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

Docket No. 2012-1452

September 11, 2013

Brief summary: DC conclusion of no double-patenting reversed and its obviousness findings affirmed due to “logical chasm” between claimed invention and combination of references.

Summary: ACI appealed DC ruling that the safe harbor provision of 35 USC 121 protects St. Jude’s “Janzen” patent from double-patenting invalidity in view of its “sibling” patent, the construction of key terms in that patent, and that it was not entitled to JMOL regarding obviousness of St. Jude’s “Fowler” patent. The patents at issue relate to methods and devices for sealing “vascular punctures” for inserting a medical device (e.g., catheter) into a patient’s vasculature. As explained in the opinion, the double-patenting safe harbor provision (35 USC 121) (“not a model of clarity”) arose to protect against an Examiner’s determination that two inventions in an application are “patentably distinct” and a court later finding that the inventions are not; under the safe harbor provision, a patent resulting from a restriction requirement is safe from invalidation for double-patenting in view of its parent (citing Gerber, FC 1990 and Boehringer, FC 2010). It was concluded that the grandparent application of the Janzen patent was restricted to device and method claims and that the Janzen patent pursued a different invention. However, it was also determined that the “sibling application was not filed ‘as a result’ of the restriction since it pursued” a generic claim that overlapped the subject matter of the Janzen patent. Accordingly, the Janzen patent was found not to claim patentably distinct subject matter from the sibling patent, “the safe harbor provision cannot apply”, and the disputed claims of the Janzen patent are invalid for double-patenting. The claim construction issues were therefore rendered moot. The FC panel did not agree with ACI that the Fowler patent was obvious in view of the alleged prior art because “a logical chasm [was] not bridged by the prior art, common sense, or ACI’s statements that the claimed invention was obvious…[e]ven under our ‘expansive and flexible’ obviousness analysis”, noting that is “must guard against ‘hindsight bias’ and ‘ex post facto reasoning'” (citing KSR and noting St. Jude’s expert testimony that the proposed combination of art was “very, very far out and it makes no sense to me whatsoever” and “[c]ombining two references which are independenty farfetched is farfetched times farfetched, it’s farfetched squared.”) Judge Lourie’s concurring opinion explains a different route for arriving at the same double-patenting conclusion.

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