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

HQ H361933 August 14, 2026 OT:RR:BSTC:EOE H361933 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), 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 not met its burden of proof that its “[[ ]] (All-In One) AIO Device” (“[[ ]]”) is 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. We further note that determinations of the Commission resulting from the underlying investigation or a related proceeding under 19 C.F.R. Part 210 are binding authority on CBP and, in the case of conflict, will by operation of law modify or revoke any contrary CBP ruling or decision pertaining to section 337 exclusion orders. This ruling letter is the result of a request for an administrative ruling under 19 C.F.R. Part 177, which was conducted on an inter partes basis. The proceeding involved the two parties with a direct and demonstrable interest in the question presented by the ruling request: (1) your client, 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 11/18/2022); 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 (collectively, the “asserted claims” or “claims at issue”) of U.S. Patent Nos. 11,369,756 (filed Mar. 17, 2021) (“the ’756 patent”); 11,369,757 (filed June 30, 2021) (“the ’757 patent”); 11,766,527 (filed Feb. 23, 2023) (“the ’527 patent”); and 11,759,580 (filed Feb. 23, 2023) (“the ’580 patent”) (collectively, the “asserted patents”). Id. at 2. The complaint also alleged that the accused products were “certain oil vaporizing devices, components 2
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. Certain Oil Vaporizing Devices, Components Thereof, and Products Containing the Same, Inv. No. 337-TA-1392, EDIS Doc. ID. 812867, Public Complaint (January 30, 2024) (“Complaint”) at 1. 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 at least one of the asserted claims of at least one of the asserted patents: STIIIZY-LIIIL, STIIIIZY-1(G)(C), STIIIZY- ORIG-1, STIIIZY-AIO (or “ITC AIO” as sometimes referred to by the parties in this proceeding), 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-REDESIGN(V) did not infringe the asserted claims of the ’580 patent. Id. at 100-101, and 112. With respect to the STIIIZY Redesigned Products noted above, the ALJ found that each infringed at least one claim 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 with respect to these patents. Id. 3
at 25, 60, and 72. The ALJ also held that STIIIZY presented 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 Pax did not meet the economic prong of section 337’s domestic industry requirement. 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 did not infringe the asserted claims of the ’580 patent; (2) certain redesigned products infringed the asserted claims of the ’580 patent; and (3) the Complainant had 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”) remained pending. Id. Upon remand, the Commission specifically requested that the ALJ “‘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. 4
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 (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 27. 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 5
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 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 to the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”). 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 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 United States Court of Appeals for the Federal Circuit (“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 the asserted claims of the asserted patents. 1392 LEO at 2, ¶ 1. The asserted patents share a common specification and are a continuation of application No. 15/396,584, now U.S. Patent No. 11,660,403 (filed Dec. 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 presented in FID. FID at 16-17, 45-49, 66-68, and 77-80. 6
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 7
user, that are leak-resistant for use with cannabinoids.” ’757 patent at codes (54) and (57). Claims 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]; 8
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 at 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] 9
a cartridge body comprising a proximal body end and a distal body end opposite the proximal body end; [527.1.a] 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] 10
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] 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] 11
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] 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 12
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 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 device, 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] 13
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] 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: 14
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 annotated photographs of an accused product alongside the domestic industry product: 15
Complaint at 8-9. B. 19 C.F.R. Part 177 Ruling Request 1. Procedural History On June 1, 2026, STIIIZY submitted a confidential letter and Exs. 1-9 (collectively, “STIIIZY Ruling Request” or “Ruling Request”) in an email to CBP requesting an administrative ruling pursuant to 19 C.F.R. Part 177. STIIIZY Email to EOE Branch, June 1, 2026. In the same email, STIIIZY indicated to the EOE Branch that it had only served a redacted version of the Ruling Request on PAX’s counsel. Id. On June 2, 2026, the EOE Branch sent an email to STIIIZY confirming receipt of the Ruling Request. EOE Branch Email to STIIIZY, June 2, 2026. That same day, STIIIZY emailed the EOE Branch indicating that it had reached an agreement on a non- disclosure agreement (NDA) with PAX and that it had served PAX with an unredacted copy of the Ruling Request. STIIIZY Email to EOE Branch, June 2, 2026. On June 5, 2026, the EOE Branch 16
sent an email to both parties confirming receipt of the NDA and requesting an initial conference call with the parties. EOE Branch Email to Parties, April 15, 2026. On June 15, 2026, the EOE Branch sent an email to the parties setting the date for the initial conference call and providing the procedural guidelines for the instant proceeding. EOE Branch Email to Parties, June 15, 2026. On June 16, 2026, the EOE Branch held an initial conference call with the parties during which the Branch discussed the procedural guidelines in more detail. On June 16, 2026, STIIIZY sent an email to the Branch that contained a procedural schedule proposed by both parties. STIIIZY Email to EOE Branch, June 16, 2026. On June 17, 2026, the EOE Branch issued the final procedural schedule for this Part 177 proceeding, which set an oral discussion date of July 23, 2026, and a target date of August 14, 2026. On July 2, 2026, PAX submitted both its confidential and redacted versions of its response to STIIIZY’s Ruling Request along with confidential and redacted versions of Exs. A-B (collectively, “PAX Response”). PAX Email to EOE Branch, July 2, 2026 (copying STIIIZY). On July 10, 2026, STIIIZY submitted its reply along with Exs. 10-20 (collectively, “STIIIZY Reply.”). STIIIZY Email to EOE Branch and PAX, July 10, 2026. On July 17, 2026, PAX filed confidential and redacted versions of its sur-reply along with Ex. C and confidential and redacted versions of the Sur-Reply Declaration of Kelly Kodama (collectively, “PAX Sur-Reply”). PAX Email to EOE Branch and STIIIZY, July 17, 2026. The EOE Branch held an oral discussion with both parties on July 23, 2026, in which STIIIZY and PAX submitted oral discussion presentations (“STIIIZY Oral Discussion Presentation” and “PAX Oral Discussion Presentation,” respectively). STIIIZY submitted its post-oral discussion brief on July 31, 2026 (“STIIIZY Post-Oral Discussion Brief”). Email from STIIIZY to EOE Branch and PAX, July 31, 2026. That same day, PAX submitted its post-oral discussion brief and Ex. D (“PAX Post-Oral Discussion Brief”). Email from PAX to EOE Branch and STIIIZY, July 31, 2026. Upon receipt of the parties’ post-oral discussion briefs, the administrative record upon which this ruling relies is complete. 2. The Articles at Issue The article at issue in this Ruling Request is a vaporizer device that STIIIZY calls the “[[ ]] AIO Device” ([[ ]]). STIIIZY Ruling Request at 1. According to STIIIZY, “[[ ]] Id. at 18 (citing STIIIZY Ex. 1 ¶ 12). STIIIZY maintains that the [[ ]] “[[ ]]” STIIIZY Ex. 1 ¶ 13. Moreover, STIIIZY asserts that [[ ]] STIIIZY Ruling Request at 18 (citing Ex. 1 ¶ 12). During the oral discussion, STIIIZY presented the following slide depicting the [[ ]]: 17
[[ ]] STIIIZY Oral Discussion Presentation at 6. According to Ramon Alarcon, the head of hardware engineering for STIIIZY, “[i]n [[ ]], STIIIZY and ALD [[ ]], which resulted in the [[ ]] AIO Device. The first working prototypes of the [[ ]] AIO Device were fabricated [[ ]].” STIIIZY Ex. 1 ¶ 11. Mr. Alarcon further asserts that the [[ ]] differs from the STIIIZY-AIO in a number of respects, and provides the following CAD drawing of these devices side by side: [[ ]] STIIIZY Ex. 1 ¶ 11. 18
According to Mr. Alarcon, differences between the STIIIZY-AIO and the [[ ]] include the [[ ]], [[ ]], [[ ]], number of [[ ]], [[ ]], [[ ]], number of [[ ]], and [[ ]]. STIIIZY Ex. 1 ¶¶ 13-20. Mr. Alarcon indicates that “[f]irst production samples have been imported into the United States.” STIIIZY Ex. 1 ¶ 12. STIIIZY asserts that “[i]n light of these differences, STIIIZY seeks a ruling that the [[ ]] AIO Device does not infringe the asserted claims of the ’580 patent or the asserted claims of the Remaining Asserted Patents. STIIIZY respectfully requests a finding of non-infringement and that the [[ ]] AIO Device is not subject to the -1392 Investigation LEO.” STIIIZY Ruling Request at 30. II. ISSUE Whether STIIIZY has met its burden of proof in establishing that its [[ ]] does not infringe the claims at issue in the asserted patents and is thus not subject to the 1392 LEO. 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).”). 19
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). 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 20
noted that the U.S. Court of Appeals for the 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 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 21
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. According to the Federal Circuit, “[t]o 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.”). 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). We apply this two-step analysis below. IV. ANALYSIS Based on the above framework, STIIIZY, as the adjudged infringer at the ITC and the party seeking to import the [[ ]], has the burden of proof to establish that this article is non- infringing and therefore not subject to the 1392 LEO. See Hyundai Elecs. Indus. Co., 899 F.2d at 1210. STIIIZY argues that its [[ ]] does not infringe the asserted claims of the ’756, ’757, ’527, and ’580 patents. STIIIZY Ruling Request at 2, 30. In their filings, STIIIZY and PAX have only raised select limitations from the asserted patents for the EOE Branch’s consideration. See Parties’ Filings. See also Greenlaw v. United States, 554 U.S. 237, 243 (2008) (“In our adversary system, in both civil and criminal cases, in the first instance and on appeal, we follow the principle of party presentation. That is, we rely on the parties to frame the issues for decision and assign to courts the role of neutral arbiter of matters the parties present.”) (emphasis added); see also Astellas Pharma, Inc. v. Sandoz Inc., 2024 U.S. App. LEXIS 23669, at *12 (Fed. Cir. 2024) (“It is for the parties—not the court—to chart the course of the litigation.”); see also Certain Robotic Floor Cleaning Devices and Components Thereof, Inv. No. 337-TA-1252, Initial Determination on Violation of Section 337 and Recommended Determination on Remedy and Bonding, EDIS Doc. ID 783814 (Public) (October 7, 2022) at 10, FN 16 (“Given that [complainant] did not dispute that the [relevant] products in this category are non-infringing, this Initial Determination finds no reason to conclude otherwise.”) (emphasis added), aff’d, Notice of Commission Final Determination Finding a Violation of Section 337, EDIS Doc. ID 792838 (Public) (March 21, 2023) (“All findings in the FID that are not inconsistent with the Commission’s determination are affirmed.”). Therefore, we consider in detail whether STIIIZY has met its burden of proof with respect to the limitations that the parties have presented before the Branch in each of the asserted patents. 22
Regarding the remaining limitations, because they have not been raised by the parties, the EOE 1 Branch finds that STIIIZY has not met its burden of proof. 1. The Asserted Patents The ’580 patent (claims 1, 6-7) a. “A vaporizer cartridge” (limitation 580.1.pre) Our review begins with the ’580 patent. According to STIIIZY, the [[ ]] does not meet the preamble of claim 1 of the ’580 patent, “[a] vaporizer cartridge.” STIIIZY Reply at 2- 3; STIIIZY Post-Oral Discussion Brief at 23. Before considering whether this feature is present in the [[ ]], however, we must first determine whether the preamble is limiting, and if so, what is its claim construction. These issues are considered below. 1. Whether the preamble “a vaporizer cartridge” of claim 1 is limiting We first turn to STIIIZY’s argument that the preamble “vaporizing cartridge” is limiting, and accordingly, must be treated as a limitation. Catalina Mktg. Int’l v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002). STIIIZY Reply at 2-3; STIIIZY Post-Oral Discussion Brief at 23. Initially, we recognize that the Commission did not specifically rule on whether the preamble is limiting, even though it labeled the preamble as a limitation in the FID and found that some of the accused products satisfied the preamble. See FID at 82-103. STIIIZY points to Federal Circuit precedent and maintains that “[p]reambles are limiting when they provide antecedent basis for terms in the claim body or when they are “‘necessary to give life, meaning, and vitality‘ to the claim.” STIIIZY Reply at 3 (citing Catalina Mktg. Int’l, Inc.,; Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 1367 (Fed. Cir. 2020)). In this regard, STIIIZY contends that: At a minimum, vaporizer cartridge is limiting because it provides the necessary context for (and thus breathes life and meaning into) the term cartridge body. As [STIIIZY expert] Mr. Wensley explains, the preamble of claim 1 is essential to understanding the term cartridge body later recited in the claim. The word cartridge in cartridge body refers back to and draws meaning from the preamble’s designation that the claimed invention is a vaporizer cartridge. Without the preamble, a person of ordinary skill in the art would have no basis for understanding what kind of device is at issue or what the “cartridge body” contains. Those words were chosen by the inventors for a reason: they must have meaning. 1 STIIIZY initially raised limitations 580.g.vi and 580.g.vii before the Branch. However, during the oral discussion on July 23, 2026, STIIIZY’s counsel indicated that STIIIZY was no longer contesting these limitations. Therefore, we find that STIIIZY has not met its burden of proof with respect to these limitations. 23
STIIIZY Reply at 3 (citing STIIIZY Ex. 11 ¶ 31) (internal citations omitted) (emphasis in original). STIIIZY goes on to argue that: The preamble is also essential to understanding the structural relationships among the claim elements; the housing piece, air tube, distal member, and bottom cover are all components of a “vaporizer cartridge,” and their structural interrelationships are defined by that context. Dependent claims 5 and 6 refer back to the vaporizer cartridge, with claim 6 reciting a vaporizer device comprising a vaporizer cartridge and a vaporizer body, further confirming that the preamble defines a specific structure (a separable cartridge component) rather than a generic collection of components. STIIIZY Reply at 3 (citing STIIIZY Ex. 11 ¶ 31) (emphasis in original); see also STIIIZY Post- Oral Discussion Brief at 23. On the other hand, PAX contends that the preamble here is not limiting and should therefore not be given patentable weight. PAX Sur-Reply at 4. Here, PAX cites Federal Circuit caselaw for the proposition that “[a] preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’” Id. at 4 (citing Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 1367 (Fed. Cir. 2020)). To this end, PAX argues that: The body of claim 1 defines a structurally complete invention—a cartridge body, mouthpiece, reservoir, vaporization chamber, extension wire, bottom cover, and distal member— each independently defined with its structural interrelationships fully specified. The preamble phrase ‘vaporizer cartridge’ merely states the intended use of the claimed structure, and its deletion would not affect the structural completeness of the claimed invention. PAX Sur-Reply at 4. Moreover, PAX contends that STIIIZY is mistaken in arguing that “the preamble is limiting because it provides antecedent basis for ‘cartridge body’ in limitation 1.a” and that STIIIZY “conflates linguistic reference with structural limitation.” Id. (citing STIIIZY Reply at 3-4). Here, PAX asserts that: The term ‘cartridge body’ is independently defined by the claim body as a structure ‘comprising a proximal body end and a distal body end opposite the proximate body end.’ The word ‘cartridge’ serves as a label, not a structural modifier importing requirements from the preamble. That dependent claims 5 and 6 refer back to the preamble term does not render the preamble limiting. Dependent claims routinely reference the preamble term as shorthand without converting it into a structural limitation. PAX Sur-Reply at 4. Lastly, PAX maintains that STIIIZY’s preamble argument is waived because “STIIIZY argues for the first time in its Reply that the [[ ]] AIO Device does not satisfy the 24
vaporizer cartridge preamble (limitation 1.pre).” Id. In this regard, PAX argues that it did not have the opportunity to present counterarguments to STIIIZY’s preamble contentions in its Response and that “STIIIZY’s belated argument is both procedurally improper and substantively meritless.” Id. (citing PAX Sur-Reply Declaration of Kelly Kodama ¶¶ 4-6). We agree with STIIIZY that the preamble to claim 1 of the ’580 patent is limiting and therefore should be afforded patentable weight. According to the Federal Circuit, “[w]hether to treat a preamble as a limitation is a determination ‘resolved only on review of the entire[] . . . patent to gain an understanding of what the inventors actually invented and intended to encompass by the claim.’” Catalina Mktg. Int’l., 289 F.3d at 808 (citing Corning Glass Works v. Sumitomo Electric U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989); Applied Materials, Inc. v. Advanced Semiconductor Materials Am., Inc., 98 F.3d 1563, 1572-73 (Fed. Cir. 1996)). Moreover, the Federal Circuit has stated that “a preamble limits the invention if it recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” Catalina Mktg. Int’l, Inc., 289 F.3d at 808 (citing Pitney Bowes, Inc. v Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999)). Here, we find that the preamble “a vaporizer cartridge” provides essential structure for understanding the remaining elements in the claim body. Contrary to PAX’s contention that the claim body describes a structurally complete invention, the limitations “reservoir,” “vaporization chamber,” and “bottom cover” recited in the claim body remain undefined if “vaporizer cartridge” is not read into the claim. For example, if untethered from “vaporizer cartridge,” these limitations could be construed as referring to ”cartridge body” (limitation 580.1.a) or “mouthpiece” (limitation 580.1.b). The FID confirms that the preamble is limiting. The ALJ himself indicated that the limitation “bottom cover” (limitation 1.f) must be a bottom cover for the “vaporizer cartridge” preamble (1.pre). FID at 19 (section IV.B.1.a.ii). According to the FID, in discussing this same “bottom cover” limitation in claim 1 of the ’756 patent, the ALJ found that: ‘Bottom cover’ has been construed to mean ‘a structure covering a bottom of a component.’ Order No. 19 at 28. Limitations are not read in isolation, however. See Phillips, 415 F.3d at 1314 (‘[T]he context in which a term is used in the asserted claim can be highly instructive.’) Thus, when read in the context of the claim, the bottom cover does not cover just any component, as Respondents claim. It covers the vaporizer cartridge. Id. (citing JX-0001, cl. 1) (emphasis added). By referring to “vaporizer cartridge” in the above quoted portion of the FID, the ALJ was referring to the preamble for the ’756 patent. ‘756 patent at 34:48. Then, when discussing the same “bottom cover” limitation for the STIIIZY-AIO device in connection to claim 1 of the ’580 patent, the ALJ cited his findings for the ’756 patent. He wrote “[t]hus, for the reasons discussed in Section IV.B.1.a.ii, the evidence shows that this limitation is met.” FID at 82 (citing CX-4747C (Kodama) at Q/A 365-366; FID at 18-19 (Section IV.B.1.a.ii) (emphasis added)). That is, the ALJ found that “vaporizer cartridge” in claim 1 of the ’580 patent provides the claim with “essential structure” so that a person of ordinary skill in the art would understand that the “bottom cover” is the bottom cover for the recited preamble “vaporizer cartridge.” Because Catalina Mktg. Int’l, Inc. dictates that a preamble is limiting if it provides essential structure to the claim, we find the preamble “vaporizer cartridge” here to be 25
limiting. Additionally, as stated above, 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. See supra p. 1. Additionally, we agree with STIIIZY that dependent claims 5 and 6, which recite the “vaporizer cartridge” in the body of the claims, refer back to the preamble of claim 1. Claims 5 and 6 read in relevant part as follows: 5. The vaporizer cartridge of claim 1, wherein the vaporizer cartridge is configured to be magnetically coupled and secured within a cartridge receiver of a vaporizer body. 6. A vaporizer device, comprising: the vaporizer cartridge of claim 1 . . . ’580 patent at 35:20-24 (emphasis added). Thus, if a person of ordinary skill in the art read out “vaporizer cartridge” from claim 1, claims 5-6 would be incomprehensible. In fact, without “vaporizer cartridge” as a limitation, this same term in claims 5-6 would lack an antecedent basis and could render these claims indefinite under 35 U.S.C 112 (b). “A claim is indefinite when it contains words or phrases where the meaning is unclear, which may be the result of the lack of an antecedent basis.” In re Downing, 754 Fed. Appx. 988, 996 (Fed. Cir. 2018) (citing In re Packard, 751 F.3d 1307, 1314 (Fed. Cir. 2014)). Moreover, the Federal Circuit has held that "[w]hen limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention." Pacing Techs., LLC v. Garmin Int’l, Inc., 778 F.3d 1021, 1024 (Fed. Cir. 2015) (citing Eaton Corp. v. Rockwell Int'l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003)). In Pacing Techs., LLC, the Federal Circuit considered whether the term “repetitive pacing system” recited in the preamble of an independent claim provided the necessary antecedent basis for the same term used in the body of one of its dependent claims. Pacing Techs., LLC, 778 F.3d at 1024. The preamble of independent claim 25 there recited “[a] repetitive motion pacing system for pacing a user comprising:” Id. at 1022. The dependent claim then provided “[t]he repetitive motion pacing system of claim 25, wherein the repetitive motion pacing system can determine a geographic location of the data storage and playback device.” Id. at 1024 (citing U.S. Patent No. 8,101,843 at 19:46-48). The Federal Circuit in that case found the preamble of the independent claim to be limiting. Id. at 1023-1024. It reasoned that “[b]ecause the preamble term[] . . . ‘repetitive motion pacing system’ provides antecedent basis for and [is] necessary to understand positive limitations in the body of claims in the ’843 patent, we hold that the preamble to claim 25 is limiting.” Similarly, here, we find the preamble term “vaporizer cartridge” in claim 1 of the ’580 patent to be a necessary antecedent basis for this same term in the body of dependent claims 5 and 6 and is therefore limiting. PAX’s arguments that the preamble is not limiting are without merit. First, we disagree with PAX that the body of claim 1 alone is a “structurally complete invention.” PAX Sur-Reply at 4. Unless “vaporization cartridge” is given patentable weight, as noted above, we find that a number of the remaining elements in the claim body would be incomprehensible to a person of ordinary skill in the art, including “reservoir,” “vaporization chamber,” and “bottom cover.” Therefore, we find that the body of claim 1 alone does not provide a “structurally complete 26
invention.” We also reject PAX’s assertion that the preamble recitation here “merely states the intended use of the claimed structure, and its deletion would not affect the structural completeness of the claimed invention.” PAX Sur-Reply at 4. “[P]reamble language merely extolling benefits or features of the claimed invention does not limit the claim scope without clear reliance on those benefits or features as patentably significant." Georgetown Rail Equip. Co. v. Holland L.P., 867 F.3d 1229, 1237 (Fed. Cir. 2017) (citing Catalina Mktg., 289 at 809. The preamble term “vaporizer cartridge” does not state an intended use or purpose but rather a structural part of the invention. Lastly, we disagree that STIIIZY has waived its right to present its preamble arguments because it introduced them for the first time in its Reply. In the email the EOE Branch sent the parties on June 15, 2026, the Branch indicated that no new evidence may be presented at the oral discussion. We wrote: The 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. EOE Branch Email to Parties, June 15, 2026. That is, the EOE Branch has traditionally allowed the parties to develop their theories of infringement and non-infringement up to the date of the oral discussion. Because STIIIZY made its arguments regarding the preamble for the first time prior to the oral discussion (i.e., in its Reply), we find that STIIIZY has not waived this right here. We also note that PAX has had sufficient opportunity to respond to STIIIZY’s preamble arguments in its Sur-Reply, Oral Discussion Presentation, and Post-Oral Discussion Brief. Therefore, after considering the parties’ arguments and evidence presented, including the ’580 specification, we conclude that the preamble “a vaporizer cartridge” in claim 1 of the ’580 patent is limiting. Accordingly, we find that STIIIZY must show CBP that the [[ ]] does not meet this limitation to satisfy its overall burden of proof. 2. Claim construction of “vaporizer cartridge” The Branch now turns to claim construction of “vaporizer cartridge.” At the outset, we note that the Commission did not construe this limitation. FID at 6-7 (citing Order No. 19 at 26, 28, 32, 34, and 39). STIIIZY provides its own express claim construction and argues that “vaporizer cartridge should be construed as ‘a component that mates with and may be installed into a vaporizer base to form a vaporizer device.’” STIIIZY Reply at 4. To support this, STIIIZY argues that a “vaporizer cartridge, as understood by a person of ordinary skill in the art, is a component that mates with and may be installed into a vaporizer base to form a vaporizer device.” STIIIZY Reply at 3 (citing STIIIZY Ex. 11 ¶ 29) (emphasis in original). Here, STIIIZY points to the specification as allegedly describing a “vaporizer component that ‘mates with’ and is ‘install[ed] . . . into the vaporizer base.’” STIIIZY Reply at 3 (citing ’580 patent at 2:43-54, 3:64- 4:1, claim 6). Additionally, STIIIZY claims that “[t]his understanding is confirmed by the plain meaning of cartridge, which standard dictionaries define as a removable container designed for insertion into a larger piece of equipment.” STIIIZY Reply at 3 (citing STIIIZY Ex. 11 ¶ 29, n.1; and Ex. 13) (emphasis in original). In this regard, STIIIZY cites the American Heritage Dictionary 27
of the English Language, which allegedly defines “cartridge” as “[a] small modular unit designed to be inserted into a larger piece of equipment: an ink cartridge.” STIIIZY Reply at 4 (citing th American Heritage Dictionary of the English Language 587 (5 ed. 2016)). PAX asserts that STIIIZY’s proposed claim construction of “vaporizer cartridge” is contradicted by the Commission’s findings in the underlying investigation. Here, PAX argues that at the ITC “STIIIZY admitted that a cartridge ‘is built in [its STIIIZY-AIO] and is not a removable or replaceable component.’” PAX Sur-Reply at 5 (citing FID at 53). Moreover, PAX contends that “[t]he Commission found that the STIIIZY AIO device satisfied the vaporizer cartridge claim 1 of the ’580 Patent” and that “[l]ike the [[ ]] AIO Device, the STIIIZY AIO device is an all-in-one device in which the battery is not detachable from the cartridge.” PAX Sur-Reply at 5 (citing FID at 82 and PAX Sur-Reply Declaration of Kelly Kodama ¶ 5). Lastly, PAX provides that the claim construction proposed by STIIIZY for “vaporizer cartridge” is too narrow. Specifically, PAX argues that STIIIZY ignored “the broader definition the same Merriam-Webster dictionary [STIIIZY cites]: ‘a case or container that holds a substance, device or material which is difficult, troublesome, or awkward to handle and that usually can be easily changed.’” PAX Sur- Reply at 5 (citing PAX Ex. 12 at 1). According to PAX, “[t]his broader definition does not require the cartridge to mate with another component.” PAX Sur-Reply at 5. PAX maintains that “STIIIZY’s selective reliance on one of the several dictionary definitions, while ignoring others that are equally applicable, does not support its proposed construction.” Id. As the Federal Circuit has confirmed, “[t]he words of a claim are generally given their ordinary and customary meaning as understood by a person of ordinary skill in the art when read in the context of the specification and prosecution history. There are only two exceptions to this general rule: 1) when a patentee sets out a definition and acts as his own lexicographer, or 2) when the patentee disavows the full scope of a claim term either in the specification or during prosecution.” Thorner v. Sony Computer Entm't Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012) (internal citations omitted). In 3M Innovative Props. Co. v. Tredegar Corp., 725 F.3d 1315, 1321, 1326 (Fed. Cir. 2013), the court stated: To the extent possible, claim terms are given their ordinary and customary meaning, as they would be understood by one of ordinary skill in the art in question at the time of the invention. Idiosyncratic language, highly technical terms, or terms coined by the inventor are best understood by reference to the specification. While we construe the claims in light of the specification, limitations discussed in the specification may not be read into the claims. Courts may rely on dictionary definitions when construing claim terms, so long as the dictionary definition does not contradict any definition found in or ascertained by a reading of the patent documents. [] Where . . . a disavowal does not exist, the ordinary and customary meaning of the claim term will be given its full effect. As supported by the above, although “the specifications may be relevant for understanding certain terms and the intention of the inventor, one may not import limitations from the specification into the claims.” HQ H334472 at 18 (citing Phillips, 415 F.3d at 1323). “One of the best ways to teach a person of ordinary skill in the art how to make and use the invention is to provide an example of how to practice the invention in a particular case. Much of the time upon 28
reading the specification in that context, it will become clear whether the patentee is setting out specific examples of the invention to accomplish the goals, or whether the patentee instead intends for the claims and the embodiments in the specification to be strictly coextensive.” Phillips, 415 F.3d at 1323 (citing SciMed Life Sys. v. Advanced Cardiovascular Sys., 242 F.3d 1337, 1341 (Fed. Cir. 2001)). The Federal Circuit has also notably held that "[a] fundamental rule of claim construction is that terms in a patent document are construed with the meaning with which they are presented in the patent document. Thus claims must be construed so as to be consistent with the specification, of which they are a part." Merck & Co. v. Teva Pharms. USA, Inc., 347 F.3d 1367, 1371 (Fed. Cir. 2003). “Ultimately, the interpretation to be given a term can only be determined and confirmed with a full understanding of what the inventors actually invented and intended to envelop with the claim. The construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be, in the end, the correct construction.” Renishaw PLC v. Marposs Societa' Per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998) (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 389 (1996); Young Dental Mfg. Co. v. Q3 Special Prods, 112 F.3d 1137, 1141 (Fed. Cir. 1997)). Lastly, the Federal Circuit has cautioned that: Although we have emphasized the importance of intrinsic evidence in claim construction, we have also authorized district courts to rely on extrinsic evidence, which ‘consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises.’ However, while extrinsic evidence ‘can shed useful light on the relevant art,’ we have explained that it is ‘less significant than the intrinsic record in determining the legally operative meaning of claim language.' Phillips, 415 F.3d at 1317 (internal citations omitted). Thus, in light of the above Federal Circuit precedent, we must apply the ordinary and customary meaning to “vaporizer cartridge” as construed by a person of ordinary skilled in the art 2 at the time of the invention consistent with the specification and prosecution history. As such, we look to the specification of the ’580 patent for guidance here. We note that the ’580 specification, while it does not specifically define a “vaporizer cartridge,” it confirms the patentee’s intent to define a vaporizer cartridge as a component that mates with a vaporizer base to form a vaporizer device. The specification provides that “[e]ither or both the vaporizer base (which mates with the vaporizer cartridge to form the vaporizer device) and vaporizer cartridge may be adapted specifically for use with cannabis liquid extracts.” ’580 patent at 2:45-49 (emphasis added). Also, the specification indicates that “[i]n general, the cartridges described herein may be configured for insertion (e.g., by friction fitting) into a vaporizer body. Thus, the cartridge, and particularly the distal end of the cartridge, may be adapted to be inserted securely into the re-usable vaporizer device.” ’580 patent at 7:42-46 (emphasis added). Also, we find significant that the specification of the ’580 patent fails to describe a vaporizer cartridge that does not mate with a vaporizer base. 2 We note that neither party presented evidence from the prosecution history of the ’580 patent. A review of the prosecution history by the Branch also did not shed any light on the patent examiner’s construction of “vaporizer cartridge.” 29
See generally ’580 patent. The following figure is a representative illustration from the ’580 patent in which a vaporizer cartridge (401) mates with a vaporizer base (411) to form a vaporizer device (400). ’580 patent at Figs. 4A-B. Additionally, the specification describes at length how mating between the vaporizer cartridge and vaporizer base helps reduce leakage in the vaporizer device, one of the patentee’s main inventive goals, through a scraping process. ’580 patent at code (54) (Title: “Leak-Resistant Vaporizer Device”); code (57). It provides: For example, the apparatuses described herein may include one or more electrical contacts (e.g., between the cartridge and the vaporizer base) referred to herein as wiping or scraping contacts. These electrical connections may be configured so that as a connection/contact is made between two electrically conductive surfaces, the contact (e.g., on the cartridge and/or the vaporizer base) scrapes the mating surface of the other contact to remove any vaporizable material, including vaporizable material that has dried on the contact. ’580 patent at 3:5-14. Further, the claims themselves provide additional support that the patentee’s intent was that a vaporizer cartridge be a device that mates with a vaporizer base. For example, claim 6 recites that “wherein the cartridge receiver comprises: a body electrical contact; an insertion end into which the vaporizer cartridge is inserted; and a base opposite the insertion end; a sensor configured to detect a draw on the mouthpiece, causing activation of the heater.” Id. at 35:25-35 (emphasis added); see also ’580 patent, claims 7-8, 10, 12-13, 15-18, and 20. Also, the specification indicates that “described herein are vaporizers with or without cartridges.” ’580 patent at 2:43-44 and 32:12- 30
17 (emphasis added). If the inventors wanted to claim a vaporizer without a cartridge, they could have easily chosen to do so. Additionally, we find that the specification strongly suggests that the ’580 patent’s cartridge is a device that is readily removable by the user. In particular, the specification states that “[f]or example, a plurality of LEDs (RGB) may be illuminated to provide qualitative feedback to a user on the operation of the vaporizer. Upon inserting a cartridge, the vaporizer apparatus may display using the LEDs an illumination corresponding to the intensity of the inhalation and/or the progression of consumption of vaporizable material from the cartridge.” ’580 patent at 6:4-110 (emphasis added). Lastly, the specification indicates under the heading “Vaporizers without Cartridges” that “[a]ny of the features described herein may be incorporated into a vaporizer apparatus that does not require the use of a separate (e.g., removable cartridge), including vaporizer apparatuses such as loose-leaf vaporizer apparatuses.” ’580 patent at 32:12-16 (emphasis added). Therefore, given the clarity provided in the specification and claims on the meaning of “vaporizer cartridge,” we adopt STIIIZY’s construction, which is “a component that mates with and may be installed into a vaporizer base to form a vaporizer device.” STIIIZY Reply at 3 (citing STIIIZY Ex. 11 ¶ 29). We find STIIIZY’s construction to be consistent with the “plain and ordinary” meaning of the limitation in light of the ’580 specification. Moreover, we are not persuaded by PAX that “vaporizer cartridge” should be construed in accordance with the broader definition it provides from Merriam-Webster’s Dictionary as a “case or container that holds a substance, device, or material which is difficult, troublesome, or awkward to handle and that usually can be easily changed.” PAX Sur-Reply at 5. Adopting PAX’s construction would run afoul of Federal Circuit precedent, which provides that “claims must be construed so as to be consistent with the specification, of which they are a part." Merck & Co., 347 F.3d at 1371 (citing Gen. Am. Transp. Corp. v. Cryo-Trans, Inc., 93 F.3d 766, 770 (Fed. Cir. 1996); Slimfold Mfg. Co. v. Kinkead Indus., Inc. 810 F.2d 1113, 1117 (Fed. Cir. 1987). 3. Whether the [[ ]] meets the limitation “vaporizer cartridge” in claim 1 The Branch now considers whether the [[ ]] practices the “vaporizer cartridge” limitation of claim 1 of the ’580 patent based on the above claim construction. STIIIZY argues that “[w]hen properly construed, the [[ ]] AIO Device is not (nor does it contain) a vaporizer cartridge. By [PAX’s expert] Mr. Kodama’s own admission, the [[ ]] AIO Device is ‘an all-in one (“AIO”) vaporizer device in which a battery is not detachable from a cartridge.’” STIIIZY Reply at 4 (citing PAX Ex. A ¶ 15). Also, citing its own expert, STIIIZY contends that the [[ ]] is not a vaporizer cartridge within the meaning of claim 1 because it does not mate with a vaporizer base, nor does it contain a component that mates with a vaporizer base.” STIIIZY Reply at 4 (citing STIIIZY Ex. 11 ¶ 30) (emphasis in original). According to STIIIZY’s expert, Martin Wensley: As set forth in the specification, a vaporizer cartridge is a component that pairs with a vaporizer base to form a vaporizer device. (’580 patent at 2:43-54 (“the vaporizer base . . . [mates] with the vaporizer cartridge to form the vaporizer device”); 3:64-4:1 (“The device may be turned on by . . . installing the cartridge 31
into the vaporizer base”); ’580 patent claim 6 (reciting a “vaporizer device” comprising a “vaporizer cartridge” and a “vaporizer body”). The [[ ]] AIO device, however, does not contain a vaporizer cartridge because [[ ]] STIIIZY Ex. 11 ¶ 29. STIIIZY also asserts that the [[ ]] does not meet the “vaporizer cartridge” preamble under the doctrine of equivalents. In this regard, Mr. Wensley explains that “[t]he [[ ]] AIO Device does not itself or contain any components that [[ ]] Id. at ¶ 30. In contrast, PAX argues that because the Commission found in the underlying investigation that the “STIIIZY AIO device satisfied the vaporizer cartridge claim of the ’580 Patent,” we must reach the same conclusion here. PAX Sur-Reply at 5. PAX contends that “[l]ike the [[ ]] AIO Device, the STIIIZY AIO device is an all-in-one device in which the battery is not detachable from the cartridge.” Id. at 5. To this end, PAX argues that “[b]ecause the STIIIZY AIO device cannot mate with or be installed into a vaporizer base either, it would not satisfy the vaporizer cartridge claim with STIIIZY’s proposed construction, which is irreconcilable with the Commission’s infringement finding.” PAX Post-Oral Discussion Brief at 3. Lastly, PAX provides testimony from its expert Kelly Kodama who states that “[a]s I stated in my July 2 Declaration, the [[ ]] AIO Device is an example of what is known as an all-in-one (“AIO”) vaporizer device in which a battery is not detachable from a cartridge. That is, the [[ ]] AIO Device includes a cartridge integrated with a battery.” Sur-Reply Declaration of Kelly Kodama ¶ 5; PAX Ex. A ¶ 15. The Branch finds STIIIZY’s arguments more availing here. Applying the construction of “vaporizer cartridge” adopted by the Branch above as “a component that mates with and may be installed into a vaporizer base to form a vaporizer device,” we do not find this feature or its equivalent present in the [[ ]]. In particular, we are persuaded by the CAD drawings and expert testimony from Martin Wensley and Ramon Alarcon that the [[ ]] does not have a cartridge that can installed into a vaporizer base to form a vaporizer device. See STIIIZY Ruling Request, STIIIZY Reply, STIIIZY Post-Oral Discussion Brief, STIIIZY Oral Discussion Presentation, and STIIIZY Ex. 1-2. We disagree with PAX that because the Commission found that the STIIIZY-AIO satisfied “vaporizer cartridge” that we are constrained to rule the same way here. First, we note that the [[ ]] is a very different device than the STIIIZY-AIO and that the Commission made no specific findings on a [[ ]] all-in-one type of device. See FID generally. During the oral discussion, in one of its slides, STIIIZY presented the following side- by-side comparison of the [[ ]] and the cartridge of the STIIIZY-AIO, where a person of ordinary skill in the art can discern clear differences: 32
[[ ]] STIIIZY Oral Presentation at 54. From the lefthand photo of the cartridge of the STIIIZY-AIO above, one can readily see a 3 vaporizer cartridge, which just one of the components of the STIIIZY-AIO. In contrast, we do not see a vaporizer cartridge that can mate with a vaporizer base to form a vaporizer device in the [[ ]] on the right. In fact, the CAD drawing of the [[ ]] shows that the device is a single unit that does not need to mate with another component to form a vaporizer device. From the Branch’s perspective, just because the ALJ found that the STIIIZY-AIO infringed the preamble of the ’580 patent, it does not follow that we are required to find that another all-in-one device (the [[ ]]) has this same feature. This is especially true considering the [[ ]] is distinctive in numerous ways from STIIIZY-AIO and the Commission did not consider a similar all-in-one product during the underlying investigation. Also, we note that the FID did not specifically indicate why the STIIIZY-AIO met the “vaporizer cartridge” limitation. FID at 82-83 (citing CX-4747C (Kodama) at Q/As 326-327, 333). The ALJ briefly cited, but did not quote from, the below testimony of Kelly Kodama. FID at 83. In the Amended Witness Statement of Kelly Kodama that the ALJ cited, the following question and answer exchange occurred: Q326. Let’s turn to the details of your analysis for claim 1 of the ’580 Patent, and for each element I’m going to ask you to explain your analysis relative to the following representative products: . . . STIIIZY All-In- One Vaporizer . . . . Are any of these accused products a vaporizer cartridge as recited in the preamble of claim 1? A326. Yes, Slide CDX-0001.0105 shows that the STIIIZY 1 Gram Cartridge, Rove Cartridge, Flare X2 Cartridge, STIIIZY 1 Gram Cartridge Redesign, Rove Cartridge Redesign, and Flare X2 Cartridge Redesign are vaporizer cartridges. Q327. Do any of these accused vaporizer products include a vaporizer cartridge as recited in the preamble of claim 1? 3 The cartridge of the STIIIZY-AIO must mate or be installed into a battery to form a complete vaporizer device. 33
A327. Yes, the STIIIZY (Original) Vaporizer with 1 Gram Cartridge, the STIIIZY LIIIL Vaporizer, STIIIZY All-In-One Vaporizer, Rove Vaporizer, Flare X2 Vaporizer, STIIIZY (Original) Vaporizer with 1 Gram Cartridge Redesign, STIIIZY All-In-One Vaporizer Redesign, Rove Vaporizer with Rove Cartridge Redesign, and Flare X2 Vaporizer with Flare X2 Cartridge Redesign all include vaporizer cartridges. . . . The vaporizer cartridge component of the STIIIZY All-In-One Vaporizer Redesign is shown on slide CDX-0001.0106. . . . Q333. Does the STIIIZY AIO Vaporizer satisfy elements [1A]-[1C]? A333. Yes, the mouthpiece, cartridge body, and reservoir of the cartridge component of the STIIIZY AIO Vaporizer are identified on slide CDX- 0001.0112. Relative to elements [1A]–[1C], the cartridge component has substantially the same features as the STIIIZY 1 Gram. PAX Ex. B, Q/A 326-327, 333. As part of his Amended Witness Statement, Mr. Kodama provided the following slide with respect to Q/A 327 above: PAX Ex. B, Q/A 327. Thus, although the ALJ cited Mr. Kodama’s witness statement as evidence that the STIIIZY-AIO infringed claim 1 of the ’580 patent, Mr. Kodama gave no specifics why this device 34
met the preamble. PAX Ex. B, Q/As 326-327, 333. All Mr. Kodama provided was general statements concerning infringement and a slide with a photograph of the cartridge of the STIIIZY- AIO (i.e., middle device in above photograph). From this alone, the Branch cannot conclude that ITC’s findings on the STIIIZY-AIO warrant a similar finding that an entirely different article with a much different structure and functionality, the [[ ]], meets the “vaporizer cartridge” preamble of claim 1. As such, we find Mr. Kodama’s testimony from the underlying investigation deficient to prove that the [[ ]] contains a “vaporizer cartridge.” Lastly, and perhaps most importantly, PAX has not pointed to any feature in the [[ ]] that satisfies the “vaporizer cartridge” preamble. See PAX Response at 4-5; Pax Sur- Reply; PAX Post Oral Discussion Brief. Rather, PAX’s arguments concerning the preamble are restricted to whether “vaporizer cartridge” is limiting and its claim construction. In other words, PAX has not provided an alternative argument of what feature of the [[ ]] meets the preamble should the Branch find “vaporizer cartridge” limiting. 4. EOE Branch’s Position on the preamble “a vaporizer cartridge” After reviewing the parties’ filings, the underlying investigative record and Federal Circuit precedent, we find that the preamble of claim 1 of the ’580 patent, “a vaporizer cartridge,” is limiting and must be afforded patentable weight. Additionally, we find that “a vaporizer cartridge” should be construed as “a component that mates with and may be installed into a vaporizer base to form a vaporizer device.” Lastly, based on this claim construction, we find that the [[ ]] does not practice the “vaporizer cartridge” preamble of claim 1. As such, the Branch finds that the [[ ]] does not infringe claim 1 of the ’580 patent. Because claims 6-7 depend from claim 1, we find that the [[ ]] does not infringe these dependent claims either. b. “a cartridge body comprising a proximal body end and a distal body end opposite the proximal body end” (limitation 1.a) The parties also dispute whether the [[ ]] meets the limitation “a cartridge body comprising a proximal body end and a distal body end opposite the proximal body end .” ’580 patent at 34:40-41. PAX argues that: The [[ ]] AIO Device includes a cartridge body that satisfies limitation 1.a. As shown in the CAD drawings and tear-down photos of the [[ ]] AIO Device below, the device includes [[ ]] that defines a proximal body end oriented toward the mouthpiece and a distal body end opposite the proximal body end. [[ ]]. PAX Response at 4. 35
[[ ]] PAX Response at 5-6. PAX also provides expert opinion from Kelly Kodama that the [[ ]] practices the “cartridge body” limitation. PAX Ex. A ¶ 17. In contrast, STIIIZY contends that the “[[ ]] AIO Device lacks this feature because it does not contain any ‘cartridge,’ as that term is properly construed.” STIIIZY Reply at 4. Here, STIIIZY relies on its claim construction of “cartridge” that it provided regarding the “vaporizer cartridge” preamble. See supra p. 27. Because we determine the preamble “vaporizer cartridge” is limiting and find that the [[ ]] does not meet this limitation, as noted above, the EOE Branch need not further consider whether the [[ ]] practices the limitation “cartridge body comprising a proximal body end and a distal body end opposite the proximal body end.” c. “a vaporizer chamber” (limitations 580.1.d, 580.1.dii, 580.1.diii) The parties next contest whether the [[ ]] meets the limitation “a vaporizer chamber comprising: . . . 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 an air tube extending from the house piece, wherein the air tube is configured to deliver the aerosol from the heater to the mouthpiece.” ’580 patent at 34:45-53. Here, STIIIZY argues that the [[ ]] does not practice a “vaporizer chamber” comprising the features noted above either directly or under the doctrine of equivalents. STIIIZY Ruling Request at 19-20; STIIIZY Reply at 6-7. To support this contention, STIIIZY cites to arguments that PAX allegedly made in the underlying investigation, expert opinion from Martin Wensley and Ramon Alarcon, various dictionary definitions, and certain Federal Circuit precedent. See STIIIZY Ruling Request at 20-21; STIIIZY Reply at 6-13; STIIIZY Post-Oral Discussion Brief at 26-27. 36
PAX, conversely, argues that the “vaporization chamber” limitation is achieved by the [[ ]] and provides annotated CAD drawings and photographs of the [[ ]] and expert opinion from Kelly Kodama. PAX Response at 7-17; PAX Sur-Reply at 6-8; PAX Post- Oral Discussion Brief at 6-19. Additionally, PAX cites a U.S. district court case and certain language from the ’580 patent as evidence that this limitation is met. PAX Sur-Reply at 6; PAX Post-Oral Discussion Brief at 6-7. Because we determine the preamble “vaporizer cartridge” is limiting and find that the [[ ]] does not meet this limitation, as noted above, the EOE Branch need not further consider whether the [[ ]] practices the limitation “a vaporizer chamber comprising: . . . 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 an air tube extending from the house piece, wherein the air tube is configured to deliver the aerosol from the heater to the mouthpiece.” d. “a bottom cover comprising a bottom portion, wherein the bottom portion comprises at least one air opening” (limitations 580.1.f) STIIIZY further argues that the [[ ]] does not practice the limitation “a bottom cover comprising a bottom portion, wherein the bottom portion comprises at least one air opening.”. STIIIZY Ruling Request at 18, 22; STIIIZY Reply at 30; STIIIZY Post-Discussion Brief at 3, 26. In support of this assertion, STIIIZY points to the ALJ’s claim construction of the term “bottom cover,” Federal Circuit precedent, various arguments allegedly made by PAX at the ITC, and expert opinion from Martin Wensley. STIIIZY Ruling Request at 18, 21-22; STIIIZY Reply at 30; STIIIZY Post-Oral Discussion Brief at 26. PAX, on the other hand, argues that the [[ ]] has a “bottom cover comprising a bottom portion, wherein the bottom portion comprises at least one air opening” by also relying on the ALJ’s claim construction of “bottom cover” and various annotated photographs from the underlying investigation and CAD drawings. PAX Response at 17-23; PAX Post-Oral Brief at 19-22. Because we determine the preamble “vaporizer cartridge” is limiting and find that the [[ ]] does not meet this limitation, as noted above, the EOE Branch need not further consider whether the [[ ]] practices the limitation “a bottom cover comprising a bottom portion, wherein the bottom portion comprises at least one air opening.” e. “a distal member positioned at least partially within the cartridge body between the housing piece and the bottom portion of the bottom portion” (limitation 580.1.g) STIIIZY also maintains that the [[ ]] does not feature “a distal member positioned at least partially within the cartridge body between the housing piece and the bottom portion of the bottom portion.” STIIIZY Ruling Request at 22-23; STIIIZY Reply at 31; STIIIZY Post-Oral Discussion Brief at 3. Here, STIIIZY relies on various arguments that PAX allegedly made at the ITC regarding the STIIIZY-AIO, expert opinion from Ramon Alarcon, and Federal Circuit Precedent. STIIIZY Ruling Request at 22-23; STIIIZY Reply at 31; STIIIZY Post-Oral Discussion Brief at 3. In contrast, PAX argues that this limitation is met by the [[ ]] and submits 37
evidence that the Commission relied on in the underlying investigation, a CAD drawing, and expert testimony from Kelly Kodama. PAX Response at 23-26. Because we determine the preamble “vaporizer cartridge” is limiting and find that the [[ ]] does not meet this limitation, as noted above, the EOE Branch need not further consider whether the [[ ]] practices the limitation “a distal member positioned at least partially within the cartridge body between the housing piece and the bottom portion of the bottom portion.” f. “an extension feature having a cylindrical shape . . . and wherein the extension feature comprises an opening extending therethrough that allows air to pass through the distal member” (limitation 1.g.iv) STIIIZY next asserts that the [[ ]] does not practice the limitation “an extension feature having a cylindrical shape, wherein the extension feature extends from the proximal side of the distal member.” STIIIZY Ruling Request at 18; STIIIZY Reply at 13-25; STIIIZY Oral Discussion Presentation at 15-23; STIIIZY Post-Oral Discussion at 3-15. In support of this position, STIIIZY relies on extensive evidence that includes CAD drawings, and expert opinions from Martin Wensley, Ramon Alarcon, and Dr. Steven Murray. STIIIZY Reply at 13-25; STIIIZY Post-Oral Discussion at 3-15. Based on this evidence, STIIIZY maintains that the [[ ]] does not meet this limitation under both theories of direct infringement and doctrine of equivalents. Additionally, STIIIZY argues that “PAX’s [doctrine of equivalents theory] is also independently barred because it would ensnare the prior art” and cited U.S. Patent App. Pub. No. 2019/0246693. STIIIZY Post-Oral Discussion Brief at 10-15. On the other hand, PAX argues that the [[ ]] achieves the extension feature limitation under the doctrine of equivalents. PAX Response at 29-37; PAX Sur-Reply at 15-20; and PAX Post-Oral Discussion at 24-33. Here, PAX provides extensive CAD drawings and expert testimony from Kelly Kodama. PAX Response at 29-37; PAX Sur-Reply at 15-20; PAX Post- Oral Discussion at 24-33. Also, PAX argues that STIIIZY’s reliance on the doctrine of prior art ensnarement is misplaced. PAX Sur-Reply at 21. Because we determine the preamble “vaporizer cartridge” is limiting and find that the [[ ]] does not meet this limitation, as noted above, the EOE Branch need not further consider whether the [[ ]] practices the limitation “an extension feature having a cylindrical shape, wherein the extension feature extends from the proximal side of the distal member.” g. “wherein an air chamber is formed between the distal member and the bottom portion of the bottom cover” (limitation 580.1.h) Lastly, the parties contest whether the [[ ]] practices the limitation “wherein an air chamber is formed between the distal member and the bottom portion of the bottom cover.” STIIIZY Ruling Request at 18:23-24; PAX Response at 42-46. STIIZY argues that “[b]ecause neither the bottom cover nor the distal member as claimed exists in the [[ ]] AIO Device, there can be no air chamber ‘formed between them.’” STIIIZY Reply at 31. On the other hand, 38
PAX argues that STIIIZY’s argument here “is without merit because . . . the [[ ]] AIO Device satisfies the “distal member” limitation. PAX Response at 43. PAX relies on expert opinion from Kelly Kodama and includes several CAD drawings and photographs allegedly showing a “air chamber” that is formed between a distal member and bottom portion of a bottom cover. PAX Response at 43-46. Because we determine the preamble “vaporizer cartridge” is limiting and find that the [[ ]] does not meet this limitation, as noted above, the EOE Branch need not further consider whether the [[ ]] practices the limitation “an extension feature having a cylindrical shape, wherein the extension feature extends from the proximal side of the distal member.” h. EOE Branch Overall Position on the ’580 patent Based on the above, we conclude that STIIIZY has met its burden of proof that the [[ ]] does not infringe claims 1 and 6-7 of the ’580 patent because the articles do not meet the following limitation as required by independent claim 1: -“a vaporizer cartridge” (limitation 580.1.pre). However, we note that STIIIZY presented insufficient arguments to CBP that the [[ ]] fails to practice independent claim 8 and dependent claim 10 of the ’580 patent. In the conclusion of its Ruling Request, STIIIZY argues that “[i]n light of these differences, STIIIZY seeks a ruling that the [[ ]] AIO Device does not infringe the asserted claims of the ’580 patent or the asserted claims of the Remaining Asserted Patents.” STIIIZY Ruling Request at 30. Additionally, STIIIZY provides in a footnote in the Ruling Request that “PAX did not accuse, nor did the ITC find, that the ITC AIO Device infringes claims 6-8 and 10 of the ’580 patent.” Id. at 7, n.4. However, as stated above, the 1392 LEO provides that “[c]ertain oil vaporizing devices, components thereof, and products containing the same, that infringes one or more claims of . . . 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.” See supra p.5 (emphasis added). In this regard, the Branch finds that STIIIZY has presented no specific arguments why the [[ ]] does not infringe claims 8 and 10 of the ’580 patent. See STIIIZY Ruling Request; STIIIZY Response; STIIIZY Oral Discussion Presentation; STIIIZY Post-Oral Discussion Brief. 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 39
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. Therefore, to prove that a redesigned article is not subject to an exclusion order issued by the Commission, the would-be importer has the burden of proof to show that the imported articles do not infringe all asserted claims in that order. Hyundai Elecs. Indus. Co. Ltd., 899 F.2d at 1210. See also Astellas Pharma, Inc,, 2024 U.S. App. LEXIS 23669, at *12 (“It is for the parties—not the court—to chart the course of the litigation”). The record does not indicate a reason for STIIIZY’s failure to argue that the [[ ]] does not infringe claims 8 and 10 of the ’580 patent. In its Ruling Request, we note that STIIIZY argues that “[t]he Commission in the -1392 Investigation found that STIIIZY’s ITC AIO Device infringes claim 1 of the ’580 Patent.” STIIIZY Ruling Request at 5. However, STIIIZY admits that the [[ ]] and STIIIZY-AIO are vastly different. In fact, STIIIZY states: [[ ]] Ex. 1, Alarcon Decl., ¶ 12. [[ ]] Ex. 1, Alarcon Decl.,¶ 12. As such, none of PAX’s infringement arguments pertaining to the ITC AIO Device apply to the [[ ]] AIO Device. STIIIZY Ruling Request at 18 (emphasis added). We find that STIIIZY should have presented arguments to the Branch on claims 8 and 10 of the ’580 patent because these claims are specifically listed in the LEO and the [[ ]] is a “covered article” under that order. See 1392 LEO ¶ 2. We further note that PAX did not present any specific arguments that CBP should deny STIIIZY’s Ruling Request due to STIIIZY failing to meet its burden regarding claims 8 and 10. See PAX Response; PAX Sur-Reply; PAX 40
Oral Discussion Presentation; PAX Post-Oral Discussion Brief. Rather, PAX maintains that “[b]y failing to argue that the [[ ]] AIO Device does not satisfy the remaining limitations, STIIIZY effectively admits that the [[ ]] AIO Device satisfies those limitations. Because STIIIZY bears the burden of proving non-infringement, PAX addresses only the claim limitations that STIIIZY has disputed and reserves the right to address any other claim limitations should disputes arise.” PAX Reply at 2. We disagree with PAX that STIIIZY’s failure to address claims 8 and 10 of the ‘580 patent necessarily amounts to an admission that the [[ ]] satisfies those claims such that STIIZY would be precluded from submitting another ruling request addressing those claims. Rather, we conclude that because STIIIZY has made insufficient arguments to the Branch that the [[ ]] does not infringe claims 8 and 10 of the ’580 patent, it has not met its burden of proof that this article is not subject to the 1392 LEO. The Branch declines to independently apply its analysis for independent claim 1 to independent claim 8, as this was not argued by STIIIZY. 19 C.F.R. § 177.2(b)(6) ("If the request for a ruling asks that a particular determination or conclusion be reached in the ruling letter, a statement must be included in the request setting forth the basis for that determination or conclusion, together with a citation of all relevant supporting authority."); see Netflix Inc., v. DivX, LLC., 84 F.4th 1377-78 (Fed Cir. 2023) (“While the [Patent Trial and Appeal Board] should review a petition holistically, it is not obligated to 'cobble together assertions from different sections of a petition or citations of various exhibits in order to infer every possible permutation of a petitioner’s argument [].') (citing Microsoft Corp. v. FG SRG, LLC, 860 F. App’x 708, 713 (Fed. Cir., 2021) (referencing Patent Trial and Appeal Board Final Written Decisions in Nos. IPR2020-00647, IPR2020- 4 00648)). Accordingly, STIIIZY is free to file a ruling request pursuant to 19 C.F.R. Part 177 addressing claims 8 and 10 of the ‘580 patent and incorporating the findings of this ruling on all other claims listed in the 1392 LEO. 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) We now discuss the ’756 patent. STIIIZY maintains that the [[ ]] does not practice the limitations “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” of the ’756 patent. ’756 patent at 34: 56-60. In support, STIIIZY argues that in the annotated CAD drawing below [[ ]] and that [[ ]] STIIIZY Ruling Request at 26 (citing STIIIZY Ex. 1 ¶ 19). 4 “In sum, we do not fault the Board for holding Netflix to the argument it chose to make in the 'filtering' section of its petition, as opposed to reading in an additional potential 'filtering' mapping from a different petition section related to a different claim limitation.” Netflix Inc., v. DivX, LLC., 84 F.4th 1377-78 (Fed Cir. 2023). 41
[[ ]] STIIIZY Ruling Request at 26 (citing STIIIZY Ex. 1 ¶ 19). STIIIZY expert Ramon Alarcon agrees that [[ ]] STIIIZY Ex. 1 ¶ 19. PAX has not introduced any counterarguments or evidence that the [[ ]] meets these limitations. See PAX Response; PAX Sur-Reply; PAX Oral Discussion Presentation; PAX Post-Oral Discussion Brief. We find that the above CAD drawing and expert opinion by Ramon Alarcon provided by STIIIZY convincingly show that [[ ]]. See STIIIZY Ruling Request; STIIIZY Reply; STIIIZY Oral Discussion Presentation; STIIIZY Post-Oral Discussion Brief. Therefore, we find that the [[ ]] does not meet the second reservoir seal/reservoir opening limitations of claim 1 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 next argues that the “[[ ]].” STIIIZY Ruling Request at 27 (citing Ex. 1 ¶ 20); see also ’756 patent at 34:61-63. To support this assertion, STIIIZY provides the following annotated photographs of the [[ ]]: [[ 42
]] STIIIZY Ruling Request at 30 (citing Ex. 1 ¶ 20). According to STIIIZY, the above photograph of the [[ ]] shows that [[ ]] STIIIZY Ruling Request at 30 (citing Ex. 1 ¶ 20). STIIIZY also presents expert opinion from Ramon Alarcon that the [[ ]] STIIIZY Ex. 3 ¶ 30. PAX does not contest the arguments and evidence that STIIIZY has submitted on this issue. See PAX Response; PAX Sur-Reply; PAX Oral Discussion Presentation; PAX Post-Oral Discussion Brief. We find that the record, including the above photograph and expert testimony provided by STIIIZY, establishes that [[ ]] See STIIIZY Ruling Request; STIIIZY Reply; STIIIZY Oral Discussion Presentation; STIIIZY Post-Oral Discussion Brief. Therefore, we hold that the STIIIZY has met its burden of proof that the [[ ]] does not practice the limitations “a first pad positioned within the interior of the mouthpiece” and “a second pad positioned within the interior of the mouthpiece” of claim 1 of the ’756 patent. c. EOE Branch Overall Position on the ’756 patent Accordingly, the EOE Branch finds that STIIIZY’s [[ ]] does not infringe claims 1, 5, and 10 of the ’756 patent. In particular, we find that STIIIZY has met its burden of proof that the [[ ]] does not practice the following limitations of claim 1 of the ’756 patent: - “a second reservoir seal, wherein … the second reservoir seal [is] … configured to cover a corresponding reservoir opening exposing the internal volume of the reservoir”; - “a first pad positioned within the interior of the mouthpiece”; and - “a second pad positioned within the interior of the mouthpiece.” 43
Because claims 5 and 10 depend from independent claim 1, we find that the [[ ]] does not infringe these dependent claims either. See Cognex Corp., 550 Fed. Appx. at 881. The ’527 patent (claims 1, 5, 10-11, 17-18, and 22) a. “Second reservoir seal/opening” (limitations 527.1.e, 527.11.a.v, and 527.18.e) Similar to its contentions for the ’756 patent, STIIIZY maintains that the [[ ]] does not infringe the ’527 patent because it does not meet the limitation a “second reservoir seal/opening” of independent claims 1, 11, and 18. STIIIZY Ruling Request at 27; see ’527 patent at 34:52-53; 36:1-3; 37:10-13. According to STIIIZY, in the figure below, the [[ ]] AIO Device [[ ]] STIIIZY Ruling Request at 29 (citing STIIIZY Ex. 1 ¶ 19). Additionally, STIIIZY expert Ramon Alarcon indicates that “[[ ]]” STIIIZY Ex. 1 ¶ 19. [[ ]] PAX does not provide any arguments or evidence that the [[ ]] practices these limitations. See PAX Response; PAX Sur-Reply; PAX Oral Discussion Presentation; PAX Post- Oral Discussion Brief. We find the above CAD drawing and expert testimony from Ramon Alarcon provided by STIIIZY sufficient to establish that [[ ]] See STIIIZY Ruling Request; STIIIZY Reply; STIIIZY Oral Discussion Presentation; STIIIZY Post-Oral Discussion Brief. Therefore, we find that the [[ ]] does not meet the second reservoir seal/opening limitations of claims 1, 11, and 18 of the ’527 patent. b. EOE Branch Overall Position on the ’527 patent 44
Accordingly, we hold that STIIIZY has met its burden of proof that the [[ ]] does not infringe the asserted claims of the ’527 patent. In particular, we find that the [[ ]] does not meet the following limitation of claims 1, 11, and 18: - “second reservoir seal/opening.” Because claims 5, 10, 17, and 22 depend from independent claims 1, 11, and 18, we find that the [[ ]] does not infringe these dependent claims either. See Cognex Corp., 550 Fed. Appx. at 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) As it did for the ’756 patent, STIIIZY argues that the [[ ]] does 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 29-30; see ’757 patent at 34:36-38; 36:8-11. PAX again does not provide arguments or evidence that the [[ ]] practices these limitations. See PAX Response; PAX Sur-Reply; PAX Oral Discussion Presentation; PAX Post-Oral Discussion Brief. We again find the above photograph of the [[ ]] and expert testimony from Ramon Alarcon provided by STIIIZY sufficient to establish that this [[ ]] See supra pp. 42-43; STIIIZY Ruling Request; STIIIZY Reply; STIIIZY Oral Discussion Presentation; STIIIZY Post-Oral Discussion Brief. Therefore, we hold that the [[ ]] does not meet the “a first pad positioned within an interior of the mouthpiece” and “a second pad positioned within the interior of the mouth” limitations of claims 1 and 15 of the ’757 patent. b. EOE Branch Overall Position on the ’757 patent Accordingly, we find that STIIIZY has met its burden of proof that the [[ ]] does not infringe the asserted claims of the ’757 patent. In particular, we find that the [[ ]] does not meet the following limitations of claims 1 and 15: - “a first pad positioned within an interior of the mouthpiece”; and -“a second pad positioned within the interior of the mouthpiece.” Because claims 13 and 20 depend from independent claims 1 and 15, respectively, we find that the [[ ]] does not infringe these dependent claims either. See Cognex Corp., 550 Fed. Appx. at 881. 45
2. Summary of Infringement Findings After reviewing the investigative record as well as submissions by both parties in this inter partes proceeding, we find that STIIIZY has met its burden of proof in establishing that its [[ ]] does not infringe the asserted claims of the ’756, ’757, and ’527 patent and claims 1 and 6-7 of the ’580 patent. Although PAX presented evidence to support its position that this article practices various limitations from independent claim 1 of the ’580 patent, we find this evidence unpersuasive for a finding of infringement because, as explained above, the [[ ]] does not have a “vaporizer cartridge.” See supra pp. 23-41. Additionally, STIIIZY has presented compelling evidence that the [[ ]] does not practice all the limitations of the ’756, ’757, and ’527 patents. However, STIIIZY has not presented sufficient arguments that the [[ ]] does not infringe claims 8 and 10 of the ’580 patent. Thus, we find that STIIIZY’s [[ ]] is subject to the 1392 LEO. STIIIZY is free to file a new ruling request addressing the unaddressed claims under 19 C.F.R. §177. The following chart summarizes our infringement findings in regard to the [[ ]]: Asserted Patents Asserted Claims Non-infringing Unaddressed Claims claims U.S. Patent No. 11,369,756 1,5,10 1, 5, 10 U.S. Patent No. 11,369,757 1,13,15,20 1, 13, 15, 20 U.S. Patent No. 11,766,527 1,5,10-11,17-18, 1,5,10-11,17-18, 22 22 U.S. Patent No. 11,759,580 1,6-8,10 1, 6-7 8, 10 V. HOLDING Having reviewed both parties’ arguments and the supporting evidence, we determine that STIIIZY has not met its burden of proof in establishing that the [[ ]] does not infringe the asserted claims of the asserted patents in the 1392 LEO. Accordingly, we hold that the [[ ]] is subject to the 1392 LEO. This 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). 46
Sincerely, Alaina van Horn Acting Chief, Exclusion Order Enforcement Branch CC: Lyle Vander Schaaf Crowell & Moring LLP 1001 Pennsylvania Avenue, NW Washington, DC 200004 [email protected] [email protected] 47