On September 12, 2018, Apple released its new Apple Watch Series 4 with a new ECG app that can take an electrocardiogram (ECG). Apple’s new Apple Watch Series 4 has been granted De Novo classification by the FDA, which allows Apple to provide its Series 4 Apple Watches as an over-the-counter ECG-monitoring device.
The FDA has announced new goals to help modernize its procedures and respond to new technologies. In a blog post by FDA Commissioner Scott Gottlieb, M.D., the agency expressed new priorities to help modernize clinical trials for medical devices and develop standards for new technologies like artificial intelligence.
Before Judges Reyna, Bryson, and Stoll. Appeal from the United States District Court for the District of Delaware.
Summary: A claim that recites a specific method for navigating through three-dimensional electronic spreadsheets is not directed to an abstract idea.
Before O’Malley, Reyna, and Hughes. Appeal from the District Court for the Northern District of California.
Summary: Testing for the presence of a bacterium that causes tuberculosis and the primers used in that testing were directed to patent-ineligible subject matter because the primers were indistinguishable from naturally occurring DNA.
Assertions of obviousness based on prior art references in combination with “routine optimization” by one skilled in the art are common in the chemical and biological fields. The Federal Circuit recently addressed this issue in E.I. DuPont De Nemours & Co. v. Synvina C.V., reversing the Patent Trial and Appeal Board’s (PTAB’s) finding that Synvina’s patent was non-obvious, in view of close prior art references and little to no additional evidence of non-obviousness.
Before Wallach, Linn, and Hughes. Appeal from the Trademark Trial and Appeal Board.
Summary: To determine whether a mark is generic, the TTAB must first properly identify the genus of the goods at issue. The genus must be based on the identification of goods set forth in the application, regardless of what the record may reveal as to the particular nature of the subject goods.
Before Prost, Moore, and Reyna. Appeal from the Patent Trial and Appeal Board
Summary: Removing the priority claim of one application in a chain can affect the ability of pending and subsequently filed applications to claim priority to earlier applications.
he United States Food and Drug Administration recently announced approval for Teva Pharmaceuticals to market generic epinephrine autoinjectors. According to the press release, Teva’s autoinjectors are the first generic versions of Mylan’s EpiPen® and EpiPen Jr ® to receive FDA approval.
In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the premarket review process for medical devices. In particular, the report suggests including cybersecurity documentation as a criterion in the FDA’s Refuse-To-Accept (RTA) checklist, using presubmission meetings to address cybersecurity questions, and including cybersecurity as an element of the FDA’s Smart template.
