81_FR_42453 81 FR 42328 - Cancer Immunotherapy Pilot Program

81 FR 42328 - Cancer Immunotherapy Pilot Program

DEPARTMENT OF COMMERCE
Patent and Trademark Office

Federal Register Volume 81, Issue 125 (June 29, 2016)

Page Range42328-42332
FR Document2016-15533

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.

Federal Register, Volume 81 Issue 125 (Wednesday, June 29, 2016)
[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Pages 42328-42332]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15533]


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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.

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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 
[email protected]) or Susy Tsang-Foster, Senior Legal Advisor 
(telephone (571) 272-7711; electronic mail at [email protected]), 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 [email protected]) or Brandon J. Fetterolf, 
Supervisory Patent Examiner (telephone (571) 272-2919; electronic mail 
at [email protected]), 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 
http://www.uspto.gov/web/forms/index.html. 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 http://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



                                                  42328                        Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices

                                                  MD 20910. Technical feedback in the                     manager, National Ocean Service, Office                matters may be considered. This agenda
                                                  form of brief annotated bibliographic                   of Coast Survey, NOAA (N/NSD), 1315                    is subject to change.
                                                  entries would be welcome. The                           East-West Highway, SSMC3 #6301,                           Special Accommodations: This
                                                  Interagency Working Group will gladly                   Silver Spring, Maryland 20910;                         meeting is physically accessible to
                                                  accept public input at any time;                        telephone: 301–713–2750 ext. 166;                      people with disabilities. Please direct
                                                  however, only those that are received on                email: lynne.mersfelder@noaa.gov.                      requests for sign language interpretation
                                                  or before August 19, 2016, may be                                                                              or other auxiliary aids to
                                                  considered when the Interagency                         SUPPLEMENTARY INFORMATION:      The                    Lynne.Mersfelder@noaa.gov by August
                                                  Working Group finalizes the plan.                       meeting is open to the public, and                     8, 2016.
                                                                                                          public seating will be available on a
                                                  FOR FURTHER INFORMATION CONTACT:                                                                                 Dated: June 17, 2016.
                                                                                                          first-come, first-served basis. The times
                                                  Caitlin Gould (Caitlin.gould@noaa.gov,                                                                         Gerd F. Glang,
                                                                                                          of onsite public comment periods,
                                                  240–533–0290) or Stacey DeGrasse
                                                                                                          scheduled for each day, will be                        Rear Admiral, Director, Office of Coast
                                                  (Stacey.Degrasse@fda.hhs.gov, 240–                                                                             Survey, National Ocean Service, National
                                                  402–1470).                                              included in the final agenda. Each
                                                                                                          individual or group making verbal                      Oceanic and Atmospheric Administration.
                                                  SUPPLEMENTARY INFORMATION:                                                                                     [FR Doc. 2016–15365 Filed 6–28–16; 8:45 am]
                                                                                                          comments will be limited to a total time
                                                  Correction                                              of five (5) minutes. Comments will be                  BILLING CODE P

                                                    The National Oceanic and                              recorded. Individuals who would like to
                                                  Atmospheric Administration published                    submit written statements should email
                                                                                                          their comments to Lynne.Mersfelder@                    DEPARTMENT OF COMMERCE
                                                  a document in the Federal Register of
                                                  June 3, 2016, entitled Interagency                      noaa.gov. The HSRP will provide
                                                                                                          webinar and teleconference capability                  Patent and Trademark Office
                                                  Working Group on the Harmful Algal
                                                  Bloom and Hypoxia Research and                          for the public sessions. Pre-registration              [Docket No.: PTO–P–2016–0015]
                                                  Control Amendments Act. The                             is required to access the webinar: http://
                                                  information concerning the webinar                      www.nauticalcharts.noaa.gov/ocs/hsrp/                  Cancer Immunotherapy Pilot Program
                                                  dates and WebEx information have been                   meetings_cleveland2016.htm.
                                                                                                                                                                 AGENCY: United States Patent and
                                                  updated.                                                   The Hydrographic Services Review                    Trademark Office, Commerce.
                                                    Dated: June 15, 2016.                                 Panel (HSRP) is a Federal Advisory                     ACTION: Notice.
                                                  Mary C. Erickson,                                       Committee established to advise the
                                                  Director, National Centers for Coastal Ocean            Under Secretary of Commerce for                        SUMMARY:    The United States Patent and
                                                  Science, National Ocean Service, National               Oceans and Atmosphere, the NOAA                        Trademark Office (USPTO or Office) is
                                                  Oceanic and Atmospheric Administration.                 Administrator, on matters related to the               implementing a pilot program to
                                                  [FR Doc. 2016–15364 Filed 6–28–16; 8:45 am]             responsibilities and authorities set forth             provide for earlier review of patent
                                                  BILLING CODE 3510–JE–P
                                                                                                          in section 303 of the Hydrographic                     applications pertaining to cancer
                                                                                                          Services Improvement Act of 1998, as                   immunotherapy (‘‘Cancer
                                                                                                          amended, and such other appropriate                    Immunotherapy Pilot Program’’ or
                                                  DEPARTMENT OF COMMERCE                                  matters that the Under Secretary refers                ‘‘Pilot Program’’) in support of the
                                                                                                          to the Panel for review and advice. The                White House national $1 billion
                                                  National Oceanic and Atmospheric                        charter and other information are                      initiative to achieve ten years’ worth of
                                                  Administration                                          located online at http://                              cancer research in the next five years
                                                                                                          www.nauticalcharts.noaa.gov/ocs/hsrp/                  (‘‘National Cancer Moonshot’’). The
                                                  Hydrographic Services Review Panel                      CharterBylawsHSIAStatute.htm.                          USPTO will advance applications
                                                  Meeting                                                                                                        containing a claim(s) to a method of
                                                                                                             Matters To Be Considered: The panel
                                                  AGENCY: National Ocean Service,                         is convening to hear federal, state,                   treating a cancer using immunotherapy
                                                  National Oceanic and Atmospheric                        regional and local partners and                        out of turn for examination if the
                                                  Administration (NOAA), Department of                    stakeholders on issues relevant to                     applicant files a grantable petition to
                                                  Commerce.                                               NOAA’s navigation services, focusing                   make special under the Pilot Program.
                                                  ACTION: Notice of open public meeting.                  on the Great Lakes area. Navigation                    The objective of the Pilot Program is to
                                                                                                          services include the data, products, and               complete the examination of the
                                                  SUMMARY:  The Hydrographic Services                     services provided by the NOAA                          application within twelve months of
                                                  Review Panel (HSRP) will hold a                         programs and activities that undertake                 special status being granted. Under the
                                                  meeting that will be open to the public.                geodetic observations, gravity modeling,               Cancer Immunotherapy Pilot Program,
                                                  Information about the HSRP and the                      shoreline mapping, bathymetric                         an application will be advanced out of
                                                  meeting agenda will be posted at: http://               mapping, hydrographic surveying,                       turn for examination without meeting
                                                  www.nauticalcharts.noaa.gov/ocs/hsrp/                   nautical charting, tide and water level                all of the current requirements of the
                                                  meetings_cleveland2016.htm.                             observations, current observations, and                accelerated examination program (e.g.,
                                                  DATES: The meeting will be held on                      marine modeling. This suite of NOAA                    the requirement for an examination
                                                  August 30, 8:30 a.m. to 3:00 p.m. EDT;                  products and services support safe and                 support document) or the Prioritized
                                                  August 31, 8:00 a.m. to 5:00 p.m.; and                  efficient navigation, resilient coasts and             Examination (Track I) program. This
                                                  September 1, 8:00 a.m. to 12:00 noon.                   communities, and the nationwide                        notice outlines the conditions,
                                                  Times are subject to change. For                        positioning information infrastructure to              eligibility requirements, and guidelines
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                                                  updates, please check: http://                          support America’s commerce. The Panel                  of the Pilot Program.
                                                  www.nauticalcharts.noaa.gov/ocs/hsrp/                   will hear from federal agencies and non-               DATES: Effective Date: June 29, 2016.
                                                  meetings_cleveland2016.htm.                             federal organizations about their                         Duration: The Cancer Immunotherapy
                                                  ADDRESSES: City Club of Cleveland, 830                  missions and their use of NOAA’s                       Pilot Program will run for twelve
                                                  Euclid Avenue, Cleveland, Ohio 44114.                   navigation services; what value these                  months from its effective date.
                                                  FOR FURTHER INFORMATION CONTACT:                        services bring; and what improvements                  Therefore, petitions to make special
                                                  Lynne Mersfelder-Lewis, HSRP program                    could be made. Other administrative                    under the Cancer Immunotherapy Pilot


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                                                                               Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices                                            42329

                                                  Program must be filed before June 29,                   1.102(e). See 37 CFR 1.102 and MPEP                    without modifications) or terminate it
                                                  2017. The USPTO may extend the Pilot                    section 708.02. The USPTO revised its                  depending on the workload and
                                                  Program (with or without modifications)                 accelerated examination procedures                     resources needed to administer the Pilot
                                                  or terminate it depending on the                        effective August 25, 2006, requiring that              Program, feedback from the public, and
                                                  workload and resources needed to                        all petitions to make special comply                   the effectiveness of the Pilot Program. If
                                                  administer the Pilot Program, feedback                  with the requirements of the revised                   the Pilot Program is extended or
                                                  from the public, and the effectiveness of               accelerated examination (AE) program,                  terminated, the USPTO will provide
                                                  the Pilot Program. If the Pilot Program                 except those based on an inventor’s                    notification to the public.
                                                  is extended or terminated, the USPTO                    health or age or the Patent Prosecution                   Applicants may participate in the
                                                  will provide notification to the public.                Highway (PPH) Pilot Program. See                       Cancer Immunotherapy Pilot Program
                                                  FOR FURTHER INFORMATION CONTACT:                        Changes to Practice for Petitions in                   by filing a petition to make special
                                                  Pinchus M. Laufer, Senior Legal Advisor                 Patent Applications To Make Special                    under 37 CFR 1.102(d) meeting all of the
                                                  (telephone (571) 272–7726; electronic                   and for Accelerated Examination, 71 FR                 requirements set forth in this notice in
                                                  mail at pinchus.laufer@uspto.gov) or                    36323 (June 26, 2006), 1308 Off. Gaz.                  either a new application or in a pending
                                                  Susy Tsang-Foster, Senior Legal Advisor                 Pat. Office 106 (July 18, 2006) (notice);              application. However, continuing
                                                  (telephone (571) 272–7711; electronic                   see also MPEP section 708.02(a).                       applications will not automatically be
                                                  mail at susy.tsang-foster@uspto.gov), of                   The USPTO is implementing the                       accorded special status based on papers
                                                  the Office of Patent Legal                              Cancer Immunotherapy Pilot Program to                  filed with a petition in a parent
                                                  Administration, Office of the Deputy                    permit an application containing at least              application. Each application must, on
                                                  Commissioner for Patent Examination                     one claim to a method of treating a                    its own, meet all requirements for
                                                  Policy.                                                 cancer using immunotherapy to be                       special status. No fee is required. The
                                                     For questions relating to a specific                 advanced out of turn (accorded special                 fee for a petition to make special under
                                                  petition, please contact Gary B. Nickol,                status) for examination without meeting                37 CFR 1.102(d) based upon the
                                                  Supervisory Patent Examiner (telephone                  all of the current requirements of the                 procedure specified in this notice is
                                                  (571) 272–0835; electronic mail at                      accelerated examination program set                    hereby waived.
                                                                                                          forth in item VIII of MPEP section                        Part I. Requirements for Petitions To
                                                  gary.nickol@uspto.gov) or Brandon J.
                                                                                                          708.02(a) (e.g., examination support                   Make Special Under the Cancer
                                                  Fetterolf, Supervisory Patent Examiner
                                                                                                          document) if the applicant files a                     Immunotherapy Pilot Program: A
                                                  (telephone (571) 272–2919; electronic
                                                                                                          grantable petition to make special under               petition to make special under the
                                                  mail at brandon.fetterolf@uspto.gov), of
                                                                                                          the Pilot Program. Applications that                   Cancer Immunotherapy Pilot Program
                                                  Technology Center 1600.
                                                                                                          have been accorded special status based                may be granted in an application
                                                  SUPPLEMENTARY INFORMATION: On                           on any USPTO established procedures                    provided the eligibility requirements set
                                                  February 1, 2016, the White House                       (such as PPH, Prioritized Examination,                 forth in Part II and the following
                                                  Office of the Press Secretary announced                 Accelerated Examination, Age, Health,                  conditions are satisfied:
                                                  a new, national $1 billion initiative to                or any other pilot program that takes up                  (1) Types of Applications. The
                                                  achieve ten years’ worth of cancer                      an application out of order for                        application must be a non-reissue, non-
                                                  research in the next five years, with the               examination) are not eligible to be made               provisional utility application filed
                                                  intent to aid in the global fight against               special under the Cancer                               under 35 U.S.C. 111(a), or an
                                                  cancer. See the White House Web site at                 Immunotherapy Pilot Program.                           international application that has
                                                  https://www.whitehouse.gov/the-press-                   Applications are accorded special status               entered the national stage under 35
                                                  office/2016/02/01/fact-sheet-investing-                 under the Cancer Immunotherapy Pilot                   U.S.C. 371.
                                                  national-cancer-moonshot. To support                    Program after grant of special status                     (2) Claim Limit and No Multiple
                                                  this initiative, the USPTO is                           until a final disposition (defined in Part             Dependent Claims. The application
                                                  implementing the Cancer                                 XII (Twelve-Month Goal)) is reached in                 must not contain more than three
                                                  Immunotherapy Pilot Program to                          the application. Under special status, an              independent claims and more than
                                                  advance patent applications pertaining                  application that has not been acted on                 twenty total claims. The application
                                                  to cancer immunotherapy out of turn for                 or an application with a proper RCE                    must not contain any multiple
                                                  examination to provide for earlier                      request will be placed on the examiner’s               dependent claims. For an application
                                                  review. The objective of the Pilot                      special new docket until a first Office                that contains more than three
                                                  Program is to complete the examination                  action on the merits. For an application               independent claims or twenty total
                                                  of an application containing a claim(s)                 in the Pilot Program where applicant is                claims, or any multiple dependent
                                                  to a method of treating a cancer using                  responding to a first Office action, the               claims, applicant must file a
                                                  immunotherapy within twelve months                      application will be placed on the                      preliminary amendment in compliance
                                                  of special status being granted. See Part               examiner’s regular amended docket.                     with 37 CFR 1.121 to cancel the excess
                                                  XII below (Twelve-Month Goal) for                       Under the Pilot Program, the USPTO is                  claims and/or the multiple dependent
                                                  more information.                                       providing examiners with incentives to                 claims at the time the petition to make
                                                     New patent applications are normally                 handle these applicant responses                       special is filed. The petition must
                                                  taken up for examination in the order of                promptly.                                              include a statement that applicant
                                                  their U.S. filing date. See section 708 of                 The USPTO will accept petitions to                  agrees that the application will not have
                                                  the Manual of Patent Examining                          make special under the Cancer                          more than three independent claims,
                                                  Procedure (9th ed., 7th Rev., November                  Immunotherapy Pilot Program provided                   more than twenty total claims, and any
                                                  2015) (MPEP). The USPTO has                             that the petitions, and applications in                multiple dependent claims while the
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                                                  procedures under which an application                   which they are filed, meet all of the                  application is in special status under the
                                                  will be advanced out of turn (accorded                  requirements set forth in this notice.                 Pilot Program.
                                                  special status) for examination if the                  The USPTO will periodically evaluate                      (3) The Application Must Include at
                                                  applicant files a petition to make special              the Pilot Program to determine whether                 Least One Method Claim of Treating a
                                                  under 37 CFR 1.102(c) and (d) with the                  and to what extent its coverage should                 Cancer Using Immunotherapy. The
                                                  appropriate showing or a request for                    be expanded. In addition, the USPTO                    application must include at least one
                                                  prioritized examination under 37 CFR                    may extend the Pilot Program (with or                  claim to a method of treating a cancer


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                                                  42330                        Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices

                                                  using immunotherapy that meets the                      Administration (FDA) that has entered                  special must be accompanied by a
                                                  eligibility requirements in Part II of this             phase II or phase III clinical trials, the             request for early publication in
                                                  notice. The petition must include a                     petition may be filed any time prior to                compliance with 37 CFR 1.219. If
                                                  statement that the applicant agrees to                  an appeal or a final rejection if patent               applicant previously filed a
                                                  include at least one claim to a method                  applicant certifies both (i) and (ii) in the           nonpublication request in the
                                                  of treating a cancer using                              petition. For an application that has an               application, applicant must file a
                                                  immunotherapy that meets the Pilot                      outstanding Office action, patent                      rescission of a nonpublication request
                                                  Program eligibility requirements while                  applicant must file a complete response                no later than the time the petition to
                                                  the application is in special status. For               together with the petition.                            make special is filed. Applicant may use
                                                  applications that have been previously                     Therefore, the petition is only                     form PTO/SB/36 to rescind the
                                                  examined, applicants will not be                        required to contain the above applicant                nonpublication request.
                                                  permitted to switch inventions in order                 certification if the patent application                   Part II. Eligibility Requirements—
                                                  to participate in the Pilot Program. See                has received a first Office action or a                Applications Pertaining to Cancer
                                                  MPEP section 821.03.                                    request for continued examination                      Immunotherapy. To be eligible for the
                                                     (4) Statement Regarding Method of                    (RCE) was not filed with the petition. By              Cancer Immunotherapy Pilot Program,
                                                  Treating a Cancer Using                                 default, for applications that have been               patent applications should be in the
                                                  Immunotherapy. The petition to make                     previously examined, if applicant makes                field of Oncology. The applications
                                                  special must state that special status                  the above certification in the petition,               must contain at least one claim
                                                  under the Pilot Program is sought                       the above certification would                          encompassing a method of ameliorating,
                                                  because the application contains a claim                necessarily apply to at least one of the               treating, or preventing a malignancy in
                                                  to a method of treating a cancer using                  examined claims since applicants are                   a human subject wherein the steps of
                                                  immunotherapy that meets the                            not permitted to switch inventions in                  the method assist or boost the immune
                                                  eligibility requirements discussed in                   order to participate in the Pilot Program.             system in eradicating cancerous cells.
                                                  Part II of this notice.                                 See MPEP section 821.03.                               For example, this can include the
                                                     (5) Statement Regarding Restriction                     (8) Office Form Available for Filing                administration of cells, antibodies,
                                                  Requirement. The petition must include                  Petition. Applicant should use form                    proteins, or nucleic acids that invoke an
                                                  a statement that, if the USPTO                          PTO/SB/443 for filing the petition. The                active (or achieve a passive) immune
                                                  determines that the claims are directed                 form will contain a check-box for the                  response to destroy cancerous cells. The
                                                  to multiple inventions, applicant will                  applicant to certify that the claimed                  Pilot Program also will consider claims
                                                  agree to make an election without                       cancer immunotherapy both (i) meets                    drawn to the co-administration of
                                                  traverse in a telephonic interview, and                 the eligibility requirements for this Pilot            biological adjuvants (e.g., interleukins,
                                                  elect an invention directed to a method                 Program and (ii) is the subject of an                  cytokines, Bacillus Comette-Guerin,
                                                  of treating a cancer using                              active IND application filed by patent                 monophosphoryl lipid A, etc.) in
                                                  immunotherapy that meets the                            applicant or their agent at the FDA that               combination with conventional
                                                  eligibility requirement discussed in Part               has entered phase II or phase III clinical             therapies for treating cancer such as
                                                  II of this notice.                                      trials. The form will be available as a                chemotherapy, radiation, or surgery.
                                                     (6) Statement that Special Status Was                Portable Document Format (PDF)                         Claims to administering any vaccine
                                                  Not Previously Granted Under Any                        fillable form in EFS-Web and on the                    that works by activating the immune
                                                  Program. The petition must state that                   USPTO Web site at http://                              system to prevent or destroy cancer cell
                                                  the application has not been previously                 www.uspto.gov/web/forms/index.html.                    growth are included. The Pilot Program
                                                  granted special status. A petition to                   The Office of Management and Budget                    also will consider in vivo, ex vivo, and
                                                  make special under this Pilot Program                   (OMB) has determined that, under 5                     adoptive immunotherapies, including
                                                  may not be filed in an application in                   CFR 1320.3(h), Form PTO/SB/443 does                    those using autologous and/or
                                                  which special status was previously                     not collect ‘‘information’’ within the                 heterologous cells or immortalized cell
                                                  granted under this Pilot Program or in                  meaning of the Paperwork Reduction                     lines.
                                                  any other program (e.g., age, health,                   Act of 1995. Information regarding EFS-                   As in other programs, eligibility for
                                                  PPH, AE, prioritized examination).                      Web is available on the USPTO Web site                 this pilot is not restricted by (i) the
                                                     (7) Time for Filing Petition. In general,            at http://www.uspto.gov/learning-and-                  nationality of the patent applicant or its
                                                  the petition to make special under the                  resources/support-centers/patent-                      agents, (ii) the location where the
                                                  Pilot Program must be filed (i) at least                electronic-business-center. Failure to                 underlying research was undertaken or
                                                  one day prior to the date that notice of                use the form or its equivalent could                   the technology was developed, or (iii)
                                                  a first Office action (which may be an                  result in the Office not recognizing the               the location where the invention may be
                                                  Office action containing only a                         request or delays in processing the                    produced or manufactured.
                                                  restriction requirement) appears in the                 request.                                                  Part III. Decision on Petition To Make
                                                  Patent Application Information                             (9) Electronic Filing of Petition                   Special Under the Cancer
                                                  Retrieval (PAIR) system (applicant may                  Required. The petition to make special                 Immunotherapy Pilot Program. If
                                                  check the status of an application using                must be filed electronically before June               applicant files a petition to make special
                                                  PAIR); or (ii) with a proper request for                29, 2017, using the USPTO electronic                   under the Cancer Immunotherapy Pilot
                                                  continued examination (RCE) that is in                  filing system, EFS-Web, and selecting                  Program, the USPTO will decide the
                                                  compliance with 37 CFR 1.114.                           the document description of ‘‘Petition                 petition once the application has been
                                                     For patent applicants whose claimed                  for Cancer Immunotherapy Pilot’’ on the                docketed for examination. Any inquiries
                                                  cancer immunotherapy both (i) meets                     EFS-Web screen. Any inquiries                          concerning a specific petition to make
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                                                  the eligibility requirements for this Pilot             concerning electronic filing of the                    special should be directed to the
                                                  Program and (ii) is the subject of an                   petition should be directed to the                     appropriate Technology Center handling
                                                  active Investigational New Drug (IND)                   Electronic Business Center (EBC) at                    the petition. If the petition is granted,
                                                  application filed by patent applicant or                (866) 217–9197.                                        the application will be accorded special
                                                  their agent (e.g., a licensee of the patent                (10) Publication Requirement for                    status under the Cancer Immunotherapy
                                                  applicant or the patent applicant’s                     Applications. For unpublished                          Pilot Program until a final disposition
                                                  assignee) at the U.S. Food and Drug                     applications, the petition to make                     (see Part XII (Twelve-Month Goal)).


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                                                                               Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices                                            42331

                                                  Under special status, an application that               immunotherapy, the examiner will treat                 be treated in accordance with the
                                                  has not been acted on or an application                 the first group of claims directed to a                normal appeal procedure (see MPEP
                                                  with a proper RCE request will be                       method of treating a cancer using                      Chapter 1200). Any amendment,
                                                  placed on the examiner’s special new                    immunotherapy that meets the                           affidavit, or other evidence after a final
                                                  docket until a first Office action on the               eligibility requirements of this notice as             Office action and prior to appeal must
                                                  merits. For an application in the Pilot                 constructively elected without traverse                comply with 37 CFR 1.116. The filing of
                                                  Program where applicant is responding                   for examination.                                       an RCE is a final disposition for
                                                  to a first Office action, the application                  Part V. First Action Interview Pilot                purposes of the twelve-month goal for
                                                  will be placed on the examiner’s regular                Program Not Available. Applications                    the Cancer Immunotherapy Pilot
                                                  amended docket. Under the Pilot                         accepted into the Cancer                               Program. The application will not retain
                                                  Program, the USPTO is providing                         Immunotherapy Pilot Program will not                   its special status after the filing of a
                                                  examiners with incentives to handle                     be eligible to participate in the First                proper RCE.
                                                  these applicant responses promptly.                     Action Interview Pilot Program.                           Part IX. Post-Allowance Processing.
                                                     Applicant will be notified of the                    However, standard interview practice                   The mailing of a notice of allowance is
                                                  decision on the petition by the deciding                and procedures applicable to regular ex                a final disposition for the purposes of
                                                  official. If the application does not                   parte prosecution will still be available              the twelve-month goal for the Pilot
                                                  comply with the sequence requirements                   See MPEP section 713.02.                               Program. The failure to pay the required
                                                  as set forth in 37 CFR 1.821 through                       Part VI. Period for Reply by                        issue fee within one (1) month of the
                                                  1.825, such that the application is not in              Applicant. The time periods set for                    mailing date of the Form PTOL–85 or
                                                  condition for examination, or has an                    reply in Office actions for an application             the submission of a non-USPTO
                                                  outstanding Office action, or if the                    granted special status under the Pilot                 required submission under 37 CFR
                                                  application and/or petition does not                    Program will be the same as those set                  1.312 will result in the allowance being
                                                  meet all the formal requirements set                    forth in section 710.02(b) of the MPEP.                processed according to the regular
                                                  forth in this notice, the USPTO will                    However, if an applicant files a petition              allowance process. A submission that
                                                  notify the applicant of the deficiency by               for any extension of time under 37 CFR                 includes both USPTO required changes
                                                  issuing a notice. The notice will give the              1.136(a), the special status of the                    and non-USPTO required changes under
                                                  applicant only one opportunity to                       application will be terminated, and the                the provisions of 37 CFR 1.312 will be
                                                  correct the deficiency. If the applicant                application will be taken up for                       considered as a non-USPTO required
                                                  still wishes to participate in the Cancer               examination in accordance with                         submission for purposes of the
                                                  Immunotherapy Pilot Program, the                        standard examination procedures.                       allowance processing.
                                                  applicant must file a proper petition and                  Part VII. Reply By Applicant. A reply                  Part X. Proceedings Outside the
                                                  make appropriate corrections within                     to an Office action must be limited to                 Normal Examination Process: If an
                                                  one month or thirty days, whichever is                  responding to rejections, objections, and              application becomes involved in
                                                  longer. The time period for reply is not                requirements made by the examiner.                     proceedings outside the normal
                                                  extendable under 37 CFR 1.136(a). If the                Any amendment to a non-final Office                    examination process (e.g., a secrecy
                                                  applicant fails to correct the deficiency               action will be treated as not fully                    order, national security review,
                                                  indicated in the notice within the time                 responsive if it attempts to: (A) Add                  interference, derivation proceeding or
                                                  period set forth therein, the application               claims which would result in more than                 petitions under 37 CFR 1.181 through
                                                  will not be eligible for the Cancer                     three independent claims, or more than                 1.183), the USPTO will place the
                                                  Immunotherapy Pilot Program, and the                    twenty total claims, pending in the                    application in special status under the
                                                  application will be taken up for                        application; (B) add any multiple                      Cancer Immunology Pilot Program
                                                  examination in accordance with                          dependent claim; or (C) cancel all                     before and after such proceedings.
                                                  standard examination procedures. If the                 method claims to treating a cancer using               During those proceedings, however, the
                                                  application does not contain a method                   immunotherapy. If a reply to a non-final               application will not be under special
                                                  claim that complies with the eligibility                Office action is not fully responsive                  status. For example, during an
                                                  requirements discussed in Part II of this               because it does not comply with the                    interference proceeding, the application
                                                  notice, the petition will be dismissed,                 Pilot Program claim requirements, but is               will be treated in accordance with the
                                                  and the applicant will not be given an                  a bona fide attempt to advance the                     normal interference procedures and will
                                                  opportunity to correct the deficiency.                  application to final action, the examiner              not be in special status under the Cancer
                                                     Part IV. Requirement for Restriction. If             may, at his or her discretion, provide                 Immunology Pilot Program. Once any
                                                  the claims in the application are                       one month or thirty days, whichever is                 one of these proceedings is completed,
                                                  directed to multiple inventions, the                    longer, for applicant to supply a fully                the application will continue in special
                                                  examiner may make a requirement for                     responsive reply. Extensions of this time              status under the Pilot Program until it
                                                  restriction in accordance with current                  period under 37 CFR 1.136(a) to the                    reaches a final disposition, but that may
                                                  restriction practice. The examiner will                 notice of nonresponsive amendment                      occur later than twelve months from the
                                                  contact the applicant by telephone and                  will not be permitted in order for the                 grant of special status under the Pilot
                                                  request an oral election of a single                    application to remain in special status.               Program.
                                                  invention for prosecution. Applicant                    Any further nonresponsive amendment                       Part XI. Withdrawal From Pilot
                                                  must make an election without traverse                  will be treated as non-bona fide and the               Program. There is no provision for
                                                  in a telephonic interview of an                         time period set in the prior notice will               ‘‘withdrawal’’ from special status under
                                                  invention that is to a method of treating               continue to run.                                       the Pilot Program. However, filing a
                                                  a cancer using immunotherapy that                          Part VIII. After-Final and Appeal                   petition for any extension of time under
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                                                  meets the eligibility requirements for                  Procedures: The mailing of a final Office              37 CFR 1.136(a) will result in the
                                                  this Pilot Program. If the applicant does               action or the filing of a Notice of                    application being taken out of the Pilot
                                                  not respond by telephone to an                          Appeal, whichever is earlier, is a final               Program. An applicant may abandon the
                                                  examiner’s request for an election                      disposition for purposes of the twelve-                application that has been granted
                                                  within two working days or refuses to                   month goal for the Cancer                              special status under the Pilot Program in
                                                  make an election of an invention that is                Immunotherapy Pilot Program. During                    favor of a continuing application, and
                                                  to a method of treating a cancer using                  the appeal process, the application will               the continuing application will not be


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                                                  42332                                  Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices

                                                  given special status under the Pilot                                       COMMODITY FUTURES TRADING                                  Centre, 1155 21st Street NW.,
                                                  Program unless the continuing                                              COMMISSION                                                 Washington, DC 20581 or by Hand
                                                  application is filed with a petition to                                                                                               Deliver/Courier at the same address.
                                                  make special under the Pilot Program.                                      Agency Information Collection                                A copy of the supporting statements
                                                                                                                             Activities Under OMB Review                                for the collection of information
                                                     Part XII. Twelve-Month Goal. The
                                                  objective of the Cancer Immunology                                         AGENCY: Commodity Futures Trading                          discussed above may be obtained by
                                                                                                                             Commission.                                                visiting http://regInfo.gov. All
                                                  Pilot Program is to complete the
                                                                                                                             ACTION: Notice.
                                                                                                                                                                                        comments must be submitted in
                                                  examination of an application within
                                                                                                                                                                                        English, or if not, accompanied by an
                                                  twelve months of special status being
                                                                                                                             SUMMARY:    In compliance with the                         English translation. Comments will be
                                                  granted under the Pilot Program (i.e.,                                                                                                posted as received to http://
                                                                                                                             Paperwork Reduction Act of 1995
                                                  within twelve months from the mailing                                      (‘‘PRA’’), this notice announces that the                  www.cftc.gov.
                                                  date of the decision granting the petition                                 Information Collection Request (‘‘ICR’’)
                                                  to make special). The twelve-month goal                                                                                               FOR FURTHER INFORMATION CONTACT:        Gary
                                                                                                                             abstracted below has been forwarded to
                                                  is successfully achieved when one of                                                                                                  Martinaitis, Division of Market
                                                                                                                             the Office of Management and Budget
                                                  the following final dispositions occurs                                                                                               Oversight, Commodity Futures Trading
                                                                                                                             (‘‘OMB’’) for review and comment. The
                                                  within twelve months from the grant of                                                                                                Commission, (202) 418–5209; email:
                                                                                                                             ICR describes the nature of the
                                                  special status under the Pilot Program:                                                                                               gmartinaitis@cftc.gov, and refer to OMB
                                                                                                                             information collection and its expected
                                                  (1) The mailing of a notice of allowance;                                                                                             Control No. 3038–0012.
                                                                                                                             costs and burden.
                                                  (2) the mailing of a final Office action;                                  DATES: Comments must be submitted on                       SUPPLEMENTARY INFORMATION: An agency
                                                  (3) the filing of an RCE; (4) the                                          or before July 29, 2016.                                   may not conduct or sponsor, and a
                                                  abandonment of the application; (5) or                                                                                                person is not required to respond to, a
                                                                                                                             ADDRESSES: Comments regarding the
                                                  the filing of a Notice of Appeal. The                                      burden estimated or any other aspect of                    collection of information unless it
                                                  final disposition of an application,                                       the information collection, including                      displays a currently valid OMB control
                                                  however, may occur later than the                                          suggestions for reducing the burden,                       number. The Federal Register notice
                                                  twelve-month time frame in certain                                         may be submitted directly to the Office                    with a 60-day comment period soliciting
                                                                                                                             of Information and Regulatory Affairs                      comments on this collection of
                                                  situations (e.g., applicant files an
                                                                                                                             (‘‘OIRA’’) in OMB, within 30 days of the                   information was published on March
                                                  amendment that does not comply with
                                                                                                                             notice’s publication, by email at                          29, 2016 (81 FR 17447).
                                                  the Pilot Program claim requirements or
                                                                                                                             OIRAsubmissions@omb.eop.gov. Please                          Title: Futures Volume, Open Interest,
                                                  applicant petitions for extension of time
                                                                                                                             identify the comments by OMB Control                       Price, Deliveries and Purchases/Sales of
                                                  under 37 CFR 1.136(a)). See Part X for                                                                                                Futures for Commodities or for
                                                  more information on other events that                                      No. 3038–0012. Please provide the
                                                                                                                             Commission with a copy of all                              Derivatives Positions (OMB Control No.
                                                  may cause examination to extend                                                                                                       3038–0012). This is a request for
                                                  beyond this twelve-month timeframe. In                                     submitted comments at the address
                                                                                                                             listed below. Please refer to OMB                          extension of a currently approved
                                                  any event, however, this twelve-month                                                                                                 information collection.
                                                                                                                             Reference No. 3038–0012, found on
                                                  time frame is simply a goal. Any failure                                                                                                Abstract: Commission Regulation
                                                                                                                             http://reginfo.gov. Comments may also
                                                  to meet the twelve-month goal or other                                     be mailed to the Office of Information                     16.01 requires the U.S. futures
                                                  issues relating to this twelve-month goal                                  and Regulatory Affairs, Office of                          exchanges to publish daily information
                                                  are neither petitionable nor appealable                                    Management and Budget, Attention:                          on the items listed in the title of the
                                                  matters.                                                                   Desk Officer for the Commodity Futures                     collection. The information required by
                                                    Dated: June 24, 2016.                                                    Trading Commission, 725 17th Street                        this rule is in the public interest and is
                                                  Michelle K. Lee,                                                           NW., Washington, DC 20503, or                              necessary for market surveillance. This
                                                                                                                             submitted through the Agency’s Web                         rule is promulgated pursuant to the
                                                  Under Secretary of Commerce for Intellectual                                                                                          Commission’s rulemaking authority
                                                  Property and Director of the United States
                                                                                                                             site at http://comments.cftc.gov. Follow
                                                                                                                             the instructions for submitting                            contained in Section 5 of the
                                                  Patent and Trademark Office.
                                                                                                                             comments through the Web site.                             Commodity Exchange Act, 7 U.S.C. 7
                                                  [FR Doc. 2016–15533 Filed 6–28–16; 8:45 am]
                                                                                                                                Comments may also be mailed to:                         (2010).
                                                  BILLING CODE 3510–16–P                                                     Christopher Kirkpatrick, Secretary of the                    Burden Statement: The respondent
                                                                                                                             Commission, Commodity Futures                              burden for this collection is estimated to
                                                                                                                             Trading Commission, Three Lafayette                        be as follows:

                                                                                                                            ESTIMATED ANNUAL REPORTING BURDEN
                                                                                                                                                  Annual        Frequency of           Total annual        Hours per
                                                                                  17 CFR Section                                                number of                                                                    Total hours
                                                                                                                                                                  response              responses          response
                                                                                                                                               respondents

                                                  16.01 ....................................................................................       15          Daily ...............      3,750               0.5               1,875
mstockstill on DSK3G9T082PROD with NOTICES




                                                    The total annual cost burden per                                         a Programmer and Compliance                                  Authority: 44 U.S.C. 3501 et seq.
                                                  respondent is estimated to be $6,875.                                      Manager.1
                                                  The Commission based its calculation
                                                                                                                               1 In arriving at a wage rate for the hourly costs
                                                  on a blended hourly wage rate of $55 for
                                                                                                                             imposed, Commission staff used the Management &
                                                                                                                             Professional Earnings in the Securities Industry           a Programmer and Compliance Manager as
                                                                                                                             Report, published in 2013 by the Securities                published in the 2013 Report and divided that
                                                                                                                             Industry and Financial Markets Associations                figure by 2000 annual working hours to arrive at the
                                                                                                                             (Report). The wage rate used the median salary of          hourly rate of $55.



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Document Created: 2018-02-08 07:42:48
Document Modified: 2018-02-08 07:42:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesEffective Date: June 29, 2016.
ContactPinchus M. Laufer, Senior Legal Advisor (telephone (571) 272-7726; electronic mail at [email protected]) or Susy Tsang-Foster, Senior Legal Advisor (telephone (571) 272-7711; electronic mail at susy.tsang- [email protected]), of the Office of Patent Legal Administration, Office of the Deputy Commissioner for Patent Examination Policy.
FR Citation81 FR 42328 

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