In a July 2017 decision designated as informative, the PTAB provided guidance as to when it may exercise its discretion under 35 U.S.C. § 325(d) to deny institution when “the same or substantially the same prior art or arguments previously were presented to the Office.” In Hospira, Inc. v. Genentech, Inc., IPR2017-00739, Paper No. 16 (PTAB July 27, 2017), the Board denied institution because the arguments presented had already been made during prosecution.

In its petition Hospira challenged claims of U.S. Patent No. 7,892,549, which relates to therapy for breast cancer. Hospira argued that certain claims were invalid as anticipated by one or more of three references. The use of those references as anticipatory prior art was premised on Hospira’s position that the challenged claims were not entitled to claim priority to an earlier application. In its priority date challenge, Hospira argued that the prior application did not enable or provide written description support for the challenged claims.

However, during prosecution, the Patent Office had already considered the issue. During prosecution, the applicant had claimed priority to the earlier application to avoid a rejection for anticipation by one of the same references Hospira included in its petition. Moreover, during prosecution the applicant had successfully amended its claims to avoid a rejection for lack of enablement.

When faced with Hospira’s written description and enablement arguments, the PTAB was not persuaded there was anything new. The Board found that Hospira had “not presented any further evidence in this proceeding that would persuade us to reach a conclusion different from the Examiner’s position that the challenged claims are adequately disclosed in the priority document.” Id. at 14. The Board was also unpersuaded by Hospira’s enablement arguments. Hospira had argued, citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1324 (Fed. Cir. 2005), that because the claims were directed to an “effective” use of the drug, the specification “must ‘provide experimental proof that his invention could be effective.’” Id. at 16. The Board was not convinced, however, and found that where, as in this case, “determining an effective amount . . . is a matter of routine experimentation within the general knowledge and skill set of a POSITA,” claims are enabled. Id. at 17. The Board concluded that because there was nothing new, there was no reason to deviate from the Office’s prior holding. Because this finding meant that none of Hospira’s asserted references were prior art, the Board declined institution.