H335304

HQ H335304 January 12, 2024 OT:RR:BSTC:EOE H335304 WMW / ACC 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 holding that Apple Inc.’s (“Apple”) redesigned versions of the Apple Watch models 8, 9, Ultra, and Ultra 2, (“Redesigned Watches” or “articles at issue”) are not 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, which 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 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 clearly identify confidential information, including information subject to the administrative protective order in the underlying investigation, with [[red brackets]] in their submissions. See 19 C.F.R. §§ 177.2, 177.8. If there is additional information in this ruling letter not currently bracketed in red [[ ]] that either party believes constitutes confidential information, and should be redacted from the published ruling, the parties are asked to contact the EOE Branch within ten (10) working days of the date of this ruling letter. 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); and OIP Guidance: Exemption 4 after the Supreme Court’s Ruling in Food Marketing Institute v. Argus Leader Media (updated 10/4/2019). BACKGROUND ITC Investigation No. 337-TA-1276 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 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 her 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. 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. 1276 LEO at 2, ¶1. The discussion below of the patents at issue initially emphasizes the independent claims, and then any asserted claims that depend therefrom, as the burden of establishing noninfringement requires that

applies here since, as in Nazomi, it is undisputed that the hardware in question is physically present as part of the Apple Redesigned Watches but the hardware is not functional without the software (i.e., pairing to an iPhone. Moreover, the pulse oximetry functionality that Masimo identifies was performed with the following modifications: jailbreaking the iPhones and installing otherwise restricted software that, but for the jailbreaking, would not have been feasible. Therefore, as in Nazomi, this would appear to resolve the issue of infringement. However, Masimo, like Nazomi, argues that jailbreaking the phones and installation of the Legizmo software is not a modification that precludes a finding of infringement. We conclude on the record before us that, like the Federal Circuit in Nazomi, jailbreaking and installation of this software “clearly constitutes a ‘modification’ of the accused products.” Id. at 1345. Additionally, in Typhoon Touch Technologies, Inc. v. Dell, Inc., 659 F.3d 1376 (Fed Cir. 2011), Typhoon made the same argument as Nazomi, namely that the accused devices infringed if they had “the capability of being configured or programmed to perform the stated function,” even though the accused devices were not structured to perform that stated function as sold. Id. at 1380. The Federal Circuit disagreed, finding that an accused device must be presently structured to store at least one data collection application. Id. at 1381. Here, as in Nazomi and Typhoon, the products designed and manufactured by Apple cannot infringe without modification—the modification of jailbreaking the iPhones that is needed for pairing with the Redesigned Watches for their operation and the installation of the software. On this basis, we conclude that Redesigned Watches do not infringe. See Telemac, 247 F.3d at 1326, 1330 (finding accused product non-infringing where the functionality present in the source code was blocked and therefore, without modification, the function coul