[Federal Register Volume 84, Number 160 (Monday, August 19, 2019)]
[Notices]
[Pages 42949-42950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17692]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1116]


Certain Blood Cholesterol Testing Strips and Associated Systems 
Containing the Same; Commission Determination To Review in Part a Final 
Initial Determination Finding a Violation of Section 337; Schedule for 
Filing Written Submissions on the Issues Under Review and on Remedy, 
the Public Interest, and Bonding; 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 in part a final initial 
determination (``ID'') issued by the presiding administrative law judge 
(``ALJ''), finding a violation of section 337 of the Tariff Act of 
1930. The Commission requests briefing from the parties on certain 
issues under review, as indicated in this notice. The Commission also 
requests briefing from the parties, interested persons, and government 
agencies on the issues of remedy, the public interest, and bonding. The 
Commission has also determined to extend the target date for the 
completion of the above-captioned investigation to October 21, 2019.

FOR FURTHER INFORMATION CONTACT: Robert Needham, Office of the General 
Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 708-5468. 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 (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 June 5, 2018, based on a complaint filed by PTS. 83 FR 23087-88. The 
complaint alleges violations of section 337 in the importation into the 
United States, the sale for importation, and the sale after importation 
within the United States after importation of certain blood cholesterol 
testing strips and associated systems containing the same by reason of 
infringement of one or more claims of U.S. Patent Nos. 7,625,721 (``the 
'721 patent''); 7,625,721 (``the '721 patent''); and 7,494,818 (``the 
'818 patent''). Id. at 26087. The notice of investigation named as 
respondents ACON Laboratories, Inc. of San Diego, California, and ACON 
Biotech (Hangzhou) Co., Ltd. of Hangzhou, China (collectively, 
``ACON''). The Office of Unfair Import Investigations is not a party to 
the investigation. Id. at 26088.
    The Commission subsequently terminated the investigation with 
respect to claims 10, 13, 14, and 20 of the '397 patent based on PTS's 
withdrawal of those allegations. See Order. No. 7 (Sept. 10, 2018), not 
reviewed, Notice (Sept. 25, 2018); Order No. 10 (Jan. 31, 2019), not 
reviewed, Notice (Feb. 21, 2019). The Commission also terminated the 
investigation for infringement purposes with respect to claim 17 of the 
'397 patent; claims 2, 3, 13, and 14 of the '721 patent; and claim 10 
of the '818 patent based on PTS's withdrawal of allegations. Order No. 
14 (Feb. 14, 2019), not reviewed, Notice (Mar. 5, 2019). Finally, the 
Commission terminated the investigation with respect to claims 1-3, 5, 
and 18 of the '397 patent and claims 5, 7, and 9 of the '721 patent 
based on PTS's withdrawal of allegations. Order No. 15 (Mar. 12, 2019), 
not reviewed, Notice (April 9, 2019). Accordingly, at the time of the 
Final ID, PTS asserted for infringement claim 19 of the '397 patent; 
claims 1, 4, 6, 8, and 15 of the '721 patent; and claims 8, 9, and 11 
of the '818 patent. Final ID at 43.
    On February 13, 2019, the ALJ issued an initial determination 
granting a motion for summary determination that PTS established 
sufficient investments and activities with respect to the PTS articles 
protected by the asserted patents to satisfy the domestic industry 
requirement under section 337(a)(3)(A), (B), and (C) for each of three 
asserted patents. Order No. 13 (Feb. 13, 2019). No party petitioned for 
review of the ID, and the Commission declined to review the ID. Notice 
(Mar. 12, 2019).
    On June 4, 2019, the ALJ issued a final ID finding a violation of 
section 337 with respect to the '397 and '721 patents, and no violation 
with respect to the '818 patent. The ID found that ACON infringed claim 
19 of the '397 patent and claims 1, 4, 6, 7, and 15 of the '721 patent, 
but does not infringe claims 8, 9, and 11 of the '818 patent. The ID 
also found that PTS showed that its domestic industry articles practice 
certain claims of each of the three asserted patents, and that no 
asserted claims are shown to be invalid by clear and convincing 
evidence.
    On June 17, 2019, ACON petitioned for review of the final ID with 
respect to the '397 and '721 patents, and contingently petitioned for 
review of the final ID with respect to the '818 patent. PTS did not 
file a petition for review, and, on June 25, 2019, PTS filed a response 
to ACON's petition.
    Having examined the record of this investigation, including the 
final ID, the petition 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 following issues: (1) 
Whether ACON Laboratories, Inc.'s use of the accused products in the 
United States constitutes a violation of 19 U.S.C. 1337(a)(1)(B)(i); 
(2) the final ID's construction of ``reacting HDL . . . without 
precipitating said one or more non-selected analytes'' in the '721 
patent, as well as related findings on infringement, the domestic 
industry, and invalidity; and (3) the final ID's finding that all of 
the asserted claims of the '721 patent are not shown to be invalid for 
a lack of enablement. The Commission has determined not to review any 
other findings presented in the final ID.
    The Commission has also determined to extend the target date for 
the completion of the investigation until October 21, 2019.
    In connection with its review, the Commission is interested in 
briefing on following issues:


[[Page 42950]]


    1. Please address whether ACON Laboratories, Inc.'s direct 
infringement through its use of the accused imported products in the 
United States is actionable under section 337(a)(1)(B)(i), 
regardless of any indirect infringement by ACON Biotech (Hangzhou) 
Co., Ltd. See PTS Post-Hearing Initial Br. at 2, n.2. and 4; 
Suprema, Inc. v. Int'l Trade Comm'n, 796 F.3d 1338 (Fed. Cir. 2015) 
(en banc); Certain Electronic Devices with Image Processing Systems, 
Components Thereof, and Associated Software, Inv. No. 337-TA-724, 
Comm'n Op. (Public Version) (Dec. 21, 2011).
    2. Please explain whether it is appropriate to construe the 
claim term ``precipitating'' to mean ``separating a substance or 
material from a solution,'' with the clarification that 
``complexing'' does not constitute ``precipitating'' in the context 
of the '721 patent.
    3. Please explain whether and how the adoption of the above 
proposed construction of ``precipitating'' would affect the issues 
of infringement, the domestic industry, and invalidity in this 
investigation.
    4. Please explain whether the specification enables the full 
scope of claims 1, 4, 6, 8, and 15 of the '721 patent. In your 
discussion, please address and cite record evidence regarding 
whether a person of ordinary skill in the art at the time of filing 
of the application resulting in the '721 patent would be able to 
practice the claimed invention without undue experimentation using 
something other than dextran sulfate. Additionally, please explain 
whether ACON preserved before the ALJ its enablement argument 
regarding the enablement of the full scope of the claims.

    The parties are invited to brief only the discrete issues described 
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 a cease and desist order that could result in the respondent 
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, Comm'n Op. at 7-10 (December 
1994).
    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 a cease and desist order 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.
    Written Submissions: The Commission requests that the parties to 
the investigation file written submissions on the issues identified in 
this notice. The Commission encourages parties to the investigation, 
interested government agencies, and any other interested parties 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 remedy and bonding, which issued on June 4, 
2019. The Commission further requests that PTS submit proposed remedial 
orders, state the date when the '397 and '721 patents expire, provide 
the HTSUS numbers under which the subject articles are imported, and 
supply a list of known importers of the subject article. The written 
submissions, exclusive of any exhibits, must not exceed 50 pages, and 
must be filed no later than close of business on August 27, 2019. Reply 
submissions must not exceed 25 pages, and must be filed no later than 
the close of business on September 3, 2019. No further submissions on 
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 8 
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 210.4(f)). Submissions should refer to the 
investigation number (``Inv. No. 337-TA-1116'') 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 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: August 13, 2019.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2019-17692 Filed 8-16-19; 8:45 am]
 BILLING CODE 7020-02-P