Last year, President Obama announced the National Cancer Moonshot, an initiative with the goal of making ten years' worth of advances in cancer research and treatment over the following five years. In support of this initiative, the USPTO announced its "Patents 4 Patients" program, also known as the Cancer Immunotherapy Pilot Program. Through this pilot program, which began June 29, 2016, applications directed to cancer immunotherapy are provided special status for examination, with the goal of completing prosecution within 12 months of the grant of special status.
To qualify for the pilot program, an application must contain at least one claim encompassing "a method of ameliorating, treating, or preventing a malignancy" such that "the steps of the method assist or boost the immune system in eradicating cancerous cells." 81 Fed. Reg. 42328 (29 June 2016). The applicant must also file a petition to participate in the Cancer Immunotherapy Pilot Program via EFS-Web using form PTO/SB/443. There is no fee to petition to make special under this program and there are no restrictions on who may apply for the program (e.g., universities vs. biotech companies) or where the technology was developed or produced.
The application must be a non-reissue application and cannot have been granted special status through any other program (e.g., Patent Prosecution Highway, Track One, or Accelerated Examination). In most cases, the petition to make special must be filed before receipt of an office action, including restriction requirement, in a new application or an in an application having a proper request for continued examination. However, special provisions apply for applications in which the claimed therapy is the subject of an Investigational New Drug application filed with the Federal Drug Administration that has entered phase II or phase III clinical trials. In such cases, a petition to make special can be filed at any time before a final office action or an appeal.
Like with other special status programs, certain requirements must be met in order to maintain special status during prosecution. For example, at no time may the application have more than three independent claims and 20 claims in total. Additionally, taking an extension of time to respond to an office action will terminate special status of the application. Special status is also terminated when a final office action issues or a notice of appeal or request for continued examination is filed.
Unless the USPTO extends the Cancer Immunotherapy Pilot Program, petitions to make special via this program must be filed before June 29, 2017. Additional information regarding this program can be found in the Federal Register Notice.
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