H351038

H351038 August 1, 2025 OT:RR:BSTC:EOE H351038 CATEGORY: 19 U.S.C. § 1337; Unfair Competition Center Director Electronics Center of Excellence and Expertise U.S. Customs and Border Protection 301 E. Ocean Blvd., Suite 900 Long Beach, California 90802 Attn: John Gerber, Supervisory Import Specialist VIA EMAIL: john.p.gerber@cbp.dhs.gov RE: Internal Advice Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1276; Certain Light-Based Physiological Measurement Devices and Components Thereof Dear Center Director: Pursuant to 19 C.F.R. § 177.11, the Exclusion Order Enforcement (“EOE”) Branch, Regulations and Rulings, U.S. Customs and Border Protection (“CBP”) issues this internal advice ruling based on your request (dated July 8, 2025) regarding the entry for consumption of five (5) Apple Watches that Apple Inc. (“Apple”) imported at the Port of Chicago under Entry Number SCS-20982810 and related to AWB 014-23379381-YYZ00011437 (H). The Apple Watches, as described in more detail below, have been detained based on the limited exclusion order that the U.S. International Trade Commission (“ITC” or “Commission”) issued resulting from ITC Investigation No. 337-TA-1276 (“the 1276 investigation” or “underlying investigation) under section 337 of the Tariff of 1930, as amended, 19 U.S.C. § 1337 (“Section 337”). See CBP Detention Notice (dated July 07, 2025) for Detention No. 1751555713390. The Apple Watches were presented for examination on July 2, 2025. See Email to the EOE Branch from the Port of Chicago (dated July 9, 2025); see also 19 U.S.C. § 1499(c)(5), as implemented by 19 C.F.R. § 151.16(b) (“For purposes of this section, merchandise will be considered to be presented for CBP examination when it is in a condition to be viewed and examined by a CBP officer.”); see also Blink Design, Inc. v. United States, 986 F. Supp. 2d 1348, 38 C.I.T. 746, 749-754 (Ct. Int’l Trade, 2014) (“In light of this regulation, Defendant contends that Customs considers merchandise ‘presented for examination’ when ‘it is in a condition to be examined by a Customs official.’ … When Customs requests that merchandise be delivered to a container examination station (‘CES’) for inspection, as occurred in the present action, Defendant specifies that ‘Customs routinely considers the date on which merchandise is presented for examination as being the date that the last requested container is delivered to the CES, its contents have been unloaded by the private contractor, and Customs has received the pertinent documents that it needs to perform the examination. … By treating the date when (1) the last requested container arrives at a CES and is unloaded and (2) Customs has the relevant explanatory documents, as the date on which merchandise is presented for examination, Customs ensures that the actual merchandise and relevant accompanying information are before its officials so that an examination may proceed.”) (emphasis added). Specifically, you have requested the EOE Branch’s admissibility determination regarding the proper administration of the limited exclusion order and, in particular, the applicability of an administrative ruling the EOE Branch issued on January 7, 2025, resulting from an inter partes proceeding under 19 C.F.R. § 177, to the importation of these Apple Watches. See CBP HQ Ruling H338254 (dated January 7, 2025) (“Apple II Ruling”). Familiarity with the EOE Branch’s administrative rulings related to the 1276 investigation is presumed and recited below are those facts necessary to address the issues presented by this entry for consumption. The EOE Branch further notes 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. A “related proceeding” is defined as, inter alia, “proceedings to enforce, modify, or revoke a remedial or consent order, or advisory opinion proceedings.” 19 C.F.R. § 210.3 (emphasis added). A determination from these proceedings represents binding authority, as noted above, and Commission action that directs CBP accordingly. Moreover, the Commission may “investigate any alleged violation of this section on complaint under oath or upon its initiative.” 19 U.S.C. § 1337(b) (emphasis added); see also Certain Road Construction Machines and Components Thereof Notice of Commission Determination To Institute a Modification Proceeding; Request for Written Submissions, 85 Fed. Reg. 3944, 3945 (Jan. 23, 2020) (“[T]he Commission has determined that institution of a modification proceeding is also warranted based on the Commission’s authority, sua sponte, to institute a modification proceeding. Commission Rule 210.76(a)(1), 19 CFR 210.76(a)(1) (‘The Commission may also in its own initiative consider such action’ to modify its remedial orders.).”). Lastly, before publication of this internal advice ruling pursuant to 19 U.S.C. § 1625, as implemented by 19 C.F.R. § 177.10, Apple is to be given an opportunity to identify any confidential information, including any information subject to the administrative protective order from the underlying investigation. See 19 C.F.R. §§ 177.2, 177.8. Consistent with the above, Apple is directed upon receiving this internal advice ruling to identify any confidential information with [[red brackets]] that indicate such information should be redacted from the public version of the ruling that will be published in accordance with 19 C.F.R. § 177.10. Apple is to contact the EOE Branch within ten (10) business days of the date of this internal advice ruling to identify such information with the brackets noted above. See, e.g., 19 C.F.R. § 177.8(a)(3). To confirm, disclosure and redaction 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 2 103, 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. The Limited Exclusion Order and Asserted Patents From ITC Investigation No. 337-TA-1276 The limited exclusion order from the 1276

A. The Apple II Ruling Only Found The Redesigned Apple Watch To Infringe When Considered In Combination With The Redesigned iPhone But Not When Considered Alone During the inter partes proceeding in Apple II, the EOE Branch addressed are whether Apple had established that: (1) the Apple Watch, as redesigned, is not a “covered article” as defined by the limited exclusion order and for purposes of the 1276 investigation; (2) the Apple Watch, as redesigned, when considered alone, does not infringe claim 22 of the ’502 patent; (3) the Apple Watch and iPhone, as redesigned, when considered in combination, do not infringe claim 22 of the ’502 patent or claims 12, 24, or 30 of the ’648 patent; and (4) the Apple Watch and iPhone, as redesigned, when considered in combination, do not infringe claim 22 of the ’502 patent or claims 12, 24, or 30 of the ’648 patent under the doctrine of equivalents as applied by CBP. Of these four arguments regarding admissibility, the only one where Apple prevailed is the second: that the redesigned Apple Watch, when considered alone, does not infringe claim 22 of the ’502 patent, which is the only patent claim from the limited exclusion order that Masimo asserted against the Apple Watch by itself. 1. The Respective Positions From The Parties On The Second Argument In Apple II Whether The Redesign Apple Watch Infringes When Considered Alone Masimo’s theory of infringement with respect to the second argument from above was that the Redesign 2 Watch, when considered alone, literally infringes Claim 22 of the ’502 patent. Apple II Ruling at 30. The basis for its contention was centered on Masimo’s view that “the LW/A 2 Watch-measured PPGs are ‘indicative of’ oxygen saturation[.]” Apple II, Masimo Post Oral 10 

Discussion Submission at 13. Apple disagreed with Masimo and made two arguments. First, Apple argued that the Redesign 2 Watch alone did not infringe claim 22 of the ’502 patent because “the preamble is limiting” and, as such, the Redesign