As a result of the success of the United States Patent and Trademark Office’s (USPTO’s) Cancer Immunotherapy Pilot Program and in order to support the White House’s renewed Cancer Moonshot initiative, the USPTO is implementing the Cancer Moonshot Expedited Examination Pilot Program to provide a broad scope of cancer-related technologies eligible for fast-track review. The new program is an expansion of and replaces the Cancer Immunotherapy Pilot Program, which was launched in 2016 and terminated on January 31, 2023.
Applications accepted into the new Cancer Moonshot Expedited Examination Pilot Program will be advanced out of turn for examination and reviewed earlier (accorded special status) until a first Office action. Participants in the new program will not incur the petition to make special fee and are not required to satisfy the other requirements of the accelerated examination program. The new program begins on February 1, 2023, and is scheduled to run until either January 31, 2025, or the date by which the USPTO accepts a total of 1,000 grantable petitions, whichever is earlier.
- The application must be a non-reissue (original), nonprovisional utility application filed under 35 U.S.C. 111(a), or an international application that has entered the national stage under 35 U.S.C. 371.
- The application must be in the field of oncology or smoking cessation and must contain at least one of the following method claims that meet the eligibility requirements of the program:
- A method of treating or reducing the incidence of a cancer using an immunotherapeutic compound or composition (cancer immunotherapy method).
- A method of treating a cancer by targeting specific genetic markers or mutations using a specific pharmaceutical composition.
- A method of treating a rare or childhood cancer using a specific pharmaceutical composition.
- A method of detecting or treating a cancer using a medical device specifically adapted to detect or treat the cancer.
- A method of treating a cancer by administering a specific pharmaceutical composition wherein the method comprises a step to diagnose the cancer; and
- A method of treating a nicotine dependency and promoting smoking cessation by administering a specific pharmaceutical composition.
- If the application contains product or apparatus claims that meet the eligibility requirements of the program (that is, claims to the immunotherapeutic compound or composition, the pharmaceutical composition, or the medical device used in an eligible method claim), the eligible method claims must depend from or be commensurate in scope with the eligible product or apparatus claims in the application (that is, the eligible method claims must contain all of the limitations of the eligible product or apparatus claims).
- The application or national stage entry must be electronically filed using Patent Center, and the specification, claims, and abstract must be submitted in DOCX format at the time of filing or national stage entry. To learn more about filing in DOCX format, please consider attending a DOCX training webinar or visiting the DOCX information page.
- Applicants must use Form PTO/SB/465—which contains the petition and requisite certifications—to request participation in this program. Form PTO/SB/465 must be filed electronically using Patent Center.
- Form PTO/SB/465 must be filed prior to a first Office action (which may be an Office action containing only a restriction requirement).
- Petition filing limitations: Applicants may not file a petition to participate in this pilot program if the inventor or any joint inventor has been named as the inventor or a joint inventor on more than nine other nonprovisional applications in which a petition to make special under this program has been filed.
- All other requirements and conditions of this program are provided in the 2022 Federal Register notice for this program.
How to file:
- Complete and sign Form PTO/SB/465. (Available on February 1, 2023)
- Save Form PTO/SB/465 and upload via Patent Center.
- When uploading Form PTO/SB/465, select the document description Petition for Cancer Moonshot Pilot (found under the Petition Category) on the Patent Center screen to ensure timely and appropriate processing.
- Federal Register notice on Cancer Moonshot Expedited Examination Pilot Program, 87 FR 75608 (December 9, 2022)
- USPTO Announces Cancer Moonshot Expedited Examination Pilot Program
- Applications granted special status for this pilot as of November 13, 2023: 48 filed / 26 granted
- For questions about Patent Center, please contact the Patent Electronic Business Center at email@example.com or 866-217-9197.
- For questions regarding a Cancer Moonshot Expedited Examination Pilot Program petition, please contact:
Gary B. Nickol, Supervisory Patent Examiner, Technology Center 1600, at 571-272-0835 or firstname.lastname@example.org; or
Brandon J. Fetterolf, Supervisory Patent Examiner, Technology Center 1600, at 571-272-2919 or email@example.com
- For questions regarding the Cancer Moonshot Expedited Examination Pilot Program Federal Register Notice, please contact the Office of Patent Legal Administration at 571-272-7704 or email PatentPractice@uspto.gov.
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