| Allowance, Patent Term Adjustment or Extension |
Referenced Items (255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 265, 266, 267, 268) |
(256) 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.
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.
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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.
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Section 1(h)(1)(A) of the AIA Technical Corrections Act amended 35
U.S.C. 154(b)(1)(A)(i)(II) to change "thedate 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
§ 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
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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
§§ 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 §§ 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
§ 1.702(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, § 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
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35 U.S.C. 371(b) or (f) in an international application."
The patent term adjustment interim rule amended § 1.702(b) to
change the paragraph heading to "Three-year pendency." No further
change to § 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
§ 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, § 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 § 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
§ 1.704(c) to remove the reference to an application for patent term
adjustment under § 1.705. With this amendment, § 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 § 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 § 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 § 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 § 1.136(a). This permits an
applicant to request reconsideration of the patent term adjustment
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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 § 1.705(c) to
provide that 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 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
§ 1.705(c) to be submitted with a request for reconsideration of
the Office's patent term adjustment determination under § 1.705(b).
The patent term adjustment interim rule removed the former
provisions of §§ 1.705(d) and (e) in view of the changes to § 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 § 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
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
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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 § 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 § 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 § 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
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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 § 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 § 1.18(e) and any fee for a petition under
§ 1.136(a) required for a timely request for reconsideration under
§ 1.705 (§ 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 § 1.18(e) or the fee necessary for
any petition under § 1.136(a) for any request for reconsideration
under § 1.705, including any previously filed request that was solely
based on the Office's alleged errorpertaining 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 § 1.705(b) that complies with the requirements of §§ 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 § 1.705(b)(2) and the fee
required by § 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 § 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
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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 § 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
§§ 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 § 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
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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 § 1.705(b) that its two-month time
period may be extended under the provisions of § 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 § 1.705(b) filed no
later than two months from the date the patent was granted. This two-
month period isextendable under the provisions of § 1.136(a).
35 U.S.C. 154(b)(3)(C) (and thus § 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 § 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 § 1.136(a)).
Comment 2: One comment questioned whether § 1.7 applies to the
time period for seeking review of a patent term adjustment determination
under § 1.705(b).
Response: The Office treats the provisions of § 1.7 as applicable to
the time for taking action to an application for patent term adjustment
filed under § 1.705, since the time period set forth in § 1.705 is a time
period for taking action in the Office within the meaning of 35
U.S.C. 21(b).
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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
§ 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 § 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
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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;(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).
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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.
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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.
. 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.
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
[1403 OG 124]