[Federal Register Volume 85, Number 78 (Wednesday, April 22, 2020)]
[Notices]
[Pages 22443-22444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08480]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1116]


Certain Blood Cholesterol Testing Strips and Associated Systems 
Containing the Same; Commission's Final Determination Finding a 
Violation of Section 337; Issuance of a Limited Exclusion Order; 
Termination of Investigation

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 found a violation of section 337 of the Tariff Act of 
1930, as amended, by ACON Biotech (Hangzhou) Co., Ltd. of Hangzhou, 
China, and ACON Laboratories, Inc., of San Diego, California, and has 
determined to issue a limited exclusion order. The investigation is 
terminated.

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 may 
be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email 
[email protected]. General information concerning the Commission may 
also be obtained by accessing its internet server (https://www.usitc.gov). Hearing-impaired persons are advised that information 
on this matter can be obtained by contacting the Commission's TDD 
terminal, telephone (202) 205-1810.

SUPPLEMENTARY INFORMATION: The Commission instituted this investigation 
on June 5, 2018, based on a complaint filed by Polymer Technology 
Systems, Inc. of Indianapolis, Indiana (``PTS''). 83 FR 26087-88. 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. 7,087,397 (``the 
'397 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 (``ACON 
Labs''), and ACON Biotech (Hangzhou) Co., Ltd. of Hangzhou, China 
(``ACON Bio'') (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 presiding administrative law judge 
(``ALJ'') issued an initial determination (``ID'') granting a summary 
determination that PTS satisfied the economic prong of the domestic 
industry requirement for each of three asserted patents under section 
337(a)(3)(A), (B), and (C). 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 ALJ found that ACON infringed 
claim 19 of the '397 patent and claims 1, 4, 6, 7, and 15 of the '721 
patent, but did not infringe claims 8, 9, and 11 of the '818 patent. 
The ALJ also found that PTS satisfies the domestic industry requirement 
with respect to all three asserted patents, and that no asserted claims 
were shown to be invalid by clear and convincing evidence.
    On June 17, 2019, ACON petitioned for review of the final ID with 
respect

[[Page 22444]]

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.
    On August 13, 2019, the Commission determined to review the Final 
ID in part. Specifically, the Commission determined to review the 
following issues: (1) Whether ACON Labs' 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 did not review any other findings 
presented in the final ID.
    The Commission also sought briefing from the parties on four issues 
and on remedy, bonding, and public interest. On August 27, 2019, PTS 
and ACON filed their initial submissions in response to the 
Commission's request for briefing. On September 3, 2019, PTS and ACON 
filed their reply submissions in response to the Commission's request 
for briefing. No third-party submissions on remedy, bonding, or the 
public interest were received.
    Having examined the record of this investigation, including the 
Final ID, the petition, response, and other submissions from the 
parties, the Commission has determined that PTS has shown a violation 
of section 337 by ACON Bio and ACON Labs with respect to the '397 and 
'721 patents. The Commission has also determined to construe the term 
``precipitating'' to mean ``separating a solid substance or material 
from a solution by a chemical reaction,'' and finds that, under this 
construction, PTS established infringement and the domestic industry 
requirement with respect to claims 1, 4, 6, 8, and 15 of the '721 
patent, and that ACON failed to show that any claim is invalid by clear 
and convincing evidence. The Commission's determinations are explained 
more fully in the accompanying Opinion. All other findings in the ID 
under review that are consistent with the Commission's determinations 
are affirmed.
    The Commission has determined that the appropriate form of relief 
in this investigation is a limited exclusion order with respect to ACON 
Bio and ACON Labs prohibiting the importation of imported blood 
cholesterol testing strips and associated systems containing the same 
that are covered by one or more of claim 19 of the '397 patent and 
claims 1, 4, 6, 8, and 15 of the '721 patent. The Commission has 
further determined that the public interest factors enumerated in 
subsection 337(d)(1) (19 U.S.C. 1337(d)(1)) do not preclude the 
issuance of the limited exclusion order. Finally, the Commission has 
determined that the bond for importation during the period of 
Presidential review shall be in the amount of zero percent of the 
entered value of such articles.
    The Commission's notice, order, and opinion were delivered to the 
President and to the United States Trade Representative on the day of 
their issuance. The Commission has also notified the Secretary of the 
Treasury and Customs and Border Protection of the order. The 
investigation is hereby terminated.
    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: April 16, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020-08480 Filed 4-21-20; 8:45 am]
BILLING CODE 7020-02-P