The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as their devices transition from Emergency Use Authorizations (EUAs). Just over three hundred EUAs were issued for diagnostic devices during the COVID-19 pandemic. In the announcement, the FDA characterized the issuance of EUAs as “proactive steps to help facilitate the availability of critical medical devices, including in vitro diagnostic tests.” Draft versions of the guidance documents were made available for public comment in December 2021.
BERTINI v. APPLE INC.
Before Moore, Taranto and Chen. Appeal from the Patent Trial and Appeal Board.
Summary: Tacking a mark for one good or service does not grant priority for every other good or service in the trademark application.
IRONBURG INVENTIONS LTD. v. VALVE CORP.
Before Lourie, Clevenger, and Stark. Appeal from the United States District Court for the Western District of Washington.
Summary: The patentee has the burden of proving that invalidity grounds not raised in a petition for inter partes review could reasonably have been raised.
ROKU, INC. v. UNIVERSAL ELECTRONICS, INC.
Before Newman, Reyna, and Stoll. Appeal from the Patent Trial and Appeal Board.
Summary: When an appeal from the PTAB addresses only a factual issue, the substantial evidence standard of review applies.
NVIDIA announced in a press release a collaboration with Medtronic to integrate NVIDIA’s artificial intelligence (AI) technology into certain of Medtronic’s products. NVIDIA is a graphics processing unit (GPU) company, and Medtronic is a medical device company.
In particular, the press release states that Medtronic will integrate both NVIDIA’s Holoscan AI computing software platform for building medical devices and NVIDIA IGX, an edge AI hardware platform, into Medtronic’s GI GeniusTM Endoscopy Module. Holoscan is described in the press release as providing an infrastructure for scalable, software-defined, real-time processing of data at the edge.
The FDA recently announced that it is seeking a budget of $7.2 Billion for 2024, part of which is intended for “Advancing Medical Product Availability.” The portion of the requested budget directed to advancing access to safe and effective medical products would be used toward various initiatives, three of which are highlighted in the FDA’s announcement.
INTEL CORP. V. PACT XPP SCHWEIZ AG
Before Newman, Prost, and Hughes. Appeal from the Patent Trial and Appeal Board.
Summary: Under the “known-techniques” rationale, a motivation to combine two prior art references exists when the references address the same problem and one of the references provides a known technique that would suitably address that problem.
ALTERWAN, INC. V. AMAZON.COM, INC., AMAZON WEB SERVICES, INC.
Before Lourie, Dyk, and Stoll. Appeal from the United States District Court for the District of Delaware.
Summary: The Federal Circuit declined to reach the merits of a claim-construction appeal after finding the parties’ stipulation of non-infringement did not provide sufficient detail.
APPLE INC. v. VIDAL
Before Lourie, Taranto, and Stoll. Appeal from the United States District Court for the Northern District of California.
Summary: Judicial review is available to determine whether the PTO Director’s instructions regarding Fintiv IPR dismissals required notice-and-comment rulemaking.
Health Tracker Systems LLC (“Health Tracker”) sued Garmin International, Inc. (“Garmin”) for patent infringement in the Central District of California on March 6, 2023. The lawsuit alleges that Garmin’s Forerunner 45/45S smartwatch infringes U.S. Patent No. 6,582,380, entitled “System and Method of Monitoring and Modifying Human Activity-Based Behavior,” which issued in 2003, and expired in June 2021.
