Opinion ID: 208066
Heading Depth: 3
Heading Rank: 3

Heading: Claims 26–31 of the ’434 Patent

Text: Claims 26–31 contain means-plus-function limitations, and all require a “means for delivering the dialysate to a dialysate compartment of a hemodialyzer.” ’434 Patent col.40 ll.33–35. The district court granted Baxter’s motion for JMOL of no invalidity based in part on its conclusion that Fresenius failed to prove that the means for delivering dialysate limitation was present in the prior art. We agree, though for somewhat different reasons than those articulated by the district court. Namely, Fresenius failed to present any evidence—let alone substantial evidence—that the structure corresponding to the means for delivering dialysate limitation, or an equivalent thereof, existed in the prior art. It is firmly established in our precedent that a structural analysis is required when means-plus-function limitations are at issue; a functional analysis alone will not suffice. 2008-1306, -1331 16 See, e.g., CytoLogix Corp. v. Ventana Med. Sys., 424 F.3d 1168, 1178 (Fed. Cir. 2005) (“To establish infringement under § 112, ¶ 6, it is insufficient for the patent holder to present testimony ‘based only on a functional, not a structural, analysis.’” (quoting Alpex Computer Corp. v. Nintendo Co., 102 F.3d 1214, 1222 (Fed. Cir. 1996))). Just as a patentee who seeks to prove infringement must provide a structural analysis by demonstrating that the accused device has the identified corresponding structure or an equivalent structure, a challenger who seeks to demonstrate that a means-plus-function limitation was present in the prior art must prove that the corresponding structure—or an equivalent—was present in the prior art. See In re Donaldson Co., 16 F.3d 1189, 1193 (Fed. Cir. 1994) (en banc) (“[W]e hold that paragraph six applies regardless of the context in which the interpretation of means-plus-function language arises, i.e., whether as part of a patentability determination in the PTO or as part of a validity or infringement determination in a court.”); see also McGinley v. Franklin Sports, Inc., 262 F.3d 1339, 1361 (Fed. Cir. 2001) (Michel, J., dissenting) (“Of course, in the context of a meansplus-function claim, the invalidating prior art must disclose not simply a means for achieving the desired function, but rather the particular structure recited in the written description corresponding to that function, or an equivalent thereof.”). Here, Fresenius neither identified the structure in the specification that corresponds to the means for delivering dialysate nor compared it to the structures present in the prior art. See CytoLogix, 424 F.3d at 1178 (“Here, CytoLogix failed to identify the structure in the specification that is the ‘temperature controller means’ and compare it to the structure of the accused device. Accordingly, because CytoLogix failed to present substantial evidence of infringement of claim 13 of the ’693 patent, the 2008-1306, -1331 17 jury verdict of infringement of claim 13 must be reversed.”). At most, the evidence of record supports a finding that some structures that could perform the claimed function existed in the prior art. Under our precedent, it is clear that such a finding is insufficient. Thus, as in CytoLogix, the jury’s verdict as to claims 26–31 cannot stand. We note also that there is an additional reason for affirming the district court’s grant of JMOL regarding dependent claim 30, which requires a “means for delivering an anticoagulant to a patient.” The district court instructed the jury that the corresponding structure is a microprocessor and stepper motor. Fresenius USA, Inc. v. Baxter Int’l, Inc., No. 03-1431, at 21 (N.D. Cal. July 5, 2006) (Dkt. No. 825) (“Jury Instructions”). Because Fresenius failed to present any evidence that the required stepper motor structure existed in the prior art, the district court correctly granted JMOL. Fresenius has cited no testimony wherein any witness discussed a “stepper motor.” Fresenius contends that the Cobe C3 manual, which was submitted to the jury, discloses the necessary structure, but notably, Fresenius has cited no manual pages that reference a “stepper motor.” After independently reviewing the record, this court notes that the CMS 08 manual briefly mentions a “stepper motor” but does not discuss that structure in the context of the claimed function—delivering an anticoagulant. Moreover, even if the CMS 08 manual disclosed a stepper motor for delivering an anticoagulant, it was Fresenius’s burden to clearly disclose, discuss, and identify for the jury the supporting evidence upon which it was relying to prove that the claim limitation was present in the prior art. See Koito, 381 F.3d at 1151 (holding that a challenger failed to meet its burden of proving a prior art reference anticipated the patent claims when it “failed to provide any testimony or other evidence that would demonstrate to the jury how that 2008-1306, -1331 18 reference met the limitations of the claims”). Here, as with the means for delivering dialysate limitation discussed above, the evidentiary burden of proof cannot be carried without clearly identifying the corresponding structure in the prior art. Thus, substantial evidence does not support the jury’s implicit finding that the prior art contained a stepper motor means for delivering an anticoagulant, and the district court correctly granted JMOL. For the foregoing reasons, we affirm the district court’s grant of JMOL as to claims 26–31 of the ’434 patent.