[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.

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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, http://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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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