Rembrandt Diagnostics, Lp v. Alere, Inc.

76 F.4th 1376
Court of Appeals for the Federal Circuit·Decided August 11, 2023·No. 21-1796·Published·Cited by 9 cases

Opinion

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.

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 Appeal 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 argues 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 substantial 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 discussed the patent in detail in Alere, Inc. v. Rembrandt Diagnostics , 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 patent at 1:15–18. The test assay device receives a fluid sample “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.

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 control 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 assembled container. Id. at 6:35–45; 7:22–27. As the assay sample 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 control channel. Id. at 6:47–54.

4 REMBRANDT DIAGNOSTICS, LP v. ALERE, INC.

Claims 3–6 and 10 are the focus of this appeal. These claims all depend (either directly or indirectly) from claim 1, which is directed toward the assay testing device. Claims 1 and 9 were disclaimed by Rembrandt and are not at issue on appeal. J.A. 3. Claims 3–6 and 10 all include this arrangement of test strips “oriented toward” the base of the container. ’019 patent at 8:57–59; J.A. 75. Claim 10 is directed to the embodiment where “all of the assay test strips are disposed in a single flow control channel.” Id. at 10:5–6.

B. The Prior Art

Alere argued before the Board that the challenged claims would have been obvious over two combinations of prior art patents relating to assay testing devices: (1) U.S. Patent No. 5,656,502 (“MacKay”) in view of U.S. Patent No. 5,985,675 (“Charm”) or U.S. Patent No. 5,602,040 (“May”) and (2) U.S. Patent No. 6,379,620 (“Tydings”) in view of MacKay or U.S. Patent No. 5,500,375 (“Lee-Own”). J.A. 13, 25. We briefly summarize the relevant portions of these prior art patents.

Turning to the first combination, MacKay describes a test strip holder that holds one test strip. J.A. 1423 at 1:5– 6. In MacKay, one end of the holder is open to allow liquid to enter so that the liquid can reach the sole test strip inside . J.A. 1424–25 at 3:10–18; 5:66–6:21; 6:55–58. Charm discloses that its “test device may employ one or more test strips directed to a variety of tests.” J.A. 1446 at 4:6–12. May explains that “a device according to the invention can incorporate two or more discrete bodies of porous solid phase material, e.g., separate strips or sheets, each carrying mobile and immobilised reagents.” J.A. 1526 at 6:26– 29.

For the second combination, Tydings, which shares an inventor with the ’019 patent, discloses test strips that are oriented upwards toward the mouth of the container (the opposite of the ’019 patent’s configuration). J.A. 1477 at

REMBRANDT DIAGNOSTICS, LP v. ALERE, INC. 5

2:46–67; Fig. 1. Tydings’s objectives include providing a testing device that is “simple to use and inexpensive and easy to manufacture.” J.A. 1477 at 1:40–42. Lee-Own’s test strip is placed inside a sealed “holder laminate” and advantageously does “not require extraneous wicks” “to augment sample migration.” J.A. 1467–69 at 3:26–34; 3:65–67; 7:28–39; 7:53–62. Lee-Own also explains “a single strip or multiple strips” may be included within the laminate structure to run multiple tests simultaneously. Id. at 1:42–44; 3:40–42; 5:1–12; 8:54–57.

PROCEDURAL HISTORY

This dispute began in 2016 when Rembrandt sued Alere in district court for patent infringement. The district court case is currently stayed pending the outcome of this appeal.

A. The Board Proceeding

After Rembrandt sued, Alere petitioned for inter partes review (“IPR”) before the Patent Trial and Appeal Board (“Board”) challenging claims 1–6 and 9–15 of the ’019 patent . J.A. 81–173. The IPR was based on, among other references, Tydings, MacKay, May, Lee-Own, and Charm. Id. The Board instituted only on certain grounds and declined to review claims 6 and 10. J.A. 302–38. In declining to review claim 10, based on MacKay in view of Charm or May, the Board explained that Alere did not sufficiently explain how MacKay’s device would be modified. J.A. 332– 33. After institution, Rembrandt disclaimed claims 1, 9, and 11–15, leaving claims 2–5 for the Board to review. J.A. 3. The Board issued a final written decision in February 2018, finding that while claim 2 was anticipated by MacKay, Alere had failed to prove claims 3–5 were unpatentable . See Alere Inc. v. Rembrandt Diagnostics, LP, 6 REMBRANDT DIAGNOSTICS, LP v. ALERE, INC.

No. IPR2016-01502, 2018 WL 852133, at *11 (P.T.A.B. Feb. 9, 2018).

Alere appealed. See Alere, Inc., 791 F. App’x at 174. It challenged the Board’s determination as to claims 3–5, the Board’s claim construction of a disputed term, and asked this court to remand for the Board to consider all non-instituted claims and grounds under the Supreme Court’s decision in SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018). Id. at 176, 178. We affirmed the Board’s claim construction but remanded for the Board to consider all the challenged claims and grounds under SAS. Id. at 178.

B. Remand Proceeding

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Rembrandt Diagnostics, Lp v. Alere, Inc., 76 F.4th 1376 (Fed. Cir. 2023).

76 F.4th 1376 (Rembrandt Diagnostics, Lp v. Alere, Inc.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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