149 F.3d 1321 (Fed. Cir. 1998), 96-1329, Baxter Intern., Inc. v. McGaw, Inc.

Docket Nº:96-1329, 96-1342, 97-1331 and 97-1350.
Citation:149 F.3d 1321
Party Name:47 U.S.P.Q.2d 1225 BAXTER INTERNATIONAL, INC., and Baxter Healthcare Corporation, Plaintiffs-Appellants, v. McGAW, INC., Defendant-Cross Appellant.
Case Date:June 30, 1998
Court:United States Courts of Appeals, Court of Appeals for the Federal Circuit

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149 F.3d 1321 (Fed. Cir. 1998)

47 U.S.P.Q.2d 1225

BAXTER INTERNATIONAL, INC., and Baxter Healthcare

Corporation, Plaintiffs-Appellants,


McGAW, INC., Defendant-Cross Appellant.

Nos. 96-1329, 96-1342, 97-1331 and 97-1350.

United States Court of Appeals, Federal Circuit

June 30, 1998

Rehearing Denied; Suggestion for Rehearing In Banc Declined

Aug. 31, 1998.

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[Copyrighted Material Omitted]

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[Copyrighted Material Omitted]

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James F. Davis, Howrey & Simon, Washington, DC, argued for plaintiffs-appellants. With him on the brief were Jerrold J. Ganzfried, Richard H. Kjeldgaard, and Thomas M. Dunham. Also on the brief were Timothy J. Malloy, Gregory J. Volger, and Sharon A. Hwang, McAndrews, Held & Malloy, Ltd., Chicago, Illinois. Of counsel on the brief was Mark J. Buonaiuto, Baxter International, Inc., of Deerfield, Illinois. Of counsel was Stephen F. Sherry, McAndrews, Held & Malloy, Ltd.

Roderick G. Dorman, and William J. O'Brien, Christie, Parker & Hale, LLP, Pasadena, California, argued for defendant-cross appellant. With them on the brief was Yar R. Chaikovsky. Also on the brief was Marvin A. Miller, Miller Faucher Chertow Cafferty and Wexler, Chicago, Illinois. Of counsel was John D. Carpenter, Christie, Parker & Hale, LLP.

Before PLAGER, RADER, and GAJARSA, Circuit Judges.

GAJARSA, Circuit Judge.


Baxter International, Inc. and Baxter Healthcare Corporation (collectively Baxter), appeal the judgment of the U.S. District Court for the Northern District of Illinois that U.S. Patent No. 5,171,234 (the '234 patent), U.S. Patent No. 5,167,648 (the '648 patent) and U.S. Patent No. 5,158,554 (the '554 patent) assigned to Baxter are unenforceable due to inequitable conduct for failure to cite material prior art to the U.S. Patent and Trademark Office (PTO). We affirm the district court's decision with respect to the '648 and '234 patents but reverse the district court's holding that the '554 patent is similarly unenforceable. Baxter also appeals the district court's construction of claim 16 of the '648 patent and claim 3 of the '554 patent which Baxter alleges led to an improper validity and infringement analysis by the jury. Finally, Baxter argues that the district court erred in refusing to grant it a new trial based upon what Baxter deems an unreasonable delay between the close of trial and submission of the case to the jury. We affirm the district court's denial of Baxter's request for a new trial.

McGaw, Inc. (McGaw) cross-appeals the district court's decision and alleges that the applications from which the '554, '234, and '648 patents issued failed to satisfy the requirements of 35 U.S.C. § 120 1 and that those patents are therefore invalid under 35 U.S.C. § 102(b) as anticipated by prior art. McGaw cross-appeals the district court's denial of its motion for judgment as a matter of law (JMOL) based upon the alleged invalidity of the '234, '554, and '648 patents. We reverse the district court's failure to enter JMOL in favor of McGaw with respect to the '554 patent based upon that patent's anticipation under 35 U.S.C. § 102(b). Because we affirm the district court's decision that the '234 and '648 patents are unenforceable due to inequitable conduct, we do not address their validity.


The present case involves three patents directed to an improved method for administering

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intravenous fluids and medications. Conventionally, when a hospital patient requires intravenous (IV) fluids, a catheter is inserted into the patient's vein through the skin. An IV administration set is then used to connect an IV fluid source to the catheter. The administration set includes access ports called injection sites through which medicine or other necessary fluids can be added to the IV fluid source as it passes to the catheter.

Conventional injection sites typically include a solid rubber septum that is pierced by a sharp steel needle in order to introduce fluids and medication into the IV system. A typical injection site 16 and its relationship to the entire IV system is depicted below:


Although using sharp needles to pierce the rubber septum is desirable in administering medications in an IV system, it also presents a dangerous risk of accidental pricks from contaminated needles, causing a significant health risk to hospital personnel. Attempts to use blunt instruments to insert medication into the IV system have in the past resulted in unacceptable leakage problems.

In 1986, Baxter engineers, Dr. Thomas Dudar and Mr. Steven Jepson, were involved in a project ("the Volts project") which attempted to solve the problems of leakage and coring of a solid rubber septum when punctured multiple times by large needles. During the course of this project, Dudar and Jepson experimented with an injection site made by Borla S.p.A., an Italian manufacturer of rubber septa and other medical products. The district court found that the Borla injection site model PF0084 ("the Borla Device") used a solid rubber septum which was placed under radial pressure and was designed to be pierced with a sharp needle. The radial pressure increased resealability and reduced leakage. The district court found that the Borla Device also included annular channels which received the displaced septum when a large needle punctured the rubber septum and reduced tearing upon insertion of the needle. The district court also found that the Borla Device used a supportive annular lip underlying the septum. Finally, the district court found that the Borla Device included a deformation of the injection site housing which caused axial forces to act upon the septum and resulted in an outwardly curved septum surface. Each of these features was claimed in differing forms in the '648 and '234 patents.

During the course of the Volts project, Dudar and Jepson developed an injection site that included an annular channel and a septum under radial compression as in the Borla Device, but with the added feature that the septum was partially slit. The pre-slit septum was designed to be pierced by a blunt cannula instead of a sharp needle. The resulting system not only solved the problems of leakage due to multiple punctures and coring, but also eliminated the sharp needle from the injection system. Baxter commercially developed this invention and incorporated it into its InterLink injection system. On January 25, 1988, Baxter filed patent application number 07/147,414 (the '414 application) on this invention in the PTO.

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Baxter's '414 application was originally filed containing claims numbered 1-59. On July 5, 1988, Baxter filed a preliminary amendment canceling claims 1-59 and adding new claims 60-120. The PTO entered this amendment and on January 13, 1989, the PTO issued a restriction requirement pursuant to 35 U.S.C. § 121. The January 13, 1989, Office Action stated that there were a total of four separate inventions defined by the '414 application. Claims 60-87 and 101-08 were drawn to an injection site and method of manufacturing; claims 110-17 were drawn to a cannula; claims 95-99 and 118-20 were drawn to a combination of an injection site and cannula; and claims 100 and 109 were drawn to a method of transferring liquids. In a response dated April 9, 1989, Baxter amended claims 95 and 96, cancelled claims 118-20 and added new claims 121-24. The examiner issued a final rejection of this application on December 14, 1989. On June 11, 1990, Baxter mailed a request under 37 C.F.R. § 1.60 to file the divisional application that resulted in the issuance of the '648 patent. In the filing, Baxter simultaneously requested that claims 1-59, 95-100, and 109-24 be formally cancelled from the application. However, the filing only included a copy of the original application with claims 1-59. The PTO assigned this application the number 07/535,935 (the '935 application). On June 26, 1990, the PTO Application Branch mailed Baxter a Notice of Incomplete Application which indicated that the divisional application could not be assigned a filing date because claims 60-124 were missing from the application. The notice indicated that the '935 application's filing date would be the date the PTO received these claims. The '414 application became abandoned by operation of law on June 14, 1990. On July 16, 1990, Baxter submitted the claims 60-124 that had been omitted from the divisional application. The PTO then gave notice of abandonment of the '414 application on July 17, 1990 and assigned the '935 application a filing date of July 16, 1990. Upon Baxter's petition to correct the filing date, the PTO changed the effective filing date of the '935 application to June 11, 1990. The '935 application ultimately issued on December 1, 1992 as the '648 patent.

On June 12, 1990, Baxter mailed the divisional applications that resulted in the '554 and '234 patents. These applications were assigned application numbers 07/537,395 (the '395 application) and 07/536,823 (the '823 application), respectively. Similar to the '935 application, the '395 and the '823 applications also lacked claims 60-124 and requested cancellation of, among others, claims 1-59, the only claims mailed with the applications. On December 17, 1990, the PTO notified Baxter that all claims in both of these applications had been cancelled. On January 4, 1991, Baxter mailed copies of claims 60-124 for inclusion in both applications. The '395 and '823 applications were ultimately issued as the '554 and '234 patents, respectively.

In addition to the United States applications, Baxter filed an International Patent Application under the Patent Cooperation Treaty (PCT) on January 23, 1989. The application was...

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