Earlier this month, in St. Jude Medical, Inc. v. Access Closure, Inc., No. 2012-1452 (Sept. 11, 2013) the Federal Circuit clarified the double patenting safe harbor provision in 35 U.S.C. § 121. The safe harbor provision is designed to prevent the inherent unfairness that would occur if claims found to be patentably distinct by the examiner and required to be restricted and filed in a separate application could then be found invalid for double patenting if a court concluded the claims were not patentably distinct. The Court clarified the requirement that the patent must maintain consonance in order for the safe harbor provision to be applicable.  This ruling is especially important to those prosecuting patents who may be making decisions about which claims to elect under a restriction requirement.

St. Jude Medical, Inc. (“St. Jude”) sued Access Closure, Inc. (“ACI”) in the United States District Court for the District of Arkansas for infringement of several patents, including U.S. Patent No. 7,008,439 (“the Janzen patent”). The Janzen patent is a descendant from U.S. Patent Application No. 07/746,339 (“the grandparent application”). During prosecution of the grandparent application, the examiner stated that the claims included two patentably distinct inventions:  Group I (device claims) and Group II (method claims) and required restriction of the application under 35 U.S.C. § 121. In addition, the examiner identified three patentably distinct species of claims and required the applicant to elect one of Species A, B and C. The Applicant elected Group I Species B.

The applicant then filed U.S. Patent Application No. 08/318,380 (“the parent application”) as a divisional of the grandparent application. The examiner imposed a similar restriction requirement and the applicant again elected Group I Species B. The applicant filed the application that became the Janzen patent as a continuation of the parent application. The applicant cancelled the original claims and added new claims including both device and method claims. The applicant also pursued another continuation of the parent application, which became the sibling patent to the Janzen patent and issued before it.

In the district court, the jury returned a verdict of infringement of the Janzen patent but also found that the patent was invalid for double patenting in light of the sibling patent. The judge had withheld from the jury the question of whether the safe harbor provision applied, and held a bench trial on that issue. The district court then concluded that the safe harbor provision did apply and upheld the validity of the claims.

ACI then appealed to the Federal Circuit and argued that the Janzen patent violated the judicially-created doctrine of “consonance” which requires that the claims in a divisional or continuation application be consonant with the restriction requirement. Specifically, ACI argued that the Janzen patent included not only the non-elected Group II claims, but also Group I claims like the grandparent application and thus violated consonance.

St. Jude argued that the examiner’s restriction requirement was more than just Group I versus Group II and that the election of the species had significance as well. The Janzen patent’s claims were directed to Group I Species C and Group II Species C and thus did not overlap with the grandparent’s claims directed to Group I Species B.

The Federal Circuit agreed with St. Jude’s argument about the effect of a species restriction requirement, noting that “[t]he election of a species, like a typical restriction, helps the examiner to focus the examination process.” The applicant typically prosecutes both generic claims to the device or method, as well as claims to the device or method plus the elected species and withdraws claims as to the device or method and the non-elected species. The USPTO regulation set forth in 37 C.F.R. § 1.146 states that the “claim will be restricted if no claim to the genus is found to be allowable.” The Court held that ACI’s argument overlooked the fact that the grandparent application lacked a generic claim. Because there was no generic claim applied for (and thus none found allowable) the election of species created a restriction and thus consonance was maintained between the Janzen patent and its grandparent application. However, the Court further held that consonance in a case like this requires that the challenged patent (the Janzen patent), the reference patent (the sibling patent) and the patent in which the restriction requirement was imposed (the grandparent application) do not claim any of the same inventions identified by the examiner. In this case, consonance was not maintained with the sibling patent. The sibling patent did have a generic Group II claim and overlapped with the Group II Species C claims in the Janzen patent. The Court thus found the Janzen patent invalid for double patenting.

Judge Lourie filed a concurrence, agreeing with the result but disagreeing with the way the majority reached it.  He asserted that both Janzen and the sibling patent failed to maintain consonance with the grandparent patent. In Judge Lourie’s view, a restriction requirement is different than an election of species, and the effect of the election of species should not be considered for purposes of consonance. In his view, the fact that there were both device and method claims in the Janzen patent meant it did not maintain consonance with the grandparent.

This case emphasizes the need to pay attention to the consonance requirement when prosecuting patents under a restriction requirement. Patent prosecutors need to keep in mind that in order to fall under the safe harbor provision, the patent must maintain consonance with other family members as well as patents from which it directly descends. It is also important to remember that a patent can maintain consonance with a patent with which it would otherwise overlap, by electing a particular species, but only so long as there is no allowable generic claim that encompasses the species.