[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.
[[Page 28933]]
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
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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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