[Federal Register Volume 87, Number 236 (Friday, December 9, 2022)]
[Notices]
[Pages 75608-75613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26776]


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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.

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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 https://patentcenter.uspto.gov). Form PTO/SB/465 is available at www.uspto.gov/PatentForms.

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 
[email protected]. 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 
[email protected]. For questions related to a particular petition, please 
contact Gary B. Nickol, Supervisory Patent Examiner, at 571-272-0835 or 
[email protected]; or Brandon J. Fetterolf, Supervisory Patent 
Examiner, at 571-272-2919 or [email protected], 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 www.whitehouse.gov/briefing-room/statements-releases/2022/02/02/fact-sheet-president-biden-reignites-cancer-moonshot-to-end-cancer-as-we-know-it/.

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 www.uspto.gov/PatentForms. 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 https://patentcenter.uspto.gov). 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 www.uspto.gov/patents/docx. Applicants can 
direct any inquiries concerning electronic filing of the petition and 
application to the EBC at 866-217-9197 or [email protected].

(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 www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/about-rare-cancers). 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]
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