eastern District of Virginia within 180 days after the date of 
the Director's decision on the applicant's request for reconsideration 
under 35 U.S.C. 154(b)(3)(B)(ii).
    Recent Decision Concerning the Continued Examination Provision of 
35 U.S.C. 154(b)(1)(B)(i): The U.S. Court of Appeals for the Federal 
Circuit (Federal Circuit) recently decided that, with respect to the 
provisions of 35 U.S.C. 154(b)(1)(B)(i), that: (1) Any time consumed by 
continued examination under 35 U.S.C. 132(b) is subtracted in 
determining the extent to which the period defined in 35 U.S.C. 
154(b)(1)(B) exceeds three years, regardless of when the continued 
examination under 35 U.S.C. 132(b) was initiated; but (2) the time 
consumed by continued examination under 35 U.S.C. 132(b) does not 
include the time after a notice of allowance is mailed, unless the 
Office actually resumes examination of the application after allowance. 
See Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir. 2014). This decision in 
Novartis that the time consumed by continued examination under 35 
U.S.C. 132(b) does not include the time after a notice of allowance, 
unless the Office actually resumes examination of the application after 
allowance, would require additional modifications of the patent term 
adjustment program. Such additional modifications of the patent term 
adjustment program were not included in the previously discussed 
modifications to the patent term adjustment program to make patent term 
adjustment determinations consistent with the changes to the patent 
term adjustment provisions in the AIA Technical Corrections Act that 
were recently completed. The Office has been holding requests for 
reconsideration of a patent term adjustment that raise issues 
pertaining to 35 U.S.C. 154(b)(1)(B)(i) pending the Federal Circuit 
decision in Novartis. The Office is now beginning to redetermine the 
patent term adjustment manually for those patentees who have timely 
challenged their patent term adjustment determination.
    The Office has adopted ad hoc procedures for seeking 
reconsideration of the patent term adjustment determination when there 
have been changes to the interpretation of the provisions of 35 U.S.C. 
154(b) as a result of court decisions. See Interim Procedure for 
Patentees To Request a Recalculation of the Patent Term Adjustment To 
Comply With the Federal Circuit Decision in Wyeth v. Kappos Regarding 
the Overlapping Delay Provision of 35 U.S.C. 154(b)(2)(A), 75 FR 5043, 
5044 (Feb. 1, 2010). These ad hoc procedures were adopted because 
former 35 U.S.C. 154(b)(4) provided a time period for seeking judicial 
review that was not related to the filing of a request for 
reconsideration of the Office's patent term adjustment determination or 
the date of the Office's decision on any request for reconsideration of 
the Office's patent term adjustment determination. In view of the 
changes to 35 U.S.C. 154(b)(3) and 154(b)(4), and to permit additional 
time to determine whether to request reconsideration of the Office's 
patent term adjustment determination, the Office has provided in its 
interim and final rules in Sec.  1.705(b) that its two-month time 
period may be extended under the provisions of Sec.  1.136(a) 
(permitting an applicant to request reconsideration of the patent term 
adjustment indicated on the patent as late as seven months after the 
date the patent was granted). See Revisions to Patent Term Adjustment, 
78 FR at 19418. Thus, the Office is not adopting ad hoc procedures for 
requesting a patent term adjustment recalculation specifically directed 
to the Federal Circuit decision in Novartis.
    Comments and Responses to Comments: The Office received three 
written submissions containing comments from individuals in response to 
the patent term adjustment interim rule. The comments and the Office's 
responses to those comments follow:
    Comment 1: Several comments requested clarification of the time 
period for seeking review of a patent term adjustment determination. 
One comment specifically requested clarification as to when a patentee 
may properly request reconsideration of a patent term adjustment 
determination on issues related to the three-month timeframe in 35 
U.S.C. 154(b)(2)(C)(ii), other than a request for reinstatement under 
35 U.S.C. 154(b)(3)(C) of an adjustment reduced under 35 U.S.C. 
154(b)(2)(C) on the basis of a showing of all due care.
    Response: For patents issued on or after January 14, 2013, any 
request for review or reconsideration of a patent term adjustment 
determination (whether or not pertaining to issues related to the 
three-month timeframe in 35 U.S.C. 154(b)(2)(C)(ii)) must be by way of 
an application for patent term adjustment under Sec.  1.705(b) filed no 
later than two months from the date the patent was granted. This two-
month period is

[[Page 27760]]

extendable under the provisions of Sec.  1.136(a).
    35 U.S.C. 154(b)(3)(C) (and thus Sec.  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. 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 Sec.  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 Sec.  1.136(a)).
    Comment 2: One comment questioned whether Sec.  1.7 applies to the 
time period for seeking review of a patent term adjustment 
determination under Sec.  1.705(b).
    Response: The Office treats the provisions of Sec.  1.7 as 
applicable to the time for taking action to an application for patent 
term adjustment filed under Sec.  1.705, since the time period set 
forth in Sec.  1.705 is a time period for taking action in the Office 
within the meaning of 35 U.S.C. 21(b).
    Comment 3: One comment stated that the language in section 1(n) of 
the AIA Technical Corrections Act concerning the effective date of the 
changes in section 1(h) means that a proceeding is commenced when 
patentee files the petition requesting reconsideration of the patent 
term adjustment rather than when the patent issues. The comment argued 
that the term ``proceedings'' refers to civil actions filed under 35 
U.S.C. 154(b)(4)(A) rather than patent term adjustment general 
proceedings and opines that the term ``proceedings'' refers to any 
petition filed on or after the effective date rather than any patent 
granted on or after the effective date.
    Response: As discussed in the patent term adjustment interim rule, 
the Office considers a patent term adjustment ``proceeding'' to be 
commenced when the Office makes a patent term adjustment and 
communicates that determination to the patentee (with the patent). A 
request for review of a patent term adjustment determination under 
Sec.  1.705(b) is not the commencement of a new proceeding, but rather 
an action in a proceeding (the patent term adjustment determination) 
that had already been commenced by a patent term adjustment 
determination and communication of that determination to the patentee. 
In addition, the AIA Technical Corrections Act did not simply change 
the provisions for making and seeking review of patent term adjustment 
determinations, but additionally changed the provisions in 35 U.S.C. 
154(b)(1)(A)(i)(II) and (b)(1)(B) pertaining to the period of patent 
term adjustment itself. It would be an anomalous situation for the 
changes to 35 U.S.C. 154(b)(1)(A)(i)(II) and (b)(1)(B) in the AIA 
Technical Corrections Act to be effective for a patent depending upon 
when and whether the patentee filed a request for review of a patent 
term adjustment determination under Sec.  1.705(b), as under the 
commenter's interpretation that the patent term adjustment itself could 
change simply by operation of a patentee seeking review or 
reconsideration of the Office's patent term adjustment determination.

Rulemaking Considerations

    A. Administrative Procedure Act (5 U.S.C. 553): This rulemaking 
relates to the rules of practice in patent cases to implement the 
changes to the patent term adjustment provisions of 35 U.S.C. 154(b) in 
the AIA Technical Corrections Act. This final rule simply adopts as 
final the revision of 37 CFR 1.702 and 1.703 originally set forth in 
the patent term adjustment interim rule for consistency with the 
changes to 35 U.S.C. 154(b)(1), and the revision of 37 CFR 1.704 and 
1.705 also originally set forth in the patent term adjustment interim 
rule to extend the time period for seeking reconsideration of a patent 
term adjustment determination in light of the changes to 35 U.S.C. 
154(b)(3). This final rule does not alter the substantive criteria of 
patentability or patent term adjustment. Therefore, these provisions 
involve rules of agency practice and procedure and/or interpretive 
rules. See Bachow Commc'ns Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 
2001) (rules governing an application process are procedural under the 
Administrative Procedure Act); Inova Alexandria Hosp. v. Shalala, 244 
F.3d 342, 350 (4th Cir. 2001) (rules for handling appeals were 
procedural where they did not change the substantive standard for 
reviewing claims); National Whistleblower Ctr. v. Nuclear Regulatory 
Comm'n, 208 F.3d 256, 262 (D.C. Cir. 2000) (rules that prescribe a 
timetable for asserting rights are procedural, unless they foreclose an 
effective opportunity to make one's case on the merits) (quoting 
Lamoille Valley R.R. Co. v. ICC, 711 F.2d 295, 328 (D.C. Cir. 1983)); 
and Nat'l Org. of Veterans' Advocates v. Sec'y of Veterans Affairs, 260 
F.3d 1365, 1375 (Fed. Cir. 2001) (rule that clarifies interpretation of 
a statute is interpretive).
    B. Regulatory Flexibility Act: For the reasons set forth herein, 
the Deputy General Counsel for General Law of the United States Patent 
and Trademark Office has certified to the Chief Counsel for Advocacy of 
the Small Business Administration that changes in this rulemaking will 
not have a significant economic impact on a substantial number of small 
entities. See 5 U.S.C. 605(b).
    This final rule adopts as final the: (1) Revision of the date from 
which the fourteen-month period in 35 U.S.C. 154(b)(1)(A)(i) is 
measured in an international application for consistency with the 
change to 35 U.S.C. 154(b)(1)(A)(i)(II); and (2) extension of the time 
period for seeking reconsideration of the Office's patent term 
adjustment in view of the changes in 35 U.S.C. 154(b)(3) and (b)(4). 
These changes mirror the provisions in the AIA Technical Corrections 
Act and do not add any additional requirements (including information 
collection requirements) or fees for patent applicants or patentees. 
For these reasons, the changes in this rulemaking will not have a 
significant economic impact on a substantial number of small entities.
    C. Executive Order 12866 (Regulatory Planning and Review): This 
rulemaking has been determined to be not significant for purposes of 
Executive Order 12866 (Sept. 30, 1993).
    D. Executive Order 13563 (Improving Regulation and Regulatory 
Review): The Office has complied with Executive Order 13563. 
Specifically, the Office has, to the extent feasible and applicable: 
(1) Made a reasoned determination that the benefits justify the costs 
of the rule; (2) tailored the rule to impose the least burden on 
society consistent with obtaining the regulatory objectives; (3) 
selected a regulatory approach that maximizes net benefits;

[[Page 27761]]

(4) specified performance objectives; (5) identified and assessed 
available alternatives; (6) involved the public in an open exchange of 
information and perspectives among experts in relevant disciplines, 
affected stakeholders in the private sector and the public as a whole, 
and provided on-line access to the rulemaking docket; (7) attempted to 
promote coordination, simplification, and harmonization across 
government agencies and identified goals designed to promote 
innovation; (8) considered approaches that reduce burdens and maintain 
flexibility and freedom of choice for the public; and (9) ensured the 
objectivity of scientific and technological information and processes.
    E. Executive Order 13132 (Federalism): This rulemaking does not 
contain policies with federalism implications sufficient to warrant 
preparation of a Federalism Assessment under Executive Order 13132 
(Aug. 4, 1999).
    F. Executive Order 13175 (Tribal Consultation): This rulemaking 
will not: (1) Have substantial direct effects on one or more Indian 
tribes; (2) impose substantial direct compliance costs on Indian tribal 
governments; or (3) preempt tribal law. Therefore, a tribal summary 
impact statement is not required under Executive Order 13175 (Nov. 6, 
2000).
    G. Executive Order 13211 (Energy Effects): This rulemaking is not a 
significant energy action under Executive Order 13211 because this 
rulemaking is not likely to have a significant adverse effect on the 
supply, distribution, or use of energy. Therefore, a Statement of 
Energy Effects is not required under Executive Order 13211 (May 18, 
2001).
    H. Executive Order 12988 (Civil Justice Reform): This rulemaking 
meets applicable standards to minimize litigation, eliminate ambiguity, 
and reduce burden as set forth in sections 3(a) and 3(b)(2) of 
Executive Order 12988 (Feb. 5, 1996).
    I. Executive Order 13045 (Protection of Children): This rulemaking 
does not concern an environmental risk to health or safety that may 
disproportionately affect children under Executive Order 13045 (Apr. 
21, 1997).
    J. Executive Order 12630 (Taking of Private Property): This 
rulemaking will not effect a taking of private property or otherwise 
have taking implications under Executive Order 12630 (Mar. 15, 1988).
    K. Congressional Review Act: Under the Congressional Review Act 
provisions of the Small Business Regulatory Enforcement Fairness Act of 
1996 (5 U.S.C. 801 et seq.), the United States Patent and Trademark 
Office will submit a report containing this final rule and other 
required information to the United States Senate, the United States 
House of Representatives, and the Comptroller General of the Government 
Accountability Office. The changes in this rulemaking will not result 
in an annual effect on the economy of 100 million dollars or more, a 
major increase in costs or prices, or significant adverse effects on 
competition, employment, investment, productivity, innovation, or the 
ability of United States-based enterprises to compete with foreign-
based enterprises in domestic and export markets. Therefore, this 
rulemaking is not a ``major rule'' as defined in 5 U.S.C. 804(2).
    L. Unfunded Mandates Reform Act of 1995: The changes set forth in 
this rulemaking do not involve a Federal intergovernmental mandate that 
will result in the expenditure by State, local, and tribal governments, 
in the aggregate, of 100 million dollars (as adjusted) or more in any 
one year, or a Federal private sector mandate that will result in the 
expenditure by the private sector of 100 million dollars (as adjusted) 
or more in any one year, and will not significantly or uniquely affect 
small governments. Therefore, no actions are necessary under the 
provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 
1501 et seq.
    M. National Environmental Policy Act: This rulemaking will not have 
any effect on the quality of the environment and is thus categorically 
excluded from review under the National Environmental Policy Act of 
1969. See 42 U.S.C. 4321 et seq.
    N. National Technology Transfer and Advancement Act: The 
requirements of section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because 
this rulemaking does not contain provisions which involve the use of 
technical standards.
    O. Paperwork Reduction Act: The Paperwork Reduction Act of 1995 (44 
U.S.C. 3501 et seq.) requires that the Office consider the impact of 
paperwork and other information collection burdens imposed on the 
public. The rules of practice pertaining to patent term adjustment and 
extension have been reviewed and approved by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501 et seq.) under OMB control number 0651-0020. The changes in this 
rulemaking: (1) Revise the date from which the fourteen-month period in 
35 U.S.C. 154(b)(1)(A)(i) is measured in an international application 
for consistency with the change to 35 U.S.C. 154(b)(1)(A)(i)(II); and 
(2) revise (extend) the time period for seeking reconsideration of the 
Office's patent term adjustment in view of the changes in 35 U.S.C. 
154(b)(3) and (b)(4). This rulemaking does not add any additional 
requirements (including information collection requirements) or fees 
for patent applicants or patentees. Therefore, the Office is not 
resubmitting information collection packages to OMB for its review and 
approval because the changes in this rulemaking do not affect the 
information collection requirements associated with the information 
collections approved under OMB control number 0651-0020 or any other 
information collections.
    Notwithstanding any other provision of law, no person is required 
to respond to nor shall any person be subject to a penalty for failure 
to comply with a collection of information subject to the requirements 
of the Paperwork Reduction Act unless that collection of information 
displays a currently valid OMB control number.

List of Subjects in 37 CFR Part 1

    Administrative practice and procedure, Courts, Freedom of 
Information, Inventions and patents, Reporting and recordkeeping 
requirements, Small businesses.


0
For the reasons set forth in the preamble, the interim rule amending 37 
CFR part 1 which was published at 78 FR 19416 on April 1, 2013, is 
adopted as a final rule without change.

    Dated: May 9, 2014.
Michelle K. Lee,
Deputy Under Secretary of Commerce for Intellectual Property and Deputy 
Director of the United States Patent and Trademark Office.
[FR Doc. 2014-11131 Filed 5-14-14; 8:45 am]
BILLING CODE 3510-16-P