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

729 F.3d 1369, 108 U.S.P.Q. 2d (BNA) 1285, 2013 WL 4826148, 2013 U.S. App. LEXIS 18834
CourtCourt of Appeals for the Federal Circuit
DecidedSeptember 11, 2013
Docket2012-1452
StatusPublished
Cited by4 cases

This text of 729 F.3d 1369 (St. Jude Medical, Inc. v. Access Closure, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
St. Jude Medical, Inc. v. Access Closure, Inc., 729 F.3d 1369, 108 U.S.P.Q. 2d (BNA) 1285, 2013 WL 4826148, 2013 U.S. App. LEXIS 18834 (Fed. Cir. 2013).

Opinions

Opinion for the court filed by Circuit Judge PLAGER.

Concurring opinion filed by Circuit Judge LOURIE.

PLAGER, Circuit Judge.

This is a patent case. Access Closure, Inc. (ACI), the defendant at trial, appeals from several rulings made by the United States District Court for the Western District of Arkansas in favor of St. Jude Medical, Inc. and St. Jude Medical Puerto Rico, LLC (collectively “St. Jude”), plaintiffs patentees. The rulings relate to three patents that St. Jude asserted against ACI: U.S. Patent No. 7,008,439 to Janzen et al. (the Janzen patent or '439 patent); and U.S. Patent No. 5,275,616 to Fowler (the '616 patent) and U.S. Patent No. 5,716,375 to Fowler (the '375 patent)—we refer to the '616 and '375 patents collectively as the “Fowler patents.”

ACI appeals three of the district court’s rulings: (1) that the safe-harbor provision of 35 U.S.C. § 121 protects the Janzen patent from invalidity due to double-patenting; (2) the construction of key terms in the Janzen patent; and (3) that ACI was not entitled to JMOL that the Fowler patents are invalid for obviousness. For the reasons that follow, we (1) reverse the district court’s safe harbor ruling regarding the Janzen patent; (2) in light of our safe harbor ruling, determine that the district court’s rulings regarding the claim constructions in the Janzen patent are moot; and (3) affirm the district court’s ruling that the Fowler patents are nonob-vious and not shown to be invalid.

I. Background

The patents in this appeal relate to methods and devices for sealing a ‘vascular puncture.’ A vascular puncture occurs when a medical procedure requires a medical professional to puncture through the skin and into a vein or artery to insert a medical device, such as a catheter, into a patient’s vasculature. After such a procedure concludes, the medical professional typically removes the medical device from the vasculature.

[1372]*1372Prior to the development of the technology at issue in this case, the medical professional was then required to apply external pressure to - the puncture site until clotting occurred. Due to a variety of factors, the medical professional often had to apply pressure to the puncture site for an extended period of time. This caused discomfort to the patient and increased the recovery time. The Janzen and Fowler patents disclose a variety of methods and devices for sealing a • vascular puncture with the objective of improving patient recovery.

A. The Janzen Patent

There are four patents of. importance in the Janzen family. The following chart illustrates the relationship between these patents.

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The Janzen patent discloses a medical device that inserts a plug into a vascular puncture to seal the puncture and prevent bleeding. Janzen patent, col.2 11.29-33. The disclosed device has a sheath and a piston or plug pusher that pushes a plug through the sheath and ejects it into the skin at the puncture site. Id. col.5 11.31-42. The plug may be composed of collagen or some other material that can be absorbed by the body. Id. col.2 11.22-24. Figure 10 of the Janzen patent, reproduced below, depicts a representative embodiment of the Janzen device.

[1373]*1373[[Image here]]

The Janzen patent has three claims at issue in this appeal, dependent claim 7, independent claim 8, and independent claim 9. Independent claim 8, which is generally representative, includes “an elongated member,” “[a] plug member ... disposed in said elongated member,” and “an ejecting mechanism for ejecting said plug member from [a] distal end of said elongated member so as to place said plug member in blocking relation with said puncture, so as to seal said puncture.” Id. col. 101.56-col. 111.2.

The Janzen patent is a descendant from U.S. Patent Application No. 07/746,339, filed on August 16, 1991 (the grandparent application). In response to the grandparent application, the examiner issued an Examiner’s Action that stated that the claims in the application included at least two patentably distinct inventions, one drawn to a device, the other drawn to a method, denominated here as Groups I and II:

[Group] I. Claims ... drawn to a device for use in sealing a puncture in a wall of a blood vessel.
[Group] II. Claims ... drawn to a method of sealing a puncture in a wall of a blood vessel.

J.A. 18,557. The Examiner’s Action required restriction of the application under 35 U.S.C. § 121 to one of the two inventions/groups. Id.

In addition to the deviee/method restriction, the examiner stated that the claims included patentably distinct Species A, B, and C (as described below), and the Examiner’s Action required that the applicant elect one of these Species in addition to electing Group I or Group II.1

Species A: Claims relating to the apparatus comprising a solid tissue dilator;
Species B: Claims relating to the apparatus comprising a hollow dilator and guidewire;
Species C: Claims relating to the apparatus comprising a guidewire and no dilator.

J.A. 18,558. The applicant responded to the restriction and elected Group I, Species B, that is, the application would now include only claims relating to a device/apparatus comprising a dilator and guide-wire. The grandparent application as thus restricted ultimately issued as U.S. Patent No. 5,391,183, the grandparent patent.

On October 5, 1994, the applicant filed U.S. Patent Application No. 08/318,380 [1374]*1374(the parent application) as a “divisional” of the grandparent application. During examination of the parent application, the examiner again imposed a restriction requirement and an election of species that were substantially identical to the restrictions imposed on the grandparent application. In response, the applicant again elected the same group and species, Group 1, Species B.2 The parent application ultimately issued as U.S. Patent No. 5,830,130, the parent patent.

Before the parent patent issued, the applicant filed U.S. Patent Application No. 08/399,585, the Janzen application, as a continuation of the parent application. However, in the Janzen application, the applicant canceled the original claims and copied both device and method claims from a different patent to provoke an interference proceeding. The Janzen application ultimately prevailed in the interference, and issued with both device and method claims as the '439 patent, i.e., the Janzen patent.

The applicant also pursued another continuation based on the parent application. This sibling to the Janzen application ultimately issued as U.S. Patent 5,725,498, the sibling patent or '498 patent. The sibling patent issued earlier than the Janzen patent due to the Janzen patent’s interference proceeding.

B. The Fowler Patents

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729 F.3d 1369, 108 U.S.P.Q. 2d (BNA) 1285, 2013 WL 4826148, 2013 U.S. App. LEXIS 18834, Counsel Stack Legal Research, https://law.counselstack.com/opinion/st-jude-medical-inc-v-access-closure-inc-cafc-2013.