“The possibility of rapid examination…should make the COVID-19 Prioritized Examination Pilot Program an attractive option for small companies, non-profit research groups, and individual inventors who are working on an expedited schedule to generate interest in or secure funding or market share for their COVID-related technologies.” – Joseph Anderson
On May 7, the U.S. Patent and Trademark Office (USPTO) published a Notice in the Federal Register regarding the implementation of a new pilot program for COVID-19 related applications (COVID-19 Pilot Program). Under the COVID-19 Pilot Program, the USPTO would grant prioritized examination, similar to the existing Track One Prioritized Examination program, to applications claiming a product or process related to COVID-19, which “must be subject to an applicable FDA approval for COVID-19 use”. Under the program, requests will be granted to qualifying small or micro entity applicants without payment of the typical prioritized examination fees.
Prioritized Examination and COVID-19
In general, the goal of prioritized examination is to provide an applicant with a final disposition within about 12 months of the date from which a petition for prioritized examination is granted, or within six months if the applicant provides timely responses to notices and actions. A final disposition is considered one of the following: “(1) the mailing of a notice of allowance; (2) the mailing of a final Office action; (3) the filing of an RCE; (4) the abandonment of the application; or (5) the filing of a Notice of Appeal.”
Scott Marty, partner at Ballard Spahr LLC, noted that the COVID-19 Pilot Program “could ultimately save the applicant thousands of dollars, as well as reducing the time to final decision to 12 months or possibly less.” The COVID-19 Pilot Program provides the possibility for a final decision in as fast as six months,while the Track One program guarantees a final decision within 12 months.
Marty’s colleague, Joseph Anderson, noted that the “possibility of rapid examination (and, potentially, the quick issuance of a patent) should make the COVID-19 Prioritized Examination Pilot Program an attractive option for small companies, non-profit research groups, and individual inventors who are working on an expedited schedule to generate interest in or secure funding or market share for their COVID-related technologies.”
The Notice explained that the COVID-19 Pilot Program will continue until the USPTO has accepted a total of 500 requests. However, the program may be extended or terminated depending on “workload and resources needed to administer the program, feedback from the public, and the effectiveness of the program.”
By way of background, the USPTO typically examines new patent applications in the order in which they are filed. However, there are circumstances that allow an application to be advanced or accorded special status, such as by the filing of a petition to make special under 37 CFR 1.102(c) and (d) with the appropriate showing, or by the filing of a grantable request for Track One prioritized examination under 37 CFR l.102(e). A grantable request for Track One prioritized examination under 37 CFR l.102(e) must be in accordance with certain requirements and must be accompanied by payment of appropriate fees, including a prioritized examination fee set forth in 37 CFR l.l7(c) and a processing fee set forth in 37 CFR 1.17(i)(l).
As set forth in 37 CFR 1.183, the USPTO may suspend or waive sua sponte any requirement of its regulations that is not a requirement of the patent statutes in an extraordinary situation, such as the COVID-19 outbreak. Thus, the USPTO has implemented the COVID-19 Pilot Program to provide prioritized examination, similar to Track One prioritized examination, for certain COVID-19 related applications, without payment of the additional fees for prioritized examination. Anderson also noted that the COVID-19 Pilot Program “removes the key financial barriers to small and micro-entities pursuing prioritized examination before the U.S. Patent and Trademark Office (USPTO)—rather than requiring payment of an extra $1,000 (micro-entity) or $2,000 (small entity) fee as is required under the existing Track One Prioritized Examination Program, the new pilot program only requires payment of the standard nonprovisional filing, search, and examination fees.”
Outline of Requirements to Participate in the COVID-19 Pilot Program
The COVID-19 Pilot Program is available for applications claiming products or processes that are subject to an applicable FDA approval for COVID-19 use. Such 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).” Further, the COVID-19 Pilot Program is limited to applicants qualifying for small or micro entity status in order to allow the USPTO to focus its resources on applicants that may be more resource constrained.
Further, as set forth in the Notice, in order to participate in the COVID-19 Pilot Program:
The request for prioritized examination under the pilot program must be made:
- with the filing of a non-continuing original utility or plant nonprovisional application;
- with the filing of an original utility or plant nonprovisional application claiming the benefit of an earlier filing date under 35 S.C. 120, 121, or 365(c) of one prior nonprovisional application or one prior international application designating the United States; or
- with or after the filing of a request for continued examination (RCE) of such plant or utility application or of a national stage of an international application. Consistent with 37 CFR 1.102(e)(2), only a single request for prioritized examination filed with or after filing an RCE may be granted in an
In addition, the COVID-19 Pilot Program may not be used in any application claiming the benefit of the filing date of two or more non-provisional U.S. or international applications. Claiming the benefit of priority to a provisional application will not disqualify an applicant from applying for the COVID-19 Pilot Program.
Requests for prioritized examination under the COVID-19 Pilot Program should be made using USPTO form PTO/SB/450, titled “Certification and Request for COVID-19 Prioritized Examination Pilot Program under 37 CFR 1.102(e)”. In making a request for prioritized examination under the COVID-19 Pilot Program, the applicant must certify that “at least one of the pending claims covers a product or process related to COVID-19 and that such product or process is subject to an applicable FDA approval for COVID-19 use” and that the applicant qualifies for small or micro entity status. Such certifications are included in Form PTO/SB/450.
Internal USPTO Processing of Requests under the COVID-19 Pilot Program
COVID-19 Pilot Program requests are reviewed for compliance with the above requirements as well as the requirements set forth in a normal Track One prioritized examination request under 37 CFR 1.102(e). Other than the payment of fees, the 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).” In addition, no extensions of time may be requested prior to the request being decided.
Similar to requests for Track One prioritized examination under 37 CFR 1.102(e), requests for extensions of time for responding to office actions under the COVID-19 Pilot Program will terminate the prioritized status and cause the application to be placed on the examiner’s regular docket. The Notice also explains that applications accepted into the First Action Interview (FIA) program are not eligible for the COVID-19 Pilot Program. However, standard interview practices and procedures are still available to applicants under the COVID-19 Pilot Program. The Notice explained that the 12-month time frame is a goal and failure to meet the 12-month goal is neither petitionable nor appealable.
The Notice indicated that comments may be sent by email to [email protected] and questions may be directed to Robert A. Clarke, Editor of the Manual of Patent Examining Procedure (MPEP) (telephone at 571-272-7735; email at [email protected] ).
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patent leatherMay 12, 2020 12:54 am
What does “such product or process is subject to an applicable FDA approval for COVID-19 use” actually mean? That the invention must have already been submitted to the FDA? That’s not very useful since it would delay the patent filing.