Hospira, Inc. v. Genentech, Inc

Informative decision only: persuasive authority, not binding precedent. When the examiner during prosecution expressly decided that the challenged claims were entitled to an earlier priority date and withdrew a rejection over a reference on that basis, and the petition asserts that same reference (and later-published references dependent on the same priority question) while presenting no new evidence or arguments showing the examiner's priority determination was unreasonable, the Board may exercise its discretion under 35 U.S.C. § 325(d) to deny institution because the same or substantially the same prior art or arguments were previously presented to the Office. The Board may likewise deny grounds based on later-published references where the earlier priority determination is dispositive of whether they qualify as prior art. No prior precedent directly addressed this issue in the text; the Board relied on § 325(d), 37 C.F.R. § 42.108, and Board decisions (Neil Ziegman, N.P.Z., Inc. v. Stephens and Fox Factory, Inc. v. SRAM, LLC) describing the balance of interests. For petitioners, an anticipation challenge that depends on defeating a priority claim the examiner already accepted, in order to make a reference prior art, will be denied unless the petition brings new evidence or arguments showing the examiner's determination was unreasonable, and the written description and enablement attack must be developed (including the Wands factors for enablement). For patent owners, a prosecution record showing the examiner expressly considered written description and enablement for priority and withdrew a rejection on that basis is strong grounds for a § 325(d) denial, and it can also dispose of later-published references. The Board cited Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356 (Fed. Cir. 2016), for the discretionary nature of institution, and In re Wands and Rasmusson v. SmithKline Beecham Corp. on the merits of enablement and priority. LEGAL TEST OR STANDARD: Section 325(d) states that in determining whether to institute, the Director may take into account whether, and reject the petition because, the same or substantially the same prior art or arguments previously were presented to the Office. The Board's discretion involves a balance of competing interests: on one hand conserving Office resources and giving patent owners repose on issues and prior art previously considered, and on the other giving petitioners an opportunity to be heard and correcting Office errors in allowing a patent. The Board asked whether the petitioner presented new evidence or arguments convincing it that the examiner's determination was unreasonable. TRIGGERING FACTS: The examiner rejected claims under § 102(b) over Nabholtz, then determined the claims were entitled to the provisional's December 12, 1997 priority date after amendment, withdrew the § 112 rejections, and withdrew the Nabholtz rejection expressly because of that priority determination. The petition's Ground I asserted the same Nabholtz reference, and Grounds II and III asserted later-published Leyland-Jones and Yardley references, all relying on the argument that the claims lack priority for the three-part combination under written description and enablement. The petitioner offered no further evidence beyond the examiner's view, and its enablement argument omitted the Wands factors. KEY QUOTE: "Because the priority determination with respect to Nabholtz is dispositive with respect to whether the later-published Leyland-Jones and Yardley references qualify as prior art, we likewise exercise our discretion under § 325(d) and decline to institute inter partes review based on Grounds II and III." (Paper 16, p. 19) PRIOR PRECEDENT AFFECTED: No prior precedential or informative decision is directly affected. The Board applied the balancing described in Neil Ziegman, N.P.Z., Inc. v. Stephens, Case IPR2015-01860, slip op. at 12-13 (PTAB Feb. 24, 2016) (Paper 11), and Fox Factory, Inc. v. SRAM, LLC, Case IPR2016-01876, slip op. 7 (PTAB Apr. 3, 2017) (Paper 8), and cited Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016), for the discretionary nature of institution. PRACTICE TIP: If your petition depends on showing the claims are not entitled to an earlier priority date, review the prosecution history first. If the examiner already decided priority and withdrew a rejection on that basis, build new evidence and argument showing why that determination was unreasonable, including a full Wands analysis for enablement. Patent owners should highlight that examiner determination in the preliminary response and invoke § 325(d).