Gilead Sciences, Inc. v. Rea, 976 F. Supp. 2d 833

Gilead filed U.S. application No. 12/036,124 on Feb. 22, 2008; USPTO mailed a restriction requirement on Nov. 18, 2009; Gilead replied on Feb. 18, 2010 and then filed a supplemental IDS on Apr. 16, 2010.
USPTO allowed the application (patent '374) and calculated Patent Term Adjustment (PTA) including 245 days A‑delay and 406 days B‑delay (651 days less 35 overlap = 616 days), then subtracted 57 days as applicant delay for the supplemental IDS, yielding 559 days PTA.
USPTO treated the supplemental IDS filed after the reply to the restriction requirement as a failure to "engage in reasonable efforts to conclude prosecution" under 35 U.S.C. § 154(b)(2)(C), applying its regulation 37 C.F.R. § 1.704(c)(8).
Gilead sued under the APA arguing the USPTO’s interpretation and application of § 154(b)(2)(C) was arbitrary and capricious and therefore the 57‑day applicant delay should not have been subtracted.
The parties filed cross‑motions for summary judgment; facts were undisputed; the sole legal question was whether the USPTO’s construction of § 154(b)(2)(C) (embodied in § 1.704(c)(8)) was permissible under Chevron.
The district court applied Chevron step two, found the USPTO’s regulation a permissible construction (agency expertise, focuses on reasonableness not actual delay, and includes exceptions), denied Gilead’s motion, and granted the USPTO summary judgment.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether filing a supplemental IDS after replying to a restriction requirement constitutes a failure to "engage in reasonable efforts to conclude prosecution" under 35 U.S.C. § 154(b)(2)(C)	Gilead: regulation is impermissible because it penalizes applicants who did not cause actual delay and penalizes submissions before a first merits office action	USPTO: Congress delegated the question to the agency; § 1.704(c)(8) reasonably targets conduct that interferes with examiners and the timeliness framework; exceptions exist for prompt/USPTO‑prompted disclosures	Court: USPTO’s interpretation is permissible under Chevron; 57‑day reduction stands; USPTO wins summary judgment

Celotex Corp. v. Catrett, 477 U.S. 317 (summary judgment standard)
Star Fruits S.N.C. v. United States, 393 F.3d 1277 (APA review of PTO action)
Holly Hill Farm v. United States, 447 F.3d 258 (scope of agency review)
Chevron U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837 (agency deference framework)
Nat’l Cable & Telecomms. Ass’n v. Brand X Internet Servs., 545 U.S. 967 (courts must accept reasonable agency constructions even if judge would prefer another)
Univ. of Massachusetts v. Kappos, 903 F. Supp. 2d 77 (characterizing restriction requirement as an "action" under § 132)