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In a notice published earlier this summer in the Federal Register (85 Fed. Reg. 41570), the U.S. Patent and Trademark Office announced that it was extending the Cancer Immunotherapy Pilot Program. According to the Office's notice, the Cancer Immunotherapy Pilot Program has been extended to June 30, 2022, and all parameters will remain the same as in the original pilot program.

The Cancer Immunotherapy Pilot Program was initiated on June 29, 2016 (see "USPTO Implements Pilot Program to Support President's National Cancer Moonshot") 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 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."

(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 500 petitions requesting participation in the pilot program have been filed, and 167 patents have been granted under the pilot program.


USPTO and IMPI Extend PPH Pilot Program

In a notice published earlier this summer in the Official Gazette (1476 OG 56), the U.S. Patent and Trademark Office announced that the USPTO and Mexican Institute of Industrial Property (IMPI) have agreed to extend the Patent Prosecution Highway (PPH) Pilot Program between the two offices until June 30, 2022. As a result of the extension, the USPTO will treat as timely any PPH request, based on IMPI work, filed with the USPTO on or before June 30, 2022.


INAPI Transitioning to Global PPH Pilot Program

In a notice issued by the U.S. Patent and Trademark Office earlier this summer, the USPTO announced that it had been informed by the National Institute of Industrial Property of Chile (INAPI) that INAPI would be participating in the Global PPH pilot program effective July 6, 2020. In November of 2018, the USPTO had commenced a Patent Prosecution Highway (PPH) pilot program in which an applicant whose claims were determined allowable/patentable in an application filed with INAPI could have the corresponding application filed with the USPTO advanced out of turn for examination. In January of 2014, the USPTO began participating in the Global PPH pilot program, which consolidated and replaced numerous prior PPH programs, streamlining and simplifying the PPH process for both applicants and Global PPH participating offices. INAPI's participation in the Global PPH pilot program will supersede the bilateral PPH pilot program that previously existed between the USPTO and INAPI.


USPTO Releases Revised MPEP

The U.S. Patent and Trademark Office announced via a Patent Alert e-mail distributed earlier this summer and a notice in the Federal Register (85 Fed. Reg. 41571) that it has released the latest version of the Manual of Patent Examining Procedure (MPEP). The new version of the MPEP -- the Ninth Edition, June 2020 Revision -- incorporates updated information on patent examination policy and procedure related to a number of issues, including subject matter eligibility and examination of computer-implemented functional claim limitations. In particular, chapters 100-1000, 1200-1500, and 1700-2800 of the MPEP have been revised. The Office notes that updated sections are indicated by a revision indicator of [R-10.2019], which means these sections have been updated to reflect USPTO patent practice and relevant case law as of October 31, 2019. The new version of the MPEP can be accessed here. Suggestions for improving the form and content of the MPEP can be submitted via e-mail to mpepfeedback@uspto.gov, via the IdeaScale® tool at https://uspto-mpep.ideascale.com/a/index, or by regular mail addressed to the Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of the Editor, Manual of Patent Examining Procedure.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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