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

H359213
May 15, 2026
OT:RR:BSTC:EOE H359213 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: [email protected]; [email protected]; [email protected] 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 holding that STIIIZY IP LLC f/k/a STIIIZY, LLC and STIIIZY Inc. d/b/a Shryne Group Inc. (collectively, “STIIIZY” or “Ruling Requester”) has met its burden to show that its redesigned vaping 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. Although STIIIZY requested the Branch to also rule on whether “the components associated with the Post-FD Redesigned Cartridge such as the vaporizer battery” are non-infringing, the Branch will issue a separate ruling (“STIIIZY II”) on these components by June 12, 2026. See STIIIZY Ruling Request at 38. 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 (“STIIIZY I”) 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)
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 A. ITC Investigation No. 337-TA-1392 1. Procedural History at the ITC The Commission instituted Investigation No. 337-TA-1392 on March 6, 2024 based on a complaint filed by PAX. Certain Oil Vaporizing Devices, Components Thereof, and Products Containing the Same, Inv. No. 337-TA-1392, EDIS Doc. ID. 871272, Public Commission Opinion (February 3, 2026) (“Comm’n Op.”) at 3. The complaint alleged a violation of section 337 by reason of infringement of certain claims of U.S. Patent Nos. 11,369,756 (“the ’756 patent”); 11,369,757 (“the ’757 patent”); 11,766,527 (“the ’527 patent”); and 11,759,580 (“the ’580 patent”)
3 (collectively, the “Asserted Patents”). Id. at 2. The complaint also alleged that the accused products were “certain oil vaporizing devices, components thereof, and products containing the same” (collectively, “Accused Products”). Id. at 3. The complaint further alleged that the respondents “import into the United States, sell for importation into the United States, and/or sell in the United States after importation Accused Products that infringe, directly or indirectly, one or more claims” of the Asserted Patents. Complaint at 1, ¶ 2. The notice of institution named STIIIZY and ALD Group Limited and ALD (Hong Kong) Holding Limited (collectively, “ALD”) as respondents (collectively, “Respondents”). Certain Oil Vaporizing Devices, Components Thereof, and Products Containing the Same, Inv. No. 337-TA-1392, EDIS Doc. ID. 815209, Notice of Institution of Investigation (February 29, 2024) (“notice of institution”) at 2-3. The Commission’s Office of Unfair Import Investigation (“OUII”) was not a party to the investigation. Comm’n Op. at 3. Through various orders, the Commission terminated the investigation with respect to certain claims of the Asserted Patents. Certain Oil Vaporizing Devices, Components Thereof, and Products Containing the Same, Inv. No. 337-TA-1392, EDIS Doc. ID. 825702, Order No. 11 (July 11, 2024), unreviewed by Comm’n Notice (July 30, 2024); and Certain Oil Vaporizing Devices, Components Thereof, and Products Containing the Same, Inv. No. 337-TA-1392, EDIS Doc. ID. 831665, Order No. 20 (Sept. 6, 2024), unreviewed by Comm’n Notice, EDIS Doc. ID. 834179, (Oct. 7, 2024). Then, after an evidentiary hearing, the presiding Administrative Law Judge (“ALJ”) terminated the investigation with respect to additional claims. Certain Oil Vaporizing Devices, Components Thereof, and Products Containing the Same, Inv. No. 337-TA-1392, EDIS Doc. ID. 836794, Order No. 32 (Nov. 8, 2024), unreviewed by Comm’n Notice, EDIS Doc. Id. 838932 (Dec. 10, 2024). At some point during the investigation, the respondents introduced several redesigned products, including the STIIIZY-1G-REDESIGN(C), STIIIZY-ORIG-1G-REDESIGN, and STIIIZY-AIO-REDESIGN (collectively, “STIIIZY Redesigned Products”). Certain Oil Vaporizing Devices, Components Thereof, and Products Containing the Same, Inv. No. 337-TA-1392, EDIS Doc. ID. 845893, Final Initial Determination (“FID”) (March 6, 2025), reviewed in part by Comm’n Notice, EDIS Doc. Id. 851435 (May 16, 2025), at 24 (citing MSD, EDIS Doc. ID. 830275). On March 6, 2025, the ALJ issued an FID. Comm’n Op. at 4. As of the FID, the remaining asserted claims were 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; and claims 1, 6-8, and 10 of the ’580 patent. Id. In the FID, the ALJ found that the following Accused Products infringed the asserted claims of at least one of the Asserted Patents: STIIIZY-LIIIL, STIIIIZY-1(G)(C), STIIIZY-ORIG-1, STIIIZY-AIO, FLARE(C), FLARE(V), ROVE(C), ROVE(V), STIIIZY-1G-REDESIGN(C), STIIIZY-ORIG-1G-REDESIGNS, STIIIIZY-AIO-REDESIGN, FLARE-REDESIGN(C), and FLARE-REDESIGN(V). FID at 111-112. Additionally, the FID held that the respondents’ ROVE-REDESIGN(C ) and ROVE-DESIGN(V) did not infringe certain claims of the ’580 patent. Id. at 112. With respect to the STIIIZY Redesigned Products noted above, the ALJ found that they infringed certain claims of the ’580 patent but not the ’756, ’757, and ’527 patents. Id. at 96, 98-99, and 112. Moreover, the ALJ noted that PAX did not introduce any evidence that the STIIIZY Redesigned Products infringed the asserted claims of the ’756, ’757, and ’527 patents and therefore failed to meet its burden of proof. Id. at 25, 60, and 72. The ALJ also held that STIIIZY presented
4 no evidence to rebut PAX’s contentions that the Accused Products indirectly infringed the asserted claims of the Asserted Patents, both contributorily and by inducement. Id. at 27, 70, 72, and 103. The FID also found that all the asserted claims were valid and that the technical prong of the domestic industry requirement of section 337 was satisfied. Id. at 112-113. However, the ALJ held that the economic prong of the domestic industry requirement was not met. Id. at 113. As such, the ALJ found no violation of section 337. Id. at 109-112. In the FID, the ALJ made a recommended determination (“RD”) that should the Commission find a section 337 violation, then an LEO should be issued against STIIIZY and ALD. Id. Moreover, the RD recommended cease and desist orders (“CDOs”) against the STIIIZY respondents only. Id. at 114-116. Lastly, the RD recommended that the Commission set a bond of one hundred percent (100%) of the entered value for the importation of any infringing articles during the presidential review period. Id. at 116-117. The parties filed petitions with the Commission for review of the FID on March 18, 2025. Comm’n Notice (May 16, 2025) at 2-3. The Commission issued a notice on May 16, 2025 that it was reviewing the FID’s findings in part. Id. at 2. Specifically, the Commission indicated that it was reviewing the FID’s findings that: (1) certain Accused Products do not infringe the asserted claims of the ’580 patent; (2) certain redesigned products infringe the asserted claims of the ’580 patent; and (3) the Complainant has not satisfied the economic prong of the domestic industry requirement. Id. at 3. On review, the Commission found that “the FID errs by stating as a bright-line rule that ‘pre-issuance investments [are not] cognizable under subparagraphs (A) and (B) of section 337(a)(3).’” Id. As such, the Commission vacated the FID’s findings on the economic prong and remanded for further proceedings. Id. The Commission also indicated that the other FID findings selected for review (“remaining issues”) were pending. Id. Upon remand, the Commission specifically requested the ALJ to “‘consider whether Complainant’s alleged domestic industry investments were made with respect to the articles protected by the patent (i.e., the products that the FID finds satisfy the technical prong of the domestic industry requirement), not limited by whether those investments were made post-patent issuance.’” Certain Oil Vaporizing Devices, Components Thereof, and Products Containing the Same, Inv. No. 337-TA-1392, Comm’n Notice, EDIS Doc. Id. 862213 (September 17, 2025) (citing Comm’n Notice May 16, 2025). On July 18, 2025, the ALJ issued a Remand Initial Determination (“RID”) that PAX satisfied the economic prong of the domestic industry requirement. Certain Oil Vaporizing Devices, Components Thereof, and Products Containing the Same, Inv. No. 337-TA-1392, Remand Initial Determination, EDIS Doc. Id. 858076 (July 30, 2025), at 23. On September 17, 2025, the Commission issued a notice that it reviewed the RID and “otherwise affirms the RID’s findings that the Complainant has satisfied the economic prong of the domestic industry requirement under section 337(a)(3)(A) and (B), including its subsidiary finding that Complainant was an exclusive licensee when it made its domestic industry investments.” Comm’n Op. at 4. In the notice, the Commission requested written submissions from the parties with respect to their recommended remedy should the Commission ultimately find a violation. Id. at 4-5. Both parties submitted their briefs on remedy to the Commission in late November 2025. Id. at 7. On February 3, 2026, the Commission issued its Opinion. See Comm’n Op. Concerning the remaining issues, the Commission found that the ROVE (C), ROVE-REDESIGN(C), ROVE
5 (V), and ROVE-REDESIGN(V) products infringed certain claims of the ’580 patent. Id. at 2. Moreover, the Commission affirmed the FID with additional reasoning that the STIIIZY-1G-REDESIGN(C), STIIIZY-ORIG-1G-REDESIGN, and STIIIZY-AIO-REDESIGN products infringed certain claims of the ’580 patent. Id. at 2. The Commission noted in its Opinion that it did not review the FID’s findings with respect to the remaining Asserted Patents, except for the economic prong of the domestic industry requirement, and as such adopted these findings. Id. at 2-3. Accordingly, the Commission found a violation of section 337 with respect to the Asserted Patents. Id. at 2. As for remedy, the Commission issued an LEO, including a standard certification provision, against STIIIZY and ALD, 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. Lastly, the Commission determined that the public interest factors did not prevent these remedial orders from being issued and required a bond of one hundred percent (100%) of the entered value for infringing products to enter the U.S. during the presidential review period. Comm’n Op. at 3. On March 4, 2026, STIIIZY filed a petition for reconsideration, which was denied by the Commission because it found that STIIIZY “[did] not identify any new questions raised by the Commission’s determination or action ordered to be taken thereunder and upon which STIIIZY had no opportunity to submit arguments.” Certain Oil Vaporizing Devices, Components Thereof, and Products Containing the Same, Inv. No. 337-TA-1392, EDIS Doc. ID. 874312, Order Denying Respondent STIIIZY’s Petition for Reconsideration (March 4, 2026) at 3. Additionally, the
6 Commission found that “STIIIZY’s petition fails to demonstrate that the Commission should ‘on its own initiative’ reconsider its finding of infringement under the doctrine of equivalents.” Id. On March 9, 2026, STIIIZY filed a motion to stay the remedial orders of the Commission pending appeal. Certain Oil Vaporizing Devices, Components Thereof, and Products Containing the Same, Inv. No. 337-TA-1392, EDIS Doc. ID. 878118, Commission Opinion Denying Motion of Respondents STIIIZY INC and STIIIZY IP LLC to Stay the Remedial Orders Pending Appeal (April 7, 2026) at 1. The Commission denied STIIIZY’s motion for a stay because “STIIIZY has not shown that the Standard Havens factors, as modified by the Commission’s jurisprudence, favor granting a stay pending appeal.” Id. at 18. On March 23, 2026, STIIIZY filed a notice of appeal and emergency motion to stay the remedial orders and for an interim administrative stay with the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”). Id. at 5 (citing STIIIZY, Inc. v. Int’l Trade Comm’n, No. 26-1554, Dkt. 2-3 (Fed. Cir. Mar. 23, 2026)). As of this Ruling Letter, STIIIZY’s appeal before the Federal Circuit remains pending. 2. The Patents And Asserted Claims In The 1392 LEO As noted above, the 1392 LEO prohibits the unlicensed entry for consumption of certain oil vaporizing devices, components thereof, and products containing the same that infringe certain claims of the Asserted Patents. 1392 LEO at 2, ¶ 1. The Asserted Patents share a common specification and claim priority to Provisional App. No 62/398,494, which was filed on September 22, 2016, and are a continuation of application No. 15/396,584, now U.S Pat. 11,600,403, filed on December 31, 2016. FID at 5-6. In general, “[t]he Asserted Patents are all directed to ‘leak-resistant vaporizer cartridges and apparatuses adapted for use with oil-based vaporizable materials including cannabis oils.’” Comm’n Op. at 8 (citing ’580 patent at code (57)). Figure 3B of the ’580 patent is representative of the Asserted Patents and is reproduced below: ’580 patent at Fig. 3B. For purposes of this Ruling Request, the EOE Branch will adopt the claim limitation labeling scheme (as shown below) presented in FID. FID at 16-17, 45-49, 66-68, and 77-80.
7 a. Claims 1, 5, and 10 of the ’756 patent The ’756 patent is titled “Leak-Resistant Vaporizer Device” and describes “[v]aporizer cartridges and vaporizer apparatuses, and methods for making, using, and delivering vapor to a user, that are leak-resistant for use with cannabinoids.” ’756 patent at codes (54) and (57). Claim 1 of the ’756 patent is an independent claim and claims 5 and 10 depend from claim 1. Claim 1 is reproduced below: 1. A vaporizer cartridge comprising [756.1.pre]: a cartridge body comprising a proximal body end and a distal body end opposite the proximal body end [756.1.a]; a mouthpiece coupled to the proximal body end, the mouthpiece comprising an outlet [756.1.b]; a reservoir comprising an internal volume at least partially defined by the cartridge body, the internal volume configured to hold a vaporizable material [756.1.c]; a first reservoir seal [756.1.d]; a second reservoir seal, wherein the first reservoir seal and the second reservoir seal are each configured to cover a corresponding reservoir opening exposing the internal volume of the reservoir [756.1.e]; a first pad positioned within an interior of the mouthpiece [756.1.f]; a second pad positioned within the interior of the mouthpiece [756.1.g]; a bottom cover comprising a bottom portion positioned distally relative to the cartridge body, the bottom portion comprising: a first air opening and a second air opening [756.1.h]; a first cartridge electrical contact configured to contact a first body electrical contact on a vaporizer body [756.1.i]; a second cartridge electrical contact configured to contact a second body electrical contact on the vaporizer body [756.1.j]; and a heater chamber comprising [756.1.k]: an atomizer configured to heat the vaporizable material from the reservoir to generate an aerosol [756.1.k.i]; a housing piece configured to house at least a portion of the atomizer, the housing piece comprising a housing opening into which at least a portion of the atomizer passes into the housing piece [756.1.k.ii]; and an air tube extending from the housing piece, the air tube configured to deliver the aerosol from the atomizer to the mouthpiece [756.1.k.iii]; wherein the first pad and the second pad do not intersect with a central axis of the air tube [756.1.l]. ’756 patent at 34:48-35:16 and 36:1-11. b. Claims 1, 13, 15, and 20 of the ’757 patent The ’757 patent is titled “Leak-Resistant Vaporizer Device” and describes “[v]aporizer cartridges and vaporizer apparatuses, and methods for making, using and delivering vapor to a user, that are leak-resistant for use with cannabinoids.” ’757 patent at codes (54) and (57). Claims
8 1 and 15 are independent claims of the ’757 patent and claims 13 and 20 depend from claims 1 and 15, respectively. Claims 1 and 15 of the ’757 patent are reproduced below: 1. A vaporizer cartridge comprising [757.1.pre]: a cartridge body comprising a proximal body end and a distal body end opposite the proximal body end [757.1.a]; a mouthpiece coupled to the proximal body end, the mouthpiece comprising an outlet [757.1.b]; a reservoir configured to hold a vaporizable material [757.1.c]; a first pad positioned within an interior of the mouthpiece [757.1.d]; a second pad positioned within the interior of the mouthpiece [757.1.e]; a heater chamber comprising [757.1.f]: a heater configured to heat the vaporizable material from the reservoir to generate an aerosol [757.1.f.i]; a housing piece configured to house at least a portion of the heater, the housing piece comprising a housing opening configured to receive at least a portion of the heater [757.1.f.ii]; an air tube extending from the housing piece [757.1.f.iii]; a bottom cover comprising a bottom portion positioned distally relative to the cartridge body, the bottom portion comprising: a first air opening and a second air opening; and [757.1.g] a distal member positioned at least partially within the cartridge body between the housing piece and the bottom cover, the distal member comprising [757.1.h]: a proximal side [757.1.h.i]; a distal side opposite the proximal side [757.1.h.ii]; a lateral side extending between the proximal side and the distal side; and [757.1.h.iii] at least one recessed surface positioned on the lateral side [757.1.h.iv]; wherein an air chamber is formed between the distal member and the bottom portion of the bottom cover [757.1.i]; and wherein the first air opening and the second air opening of the bottom portion allow air to pass into the air chamber [757.1.j]. 15. A vaporizer device comprising: [757.15.pre] a vaporizer cartridge, comprising [757.15.a]: a cartridge body comprising a proximal body end and a distal body end opposite the proximal body end [757.15.a.i]; a mouthpiece coupled to the proximal body end, the mouthpiece comprising an outlet [757.15.a.ii]; a reservoir configured to hold a vaporizable material [757.15.a.iii]; a first pad positioned within an interior of the mouthpiece [757.15.a.iv]; a second pad positioned within the interior of the mouthpiece [757.15.a.v]; a heater chamber comprising [757.15.a.vi]: a heater configured to heat the vaporizable material from the reservoir to generate an aerosol [757.15.a.vi.a];
9 a housing piece configured to house at least a portion of the heater, the housing piece configured to receive at least a portion of the heater [757.15.a.vi.b]; an air tube extending from the housing piece [757.15.a.vi.c]; a bottom cover comprising a bottom portion positioned distally relative to the cartridge body, the bottom portion comprising: a first air opening and a second air opening [757.15.a.vii]; a distal member positioned at least partially within the cartridge body between the housing piece and the bottom cover, the distal member comprising [757.15.a.viii]: a proximal side [757.15.a.viii.a]; a distal side opposite the proximal side [757.15.a.viii.b]; a lateral side extending between the proximal side and the distal side; and [757.15.a.viii.c] at least one recessed surface positioned on the lateral side [757.15.a.viii.d]; wherein an air chamber is formed between the distal member and the bottom portion of the bottom cover; and [757.15.a.ix] wherein the first air opening and the second air opening of the bottom portion allow air to pass into the air chamber; [757.15.a.x] a first cartridge electrical contact; and [757.15.a.xi] a second cartridge electrical contact; and [757.15.a.xii] a vaporizer body, comprising:[757.15.b] a cartridge receiver configured to insertably receive the vaporizer cartridge, the cartridge receiver comprising: [757.15.b.i] a first body electrical contact configured to electrically couple to the first cartridge electrical contact of the vaporizer cartridge; [757.15.b.i.a] a second body electrical contact configured to electrically couple to the second cartridge electrical contact of the vaporizer cartridge; [757.15.b.i.b] an insertion end into which the vaporizer cartridge is inserted; and [757.15.b.i.c] a base opposite the insertion end; and [757.15.b.i.d] one or more LEDs, wherein the vaporizer device is configured to cause the one or more LEDs to illuminate during the generation of the aerosol by the heater of the vaporizer cartridge. [757.15.b.ii] ’757 patent 34:30-65 and 36:1-15. c. Claims 1, 5, 10-11, 17-18, and 22 of the ’527 patent The ‘527 patent is titled “Leak-Resistant Vaporizer Device” and describes “[v]aporizer cartridges and vaporizer apparatus, and methods for making, using and delivering vapor to a user, that are leak-resistant for use with cannabinoids.” ’527 patent at codes (54) and (57). Claims 1, 11, and 18 of the ’527 patent are independent claims. Claims 5 and 10 depend from claim 1 and claims 17 and 22 depend from claims 11 and 18, respectively. Claims 1, 11, and 18 of the ’527 patent are reproduced below: 1. A vaporizer cartridge comprising: [527.1.pre] a cartridge body comprising a proximal body end and a distal body end opposite the proximal body end; [527.1.a]
10 a mouthpiece coupled to the proximal body end, wherein the mouthpiece comprises an outlet; [527.1.b] a reservoir comprising an internal volume at least partially defined by the cartridge body, wherein the internal volume is configured to hold a vaporizable material; [527.1.c] a first reservoir seal configured to cover a first reservoir opening exposing the internal volume of the reservoir; [527.1.d] a second reservoir seal configured to cover a second reservoir opening exposing the internal volume of the reservoir, wherein the first reservoir seal and the second reservoir seal are positioned within an interior of the mouthpiece; [527.1.e] a bottom cover comprising a bottom portion positioned distally relative to the cartridge body, wherein the bottom portion comprises at least a first air opening; [527.1.f] a first cartridge electrical contact configured to contact a first body electrical contact on a vaporizer body; [527.1.g] a second cartridge electrical contact configured to contact a second body electrical contact on the vaporizer body; and [527.1.h] a vaporization chamber comprising: [527.1.i] a heating element configured to heat the vaporizable material from the reservoir to generate an aerosol [527.1.i.i] a wicking material comprising ceramic; [527.1.i.ii] a housing piece configured to house at least a portion of the wicking material, wherein the housing piece comprises a housing opening into which at least the portion of the wicking material passes into the housing piece; and [527.1.i.iii] an air tube configured to deliver the aerosol to the mouthpiece. [527.1.i.iv] 11. A vaporizer device, comprising: [527.11.pre] a vaporizer cartridge comprising: [527.11.a] a cartridge body comprising a proximal body end and a distal body end opposite the proximal body end; [527.11.a.i] a mouthpiece coupled to the proximal body end, wherein the mouthpiece comprises an outlet; [527.11.a.ii] a reservoir comprising an internal volume at least partially defined by the cartridge body, wherein the internal volume is configured to hold a vaporizable material; [527.11.a.iii] a first reservoir seal configured to cover a first reservoir opening exposing the internal volume of the reservoir; [527.11.a.iv] a second reservoir seal configured to cover a second reservoir opening exposing the internal volume of the reservoir, wherein the first reservoir seal and the second reservoir seal are positioned within an interior of the mouthpiece; [527.11.a.v] a bottom cover comprising a bottom portion positioned distally relative to the cartridge body, wherein the bottom portion comprises at least a first air opening; [527.11.a.vi] a first cartridge electrical contact configured to contact a first body electrical contact on a vaporizer body; [527.11.a.vii] a second cartridge electrical contact configured to contact a second body electrical contact on the vaporizer body; and [527.11.a.viii] a vaporization chamber comprising: [527.11.a.ix]
11 a heating element configured to heat the vaporizable material from the reservoir to generate an aerosol; [527.11.a.ix.a] a wicking material comprising ceramic; [527.11.a.ix.b] a housing piece configured to house at least a portion of the wicking material, wherein the housing piece comprises a housing opening into which at least the portion of the wicking material passes into the housing piece; and [527.11.a.ix.c] an air tube configured to deliver the aerosol to the mouthpiece; and [527.11.a.ix.d] a vaporizer body, comprising: [527.11.b] a cartridge receiver configured to insertably receive the vaporizer cartridge, [527.11.b.i] wherein the cartridge receiver comprises: [527.11.b.ii] a first body electrical contact configured to electrically couple to the first cartridge electrical contact of the vaporizer cartridge; [527.11.b.ii.a] a second body electrical contact configured to electrically couple to the second cartridge electrical contact of the vaporizer cartridge; [527.11.b.ii.b] an insertion end into which the vaporizer cartridge is inserted; and [527.11.b.ii.c] a base opposite the insertion end; [527.11.b.ii.d] a pressure sensor configured to detect a change in pressure, causing activation of the vaporizer device; and [527.11.b.iii] a channel extending between the base of the cartridge receiver and the pressure sensor. [527.11.b.iv] 18. A vaporizer cartridge comprising: [527.18.pre] a cartridge body comprising a proximal body end and a distal body end opposite the proximal body end; [527.18.a] a mouthpiece coupled to the proximal body end, wherein the mouthpiece comprises an outlet; [527.18.b] a reservoir comprising an internal volume at least partially defined by the cartridge body, wherein the internal volume is configured to hold a vaporizable material; [527.18.c] a first reservoir seal configured to cover a first reservoir opening exposing the internal volume of the reservoir; [527.18.d] a second reservoir seal configured to cover a second reservoir opening exposing the internal volume of the reservoir, wherein the first reservoir seal and the second reservoir seal are positioned within an interior of the mouthpiece; [527.18.e] at least one pad positioned within an interior of the mouthpiece; [527.18.f ] a bottom cover comprising a bottom portion positioned distally relative to the cartridge body, wherein the bottom portion comprises at least a first air opening; [527.18.g] a first cartridge electrical contact configured to contact a first body electrical contact on a vaporizer body; [527.18.h] a second cartridge electrical contact configured to contact a second body electrical contact on the vaporizer body; and [527.18.i] a vaporization chamber comprising: [527.18.j] a heating element configured to heat the vaporizable material from the reservoir to generate an aerosol; [527.18.j.i] a wicking material comprising ceramic; [527.18.j.ii]
12 a housing piece configured to house at least a portion of the wicking material, wherein the housing piece comprises a housing opening into which at least the portion of the wicking material passes into the housing piece; and [527.18.j.iii] an air tube configured to deliver the aerosol to the mouthpiece. [527.18.j.iv] ’527 patent at 34:1-35:8, 36:1-43, and 38:6-62. d. Claims 1, 6-8, and 10 of the ’580 patent The ’580 patent is titled “Leak-Resistant Vaporizer Device” and describes “[v]aporizer cartridges and vaporizer apparatuses, and methods for making, using and delivering vapor to a user, that are leak-resistant for use with cannabinoids.” ’580 patent at codes (54) and (57). Claims 1 and 8 of the ’580 patent are independent and claims 6-7 and claim 10 depend from claims 1 and 8, respectively. Claims 1 and 8 are reproduced below: 1. A vaporizer cartridge comprising [580.1.pre]: a cartridge body comprising a proximal body end and a distal body end opposite the proximal body end [580.1.a]; a mouthpiece coupled to the proximal body end, where the mouthpiece comprises an outlet [580.1.b]; a reservoir configured to hold a vaporizable material [580.1.c]; a vaporization chamber comprising [580.1.d]: a heater configured to heat the vaporizable material from the reservoir to generate an aerosol [580.1.d.i]; a housing piece configured to house at least a portion of the heater, wherein the housing piece comprises a housing opening configured to receive at least the portion of the heater [580.1.d.ii]; and an air tube extending from the housing piece, wherein the air tube is configured to deliver the aerosol from the heater to the mouthpiece [580.1.d.iii]; an extension wire extending from the heater [580.1.e]; a bottom cover comprising a bottom portion, wherein the bottom portion comprises at least one air opening [580.1.f]; and a distal member positioned at least partially within the cartridge body between the housing piece and the bottom portion of the bottom cover, wherein the distal member comprises [580.1.g]: a proximal side [580.1.g.i]; a distal side opposite the proximal side [580.1.g.ii]; a lateral side extending between the proximal side and the distal side [580.1.g.iii]; and an extension feature having a cylindrical shape, wherein the extension feature extends from the proximal side of the distal member [580.1.g.iv], and wherein the extension feature comprises an opening extending therethrough that allows air to pass through the distal member [580.1.g.v]; wherein at least a portion of the distal member comprises a perimeter that has a first shape corresponding to a second shape of an inner surface of the cartridge body [580.1.g.vi]; and
13 wherein at least a portion of the extension wire extends at least partially through the distal member [580.1.g.vii]; wherein an air chamber is formed between the distal member and the bottom portion of the bottom cover [580.1.h]. 8. A vaporizer cartridge, comprising: [580.8.pre] a vaporizer cartridge, comprising: [580.8.a] a cartridge body comprising a proximal body end and a distal body end opposite the proximal body end; [580.8.a.i] a mouthpiece coupled to the proximal body end, wherein the mouthpiece comprises an outlet; [580.8.a.ii] a reservoir configured to hold a vaporizable material; [580.8.a.iii] a vaporization chamber comprising: [580.8.a.iv] a heater configured to heat the vaporizable material from the reservoir to generate an aerosol; [580.8.a.iv.a] a housing piece configured to house at least a portion of the heater, wherein the housing piece comprises a housing opening configured to receive at least the portion of the heater; and [580.8.a.iv.b] an air tube extending from the housing piece, wherein the air tube is configured to deliver the aerosol from the heater to the mouthpiece; [580.8.a.iv.c] an extension wire extending from the heater; [580.8.a.v] a bottom cover comprising a bottom portion, wherein the bottom portion comprises at least one air opening; [580.8.a.vi] at least one cartridge electrical contact; and [580.8.a.vii] a distal member positioned at least partially within the cartridge body between the housing piece and the bottom portion of the bottom cover, wherein the distal member comprises: [580.8.a.viii] a proximal side; [580.8.a.viii.a] a distal side opposite the proximal side; [580.8.a.viii.b] a lateral side extending between the proximal side and the distal side; and [580.8.a.viii.c] an extension feature having a cylindrical shape, wherein the extension feature extends from the proximal side of the distal member, and [580.8.a.viii.d] wherein the extension feature comprises an opening extending therethrough that allows air to pass through the distal member; [580.8.a.viii.e] wherein at least a portion of the distal member comprises a perimeter that has a first shape corresponding to a second shape of an inner surface of the cartridge body; and [580.8.a.viii.f] wherein at least a portion of the extension wire extends at least partially through the distal member; [580.8.a.viii.g] wherein an air chamber is formed between the distal member and the bottom portion of the bottom cover; and [580.8.a.ix] a vaporizer body, comprising: [580.8.b] a cartridge receiver configured to insertably receive the vaporizer cartridge, wherein the cartridge receiver comprises: [580.8.b.i]
14 at least one body electrical contact configured to electrically couple to the at least one cartridge electrical contact of the vaporizer cartridge; [580.8.b.i.a] an insertion end into which the vaporizer cartridge is inserted; and [580.8.b.i.b] a base opposite the insertion end; [580.8.b.i.c] a sensor configured to detect a draw on the mouthpiece, causing activation of the heater; and [580.8.b.ii] a channel extending from the base of the cartridge receiver to the sensor. [580.8.b.iii] ’580 patent at 34:1-35:11 and 35:47-36:40. 3. The Accused Products from the Underlying Investigation The Accused Products in the underlying investigation consisted of “numerous vaporizer and vaporizer cartridge products.” FID at 3. The notice of institution described the Accused Products 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. Notice of Institution at 1. The Commission Opinion provided the following chart of the parties’ agreed upon representative Accused Products and which of the Asserted Patents these products were alleged to have infringed:
15 Comm’n Op. at 10-11 (citing FID at 4 and JX-0459). PAX maintained that “[t]he accused cartridges all have substantially the same components (e.g., mouthpiece, cartridge body, atomizer/heater, bottom cover), and they all function in substantially the same way.” FID at 3 (citing CIB at 4). Moreover, according to the FID, the “accused vaporizers all include substantially the same components (e.g., vaporizer cartridge, vaporizer body, battery), and they all function in substantially the same way.” Id. (citing CIB at 5). In its complaint, PAX provided the following photographs of an accused product alongside the domestic industry product:
16 Complaint at 8-9. B. 19 C.F.R. Part 177 Ruling Request 1. Procedural History On February 20, 2026, STIIIZY submitted a confidential letter to CBP requesting an administrative ruling pursuant to 19 C.F.R. Part 177 with Ex. 1-10 and attachments (together, “STIIIZY Ruling Request”). STIIIZY Email to EOE Branch, February 20, 2026. At the time of the filing, the parties had not agreed upon a Non-Disclosure Agreement (“NDA”). PAX Email to STIIIZY, February 23, 2026 (copying EOE Branch). STIIIZY confirmed to the EOE Branch on February 23, 2026 that it provided PAX with a redacted copy of the Ruling Request. STIIIZY Email to EOE Branch, February 23, 2026 (copying PAX). On February 24, 2026, the parties submitted a fully executed NDA to the EOE Branch, and STIIIZY indicated that “[w]e will be providing PAX’s counsel with access to the unredacted request letter and associated exhibits shortly.” STIIIZY Email to the EOE Branch, February 24, 2026 (copying PAX). That same day,
17 PAX submitted an updated NDA to the EOE Branch containing an additional signature of one of its experts. PAX Email to STIIIZY, February 24, 2026 (copying EOE Branch). On February 25, 2026, the EOE Branch sent an email to both parties confirming receipt of the Ruling Request and fully executed NDA and requested an initial conference call with the parties. EOE Branch Email to Parties, February 25, 2026. On February 27, 2026 the EOE Branch sent an email to the parties providing the procedural guidelines for the proceeding. EOE Branch Email to Parties, February 27, 2026. On March 6, 2026, the EOE Branch held an initial conference call with the parties in which the procedural guidelines were discussed in more detail. At the conference call, the EOE Branch also requested the parties to propose a joint-procedural schedule for this proceeding. On March 11, 2026, the parties submitted a proposed joint-procedural schedule to the EOE Branch. STIIIZY Email to EOE Branch, March 11, 2026 (copying PAX). The parties’ joint-procedural schedule was confirmed and the EOE Branch notified both parties that the oral discussion would occur on April 30, 2026. EOE Branch Email to Parties, March 16, 2026. On March 20, 2026, PAX provided its response to STIIIZY’s Ruling Request along with Ex. 1-6 (collectively, “PAX Response”). PAX Email to EOE Branch, March 20, 2026 (copying STIIIZY). On March 23, 2026, STIIIZY sent an email to the EOE Branch indicating that PAX in its Response “presents no arguments for why the Redesigned Cartridge infringes the patents-at-issue.” STIIIZY Email to EOE Branch, March 23, 2026 (copying PAX). Accordingly, STIIIZY requested “(1) that the EOE Branch issue an immediate ruling on the Redesigned Cartridge and address PAX’s non-merits arguments through a certification; and (2) that the EOE Branch clarify that PAX may not offer new arguments / evidence in the sur-reply that it could have presented in its Response but chose not to.” Id. On March 25, 2026, the EOE Branch responded to STIIIZY, respectfully declining STIIIZY’s request for an immediate ruling. EOE Branch Email to Parties, March 25, 2026. In its response, the EOE Branch noted that it has “traditionally allowed both parties to develop their theories of infringement/non-infringement during the inter partes process right up until the sur-reply.” Id. (emphasis in original). Moreover, the EOE Branch indicated that STIIIZY “has an opportunity to challenge any arguments PAX presents in the sur-reply at the oral discussion and in its post-oral discussion submission.” Id. On March 27, 2026, STIIIZY submitted its reply along with Ex. 4-6 (collectively, “STIIIZY Reply.”). STIIIZY Email to EOE Branch and PAX, March 27, 2026. On April 3, 2026, PAX submitted its sur-reply along with Ex. 7-10 (collectively, “PAX Sur-Reply”). PAX Email to EOE Branch and STIIIZY, April 3, 2026. The EOE Branch held an oral discussion with both parties on April 30, 2026, in which STIIIZY and PAX submitted respective oral discussion presentations (“STIIIZY Oral Discussion Presentation” and “PAX Oral Discussion Presentation” (and Ex. 11-12), respectively). Both STIIIZY and PAX submitted their post-oral discussion briefs on May 1 (“STIIIZY Post-Oral Discussion Brief” and “PAX Post-Oral Discussion Brief,” respectively). Email from STIIIZY to EOE Branch (copying PAX), May 1, 2026; and Email from PAX to EOE Branch, May 1, 2026 (copying STIIIZY). On May 1, 2026, the Branch notified the parties that it was seeking confirmation and clarification (“Request for 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. Email from EOE Branch to Parties, May 1, 2026. On May 4, 2026, STIIIZY replied to the Branch with the following: “[i]n the event that the Branch’s request to the Commission relates
18 only to the issue of whether STIIIZY’s batteries should be cleared under Part 177, and not to the issue of whether the Post-FD Redesigned cartridge should be cleared, STIIIZY respectfully asks whether the Branch would be amenable to issuing a ruling on May 15, related solely to the cartridge and deferring the issue of the battery until the Commission provides the Branch with the requested information.” Email from STIIIZY to EOE Branch, May 4, 2026 (copying PAX). The EOE Branch initially indicated to the parties that it would be able to issue a decision concerning both the cartridge and the battery on May 15, however, as stated above, this ruling is limited only to the cartridge and the ruling concerning the battery will be issued no later than 7 days after we receive a response from the Commission to the Request for Clarification made on May 8, 2026. Email to STIIIZY, May 6, 2026 (copying PAX). 2. The Articles at Issue The articles at issue in this Ruling Letter are redesigned cartridges that STIIIZY calls the “Post-FD Redesigned Cartridges.” STIIIZY Ruling Request at 1. STIIIZY alleges that its Post-FD Redesigned Cartridges differ from several of the STIIIZY Redesigned Products, the STIIIZY-1G-REDESIGN(C) and STIIIZY-ORIG-1G-REDESIGN (collectively, referred to as the “ITC Products” by STIIIZY), which were found to infringe the asserted claims of the ’580 patent. Id. at 20-22. STIIIZY claims that “[t]here are [[ ]].” Id. at 29 (citing Ex. 2 ¶ 30). STIIIZY provides the following illustration of the ITC Products next to the Post-FD Redesigned Cartridges: [[
19 ]] Id. at 20-21. According to STIIIZY’s head of hardware engineering Ramon Alarcon, [[ ]] STIIIZY Ex. 2 at ¶ 1, 17. Additionally, Mr. Alarcon states: Unlike the ITC Products, [[ ]]. Id. at ¶ 18 (emphasis in original). [[
20 ]] STIIIZY Ruling Request at 24. As such, STIIIZY alleges that the Post-FD Redesigned Cartridges “are outside the scope of and not subject of the [LEO].” Id. at 1. Lastly, STIIIZY indicates that it “has fabricated and imported first production samples of the Post-FD Redesigned Cartridges into the United States” and that these “first production samples are being made available for review by PAX’s counsel and the EOE Branch.” Id. at 4 (citing STIIIZY Ex. 2 at ¶ 15). II. ISSUE The issue addressed in this Ruling Letter is whether STIIIZY has met its burden to show that its Post-FD Redesigned Cartridges do not infringe the claims at issue in the Asserted Patents and are thus not subject to the 1392 LEO.1 1 STIIIZY also requested that the EOE Branch make “a finding of non-infringement . . . that the Post-FD Redesigned Cartridge is outside the scope of the . . . CDO, including the components associated with the Post-FD Redesigned Cartridge such as the vaporizer battery.” STIIIZY Ruling Request at 38. However, CBP has no role in the enforcement of CDOs. Further, we asked STIIIZY’s counsel during the oral discussion on April 30 to verify whether STIIIZY is
21 III. LEGAL FRAMEWORK A. Section 337 Exclusion Order Administration The Commission shall investigate any alleged violation of section 337 to determine, with respect to each investigation conducted by it under this section, whether there is a violation of this section. See 19 U.S.C. § 1337(b)(1) and (c). If the Commission determines, as a result of an investigation under this section, that there is a violation of this section, it shall direct that the articles concerned, imported by any person violating the provision of this section, be excluded from entry into the United States unless the Commission finds based on consideration of the public interest that such articles should not be excluded from entry. See 19 U.S.C. § 1337(d)(1). When the Commission determines that there is a violation of section 337, it generally issues one of two types of exclusion orders: (1) a limited exclusion order or (2) a general exclusion order. See Fuji Photo Film Co., Ltd. v. ITC, 474 F.3d 1281, 1286 (Fed. Cir. 2007). Both types of orders direct CBP to bar infringing products from entering the country. See Yingbin-Nature (Guangdong) Wood Indus. Co. v. ITC, 535 F.3d 1322, 1330 (Fed Cir. 2008). “A limited exclusion order is ‘limited’ in that it only applies to the specific parties before the Commission in the investigation. In contrast, a general exclusion order bars the importation of infringing products by everyone, regardless of whether they were respondents in the Commission's investigation.” Id. A general exclusion order is appropriate only if two exceptional circumstances apply. See Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1356 (Fed. Cir. 2008). A general exclusion order may only be issued if (1) “necessary to prevent circumvention of a limited exclusion order,” or (2) “there is a pattern of violation of this section and it is difficult to Identify the source of infringing products.” 19 U.S.C. § 1337(d)(2); see Kyocera, 545 F.3d at 1356 (“If a complainant wishes to obtain an exclusion order operative against articles of non-respondents, it must seek a GEO [general exclusion order] by satisfying the heightened burdens of §§ 1337(d)(2)(A) and (B).”). In addition to the action taken above, the Commission may issue an order under 19 U.S.C. § 1337(i) directing CBP to seize and forfeit articles attempting entry in violation of an exclusion order if their owner, importer, or consignee previously had articles denied entry on the basis of that exclusion order and received notice that seizure and forfeiture would result from any future attempt to enter articles subject to the same. An exclusion order under § 1337(d)—either limited or general—and a seizure and forfeiture order under § 1337(i) apply at the border only and are operative against articles presented for customs examination or articles conditionally released from customs custody but still subject to a timely demand for redelivery. See 19 U.S.C. §§ 1337(d)(1) (“The Commission shall notify the Secretary of the Treasury of its action under this subsection directing such exclusion from entry, and upon receipt of such notice, the Secretary shall, through the proper officers, refuse such entry.”); Id. at (i)(3) (“Upon the attempted entry of articles subject to an order issued under this subsection, the Secretary of the Treasury shall immediately notify all ports of entry of the attempted importation and shall identify the persons notified under paragraph (1)(C).”) (emphasis added). still seeking a ruling from the Branch regarding the CDOs. STIIIZY’s counsel said that this was no longer the case. Accordingly, the EOE Branch considers this request withdrawn and will not rule on this issue.
22 Significantly, unlike district court injunctions, the Commission can issue a general exclusion order that broadly prohibits entry of articles that violate section 337 of the Tariff Act of 1930 without regard to whether the persons importing such articles were parties to, or were related to parties to, the investigation that led to issuance of the general exclusion order. See Vastfame Camera, Ltd. v. ITC, 386 F.3d 1108, 1114 (Fed. Cir. 2004). The Commission also has recognized that even limited exclusion orders have broader applicability beyond just the parties found to infringe during an investigation. See Certain GPS Devices and Products Containing Same, Inv. No. 337-TA-602, Comm’n Op. at 17, n.6, Doc ID 317981 (Jan. 2009) (“We do not view the Court’s opinion in Kyocera as affecting the issuance of LEOs [limited exclusion orders] that exclude infringing products made by respondents found to be violating Section 337, but imported by another entity. The exclusionary language in this regard that is traditionally included in LEOs is consistent with 19 U.S.C. § 1337(a)(1)(B)-(D) and 19 U.S.C. § 1337(d)(1).”). Moreover, “[t]he Commission has consistently issued exclusion orders coextensive with the violation of section 337 found to exist.” See Certain Erasable Programmable Read Only Memories, Inv. No. 337-TA-276, Enforcement Proceeding, Comm’n Op. at 11, Doc ID 43536 (Aug. 1991) (emphasis added). “[W]hile individual models may be evaluated to determine importation and [violation], the Commission's jurisdiction extends to all models of [violative] products that are imported at the time of the Commission’s determination and to all such products that will be imported during the life of the remedial orders.” See Certain Optical Disk Controller Chips and Chipsets, Inv. No. 337-TA-506, Comm’n Op. at 56-57, USITC Pub. 3935, Doc ID 287263 (July 2007). Lastly, despite the well-established principle that “the burden of proving infringement generally rests upon the patentee [or plaintiff],” Medtronic, Inc. v. Mirowski Family Ventures, LLC, 571 U.S. 191 (2014), the Commission has held that Medtronic is not controlling precedent and does not overturn its longstanding practice of placing the burden of proof on the party who, in light of the issued exclusion order, is seeking to have an article entered for consumption. See Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof, Inv. No. 337-TA-879, Advisory Opinion at 6-11. In particular, the Commission has noted that the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) “has upheld a Commission remedy which effectively shifted the burden of proof on infringement issues to require a company seeking to import goods to prove that its product does not infringe, despite the fact that, in general, the burden of proof is on the patentee to prove, by a preponderance of the evidence, that a given article does infringe[.]” Certain Integrated Circuit Telecommunication Chips, Inv. No. 337-TA-337, Comm’n Op. at 21, n.14, USITC Pub. 2670, Doc ID 217024 (Aug. 1993) (emphasis in original) (citing Sealed Air Corp. v. ITC, 645 F.2d 976, 988-89 (C.C.P.A. 1981)). This approach is supported by Federal Circuit precedent. See Hyundai Elecs. Indus. Co. v. ITC, 899 F.2d 1204, 1210 (Fed. Cir. 1990) (“Indeed, we have recognized, and Hyundai does not dispute, that in an appropriate case the Commission can impose a general exclusion order that binds parties and non-parties alike and effectively shifts to would-be importers of potentially infringing articles, as a condition of entry, the burden of establishing noninfringement. The rationale underlying the issuance of general exclusion orders—placing the risk of unfairness
23 associated with a prophylactic order upon potential importers rather than American manufacturers that, vis-a-vis at least some foreign manufacturers and importers, have demonstrated their entitlement to protection from unfair trade practices—applies here [in regard to a limited exclusion order] with increased force.”) (emphasis added) (internal citation omitted). B. Patent Infringement Determining patent infringement requires two steps. Advanced Steel Recovery, LLC v. X-Body Equip., Inc., 808 F.3d 1313, 1316 (2015). The first is to construe the limitations of the asserted claims and the second is to compare the properly construed claims to the accused product. Id. To 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. 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). As for the first step above, “claim construction is a matter of law.” SIMO Holdings, Inc. v. H.K. uCloudlink Network Tech., Ltd., 983 F.3d 1367, 1374 (Fed. Cir. 2021). Moreover, the ultimate construction of a claim limitation is a legal conclusion, as are interpretations of the patent’s intrinsic evidence (the patent claims, specifications, and prosecution history). UltimatePointer, L.L.C. v. Nintendo Co., 816 F.3d 816, 822 (Fed. Cir. 2016) (citing Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841, 190 L. Ed. 2d 719 (2015). “Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). “In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges.” Id. at 1314. In others, courts look to public sources such as “the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.” Id. “To begin with, the context in which a term is used in the asserted claim can be highly instructive.” Phillips, 415 F.3d at 1314 (“To take a simple example, the claim in this case refers to ‘steel baffles,’ which strongly implies that the term ‘baffles’ does not inherently mean objects made of steel.”). The context in which a claim term is used also includes the full chain of dependence as well as the remaining suite of claims and the written description. See Inline Plastics Corp. v. EasyPak, LLC, 799 F.3d 1364, 1371 (Fed. Cir. 2015) (“Since the specification explicitly mentions the ‘alternative’ . . . there can be no debate concerning the application of the doctrine of claim differentiation.”).
24 The second step to establish infringement involves a comparison of the claims, as properly construed, to the accused product, which is a question of fact. Apple Inc. v. Samsung Elecs. Co., Ltd., 839 F.3d 1034, 1040 (Fed. Cir. 2016) (en banc). IV. ANALYSIS STIIIZY argues that its Post-FD Redesigned Cartridges do not infringe the asserted claims of the ’580 patent, ’756 patent, ’757 patent, and ’527 patent. STIIIZY Ruling Request at 1. We consider whether STIIIZY has met its burden of proof with respect to each of the Asserted Patents in turn. 1. The Asserted Patents The ’580 patent (claims 1, 6-8, and 10) a. “an extension feature having a cylindrical shape, wherein the extension feature extends from the proximal side of the distal member” (limitations 580.1.g.iv and 580.8.h.iv) According to STIIIZY, the Post-FD Redesigned Cartridges do not meet the following limitation of claims 1 and 8 of the ’580 patent: “an extension feature having a cylindrical shape, wherein the extension feature extends from the proximal side of the distal member.” STIIIZY Ruling Request at 20, 22-23, and 28. Specifically, STIIIZY argues that the “[[ ]]” Id. at 22 (citing Ex. 1 ¶¶ 38-40; Ex. 2 ¶ 17) (emphasis in original). In fact, STIIIZY maintains that it “has [[ ]]” altogether and provides the following CAD drawings comparing the ITC Products to the Post-FD Redesigned Cartridges: [[
25 ]] STIIIZY Ruling Request at 23. According to STIIIZY, the ALJ ruled that the above triangular-shaped extension feature (i.e., area inside the solid red rectangle) in the ITC Products satisfied the “extension feature having a cylindrical shape” limitation under the doctrine of equivalents and that this finding was adopted by the Commission. Id. at 22. STIIIZY claims that it has avoided infringement in the Post-FD Redesigned Cartridges by removing this extension feature in its entirety. Id. at 20. As such, STIIIZY maintains that “the Post-FD Redesigned Cartridge cannot infringe because [[ ]], required by claim limitations 580.1.g.iv and 580.1.g.v.” Id. at 23 (emphasis in original). PAX does not address whether STIIIZY’s Post-FD Redesigned Cartridges practice this limitation. See PAX Response; PAX Sur-Reply; PAX Oral Discussion Presentation; and PAX Post Oral Discussion Brief. From the above CAD drawings and expert testimony of Ramon Alarcon and Martin Wensley provided by STIIIZY, we find that the Post-FD Redesigned Cartridges do not have the “extension feature having a cylindrical shape.” See STIIIZY Ruling Request and Ex. 1-2; STIIIZY Response; STIIIZY Oral Discussion Brief; and STIIIZY Post-Oral Discussion Brief. PAX has not presented any arguments or evidence to counter STIIIZY’s contentions here. Based on the arguments and evidence that STIIIZY submitted, and PAX’s failure to refute them, therefore, the EOE Branch finds that STIIIZY’s Post-FD Redesigned Cartridges do not meet the limitation “an extension feature having a cylindrical shape, wherein the extension feature extends from the proximal side of the distal member” of claims 1 and 8 of the ’580 patent. b. “wherein the extension feature comprises an opening extending therethrough that allows air to pass through the distal member” (limitations 580.1.g.v and 580.8.h.iv) STIIIZY also contends that the Post-FD Redesigned Cartridges do not meet the limitation “wherein the extension feature comprises an opening extending therethrough that allows air to pass through the distal member” of claims 1 and 8 of the ’580 patent. STIIIZY Ruling Request at 23. In this regard, STIIIZY has provided extensive expert opinion from Ramon Alarcon, Martin Wensley, and Steven Murray, and testing results, that no air passes through the distal member of the Post-FD Redesigned Cartridges. See STIIIZY Ruling Request and Ex. 1-3; STIIIZY Response; STIIIZY Oral Discussion Presentation; and STIIIZY Post-Oral Discussion Brief. On the other hand, PAX has submitted expert opinion of its own from Kelly Kodama that air passes through the Post-FD Redesigned Cartridges’ distal member under certain testing. See PAX Response; PAX Sur-Reply; and PAX Post-Oral Discussion Brief. Because we find that the Post-FD Redesigned
26 Cartridges do not meet the limitation “extension feature” of claims 1 and 8 of the ’580 patent, as noted above, the EOE Branch does not need to reach a determination as to whether they practice the limitation “wherein the extension feature comprises an opening extending therethrough that allows air to pass through the distal member.” c. EOE Branch Position In accordance with the above, we conclude that STIIIZY has met its burden of proof that the Post-FD Redesigned Cartridges do not infringe the asserted claims of the ’580 patent because the articles do not meet the following limitation as required by claims 1 and 8 of the patent at issue: - “an extension feature having a cylindrical shape, wherein the extension feature extends from the proximal side of the distal member.” The Federal Circuit has held that “[i]nfringement generally requires a factual determination as to whether all of the limitations of a claim, properly construed, are met by an accused device.” Nazir Khan v. Merit Med. Sys., Inc., U.S. App. LEXIS 17357 at 5 (Fed. Cir. 2024) (citing AbbVie Deuthschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1295 (Fed. Cir. 2014) (emphasis added). Because we find that the Post-FD Redesigned Cartridges do not practice all the limitations required by claims 1 and 8 of the ’580 patent, PAX’s argument that “CBP should deny STIIIZY’s Request” because its expert made findings of [[ ]] of the Post-FD Redesigned Cartridges, which undermines many of the allegations in STIIIZY’s Reply” is unavailing. PAX Sur-Reply at 1. Additionally, because claims 6-7 and 10 depend on independent claims 1 and 8, respectively, these dependent claims are also not infringing. See Cognex Corp. v. Int’l Trade Comm’n, 550 Fed. Appx. 867, 881 (Fed. Cir. 2013) (“a dependent claim necessarily cannot be infringed if the independent claim is not infringed”) (citing Wahpeton Canvas Co., Inc. Frontier, Inc., 870 F.2d 1546, 1552 (Fed. Cir. 1989). Accordingly, we find that the Post-FD Redesigned Cartridges do not infringe the asserted claims of the ’580 patent. The ’756 patent (claims 1, 5, and 10) a. “a first reservoir seal” and “a second reservoir seal” (limitations 756.1.d and 756.1.e) With respect to the ’756 patent, STIIIZY contends that the Post-FD Redesigned Cartridges do not practice the limitations of claim 1, “a first reservoir seal” and “a second reservoir seal, wherein the first reservoir seal and the second reservoir seal are each configured to cover a corresponding reservoir opening exposing the internal volume of the reservoir.” STIIIZY Ruling Request at 30. In particular, STIIIZY argues that its Post-FD Redesigned Cartridges “[[ ]]” and provides the following photographs of the redesigned product: [[
27 ]] Id. at 36. PAX does not dispute whether the Post-FD Redesigned Cartridges meet these limitations. See PAX Response; PAX Sur-Reply; PAX Oral Discussion Presentation; and PAX Post Oral Discussion Brief. We find the evidence presented by STIIIZY, including the above photographs, conclusive that the Post-FD Redesigned Cartridges only have one reservoir seal. See STIIIZY Ruling Request; STIIIZY Response; STIIIZY Oral Discussion Presentation; and STIIIZY Post-Oral Discussion Brief. Therefore, we are persuaded by STIIIZY that its Post-FD Redesigned Cartridges do not practice the “second reservoir seal” limitation of the asserted claims of the ’756 patent. b. “A first pad positioned within the interior of the mouthpiece” and “a second pad positioned within the interior of the mouthpiece” (limitations 756.1.f and 756.1.g) STIIIZY argues that the Post-FD Redesigned Cartridges [[ ]] and as such do not meet the limitations of claim 1 of the ’756 patent, “a first pad positioned within the interior of the mouthpiece” and “a second pad positioned within the interior of the mouthpiece.” STIIIZY Ruling Request at 32-33. As support for this argument, STIIIZY provides the following annotated photographs of the Post-FD Redesigned Cartridges: [[
28 ]] Id. at 36. According to STIIIZY, the above photographs of the Post-FD Redesigned Cartridges show only one pad in the mouthpiece. Id. at 33. PAX does not contest the arguments and evidence submitted by STIIIZY that the Post-FD Redesigned Cartridges do not meet these limitations. See PAX Response; PAX Sur-Reply; PAX Oral Discussion Presentation; and PAX Post Oral Discussion Brief. We find the record, including the above photographs provided by STIIIZY, conclusive that the Post-FD Redesigned Cartridges only have one pad. See STIIIZY Ruling Request; STIIIZY Response; STIIIZY Oral Discussion Presentation; and STIIIZY Post-Oral Discussion Brief. Therefore, we hold that the STIIIZY has met its burden that the Post-FD Redesigned Cartridges do not practice the “a second pad positioned within the interior of the mouthpiece” of claim 1 of the ’756 patent. c. EOE Branch Position Accordingly, the EOE Branch finds that STIIIZY’s Post-FD Redesigned Cartridges do not infringe claims 1, 5, and 10 of the ’756 patent. We find that STIIIZY has met its burden to show that the Post-FD Redesigned Cartridges do not practice the following limitations of claim 1 of the ’756 patent: - “a second reservoir opening”; and - “a second pad positioned within the interior of the mouthpiece.” Since claims 5 and 10 depend from independent claim 1, these dependent claims also do not infringe the ’756 patent. See Cognex Corp., 550 Fed. Appx. 867, 881. The ’757 patent (claims 1, 13, 15, and 20) a. “a first pad positioned within an interior of the mouthpiece” and “a second pad positioned within the interior of the mouthpiece” (limitations 757.1.d, 757.1.e, 757.15.a.iv, and 757.15.a.v)
29 As it did for the ’756 patent, STIIIZY argues that the Post-FD Redesigned Cartridges do not infringe the ’757 patent because it does not have “a first pad positioned within an interior of the mouthpiece” and “a second pad positioned within the interior of the mouth” as required by claims 1 and 15. STIIIZY Ruling Request at 36-37. PAX again does not provide arguments or evidence that the Post-FD Redesigned Cartridges practice these limitations. See PAX Response; PAX Sur-Reply; PAX Oral Discussion Presentation; and PAX Post Oral Discussion Brief. We find the above photographs of the Post-FD Redesigned Cartridges conclusive that these products only have one pad in the interior of the mouthpiece. See STIIIZY Ruling Request; STIIIZY Response; STIIIZY Oral Discussion Presentation; and STIIIZY Post-Oral Discussion Brief. Therefore, we hold that the Post-FD Redesigned Cartridges do not meet the “second pad” limitation of claims 1 and 15 of the ’757 patent. b. EOE Branch Position Accordingly, we find that STIIIZY has met its burden that the Post-FD Redesigned Cartridge does not infringe the asserted claims of the ’757 patent. In particular, we find that the Post-FD Redesigned Cartridges do not meet the following limitation of claims 1 and 15 of the ’757 patent: - “a second pad positioned within the interior of the mouthpiece.” Because claims 13 and 20 depend from claims 1 and 15, respectively, these dependent claims also do not infringe the ’757 patent. See Cognex Corp., 550 Fed. Appx. 867, 881. The ’527 patent (claims 1, 5, 10, 11, 17, 18, and 22) a. “First reservoir seal/opening” and “second reservoir seal/opening” (limitations 527.1.d, 527.1.e, 527.11.a.iv, 527.11.a.v, 527.18.d, and 527.18.e) STIIIZY also maintains that the Post-FD Redesigned Cartridges do not infringe the ’527 patent because it does not meet the limitations “first reservoir seal/opening” and a “second reservoir seal/opening” of claims 1, 11, and 18. STIIIZY Ruling Request at 34. According to STIIIZY, the Post-FD Redesigned Cartridges “[[ ]].” Id. at 35. STIIIZY maintains that the lack of two reservoir seals/openings can be seen in the following photographs of the Post-FD Redesigned Cartridges: [[
30 ]] Id. at 36. PAX does not provide any arguments or evidence that the Post-FD Redesigned Cartridges practice the “first reservoir seal/opening” and “second reservoir seal/opening” limitations. See PAX Response; PAX Sur-Reply; PAX Oral Discussion Presentation; and PAX Post Oral Discussion Brief. We find the above photographs provided by STIIIZY convincing and show that the Post-FD Resigned Cartridges only have one reservoir opening. See STIIIZY Ruling Request; STIIIZY Response; STIIIZY Oral Discussion Presentation; and STIIIZY Post-Oral Discussion Brief. Therefore, we find that the Post-FD Redesigned Cartridges do not meet second reservoir seal/opening limitations of claims 1, 11, and 18 of the ’527 patent. b. EOE Branch Position Accordingly, we hold that STIIIZY has met its burden that the Post-FD Redesigned Cartridges do not infringe the asserted claims of the ’527 patent. In particular, we find that the redesigned articles do not meet the following limitation of claims 1, 11, and 18: - “second reservoir seal/opening.” Because claims 5, 10, 17, and 22 depend from claims independent claims 1, 11, and 18, these dependent claims also do not infringe the ’527 patent. See Cognex Corp., 550 Fed. Appx. 867, 881. 2. Summary of Infringement Findings After reviewing the record, including submissions by both parties, we find that STIIIZY has met its burden that its Post-FD Redesigned Cartridges do not infringe the asserted claims of the ’580 patent, ’756 patent, ’757 patent, and ’527 patent. Although PAX presented evidence to support its position that these products practice the limitation “wherein the extension feature comprises an opening extending therethrough that allows air to pass through the distal member” from independent claims 1 and 8 of the ’580 patent, we find this evidence unpersuasive because, as explained above, the Post-FD Redesigned Cartridges do not have an “extension feature having a cylindrical shape.” See supra pp. 24-25. Additionally, STIIIZY has presented enough evidence that the Post-FD Redesigned Cartridges do not practice the limitations of the ’756 patent, ’757, and ’527 patents. Thus, we find that STIIIZY’s Post-FD Redesigned Cartridges are not subject to the 1392 LEO.
31 V. CERTIFICATION Despite this ruling’s determination that the articles at issue are not subject to the 1392 LEO, the EOE Branch acknowledges PAX’s concerns regarding the possibility of circumvention. See PAX Response at 5; PAX Sur-Reply at 8-9. Thus, these concerns warrant conditioning entry for consumption of the articles at issue into the United States on the drafting and submission of a certification pursuant to paragraph 4 of the 1392 LEO. According to the 1392 LEO, “[a]t the discretion of CBP and pursuant to the procedures it establishes, persons seeking to import articles may be required to certify that they are familiar with the terms of this Order, that they have made appropriate inquiry, and thereupon state that, to the best of their knowledge and belief, the products being imported are not excluded from entry under paragraph 1 of this Order. At its discretion, CBP may require persons who have provided the certification described in this paragraph to furnish such records or analyses as are necessary to substantiate the certification.” 1392 at ¶ 4. Significantly, an importer’s ability to enter for consumption into the United States an article addressed in a ruling under 19 C.F.R. Part 177 that resulted from an inter partes proceeding has previously been conditioned by CBP to require a certification drafted with the participation of the complainant. The EOE Branch previously explained the reasoning for this approach in HQ H329187: [I]n appropriate circumstances, the EOE Branch has conditioned an importer’s ability to enter for consumption into the United States the article at issue according to a ruling under 19 C.F.R. Part 177 that resulted from an inter partes proceeding. See CBP Headquarters Ruling H324813 (dated June 3, 2022) at 47 (“Thus, it is CBP’s position that the articles at issue are subject to exclusion from entry for consumption based on the 1191 LEO until Google: (1) disables or renders inoperable the Device Utility app such that it can no longer be used with the articles at issue and provide notice of this action or (2) establishes non-infringement for the articles at issue pursuant to an ancillary proceeding at the Commission or an inter partes proceeding requested from CBP under 19 C.F.R. Part 177 that addresses operation of the Device Utility app on the articles at issue.”). Additionally, in certain cases, the Intellectual Property Rights Branch (the predecessor to the EOE Branch) treated the filing of a certification as a condition for entry following a favorable ruling under 19 C.F.R. Part 177. See CBP Headquarters Ruling H282234 (dated May 16, 2017) at 9 (“Because there is currently no simple method to test whether a particular GFCI utilizes three electrically isolated conductors without disassembling the GFCI, we are requiring that Royal Pacific Corporation file a certification upon ENTRY (along with any other required entry documents) for any imported GFCIs certifying that said merchandize does not utilize three electrically isolated conductors and thus does not satisfy the independent claim limitations of the ’809 patent.”); see also CBP Headquarters Ruling H311351 (dated August 19, 2020) at 29 (“In addition, with each entry of the articles at issue, CBP will require from persons importing the articles at issue (1) a certification, as approved by CBP; and (2) upon request by CBP, to furnish such records or analyses necessary to substantiate the certification.”) (internal citation omitted). Based on the concerns raised by the potential to modify the articles at issue post-importation, we find that the use of a certification as a condition of entry is appropriate.
32 Thus, the EOE Branch finds that conditioning the entry for consumption into the United States of the articles at issue on the submission of a certification is appropriate. VI. HOLDING We determine that STIIIZY has met its burden to establish that the Post-FD Redesigned Cartridges do not infringe any of the asserted claims of the Asserted Patents. Accordingly, we find that the Post-FD Redesigned Cartridges are not subject to the LEO issued as a result of Inv. No. 337-TA-1392. 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, Exclusion Order Enforcement Branch / Intellectual Property Enforcement Branch CC: Lyle Vander Schaaf Crowell & Moring LLP 1001 Pennsylvania Avenue, NW Washington, DC 200004 [email protected] [email protected]