[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28932-28935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10372]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No.: PTO-P-2020-0026]


COVID-19 Prioritized Examination Pilot Program

AGENCY: United States Patent and Trademark Office, Department of 
Commerce.

ACTION: Notice.

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SUMMARY: The United States Patent and Trademark Office (USPTO or 
Office) is implementing a pilot program to provide prioritized 
examination of certain patent applications. 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.
    Under this pilot program, the USPTO will grant qualified requests 
for prioritized examination without payment of certain fees associated 
with prioritized examination for applicants that qualify for small or 
micro entity status. The goal of prioritized examination is to provide 
a final disposition within 12 months, on average, from the date the 
prioritized status has been granted. Furthermore, the USPTO believes it 
can achieve final disposition in six months if applicants provide more 
timely responses to notices and actions from the USPTO, as compared to 
those required by prioritized examination. This notice outlines the 
conditions, eligibility requirements, and guidelines of the pilot 
program.

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DATES: Comments must be received by July 13, 2020 to ensure 
consideration.
    Pilot Duration: The COVID-19 Prioritized Examination Pilot Program 
will accept requests for prioritized examination beginning July 13, 
2020 until such time as the USPTO has accepted a total of 500 requests. 
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.

ADDRESSES: Comments should be sent by email addressed to 
[email protected]. If submission of comments by 
email is not feasible due to, e.g., a lack of access to a computer and/
or the internet, please contact the USPTO for special instructions 
using the contact information provided in the FOR FURTHER INFORMATION 
CONTACT section of this notice.
    Comments will be available for viewing via the USPTO's website 
(https://www.uspto.gov). Because the comments will be made available 
for public viewing, information the submitter does not desire to make 
public, such as an address or phone number, should not be included in 
the comments.

FOR FURTHER INFORMATION CONTACT: Robert A. Clarke, Editor of the Manual 
of Patent Examining Procedure (MPEP) (telephone at 571-272-7735; email 
at [email protected]).

SUPPLEMENTARY INFORMATION: New patent applications are normally taken 
up for examination in the order of their U.S. filing dates. See section 
708 of the MPEP (9th ed., Rev. 08.2017, 2018). The USPTO has procedures 
under which an application will be advanced out of turn (accorded 
special status) for examination if the applicant files a petition to 
make special under 37 CFR 1.102(c) and (d) with the appropriate 
showing. See 37 CFR 1.102(c) and (d) and MPEP 708.02 and 708.02(a).
    In addition, an application can be advanced out of turn (accorded 
special status) for examination if the applicant files a grantable 
request for prioritized examination under 37 CFR 1.102(e). Section 
11(h) of the Leahy-Smith America Invents Act, Public Law 112-29, 125 
Stat. 284 (2011), effective September 26, 2011, provides for 
prioritized examination whereby an applicant may request prioritized 
examination upon payment of appropriate fees and compliance with 
certain requirements. See MPEP 708.02(b). 35 U.S.C. 2(b)(2)(G) 
authorizes the USPTO to provide for prioritization of examination of 
applications for products, processes, or technologies that are 
important to the national economy or national competitiveness without 
requiring the prioritized examination fee.
    In an extraordinary situation, 37 CFR 1.183 permits the USPTO to 
suspend or waive sua sponte any requirement of its regulations that is 
not a requirement of the patent statutes. The USPTO considers the 
effects of the COVID-19 outbreak that began in approximately January 
2020 to be an ``extraordinary situation'' within the meaning of 37 CFR 
1.183 for affected patent applicants and innovators. Consistent with 
this determination and the provisions of 35 U.S.C. 2(b)(2)(G), the 
USPTO has decided to implement a pilot program to provide prioritized 
examination without payment of the additional fees for prioritized 
examination for certain applications that claim products or processes 
that are subject to an applicable FDA approval for COVID-19 use. Such 
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 INDs, IDEs, NDAs, BLAs, PMAs, and EUAs may be obtained 
at www.fda.gov. To focus the USPTO's resources on those applicants that 
may be more resource constrained, the pilot is limited to applicants 
that qualify for either small or micro entity status. The USPTO will 
periodically evaluate the pilot program to determine whether and to 
what extent its coverage should be expanded or limited.
    The USPTO currently provides for prioritized examination of utility 
and plant original applications if certain requirements are met. See 37 
CFR 1.102(e) and MPEP 708.02(b). Upon filing a request for prioritized 
examination, an applicant must pay certain fees, including a 
prioritized examination fee set forth in 37 CFR 1.17(c) and a 
processing fee set forth in 37 CFR 1.17(i)(1). The requirement to pay 
these two fees will be waived under this pilot program if the 
requirements are met. The remaining fees listed in 37 CFR 1.102(e) and 
MPEP 708.02(b), subsection I. A. 2., that are not currently set to $0 
must be paid by all applicants, and the requirement to pay those fees 
by the time the request for prioritized examination is made is not 
waived under this pilot program.

Part I. Requirements To Participate

    (1) The request for prioritized examination under the pilot program 
must be made:
    (a) With the filing of a non-continuing original utility or plant 
nonprovisional application;
    (b) with the filing of an original utility or plant nonprovisional 
application claiming the benefit of an earlier filing date under 35 
U.S.C. 120, 121, or 365(c) of one prior nonprovisional application or 
one prior international application designating the United States; or
    (c) 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 application.
    The pilot program is reserved for the above nonprovisional 
applications. Any application that claims the benefit of the filing 
date of two or more prior filed nonprovisional 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 under the 
pilot program, but the applicant may request prioritized examination 
under 37 CFR 1.102(e). Claiming the benefit under 35 U.S.C. 119(e) of 
one or more prior provisional applications or claiming a right of 
foreign priority under 35 U.S.C. 119(a)-(d) or (f) to one or more 
foreign applications will not cause a nonprovisional application to be 
ineligible for the pilot program.
    The USPTO encourages the use of form PTO/SB/450, titled 
``Certification and Request for COVID-19 Prioritized Examination Pilot 
Program under 37 CFR 1.102(e),'' to make the request for prioritized 
examination under the pilot. Form PTO/SB/450 is available at https://www.uspto.gov/patent/forms/forms-patent-applications-filed-or-after-september-16-2012. Form PTO/SB/450 contains the necessary 
certifications for qualification to participate in the pilot. Use of 
form PTO/SB/450 will also enable the USPTO to quickly identify and 
timely process the request.
    (2) 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. Form PTO/SB/450 contains this certification.
    (3) The request must include a certification that the applicant 
qualifies for either small entity (37 CFR 1.27) or micro entity (37 CFR 
1.29) status when

[[Page 28934]]

the request is made. Form PTO/SB/450 contains this certification.
    (4) The request must include an executed application data sheet 
meeting the conditions specified in 37 CFR 1.53(f)(3)(i).

Part II. Internal Processing of the Request Under the Pilot Program

    Requests complying with the four requirements above will be further 
reviewed to determine if the other requirements for prioritized 
examination are met, e.g., the requirements of 37 CFR 1.102(e) other 
than payment of the fees set forth in 37 CFR 1.17(c) and 1.17(i)(1). 
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). In addition, obtaining an extension of time to a 
notice before the request has been acted upon will result in the 
request being denied. See MPEP 708.02(b), subsection I, for a 
discussion of the requirements.

Part III. Office Actions and Replies Under the Pilot Program

    The time periods set for reply in Office actions for applications 
undergoing prioritized examination under the pilot program will be the 
same as those for other applications undergoing prioritized examination 
and are set forth in MPEP 710.02(b). 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. In addition, in order to maintain special 
status, 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, as is the 
case with other applications undergoing prioritized examination. Upon 
termination of prioritized examination, 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.
    A reply to an Office action must be fully responsive to the 
rejections, objections, and requirements made by the examiner. Any 
amendment filed in reply to a non-final Office action will be treated 
as not fully responsive if it attempts to: (1) Add claims that would 
result in more than four independent claims or more than 30 total 
claims pending in the application; or (2) add any multiple dependent 
claim. If a reply to a non-final Office action is not fully responsive 
because it does not comply with the pilot program requirements but is a 
bona fide attempt to advance the application to final action, the 
examiner may, at his or her discretion, provide one month or 30 days, 
whichever is longer, for the applicant to supply a fully responsive 
reply, in which case prioritized examination would not be terminated. 
Submission of a petition for extension of time under 37 CFR 1.136(a) to 
the notice of nonresponsive amendment will result in termination of 
special status. Any further nonresponsive amendment will not be treated 
as bona fide, and the time period set in the prior notice will continue 
to run.

Part IV. After-Final and Appeal Procedures

    The mailing of a final Office action or the filing of a Notice of 
Appeal, whichever is earlier, is a final disposition for purposes of 
the 12-month goal for the pilot program. During the appeal process, the 
application will be treated in accordance with the normal appeal 
procedure (see MPEP chapter 1200). Any amendment, affidavit, or other 
evidence submitted after a final Office action and prior to appeal must 
comply with 37 CFR 1.116. 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.

Part V. Proceedings Outside the Normal Examination Process

    If an application becomes involved in proceedings outside the 
normal examination process (e.g., a secrecy order or petitions under 37 
CFR 1.181-1.183), the USPTO will place the application in special 
status under the pilot program before and after such proceedings. 
During those proceedings, however, the application will not be under 
special status. For example, while under a secrecy order, the 
application will be treated in accordance with the normal secrecy order 
procedures and will not be in special status under the pilot program. 
Once the proceeding outside the normal examination process is 
completed, the application will continue in special status until it 
reaches a final disposition, which may occur later than 12 months from 
the grant of special status under the pilot program.

Part VI. First Action Interview (FAI) Pilot Program Is Not Available

    Applications accepted into the FAI Pilot Program are not eligible 
for this pilot program. In addition, applications accepted into this 
pilot program will not be eligible to participate in the FAI Pilot 
Program. However, standard interview practices and procedures 
applicable to regular ex parte prosecution will still be available. See 
MPEP 713.02. For more information about the FAI Pilot Program, please 
visit https://www.uspto.gov/patent/initiatives/first-action-interview/full-first-action-interview-pilot-program.

Part VII. Actions Resulting in Termination From the Pilot Program

    There is no provision for withdrawal from special status under the 
pilot program. However, the filing of a petition for any extension of 
time under 37 CFR 1.136(a) 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.
    An applicant may abandon the application that has been granted 
special status under the pilot program in favor of a continuing 
application. However, a continuing application will not automatically 
be given prioritized examination status based on the request filed in 
the parent application. Each application (including each continuing 
application) must, on its own, meet all requirements for prioritized 
examination under the pilot program.

Part VIII. Twelve-Month Goal

    The objective of the pilot program is to complete, on average, the 
examination of an application within 12 months of special status being 
granted (i.e., within 12 months from the mailing date of the decision 
granting the petition to make special). The 12-month goal is 
successfully achieved when one of the following final dispositions 
occurs within 12 months from the grant of special status under the 
pilot program: (1) The mailing of a notice of allowance; (2) the 
mailing of a final Office action; (3) the filing of an RCE; (4) the

[[Page 28935]]

abandonment of the application; or (5) the filing of a Notice of 
Appeal. The final disposition of an application, however, may occur 
later than the 12-month time frame in certain situations (e.g., when 
the applicant filed a petition under 37 CFR 1.181). In any event, 
however, the 12-month time frame is a goal. Any failure to meet the 12-
month goal, or other issues related to this goal that arise, are 
neither petitionable nor appealable matters.
    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. Current 
statistics for prioritized examination are available at https://www.uspto.gov/corda/dashboards/patents/main.dashxml?CTNAVID=1007.

Andrei Iancu,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2020-10372 Filed 5-13-20; 8:45 am]
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