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Transonic Systems, Inc. v. Fresenius USA

April 4, 2006


The opinion of the court was delivered by: Susan Illston United States District Judge


Now before the Court are the parties' cross-motions for summary judgment, which were submitted without oral argument pursuant to Civil Local Rule 7-1(b), and defendants' motion to strike what they claim is new evidence improperly submitted with plaintiff's reply. Having carefully considered the submitted papers, and for good cause shown, the Court hereby GRANTS defendants' motion for summary judgment and DENIES plaintiff's cross-motion. In addition, the Court DENIES defendants' motion to strike as being moot.


On November 7, 2003, plaintiff Transonic Systems, Inc. ("Transonic") sued defendants Fresenius USA, Inc. and Fresenius Medical Care Holdings, Inc. ("Fresenius") for infringement of two patents owned by Transonic, U.S. Patent Nos. 5,685,989 ("the '989 patent") and 6,514,419 B2 ("the '419 patent"). Transonic and Fresenius both develop and market technology related to kidney dialysis. Patients are prepared for dialysis by having a shunt surgically implanted, connecting an artery and a vein; blood flows naturally from the arterial or "upstream" end of the shunt to the venous or "downstream" end. See Krivitski Decl. ¶ 12. Dialysis works by drawing blood from the upstream (arterial) end of the shunt into one chamber of a two-chamber dialyzer. See id. at ¶¶ 13-15. An electrolyte solution called "dialysate" is pumped through the other dialyzer chamber. See id. A semi-permeable membrane separates the two chambers, allowing certain particles to diffuse through it in either direction. See id. Urea and other impurities that are present in the blood but not in the dialysate are thus drawn into the dialysate, which flows out of the dialysate chamber and is discarded. See id. at ¶ 16. The cleaned blood then flows back into the shunt downstream of the location from which it was drawn into the dialyzer. See id. at ¶ 13. A problem called "recirculation" can occur if the downstream portion of the shunt becomes clogged, as this causes already-cleaned blood to be drawn back into the dialyzer. See id. at ¶ 20. The Transonic patents and the method used by Fresenius each seek to calculate the rate of blood flow through the shunt to determine whether recirculation is reducing dialysis efficiency to an undesirable extent. See id. at ¶ 21; Ward Decl. ¶ 36.*fn1

I. Transonic's Patents

The '989 and '419 patents teach a method of ascertaining the rate of shunt blood flow through principles of indicator dilution. See '989 patent col. 1, ll. 50-65; '419 patent col. 1, l. 60 - col 2, l. 6. Specifically, Transonic's method requires the temporary reversal of the blood lines such that blood is drawn into the dialyzer chamber from the downstream end of the shunt and returned to the shunt at the upstream location, maximizing recirculation for the purpose of flow rate calculation. See '989 patent col. 2, ll. 1-34; '419 patent col. 2, ii. 6-40. An indicator, such as sodium, is then injected into the upstream line, from which it enters the shunt and mixes with the blood flowing through the shunt. See id. This mixed blood is then drawn up into the dialyzer chamber through the downstream line. See id.

The sodium concentration of the mixed blood in the downstream line is ascertained by measuring the sound velocity of the blood, and this value is then used in an indicator dilution equation that solves for the shunt blood flow rate. See id.

II. The Fresenius Method

Fresenius' method, for which it has obtained U.S. Patent No. 6,648,845 ("the '845 patent"), calculates shunt blood flow through measurements of dialysis efficiency called "dialysance." Ward Decl. ¶¶ 45-47. This is done by increasing the concentration of a particle contained in the inflow dialysate, typically sodium,*fn2 which then enters the chamber and interacts with the blood through the membrane until the sodium level in the dialysate reaches a steady state. See id. at ¶¶ 33, 40. Once steady state is reached, a single reading of inlet and outlet dialysate conductivity is taken. See id. at ¶ 40. The dialysate sodium concentration is then reduced, and the same reading is taken when sodium concentration again reaches steady state. See id. These two values are used to calculate dialysance. See id. The Fresenius method requires one dialysance measurement with the blood lines in their standard configuration and a second dialysance measurement with the blood lines reversed. See id. at ¶¶ 46-47. These two dialysance measurements can then be used to calculate shunt blood flow. See id. at ¶ 50.

Now before the Court are Fresenius' motion for summary judgment of noninfringement of the '989 and '419 patents and Transonic's cross-motion for summary judgment of infringement of the same patents, as well as Fresenius' motion to strike what it alleges is new evidence submitted with Transonic's reply brief.


"Summary judgment is appropriate in a patent case, as in other cases, when there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law." Nike Inc. v. Wolverine World Wide, Inc., 43 F.3d 644, 646 (Fed. Cir. 1994) (citations omitted). The moving party bears the initial burden of demonstrating the absence of a genuine issue of material fact. See Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986).

The burden then shifts to the non-moving party to "designate 'specific facts showing there is a genuine issue for trial.'" Id. at 324 (quoting Rule 56(e)). To carry this burden, the non-moving party must "do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986). "The mere existence of a scintilla of evidence . . . will be insufficient; there must be evidence on which the jury could reasonably find for the [non-moving party]." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252 (1986). Summary judgment is proper "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed. R. Civ. P. 56(c).

To establish infringement every limitation in a claim must be in the accused product, either exactly or by substantial equivalent. See Carroll Touch, Inc., v. Electro Mechanical Systems, 15 F.3d 1573, 1576 (Fed. Cir. 1993). A claim is literally infringed if the accused product is exactly the same as each element of the asserted claim. See Hi-Life Products, Inc. v. American National Water-Mattress Corp., 842 F.2d 323, 325 (Fed. Cir. 1986). Even if a product does not literally infringe it may infringe under the doctrine of equivalents. See Warner-Jenkinson Co. v. Hilton Davis Chemical Co., 520 U.S. 17, 21 (1997). "A claim element is equivalently present in an accused device if only 'insubstantial ...

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