## Facts

- St. Jude sued Access Closure, Inc. (ACI) in the Western District of Arkansas alleging infringement of vascular-closure patents covering methods and devices for sealing vascular punctures created during catheter procedures.
- The case involved U.S. Patent No. 7,008,439 (Janzen ’439) and U.S. Patent Nos. 5,275,616 and 5,716,375 (Fowler patents).
- A jury found infringement and awarded damages, but also found Janzen ’439 invalid for obviousness-type double patenting over a related “sibling” patent in the same family.
- The district court set aside the jury’s double-patenting invalidity finding, ruling that 35 U.S.C. § 121’s safe harbor barred use of the sibling patent as a reference against Janzen ’439.
- The district court also rejected ACI’s obviousness challenge to the Fowler patents and adopted claim constructions for Janzen ’439 favorable to St. Jude.
- ACI appealed: (i) the § 121 safe-harbor ruling, (ii) Janzen claim constructions, and (iii) denial of JMOL that the Fowler patents were obvious.

## Issues

1. Whether § 121’s safe harbor applied to protect Janzen ’439 from obviousness-type double patenting over a related patent when prosecution history included continuations and allegedly departed from the PTO restriction requirement’s claim groupings.
2. Whether the district court’s constructions of disputed terms in Janzen ’439 were erroneous.
3. Whether substantial evidence supported the jury’s finding that the Fowler patents were not obvious, such that the district court properly denied ACI’s JMOL motion.

## Decision

- Reversed the district court’s holding that § 121 safe harbor protected Janzen ’439.
- Held Janzen ’439 invalid for obviousness-type double patenting over the sibling patent because the statutory requirements for § 121 protection were not met.
- Declined to reach ACI’s claim-construction challenges to Janzen ’439 as moot in light of invalidity.
- Affirmed the denial of JMOL and upheld the Fowler patents against ACI’s obviousness challenge based on substantial evidence supporting the jury’s verdict.

## Legal Principles

- § 121 safe harbor is limited to patents issuing from divisional applications filed in response to a PTO restriction requirement and is applied according to the statute’s strict terms.
- To receive § 121 protection, the patent’s claims must maintain “consonance” with the original restriction requirement; departing from the restricted groupings defeats the safe harbor.
- Breaking the divisional chain (including by inserting continuation filings that disrupt the required lineage) can render § 121 inapplicable.
- Obviousness is a question of law based on underlying fact findings; on appeal from a jury verdict, the court sustains the verdict if supported by substantial evidence and does not reweigh competing expert testimony.

## Conclusion

The Federal Circuit held that § 121 did not shield Janzen ’439 from obviousness-type double patenting because the required divisional lineage and consonance with the restriction requirement were not preserved, rendering the patent invalid; it treated claim-construction disputes as moot and separately affirmed the jury-supported finding that the Fowler patents were not obvious.


St. Jude Med., Inc. v. Access Closure, Inc., 729 F.3d 1369 (Fed. Cir. 2013)