Federal Register / Vol. 90, No. 25 / Friday, February 7, 2025 / Notices 9165 

confidence must request confidential 

treatment by marking each document 

with a header indicating that the 

document contains confidential 

information. This marking will be 

deemed to satisfy the request procedure 

set forth in Rules 201.6(b) and 

210.5(e)(2) (19 CFR 201.6(b) & 

210.5(e)(2)). Documents for which 

confidential treatment by the 

Commission is properly sought will be 

treated accordingly. Any non-party 

wishing to submit comments containing 

confidential information must serve 

those comments on the parties to the 

investigation pursuant to the applicable 

Administrative Protective Order. A 

redacted non-confidential version of the 

document must also be filed 

simultaneously with any confidential 

filing and must be served in accordance 

with Commission Rule 210.4(f)(7)(ii)(A) 

(19 CFR 210.4(f)(7)(ii)(A)). All 

information, including confidential 

business information and documents for 

which confidential treatment is properly 

sought, submitted to the Commission for 

purposes of this investigation may be 

disclosed to and used: (i) by the 

Commission, its employees and Offices, 

and contract personnel (a) for 

developing or maintaining the records 

of this or a related proceeding, or (b) in 

internal investigations, audits, reviews, 

and evaluations relating to the 

programs, personnel, and operations of 

the Commission including under 5 

U.S.C. Appendix 3; or (ii) by U.S. 

government employees and contract 

personnel, solely for cybersecurity 

purposes. All contract personnel will 

sign appropriate nondisclosure 

agreements. All nonconfidential written 

submissions will be available for public 

inspection on EDIS. 

This action is taken under the 

authority of section 337 of the Tariff Act 

of 1930, as amended (19 U.S.C. 1337), 

and in Part 210 of the Commission’s 

Rules of Practice and Procedure (19 CFR 

part 210). 

By order of the Commission. 

Issued: February 3, 2025. 

Lisa Barton, 

Secretary to the Commission. 

[FR Doc. 2025–02337 Filed 2–6–25; 8:45 am] 

BILLING CODE 7020–02–P 

INTERNATIONAL TRADE 

COMMISSION 

[Investigation No. 337–TA–1362 (Remand)] 

Certain Liquid Transfer Devices With 

an Integral Vial Adapter; Notice of a 

Commission Determination Finding a 

Violation of Section 337; Issuance of a 

Limited Exclusion Order and a Cease 

and Desist Order; Termination of the 

Investigation 

AGENCY: U.S. International Trade 

Commission. 

ACTION: Notice. 

SUMMARY: Notice is hereby given that 

the U.S. International Trade 

Commission has determined to affirm 

the determination finding a violation of 

section 337 of the Tariff Act of 1930, as 

amended, in the remand initial 

determination (‘‘Remand ID’’) issued by 

the Chief Administrative Law Judge 

(‘‘CALJ’’) and to take no position with 

respect to a portion of the Remand ID. 

The Commission has also determined to 

issue a limited exclusion order 

prohibiting further importation of 

infringing products by the three 

remaining respondents and a cease and 

desist order against one respondent. 

FOR FURTHER INFORMATION CONTACT: 

Edward S. Jou, Esq., Office of the 

General Counsel, U.S. International 

Trade Commission, 500 E Street SW, 

Washington, DC 20436, telephone (202) 

205–3316. Copies of non-confidential 

documents filed in connection with this 

investigation may be viewed on the 

Commission’s electronic docket (EDIS) 

at https://edis.usitc.gov. For help 

accessing EDIS, please email 

EDIS3Help@usitc.gov. General 

information concerning the Commission 

may also be obtained by accessing its 

internet server at https://www.usitc.gov. 

Hearing-impaired persons are advised 

that information on this matter can be 

obtained by contacting the 

Commission’s TDD terminal on (202) 

205–1810. 

SUPPLEMENTARY INFORMATION: The 

Commission instituted this investigation 

on May 11, 2023, based on a complaint, 

as supplemented, (the ‘‘Complaint’’) 

filed by West Pharmaceutical Services, 

Inc. and West Pharma. Services IL, Ltd. 

(collectively, ‘‘West’’ or 

‘‘Complainants’’). 88 FR 30342 (May 11, 

2023). The Complaint alleged violations 

of section 337 of the Tariff Act of 1930, 

as amended, 19 U.S.C. 1337, based on 

the importation into the United States, 

the sale for importation, and the sale 

within the United States after 

importation of certain liquid transfer 

devices with an integral vial adapter by 

reason of the infringement of claim 1 of 

U.S. 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 30342. 

The Commission’s notice of 

investigation named four respondents: 

Advcare Medical, Inc. (‘‘Advcare’’) of 

New Taipei City, Taiwan, Dragon Heart 

Medical Devices Co., Ltd. (‘‘Dragon 

Heart Devices’’) of Kaiping City, China, 

Dragon Heart Medical, Inc. (‘‘Dragon 

Heart’’) of Addison, Illinois, and 

Summit International Medical 

Technologies, Inc. (‘‘Summit’’) of 

Franklin, Massachusetts. Id. The Office 

of Unfair Import Investigations (‘‘OUII’’) 

is also a party to this investigation. Id. 

The investigation was terminated as 

to Dragon Heart Devices by withdrawal 

of the Complaint. Order No. 9 (Aug. 24, 

2023), unreviewed by Comm’n Notice 

(Sept. 20, 2023). 

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 of the Complaint. Order 

No. 12 (Sept. 19, 2023), unreviewed by 

Comm’n Notice (Oct. 19, 2023); Order 

No. 14 (Oct. 4, 2023), unreviewed by 

Comm’n Notice (Nov. 2, 2023). 

Accordingly, the ’295 patent is the only 

remaining asserted intellectual property 

in this investigation, and the 

respondents remaining in the 

investigation are Summit, Advcare, and 

Dragon Heart (collectively, 

‘‘Respondents’’). 

On October 16, 2023, West filed an 

unopposed motion for summary 

determination that it satisfied the 

economic prong of the domestic 

industry requirement, which was 

granted. Order No. 17 (Nov. 28, 2023), 

unreviewed by Comm’n Notice (Dec. 28, 

2023). 

A claim construction hearing was 

held on October 26, 2023, and the CALJ 

issued a claim construction order on 

November 13, 2023. Order No. 15 (Nov. 

13, 2023). The parties filed motions in 

limine, and the CALJ precluded certain 

evidence and arguments in Order No. 19 

(Dec. 1, 2023). In particular, the CALJ 

granted West’s motion in limine no. 2, 

precluding Respondents and OUII from 

challenging the validity of the ’295 

patent. Id. at 2–6. 

An evidentiary hearing was held on 

December 4–5, 2023, and the CALJ 

issued a final initial determination 

(‘‘Final ID’’) on March 15, 2024, finding 

a violation of section 337 based on 


lotter on DSK11XQN23PROD with NOTICES1
9166 Federal Register / Vol. 90, No. 25 / Friday, February 7, 2025 / Notices 

1Commissioner Schmidtlein stepped down from 

the Commission on January 31, 2025. 

2Commissioner Kearns respectfully dissents from 

the Commission’s decision and has filed a separate 

opinion explaining his views. 

1Based on the Government’s submissions in its 

RFAA dated April 18, 2024, the Agency finds that 

service of the OSC on Registrant was adequate. 

Specifically, the Declaration from a DEA Diversion 

Investigator (DI) indicates that on February 29, 

2024, the DI successfully served the OSC via email 

to Registrant’s registered email address, as the DI’s 

email was not returned undeliverable. RFAAX 2, at 

2; Mohammed S. Aljanaby, M.D., 82 FR 34552, 

34552 (2017) (finding that service by email satisfies 

due process where the email is not returned as 

undeliverable and other methods have been 

unsuccessful). 

The DI made several other attempts to serve 

Registrant with the OSC, but they were unsucessful. 

On February 27, 2024, the DI attempted personal 

service at Registrant’s last known forwarding 

address. RFAAX 2, at 2. The DI left a copy of the 

OSC at the address and asked the current residents 

to give the documents to Registrant. Id. Also on this 

date, the DI called and texted Registrant via a 

telephone number provided by the current residents 

and received no response. Id. On February 29, 2024, 

the DI attempted to contact Registrant by his 

registered phone number and left her contact 

information with an acquaintance of Registrant who 

answered the phone. Id. at 2–3. On March 1, 2024, 

the DI sent the OSC via certified mail to four 

addresses associated with Registrant, including 

Registrant’s registered address. Id. at 3, Attachment 

C. According to the DI, all four mailings were 

returned unable to forward. Id. at 3. The DI also 

contacted the Medical Board of California in 

attempting service, but the Board was unable to 

provide a current address. Id. at 3. 

In sum, the Agency finds that Registrant was 

successfully served the OSC by email and the DI’s 

efforts to serve Registrant by other means were 

‘‘ ‘reasonably calculated, under all the 

circumstances, to apprise [Registrant] of the 

pendency of the action.’ ’’ Jones v. Flowers, 547 U.S. 

220, 226 (2006) (quoting Mullane v. Central 

Hanover Bank & Trust Co., 339 U.S. 306, 314 

(1950)). Therefore, due process notice requirements 

have been satisfied. 

infringement of claim 1 of the ’295 

patent. The Final ID included a 

recommended determination (‘‘RD’’) on 

remedy and bonding that recommended 

issuance of a limited exclusion order 

directed to the three remaining 

respondents and a cease and desist 

order directed to Summit. See Final ID 

at 73–87. 

On May 16, 2024, the Commission 

determined to review the Final ID in 

part. 89 FR 45012–15 (May 22, 2024). 

The Commission determined not to 

review the Final ID’s findings with 

respect to claim construction, 

infringement, and the technical prong of 

the domestic industry requirement. Id. 

at 45013. On July 23, 2024, the 

Commission determined to supplement 

the Final ID and to reverse-in-part Order 

No. 19 and remand the investigation to 

the CALJ for further proceedings with 

respect to the written description 

requirement. See Comm’n Notice (July 

23, 2024); Comm’n Op. (July 23, 2024); 

Remand Order (July 23, 2024). 

On remand, the parties agreed that a 

live hearing was unnecessary and the 

CALJ set a procedural schedule for the 

submission of evidence and the parties’ 

briefing and extended the target date to 

February 10, 2025. Order No. 23 (Aug. 

1, 2024), unreviewed by Comm’n Notice 

(Aug. 27, 2024). The parties conducted 

additional expert discovery and the 

CALJ admitted the resulting evidence 

into the record. Order No. 24 (Sept. 3, 

2024). 

On November 8, 2024, the CALJ 

issued the Remand ID finding that claim 

1 of the ’295 is not invalid for lack of 

written description under 35 U.S.C. 112. 

OUII filed a petition for review on 

November 21, 2024. Respondents filed a 

petition for review on November 29, 

2024. West filed a response to OUII’s 

petition for review on November 29, 

2024. West filed a response to 

Respondents’ petition for review on 

December 6, 2024. 

On December 20, 2024, the 

Commission determined to review the 

Remand ID in its entirety. On review, 

the Commission has determined to take 

no position with respect to certain 

statements in the Remand ID.1

Specifically, the Commission takes no 

position on the second sentence of the 

last paragraph on page 5 continuing to 

page 6 (‘‘The Commission concluded 

that OUII, . . .’’) and the subsequent 

citations (‘‘Id. at 18 . . .; see also; . . .; 

but cf. . . . .’’); and the Commission 

takes no position on the second 

sentence in the first full paragraph on 

page 7 (‘‘Because OUII . . . .’’). The 

Commission has determined to affirm 

the remainder of the Remand ID. 

Because the Commission previously 

determined not to review the finding on 

summary determination with respect to 

the economic prong of the domestic 

industry requirement and the findings 

in the Final ID with respect to claim 

construction, infringement, and the 

technical prong of the domestic industry 

requirement, the Commission has 

determined that there has been a 

violation of section 337 with respect to 

infringement of claim 1 of the ’295 

patent.2

For remedy, the Commission has 

determined to issue a limited exclusion 

order prohibiting further importation of 

infringing products by the three 

remaining respondents and a cease and 

desist order against Respondent 

Summit. The Commission has 

determined that the public interest 

factors do not counsel against issuing 

remedial orders. The Commission has 

determined that bond should be set in 

the amount of zero percent (0%) (i.e., no 

bond). 

The Commission vote for this 

determination took place on February 3, 

2025. 

This action is taken under the 

authority of section 337 of the Tariff Act 

of 1930, as amended (19 U.S.C. 1337), 

and in Part 210 of the Commission’s 

Rules of Practice and Procedure (19 CFR 

part 210). 

By order of the Commission. 

Issued: February 3, 2025. 

Lisa Barton, 

Secretary to the Commission. 

[FR Doc. 2025–02336 Filed 2–6–25; 8:45 am] 

BILLING CODE 7020–02–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Massoud Amini, M.D.; Decision and 

Order 

On February 23, 2024, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause (OSC) to Massoud Amini, M.D., 

of Woodland Hills, California. 

(Registrant). Request for Final Agency 

Action (RFAA), Exhibit (RFAAX) 1, at 1, 

3. The OSC proposed the revocation of 

Registrant’s DEA Certificate of 

Registration No. BA6612142, alleging 

that Registrant’s registration should be 

revoked because Registrant is ‘‘currently 

without authority to handle controlled 

substances in California, the state in 

which [he is] registered with DEA.’’ Id. 

at 2 (citing 21 U.S.C. 824(a)(3)). 

The OSC notified Registrant of his 

right to file with DEA a written request 

for hearing, and that if he failed to file 

such a request, he would be deemed to 

have waived his right to a hearing and 

be in default. Id. (citing 21 CFR 

1301.43). Here, Registrant did not 

request a hearing. RFAA, at 2.1 ‘‘A 

default, unless excused, shall be 

deemed to constitute a waiver of the 

[registrant’s] right to a hearing and an 

admission of the factual allegations of 

the [OSC].’’ 21 CFR 1301.43(e). 

Further, ‘‘[i]n the event that a 

registrant . . . is deemed to be in 

default . . . DEA may then file a request 

for final agency action with the 

Administrator, along with a record to 

support its request. In such 

circumstances, the Administrator may 

enter a default final order pursuant to 

[21 CFR] § 1316.67.’’ Id. § 1301.43(f)(1). 

Here, the Government has requested 

final agency action based on Registrant’s 

default pursuant to 21 CFR 1301.43(c), 

(f), 1301.46. RFAA, at 1; see also 21 CFR 

1316.67. 


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