Grayzel v. St. Jude Med., Inc., 122305 FEDFED, 05-1126

Docket Nº:05-1126
Party Name:Joseph Grayzel, Plaintiff-Appellant, v. St. Jude Medical, Inc., St. Jude Medical, Daig Division, Inc., and St. Jude Medical S.C., Inc., Defendants-Appellees.
Case Date:December 23, 2005
Court:United States Courts of Appeals, Court of Appeals for the Federal Circuit

Joseph Grayzel, Plaintiff-Appellant,


St. Jude Medical, Inc., St. Jude Medical, Daig Division, Inc., and St. Jude Medical S.C., Inc., Defendants-Appellees.

No. 05-1126

United States Court of Appeals, Federal Circuit

December 23, 2005

Before MICHEL,Chief Judge, SCHALL and GAJARSA, Circuit Judges.

MICHEL, Chief Judge.

Dr. Joseph Grayzel ("Grayzel") appeals the United States District Court for the District of New Jersey's grant of summary judgment of invalidity of claims 13, 14, and 16 of U.S. Patent No. 4,850,960 ("the '960 patent") in favor of St. Jude Medical, Inc., St. Jude Medical S.C., Inc., and St. Jude Medical, Daig Division, Inc. (collectively, "St. Jude"). Grayzel v. St. Jude Med., Inc., No. 01-CV-3737 (D.N.J. Oct. 29, 2004) (" Summary Judgment Decision "). Grayzel also appeals the district court's grant of an injunction to enforce a protective order entered into by the parties during the course of discovery. Because we agree with the district court's construction of the "sheath," "flexible," and "uniformly-thin" claim limitations and its finding that the prior art anticipates each and every limitation of claim 13 of the '960 patent, we affirm the summary judgment of invalidity. We further hold that the district court's grant of an injunction enforcing the protective order is moot as to claims 13, 14, and 16 and affirm as to claims 1-12, 15, and 17-26.


A. The Asserted Patent

In 1953, Dr. Sven Seldinger developed a new percutaneous technique for introducing a catheter into a patient's blood vessel. See Sven Seldinger, "Catheter Replacement of the Needle in Percutaneous Arteriography: A New Technique," Acta Radiologica 39: 368-76 (1953). His technique, which became known as the "Seldinger technique," involved: (1) inserting a hollow needle through the skin; (2) puncturing the blood vessel with the needle; (3) inserting a guidewire through the bore of the needle into the vessel; (4) removing the needle, leaving the guidewire in the vessel; (5) advancing a catheter over the guidewire into the vessel; and (6) removing the guidewire, leaving the catheter in the vessel through which a cardiologist may insert diagnostic and therapeutic devices. Prior to the "Seldinger technique," a doctor cut an incision in the skin and artery and then inserted the desired catheter.

In 1965, Drs. Donald Desilets and Richard Hoffman improved the Seldinger technique. See Donald T. Desilets & Richard Hoffman, "A New Method of Percutaneous Catheterization," Radiology 85: 147-48 (1965). They introduced a thin-walled, flexible sheath on top of the catheter and inserted that unit into the vessel as described above. The catheter was, however, removed along with the guidewire, leaving only the sheath in the vessel to act as a channel through which multiple devices could be inserted and removed without having to pass each new device over a reinserted guidewire. This technique became known as the "modified Seldinger technique." Notably, because both the catheter and the sheath contained blunt or flat tips, considerable force was needed to insert the sheath-covered catheter into the vessel. That force often caused tearing and trauma at the puncture site.

In July of 1987, Grayzel filed a patent application claiming an improvement to the modified Seldinger technique. Specifically, he disclosed using a beveled tip at the end of the sheath, as shown in the figure below, to reduce the force needed to insert the sheath-covered catheter and to avoid traumatizing the insertion site. See '960 patent, col. 2, ll. 43-58.

'960 patent, fig. 9. The beveled tip is indicated by the number 15 with the leading point shown as number 4 and rearmost point shown as number 3. The catheter is designed number 6 with the distal portion shown as number 5 and cylindrical section leading to the beveled tip shown as number 9.

This application issued as the '960 patent in July of 1989. Independent claim 13 recites:


[1] A sheath of a size for use in the vascular system for assisting in the insertion of other devices in blood vessels through the wall of the blood vessel, said sheath comprising:

[2] a flexible catheter for use in the vascular system;

[3] said sheath having a flexible uniformly thin walled cylindrical shell body portion having a bore therethrough and a distal end and a proximal end, said bore constructed to coact with and be supported by said flexible catheter extending within the bore;

[4] a bevelled tip portion formed on the distal end of said sheath, said bevelled tip being formed at an acute angle with respect to the longitudinal axis of said tubular portion, to facilitate entry into an existing puncture in the wall of a blood vessel.

'960 patent, col. 11, ll. 61-68 (emphases added) (underlined text shows disputed limitations; bracketed numbers reflect district court's designation of claim limitations).

B. The Prior Art

Two years before Grayzel filed his application, Dr. S. Murthy Tadavarthy and others published an article describing a percutaneous technique for introducing a filter into the inferior vena cava to snare blood clots ("Tadavarthy Article"). See S. Murthy Tadavarthy, "Kimray-Greenfield Inferior vena cava Filter: Percutaneous Introduction," Radiology 151: 525-26 (May 1984). The article disclosed a blood vessel dilation system having four parts: (1) a guidewire; (2) an 8 French dilator; (3) a 24 French dilator; and (4) a 24 French Teflon tube that fits over the 24 French dilator.1 The article explained that after the two dilators and tube are inserted percutaneously into a patient's inferior vena cava by way of the guidewire, the dilators are removed, leaving the tube in position. It further explained that a Kimray-Greenfield filter may be placed into a patient's inferior vena cava through the tube to catch loose blood clots.

C. The District Court Decision

In August of 2001, Grayzel filed a patent infringement action against St. Jude, alleging that St. Jude's Angio-Seal vascular closure device infringes independent claim 13 and dependent claims 14 and 16 of the '960 patent.2

During the course of discovery, St. Jude identified numerous prior art references that were not disclosed during the prosecution of the '960 patent. Grayzel in turn filed a request for an ex parte reexamination with the U.S. Patent and Trademark Office ("PTO") for claims 13, 14, and 16, and moved to stay the district court action pending reexamination. The PTO granted Grayzel's request for reexamination not just for claims 13, 14, and 16 as requested, but also for claims 1-12, 15, and 17-26. The district court denied Grayzel's motion to stay the litigation.

In response, St. Jude filed a motion for an injunction to enforce the protective order entered by the district court at the start of the litigation to bar both Grayzel and his litigation counsel from participating in the ex parte reexamination. That protective order identified two classes of information: (1) "Confidential Information;" and (2) "Attorneys' Eyes Only Information." Under the terms of the order, Grayzel had access to the Confidential Information, but not the Attorneys' Eyes Only Information. His use of Confidential Information was, however, restricted such that he could not use it "for any purpose other than in connection with [the] litigation." The protective order also contained a so-called "prosecution bar" provision, which prohibited any person "who ha[d] come into the possession of Attorney's [sic] Eyes Only Information" from "any involvement in the prosecution of" the '960 patent. That same provision likewise specifically stated: "Joseph Grayzel understands the terms of this Protective Order limiting the use of CONFIDENTIAL INFORMATION and ATTORNEY'S [sic] EYES ONLY INFORMATION only for purposes in connection with this litigation and that no patent application can be filed or prosecuted at any time based on CONFIDENTIAL INFORMATION or ATTORNEY'S [sic] EYES ONLY INFORMATION produced by St. Jude or Daig in this litigation." The district court referred the injunction motion to a magistrate judge for resolution.

Following briefing and a two-day hearing, the magistrate judge recommended barring Grayzel and his counsel from participating in the ex parte reexamination. The magistrate judge reasoned that the "entire tenor of the protective order was to protect information within the four corners of this litigation and not to allow discovery that is confidential to be used for outside purposes." The district court adopted the magistrate judge's recommendation and granted St. Jude's motion for an injunction to enforce the protective order. Grayzel v. St. Jude Med., Inc., No. 01-CV-3737 (D.N.J. Dec. 4, 2003).

In March of 2003, St. Jude filed a motion for summary judgment of invalidity due to anticipation under 35 U.S.C. § 102 and obviousness under 35 U.S.C. § 103. The district court issued its claim construction and granted summary judgment in favor of St. Jude in October of 2004. It held that...

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