Shifting Arguments at the PTAB

by Dennis Crouch

The Federal Circuit’s new decision in Rembrandt 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 petitioner must stick to the arguments and reasoning that it sets forth in the original petition.  These two cases take a contrary position and permit the petitioner to shift 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 Rembrandt.  A prior post looked at Axonics.

Rembrandt was previously before the Federal Circuit on the full-institution issue that the Supreme Court addressed in SAS Institute.  The PTAB had originally instituted Alere’s IPR petition 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-instituted grounds.   On remand, the PTAB instituted 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.

Rembrandt owns U.S. Patent No. 6,548,019 related to assay test strip devices for testing biological fluids.  As the figure shows, the setup is quite simple and allows for multiple strips to be tested at once.

One of the key issues raised on appeal was the presentation of new theories mid-stream by the petitioner Alere.  In particular, Rembrandt pointed to Alere’s reply brief as offering new theories.

Rembrandt argued Alere raised new theories about cost/time savings as a motivation to modify the MacKay reference to hold multiple test strips. However, the Federal Circuit found this was responsive to Rembrandt’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 Rembrandt’s prior argument and is responsive. It refutes Rembrandt’s assertions that there is no motivation to add multiple test strips 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.

Slip Op.

The Federal Circuit found an alternative reason to affirm — holding that forfeited its argument.  Before the PTAB, Rembrandt had generally objected to new theories presented by Alere.  However, the Federal Circuit concluded that generic objection was insufficient to timely assert its right. The Federal Circuit’s position was bolstered by the fact that Rembrandt had made a very specific objection regarding another new-theory issue that is not on appeal. “We hold that Rembrandt’s generic objection is insufficient to constitute a proper objection—especially because Rembrandt expressly objected to other allegedly new theories without 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 Rembrandt 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 teachings of the prior art and motivation to combine.