BPAI Informative Opinion Underscores Different Validity Standards for Reexams

Ex Parte Baxter International, Inc., No. 2009-006493 (18 March 2010) (informative opinion)

Baxter and Fresenius engaged in a hard-fought battle over patents relating to hemodialysis machines with touch screen user/machine interfaces.  During litigation, Fresenius submitted Baxter's patents to the USPTO for reexamination.  In the meantime, the jury returned a verdict finding the patents invalid for obviousness.  On motion for JMOL, the trial judge overturned the jury's finding of obviousness.  Fresenius appealed.

The Federal Circuit then overturned the trial judge one one patent, finding that substantial evidence supported the jury's finding of obviousness.  On another patent, the Federal Circuit The court found that Fresenius failed to prove invalidity by clear and convincing evidence and "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 . . . [and] failed to present any evidence that the required stepper motor structure existed in the prior art.”

While this was going on, the USPTO rejected the remaining patent as obvious over multiple prior art references.  Baxter appealed to the BPAI.

On appeal, the BPAI emphasized that the Office is free to reach its own conclusions from the evidentiary record, notwithstanding the findings from the courts:

Although [the claims at issue] 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. Ethicon v. Quigg, 849 F.2d 1422, 1429 (Fed.Cir. 1988) (“[T]he Board and the courts take different approaches in determining invalidity and on the same evidence could quite correctly come to different conclusions.”); In re Swanson, 540 F.3d 1368, 1377 (Fed. Cir.2008) (explaining the different standards of proof and claim construction used in reexamination relative to civil litigation in district court).

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[H]ere, Appellant has urged in the present appeal that we should defer to the district court’s ruling because “[a]part from the Thompson reference, the evidence here is the same as that examined by the District Court” . . . Because Appellant has repeatedly relied on the district court proceeding in support of nonobviousness, we discern no unfairness in subjecting Appellant to any adverse consequence that may arise from such reliance in the current reexamination, which is conducted under the preponderance of the evidence standard – a standard that is substantially lower than the clear and convincing standard used in district court.

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On this record, we conclude that there is no error in the Examiner’s factual findings and conclusions that a person of ordinary skill in the art would have been prompted to couple a touch screen user/machine interface with a hemodialysis machine in view of the collective teachings of the prior art references

Read/download the opinion here (link)