Certain Smart Wearable Devices, Systems, and Components Thereof; Notice of a Commission Determination To Review in Part a Final Initial Determination; Request for Written Submissions on Remedy, the Public Interest, and Bonding

3 days ago 1

The Commission instituted this investigation on April 17, 2024, based on a complaint filed on behalf of Ouraring, Inc. of San Francisco, California, and Ōura Health Oy of Finland (collectively, “Oura,” or “Complainants”). 89 FR 27452-53 (Apr. 17, 2024). The complaint, as amended, alleged violations of section 337, based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain smart wearable devices, systems, and components thereof by reason of the infringement of certain claims of U.S. Patent Nos. 11,868,178 (“the '178 patent”); 10,842,429 (“the '429 patent”); and 11,868,179 (“the '179 patent”). The Commission's notice of investigation named as respondents Ultrahuman Healthcare Pvt. Ltd. of Karnataka, India; Ultrahuman Healthcare SP LLC of Abu Dhabi, UAE; Ultrahuman Healthcare Ltd. of London, United Kingdom (collectively “Ultrahuman”); Guangdong Jiu Zhi Technology Co. Ltd. of Guangdong, China; RingConn LLC of Wilmington, Delaware; and Circular SAS of Paris, France. The Office of Unfair Import Investigations (“OUII”) is also a party in this investigation.

Subsequently, the ALJ issued an ID granting Oura's motion to amend its first amended complaint and the notice of investigation to change the name of respondent Guangdong Jiu Zhi Technology Co. Ltd. to Shenzhen Ninenovo Technology Limited because of a corporate name change, and to amend the address for RingConn LLC (collectively, “RingConn”). Order No. 8 (May 3, 2024), unreviewed by Comm'n Notice, 89 FR 48686-87 (June 7, 2024).

The ALJ also issued an ID granting a joint motion for partial termination of the investigation as to respondent Circular SAS based on settlement. Order No. 12 (July 9, 2024), unreviewed by Comm'n Notice (Aug. 6, 2024).

Moreover, the ALJ issued three IDs granting the complainants' unopposed motions for partial termination as to certain claims, including all claims of the '429 and '179 patents. Order No. 13 (July 30, 2024), unreviewed by Comm'n Notice (Aug. 22, 2024); Order No. 15 (Sept. 16, 2024), unreviewed by Comm'n Notice (Oct. 7, 2024); Order No. 21 (Dec. 9, 2024), unreviewed by Comm'n Notice (Dec. 23, 2024).

On August 15, 2024, the ALJ held a hearing on claim construction, and on October 13, 2024, the ALJ issued a claim construction order. Order No.17 (Oct. 23, 2024).

The ALJ held an evidentiary hearing on December 11-13 and 16-17, 2024. As of the hearing, Oura only asserted claims 1, 2, and 12-14 of the '178 patent (the “Asserted Claims”) against the RingConn's accused Smart Ring and associated applications and the Ultrahuman Ring AIR and its associated application. FID at 7-8. Oura also asserted that its domestic industry products practice claims 1, 2, and 12-14 of the '178 patent for purposes of the domestic industry requirement. Id.

On April 18, 2025, the presiding ALJ issued the FID, finding that there has been a violation of section 337 in the importation into the United States, the sale for importation, and/or the sale in the United States after importation of certain smart ring wearable devices, systems, and components thereof with respect to certain claims of the '178 patent. Specifically, the FID found that: (1) The importation requirement was satisfied for the accused products; (2) claims 1, 2, and 12-14 of the '178 patent were shown to be infringed; (3) the technical prong of the domestic industry requirement was satisfied with respect to the '178 patent; (4) claims 1, 2, and 12-14 of the '178 patent were not shown to be invalid; and (5) the economic prong of the domestic industry requirement was satisfied with respect to the '178 patent. Id. at 130.

The FID included a Recommended Determination on Remedy and Bonding (“RD”). Id. at 136-41. It recommended that the Commission issue a limited exclusion order and cease and desist orders in the event the Commission finds a violation of section 337 and impose a bond of zero percent (0%) during the period of Presidential Review. Id. The ALJ also issued a Recommended Determination on the Public Interest pursuant to the Commission's delegation of public interest to the ALJ in the notice of investigation.

On May 2, 2025, RingConn and Ultrahuman (collectively, “Respondents”) filed a joint petition for review of several of the FID's findings. On May 12, 2025, Oura and OUII filed separate responses to Respondents' petition.

Having reviewed the record of the investigation, including the parties' petitions for review and related submissions, the Commission has determined to review the final initial determination in part. Specifically, the Commission has determined to review the economic prong of the domestic industry requirement for the '178 patent.

In connection with the final disposition of this investigation, the statute authorizes issuance of, inter alia, (1) an exclusion order that could result in the exclusion of the subject articles from entry into the United States; and/or (2) cease and desist orders that could result in the respondents 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 (Dec. 1994). In connection with these findings, the Commission requests responses from the parties to the following questions:

(1) To the extent that any party seeks an exemption from any proposed remedy for customer service and warranty obligations, please explain:

a. What is the rationale for providing an exemption, including under the public interest factors (in particular, U.S. consumers)? Please identify and describe specific evidence supporting this rationale and where in the record such evidence was first submitted to the ALJ. If such evidence was not submitted to the ALJ, please explain why the Commission should give such evidence any weight at this stage in the investigation.

b. What are the warranty terms, if any, for the merchandise in question? Should the exemption apply only to merchandise under warranty, or to all needed service and repair?

c. Should the exemption cover only parts for service/repair, or should it also allow complete replacement of merchandise?

d. What should the temporal cutoff be for the exemption, e.g., (1) should the ( printed page 27056) operative date be the issuance of the Commission's final determination or the end of the Presidential review period, and (2) should it apply to merchandise sold prior to such date or to merchandise imported prior to such date?

The parties are invited to brief only the discrete issues requested above. The parties are not to brief other issues on review, which are adequately presented in the parties' existing filings.

The statute requires the Commission to consider the effects of that remedy upon the public interest. The public interest factors the Commission will consider include the effect that an exclusion order and cease and desist orders 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. To the extent that any party in this investigation asserts that the proposed remedy would adversely impact the public interest, please identify and describe specific evidence supporting this assertion and where in the record such evidence was first submitted to the ALJ. If such evidence was not submitted to the ALJ, please explain what weight, if any, the Commission should give such evidence at this stage in the investigation.

In connection with the consideration of the public interest, the Commission requests responses from the parties to the following questions:

(1) Please identify whether any reasonable substitutes for the infringing devices are available to consumers, researchers, or other professionals, for example those participating in the uses described in the third-party public interest submissions, and whether they are capable of meeting any public health and welfare concerns raised by any remedial relief in this investigation. Is or would there be sufficient supply of any such reasonable substitutes for the infringing devices?

(2) With respect to the medical, health, and wellness studies using the accused products referenced during the hearing, please provide documents sufficient to show:

a. What is the goal of the study?

b. When did the study start?

c. How long is the study planned for?

d. How many devices are being used?

e. How many participants are involved in the study?

f. Are there reasonable substitutes for the accused product currently used in the study? Are Complainants' domestic industry products reasonable substitutes?

(3) Please explain why the parties failed to develop the evidentiary record in the hearing before the ALJ to include specific documents and statements from third party researchers that use the accused products.

If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve, disapprove, or take no action on the Commission's determination. 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 parties to the investigation are requested to file written submissions on the issues identified in this notice. Parties to the investigation, interested government agencies, and any other interested parties are encouraged to file written submissions on the issues of remedy, the public interest, and bonding. Such submissions should address the RD by the ALJ on remedy and bonding.

In their initial submission, Complainants are also requested to identify the remedy sought, and Complainants and OUII are requested to submit proposed drafts of remedial orders for the Commission's consideration. Complainants are further requested to provide the HTSUS subheadings under which the accused products are imported and to supply the identification information for all known importers of the products at issue in this investigation. All initial written submissions, from the parties and/or third parties/interested government agencies, and proposed remedial orders from the parties must be filed no later than close of business on July 7, 2025. All reply submissions must be filed no later than the close of business on July 14, 2025. Opening submissions from the parties are limited to 50 pages. Reply submissions from the parties are limited to 25 pages. All submission from third parties and/or interested government agencies are limited to 10 pages. No further submissions on any of 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. The Commission's paper filing requirements in 19 CFR 210.4(f) are currently waived. 85 FR 15798 (Mar. 19, 2020). Submissions should refer to the investigation number (“Inv. No. 337-TA-1398”) in a prominent place on the cover page and/or the first page. ( See Handbook for Electronic Filing Procedures, https://www.usitc.gov/​documents/​handbook_​on_​filing_​procedures.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 by marking each document with a header indicating that the document contains confidential information. This marking will be deemed to satisfy the request procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b) & 210.5(e)(2)). Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. Any non-party wishing to submit comments containing confidential information must serve those comments on the parties to the investigation pursuant to the applicable Administrative Protective Order. A redacted non-confidential version of the document must also be filed with the Commission and served on any parties to the investigation within two business days of any confidential filing. 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, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. All nonconfidential written submissions will be available for public inspection on EDIS.

The Commission's vote on this determination took place on June 20, 2025.

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.

( printed page 27057)

Issued: June 20, 2025.

Lisa Barton,

Secretary to the Commission.

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