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9570 Federal Register / Vol. 70, No.

38 / Monday, February 28, 2005 / Proposed Rules

§ 803.55 If I am a manufacturer, in what (8) Shelf life of the device, if (b) U.S.-designated agents of foreign
circumstances must I submit a baseline applicable, and expected life of the manufacturers are required to:
report, and what are the requirements for device; (1) Report to FDA in accordance with
such a report? (9) The number of devices §§ 803.50, 803.52, 803.53, 803.55, and
(a) You must submit a baseline report manufactured and distributed in the last 803.56;
for a device when you submit the first 12 months and an estimate of the (2) Conduct, or obtain from the
report under § 803.50 involving that number of devices in current use; and foreign manufacturer the necessary
device model. Submit this report on (10) Brief description of any methods information regarding, the investigation
FDA Form 3417 or an electronic that you used to estimate the number of and evaluation of the event to comport
equivalent approved under § 803.14. devices distributed and the number of with the requirements of § 803.50;
(b) You must update each baseline devices in current use. If this (3) Forward MDR complaints to the
report annually on the anniversary information was provided in a previous foreign manufacturer and maintain
month of the initial submission, after baseline report, in lieu of resubmitting documentation of this requirement;
the initial baseline report is submitted. the information, it may be referenced by (4) Maintain complaint files in
Report changes to baseline information providing the date and product accordance with § 803.18; and
in the manner described in § 803.56 (5) Register, list, and submit
identification for the previous baseline
(i.e., include only the new, changed, or premarket notifications in accordance
report.
corrected information in the appropriate with part 807 of this chapter.
portion(s) of the report form). In each § 803.56 If I am a manufacturer, in what Dated: February 17, 2005.
baseline report, you must include the circumstances must I submit a
Jeffrey Shuren,
following information: supplemental or followup report and what
are the requirements for such reports? Assistant Commissioner for Policy.
(1) Name, complete address, and
If you are a manufacturer, when you [FR Doc. 05–3833 Filed 2–25–05; 8:45 am]
establishment registration number of
BILLING CODE 4160–01–S
your reporting site. If your reporting site obtain information required under this
is not registered under part 807, we will part that you did not provide because it
assign a temporary number for use in was not known or was not available
MDR reporting until you register your when you submitted the initial report, DEPARTMENT OF COMMERCE
reporting site in accordance with part you must submit the supplemental
United States Patent and Trademark
807. We will inform you of the information to us within 1 month of the
Office
temporary MDR reporting number; day that you receive this information.
(2) FDA registration number of each On a supplemental or followup report,
37 CFR Part 1
site where you manufacture the device; you must:
(3) Name, complete address, and (a) Indicate on the envelope and in [Docket No.: 2005–P–055]
telephone number of the individual who the report that the report being RIN 0651–AB87
you have designated as your MDR submitted is a supplemental or followup
contact, and the date of the report. For report. If you are using FDA form Changes to the Practice for Handling
foreign manufacturers, we require a 3500A, indicate this in Block Item H–2; Patent Applications Filed Without the
confirmation that the individual (b) Submit the appropriate Appropriate Fees
submitting the report is the agent of the identification numbers of the report that
manufacturer designated under you are updating with the supplemental AGENCY: United States Patent and
§ 803.58(a); information (e.g., your original Trademark Office, Commerce.
(4) Product identification, including manufacturer report number and the ACTION: Notice of proposed rulemaking.
device family, brand name, generic user facility or importer report number
SUMMARY: Among other changes to
name, model number, catalog number, of any report on which your report was
patent and trademark fees, the
product code, and any other product based), if applicable; and
Consolidated Appropriations Act, 2005
identification number or designation; (c) Include only the new, changed, or
(5) Identification of any device that (Consolidated Appropriations Act),
corrected information in the appropriate
you previously reported in a baseline splits the patent application filing fee
portion(s) of the respective form(s) for
report that is substantially similar (e.g., into a separate filing fee, search fee and
reports that cross reference previous
same device with a different model examination fee, and requires an
reports.
number, or same device except for additional fee (application size fee) for
cosmetic differences in color or shape) § 803.58 Foreign manufacturers. applications whose specification and
to the device being reported. This (a) Every foreign manufacturer whose drawings exceed 100 sheets of paper,
includes additional identification of the devices are distributed in the United during fiscal years 2005 and 2006. The
previously reported device by model States shall designate a U.S. agent to be United States Patent and Trademark
number, catalog number, or other responsible for reporting in accordance Office is in this notice proposing
product identification, and the date of with § 807.40 of this chapter. The U.S. changes in the Office’s practice for
the baseline report for the previously designated agent accepts responsibility handling patent applications filed
reported device; for the duties that such designation without the appropriate filing, search,
(6) Basis for marketing, including entails. Upon the effective date of this and examination fees. The Office has
your 510(k) premarket notification regulation, foreign manufacturers shall implemented the changes to the patent
number or PMA number, if applicable, inform FDA, by letter, of the name and fees provided in the Consolidated
and whether the device is currently the address of the U.S. agent designated Appropriations Act in a separate
subject of an approved postmarket study under this section and § 807.40 of this rulemaking.
under section 522 of the act; chapter, and shall update this DATES: Comment Deadline Date: To be
(7) Date that you initially marketed information as necessary. Such updated ensured of consideration, written
the device and, if applicable, the date on information shall be submitted to FDA, comments must be received on or before
which you stopped marketing the within 5 days of a change in the March 30, 2005. No public hearing will
device; designated agent information. be held.

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Federal Register / Vol. 70, No. 38 / Monday, February 28, 2005 / Proposed Rules 9571

ADDRESSES: Comments should be sent application filed under 35 U.S.C. 111(a), benefit claims under 35 U.S.C. 120 and
by electronic mail message over the and that the provisions of 35 U.S.C. § 1.78(a). Under the revised patent fee
Internet addressed to 371(d) for the payment of the national structure set forth in the Consolidated
AB69Comments@uspto.gov. Comments fee apply to the payment of the Appropriations Act, the basic filing fee
may also be submitted by mail examination fee (35 U.S.C. 41(a)(3)) and covers only the cost of the initial
addressed to: Mail Stop Comments— search fee (35 U.S.C. 41(d)(1)) in an processing of an application. Thus, the
Patents, Commissioner for Patents, P.O. international application filed under the Office is proposing to require payment
Box 1450, Alexandria, VA 22313–1450, Patent Cooperation Treaty (PCT) and of the basic filing fee (rather than just
or by facsimile to (571) 273–7735, entering the national stage under 35 the current processing and retention fee
marked to the attention of Robert W. U.S.C. 371. See 35 U.S.C. 41(a)(3) and set forth in § 1.21(l)) to retain the
Bahr. Although comments may be 41(d)(1)(C). Thus, the examination fee application. Since the Office must retain
submitted by mail or facsimile, the and search fee are due on filing in an an application to permit benefit of the
Office prefers to receive comments via application filed under 35 U.S.C. 111(a) application to be claimed under 35
the Internet. If comments are submitted or on commencement of the national U.S.C. 120 and § 1.78 in a subsequent
by mail, the Office prefers that the stage in a PCT international application, nonprovisional or international
comments be submitted on a DOS but may be paid at a later time if paid application, the Office is also proposing
formatted 31⁄2 inch disk accompanied by within such period and under such to require payment of the basic filing fee
a paper copy. conditions (including payment of a (rather than just the current processing
Comments may also be sent by surcharge) as may be prescribed by the and retention fee set forth in § 1.21(l)) to
electronic mail message over the Director. See H.R. Rep. 108–241, at 16 permit benefit of the application to be
Internet via the Federal eRulemaking (2003) (H.R. Rep. 108–241 contains an claimed under 35 U.S.C. 120 and § 1.78
Portal. See the Federal eRulemaking analysis and discussion of an identical in a subsequent nonprovisional or
Portal Web site (http:// provision in H.R. 1561, 108th Cong. international application.
www.regulations.gov) for additional (2004)). The Office is also implementing the
instructions on providing comments via In view of the revised patent fee provision in 35 U.S.C. 41(a)(1)(G) for the
the Federal eRulemaking Portal. structure during fiscal years 2005 and Office to prescribe the paper size
The comments will be available for 2006 set forth in the Consolidated equivalent of an application filed in
public inspection at the Office of the Appropriations Act, the Office is whole or in part in an electronic
Commissioner for Patents, located in proposing the following changes in medium for purposes of the application
Madison East, Tenth Floor, 600 Dulany Office practice for handling patent size fee specified in 35 U.S.C.
Street, Alexandria, Virginia, and will be applications filed without the 41(a)(1)(G) (§ 1.16(s) and § 1.492(j)). A
available via the Office Internet Web site appropriate fees: That is, the filing fee, 21.6 cm by 27.9 cm (8 1⁄2 by 11 inches)
(address: http://www.uspto.gov). search fee, and examination fee. sheet of paper with a top margin of 2.0
Because comments will be made The Office is proposing to: (1) Require cm (3⁄4 inch), a left side margin of 2.5
available for public inspection, the surcharge under § 1.16(f) in any cm (1 inch), a right side margin of 2.0
application filed under 35 U.S.C. 111(a) cm (3⁄4 inch), and a bottom margin of
information that is not desired to be
in which the search fee or examination 2.0 cm (3⁄4 inch)), will contain about 30
made public, such as an address or
fee is paid on a date later than the filing lines of double-spaced text, with each
phone number, should not be included
date; and (2) require the surcharge line having about 50 to 65 characters.
in the comments.
under § 1.492(h) in any application filed An ASCII text (the only format
FOR FURTHER INFORMATION CONTACT:
under the PCT in which the search fee permitted by § 1.52(e)) document
Robert W. Bahr, Senior Patent Attorney, or examination fee is paid on a date containing 30 lines of text, each line
Office of the Deputy Commissioner for later than thirty months from the having about 50 to 65 characters, will be
Patent Examination Policy, by telephone priority date. This change is because the slightly less than two kilobytes in size.
at (571) 272–8800, by mail addressed to: Consolidated Appropriations Act splits Therefore, the Office is proposing that
Mail Stop Comments—Patents, the former patent application filing (or each two kilobytes of content submitted
Commissioner for Patents, P.O. Box national) fee into a separate filing (or on an electronic medium shall be
1450, Alexandria, VA 22313–1450, or by national) fee, search fee and counted as a sheet of paper for purposes
facsimile to (571) 273–7735, marked to examination fee during fiscal years 2005 of the application size fee specified in
the attention of Robert W. Bahr. and 2006. The filing of an application 35 U.S.C. 41(a)(1)(G) (§ 1.16(s) and
SUPPLEMENTARY INFORMATION: Among which lacks any of the basic filing (or § 1.492(j)).
other changes, the Consolidated national) fee, the search fee, the
Appropriations Act (section 801 of examination fee, or oath or declaration Discussion of Specific Rules
Division B) provides that 35 U.S.C. requires the Office to issue a notice to Title 37 of the Code of Federal
41(a), (b), and (d) shall be administered file the missing parts (or requirements) Regulations, Part 1, is proposed to be
in a manner that revises patent of the application. amended as follows:
application fees (35 U.S.C. 41(a)) and The Office is also proposing to Section 1.16: Section 1.16(f) is
patent maintenance fees (35 U.S.C. eliminate the processing and retention proposed to be amended to require a
41(b)), and provides for a separate filing fee (§ 1.21(l)) practice. The processing surcharge if any of the basic filing fee,
fee (35 U.S.C. 41(a)), search fee (35 and retention fee practice permits an the search fee, the examination fee, or
U.S.C. 41(d)(1)), and examination fee applicant to file an application without oath or declaration is filed in a
(35 U.S.C. 41(a)(3)) during fiscal years the basic filing fee (which formerly nonprovisional application on a date
2005 and 2006. The Consolidated covered the cost of the initial processing later than the filing date of the
Appropriations Act also provides that of an application and part of the cost of application. Section 1.16(s) is proposed
the provisions of 35 U.S.C. 111(a) for the search and examination of an to be amended to include a cross
payment of the fee for filing the application) and pay only the reference to § 1.52(f).
application apply to the payment of the processing and retention fee set forth in Section 1.21: Section 1.21 is proposed
examination fee (35 U.S.C. 41(a)(3)) and § 1.21(l) in order for the application to to be amended to remove and reserve
search fee (35 U.S.C. 41(d)(1)) in an be used as a basis for foreign filing and paragraph (l), which set forth the fee for

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9572 Federal Register / Vol. 70, No. 38 / Monday, February 28, 2005 / Proposed Rules

processing and retaining an application agency practice and procedure under 5 basis for foreign filing and for priority
in which the basic filing fee has not U.S.C. 553(b)(A). See Bachow under 35 U.S.C. 120 is more compatible
been paid. Communications Inc. v. FCC, 237 F.3d with the filing fee scheme set forth in
Section 1.52: Section 1.52(f)(1) is 683, 690 (D.C. Cir. 2001) (rules the Consolidated Appropriations Act
proposed to be amended to provide that governing an application process are than is continuing the processing and
for purposes of determining the ‘‘rules of agency organization, retention fee practice.
application size fee required by § 1.16(s) procedure, or practice’’ and are exempt The Consolidated Appropriations Act
or § 1.492(j), for an application the from the Administrative Procedure Act’s provides for the Office to prescribe the
specification and drawings of which notice and comment requirement); see paper size equivalent of an application
(excluding any sequence listing in also Merck & Co., Inc. v. Kessler, 80 F.3d filed in whole or in part in an electronic
compliance with § 1.821(c) or (e), and 1543, 1549–50, 38 USPQ2d 1347, 1351 medium for purposes of the application
any computer program listing filed in an (Fed. Cir. 1996) (the rules of practice size fee specified in 35 U.S.C.
electronic medium in compliance with promulgated under the authority of 41(a)(1)(G). Thus, setting a paper size
§§ 1.52(e) and 1.96) are submitted in former 35 U.S.C. 6(a) (now in 35 U.S.C. equivalent based upon the number of
whole or in part on an electronic 2(b)(2)) are not substantive rules (to kilobytes of content that can fit onto a
medium other than the Office electronic which the notice and comment sheet of paper (given the current
filing system, each two kilobytes of requirements of the Administrative requirements for applications filed in
content submitted on an electronic Procedure Act apply)), and Fressola v. part on CD and for paper size and
medium shall be counted as a sheet of Manbeck, 36 USPQ2d 1211, 1215 margins) simply sets forth the
paper. (D.D.C. 1995) (‘‘it is doubtful whether procedures for determining the paper
Section 1.53: Section 1.53(f)(5) is any of the rules formulated to govern size equivalent of an application filed in
proposed to be amended to provide that patent and trade-mark practice are other whole or in part in an electronic
if the applicant does not pay the basic than ‘interpretative rules, general medium for purposes of the application
filing fee during the pendency of the statements of policy, * * * procedure, size fee.
application, the Office may dispose of or practice.’ ’’) (quoting C.W. Ooms, The Accordingly, prior notice and
the application. United States Patent Office and the opportunity for public comment are not
Section 1.78: Section 1.78(a)(1) is Administrative Procedure Act, 38 required pursuant to 5 U.S.C. 553(b) or
proposed to be amended to provide that Trademark Rep. 149, 153 (1948)). (c) (or any other law). Nevertheless, the
to claim the benefit of a prior-filed Under the Office’s pre-existing Office is providing this opportunity for
nonprovisional application under 35 ‘‘missing parts’’ or ‘‘missing public comment on the changes
U.S.C. 120 and § 1.78(a) in a subsequent requirements’’ practice, an applicant proposed in this notice because the
nonprovisional or international was required to pay a surcharge if the Office desires the benefit of public
application, the prior-filed basic filing fee was not present on filing comment on these proposed changes.
nonprovisional application must be in an application filed under 35 U.S.C. Regulatory Flexibility Act: As prior
entitled to a filing date as set forth in 111 or if the basic national fee was not notice and an opportunity for public
§ 1.53(b) or § 1.53(d) and have paid present on the date of commencement of comment are not required pursuant to 5
therein the basic filing fee set forth in the national stage of processing in a PCT U.S.C. 553 (or any other law), an initial
§ 1.16 within the pendency of the application entering the national stage regulatory flexibility analysis under the
application. under 35 U.S.C. 371. The Consolidated Regulatory Flexibility Act (5 U.S.C. 601
Section 1.492: Section 1.492(h) is Appropriations Act split the patent et seq.) is not required. See 5 U.S.C. 603.
proposed to be amended to require a application filing (or national) fee into Executive Order 13132: This rule
surcharge if any of the search fee, the a separate filing (or national) fee, search making does not contain policies with
examination fee, or the oath or fee and examination fee. Therefore, the federalism implications sufficient to
declaration is filed later than thirty proposed replacement of the basic filing warrant preparation of a Federalism
months from the priority date. Section (or national) fee in §§ 1.16 and 1.492 Assessment under Executive Order
1.492(j) is proposed to be amended to with the basic filing (or national) fee, 13132 (Aug. 4, 1999).
include a cross reference to § 1.52(f). the search fee, or the examination fee is Executive Order 12866: This rule
simply a procedural change that is making has been determined to be not
Rulemaking Considerations significant for purposes of Executive
necessary to maintain (or restore) the
Administrative Procedure Act: The status quo ante with respect to the Order 12866 (Sept. 30, 1993).
changes proposed in this notice relate Office’s pre-existing ‘‘missing parts’’ or Paperwork Reduction Act: This notice
solely to the procedures to be followed ‘‘missing requirements’’ practice. involves information collection
in prosecuting a patent application: i.e., The processing and retention fee requirements which are subject to
the procedures for paying the fees due practice allows applicants to file an review by the Office of Management and
upon filing an application for patent. application without the filing fee and to Budget (OMB) under the Paperwork
This notice does not propose any pay only a processing and retention fee Reduction Act of 1995 (44 U.S.C. 3501
change to the amount of fees charged by in order for the application to be used et seq.). The collections of information
the Office. Specifically, the changes as a basis for foreign filing and for involved in this notice have been
proposed in this notice concern the priority under 35 U.S.C. 120. Under the reviewed and previously approved by
procedures for payment of the filing fee, revised patent fee structure set forth in OMB under OMB control numbers:
search fee, and examination fee, and the Consolidated Appropriations Act 0651–0021, 0651–0031, and 0651–0032.
setting forth which fees must be paid in (which split the filing fee into a separate The United States Patent and Trademark
order for a nonprovisional application filing, search fee and examination fee), Office is not resubmitting any
to be processed and retained by the the filing fee covers the cost of the information collection package to OMB
Office such that it may be used as the initial processing and retention of an for its review and approval because the
basis for foreign filing and for benefit application. Thus, requiring payment of changes in this notice do not affect the
claims under 35 U.S.C. 120 and the basic filing fee under the information collection requirements
§ 1.78(a). Therefore, these rule changes Consolidated Appropriations Act in associated with the information
involve interpretive rules, or rules of order for an application to be used as a collection under these OMB control

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Federal Register / Vol. 70, No. 38 / Monday, February 28, 2005 / Proposed Rules 9573

numbers. The changes proposed in this or after December 8, 2004, the therein the basic filing fee set forth in
notice concern the procedures for specification and drawings of which § 1.16 within the pendency of the
payment of the filing fee, search fee, exceed 100 sheets of paper, for each application.
examination fee, and the application additional 50 sheets or fraction thereof * * * * *
size fee, including setting forth which (see § 1.52(f) for applications submitted 7. Section 1.492 is amended by
fees must be paid in order for an in whole or in part on an electronic revising paragraphs (h) and (j) to read as
application to be processed and retained medium): follows:
by the Office such that it may be used By a small entity (§ 1.27(a))—$125.00
as the basis for foreign filing and for By other than a small entity—$250.00 § 1.492 National stage fees.
benefit claims under 35 U.S.C. 120 and * * * * * * * * * *
§ 1.78(a). 3. Section 1.21 is amended by (h) Surcharge for filing any of the
Interested persons are requested to removing and reserving paragraph (l): search fee, the examination fee, or the
send comments regarding these oath or declaration later than thirty
information collections, including § 1.21 Miscellaneous fees and charges. months from the priority date pursuant
suggestions for reducing this burden, to * * * * * to § 1.495(c):
Robert J. Spar, Director, Office of Patent (l) [Reserved] By a small entity (§ 1.27(a))—$65.00
Legal Administration, Commissioner for * * * * * By other than a small entity—$130.00
Patents, P.O. Box 1450, Alexandria, VA 4. Section 1.52 is amended by revising * * * * *
22313–1450, or to the Office of paragraph (f)(1) to read as follows: (j) Application size fee for any
Information and Regulatory Affairs, international application for which the
Office of Management and Budget, New § 1.52 Language, paper, writing, margins, basic national fee was not paid before
Executive Office Building, Room 10235, compact disc specifications.
December 8, 2004, the specification and
725 17th Street, NW., Washington, DC * * * * * drawings of which exceed 100 sheets of
20503, Attention: Desk Officer for the (f)(1) Any sequence listing in an paper, for each additional 50 sheets or
Patent and Trademark Office. electronic medium in compliance with fraction thereof (see § 1.52(f) for
Notwithstanding any other provision §§ 1.52(e) and 1.821(c) or (e), and any applications submitted in whole or in
of law, no person is required to respond computer program listing filed in an part on an electronic medium):
to nor shall a person be subject to a electronic medium in compliance with
By a small entity (§ 1.27(a))—$125.00
penalty for failure to comply with a §§ 1.52(e) and 1.96, will be excluded By other than a small entity—$250.00
collection of information subject to the when determining the application size
fee required by § 1.16(s) or § 1.492(j). Dated: February 22, 2005.
requirements of the Paperwork
Reduction Act unless that collection of For purposes of determining the Jon W. Dudas,
information displays a currently valid application size fee required by § 1.16(s) Under Secretary of Commerce for Intellectual
OMB control number. or § 1.492(j), for an application the Property and Director of the United States
specification and drawings of which, Patent and Trademark Office.
List of Subjects in 37 CFR Part 1 excluding any sequence listing in [FR Doc. 05–3743 Filed 2–25–05; 8:45 am]
Administrative practice and compliance with § 1.821(c) or (e), and BILLING CODE 3510–16–P
procedure, Courts, Freedom of any computer program listing filed in an
Information, Inventions and patents, electronic medium in compliance with
Reporting and recordkeeping §§ 1.52(e) and 1.96, are submitted in ENVIRONMENTAL PROTECTION
requirements, Small businesses. whole or in part on an electronic AGENCY
For the reasons set forth in the medium other than the Office electronic
filing system, each two kilobytes of 40 CFR Part 52
preamble, 37 CFR part 1 is proposed to
be amended as follows: content submitted on an electronic [R05–OAR–2004–IN–0007; FRL–7875–4]
medium shall be counted as a sheet of
PART 1—RULES OF PRACTICE IN paper. Approval and Promulgation of Air
PATENT CASES * * * * * Quality Implementation Plans; Indiana
5. Section 1.53 is amended by revising
1. The authority citation for 37 CFR AGENCY: Environmental Protection
paragraph (f)(5) to read as follows:
part 1 continues to read as follows: Agency (EPA).
Authority: 35 U.S.C. 2(b)(2). § 1.53 Application number, filing date, and ACTION: Proposed rule.
completion of application.
2. Section 1.16 is amended by revising * * * * * SUMMARY: The EPA is proposing to
paragraphs (f) and (s) to read as follows: (f) * * * approve revisions to the particulate
(5) If applicant does not pay the basic matter (PM) and sulfur dioxide (SO2)
§ 1.16 National application filing, search,
and examination fees. filing fee during the pendency of the emission requirements for Pfizer, Inc.
application, the Office may dispose of (Pfizer). Pfizer operates a medicinal
* * * * * chemical manufacturing facility in Vigo
(f) Surcharge for filing any of the basic the application.
County, Indiana. On October 7, 2004,
filing fee, the search fee, the * * * * *
6. Section 1.78 is amended by Indiana submitted a request for PM and
examination fee, or oath or declaration SO2 emission limit revisions as an
on a date later than the filing date of the removing paragraph (a)(1)(iii) and
revising paragraph (a)(1)(ii) to read as amendment to its State Implementation
application, except provisional Plan (SIP). Pfizer has removed five
applications: follows:
boilers from its facility. Indiana has
By a small entity (§ 1.27(a))—$65.00 § 1.78 Claiming benefit of earlier filing date requested the deletion of the site-
By other than a small entity—$130.00 and cross references to other applications. specific PM and SO2 emission limits for
* * * * * (a)(1) * * * all five removed boilers. A new boiler
(s) Application size fee for any (ii) Entitled to a filing date as set forth has replaced three of the removed
application under 35 U.S.C. 111 filed on in § 1.53(b) or § 1.53(d) and have paid boilers. It is subject to the applicable

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