Case: St. Jude Medical, Inc. v. Access Closure, Inc., No. 2012-1452 (Fed. Cir. Sept. 11, 2013). On appeal from W.D. Ark. Before Lourie, Plager, and Wallach.

Procedural Posture: Defendant appealed the district court’s rulings that the safe harbor provision of 35 U.S.C. § 121 protects one of the asserted patents from invalidity due to double-patenting, the construction of certain claim terms from this patent, and the district court’s denial of judgment as a matter of law that the other asserted patents were not invalid for obviousness. The CAFC reversed the district court’s safe harbor ruling, determined that the claim construction issues were moot, and affirmed that the remaining patents were nonobvious.

  • Safe Harbor Provision: A grandparent application of an asserted patent was subject to a restriction requirement between two groups of claims. The Examiner also required election of one of three species within each group. The CAFC ruled that consonance, i.e., the judicially-created limitation on the safe harbor provision of 35 U.S.C. § 121 requiring demarcation between independent and distinct inventions, was maintained with respect to election of a species because the grandparent application did not contain any generic claims. Applying this rule, the CAFC held that consonance was maintained (and the safe-harbor provision applied) between the asserted patent and the grandparent application because they were each directed to different species in the same group. However, the CAFC held that consonance was not maintained (and that the safe-harbor provision did not apply) between the asserted patent and an earlier-issued sibling because the sibling contained generic claims to all species within the same group as the asserted patent. Accordingly, the CAFC held that the safe harbor provision did not apply, and reversed the district court’s holding to the contrary.
  • Claim Construction: In view of the invalidity of the claims at issue for double patenting, the clam construction issues were mooted.
  • Nonobviousness: The CAFC found no error in the district court’s finding of nonobviousness. The cited prior art did not disclose a balloon configured to operate as a positioning device to prevent a plug from entering a blood vessel as claimed. In addition, the defendant did not establish that it would have been obvious to combine the teachings of the two cited prior art references, because each reference taught the same method of inserting an object into a wound to achieve hemostasis, and were thus substitutes, not complementary devices to obtain the positioning benefit claimed by the patents.

Lourie, concurring:

  • Application of Consonance: The majority correctly determined that the asserted patent was invalid, but did not need to address whether it maintained consonance with the sibling patent. Instead, the asserted patent should be held invalid for failure to maintain consonance with the original restriction requirement filed in the grandparent application. This restriction required the division of device claims from method claims, and the asserted patent contained claims to both devices and methods; therefore, the asserted patent lacked consonance. The majority overcomplicated the analysis by commingling the restriction requirement and the requirement for an election of species, but ultimately reached the correct result.