News & Events

Sep 2, 2016

This article was written by Doreen Hogle, partner at HoustonHogle LLP. We are proud to announce that Doreen was selected for inclusion in both the 2016 and 2017 “Best Lawyers in America” in the practice area of patent law.

Recently the USPTO announced two new pilot programs aimed toward streamlining patent prosecution. The “Post-Prosecution Pilot Program”, (the “P3” Program), provides a new option to applicants facing a final rejection, giving the applicant an opportunity to present claim amendments and written and oral arguments directly to a panel of examiners for a quick determination of patentability.  The “Patents 4 Patients” Initiative supports the National Cancer Moonshot mandate to increase patient access to new and promising cancer treatments by fast-tracking the examination of patent applications directed to treating cancers with immunotherapeutic methods.

Post-Prosecution Pilot Program (P3)

In order to reduce the number of appeals and RCEs filed in response to final rejections, the USPTO announced the P3 program as an alternative to the now-existing Pre-Appeal Brief Conference Program and the After-Final Consideration Program (AFCP 2.0). When a final rejection is issued in a utility application, but prior to filing a Notice of Appeal, the applicant has two months from the mail date of the final rejection to file a request for participation in the P3 program along with filing a written response to the rejection(s) and a statement that the applicant will be available to participate in a conference with a panel of USPTO examiners. No filing fee for the request is required.

A response to the final rejection(s), with no more than 5 pages of arguments, must be filed with the P3 request. In addition to the 5 pages of arguments, the response can optionally include pages of proposed, non-broadening claim amendments. The purpose of the response is to focus the issues and if the proposed arguments and/or amendments are too extensive so as to require further search and consideration, the P3 request may be found to be non-compliant and denied.

If the request is found to be timely-filed and compliant, the USPTO will contact the applicant to schedule a conference (telephonic, video or in-person) with a panel of three examiners (typically the examiner of record, a supervisory examiner and a primary examiner). During the conference, applicant will have 20 minutes to present arguments and evidence to the panel. After the presentation the applicant is excused, the panel will consider the arguments and render a decision. Applicant will be notified of the examiners’ decision by a written Notice of Decision indicating either: the final rejection is upheld; the application is allowable; or prosecution is reopened. If the final rejection is upheld, applicant may still file an appeal or RCE within the statutory time period for responding to the final office action. The examiners’ decision under the P3 program is not appealable.

Details of the P3 program can be found at:
https://www.federalregister.gov/articles/2016/07/11/2016-16423/post-prosecution-pilot-program

Patents 4 Patients

In support of the National Cancer Moonshot announced by the White House, the USPTO initiated a pilot program for accelerated examination of utility patent applications with claims directed to methods of treating cancer using immunotherapy upon grant of a Petition to Make Special. There is no fee for the Petition, but the applicant must make specific statements to certify that the application qualifies for the pilot program. The Petition must include a request for early publication of the application if the application has not yet been published by the USPTO.

Under this program, an application granted special status will be taken out of turn for examination with the objective to complete examination within 12 months of special status being granted. Completion of examination is achieved by one of the following final dispositions occurring: the mailing of a Notice of Allowance; the mailing of a Final Office Action; the filing of an RCE; abandonment of the application; or the filing of a Notice of Appeal.

The Petition to Make Special must be electronically filed at least one day prior to issuance of a first Office Action as indicated in PAIR (even a Restriction Requirement counts), or with an RCE. However, the Petition can be filed after receipt of a first Office Action if the claimed method of immunotherapy treatment is the subject of an active Investigational New Drug application during Phase II or III clinical trials.

In the Petition applicant must state that, upon filing the Petition and throughout prosecution under special status, the application contains at least one claim directed to a method of treating cancer using immunotherapy, with no more than 3 independent claims, no multiple dependent claims and 20 claims total. A preliminary Amendment can be filed with the Petition to amend the claims to comply with these requirements.

The applicant must also state that if a Restriction Requirement is issued, applicant will make an election to prosecute a program-eligible method claim without traverse in a telephonic interview with the examiner within 2 business days of receiving the requirement. If the applicant cannot elect within the time limits, the examiner will make the election for the applicant.

During the examination process no extensions of time are granted for replies, and a request for an extension of time automatically kicks the application out of the special program and back into the regular queue of applications waiting for examination.

Details of the Patents 4 Patients program can be found at:
https://www.federalregister.gov/articles/2016/06/29/2016-15533/cancer-immunotherapy-pilot-program