Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1398; Certain Smart Wearable Devices, Systems, and Components Thereof

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 between the outer circumferential surface of the external housing component and the inner circumferential surface of the internal housing component, and [1.f] wherein the battery extends through at least a first portion of the cavity of the finger-worn wearable ring device; 3 [1.g] a printed circuit board disposed between the internal housing component and the external housing component, [1.h] wherein the printed circuit board extends through at least a second portion of the cavity of the finger-worn wearable ring device different from the first portion; and [1.i] one or more sensors electrically coupled with the printed circuit board and the battery and [1.j] configured to acquire data from the user through the internal housing component (emphasis added)2 ’178 patent at Fig. 1A, Fig. 1B. 3. The Ultrahuman Legacy Product Found to Infringe in the Underlying Investigation In the underlying investigation, Ultrahuman’s accused product was its Ultrahuman Ring AIR and its associated application. FID at 7. “The Ultrahuman Ring AIR pairs with the Ultrahuman app so users can access collected data.” Id. at 8. This legacy product was found to meet all the claim limitations of claim 1. Id. at 66. For example, the Ultrahuman legacy product possessed a metal outer structure defining an outer circumferential surface which was found to meet the claim limitation 1[a] of “an external housing component defining an outer circumferential surface”. FID at 29-30. Additionally, the Ultrahuman legacy product was found to “include[] an internal housing component in the form of potting material” and thus met the claim limitation in 2 The bolded claim limitations are the limitations at issue in the Ruling Request. See e.g., Ruling Request at 3. The numbering of the claim limitations corresponds with the numbering used in the Ruling Request. See id. at 4. 4 1[b] of “an internal housing component[3] defining an inner circumferential surface.” See e.g., id. at 32-9. B. 19 C.F.R. Part 177 Ruling Request Procedural History 1. Ultrahuman’s Ruling Request On August 22, 2025, Ultrahuman submitted the Ruling Request to the EOE Branch. Ultrahuman Email to EOE Branch (dated August 22, 2025). Ultrahuman requested “a ruling that Ultrahuman’s Ring Pro (“redesigned ring”), does not infringe claims 1, 2, and 12-14 of the ‘178 patent [and therefore] are outside the scope of and not subject to the Limited Exclusion Order (‘LEO’) issued on August 21, 2025, by the U.S. International Trade Commission (ITC) in Certain Smart Wearable Devices, Systems, and Components Thereof, Inv. No. 337-TA-1398 (the ‘1398 Investigation’).” Ruling Request at 1. On August 26, 2025, Ultrahuman also confirmed that it had transmitted a redacted version of the ruling request to Oura’s counsel. Ultrahuman Email to EOE Branch (dated August 26, 2025). On September 2, 2025, the EOE Branch had an initial conference call with Ultrahuman and Oura, on which both parties agreed to conduct this proceeding on an inter partes basis as administered by the EOE Branch. During this initial call, the EOE Branch and the parties discussed the ground rules and scheduling for the inter partes proceeding. On September 4, 2025, the EOE Branch distributed the procedural schedule for the inter partes proceeding. EOE Branch Email to parties (dated September 4, 2025). On September 26, 2025, Oura submitted their substantive response to the ruling request. Oura email to parties (dated September 26, 2025). On October 3, 2025, Ultrahuman submitted their reply. Ultrahuman email to parties (dated October 3, 2025). On October 10, 2025, Oura submitted their sur-reply. Oura email to parties (dated October 10, 2025). On October 22, 2025, the EOE Branch conducted its oral discussion with both Ultrahuman and Oura. Also on October 22, 2025, both Ultrahuman and Oura submitted copies of the presentations used during the oral discussion. Ultrahuman email to parties (dated October 22, 2025) and Oura email to parties (dated October 22, 2025). On October 29, 2025, both parties submitted their final post oral-discussion brief. Ultrahuman email to parties (dated October 29, 2025) and Oura email to parties (dated October 29, 2025). 2. The Articles at Issue Ultrahuman requests a ruling that “Ultrahuman’s Ring Pro” (“the articles at issue” or “redesigned ring”) do not infringe the asserted claims of the ‘178 patent. Ruling Request at 1. The redesigned ring differs from the original ring in that the exterior titanium ring found to be the “exterior housing component” in the underlying investigation and the “internal housing component” user--contacting epoxy layer have been replaced by a housing tube. Id. at 8. The housing tube is a single, continuous, and integrally formed open-ended titanium tube. Id. The 3 “The term ‘internal housing component’ was construed as ‘an internal structure that encloses space and which does not necessarily exclude potting material.’” FID at 30 (citation omitted). 5 redesigned ring also has a bottom cap which is a single piece of titanium that snaps into the housing tube. Id. at 10. Ruling Request at 8. Ruling Request at 9. Ruling Request at 10. II. ISSUE Whether Ultrahuman has met its burden to show that the articles at issue do not infringe claims 1, 2, and 12-14 of the ’178 patent and thus are not subject to the LEO issued in the 1398 investigation. III. LEGAL FRAMEWORK A. Section 337 Exclusion Order Administration The Commission shall investigate any alleged violation of Section 337 to determine, with respect to each investigation conducted by it under this section, whether there is a violation of this section. See 19 U.S.C. § 1337(b)(1) and (c). If the Commission determines, as a result of an investigation under this section, that there is a violation of this section, it shall direct that the articles concerned, imported by 6 any person violating the provision of this section, be excluded from entry into the United States unless the Commission finds based on consideration of the public interest that such articles should not be excluded from entry. See 19 U.S.C. § 1337(d)(1). When the Commission determines that there is a violation of Section 337, it generally issues one of two types of exclusion orders: (1) a limited exclusion order or (2) a general exclusion order. See Fuji Photo Film Co., Ltd. v. ITC, 474 F.3d 1281, 1286 (Fed. Cir. 2007). Both types of orders direct CBP to bar infringing products from entering the country. See Yingbin-Nature (Guangdong) Wood Indus. Co. v. ITC, 535 F.3d 1322, 1330 (Fed Cir. 2008). “A limited exclusion order is ‘limited’ in that it only applies to the specific parties before the Commission in the investigation. In contrast, a general exclusion order bars the importation of infringing products by everyone, regardless of whether they were respondents in the Commission's investigation.” Id. A general exclusion order is appropriate only if two exceptional circumstances apply: if (1) “necessary to prevent circumvention of a limited exclusion order,” or (2) “there is a pattern of violation of this section and it is difficult to Identify the source of infringing products.” See Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1356 (Fed. Cir. 2008) (“If a complainant wishes to obtain an exclusion order operative against articles of non-respondents, it must seek a GEO [general exclusion order] by satisfying the heightened burdens of §§ 1337(d)(2)(A) and (B).”); 19 U.S.C. § 1337(d)(2). In addition to the action taken above, the Commission may issue an order under 19 U.S.C. § 1337(i) directing CBP to seize and forfeit articles attempting entry in violation of an exclusion order if their owner, importer, or consignee previously had articles denied entry on the basis of that exclusion order and received notice that seizure and forfeiture would result from any future attempt to enter articles subject to the same. An exclusion order under § 1337(d)—either limited or general—and a seizure and forfeiture order under § 1337(i) apply at the border only and are operative against articles presented for customs examination or articles conditionally released from customs custody but still subject to a timely demand for redelivery. See 19 U.S.C. §§ 1337(d)(1) (“The Commission shall notify the Secretary of the Treasury of its action under this subsection directing such exclusion from entry, and upon receipt of such notice, the Secretary shall, through the proper officers, refuse such entry.”); id. at (i)(3) (“Upon the attempted entry of articles subject to an order issued under this subsection, the Secretary of the Treasury shall immediately notify all ports of entry of the attempted importation and shall identify the persons notified under paragraph (1)(C).”) (emphasis added). Significantly, unlike district court injunctions, the Commission can issue a general exclusion order that broadly prohibits entry of articles that violate Section 337 of the Tariff Act of 1930 without regard to whether the persons importing such articles were parties to, or were related to parties to, the investigation that led to issuance of the general exclusion order. See Vastfame Camera, Ltd. v. ITC, 386 F.3d 1108, 1114 (Fed. Cir. 2004). The Commission also has recognized that even limited exclusion orders have broader applicability beyond just the parties found to infringe during an investigation. See Certain GPS Devices and Products Containing Same, Inv. No. 337-TA-602, Comm’n Op. at 17, n.6, Doc ID 317981 (Jan. 2009) (“We do not view the Court’s opinion in Kyocera as affecting the issuance of LEOs [limited exclusion orders] that exclude infringing products made by respondents found to be violating Section 337, but imported by 7 another entity. The exclusionary language in this regard that is traditionally included in LEOs is consistent with 19 U.S.C. § 1337(a)(1)(B)-(D) and 19 U.S.C. § 1337(d)(1).”). Moreover, “[t]he Commission has consistently issued exclusion orders coextensive with the violation of Section 337 found to exist.” See Certain Erasable Programmable Read Only Memories, Inv. No. 337-TA-276, Enforcement Proceeding, Comm’n Op. at 11, Doc ID 43536 (Aug. 1991) (emphasis added). “[W]hile individual models may be evaluated to determine importation and [violation], the Commission's jurisdiction extends to all models of [violative] products that are imported at the time of the Commission’s determination and to all such products that will be imported during the life of the remedial orders.” See Certain Optical Disk Controller Chips and Chipsets, Inv. No. 337-TA-506, Comm’n Op. at 56-57, USITC Pub. 3935, Doc ID 287263 (July 2007). Lastly, despite the well-established principle that “the burden of proving infringement generally rests upon the patentee [or plaintiff],” Medtronic, Inc. v. Mirowski Family Ventures, LLC, 571 U.S. 191 (2014), the Commission has held that Medtronic is not controlling precedent and does not overturn its longstanding practice of placing the burden of proof on the party who, in light