Federal Register / Vol. 89, No. 190 / Tuesday, October 1, 2024 / Notices 79899 

Notification to Interested Parties 

We are issuing and publishing these 

results in accordance with sections 

751(a)(1) and 777(i)(1) of the Act and 19 

CFR 351.221(b)(4). 

Dated: September 6, 2024. 

Abdelali Elouaradia, 

Deputy Assistant Secretary for Enforcement 

and Compliance. 

Appendix 

List of Topics Discussed in the Preliminary 

Decision Memorandum 

I. Summary 

II. Background 

III. Scope of the Order 

IV. Discussion of the Methodology 

V. Currency Conversion 

VI. Recommendation 

[FR Doc. 2024–22521 Filed 9–30–24; 8:45 am] 

BILLING CODE 3510–DS–P 

DEPARTMENT OF COMMERCE 

Patent and Trademark Office 

[Docket No. PTO–P–2024–0047] 

Grant of Interim Extension of the Term 

of U.S. Patent No. 7,199,162— 

GRAFAPEXTM (Treosulfan) 

AGENCY: United States Patent and 

Trademark Office, Commerce. 

ACTION: Notice of interim patent term 

extension. 

SUMMARY: The United States Patent and 

Trademark Office has issued a 

certificate for a one-year interim 

extension of the term of U.S. Patent No. 

7,199,162. 

FOR FURTHER INFORMATION CONTACT: 

Kathleen Kahler Fonda, Senior Legal 

Advisor (telephone (571) 272–7754; 

email kathleen.fonda@uspto.gov). 

Alternatively, mail may be addressed to 

Commissioner for Patents, Mail Stop 

Hatch-Waxman PTE, P.O. Box 1450, 

Alexandria, VA 22313–1450, and 

marked to the attention of Ms. Fonda. 

SUPPLEMENTARY INFORMATION: Section 

156 of title 35, United States Code, 

generally provides that the term of a 

patent may be extended for a period of 

up to five years if the patent claims a 

product, or a method of making or using 

a product, that has been subject to 

certain defined regulatory review, and 

that the patent may be extended for 

interim periods of up to one year if the 

regulatory review is anticipated to 

extend beyond the expiration date of the 

patent. 

On August 20, 2024, Medac 

Gesellschaft fu ̈r Klinische 

Spezialpra ̈parate mbH, the patent owner 

of record, timely filed an application 

under 35 U.S.C. 156(d)(5) for a fourth 

interim extension of the term of U.S. 

Patent No. 7,199,162. The patent claims 

a method of using the human drug 

product GRAFAPEXTM (treosulfan). The 

application for patent term extension 

indicates that New Drug Application 

214759 was submitted to the Food and 

Drug Administration on August 11, 

2020, and its review in order for the 

patent owner to obtain permission to 

market and use the product 

commercially is ongoing. 

Review of the patent term extension 

application indicates that, except for 

permission to market or use the product 

commercially, the subject patent would 

be eligible for an extension of the patent 

term under 35 U.S.C. 156, and that the 

patent should be extended for one year 

as required by 35 U.S.C. 156(d)(5)(B). 

Because the regulatory review period 

will continue beyond the thriceextended expiration date of the patent, 

October 12, 2024, interim extension of 

the patent term under 35 U.S.C. 

156(d)(5) is appropriate. 

A fourth interim extension under 35 

U.S.C. 156(d)(5) of the term of U.S. 

Patent No. 7,199,162 is granted for a 

period of one year from the thriceextended expiration date of the patent. 

Charles Kim, 

Deputy Commissioner for Patents, United 

States Patent and Trademark Office. 

[FR Doc. 2024–22480 Filed 9–30–24; 8:45 am] 

BILLING CODE 3510–16–P 

DEPARTMENT OF COMMERCE 

Patent and Trademark Office 

[Docket No.: PTO–P–2024–0051] 

Extension and Termination of the After 

Final Consideration Pilot Program 2.0 

AGENCY: United States Patent and 

Trademark Office, Department of 

Commerce. 

ACTION: Notice. 

SUMMARY: On April 3, 2024, the United 

States Patent and Trademark Office 

(USPTO), when setting and adjusting 

patent fees for fiscal year 2025, 

proposed a new fee to recuperate costs 

affiliated with the submission of a 

request for consideration under the 

After Final Consideration Pilot Program 

2.0 (AFCP 2.0). Commenters on the 

proposal expressed concerns about the 

AFCP 2.0 and the proposed fee. In view 

of these comments, the USPTO has 

decided to allow AFCP 2.0 to expire. 

While the program currently runs 

through September 30, 2024, to 

accommodate those who may be in the 

process of preparing to use the program, 

the USPTO will provide a short 

extension of the expiration of the 

program. The USPTO is setting 

December 14, 2024, as the last day to 

submit a request for participation under 

the program. 

DATES: The USPTO will not accept 

requests for consideration under the 

AFCP 2.0 filed after December 14, 2024. 

FOR FURTHER INFORMATION CONTACT: Kery 

Fries, Senior Legal Advisor, at 571–272– 

7757; or Raul Tamayo, Senior Legal 

Advisor, at 571–272–7728, both with 

the Office of Patent Legal 

Administration, Office of the Deputy 

Commissioner for Patents. 

SUPPLEMENTARY INFORMATION: On May 

19, 2013, the USPTO modified the After 

Final Consideration Pilot Program 

(AFCP) to create the AFCP 2.0. The 

three main differences between the 

AFCP and the AFCP 2.0 are: (1) an 

applicant must request to participate in 

AFCP 2.0; (2) a response to an after final 

rejection under AFCP 2.0 must include 

a non-broadening amendment to at least 

one independent claim; and (3) the 

examiner will schedule an interview 

with the applicant if the after-final 

response did not result in a 

determination by the examiner that all 

pending claims in the application were 

in condition for allowance. 

The goal of the AFCP 2.0 was to 

improve pendency by reducing the 

number of Requests for Continued 

Examination (RCE) and encourage 

increased collaboration between the 

applicant and the examiner to 

effectively advance prosecution of the 

application. The AFCP 2.0 does not 

require any additional fees for an 

applicant to request consideration of an 

amendment after final rejection, but any 

necessary existing fee, e.g., the fee for an 

extension of time, is required. Initially, 

the pilot program was scheduled to run 

for approximately one year and was set 

to end on September 30, 2014. The 

USPTO notified the public that the 

AFCP 2.0 may be extended (with or 

without modifications) depending on 

feedback from participants and based on 

a determination of the effectiveness of 

the pilot program. The USPTO 

repeatedly extended the pilot program, 

with the most recent extension set to 

end on September 30, 2024. 

Since 2016, applicants have filed 

more than 60,000 AFCP 2.0 requests 

annually. Due to the high usage of the 

AFCP 2.0, costs to administer the 

program are significant. A large part of 

the AFCP 2.0’s high usage is due to 

economic inefficiencies where 

participants receive program benefits 

without paying for the cost of the 


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