[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
[[Page 58041]]
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