Request for Continued Examination

Fast Track for Cancer Applications – Limited Time

July 12, 2016

The USPTO recently established Patents 4 Patients, also known as the Cancer Immunotherapy Pilot Program, to speed up prosecution of cancer related patents. The goal of Patents 4 Patients is to reduce the time the USPTO takes to review patent applications pertaining to cancer immunotherapy in half by issuing final decisions in 1 year or less after special status is granted. Unlike other fast track applications, there are no additional fees required to participate in the program. The USPTO will advance these applications out of turn (accorded special status) for examination if the applicant files a petition to make special under the Patents 4 Patients Program.

The Patents 4 Patients program is open to any applicant, regardless of the nationality of the patent applicant or its agents. The location where the underlying research was undertaken or the technology was developed does not matter nor does the location where the invention may be produced or manufactured.

The Patents 4 Patients program requires at least one or more claims to a method of treating a cancer using immunotherapy. Most importantly, if the application does not contain a method claim that complies with the USPTO eligibility requirements, the petition will be dismissed, and the applicant will not be given an opportunity to correct the deficiency.

The patent application must be a non-reissue, non-provisional utility application, or an international application that entered the US national stage. The maximum total claim limit is 20 with 3 independent claims and no multiple dependent claims. Applications that have been previously granted special status are not eligible for the Patents 4 Patients program. A petition for the program must be filed either (i) at least one day prior to the date of a first Office action or (ii) with a proper request for continued examination (RCE).

For patent applicants whose claimed cancer immunotherapy both (i) meets the eligibility requirements for the Patents 4 Patients Program and (ii) is the subject of an active Investigational New Drug (IND) application filed by patent applicant at the U.S. Food and Drug Administration (FDA) that has entered phase II or phase III clinical trials, the petition may be filed any time prior to an appeal or a final rejection if patent applicant certifies both (i) and (ii) in the petition. For an application that has an outstanding Office action, patent applicant must file a complete response together with the petition.

Publication of the patent application is a requirement of the Patents 4 Patients program. If a nonpublication request was previously filed, applicant must file a rescission of nonpublication with the petition.

According to the USPTO, the 1 year goal is achieved when one of the following final dispositions occurs within twelve months from the grant of special status: (1) The mailing of a notice of allowance; (2) the mailing of a final Office action; (3) the filing of an RCE; (4) the abandonment of the application; (5) or the filing of a Notice of Appeal.

The Patents 4 Patients program will run until June 29, 2017; therefore applicants must file a petition before then. The USPTO may or may not extend the Patents 4 Patients program with or without changes. To learn more about Patents 4 Patients program and the eligibility requirements, feel free to contact one of our attorneys.


May 2015 Patent Prosecution Lunch Presentation

June 3, 2015

The May patent prosecution lunch presentation includes a discussion of the requirement to have a signed oath or declaration for a 371 national stage PCT application in order to have the ability to file a Request for Continued Examination (RCE). In addition, the presentation provides information concerning the United States Patent and Trademark Office’s (USPTO) Patent Application Alert System (PAAS) as well as the new USPTO patent dashboard. The presentation also provides information concerning the ArcelorMittal France v. AK Steel Corporation case in which the Federal Circuit found an improper broadening reissue when no specific claim amendment was made directly to the independent claim but rather to a dependent claim. A few USPTO notices and final rules are also presented, including the USPTO relaxing the requirements for written authorization in order to conduct a video web-based (i.e., WebEx) interview and final rule changes concerning the briefing requirements for AIA post-grant proceedings. The presentation can be downloaded here.