Requirements under COVID-19 Prioritized Examination Pilot Program

June 8, 2020 – Article

The USPTO has launched a new Covid-19 Prioritized Examination Pilot Program to help small and micro entities. The USPTO will accept requests for prioritized examination of up to 500 qualifying patent applications 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. 

Under the COVID-19 Prioritized Examination Pilot Program: 
  • Applications must contain one or more claims to a product or process related to COVID-19. To qualify, the claims 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.
  • The 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 using the USPTO patent electronic filing system 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.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).

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.

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.

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. 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.