FAA Request for Information Related to a New Air Traffic Control Platform
The Federal Aviation Administration (FAA) issued a request for information (RFI) related to “a single, state-of-the art platform for air traffic control called the Common Automation Platform (CAP).” The CAP...
Vertos Medical Latest Acquistion in Stryker’s M&A Streak
Medical technologies giant Stryker announced on Tuesday, October 1st, that it completed the acquisition of Vertos Medical for an undisclosed amount. Vertos Medical is a privately held company specializing in interventional pain management solutions for chronic back pain caused by lumbar spinal stenosis.
ARPA-H Announces New Funding related to AI-Enabled Medical Tools
The U.S. Advanced Research Projects Agency for Health (ARPA-H) announced new funding for a “program to help AI-enabled medical tools maintain peak performance.” The new funding is through the Performance and Reliability Evaluation for Continuous Modifications and Usability of Artificial Intelligence (PRECISE-AI) program.
Knobbe Martens Advises Vertos Medical, Inc. in Definitive Agreement To Be Acquired by Stryker
IRVINE, Calif., August 23, 2024 – Stryker, a global leader in medical technologies, announced today a definitive agreement to acquire Vertos Medical Inc., a privately held company providing a minimally...
Expect Future FDA Clarification on Machine Learning-Enabled Medical Devices
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.
FDA Releases Draft Guidances on 510(k) Submissions
On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing complexity of rapidly evolving technology.” As stated on the FDA website: “[E]ach person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless” the device meets certain limited exemptions. A 510(k) submission provides, for the FDA’s review, safety and effectiveness data to show that a new device is substantially equivalent to a legally marketed predicate device.
FDA Seeks $7.2 Billion Budget for 2024
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.
FDA to Collaborate With Veterans Group on Medical Device Innovation
On September 28, 2022 the FDA announced a collaboration with the Veterans Health Administration (VHA), in particular the VA Ventures Innovation Institute. According to the FDA, the intent of the collaboration is to “help accelerate American medical device innovation to further improve and benefit public health. One goal of the collaboration is providing innovators with “straightforward, reproducible, and cost-effective testing methods throughout the product development cycle.”
FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program
On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, can be found here.
Limitations in Claim Language Frame Reasonable Expectation of Success Analysis
TEVA PHARMACEUTICALS USA, INC., v. CORCEPT THERAPEUTICS, INC.
Before Moore, Newman, and Reyna. Appeal from the Patent Trial and Appeal Board.
Summary: Limitations, such as specific drug doses, in claim language can impact the application of the reasonable expectation of success analysis for obviousness.
FDA Issues Draft Guidance for Software Contained in Medical Devices
On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The final version will eventually replace the FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” originally released in May 2005.
Billion Dollar Verdict Erased by Inadequate Description of Functional Claims
JUNO THERAPEUTICS, INC. v. KITE PHARMA, INC.
Before Moore, Prost, and O’Malley. Appeal from the United States District Court for the Central District of California.
Summary: Knowledge of a common general structure and the disclosure of two representative species is insufficient to support the written description of a functionally-claimed genus when the claimed function results from specific structures and the specification does not provide distinguishing characteristics for structures that achieve the claimed function and those that do not.
FDA Taking Steps to Prevent Future Medical Device Shortages
According to the FDA, the medical device industry experienced significant supply chain disruptions during the COVID-19 pandemic. Such disruptions caused shortages of PPE, ventilators, diagnostic testing, and other medical devices.
Dictionary Definitions Overshadowed by Intrinsic Evidence
UNILOC 2017 LLC v. APPLE INC.
Before Prost, Bryson, and Reyna. Appeal from the Patent Trial and Appeal Board.
Summary: Evidence of the plain and ordinary meaning of the term “intercepting” as set forth in dictionary definitions was outweighed by evidence of the meaning of the term in the prosecution history, specification, and context of the claims.
Knobbe Martens Welcomes First-Year Associates
Knobbe Martens is pleased to announce it has welcomed a class of first-year associates to the firm. While currently working in a remote capacity along with their colleagues firmwide due...
