Shifting Arguments on the PTAB

by Dennis Crouch

The Federal Circuit’s new choice in Rembrandt Diagnostics, LP v. Alere, Inc., 2021-1796 (Fed. Cir. Aug 11, 2023) enhances the court docket’s latest choice in Axonics, Inc. v. Medtronic, Inc., 2022-1532 (Fed. Cir. Aug. 7, 2023). Ordinarily, an IPR petitioner should keep on with the arguments and reasoning that it units forth within the unique petition.  These two circumstances take a opposite place and allow the petitioner to shift as late because the  ultimate reply temporary. The court docket permits these adjustments provided that conscious of new arguments by the patentee and sufficiently linked to beforehand raised arguments.

This put up focuses on Rembrandt.  A previous put up checked out Axonics.

Rembrandt was beforehand earlier than the Federal Circuit on the full-institution concern that the Supreme Courtroom addressed in SAS Institute.  The PTAB had initially instituted Alere’s IPR petition on some however not all grounds introduced.  In its 2019 choice, the Federal Circuit affirmed the PTAB’s declare development however remanded for the PTAB to contemplate non-instituted grounds.   On remand, the PTAB instituted on all grounds and ultimately concluded that further claims have been additionally unpatentable as apparent. On attraction this time, the Federal Circuit has affirmed — discovering that the PTAB had correctly discovered the claims apparent.

Rembrandt owns U.S. Patent No. 6,548,019 associated to assay take a look at strip units for testing organic fluids.  Because the determine exhibits, the setup is kind of easy and permits for a number of strips to be examined directly.

One of many key points raised on attraction was the presentation of recent theories mid-stream by the petitioner Alere.  Specifically, Rembrandt pointed to Alere’s reply temporary as providing new theories.

Rembrandt argued Alere raised new theories about value/time financial savings as a motivation to change the MacKay reference to carry a number of take a look at strips. Nevertheless, the Federal Circuit discovered this was conscious of Rembrandt’s argument that there was no motivation to change MacKay. Additional, the fee/time financial savings was seen as correctly increasing on Alere’s earlier “effectivity” argument.

Alere’s reply argument discussing value and time financial savings has a nexus to Rembrandt’s prior argument and is responsive. It refutes Rembrandt’s assertions that there isn’t any motivation so as to add a number of take a look at strips or an expectation of success. And by discussing time and price financial savings as a type of effectivity, it additionally correctly expands on and is a good extension of its beforehand raised effectivity argument.

Slip Op.

The Federal Circuit discovered another purpose to affirm — holding that forfeited its argument.  Earlier than the PTAB, Rembrandt had typically objected to new theories introduced by Alere.  Nevertheless, the Federal Circuit concluded that generic objection was inadequate to well timed assert its proper. The Federal Circuit’s place was bolstered by the truth that Rembrandt had made a really particular objection relating to one other new-theory concern that isn’t on attraction. “We maintain that Rembrandt’s generic objection is inadequate to represent a correct objection—particularly as a result of Rembrandt expressly objected to different allegedly new theories with out doing so right here.”

Along with these procedural concern, the court docket additionally concluded that the Board’s conclusions have been supported by substantial proof. A key right here is that Rembrandt didn’t present knowledgeable testimony to rebut Alere’s knowledgeable. The prior artwork and knowledgeable testimony present substantial proof to help the PTAB’s findings on the teachings of the prior artwork and motivation to mix.