Certain X-Ray Breast Imaging Devices and Components Thereof; Notice of a Commission Determination To Review the Final Initial Determination In-Part; Extension of the Target Date, 54608-54610 [2018-23618]
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Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices
Notice elicited no comments.
Accordingly, no changes have been
made to the Collections.
FOR FURTHER INFORMATION CONTACT:
Information Collection Request
Title: Bridge Permit Application
Guide.
OMB Control Number: 1625–0015.
Summary: The collection of
information is a request for a bridge
permit submitted as an application for
approval by the Coast Guard of any
proposed bridge project. An applicant
must submit to the Coast Guard a letter
of application along with letter-size
drawings (plans) and maps showing the
proposed project and its location.
Need: 33 U.S.C. 401, 491, and 525
authorize the Coast Guard to approve
plans and locations for all bridges and
causeways that go over navigable waters
of the United States.
Forms: None.
Respondents: Public and private
owners of bridges over navigable waters
of the United States.
Frequency: On occasion.
Hour Burden Estimate: The estimated
burden has increased from 12,354 hours
to 17,607 hours a year due to the
increase in the annual number of
respondents.
Authority: The Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended.
DEPARTMENT OF THE INTERIOR
Bureau of Safety and Environmental
Enforcement
[19XE8370SD//EEGG600000//
ED1OS0000.JR0000]
Notice of Public Meeting
Bureau of Safety and
Environmental Enforcement (BSEE),
Interior.
ACTION: Notice of public meeting.
AGENCY:
The Bureau of Safety and
Environmental Enforcement (BSEE) is
hosting a public meeting to discuss
advancement of a low-emission spray
combustion unit for responding to oil
spills.
khammond on DSK30JT082PROD with NOTICES
SUMMARY:
This public meeting will be held
on December 10, 2018 from 9 to 11 a.m.
ADDRESSES: The meeting will be held in
Room 121 at 1201 Elmwood Park Blvd.,
New Orleans, LA 70123.
Jkt 247001
BILLING CODE 4310–VH–P
INTERNATIONAL TRADE
COMMISSION
[Inv. No. 337–TA–1063]
Certain X-Ray Breast Imaging Devices
and Components Thereof; Notice of a
Commission Determination To Review
the Final Initial Determination In-Part;
Extension of the Target Date
Notice is hereby given that
the U.S. International Trade
Commission has determined to review
the final initial determination (‘‘ID’’) inpart and extend the target date for
completion of the investigation until
January 25, 2019.
FOR FURTHER INFORMATION CONTACT:
Amanda Pitcher Fisherow, Esq., Office
of the General Counsel, U.S.
International Trade Commission, 500 E
Street SW, Washington, DC 20436,
telephone (202) 205–2737. Copies of
non-confidential documents filed in
connection with this investigation are or
will be available for inspection during
official business hours (8:45 a.m. to 5:15
p.m.) in the Office of the Secretary, U.S.
International Trade Commission, 500 E
Street SW, Washington, DC 20436,
telephone (202) 205–2000. General
information concerning the Commission
may also be obtained by accessing its
internet server at https://www.usitc.gov.
The public record for this investigation
may be viewed on the Commission’s
electronic docket (EDIS) at https://
edis.usitc.gov. Hearing-impaired
persons are advised that information on
this matter can be obtained by
SUMMARY:
BILLING CODE 9110–04–P
17:34 Oct 29, 2018
[FR Doc. 2018–23709 Filed 10–29–18; 8:45 am]
U.S. International Trade
Commission.
ACTION: Notice.
[FR Doc. 2018–23638 Filed 10–29–18; 8:45 am]
VerDate Sep<11>2014
Dated: October 24, 2018.
Scott A. Angelle,
Director, Bureau of Safety and Environmental
Enforcement.
AGENCY:
Dated: October 25, 2018.
James D. Roppel,
Acting Chief, U.S. Coast Guard, Office of
Information Management.
DATES:
Karen N. Stone, (703) 787–1810 or email
karen.stone@bsee.gov.
SUPPLEMENTARY INFORMATION: This
notice is to inform the interested public
that BSEE, Oil Spill Preparedness
Division (OSPD), Response Research
Branch will be conducting a public
meeting to discuss advancement of a
low-emission spray combustion unit
being designed to burn water-in-oil
emissions. System integration including
platform/barge configurations will be
discussed to ready the unit towards use
in oil spill cleanup operations.
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contacting the Commission’s TDD
terminal on (202) 205–1810.
SUPPLEMENTARY INFORMATION: The
Commission instituted this investigation
on August 1, 2017, based on a complaint
and supplement, filed on behalf of
Hologic, Inc. of Marlborough,
Massachusetts (‘‘Hologic’’). 82 FR
35829–24 (Aug. 1, 2017). The
complaint, as supplemented, alleges
violations of section 337 based upon the
importation into the United States, the
sale for importation, and the sale within
the United States after importation of
certain x-ray breast imaging and
components thereof by reason of
infringement of certain claims of U.S.
Patent No. 7,831,296 (‘‘the ’296 patent’’);
U.S. Patent No. 8,452,379 (‘‘the ’379
patent’’); U.S. Patent No. 7,688,940 (‘‘the
’940 patent’’); U.S. Patent No. 7,986,765
(‘‘the ’765 patent’’); and U.S. Patent No.
7,123,684 (‘‘the ’684 patent’’). The
complaint further alleges that an
industry in the United States exists as
required by section 337. The Notice of
Investigation named FUJIFILM
Corporation of Tokyo, Japan; FUJIFILM
Medical Systems USA, Inc. of Stamford,
Connecticut; and FUJIFILM Techno
Products Co., Ltd. of Hanamaki-Shi
Iwate, Japan (collectively, ‘‘Fujifilm’’) as
respondents. The Office of Unfair
Import Investigations (‘‘OUII’’) was
named as a party. On January 18, 2018,
the ’765 patent was terminated in its
entirety from the investigation. See
Order No. 18 (Jan. 18, 2018)
(unreviewed).
On July 26, 2018, the ALJ issued the
final ID and found a violation of section
337 has occurred. On August 8, 2018,
Fujifilm and OUII each filed petitions
for review of the final ID. On August 16,
2018, OUII and Hologic filed responses
to the petitions for review.
Having examined the record of this
investigation, including the ALJ’s final
ID, the petitions for review, and the
responses thereto, the Commission has
determined to review the final ID in
part. Specifically, the Commission has
determined to review the ID’s findings
on (1) in rem jurisdiction and
importation; (2) all findings concerning
infringement; (3) claim construction of
the ‘‘dose’’ limitations of the ’379 and
’296 patents; (3) claim construction of
the limitations including terms of
degree (i.e., similar, substantially less,
much less, and substantially higher) in
the ’379 and ’296 patents; (4) the
‘‘control’’/‘‘motion control’’ and
‘‘processor’’ limitations of the ’379 and
’296 patents; (5) the technical prong of
domestic industry for the ’379 and ’296
patents; (6) claim construction of the
‘‘control’’ limitations of the ’940 patent;
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(7) anticipation by the Kopans 2000
Army Report for the ’379 and ’296
patents; (8) anticipation by MGH/GE
Prototype #2 for the ’379 and ’296
patents; (9) obviousness based on the
publicly available MGH/GE References
related to the MGH/GE Prototypes for
the ’379 and ’296 patents; (10)
anticipation by GE Senographe 2000D
System and/or Manual for the ’940
patent; (11) obviousness based on GE
Senographe 2000D System and/or
Manual with Dornheim for the ’940
patent; (12) obviousness based on
Niklason article, the GE Senographe
DMR System and Dornheim for the ’940
patent; and (13) indefiniteness under 35
U.S.C. 112 for the ’940 patent.
In connection with its review, the
Commission is interested in responses
to the following questions:
1. Was the argument that ‘‘conventional
mammogram,’’ as used in the ’379 and ’296
patents, should be construed to include
diagnostic images waived? See, e.g., OUII
Petition for Review at 9–12; Complainant’s
Resp. to OUII Petition at 2–3.
2. Does the claimed ‘‘dose’’ for a
‘‘conventional mammogram,’’ as used in the
’379 and ’296 patents, meet the
indefiniteness standard set forth in Nautilus,
Inc. v. Biosig Instruments, Inc., 134 S. Ct.
2120 (2014). The Commission is most
interested in a discussion of the relevant
Federal Circuit precedent.
3. To what extent are the ID’s findings on
whether the ‘‘dose’’ for a conventional
mammogram has changed over time
necessary in establishing whether the ‘‘dose’’
for conventional mammogram is definite/
indefinite? See ID at 60–61.
4. Please discuss whether the terms of
degree, as used in the asserted claims of ’379
and ’296 patents, are indefinite. The
Commission is interested in evidence that
would provide an understanding of the terms
to a person of ordinary skill in the art and
the relevant case law.
5. The asserted claims of the ’379 and ’296
patents require a comparison of different xray doses and in particular, to a dose used
for a conventional mammogram. Does the
specification, claims, prosecution history, or
extrinsic record shed light on whether the
comparison is made to a conventional twodimensional system or whether the
comparison is made to the two-dimensional
mode on a device that performs both twodimensional and three-dimensional imaging?
See, e.g., Fujifilm Petition for Review at 17.
6. Would claims 1, 2, and 22 of the ’940
patent be anticipated by the GE Senographe
2000D System and/or Manual if the
Commission were to find that the claims
allow for the anti-scatter grid to be
completely removed? See, e.g., Fujifilm
Petition for Review at 55–59.
The parties are requested to brief only
the discrete issues above, with reference
to the applicable law and evidentiary
record. The parties are not to brief other
issues on review, which are adequately
presented in the parties’ existing filings.
VerDate Sep<11>2014
17:34 Oct 29, 2018
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In connection with the final
disposition of this investigation, the
Commission may (1) issue an order that
could result in the exclusion of the
subject articles from entry into the
United States, and/or (2) issue one or
more cease and desist orders that could
result in the respondents being required
to cease and desist from engaging in
unfair acts in the importation and sale
of such articles. Accordingly, the
Commission is interested in receiving
written submissions that address the
form of remedy, if any, that should be
ordered. If a party seeks exclusion of an
article from entry into the United States
for purposes other than entry for
consumption, the party should so
indicate and provide information
establishing that activities involving
other types of entry either are adversely
affecting it or likely to do so. For
background, see Certain Devices for
Connecting Computers via Telephone
Lines, Inv. No. 337–TA–360, USITC
Pub. No. 2843 (December 1994)
(Commission Opinion).
If the Commission contemplates some
form of remedy, it must consider the
effects of that remedy upon the public
interest. The factors the Commission
will consider include the effect that an
exclusion order and/or cease and desist
orders would have on (1) the public
health and welfare, (2) competitive
conditions in the U.S. economy, (3) U.S.
production of articles that are like or
directly competitive with those that are
subject to investigation, and (4) U.S.
consumers. The Commission is
therefore interested in receiving written
submissions that address the
aforementioned public interest factors
in the context of this investigation.
If the Commission orders some form
of remedy, the U.S. Trade
Representative, as delegated by the
President, has 60 days to approve or
disapprove the Commission’s action.
See Presidential Memorandum of July
21, 2005. 70 FR 43251 (July 26, 2005).
During this period, the subject articles
would be entitled to enter the United
States under bond, in an amount
determined by the Commission and
prescribed by the Secretary of the
Treasury. The Commission is therefore
interested in receiving submissions
concerning the amount of the bond that
should be imposed if a remedy is
ordered.
The Commission has also determined
to extend the target date for completion
of this investigation until January 25,
2019.
Written Submissions: The parties to
the investigation are requested to file
written submissions on the issues
identified in this notice. Parties to the
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investigation, interested government
agencies, and any other interested
parties are encouraged to file written
submissions on the issues of remedy,
the public interest, and bonding. Such
submissions should address the
recommended determination by the ALJ
on public interest, remedy, and
bonding. Complainant and the OUII are
requested to submit proposed remedial
orders for the Commission’s
consideration. Complainant is also
requested to state the date that the
subject patents expire and the HTSUS
numbers under which the accused
products are imported. Complainant is
further requested to supply the names of
known importers of the Respondents’
products at issue in this investigation.
Also specifically, with respect to the
public interest, the Commission
requests briefing on the following issue:
Please discuss whether the accused
Fujifilm products have been proven to be
more effective in screening for breast cancer
than comparable systems available in the
United States (e.g., systems from Hologic,
Siemens, or GE). Please include evidence to
support your position.
The written submissions and
proposed remedial orders must be filed
no later than close of business on
November 5, 2018. Reply submissions
must be filed no later than the close of
business on November 13, 2018.
Opening submissions are limited to 75
pages. Reply submissions are limited to
50 pages. No further submissions on any
of these issues will be permitted unless
otherwise ordered by the Commission.
Persons filing written submissions
must file the original document
electronically on or before the deadlines
stated above and submit eight true paper
copies to the Office of the Secretary by
noon the next day pursuant to section
210.4(f) Of the Commission’s Rules of
Practice and Procedure (19 CFR
2.10.4(f)). Submissions should refer to
the investigation number (‘‘Inv. No.
337–TA–1063’’) in a prominent place on
the cover page and/or the first page. (See
Handbook for Electronic Filing
Procedures, https://www.usitc.gov/
secretary/fed_reg_notices/rules/
handbook_on_electronic_filing.pdf).
Persons with questions regarding filing
should contact the Secretary (202–205–
2000).
Any person desiring to submit a
document to the Commission in
confidence must request confidential
treatment. All such requests should be
directed to the Secretary to the
Commission and must include a full
statement of the reasons why the
Commission should grant such
treatment. See 19 CFR 201.6. Documents
for which confidential treatment by the
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Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices
Commission is properly sought will be
treated accordingly. All information,
including confidential business
information and documents for which
confidential treatment is properly
sought, submitted to the Commission for
purposes of this Investigation may be
disclosed to and used: (i) By the
Commission, its employees and Offices,
and contract personnel (a) for
developing or maintaining the records
of this or a related proceeding, or (b) in
internal investigations, audits, reviews,
and evaluations relating to the
programs, personnel, and operations of
the Commission including under 5
U.S.C. Appendix 3; or (ii) by U.S.
government employees and contract
personnel,1 solely for cybersecurity
purposes. All nonconfidential written
submissions will be available for public
inspection at the Office of the Secretary
and on EDIS.
The authority for the Commission’s
determination is contained in section
337 of the Tariff Act of 1930, as
amended (19 U.S.C. 1337), and in part
210 of the Commission’s Rules of
Practice and Procedure (19 CFR part
210).
By order of the Commission.
Issued: October 24, 2018.
Jessica Mullan,
Attorney Advisor.
[FR Doc. 2018–23618 Filed 10–29–18; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Cambrex High Point, Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before November 29, 2018. Such
persons may also file a written request
for a hearing on the application on or
before November 29, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION:
The Attorney General has delegated
his authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on July 16,
DATES:
2018, Cambrex High Point, Inc., 4180
Mendenhall Oaks Parkway, High Point,
North Carolina 27265–8017 applied to
be registered as an importer of the
following basic class of controlled
substance:
Controlled
substance
Poppy Straw Concentrate.
[FR Doc. 2018–23699 Filed 10–29–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration
ACTION:
Notice of registration.
The registrant listed below
has applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as an importer of
schedule I or schedule II controlled
substances.
SUMMARY:
SUPPLEMENTARY INFORMATION:
The company listed below applied to
be registered as an importer of various
basic classes of controlled substances.
Information on the previously published
notice is listed in the table below. No
comments or objections were submitted
and no requests for hearing were
submitted for this notice.
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Cody Laboratories, Inc. ........................................................................................................................................
83 FR 37524
17:34 Oct 29, 2018
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Published
August 1, 2018.
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the DEA has
granted a registration as an importer for
schedule II controlled substances to the
above listed company.
1 All contract personnel will sign appropriate
nondisclosure agreements.
VerDate Sep<11>2014
II
Dated: October 22, 2018.
John J. Martin,
Assistant Administrator.
FR Docket
treaties, conventions, or protocols in
effect on May 1, 1971. The DEA
investigated the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
physical security systems, verifying the
company’s compliance with state and
9670
Schedule
The company plans to import the
listed controlled substance for clinical
trial narcotic material for bulk
manufacture.
Company
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of the
listed registrant to import the applicable
basic classes of schedule I or II
controlled substances is consistent with
the public interest and with United
States obligations under international
Drug code
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]]>Agencies
[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Pages 54608-54610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23618]
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INTERNATIONAL TRADE COMMISSION
[Inv. No. 337-TA-1063]
Certain X-Ray Breast Imaging Devices and Components Thereof;
Notice of a Commission Determination To Review the Final Initial
Determination In-Part; Extension of the Target Date
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that the U.S. International Trade
Commission has determined to review the final initial determination
(``ID'') in-part and extend the target date for completion of the
investigation until January 25, 2019.
FOR FURTHER INFORMATION CONTACT: Amanda Pitcher Fisherow, Esq., Office
of the General Counsel, U.S. International Trade Commission, 500 E
Street SW, Washington, DC 20436, telephone (202) 205-2737. Copies of
non-confidential documents filed in connection with this investigation
are or will be available for inspection during official business hours
(8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S.
International Trade Commission, 500 E Street SW, Washington, DC 20436,
telephone (202) 205-2000. General information concerning the Commission
may also be obtained by accessing its internet server at https://www.usitc.gov. The public record for this investigation may be viewed
on the Commission's electronic docket (EDIS) at https://edis.usitc.gov.
Hearing-impaired persons are advised that information on this matter
can be obtained by contacting the Commission's TDD terminal on (202)
205-1810.
SUPPLEMENTARY INFORMATION: The Commission instituted this investigation
on August 1, 2017, based on a complaint and supplement, filed on behalf
of Hologic, Inc. of Marlborough, Massachusetts (``Hologic''). 82 FR
35829-24 (Aug. 1, 2017). The complaint, as supplemented, alleges
violations of section 337 based upon the importation into the United
States, the sale for importation, and the sale within the United States
after importation of certain x-ray breast imaging and components
thereof by reason of infringement of certain claims of U.S. Patent No.
7,831,296 (``the '296 patent''); U.S. Patent No. 8,452,379 (``the '379
patent''); U.S. Patent No. 7,688,940 (``the '940 patent''); U.S. Patent
No. 7,986,765 (``the '765 patent''); and U.S. Patent No. 7,123,684
(``the '684 patent''). The complaint further alleges that an industry
in the United States exists as required by section 337. The Notice of
Investigation named FUJIFILM Corporation of Tokyo, Japan; FUJIFILM
Medical Systems USA, Inc. of Stamford, Connecticut; and FUJIFILM Techno
Products Co., Ltd. of Hanamaki-Shi Iwate, Japan (collectively,
``Fujifilm'') as respondents. The Office of Unfair Import
Investigations (``OUII'') was named as a party. On January 18, 2018,
the '765 patent was terminated in its entirety from the investigation.
See Order No. 18 (Jan. 18, 2018) (unreviewed).
On July 26, 2018, the ALJ issued the final ID and found a violation
of section 337 has occurred. On August 8, 2018, Fujifilm and OUII each
filed petitions for review of the final ID. On August 16, 2018, OUII
and Hologic filed responses to the petitions for review.
Having examined the record of this investigation, including the
ALJ's final ID, the petitions for review, and the responses thereto,
the Commission has determined to review the final ID in part.
Specifically, the Commission has determined to review the ID's findings
on (1) in rem jurisdiction and importation; (2) all findings concerning
infringement; (3) claim construction of the ``dose'' limitations of the
'379 and '296 patents; (3) claim construction of the limitations
including terms of degree (i.e., similar, substantially less, much
less, and substantially higher) in the '379 and '296 patents; (4) the
``control''/``motion control'' and ``processor'' limitations of the
'379 and '296 patents; (5) the technical prong of domestic industry for
the '379 and '296 patents; (6) claim construction of the ``control''
limitations of the '940 patent;
[[Page 54609]]
(7) anticipation by the Kopans 2000 Army Report for the '379 and '296
patents; (8) anticipation by MGH/GE Prototype #2 for the '379 and '296
patents; (9) obviousness based on the publicly available MGH/GE
References related to the MGH/GE Prototypes for the '379 and '296
patents; (10) anticipation by GE Senographe 2000D System and/or Manual
for the '940 patent; (11) obviousness based on GE Senographe 2000D
System and/or Manual with Dornheim for the '940 patent; (12)
obviousness based on Niklason article, the GE Senographe DMR System and
Dornheim for the '940 patent; and (13) indefiniteness under 35 U.S.C.
112 for the '940 patent.
In connection with its review, the Commission is interested in
responses to the following questions:
1. Was the argument that ``conventional mammogram,'' as used in
the '379 and '296 patents, should be construed to include diagnostic
images waived? See, e.g., OUII Petition for Review at 9-12;
Complainant's Resp. to OUII Petition at 2-3.
2. Does the claimed ``dose'' for a ``conventional mammogram,''
as used in the '379 and '296 patents, meet the indefiniteness
standard set forth in Nautilus, Inc. v. Biosig Instruments, Inc.,
134 S. Ct. 2120 (2014). The Commission is most interested in a
discussion of the relevant Federal Circuit precedent.
3. To what extent are the ID's findings on whether the ``dose''
for a conventional mammogram has changed over time necessary in
establishing whether the ``dose'' for conventional mammogram is
definite/indefinite? See ID at 60-61.
4. Please discuss whether the terms of degree, as used in the
asserted claims of '379 and '296 patents, are indefinite. The
Commission is interested in evidence that would provide an
understanding of the terms to a person of ordinary skill in the art
and the relevant case law.
5. The asserted claims of the '379 and '296 patents require a
comparison of different x-ray doses and in particular, to a dose
used for a conventional mammogram. Does the specification, claims,
prosecution history, or extrinsic record shed light on whether the
comparison is made to a conventional two-dimensional system or
whether the comparison is made to the two-dimensional mode on a
device that performs both two-dimensional and three-dimensional
imaging? See, e.g., Fujifilm Petition for Review at 17.
6. Would claims 1, 2, and 22 of the '940 patent be anticipated
by the GE Senographe 2000D System and/or Manual if the Commission
were to find that the claims allow for the anti-scatter grid to be
completely removed? See, e.g., Fujifilm Petition for Review at 55-
59.
The parties are requested to brief only the discrete issues above,
with reference to the applicable law and evidentiary record. The
parties are not to brief other issues on review, which are adequately
presented in the parties' existing filings.
In connection with the final disposition of this investigation, the
Commission may (1) issue an order that could result in the exclusion of
the subject articles from entry into the United States, and/or (2)
issue one or more cease and desist orders that could result in the
respondents being required to cease and desist from engaging in unfair
acts in the importation and sale of such articles. Accordingly, the
Commission is interested in receiving written submissions that address
the form of remedy, if any, that should be ordered. If a party seeks
exclusion of an article from entry into the United States for purposes
other than entry for consumption, the party should so indicate and
provide information establishing that activities involving other types
of entry either are adversely affecting it or likely to do so. For
background, see Certain Devices for Connecting Computers via Telephone
Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843 (December 1994)
(Commission Opinion).
If the Commission contemplates some form of remedy, it must
consider the effects of that remedy upon the public interest. The
factors the Commission will consider include the effect that an
exclusion order and/or cease and desist orders would have on (1) the
public health and welfare, (2) competitive conditions in the U.S.
economy, (3) U.S. production of articles that are like or directly
competitive with those that are subject to investigation, and (4) U.S.
consumers. The Commission is therefore interested in receiving written
submissions that address the aforementioned public interest factors in
the context of this investigation.
If the Commission orders some form of remedy, the U.S. Trade
Representative, as delegated by the President, has 60 days to approve
or disapprove the Commission's action. See Presidential Memorandum of
July 21, 2005. 70 FR 43251 (July 26, 2005). During this period, the
subject articles would be entitled to enter the United States under
bond, in an amount determined by the Commission and prescribed by the
Secretary of the Treasury. The Commission is therefore interested in
receiving submissions concerning the amount of the bond that should be
imposed if a remedy is ordered.
The Commission has also determined to extend the target date for
completion of this investigation until January 25, 2019.
Written Submissions: The parties to the investigation are requested
to file written submissions on the issues identified in this notice.
Parties to the investigation, interested government agencies, and any
other interested parties are encouraged to file written submissions on
the issues of remedy, the public interest, and bonding. Such
submissions should address the recommended determination by the ALJ on
public interest, remedy, and bonding. Complainant and the OUII are
requested to submit proposed remedial orders for the Commission's
consideration. Complainant is also requested to state the date that the
subject patents expire and the HTSUS numbers under which the accused
products are imported. Complainant is further requested to supply the
names of known importers of the Respondents' products at issue in this
investigation. Also specifically, with respect to the public interest,
the Commission requests briefing on the following issue:
Please discuss whether the accused Fujifilm products have been
proven to be more effective in screening for breast cancer than
comparable systems available in the United States (e.g., systems
from Hologic, Siemens, or GE). Please include evidence to support
your position.
The written submissions and proposed remedial orders must be filed
no later than close of business on November 5, 2018. Reply submissions
must be filed no later than the close of business on November 13, 2018.
Opening submissions are limited to 75 pages. Reply submissions are
limited to 50 pages. No further submissions on any of these issues will
be permitted unless otherwise ordered by the Commission.
Persons filing written submissions must file the original document
electronically on or before the deadlines stated above and submit eight
true paper copies to the Office of the Secretary by noon the next day
pursuant to section 210.4(f) Of the Commission's Rules of Practice and
Procedure (19 CFR 2.10.4(f)). Submissions should refer to the
investigation number (``Inv. No. 337-TA-1063'') in a prominent place on
the cover page and/or the first page. (See Handbook for Electronic
Filing Procedures, https://www.usitc.gov/secretary/fed_reg_notices/rules/handbook_on_electronic_filing.pdf). Persons with questions
regarding filing should contact the Secretary (202-205-2000).
Any person desiring to submit a document to the Commission in
confidence must request confidential treatment. All such requests
should be directed to the Secretary to the Commission and must include
a full statement of the reasons why the Commission should grant such
treatment. See 19 CFR 201.6. Documents for which confidential treatment
by the
[[Page 54610]]
Commission is properly sought will be treated accordingly. All
information, including confidential business information and documents
for which confidential treatment is properly sought, submitted to the
Commission for purposes of this Investigation may be disclosed to and
used: (i) By the Commission, its employees and Offices, and contract
personnel (a) for developing or maintaining the records of this or a
related proceeding, or (b) in internal investigations, audits, reviews,
and evaluations relating to the programs, personnel, and operations of
the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S.
government employees and contract personnel,\1\ solely for
cybersecurity purposes. All nonconfidential written submissions will be
available for public inspection at the Office of the Secretary and on
EDIS.
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\1\ All contract personnel will sign appropriate nondisclosure
agreements.
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The authority for the Commission's determination is contained in
section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and
in part 210 of the Commission's Rules of Practice and Procedure (19 CFR
part 210).
By order of the Commission.
Issued: October 24, 2018.
Jessica Mullan,
Attorney Advisor.
[FR Doc. 2018-23618 Filed 10-29-18; 8:45 am]
BILLING CODE 7020-02-P
