Last month, in Federal Register notices published on the same day (84 Fed. Reg. 411), the U.S. Patent and Trademark Office announced that it was extending the Cancer Immunotherapy Pilot Program, but that it had decided to discontinue the Extended Missing Parts Pilot Program. According to the Office's notices, the Cancer Immunotherapy Pilot Program has been extended to June 30, 2020, and the Extended Missing Parts Pilot Program came to an end on January 2, 2019.
The Extended Missing Parts Pilot Program was initiated by the Office on December 8, 2010 to "effectively provide a 12-month extension to the existing 12-month provisional application period, providing applicants additional time to find financial help, evaluate a product's worth in the marketplace or further develop the invention for commercialization." Under the Extended Missing Parts Pilot Program, the Office modified its current missing parts practice such that applicants could file a nonprovisional application within the 12-month statutory period after the provisional application was filed (as well as pay the basic filing fee) and then be given a 12-month period within which to decide whether the nonprovisional application should be completed by paying the required surcharge and the search, examination, and any excess claim fees.
When implementing the pilot program, however, the Office noted that participation in the program would have patent term adjustment (PTA) effects, with the Office's certification and request form stating that:
Any patent term adjustment (PTA) accrued by applicant based on certain administrative delays by the USPTO is offset by a reduction for failing to reply to a notice by the USPTO within three months. See 37 CFR 1.704(b). Thus, if applicant replies to a notice to file missing parts more than three months after the mailing date of the notice, the additional time that applicant takes to reply to the notice will be treated as an offset to any positive PTA accrued by the applicant.
The Office also explained at the time that:
[T]he extended missing parts period does not affect the twelve-month priority period provided by the Paris Convention for the Protection of Industrial Property. Thus, any foreign filings must still be made within twelve months of the filing date of the provisional application if applicant wishes to rely on the provisional application in the foreign-filed application or if protection is desired in a country requiring filing within twelve months of the earliest application for which rights are left outstanding in order to be entitled to priority.
In its notice announcing the end of the Extended Missing Parts Pilot Program, the Office indicated that the pilot program was being allowed to expire because of "the limited number of grantable requests and the administrative burden on the USPTO in processing improper requests." In particular, the Office noted that it had received fewer than 200 grantable requests per year during the pilot program's tenure, and that the number of grantable requests had decreased over the past year.
The Cancer Immunotherapy Pilot Program was initiated on June 29, 2016 to provide for earlier review of patent applications pertaining to cancer immunotherapy in support of the "National Cancer Moonshot," an initiative of the Obama Administration to achieve ten years' worth of cancer research from 2016 to 2021 (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 are 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. 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.
(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, and 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." Examples of acceptable claims include 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 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, and 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 fee for a petition to make special under 37 C.F.R. § 1.102(d) has been waived by the Office.
In its notice extending the Cancer Immunotherapy Pilot Program, the Office noted that as of the date of the notice, more than 300 petitions requesting participation in the pilot program had been filed, and more than 100 patents had been granted under the pilot program.
