H338253

HQ H338253 June 20, 2024 OT:RR:BSTC:EOE H338253 FKM CATEGORY: 19 U.S.C. § 1337; Unfair Competition Benjamin C. Elacqua Fish & Richardson P.C. 909 Fannin St. Suite 2100 Houston, Texas 77010 VIA EMAIL: elacqua@fr.com; Apple_AliveCor_177_Request@fr.com RE: Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1266; Certain Wearable Devices with ECG Functionality and Components Thereof Dear Mr. Elacqua: 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 letter. We find that Apple Inc. (“Apple”) has met its burden to show that certain redesigned wearable devices (“articles at issue”) do not infringe one or more of claims 12, 13, and 19-23 of U.S. Patent No. 10,638,941 (“the ’941 Patent”) and claims 1, 3, 5, 8-10, 12, 15, and 16 of U.S. Patent No. 10,595,731 (“the ’731 Patent). Thus, CBP’s position is that the articles at issue are not subject to the limited exclusion order that the U.S. International Trade Commission (“Commission” or “ITC”) issued in Investigation No. 337-TA-1266 (“the underlying investigation” or “the 1266 investigation”), pursuant to Section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337 (“Section 337”). 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 the drafting and submission of a certification, as provided for in this ruling, that would take effect should the Commission lift the suspension on enforcement of the limited exclusion order. 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 regarding application of an exclusion order under Section 337. This ruling letter 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, Apple, the ruling requester and respondent in the 1266 investigation; and (2) AliveCor, Inc. (“AliveCor”), complainant in the 1266 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 all of their submissions to CBP. 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, then the parties are asked to contact CBP 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: 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). BACKGROUND ITC Investigation No. 337-TA-1266 Procedural History at the ITC The Commission instituted Investigation No. 337-TA-1266 on May 26, 2021, based on a complaint filed by AliveCor. Certain Wearable Electronic Devices with ECG Functionality and Components Thereof, Inv. No. 337-TA-1266, EDIS Doc. ID 788332, Public Commission Opinion (Dec. 22, 2022) (“Comm’n Op.”) at 4 (citing 86 Fed. Reg. 28382 (May 26, 2021)). The complaint, as supplemented, alleged a violation of Section 337 by reason of infringement of certain claims of the ’731 patent, the ’941 patent, and U.S. Patent No. 9,572,499 (“the ’499 patent”). Id. The notice of investigation named Apple as the sole respondent. Id. The Commission’s Office of Unfair Import Investigations (“OUII”) was named as a party in the investigation. Id. On June 27, 2022, the Administrative Law Judge (“ALJ”) issued the final initial determination (“FID”) finding a violation of Section 337. Id. at 5. 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 that infringed the ’731 and ’941 patents, but these products were found not to infringe the ’499 patent. Id. On September 22, 2022, the Commission issued a notice in which it determined to review the FID in part and requested submissions responding to the Commission’s issues under review and on remedy, the public interest, and bonding. Comm’n Op. at 6 (citing 87 Fed. Reg. 58819-21 (Sept. 28, 2022)). On December 7, 2022, Apple filed an emergency motion requesting the Commission to suspend any remedial order or extend the target date and stay all proceedings prior to the issuance of a Final Determination, pending the resolution of any appeal of the decision by the Patent Trial and Appeal Board (“PTAB”), which determined that the claims of the three patents are unpatentable because they are obvious under 35 U.S.C. § 103. Id. at 7 (quoting Respondent Apple Inc.’s Emergency Motion to Suspend any Remedy or Extend the Target Date and Stay Proceedings Pending Resolution of any Appeal of the Patent Office’s Decision that United States Patent Nos. 10,638,941, 10,595,731, and 9,572,499 Are Unpatentable at 1; see also Apple Emergency Motion to the Commission at 2. The Commission, in its review of the FID, found a violation of Section 337 as to the ’941 and ’731 patents and determined that the appropriate remedy was a limited exclusion order and cease and desist order. Comm’n Op. at 88. However, the Commission “determined to suspend enforcement of the orders, including the bond provision, pending final resolution of the PTAB’s Final Written Decision finding the asserted claims of the ’941, ’731, and ’499 patents unpatentable.” Id.; see Apple, Inc. v. AliveCor, Inc., IPR2021-00971, Patent 10,595,731, Final Written Decision Determining All Challenged Claims Unpatentable (Dec. 6, 2022); Apple, Inc. v. AliveCor, Inc., IPR2021-00972, Patent 

and classification algorithms printed by AliveCor on pages APL-ALIVE-177R_ECG_2_SC-0000012-34 [[ ]]”). Thus, we will continue with our analysis of infringement by the articles at issue.Literal Infringement AliveCor has not asserted in this inter partes proceeding that the articles at issue literally infringe the ’731 patent. See Oral Discussion Transcript at 106: 14-21 (“Chief Terrill: . . . AliveCor, for purposes of the ’941 patent, is asserting a theory of infringement under literal and DOE, but for purposes of the ’731, it’s just DOE, is that correct? … Mr. Saunders [for AliveCor]: Yes, that is correct.”). Therefore, the parties’ dispute regarding literal infringement concerns the ’941 patent only. To begin, Apple argues that “. . . the Redesigned Watch cannot infringe as a matter of law because any hypothetical way of causing [[ ]]—to execute on Watch would require a significant modification.” Ruling Request at 50. Further, “. . . there can be no evidence of even a single instance of the Redesigned Watches operating with [[ ]]” Id. at 46. Accordingly, Apple’s view is that the articles cannot literally infringe the claims at issue, citing H329187, and reasoning that, in that ruling, “. . . the Branch stated that ‘evidence that the articles at issue perform the claimed function at least once is crucial to show that they are reasonably capable of satisfying the claim limitations for infringement of [the] apparatus claim at issue here that is drawn to capability.’ [] HQ [] H329187 at 16 (citing INVT, [46 F.4th] at 1377). And because [[ ]] required ‘further modification—in the form of a software update—’ they were found non-infringing. Id. at 18.” Ruling Request at 40.AliveCor counters that the articles at issue literally infringe the ’941 patent because “. . . claim 12 does not require that the processor of the smartwatch necessarily carry out the ‘confirm’ portion of the claim[.]” AliveCor Post-Oral Discussion Submission at 10. AliveCor argues that an external proc