Last month, the U.S. Patent and Trademark Office published a notice in the Federal Register (81 Fed. Reg. 42328) regarding the implementation of a new pilot program that will provide for earlier review of patent applications pertaining to cancer immunotherapy in support of the "National Cancer Moonshot," a White House initiative to achieve ten years' worth of cancer research in the next five years that was announced earlier this year (see "FACT SHEET: Investing in the National Cancer Moonshot"). Under the Cancer Immunotherapy Pilot Program, applications containing at least one claim reciting a method of treating a cancer using immunotherapy will be advanced out of turn for examination if the applicant files a grantable petition to make special, with the goal of completing examination of the application within twelve months of special status being granted.
In order to participate in the Cancer Immunotherapy Pilot Program, an applicant must satisfy the following requirements:
(1) File a petition to make special under 37 C.F.R. § 1.102(d) in a non-reissue, nonprovisional utility application filed under 35 U.S.C. § 111(a), or an international application that has entered national stage under 35 U.S.C. § 371. According to the notice, the petition must be filed 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 on PAIR, or with a Request for Continued Examination (RCE). For applications in which the claimed cancer immunotherapy is the subject of an active Investigational New Drug (IND) application, a petition to make special may be accepted any time prior to appeal or final rejection. The Office recommends that applicants use form PTO/SB/443 for filing the petition, as the form contains check boxes that will allow the applicant to comply with several certification requirements under the new pilot program (as discussed in the Office's notice).
(2) The application cannot contain more than three independent claims, more than twenty total claims, or any multiple dependent claims. For applications not meeting this requirement, an applicant must file a preliminary amendment to cancel the excess claims or multiple dependent claims at the time the petition to make special is filed.
(3) The application must include at least one claim to a method of treating a cancer using immunotherapy. The notice explains that such claim must "encompass[] 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." Among the examples of acceptable claims provided in the notice are those directed to "the administration of cells, antibodies, proteins, or nucleic acids that invoke an active (or achieve a passive) immune response to destroy cancerous cells," "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," "administering any vaccine that works by activating the immune system to prevent or destroy cancer cell growth," or "in vivo, ex vivo, and adoptive immunotherapies, including those using autologous and/or heterologous cells or immortalized cell lines."
(4) If restriction is required, the applicant must 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. The notice indicates that the applicant will be given two working days to respond to an examiner's request for an election, and in the event that the applicant fails to respond within that period, the examiner will treat the first group of claims directed to a method of treating a cancer using immunotherapy as being constructively elected without traverse.
(5) The application cannot have been previously granted special status.
(6) The petition to make special must be filed electronically via the EFS-Web (the Office notes that the document description "Petition for Cancer Immunotherapy Pilot" must be selected for the petition).
(7) If the application has not been published, the applicant must file a request for early publication in compliance with 37 C.F.R § 1.219 with the petition to make special (or a rescission of a nonpublication request if one was filed).
For the purposes of the pilot program, the Office has waived the fee for a petition to make special under 37 C.F.R. § 1.102(d).
In the event that an application does not comply with the sequence listing requirements, has an outstanding Office action, or does not meet all the formal requirements of the pilot program (with one exception described below), the applicant will be given one opportunity to correct the deficiency within the longer of one month or thirty days from the Office's notice of noncompliance (with the deadline being non-extendable). According to the notice, the lone exception will be failure to present a method claim complying with the requirements above, for which applicant's petition will be dismissed without opportunity to correct the deficiency. In addition, if an applicant files an amendment that results in noncompliance with the claim requirements or cancels all method claims for treating a cancer using immunotherapy, an examiner may provide -- at his or her discretion -- an opportunity to file a response that complies with the requirements of the pilot program.
According to the notice, a participating application's special status will be terminated if an applicant files an extension of time under 37 C.F.R. § 1.136(a), an RCE, or a Notice of Appeal. Special status will also be terminated (and the 12-month objective of the pilot program satisfied) by a final disposition, which under the pilot program will include the mailing of a final Office action or notice of allowance.
The Office began accepting petitions under the new pilot program on June 29, 2016, and will continue to accept petitions until June 29, 2017 (although the Office has reserved the right to extend or terminate the program depending on the workload and resources needed to administer the program, feedback from the public, and effectiveness of the program). The notice indicates that questions relating to a specific petition should be directed to Supervisory Patent Examiners Gary B. Nickol or Brandon J. Fetterolf.
Additional information regarding the Cancer Immunotherapy Pilot Program can be found in the Office's notice.
