Opinion ID: 4451027
Heading Depth: 2
Heading Rank: 1

Heading: The Challenged Patent

Text: Rembrandt Diagnostics, LP, owns U.S. Patent No. 6,548,019 (“the ’019 patent”). The patent, entitled “Method for Single Step Collection and Assaying of Biological Fluids” relates to a device and method for collecting biological fluid samples. The ’019 patent explains that prior art immunoassay devices used wicking material to bring test sample fluid into contact with the sample loading zone of assay test strips. According to the ’019 patent, the method of using wicking material was undesirable because it was slow in producing results, the wicking could occur unevenly, and it increased manufacturing costs because of the need to overlap the wicking material with the test strips. The ’019 patent overcomes these problems by removing the wicking material and introducing the sample loading zone of the test strip directly into the fluid sample while also providing a means for preventing oversaturation of the test strip. The ’019 patent discloses one such means that uses “flow control channels” consisting of liquid impervious ALERE, INC. v. REMBRANDT DIAGNOSTICS, LP 3 walls and backing that encapsulate the assay test strip, except where one liquid pervious side has an opening through which the sample loading zone of the assay test strip protrudes. Figure 3 from the ’019 patent shows this configuration: ’019 patent Fig. 3. In Figure 3, 36 labels the opening, 34 labels the flow control channel, and 30 labels the sample loading zone of the assay test strip (22). Id. at col. 6 ll. 10– 15. In the patented device, several flow control channels are placed around the perimeter of a collection cup with the opening (36) oriented toward the bottom. As fluid is introduced into the cup, the fluid contacts the sample loading zone of the test strip and “begins migrating up through the assay test strip.” Id. at col. 6 ll. 55–57. The trapped air and ambient air pressure within the flow control channel prevent oversaturation of the test strip. Id. at col. 1 ll. 39– 47. Figure 6 shows the assay sample fluid collection device with the assembly of Figure 3 in place in a collection cup. 4 ALERE, INC. v. REMBRANDT DIAGNOSTICS, LP Id. Fig. 6. Figure 6 confirms that the openings of the flow control channels shown in Figure 3 are oriented toward the bottom of the cup when disposed in the collection cup. Claim 1 is illustrative of the challenged claims and includes the disputed claim terms:
biological fluid, the device comprising:
liquid pervious side joined to liquid impervious sides, wherein the internal dimensions of the flow control channel are sufficient to permit placement therein of an assay test strip; (b) an assay test strip within the flow control channel, wherein the assay test strip has a sample loading zone therein, and wherein further the assay test strip is disposed within the flow control channel so the sample fluid contacts the sample loading zone at a liquid pervious side of the flow control channel; and (c) a sample fluid container having a base, an open mouth, and walls connecting the base to the mouth; ALERE, INC. v. REMBRANDT DIAGNOSTICS, LP 5 wherein the flow control channel is disposed inside the sample fluid container with the liquid pervious side oriented toward the base of the sample fluid container so that the assay sample fluid, when added to the container, is delivered to the sample loading zone of the assay test strip by entry through a liquid pervious side of the flow control channel without migration through an intermediate structure, and wherein entry of the fluid into the flow control channel creates an ambient pressure within the flow control channel equivalent to the ambient pressure outside of the flow control channel, thereby eliminating a pressure gradient along which excess sample fluid could flow into the flow control channel. ’019 patent col. 8 l. 42–col. 9 l. 2 (emphases added). Like claim 1, all claims in the ’019 patent are directed to a “device.”