Inverness Medical Switzerland Gmbh and Unipath Diagnostics, Inc. v. Princeton Biomeditech Corporation

309 F.3d 1365, 64 U.S.P.Q. 2d (BNA) 1926, 2002 U.S. App. LEXIS 22693, 2002 WL 31429033
CourtCourt of Appeals for the Federal Circuit
DecidedOctober 31, 2002
Docket01-1188
StatusPublished
Cited by45 cases

This text of 309 F.3d 1365 (Inverness Medical Switzerland Gmbh and Unipath Diagnostics, Inc. v. Princeton Biomeditech Corporation) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Inverness Medical Switzerland Gmbh and Unipath Diagnostics, Inc. v. Princeton Biomeditech Corporation, 309 F.3d 1365, 64 U.S.P.Q. 2d (BNA) 1926, 2002 U.S. App. LEXIS 22693, 2002 WL 31429033 (Fed. Cir. 2002).

Opinion

DYK, Circuit Judge.

Inverness Medical Switzerland GmbH and Unipath Diagnostics, Inc. (collectively “Unipath”) appeal from the decision of the United States District Court for the District of New Jersey granting summary judgment of non-infringement of U.S. Patent Nos. 5,622,871 (“the '871 patent”), 5,602,040 (“the '040 patent”), and 5,656,506 (“the '506 patent”) (collectively “the patents-in-suit”). Conop co, Inc. v. Princeton Biomeditech Corp., No. 97-6254 (D.N.J. Dec. 18, 2000) (“Order”). In construing the claims of the patents-in-suit, we conclude that the phrase “mobility ... is facilitated” is not limited to release of the labelled reagent, but rather must be given its ordinary meaning of capacity to make movement easier at any stage. Under this claim construction, issues of material fact remain regarding infringement of the '871, '040, and '506 patents. Therefore, we vacate the grant of summary judgment of non-infringement in favor of Princeton Biomeditech Corp. (“Princeton”) and remand for further proceedings.

BACKGROUND

Unipath is the assignee of the '871, '040, and '503 patents, respectively entitled “Capillary Immunoassay and Device Therefor Comprising Mobilizable Particulate Labelled Reagents,” “Assays,” and “Test Device for Detecting Analytes in Biological Samples.” The patents all claim original priority back to U.S. Patent App. No. 294,146 (“the '146 application”). The disclosures of the three patents are substantially identical, and are generally directed to the field of analytical testing devices.

A preferred embodiment of the disclosed invention is as a pregnancy-testing device. The urine of pregnant women includes human chorionic gonadotropin (hCG), a protein indicative of pregnancy. In the preferred embodiment a portion of the device is placed in contact with a test subject’s urine. If the woman is pregnant a colored label binds with high specificity to the hCG protein. Two binding zones are located on the device. The first binding zone includes a reagent that binds solely to the protein, such that when the protein is present it (and its colored label) provide a visual indication of the presence of the protein. The second zone (a control zone) includes a reagent that binds to the colored label, so *1367 that whether or not the hCG protein is present a visual indication is provided in the control zone. Thus, the test subject is able to determine whether the device is operating properly.

A diagram of the operative portion of an assay device in accordance with the disclosed invention is shown in figure 10 of the patents (reproduced below), which depicts a cross-sectional view of the interior of the device. The device includes a porous member 506 in contact with a strip of porous material 510. Strip 510 contains three reagent zones disclosed as follows:

[[Image here]]
Test zone 517 incorporates [an] immobil-ised specific binding reagent, and control zone 518 contains a reagent to indicate that the sample has permeated a sufficient distance along the test strip. A portion of the test strip surface ... carries a glaze [of sugar] 519 on which is deposited a layer 520 of labelled specific binding reagent.

’871 patent, col. 13, 11. 42-48. The labelled reagent is a direct-labelled antibody that binds with high-specificity to an analyte (e.g. hCG). Id. at col. 4, 11. 21-22. The fixed specific binding reagent in zone 517 also binds with high-specificity to the same analyte, but is unlabelled. Id. at col. 11,11. 49-53. Finally, the reagent in zone 518 is an unlabelled fixed reagent that will bind to the labelled reagent without regard to the presence of the analyte in the sample. Id. at col. 11, ll. 55-60.

In operation a liquid sample is brought into contact with porous member 506, which carries the liquid sample so as to permeate test strip 510. Id. at col. 12, 11. 43-51. As the liquid sample moves through test strip 510 it releases the la-belled reagent and dissolves the sugar, both of which are then carried along the strip to test and control zones. Id. at col. 13, 11. 57-62. The sugar assists in the “mobility” of the labelled reagent. If present in the sample, the analyte will bind to the labelled reagent and thereafter to the fixed unlabelled reagent in the test zone, thereby providing a visual indication (the label) of the analyte. Regardless of the presence of the analyte in the test sample, the labelled reagent will bind to the reagent in the control zone, thereby providing a visual indication in the control zone. Id. at col. 11,11. 45-60.

Unipath initiated an action against Princeton in the District of New Jersey on December 23,1997, for infringement of the claims '871, '040, and '503 patents. Claim 1 of the '871 patent is representative and provides:

An analytical test device for detecting an analyte suspected of being present in a liquid biological sample, said device comprising:
a) a hollow casing having a liquid biological sample application aperture and means permitting observation of a test result;
b) a test strip comprising a dry porous carrier contained within said hollow casing, said carrier communicating directly or indirectly with the exteri- or of said hollow casing through said liquid biological sample application aperture to receive applied liquid bio *1368 logical sample, said carrier having a test result zone observable via said means permitting observation, said test strip, in the dry unused state, containing a labelled reagent capable of specifically binding with said ana-lyte to form a first complex of said labelled reagent and said analyte, said label being a particulate direct label, wherein said labelled reagent is dry on said test strip prior to use and is released into mobile form by said applied liquid biological sample,
wherein mobility of said labelled reagent within said test strip is facilitated by at least one of 1) coating at least a portion of said test strip upstream from said test result zone with, or 2) drying said labelled reagent onto a portion of said test strip upstream from said test result zone in the presence of, a material comprising a sugar, in an amount effective to reduce interaction between said test strip and said labelled reagent;
said carrier containing in said test result zone a means for binding said first complex, said means for binding comprising specific binding means and being immobilized in said test result zone;
migration of said applied liquid biological sample through said dry porous carrier conveying by capillarity said first complex to said test result zone of said dry porous carrier whereat said binding means binds said first complex thereby to form a second complex;
said second complex being observable via said means permitting observation, thereby to indicate the presence of said analyte in said liquid biological sample.

(emphases added).

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309 F.3d 1365, 64 U.S.P.Q. 2d (BNA) 1926, 2002 U.S. App. LEXIS 22693, 2002 WL 31429033, Counsel Stack Legal Research, https://law.counselstack.com/opinion/inverness-medical-switzerland-gmbh-and-unipath-diagnostics-inc-v-cafc-2002.