Intra-Cellular Therapies, Inc. v. Iancu, No. 18-1849 (Fed. Cir. 2019)Annotate this Case
In September 2010, IntraCellular filed the application leading to the 077 patent. In October 2012, the Patent Office issued a non-final office action including rejections under 35 U.S.C. 103 and 112. Intra-Cellular argued against section 103 rejections without amendment. In April 2013, the Patent Office mailed a final Office action, allowing no claims. In July 2013, on the last day for filing a “reply” to the final Office action without accruing applicant delay, 36 U.S.C. 154(b)(2)(C)(ii), Intra-Cellular responded with “Amendments and Response,” repeating the same arguments and adding a new claim. Nine days later, the Patent Office mailed an Advisory Action: Intra-Cellular’s after-final submission overcame some of the previous rejections but failed to overcome the section 103 rejection for the prior reasons of record. The examiner suggested amending or cancelling certain claims. Ten days later, Intra-Cellular filed its second after-final submission adopting all of those suggestions. A Notice of Allowance was mailed on August 20, 2013. In January 2017, the Patent Office issued a determination that the patent was entitled to 264 days of patent term adjustment ( for agency delays, after subtracting 21 days for applicant delay based on the time it took Intra-Cellular to file its second after-final submission after the response deadline, reasoning that Intra-Cellular’s first after-final submission did not constitute a proper “reply” under 37 CFR 1.704(b). The clock stopped with the second after-final submission, 21 days later. The Federal Circuit affirmed that determination. While timely, Intra-Cellular’ initial response continued to argue the merits of the final rejections, failing to comply with regulatory requirements for what constitutes a proper “reply” to a final Office action.