United States Court of Appeals for the Federal Circuit ______________________

REMBRANDT DIAGNOSTICS, LP, Appellant

v.

ALERE, INC., Appellee

KATHERINE K. VIDAL, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Intervenor ______________________

2021-1796 ______________________

Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. IPR2016- 01502. ______________________

Decided: August 11, 2023 ______________________

JARED C. BUNKER, Knobbe, Martens, Olson & Bear, LLP, Irvine, CA, argued for appellant. Also represented by JOSEPH F. JENNINGS.

JASON M. WILCOX, Kirkland & Ellis LLP, Washington, DC, argued for appellee. Also represented by JOHN C. Case: 21-1796 Document: 56 Page: 2 Filed: 08/11/2023

2 REMBRANDT DIAGNOSTICS, LP v. ALERE, INC.

O'QUINN; AMANDA J. HOLLIS, MEREDITH ZINANNI, Chicago, IL.

MONICA BARNES LATEEF, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA, for intervenor. Also represented by THOMAS W. KRAUSE, MAUREEN DONOVAN QUELER, FARHEENA YASMEEN RASHEED. ______________________

Before MOORE, Chief Judge, DYK and REYNA, Circuit Judges. REYNA, Circuit Judge. This case returns to us from the Patent Trial and Ap- peal Board. Appellant Rembrandt appeals a final written decision in an inter partes review in which the Board found that claims 3–6 and 10 of U.S. Patent No. 6,548,019 would have been unpatentable for obviousness. Rembrandt ar- gues that the Board erred by relying on Appellee Alere’s new theories asserted for the first time in its reply brief. Because Alere did not offer new theories and because sub- stantial evidence supports the Board’s determinations, we affirm. BACKGROUND A. The ’019 Patent We provide a brief overview of U.S. Patent No. 6,548,019 (the “’019 patent”) because we previously dis- cussed the patent in detail in Alere, Inc. v. Rembrandt Di- agnostics, LP, 791 F. App’x 173 (Fed. Cir. 2019) and Rembrandt Diagnostics, LP v. Alere, Inc., 809 F. App’x 903 (Fed. Cir. 2020). The ’019 patent is directed to test assay devices and methods for testing biological fluids. ’019 pa- tent at 1:15–18. The test assay device receives a fluid sam- ple “introduced directly to the sample loading zone” (30) of one or more assay test strips (22). Id. at 4:65–5:6; 7:54–62. Case: 21-1796 Document: 56 Page: 3 Filed: 08/11/2023

REMBRANDT DIAGNOSTICS, LP v. ALERE, INC. 3

As shown in Figures 3 and 6 below, the assay test strips (22) may each be encapsulated within separate “flow con- trol channel[s]” (34) in one embodiment. Id. at 1:39–47; 5:51–59; 6:46–47.

Id. at Figs. 3 & 6. Figure 6 illustrates that to assemble the full testing assay device, the test strip assembly (22, 28, 34) from Figure 3 may be combined with a holder (40) and placed inside a fluid sample container (i.e., a cup) (2) that has a cap (45) to fit over the opening (3) of the container. Id. at 5:53–64; 6:15–45; 7:11–28; Figs. 5 & 6. Figure 6 also shows that the sample loading zones (30) of the assay test strips are oriented toward the base (1) of the fully assem- bled container. Id. at 6:35–45; 7:22–27. As the assay sam- ple fluid in the container contacts the sample loading zone (30), it migrates upward through the assay test strip. Id. at 6:55–67. In another embodiment, multiple test strips may be held within a single “continuous in width” flow con- trol channel. Id. at 6:47–54. Case: 21-1796 Document: 56