H347235

H347235 March 27, 2026 OT:RR:BSTC:EOE H347235 RPR CATEGORY: 19 U.S.C. § 1337; Unfair Competition Christopher J. Lutz Armis IP Law, L.L.C. P.O. Box 1564 Westborough, MA 01581 VIA EMAIL: chris.lutz@armisiplaw.com RE: Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1362; Certain Liquid Transfer Devices With an Integral Vial Adapter Dear Mr. Lutz, 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 holding that Summit International Medical Technologies Inc. (“Summit” or “Ruling Requester”) has not met its burden to show that its redesigned versions of liquid transfer devices (“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-1362 (“the 1362 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, Summit, the Ruling Requester and a respondent in the 1362 investigation; and (2) West Pharmaceutical Services, Inc. and West Pharma Services, IL, Ltd. (collectively, “West”), the patent 1 owner and complainant in the 1362 investigation (together, the “parties”). 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). I. BACKGROUND A. ITC Investigation No. 337-TA-1362 1. Procedural History at the ITC The Commission instituted Investigation No. 337-TA-1362 on May 11, 2023, based on a complaint filed by West Pharmaceutical Services, Inc. of Exton, Pennsylvania and West Pharma. Services IL, Ltd. of Ra’anana, Israel. Certain Liquid Transfer Devices With an Integral Vial Adapter, Inv. No. 337-TA-1362, EDIS Doc. ID 843955, Public Commission Opinion (Feb. 20, 2025) (“Comm’n Op.”) at 2 (citing 88 Fed. Reg. 30342 (May 11, 2023)). The complaint, as supplemented, alleged a violation of section 337 by reason of infringement of claim 1 of U.S. 2 Patent No. 10,688,295 (“the ’295 patent”), the claim of U.S. Design Patent No. D767,124 (“the D’124 patent”); the claim of U.S. Design Patent No. D765,837 (“the D’837 patent”); the claim of U.S. Design Patent No. D630,732 (“the D’732 patent”); and U.S. Trademark Registration No. 5,810,583 (“the ’583 mark”). Id. at 3. The notice of investigation named four respondents: Advcare Medical, Inc. of New Taipei City, Taiwan (“Advcare”), Dragon Heart Medical Devices Co., Ltd. Of Kaiping City, China (“Dragon Heart Devices”), Dragon Heart Medical, Inc. of Addison, Illinois (“Dragon Heart”), and Summit International Medical Technologies, Inc. of Franklin, Massachusetts (“Summit”). Id. The Commission’s Office of Unfair Import Investigations (“OUII”) was also named as a party in the investigation. Id. The 1362 investigation was terminated as to Dragon Heart Devices but not as to the other Dragon Heart respondent. Id. The ’583 mark and the three asserted design patents (the D’124 patent, the D’837 patent, and the D’732 patent) were terminated from the investigation by withdrawal. Id. Accordingly, the ’295 patent was the only asserted intellectual property right remaining in this investigation, and the remaining respondents in the investigation were Summit, Advcare, and Dragon Heart (collectively, “respondents”). Id. On March 15, 2024, the presiding Administrative Law Judge (“ALJ”) issued a final initial determination, Certain Liquid Transfer Devices With an Integral Vial Adapter, Inv. No. 337-TA- 1362, EDIS Doc. ID 816231, Public Final Initial Determination (March 15, 2024) (“FID”) finding a violation of section 337. Comm’n Op. 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 claim 1 of the ’295 patent. Id. On May 16, 2024, the Commission issued a notice in which it determined to review in part the FID. Id. Specifically, the Commission determined to review the FID’s findings with respect to standing and jurisdiction as well as the ALJ’s preclusion of the respondents’ and OUII’s invalidity arguments. Id. The Commission determined not to review the remaining findings in the FID, including the findings on claim construction, infringement, and the technical prong of the domestic industry requirement. Id. On November 8, 2024, the ALJ issued a Remand ID finding that claim 1 of the ’295 patent is not invalid for lack of written description under 35 U.S.C. § 112. Certain Liquid Transfer Devices With an Integral Vial Adapter, Inv. No. 337-TA-1362, EDIS Doc. ID 836774, Remand ID (Nov. 8, 2024) (“Remand ID”); Comm’n Op. at 5. The respondents and OUII subsequently filed petitions for review. Comm’n Op. at

below. C. Claim Construction As mentioned above, “[t]o establish literal infringement, every limitation recited in a claim must be found in the accused product whereas, under the doctrine of equivalents, infringement occurs when there is equivalence between the elements of the accused product and the claimed elements of the patented invention.” See Microsoft Corp., 817 F.3d at 1313 (Fed. Cir. 2016). “Claim terms are generally given their plain and ordinary meaning, which is the meaning one of ordinary skill in the art would ascribe to a term when read in the context of the claim, 1 Although claim construction is a question of law, the consideration of extrinsic evidence may constitute a subsidiary finding of fact. Teva, 135 S. Ct. at 841, 190 L. Ed. 2d at 733. 17 

 specification, and prosecution history.” Kyocera 22 F.4th at 1378. “There are only two exceptions to this general rule: 1) when a patentee sets out a definition and acts as his own lexicographer, or 2) when the patentee disavows the full scope of a claim term either in the specification or during prosecution.” Thorner v. Sony Computer Ent. Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). However, when the parties seek no claim construction and a claim phrase is not construed, the Federal Circuit has instructed: When a claim limitation, like the one at issue here, is not expressly construed, a jury is entitled to give that limitation any reasonable meaning in determining, as a factual matter, what comes within its scope. See Akamai Techs., Inc. v. MediaPointe Inc., 159 F.4th 1370, 1380 (Fed. Cir. 2025); see also VLSI Tech. LLC v. Intel. Corp., 87 F.4th 1332, 1341 (Fed. Cir. 2023) (“When a claim phrase is not construed, we defer to the jury's view of the claim element unless that view is contrary to the only reasonable view of the claim element.”) (emphasis added). IV. ANALYSIS The parties’ dispute in this proceeding centers around whether Summit has met its burden of proof that its redesigned products do no