Aerospace Update | September 2026
Hosted Payloads and Exceptions to Patent Protection Under the U.S. Space Act Sashank Krothapally Companies relying on the U.S. Space Act for patent protection of inventions in orbit should be...
FAA Rollout of AI-Supported System and Patent Implications for Federal Government Partnerships
Key Takeaway(s): Companies receiving federal funding and assistance, for example in connection with the FAA’s AI-supported system, should be aware of the requirement to include a statement of government support...
AI-Powered Skin Cancer Detection Device Developer Announces Commercialization Partnerships
On September 1, 2026, medical device company DermaSensor Inc. announced four new industry partnerships. DermaSensor is focused on early detection of skin cancer. DermaSensor’s website states: “The DermaSensor device is the...
Dozens of Knobbe Martens Lawyers Recognized in 2027 Best Lawyers in America Guides
IRVINE, Calif., August 20, 2026 – Leading intellectual property law firm Knobbe Martens is pleased to share that more than 40 firm lawyers have been featured in the 2027 editions...
Knobbe Martens Lawyers Named Washington, D.C. Super Lawyers and Rising Stars
WASHINGTON, D.C., June 1, 2026 – Knobbe Martens is pleased to share that four of the firm’s lawyers have been recognized by Washington, D.C. Super Lawyers. William Zimmerman was named...
Aerospace Update | April 2026
Space Force Awards Kratos $447 Million Contract for Missile Warning Tracking Lizzy T. Do & Scott Cromar Kratos wins $447 million contract with U.S. Space Force to develop a ground...
FDA Announces “RAPID” Pathway for Expedited Access to Breakthrough Devices by Medicare Population
On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced “a new pathway designed to expedite access to certain FDA-designated Class II...
Veteran Ventures Capital Announces Investment in Hybron Technologies as Hybron Technologies Closes $25M Seed Round
Key Takeaways: Hybron Technologies, a U.S. based Manufacturing company focused on lightweight composites for aerospace and defense applications, closes an oversubscribed $25M seed round. The increased need for domestic production...
Aerospace Update | December 2025
FAA Request for Information Related to a New Air Traffic Control Platform Josue A. Villalta & Paige L. Cappelli The Federal Aviation Administration (FAA) issued a request for information (RFI)...
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.
