Part 1 and Part 2 of this series introduced the United States Patent and Trademark Office's (USPTO) pilot program for accelerated examination of patent applications directed to methods of treating cancer with immunotherapy. We outlined the accelerated examination of our first application accepted onto this program and, in this article, we consider examination of a second application we successfully had accepted onto the pilot program.
The second application was accepted onto the pilot program in November 2016, with claims directed to a combination of an antigen and a chemotherapeutic agent. In particular, it is a common strategy to claim a combination therapy once an initial therapeutic antigen has been identified, in order to extend patent protection.
A restriction requirement was received within two months of the application being accepted onto the pilot program, and we were given only five days to respond. The restriction requirement was received as a telephone call from the examiner and, normally, an informal note to the examiner confirming the election would have been sufficient, rather than a formal written reply. However, our reply also included an amendment to one of the claims, such that a formal Preliminary Amendment and written reply were required, in this instance.
Having elected the claims directed to the method of treating cancer, in order to remain on the pilot program, the first substantive Office Action was received within six days of filing the response to the restriction requirement. Although the pilot program increases the speed with which the application is dealt with by the USPTO, it should be noted that the deadlines set for responding to Office Actions are unaffected (although use of any extensions removes the application from the pilot program). Thus, we were still given three months in which to respond to the first Office Action.
We received and responded to an objection that the subject matter of the claims was not adequately described in the specification.
Another objection raised was that the specification did not actually describe a method of treating cancer, but merely a method of inducing an immune response. This objection was overcome by filing a Declaration explaining the significance of the measured immune response, and that it is sufficient evidence of effective treatment of cancer.
The next official communication was a Notice of Allowance for Grant, and was received within one month of the response to the first Office Action. As with the first Office Action, the usual deadline for responding applied, such that we were given the usual three months to pay the issue fee. It took just over 10 months from the date of filing this application with the USPTO to the date of grant.
The pilot program was due to end on 29 June 2017, but we are pleased that it has been confirmed that the pilot program has been extended until 31 December 2018, due to continued interest and participation from various stakeholders around the world. The USPTO has confirmed that the conditions of the pilot program will remain the same as the original pilot program. In addition, the USPTO has stated that the pilot program may be further extended (with or without amendments) or may be terminated depending on feedback received, continued interest and program effectiveness. We hope to be able to continue to make use of this program.