Cancer Immunotherapy Pilot Program, 42328-42332 [2016-15533]

Download as PDF 42328 Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices MD 20910. Technical feedback in the form of brief annotated bibliographic entries would be welcome. The Interagency Working Group will gladly accept public input at any time; however, only those that are received on or before August 19, 2016, may be considered when the Interagency Working Group finalizes the plan. FOR FURTHER INFORMATION CONTACT: Caitlin Gould (Caitlin.gould@noaa.gov, 240–533–0290) or Stacey DeGrasse (Stacey.Degrasse@fda.hhs.gov, 240– 402–1470). SUPPLEMENTARY INFORMATION: Correction The National Oceanic and Atmospheric Administration published a document in the Federal Register of June 3, 2016, entitled Interagency Working Group on the Harmful Algal Bloom and Hypoxia Research and Control Amendments Act. The information concerning the webinar dates and WebEx information have been updated. Dated: June 15, 2016. Mary C. Erickson, Director, National Centers for Coastal Ocean Science, National Ocean Service, National Oceanic and Atmospheric Administration. [FR Doc. 2016–15364 Filed 6–28–16; 8:45 am] BILLING CODE 3510–JE–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Hydrographic Services Review Panel Meeting National Ocean Service, National Oceanic and Atmospheric Administration (NOAA), Department of Commerce. ACTION: Notice of open public meeting. AGENCY: The Hydrographic Services Review Panel (HSRP) will hold a meeting that will be open to the public. Information about the HSRP and the meeting agenda will be posted at: http:// www.nauticalcharts.noaa.gov/ocs/hsrp/ meetings_cleveland2016.htm. DATES: The meeting will be held on August 30, 8:30 a.m. to 3:00 p.m. EDT; August 31, 8:00 a.m. to 5:00 p.m.; and September 1, 8:00 a.m. to 12:00 noon. Times are subject to change. For updates, please check: http:// www.nauticalcharts.noaa.gov/ocs/hsrp/ meetings_cleveland2016.htm. ADDRESSES: City Club of Cleveland, 830 Euclid Avenue, Cleveland, Ohio 44114. FOR FURTHER INFORMATION CONTACT: Lynne Mersfelder-Lewis, HSRP program mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:18 Jun 28, 2016 Jkt 238001 manager, National Ocean Service, Office of Coast Survey, NOAA (N/NSD), 1315 East-West Highway, SSMC3 #6301, Silver Spring, Maryland 20910; telephone: 301–713–2750 ext. 166; email: lynne.mersfelder@noaa.gov. The meeting is open to the public, and public seating will be available on a first-come, first-served basis. The times of onsite public comment periods, scheduled for each day, will be included in the final agenda. Each individual or group making verbal comments will be limited to a total time of five (5) minutes. Comments will be recorded. Individuals who would like to submit written statements should email their comments to Lynne.Mersfelder@ noaa.gov. The HSRP will provide webinar and teleconference capability for the public sessions. Pre-registration is required to access the webinar: http:// www.nauticalcharts.noaa.gov/ocs/hsrp/ meetings_cleveland2016.htm. The Hydrographic Services Review Panel (HSRP) is a Federal Advisory Committee established to advise the Under Secretary of Commerce for Oceans and Atmosphere, the NOAA Administrator, on matters related to the responsibilities and authorities set forth in section 303 of the Hydrographic Services Improvement Act of 1998, as amended, and such other appropriate matters that the Under Secretary refers to the Panel for review and advice. The charter and other information are located online at http:// www.nauticalcharts.noaa.gov/ocs/hsrp/ CharterBylawsHSIAStatute.htm. Matters To Be Considered: The panel is convening to hear federal, state, regional and local partners and stakeholders on issues relevant to NOAA’s navigation services, focusing on the Great Lakes area. Navigation services include the data, products, and services provided by the NOAA programs and activities that undertake geodetic observations, gravity modeling, shoreline mapping, bathymetric mapping, hydrographic surveying, nautical charting, tide and water level observations, current observations, and marine modeling. This suite of NOAA products and services support safe and efficient navigation, resilient coasts and communities, and the nationwide positioning information infrastructure to support America’s commerce. The Panel will hear from federal agencies and nonfederal organizations about their missions and their use of NOAA’s navigation services; what value these services bring; and what improvements could be made. Other administrative SUPPLEMENTARY INFORMATION: PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 matters may be considered. This agenda is subject to change. Special Accommodations: This meeting is physically accessible to people with disabilities. Please direct requests for sign language interpretation or other auxiliary aids to Lynne.Mersfelder@noaa.gov by August 8, 2016. Dated: June 17, 2016. Gerd F. Glang, Rear Admiral, Director, Office of Coast Survey, National Ocean Service, National Oceanic and Atmospheric Administration. [FR Doc. 2016–15365 Filed 6–28–16; 8:45 am] BILLING CODE P DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No.: PTO–P–2016–0015] Cancer Immunotherapy Pilot Program United States Patent and Trademark Office, Commerce. ACTION: Notice. AGENCY: The United States Patent and Trademark Office (USPTO or Office) is implementing a pilot program to provide for earlier review of patent applications pertaining to cancer immunotherapy (‘‘Cancer Immunotherapy Pilot Program’’ or ‘‘Pilot Program’’) in support of the White House national $1 billion initiative to achieve ten years’ worth of cancer research in the next five years (‘‘National Cancer Moonshot’’). The USPTO will advance applications containing a claim(s) to a method of treating a cancer using immunotherapy out of turn for examination if the applicant files a grantable petition to make special under the Pilot Program. The objective of the Pilot Program is to complete the examination of the application within twelve months of special status being granted. Under the Cancer Immunotherapy Pilot Program, an application will be advanced out of turn for examination without meeting all of the current requirements of the accelerated examination program (e.g., the requirement for an examination support document) or the Prioritized Examination (Track I) program. This notice outlines the conditions, eligibility requirements, and guidelines of the Pilot Program. DATES: Effective Date: June 29, 2016. Duration: The Cancer Immunotherapy Pilot Program will run for twelve months from its effective date. Therefore, petitions to make special under the Cancer Immunotherapy Pilot SUMMARY: E:\FR\FM\29JNN1.SGM 29JNN1 mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices Program must be filed before June 29, 2017. The USPTO may extend the Pilot Program (with or without modifications) or terminate it depending on the workload and resources needed to administer the Pilot Program, feedback from the public, and the effectiveness of the Pilot Program. If the Pilot Program is extended or terminated, the USPTO will provide notification to the public. FOR FURTHER INFORMATION CONTACT: Pinchus M. Laufer, Senior Legal Advisor (telephone (571) 272–7726; electronic mail at pinchus.laufer@uspto.gov) or Susy Tsang-Foster, Senior Legal Advisor (telephone (571) 272–7711; electronic mail at susy.tsang-foster@uspto.gov), of the Office of Patent Legal Administration, Office of the Deputy Commissioner for Patent Examination Policy. For questions relating to a specific petition, please contact Gary B. Nickol, Supervisory Patent Examiner (telephone (571) 272–0835; electronic mail at gary.nickol@uspto.gov) or Brandon J. Fetterolf, Supervisory Patent Examiner (telephone (571) 272–2919; electronic mail at brandon.fetterolf@uspto.gov), of Technology Center 1600. SUPPLEMENTARY INFORMATION: On February 1, 2016, the White House Office of the Press Secretary announced a new, national $1 billion initiative to achieve ten years’ worth of cancer research in the next five years, with the intent to aid in the global fight against cancer. See the White House Web site at https://www.whitehouse.gov/the-pressoffice/2016/02/01/fact-sheet-investingnational-cancer-moonshot. To support this initiative, the USPTO is implementing the Cancer Immunotherapy Pilot Program to advance patent applications pertaining to cancer immunotherapy out of turn for examination to provide for earlier review. The objective of the Pilot Program is to complete the examination of an application containing a claim(s) to a method of treating a cancer using immunotherapy within twelve months of special status being granted. See Part XII below (Twelve-Month Goal) for more information. New patent applications are normally taken up for examination in the order of their U.S. filing date. See section 708 of the Manual of Patent Examining Procedure (9th ed., 7th Rev., November 2015) (MPEP). The USPTO has procedures under which an application will be advanced out of turn (accorded special status) for examination if the applicant files a petition to make special under 37 CFR 1.102(c) and (d) with the appropriate showing or a request for prioritized examination under 37 CFR VerDate Sep<11>2014 17:18 Jun 28, 2016 Jkt 238001 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 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 42329 without modifications) or terminate it depending on the workload and resources needed to administer the Pilot Program, feedback from the public, and the effectiveness of the Pilot Program. If the Pilot Program is extended or terminated, the USPTO will provide notification to the public. Applicants may participate in the Cancer Immunotherapy Pilot Program by filing a petition to make special under 37 CFR 1.102(d) meeting all of the requirements set forth in this notice in either a new application or in a pending application. However, continuing applications will not automatically be accorded special status based on papers filed with a petition in a parent application. Each application must, on its own, meet all requirements for special status. No fee is required. The fee for a petition to make special under 37 CFR 1.102(d) based upon the procedure specified in this notice is hereby waived. Part I. Requirements for Petitions To Make Special Under the Cancer Immunotherapy Pilot Program: A petition to make special under the Cancer Immunotherapy Pilot Program may be granted in an application provided the eligibility requirements set forth in Part II and the following conditions are satisfied: (1) Types of Applications. The application must be a non-reissue, nonprovisional utility application filed under 35 U.S.C. 111(a), or an international application that has entered the national stage under 35 U.S.C. 371. (2) Claim Limit and No Multiple Dependent Claims. The application must not contain more than three independent claims and more than twenty total claims. The application must not contain any multiple dependent claims. For an application that contains more than three independent claims or twenty total claims, or any multiple dependent claims, applicant must file a preliminary amendment in compliance with 37 CFR 1.121 to cancel the excess claims and/or the multiple dependent claims at the time the petition to make special is filed. The petition must include a statement that applicant agrees that the application will not have more than three independent claims, more than twenty total claims, and any multiple dependent claims while the application is in special status under the Pilot Program. (3) The Application Must Include at Least One Method Claim of Treating a Cancer Using Immunotherapy. The application must include at least one claim to a method of treating a cancer E:\FR\FM\29JNN1.SGM 29JNN1 mstockstill on DSK3G9T082PROD with NOTICES 42330 Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices 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 VerDate Sep<11>2014 17:18 Jun 28, 2016 Jkt 238001 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 EFSWeb is available on the USPTO Web site at http://www.uspto.gov/learning-andresources/support-centers/patentelectronic-business-center. Failure to use the form or its equivalent could result in the Office not recognizing the request or delays in processing the request. (9) Electronic Filing of Petition Required. The petition to make special must be filed electronically before June 29, 2017, using the USPTO electronic filing system, EFS-Web, and selecting the document description of ‘‘Petition for Cancer Immunotherapy Pilot’’ on the EFS-Web screen. Any inquiries concerning electronic filing of the petition should be directed to the Electronic Business Center (EBC) at (866) 217–9197. (10) Publication Requirement for Applications. For unpublished applications, the petition to make PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 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)). E:\FR\FM\29JNN1.SGM 29JNN1 mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices 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 VerDate Sep<11>2014 17:18 Jun 28, 2016 Jkt 238001 immunotherapy, the examiner will treat the first group of claims directed to a method of treating a cancer using immunotherapy that meets the eligibility requirements of this notice as constructively elected without traverse for examination. Part V. First Action Interview Pilot Program Not Available. Applications accepted into the Cancer Immunotherapy Pilot Program will not be eligible to participate in the First Action Interview Pilot Program. However, standard interview practice and procedures applicable to regular ex parte prosecution will still be available See MPEP section 713.02. Part VI. Period for Reply by Applicant. The time periods set for reply in Office actions for an application granted special status under the Pilot Program will be the same as those set forth in section 710.02(b) of the MPEP. However, if an applicant files a petition for any extension of time under 37 CFR 1.136(a), the special status of the application will be terminated, and the application will be taken up for examination in accordance with standard examination procedures. Part VII. Reply By Applicant. A reply to an Office action must be limited to responding to rejections, objections, and requirements made by the examiner. Any amendment to a non-final Office action will be treated as not fully responsive if it attempts to: (A) Add claims which would result in more than three independent claims, or more than twenty total claims, pending in the application; (B) add any multiple dependent claim; or (C) cancel all method claims to treating a cancer using immunotherapy. If a reply to a non-final Office action is not fully responsive because it does not comply with the Pilot Program claim requirements, but is a bona fide attempt to advance the application to final action, the examiner may, at his or her discretion, provide one month or thirty days, whichever is longer, for applicant to supply a fully responsive reply. Extensions of this time period under 37 CFR 1.136(a) to the notice of nonresponsive amendment will not be permitted in order for the application to remain in special status. Any further nonresponsive amendment will be treated as non-bona fide and the time period set in the prior notice will continue to run. Part VIII. After-Final and Appeal Procedures: The mailing of a final Office action or the filing of a Notice of Appeal, whichever is earlier, is a final disposition for purposes of the twelvemonth goal for the Cancer Immunotherapy Pilot Program. During the appeal process, the application will PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 42331 be treated in accordance with the normal appeal procedure (see MPEP Chapter 1200). Any amendment, affidavit, or other evidence after a final Office action and prior to appeal must comply with 37 CFR 1.116. The filing of an RCE is a final disposition for purposes of the twelve-month goal for the Cancer Immunotherapy Pilot Program. The application will not retain its special status after the filing of a proper RCE. Part IX. Post-Allowance Processing. The mailing of a notice of allowance is a final disposition for the purposes of the twelve-month goal for the Pilot Program. The failure to pay the required issue fee within one (1) month of the mailing date of the Form PTOL–85 or the submission of a non-USPTO required submission under 37 CFR 1.312 will result in the allowance being processed according to the regular allowance process. A submission that includes both USPTO required changes and non-USPTO required changes under the provisions of 37 CFR 1.312 will be considered as a non-USPTO required submission for purposes of the allowance processing. Part X. Proceedings Outside the Normal Examination Process: If an application becomes involved in proceedings outside the normal examination process (e.g., a secrecy order, national security review, interference, derivation proceeding or petitions under 37 CFR 1.181 through 1.183), the USPTO will place the application in special status under the Cancer Immunology Pilot Program before and after such proceedings. During those proceedings, however, the application will not be under special status. For example, during an interference proceeding, the application will be treated in accordance with the normal interference procedures and will not be in special status under the Cancer Immunology Pilot Program. Once any one of these proceedings is completed, the application will continue in special status under the Pilot Program until it reaches a final disposition, but that may occur later than twelve months from the grant of special status under the Pilot Program. Part XI. Withdrawal From Pilot Program. There is no provision for ‘‘withdrawal’’ from special status under the Pilot Program. However, filing a petition for any extension of time under 37 CFR 1.136(a) will result in the application being taken out of the Pilot Program. An applicant may abandon the application that has been granted special status under the Pilot Program in favor of a continuing application, and the continuing application will not be E:\FR\FM\29JNN1.SGM 29JNN1 42332 Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices given special status under the Pilot Program unless the continuing application is filed with a petition to make special under the Pilot Program. Part XII. Twelve-Month Goal. The objective of the Cancer Immunology Pilot Program is to complete the examination of an application within twelve months of special status being granted under the Pilot Program (i.e., within twelve months from the mailing date of the decision granting the petition to make special). The twelve-month goal is successfully achieved when one of the following final dispositions occurs within twelve months from the grant of special status under the Pilot Program: (1) The mailing of a notice of allowance; (2) the mailing of a final Office action; (3) the filing of an RCE; (4) the abandonment of the application; (5) or the filing of a Notice of Appeal. The final disposition of an application, however, may occur later than the twelve-month time frame in certain situations (e.g., applicant files an amendment that does not comply with the Pilot Program claim requirements or applicant petitions for extension of time under 37 CFR 1.136(a)). See Part X for more information on other events that may cause examination to extend beyond this twelve-month timeframe. In any event, however, this twelve-month time frame is simply a goal. Any failure to meet the twelve-month goal or other issues relating to this twelve-month goal are neither petitionable nor appealable matters. Dated: June 24, 2016. Michelle K. Lee, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. [FR Doc. 2016–15533 Filed 6–28–16; 8:45 am] BILLING CODE 3510–16–P COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities Under OMB Review Commodity Futures Trading Commission. ACTION: Notice. AGENCY: In compliance with the Paperwork Reduction Act of 1995 (‘‘PRA’’), this notice announces that the Information Collection Request (‘‘ICR’’) abstracted below has been forwarded to the Office of Management and Budget (‘‘OMB’’) for review and comment. The ICR describes the nature of the information collection and its expected costs and burden. DATES: Comments must be submitted on or before July 29, 2016. ADDRESSES: Comments regarding the burden estimated or any other aspect of the information collection, including suggestions for reducing the burden, may be submitted directly to the Office of Information and Regulatory Affairs (‘‘OIRA’’) in OMB, within 30 days of the notice’s publication, by email at OIRAsubmissions@omb.eop.gov. Please identify the comments by OMB Control No. 3038–0012. Please provide the Commission with a copy of all submitted comments at the address listed below. Please refer to OMB Reference No. 3038–0012, found on http://reginfo.gov. Comments may also be mailed to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Commodity Futures Trading Commission, 725 17th Street NW., Washington, DC 20503, or submitted through the Agency’s Web site at http://comments.cftc.gov. Follow the instructions for submitting comments through the Web site. Comments may also be mailed to: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette SUMMARY: Centre, 1155 21st Street NW., Washington, DC 20581 or by Hand Deliver/Courier at the same address. A copy of the supporting statements for the collection of information discussed above may be obtained by visiting http://regInfo.gov. All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to http:// www.cftc.gov. Gary Martinaitis, Division of Market Oversight, Commodity Futures Trading Commission, (202) 418–5209; email: gmartinaitis@cftc.gov, and refer to OMB Control No. 3038–0012. SUPPLEMENTARY INFORMATION: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The Federal Register notice with a 60-day comment period soliciting comments on this collection of information was published on March 29, 2016 (81 FR 17447). Title: Futures Volume, Open Interest, Price, Deliveries and Purchases/Sales of Futures for Commodities or for Derivatives Positions (OMB Control No. 3038–0012). This is a request for extension of a currently approved information collection. Abstract: Commission Regulation 16.01 requires the U.S. futures exchanges to publish daily information on the items listed in the title of the collection. The information required by this rule is in the public interest and is necessary for market surveillance. This rule is promulgated pursuant to the Commission’s rulemaking authority contained in Section 5 of the Commodity Exchange Act, 7 U.S.C. 7 (2010). Burden Statement: The respondent burden for this collection is estimated to be as follows: FOR FURTHER INFORMATION CONTACT: ESTIMATED ANNUAL REPORTING BURDEN Annual number of respondents Frequency of response Total annual responses Hours per response Total hours 16.01 .................................................................................... mstockstill on DSK3G9T082PROD with NOTICES 17 CFR Section 15 Daily ............... 3,750 0.5 1,875 The total annual cost burden per respondent is estimated to be $6,875. The Commission based its calculation on a blended hourly wage rate of $55 for VerDate Sep<11>2014 17:18 Jun 28, 2016 Jkt 238001 a Programmer and Compliance Manager.1 1 In arriving at a wage rate for the hourly costs imposed, Commission staff used the Management & Professional Earnings in the Securities Industry Report, published in 2013 by the Securities Industry and Financial Markets Associations (Report). The wage rate used the median salary of PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 Authority: 44 U.S.C. 3501 et seq. a Programmer and Compliance Manager as published in the 2013 Report and divided that figure by 2000 annual working hours to arrive at the hourly rate of $55. E:\FR\FM\29JNN1.SGM 29JNN1

Agencies

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


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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 
pinchus.laufer@uspto.gov) or Susy Tsang-Foster, Senior Legal Advisor 
(telephone (571) 272-7711; electronic mail at susy.tsang-foster@uspto.gov), of the Office of Patent Legal Administration, Office 
of the Deputy Commissioner for Patent Examination Policy.
    For questions relating to a specific petition, please contact Gary 
B. Nickol, Supervisory Patent Examiner (telephone (571) 272-0835; 
electronic mail at gary.nickol@uspto.gov) or Brandon J. Fetterolf, 
Supervisory Patent Examiner (telephone (571) 272-2919; electronic mail 
at brandon.fetterolf@uspto.gov), of Technology Center 1600.

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

[[Page 42330]]

using immunotherapy that meets the eligibility requirements in Part II 
of this notice. The petition must include a statement that the 
applicant agrees to include at least one claim to a method of treating 
a cancer using immunotherapy that meets the Pilot Program eligibility 
requirements while the application is in special status. For 
applications that have been previously examined, applicants will not be 
permitted to switch inventions in order to participate in the Pilot 
Program. See MPEP section 821.03.
    (4) Statement Regarding Method of Treating a Cancer Using 
Immunotherapy. The petition to make special must state that special 
status under the Pilot Program is sought because the application 
contains a claim to a method of treating a cancer using immunotherapy 
that meets the eligibility requirements discussed in Part II of this 
notice.
    (5) Statement Regarding Restriction Requirement. The petition must 
include a statement that, if the USPTO determines that the claims are 
directed to multiple inventions, applicant will agree to make an 
election without traverse in a telephonic interview, and elect an 
invention directed to a method of treating a cancer using immunotherapy 
that meets the eligibility requirement discussed in Part II of this 
notice.
    (6) Statement that Special Status Was Not Previously Granted Under 
Any Program. The petition must state that the application has not been 
previously granted special status. A petition to make special under 
this Pilot Program may not be filed in an application in which special 
status was previously granted under this Pilot Program or in any other 
program (e.g., age, health, PPH, AE, prioritized examination).
    (7) Time for Filing Petition. In general, the petition to make 
special under the Pilot Program must be filed (i) at least one day 
prior to the date that notice of a first Office action (which may be an 
Office action containing only a restriction requirement) appears in the 
Patent Application Information Retrieval (PAIR) system (applicant may 
check the status of an application using PAIR); or (ii) with a proper 
request for continued examination (RCE) that is in compliance with 37 
CFR 1.114.
    For patent applicants whose claimed cancer immunotherapy both (i) 
meets the eligibility requirements for this Pilot Program and (ii) is 
the subject of an active Investigational New Drug (IND) application 
filed by patent applicant or their agent (e.g., a licensee of the 
patent applicant or the patent applicant's assignee) at the U.S. Food 
and Drug Administration (FDA) that has entered phase II or phase III 
clinical trials, the petition may be filed any time prior to an appeal 
or a final rejection if patent applicant certifies both (i) and (ii) in 
the petition. For an application that has an outstanding Office action, 
patent applicant must file a complete response together with the 
petition.
    Therefore, the petition is only required to contain the above 
applicant certification if the patent application has received a first 
Office action or a request for continued examination (RCE) was not 
filed with the petition. By default, for applications that have been 
previously examined, if applicant makes the above certification in the 
petition, the above certification would necessarily apply to at least 
one of the examined claims since applicants are not permitted to switch 
inventions in order to participate in the Pilot Program. See MPEP 
section 821.03.
    (8) Office Form Available for Filing Petition. Applicant should use 
form PTO/SB/443 for filing the petition. The form will contain a check-
box for the applicant to certify that the claimed cancer immunotherapy 
both (i) meets the eligibility requirements for this Pilot Program and 
(ii) is the subject of an active IND application filed by patent 
applicant or their agent at the FDA that has entered phase II or phase 
III clinical trials. The form will be available as a Portable Document 
Format (PDF) fillable form in EFS-Web and on the USPTO Web site at 
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