safe harbor rule : CAFC Alert

Election of species in case where there is no generic claim amounts to a “restriction” for applying safe harbor provision of 35 U.S.C. §121

| September 18, 2013

St. Jude Medical, Inc. v. Access Closure, Inc.

September 11, 2013

Panel: Lourie, Plager and Wallach.  Opinion by Plager. Concurring opinion by Lourie.


St Jude Medical, Inc. asserts two sets of patents against Access Closure, Inc. (ACI).  The patents claim methods and devices for sealing a “vascular puncture” into a vein or artery made during a medical procedure.

Claims 7, 8 and 9 of the Janzen patent are invalid for double patenting over the claims of a copending “sibling” application because claims 7, 8 and 9 are directed to an invention identified as Group II in a restriction requirement, further limited to species C, and the claims in the sibling patent are directed to a Group II invention but without any limitation to species.  The safe harbor provision of 35 U.S.C. §121 does not apply because the claims of the Janzen patent are not patentably distinct from the claims of the sibling patent, and the patents do not maintain the “consonance” created by the original restriction requirement and requirement for election of species.

The claims of the two Fowler patents asserted by St Jude Medical are not obvious over a combination of two cited references because the references teach alternative methods (inserting a balloon or inserting a gelfoam stick) for achieving hemostasis, whereas the claims in the Fowler patents use a balloon for another purpose, i.e., to help position a plug and prevent it from entering a blood vessel.

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