(238) 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 Program must be filed before June 29, 2017.
The USPTO may extend the Pilot Program (with or without modifications) or
terminate it depending on the workload and resources needed to administer
the Pilot Program, feedback from the public, and the effectiveness of the
Pilot Program. If the Pilot Program is extended or terminated, the USPTO
will provide notification to the public.
FOR FURTHER INFORMATION CONTACT: Pinchus M. Laufer, Senior Legal Advisor
(telephone (571) 272-7726; electronic mail at pinchus.laufer@uspto.gov) or
Susy Tsang-Foster, Senior Legal Advisor (telephone (571) 272-7711;
electronic mail at susy.tsang-foster@uspto.gov), of the Office of Patent
Legal Administration, Office of the Deputy Commissioner for Patent
Examination Policy.
For questions relating to a specific petition, please contact Gary B.
Nickol, Supervisory Patent Examiner (telephone (571) 272-0835; electronic
mail at gary.nickol@uspto.gov) or Brandon J. Fetterolf, Supervisory Patent
Examiner (telephone (571) 272-2919; electronic mail at brandon.fetterolf@
uspto.gov), of Technology Center 1600.
SUPPLEMENTARY INFORMATION: On February 1, 2016, the White House Office of
the Press Secretary announced a new, national $1 billion initiative to
achieve ten years' worth of cancer research in the next five years, with
the intent to aid in the global fight against cancer. See the White House
Web site at https://www.whitehouse.gov/the-press-office/2016/02/01/fact-
sheet-investing-national-cancer-moonshot. To support this initiative, the
USPTO is implementing the Cancer Immunotherapy Pilot Program to advance
patent applications pertaining to cancer immunotherapy out of turn for
examination to provide for earlier review. The objective of the Pilot
Program is to complete the examination of an application containing a
claim(s) to a method of treating a cancer using immunotherapy within twelve
months of special status being granted. See Part XII below (Twelve-Month
Goal) for more information.
New patent applications are normally taken up for examination in the
order of their U.S. filing date. See section 708 of the Manual of Patent
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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
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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 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
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(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)). 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
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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
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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 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.
June 24, 2016 MICHELLE K. LEE
Under Secretary of Commerce for Intellectual Property and
Director of the United States Patent and Trademark Office
[1428 OG 253]