(February 22, 2024) Dario health announced on February 21, 2024 that it has acquired digital health company Twill. DarioHealth Corp. is a leading digital health company, shaping how people with chronic conditions manage their health through a user-centric, multi-chronic condition digital therapeutics platform. Twill is a digital-led care leader. DarioHealth says its acquisition of Twill will enable DarioHealth to create a comprehensive digital platform for chronic conditions. DarioHealth plans to leverage Twill’s innovation in well-being and navigation to enhance DarioHealth’s end-to-end member journey for optimization across solutions.
In this episode of the Knobbe IP+ podcast, Knobbe Martens partner Mauricio A. Uribe speaks with author, technology disruptor, strategist and CEO Linda Bernardi on the role of patent strategies…
The inaugural AAMI/FDA neXus medical device standards conference was held February 20-23, 2024 in Washington DC. The conference was hosted by the Association for the Advancement of Medical Instrumentation (AAMI). Additional information regarding the conference can be found here.
The Federal Trade Commission is cracking down on Florida-based EXOTOUSA LLC d/b/a Old Southern Brass and its owner (collectively, “OSB”) for deceptive claims regarding the origin of its products and its alleged financial donations to military causes. OSB advertised that its products, including glassware, mugs, pens, and other novelty items, were made entirely in the U.S. by displaying statements on its product listings such as “100% American made,” “made right here in the United States of America,” and “100% USA made.” OSB also purported to be veteran-operated and pledged to donate 10% of its sales to military charities. The FTC’s order, finalized in January 2024, found those claims inaccurate, halted the deceptive practices, and imposed a monetary judgment against OSB.
On June 6, 2023, the Senate Judiciary Committee’s Subcommittee on Intellectual Property introduced a Bill entitled “Patent Eligibility Restoration Act of 2023” (PERA) aiming to amend the law relating to patent subject matter eligibility. The bill seeks to eliminate the so-called “judicial exceptions” to patent eligibility that have led to a significant number of “inventions” being deemed ineligible for patent protection. Additionally, this legislation seeks to clarify the confusion and inconsistency brought about by the Alice/Mayo framework, which has been criticized for its failure to provide a clear and consistent standard for patent eligibility, negatively impacting the protection of innovations in various fields.
The U.S. Food and Drug Administration (FDA) recently issued a Letter to Industry warning medical device manufacturers and device study sponsors (“device firms”) of a source of “fraudulent and unreliable laboratory testing data in premarket submissions.” According to the Letter, this suspect testing data can come from “entities that contract with device firms to conduct testing on medical devices (‘third-party test labs’).”
RAI STRATEGIC HOLDINGS, INC. v. PHILIP MORRIS PRODUCTS S.A
Before Chen, Stoll, and Cunningham. Appeal from the Patent Trial and Appeal Board.
Summary: Claimed ranges can be narrower than alternative, broader ranges disclosed in the specification if one of ordinary skill in the art can adequately determine that the broader range does not result in a different invention than the narrower range.
WEBER, INC. v. PROVISUR TECHNOLOGIES, INC.
Before Reyna, Hughes, and Stark. Appeal from the Patent Trial and Appeal Board.
Summary: Copyright notices in product manuals, which prohibited their reproduction and transfer, did not remove the manuals from the prior art.
The U.S. Food and Drug Administration (“FDA”) recently approved the Edwards EVOQUE® Tricuspid Valve Replacement System (the “EVOQUE® system”) for use in treating Tricuspid Regurgitation (“TR”). The EVOQUE® system is designed to replace the native tricuspid valve in patients suffering from severe TR without the need for conventional open-heart surgery, according to the system’s Instructions For Use. As shown in the following illustrations from page 5 of the EVOQUE® system’s Patient Guide, the EVOQUE® valve is made of a nitinol self-expanding frame, an intra-annular sealing skirt and anchors, and tissue leaflets made from bovine pericardial tissue.
The World Health Organization (WHO) recently released guidelines for the ethics and governance of large multi-modal models (LMMs). In the past year, LMMs like Chat GPT have come to the forefront of the news, and people have begun using them in different fields with varying success. Within the healthcare space, LMMs have the potential to respond to patients’ inquiries, identify research topics, and maintain electronic health records. However, the use of LMMs in healthcare raises many legal and ethical questions, such as how they can be used effectively without jeopardizing patient safety and privacy.
