Cancer Immunotherapy Pilot Program, 42328-42332 [2016-15533]
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Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices
MD 20910. Technical feedback in the
form of brief annotated bibliographic
entries would be welcome. The
Interagency Working Group will gladly
accept public input at any time;
however, only those that are received on
or before August 19, 2016, may be
considered when the Interagency
Working Group finalizes the plan.
FOR FURTHER INFORMATION CONTACT:
Caitlin Gould (Caitlin.gould@noaa.gov,
240–533–0290) or Stacey DeGrasse
(Stacey.Degrasse@fda.hhs.gov, 240–
402–1470).
SUPPLEMENTARY INFORMATION:
Correction
The National Oceanic and
Atmospheric Administration published
a document in the Federal Register of
June 3, 2016, entitled Interagency
Working Group on the Harmful Algal
Bloom and Hypoxia Research and
Control Amendments Act. The
information concerning the webinar
dates and WebEx information have been
updated.
Dated: June 15, 2016.
Mary C. Erickson,
Director, National Centers for Coastal Ocean
Science, National Ocean Service, National
Oceanic and Atmospheric Administration.
[FR Doc. 2016–15364 Filed 6–28–16; 8:45 am]
BILLING CODE 3510–JE–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
Hydrographic Services Review Panel
Meeting
National Ocean Service,
National Oceanic and Atmospheric
Administration (NOAA), Department of
Commerce.
ACTION: Notice of open public meeting.
AGENCY:
The Hydrographic Services
Review Panel (HSRP) will hold a
meeting that will be open to the public.
Information about the HSRP and the
meeting agenda will be posted at: https://
www.nauticalcharts.noaa.gov/ocs/hsrp/
meetings_cleveland2016.htm.
DATES: The meeting will be held on
August 30, 8:30 a.m. to 3:00 p.m. EDT;
August 31, 8:00 a.m. to 5:00 p.m.; and
September 1, 8:00 a.m. to 12:00 noon.
Times are subject to change. For
updates, please check: https://
www.nauticalcharts.noaa.gov/ocs/hsrp/
meetings_cleveland2016.htm.
ADDRESSES: City Club of Cleveland, 830
Euclid Avenue, Cleveland, Ohio 44114.
FOR FURTHER INFORMATION CONTACT:
Lynne Mersfelder-Lewis, HSRP program
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SUMMARY:
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manager, National Ocean Service, Office
of Coast Survey, NOAA (N/NSD), 1315
East-West Highway, SSMC3 #6301,
Silver Spring, Maryland 20910;
telephone: 301–713–2750 ext. 166;
email: lynne.mersfelder@noaa.gov.
The
meeting is open to the public, and
public seating will be available on a
first-come, first-served basis. The times
of onsite public comment periods,
scheduled for each day, will be
included in the final agenda. Each
individual or group making verbal
comments will be limited to a total time
of five (5) minutes. Comments will be
recorded. Individuals who would like to
submit written statements should email
their comments to Lynne.Mersfelder@
noaa.gov. The HSRP will provide
webinar and teleconference capability
for the public sessions. Pre-registration
is required to access the webinar: https://
www.nauticalcharts.noaa.gov/ocs/hsrp/
meetings_cleveland2016.htm.
The Hydrographic Services Review
Panel (HSRP) is a Federal Advisory
Committee established to advise the
Under Secretary of Commerce for
Oceans and Atmosphere, the NOAA
Administrator, on matters related to the
responsibilities and authorities set forth
in section 303 of the Hydrographic
Services Improvement Act of 1998, as
amended, and such other appropriate
matters that the Under Secretary refers
to the Panel for review and advice. The
charter and other information are
located online at https://
www.nauticalcharts.noaa.gov/ocs/hsrp/
CharterBylawsHSIAStatute.htm.
Matters To Be Considered: The panel
is convening to hear federal, state,
regional and local partners and
stakeholders on issues relevant to
NOAA’s navigation services, focusing
on the Great Lakes area. Navigation
services include the data, products, and
services provided by the NOAA
programs and activities that undertake
geodetic observations, gravity modeling,
shoreline mapping, bathymetric
mapping, hydrographic surveying,
nautical charting, tide and water level
observations, current observations, and
marine modeling. This suite of NOAA
products and services support safe and
efficient navigation, resilient coasts and
communities, and the nationwide
positioning information infrastructure to
support America’s commerce. The Panel
will hear from federal agencies and nonfederal organizations about their
missions and their use of NOAA’s
navigation services; what value these
services bring; and what improvements
could be made. Other administrative
SUPPLEMENTARY INFORMATION:
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matters may be considered. This agenda
is subject to change.
Special Accommodations: This
meeting is physically accessible to
people with disabilities. Please direct
requests for sign language interpretation
or other auxiliary aids to
Lynne.Mersfelder@noaa.gov by August
8, 2016.
Dated: June 17, 2016.
Gerd F. Glang,
Rear Admiral, Director, Office of Coast
Survey, National Ocean Service, National
Oceanic and Atmospheric Administration.
[FR Doc. 2016–15365 Filed 6–28–16; 8:45 am]
BILLING CODE P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No.: PTO–P–2016–0015]
Cancer Immunotherapy Pilot Program
United States Patent and
Trademark Office, Commerce.
ACTION: Notice.
AGENCY:
The United States Patent and
Trademark Office (USPTO or Office) is
implementing a pilot program to
provide for earlier review of patent
applications pertaining to cancer
immunotherapy (‘‘Cancer
Immunotherapy Pilot Program’’ or
‘‘Pilot Program’’) in support of the
White House national $1 billion
initiative to achieve ten years’ worth of
cancer research in the next five years
(‘‘National Cancer Moonshot’’). The
USPTO will advance applications
containing a claim(s) to a method of
treating a cancer using immunotherapy
out of turn for examination if the
applicant files a grantable petition to
make special under the Pilot Program.
The objective of the Pilot Program is to
complete the examination of the
application within twelve months of
special status being granted. Under the
Cancer Immunotherapy Pilot Program,
an application will be advanced out of
turn for examination without meeting
all of the current requirements of the
accelerated examination program (e.g.,
the requirement for an examination
support document) or the Prioritized
Examination (Track I) program. This
notice outlines the conditions,
eligibility requirements, and guidelines
of the Pilot Program.
DATES: Effective Date: June 29, 2016.
Duration: The Cancer Immunotherapy
Pilot Program will run for twelve
months from its effective date.
Therefore, petitions to make special
under the Cancer Immunotherapy Pilot
SUMMARY:
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Program must be filed before June 29,
2017. The USPTO may extend the Pilot
Program (with or without modifications)
or terminate it depending on the
workload and resources needed to
administer the Pilot Program, feedback
from the public, and the effectiveness of
the Pilot Program. If the Pilot Program
is extended or terminated, the USPTO
will provide notification to the public.
FOR FURTHER INFORMATION CONTACT:
Pinchus M. Laufer, Senior Legal Advisor
(telephone (571) 272–7726; electronic
mail at pinchus.laufer@uspto.gov) or
Susy Tsang-Foster, Senior Legal Advisor
(telephone (571) 272–7711; electronic
mail at susy.tsang-foster@uspto.gov), of
the Office of Patent Legal
Administration, Office of the Deputy
Commissioner for Patent Examination
Policy.
For questions relating to a specific
petition, please contact Gary B. Nickol,
Supervisory Patent Examiner (telephone
(571) 272–0835; electronic mail at
gary.nickol@uspto.gov) or Brandon J.
Fetterolf, Supervisory Patent Examiner
(telephone (571) 272–2919; electronic
mail at brandon.fetterolf@uspto.gov), of
Technology Center 1600.
SUPPLEMENTARY INFORMATION: On
February 1, 2016, the White House
Office of the Press Secretary announced
a new, national $1 billion initiative to
achieve ten years’ worth of cancer
research in the next five years, with the
intent to aid in the global fight against
cancer. See the White House Web site at
https://www.whitehouse.gov/the-pressoffice/2016/02/01/fact-sheet-investingnational-cancer-moonshot. To support
this initiative, the USPTO is
implementing the Cancer
Immunotherapy Pilot Program to
advance patent applications pertaining
to cancer immunotherapy out of turn for
examination to provide for earlier
review. The objective of the Pilot
Program is to complete the examination
of an application containing a claim(s)
to a method of treating a cancer using
immunotherapy within twelve months
of special status being granted. See Part
XII below (Twelve-Month Goal) for
more information.
New patent applications are normally
taken up for examination in the order of
their U.S. filing date. See section 708 of
the Manual of Patent Examining
Procedure (9th ed., 7th Rev., November
2015) (MPEP). The USPTO has
procedures under which an application
will be advanced out of turn (accorded
special status) for examination if the
applicant files a petition to make special
under 37 CFR 1.102(c) and (d) with the
appropriate showing or a request for
prioritized examination under 37 CFR
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1.102(e). See 37 CFR 1.102 and MPEP
section 708.02. The USPTO revised its
accelerated examination procedures
effective August 25, 2006, requiring that
all petitions to make special comply
with the requirements of the revised
accelerated examination (AE) program,
except those based on an inventor’s
health or age or the Patent Prosecution
Highway (PPH) Pilot Program. See
Changes to Practice for Petitions in
Patent Applications To Make Special
and for Accelerated Examination, 71 FR
36323 (June 26, 2006), 1308 Off. Gaz.
Pat. Office 106 (July 18, 2006) (notice);
see also MPEP section 708.02(a).
The USPTO is implementing the
Cancer Immunotherapy Pilot Program to
permit an application containing at least
one claim to a method of treating a
cancer using immunotherapy to be
advanced out of turn (accorded special
status) for examination without meeting
all of the current requirements of the
accelerated examination program set
forth in item VIII of MPEP section
708.02(a) (e.g., examination support
document) if the applicant files a
grantable petition to make special under
the Pilot Program. Applications that
have been accorded special status based
on any USPTO established procedures
(such as PPH, Prioritized Examination,
Accelerated Examination, Age, Health,
or any other pilot program that takes up
an application out of order for
examination) are not eligible to be made
special under the Cancer
Immunotherapy Pilot Program.
Applications are accorded special status
under the Cancer Immunotherapy Pilot
Program after grant of special status
until a final disposition (defined in Part
XII (Twelve-Month Goal)) is reached in
the application. Under special status, an
application that has not been acted on
or an application with a proper RCE
request will be placed on the examiner’s
special new docket until a first Office
action on the merits. For an application
in the Pilot Program where applicant is
responding to a first Office action, the
application will be placed on the
examiner’s regular amended docket.
Under the Pilot Program, the USPTO is
providing examiners with incentives to
handle these applicant responses
promptly.
The USPTO will accept petitions to
make special under the Cancer
Immunotherapy Pilot Program provided
that the petitions, and applications in
which they are filed, meet all of the
requirements set forth in this notice.
The USPTO will periodically evaluate
the Pilot Program to determine whether
and to what extent its coverage should
be expanded. In addition, the USPTO
may extend the Pilot Program (with or
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without modifications) or terminate it
depending on the workload and
resources needed to administer the Pilot
Program, feedback from the public, and
the effectiveness of the Pilot Program. If
the Pilot Program is extended or
terminated, the USPTO will provide
notification to the public.
Applicants may participate in the
Cancer Immunotherapy Pilot Program
by filing a petition to make special
under 37 CFR 1.102(d) meeting all of the
requirements set forth in this notice in
either a new application or in a pending
application. However, continuing
applications will not automatically be
accorded special status based on papers
filed with a petition in a parent
application. Each application must, on
its own, meet all requirements for
special status. No fee is required. The
fee for a petition to make special under
37 CFR 1.102(d) based upon the
procedure specified in this notice is
hereby waived.
Part I. Requirements for Petitions To
Make Special Under the Cancer
Immunotherapy Pilot Program: A
petition to make special under the
Cancer Immunotherapy Pilot Program
may be granted in an application
provided the eligibility requirements set
forth in Part II and the following
conditions are satisfied:
(1) Types of Applications. The
application must be a 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.
(2) Claim Limit and No Multiple
Dependent Claims. The application
must not contain more than three
independent claims and more than
twenty total claims. The application
must not contain any multiple
dependent claims. For an application
that contains more than three
independent claims or twenty total
claims, or any multiple dependent
claims, applicant must file a
preliminary amendment in compliance
with 37 CFR 1.121 to cancel the excess
claims and/or the multiple dependent
claims at the time the petition to make
special is filed. The petition must
include a statement that applicant
agrees that the application will not have
more than three independent claims,
more than twenty total claims, and any
multiple dependent claims while the
application is in special status under the
Pilot Program.
(3) The Application Must Include at
Least One Method Claim of Treating a
Cancer Using Immunotherapy. The
application must include at least one
claim to a method of treating a cancer
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using immunotherapy that meets the
eligibility requirements in Part II of this
notice. The petition must include a
statement that the applicant agrees to
include at least one claim to a method
of treating a cancer using
immunotherapy that meets the Pilot
Program eligibility requirements while
the application is in special status. For
applications that have been previously
examined, applicants will not be
permitted to switch inventions in order
to participate in the Pilot Program. See
MPEP section 821.03.
(4) Statement Regarding Method of
Treating a Cancer Using
Immunotherapy. The petition to make
special must state that special status
under the Pilot Program is sought
because the application contains a claim
to a method of treating a cancer using
immunotherapy that meets the
eligibility requirements discussed in
Part II of this notice.
(5) Statement Regarding Restriction
Requirement. The petition must include
a statement that, if the USPTO
determines that the claims are directed
to multiple inventions, applicant will
agree to make an election without
traverse in a telephonic interview, and
elect an invention directed to a method
of treating a cancer using
immunotherapy that meets the
eligibility requirement discussed in Part
II of this notice.
(6) Statement that Special Status Was
Not Previously Granted Under Any
Program. The petition must state that
the application has not been previously
granted special status. 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 in
any other program (e.g., age, health,
PPH, AE, prioritized examination).
(7) Time for Filing Petition. In general,
the petition to make special under the
Pilot Program must be filed (i) at least
one day prior to the date that notice of
a first Office action (which may be an
Office action containing only a
restriction requirement) appears in the
Patent Application Information
Retrieval (PAIR) system (applicant may
check the status of an application using
PAIR); or (ii) with a proper request for
continued examination (RCE) that is in
compliance with 37 CFR 1.114.
For patent applicants whose claimed
cancer immunotherapy both (i) meets
the eligibility requirements for this Pilot
Program and (ii) is the subject of an
active Investigational New Drug (IND)
application filed by patent applicant or
their agent (e.g., a licensee of the patent
applicant or the patent applicant’s
assignee) at the U.S. Food and Drug
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Administration (FDA) that has entered
phase II or phase III clinical trials, the
petition may be filed any time prior to
an appeal or a final rejection if patent
applicant certifies both (i) and (ii) in the
petition. For an application that has an
outstanding Office action, patent
applicant must file a complete response
together with the petition.
Therefore, the petition is only
required to contain the above applicant
certification if the patent application
has received a first Office action or a
request for continued examination
(RCE) was not filed with the petition. By
default, for applications that have been
previously examined, if applicant makes
the above certification in the petition,
the above certification would
necessarily apply to at least one of the
examined claims since applicants are
not permitted to switch inventions in
order to participate in the Pilot Program.
See MPEP section 821.03.
(8) Office Form Available for Filing
Petition. Applicant should use form
PTO/SB/443 for filing the petition. The
form will contain a check-box for the
applicant to certify that the claimed
cancer immunotherapy both (i) meets
the eligibility requirements for this Pilot
Program and (ii) is the subject of an
active IND application filed by patent
applicant or their agent at the FDA that
has entered phase II or phase III clinical
trials. The form will be available as a
Portable Document Format (PDF)
fillable form in EFS-Web and on the
USPTO Web site at https://
www.uspto.gov/web/forms/.
The Office of Management and Budget
(OMB) has determined that, under 5
CFR 1320.3(h), Form PTO/SB/443 does
not collect ‘‘information’’ within the
meaning of the Paperwork Reduction
Act of 1995. Information regarding EFSWeb is available on the USPTO Web site
at https://www.uspto.gov/learning-andresources/support-centers/patentelectronic-business-center. Failure to
use the form or its equivalent could
result in the Office not recognizing the
request or delays in processing the
request.
(9) Electronic Filing of Petition
Required. The petition to make special
must be filed electronically before June
29, 2017, using the USPTO electronic
filing system, EFS-Web, and selecting
the document description of ‘‘Petition
for Cancer Immunotherapy Pilot’’ on the
EFS-Web screen. Any inquiries
concerning electronic filing of the
petition should be directed to the
Electronic Business Center (EBC) at
(866) 217–9197.
(10) Publication Requirement for
Applications. For unpublished
applications, the petition to make
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special must be accompanied by a
request for early publication in
compliance with 37 CFR 1.219. If
applicant previously filed a
nonpublication request in the
application, applicant must file a
rescission of a nonpublication request
no later than the time the petition to
make special is filed. Applicant may use
form PTO/SB/36 to rescind the
nonpublication request.
Part II. Eligibility Requirements—
Applications Pertaining to Cancer
Immunotherapy. To be eligible for the
Cancer Immunotherapy Pilot Program,
patent applications should be in the
field of Oncology. The applications
must contain at least one claim
encompassing a method of ameliorating,
treating, or preventing a malignancy in
a human subject wherein the steps of
the method assist or boost the immune
system in eradicating cancerous cells.
For example, this can include the
administration of cells, antibodies,
proteins, or nucleic acids that invoke an
active (or achieve a passive) immune
response to destroy cancerous cells. The
Pilot Program also will consider claims
drawn to the co-administration of
biological adjuvants (e.g., interleukins,
cytokines, Bacillus Comette-Guerin,
monophosphoryl lipid A, etc.) in
combination with conventional
therapies for treating cancer such as
chemotherapy, radiation, or surgery.
Claims to administering any vaccine
that works by activating the immune
system to prevent or destroy cancer cell
growth are included. The Pilot Program
also will consider in vivo, ex vivo, and
adoptive immunotherapies, including
those using autologous and/or
heterologous cells or immortalized cell
lines.
As in other programs, eligibility for
this pilot is not restricted by (i) the
nationality of the patent applicant or its
agents, (ii) the location where the
underlying research was undertaken or
the technology was developed, or (iii)
the location where the invention may be
produced or manufactured.
Part III. Decision on Petition To Make
Special Under the Cancer
Immunotherapy Pilot Program. If
applicant files a petition to make special
under the Cancer Immunotherapy Pilot
Program, the USPTO will decide the
petition once the application has been
docketed for examination. Any inquiries
concerning a specific 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 Cancer Immunotherapy
Pilot Program until a final disposition
(see Part XII (Twelve-Month Goal)).
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Under special status, an application that
has not been acted on or an application
with a proper RCE request will be
placed on the examiner’s special new
docket until a first Office action on the
merits. For an application in the Pilot
Program where applicant is responding
to a first Office action, the application
will be placed on the examiner’s regular
amended docket. Under the Pilot
Program, the USPTO is providing
examiners with incentives to handle
these applicant responses promptly.
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 through
1.825, such that the application is not in
condition for examination, or has an
outstanding Office action, or if the
application and/or petition does not
meet all the formal requirements set
forth in this notice, the USPTO will
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 Cancer
Immunotherapy Pilot Program, the
applicant must file a proper petition and
make appropriate corrections within
one month or thirty days, whichever is
longer. 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 eligible for the Cancer
Immunotherapy Pilot Program, and the
application will be taken up for
examination in accordance with
standard examination procedures. If the
application does not contain a method
claim that complies with the eligibility
requirements discussed in Part II of this
notice, the petition will be dismissed,
and the applicant will not be given an
opportunity to correct the deficiency.
Part IV. Requirement for Restriction. If
the claims in the application are
directed to multiple inventions, the
examiner may make a requirement for
restriction in accordance with current
restriction practice. The examiner will
contact the applicant by telephone and
request an oral election of a single
invention for prosecution. Applicant
must make an election without traverse
in a telephonic interview of an
invention that is to a method of treating
a cancer using immunotherapy that
meets the eligibility requirements for
this Pilot Program. If the applicant does
not respond by telephone to an
examiner’s request for an election
within two working days or refuses to
make an election of an invention that is
to a method of treating a cancer using
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immunotherapy, the examiner will treat
the first group of claims directed to a
method of treating a cancer using
immunotherapy that meets the
eligibility requirements of this notice as
constructively elected without traverse
for examination.
Part V. First Action Interview Pilot
Program Not Available. Applications
accepted into the Cancer
Immunotherapy Pilot Program will not
be eligible to participate in the First
Action Interview Pilot Program.
However, standard interview practice
and procedures applicable to regular ex
parte prosecution will still be available
See MPEP section 713.02.
Part VI. Period for Reply by
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.
However, if an applicant files a petition
for any extension of time under 37 CFR
1.136(a), the special status of the
application will be terminated, and the
application will be taken up for
examination in accordance with
standard examination procedures.
Part VII. Reply By Applicant. A reply
to an Office action must be limited to
responding to rejections, objections, and
requirements made by the examiner.
Any amendment to a non-final Office
action will be treated as not fully
responsive if it attempts to: (A) Add
claims which would result in more than
three independent claims, or more than
twenty total claims, pending in the
application; (B) add any multiple
dependent claim; or (C) cancel all
method claims to treating a cancer using
immunotherapy. If a reply to a non-final
Office action is not fully responsive
because it does not comply with the
Pilot Program claim requirements, but is
a bona fide attempt to advance the
application to final action, the examiner
may, at his or her discretion, provide
one month or thirty days, whichever is
longer, for 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 not be permitted in order for the
application to remain in special status.
Any further nonresponsive amendment
will be treated as non-bona fide and the
time period set in the prior notice will
continue to run.
Part VIII. After-Final and Appeal
Procedures: The mailing of a final Office
action or the filing of a Notice of
Appeal, whichever is earlier, is a final
disposition for purposes of the twelvemonth goal for the Cancer
Immunotherapy Pilot Program. During
the appeal process, the application will
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42331
be treated in accordance with the
normal appeal procedure (see MPEP
Chapter 1200). Any amendment,
affidavit, or other evidence after a final
Office action and prior to appeal must
comply with 37 CFR 1.116. The filing of
an RCE is a final disposition for
purposes of the twelve-month goal for
the Cancer Immunotherapy Pilot
Program. The application will not retain
its special status after the filing of a
proper RCE.
Part IX. Post-Allowance Processing.
The mailing of a notice of allowance is
a final disposition for the purposes of
the twelve-month goal for the Pilot
Program. The failure to pay the required
issue fee within one (1) month of the
mailing date of the Form PTOL–85 or
the submission of a non-USPTO
required submission under 37 CFR
1.312 will result in the allowance being
processed according to the regular
allowance process. A submission that
includes both USPTO required changes
and non-USPTO required changes under
the provisions of 37 CFR 1.312 will be
considered as a non-USPTO required
submission for purposes of the
allowance processing.
Part X. Proceedings Outside the
Normal Examination Process: If an
application becomes involved in
proceedings outside the normal
examination process (e.g., a secrecy
order, national security review,
interference, derivation proceeding or
petitions under 37 CFR 1.181 through
1.183), the USPTO will place the
application in special status under the
Cancer Immunology Pilot Program
before and after such proceedings.
During those proceedings, however, the
application will not be under special
status. For example, during an
interference proceeding, the application
will be treated in accordance with the
normal interference procedures and will
not be in special status under the Cancer
Immunology Pilot Program. Once any
one of these proceedings is completed,
the application will continue in special
status under the Pilot Program until it
reaches a final disposition, but that may
occur later than twelve months from the
grant of special status under the Pilot
Program.
Part XI. Withdrawal From Pilot
Program. There is no provision for
‘‘withdrawal’’ from special status under
the Pilot Program. However, filing a
petition for any extension of time under
37 CFR 1.136(a) will result in the
application being taken out of the Pilot
Program. An applicant may abandon the
application that has been granted
special status under the Pilot Program in
favor of a continuing application, and
the continuing application will not be
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29JNN1
42332
Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices
given special status under the Pilot
Program unless the continuing
application is filed with a petition to
make special under the Pilot Program.
Part XII. Twelve-Month Goal. The
objective of the Cancer Immunology
Pilot Program is to complete the
examination of an application within
twelve months of special status being
granted under the Pilot Program (i.e.,
within twelve months from the mailing
date of the decision granting the petition
to make special). The twelve-month goal
is successfully achieved when one of
the following final dispositions occurs
within twelve months from the grant of
special status under the Pilot Program:
(1) The mailing of a notice of allowance;
(2) the mailing of a final Office action;
(3) the filing of an RCE; (4) the
abandonment of the application; (5) or
the filing of a Notice of Appeal. The
final disposition of an application,
however, may occur later than the
twelve-month time frame in certain
situations (e.g., applicant files an
amendment that does not comply with
the Pilot Program claim requirements or
applicant petitions for extension of time
under 37 CFR 1.136(a)). See Part X for
more information on other events that
may cause examination to extend
beyond this twelve-month timeframe. In
any event, however, this twelve-month
time frame is simply a goal. Any failure
to meet the twelve-month goal or other
issues relating to this twelve-month goal
are neither petitionable nor appealable
matters.
Dated: June 24, 2016.
Michelle K. Lee,
Under Secretary of Commerce for Intellectual
Property and Director of the United States
Patent and Trademark Office.
[FR Doc. 2016–15533 Filed 6–28–16; 8:45 am]
BILLING CODE 3510–16–P
COMMODITY FUTURES TRADING
COMMISSION
Agency Information Collection
Activities Under OMB Review
Commodity Futures Trading
Commission.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995
(‘‘PRA’’), this notice announces that the
Information Collection Request (‘‘ICR’’)
abstracted below has been forwarded to
the Office of Management and Budget
(‘‘OMB’’) for review and comment. The
ICR describes the nature of the
information collection and its expected
costs and burden.
DATES: Comments must be submitted on
or before July 29, 2016.
ADDRESSES: Comments regarding the
burden estimated or any other aspect of
the information collection, including
suggestions for reducing the burden,
may be submitted directly to the Office
of Information and Regulatory Affairs
(‘‘OIRA’’) in OMB, within 30 days of the
notice’s publication, by email at
OIRAsubmissions@omb.eop.gov. Please
identify the comments by OMB Control
No. 3038–0012. Please provide the
Commission with a copy of all
submitted comments at the address
listed below. Please refer to OMB
Reference No. 3038–0012, found on
https://reginfo.gov. Comments may also
be mailed to the Office of Information
and Regulatory Affairs, Office of
Management and Budget, Attention:
Desk Officer for the Commodity Futures
Trading Commission, 725 17th Street
NW., Washington, DC 20503, or
submitted through the Agency’s Web
site at https://comments.cftc.gov. Follow
the instructions for submitting
comments through the Web site.
Comments may also be mailed to:
Christopher Kirkpatrick, Secretary of the
Commission, Commodity Futures
Trading Commission, Three Lafayette
SUMMARY:
Centre, 1155 21st Street NW.,
Washington, DC 20581 or by Hand
Deliver/Courier at the same address.
A copy of the supporting statements
for the collection of information
discussed above may be obtained by
visiting https://regInfo.gov. All
comments must be submitted in
English, or if not, accompanied by an
English translation. Comments will be
posted as received to https://
www.cftc.gov.
Gary
Martinaitis, Division of Market
Oversight, Commodity Futures Trading
Commission, (202) 418–5209; email:
gmartinaitis@cftc.gov, and refer to OMB
Control No. 3038–0012.
SUPPLEMENTARY INFORMATION: An agency
may not conduct or sponsor, and a
person is not required to respond to, a
collection of information unless it
displays a currently valid OMB control
number. The Federal Register notice
with a 60-day comment period soliciting
comments on this collection of
information was published on March
29, 2016 (81 FR 17447).
Title: Futures Volume, Open Interest,
Price, Deliveries and Purchases/Sales of
Futures for Commodities or for
Derivatives Positions (OMB Control No.
3038–0012). This is a request for
extension of a currently approved
information collection.
Abstract: Commission Regulation
16.01 requires the U.S. futures
exchanges to publish daily information
on the items listed in the title of the
collection. The information required by
this rule is in the public interest and is
necessary for market surveillance. This
rule is promulgated pursuant to the
Commission’s rulemaking authority
contained in Section 5 of the
Commodity Exchange Act, 7 U.S.C. 7
(2010).
Burden Statement: The respondent
burden for this collection is estimated to
be as follows:
FOR FURTHER INFORMATION CONTACT:
ESTIMATED ANNUAL REPORTING BURDEN
Annual
number of
respondents
Frequency of
response
Total annual
responses
Hours per
response
Total hours
16.01 ....................................................................................
mstockstill on DSK3G9T082PROD with NOTICES
17 CFR Section
15
Daily ...............
3,750
0.5
1,875
The total annual cost burden per
respondent is estimated to be $6,875.
The Commission based its calculation
on a blended hourly wage rate of $55 for
VerDate Sep<11>2014
17:18 Jun 28, 2016
Jkt 238001
a Programmer and Compliance
Manager.1
1 In arriving at a wage rate for the hourly costs
imposed, Commission staff used the Management &
Professional Earnings in the Securities Industry
Report, published in 2013 by the Securities
Industry and Financial Markets Associations
(Report). The wage rate used the median salary of
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
Authority: 44 U.S.C. 3501 et seq.
a Programmer and Compliance Manager as
published in the 2013 Report and divided that
figure by 2000 annual working hours to arrive at the
hourly rate of $55.
E:\FR\FM\29JNN1.SGM
29JNN1
]]>Agencies
[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Pages 42328-42332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15533]
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No.: PTO-P-2016-0015]
Cancer Immunotherapy Pilot Program
AGENCY: United States Patent and Trademark Office, Commerce.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The United States Patent and Trademark Office (USPTO or
Office) is implementing a pilot program to provide for earlier review
of patent applications pertaining to cancer immunotherapy (``Cancer
Immunotherapy Pilot Program'' or ``Pilot Program'') in support of the
White House national $1 billion initiative to achieve ten years' worth
of cancer research in the next five years (``National Cancer
Moonshot''). The USPTO will advance applications containing a claim(s)
to a method of treating a cancer using immunotherapy out of turn for
examination if the applicant files a grantable petition to make special
under the Pilot Program. The objective of the Pilot Program is to
complete the examination of the application within twelve months of
special status being granted. Under the Cancer Immunotherapy Pilot
Program, an application will be advanced out of turn for examination
without meeting all of the current requirements of the accelerated
examination program (e.g., the requirement for an examination support
document) or the Prioritized Examination (Track I) program. This notice
outlines the conditions, eligibility requirements, and guidelines of
the Pilot Program.
DATES: Effective Date: June 29, 2016.
Duration: The Cancer Immunotherapy Pilot Program will run for
twelve months from its effective date. Therefore, petitions to make
special under the Cancer Immunotherapy Pilot
[[Page 42329]]
Program must be filed before June 29, 2017. The USPTO may extend the
Pilot Program (with or without modifications) or terminate it depending
on the workload and resources needed to administer the Pilot Program,
feedback from the public, and the effectiveness of the Pilot Program.
If the Pilot Program is extended or terminated, the USPTO will provide
notification to the public.
FOR FURTHER INFORMATION CONTACT: Pinchus M. Laufer, Senior Legal
Advisor (telephone (571) 272-7726; electronic mail at
pinchus.laufer@uspto.gov) or Susy Tsang-Foster, Senior Legal Advisor
(telephone (571) 272-7711; electronic mail at susy.tsang-foster@uspto.gov), of the Office of Patent Legal Administration, Office
of the Deputy Commissioner for Patent Examination Policy.
For questions relating to a specific petition, please contact Gary
B. Nickol, Supervisory Patent Examiner (telephone (571) 272-0835;
electronic mail at gary.nickol@uspto.gov) or Brandon J. Fetterolf,
Supervisory Patent Examiner (telephone (571) 272-2919; electronic mail
at brandon.fetterolf@uspto.gov), of Technology Center 1600.
SUPPLEMENTARY INFORMATION: On February 1, 2016, the White House Office
of the Press Secretary announced a new, national $1 billion initiative
to achieve ten years' worth of cancer research in the next five years,
with the intent to aid in the global fight against cancer. See the
White House Web site at https://www.whitehouse.gov/the-press-office/2016/02/01/fact-sheet-investing-national-cancer-moonshot. To support
this initiative, the USPTO is implementing the Cancer Immunotherapy
Pilot Program to advance patent applications pertaining to cancer
immunotherapy out of turn for examination to provide for earlier
review. The objective of the Pilot Program is to complete the
examination of an application containing a claim(s) to a method of
treating a cancer using immunotherapy within twelve months of special
status being granted. See Part XII below (Twelve-Month Goal) for more
information.
New patent applications are normally taken up for examination in
the order of their U.S. filing date. See section 708 of the Manual of
Patent Examining Procedure (9th ed., 7th Rev., November 2015) (MPEP).
The USPTO has procedures under which an application will be advanced
out of turn (accorded special status) for examination if the applicant
files a petition to make special under 37 CFR 1.102(c) and (d) with the
appropriate showing or a request for prioritized examination under 37
CFR 1.102(e). See 37 CFR 1.102 and MPEP section 708.02. The USPTO
revised its accelerated examination procedures effective August 25,
2006, requiring that all petitions to make special comply with the
requirements of the revised accelerated examination (AE) program,
except those based on an inventor's health or age or the Patent
Prosecution Highway (PPH) Pilot Program. See Changes to Practice for
Petitions in Patent Applications To Make Special and for Accelerated
Examination, 71 FR 36323 (June 26, 2006), 1308 Off. Gaz. Pat. Office
106 (July 18, 2006) (notice); see also MPEP section 708.02(a).
The USPTO is implementing the Cancer Immunotherapy Pilot Program to
permit an application containing at least one claim to a method of
treating a cancer using immunotherapy to be advanced out of turn
(accorded special status) for examination without meeting all of the
current requirements of the accelerated examination program set forth
in item VIII of MPEP section 708.02(a) (e.g., examination support
document) if the applicant files a grantable petition to make special
under the Pilot Program. Applications that have been accorded special
status based on any USPTO established procedures (such as PPH,
Prioritized Examination, Accelerated Examination, Age, Health, or any
other pilot program that takes up an application out of order for
examination) are not eligible to be made special under the Cancer
Immunotherapy Pilot Program. Applications are accorded special status
under the Cancer Immunotherapy Pilot Program after grant of special
status until a final disposition (defined in Part XII (Twelve-Month
Goal)) is reached in the application. Under special status, an
application that has not been acted on or an application with a proper
RCE request will be placed on the examiner's special new docket until a
first Office action on the merits. For an application in the Pilot
Program where applicant is responding to a first Office action, the
application will be placed on the examiner's regular amended docket.
Under the Pilot Program, the USPTO is providing examiners with
incentives to handle these applicant responses promptly.
The USPTO will accept petitions to make special under the Cancer
Immunotherapy Pilot Program provided that the petitions, and
applications in which they are filed, meet all of the requirements set
forth in this notice. The USPTO will periodically evaluate the Pilot
Program to determine whether and to what extent its coverage should be
expanded. In addition, the USPTO may extend the Pilot Program (with or
without modifications) or terminate it depending on the workload and
resources needed to administer the Pilot Program, feedback from the
public, and the effectiveness of the Pilot Program. If the Pilot
Program is extended or terminated, the USPTO will provide notification
to the public.
Applicants may participate in the Cancer Immunotherapy Pilot
Program by filing a petition to make special under 37 CFR 1.102(d)
meeting all of the requirements set forth in this notice in either a
new application or in a pending application. However, continuing
applications will not automatically be accorded special status based on
papers filed with a petition in a parent application. Each application
must, on its own, meet all requirements for special status. No fee is
required. The fee for a petition to make special under 37 CFR 1.102(d)
based upon the procedure specified in this notice is hereby waived.
Part I. Requirements for Petitions To Make Special Under the Cancer
Immunotherapy Pilot Program: A petition to make special under the
Cancer Immunotherapy Pilot Program may be granted in an application
provided the eligibility requirements set forth in Part II and the
following conditions are satisfied:
(1) Types of Applications. The application must be a non-reissue,
non-provisional 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.
(2) Claim Limit and No Multiple Dependent Claims. The application
must not contain more than three independent claims and more than
twenty total claims. The application must not contain any multiple
dependent claims. For an application that contains more than three
independent claims or twenty total claims, or any multiple dependent
claims, applicant must file a preliminary amendment in compliance with
37 CFR 1.121 to cancel the excess claims and/or the multiple dependent
claims at the time the petition to make special is filed. The petition
must include a statement that applicant agrees that the application
will not have more than three independent claims, more than twenty
total claims, and any multiple dependent claims while the application
is in special status under the Pilot Program.
(3) The Application Must Include at Least One Method Claim of
Treating a Cancer Using Immunotherapy. The application must include at
least one claim to a method of treating a cancer
[[Page 42330]]
using immunotherapy that meets the eligibility requirements in Part II
of this notice. The petition must include a statement that the
applicant agrees to include at least one claim to a method of treating
a cancer using immunotherapy that meets the Pilot Program eligibility
requirements while the application is in special status. For
applications that have been previously examined, applicants will not be
permitted to switch inventions in order to participate in the Pilot
Program. See MPEP section 821.03.
(4) Statement Regarding Method of Treating a Cancer Using
Immunotherapy. The petition to make special must state that special
status under the Pilot Program is sought because the application
contains a claim to a method of treating a cancer using immunotherapy
that meets the eligibility requirements discussed in Part II of this
notice.
(5) Statement Regarding Restriction Requirement. The petition must
include a statement that, if the USPTO determines that the claims are
directed to multiple inventions, applicant will agree to make an
election without traverse in a telephonic interview, and elect an
invention directed to a method of treating a cancer using immunotherapy
that meets the eligibility requirement discussed in Part II of this
notice.
(6) Statement that Special Status Was Not Previously Granted Under
Any Program. The petition must state that the application has not been
previously granted special status. 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 in any other
program (e.g., age, health, PPH, AE, prioritized examination).
(7) Time for Filing Petition. In general, the petition to make
special under the Pilot Program must be filed (i) at least one day
prior to the date that notice of a first Office action (which may be an
Office action containing only a restriction requirement) appears in the
Patent Application Information Retrieval (PAIR) system (applicant may
check the status of an application using PAIR); or (ii) with a proper
request for continued examination (RCE) that is in compliance with 37
CFR 1.114.
For patent applicants whose claimed cancer immunotherapy both (i)
meets the eligibility requirements for this Pilot Program and (ii) is
the subject of an active Investigational New Drug (IND) application
filed by patent applicant or their agent (e.g., a licensee of the
patent applicant or the patent applicant's assignee) at the U.S. Food
and Drug Administration (FDA) that has entered phase II or phase III
clinical trials, the petition may be filed any time prior to an appeal
or a final rejection if patent applicant certifies both (i) and (ii) in
the petition. For an application that has an outstanding Office action,
patent applicant must file a complete response together with the
petition.
Therefore, the petition is only required to contain the above
applicant certification if the patent application has received a first
Office action or a request for continued examination (RCE) was not
filed with the petition. By default, for applications that have been
previously examined, if applicant makes the above certification in the
petition, the above certification would necessarily apply to at least
one of the examined claims since applicants are not permitted to switch
inventions in order to participate in the Pilot Program. See MPEP
section 821.03.
(8) Office Form Available for Filing Petition. Applicant should use
form PTO/SB/443 for filing the petition. The form will contain a check-
box for the applicant to certify that the claimed cancer immunotherapy
both (i) meets the eligibility requirements for this Pilot Program and
(ii) is the subject of an active IND application filed by patent
applicant or their agent at the FDA that has entered phase II or phase
III clinical trials. The form will be available as a Portable Document
Format (PDF) fillable form in EFS-Web and on the USPTO Web site at
https://www.uspto.gov/web/forms/. The Office of Management and
Budget (OMB) has determined that, under 5 CFR 1320.3(h), Form PTO/SB/
443 does not collect ``information'' within the meaning of the
Paperwork Reduction Act of 1995. Information regarding EFS-Web is
available on the USPTO Web site at https://www.uspto.gov/learning-and-resources/support-centers/patent-electronic-business-center. Failure to
use the form or its equivalent could result in the Office not
recognizing the request or delays in processing the request.
(9) Electronic Filing of Petition Required. The petition to make
special must be filed electronically before June 29, 2017, using the
USPTO electronic filing system, EFS-Web, and selecting the document
description of ``Petition for Cancer Immunotherapy Pilot'' on the EFS-
Web screen. Any inquiries concerning electronic filing of the petition
should be directed to the Electronic Business Center (EBC) at (866)
217-9197.
(10) Publication Requirement for Applications. For unpublished
applications, the petition to make special must be accompanied by a
request for early publication in compliance with 37 CFR 1.219. If
applicant previously filed a nonpublication request in the application,
applicant must file a rescission of a nonpublication request no later
than the time the petition to make special is filed. Applicant may use
form PTO/SB/36 to rescind the nonpublication request.
Part II. Eligibility Requirements--Applications Pertaining to
Cancer Immunotherapy. To be eligible for the Cancer Immunotherapy Pilot
Program, patent applications should be in the field of Oncology. The
applications must contain at least one claim encompassing a method of
ameliorating, treating, or preventing a malignancy in a human subject
wherein the steps of the method assist or boost the immune system in
eradicating cancerous cells. For example, this can include the
administration of cells, antibodies, proteins, or nucleic acids that
invoke an active (or achieve a passive) immune response to destroy
cancerous cells. The Pilot Program also will consider claims drawn to
the co-administration of biological adjuvants (e.g., interleukins,
cytokines, Bacillus Comette-Guerin, monophosphoryl lipid A, etc.) in
combination with conventional therapies for treating cancer such as
chemotherapy, radiation, or surgery. Claims to administering any
vaccine that works by activating the immune system to prevent or
destroy cancer cell growth are included. The Pilot Program also will
consider in vivo, ex vivo, and adoptive immunotherapies, including
those using autologous and/or heterologous cells or immortalized cell
lines.
As in other programs, eligibility for this pilot is not restricted
by (i) the nationality of the patent applicant or its agents, (ii) the
location where the underlying research was undertaken or the technology
was developed, or (iii) the location where the invention may be
produced or manufactured.
Part III. Decision on Petition To Make Special Under the Cancer
Immunotherapy Pilot Program. If applicant files a petition to make
special under the Cancer Immunotherapy Pilot Program, the USPTO will
decide the petition once the application has been docketed for
examination. Any inquiries concerning a specific 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 Cancer Immunotherapy Pilot Program
until a final disposition (see Part XII (Twelve-Month Goal)).
[[Page 42331]]
Under special status, an application that has not been acted on or an
application with a proper RCE request will be placed on the examiner's
special new docket until a first Office action on the merits. For an
application in the Pilot Program where applicant is responding to a
first Office action, the application will be placed on the examiner's
regular amended docket. Under the Pilot Program, the USPTO is providing
examiners with incentives to handle these applicant responses promptly.
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 through 1.825, such that the
application is not in condition for examination, or has an outstanding
Office action, or if the application and/or petition does not meet all
the formal requirements set forth in this notice, the USPTO will 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 Cancer Immunotherapy
Pilot Program, the applicant must file a proper petition and make
appropriate corrections within one month or thirty days, whichever is
longer. 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 eligible for the Cancer Immunotherapy Pilot Program, and
the application will be taken up for examination in accordance with
standard examination procedures. If the application does not contain a
method claim that complies with the eligibility requirements discussed
in Part II of this notice, the petition will be dismissed, and the
applicant will not be given an opportunity to correct the deficiency.
Part IV. Requirement for Restriction. If the claims in the
application are directed to multiple inventions, the examiner may make
a requirement for restriction in accordance with current restriction
practice. The examiner will contact the applicant by telephone and
request an oral election of a single invention for prosecution.
Applicant must make an election without traverse in a telephonic
interview of an invention that is to a method of treating a cancer
using immunotherapy that meets the eligibility requirements for this
Pilot Program. If the applicant does not respond by telephone to an
examiner's request for an election within two working days or refuses
to make an election of an invention that is to a method of treating a
cancer using immunotherapy, the examiner will treat the first group of
claims directed to a method of treating a cancer using immunotherapy
that meets the eligibility requirements of this notice as
constructively elected without traverse for examination.
Part V. First Action Interview Pilot Program Not Available.
Applications accepted into the Cancer Immunotherapy Pilot Program will
not be eligible to participate in the First Action Interview Pilot
Program. However, standard interview practice and procedures applicable
to regular ex parte prosecution will still be available See MPEP
section 713.02.
Part VI. Period for Reply by 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. However, if an applicant files a petition for
any extension of time under 37 CFR 1.136(a), the special status of the
application will be terminated, and the application will be taken up
for examination in accordance with standard examination procedures.
Part VII. Reply By Applicant. A reply to an Office action must be
limited to responding to rejections, objections, and requirements made
by the examiner. Any amendment to a non-final Office action will be
treated as not fully responsive if it attempts to: (A) Add claims which
would result in more than three independent claims, or more than twenty
total claims, pending in the application; (B) add any multiple
dependent claim; or (C) cancel all method claims to treating a cancer
using immunotherapy. If a reply to a non-final Office action is not
fully responsive because it does not comply with the Pilot Program
claim requirements, but is a bona fide attempt to advance the
application to final action, the examiner may, at his or her
discretion, provide one month or thirty days, whichever is longer, for
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 not be permitted in order for the application to remain in special
status. Any further nonresponsive amendment will be treated as non-bona
fide and the time period set in the prior notice will continue to run.
Part VIII. After-Final and Appeal Procedures: The mailing of a
final Office action or the filing of a Notice of Appeal, whichever is
earlier, is a final disposition for purposes of the twelve-month goal
for the Cancer Immunotherapy Pilot Program. During the appeal process,
the application will be treated in accordance with the normal appeal
procedure (see MPEP Chapter 1200). Any amendment, affidavit, or other
evidence after a final Office action and prior to appeal must comply
with 37 CFR 1.116. The filing of an RCE is a final disposition for
purposes of the twelve-month goal for the Cancer Immunotherapy Pilot
Program. The application will not retain its special status after the
filing of a proper RCE.
Part IX. Post-Allowance Processing. The mailing of a notice of
allowance is a final disposition for the purposes of the twelve-month
goal for the Pilot Program. The failure to pay the required issue fee
within one (1) month of the mailing date of the Form PTOL-85 or the
submission of a non-USPTO required submission under 37 CFR 1.312 will
result in the allowance being processed according to the regular
allowance process. A submission that includes both USPTO required
changes and non-USPTO required changes under the provisions of 37 CFR
1.312 will be considered as a non-USPTO required submission for
purposes of the allowance processing.
Part X. Proceedings Outside the Normal Examination Process: If an
application becomes involved in proceedings outside the normal
examination process (e.g., a secrecy order, national security review,
interference, derivation proceeding or petitions under 37 CFR 1.181
through 1.183), the USPTO will place the application in special status
under the Cancer Immunology Pilot Program before and after such
proceedings. During those proceedings, however, the application will
not be under special status. For example, during an interference
proceeding, the application will be treated in accordance with the
normal interference procedures and will not be in special status under
the Cancer Immunology Pilot Program. Once any one of these proceedings
is completed, the application will continue in special status under the
Pilot Program until it reaches a final disposition, but that may occur
later than twelve months from the grant of special status under the
Pilot Program.
Part XI. Withdrawal From Pilot Program. There is no provision for
``withdrawal'' from special status under the Pilot Program. However,
filing a petition for any extension of time under 37 CFR 1.136(a) will
result in the application being taken out of the Pilot Program. An
applicant may abandon the application that has been granted special
status under the Pilot Program in favor of a continuing application,
and the continuing application will not be
[[Page 42332]]
given special status under the Pilot Program unless the continuing
application is filed with a petition to make special under the Pilot
Program.
Part XII. Twelve-Month Goal. The objective of the Cancer Immunology
Pilot Program is to complete the examination of an application within
twelve months of special status being granted under the Pilot Program
(i.e., within twelve months from the mailing date of the decision
granting the petition to make special). The twelve-month goal is
successfully achieved when one of the following final dispositions
occurs within twelve months from the grant of special status under the
Pilot Program: (1) The mailing of a notice of allowance; (2) the
mailing of a final Office action; (3) the filing of an RCE; (4) the
abandonment of the application; (5) or the filing of a Notice of
Appeal. The final disposition of an application, however, may occur
later than the twelve-month time frame in certain situations (e.g.,
applicant files an amendment that does not comply with the Pilot
Program claim requirements or applicant petitions for extension of time
under 37 CFR 1.136(a)). See Part X for more information on other events
that may cause examination to extend beyond this twelve-month
timeframe. In any event, however, this twelve-month time frame is
simply a goal. Any failure to meet the twelve-month goal or other
issues relating to this twelve-month goal are neither petitionable nor
appealable matters.
Dated: June 24, 2016.
Michelle K. Lee,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2016-15533 Filed 6-28-16; 8:45 am]
BILLING CODE 3510-16-P
