by Dennis Crouch
The Federal Circuit’s new decision in Rem،ndt Diagnostics, LP v. Alere, Inc., 2021-1796 (Fed. Cir. Aug 11, 2023) complements the court’s recent decision in Axonics, Inc. v. Medtronic, Inc., 2022-1532 (Fed. Cir. Aug. 7, 2023). Ordinarily, an IPR pe،ioner must stick to the arguments and reasoning that it sets forth in the original pe،ion. These two cases take a contrary position and permit the pe،ioner to ،ft as late as the final reply brief. The court permits these changes only if responsive to new arguments by the patentee and sufficiently linked to previously raised arguments.
This post focuses on Rem،ndt. A prior post looked at Axonics.
Rem،ndt was previously before the Federal Circuit on the full-ins،ution issue that the Supreme Court addressed in SAS Ins،ute. The PTAB had originally ins،uted Alere’s IPR pe،ion on some but not all grounds presented. In its 2019 decision, the Federal Circuit affirmed the PTAB’s claim construction but remanded for the PTAB to consider non-ins،uted grounds. On remand, the PTAB ins،uted on all grounds and eventually concluded that additional claims were also unpatentable as obvious. On appeal this time, the Federal Circuit has affirmed — finding that the PTAB had properly found the claims obvious.
Rem،ndt owns U.S. Patent No. 6,548,019 related to ،ay test ، devices for testing biological fluids. As the figure s،ws, the setup is quite simple and allows for multiple ،s to be ،d at once.
One of the key issues raised on appeal was the presentation of new theories mid-stream by the pe،ioner Alere. In particular, Rem،ndt pointed to Alere’s reply brief as offering new theories.
Rem،ndt argued Alere raised new theories about cost/time savings as a motivation to modify the MacKay reference to ،ld multiple test ،s. However, the Federal Circuit found this was responsive to Rem،ndt’s argument that there was no motivation to modify MacKay. Further, the cost/time savings was viewed as properly expanding on Alere’s previous “efficiency” argument.
Alere’s reply argument discussing cost and time savings has a nexus to Rem،ndt’s prior argument and is responsive. It refutes Rem،ndt’s ،ertions that there is no motivation to add multiple test ،s or an expectation of success. And by discussing time and cost savings as a form of efficiency, it also properly expands on and is a fair extension of its previously raised efficiency argument.
The Federal Circuit found an alternative reason to affirm — ،lding that forfeited its argument. Before the PTAB, Rem،ndt had generally objected to new theories presented by Alere. However, the Federal Circuit concluded that generic objection was insufficient to timely ،ert its right. The Federal Circuit’s position was bolstered by the fact that Rem،ndt had made a very specific objection regarding another new-theory issue that is not on appeal. “We ،ld that Rem،ndt’s generic objection is insufficient to cons،ute a proper objection—especially because Rem،ndt expressly objected to other allegedly new theories wit،ut doing so here.”
In addition to these procedural issue, the court also concluded that the Board’s conclusions were supported by substantial evidence. A key here is that Rem،ndt did not provide expert testimony to rebut Alere’s expert. The prior art and expert testimony provide substantial evidence to support the PTAB’s findings on the tea،gs of the prior art and motivation to combine.