Incomplete response to Final Office Action results in reduced Patent Term Adjustment

Intra-Cellular Therapies, Inc. v. Andrei Iancu (USPTO)

Docket No. 2018-1849
September 18, 2019

Brief Summary: DC decision affirming USPTO’s PTA calculation penalizing IC for 21-day delay in filing proper response to FOA affirmed.

Summary: Intra-Cellular (IC) appealed the DC’s grant of summary judgment affirming the USPTO’s patent term adjustment (PTA) determination for US 8,648,077 because “that the extra 21 days it took [IC] to file a successful response after a three-month deadline for responding to the final Office action [FOA] constituted applicant delay.” IC filed a first response to the FOA at the three-month deadline that “failed to comply with the Patent Office’s regulatory requirements for what constitutes a proper ‘reply’ to a” FOA. IC then filed a second response 21 days later that “successfully overcame all outstanding rejections and objections”, which was followed by a Notice of Allowance. In making its PTA determination, the USPTO concluded that the “second response stopped the accrual of any further applicant delay.” The PTA (Section 154) accounts for three types of USPTO delays: the “A Delay” for “when the PTO does not meet certain deadlines in the processing of patent applications”; the “B Delay” “for each day the application is pending beyond three years”; and, the “C Delay” “for each day the application is pending in an interference proceeding, a secrecy order, or a successful appeal” to the USPTO or a federal court. Section 154(b)(2)(C) requires the PTA to be reduced “by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution” (Gilead, FC 2015 (untimely filing of IDS caused applicant delay)). Section 154(b)(2)(C)(ii) defines a “fail[ure] to engage in reasonable efforts” as including “the cumulative total of any periods of time in excess of 3 months” the applicant took to respond to a USPTO notice, calculated “from the date the notice was given or mailed to the applicant” (see also 37 CFR section 1.704(b)). The FC panel explained that “filing a § 1.113(c) reply will cut off accrual of applicant delay under § 1.704(b)” (“cancellation of, or appeal from the rejection of, each rejected claim”, “no claim amendments or arguments are allowed”), as does the filing of a Request for Continued Examination (RCE) under § 1.114 (which “stops the accrual of B Delay…cutting off a potential significant source of PTA” (Novartis, FC 2014)). “A third option is to file a 37 C.F.R. § 1.116 amendment” under which an application can cancel claims or “comply[] with any requirement of form” or “an ‘amendment touching the merits of the application” with “good and sufficient reasons why the amendment is necessary and was not earlier presented”, that “[o]nly a ‘complete and proper reply’” to the FOA “will save the application from abandonment”, and that “the acceptance of any after-final amendment by itself is not regarded as a ‘complete and proper reply’”. The FC panel considered the DC’s decision under Chevron (US 1984) (whether the statute addresses the issue and whether the PTA determination is supported by a permissible construction), finding the DC’s analysis to be correct (e.g., IC’s “first after-final ‘submission was not a proper reply under § 1.113(c)’, and therefore not a ‘reply’ under § 1.704(b)”, “constituted a ‘fail[ure] to engage in reasonable efforts to conclude processing or examination”; IC “could have chose either path for filing a proper reply” (§ 1.113(c) or § 1.114) “but it chose not to”; reply to non-final OA under § 1.111(b) (“must reply to every ground of objection and rejection”) not the same standard as for a reply to a FOA (§ 1.111(b); “not part of the typical ‘back and forth’ process of prosecution” (Pfizer, FC 2016); no “unfair surprise” (Christopher, US 2012)). The DC decision was therefore affirmed.

This entry was posted in Patent Term Adjustment (PTA), Patent Term Extension, Uncategorized. Bookmark the permalink.

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