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Alere, Inc. v. Rembrandt Diagnostics, LP

United States Court of Appeals for the Federal Circuit

October 29, 2019, Decided

2018-1812

Opinion

 [*174]  REYNA, Circuit Judge.

Alere, Inc., appeals from a final written decision of the Patent Trial and Appeal Board in an inter partes review proceeding, upholding certain challenged claims as not unpatentable. We conclude that the Board correctly construed the disputed "wherein" clause in claim 1 and affirm that limited portion of the Board's final written decision. Because the Board improperly declined to institute review on certain claims and grounds included in Alere's petition and its final written decision did not address those claims and grounds, we vacate the remaining aspects of the final written decision [**2]  and remand for further proceedings.

BACKGROUND

I. The Challenged Patent

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 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]  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.  [*175]  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.

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791 Fed. Appx. 173 *; 2019 U.S. App. LEXIS 32350 **; 2019 U.S.P.Q.2D (BNA) 413707; 2019 WL 5566744

ALERE, INC., Appellant, v. REMBRANDT DIAGNOSTICS, LP, Appellee.

Notice: THIS DECISION WAS ISSUED AS UNPUBLISHED OR NONPRECEDENTIAL AND MAY NOT BE CITED AS PRECEDENT. PLEASE REFER TO FEDERAL RULES OF APPELLATE PROCEDURE RULE 32.1 GOVERNING THE CITATION TO UNPUBLISHED OPINIONS.

Prior History:  [**1] Appeal from the United States Patent and Trademark. Office, Patent Trial and Appeal Board in No. IPR2016-01502.

Rembrandt Diagnostics, LP v. Alere, Inc., 2017 U.S. Dist. LEXIS 46009 (S.D. Cal., Mar. 28, 2017)

Disposition: AFFIRMED-IN-PART, VACATED-IN-PART, AND REMANDED.

CORE TERMS

fluid, channel, flow control, container, assay, strip, liquid, disposed, grounds, loading zone, collection, inside, specification, written decision, patentability, migration, pervious, cup, embodiments, determinations, intermediate, challenges, instituted, includes, wicking, merits

Administrative Law, Judicial Review, Standards of Review, Patent Law, Jurisdiction & Review, Standards of Review, De Novo Review, Substantial Evidence, Claims & Specifications, Claims