United States: USPTO Fast-Tracks Cancer Immunotherapy Patent Applications

Last Updated: July 12 2016
Article by Terri Shieh-Newton

Effective June 29, 2016, the United States Patent and Trademark Office (USPTO) implemented a pilot program to provide for earlier review of patent applications pertaining to cancer immunotherapy. The Cancer Immunotherapy Pilot Program was established in support of the White House national $1 billion initiative to achieve ten years' worth of cancer research in the next five years as part of the National Cancer Moonshot initiative. The Cancer Immunotherapy Pilot Program aims to complete examination of an application within 12 months of the special status being granted. The patent applications that qualify will be advanced out of turn for examination without meeting all the current requirements of the accelerated examination program.

The Cancer Immunotherapy Pilot Program will run 12 months until June 29, 2017. Applicants who are interested in participating in the program should file a petition to make special under the Cancer Immunotherapy Pilot Program.

Requirements for participating in the program are as follows:

  1. Type of Application. The application must be a non-reissue, non-provisional utility application.
  2. Claim Requirements. The application must not contain more than three independent claims in more than 20 claims. The application cannot contain any multiple dependent claims. Applicants can file a preliminary amendment to bring the claims into compliance with these requirements at the time the petition to make special is filed.
  3. Method of Treating Cancer Claim Required. The application must include at least one claim to a method of treating a cancer with immunotherapy. More specifically, the application must contain at least one claim encompassing a method of ameliorating, treating, or preventing a malignancy in a human subject where the steps of the method assist or boost the immune system in eradicating cancer cells. Examples of subject matter of claims that would qualify include, without limitation: antibodies, proteins, nucleic acids that invoke active or passive immune response to destroy cancer cells, co-administration of biological adjuvants (e.g., interleukins, cytokines, Bacillus Comette-Geurin, monophosphoryl lipid A, etc.) in combination with conventional therapies for treating cancer such as chemotherapy, radiation, or surgery. In addition, vaccines that work by activating the immune system to destroy or prevent cancer cell growth are eligible subject matter as well as in vivo, ex vivo, and adoptive immunotherapies including those using autologous and/or heterologous cells or immortalized cell lines.
  4. Statement Regarding a Method of Treating a Cancer Using Immunotherapy. The petition to make special must state that the 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 above in item 3.
  5. Restriction Requirement. The petition must also include a statement that, if the USPTO determines that the claims are directed to multiple inventions, then the applicant will agree to make an election (no traversal permitted) in a telephonic interview and elect an invention directed to a method of treating a cancer using immunotherapy that meets the eligibility requirements discussed above. In the event of a restriction requirement, Applicant must make the election within two working days. In the event that the Applicant does not make an election within two working days or refuses to make an election of an invention that is to a method of treating cancer using an immunotherapy, then the examiner will treat the first group of claims directed to method of treating a cancer using immunotherapy that meets the eligibility requirements as being constructively elected without traverse.
  6. Statement that Special Status Was Not Previously Granted Under Any Other Program. Applicants must also provide a statement that the application has not been previously granted special status under any other program (e.g., age, health, Patent Prosecution Highway, accelerated examination, etc.)
  7. Timing for Filing Petition. The petition to make special must be filed (i) at least one day prior to the date of a first office action (which can be a restriction requirement) or (ii) with a proper request for a request for continued examination (RCE).
  8. Office Form to be used for Filing Petition. Applicants should use the form PTO/SP/443 for filing the petition. This form contains a checkbox for the Applicant to certify that the claimed cancer immunotherapy both (i) meets the eligibility requirement for this Cancer Immunotherapy Pilot Program and (ii) is a subject of an active Investigational New Drug (IND) application filed by the Applicant or their agent at the FDA that has entered phase II or phase III clinical trials.
  9. Electronic filing required. The petition to make special must be filed electronically before June 27, 2017 using the USPTO electronic filing system.
  10. Publication requirements for applications. For Applicants with an unpublished application, the petition to make special must be accompanied by request for early publication in compliance with 37 CFR 1.219. If the Applicant had previously filed a request for non-publication, then this request must be rescinded.

Once the Applicant files the petition to make special, the USPTO will decide the petition once the application has been docketed for examination. If the application is granted special status, then an application that has not been acted upon or an application with the proper RCE request will be placed on the examiner's special new docket until the first Office Action on the merits. In the case where the Applicant is responding to a first Office Action and the application has been granted special status, then the application will be placed on the examiner's regular amended docket. Under this pilot program, the USPTO is providing examiners with incentives to handle these Applicant responses promptly.

Other aspects of the Cancer Immunotherapy Pilot Program for which Applicant should be aware include:

  • For an application to be eligible to participate in the Cancer Immunotherapy Pilot Program, all formal requirements must be met. This includes sequence listing compliance and other formalities. The USPTO will give the Applicant only one opportunity to correct any deficiencies within one month or 30 days, whichever is longer. Extensions of time are not permitted and, if taken, will result in the application losing its special status.
  • Extensions of time are not permitted in responding to Office Actions and Restriction Requirements and, if taken, will result in special status being revoked.
  • Applications accepted in the Cancer Immunotherapy Pilot Program will not be eligible to participate in the first action interview pilot program. However, standard interview practice and procedures will still be applicable for the cancer immunotherapy applications.
  • The 12-month goal is successfully achieved when one of the following final dispositions occur within 12 months from a grant of special status under the pilot program:

    • the mailing of a notice of allowance
    • the mailing of the final Office Action
    • the filing of an RCE
    • the abandonment of the application
    • the filing of a notice of appeal
  • Upon receipt of a notice of allowance, Applicant is given one month to pay the issue fee. The failure to pay the issue fee within one month will result in the allowance being processed under regular allowance processes.
  • The special status applies only during regular examination process. The application will be treated as a regular application (i.e., no special status) if the application becomes involved in proceedings outside of the normal examination process (e.g., a secrecy order, necessary security review, interference, derivation proceedings, etc.).
  • There is no provision for withdrawal from the special status in the Cancer Immunotherapy Pilot Program; however, taking an extension of time for a response will take the application out of the pilot program and therefore, the application will lose its special status.

In sum, Applicants who are working in the oncology space should be aware of this Cancer Immunotherapy Pilot Program and use it to their advantage to advance examination of their cases where appropriate.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Foley & Lardner
Sheppard Mullin Richter & Hampton
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Foley & Lardner
Sheppard Mullin Richter & Hampton
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions