St. Jude Medical, Inc. v. Access Closure, Inc.
108 U.S.P.Q. 2d (BNA) 1285, 729 F.3d 1369, 2013 WL 4826148 (2013)
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Rule of Law:
The safe harbor provision of 35 U.S.C. § 121, which protects patents from invalidity for double patenting, does not apply if the patents at issue fail to maintain "consonance" with the original restriction requirement, meaning the distinct inventive lines drawn by the examiner must be respected across all related patents in the family.
Facts:
- St. Jude Medical's predecessor filed a patent application (the grandparent application) disclosing methods and devices for sealing a vascular puncture.
- A patent examiner issued a restriction requirement, forcing the applicant to elect between claims drawn to a device (Group I) and claims drawn to a method (Group II).
- The examiner also required the applicant to elect one of three patentably distinct species of the invention: Species A (solid tissue dilator), Species B (hollow dilator and guidewire), or Species C (guidewire and no dilator).
- The applicant elected to prosecute the device claims (Group I) and Species B, which eventually issued as the grandparent patent.
- The applicant later filed a continuation application (the Janzen application) which, after an interference proceeding, issued as the '439 Janzen patent containing claims to both devices (Group I) and methods (Group II).
- The applicant also filed another continuation (the sibling application) which issued as the '498 patent prior to the Janzen patent, containing a method claim that was generic to all species in Group II.
Procedural Posture:
- St. Jude Medical sued Access Closure, Inc. (ACI) in the U.S. District Court for the Western District of Arkansas for infringement of three patents.
- The district court issued a `Markman` order construing disputed claim terms.
- Following a trial, the jury found ACI infringed the Janzen and Fowler patents.
- The jury also found the asserted claims of the Janzen patent were invalid for double patenting over a sibling patent.
- The district court treated the jury's invalidity finding as advisory and held a separate bench trial on the applicability of the 35 U.S.C. § 121 safe harbor provision.
- The district court ruled that the safe harbor did apply, overturning the jury's finding and upholding the validity of the Janzen patent claims.
- The district court denied ACI's renewed motion for Judgment as a Matter of Law (JMOL) that the Fowler patents were invalid for obviousness.
- ACI, as appellant, appealed the district court's rulings on the safe harbor and obviousness to the U.S. Court of Appeals for the Federal Circuit.
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Issue:
Does the safe harbor provision of 35 U.S.C. § 121 protect a patent from invalidity for obviousness-type double patenting when the challenged patent and its reference patent claim inventions that do not maintain consonance with the restriction requirement imposed on an ancestor application?
Opinions:
Majority - Plager
No, the safe harbor provision of 35 U.S.C. § 121 does not protect the patent because consonance was not maintained. The consonance requirement demands that the line of demarcation from the original restriction be maintained in the challenged patent, the reference patent, and the original restricted patent. The court determined that both the device/method restriction and the election of species (because no generic claim was present) created lines of demarcation. While the Janzen patent itself may have maintained consonance with the grandparent patent, its sibling patent (the reference patent) did not. The sibling patent pursued a claim generic to all species in the method group, thereby overlapping with inventions designated for other lanes, breaking consonance and forfeiting the safe harbor's protection for the Janzen patent against the double patenting charge.
Concurring - Lourie
No, the patent is not protected by the safe harbor, but for a simpler reason. The analysis does not need to consider the election of species, which is a tentative and distinct practice from a restriction requirement. The Janzen patent is invalid because it fails the consonance requirement on its own terms. The original restriction required a division between device claims (Group I) and method claims (Group II). The Janzen patent blatantly violates this by containing claims to both devices and methods, making it the "opposite of consonant" and thus ineligible for § 121's safe harbor protection.
Analysis:
This case clarifies the stringent requirements for invoking the § 121 safe harbor against double patenting, emphasizing the doctrine of consonance. It establishes that all patents in a family—the challenged, the reference, and the originally restricted patent—must consistently adhere to the examiner's lines of demarcation. The majority's holding that an election of species can create a binding restriction in the absence of a generic claim adds a new layer of complexity for patent prosecutors. The decision serves as a significant warning that failure to maintain strict separation of non-elected inventions in subsequent applications can lead to the forfeiture of safe harbor protection and the invalidation of an otherwise valid patent.
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