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In Re Baxter International

May 17, 2012

IN RE BAXTER INTERNATIONAL, INC.


Appeal from the United States Patent and Trademark Office, Board of Patent Appeals and Interferences in Reexamination No. 90/007,751.

The opinion of the court was delivered by: Lourie, Circuit Judge.

(Reexamination No. 90/007,751)

Before NEWMAN, LOURIE, and MOORE, Circuit Judges.

Opinion for the court filed by Circuit Judge LOURIE.

Dissenting opinion filed by Circuit Judge NEWMAN.

Baxter International Inc. ("Baxter") appeals from the decision of the Board of Patent Appeals and Interferences ("the Board") affirming the examiner's rejections of claims 26--31 of U.S. Patent 5,247,434 ("the '434 patent") for obviousness under 35 U.S.C. § 103(a). See Ex parte Baxter Int'l, Inc., No. 2009-006493, 2010 WL 1048980 (B.P.A.I. Mar. 18, 2010) ("Board Decision"); Ex parte Baxter Int'l, Inc., No. 2009-006493, 2010 WL 3032865 (B.P.A.I. July 20, 2010) ("Board Rehearing Decision"). Because the Board did not err in determining that those claims would have been obvious to one of ordinary skill in the art, we affirm.

BACKGROUND

I.

This patent appeal relates to hemodialysis machines that can function in place of a patient's kidney to cleanse the blood of toxins using a solution called a dialysate. During hemodialysis, the patient's blood is pumped though the hemodialysis machine and the dialysate acts to absorb the toxins. To ensure that the process does not filter essential nutrients from the blood, a hemodialysis machine must facilitate the monitoring and control of a number of parameters.

Baxter owns the '434 patent, entitled "Method and Apparatus for Kidney Dialysis," which discloses and claims a hemodialysis machine integrated with a touch screen user interface that allows an operator to monitor and control a number of parameters. Figure 8 of the patent, reproduced below, depicts an exemplary touch screen interface:

As depicted above, the interface allows an operator to monitor and control a number of treatment parameters, such as the dialysate temperature, and the patent details the computer system that interfaces with the touch screen to control the delivery of the dialysate and other liquids. Claim 26 of the patent, reproduced below, recites the elements of the integrated hemodialysis machine:

26. A hemodialysis machine comprising:

(a) means for controlling a dialysate parameter selected from a group consisting of dialysate temperature and dialysate concentration, and means for delivering the dialysate to a dialysate compartment of a hemodialyzer; and

(b) a user/machine interface operably coupled to said dialysate-delivery means, the user/machine interface comprising a touch screen adapted to display an indicium corresponding to a parameter pertinent to operation of the hemodialysis machine for performing hemodialysis and to permit the user, by touching the indicium, to cause a change in the parameter.

'434 patent, col.40 ll.29--43 (emphases added). Dependent claim 30 includes an additional means plus function limitation, reciting that the hemodialysis machine further comprises a "means for delivering an anticoagulant to a patient." Id. col.40 ll.60--64. Finally, dependent claims 27, 30, and 31 recite that the touch screen provide "indicium soliciting" specific information from the machine's user: "programmed settings of a time-varying machine-operating parameter" (claim 27); "input from the user corresponding to a rate of anticoagulant delivery" (claim 30); or "a programmed setting of an alarm limit about the machine-operating parameter" (claim 31). Id. col.40 ll.44-- 47, 60--68.

II.

The '434 patent has been subject to litigation. In 2003, one of Baxter's competitors, Fresenius, filed a declaratory judgment action in the United States District Court for the Northern District of California, seeking, among other claims, a declaration that the patent's claims were invalid. Fresenius Med. Care Holdings, Inc. v. Baxter Int'l, Inc., No. C 03-1431 SBA, 2007 WL 518804, at *1 (N.D. Cal. Feb. 13, 2007). The parties tried Fresenius's invalidity claims to a jury, which found that Fresenius had proved by clear and convincing evidence that claims 26--31 of the patent would have been obvious at the time the invention was made. Id. at *2. After trial, Baxter moved for judgment as a matter of law, and the district court granted Baxter's motion. Id. at *2, *8--9. In particular, the district court concluded that Fresenius failed as a matter of law to show by clear and convincing evidence that Fresenius's proffered prior art, viz., the CMS 08 Manual, the Cobe C3 Manual, or the Seratron System, contained the "means for controlling" and "means for delivering" limitations of claim 26. Id. at *8.

Upon the entry of a final judgment, Fresenius appealed. We affirmed the district court's grant of judgment as a matter of law, but for "somewhat different reasons than those articulated by the district court." Fresenius USA, Inc. v. Baxter Int'l, Inc., 582 F.3d 1288, 1299 (Fed. Cir. 2009). We concluded that "Fresenius failed to present any evidence-let alone substantial evidence-that the structure corresponding to the means for delivering dialysate limitation [in claim 26], or an equivalent thereof, existed in the prior art." Id. In particular, Fresenius failed to identify "the structure in the specification that corresponds to the means for delivering dialysate" and further failed to compare the identified structure to those structures present in the prior art. Id. at 1300. We thus held that the district court correctly granted Baxter's motion for judgment as a matter of law. Id.

III.

In 2006, in parallel with the Fresenius litigation, the United States Patent & Trademark Office ("PTO") began to re-examine the '434 patent, stimulated by Fresenius. In the course of those proceedings, the examiner found that a number of references rendered obvious claims 26--31 of the patent, including, among other references, the CMS 08 Manual, the Sarns 9000 Manual, U.S. Patent 4,370,983 ("Lichtenstein"), and U.S. Patent 4,710,166 ("Thompson"). Specifically, with regard to claims 26--29 and 31, the examiner concluded that those claims would have been obvious in light of the combined teachings of the CMS 08 Manual, Lichtenstein, the Sarns 9000 Manual, and two other references not at issue on appeal. Board Decision, 2010 WL 1048980, at *4. Regarding claim 30, the examiner concluded that it would not have been patentable over a combination of the same references in view of Thompson. Id.

Baxter appealed the examiner's final rejections to the Board. After briefing and oral argument before the Board but prior to issuance of the Board's decision, we decided the Fresenius case. Shortly thereafter, Baxter petitioned the Director of the PTO to remand the reexamination to the examiner to consider the rejections in light of our Fresenius decision. The Director denied the petition but ordered the Board to consider our decision in Fresenius.

The Board affirmed the examiner's rejections of claims 26--31. Regarding our Fresenius decision, the Board discussed the holding of the case and concluded that "[a]lthough claims 26--31 were not proven invalid in court, a lower standard of proof and the broadest reasonable interpretation standard of claim construction apply at the PTO and therefore the agency is not bound by the court's determination." Board Decision, 2010 WL 1048980, at *12 (citing Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1429 (Fed. Cir. 1988); In re Swanson, 540 F.3d 1368, 1377 (Fed. Cir. 2008)).

Turning to the merits of the examiner's rejections, the Board found that the CMS 08 Manual describes the "control of Na, K, and HCO3 flow rates using a control unit that may be programmed in ten minute intervals

(i.e., a microprocessor) and a pump driven by a stepper motor," a disclosure that met the corresponding structure in the specification identified by Baxter and the examiner for the "means for controlling" limitation. Board Decision, 2010 WL 1048980, at *14. The Board also found that Baxter "did not assert that Lichtenstein lacks any structure corresponding to element (a) of claim 26" and thus declined to address the rejections based on Lichtenstein. Id.

The Board also affirmed the examiner's findings regarding the "soliciting" limitations in claims 27, 30, and 31. With respect to claim 27, the Board found that the CMS 08 Manual disclosed that a user can adjust or control time-dependent hemodialysis parameters such as the ultrafiltrate rate and the concentration of substances in the dialysate. Board Decision, 2010 WL 1048980, at *14. Regarding claim 30, the Board found that Thompson in combination with the CMS 08 Manual or the Sarns 9000 Manual rendered obvious the "indicium soliciting input from the user corresponding to a rate of anticoagulant delivery" limitation. Id. at *9--10, *15. Finally, the Board found that the Sarns 9000 Manual described the "indicium soliciting, from the user, a programmed setting of an alarm limit about the machine-operating parameter" limitation in claim 31. Id.

Following the Board decision, Baxter requested re-hearing, which the Board denied. Board Rehearing Decision, 2010 WL 3032865, at *1. In particular, the Board rejected Baxter's argument that the Board had erroneously equated "soliciting" with "control" or "adjust," reiterating that the CMS 08 Manual disclosed that "the machine interface solicits ...


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