INTRA-CELLULAR THERAPIES, INC v. IANCU
- Sep 18 2019 |
- Category: CAFC Updates
Intra-Cellular Therapies appeals the District Court’s summary judgment decision affirming the patent term adjustment (PTA) determination made by the United States Patent Office. During prosecution of Intra-Cellular’s patent application, the Patent Office issued a final Office action rejecting some claims and objecting to the others. A final Office action, as opposed to a non-final Office action, marks the end of formal prosecution of an application. On the three-month deadline for responding to the final Office action, Intra-Cellular filed its first response. While timely, this initial response continued to argue the merits of the examiner’s final rejections and failed to comply with the Patent Office’s regulatory requirements for what constitutes a proper “reply” to a final Office action. For that reason, the Patent Office concluded that Intra-Cellular’s first response (which did not cancel or appeal every rejected claim and therefore failed to engage in reasonable efforts to conclude prosecution) did not prevent the accrual of applicant delay for purposes of calculating PTA for the resulting patent. Twenty-one days after filing its unsuccessful first response, Intra-Cellular tried again by filing a second response. This time, Intra-Cellular successfully overcame all outstanding rejections and objections. Adopting all of the examiner’s suggestions, the second response capitulated to all of the examiner’s rulings by canceling or amending every rejected or objected to claim based on the examiner’s positions. As a result of these amendments, the Patent Office issued a Notice of Allowance and concluded that this second response stopped the accrual of any further applicant delay. In calculating PTA, the Patent Office determined that the extra 21 days it took Intra-Cellular to file a successful response after the three-month deadline for responding to the final Office action constituted applicant delay. Finding that the Patent Office’s determination of applicant delay was based on a permissible interpretation of statute and proper reading of the regulations, the CAFC affirms the district court’s grant of summary judgment in favor of the Patent Office.