H354023

H354023 March 6, 2026 OT:RR:BSTC:EOE H354023 WMW CATEGORY: 19 U.S.C. § 1337; Unfair Competition K. Kevin Chu Quinn Emanuel 1300 I Street NW, Suite 900 Washington, DC 20005 VIA EMAIL: kevinchu@quinnemanuel.com RE: Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1398; Certain Smart Wearable Devices, Systems, and Components Thereof Dear Mr. Chu: Pursuant to 19 C.F.R. Part 177, the Exclusion Order Enforcement Branch (“EOE Branch”), Regulations and Rulings, U.S. Customs and Border Protection (“CBP”) issues this ruling in response to the request from Ultrahuman Healthcare Pvt. Ltd., Ultrahuman Healthcare Ltd., and Ultrahuman Healthcare SP LLC (“Ultrahuman”) for an administrative ruling, dated August 22, 2025, which included Exhibits 1-4 (collectively, “Ruling Request”). We find that Ultrahuman has met its burden to show that the Ring Pro (“redesigned ring” or “the articles at issue”), as described below, is not subject to exclusion from entry based on the limited exclusion order (“LEO”) that the U.S. International Trade Commission (“Commission” or “ITC”) issued in Investigation No. 337-TA-1398 (“the underlying investigation” or “the 1398 investigation”) on August 21, 2025, pursuant to Section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337 (“Section 337”).1 Entry for consumption into the United States, entry for consumption from a foreign trade zone, or withdrawal from a warehouse for consumption of the articles at issue, however, is conditioned on certain terms, including the drafting and approval of a certification, as discussed in this ruling. Ultrahuman must provide notice to the EOE Branch and Ouraring, Inc. and Oura Health Oy (“Oura”), as the other interested party in this inter partes proceeding, no later than 10 business days 1 The 1398 LEO, inter alia, prohibits the unlicensed entry for consumption of smart wearable devices, systems, and components that infringe one or more of claims 1, 2, and 12-14 of U.S. Patent No. 11,868,178 (“the ’178 patent”) Certain Smart Wearable Devices, Systems, and Components Thereof, Inv. No. 337-TA-1398, EDIS Doc. ID 860139, Limited Exclusion Order (August 21, 2025) at 2 (“1398 LEO”). after the issuance of this ruling, confirming that it accepts the terms as set forth in this ruling. See p. 13 infra. We further note that determinations of the Commission resulting from the underlying investigation or a related proceeding under 19 C.F.R. Part 210 are binding authority on CBP and, in the case of conflict, will modify or revoke any contrary CBP ruling or decision pertaining to Section 337 exclusion orders by operation of law. This ruling is the result of a request for an administrative ruling from CBP under 19 C.F.R. Part 177, which was conducted on an inter partes basis. The process involved the two parties with a direct and demonstrable interest in the question presented by the ruling request: (1) your client, Ultrahuman, the ruling requester and importer of the articles at issue; and (2) Ouraring, Inc. and Oura Health Oy (“Oura”), the Complainant and patent owner in the 1398 investigation. See, e.g., 19 C.F.R. § 177.1(c). I. BACKGROUND A. ITC Investigation No. 337-TA-1389 1. Procedural History at the ITC The Commission instituted Investigation No. 337-TA-1389 on April 17, 2024, based on a complaint filed by Oura. Certain Smart Wearable Devices, Systems, and Components Thereof, Inv. No. 337-TA-1398, EDIS Doc. ID 861286, Public Commission Opinion (September 5, 2020) (“Comm’n Op.”) at 1 (citing 89 Fed. Reg. 27452-53 (Apr. 17, 2024)). The complaint, as amended, alleged a violation of Section 337 by reason of infringement of claims 1, 2, and 12-14 of the ’178 patent. Id. The notice of investigation named Ultrahuman Healthcare Pvt. Ltd., Ultrahuman Healthcare SP LLC, Ultrahuman Healthcare Ltd., Guangdong Jiu Zhi Technology, Co. Ltd., RingConn LLC, and Circular SAS as respondents. Certain Smart Wearable Devices, Systems, and Components Thereof, Inv. No. 337-TA-1398, EDIS Doc. ID 849708, Public Final Initial Determination (Apr. 18, 2025) (“FID”) at 1 (citation omitted). The Office of Unfair Import Investigations (“OUII”) was also a party in the investigation. Id. On April 18, 2025, the ALJ issued the final initial determination finding a violation of Section 337. Comm’n Op. at 1. Specifically, the ALJ determined that a violation of Section 337 occurred in the importation into the United States, the sale for importation, or the sale within the United States after importation, of the accused products due to infringement of claims 1, 2, and 12-14 of the ’178 patent. Id. at 2. On June 20, 2025, the Commission issued a notice in which it determined to review in part the FID. Comm’n Op. at 5. (citing 90 Fed. Reg. 27054-57 (June 25, 2025)). The Commission, in its review of the FID, adopted the FID’s finding of a violation of Section 337 as to the asserted patent claims. Id. at 29. On September 5, 2025, the Commission found a violation of Section 337 with regard to infringement of the asserted claims of the ’178 patent and determined that the appropriate remedy was a limited exclusion order and cease and desist orders directed to Respondents. Id. 2 In the LEO, the Commission ordered that “[s]mart wearable devices, systems, and components thereof that infringe one or more of claims 1, 2, and 12-14 of the ’178 patent and that are manufactured abroad by, or on behalf of, or imported by or on behalf of Respondents or any of their affiliated companies, parents, subsidiaries, agents, or other related business entities, or their successors or assigns, are excluded from entry for consumption into the United States, entry for consumption from a foreign-trade zone, or withdrawal from a warehouse for consumption, for the remaining term of the ‘178 patent, except under license from, or with the permission of, the patent owner or as provided by law, and except for smart wearable devices imported for replacement, under warranty terms, of covered articles sold to end users prior to the expiration of the period of Presidential review[.]” Certain Smart Wearable Devices, Systems, and Components Thereof, Inv. No. 337-TA-1398, EDIS Doc. ID 2423293, Limited Exclusion Order (August 21, 2025) at 2 (“1398 LEO”). The LEO defines, “[t]he smart wearable devices, systems, and components thereof subject to this Order (i.e., ‘covered articles’) are as follows: smart ring wearable devices, systems, and components thereof.” Id. 2. The Patent and Claims in the 1398 LEO As noted above, the 1398 LEO prohibits the unlicensed entry for consumption of smart wearable devices, systems, and components thereof that infringe one or more of claims 1, 2, and 12-14 of the ’178 patent. The ‘178 patent is directed to a smart ring with a curved housing that contains a curved battery, a semi-flexible printed circuit control board along with a window to facilitate either data transmission, battery recharge or status indication. Claim 1 is the sole independent claim. a. Claim 1 of the ’178 Patent The ’178 patent is titled “Wearable Computing Device.” FID at 6 (internal citation omitted). Claim 1 of the ’178 patent is reproduced below: 1 [Preamble]. A finger-worn device, comprising: [1.a] an external housing component defining an outer circumferential surface of the finger-worn wearable ring device; [1.b] an internal housing component defining an inner circumferential surface of the finger-worn wearable ring device, the internal housing component coupled with the external housing component, [1.c] wherein at least a portion of the inner circumferential surface of the internal housing component is configured to contact a tissue of a user when the finger-worn wearable ring device is being worn by the user; [1.d] a battery positioned within a cavity formed between the internal housing component and the external housing component, [1.e] wherein the battery comprises a shape and size configured to fit within the cavity betwe

below. IV. ANALYSIS Ultrahuman argues that the redesigned ring does not infringe independent claim 1 of the ‘178 patent for at least two reasons: (1) The redesigned ring is formed with a single, continuous, and integrally formed titanium Housing Tube and has no distinct internal and external housing component[s] that satisfy claim limitations [1.a] and [1.b]; and 4 Although claim construction is a question of law, the consideration of extrinsic evidence may constitute a subsidiary finding of fact. Teva, 135 S. Ct. at 841, 190 L. Ed. 2d at 733. 9 

 (2) The battery in the redesigned ring is neither positioned within nor configured to fit within the claimed cavity because it is located entirely within the bore of the Housing Tube as opposed to being positioned within a cavity formed between the internal and external housing components and as such does not satisfy claim limitations [1.d] and [1.e]. Ruling Request at 3, 13. In response, Oura argues that the redesigned ring is no more than a “concept outlined in a Computer-Aided Drawing (CAD)” as none of the prototypes were working samples nor assembled rings. Response at 1. Oura states this concerns them, because if the redesigned ring is not a final product ready for importation, Ultrahuman may release “variations of this unfinished design later.” Id. Nonetheless, Oura argues that even if the redesigned ring were not merely conceptual, Ultrahuman has failed to meet its burden to show that it does not infringe claims 1, 2, and 12-14 of the ’178 patent. Id. at 8. We address these arguments in the context of the three main issues in dispute: (1) whether the redesigned ring practices independent claim 1; (2) whether the ruling requestor Ultrahuman has met their burden of proof in showing non-infringement; and (3) whether the redesigned ring is hypothetical such that a ruling should not issue. These arguments are discussed separately, below. 1. Redesigned Ring and Claim 1 of the ‘178 Patent In its ruling request, Ultrahuman