• HQ H347235
• Mar 27, 2026

• Type : 19 U.S.C. § 1337; Unfair Competition • HTSUS :
•  Related:   H339732; H338254; H334472   

OT:RR:BSTC:EOE H347235 RPR

Christopher J. Lutz
Armis IP Law, L.L.C.
P.O. Box 1564
Westborough, MA 01581
VIA EMAIL: [email protected]

RE: Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1362; Certain Liquid Transfer Devices With an Integral Vial Adapter

Dear Mr. Lutz,

Pursuant to 19 C.F.R. Part 177, the Exclusion Order Enforcement Branch (“EOE Branch”), Regulations and Rulings, U.S. Customs and Border Protection (“CBP”) issues this ruling letter holding that Summit International Medical Technologies Inc. (“Summit” or “Ruling Requester”) has not met its burden to show that its redesigned versions of liquid transfer devices (“articles at issue”) are not subject to the limited exclusion order (“LEO”) that the U.S. International Trade Commission (“ITC” or “Commission”) issued as a result of Investigation No. 337-TA-1362 (“the 1362 investigation”) under Section 337 of the Tariff of 1930, as amended, 19 U.S.C. § 1337.

We further note that determinations of the Commission resulting from the underlying investigation or a related proceeding under 19 C.F.R. Part 210 are binding authority on CBP and, in the case of conflict, will by operation of law modify or revoke any contrary CBP ruling or decision pertaining to section 337 exclusion orders.

This ruling letter is the result of a request for an administrative ruling under 19 C.F.R. Part 177, which was conducted on an inter partes basis. The proceeding involved the two parties with a direct and demonstrable interest in the question presented by the ruling request: (1) your client, Summit, the Ruling Requester and a respondent in the 1362 investigation; and (2) West Pharmaceutical Services, Inc. and West Pharma Services, IL, Ltd. (collectively, “West”), the patent

1  owner and complainant in the 1362 investigation (together, the “parties”). See, e.g., 19 C.F.R. § 177.1(c).

The parties were asked to clearly identify confidential information, including information subject to the administrative protective order in the underlying investigation, with [[red brackets]] in their submissions. See 19 C.F.R. §§ 177.2, 177.8. If there is additional information in this ruling letter not currently bracketed in red [[ ]] that either party believes constitutes confidential information, and should be redacted from the published ruling, the parties are asked to contact the EOE Branch within ten (10) working days of the date of this ruling letter. See, e.g., 19 C.F.R. § 177.8(a)(3).

Please note that disclosure of information related to administrative rulings under 19 C.F.R. Part 177 is governed by, for example, 6 C.F.R. Part 5, 31 C.F.R. Part 1, 19 C.F.R. Part 103, and 19 C.F.R. § 177.8(a)(3). See, e.g., 19 C.F.R. § 177.10(a). In addition, CBP is guided by the laws relating to confidentiality and disclosure, such as the Freedom of Information Act (“FOIA”), as amended (5 U.S.C. § 552), the Trade Secrets Act (18 U.S.C. § 1905), and the Privacy Act of 1974, as amended (5 U.S.C. § 552a). A request for confidential treatment of information submitted in connection with a ruling requested under 19 C.F.R. Part 177 faces a strong presumption in favor of disclosure. See, e.g., 19 C.F.R. § 177.8(a)(3). The person seeking this treatment must overcome that presumption with a request that is appropriately tailored and supported by evidence establishing that: the information in question is customarily kept private or closely-held and either that the government provided an express or implied assurance of confidentiality when the information was shared with the government or there were no express or implied indications at the time the information was submitted that the government would publicly disclose the information. See Food Marketing Institute v. Argus Leader Media, 139 S. Ct. 2356, 2366 (2019) (concluding that “[a]t least where commercial or financial information is both customarily and actually treated as private by its owner and provided to the government under an assurance of privacy, the information is ‘confidential’ within the meaning of exemption 4.”); see also U.S. Department of Justice, Office of Information Policy (OIP): Step-by-Step Guide for Determining if Commercial or Financial Information Obtained from a Person is Confidential Under Exemption 4 of the FOIA (updated 10/7/2019); and OIP Guidance: Exemption 4 after the Supreme Court’s Ruling in Food Marketing Institute v. Argus Leader Media (updated 10/4/2019).

I. BACKGROUND

A. ITC Investigation No. 337-TA-1362

1. Procedural History at the ITC

The Commission instituted Investigation No. 337-TA-1362 on May 11, 2023, based on a complaint filed by West Pharmaceutical Services, Inc. of Exton, Pennsylvania and West Pharma. Services IL, Ltd. of Ra’anana, Israel. Certain Liquid Transfer Devices With an Integral Vial Adapter, Inv. No. 337-TA-1362, EDIS Doc. ID 843955, Public Commission Opinion (Feb. 20, 2025) (“Comm’n Op.”) at 2 (citing 88 Fed. Reg. 30342 (May 11, 2023)). The complaint, as supplemented, alleged a violation of section 337 by reason of infringement of claim 1 of U.S.

2 Patent No. 10,688,295 (“the ’295 patent”), the claim of U.S. Design Patent No. D767,124 (“the D’124 patent”); the claim of U.S. Design Patent No. D765,837 (“the D’837 patent”); the claim of U.S. Design Patent No. D630,732 (“the D’732 patent”); and U.S. Trademark Registration No. 5,810,583 (“the ’583 mark”). Id. at 3. The notice of investigation named four respondents: Advcare Medical, Inc. of New Taipei City, Taiwan (“Advcare”), Dragon Heart Medical Devices Co., Ltd. Of Kaiping City, China (“Dragon Heart Devices”), Dragon Heart Medical, Inc. of Addison, Illinois (“Dragon Heart”), and Summit International Medical Technologies, Inc. of Franklin, Massachusetts (“Summit”). Id. The Commission’s Office of Unfair Import Investigations (“OUII”) was also named as a party in the investigation. Id.

The 1362 investigation was terminated as to Dragon Heart Devices but not as to the other Dragon Heart respondent. Id. The ’583 mark and the three asserted design patents (the D’124 patent, the D’837 patent, and the D’732 patent) were terminated from the investigation by withdrawal. Id. Accordingly, the ’295 patent was the only asserted intellectual property right remaining in this investigation, and the remaining respondents in the investigation were Summit, Advcare, and Dragon Heart (collectively, “respondents”). Id.

On March 15, 2024, the presiding Administrative Law Judge (“ALJ”) issued a final initial determination, Certain Liquid Transfer Devices With an Integral Vial Adapter, Inv. No. 337-TA- 1362, EDIS Doc. ID 816231, Public Final Initial Determination (March 15, 2024) (“FID”) finding a violation of section 337. Comm’n Op. at 4. Specifically, the ALJ determined that a violation of section 337 occurred in the importation into the United States, the sale for importation, or the sale within the United States after importation, of the accused products due to infringement of claim 1 of the ’295 patent. Id.

On May 16, 2024, the Commission issued a notice in which it determined to review in part the FID. Id. Specifically, the Commission determined to review the FID’s findings with respect to standing and jurisdiction as well as the ALJ’s preclusion of the respondents’ and OUII’s invalidity arguments. Id. The Commission determined not to review the remaining findings in the FID, including the findings on claim construction, infringement, and the technical prong of the domestic industry requirement. Id.

On November 8, 2024, the ALJ issued a Remand ID finding that claim 1 of the ’295 patent is not invalid for lack of written description under 35 U.S.C. § 112. Certain Liquid Transfer Devices With an Integral Vial Adapter, Inv. No. 337-TA-1362, EDIS Doc. ID 836774, Remand ID (Nov. 8, 2024) (“Remand ID”); Comm’n Op. at 5. The respondents and OUII subsequently filed petitions for review. Comm’n Op. at 5. On December 20, 2024, the Commission determined to review the Remand ID. Id.

On February 20, 2025, the Commission affirmed the Remand ID and found a violation of section 337 with respect to the ’295 patent. Id. at 2. The Commission also determined that the appropriate remedy was a LEO directed to the respondents and a cease and desist order directed to Summit. Id. at 17.

In the LEO, the Commission ordered that “[c]ertain liquid transfer devices with an integral vial adapter that infringe claim 1 of the ’295 patent and are manufactured abroad by, or on behalf

3 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 Liquid Transfer Devices With an Integral Vial Adapter, Inv. No. 337-TA-1362, EDIS Doc. ID 842456, Limited Exclusion Order (Feb. 3, 2025) at 2, ¶1 (“1362 LEO”).

2. The Patents and Claims in the 1362 LEO

As noted above, the 1362 LEO prohibits the unlicensed entry for consumption of liquid transfer devices with an integral vial adapter that infringe claim 1 of the ’295 patent. Id. at 2, ¶1. The Commission further defined the articles covered by the LEO as “liquid transfer devices that have a trifurcated connector body, with one end including an integral vial adapter, and wherein the integral vial adapter has a diameter of 13mm or 20mm and may only be used with a vial.” Id. at 2, ¶2.

a. Claim 1 of the ’295 Patent

The ’295 patent is titled “Liquid Transfer Devices for Use With Infusion Liquid Containers” and describes a device that can be used with an administration set to administer medicine intravenously to a patient. FID at 7; ’295 patent at (54) and 3:34-46. The ’295 patent has only one claim, which is reproduced below:

1. A liquid transfer device configured for use with each of an infusion liquid container containing an infusion liquid and having an intravenous (IV) port for administering the infusion liquid, a vial including a vial bottle sealed by a vial stopper and containing a medicament additive, and an infusion set including an IV spike for sealing insertion into an IV port and a connector for administration purposes to a patient, the liquid transfer device comprising: (Claim Limitation 1.0)

i) an integral trifurcated connector body; (Claim Limitation 1.1)

ii) a single IV spike defining a first end of the integral trifurcated connector body for sealing insertion into the infusion liquid container's IV port, (Claim Limitation 1.2)

iii) an integral vial adapter extending from a second end of the integral trifurcated connector body for telescopically mounting on the vial, said integral vial adapter including a puncturing cannula for puncturing the vial stopper upon said mounting of said vial adapter onto the vial for flow communication therewith, and (Claim Limitation 1.3)

iv) an administration port extending from a third end of the integral trifurcated connector body and constituted by a substitute IV port for sealingly receiving the infusion set’s IV spike, (Claim Limitation 1.4)

4  the integral trifurcated connector body connecting said single IV spike in direct and continuous fluid communication with said integral vial adapter and (Claim Limitation 1.5)

connecting said single IV spike in direct and continuous fluid communication with said administration port, (Claim Limitation 1.6)

thereby enabling initial introduction of the medicament additive from the vial to the infusion liquid container through the vial adapter and the single IV spike for mixing with the infusion liquid to form a medicated infusion liquid, and subsequent administration of the medicated infusion liquid to a patient from the infusion liquid container through the single IV spike and the administration port to the infusion set. (Claim Limitation 1.7)

FID at 8-9 (citing ’295 patent at 6:2-35). The FID adopted the claim limitation labels that West utilized in its initial post-hearing brief. Id. at 8, n.4.

’295 patent at Fig. 5B.

The ALJ described the use of the invention taught by the ’295 patent as:

[t]he patent teaches that the liquid transfer device illustrated in Figure 6 includes a “trifurcated connector body” 21 that can connect to three components. Id. at 2:25-

5  28, 4:29-31, 4:56-5:18. First, “an infusion liquid bag” 10 (an IV bag) is connected by pushing a spike 22 into the IV bag through a port 11. Id. at 4:56-5:18. Second, a vial 19 containing medication is connected by a vial adapter 102 Id. The patent explains that the medication can be transferred from the vial to the infusion liquid bag “by squeezing the infusion liquid bag 10 to urge infusion liquid into the vial 19 and then inverting the infusion liquid bag 10 such that the vial contents drain thereinto.” ’295 patent at 4:60-63. Finally, an infusion set 112 is connected via an administration port 43. Id. An infusion set may comprise tubing, clamps, and other components that will ultimately be connected to a patient’s IV catheter or the like. See, e.g., id. at 3:54-61.

FID at 7-8.

3. The Products from the Underlying Investigation

The accused products in the underlying investigation consist of “liquid transfer devices that have a trifurcated connector body, with one end including an integral vial adapter, and wherein the integral vial adapter has a diameter of 13mm or 20mm and may only be used with a vial.” Comm’n Op. at 7. The products specifically were Summit’s “Vial Direct to Bag” 20-millimeter admixture device and “Vial Direct to Bag” 13-millimeter device. Id. Depictions of the accused products from the FID, are inserted below:

FID at 25.

6 Id. at 50.

Id. at 51.

7  The parties stipulated that (i) Advcare sold these articles for importation, (ii) Dragon Heart was the importer, and (iii) Summit sold the articles after importation. Id. at 5-6. Ultimately, these products were found to practice each limitation in claim 1 of the ’295 patent. Id. at 65.

Addressing limitation 1.2, West contended that the products satisfied this limitation while OUII contended the products did not satisfy this limitation due to the lack of an “integral trifurcated connector body.” Id. at 38. The respondents did not specifically address limitation 1.2. Id. Finding the connector body to be trifurcated for the reasons discussed under limitation 1.1, the ALJ found that the accused products satisfied limitation 1.2. Id. at 38-39.

Similarly, with respect to limitation 1.3, West contended that the products satisfied this limitation while OUII contended the products did not satisfy this limitation due to the lack of an “integral trifurcated connector body.” Id. at 39. The respondents did not specifically address limitation 1.3. Id. Finding the connector body to be trifurcated for the reasons discussed under limitation 1.1, the ALJ found that the accused products satisfied limitation 1.3. Id.

With regards to limitation 1.4, West contended the products satisfy the limitation while the respondents did not specifically address limitation 1.4. Id. at 39-40. OUII argued that the accused products did not satisfy this limitation because they could not receive an IV spike unless a tab on the administration port was twisted off. Id. at 39-49. The ALJ rejected this argument reasoning that the twist-off tab was simply another feature above and beyond what was required to satisfy the claim, finding that the accused products satisfied limitation 1.4. Id. at 48-49.

Next, addressing limitation 1.5, West contended the products satisfied the limitation. Id. at 49. OUII contended the accused products did not satisfy the “integral trifurcated connector body,” an argument that was rejected by the ALJ as discussed in limitation 1.1. Id. The respondents contended the accused products did not satisfy the “direct and continuous fluid communication” aspect of limitation 1.5. Id. In particular, the respondents argued that limitation 1.5 required fluid to flow in both channels of their device at the same time, while fluid only flowed in one channel during medication administration. Id. at 52-53. The ALJ rejected this argument, noting that even accepting the respondents’ argument there was direct and continuous fluid communication in both channels, even though the flow in one of the channels was primarily air. Id. at 54-55.

The ALJ next addressed the domestic industry requirement. Id. at 65-72. With regards to the economic prong, the ALJ noted that West’s motion for summary determination had been granted because it had established, at a minimum, that it was in the process of establishing a domestic industry. Id. at 66. With regards to the technical prong, the respondents and OUII raised arguments that West’s product did not practice claim 1 of the ’295 patent for the same reasons they argued the accused products did not satisfy the limitations of claim 1. Id. at 66-71. The ALJ found that West’s domestic industry product satisfied each limitation of claim 1 for the same reasons that the accused products satisfied each limitation of claim 1. Id. Accordingly, the ALJ found both prongs of the domestic industry requirement to be satisfied. Id. at 72. As a result of the above findings, the ALJ issued an initial determination that a violation of section 337 had occurred. Id. In its decision to review the FID in part, the Commission did not review the ALJ’s findings as to claim construction, infringement, nor the technical prong of the domestic industry requirement, but instead focused on arguments raised as to standing, jurisdiction, and the ALJ’s preclusion of 8 certain arguments. Comm’n Op. at 4. The Commission ultimately determined that West had established a violation of section 337 by the respondents and issued an LEO directed to the respondents and a cease and desist order directed to Summit. Comm’n Op. at 17.

B. 19 C.F.R. Part 177 Ruling Request

1. Procedural History

On April 22, 2025, Summit submitted a letter to CBP requesting an administrative ruling pursuant to 19 C.F.R. Part 177 (“Ruling Request”). In the same letter, Summit stated it had provided a copy of the Ruling Request to West’s counsel. Summit requested an administrative ruling that its redesigned infusion vial adapters presented in the Ruling Request, containing an additional valve along the channel between the vial and connector body, avoid infringing the ’295 patent and fall outside the 1362 LEO. Ruling Request at 7-8. On April 22, 2025, the EOE Branch confirmed receipt of the Ruling Request submitted by Summit and requested a preliminary meeting with the parties to discuss procedural aspects of the inter partes process. EOE Branch email to Parties, dated April 22, 2025.

On April 29, 2025, the EOE Branch had an initial conference call with Summit and West, on which both parties agreed to conduct this proceeding on an inter partes basis as administered by the EOE Branch. On May 20, 2025, the parties executed a non-disclosure agreement (“NDA”) and submitted a proposed procedural schedule. On May 28, 2025, Summit submitted a Revised Ruling Request to CBP and West, which included addendums A-D (collectively, “Revised Ruling Request”). Detailed CAD files of the proposed redesign were requested by West during a conference call with CBP and Summit on April 29, 2025, to ensure proper documentation of what the redesign entailed. Summit included these CAD files in its Revised Ruling Request.

On June 18, 2025, West submitted its response to Summit’s Revised Ruling Request, which included exhibits 1-5 (collectively, “West Response”). On July 2, 2025, Summit provided its reply to the West Response, which included addendums E-J (collectively, “Summit Reply”). On July 16, 2025, West provided its sur-reply in response to the Summit Reply, which included Exhibits 7- 9 (collectively, West Sur-Reply).

On July 15, 2025, EOE Branch emailed the parties to confirm scheduling for the oral discussion. On July 15, 2025, Summit’s President indicated an intent to participate in the oral discussion. Summit email to CBP, dated July 15, 2025. The EOE Branch sent a second email to the parties that same day indicating that participation at the oral discussion would be limited to outside counsel and therefore exclude in-house representatives, in line with EOE Branch practice when administering exclusion orders with inter partes proceedings, namely:

[a]s stated in CBP HQ Ruling H339732 (dated June 11, 2024), ‘CBP models the Commission’s practices to the extent possible for purposes of uniformity under the Tariff Act. The Commission’s approach to the handling of CBI, therefore, is highly instructive for CBP and the EOE Branch’s inter partes proceedings under 19 C.F.R. Part 177, and the EOE Branch sees no reason to depart from that approach in this case. Consequently, access to CBI in this proceeding will be limited to outside

9  counsel and experts and exclude internal [company] personnel.” Id. at 16-17, FN 4. As the Commission restricts access to CBI to outside counsel while denying such access to in-house representatives, the EOE Branch has likewise adopted this approach for its inter partes proceedings. Consistent with the above, such in-house representatives are precluded from participating in these inter partes proceedings and should not be included on future emails or other communications as well as the submissions filed in this proceeding. This position applies equally to both parties to the proceeding.’

EOE Branch email to Parties, dated July 15, 2025.

On July 25, 2025, the EOE Branch sent an email to the parties confirming the oral discussion date as July 30, 2025, and providing logistical information.

On July 30, 2025, the EOE Branch conducted an oral discussion with the parties, with each party providing a presentation (“Summit Oral Discussion Presentation” and “West Oral Discussion Presentation,” respectively). Lastly, on August 6, 2025, West submitted a Post-Oral Discussion Submission (“West Post-Oral Discussion Submission”) and Oral Discussion Transcript, while Summit submitted a Post-Oral Discussion Submission which included exhibits A-C (collectively, “Summit Post-Oral Discussion Submission”). On August 14, 2025, aside from the established procedural schedule and without discussing with either the EOE Branch or Summit, West submitted comments on Summit’s Post-Oral Discussion Submission, alleging that in Summit’s Post-Oral Discussion Submission, new arguments were raised. That same day, the EOE Branch sent an email to the parties inviting Summit the opportunity to respond by stating:

Summit response should address whether, in its view, the arguments are not new, in which case it should identify where in the submissions during this inter partes proceeding these arguments have been raised (with specific reference to the exact submission and page number). And if instead Summit acknowledges that these are new arguments, its response should be limited to the question why the EOE Branch should entertain these arguments.

EOE Branch email to Parties, dated August 14, 2025.

On August 15, 2025, Summit submitted a response to the comments from West regarding Summit’s Post-Oral Discussion Submission, addressing the alleged new arguments, with cites to previous submissions to argue that the new arguments were in fact ones previously raised. Summit Supplemental Response, August 15, 2025. The EOE Branch does not rely on any of Summit’ arguments that West alleges are “new” in adjudicating this Ruling Request. As such, the EOE Branch need not reach a determination as to whether these arguments are waived. See West Letter to EOE Branch, August 14, 2025; and Summit Supplemental Response, August 15, 2025.

2. The Articles at Issue

The articles at issue in the Revised Ruling Request consist of two models of infusion vial adapters, which are identical in design aside from the diameter of the vial adapter (20mm in one

10 model and 13mm in the other). Specifically, the products for which Summit requested a ruling are:

a) Summit International Medical Technologies, Inc. Recon Vial Bag Spike with Flow Control 20mm

b) Summit International Medical Technologies, Inc. Recon Vial Bag Spike with Flow Control 13mm

Revised Ruling Request at Addendum C.

The articles at issue are redesigns of the “Vial Direct to Bag” 20mm and 13mm devices accused and found to infringe during the 1362 Investigation. FID at 11. The articles at issue in the Revised Ruling Request are depicted below:

Revised Ruling Request at Addendum A.

11 Id. at Addendum B.

The articles at issue in this Revised Ruling Request are identical to the accused infusion vial adapters from the underlying proceeding, aside from the addition of a valve in the channel between the integral vial adapter and the IV bag spike. Id. at 8-9. Summit’s instructions for use (“IFU”) provided to users of the articles at issue are:

1. Remove the cap on the Drug Vial and disinfect the top of the vial with an alcohol wipe.

2. Remove the Recon Vial Bag Spike with Flow Control from the sterile package and check to ensure that the valve handle is in the “off” position.

3. Place and hold the Drug Vial on a hard-flat surface and holding the Vial Direct To Bag Spike above the Vial Adapter center the Vial Adapter over the center of the Drug Vial and push the Vial Adapter Spike down until it penetrates the rubber cap of the drug vial and the Vial Adapter snaps into place.

4. Remove the Spike Cover of the Recon Vial Bag Spike with Flow Control and insert the Spike into the IV Port of the IV Bag. Push the Spike into the IV Port until the Spike is firmly seated in the IV Bag IV Port.

5. When ready to reconstitute the drug in the vial turn the valve handle to the “on” position.

12  6. To reconstitute the drug, hold the IV Bag with the Drug Vial hanging below the IV Bag and squeeze the IV Bag forcing fluid into the Drug Vial.

7. To Mix the reconstituted drug in the vial fold the Drug Vial and the Vial Direct To Bag Spike up onto the side of the IV Bag and while holding the Vial Direct To Bag Spike and the IV Bag together use a gentle swirling motion so that the drug mixes in the Drug Vial.

8. To add the reconstituted drug into the IV Bag, invert the IV Bag and hold the Vial Direct To Bag Spike and Drug Vial above the IV Bag and squeeze the IV Bag. This forces air into the drug vial and the reconstituted drug will flow into the IV Bag.

9. After successfully transferring all of the reconstituted drug from the vial to the IV bag turn the valve handle to the “off” position. This prevents any reconstituted drug from migrating back into the vial.

10. To connect the IV Line to the Vial Direct To Bag Spike twist the bottom section of the IV Port of the Recon Vial Bag Spike with Flow Control until the bottom section snaps off.

11. Remove the cover of the IV Line Spike and insert the IV Line Spike into the Vial Direct to Bag Spike IV Port. The IV Bag is now ready for Fluid administration.

Id. at Addendum C.

The valve may be turned to an open position permitting fluid flow from the bag channel to the vial channel or to a closed position that discontinues fluid flow. Id. at 8-9. The location of the valve, as discussed above, is depicted below:

13  Id. at Addendum D.

Fluid administration is the process where the mixed fluid of the IV bag is administered to the patient through the IV line. Complaint at 37. This process can take anywhere from 30 minutes to 10 hours depending on the size of the IV bag, infusion rate, and condition of the patient. See Ernstmeyer K & Christman E, Open Resources for Nursing (Open RN) 2021.

II. ISSUE

Whether Summit has met its burden to show that the articles at issue do not infringe claim 1 of the ’295 patent and are thus not subject to the 1362 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).

14  When the Commission determines that there is a violation of section 337, it generally issues one of two types of exclusion orders: (1) a limited exclusion order or (2) a general exclusion order. See Fuji Photo Film Co., Ltd. v. ITC, 474 F.3d 1281, 1286 (Fed. Cir. 2007). Both types of orders direct CBP to bar infringing products from entering the country. See Yingbin-Nature (Guangdong) Wood Indus. Co. v. ITC, 535 F.3d 1322, 1330 (Fed. Cir. 2008). “A limited exclusion order is ‘limited’ in that it only applies to the specific parties before the Commission in the investigation. In contrast, a general exclusion order bars the importation of infringing products by everyone, regardless of whether they were respondents in the Commission's investigation.” Id. A general exclusion order is appropriate only if two exceptional circumstances apply. See Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1356 (Fed. Cir. 2008). A general exclusion order may only be issued if (1) “necessary to prevent circumvention of a limited exclusion order,” or (2) “there is a pattern of violation of this section and it is difficult to identify the source of infringing products.” 19 U.S.C. § 1337(d)(2); see Kyocera, 545 F.3d at 1356 (“If a complainant wishes to obtain an exclusion order operative against articles of non-respondents, it must seek a GEO [general exclusion order] by satisfying the heightened burdens of §§ 1337(d)(2)(A) and (B).”).

In addition to the action taken above, the Commission may issue an order under 19 U.S.C. § 1337(i) directing CBP to seize and forfeit articles attempting entry in violation of an exclusion order if their owner, importer, or consignee previously had articles denied entry on the basis of that exclusion order and received notice that seizure and forfeiture would result from any future attempt to enter articles subject to the same. An exclusion order under § 1337(d)—either limited or general—and a seizure and forfeiture order under § 1337(i) apply at the border only and are operative against articles presented for customs examination or articles conditionally released from customs custody but still subject to a timely demand for redelivery. See 19 U.S.C. §§ 1337(d)(1) (“The Commission shall notify the Secretary of the Treasury of its action under this subsection directing such exclusion from entry, and upon receipt of such notice, the Secretary shall, through the proper officers, refuse such entry.”); Id. at (i)(3) (“Upon the attempted entry of articles subject to an order issued under this subsection, the Secretary of the Treasury shall immediately notify all ports of entry of the attempted importation and shall identify the persons notified under paragraph (1)(C).”) (emphasis added).

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

15 Memories, Inv. No. 337-TA-276, Enforcement Proceeding, Comm’n Op. at 11, Doc ID 43536 (Aug. 1991) (emphasis added). “[W]hile individual models may be evaluated to determine importation and [violation], the Commission's jurisdiction extends to all models of [violative] products that are imported at the time of the Commission’s determination and to all such products that will be imported during the life of the remedial orders.” See Certain Optical Disk Controller Chips and Chipsets, Inv. No. 337-TA-506, Comm’n Op. at 56-57, USITC Pub. 3935, Doc ID 287263 (July 2007).

Lastly, despite the well-established principle that “the burden of proving infringement generally rests upon the patentee [or plaintiff],” Medtronic, Inc. v. Mirowski Family Ventures, LLC, 571 U.S. 191 (2014), the Commission has held that Medtronic is not controlling precedent and does not overturn its longstanding practice of placing the burden of proof on the party who, in light of the issued exclusion order, is seeking to have an article entered for consumption. See Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof, Inv. No. 337- TA-879, Advisory Opinion at 6-11. In particular, the Commission has noted that “[t]he 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 U.S. Court of Appeals for the Federal Circuit (“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

16 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).1

“Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). “In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges.” Id. at 1314. In others, courts look to public sources such as “the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.” Id.

“To begin with, the context in which a term is used in the asserted claim can be highly instructive.” Phillips, 415 F.3d at 1314 (“To take a simple example, the claim in this case refers to ‘steel baffles,’ which strongly implies that the term ‘baffles’ does not inherently mean objects made of steel.”). The context in which a claim term is used also includes the full chain of dependence as well as the remaining suite of claims and the written description. See Inline Plastics Corp. v. EasyPak, LLC, 799 F.3d 1364, 1371 (Fed. Cir. 2015) (“Since the specification explicitly mentions the ‘alternative’ . . . there can be no debate concerning the application of the doctrine of claim differentiation.”).

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.

C. Claim Construction

As mentioned above, “[t]o establish literal infringement, every limitation recited in a claim must be found in the accused product whereas, under the doctrine of equivalents, infringement occurs when there is equivalence between the elements of the accused product and the claimed elements of the patented invention.” See Microsoft Corp., 817 F.3d at 1313 (Fed. Cir. 2016).

“Claim terms are generally given their plain and ordinary meaning, which is the meaning one of ordinary skill in the art would ascribe to a term when read in the context of the claim,

1 Although claim construction is a question of law, the consideration of extrinsic evidence may constitute a subsidiary finding of fact. Teva, 135 S. Ct. at 841, 190 L. Ed. 2d at 733.

17 specification, and prosecution history.” Kyocera 22 F.4th at 1378. “There are only two exceptions to this general rule: 1) when a patentee sets out a definition and acts as his own lexicographer, or 2) when the patentee disavows the full scope of a claim term either in the specification or during prosecution.” Thorner v. Sony Computer Ent. Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012).

However, when the parties seek no claim construction and a claim phrase is not construed, the Federal Circuit has instructed:

When a claim limitation, like the one at issue here, is not expressly construed, a jury is entitled to give that limitation any reasonable meaning in determining, as a factual matter, what comes within its scope.

See Akamai Techs., Inc. v. MediaPointe Inc., 159 F.4th 1370, 1380 (Fed. Cir. 2025); see also VLSI Tech. LLC v. Intel. Corp., 87 F.4th 1332, 1341 (Fed. Cir. 2023) (“When a claim phrase is not construed, we defer to the jury's view of the claim element unless that view is contrary to the only reasonable view of the claim element.”) (emphasis added).

IV. ANALYSIS

The parties’ dispute in this proceeding centers around whether Summit has met its burden of proof that its redesigned products do not practice the following limitations of claim 1 of the ’295 patent:

A. “an integral trifurcated connector body” [Limitation 1.1];

B. “the integral trifurcated connector body connecting said single IV spike in direct and continuous fluid communication with said integral vial adapter” [Limitation 1.5]; and

C. “an integral vial adapter extending from a second end of the integral trifurcated connector body” [Limitation 1.3].

See Summit Revised Ruling Request and West Response. There is no dispute between the parties that the remaining limitations are met. See Parties’ Submissions to EOE Branch.

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 at 47 (January 7, 2025), the EOE Branch provided the following explanation for this approach:

the Federal Circuit has noted that, as ‘two distinct burdens of proof’ for a party to carry, ‘the burden of persuasion is the ultimate burden assigned to a party who must prove something to a specified degree of certainty, such as by a preponderance of the evidence or by clear and convincing evidence’ and the distinct ‘burden of production may entail producing additional evidence and presenting persuasive argument based on new evidence 18  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 at 47.

A. “An Integral Trifurcated Connector Body” (Limitation 1.1) The parties in this proceeding first dispute whether the redesigned articles meet the “integral trifurcated connector body” limitation of claim 1 of the ’295 patent. Here, both Summit and West disagree whether the internal flow path of the redesigned liquid transfer device is relevant to the definition of “trifurcated connector body.” Each side’s arguments are summarized below followed by the EOE Branch’s position.

1. The Parties’ Arguments

Summit Revised Ruling Request

In its Revised Ruling Request, Summit argues that “[t]he proposed redesign, by disposing a valve in the branch to the vial adapter apron, avoids [the] trifurcated connector body element because the trifurcated connector body of the ’295 patent claims and discloses only three uninterrupted and continuous flow paths or lumens in the interior of the ’295 device.” Summit Revised Ruling Request at 9. Moreover, Summit maintains that:

the ’295 claim and disclosure have been established to support 3 way direct and continuous fluid communication. The ID, in view of Order No. 15, extended this coverage to a device with only two direct and continuous paths, between the vial and bag, and between the bag and admin port. Taking in the light most favorable to the Complainants, the LEO applies to a trifurcated connector body with “3-way direct and continuous fluid communication” as well as the adjudicated claim 1 “flow limitation” with two separate instances of “direct and continuous fluid communication.” ID at 30, Comm’r Op., Dissent, at 16.

Id. at 10.

19  West Response In its Response, West disputes that the “integral trifurcated connector body” (limitation 1.1) requires any sort of flow communication. West Response at 6-7. To this end, West argues that “[b]ased on the claim language, prosecution history, specification, and other patent documents of record, the ALJ rejected [Summit’s] position and construed the term ‘trifurcated connector body’ as having plain and ordinary meaning, where the plain and ordinary meaning does not require 3- way flow.” Id. (citing Claim Construction Order, EDIS ID. No. 808334 (November 13, 2023) at 6-19) (emphasis in original). More specifically, according to West, “[t]he CALJ found, inter alia, that term does not suggest 3-way flow; rather the terms ‘trifurcated’ and ‘connector’ when used to modify ‘body’ simply indicate that the body in question has three branches or forks, and connects things.” Id. at 6-7. West contends that “[t]he CALJ also found the plain meaning of ‘trifurcated connector’ body does not define whether flow paths are required in the claimed LTD” and found “‘credible’ [West Expert] Dr. Cameron’s testimony that ‘the plain meaning of a ‘trifurcated connector body’ is understood by considering the body’s exterior because the term ‘trifurcated connector body’ is not talking about ‘fluid flow within.’” Id. at 7 (citing Claim Construction Ruling at 8 and FID at 31). According to West, Summit’s arguments concerning the claim construction of “integral trifurcated connector body” are nothing but “rehashed” arguments made in the underlying 1362 investigation that were rejected by the ALJ. Id. at 14.

Summit Reply In its Reply, Summit argues that: “[t]he claim construction order refers to interpretation of the claims, not the extent of the disclosure” and that “[the trifurcated connector body] element is disclosed only as having ‘3 way direct and continuous fluid communication.’” Summit Reply at 8 (emphasis added). Summit then goes on to state that:

[t]he claim construction order relaxes this need for enforcement, based on the rationale that other claim elements call out two flow paths of the 3 physically present in the device. But this does not change or remove the physical characteristics of the trifurcated connector body – it is merely a judicial interpretation that only 2, and not 3 flow paths, are required to assert the ’295 patent against an infringing device. The existence of the valve prior to the endpoint receiving the vial nullifies this integral feature and differentiates from the claim element Integral Trifurcated Connector Body as it is disclosed.

Id. (emphasis in original).

West Sur-Reply In its Sur-Reply, West again disputes Summit’s contention that “the redesigned products do not meet limitation 1.1 because the ’295 Patent specification… only discloses a trifurcated connector body with ‘3 way direct and continuous fluid communication.’” West Sur-Reply at 4 (citing Summit Reply at 7-8) (emphasis added). Here, West reiterates that “the Commission already decisively rejected Summit’s argument that the ’295 Patent specification only provides written description for a trifurcated connector body with 3-way flow when it affirmed the ALJ’s

20 finding that the patent has written description support for 2-way flow. Id. at 4 (citing Commission Notice at 3). According to West, “[p]ut simply, Summit’s 3-way flow written description arguments have no relevance to this Rule 177 proceeding.” Id. at 4-5.

Post Oral Discussion Submissions

In its Post-Oral Discussion Submission, Summit continues to maintain that “[t]he Summit Redesigned Product uses a valve assembly and flow paths that interrupt the claimed architecture. The presence of the valve means the flow paths are not direct, and the three-way structural relationship described in the claim no longer exists.” Summit Post-Oral Discussion Submission at 3. West in its Post-Oral Discussion Submission contends that this argument “is incorrect and inconsistent with the Commission’s binding claim construction order. The Commission construed ‘trifurcated connector body’ as having its plain and ordinary meaning, where that plain and ordinary meaning does not require 3-way flow.” West Post-Oral Discussion Submission at 2 (citing Ex. 3 at 19 and Ex. 4 at 3). Moreover, West once again argues that “[t]he Commission also found the plain meaning of ‘trifurcated connector’ body does not require any flow paths in the claimed liquid transfer device. Ex. 3 at 8; Ex. 1 at 31-37; Ex. 4 at 3. Rather, limitations 1.5 and 1.6 define the internal flow path requirements. Ex. 3 at 8; Ex. 1 at 31-35; Ex. 4 at 3 (adopting the CALJ’s claim construction and infringement findings). Thus, whether the redesigned products have ‘direct and continuous fluid communication’ within the body has no relevance to whether those products meet limitation 1.1” (emphasis added). Id.

2. EOE Branch Position The EOE Branch finds Summit’s arguments here unavailing and concludes that it has not met its burden of proof that “trifurcated connector body” should have a different construction other than that determined by Commission, namely a body that “(1) has three branches or forks and (2) connects things.” Claim Construction Order at 7 (citing Bancorp Servs., L.L.C. v. Hartford Life Ins. Co., 359 F.3d 1367, 1372 (Fed. Cir. 2004) (construing term where “the components of the term have well-recognized meanings, which allow the reader to infer the meaning of the entire phrase with reasonable confidence”). As with other Commission conclusions of law or findings of fact, a claim construction from the underlying investigation is binding for the purposes of an inter partes proceeding under 19 C.F.R. Part 177. See H334472 (December 20, 2023). We agree with West that that “the term ‘trifurcated connector body’ as having plain and ordinary meaning, where the plain and ordinary meaning does not require 3-way flow” because this was already determined by the ALJ and then adopted by the Commission.2 West Response at 6 (citing Claim Construction Order at 6-19); see also Claim Construction Order at 10. As such, for purposes of this Ruling Request, the EOE Branch adopts the definition of “trifurcated connector body” as stated in the ALJ’s Claim Construction Order.

2 In the Commission Opinion, the Commission stated that it was partially reviewing the Final Initial Determination for certain matters: “The Commission determined not to review the remaining findings in the Final ID, including the findings on claim construction, infringement, and the technical prong of the domestic industry requirement.” Commission Opinion at 4.

21  Thus, we reject Summit’s argument that the written description of the ’295 patent mandates a construction of a “trifurcated connector body” with a “3-way direction and continuous fluid communication.” According to the Claim Construction Order, “[t]he ’295 patent never uses the phrase ‘3 way direct and continuous fluid communication’” and “[t]he ’295 patent does not use the phrase ‘3 way direct and continuous fluid connection’ once.” Id. at 16 (emphasis in original). The respondents and OUII in the 1362 investigation attempted to point out several instances in the specification where it appears to suggest that the “trifurcated connector body” requires “3-way direct and continuous fluid communication,” but the ALJ disagreed. Id. at 16-17. Rather, the ALJ ruled that the specification’s failure to mention a 3-way direct and continuous fluid communication in writing “suggests that having 3-way direct and continuous fluid communication is not an imperative feature of the Figure 5B embodiment or of the invention claimed in the ’295 patent.” Id. at 17-18 (emphasis in original).

Because the Commission’s claim construction is binding on CBP, the EOE Branch will apply the Commission’s claim construction of “trifurcated connector body” here. See also H334472. Accordingly, the EOE Branch finds that the limitation “trifurcated connector body” has a plain and ordinary meaning as construed by the ALJ and that the internal flow path is not relevant to its construction. As such, the EOE Branch finds that Summit has not met its burden to show that the redesign in question does not have a “integral trifurcated connector body.”

B. “Direct and Continuous Fluid Communication” between the IV Spike and Integral Vial Adapter (Limitation 1.5) The parties also disagree whether the “direct and continuous fluid communication” requirement of limitation 1.5 is achieved when there is a valve interposed between the IV spike and integral vial adapter in the redesigned product. This is discussed in more detail below, followed by the EOE Branch’s position on this question.

1. The Parties’ Arguments Summit’s Revised Ruling Request

In its Revised Ruling Request, Summit argues that its redesigned liquid transfer device does not meet the “direct and continuous fluid communication” requirement of limitation 1.5. Summit Revised Ruling Request at 8. To this end, Summit provides a definition of “continuous” from a Merriam-Webster Dictionary that defines this term as “[m]arked by uninterrupted extension in space, time, or sequence.” Id. at 6. Summit did not provide a corresponding dictionary definition of “direct” in the Revised Ruling Request. However, Summit cited to testimony from Complainant’s expert, Dr. Cameron, in the 1362 investigation regarding the plain and ordinary meaning of “direct and continuous.” Id. at 5. Specifically, Summit notes that Dr. Cameron “testified that the IV spike of each accused product is in direct and continuous fluid communication with the integral vial adapter because the pathway between those components has no obstructions or intermediary structures.” Id. (citing Tr. (Cameron) at 122:11-16 (“Q. … what about it makes it direct and continuous? A. … there is no obstruction in that path. It goes straight from the vial

22 adapter to the spike. There are no other structures in between. So that’s direct and continuous fluid communication.”); see also FID at 51-52.

Summit additionally cites to a submission in the underlying investigation from OUII that described how the legacy products at issue before the ITC met the “direct and continuous” limitation. Specifically, Summit claims that the OUII argued that “those components are in ‘direct and continuous fluid communication’ because the path ‘allows for the uninterrupted movement of fluid, either liquid or gas, between the vial adapter and the IV spike without passing through any intermediary or intervening structures, components, or obstructions, such as valves or flow- regulating components or structures.” Revised Ruling Request at 5; FID at 52. We understand that Summit would like the EOE Branch to take this argument into consideration, however, we note that the only binding precedent on us is the ALJ’s findings in this investigation that were adopted by the Commission. In considering the above OUII argument, the ALJ did not indicate that a liquid transfer device that contains “any intermediary or intervening structures, components, or obstructions, such as valves or flow-regulating components or structures” would automatically overcome limitation 1.5. Rather, he took OUII’s statement into account along with other findings to conclude that, with respect to legacy products that contain no such intermediaries, “[v]iewed collectively, I find that the evidence demonstrates that the accused products satisfy limitation 1.5.” FID at 52. Accordingly, we adopt the ALJ’s finding, as opposed to the approach advanced by OUII in the underlying investigation.

West Response

West maintains in its Response that “[d]uring operation, liquid flows between a medicine vial and IV bag along that path,” thus meeting the “direct and continuous fluid communication” requirement of limitation 1.5. West Response at 10 (although West does not provide an exact citation for this in its Response, it appears to quote from the ALJ’s Final Initial Determination; see FID at 51) (emphasis added). West further argues:

[t]he only difference between the Original Infringing VDB Products and the redesigned products is the redesigned products have a valve (310) with a handle (50) between the IV spike and the integral vial adapter. The handle (50) switches the valve between an on (open) position when the product is used to transfer medicine to the IV bag. However, when the valve of the redesigned products is open, the interior flow paths and operation of the redesigned products and the Original Infringing VDB Products are the same. Of relevance here, as shown in the below side-by-sides, both the Original Infringing VDB Products and Summit’s redesigned products have a “direct,” i.e., no structures in between that would prevent fluid communication, and “continuous,” i.e., unobstructed, open flow path (red) between the IV spike and the integral vial adapter.

Id. at 12, see also Id. at 20-21. West additionally maintains that “[i]mportantly, Summit admits that the valve is not always closed.” Id. at 21 (citing Request at 11). According to West, therefore, “[e]ven from Summit’s perspective, the flow path between the IV spike and the integral vial adapter is only obstructed

23 when the valve is closed. However, when that valve is open, the redesigned products literally meet limitation 1.5.” Id.

Summit Reply In its Reply, Summit provides a definition of “direct” from Oxford Languages that defines this term as “without intervening factors or intermediaries” or “with no one or nothing in between.” Reply at 13. Also, Summit points out that “[t]he plain language of the claim allows for no interpretation of intermittent or that there is ‘sometimes’ fluid communication…” Id. at 15. Here, Summit reiterates, as it stated in the Revised Ruling Request, that “continuous” means “[m]arked by uninterrupted space, time, or sequence.” Id. at 13 (citing Merriam-Webster Dictionary). Lastly, Summit alleges that the parties agreed at the Markman hearing in the underlying investigation that “direct and continuous” was defined as “3-way flow.” Id. at 3-4.

West Sur-Reply In its Sur-Reply, West argues that Summit’s contention that “the redesigned products must infringe all of the time . . . is not the law.” West Sur-Reply at 12 (citing Summit Reply at 15-17 and Broadcom Corp. v. Emulex Corp., 732 F.3d 1325, 1333 (Fed. Cir. 2013)). West also contends in its Sur-Reply that the “[ALJ] properly recognized that “the phrase ‘direct and continuous fluid communication’ indicates a type of structure; it does not impose a claim requirement of actual liquid flow.” Id. at 9 (citing FID at 59). Lastly, West disputes Summit’s contention made in the Reply that the parties agreed at the Markman hearing that “direct and continuous” meant “3-way flow.” Id. at 10, n.4. We note that West did not provide any claim construction of the limitation “direct and continuous fluid communication” in its Sur-Reply. See id. However, at the oral discussion, when questioned, West stated that the construction for “direct and continuous” was “plain meaning” and the same as in the underlying investigation. See Oral Discussion Transcript at 60. West further elaborated at the oral discussion that this meant “unimpeded, unobstructed flow.” Id.

Post-Oral Discussion Submissions

In its Post-Oral Discussion Submission, Summit argues that “direct and continuous fluid communication” means an “an unbroken path.” Summit Post-Oral Discussion Submission at 2. Summit goes on to contend that “‘[c]ontinuous’ means unbroken, persistent, and uninterrupted.” Id. at 8. Summit then states that “[t]he plain meaning of ‘direct and continuous fluid communication’ is that the fluid pathway for the IV spike to the vial adapter is unobstructed and unbroken – i.e., a direct channel through which fluid can flow continuously.” Id. at 10.

In its Post-Oral Discussion Submission, West maintains that the definition of “continuous” proposed by Summit is deficient because Summit “did not include a claim construction argument based on Markman, Phillips, and their progeny in its briefs.” West Post-Oral Discussion Submission at 8. West then states that “Summit’s attempt to construe ‘continuous’ based on the extrinsic evidence rather than first trying to construe that term in view of intrinsic evidence violates

24 Federal Circuit law.” Id. (citing Phillips, 415 F.3d at 1314-19). West then maintains that Summit is misconstruing the Merriam-Webster Dictionary definition Summit provided to require “continuity ‘all of the time.’” Id. In this regard, West argues the “definition is ‘defined by uninterrupted extension in space, time, or sequence.’ As such, something can be continuous if it is uninterrupted in space or sequence, but not uninterrupted in time, and vice versa.” Id. (emphasis in original). Similarly, West then maintains that although Summit introduced its definition of “direct” in the Reply, it was nonetheless “untimely, waived, and inconsistent with Federal Circuit law” because “it did not include a claim construction argument or explain why the intrinsic evidence of the ’295 Patent purportedly limits ‘direct’ to a definition provided in the extrinsic evidence in either of its briefs.” Id. at 11.

2. Analysis a. Summit has not met its burden of proof that there is not “direct and continuous fluid communication” between the IV spike and the vial adapter in the redesigned articles At the outset, we disagree with West that Summit has waived its right to provide definitions of “continuous” and “direct” because we are unaware of the Federal Circuit caselaw which holds that dictionary definitions outside a Markman or Phillips context or without other intrinsic evidence cannot be considered. Rather, the Federal Circuit has stated “[w]ithin the class of extrinsic evidence, the court has observed that dictionaries and treatises can be useful in claim construction” and that “[s]uch evidence, we have held, may be considered if the court deems it useful in determining ‘the true meaning of language used in the patent claims.’” Phillips at 1318 (citing Renishaw PLC v. Marposs Societa’ per Azioni, 158.F.3d 1243, 1250 (Fed. Cir. 1998); Rexnord Corp. v. Laitram Corp., 274 F.3d 1336, 1344 (Fed. Cir. 1997); and Markman, 52 F.3d at 980). Moreover, the Phillips court stated that “[a]lthough we have emphasized the importance of intrinsic evidence in claim construction, we have also authorized the 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.’” Phillips at 1317 (citing Markman at 980). That is, while the Federal Circuit considers extrinsic evidence less significant than intrinsic evidence in claim construction, it is still useful in determining the meaning of claims. Accordingly, the EOE Branch will consider the definitions of these terms submitted by Summitt. Using these definitions, Summit argues that the articles at issue do not practice the limitation “the integral trifurcated connector body connecting said single IV spike in direct and continuous fluid communication with said integral vial adapter” (limitation 1.5) because of the intervening valve between the IV spike and integral vial adapter. Summit Revised Ruling Request at 8. We note that the Commission did not expressly construe the terms “direct” or “continuous” in the underlying investigation. See Claim Construction Order; see also FID. To repeat Summit’s assertions, Summit argues that “continuous” means “marked by uninterrupted extension in space, time, or sequence.” Summit Revised Ruling Request at 6 (citing Merriam-Webster Dictionary). Summit also contends that “direct” means “without intervening factors or intermediaries” or “with no one or nothing in between.” Summit Reply at 13 (citing Oxford Languages). On the other hand, West has not provided an express claim construction of these terms. See West Response, West Sur-Reply, and West Post-Oral Discussion Submission. Rather, West attacks the dictionary

25 definitions provided by Summit and stated at the oral discussion that these terms should be given their “plain meaning.” West Post-Oral Discussion Submission at 8; Oral Discussion Transcript at 60. As far as intrinsic evidence is concerned, the ’295 patent itself does not define “direct” or “continuous,” and Summit has not provided any evidence from the prosecution history that defines these terms. Accordingly, because West has not presented alternative definitions of these terms and the parties have not submitted any intrinsic evidence, the EOE Branch will adopt and apply Summit’s definitions of “direct” and “continuous” to the redesigned articles at issue.

Although the ALJ did not expressly construe “direct” or “continuous” in the 1362 investigation, we find his discussion of limitation 1.6 in the FID, which recites similar language, instructive here. In particular, the ALJ ruled that certain impediments in the accused product between the IV spike and administration port do not disrupt the “direct and continuous fluid communication” language of limitation 1.6. FID at 59. Specifically, the ALJ considered whether the presence of a breakaway tab and sealing membrane in the accused product traverse limitation 1.6’s requirement of “connecting said single IV spike in direct and continuous fluid communication with said administration port.” Id. at 55-57 (emphasis added). The respondents in the underlying investigation, including Summit, admitted that these impediments had to be removed for the accused product to perform as intended. Id. at 61. Citing the Specification, the ALJ noted that:

the inventors said that ‘[t]he puncturing member 106 [in Figs. 5A and 5B] is in direct and continuous fluid communication…with the substitute IV port.” Id. at 60 (citing ’295 patent 4:53-55) (emphasis added). Relying on this portion of the Specification, the ALJ found that the “inventors’ description of Figures 5A and 5B [stated above] demonstrates that a sealing membrane and breakaway tab are not incompatible with a structure that satisfied the ‘direct and continuous fluid communication’ requirement.

Id. at 59 (emphasis added). The ALJ also found that “Figures 5A and 5B . . . illustrate one example of a liquid transfer device that has a sealing membrane 46 and a breakaway tab below the sealing membrane.” Id. at 59. Thus, despite the presence of these impediments, which are temporary, the ALJ found that the legacy product practiced the “direct and continuous fluid communication” requirement of claim 1.6. Likewise, we find the redesigned product under consideration to contain an analogous “temporary impediment” in the form of the valve that can be removed by the user during operation. That is, using Summit’s definitions, there is direct (no barriers) and continuous (uninterrupted in time) fluid communication between the IV spike and vial adapter in the redesigned product once the valve is turned on.

We also find the definitions submitted by Summit inadequate to support its own argument that the IV spike and integral vial adapter must be in communication without interruption perpetually. See Summit Reply at 13 (“something cannot be ‘partially’ continuous, or continuous only at certain times; rather it is either uninterrupted or not”). First, Summit’s definition of “continuous,” which is “marked by uninterrupted extension in space, time, or sequence,” does not support Summit’s argument that “continuous” cannot mean continuous “sometimes” or “intermittently.” Id. at 15. In fact, the same dictionary Summit cites, Merriam-Webster Dictionary, provides an example sentence in which the term is used that contradicts Summit’s assertions: “The batteries provide enough power for up to five hours of continuous use.” See Merriam-Webster

26 Online Dictionary, https://www.merriam-webster.com/dictionary/continuous (last visited March 17, 2026) (emphasis added). That is, according to Merriam-Webster, “continuous” does not have a connotation of “all the time” and can be achieved during a limited time period. Under Summit’s reasoning, “continuous” has no end point, which is contradicted by Merriam-Webster Dictionary. Similarly, Summit’s definition of “direct,” which is “with no one or nothing in between,” fails to take into account that direct connections can have removable barriers. As a real life example, if a driver has a direct path from point A to point B, but a railroad crossing gate stands in between, once that gate is lifted, the path becomes direct. Lastly, these definitions are inconsistent with ALJ’s view of these terms. As discussed above, the ALJ himself indicated that “direct and continuous” can still be achieved if there are removable barriers as the case with the valve here.

Turning to the redesigned products here, West is correct that “[d]uring operation, liquid flows between a medicine vial and IV bag along that path.” West Response at 10. We also note that Summit’s own Addendum to its Revised Ruling Request provides Figures (shown above) of the redesigned product in both a “closed position” and “open position.” In the opened position, Summit admits that “[b]y movement of the handle 50 [in Addendum B], the valve element 40 rotates about 90o to align the valve passage 20’ with the bag channel 10 and vial channel 30.” Summit Revised Ruling Request at 11 (citing Addendum B). Moreover, Summit’s own IFU indicates that in step 5 “[w]hen ready to reconstitute the drug in the vial turn the handle to the ‘on’ position” and that in step 6 “[t]o reconstitute the drug, hold the IV Bag with the Drug Vial hanging below the IV bag and squeeze the IV Bag forcing fluid into the Drug Vial.” Revised Ruling Request Addendum B at 3. Moreover, step 8 in the IFU states that “[t]to add the reconstituted drug into the IV Bag, invert the IV Bag and hold the Vial Direct to Bag Spike and Drug Vial above the IV Bag and squeeze the IV Bag. This forces air into the drug vial and the reconstituted drug will flow into the IV Bag.” Id. Thus, according to Summit’s own IFU, there is a “direct and continuous” two-way flow of liquid between the IV Spike and the vial adapter that occurs by turning on the valve. Additionally, in the Figure of the redesigned article in the “open position,” there is no structural impediment between the IV spike and valve adapter, allowing liquid to flow directly and continuously when the valve is on. Id. at 2.

Accordingly, we find that Summit’s construction of “direct” and “continuous” provided in this proceeding does not prove non-infringement. Moreover, we find the dictionary definitions submitted by Summit contrary to the ALJ’s own view that “direct and continuous” can be practiced despite the presence of removable barriers. As such, we find that Summit has not met its burden of proof that its redesigned products do not practice the “direct and continuous” requirement of limitation 1.5.

b. Doctrine of Equivalents

In its Sur-Reply, for the first time, West presents an alternative theory of infringement under the doctrine of equivalents. See Sur-Reply at 11. West states that when the valve is open, the same function as “direct and continuous fluid communication” is met and accomplishes this function in substantially the same way and achieves the same result. Id. However, as the Federal Circuit has held “[u]nder the doctrine of equivalents, an infringement theory thus fails if it renders a claim limitation inconsequential or ineffective.” See Akzo Nobel Coatings, Inc. v. Dow Chem. Co., 811 F.3d 1334, 1342. Because we find above that Summit has not met its burden that the redesigned

27 products do not infringe the ’295 under literal infringement, we need not consider whether it has met its burden under the doctrine of equivalents.

c. Summary of EOE Branch Position

Accordingly, the EOE Branch finds that Summit has not met its burden to show that the redesigned product does not practice the “direct and continuous fluid communication” requirement of limitation 1.5 because (1) Summit’s own claim construction of “direct” and “continuous” are inadequate and (2) its dictionary definitions of these terms are inconsistent with the view of the ALJ that “direct and continuous” can be practiced despite the presence of temporary barriers. As such, we find that Summit has not carried its burden in showing its redesigned product does not practice the “direct and continuous fluid communication” requirement of limitation 1.5 of the ’295 patent.

C. “An Integral Vial Adapter Extending from a Second End of the Integral Trifurcated Connector Body” (Limitation 1.3) The parties also dispute whether the redesigned products practice limitation 1.3 of the ’295 patent, which requires “an integral vial adapter extending from a second end of the integral trifurcated connector body.” Each party’s arguments are summarized below followed by the EOE Branch’s position.

1. The Parties’ Arguments

Summit Initial Ruling Request

Summit argues that “[a] further element avoided by the redesign is limitation 1.3 of the ’295 claim. Limitation 1.3: “iii) an integral vial adapter extending from a second end of the integral trifurcated connector body for telescopically mounting on the vial, said integral vial adapter including a puncturing cannula for puncturing the vial stopper upon said mounting of said vial adapter onto the vial for flow communication therewith.” Summit Revised Ruling Request at 10 (citing FID at 9, 39). Particularly, Summit maintains that:

[i]n the redesign, the vial-engaging branch is not integral with the connector body, but rather the vial branch terminates at the valve. A post-valve segment or channel extends to engage the vial. Such an element extending from the integral trifurcated connector body does not also meet the latter requirement of mounting of said vial adapter onto the vial for flow communication therewith. The valve element of the redesign imposes a separate vessel or channel, such that the vial communication requires an aggregation of a branch from the connector body to the valve, and from the valve to the vial. The redesign avoids limitation 1.3 of the ’295 claim supporting the 1362 LEO.

Id. at 11 (emphasis in original).

28  West Response

West responds that “[b]oth the valve and the vial adapter are integral to the trifurcated connector body because they are not separable from that body. Summit admits each redesigned product is a ‘one-piece design.’” West Response at 17 (citing Summit’s Addendum C). West also contends that the “IFU also does not include any instructions for assembling the redesigned products. Nor did Summit provide any evidence showing the vial adapter 30 (or valve 310 for that matter) of the redesigned products is separable from the integral trifurcated connector body.” Id. West goes on to state that “even if one assumes that the valve is not part of the trifurcated connector body or the vial adapter . . . the vial adapter . . . extends from the integral trifurcated connector body . . . because each redesigned product is ‘one piece.’ Neither the vial adapter nor the valve is separable from the trifurcated connector body. Both are integral to and extend from the second end of the trifurcated connector body.” Id. at 18 (internal citations omitted).

Summit Reply

In its Reply, Summit argues that “[t]he ‘one piece’ characterization is a customer/user facing communication, not an engineering or technical specification. The ‘one piece’ language refers to the manner of use whereby the user need only handle a single Vial Adapter device. It does not refer to the manner of assembly or molding of the Summit Vial Adapter device which, having a moving valve element, necessarily requires a plurality of parts.” Summit Reply at 10. As such, Summit contends that “[t]he instructions for use are not a relevant article to demonstrate infringement of the redesigned product.” Id.

West Sur-Reply

In its Sur-Reply, West states that:

[a]s West demonstrated in its response, both the valve and the vial adapter are integral to and extend from the second end of the integral trifurcated connector body for three main reasons. One, those parts are not separable from the trifurcated connector body and therefore extend from the integral trifurcated connector body. Id. Summit even admits in its IFU that the redesigned products have a ‘one-piece design.’ Two, Summit has provided no evidence that that valve is not part of the integral trifurcated connector body or the integral vial adapter. Id. 18. Three, Summit admits the valve extends from the second end of the integral trifurcated connector and the vial adapter is connected to and extends from the valve. Logically, that means the vial adapter also extends from the second end of the trifurcated connector body. Summit’s counterarguments are unsupported, meritless, and contravene the Commission’s infringement determination.

West Sur-Reply at 5 (internal citations omitted).

29  Post-Oral Discussion Submissions

Summit in its Post-Oral Discussion Submission argues that West is incorrect in arguing that “the valve is merely an addition to an otherwise infringing article.” Summit Post-Oral Discussion Submission at 12. Rather, Summit argues “[t]he valve replaces the engagement or connection between the integral trifurcated connector body and the integral vial adapter.” Id. Summit then maintains that “[e]ven if [West’s] ‘addition’ theory is given weight, it still fails because the alleged insertion must be between the bag spike 22 and integral vial adapter 102. This avoids limitation 1.3.” Id.

In its Post-Oral Discussion Submission, West again contends that “both the valve and the vial adapter of the redesigned products are inseparable from and extend from the integral trifurcated connector body. In other words, the vial adapter of each redesigned product is integral because it is not separable from the integral trifurcated connector body, whether it is directly connected or not. Summit even admits the redesigned products have a ‘one-piece design.’” West Post-Oral Discussion Submission at 7. Also, West maintains “Summit admits the valve extends from the second end of the integral trifurcated connector body and the vial adapter is connected to and extends from the valve. Logically, and necessarily, that means the vial adapter also extends from the second end of the integral trifurcated connector body.” Id. (internal citation omitted).

2. Analysis

As stated above, the burden of proof of non-infringement of a redesigned article is on the importer. See Hyundai Elecs. Indus. Co. at 1210. As such, Summit must prove that its redesigned product does not meet the limitation “an integral vial adapter extending from a second end of the integral trifurcated body.” For the reasons set forth below, we find that Summit has not carried its burden here.

The thrust of Summit’s argument is that the “integral vial adapter,” which is the portion of the redesigned product that directly engages with medicine vial, does not extend from the second branch of the trifurcated connector body because of the intervening valve. See Summit Ruling Request at 11. To support this contention, Summit presented the below annotated diagram of the redesigned product at the Oral Discussion. Summit appears to be contending that the second branch of the trifurcated connector body terminates at the valve and therefore the vial adapter cannot extend from the second branch, as the claim limitation requires. In other words, according to Summit, the presence of the valve disrupts the connection between the integral vial adapter and integral trifurcated connector body so that the integral vial adapter cannot extend from the second end of the integral trifurcated connector body.

30 Summit Oral Discussion Presentation at 15.

West, on the other hand, argues that Summit admitted in its IFU that its redesigned product is “one piece” and the valve and vial are therefore not separable. West Sur-Reply at 5. West also contends that Summit has not provided any evidence that the valve and vial are not part of the integral trifurcated connector body. Id. In other words, West maintains that Summit has not proven the location of the “second end” of the trifurcated body of the redesigned product and has not met its burden as a result.

We agree with West that Summit has not provided any evidence that the integral vial adapter of the redesigned product does not extend from a second end of the trifurcated connector body. First, it is unclear what constitutes the “second end” in Summit’s redesigned product. Neither party has provided the EOE Branch with an express construction of “second end” in their filings, which is critical to making a determination with respect to limitation 1.3, nor has the Commission provided one. See Parties’ Submissions; Claim Construction Order; and FID. As stated above, the Federal Circuit has held that “[w]hen a claim limitation, like the one at issue here, is not expressly construed, a jury is entitled to give that limitation any reasonable meaning in determining, as a factual matter, what comes within its scope. Akamai Techs., Inc., 159 F.4th at 1380; see also VLSI Tech., at 1341 (emphasis added). That is, when neither party offers an express claim construction of a limitation, the fact finder, which in this case is the EOE Branch, is free to adopt any construction that is reasonable. Accordingly, the EOE Branch construes the “second end” to have a plain and ordinary meaning, which in this proceeding means “a second end of the integral trifurcated body.”

Based on the above construction, Summit has not shown that the “second end” of the integral trifurcated body is located at the point where the valve begins, as they allege. As West contends, “Summit has provided no evidence that [the] valve is not part of the integral trifurcated connector body or the integral vial adapter.” Id. Summit has not in fact submitted any proof that the valve and/or vial adapter are in fact separate from the rest of the redesigned article, rather, they indicated in their IFU that the redesigned product is a “one-piece design” (emphasis added) and in

31 its submission to the EOE Branch on August 15, 2025 indicates that “Summit has never denied the trifurcated connector body, the valve, and vial adapter of each redesigned product are one-piece.” See Summit Revised Ruling Request at Addendum C; and Summit’s Supplemental Response, August 15, 2025 at 2. Thus, we disagree with Summit’s characterization of the IFU as a “customer/user facing communication, not an engineering or technical specification,” and that the “‘one piece’ language refers to the manner of use whereby the user need only handle a single Vial Adapter device” constitutes sufficient proof of non-infringement. The fact that Summit admits that its new product is “designed” to be one piece contradicts these assertions.

Moreover, we note that the language of limitation 1.3 does not require the integral vial adapter to extend directly from the second end of the vial adapter. As West contends, Summit’s admission that the “valve extends from the second end of the integral trifurcated connector . . . [l]ogically . . . means that the vial adapter also extends from the second end of the trifurcated connector body.” Id. That is, even assuming arguendo that the second end terminates at the valve, the vial adapter of the redesigned product still extends from the second end indirectly through the valve. As such, regardless of whether the second end begins at the valve or after the valve, we find the redesigned product practices limitation 1.3.

Without any evidence from Summit that the second end of the redesigned articles terminate at the valve, the EOE Branch cannot conclude that the vial adapter in the redesigned product does not extend from the second end of the trifurcated connector body as claim 1 requires. The statements made by Summit are attorney argument, rather than record evidence, and relying on such assertions would be improper. See Enzo Biochem, Inc. v. Gen-Probe, Inc., 424 F.3d 1276, 1284 (Fed. Cir. 2005) (“Attorney argument is no substitute for evidence.”). In the absence of this evidence, Summit cannot be found to have carried its burden to establish admissibility when it has not come forward with any evidence, let alone sufficient record evidence, that establishes the features of the articles at issue and the evidentiary basis for their non infringement.

3. EOE Branch Position

Accordingly, we find that Summit has not met its burden of proof in establishing that the redesigned articles do not have “an integral vial adapter extending from a second end of the integral trifurcated connector body” as limitation 1.3 requires. As such, we find that Summit’s redesign practices this limitation.

D. Capability Claiming Line of Precedent

We note that our analysis above is for an apparatus patent claim that does not contain capability language. The EOE Branch also recognizes that in the FID the ALJ cited a line of cases that is directed towards patents with capability claim language. Particularly, the ALJ noted “[a] device that infringes only some of the time is still a device that infringes.” FID at 64 (citing Hilgraeve Corp. v. Symanetic Corp., 265 F.3d 1336, 1343 (Fed. Circ, 2001)). But the Federal Circuit has indicated that this line of reasoning only applies to capability claims. In general, the Federal Circuit has established that for infringement of a claim that recites capability and not actual operation, an accused device “need only be capable of operating” in the described mode. Intel

32 Corp. v. U.S. Int'l Trade Comm’n, 946 F.2d 821, 832 (Fed. Cir. 1991). Thus, depending on the claims, “an accused device may be found to infringe if it is reasonably capable of satisfying the claim limitations, even though it may also be capable of noninfringing modes of operation.” Hilgraeve Corp. at 1343; Finjan, Inc. v. Secure Computing Corp., 626 F.3d 1197, 1204 (Fed. Cir. 2010) (emphasis added) (citing Intel Corp., 946 F.2d at 832).

Applying the above capability line of precedent to the redesigned products at issue here, we find that the redesigned articles do not traverse limitation 1.5’s requirement of a “direct and continuous fluid communication” between the IV spike and integral vial adapter. This is because in the redesigned liquid transfer device the “direct and continuous fluid communication” limitation is reasonably capable of being met during operation, that is, when the valve is turned on. As such, even applying the capability line of cases to the redesigned products, we would still find infringement.

V. HOLDING

We find that Summit has not met its burden to establish that the articles at issue do not infringe claim 1 of the ’295 patent. Accordingly, we find that the articles at issue practice the contested limitations and are therefore subject to the 1362 LEO.

Should Summit wish to submit another request for an administrative ruling addressing at least the deficiencies noted supra, it should do so within 60 calendar days. See e.g., 19 C.F.R. § 177.12 (e).

The decision is limited to the specific facts set forth herein. If articles differ in any material way from the articles at issue described above, or if future importations vary from the facts stipulated to herein, this decision shall not be binding on CBP as provided for in 19 C.F.R. §§ 177.2(b)(1), (2), (4), and 177.9(b)(1) and (2).


Sincerely,

Alaina van Horn
Chief, Intellectual Property Enforcement Branch/
Exclusion Order Enforcement Branch

CC: Domingo M. LLagostera
Blank Rome LLP
717 Texas Ave., Suite 1400
Houston, TX 77002
Email: [email protected]

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