The United States Patent and Trademark Office (USPTO) will accept requests for prioritized examination filed in qualifying patent applications until midnight on December 31, 2021 without requiring payment of certain fees associated with prioritized examination. Under this pilot, the USPTO will advance out of turn certain patent applications related to COVID-19 for examination, resulting in their prioritized examination. The USPTO aims to provide final disposition of patent applications in the pilot in one year or less after it grants prioritized status.
COVID-19 Prioritized Examination Pilot Program description:
- Applications must contain one or more claims to a product or process related to COVID-19.
- Such claimed product or process must be subject to an applicable Food and Drug Administration (FDA) approval for COVID-19 use.
- The request must include a certification that the applicant qualifies for either small or micro entity status and an executed Application Data Sheet (ADS) meeting the requirements of 37 CFR 1.53(f)(3)(i).
- Applicants must file a grantable request under this initiative using the USPTO patent electronic filing system (EFS-Web or Patent Center) if filing the request in a utility application.
- Applicants should use Pilot Program Form PTO/SB/450 to request participation in the pilot.
- The pilot is open to:
- non-continuing, original, nonprovisional utility or plant patent applications filed with an acceptable request to participate
- original, nonprovisional utility or plant applications making a benefit claim under 35 U.S.C. 120, 121, or 365(c) to one prior nonprovisional application or one prior international application designating the United States filed with an acceptable request to participate
- utility or plant applications, including the national stage of a prior international application, in which an acceptable request to participate has been filed with or after a request for continued examination (RCE), if no prior RCE was granted prioritized examination status.
- The fees set forth in 37 CFR 1.17(c) and (i)(1) are not required to participate in the program.
Any application that claims the benefit of the filing date of two or more previously filed non-provisional U.S. applications or international applications designating the United States under 35 U.S.C. 120, 121, or 365(c) is not eligible for participation in this pilot, but the applicant may request prioritized examination under 37 CFR 1.102(e).
Benefit claims to one or more prior provisional applications under 35 U.S.C. 119(e) or foreign priority claims under 35 U.S.C. 119(a)-(d) or (f) will not cause a non-provisional application to be ineligible for this pilot.
How to file
- Fill out Pilot Program Form PTO/SB/450.
- Save the form and upload it via our patent electronic filing system, EFS-Web.
- For Original Utility (Track One)—Prioritized Examination, select “New application/proceeding Utility > Track I Prioritized Examination - Nonprovisional Application under 35 USC 111(a)” as the EFS-Web submission type. Do not choose “Utility > Nonprovisional Application under 35 USC 111(a)“ or “Utility > Accelerated Exam.”
- For Request for Continued Examination—Prioritized Examination, select “Existing application/patent/proceeding” > “Documents/Fees for an existing application/proceeding” as the EFS-Web submission type.
- When uploading your PTO/SB/450 form, select document description “COVID-19 Prioritized Examination Request” (found under both the “Track I - Prioritized Examination” and “Pilot Programs” categories) on the EFS-Web Attach Documents screen to ensure processing.
Questions and Answers
When does the pilot go into effect?
The pilot is effective upon the publication of the notice in the Federal Register. Note, the initial published notice erroneously stated that the effective date was July 13. The effective date is May 14.
How long will the pilot last?
The USPTO will accept requests for the prioritized examination pilot program until midnight on December 31, 2021. The USPTO may extend the pilot program (with or without modifications) or terminate it depending on the workload and resources needed to administer the program, feedback from the public, and the effectiveness of the program. If the pilot program is extended or terminated, the USPTO will notify the public.
What does “subject to an applicable FDA approval for COVID-19 use” mean?
U.S. FDA approvals may include, but are not limited to, an Investigational New Drug (IND) application, an Investigational Device Exemption (IDE), a New Drug Application (NDA), a Biologics License Application (BLA), a Premarket Approval (PMA), or an Emergency Use Authorization (EUA). Information on these items are available at www.fda.gov
Is an invention that is an apparatus or composition of matter that is related to COVID-19 and subject to an applicable FDA approval eligible for the pilot program?
Yes. To qualify, the claim(s) of an application must cover a product or process related to COVID-19, and such product or process must be subject to an applicable FDA approval for COVID-19 use. The phrase “product or process” includes any process, machine, manufacture, or composition of matter as set forth in 35 U.S.C. 101.
Can a large entity (i.e., an applicant that does not qualify for small or micro entity status) file a request for the pilot program?
No. The pilot program is only for applicants that qualify for either small entity (37 CFR 1.27) or micro entity (37 CFR 1.29) status. An applicant that does not qualify as either a small or a micro entity applicant may request prioritized examination under 37 CFR 1.102(e).
Why does the pilot program include RCEs when COVID-19 is a new virus?
Some inventions that are useful in treating COVID-19 patients were invented prior to the known cases of COVID-19 in humans. An application directed to such an invention may currently be under final rejection, and therefore, could benefit from the pilot program.
Can a request for the pilot program be filed after receiving a first Office action subsequent to the filing of an RCE?
No. The request must be filed before the mailing of the first Office action after the filing of the RCE. See Manual of Patent Examining Procedure (MPEP) § 708.02(b), subsection I.C.3.
What requirements for prioritized examination under 37 CFR 1.102(e) are waived in the pilot program?
The payment of the prioritized examination fee set forth in 37 CFR 1.17(c) and the processing fee set forth in 37 CFR 1.17(i) is waived in the pilot program. All other requirements set forth in 37 CFR 1.102(e) are applicable to applications in the pilot program. These requirements include: filing the application and request for prioritized examination under the pilot program via the USPTO’s patent electronic filing systems (EFS-Web or Patent Center) if the application is a utility application; presenting no more than four independent claims and 30 total claims, and no multiple dependent claims; and paying the other required fees (e.g., the basic filing fee, search fee, and examination fee).
If an applicant has already provided a proper, executed ADS in an application, must a copy of the executed ADS be provided with a request to participate in the pilot?
No. The request will be treated as though it includes the required executed ADS if a proper, executed ADS was previously provided in the application.
What will the time periods set for reply in Office actions be for applications in the pilot program?
The time periods set for reply in Office actions for applications undergoing prioritized examination under the pilot program are set forth in MPEP § 710.02(b), which are the same time periods set for other applications undergoing prioritized examination. If an applicant files a petition for an extension of time to file a reply or a request for suspension of action, the petition or request will be acted upon, but the prioritized examination of the application under the pilot program will be terminated, as is the case with other applications undergoing prioritized examination.
What does “final disposition” mean?
The goal of the Office is to provide a final disposition within 12 months, on average, of the date prioritized status was granted. The final disposition for the 12-month goal means that within 12 months from the date prioritized status is granted, one of the following will occur: (1) mailing of a notice of allowance; (2) mailing of a final Office action; (3) filing of a notice of appeal; (4) completion of examination as defined in 37 CFR 41.102; (5) filing of an RCE; or (6) abandonment of the application.
Is it possible to achieve final disposition in less than 12 months?
Applicants may shorten the overall pendency of an application in the pilot program by replying to Office actions and notices earlier than required by the USPTO. For example, the USPTO will endeavor to reduce pendency—from approval of the request for prioritized examination to final disposition—to six months if all replies occur within 30 days of a notice by the USPTO. This goal depends on additional factors, including the demands placed on specific examiners by multiple co-pending applications under the pilot program.
Will the prioritized status apply when the application enters the post-allowance process or the appeal process?
No. The mailing of a notice of allowance or a final Office action, or the filing of a Notice of Appeal, whichever is earlier, ends the prioritized status granted under the pilot program. In addition, the filing of an RCE for an application in the pilot program is a final disposition for purposes of the 12-month goal for the program. The application will not retain its special status after the filing of a proper RCE.
Can an applicant withdraw the application from the pilot program?
No. There is no provision for withdrawal from special status under the pilot program. However, filing a petition for any extension of time under 37 CFR 1.136(a) or abandoning the application will result in the termination of special status under the pilot program. Presenting more than one benefit claim to previously filed nonprovisional U.S. applications or international applications designating the United States under 35 U.S.C. 120, 121, or 365(c) will also result in the termination of special status under the pilot program. In addition, filing an amendment to the application that results in more than four independent claims, more than 30 total claims, or a multiple dependent claim will terminate the prioritized examination status unless the amendment is treated as not fully responsive by the examiner.
What happens to the application if its prioritized examination status is terminated?
Upon termination of prioritized examination status, the application will be removed from the examiner’s special docket and placed on the examiner’s regular docket in accordance with its stage of prosecution, as is the case with other applications undergoing prioritized examination.
For questions about EFS-Web or the PAIR system, please contact the Patent Electronic Business Center at 866-217-9197.
For questions regarding the COVID-19 Prioritized Examination Pilot Program Federal Register notice, please contact Robert Clarke at 571-272-7735 or via email at covid19PrioritizedExamPilot@uspto.gov.