Ventana Medical Systems v. Biogenex Laboratories
| Decision Date | 29 December 2006 |
| Docket Number | No. 06-1074.,06-1074. |
| Citation | 473 F.3d 1173 |
| Parties | VENTANA MEDICAL SYSTEMS, INC., Plaintiff-Appellant, v. BIOGENEX LABORATORIES, INC., Defendant-Appellee. |
| Court | U.S. Court of Appeals — Federal Circuit |
Ron E. Shulman, Wilson Sonsini Goodrich & Rosati, of Palo Alto, CA, argued for plaintiff-appellant. With him on the brief were Roger J. Chin, and Nicole W. Stafford, of Austin, TX.
Peter B. Goldman, Leonard Felker Altfeld Greenberg & Battaile, P.C., of Tucson, AZ, argued for defendant-appellee. With him on the brief were Jeffrey H. Greenberg and Lorenzo B. Cellini.
Before LOURIE, DYK, and PROST, Circuit Judges.
Plaintiff-Appellant, Ventana Medical Systems, Inc. ("Ventana") appeals the decision of the United States District Court for the District of Arizona granting judgment of noninfringement of U.S. Patent No. 6,352,861 (the "'861 patent") in favor of Defendant-Appellee, BioGenex Laboratories, Inc. ("BioGenex"). Because the district court erred in its claim construction, we vacate the judgment of noninfringement and remand for further proceedings.
Ventana is the owner of several patents relating to automated methods and apparatuses for staining microscope slides. Such methods and apparatuses may be used, for example, to detect diseases in the tissues of patients. In a process known as immunostaining, pathologists first mount tissue samples on microscope slides. The slides then undergo a series of treatment steps including the application of various reagents such as antibody stains. Each of these treatment steps is separated by multiple rinse steps, during which unreacted reagents are removed from the slides. Finally, the stained slides are examined by pathologists to detect the presence of diseases.
At issue in this case is Ventana's 861 patent, col. 2, ll. 26-28. To overcome these problems, the inventors of this family of patents sought to
provide a device which provides more rapid, reliable and more reproducible results than standard methods; can perform any standard immunochemical assay . . .; preforms [sic] all steps of the immunohistochemical assay irrespective of complexity or their order, at the time and temperature, and in the environment needed; and is cost effective in terms of equipment, reagent and labor costs.
'861 patent, col. 2, ll. 29-38.
The common specification discloses an automated slide staining apparatus possessing multiple features, and each of Ventana's seven patents claims various combinations of these features and methods related to these features. For example, the '327 patent is entitled "Method for Mixing Reagent and Sample Mounted on a Slide" and the claims relate to methods that use streams of gas to stir the reagents on the slide surface. In contrast, the claims of the '861 patent relate to automated dispensing systems that employ bar code-labeled reagent containers and/or slides. As described in the patent specification,
[b]ar code reader 231 (FIG.14) above slide 205 reads a slide bar code 233 (FIGS. 13 and 17) on each slide. The slide bar codes [sic] 233 identifies the slide sample and the particular immunohistochemical process required for that sample. This information is fed into the computer and correlated with the indexed position of that slide with respect to "home", to control the sequence of reagent chemicals to be applied to that slide in the reagent application zone.
'861 patent, col. 9, ll. 48-55. The specification further discloses that the reagent containers may also be labeled with bar codes:
A reagent bar code reader 346 can be mounted on post 302, positioned to scan a reagent bar code 348 on the reagent bottle 12. Bar code 348 identifies the contents of the reagent bottle. At the beginning of a slide treatment operation, the reagent carousel 10 is rotated past the bar code reader 346, and the bar code 348 on each reagent bottle 12 is scanned. The scanned information is fed to the computer and correlated with the indexed position of the reagent carousel 10. This information is used to rotate the reagent carousel 10 to place the correct reagent bottle 12 in the application zone for each slide treatment step for each slide.
Id., col. 12, ll. 28-38.
BioGenex manufactures and sells automated staining devices. On February 11, 2003, Ventana filed suit against BioGenex alleging infringement of claims 1, 2, 3, 5, 6, and 8 of the '861 patent. The district court held a Markman hearing and construed certain disputed claim terms in a written opinion. Ventana Med. Sys., Inc. v. BioGenix [sic] Labs., Inc., No. 03-CV-92, slip op. at 1-17 (D.Ariz. Aug. 23, 2005) ("Claim Construction Order"). In light of the district court's construction of the claim term "dispensing," which appears in all of the asserted claims, Ventana stipulated to a judgment of noninfringement and reserved its right to appeal the district court's claim construction. Accordingly, the district court entered a final judgment of noninfringement. Ventana Med. Sys., Inc. v. BioGenex Labs., Inc., No. 03-CV-92, slip op. at 1-2 (D.Ariz. Oct. 4, 2005). Ventana now appeals.
The sole issue on appeal is the proper construction of the claim term "dispensing" in asserted claims 1, 2, 3, 5, 6, and 8 of the '861 patent. Of the asserted claims, claims 1 and 5 are independent. Both cover "[a] method of dispensing reagents onto a slide." Claim 1 reads:
1. A method of dispensing reagents onto a slide, the method comprising the steps of:
providing at least one reagent container;
providing at least one slide on a slide support;
automatically identifying the reagent container using a computer;
wherein the step of automatically determining whether reagent in the reagent container should be dispensed onto the slide includes the steps of:
providing a bar code reader;
reading a slide bar code placed on the slide using the bar code reader thereby acquiring slide information, the slide information indicating reagents to be applied to the slide; and
sending the slide information to the computer.
'861 patent, col. 24, l. 53-col. 25 l. 6 (emphases added). And claim 5 reads:
5. A method of dispensing reagents onto a slide, the method comprising the steps of:
providing a plurality of reagent containers in a reagent support, each of the reagent containers having a reagent bar-code;
providing at least one slide on a slide support, the slide having a bar code; providing a bar code reader;
reading the bar codes on the reagent containers;
determining reagents in the reagent containers based upon the reading of the bar codes on the reagent containers;
reading the slide bar code on the at least one slide;
determining a sequence of reagents to be applied on the at least one slide based upon the reading of the slide bar code on the slide; and
dispensing the reagents in the reagent containers based upon the sequence of reagents to be applied.
'861 patent, col. 25, ll. 18-36 (emphases added).
The district court construed the "dispensing" claim limitation to require "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. Claim Construction Order, slip op. at 5-7. The district court held that the context in which the "dispensing" term is used in the claim "necessitates `direct dispensing' by stating that the reagent in the reagent container is dispensed onto the slide, meaning the reagent is dispensed directly from the reagent container." Id., slip op. at 6. The district court also noted that the written description and figures supported a narrow construction of "dispensing" because all of the disclosed embodiments dispense reagent directly from the bottom of the reagent container without using any intermediate transfer device. Id., slip op. at 7.
After construing the term "dispensing" to mean "direct dispensing," the district court held that the inventors disclaimed a particular type of dispensing, "sip and spit" dispensing, during the prosecution of an ancestor application. In "sip and spit" dispensing, an intermediate transport mechanism such as a pipette uses suction to "sip" the reagent from the reagent container and then releases or "spits" the reagent onto the slide. The '861 patent issued from a continuation of a continuation of a division of a continuation of U.S. Patent Application No. 07/924,052 (the "'052 application"), which originally presented 93 claims.1 Independent claim 1 of the '052 application provided:
1. A biological reaction apparatus for dispensing a selected reagent directly to a sample, said biological reaction apparatus having:
a reagent carousel having a plurality of...
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