Readers will recall that, back in October 2016, we wrote about the US Patent and Trademark Office’s (USPTO) new pilot program for accelerated examination of US patent applications directed to a method of treating cancer using immunotherapy. As mentioned in our previous article, we had a first application accepted onto the pilot program and, subsequently, received a restriction requirement. We are pleased that the application is progressing well, and are hopeful that the application will be accepted for grant in the near future.

Examination of the application was certainly accelerated. In particular, the first substantive Office Action was received only two weeks after the response to the restriction requirement was filed, and the Final Office Action was received less than a month after the response to the first Office Action was filed at the USPTO. A Final Office Action is considered to be the end of examination for the purpose of the pilot program, which means that the application no longer receives special accelerated status. However, as with standard patent applications, if a response and amendments are filed within two months of the date of issue of the Final Office Action, then the examiner will issue an Advisory Action on the amendments, thereby maintaining momentum.

It appears that, while the claims of the application must recite a method of treating cancer using immunotherapy, in order for the application to be accepted onto the pilot program, the claims at the end of the procedure do not need to do so. In the Final Office Action, the examiner rejected the claims as lacking enablement for a method of treating cancer and, in response, we amended the claims so that they no longer specifically recited a method of treating cancer. The examiner indicated, in a subsequent telephone interview, that the claims would be accepted for grant. This has fitted well with our strategy of getting the application granted quickly and we retain the option of filing a subsequent continuation application that pursues the claims to the method of treating cancer to be prosecuted in more detail.

This application has also provided us with new insight into processes at the USPTO, independent of the pilot program. Although the examiner has indicated that the claims would be accepted for grant, we have yet to receive the Notice of Allowance. We have been informed that this is because the USPTO has not yet decided upon a request to republish the application with previously-omitted bibliographic data, and the examiner is unable to issue any further official communications until this request is decided upon. We hope that this situation will be resolved shortly.