Notice2022-26776
Cancer Moonshot Expedited Examination Pilot Program
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 9, 2022
Issuing agencies
Commerce DepartmentPatent and Trademark Office
Abstract
The United States Patent and Trademark Office (USPTO or Office) is implementing the Cancer Moonshot Expedited Examination Pilot Program to replace the Cancer Immunotherapy Pilot Program, which expedited examination for eligible patent applications pertaining to methods of treating a cancer using immunotherapy. The new pilot program broadens the scope of qualifying technologies. Applications accepted into the new pilot program will be advanced out of turn (accorded special status) for examination until a first Office action. The new pilot program supports the renewed national Cancer Moonshot initiative that aims to reduce the cancer mortality rate by at least 50% within 25 years. This notice outlines the conditions, eligibility requirements, and guidelines of the new pilot program.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 236 (Friday, December 9, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 236 (Friday, December 9, 2022)]
[Notices]
[Pages 75608-75613]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-26776]
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO-P-2022-0038]
Cancer Moonshot Expedited Examination Pilot Program
AGENCY: United States Patent and Trademark Office, Department of
Commerce.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The United States Patent and Trademark Office (USPTO or
Office) is implementing the Cancer Moonshot Expedited Examination Pilot
Program to replace the Cancer Immunotherapy Pilot Program, which
expedited examination for eligible patent applications pertaining to
methods of treating a cancer using immunotherapy. The new pilot program
broadens the scope of qualifying technologies. Applications accepted
into the new pilot program will be advanced out of turn (accorded
special status) for examination until a first Office action. The new
pilot program supports the renewed national Cancer Moonshot initiative
that aims to reduce the cancer mortality rate by at least 50% within 25
years. This notice outlines the conditions, eligibility requirements,
and guidelines of the new pilot program.
DATES: Pilot Duration: The Cancer Moonshot Expedited Examination Pilot
Program will accept petitions to make special beginning on February 1,
2023, until either January 31, 2025, or the date the USPTO accepts a
total of 1,000 grantable petitions under the pilot program, whichever
is earlier. The USPTO may, at its sole discretion, terminate the pilot
program depending on factors such as workload and resources needed to
administer the program, feedback from external stakeholders, and the
program's effectiveness. If the pilot program is terminated, the USPTO
will notify the public. The USPTO will publish on its website an
ongoing count of the number of petitions filed and the number of
petitions granted under the pilot program.
ADDRESSES: Petitions to make special under the Cancer Moonshot
Expedited Examination Pilot Program must use form PTO/SB/465 and must
be filed electronically using the USPTO's Patent Center (at <a href="https://patentcenter.uspto.gov">https://patentcenter.uspto.gov</a>). Form PTO/SB/465 is available at <a href="http://www.uspto.gov/PatentForms">www.uspto.gov/PatentForms</a>.
FOR FURTHER INFORMATION CONTACT: For general questions regarding this
pilot program, please contact Susy Tsang-Foster, Senior Legal Advisor,
Office of Patent Legal Administration, Office of the Deputy
Commissioner for Patent Examination Policy, at 571-272-7711 or
<a href="/cdn-cgi/l/email-protection#0d7e787e7423797e6c636a206b627e79687f4d787e7d7962236a627b"><span class="__cf_email__" data-cfemail="6f1c1a1c16411b1c0e01084209001c1b0a1d2f1a1c1f1b0041080019">[email protected]</span></a>. For questions on electronic filing, please
contact the Electronic Business Center (EBC) at 866-217-9197 (during
its operating hours of 6 a.m. to midnight ET, Monday-Friday) or
<a href="/cdn-cgi/l/email-protection#395c5b5a794c4a494d56175e564f"><span class="__cf_email__" data-cfemail="e4818687a4919794908bca838b92">[email protected]</span></a>. For questions related to a particular petition, please
contact Gary B. Nickol, Supervisory Patent Examiner, at 571-272-0835 or
<a href="/cdn-cgi/l/email-protection#432422313a6d2d2a20282c2f03363033372c6d242c35"><span class="__cf_email__" data-cfemail="a3c4c2d1da8dcdcac0c8cccfe3d6d0d3d7cc8dc4ccd5">[email protected]</span></a>; or Brandon J. Fetterolf, Supervisory Patent
Examiner, at 571-272-2919 or <a href="/cdn-cgi/l/email-protection#553727343b313a3b7b3330212130273a393315202625213a7b323a23"><span class="__cf_email__" data-cfemail="f39181929d979c9ddd9596878796819c9f95b3868083879cdd949c85">[email protected]</span></a>, both of
Technology Center 1600.
SUPPLEMENTARY INFORMATION:
I. Background
New patent applications are normally taken up for examination in
the order of their U.S. filing date or national stage entry date. See
Sec. Sec. 708 and 1893.03(b) of the Manual of Patent Examining
Procedure (MPEP) (9th ed., rev. 10.2019, June 2020). The USPTO has
procedures under which an application will be advanced out of turn
(accorded special status) for examination if the applicant files (1) a
petition to make special under 37 CFR 1.102(c) or (d) with the
appropriate showing, or (2) a request for prioritized examination under
37 CFR 1.102(e). See 37 CFR 1.102(c)-(e) and MPEP Sec. Sec. 708.02,
708.02(a), and 708.02(b).
[[Page 75609]]
In 2016, the USPTO published a notice on the implementation of the
Cancer Immunotherapy Pilot Program. See Cancer Immunotherapy Pilot
Program, 81 FR 42328 (June 29, 2016) (Cancer Immunotherapy Notice). The
pilot program was implemented to support the 2016 National Cancer
Moonshot initiative to accelerate technological progress to eliminate
cancer. The Cancer Immunotherapy Notice indicated that an applicant
could have an application advanced out of turn (accorded special
status) for examination without meeting all of the current requirements
of the accelerated examination program that are set forth in section
708.02(a) of the MPEP if the application contained at least one claim
to a method of treating a cancer using immunotherapy and the applicant
met other requirements specified in the notice.
The Cancer Immunotherapy Notice established that the pilot program
would run for 12 months, beginning on June 29, 2016. Since then, the
USPTO has extended the Cancer Immunotherapy Pilot Program multiple
times through notices published in the Federal Register. The most
recent notice (87 FR 58772, September 28, 2022) extended the program
until January 31, 2023, to enable the USPTO to continue with its
ongoing evaluation of whether to expand the program and to what extent.
Recently, the White House renewed the Cancer Moonshot initiative and
set a new goal of reducing the cancer death rate by at least 50% over
the next 25 years. See White House statement at <a href="http://www.whitehouse.gov/briefing-room/statements-releases/2022/02/02/fact-sheet-president-biden-reignites-cancer-moonshot-to-end-cancer-as-we-know-it/">www.whitehouse.gov/briefing-room/statements-releases/2022/02/02/fact-sheet-president-biden-reignites-cancer-moonshot-to-end-cancer-as-we-know-it/</a>.
II. Termination of the Cancer Immunotherapy Pilot Program and
Implementation of the New Cancer Moonshot Expedited Examination Pilot
Program
In view of the continued interest in and success of the Cancer
Immunotherapy Pilot Program and to support the renewed national Cancer
Moonshot initiative by providing a broader scope of qualifying
technologies, the USPTO is implementing the Cancer Moonshot Expedited
Examination Pilot Program, which is an expansion of the Cancer
Immunotherapy Pilot Program and replaces that program. Any compliant
petition to make special under the Cancer Immunotherapy Pilot Program
filed in an application on or before January 31, 2023, will be granted,
and the application will be examined in accordance with the provisions
of the Cancer Immunotherapy Pilot Program. Any petition to make special
under the Cancer Immunotherapy Pilot Program filed in an application
after January 31, 2023, will not be accepted.
In contrast to the Cancer Immunotherapy Pilot Program, which
required the application to contain a claim to a method of treating a
cancer using immunotherapy and the election of that method claim for
examination, the Cancer Moonshot Expedited Examination Pilot Program
covers a wider range of eligible technologies. Under the new program,
applications must be in the field of oncology or smoking cessation and
must contain at least one of the following method claims that meet the
eligibility requirements of the program as set forth in section V of
this notice (``eligible method claims''):
(1) A method of treating or reducing the incidence of a cancer
using an immunotherapeutic compound or composition (cancer
immunotherapy method);
(2) A method of treating a cancer by targeting specific genetic
markers or mutations using a specific pharmaceutical composition;
(3) A method of treating a rare or childhood cancer using a
specific pharmaceutical composition;
(4) A method of detecting or treating a cancer using a medical
device specifically adapted to detect or treat the cancer;
(5) A method of treating a cancer by administering a specific
pharmaceutical composition wherein the method comprises a step to
diagnose the cancer; and
(6) A method of treating a nicotine dependency and promoting
smoking cessation by administering a specific pharmaceutical
composition.
Furthermore, if the application contains eligible product or
apparatus claims as set forth in section V of this notice (that is,
claims to the immunotherapeutic compound or composition, the
pharmaceutical composition, or the medical device used in an eligible
method claim), the eligible method claims must depend from or be
commensurate in scope with the eligible product or apparatus claims in
the application (that is, the eligible method claims must contain all
of the limitations of the eligible product or apparatus claims).
III. How To Participate in the Cancer Moonshot Expedited Examination
Pilot Program
Applicants may participate in the Cancer Moonshot Expedited
Examination Pilot Program without meeting all of the requirements of
the accelerated examination program set forth in MPEP 708.02(a) (for
example, providing an examination support document) by filing a
petition to make special, under 37 CFR 1.102(d), in an application that
meets all of the requirements set forth in this notice. All other
requirements of the accelerated examination program that are not
required by this notice, including the 37 CFR 1.17(h) fee for a
petition to make special under 37 CFR 1.102(d), are hereby waived based
on the special procedure specified in this notice.
If the petition is granted, the application will be treated as
special on the examiner's docket and will be accorded special status
until a first Office action (which may be an Office action containing
only a restriction requirement) is issued. After the first Office
action is issued, the application will no longer be treated as special
during examination. For example, if an amendment is filed, it will be
placed on the examiner's regular amended docket. The USPTO will
periodically evaluate the pilot program to determine whether and to
what extent its coverage should be expanded or limited.
IV. Requirements for Petitions To Make Special Under the Cancer
Moonshot Expedited Examination Pilot Program
A petition to make special under the Cancer Moonshot Expedited
Examination Pilot Program may be granted in an application provided the
eligibility requirements set forth in section V of this notice and the
following conditions are satisfied:
(A) Types of Applications
The application must be a non-reissue (original), nonprovisional
utility application filed under 35 U.S.C. 111(a), or an international
application that has entered the national stage under 35 U.S.C. 371.
(B) Claim Limits and No Multiple Dependent Claims
The application must contain no more than 3 independent claims and
no more than 20 total claims (``program claim limits'') and must not
contain any multiple dependent claims. If an application exceeds 3
independent claims or 20 total claims, or if it contains any multiple
dependent claims, the applicant should file a preliminary amendment in
compliance with 37 CFR 1.121 to cancel any excess claims or multiple
dependent claims no later than the date the petition to make special is
filed. Throughout pendency, an application granted special status under
the pilot program must meet the
[[Page 75610]]
program claim limits and must not contain any multiple dependent
claims. The petition must include a statement that the applicant agrees
not to exceed the program claim limits or add any multiple dependent
claims throughout the pendency of the application. The examiner may
refuse entry of any amendment filed in reply to an Office action that,
if entered, would result in a set of pending claims that exceeds the
program claim limits or adds any multiple dependent claims. See section
IX of this notice.
(C) Inclusion of at Least One Method Claim That Meets the Eligibility
Requirements of the Pilot Program
The application must include at least one method claim that meets
the eligibility requirements set forth in section V of this notice.
(D) Statements Regarding a Method Claim and Any Product Claim or
Apparatus Claim That Meet the Eligibility Requirements of the Pilot
Program
The petition to make special must include a statement that special
status under this program is being sought because the application is
limited to the field of oncology or smoking cessation and contains at
least one method claim that meets the eligibility requirements of the
pilot program, which are discussed in section V of this notice. The
petition must also identify the eligible method claim(s). In addition,
the petition must include a statement that the applicant agrees not to
cancel all method claims that meet the eligibility requirements of the
pilot program throughout the pendency of the application.
Furthermore, the petition must include a statement that if the
application contains eligible product or apparatus claims as set forth
in section V of this notice (that is, claims to the immunotherapeutic
compound or composition, the pharmaceutical composition, or the medical
device used in eligible method claims), the eligible method claims
depend from or are commensurate in scope with the eligible product or
apparatus claims (that is, the eligible method claims contain all of
the limitations of the eligible product or apparatus claims).
(E) Statements Regarding Restriction Requirement and Elected Invention
The petition must include a statement that, if a requirement for
restriction or unity of invention is made, the applicant will agree to
make an election without traverse to an invention that meets the
eligibility requirements of the pilot program. The petition must also
include a statement that the applicant agrees not to cancel all claims
to the elected invention throughout the pendency of the application.
(F) Statement That Special Status Was Not Previously Granted Under Any
Program
The petition must include a statement that the application was not
previously granted special status under any program. A petition to make
special under this pilot program may not be filed in an application in
which special status was previously granted under this pilot program or
any other program (for example, for reasons of age or health, Patent
Prosecution Highway, Accelerated Examination, Prioritized Examination,
etc.).
(G) Time for Filing a Petition
The petition to make special under the Cancer Moonshot Expedited
Examination Pilot Program must be filed prior to a first Office action
(which may be an Office action containing only a restriction
requirement). A petition under the pilot program may not be filed in
any application in which a request for continued examination under 37
CFR 1.114 has been filed.
(H) Required USPTO Form for Filing a Petition
Form PTO/SB/465, titled ``CERTIFICATION AND PETITION TO MAKE
SPECIAL UNDER THE CANCER MOONSHOT EXPEDITED EXAMINATION PILOT
PROGRAM,'' must be used to file the petition to make special under the
pilot program. The form is available at <a href="http://www.uspto.gov/PatentForms">www.uspto.gov/PatentForms</a>. Form
PTO/SB/465 contains the necessary certifications for qualification to
participate in the pilot program. Use of the form will enable the USPTO
to quickly identify and timely process the petition. In addition, use
of the form will help applicants understand and comply with the
petition requirements of the pilot program. Under 5 CFR 1320.3(h), form
PTO/SB/465 does not collect ``information'' within the meaning of the
Paperwork Reduction Act of 1995.
(I) Required Electronic Filing of an Application and Petition
The petition to make special may only be made by filing form PTO/
SB/465, which must be filed electronically using the USPTO's Patent
Center (at <a href="https://patentcenter.uspto.gov">https://patentcenter.uspto.gov</a>). Applicants must file the
petition using the document description (``Petition for Cancer Moonshot
Pilot'') indicated on form PTO/SB/465. In addition, the application or
national stage entry must be filed electronically using Patent Center.
(J) Required Use of DOCX Format for Specification, Claim(s), and
Abstract on Filing or on National Stage Entry
The specification, claim(s), and abstract of the application must
be submitted in DOCX format at the time of filing or national stage
entry. Prior to submitting the application for filing in DOCX format,
applicants will receive a feedback document. Applicants may find it
beneficial to review the feedback document and make corrections to the
application before filing the application. By making the necessary
corrections before filing, applicants may avoid delays that can occur
in the pre-examination process. For more information on DOCX filing in
Patent Center, please see <a href="http://www.uspto.gov/patents/docx">www.uspto.gov/patents/docx</a>. Applicants can
direct any inquiries concerning electronic filing of the petition and
application to the EBC at 866-217-9197 or <a href="/cdn-cgi/l/email-protection#f7929594b78284878398d9909881"><span class="__cf_email__" data-cfemail="8ce9eeefccf9fffcf8e3a2ebe3fa">[email protected]</span></a>.
(K) Publication Requirement for Applications
If an applicant files the petition to make special on the date of
filing of the application, the application may not be filed with a
nonpublication request. If the applicant previously filed a
nonpublication request in the application, the applicant must file a
rescission of the nonpublication request no later than the date the
petition to make special is filed. The applicant may use form PTO/SB/36
to rescind the nonpublication request.
(L) Statement Concerning Filing Limitations
An applicant may file a petition to participate in the pilot
program if the inventor or any joint inventor has not been named as the
inventor or a joint inventor on more than nine other nonprovisional
patent applications in which a petition to make special under this
program has been filed. In other words, the inventor or any joint
inventor named on the application can only be named as the inventor or
a joint inventor on a maximum of 10 nonprovisional applications in
which a petition under the pilot program has been filed. Therefore, if
the inventor or any one of the joint inventors of the instant
application has been named as the inventor or a joint inventor on more
than nine other nonprovisional applications in which petitions under
this pilot program have been filed, then the petition for the instant
application may not be appropriately filed. Petitions filed under the
Cancer Immunotherapy Pilot Program do not count toward the
[[Page 75611]]
filing limits in the Cancer Moonshot Expedited Examination Pilot
Program.
The petition must include the following statement: ``The inventor
or any joint inventor has not been named as the inventor or a joint
inventor on more than nine other nonprovisional applications in which a
petition to make special under this program has been filed.''
V. Eligibility Requirements
To be eligible for the Cancer Moonshot Expedited Examination Pilot
Program, patent applications must be in the field of oncology or
smoking cessation. The applications must claim an invention in at least
one of the following technologies:
(A) Cancer Immunotherapies
The program will consider the following claims pertaining to cancer
immunotherapy:
(i) Method claims to treat or reduce the incidence of a cancer
using an immunotherapeutic compound or composition (``cancer
immunotherapy method claims'').
These claims encompass a method of ameliorating, treating, or
reducing the incidence of a malignancy in a human subject wherein the
steps of the method assist or boost the immune system in eradicating
cancerous cells. Examples include:
(a) Claims drawn to the administration of cells, antibodies,
proteins, or nucleic acids that invoke an active (or achieve a passive)
immune response to destroy cancerous cells;
(b) Claims drawn to the co-administration of biological adjuvants
(for example, interleukins, cytokines, Bacillus Calmette-Guerin,
monophosphoryl lipid A, etc.) in combination with conventional
therapies for treating cancer such as chemotherapy, radiation, or
surgery;
(c) Claims drawn to the administration of any vaccine that works by
activating the immune system to destroy or reduce the incidence of
cancer cell growth; and
(d) Claims drawn to in vivo, ex vivo, and adoptive immunotherapies
for treating a cancer, including those using autologous and/or
heterologous cells or immortalized cell lines.
(ii) Product claims to the immunotherapeutic compound or
composition used in a cancer immunotherapy method eligible under
section V(A)(i) of this notice that is also claimed in the application.
Immunotherapeutic compounds and compositions work by invoking an
immune response to destroy or reduce the incidence of cancer cell
growth. The petition under the program must include a statement that
the applicant has a good faith belief that the specification contains
evidence that the compound or composition used in the method claim to
treat or reduce the incidence of a cancer is immunotherapeutic, and the
statement must also identify the specific page(s) of the specification
containing the evidence.
If product claims to immunotherapeutic compounds or compositions
are presented in the application, claims to an eligible method of
treating or reducing the incidence of a cancer using these
immunotherapeutic compounds or compositions must also be presented in
the same application and must depend from or be commensurate in scope
with the product claims (that is, the method claims must contain all of
the limitations of the product claims) throughout the pendency of the
application. The eligible method claims to treating or reducing the
incidence of a cancer using an immunotherapeutic compound or
composition are required in the application throughout pendency because
the immunotherapeutic compound or composition claimed may have an
additional use not related to the treatment of cancer. The requirement
for the eligible method claims to be commensurate in scope with the
eligible product claims in the application facilitates rejoinder of
these method claims in the event that there is a restriction
requirement between the eligible product claims and eligible method
claims and the product claims are elected.
(B) Personalized Medicine To Treat a Cancer by Targeting Specific
Genetic Markers or Mutations Using a Specific Pharmaceutical
Composition
The program will consider method claims to treat a cancer by
targeting specific genetic markers or mutations using a specific
pharmaceutical composition and any product claims to the pharmaceutical
composition used in these method claims. The petition under the program
must include a statement that the applicant has a good faith belief
that the specification contains evidence that the pharmaceutical
composition used in the method claim targets the specific genetic
markers or mutations to treat the cancer, and the statement must also
identify the specific page(s) of the specification containing the
evidence.
If product claims to the pharmaceutical composition are presented
in the application, claims to a method to treat a cancer by targeting
specific genetic markers or mutations using the pharmaceutical
composition must also be presented in the same application and must
depend from or be commensurate in scope with the product claims to the
pharmaceutical composition (that is, the method claims must contain all
of the limitations of the product claims) throughout the pendency of
the application. The method claims to treat a cancer by targeting
specific genetic markers or mutations using the pharmaceutical
composition are required in the application throughout pendency because
the pharmaceutical composition claimed may have an additional use not
related to the treatment of cancer. The requirement for all eligible
method claims to be commensurate in scope with the eligible product
claims presented in the application facilitates rejoinder of these
method claims in the event that there is a restriction requirement
between the eligible product claims and eligible method claims and the
product claims are elected.
(C) Cancer Treatments for Rare Cancers, Including All Childhood
Cancers, Using a Specific Pharmaceutical Composition
The program will consider method claims to treat rare cancers,
including all childhood cancers, using a specific pharmaceutical
composition, and any product claims to the pharmaceutical composition
used to treat the cancer in these method claims. Rare cancers, which
include all childhood cancers, are defined by the National Institutes
of Health (see <a href="http://www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/about-rare-cancers">www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/about-rare-cancers</a>). If product claims to the pharmaceutical
composition are presented in the application, claims to a method to
treat a rare or childhood cancer using this pharmaceutical composition
must also be presented in the same application and must depend from or
be commensurate in scope with the product claims (that is, the method
claims must contain all of the limitations of the product claims)
throughout the pendency of the application. The method claims to treat
a rare or childhood cancer using the pharmaceutical composition are
required in the application throughout pendency because the
pharmaceutical composition claimed may have an additional use not
related to the treatment of cancer. The requirement for the eligible
method claims to be commensurate in scope with the eligible product
claims in the application facilitates rejoinder of these method claims
in the event that there is a restriction requirement between the
eligible product claims and eligible
[[Page 75612]]
method claims and the product claims are elected.
(D) Detecting or Treating a Cancer Using a Medical Device Specifically
Adapted To Detect or Treat the Cancer
The program will consider method claims to detect or treat a cancer
using a medical device that is specifically adapted to detect or treat
the cancer and any claims to the medical device used to detect or treat
the cancer in these method claims if the only use disclosed in the
specification for the medical device is to treat or detect a cancer.
Applications disclosing any use for the medical device claimed or used
in the method to treat or detect a cancer that is not related to the
treatment or detection of a cancer are not eligible for the program.
For the purposes of this program, a medical device and a medical
device specifically adapted to detect or treat a cancer are defined as
follows: A medical device is defined as an instrument, apparatus,
machine, or implant used in the diagnosis or treatment of a disease. A
medical device specifically adapted to detect or treat a cancer is a
medical device that is modified or adapted in some way that enables it
to detect or treat a cancer.
If claims to the medical device are presented in the application,
claims to a method to detect or treat a cancer using the medical device
must also be presented in the same application and must depend from or
be commensurate in scope with the claims to the medical device (that
is, the method claims must contain all of the limitations of the claims
to the medical device) throughout the pendency of the application.
The requirement for the eligible method claims to be commensurate
in scope with the claims to the medical device in the application
facilitates rejoinder of these method claims in the event that there is
a restriction requirement between the claims to the medical device and
the eligible method claims and the claims to the medical device are
elected. The eligible method claims to detect or treat a cancer using
the medical device are required in the application throughout pendency
because the medical device claimed may have an additional use (not
disclosed in the specification) that is not related to the treatment of
a cancer.
(E) Treating a Cancer by Administering a Specific Pharmaceutical
Composition After Diagnosing the Cancer
The program will consider method claims to treat a cancer by
administering a specific pharmaceutical composition wherein the method
comprises a step to diagnose the cancer and any product claims to the
pharmaceutical composition used to treat the cancer in these method
claims. If product claims to the pharmaceutical composition are
presented in the application, claims to a method to treat a cancer
using this pharmaceutical composition must also be presented in the
same application and must depend from or be commensurate in scope with
the product claims (that is, the method claims must contain all of the
limitations of the product claims) throughout the pendency of the
application. The method of treatment claims using the pharmaceutical
composition are required in the application throughout pendency because
the pharmaceutical composition claimed may have an additional use not
related to the treatment of cancer. The requirement for the eligible
method claims to be commensurate in scope with the eligible product
claims in the application facilitates rejoinder of these method claims
in the event that there is a restriction requirement between the
eligible product claims and eligible method claims and the product
claims are elected.
(F) Treating a Nicotine Dependency and Promoting Smoking Cessation by
Administering a Specific Pharmaceutical Composition
The program will consider method claims to treat a nicotine
dependency and promote smoking cessation by administering a specific
pharmaceutical composition and any product claims to the pharmaceutical
composition used to treat the nicotine dependency in these method
claims. If product claims to the pharmaceutical composition are
presented in the application, claims to a method to treat the nicotine
dependency using this pharmaceutical composition must also be presented
in the same application and must depend from or be commensurate in
scope with the product claims (that is, the method claims must contain
all of the limitations of the product claims) throughout the pendency
of the application. The method of treatment claims using the
pharmaceutical composition are required in the application throughout
pendency because the pharmaceutical composition claimed may have an
additional use not related to the treatment of a nicotine dependency.
The requirement for the eligible method claims to be commensurate in
scope with the eligible product claims in the application facilitates
rejoinder of these method claims in the event that there is a
restriction requirement between the eligible product claims and
eligible method claims and the product claims are elected.
VI. Internal Processing of the Petition Under the Pilot Program
If an applicant files a petition to make special under the pilot
program, the USPTO will not render a decision on the petition until the
application is in condition for examination. Any inquiries concerning a
particular petition to make special should be directed to the
appropriate Technology Center handling the petition. If the petition is
granted, the application will be accorded special status under the
pilot program. The application will then be placed on an examiner's
special docket until a first Office action is issued. After the first
Office action, the application will no longer be treated as special
during examination. For example, if an amendment is filed, it will be
placed on the examiner's regular amended docket.
The applicant will be notified of the decision on the petition by
the deciding official. If the application does not comply with the
sequence requirements as set forth in 37 CFR 1.821-1.825 or 1.831-
1.835, as applicable, such that the application is not in condition for
examination, or if the application and/or petition do not meet all the
requirements set forth in this notice, the USPTO may notify the
applicant of the deficiency by issuing a notice. The notice will give
the applicant only one opportunity to correct the deficiency.
If the applicant still wishes to participate in the pilot program,
the applicant must file a reply via Patent Center that includes
appropriate corrections and a properly signed petition form PTO/SB/465
within 1 month or 30 days, whichever is longer, from the mail/
notification date of the notice informing the applicant of the
deficiency. The time period for reply is not extendable under 37 CFR
1.136(a). If the applicant fails to correct the deficiency indicated in
the notice within the time period set forth therein, the application
will not be accepted into the pilot program and will be taken up for
examination in regular turn.
In addition, the petition will be dismissed without an opportunity
for correction if any of the following deficiencies exist: (1) the
petition was not filed prior to the first Office action (including an
Office action containing only a restriction requirement); (2) the
specification, abstract, and claim(s) of the application were not
submitted in DOCX format at the time of filing or
[[Page 75613]]
national stage entry; (3) the application or national stage entry was
not filed electronically in Patent Center; (4) the application is not
an original (non-reissue), nonprovisional utility application filed
under 35 U.S.C. 111(a), or an international application that has
entered the national stage under 35 U.S.C. 371; (5) the application was
previously granted special status; (6) the application does not contain
at least one method claim that complies with the eligibility
requirements set forth in section V of this notice; or (7) the
application pertains to a medical device adapted to detect or treat a
cancer and discloses a use for the medical device that is not related
to the treatment or detection of a cancer.
VII. Requirement for Restriction or Unity of Invention
If the claims in the application are directed to multiple
inventions, the examiner may make a requirement for restriction or
unity of invention in accordance with current restriction practice. If
such a requirement is made, the applicant must make an election without
traverse to an invention that meets the eligibility requirements of
this program.
If the applicant elects the product or apparatus, claims to the
qualifying method will be withdrawn but must remain pending and depend
from or be commensurate in scope with the examined product or apparatus
claims (that is, the qualifying method claims must contain all of the
limitations of the examined product or apparatus claims). Any reply to
an Office action that cancels all of the method claims that meet the
eligibility requirements for the pilot program or does not present
eligible method claims that are commensurate in scope with or depend
from the product or apparatus claims under examination will be treated
as not fully responsive. The petition must include a statement that if
the applicant elects a product or an apparatus for examination, the
applicant agrees to present eligible method claims that are
commensurate in scope with or depend from the claims to the elected
product or apparatus throughout the pendency of the application.
Where the applicant elects claims directed to an eligible product
or apparatus, and all product or apparatus claims are subsequently
found allowable, withdrawn eligible method claims that include all the
limitations of the allowable product or apparatus claims will be
considered for rejoinder in accordance with sections 806.05 et seq. and
821.04 et seq. of the MPEP. In the event of rejoinder, the requirement
for restriction between the product or apparatus claims and the
rejoined method claims will be withdrawn, and the rejoined method
claims will be fully examined for patentability in accordance with 37
CFR 1.104.
VIII. Period for Reply by the Applicant
The time periods set for reply in Office actions for an application
granted special status under the pilot program will be the same as
those set forth in section 710.02(b) of the MPEP.
IX. Replies by the Applicant Under the Pilot Program
Throughout the pendency of an application granted special status
under the pilot program, the applicant's replies to Office actions must
be fully responsive to the rejections, objections, and requirements
made by the examiner. Any amendment filed in reply to an Office action
may be treated as not fully responsive if it attempts to: (1) add
claims that would result in more than 3 independent claims or more than
20 total claims pending in the application; (2) add any multiple
dependent claim(s); (3) cancel all method claims that meet the
eligibility requirements of the pilot program; or (4) cancel all claims
to the elected invention. The amendment may also be treated as not
fully responsive if it does not present eligible method claims that are
commensurate in scope with or depend from the claims to the elected
product or apparatus. If a reply to a non-final Office action is not
fully responsive for the reasons set forth above but is a bona fide
attempt to advance the application to final action, the examiner may,
at their discretion, issue a notice of nonresponsive amendment and
provide a shortened statutory period of two months for the applicant to
supply a fully responsive reply. Extensions of this time period under
37 CFR 1.136(a) to the notice of nonresponsive amendment will be
permitted, but in no case can any extension carry the date for reply to
this notice beyond the maximum period of six months set by statute (35
U.S.C. 133). However, any further nonresponsive amendment typically
will not be treated as bona fide; therefore, the time period set in the
prior notice will continue to run.
X. After-Final and Appeal Procedures
Any amendment, affidavit, or other evidence after a final Office
action and prior to appeal must comply with 37 CFR 1.116. During the
appeal process, the application will be treated in accordance with the
normal appeal procedure (see MPEP Chapter 1200).
XI. Withdrawal From the Pilot Program
There is no provision for withdrawal from the pilot program. The
applicant may abandon an 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 granted
special status based on the petition filed in the parent application.
Each application (including each continuing application) must, on its
own, meet all requirements for special status under the pilot program,
and be accompanied by its own petition as detailed in section IV above.
Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2022-26776 Filed 12-8-22; 8:45 am]
BILLING CODE 3510-16-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 9, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.