Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that it has petitioned the United States Patent and Trademark Office (USPTO) for inter partes review challenging the patentability of United States Patent No. 11,634,781 (“the ’781 patent”) owned by Exact Sciences.

Nothing in the ’781 patent’s claims is inventive. The petition explains that the claims of the ’781 patent are directed to the separation of a fecal sample into two portions to permit two standard diagnostic tests – one detecting blood proteins and the other detecting nucleic acids – to be performed on the sample. The fecal tests for detecting blood protein and nucleic acids recited by the claims were known and routine. The method claimed by the ’781 patent amounts to no more than the routine use of standard methods to prepare a fecal sample for the performance of well-established complementary diagnostic assays. Separating a fecal sample so it can be tested for both blood proteins and nucleic acids is reported throughout the prior art. The claimed method of the ’781 patent is obvious, and the claims directed to the method are invalid.

“Geneoscopy stands deeply committed to advancing our patented RNA biomarker technology, which helps enable the early detection and prevention of pre-cancerous polyps and colorectal cancer (CRC), with the highest, consistent sensitivity levels for patients of all ages,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “With the goal of expanding cancer screening options and improving outcomes for millions of patients, Geneoscopy seeks to ensure that Exact Sciences does not foreclose innovation and advancement in the field of cancer detection by claiming exclusive rights to diagnostic methods it did not invent. We strongly deny Exact Sciences’ allegations and will vigorously defend our ability to fulfill our mission to empower patients and providers to transform gastrointestinal health.”

Related Litigation

On December 22, 2023, Geneoscopy moved to dismiss the civil action pending in the United States District Court for the District of Delaware entitled Exact Sciences Corp. v. Geneoscopy, Inc., in which Exact Sciences has asserted baseless claims of infringement of the ’781 patent. Geneoscopy’s motion requests the dismissal of the complaint in its entirety.