[Federal Register Volume 85, Number 181 (Thursday, September 17, 2020)]
[Notices]
[Pages 58038-58041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20443]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2020-0036]


Deferred-Fee Provisional Patent Application Pilot Program and 
Collaboration Database To Encourage Inventions Related To COVID-19

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

ACTION: Notice.

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SUMMARY: Patents and published patent applications provide a key source 
of free-flowing technical information among the world's brightest 
minds, thus promoting further innovation. The United States Patent and 
Trademark Office (USPTO or Office) recognizes that its charge to issue 
high-quality patents to inventors goes hand-in-hand with dissemination 
of this important information. Such information flow is now more 
important than ever in view of the urgent challenges posed by COVID-19. 
Therefore, the USPTO is implementing a deferred-fee provisional patent 
application pilot program (the program) to promote the expedited 
exchange of information about inventions designed to combat COVID-19. 
Under this program, the USPTO will permit applicants to defer payment 
of the provisional application filing fee until the filing of a 
corresponding nonprovisional application. In turn, applicants must 
agree that the technical subject matter disclosed in their provisional 
applications will be made available to the public via a searchable 
collaboration database maintained on the USPTO's website. To qualify 
for the program, the subject matter disclosed in the provisional 
application must concern a product or process related to COVID-19, and 
such product or process must be subject to an applicable Food and Drug 
Administration (FDA) approval for COVID-19 use, whether such approval 
has been obtained, is pending, or will be sought prior to marketing the 
subject matter for COVID-19.

DATES: Comments must be received by November 16, 2020 to ensure 
consideration.
    Pilot Duration: The deferred-fee provisional patent application 
pilot program will accept certifications and requests for participation 
for a period of 12 months, beginning on September 17, 2020. The USPTO 
may extend the pilot program (with or without modifications) or 
terminate it depending on the workload and resources needed to 
administer it, feedback from the public, and its effectiveness. 
Depending on feedback and public interest, the technological scope 
could also be expanded beyond COVID-19 to other areas that are the 
focus of pioneering or rapid innovation. If the pilot program is 
extended or terminated, the USPTO will notify the public. The USPTO may 
also make the program permanent via the rule-making process.

ADDRESSES: Comments should be sent by email addressed to 
[email protected]. If submission of comments by

[[Page 58039]]

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 Further Information 
section of this notice below.
    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.

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]); or Kathleen Kahler Fonda, Senior Legal 
Advisor, Office of Patent Legal Administration (telephone at 571-272-
7754, email at [email protected]).

SUPPLEMENTARY INFORMATION:

I. Background

    The COVID-19 outbreak is a global crisis in urgent need of creative 
solutions. The American patent system has long facilitated creative 
solutions to important challenges by securing exclusive rights for 
inventors and disseminating technical information to the public to 
promote follow-on innovation. To disseminate information about 
inventions designed to combat COVID-19 on a more expedited basis while 
still securing rights for inventors, the USPTO is implementing a 
deferred-fee provisional patent application pilot program. The intent 
is to provide a cost-effective way for inventors to disclose their 
ideas to others quickly, but without losing their right to claim what 
is described and enabled by their disclosure. This expedited disclosure 
may allow the public to benefit from the efforts of inventors seeking 
to address the COVID-19 outbreak sooner than would otherwise be 
possible. Early public disclosure can facilitate collaborations, 
partnerships, or joint ventures, and, in turn, spur and expedite the 
development of critically needed technologies.

II. Description of the Program

    The program provides for early disclosure of the technical subject 
matter of provisional applications. Program participants will submit a 
technical disclosure as well as a provisional application cover sheet 
and a certification and request to participate in the program (form 
PTO/SB/452, titled ``Certification and Request for COVID-19 Provisional 
Patent Application Program,'' available at https://www.uspto.gov/patent/forms/forms-patent-applications-filed-or-after-september-16-2012). The Office will upload the technical disclosure and the form 
into a searchable public collaborative database and process the 
technical disclosure and the cover sheet as a filing of a provisional 
application. In exchange for the disclosure of the technical subject 
matter, program participants may defer payment of the provisional 
application filing fee until such time as a nonprovisional application 
claiming the benefit of the provisional application is filed. The basic 
filing fee need not be paid at all by those who desire publication of 
the technical subject matter in the collaborative database but do not 
make a benefit or priority claim in a corresponding later-filed 
application.
    The statutory basis for provisional patent applications is 35 
U.S.C. 111(b). In order to be entitled to a filing date, a provisional 
application must include a specification in accordance with 35 U.S.C. 
112; see 37 CFR 1.53(c). Claims may also be included but are not 
required. Under 35 U.S.C. 111(b)(3), a fee is also required for a 
provisional application. Currently, the undiscounted fee is $280; 
applicants who qualify for small entity status pay $140, and those who 
qualify for micro entity status pay $70. See 37 CFR 1.16(d). Although 
payment of the fee is a statutory requirement, 35 U.S.C. 111(b)(3) 
authorizes the Director of the USPTO to permit payment after the filing 
date of the application. The filing requirements for provisional 
applications are discussed in MPEP 601.01(b).
    A later-filed international, foreign or domestic nonprovisional 
application may be entitled to claim benefit or priority of the filing 
date of a provisional application. Domestic benefit under 35 U.S.C. 
119(e)(1) and 37 CFR 1.78 requires that the provisional application be 
entitled to a filing date, and name the inventor or a joint inventor 
also named in the later-filed nonprovisional application. Furthermore, 
the basic filing fee set forth in 37 CFR 1.16(d) must be paid in order 
to rely on the provisional application in a later-filed nonprovisional 
application, although there is no requirement that the basic filing fee 
be paid in order for the technical subject matter to be posted in the 
program's collaborative database. See 37 CFR 1.78(a)(2). For more 
information about claiming the right of priority in an international 
application under the Patent Cooperation Treaty, see MPEP 1828. 
Regardless, the later-filed nonprovisional, international or foreign 
application should be filed not later than 12 months after the date on 
which the provisional application was filed if a benefit or priority 
claim to the provisional application is to be made.

Fee Deferral Under the Program

    Under the program, payment of the basic filing fee for a 
provisional application may be deferred past the date on which the 
provisional application is filed, without imposition of a surcharge, 
provided that the fee is paid not later than the date on which a 
nonprovisional application that claims benefit or priority of the 
provisional application is filed. If the provisional application basic 
filing fee was not paid, a reminder will be sent 10 months after the 
provisional application filing date indicating that the basic filing 
fee must be paid not later than 12 months after the provisional 
application filing date, and in any case, the fee must be paid in order 
for an applicant to claim the benefit of the filing date of the 
provisional application in a nonprovisional application.\1\
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    \1\ Ordinarily, when the basic filing fee is not paid upon 
filing, the Office notifies the applicant that it must be paid 
within an extendable two-month time period from the date of the 
notice, and imposes a surcharge in accordance with 37 CFR 1.16(g). 
See MPEP 601.01(b). However, no notice requiring a basic filing fee 
or surcharge will be sent in an application submitted under the 
program.
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Certification of Eligibility for the Program

    Consistent with the goal of encouraging information-sharing 
regarding inventions related to COVID-19, participation in the program 
requires a certification that the subject matter disclosed in the 
provisional patent application concerns a product or process related to 
COVID-19. The product or process must be 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.
    The subject matter requirement for participation in the program is 
the same as that for participation in the COVID-19 Prioritized 
Examination Pilot Program announced on May 8, 2020 (85 FR 28932). The 
requirement is broadly drafted to include any sort of FDA premarket 
regulatory review procedure.

[[Page 58040]]

An applicant need not have obtained or sought FDA approval prior to 
requesting to participate in either the program or the prioritized 
examination pilot. However, the product or process disclosed in the 
application must require premarket regulatory review by the FDA prior 
to commercial marketing or use.

III. Prior Art Considerations

    An inventor's technical disclosure published in the collaboration 
database cannot be used against the inventor's own corresponding later-
filed nonprovisional application in the United States, provided that 
the later-filed application is filed within one year of the public 
disclosure. Regardless, applicant should consider filing a 
nonprovisional application making a proper benefit claim under 35 
U.S.C. 119(e) and 37 CFR 1.78(a) no more than one year after filing of 
the provisional application. Special care should be taken where foreign 
patent protection is desired. Many foreign jurisdictions treat an 
inventor's public disclosure made within one year of filing as prior 
art against the inventor's own application unless that earlier 
disclosure is the subject of a proper priority claim in that 
jurisdiction. For this reason, applicants should be aware of the prior 
art implications of their submissions. Making a submission under the 
program will result in a public disclosure of the technical subject 
matter via the Office's searchable collaboration database. Thus, such a 
public disclosure may be citable as prior art under 35 U.S.C. 102(a)(1) 
as of the date it publishes. In addition, the complete provisional 
patent application submitted under the program may become prior art 
under 35 U.S.C. 102(a)(2) as of the filing date, but only if there has 
been a proper benefit claim under 35 U.S.C. 119(e) in a later-filed 
nonprovisional application or international application and the later-
filed application has been published or deemed published under 35 
U.S.C. 122(b) or has issued as a U.S. patent.
    It is important to note, for the purpose of understanding prior art 
implications, that the Office does not consider adding the technical 
subject matter disclosed in submissions to the Office's collaboration 
database under the program to constitute publication of the provisional 
application under 35 U.S.C. 122(b).\2\ Rather, by way of submission of 
form PTO/SB/452 and in accordance with the confidentiality waiver 
provision of 35 U.S.C. 122(a), the program participant specifically 
authorizes the database to publish the technical subject matter 
disclosed as well as any contact information the participant wishes to 
include. The database will also publish the name of the inventor or the 
first named joint inventor, the provisional application filing date, 
and the date the submission was placed in the database. However, the 
database will not publish the cover sheet, which is a requirement for a 
provisional application. Furthermore, the basic filing fee need not 
have been paid at the time of publication in the database. For these 
reasons, the disclosure in the database is not a complete provisional 
patent application under 35 U.S.C. 111(b).
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    \2\ Provisional applications are generally maintained in 
confidence and not published under 35 U.S.C. 122(b). See 35 U.S.C. 
122(b)(2)(A)(iii).
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IV. Requirements To Participate in the Program

    (1) The certification and request for participation in the program 
must be by way of a completed form PTO/SB/452, titled ``Certification 
and Request for COVID-19 Provisional Patent Application Program.'' Form 
PTO/SB/452 is available at https://www.uspto.gov/patent/forms/forms-patent-applications-filed-or-after-september-16-2012. The form must be 
submitted with a specification upon filing of the application. Form 
PTO/SB/452 cannot be used to request that a provisional application 
that had previously received a filing date be included in the program; 
such a request will be denied. Form PTO/SB/452 contains the necessary 
certification regarding the need for the product or process disclosed 
to obtain FDA approval prior to marketing for a COVID-19 use, as well 
as a statement authorizing publication of the technical subject matter 
of the program submission. It includes a field for the name of the sole 
inventor or the first joint inventor. (Program participants should 
note, as discussed below, that the provisional application cover sheet 
required by 37 CFR 1.51(c)(1), and not form PTO/SB/452, will be used to 
establish the inventorship of the provisional application.) Form PTO/
SB/452 also allows the program participant to provide any desired 
contact information to be included in the database. Form PTO/SB/452 
must be signed in compliance with 37 CFR 1.33(b). This requires that 
the form be signed by: (1) A patent practitioner of record; (2) a 
patent practitioner not of record who acts in a representative capacity 
under the provisions of 37 CFR 1.34; or (3) the applicant (37 CFR 
1.42), if the applicant is not a juristic entity. If the applicant is 
the inventor (as defined in 35 U.S.C. 100(f)), and the inventor is not 
represented by a patent practitioner, then all individuals who 
constitute the inventive entity must sign; limited exceptions are 
provided in 35 U.S.C. 117. Use of form PTO/SB/452 will enable the USPTO 
to identify the provisional application as a program submission and to 
process the certification and request in a timely manner.
    The program is reserved for provisional patent applications filed 
under 35 U.S.C. 111(b). No nonprovisional patent application or 
international application designating the United States is eligible for 
participation.
    (2) The program submission must be in the English language.
    (3) The program submission must include the provisional application 
cover sheet required by 37 CFR 1.51(c)(1). In accordance with 37 CFR 
1.51(c)(1)(ii), this cover sheet will be used to establish the 
inventorship of the provisional application. Although form PTO/SB/452 
provides a field to indicate the first named inventor for inclusion in 
the searchable online database, the entry in that field will not 
override the inventorship established in the required cover sheet. If 
the applicant is a juristic entity, the applicant must be identified on 
an application data sheet (ADS) included with the program submission; 
in that circumstance, form PTO/SB/452 must be signed by a registered 
practitioner. See 36 CFR 1.46(b). The ADS may serve as the required 
cover sheet. See 37 CFR 1.53(c)(1) and MPEP 601.01(b).
    (4) The provisional application specification including any 
drawings, claims and/or abstract, cover sheet (which may be an ADS), 
and form PTO/SB/452 must be filed electronically via Patent Center. The 
specification must be filed in DOCX format to facilitate making the 
material text searchable. Requests for assistance with electronic 
filing should be directed to the Patent Electronic Business Center at 
[email protected].
    (5) In order for the technical subject matter of a program 
submission to be posted in the Office's collaboration database, the 
submission must meet the requirements for a provisional application as 
indicated in 35 U.S.C. 111(b)(1) and 37 CFR 1.53(c), with the exception 
that payment of the basic filing fee may be deferred until the filing 
of a nonprovisional application that is entitled to claim benefit of 
the provisional application. However, there is no requirement that an 
applicant must file a later application that claims benefit or priority 
of a provisional application filed under the program.

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V. Internal Processing of the Certification and Request Under the 
Program

    (1) A provisional patent application number will be assigned to an 
application filed by a program participant in accordance with 37 CFR 
1.53(a).
    (2) A program submission that includes a legible specification in 
DOCX format, with or without claims, will be given a provisional 
application filing date under 37 CFR 1.53(c). The program participant 
will be notified of the filing date.
    A submission that fails to include a legible specification in DOCX 
format will not be treated as a program submission, even if it is 
accompanied by form PTO/SB/452. The submission will be handled as a 
provisional application, and a notice will be sent pursuant to 37 CFR 
1.53(g), including a requirement for payment of the basic filing fee 
ordinarily within two months of the date of the notice. See MPEP 
601.01(b).
    (3) If a program submission is otherwise complete but does not 
include a cover sheet as required for a provisional application by 37 
CFR 1.51(c)(1), or any necessary application size fee as required by 37 
CFR 1.51(c)(4), the applicant will be notified and given an extendable 
two-month time period from the date of the notice to submit the missing 
items in accordance with 37 CFR 1.53(g). However, the applicant may 
continue to defer payment of the basic filing fee until a 
nonprovisional application claiming benefit of the provisional 
application is filed. Even if the notice sets a due date for the basic 
filing fee that is earlier than 12 months after the date the 
provisional application was filed, the fee will be considered timely if 
paid not later than the date on which a nonprovisional application that 
is entitled to claim benefit of the provisional application is filed. A 
reply to an Office notice that purports to require payment of the basic 
filing fee earlier than 12 months after the date the provisional 
application was filed will be considered complete, as to the fee 
payment issue, if it refers to this Federal Register notice as the 
basis for deferring payment or includes a copy of this notice. Failure 
to draw the Office's attention to this Federal Register notice will 
result in the application being processed as if the fee were due in 
response to the Office notice, and substantial processing delays may 
occur.
    (4) When all the requirements for a provisional application have 
been met, with the exception that the basic filing fee set forth in 37 
CFR 1.16(d) can be deferred, the specification and form PTO/SB/452 will 
be placed in a text-searchable online collaboration database that is 
available to the public and maintained by the Office. The collaboration 
database will also include the first named inventor, any contact 
information provided on form PTO/SB/452, the provisional application 
filing date, and the date the information is posted in the database. 
The cover sheet, as required for a provisional application by 37 CFR 
1.51(c)(1), will not be posted in the database. The Office will notify 
the program participant of the posting date of the information.
    (5) If the basic filing fee set forth in 37 CFR 1.16(d) has not 
been paid by 10 months after the provisional application filing date, 
the Office will notify the applicant that the fee must be paid not 
later than 12 months after the provisional application filing date, and 
in any case, the fee is required in order to claim 35 U.S.C. 119(e) 
benefit of the provisional application in a corresponding 
nonprovisional application.
    The mere absence of the basic filing fee, without any other defects 
in the submission, will not trigger a notification regarding payment 
earlier than the 10-month notice. If, however, the Office inadvertently 
sends such a notice requiring payment of the basic filing fee prior to 
the date a corresponding nonprovisional application is filed, a 
participant may respond by drawing attention to this Federal Register 
notice. Deferring payment until filing of a corresponding 
nonprovisional application is permitted under the program, even if a 
notice setting an earlier payment date is inadvertently sent.

VI. Actions Resulting in Termination From the Program

    There is no provision for withdrawal from the program. Once the 
technical subject matter of a program submission is made available to 
the public in the searchable collaboration database on the USPTO's 
website, that public availability cannot be revoked. This is in keeping 
with the goal of providing a publicly available repository of 
information relevant to technologies that may help to combat the COVID-
19 pandemic. However, there is no requirement that an applicant must 
file a later application that claims benefit or priority of a 
provisional application filed under the program.

Andrei Iancu,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2020-20443 Filed 9-16-20; 8:45 am]
BILLING CODE 3510-16-P