[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Pages 42328-42332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15533]


-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

 Patent and Trademark Office

[Docket No.: PTO-P-2016-0015]


Cancer Immunotherapy Pilot Program

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The United States Patent and Trademark Office (USPTO or 
Office) is implementing a pilot program to provide for earlier review 
of patent applications pertaining to cancer immunotherapy (``Cancer 
Immunotherapy Pilot Program'' or ``Pilot Program'') in support of the 
White House national $1 billion initiative to achieve ten years' worth 
of cancer research in the next five years (``National Cancer 
Moonshot''). The USPTO will advance applications containing a claim(s) 
to a method of treating a cancer using immunotherapy out of turn for 
examination if the applicant files a grantable petition to make special 
under the Pilot Program. The objective of the Pilot Program is to 
complete the examination of the application within twelve months of 
special status being granted. Under the Cancer Immunotherapy Pilot 
Program, an application will be advanced out of turn for examination 
without meeting all of the current requirements of the accelerated 
examination program (e.g., the requirement for an examination support 
document) or the Prioritized Examination (Track I) program. This notice 
outlines the conditions, eligibility requirements, and guidelines of 
the Pilot Program.

DATES: Effective Date: June 29, 2016.
    Duration: The Cancer Immunotherapy Pilot Program will run for 
twelve months from its effective date. Therefore, petitions to make 
special under the Cancer Immunotherapy Pilot

[[Page 42329]]

Program must be filed before June 29, 2017. The USPTO may extend the 
Pilot Program (with or without modifications) or terminate it depending 
on the workload and resources needed to administer the Pilot Program, 
feedback from the public, and the effectiveness of the Pilot Program. 
If the Pilot Program is extended or terminated, the USPTO will provide 
notification to the public.

FOR FURTHER INFORMATION CONTACT: Pinchus M. Laufer, Senior Legal 
Advisor (telephone (571) 272-7726; electronic mail at 
[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