[Federal Register Volume 79, Number 142 (Thursday, July 24, 2014)]
[Notices]
[Pages 43067-43068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-17394]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-879]


Certain Sleep-Disordered Breathing Treatment Systems and 
Components Thereof; Commission Determination To Review an Initial 
Advisory Opinion in its Entirety; Issuance of Commission Advisory 
Opinion

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 presiding administrative law 
judge (``ALJ'')'s initial advisory opinion, and to issue a modified 
advisory opinion in the above-captioned investigation.

FOR FURTHER INFORMATION CONTACT: Cathy Chen, Office of the General 
Counsel, U.S. International Trade Commission, 500 E Street SW., 
Washington, DC 20436, telephone (202) 205-2392. 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 (http://www.usitc.gov). The public record for this investigation may be viewed 
on the Commission's electronic docket (EDIS) at http://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 April 25, 2013, based on a complaint filed on March 28, 2013, and 
supplemented on April 19, 2013, on behalf of ResMed Corp. of San Diego, 
California; ResMed Inc. of San Diego, California; and ResMed Ltd. of 
Australia (collectively, ``ResMed''). 78 FR 25475 (May 1, 2013). The 
complaint alleged violations of Section 337 of the Tariff Act of 1930, 
as amended, 19 U.S.C. 1337, in the sale for importation, importation, 
or sale within the United States after importation of certain sleep-
disordered breathing treatment systems and components thereof by reason 
of infringement of claims 1, 2, 4, 5, 17, and 28 of U.S. Patent No. 
6,216,691; claims 1 and 20 of U.S. Patent No. 6,935,337 (``the '337 
patent''); claim 15 of U.S. Patent No. 7,159,587 (``the '587 patent''); 
claims 1, 5, 6, 11, 12, 18-20, 35, and 36 of U.S. Patent No. 7,487,772; 
claims 1-7 of U.S. Patent No. 7,614,398; claims 59, 60, 63, and 72-75 
of U.S. Patent No. 7,743,767; and claims 17, 21-24, 29, and 32-37 of 
U.S. Patent No. 7,997,267. The Commission's notice of investigation 
named as respondents Apex Medical Corp. of New Taipei City, Taiwan and 
Apex Medical USA Corp. of Brea, California (collectively, ``Apex''), 
and Medical Depot Inc., d/b/a Drive Medical Design & Manufacturing of 
Port Washington, New York. The Office of

[[Page 43068]]

Unfair Import Investigations (``OUII'') participated in the original 
investigation.
    Medical Depot Inc. and Apex were terminated from the original 
investigation on the basis of consent orders. Order Nos. 8 (unreviewed 
by the Commission, July 18, 2013) and 11 (unreviewed by the Commission, 
Aug. 8, 2013).
    On September 23, 2013, Apex filed a request for an advisory opinion 
under Commission Rule 210.79 (19 CFR 210.79) that would declare that 
its redesigned iCH and XT CPAP humidifiers and WiZARD 220 mask are 
outside the scope of the Commission's August 8, 2013 Consent Order. On 
December 11, 2013, the Commission determined to institute an advisory 
opinion proceeding based on Apex's request. 78 FR 76320-21 (Dec. 17, 
2013). ResMed and OUII both participated in the advisory opinion 
proceeding.
    On June 3, 2014, the ALJ issued an initial advisory opinion 
(``IAO'') finding that Apex's redesigned iCH and XT CPAP humidifiers 
are covered, and Apex's redesigned WiZARD 220 mask is not covered, by 
the Consent Order. Even though Apex requested the advisory opinion, the 
ALJ placed the burden of proof on the patent owner, ResMed, in view of 
the Supreme Court's recent decision in Medtronic, Inc. v. Mirowski 
Family Ventures, LLC, 134 S. Ct. 843 (2014). However, the ALJ stated 
that the outcome of this particular advisory opinion proceeding was not 
dependent on which party carried the burden of proof. In addition, the 
ALJ found that the iCH CPAP humidifier infringes claim 20 of the '337 
patent both literally and under the doctrine of equivalents, and that 
the XT CPAP humidifier infringes claim 20 of the '337 patent under the 
doctrine of equivalents. The ALJ also found that the WiZARD 220 mask 
does not infringe claim 15 of the '587 patent.
    ResMed, Apex, and OUII each filed a petition for review of the IAO 
on June 16, 2014. They each filed a response to the other petitions for 
review on June 23, 2014.
    Having reviewed the IAO, the record evidence, and the parties' 
submissions, the Commission has determined to continue to place the 
burden of proof in an advisory opinion proceeding on the party that 
requested the advice. Accordingly, in this proceeding, Apex must carry 
the burden of proving that its redesigned products are outside the 
scope of the Consent Order. The Commission has also determined to 
adopt, with modified reasoning, the ALJ's finding that Apex's 
redesigned iCH CPAP humidifier is covered, and the ALJ's finding that 
Apex's redesigned WiZARD 220 mask is not covered, by the Consent Order. 
The Commission has further determined Apex's redesigned XT CPAP 
humidifier is not covered by the Consent Order, thereby reversing the 
ALJ's finding on this point. A modified advisory opinion will follow 
shortly.
    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 section 210 of the Commission's Rules of Practice and Procedure (19 
CFR part 210).

    Issued: July 18, 2014.

    By order of the Commission.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2014-17394 Filed 7-23-14; 8:45 am]
BILLING CODE 7020-02-P