[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