Deciding the sole issue of proper construction for the term "dispensing," the U.S. Court of Appeals for the Federal Circuit overturned a decision of no infringement of a medical patent for an automated process. A panel majority found that the lower court’s construction requiring "direct dispensing" improperly imported a claim limitation from the specification. Ventana Medical Systems, Inc. v. BioGenex Laboratories, Inc., Case No. 06-1074 (Fed. Cir., Dec. 29, 2006) (Prost, J.; Lourie, J., dissenting).
Ventana’s U.S. Patent No. 6,352,861, directed to an automated dispensing system to perform a variety of biological assays, is one of seven patents that share a common specification. BioGenex manufactures and sells automated staining devices. Ventana filed suit against BioGenex alleging infringement, asserting several claims of the ’861 patent. Based on the claim context and the written description, the district court construed the term "dispensing" as "direct dispensing," meaning that "the reagent is dispensed directly from the reagent container" onto the slide, rather than utilizing an intermediate transport mechanism to transfer reagent from the reagent container to the slide. The district court also concluded that statements made during prosecution of an ancestor application amounted to a "clear and unmistakable" disclaimer of a particular type of indirect dispensing, referred to as "sip and spit" dispensing. Following the Markman ruling, Ventana stipulated that BioGenex did not infringe the ’861 patent under the district court’s claim construction, which it appealed.
In a stepwise analysis, the Federal Circuit first noted that the ’861 claims do not contain any language limiting the disputed term to direct dispensing and that BioGenex admitted that the word "onto" does not exclude indirect dispensing methods from the term’s ordinary meaning. The Court declined to interpret general statements in the application distinguishing "sip and spit" art as a complete surrender of indirect mechanisms because such logic could similarly be applied to statements distinguishing direct dispensing art. Narrowing the construction based on disclosed embodiments also was refuted as improper.
The Court further found that coverage of "sip and spit" methods was not disclaimed during prosecution of the ancestor patent because the two patents did not share the same claim language. The ancestor patent required the reagent container to be "dispensable directly to a sample," whereas the ’861 patent claims only required dispensing a reagent onto a slide. The Court found statements made to distinguish indirect dispensing methods in the ancestor patent to be irrelevant to the construction of "dispensing" in the disputed patent. Applying a similar rationale, the Court further rejected the argument of prosecution disclaimer arising from two later-issued patents within the lineage.
In a dissent that relied heavily on the intrinsic record, Judge Lourie concluded that the common specification shared by all seven patents and the prosecution history made clear that direct dispensing was "the essence of the invention" and that the specification lacked any suggestion of an alternative indirect mechanism.
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