Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1392; Certain Oil Vaporizing Devices, Components Thereof, and Products Containing the Same

H360688 June 17, 2026 OT:RR:BSTC:EOE H360688 RPR CATEGORY: 19 U.S.C. § 1337; Unfair Competition Bryan Nese Mayer Brown LLP 1999 K Street, N.W. Washington, DC 20006-1101 VIA EMAIL: Bnese@mayerbrown.com; STIIIZY-177@mayerbrown.com; afs_stiiizy-pax_itc1392@afslaw.com RE: Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1392; Certain Oil Vaporizing Devices, Components Thereof, and Products Containing the Same Dear Mr. Nese, Pursuant to 19 C.F.R. Part 177, the Exclusion Order Enforcement Branch (EOE Branch or Branch), Regulations and Rulings, U.S. Customs and Border Protection (CBP) issues this ruling letter (“STIIIZY II” or “Ruling Letter”) holding that STIIIZY IP LLC f/k/a STIIIZY, LLC and STIIIZY Inc. d/b/a Shryne Group Inc. (collectively, “STIIIZY”) has met its burden of proof that the associated components to its redesigned cartridges, the Post-FD Redesigned Cartridges, imported together with the Post-FD Redesigned Cartridges are not subject to the limited exclusion order (LEO or 1392 LEO) that the U.S. International Trade Commission (ITC or Commission) issued as a result of Investigation No. 337-TA-1392 (“the 1392 investigation”) under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337. As articulated below, we also find that STIIIZY has not met its burden of proof that the associated components to the Post-FD Redesigned Cartridges, including the batteries, when imported by themselves are not subject to the 1392 LEO. Although STIIIZY initially requested the Branch to rule on whether the Post-FD Redesigned Cartridges and “the components associated with [them] such as the vaporizer battery” (collectively, “associated components”) are non-infringing, the Branch decided to issue a separate ruling on the associated components, including the batteries. STIIIZY Ruling Request at 38; HQ H359213 at 1 (“STIIIZY I”) (May 15, 2026). 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. 2 STIIIZY II 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, STIIIZY, the Ruling Requester and a respondent in the 1392 investigation; and (2) PAX Labs, Inc. (“PAX”), the patent owner and complainant in the 1392 investigation (collectively, 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, 588 U.S. 427, 440 (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 The Commission found a violation of section 337 by reason of infringement of claims 1, 5, and 10 of U.S. Patent No. 11,369,756 (“the ’756 patent”); claims 1, 13, 15, and 20 of U.S. Patent No. 11,369,757 (“the ’757 patent”); claims 1, 5, 10-11, 17-18, and 22 of U.S. Patent No. 11,766,527 (“the ’527 patent”); and claims 1, 6-8, and 10 of U.S. Patent No. 11,759,580 (“the ’580 patent”) (collectively, the “asserted patents”). Certain Oil Vaporizing Devices, Components Thereof, and Products Containing the Same, Inv. No. 337-TA-1392, EDIS Doc. ID. 871272, 3 Public Commission Opinion (February 3, 2026) (“Comm’n Op.”) at 41. As such, the Commission issued an LEO, including a standard certification provision, against STIIIZY and ALD Group Limited and ALD (Hong Kong) Holding Limited, as well as CDOs against both STIIIZY respondents. Id. at 3, 28. In the 1392 LEO, the Commission ordered that: [c]ertain oil vaporizing devices, components thereof, and products containing the same, that infringe one or more of claims 1, 5, and 10 of the ’756 patent; claims 1, 5, 10, 11, 17, 18, and 22 of the ’527 patent; claims 1, 13, 15, and 20 of the ’757 patent; or claims 1, 6-8, and 10 of the ’580 patent and are manufactured abroad by, or on behalf of, or imported by or on behalf of Respondents or any of their affiliated companies, parents, subsidiaries, agents, or other related business entities, or its successors or assigns, 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 Oil Vaporizing Devices, Components Thereof, and Products Containing the Same, Inv. No. 337-TA-1392, EDIS Doc. ID. 869418, Limited Exclusion Order (January 20, 2026) at 2, ¶ 1. The 1392 LEO further defined the “covered articles” as follows: [v]aporizing devices capable of vaporizing oils, components thereof and products containing the same where the components of a vaporizing device are ‘a mouthpiece, a cartridge body, an atomizer, a distal member, a bottom cover, a vaporizer body including a cartridge receiver,’ as well as a ‘battery,’ and where products containing the same are cartridge and battery components ‘sold in combination with a power charging device in which the [cartridge] or battery would each be one component of the downstream product.’ Id. at 2, ¶ 2. A more detailed description of the background of the underlying investigation, the patents and asserted claims in the 1392 LEO, the accused products from the underlying investigation, and the procedural history of the instant ruling request, other than the new procedural developments described below, was provided in STIIIZY I and is adopted herein. HQ H359213 at 2-16. A. 19 C.F.R. Part 177 Ruling Request 1. Procedural History As noted in STIIIZY I, on May 1, 2026, the Branch notified the parties that it was planning to seek clarification from the Commission on an issue related to this proceeding and thus would need to extend the original target date of May 15, 2026 to one week after the Branch received a response from the Commission. HQ H359213 at 17-18 (citing Email from EOE Branch to Parties, May 1, 2026). On May 8, 2026, the EOE Branch formally transmitted a Request for Clarification 4 (“Request for Clarification”) to the Commission, asking the Commission to provide confirmation and clarification on the following questions: (1) whether the Commission found that Respondents’ batteries by themselves were indirectly infringing the asserted patents; or (2) whether the Commission found that Respondents’ batteries were infringing only in combination with an infringing cartridge. EOE Branch Request for Clarification at 1-2 (May 8, 2026). To provide sufficient opportunity for the Commission to respond to the Branch’s Letter for Clarification, the Branch decided to issue separate ruling letters for the Post-FD Redesigned Cartridges and associated components, respectively. On May 15, 2026, the Branch issued STIIIZY I, holding that the Post-FD Redesigned Cartridges are not subject to the 1392 LEO. HQ H359213. The EOE Branch received a response to its Request for Clarification from the Commission on June 8, 2026. Certain Oil Vaporizing Devices, Components Thereof, and Products Containing the Same, Inv. No. 337-TA-1392, EDIS Doc. ID. 884442, Clarification of the Commission’s Findings (June 8, 2026) (“Commission Response”). 2. The Articles at Issue The articles at issue in this Ruling Letter are “the components associated with the Post-FD Redesigned Cartridge such as the vaporizer battery.” Ruling Request at 38. STIIIZY’s head of hardware engineering, Ramon Alarcon, describes that the batteries and certain legacy cartridges interact as follows: [[ ]]. STIIIZY Ex. 2 at 3. Mr. Alarcon also provided the following illustration of a legacy cartridge inserted into the battery: [[ 5 ]] Id. at 4. STIIIZY admitted during the oral discussion held by the Branch and parties on April 30, 2026 that the batteries at issue here are the same as those from the underlying investigation. STIIIZY did not indicate in its filings in this proceeding what the other “associated components” are, but the Commission’s Opinion mentioned that the “components of a vaporizer device are ‘a mouthpiece, a cartridge body, an atomizer, a distal member, a bottom cover, a vaporizer body including a cartridge receiver,’ as well as a ‘battery.’” Comm’n Op. at 10. Because STIIIZY did not present any arguments or evidence that any of the associated components to the Post-FD Redesigned Cartridges have been modified, the Branch will presume that they are the same as in the underlying investigation. II. ISSUE Whether STIIIZY has met its burden of proof to show that the associated components to the Post-FD Redesigned Cartridges, including the batteries, do not infringe the claims at issue in the asserted patents and are thus not subject to the 1392 LEO. III. LEGAL FRAMEWORK The legal framework on section 337 exclusion order administration and patent infringement was discussed in STIIIZY I and is adopted herein. HQ H359213 at 21-24. IV. ANALYSIS In STIIIZY’s Ruling Request, STIIIZY requested the EOE Branch issue “a finding of non-infringement and that the Post-FD Redesigned Cartridge is outside the scope of the LEO . . . including the components associated with the Post-FD Redesigned Cartridge such as the vaporizer 6 battery.” STIIIZY Ruling Request at 38 (emphasis added). We first summarize the parties’ arguments, then consider the Commission’s findings, and lastly provide our analysis. A. The Parties’ Arguments On the Associated Components As stated above, the Branch previously addressed the importation of the Post-FD Redesigned Cartridges in STIIIZY I. We now turn our attention to the associated components to the Post-FD Redesigned Cartridges. Although STIIIZY requests a ruling with respect to all of the associated components to the Post-FD Redesigned Cartridges, its filings focused on the batteries. See STIIIZY Reply and STIIIZY Post-Oral Discussion Brief. With respect to the batteries, STIIIZY argues that the “[b]atteries do not directly infringe any of the Asserted Patents” and that “[n]one of the asserted claims in the 1392 investigation are directed solely to batteries; rather, those claims recite a ‘vaporizer cartridge’ or a ‘vaporizer device.’” STIIIZY Reply at 15 (citing ’580 patent at 34:39, 35:47; ’756 patent at 34:48, 35:26, 36:1; ’527 patent at 34:42, 35:55, 37:1; ’757 patent at 34:30, 36:1; and PAX Response at 4) (emphasis in original). Additionally, STIIIZY maintains that the “[b]atteries alone do not indirectly infringe any of the Asserted Patents” and “[b]ecause a battery alone cannot directly infringe any of the claims-at-issue, a battery alone also cannot be the basis for induced infringement.” STIIIZY Reply at 15 (citing Limelight Networks, Inc. v. Akamai Techs., Inc., 572 U.S. 915 (2014) (“liability for inducement must be predicated on direct infringement”) (emphasis in original). In STIIIZY’s view, “a battery is thus subject to the LEO only by virtue of it being part of an otherwise infringing device. If that device were no longer infringing (as is the case for devices incorporating the Post-FD Redesigned Cartridge), then none of the components enumerated in paragraph 2 of the LEO would be excluded from entry into the United States.” STIIIZY Reply at 16 (emphasis in original). On the other hand, PAX argues that the “Commission determined that all accused STIIIZY vaporizer batteries infringe the Asserted Patents” and “[t]hat determination is embodied in the LEO (and CDO), and CBP is bound to enforce the LEO as issued.” PAX Response at 3 (emphasis in original). According to PAX, because “[t]he Commission’s LEO explicitly identified the ‘battery’ as excluded by the issued LEO” . . . “CBP must enforce the ITC’s exclusion orders as issued, without independent authority to alter their terms.” Id. at 4 (citing 19 U.S.C.A. §1337(d)(1); Wirtgen Am., Inc. v. United States, 447 F. Supp. 3d 1359, 1376 (Ct. Int’l Trade 2020); and Eaton Corp. v. United States, 29 C.I.T. 1149, 1164-65 (Ct. Int’l Trade 2005)). More specifically, PAX maintains that “[g]iven that the accused STIIIZY batteries are subject to the LEO and STIIIZY failed to present any evidence of new or modified batteries in the Request, respectfully, CBP has no authority to override the Commission’s prior determination.” Id. at 5. Additionally, according to PAX, “[w]ith respect to indirect infringement, the ALJ concluded from the evidence of record that STIIIZY’s importation of all Accused Products, including batteries specifically, both contributed to and induced infringement of the asserted patents by others.” Id. at 4 (citing PAX Ex. 1, FID at 27, 60, 72, and 103; and Ex. 3, CIB at 74-75) (emphasis in original). To this end, PAX alleges that the ALJ found that PAX presented substantial evidence of contributory and induced infringement and this evidence went unrebutted in the underlying investigation. PAX Sur-Reply at 6 (citing FID at 26, 60, 72, and 103). Part of this unrebutted evidence, PAX alleges, was a statement by one of its experts, Kelly Kodama, in which he opined 7 that it would be contributory infringement for Respondents to import STIIIZY batteries separately from the accused cartridges. PAX Sur-Reply at 6 (citing FID at 27; Kodama WS at Q/A 588; and PAX Oral Discussion Presentation at 17). In PAX’s view, “[t]he FID relied on that unrebutted testimony in finding indirect infringement arising from importation of the accused batteries (in addition to indirect infringement arising from other components of infringing vaporizer devices, like cartridges without mouthpieces).” PAX Sur-Reply at 6 (citing FID at 27). PAX further contends that STIIIZY “presents no evidence showing how any of its battery products previously found to be indirectly infringing can be combined with the Post-FD Redesigned Cartridge.” Id. at 5. Additionally, PAX argues that “STIIIZY presents no evidence that the imported STIIIZY batteries will not be used in devices that directly infringe the asserted patents.” Id. at 7. In this regard, PAX indicates it is concerned that “[w]hen a consumer combines a STIIIZY battery with a legacy infringing cartridge to form a vaporizer device, direct infringement by the resulting device occurs.” PAX Post-Oral Discussion Brief at 4. Lastly, PAX argues that “[e]ven if STIIIZY’s Request included non-infringement evidence or arguments concerning the infringing STIIIZY batteries – which it does not – such arguments would be procedurally barred.” PAX Post-Oral Discussion Brief at 6; See also PAX Sur-Reply at 6. According to PAX, STIIIZY waived any right to “dispute indirect infringement as to the batteries that were at issue in the 1392 Investigation because it forfeited that defense by failing to assert it in the 1392 Investigation.” PAX Sur-Reply at 6. B. The Commission’s Findings on Infringement with Respect to the Associated Components, Including the Batteries, of the Legacy Cartridges The Commission found that several accused products that were a combination of an infringing cartridge and battery were directly infringing. Comm’n Op. at 26. For example, the Commission found that STIIIZY-ORIG-1G, which is a combination of an infringing cartridge and battery, directly infringed the asserted claims of the asserted patents. FID at 23, 55-56, 71, 84-85, 97-98, and 111, ¶ 6; Comm’n Op. at 26.1 However, the Commission did not find that any of the associated components to the legacy cartridges alone directly infringed the asserted claims of the asserted patents. See FID at 111-112; Comm’n Op. at 26. With respect to indirect infringement, the ALJ found that: PAX has introduced substantial evidence to show that Respondents are liable for contributory infringement and that they have induced others to infringe the ’756 patent. See, e.g., CX-4747X (Kodama) at Q/As 584-594; JX-0068 at 30:12-20; JX-0009C at 37:3-38:21; JX-0092C at 19:7-10; CX-0054; JX-0116C at 11; CX-1466C; JX-0357C; JX-0079C; JX-0358C; RX-0471C at Q/A 22; CX-1644C–CX-1652; CX-4301C; CX-1422C; CX-1423C; JX-0312C at 84:20-90:16; JX-0016C; JX-0009C at 38:13-39:13, 75:21-80:4; JX-0013C; JX-0014C; JX-0307. This evidence 1 The STIIIZY-ORIG-1G is a combination of the STIIIZY 1 Gram Pod and STIIIZY (Original) Battery. FID at 4; and PAX Oral Discussion Presentation at 11. In the parties’ Joint Stipulation Regarding Representative Products, Asserted Claims, and Asserted Prior Art References, the parties agreed that this combination was a representative accused product of a number of different cartridge and battery combinations. PAX Ex. 2 at 2, ¶ 3b. 8 stands unrebutted. Accordingly, I find that Respondents indirectly infringe claims 1, 5, and 10 of the ’756 patent, both contributorily and by inducement. FID at 26-27. The ALJ made similar findings on indirect infringement with respect to each of the asserted claims of the remaining asserted patents. Id. at 60, 72, and 103. The Commission decided not to review these findings, thereby adopting them. See Comm’n Op. at 2-3. While the FID made findings of indirect infringement, we note that the ALJ made no specific findings whether any of the components associated with the infringing cartridges by themselves indirectly infringed the asserted patents. See FID 26-27, 60, 72, and 103. This is confirmed in the Commission’s Response to the EOE Branch’s request for clarification on this point. In particular, the Commission noted in its Response that it: did not make a specific finding that any particular batteries imported by Respondents constitute indirect infringement of one or more claims of the asserted patents. As discussed further below, the Commission made detailed findings, as adopted from the final initial determination (“FID”), that importation of Respondents’ batteries are infringing in combination with an infringing cartridge. Commission Response at 1 (emphasis added).2 Additionally, the Commission’s Response notes that “while the FID cites to [a] portion of Mr. Kodama’s testimony as providing substantial evidence of indirect infringement, neither the FID nor the Commission Opinion explicitly discusses that evidence regarding the importation or sale of a particular battery product separate from the other components of the device.” Id. at 2 (emphasis added). Thus, the Commission’s findings on indirect infringement of the associated components are restricted to when they are combined with an infringing cartridge. C. The EOE Branch’s Analysis As an initial matter, we find STIIIZY’s request to the Branch regarding the associated components to the Post-FD Redesigned Cartridges, including the batteries, to be ambiguous. Initially, STIIIZY asked the Branch in its Ruling Request “for a finding of non-infringement and that the Post-FD Redesigned Cartridge is outside the scope of the LEO . . . , including the components associated with the Post-FD Redesigned Cartridge such as the vaporizer battery.” STIIIZY Ruling Request at 38 (emphasis added). Then STIIIZY later stated in its Post-Oral Discussion Brief that “[t]he Post-FD Redesigned Cartridges will be [[ ]].” STIIIZY Post-Oral Discussion Brief at 21. 2 Although the Commission’s Response focuses on STIIIZY’s batteries, we find the language in the Response also applies to the other associated components to the post-FD Redesigned Cartridges because the FID made similar findings on all the associated components. See FID at 26-27, 60, 72, and 103. The 1392 LEO specifically identifies other associated components to the infringing cartridges, including a mouthpiece, cartridge body, atomizer, a distal member, a bottom cover, and a vaporizer including cartridge receiver. 1392 LEO ¶ 2. 9 From the above, the Branch is unclear whether STIIIZY is asking for a finding that (1) the associated components, including the batteries, are not subject to the 1392 LEO when imported in combination with the Post-FD Redesigned Cartridges; and/or (2) the associated components when imported separately are not subject to the 1392 LEO. For example, with respect to the associated components, STIIIZY’s initial request can be read as a request for a finding of non-infringement of the associated components either when imported together with the Post-FD Redesigned Cartridges or alone. Because of the uncertainty of the request, we address both of these prospective transactions under 19 C.F.R. §177 separately. 1. Whether the Combination of the Post-Redesigned Cartridges and Associated Components, including the Batteries, is Subject to the 1392 LEO The first prospective transaction we consider is whether the associated components to the Post-FD Redesigned Cartridges, including the batteries, are subject to the 1392 LEO when imported in combination with the Post-FD Redesigned Cartridges. Here, we hold that STIIIZY has met its burden of proof that this prospective transaction does not infringe the asserted claims of the asserted patents, and thus, are not subject to exclusion pursuant to the 1392 LEO. Commission Response at 1. As we noted in STIIIZY I, STIIIZY met its burden of proof that the Post-FD Redesigned Cartridges alone do not directly infringe the asserted claims of the asserted patents and as such are not subject to the 1392 LEO. See H359213 at 24-32. Specifically, we found that the Post-FD Redesigned Cartridges do not meet every limitation of the asserted claims of the asserted patents. Id. Because we found that these cartridges do not directly infringe, it follows that the combination of the Post-FD Redesigned Cartridges and any associated components, including the batteries, also cannot directly infringe. As the Federal Circuit has held, “[f]or direct infringement, ‘one or more claims of the patent [must] read on the accused device . . . .’ Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1310 (Fed. Cir. 2005)). A claim reads on the accused device only if ‘each and every limitation set forth in a claim appear[s] in an accused product.’” V-Formation, Inc. v. Benetton Grp. SpA, 401 F.3d 1307, 1312 (Fed. Cir. 2005). Heidary v. Amazon.com, Inc., 2024 U.S. App. LEXIS 25826 at *7 (Fed. Cir. 2024). In accordance with the above, we find that the combination of the Post-FD Redesigned Cartridges and associated components does not directly infringe the asserted claims of the asserted patents. We now turn to whether the associated components indirectly infringe the asserted claims of the asserted patents when imported in combination with the Post-FD Redesigned Cartridges. It is a well-known principle in patent law that a finding of indirect infringement is predicated on direct infringement. As the Federal Circuit has held, “[i]ndirect infringement, whether inducement to infringe or contributory infringement, can only arise in the presence of direct infringement, though the direct infringer is typically someone other than the defendant accused of indirect infringement.” Dynacore Holdings Corp. v. U.S. Philips Corp., 363 F.3d 1263, 1272 (Fed. Cir. 2004) (citing Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1334 (Fed. Cir. 2003)). As indicated above, the combination of the associated components and Post-FD Redesigned Cartridges does not directly infringe the asserted claims of the asserted Patents, therefore, under Federal Circuit precedent, the associated components cannot indirectly infringe the asserted claims of the asserted Patents when imported in combination with the Post-FD Redesigned Cartridges. 10 We disagree with PAX that the “Commission determined that all accused STIIIZY vaporizer batteries infringe the Asserted Patents.” PAX Response at 3. As indicated in the Commission Response to the EOE Branch, the Commission found that the batteries infringe the asserted patents only when imported with infringing cartridges. Commission Response at 1. As such, the record supports STIIIZY’s contention that “the vaporizer batteries at issue here are only subject to the Commission’s remedial orders if they are to be used in a device that actually infringes.” STIIIZY Reply at 16. We also find PAX’s argument that STIIIZY “presents no evidence showing how any of its battery products previously found to be indirectly infringing can be combined with the Post-FD Redesigned Cartridge” to be without merit. PAX Sur Reply at 5. STIIIZY indicated in its Ruling Request that the batteries provide [[ ]] of the Post-FD Redesigned Cartridges and that the “[[ ]].” STIIIZY Ruling Request at 26, N. 5 (citing Ex. 2 ¶¶ 12, 16). Thus, contrary to PAX’s assertions, STIIIZY has provided sufficient evidence that the batteries at issue here can function with the Post-FD Redesigned Cartridges. In sum, after reviewing the record in the underlying investigation and filings by both parties with CBP pursuant this ruling request, we find that the associated components to the Post-FD Redesigned Cartridges do not infringe the asserted claims of the asserted patents directly or indirectly when imported in combination with Post-FD Redesigned Cartridges. Therefore, the associated components, including the batteries, are not subject to the 1392 LEO when imported in combination with the Post-FD Redesigned Cartridges. 2. Whether STIIIZY Has Met Its Burden of Proof in Showing That the Associated Components to the Post-FD Redesigned Cartridge, Including the Batteries, are Non-Infringing When Imported Alone The second prospective transaction we consider is the associated components, including the batteries, to the Post-FD Redesigned Cartridges, when they are imported separately. As stated above, the 1392 LEO provides that “[c]ertain oil vaporizing devices, components thereof, and products containing the same, that infringe one or more” of certain claims of the Asserted Patents are barred from entry for consumption. 1392 LEO at 2, ¶ 2 (emphasis added). “Components thereof” in the 1392 LEO refers back to “certain oil vaporizing devices . . . that infringe.” That is, the plain language of the 1392 LEO dictates that components that are part of oil vaporizing devices that are infringing are barred from entry for consumption. As such, STIIIZY bears the burden of proof and the burden of production in showing that the associated components to the Post-FD Redesigned Cartridges, including the batteries, are not subject to the 1392 LEO and will not be used in an infringing manner. The associated components, as noted above, have not been modified and are the same as the ones from the underlying investigation. First, we find the associated components by themselves, including the batteries, do not directly infringe the claims at issue in the asserted patents. The EOE Branch has held that “[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. 11 Microsoft Corp. v. GeoTag, Inc., 817 F.3d 1305, 1313 (Fed. Cir. 2016). One way to establish equivalence is by showing, on an element-by-element basis, that the accused product performs substantially the same function in substantially the same way with substantially the same result as each claim limitation of the patented invention, which is often referred to as the function-way-result test. See Intendis GmbH v. Glenmark Pharms., Inc., 822 F.3d 1355, 1361 (Fed. Cir. 2016).” HQ H351038 at 8-9 (August 1, 2025). None of the asserted claims in the asserted patents are solely directed towards any of the associated components to the Post-FD Redesigned Cartridges. Rather, these claims are directed to “vaporizer devices” and “vaporizer cartridges.” See ’580 patent at 34:39, 35:47; ’756 patent at 34:48, 35:26, 36:1; ’527 patent at 34:42, 35:55, 37:1; and ’757 patent at 34:30, 36:1. Moreover, the Commission did not find direct infringement by any of the associated components as standalone products. See FID at 26-27, 60, 72, and 103. In fact, both parties acknowledge that the asserted claims in the asserted patents are directed only to vaporizer device and vaporizer cartridge claims. STIIIZY Reply at 15; and PAX Post-Oral Discussion Brief at 6 (“asserted vaporizer device claims”). As such, the associated components alone cannot satisfy the limitations of the asserted claims of the asserted patents under direct infringement, either literally or under the doctrine of equivalents. “For literal infringement, each limitation of the claim must be met by the accused device exactly, any deviation from the claim precluding a finding of infringement.” Lantech, Inc. v. Keip Mach. Co., 1994 U.S. App. LEXIS 20586 at *547 (Fed. Cir. 1994) (citing Johnston v. IVAC Corp., 885 F.2d 1574, 1577, 12 USPQ2d 1382, 1384 (Fed. Cir. 1989)). Turning to indirect infringement, we find that both parties have proffered erroneous arguments. As an initial matter, STIIIZY maintains that it “is not asking the EOE Branch to “conduct[] an indirect infringement analysis.” (See Response at 5 n.3.) Rather than ask the Branch to determine whether there is indirect infringement by a component (i.e., a battery), STIIIZY is asking for an adjudication of no direct infringement by the claimed articles (i.e., vaporizer devices and vaporizer cartridges).” STIIIZY Reply at 17 (emphasis added). However, just because the associated components do not directly infringe the asserted claims of the asserted patents, it does not mean they do not indirectly infringe an article previously found by CBP or the Commission to directly infringe. As such, CBP must determine whether STIIIZY has met its burden of proof that the associated components, including the batteries, by themselves do not indirectly infringe the asserted claims of the asserted patents. In its arguments concerning indirect infringement, STIIIZY erroneously asserts that “[b]ecause a battery alone cannot directly infringe any of the claims-at-issue, a battery alone also cannot be the basis for induced infringement” (citing Limelight Networks, Inc. v. Akamai Techs., Inc., 572 U.S. 915 (2014)). This statement reflects a misunderstanding of the doctrine of induced infringement. The EOE Branch, supported by Federal Circuit precedent, has previously held that “induced infringement requires a showing that the accused inducer took an affirmative act to encourage infringement.” HQ H324074 at 12 (November 30, 2023) (citing Microsoft Corp. V. Datatern, Inc., 755 F.3d 899, 904 (Fed. Cir. 2013)). In Tegal Corp. v. Tokyo Electron Co., 248 F.3 1376, 1378-79 (Fed. Circ. 2001), the Federal Circuit explained that “[o]f course inducement has connotations of active steps knowingly taken--knowingly at least in the sense of purposeful, intentional as distinguished from accidental or inadvertent. But with that qualifying approach, the term is as broad as the range of actions by which one in fact causes, or urges, or encourages, or 12 aids another to infringe a patent” (citing Fromberg, Inc. v. Thornhill, 315 F.2d 407, 411, 137 U.S.P.Q. (BNA 84,87 (5th Cir, 1963) (emphasis in original). Thus, for induced infringement, the Federal Circuit suggests that a broad range of acts may satisfy the “affirmative act” requirement of this theory of infringement. Certainly, under Federal Circuit precedent, the act of importing an associated component to a device found previously to directly infringe could potentially be the basis for a finding of induced infringement. Thus, whether the batteries alone directly infringe the asserted claims of the asserted patents is irrelevant to a finding of induced infringement. In fact, the Commission in the underlying investigation found that the combination of the batteries with an infringing cartridge was indirect infringement. FID at 26-27, 60, 72, and 103; Commission Response at 1-2. Therefore, STIIIZY is incorrect in its assertion that the batteries associated with the Post-FD Redesigned Cartridges themselves have to directly infringe for there to be a finding of indirect infringement by the batteries. Similarly, PAX’s reading of the FID is misguided. Contrary to PAX’s assertions, the FID made no findings of indirect infringement concerning the associated components by themselves, including the batteries. FID at 26-27, 60, 72, and 103; Commission Response at 1-2. This is confirmed by the Commission’s Response to the EOE Branch which indicated that the Commission “did not make a specific finding that any particular batteries imported by Respondents constitute indirect infringement of one or more claims of the asserted patents” and that the only infringement findings it made regarding the batteries is that they were infringing in combination with an infringing cartridge. See FID at 26-27, 60, 72, and 103; Commission Response at 1-2. In fact, the Commission noted in its response that “the FID is silent as to whether Respondents’ importation of any specific battery products constitutes indirect infringement of any asserted claim.” Commission Response at 2 (citing Joint Statement Identifying Accused Products). As such, PAX has misinterpreted the FID’s reliance on the evidence PAX presented in the underlying investigation on the question of indirect infringement. While the Commission ruled that PAX provided “substantial evidence” of contributory and induced infringement that went unrebutted, and found indirect infringement, it does not follow that the Commission adopted the entirety of this evidence as conclusions of law. See FID at 26-27, 60, 72, and 103; Commission Response at 1-2. As noted in the Commission Response to the EOE Branch, and cited above, “while the FID cites to [a] portion of Mr. Kodama’s testimony as providing substantial evidence of indirect infringement, neither the FID nor the Commission Opinion explicitly discusses that evidence regarding the importation or sale of a particular battery product separate from the other components of the device.” Commission Response at 2 (emphasis added). As such, we cannot conclude that the Commission found that any of the associated components to the legacy cartridges would indirectly infringe the asserted claims of the asserted patents based on Mr. Kodama’s testimony. Contrary to PAX’s assertions, the Commission did not find that the batteries alone would indirectly infringe by causing others to combine the batteries with legacy products. See FID at 26-27, 60, 72, and 103; Commission Response at 1-2. Lastly, we disagree with PAX’s contention that STIIIZY waived any right to “dispute indirect infringement as to the batteries that were at issue in the 1392 Investigation because it forfeited that defense by failing to assert it in the 1392 Investigation.” PAX Sur-Reply at 6. The Post-FD Redesigned Cartridges were not at issue before the Commission, so we find that any indirect infringement arguments pertaining to the associated components to these cartridges are not waived in this proceeding. 13 Nonetheless, it remains STIIIZY’s burden to prove to CBP that the associated components, including the batteries, to the Post-FD Redesigned Cartridges are not by themselves subject to the 1392 LEO. In the exclusion order context, it is well established that the party who is seeking to enter an article in light of an exclusion order has both the burden of production and persuasion. In CBP HQ Ruling H338254, the EOE Branch provided the following explanation for this approach: [T]he Federal Circuit has noted that, as “two distinct burdens of proof” for a party to carry, “the burden of persuasion is the ultimate burden assigned to a party who must prove something to a specified degree of certainty, such as by a preponderance of the evidence or by clear and convincing evidence” and the distinct “burden of production may entail producing additional evidence and presenting persuasive argument based on new evidence or evidence already of record.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016) (internal quotations and citations omitted). Significantly, when Hyundai places the “burden” on the “would be importer,” that is understood to encompass both the “burden of persuasion” and the “burden of production” such that [the importer] must produce sufficient record evidence that proves to the requisite degree of certainty the relevant question of fact. This approach is generally consistent with application of the Customs laws in other contexts. See Shamrock Bldg. Materials, Inc. v. United States, 119 F.4th 1346, 1352 (Fed. Cir. 2024) (“[T]the importer must produce evidence (the burden of production portion of the burden of proof) that demonstrates by a preponderance (the burden of persuasion portion of the burden of proof) that Customs’ classification decision is incorrect.”) (citing Universal Electronics Inc. v. United States, 112 F.3d 488, 492 (Fed. Cir. 1997); Timber Products Co. v. United States, 515 F.3d 1213, 1219 (Fed. Cir. 2008); and Libas, Ltd. v. United States, 193 F.3d 1361, 1365 (Fed. Cir. 1999)). CBP HQ Ruling H338254 (January 7, 2025) at 47. We find that STIIIZY has not provided sufficient evidence to meet its burden of proof or burden of production with respect to any of the associated components to the Post-FD Redesigned Cartridges, including the batteries, that these components do not indirectly infringe the asserted claims of the asserted patents and are therefore not subject to the 1392 LEO. In its filings before us, STIIIZY has only made general statements that it will no longer import infringing cartridges, which the EOE Branch finds are tantamount to self-certification. The Branch has traditionally rejected such statements as a substitute for actual evidence of non-infringement. In HQ H324813, we held that “Google’s reliance on its certification as a basis for the EOE Branch to reach an opposite holding in this inter partes proceeding is without merit. If reliance on a certification was dispositive, it would allow a respondent to self-judge that it was complying with the Commission’s remedial orders. CBP has previously refused to permit such a self-certification.” HQ H324813 at 45-46 (citing Wirtgen Am., Inc. v. United States, 443 F. Supp. 3d 198, 208 (D.D.C. 2020) (“Customs refused to accept Wirtgen’s self-certification stat[ing] that the articles being imported are not subject to the exclusion order.”). Here, in its Post-Oral Discussion Submission, STIIIZY contends that: 14 STIIIZY is not (and cannot) continue to sell in the United States imported cartridges that infringe the ’580 patent, and moving forward the only cartridges STIIIZY will make available to consumers will be those that do not infringe. In such a circumstance, there can be no induced infringement. See Vita-Mix Corp. v. Basic Holding, Inc., 581 F.3d 1317, 1329 (Fed. Cir. 2009) (“Especially where a product has substantial non-infringing uses, intent to induce infringement cannot be inferred even when the defendant has actual knowledge that some users of its product may be infringing the patent.”) (quoting Warner–Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365 (Fed. Cir. 2003). STIIIZY Post-Oral Discussion Brief at 8. Additionally, STIIIZY states that: PAX’s argument regarding legacy infringing cartridges in the market is speculative. PAX offers no evidence regarding the volume of legacy cartridges in the U.S., the rate at which such cartridges are being consumed or retired, or the likelihood that consumers will combine newly imported batteries with older cartridges rather than with the redesigned cartridges. Indeed, with no legacy cartridges being imported into the U.S. as of March 20, the number of these cartridges will quickly dwindle, further diminishing PAX’s concerns. PAX’s argument, therefore, is based on unfounded speculation about consumer behavior for products no longer being imported or sold by STIIIZY. Put simply, because there can no longer be a supply of infringing cartridges, there can no longer be indirect infringement by the associated batteries. Id. Furthermore, STIIIZY contends that: While the specific ratio of cartridges to batteries varies based on sales and consumer demand, [[ ]]. For example from the period from January 2024 through December 2025, batteries represented about [[ ]] by unit to cartridges. STIIIZY expects that the legacy version of the ITC cartridges [[ ]]. Further, STIIIZY also states that it now directs users to use the STIIIZY battery with cartridges sold after March 20, 2026 (i.e., the Post-FD Redesigned Cartridges). STIIIZY Post-Oral Discussion Brief at 9. We note that STIIIZY introduced the foregoing contentions about no longer importing the infringing cartridges and statistics related to the legacy cartridges for the first time in its Post-Oral Discussion Brief. However, the EOE Branch notified both parties that the “[t]he oral discussion is not an evidentiary hearing. Instead, it is an opportunity for the parties to provide the EOE Branch with a better understanding of the facts, issues, and arguments presented in the prior submissions. Accordingly, no new facts or arguments are to be presented in the oral discussion.” Email from EOE Branch to Parties, February 27, 2026 (emphasis added). We note that PAX did not have an opportunity to present counterarguments to these contentions. Therefore, 15 for purposes of this Part 177 proceeding, the Branch will not consider these arguments and evidence. Moreover, even if STIIIZY presented these arguments prior to the oral discussion, we find they are insufficient by themselves to prove that the associated components to the Post-FD Redesigned Cartridges, including the batteries, do not indirectly infringe the asserted claims in the asserted patents. STIIIZY has only provided assertions that “moving forward the only cartridges STIIIZY will make available to consumers will be those that do not infringe” and that “[i]ndeed, with no legacy cartridges being imported into the U.S. as of March 20, the number of these cartridges will quickly dwindle, further diminishing PAX’s concerns.” STIIIZY Post Oral Discussion Brief at 8. However, STIIIZY has not submitted any expert testimony or other documentation to support these contentions. Additionally, STIIIZY argues that “[t]here is also no merit to PAX’s accusation that STIIIZY will ‘circumvent the LEO by way of cartridges that the Commission found to infringe.’ PAX cites no evidence to support this unfounded fear, and STIIIZY respectfully submits that this matter should not be decided on mere speculation or attorney argument. Whatever concerns PAX has can be addressed with an appropriate certification.” STIIIZY Reply at 17 (internal citations omitted). However, certifications filed with CBP only ensure that “the products being imported are not excluded from entry under paragraph 1 of this [LEO]” and does not serve as evidence that the products will be used in a non-infringing manner. 1392 LEO ¶ 1, 4. In HQ H308232, we held that “CBP only accepts a certification that the goods have been previously determined by CBP or the Commission not to violate the exclusion order.” HQ H308232 at 5, N. 9 (emphasis added). As such, the Branch finds that STIIIZY has not met its burden of proof to show that the associated components to the Post-FD Redesigned Cartridges, including the batteries, when imported alone will not be used with an infringing cartridge. Therefore, we find that STIIIZY has not met its burden of proof that the associated components, including the batteries, to the Post-FD Redesigned Cartridges when imported separately do not indirectly infringe the asserted claims of the asserted patents. Accordingly, the associated components, when not being imported in combination with the Post-FD Redesigned Cartridges, are subject to the 1392 LEO. V. HOLDING We hold that STIIIZY has met its burden to establish that the associated components to the Post-FD Redesigned Cartridges, including the batteries, do not infringe any of the asserted claims of the asserted patents if imported with a non-infringing device. Accordingly, we find that the associated components, if imported with a non-infringing device, are not subject to the 1392 LEO. However, we find that STIIIZY has not met its burden to establish that the associated components to the Post-FD Redesigned Cartridges, including the batteries, do not infringe the asserted claims of the asserted patents when imported separately. As such, the associated components are subject to the 1392 LEO when imported without the Post-FD Redesigned Cartridges. 16 We also note that the Commission in its Response to the EOE Branch indicated “the parties may request that the Commission institute proceedings under section 337(k) and Commission Rule 210.76 or 210.79 to obtain a ruling as to the specific battery products at issue” (citing 19 U.S.C. § 1337(k); 19 C.F.R. §§ 210.76 (modification proceeding), 210.79 (advisory opinions)). Id. at 3. The decision is limited to the specific facts set forth herein. If articles differ in any material way from the articles at issue described above, or if future importations vary from the facts stipulated to herein, this decision shall not be binding on CBP as provided for in 19 C.F.R. §§ 177.2(b)(1), (2), (4), and 177.9(b)(1) and (2). Sincerely, Alaina van Horn Chief, Intellectual Property Enforcement Branch / Exclusion Order Enforcement Branch CC: Lyle Vander Schaaf Crowell & Moring LLP 1001 Pennsylvania Avenue, NW Washington, DC 200004 LVanderSchaaf@crowell.com PAX-ITC@crowell.com