H338254

H338254 January 7, 2025 OT:RR:BSTC:EOE H338254 ACC / WMW CATEGORY: 19 U.S.C. § 1337; Unfair Competition Mark D. Selwyn WilmerHale 2600 El Camino Real Suite 400 Palo Alto, California 94306 VIA EMAIL: mark.selwyn@wilmerhale.com RE: Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1276; Certain Light-Based Physiological Measurement Devices and Components Thereof Dear Mr. Selwyn: Pursuant to 19 C.F.R. Part 177, the Exclusion Order Enforcement Branch, Regulations and Rulings, U.S. Customs and Border Protection (“CBP”) issues this ruling letter, based on a request from Apple Inc. (“Apple”) submitted on March 26, 2024 (“Ruling Request”), holding that the articles at issue, related to certain redesigned versions of the Apple Watch, as described below, are subject to the limited exclusion order (“LEO”) that the U.S. International Trade Commission (“ITC” or “Commission”) issued as a result of Investigation No. 337-TA-1276 (“the 1276 investigation”) under Section 337 of the Tariff of 1930, as amended, 19 U.S.C. § 1337. 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 by operation of law modify or revoke any contrary CBP ruling or decision pertaining to Section 337 exclusion orders. This ruling letter is the result of a request for an administrative ruling under 19 C.F.R. Part 177 that was conducted on an inter partes basis. The proceeding involved the two parties with a direct and demonstrable interest in the question presented by the Ruling Request: (1) your client, Apple, the ruling requester and respondent in the 1276 investigation; and (2) Masimo Corporation 1 and Cercacor Laboratories, Inc. (“Masimo”), the patent owner and complainant in the 1276 investigation. See, e.g., 19 C.F.R. § 177.1(c). The parties were asked to identify in their submissions confidential information, including information subject to the administrative protective order in the underlying investigation, with [[red brackets]]. See 19 C.F.R. §§ 177.2, 177.8. Consistent with the above, the parties are directed to identify information in this ruling that should be bracketed in red [[ ]] because it constitutes confidential information, as defined below, such that it should be redacted from the public version of this ruling that will be published in accordance with 19 C.F.R. § 177.10. The parties are to contact the EOE Branch within ten (10) business days of the date of this ruling letter to identify such information with brackets. See, e.g., 19 C.F.R. § 177.8(a)(3). Please note that disclosure of information related to administrative rulings under 19 C.F.R. Part 177 is governed by, for example, 6 C.F.R. Part 5, 31 C.F.R. Part 1, 19 C.F.R. Part 103, and 19 C.F.R. § 177.8(a)(3). See, e.g., 19 C.F.R. § 177.10(a). In addition, CBP is guided by the laws relating to confidentiality and disclosure, such as the Freedom of Information Act (“FOIA”), as amended (5 U.S.C. § 552), the Trade Secrets Act (18 U.S.C. § 1905), and the Privacy Act of 1974, as amended (5 U.S.C. § 552a). A request for confidential treatment of information submitted in connection with a ruling requested under 19 C.F.R. Part 177 faces a strong presumption in favor of disclosure. See, e.g., 19 C.F.R. § 177.8(a)(3). The person seeking this treatment must overcome that presumption with a request that is appropriately tailored and supported by evidence establishing that: the information in question is customarily kept private or closely-held and either that the government provided an express or implied assurance of confidentiality when the information was shared with the government or there were no express or implied indications at the time the information was submitted that the government would publicly disclose the information. See Food Marketing Institute v. Argus Leader Media, 139 S. Ct. 2356, 2366 (2019) (concluding that “[a]t least where commercial or financial information is both customarily and actually treated as private by its owner and provided to the government under an assurance of privacy, the information is ‘confidential’ within the meaning of exemption 4.”); see also U.S. Department of Justice, Office of Information Policy (OIP): Step-by-Step Guide for Determining if Commercial or Financial Information Obtained from a Person is Confidential Under Exemption 4 of the FOIA (updated 10/7/2019); see also OIP Guidance: Exemption 4 after the Supreme Court’s Ruling in Food Marketing Institute v. Argus Leader Media (updated 10/4/2019). I. BACKGROUND A. ITC Investigation No. 337-TA-1276 1. Procedural History At The ITC The Commission instituted Investigation No. 337-TA-1276 on August 21, 2021, based on a complaint filed by Masimo Corporation of Irvine, California and Cercacor Laboratories, Inc. of Irvine, California. Certain Light-Based Physiological Measurement Devices and Components Thereof, Inv. No. 337-TA-1276, EDIS Doc. ID 808521, Public Commission Opinion (Nov. 14, 2023) (“Comm’n Op.”) at 2 (citing 86 Fed. Reg. 46275-76 (Aug. 18, 2021)). The complaint, as supplemented, alleged a violation of section 337 by reason of infringement of certain claims of 2 U.S. Patent Nos. 10,945,648 (“the ’648 patent”), 10,912,502 (“the ’502 patent”), 10,912,501 (“the ’501 patent”), 10,687,745 (“the ’745 patent”), and 7,761,127 (“the ’127 patent”). Comm’n Op. at 3. The notice of investigation named Apple as the sole respondent. Id. at 3. The Commission’s Office of Unfair Import Investigations (“OUII”) was not named as a party in the investigation. Id. On January 10, 2023, the presiding Administrative Law Judge (“ALJ”) issued a final initial determination, Certain Light-Based Physiological Measurement Devices and Components Thereof, Inv. No. 337-TA-1276, EDIS Doc. ID 1950712, Public Final Initial Determination (January 10, 2023) (“FID”), finding a violation of section 337. Id. at 4. 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 certain claims of the ’648 patent. Id. On May 15, 2023, the Commission issued a notice in which it determined to review in part the FID and requested submissions responding to the Commission’s questions on review and remedy, the public interest, and bonding. Id. at 6 (citing 88 Fed. Reg. 32243-46 (May 15, 2023)). The Commission, in its review of the FID, found a violation of section 337 as to the ’502, and ’648 patents and determined that the appropriate remedy was a limited exclusion order directed to Apple. Id. at 54. In the limited exclusion order, the Commission ordered that “light-based physiological measurement devices and components thereof . . . that infringe one or more of claims 22 and 28 of the ’502 patent and claims 12, 24 and 30 of the ’648 patent 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 terms of the Asserted Patents, except under license from, or with the permission of, the patent owner or as provided by law.” Certain Light-Based Physiological Measurement Devices and Components Thereof, Inv. No. 337- TA-1276, EDIS Doc. ID 2011470, Limited Exclusion Order (Oct. 26, 2023) at 2, ¶ 1 (“1276 LEO”). The Commission further defined the articles covered by the limited exclusion order as “wearable electronic devices with light-based pulse oximetry functionality and components thereof.” Id. at 2, ¶ 2. 2. The Patents And Claims In The 1276 LEO The 1276 LEO prohibits the unlicensed entry for consumption of light-based physiological devices and components thereof that infringe one or more of claims 22 and 28 of the ’502 patent and claims 12, 24 and 30 of the ’648 patent. 127

A. Apple’s Position That The Redesign 2 Watch By Itself Or In Combination With The Redesigned iPhone Is Not A “Covered Article” As a preliminary matter, Apple alleges that the Redesign 2 Watch simply lacks pulse oximetry functionality and therefore falls outside the scope of the “covered articles” that are subject to the limited exclusion order. Ruling Request at 29-30 (citing Certain Automated Mechanical Transmission Systems For Medium-Duty and Heavy-Duty Trucks and Components Thereof, Inv. No. 337-TA-503, Commission Opinion at 4 (May 9, 2005)). Specifically, Apple contends that, “[w]ithout blood oxygen processing or measurements, Apple’s Redesign 2 Watch lacks the pulse oximetry functionality required to meet the definition of “covered articles” under the 1276 LEO.” Id. at 29. (emphasis added). This argument is focused on Apple’s position that “the Redesign 2 Watch does not calculate, output, measure, or determine results for any PPG signals, [such that] without these features, it does not contain the pulse oximetry functionality required for ‘covered articles’ under the 1276 LEO.” Id. at 30; see also Apple’s Reply at 4 (“Without that processing [for the final calculation of a user’s blood oxygen saturation], the Redesign 2 Watch cannot provide pulse oximetry functionality. Because the Redesign 2 Watch lacks ‘light-based pulse oximetry functionality,’ it falls outside the scope of the 1276 LEO.”). Apple concludes that, given its view above, “no further noninfringement analysis is necessary” to determine that the Redesign 2 Watch falls outside the limited exclusion order’s scope and therefore is admissible into the United States. Id. Additionally, in response to Masimo’s arguments that “that the combination of the Redesign 2 Watch and Redesigned iPhone are together a ‘covered article’ that contains light-based pulse oximetry[,]” Apple takes the position that “those arguments directly contradict both the plain language of the ITC’s remedial orders and Complainants’