| Allowance, Patent Term Adjustment or Extension |
Referenced Items (292, 293, 294, 295, 296, 297, 298, 299, 300, 301, 302, 303, 304, 305, 306, 307, 308) |
(305) DEPARTMENT OF COMMERCE
Patent and Trademark Office
37 CFR Part 1
[Docket No.: 2003-P-029]
RIN 0651-AB71
Revision of Patent Term Extension and
Patent Term Adjustment Provisions
AGENCY: Patent and Trademark Office, Commerce.
ACTION: Final rule.
SUMMARY: The patent term extension provisions of the Uruguay Round
Agreements Act (URAA) and the patent term adjustment provisions of the
American Inventors Protection Act of 1999 (AIPA) each provide for the
possibility of patent term extension or adjustment if the issuance of
the patent was delayed due to review by the Board of Patent Appeals and
Interferences (BPAI) or by a Federal court and the patent was issued
pursuant to or under a decision in the review reversing an adverse
determination of patentability. The United States Patent and Trademark
Office (Office) is revising the rules of practice in patent cases to
indicate that under certain circumstances a panel remand by the BPAI
shall be considered a decision in the review reversing an adverse
determination of patentability for purposes of patent term extension or
patent term adjustment. The Office is also adopting other miscellaneous
changes to the patent term adjustment provisions of the rules of
practice.
DATES: Effective Date: May 24, 2004.
Any request for reconsideration of the patent term extension or
adjustment indicated on a patent resulting from an application in which
the notice of allowance was mailed before May 24, 2004 on the basis of
the changes to 37 CFR 1.701 or 1.702 in this final rule must be filed no
later than July 21, 2004.
FOR FURTHER INFORMATION CONTACT: Kery A. Fries, Legal Advisor, Office
of Patent Legal Administration, by telephone at (703) 305-1383, by mail
addressed to: Box Comments-Patents, Commissioner for Patents, P.O. Box
1450, Alexandria, VA 22313-1450, or by facsimile to (703) 746-3240,
marked to the attention of Kery A. Fries.
SUPPLEMENTARY INFORMATION: Section 532(a) of the URAA (Pub. L. 103-465,
108 Stat. 4809 (1994)) amended 35 U.S.C. 154 to provide that the term
of a patent ends on the date that is twenty years from the filing date
of the application, or the earliest filing date for which a benefit is
claimed under 35 U.S.C. 120, 121, or 365(c). Public Law 103-465 also
contained provisions, codified at 35 U.S.C. 154(b), for patent term
extension due to certain examination delays. The Office implemented the
patent term extension provisions of the URAA in a final rule published
in April of 1995. See Changes to Implement 20-Year Patent Term and
Provisional Applications, 60 FR 20195 (Apr. 25, 1995), 1174 Off. Gaz.
Pat. Office 15 (May 2, 1995) (final rule).
The AIPA (Pub. L. 106-113, 113 Stat. 1501, 1501A-552 through
1501A-591 (1999)) further amended 35 U.S.C. 154(b) to include additional
bases for patent term extension (characterized as "patent term
adjustment" in the AIPA). Original utility and plant patents issuing
from applications filed on or after May 29, 2000, may be eligible for
patent term adjustment if issuance of the patent is delayed due to one
or more of the enumerated administrative delays listed in 35 U.S.C.
154(b)(1). The Office implemented the patent term adjustment provisions
of the AIPA in a final rule published in September of 2000. See Changes
to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65
FR 56365 (Sept. 18, 2000), 1239 Off. Gaz. Pat. Office 14 (Oct. 3, 2000)
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(final rule). The patent term adjustment provisions of the AIPA apply
to original (i.e., non-reissue) utility and plant applications filed on
or after May 29, 2000. See Changes to Implement Patent Term Adjustment
Under Twenty-Year Patent Term, 65 FR at 56367, 1239 Off. Gaz. Pat.
Office at 14-15. The patent term extension provisions of the URAA (for
delays due to secrecy order, interference or successful appellate
review) continue to apply to original utility and plant applications
filed on or after June 8, 1995, and before May 29, 2000. See id.
The Office is amending the rules of practice in patent cases to
indicate that certain remands by the BPAI shall be considered "a
decision in the review reversing an adverse determination of
patentability" for patent term adjustment and patent term extension
purposes. Specifically, if an application is remanded by a panel of the
BPAI and the remand is the last action by a BPAI panel prior to the
mailing of a notice of allowance under 35 U.S.C. 151 in the
application, the remand shall be considered a decision reversing an
adverse determination of patentability for patent term adjustment and
patent term extension purposes. However, a panel remand shall not be
considered a decision in the review reversing an adverse determination
of patentability if there is filed a request for continued examination
under 35 U.S.C. 132(b) (Sec. 1.114) that was not first preceded by the
mailing, after such remand, of at least one of an action under 35
U.S.C. 132 or a notice of allowance under 35 U.S.C. 151.
The term "panel" of the BPAI means a panel comprised of members
of the BPAI as defined in 35 U.S.C. 6(a). The phrase "remanded by a
panel" of the BPAI does not pertain to a remand or order returning an
appeal to the examiner issued by a BPAI administrator. See e.g.,
Revised Docketing Procedures for Appeals Arriving at the Board of
Patent Appeals and Interferences, 1260 Off. Gaz. Pat. Office 18 (July
2, 2002). The phrase "remanded by a panel" of the BPAI also does not
pertain to a remand or order returning an appeal to the examiner that
is issued by a BPAI administrator subsequent to the issuance of a
docketing notice.
The Office initially took the position that a remand by a BPAI
panel was not a "decision" within the meaning of 35 U.S.C.
154(b)(1)(A)(iii), much less "a decision reversing an adverse
determination of patentability" as that phrase is used in 35 U.S.C.
154(b)(1)(C)(iii). See Changes to Implement Patent Term Adjustment
Under Twenty-Year Patent Term, 65 FR at 56369, 1239 Off. Gaz. Pat.
Office at 16. The Office has subsequently determined that there are a
number of BPAI panel remands that convey the weakness in the examiner's
adverse patentability determination in a manner tantamount to a
decision reversing the adverse patentability determination. Such a BPAI
panel remand generally results in the examiner allowing the application
(either with or without further action by applicant) without returning
the application with a response to the issues raised in the remand to
the BPAI for a decision on the appeal. The changes in this final rule
address the situation in which an examiner responds to a remand by a
BPAI panel by allowing the application (either with or without further
action by applicant), rather than returning the application with a
response to the issues raised in the remand to the BPAI for a decision
on the appeal. In this situation, the BPAI panel remand shall be
considered "a decision in the review reversing an adverse
determination of patentability" for patent term extension and patent
term adjustment purposes. The changes in this final rule, however, will
not apply if, after the BPAI panel remand, there is filed a request for
continued examination under 35 U.S.C. 132(b) (Sec. 1.114) that was not
first preceded by the mailing, after such remand, of at least one of an
action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C.
151.
If the patent issues after a remand that is considered "a decision
in the review reversing an adverse determination of patentability,"
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the BPAI panel remand is deemed by the Office to be the "final
decision in favor of the applicant" for purposes of a patent term
extension or adjustment calculation under Sec. 1.701(c)(3) or Sec.
1.703(e) (as applicable). The period of extension or adjustment
calculated under Sec. 1.701(c)(3) or Sec. 1.703(e) (as applicable)
would equal the number of days in the period beginning on the date on
which a notice of appeal to the BPAI was filed under 35 U.S.C. 134 and
Sec. 1.191 and ending on the mailing date of the BPAI panel remand.
The Office also proposed changes to Secs. 1.704 and 1.705 in a
rule making to implement portions of the Office's 21st Century
Strategic Plan. See Changes to Support Implementation of the United
States Patent and Trademark Office 21st Century Strategic Plan, 68 FR
53816, 53843, 53857-58 (Sept. 12, 2003), 1275 Off. Gaz. Pat. Office 23,
45-46, 60 (Oct. 7, 2003) (proposed rule) (hereinafter "21st Century
Strategic Plan notice of proposed rule making"). The Office is
adopting changes to Secs. 1.704 and 1.705 proposed in the 21st
Century Strategic Plan notice of proposed rule making in this final
rule so that all changes to the patent term adjustment provisions of
the rule of practice currently under consideration will be adopted in
the same final rule.
Discussion of Specific Rules
Section 1.701: Section 1.701(a)(3) is amended by adding the
following sentence: If an application is remanded by a panel of the
Board of Patent Appeals and Interferences and the remand is the last
action by a panel of the Board of Patent Appeals and
Interferences prior to the mailing of a notice of allowance under 35
U.S.C. 151 in the application, the remand shall be considered a
decision in the review reversing an adverse determination of
patentability as that phrase is used in 35 U.S.C. 154(b)(2) as amended
by section 532(a) of the Uruguay Round Agreements Act, Public Law 103-
465, 108 Stat. 4809, 4983-85 (1994), and a final decision in favor of
the applicant under Sec. 1.701(c)(3). Section 1.701(a)(3) is also
amended to provide that a panel remand shall not be considered a
decision in the review reversing an adverse determination of
patentability as provided in Sec. 1.701(a)(3) if there is filed a
request for continued examination under 35 U.S.C. 132(b) (Sec. 1.114)
that was not first preceded by the mailing, after such remand, of at
least one of an action under 35 U.S.C. 132 or a notice of allowance
under 35 U.S.C. 151. Section 1.701(a)(3) is also amended to change
"decision reversing an adverse determination of patentability" to
"decision in the review reversing an adverse determination of
patentability" for consistency with 35 U.S.C. 154(b)(2) as amended by
section 532(a) of the URAA.
Section 1.702: Section 1.702(e) is amended by adding the following
sentence: If an application is remanded by a panel of the Board of
Patent Appeals and Interferences and the remand is the last action by a
panel of the Board of Patent Appeals and Interferences prior to the
mailing of a notice of allowance under 35 U.S.C. 151 in the
application, the remand shall be considered a decision by the Board of
Patent Appeals and Interferences as that phrase is used in 35 U.S.C.
154(b)(1)(A)(iii), a decision in the review reversing an adverse
determination of patentability as that phrase is used in 35 U.S.C.
154(b)(1)(C)(iii), and a final decision in favor of the applicant under
Sec. 1.703(e). Section 1.702(e) is also amended to provide that a
panel remand shall not be considered a decision in the review reversing
an adverse determination of patentability as provided in Sec. 1.702(e)
if there is filed a request for continued examination under 35 U.S.C.
132(b) (Sec. 1.114) that was not first preceded by the mailing, after
such remand, of at least one of an action under 35 U.S.C. 132 or a
notice of allowance under 35 U.S.C. 151. Section 1.702(e) is also
amended to change "decision reversing an adverse determination of
patentability" to "decision in the review reversing an adverse
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determination of patentability" for consistency with 35 U.S.C.
154(b)(1)(C)(iii).
Section 1.703: Section 1.703(f) is amended to change "[t]o the
extent that periods of adjustment attributable to the grounds specified
in Sec. 1.702 overlap" to "[t]o the extent that periods of delay
attributable to the grounds specified in Sec. 1.702 overlap" for
consistency with 35 U.S.C. 154(b)(2)(A). The language of former Sec.
1.703(f) misled applicants into believing that delays under 35 U.S.C.
154(b)(1)(A) (Secs. 1.702(a) and 1.703(a)) and delays under 35
U.S.C. 154(b)(1)(B) (Secs. 1.702(b) and 1.703(b)) were overlapping
only if the period of delay under 35 U.S.C. 154(b)(1)(A) occurred more
than three years after the actual filing date of the application. If an
application is entitled to an adjustment under 35 U.S.C. 154(b)(1)(B),
the entire period during which the application was pending before the
Office (except for periods excluded under 35 U.S.C. 154(b)(1)(B)(i)-
(iii)), and not just the period beginning three years after the actual
filing date of the application, is the period of delay under 35 U.S.C.
154(b)(1)(B) in determining whether periods of delay overlap under 35
U.S.C. 154(b)(2)(A).
Section 1.704: Section 1.704(d) is amended to change "cited in a
communication" to "first cited in any communication" in order to
clarify that the item must have been first cited in any communication
from a foreign patent office in a counterpart application instead of
merely being cited in such a communication. An applicant who fails to
cite an item, within thirty days of receipt by an individual designated
in Sec. 1.56(c) of a first communication from a foreign patent office
in a counterpart application citing the item, and instead files an
information disclosure statement, within thirty days of a subsequent
communication citing the item, cannot be considered to have acted with
reasonable efforts to conclude prosecution of the application. The
change to require that this thirty-day time period run from a first
communication parallels the corresponding language in Sec. 1.97(e)(1).
The provisions of Sec. 1.704(d) do not apply if the applicant does not
submit the information disclosure statement within thirty days of a
first communication including a citation of an item to a party
designated in Sec. 1.56(c). In such situations, the submission of an
information disclosure statement may be considered a failure to engage
in reasonable efforts to conclude prosecution (processing or
examination) of the application under Sec. 1.704(c)(6), (c)(8),
(c)(9), or (c)(10).
Section 1.705: Section 1.705(d) is amended to provide that a
patentee may request reconsideration of the patent term adjustment
within two months of the date the patent issued if the patent indicates
a revised patent term adjustment relative to the patent term adjustment
indicated on the notice of allowance. The Office currently includes the
patent term adjustment information that will be printed on the face of
the patent on the Issue Notification. See Changes to Implement Patent
Term Adjustment Under Twenty-Year Patent Term, 65 FR at 56388, 1239
Off. Gaz. Pat. Office at 33 (response to comment 49). The Office plans
to discontinue the practice of including patent term adjustment
information on the Issue Notification, but is changing the period for
filing a request for reconsideration under Sec. 1.705(d) of the patent
term adjustment indicated in the patent from thirty days to two months.
This two-month period in Sec. 1.705(d) is non-extendable. See Sec.
1.705(e).
The Patent Application Locating and Monitoring (PALM) system
maintains computerized contents records of all patent applications and
reexaminations. The Patent Application Information and Retrieval (PAIR)
system provides public access to PALM for patents and applications that
have been published (i.e., applications no longer being maintained in
confidence), which can be accessed over the Internet at <http://frwebgate.
access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=
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http://pair.uspto.gov> The PAIR system also has a private side
(<http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.
html&log=linklog&to=http://pair->.direct.uspto.gov) which may be used by
an applicant to access confidential information about his or her pending
application. See Clarification of 37 CFR 1.704(c)(10)-Reduction of Patent
Term Adjustment for Certain Types of Papers Filed After a Notice of
Allowance has been Mailed, 1247 Off. Gaz. Pat. Office 111, 112 (June
26, 2001). While the Office plans to discontinue the practice of
including patent term adjustment information on the Issue Notification,
applicants can check PAIR to see the Office's current patent term
adjustment determination upon receipt of the Issue Notification to
ascertain whether the patent term adjustment determination has been
revised since the mailing of the notice of allowance.
Section 1.705(d) is also amended to permit a patentee to file the
request for reconsideration if the patent indicates or should have
indicated a revised patent term adjustment of a revision to patent term
adjustment indicated in the notice of allowance. Section 1.705(d)
formerly provided that a request for reconsideration under Sec.
1.705(d) was limited to the situation where the patent issues on a date
other than the projected date of issue. There are a number of papers
which if submitted by an applicant after the mailing of the notice of
allowance will result in a reduction of any patent term adjustment,
such as: (1) Request for refunds; (2) status letter; (3) amendments under
Sec. 1.312; (4) late priority claims; (5) a certified copy of a priority
document; (6) drawings; (7) letters related to biological deposits; and
(8) oaths or declarations. See Sec. 1.704(c)(10). In addition, receipt of
the payment of the issue fee more than three months after mailing of the
notice of allowance will also result in a reduction of any patent term
adjustment. See Sec. 1.704(b) and Sec. 1.703(f) ("[t]he date
indicated on any certificate of mailing or transmission under Sec. 1.8
shall not be taken into account in this calculation"). There are also
Office delays that may occur after the mailing of the notice of
allowance which may result in an increase in the amount of patent term
adjustment, such as the failure to issue the patent within four months
after the date the issue fee was paid under 35 U.S.C. 151 and all
outstanding requirements were satisfied, or the failure to issue the
patent within three years after the date on which an application was
filed under 35 U.S.C. 111(a). See Sec. 1.702(a)(4) and Sec. 1.702(b).
Section 1.705(d) is also amended to provide that any request for
reconsideration under Sec. 1.705(d) that raises issues that were
raised, or could have been raised, in an application for patent term
adjustment under Sec. 1.704(b) shall be dismissed as untimely as to
those issues. The purpose of Sec. 1.705(d) is to provide patentees
with an avenue to obtain reconsideration of the patent term adjustment
indicated in the patent when the patent term adjustment indicated in
the patent differs or should have differed from the patent term
adjustment indicated in the notice of allowance due to events occurring
after the mailing of the notice of allowance. Section 1.705(d) is not
an avenue for patentees to seek review of issues that were raised, or
could have been raised, in an application for patent term adjustment
under Sec. 1.704(b). Any request for reconsideration of the patent
term adjustment indicated in the patent on the basis of issues that
were raised, or could have been raised, in an application for patent
term adjustment under Sec. 1.704(b) is considered untimely if not
filed within the period specified in Sec. 1.705(b).
Requests for reconsideration of patent term adjustment
determinations indicated in notice of allowances and patents under 35
U.S.C. 154(b) and Secs. 1.702 through 1.704 are provided for in
Sec. 1.705. Petitions under Sec. 1.182 or 1.183, or requests for a
certificate of correction under either 35 U.S.C. 254 and Sec. 1.323 or
35 U.S.C. 255 and Sec. 1.324, are not substitute fora to obtain
reconsideration of a patent term adjustment determination indicated in
a notice of allowance if an applicant fails to submit a request for
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reconsideration within the time period specified in Sec. 1.705(b), or
to obtain reconsideration of a patent term adjustment determination
indicated in a patent if a patentee fails to submit a request for
reconsideration within the time period specified in Sec. 1.705(d).
Response to comments: The Office published a notice proposing
changes to the rules of practice to provide that under certain
circumstances a panel remand by the BPAI shall be considered a decision
in the review reversing an adverse determination of patentability for
purposes of patent term extension or patent term adjustment. See
Revision of Patent Term Extension and Patent Term Adjustment Provisions
Related to Decisions by the Board of Patent Appeals and Interferences
68 FR 67818 (Dec. 4, 2003), 1277 Off. Gaz. Pat. Office 227 (Dec. 30,
2003) (proposed rule). The Office received seven written comments (from
an intellectual property organization, a law firm, a business, and
patent practitioners) in response to this notice of proposed rule
making. The Office also received five written comments concerning
Secs. 1.704 and 1.705 in response to the 21st Century Strategic
Plan notice of proposed rule making. Comments generally in support of a
change are not discussed. The comments and the Office's responses to
those comments follow:
Comment 1: One comment questioned whether the Office has the
authority to interpret a remand from the BPAI as a decision by the BPAI
reversing an adverse determination of patentability. The comment
suggested that the Office should amend the rules of practice to permit
the BPAI to designate a remand as a decision by the BPAI reversing an
adverse determination of patentability.
Response: 35 U.S.C. 2(b)(2) provides that the Office may establish
regulations, not inconsistent with law, which shall govern the conduct
of proceedings in the Office, 35 U.S.C. 3(a)(2)(A) provides that the
Director is responsible for providing policy direction and management
supervision for the Office, and 35 U.S.C. 154(b)(3)(A) provides that
the Director shall prescribe regulations establishing procedures for
the application for and determination of patent term adjustments under
35 U.S.C. 154(b). Therefore, the Office has sufficient rule making
authority to promulgate regulations to avoid situations in which an
applicant is deprived of patent term extension or adjustment because a
BPAI panel designates a decision as a remand rather than as a reversal
coupled with a remand.
Comment 2: One comment suggested that the Office should amend the
rules of practice to permit the BPAI to designate a remand as a
decision by the BPAI reversing an adverse determination of
patentability.
Response: It is unnecessary to amend the rules of practice to
provide that a BPAI panel may designate a remand as a decision by the
BPAI reversing an adverse determination of patentability. First, a BPAI
panel may do so in essence by designating the decision as a reversal
coupled with a remand. Second, a BPAI panel remand will be considered a
"decision in the review reversing an adverse determination of
patentability" under Sec. 1.701(a)(3) or Sec. 1.702(e) as amended in
this final rule if the remand is the last action by a panel of the
Board of Patent Appeals and Interferences prior to the mailing of a
notice of allowance under 35 U.S.C. 151 in the application (except if
there is filed a request for continued examination under 35 U.S.C.
132(b) (Sec. 1.114) that was not first preceded by the mailing, after
such remand, of at least one of an action under 35 U.S.C. 132 or a
notice of allowance under 35 U.S.C. 151.).
Comment 3: One comment suggested that the Office should treat a
remand by a BPAI administrator the same as a remand by a BPAI panel in
determining whether the remand is considered a decision in the review
reversing an adverse determination of patentability for patent term
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extension and adjustment purposes.
Response: The Office cannot treat a remand or other order by an
administrator as a "decision in the review reversing an adverse
determination of patentability" for patent term extension or
adjustment purposes because an administrator is not a member of the
BPAI as defined in 35 U.S.C. 6(a) and because 35 U.S.C. 6(b) requires
that appeals be heard by at least three members of the BPAI. While the
Office has proposed to define BPAI as including a BPAI member or
employee acting with the authority of the BPAI for certain purposes
(proposed Sec. 41.2(2)), the Office has cautioned that this definition
of "BPAI" is not applicable in a situation in which action by a BPAI
panel is required by statute, and has also proposed to define BPAI
member as a member of the BPAI as set forth in 35 U.S.C. 6(a) (proposed
Sec. 41.2(3)). See Rules of Practice Before the Board of Patent
Appeals and Interferences, 68 FR 66647, 66649 (Nov. 26, 2003), 1277
Off. Gaz. Pat. Office 157, 159 (Dec. 23, 2003) (proposed rule).
Comment 4: Several comments suggested that the filing of an
information disclosure statement or certain amendments should not
preclude a remand from being considered a decision in the review
reversing an adverse determination of patentability for patent term
extension or adjustment purposes. The comments provided the following
examples of amendments that should not preclude a remand from being
considered a decision in the review reversing an adverse determination
of patentability for patent term extension or adjustment purposes: (1)
Amendments which only correct formal matters (e.g., update the address
of a depository such as the American Type Culture Collection (ATCC);
(2) amendments which improve the clarity of the claims; (3) amendments
which rejoin claims that were withdrawn pending the allowance of a
product claim; (4) amendments which only define the claims over newly
cited prior art; (5) an examiner's amendment or examiner requested
amendment; (6) amendments that do not address the merits of the claims;
(7) amendments that change the title or abstracts to correspond to all
of the allowed claims; (8) inconsistencies between reference characters
used in the specification and those used in the drawings; (9)
inconsistent case use of pronouns; (10) resubmission of documents that
were lost by the Office; (11) amendments which incorporate limitations
from a dependent claim into an independent claim; and (12) any
amendment so long as at least one previously rejected claim is allowed
in unamended form. One comment suggested that if an information
disclosure statement contains a certification under Sec. 1.704(d), the
information disclosure statement should not preclude a remand from
being considered a decision in the review reversing an adverse
determination of patentability for patent term extension or adjustment
purposes. One comment suggested that a remand should be treated as a
decision by the BPAI reversing an adverse determination of
patentability any time the examiner sua sponte withdraws all of the
rejections against any one claim. Finally, one comment suggested that
if the Office drops any issue raised upon appeal after the remand, the
examiner's dropping of an issue raised upon appeal should be considered
a decision in the review reversing an adverse determination of
patentability.
Response: The suggestions are adopted in part as follows. If an
application is remanded by a panel of the BPAI and the remand is the
last action of a BPAI panel prior to the mailing of a notice of
allowance under 35 U.S.C. 151 in the application, the Office will
consider that remand to be a decision in the review reversing an
adverse determination of patentability. Therefore, if the examiner
allows the application (patent term extension or adjustment is not
relevant if the application is not ultimately allowed) without
returning the application to the BPAI for decision (and thus the BPAI
panel remand is the last action by a BPAI panel in the application),
the Office will consider that remand to be a decision in the review
reversing an adverse determination of patentability. A panel remand,
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however, shall not be considered a decision in the review reversing an
adverse determination of patentability if there is filed a request for
continued examination under 35 U.S.C. 132(b) (Sec. 1.114) that was not
first preceded by the mailing, after such remand, of at least one of an
action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C.
151.
Comment 5: One comment also suggested that the Office should permit
applicant to petition under Sec. 1.705 for a case-by-case
determination of whether the BPAI remand should be considered a
decision in the review reversing an adverse determination of
patentability for patent term extension or adjustment purposes.
Response: The statutory scheme of 35 U.S.C. 154(b) provides that
patent term adjustment and reductions to patent term adjustment are
determined by objective criteria rather than on the basis of ad hoc
determinations. That is, 35 U.S.C. 154(b)(1) specifies certain
objective conditions under which (subject to certain conditions and
limitations) an applicant is entitled to patent term adjustment, and 35
U.S.C. 154(b)(2)(C) requires the Office to specify (by regulations) the
conditions under which there will be a reduction of patent term
adjustment under 35 U.S.C. 154(b)(1). Thus, it is more in line with the
statutory scheme set forth in 35 U.S.C. 154(b) for the Office to
specify objective criteria under which a BPAI panel remand will be
considered a decision in the review reversing an adverse determination
of patentability for patent term extension or adjustment purposes, than
it would be to leave this to case-by-case determinations.
In addition, as discussed in the final rule to implement the patent
term adjustment provisions of the AIPA: "the Office must make its
patent term adjustment determinations by a computer program that uses
the information recorded in the Office's automated patent application
information system (the Patent Application Location and Monitoring
system or PALM system). Thus, the Office must determine whether the
Board of Patent Appeals and Interferences (or court) decision was of a
nature such that `the patent was issued under a decision in the review
reversing an adverse determination of patentability' under 35 U.S.C.
154(b)(1)(C)(iii) from information concerning the decision susceptible
of being recorded in the PALM system (rather than by a case-by-case
review of each decision)." See Changes To Implement Patent Term
Adjustment Under Twenty-Year Patent Term, 65 FR at 56370, 1239 Off.
Gaz. Pat. Office at 17 (quoting 35 U.S.C. 154(b)(1)(C)(iii)).
Comment 6: One comment suggests that the rule be automatically
retroactively applied or alternately set up a petition procedure where
patentees would be allowed to petition for recalculation of the patent
term extension or adjustment determination based upon the amended rule.
Response: The Office cannot "automatically" apply revised
Secs. 1.701(a)(3) and 1.702(e) retroactively in applications in
which the notice of allowance was mailed before May 24, 2004. However,
a patentee who believes that the patent term extension or adjustment
indicated on his or her patent would have been calculated differently
under Sec. 1.701(a)(3) or Sec. 1.702(e) as amended in this final rule
may file a request for reconsideration of the patent term extension or
adjustment indicated on the patent. Any such request for
reconsideration must be filed no later than July 21, 2004.
For applications in which the notice of allowance is mailed on or
after May 24, 2004, any applicant who believes that the URAA patent
term extension (Sec. 1.701) or AIPA patent term adjustment (Secs.
1.702 through 1.705) indicated in the notice of allowance was not
calculated correctly in view of the changes to Sec. 1.701(a)(3) or
Sec. 1.702(e) in this final rule must file a timely petition under
Sec. 1.181 or timely request for reconsideration under Sec. 1.705(b)
(respectively) to have the patent term extension or adjustment
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determination corrected. Any applicant who believes that the URAA
patent term extension (Sec. 1.701) or AIPA patent term adjustment
(Secs. 1.702 through 1.705) indicated in the notice of allowance
was not calculated correctly on any basis other than the changes to
Sec. 1.701(a)(3) or Sec. 1.702(e) in this final rule must file a
timely petition under Sec. 1.181 or timely request for reconsideration
under Sec. 1.705(b) (respectively) to have the patent term extension
or adjustment determination corrected.
Comment 7: One comment suggests that the period of adjustment for
administrative delay should end on the date of the mailing of the
notice of allowance, not on the mailing date of the remand.
Response: The suggestion is not adopted. If an application is
allowed after a panel remand by the BPAI, the period of appellate
review ended with the decision (remand) by the BPAI.
Comment 8: Several comments indicated that events such as the
filing of a request for refund or the filing of a status letter are
caused by an Office error or delay, and should not result in a
reduction of patent term adjustment under Sec. 1.704(c)(10).
Response: The patent term adjustment provisions of 35 U.S.C. 154(b)
provide that "[t]he Director shall prescribe regulations establishing
the circumstances that constitute a failure of an applicant to engage
in reasonable efforts to conclude processing or examination of an
application." See 35 U.S.C. 154(b)(2)(C)(iii). Section 1.704(c)(10)
provides that circumstances that constitute a failure of the applicant
to engage in reasonable efforts to conclude processing or examination
of an application also include "[s]ubmission of an amendment under
Sec. 1.312 or other paper after a notice of allowance has been given
or mailed, in which case the period of adjustment set forth in Sec.
1.703 shall be reduced by the lesser of: (i) [t]he number of days, if
any, beginning on the date the amendment under Sec. 1.312 or other
paper was filed and ending on the mailing date of the Office action or
notice in response to the amendment under Sec. 1.312 or such other
paper; or (ii) [f]our months." The Office did not propose any change
to the provisions of Sec. 1.704(c). The 21st Century Strategic Plan
notice of proposed rule making, however, did include a previously
published clarification of the provisions of Sec. 1.704(c)(10). See
Clarification of 37 CFR 1.704(c)(10)-Reduction of Patent Term
Adjustment for Certain Types of Papers Filed After a Notice of
Allowance Has Been Mailed, 1247 Off. Gaz. Pat. Office at 111-12.
The filing of certain papers, such as a request for refund or a
status letter, after a notice of allowance has been mailed causes
substantial interference with the patent issue process. See id.
Therefore, pursuant to the authority to 35 U.S.C. 154(b)(2)(C)(iii),
the Office has prescribed a regulation (Sec. 1.704(c)(1)) establishing
the filing of such papers after a notice of allowance has been mailed
as a failure of an applicant to engage in reasonable efforts to
conclude processing or examination of an application.
Section 1.26(b) provides a lengthy (two-year) period for filing any
request for refund. Thus, applicants may avoid a reduction of any
patent term adjustment by not filing a request for refund during the
period between the mailing of a notice of allowance and the date the
patent is issued. Applicants who choose to file a request for refund at
a time when the filing of such a paper causes interference with the
patent issue process must accept the negative impact on patent term
adjustment that will result from such a course of action.
As discussed above, the PAIR system provides public access to PALM
for patents and applications that have been published which can be
accessed over the Internet (at <http://frwebgate.access.gpo.gov/cgi-bin/
leaving.cgi?from=leavingFR.html&log=linklog&to=http://pair.uspto.gov>),
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and has a private side (<http://frwebgate.access.gpo.gov/cgi-bin/leaving.
cgi? from=leavingFR.html&log=linklog&to=http://pair-direct.uspto.gov>)
which may be used by an applicant to access confidential information about
his or her pending application. See id. Thus, applicants who choose to
file status letters rather than check the status of their applications
via the PAIR system must accept the negative impact on patent term
adjustment that will result from such a course of action.
Comment 9: Several comments indicated that the thirty-day period
provided in Sec. 1.704(d) was too short and should be changed to three
months for consistency with Sec. 1.97(e).
Response: Section 1.704(d) was adopted to permit applicants to
submit information cited in a communication from a foreign patent
office in a counterpart application to the Office without a reduction
in patent term adjustment if an information disclosure statement is
promptly (within thirty days of receipt of the communication) submitted
to the Office.
See Changes to Implement Patent Term Adjustment Under Twenty-Year
Patent Term, 65 FR at 56373, 56385, 1239 Off. Gaz. Pat. Office at 20,
30-31. The Office did not propose to change the thirty-day period
provided in Sec. 1.704(d).
Section 1.704(d) does not provide that an information disclosure
statement must be submitted within its thirty-day period to avoid a
reduction of patent term adjustment (or to be considered by the
Office), but rather provides a "safe-harbor" against reductions to
patent term adjustment under Secs. 1.704(c)(6), (c)(8), (c)(9), or
(c)(10) that may result from the filing of an information disclosure
statement. The filing of an information disclosure statement during any
of the periods set forth in Secs. 1.704(c)(6), (c)(8), (c)(9), or
(c)(10) will interfere with the patent examination or printing process.
Therefore, the Office must limit the time period in Sec. 1.704(d) to
thirty days to avoid substantial interference with the Office's ability
to meet the time frames specified in 35 U.S.C. 154(b)(1). See Changes
to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65
FR at 56385, 1239 Off. Gaz. Pat. Office at 30.
Rule Making Considerations
Administrative Procedure Act
The change to Sec. 1.703 in this final rule simply amends its
provisions for consistency with 35 U.S.C. 154(b)(2)(A), and the change
to Sec. 1.705 concerns only the procedures for requesting
reconsideration of the patent term adjustment determination printed on
the patent. Therefore, these rule changes involve interpretive rules,
or rules of agency practice and procedure under 5 U.S.C. 553(b)(A), and
prior notice and an opportunity for public comment were not required
pursuant to 5 U.S.C. 553(b)(A) (or any other law). See Bachow
Communications Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (rules
governing an application process are "rules of agency organization,
procedure, or practice" and exempt from the Administrative Procedure
Act's notice and comment requirement).
Regulatory Flexibility Act
As discussed previously, the changes to Secs. 1.703 and 1.705
involve interpretive rules, or rules of agency practice and procedure
under 5 U.S.C. 553(b)(A), for which prior notice and an opportunity for
public comment were not required pursuant to 5 U.S.C. 553(b)(A) (or any
other law).
The Deputy General Counsel for General Law of the United States
Patent and Trademark Office has certified to the Chief Counsel for
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Advocacy of the Small Business Administration that changes in this
final rule will not have a significant economic impact on a substantial
number of small entities (Regulatory Flexibility Act, 5 U.S.C. 605(b)).
The provisions of the Regulatory Flexibility Act relating to the
preparation of a flexibility analysis are not applicable to this rule
making because the changes in this final rule will not have a
significant economic impact on a substantial number of small entities.
The primary change in this final rule (Secs. 1.701 and 1.702)
is to set forth the circumstances under which the Office
will consider a remand by the BPAI to be a decision in the review
reversing an adverse determination of patentability for purposes of
patent term extension and patent term adjustment. Of the 3,843
decisions in ex parte appeals in fiscal year 2003, 454 of these
decisions remanded the application without affirming or reversing any
of the rejections on appeal. Since approximately 25% of the patents
granted in fiscal year 2003 were to small entities, the Office
estimates that approximately 114 small entity applicants may be
affected by the change to Secs. 1.701 and 1.702 in this final
rule. Since the Office received over 350,000 nonprovisional
applications in fiscal year 2003, the change to Secs. 1.701 and
1.702 in this final rule would impact relatively few (fewer than 0.1%
of) patent applicants.
The change to Sec. 1.704 merely clarifies that the thirty-day time
period in Sec. 1.704(d) runs from the first citation of the
information by a foreign patent office, and that a subsequent citation
of the same information by another foreign patent office would not
start a new thirty-day period. Thus, the change to Sec. 1.704 in this
final rule will not have a significant economic impact on any entity.
In any event, the changes in this final rule merely concern the
Office's manner of calculating patent term extension or patent term
adjustment determination in certain situations, and revise the time
period (from thirty days to two months) for requesting reconsideration
of the patent term adjustment determination printed on the patent. The
changes in this final rule would not impose any additional fees or
requirements on any patent applicant. The Office published a notice of
proposed rule making and certified that an initial Regulatory Act
Analysis was not required. No comment on the changes being adopted in
this final rule made reference to any impact of the changes on small
entities.
Executive Order 13132
This rule making does not contain policies with federalism
implications sufficient to warrant preparation of a Federalism
Assessment under Executive Order 13132 (Aug. 4, 1999).
Executive Order 12866
This rule making has been determined to be not significant for
purposes of Executive Order 12866 (Sept. 30, 1993).
Paperwork Reduction Act
This final rule involves information collection requirements which
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The
collection of information involved in this final rule has been reviewed
and previously approved by OMB under OMB control number 0651-0020. The
United States Patent and Trademark Office is not resubmitting an
information collection package to OMB for its review and approval
because the changes in this final rule do not affect the information
collection requirements associated with the information collection
under OMB control number 0651-0020.
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The title, description and respondent description of this
information collection is shown below with an estimate of the annual
reporting burdens. Included in the estimate is the time for reviewing
instructions, gathering and maintaining the data needed, and completing
and reviewing the collection of information. The primary change in this
final rule is to set forth the circumstances under which the Office
will consider a remand by the BPAI to be a decision in the review
reversing an adverse determination of patentability for purposes of
patent term extension and patent term adjustment.
OMB Number: 0651-0020.
Title: Patent Term Extension.
Form Numbers: None.
Type of Review: Approved through October of 2004.
Affected Public: Individuals or households, business or other for-
profit institutions, not-for-profit institutions, farms, Federal
Government and State, Local and Tribal Governments.
Estimated Number of Respondents: 26,859.
Estimated Time Per Response: Between 1 and 25 hours.
Estimated Total Annual Burden Hours: 30,905 hours.
Needs and Uses: The information supplied to the United States
Patent and Trademark Office by an applicant requesting reconsideration
of a patent term adjustment determination under 35 U.S.C. 154(b) (Sec.
1.702 et seq.) is used by the United States Patent and Trademark Office
to determine whether its determination of patent term adjustment under
35 U.S.C. 154(b) is correct, and whether the applicant is entitled to
reinstatement of reduced patent term adjustment. The information
supplied to the United States Patent and Trademark Office by an
applicant seeking a patent term extension under 35 U.S.C. 156 (Sec.
1.710 et seq.) is used by the United States Patent and Trademark
Office, the Department of Health and Human Services, and the Department
of Agriculture to determine the eligibility of a patent for extension
and to determine the period of any such extension. The applicant can
apply for patent term and interim extensions, petition the Office to
review final eligibility decisions, withdraw patent term applications,
and declare his or her eligibility to apply for a patent term
extension.
Comments are invited on: (1) whether the collection of information
is necessary for proper performance of the functions of the agency; (2)
the accuracy of the agency's estimate of the burden; (3) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (4) ways to minimize the burden of the collection of
information to respondents.
Interested persons are requested to send comments regarding these
information collections, including suggestions for reducing this
burden, to Robert J. Spar, Director, Office of Patent Legal
Administration, Commissioner for Patents, P.O. Box 1450, Alexandria, VA
22313-1450, or to the Office of Information and Regulatory Affairs,
Office of Management and Budget, New Executive Office Building, Room
10235, 725 17th Street, NW., Washington, DC 20503, Attention: Desk
Officer for the United States Patent and Trademark Office.
Notwithstanding any other provision of law, no person is required
to respond to nor shall a 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 record keeping
requirements, Small Businesses.
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. For the reasons set forth in the preamble, 37 CFR Part 1 is amended
as follows:
PART 1-RULES OF PRACTICE IN PATENT CASES
.1. The authority citation for 37 CFR Part 1 continues to read as
follows:
Authority: 35 U.S.C. 2(b)(2).
.2. Section 1.701 is amended by revising paragraph (a)(3) to read as
follows:
Sec. 1.701 Extension of patent term due to examination delay under
the Uruguay Round Agreements Act (original applications, other than
designs, filed on or after June 8, 1995, and before May 29, 2000).
(a) * * *
(3) Appellate review by the Board of Patent Appeals and
Interferences or by a Federal court under 35 U.S.C. 141 or 145, if the
patent was issued pursuant to a decision in the review reversing an
adverse determination of patentability and if the patent is not subject
to a terminal disclaimer due to the issuance of another patent claiming
subject matter that is not patentably distinct from that under
appellate review. If an application is remanded by a panel of the Board
of Patent Appeals and Interferences and the remand is the last action
by a panel of the Board of Patent Appeals and Interferences prior to
the mailing of a notice of allowance under 35 U.S.C. 151 in the
application, the remand shall be considered a decision in the review
reversing an adverse determination of patentability as that phrase is
used in 35 U.S.C. 154(b)(2) as amended by section 532(a) of the Uruguay
Round Agreements Act, Public Law 103-465, 108 Stat. 4809, 4983-85
(1994), and a final decision in favor of the applicant under paragraph
(c)(3) of this section. A remand by a panel of the Board of Patent
Appeals and Interferences shall not be considered a decision in the
review reversing an adverse determination of patentability as provided
in this paragraph if there is filed a request for continued examination
under 35 U.S.C. 132(b) that was not first preceded by the mailing,
after such remand, of at least one of an action under 35 U.S.C. 132 or
a notice of allowance under 35 U.S.C. 151.
* * * * *
.3. Section 1.702 is amended by revising paragraph (e) to read as
follows:
Sec. 1.702 Grounds for adjustment of patent term due to examination
delay under the Patent Term Guarantee Act of 1999 (original
applications, other than designs, filed on or after May 29, 2000).
* * * * *
(e) Delays caused by successful appellate review. Subject to the
provisions of 35 U.S.C. 154(b) and this subpart, the term of an
original patent shall be adjusted if the issuance of the patent was
delayed due to review by the Board of Patent Appeals and Interferences
under 35 U.S.C. 134 or by a Federal court under 35 U.S.C. 141 or 145,
if the patent was issued under a decision in the review reversing an
adverse determination of patentability. If an application is remanded
by a panel of the Board of Patent Appeals and Interferences and the
remand is the last action by a panel of the Board of Patent Appeals and
Interferences prior to the mailing of a notice of allowance under 35
U.S.C. 151 in the application, the remand shall be considered a
decision by the Board of Patent Appeals and Interferences as that
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phrase is used in 35 U.S.C. 154(b)(1)(A)(iii), a decision in the review
reversing an adverse determination of patentability as that phrase is
used in 35 U.S.C. 154(b)(1)(C)(iii), and a final decision in favor of
the applicant under Sec. 1.703(e). A remand by a panel of the Board of
Patent Appeals and Interferences shall not be considered a decision in
the review reversing an adverse determination of patentability as
provided in this paragraph if there is filed a request for continued
examination under 35 U.S.C. 132(b) that was not first preceded by the
mailing, after such remand, of at least one of an action under 35
U.S.C. 132 or a notice of allowance under 35 U.S.C. 151.
* * * * *
.4. Section 1.703 is amended by revising paragraph (f) to read as
follows.
Sec. 1.703 Period of adjustment of patent term due to examination
delay.
* * * * *
(f) The adjustment will run from the expiration date of the patent
as set forth in 35 U.S.C. 154(a)(2). To the extent that periods of
delay attributable to the grounds specified in Sec. 1.702 overlap, the
period of adjustment granted under this section shall not exceed the
actual number of days the issuance of the patent was delayed. The term
of a patent entitled to adjustment under Sec. 1.702 and this section
shall be adjusted for the sum of the periods calculated under
paragraphs (a) through (e) of this section, to the extent that such
periods are not overlapping, less the sum of the periods calculated
under Sec. 1.704. The date indicated on any certificate of mailing or
transmission under Sec. 1.8 shall not be taken into account in this
calculation.
* * * * *
.5. Section 1.704 is amended by revising paragraph (d) to read as
follows.
Sec. 1.704 Reduction of period of adjustment of patent term.
* * * * *
(d) A paper containing only an information disclosure statement in
compliance with Secs. 1.97 and 1.98 will not be considered a
failure to engage in reasonable efforts to conclude prosecution
(processing or examination) of the application under paragraphs (c)(6),
(c)(8), (c)(9), or (c)(10) of this section if it is accompanied by a
statement that each item of information contained in the information
disclosure statement was first cited in any communication from a
foreign patent office in a counterpart application and that this
communication was not received by any individual designated in Sec.
1.56(c) more than thirty days prior to the filing of the information
disclosure statement. This thirty-day period is not extendable.
* * * * *
.6. Section 1.705 is amended by revising paragraph (d) to read as
follows:
Sec. 1.705 Patent term adjustment determination.
* * * * *
(d) If there is a revision to the patent term adjustment indicated
in the notice of allowance, the patent will indicate the revised patent
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term adjustment. If the patent indicates or should have indicated a
revised patent term adjustment, 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 must comply with the
requirements of paragraphs (b)(1) and (b)(2) of this section. Any
request for reconsideration under this section that raises issues that
were raised, or could have been raised, in an application for patent
term adjustment under paragraph (b) of this section shall be dismissed
as untimely as to those issues.
* * * * *
April 16, 2004 JON W. DUDAS
Acting Under Secretary of
Commerce for Intellectual Property and
Acting Director of the
United States Patent and Trademark Office
[1282 OG 100]