United States: If No Generic Claim Is Finally Held Allowable, Election Of A Species Creates A Restriction Under 35 U.S.C. § 121

In St. Jude Medical, Inc. v. Access Closure, Inc., No. 12-1452 (Fed. Cir. Sept. 11, 2013), the Federal Circuit reversed the district court's safe harbor ruling regarding U.S. Patent No. 7,008,439 ("the Janzen patent"), determined that the district court's rulings on claim constructions in the Janzen patent were moot, and affirmed the district court's ruling that U.S. Patent Nos. 5,275,616 and 5,716,375 (collectively "the Fowler patents") are nonobvious and not shown to be invalid.

St. Jude Medical, Inc. and St. Jude Medical Puerto Rico, LLC (collectively "St. Jude") own the Janzen patent and the Fowler patents, which relate to methods and devices for sealing a vascular puncture. During prosecution of the Janzen patent's grandparent application, the examiner required restriction of the application under 35 U.S.C. § 121 to Group I (device) or Group II (method) and an election of Species A, B, or C. The applicant elected Group I, Species B. Subsequently, the applicant filed U.S. Patent Application No. 08/318,380 ("the parent application") as a divisional of the grandparent application. Before the parent application issued, the applicant filed U.S. Patent Application No. 08/399,535 ("the Janzen application") as a continuation of the parent application. The Janzen patent ultimately issued with both device and method claims. The applicant also filed another continuation based on the parent application, which issued as U.S. Patent No. 5,725,498 ("the sibling patent").

St. Jude sued Access Closure, Inc. ("ACI"), alleging that ACI infringed several patents, including the Janzen patent and the Fowler patents. The jury found that ACI had infringed the Janzen patent, but that the Janzen patent was invalid for double patenting in light of the sibling patent. Subsequently, the district court determined that the safe harbor provision of 35 U.S.C. § 121 prevented the claims of the Janzen patent from being invalidated, and overturned the jury's finding of invalidity. The jury also found that ACI infringed the Fowler patents, and that those claims were valid. After the verdict, ACI filed a renewed JMOL motion on various claims in the Fowler patents, but the district court denied the motion. ACI appealed three of the district court's rulings: (1) that the safe harbor provision of § 121 protects the Janzen patent from invalidity for double patenting; (2) the construction of key terms in the Janzen patent; and (3) that ACI was not entitled to JMOL that the Fowler patents are invalid for obviousness.

"Since no generic claim was applied for, and no such claim was finally held allowable, that is what occurred: the election of species in the grandparent created a restriction." Slip op. at 15.

On appeal, the Federal Circuit first reversed the district court's ruling that the safe harbor provision of § 121 applied to the Janzen patent. The Court explained that the safe harbor provision of 35 U.S.C. § 121 provides that a patent issuing on an application to which a restriction requirement was made, or an application filed as a result of such requirement, shall not be used as a reference in either the PTO or the courts "against a divisional application or against the original application or any patent issued on either of them if the divisional is filed before the issuance of the patent on the other application." Slip op. at 11 (quoting 35 U.S.C. § 121). The Court noted that the safe harbor provision arose from difficulties created by restriction requirements imposed by the PTO during examination, followed by double patenting challenges in the courts. The Court explained the "judicially-created consonance concept," which derives from the safe harbor's "as a result of" requirement and specifies that the "line of demarcation between the 'independent and distinct inventions' that prompted the restriction requirement be maintained." Id. at 11-12 (quoting Gerber Garment Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 688 (Fed. Cir. 1990)). The Court explained that "[c]onsonance in a case like this requires that the challenged patent, the reference patent, and the patent in which the restriction requirement was imposed (the restricted patent) do no claim any of the same inventions identified by the examiner." Id. at 12.

The Court first considered the grandparent application (the restricted patent). According to ACI, during prosecution of the grandparent application, the examiner defined two inventions: the device of Group I and the method of Group II. ACI agreed that the method/device restriction in the grandparent application affected the line of demarcation, but argued that the election of species did not affect the line because an election of species is inherently different from a restriction requirement. According to St. Jude, the restriction imposed was a multilevel restriction, which demarcated six different inventions: Group I, Species A; Group I, Species B; Group I, Species C; Group II, Species A; Group II, Species B; and Group II, Species C. St. Jude asserted that the claims of the Janzen patent maintained consonance since the Janzen patent included claims to Group I, Species C and Group II, Species C, which did not overlap with the inventions, Group I, Species B, pursued in the grandparent application.

The Federal Circuit found that ACI's argument overlooked a critical point—that the grandparent application lacked a generic claim and that the applicant was required under § 121 to elect a single disclosed species to which the claims would be restricted if no generic claim was finally held allowable. The Court concluded that, as no generic claim was applied for or finally held allowable, the election of the species in the grandparent created a restriction. Thus, the Court found that "there were two restriction requirements imposed on the grandparent application: the original device/method restriction, and the second restriction that resulted from the election of species." Id. at 15.

With the line of demarcation settled, the Court next determined whether that line was honored, i.e., whether any of the same restricted inventions were claimed in the challenged patent (the Janzen patent), the reference patent (the sibling patent), or the restricted patent (the grandparent application). The Court found that the line of demarcation was maintained with respect to the grandparent application and the Janzen patent, but not with respect to the sibling patent. The Court explained that the sibling patent "pursued a claim generic to all of the Species in Group II, and therefore overlapped Group II, Species C found in the Janzen patent." Id. at 16-17. Consequently, the Court concluded that "the Janzen patent and the sibling patent did not maintain consonance, and therefore the safe harbor provision cannot apply." Id. at 17. Because the jury found that claims 7-9 of the Janzen patent were not patently distinct from the claims of the sibling patent, and the safe harbor provision could not apply, the Federal Circuit held claims 7-9 of the Janzen patent invalid for double patenting.

Because the Court held the claims invalid for double patenting, it concluded that the claim construction issues on appeal were moot. The Court also saw no error in the district court's legal conclusion of nonobviousness. Therefore, the Court affirmed the district court's denial of ACI's renewed motion for JMOL.

Judge Lourie concurred, stating that "this case is resolved by the failure of the granted Janzen and '498 (sibling) patents to maintain consonance with the original restriction requirement." Lourie Concurrence at 1. Judge Lourie further stated that "[t]he restriction requirement required dividing claims to devices from claims to methods, and the Janzen patent contains both device and method claims. It is the opposite of consonant." Id. at 2. Judge Lourie opined that "the district court and the majority err in even considering the effect of the requirement for election of species in this case." Id. at 3.

Judges: Lourie (concurring), Plager (author), Wallach

[Appealed from W.D. Ark., Senior Judge Barnes]

This article previously appeared in Last Month at the Federal Circuit, October 2013.

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