Rembrandt Diagnostics, LP v. Alere, Inc. (USPTO as Intervenor)
Docket No. 2021-1796 (IPR2016-01502) (https://cafc.uscourts.gov/opinions-orders/21-1796.OPINION.8-11-2023_2172379.pdf)
LOURIE, DYK, TARANTO
July 10, 2023
Brief Summary: Board IPR obviousness decisions affirmed (e.g., Alere did not raise new arguments, “a nexus to Rembrandt’s prior argument”). Summary: Rembrandt appealed USPTO Board “erred by relying on Appellee Alere’s new theories asserted for the first time in its reply brief” during an IPR regarding US 6,548,019 “directed to test assay devices and methods for testing biological fluids.” The Board previously issued a Final Written Decision (FWD) finding claim 2 to be anticipated by the MacKay reference but found “Alere had failed to prove claims 3–5 were unpatentable” in view of the Tydings, MacKay, May, Lee-Own, and Charm references. Alere appealed the FWD, and the FC panel “affirmed the Board’s claim construction but remanded for the Board to consider all the challenged claims and grounds under SAS” (US 2018). On remand, “the Board authorized ‘briefing with respect to all non-instituted grounds set forth in the [p]etition’”. Rembrandt argued to the Board and in this appeal that Alere relied upon new theories and evidence, and that it does not support the Board’s unpatentability determinations. The FC first found “that Rembrandt forfeited its argument that Alere offered new theories” as it failed to “timely” make those assertions (Phillip Morris, FC 2023; “Rembrandt’s generic objection is insufficient”, it “objected to other allegedly new theories without doing so here… Neither [the Board nor Alere] would have adequate notice of which theories are allegedly new.”) The FC panel explained that “there is no blanket prohibition against the introduction of new evidence during an IPR” (Anacor Pharms., FC 2018; Genzyme, FC 2016), but found Alere’s allegedly new “cost and time savings” arguments to be responsive and have “a nexus to Rembrandt’s prior argument” regarding a motivation to combine and expectation of success. The FC panel also found “Alere [did] not point to any new embodiments not previously identified to advance a meaningfully distinct contention from what it first asserted in its petition” (e.g., “the motivation to remove Tydings’s wicking material and reverse its orientation”; unlike Apple (FC 2020), Ariosa (FC 2015)). It explained that “[t]he Board was presented with ‘two alternative theories’ about what the prior art discloses, and it is not this court’s task ‘to determine which theory we find more compelling’” (Shoes by Firebug, FC 2020), and that substantial evidence supported the Board’s conclusions. The Board decision was therefore affirmed.