[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Notices]
[Pages 78905-78907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30584]


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INTERNATIONAL TRADE COMMISSION

[Investigation Nos. 337-TA-890]


Certain Sleep-Disordered Breathing Treatment Systems and 
Components Thereof; Notice of the Commission's Final Determination; 
Issuance of a Limited Exclusion Order and Cease and Desist Orders; 
Termination of the 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 in this investigation 
and has (1) issued a limited exclusion order prohibiting importation of 
infringing sleep-disordered breathing treatment systems and components 
thereof and (2) issued cease and desist orders directed to domestic 
respondents.

FOR FURTHER INFORMATION CONTACT: Panyin A. Hughes, Office of the 
General Counsel, U.S. International Trade Commission, 500 E Street SW., 
Washington, DC 20436, telephone (202) 205-3042. 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).

[[Page 78906]]

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 August 23, 2013, based on a complaint filed by ResMed Corporation of 
San Diego, California; ResMed Incorporated of San Diego, California; 
and ResMed Limited of New South Wales, Australia (collectively, 
``ResMed''). 78 FR 52564 (Aug. 23, 2013). The complaint alleged 
violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in 
the importation into the United States, the sale for importation, and 
the sale within the United States after importation of certain sleep-
disordered breathing treatment systems and components thereof that 
infringe one or more of claims 32-37, 53, 79, 80, and 88 of U.S. Patent 
No. 7,997,267 (``the '267 patent''); claims 1-7 of U.S. Patent No. 
7,614,398 (``the '398 patent''); claim 1 of U.S. Patent No. 7,938,116 
(``the '116 patent''); claims 30, 37, and 38 of U.S. Patent No. 
7,341,060 (the '060 patent); claims 1, 3, 5, 11, 28, 30, 31, and 56 of 
U.S. Patent No. 8,312,883 (``the '883 patent''); claims 1, 3, 6, 7, 9, 
29, 32, 35, 40, 42, 45, 50, 51, 56, 59, 89, 92, 94, and 96 of U.S. 
Patent No. 7,178,527 (the '527 patent); claims 19-24, 26, 29-36, and 
39-41 of U.S. Patent No. 7,950,392 (the '392 patent); and claims 13, 
15, 16, 26-28, 51, 52, and 55 of U.S. Patent No. 7,926,487 (``the '487 
patent''). The notice of investigation named the following respondents: 
BMC Medical Co., Ltd. of Beijing, China; 3B Medical, Inc. of Lake 
Wales, Florida; and 3B Products, L.L.C., of Lake Wales, Florida 
(collectively ``Respondents''). The Office of Unfair Import 
Investigations (``OUII'') is participating in the investigation.
    On January 9, 2014, the ALJ issued an ID granting a motion by 
ResMed to amend the complaint and notice of investigation to substitute 
U.S. Patent No. RE 44,453 (``the '453 patent'') for the '398 patent and 
to terminate the investigation as to the '398 patent. See Order No. 7 
(Jan. 9, 2014). The Commission determined not to review the ID. See 
Notice of Commission Determination Not to Review an Initial 
Determination Granting the Complainants' Motion to Amend the Complaint 
and Notice of Investigation (Feb. 10, 2014); 79 FR 9000-01 (Feb. 14, 
2014).
    On February 24, 2014, the ALJ issued an ID granting a motion by 
ResMed to withdraw its allegations with respect to the '116 patent. See 
Order No. 11 (Feb. 24, 2014). The Commission determined not to review 
the ID. See Notice of Commission Determination Not to Review an Initial 
Determination Granting the Complainants' Motion to Partially Terminate 
the Investigation by Withdrawing Allegations with Respect to U.S. 
Patent No. 7,938,116 (March 11, 2014).
    On March 18, 2014, the ALJ granted a motion by ResMed to terminate 
the investigation as to claims 26-28 of the '487 Patent. See Order No. 
20 (Mar 18, 2012). The Commission determined not to review the ID. See 
Notice of Commission Determination Not to Review an Initial 
Determination Granting Complainants' Unopposed Motion for Partial 
Termination of the Investigation by Withdrawal of Claims 26-28 of U.S. 
Patent No. 7,926,487 (Apr. 29, 2014).
    On August 21, 2014, the ALJ issued his final ID, finding a 
violation of section 337 by Respondents with respect to certain 
asserted claims of the '392, '267, '060, '883, '527, and '453 patents. 
The ALJ found no violation of section 337 with respect to the asserted 
claims of the '487 patent. Specifically, the ALJ found that the 
Commission has subject matter jurisdiction, in rem jurisdiction over 
the accused products, and in personam jurisdiction over the 
respondents. ID at 10-11. The parties stipulated to importation of the 
accused products and the ALJ found that the importation requirement of 
section 337 (19 U.S.C. 1337(a)(1)(B)) has been satisfied. Id. at 3. The 
ALJ found that the accused products infringe asserted claims 1, 9, 32, 
89, and 92 of the '527 patent; asserted claims 19, 21, 29, 32, and 36 
of the '392 patent; asserted claims 32-34 and 53 of the '267 patent; 
asserted claims 30, 37, and 38 of the '060 patent; asserted claims 1, 
3, 5, 11, 28, 30, 31, and 56 of the '883 patent; and asserted claim 2 
of the '453 patent. See ID at 23, 46, 57-58, 71-78, 95, 99, and 102. 
The ALJ found that Respondents failed to establish by clear and 
convincing evidence that the asserted claims of the '392, '267, '060, 
'883, '527, or claim 2 of the '453 patents were invalid in light of the 
cited prior art references. See id. at 25-45, 48-55, 96, and 100. The 
ALJ concluded that the accused products satisfy each limitation of 
claims 4 and 7 of the '453 patent but found those claims invalid in 
view of the prior art. See id. at 103-139. The ALJ also found that the 
accused products satisfy each limitation of asserted claims 13, 51, 52, 
and 55 of the '487 patent, but found those claims invalid in view of 
the prior art. See id. at 78-92. The ALJ further found that ResMed 
established the existence of a domestic industry that practices the 
asserted patents under 19 U.S.C. 1337(a)(2). See ID at 139-188.
    On September 3, 2014, Respondents and the Commission investigative 
attorney filed petitions for review of the ID. That same day, ResMed 
filed a contingent petition for review of the ID. On September 11, 
2014, the parties filed responses to the various petitions and 
contingent petition for review.
    On October 16, 2014, the Commission determined to review the final 
ID in part. 79 FR 63163-65 (Oct. 22, 2014). Specifically, with respect 
to the '487 patent, the Commission determined to review the ALJ's 
construction of the claim term ``gas washout vent'' and construed the 
limitation to mean ``a vent comprising a thin air permeable membrane 
extending across an opening for exhausting gas to the atmosphere.'' As 
a result of the new claim construction, the Commission determined to 
review the ALJ's findings on infringement, invalidity, and the 
technical prong of the domestic industry requirement. Regarding the 
'453 patent, the Commission determined to review (1) the ALJ's 
construction of the claim limitation ``a retaining mechanism configured 
to secure the connecting structure to the CPAP apparatus'' and struck 
the ID's requirement that the claimed ``retaining mechanism'' must 
include an arrangement of moving parts; (2) the ALJ's finding that the 
prior art REMstar device does not anticipate the asserted claims of the 
'453 patent; and (3) the ALJ's findings on infringement and the 
technical prong of the domestic industry requirement. The Commission 
also determined to review the ID's findings and conclusions regarding 
the economic prong of the domestic industry requirement under 19 U.S.C. 
1337(a)(3)(C).
    On October 31, 2014, the parties filed written submissions on the 
issues under review, remedy, the public interest, and bonding. On 
November 7, 2014, the parties filed reply submissions.
    Having examined the record of this investigation, including the 
ALJ's final ID, with respect to the '487 patent, the Commission has 
determined that under its construction of the claim term ``gas washout 
vent'' to mean ``a vent comprising a thin air permeable membrane 
extending across an opening for exhausting gas to the atmosphere,'' a 
violation of section 337 has not occurred because, as all the parties 
agree, ResMed failed to show that its domestic industry products 
practice the

[[Page 78907]]

'487 patent. To conserve resources, the Commission has determined to 
take no position on infringement and validity as it pertains to the 
'487 patent. Regarding the '453 patent, the Commission has determined 
that the prior art REMstar device anticipates the asserted claims of 
the '453 patent under the Commission's construction of the claim 
limitation ``a retaining mechanism configured to secure the connecting 
structure to the CPAP apparatus'' to mean ``one or more parts for 
holding in place the CPAP apparatus that is configured to attach the 
connecting structure to the CPAP apparatus.'' Given that Commission's 
construction is broader than the ALJ's construction, the Commission has 
determined to affirm the ALJ's infringement and domestic industry, 
technical prong, findings. With respect to domestic industry the 
Commission has determined to vacate the ID's findings and conclusion 
that ResMed established a domestic industry under 19 U.S.C. 
1337(a)(3)(C).
    Having found a violation of section 337 in this investigation, the 
Commission has determined that the appropriate form of relief is: (1) A 
limited exclusion order prohibiting the unlicensed entry of sleep-
disordered breathing treatment systems and components thereof that 
infringe one or more of claims 1, 9, 32, 89, and 92 of the '527 patent; 
claims 19, 21, 29, 32, and 36 of the '392 patent; claims 32, 33, 34, 
and 53 of the '267 patent; claims 30, 37, and 38 of the '060 patent; 
and claims 1, 3, 5, 11, 28, 30, 31, and 56 of the '883 patent that are 
manufactured by, or on behalf of, or are imported by or on behalf of 
BMC Medical Co., Ltd., 3B Medical, Inc., or 3B Products L.L.C. or any 
of their affiliated companies, parents, subsidiaries, agents, or other 
related business entities, or their successors or assigns, except for 
service and replacement parts for customers that purchased their 
covered products prior to the date the exclusion order becomes final; 
and (2) cease and desist orders prohibiting domestic respondents BMC 
Medical Co., Ltd., 3B Medical, Inc. from conducting any of the 
following activities in the United States: Importing, selling, 
marketing, advertising, distributing, transferring (except for 
exportation), and soliciting U.S. agents or distributors for, sleep-
disordered breathing treatment systems and components thereof covered 
by claims 1, 9, 32, 89, and 92 of the '527 patent; claims 19, 21, 29, 
32, and 36 of the '392 patent; claims 32, 33, 34, and 53 of the '267 
patent; claims 30, 37, and 38 of the '060 patent; and claims 1, 3, 5, 
11, 28, 30, 31, and 56 of the '883 patent. The proposed cease and 
desist orders include the following exemptions: (1) If in a written 
instrument, the owner of the patents authorizes or licenses such 
specific conduct, or such specific conduct is related to the 
importation or same of covered products by or for the United States; or 
(2) conduct limited to the provision of service and replacement parts 
for customers that purchased their covered products prior to the date 
this Order becomes final within the meaning of 19 U.S.C. 1337(j)(4).
    The Commission has also determined that the public interest factors 
enumerated in section 337(d) and (f) (19 U.S.C. 1337(d) and (f)) do not 
preclude issuance of the limited exclusion order or cease and desist 
orders. Finally, the Commission has determined that a bond in the 
amount of 65 percent of entered value is required to permit temporary 
importation during the period of Presidential review (19 U.S.C. 
1337(j)) of sleep-disordered breathing treatment systems and components 
thereof that are subject to the limited exclusion order. The 
Commission's orders and opinion were delivered to the President and to 
the United States Trade Representative on the day of their issuance.
    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: December 23, 2014.
Jennifer Rohrbach,
Supervisory Attorney.
[FR Doc. 2014-30584 Filed 12-30-14; 8:45 am]
BILLING CODE 7020-02-P