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:
- Type of Application. The application must be a non-reissue, non-provisional utility application.
- 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.
- 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.
- 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.
- 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.
- 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.)
- 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).
- 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.
- Electronic filing required. The petition to make special must be filed electronically before June 27, 2017 using the USPTO electronic filing system.
- 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.