In addition to its significant efforts to fast track the approval of COVID-19 related devices, the FDA’s Center for Devices and Radiological Health (CDRH) has also maintained its high priority focus on supporting innovation of new medical devices in the United States.
IPR estoppel in district court proceedings applies to all claims and grounds which reasonably could have been included in the petition; a two-tier damage award providing a higher royalty for the same device at a different points in the supply chain was not permitted in the absence of compelling evidence.
Despite applying the standard of broadest reasonable construction, a claim term’s narrowed construction to refer to a specific detection method was proper in view of its exclusive use in the written description as referring to the specific method as well as its foundational relationship to the claims.
Construing a broad claim term to be re-defined as a disclosed species on a theory that the terms are interchangeable requires that the intrinsic record clearly manifest a departure from the term’s plain and ordinary meaning.
Conclusory statements about how a skilled artisan would combine embodiments in a prior art reference are insufficient to defeat a preliminary injunction.
Agreement to the definition of a term within settlement negotiations may create a binding, enforceable agreement as to that term, despite the absence of a finalized settlement agreement as to all terms.
Stylizing an otherwise generic character mark using ubiquitous lettering does not make it a source identifier.
NATURE SIMULATION SYSTEMS INC. v. AUTODESK, INC.
Before Newman, Lourie, and Dyk. Appeal from the United States District Court for the Northern District of California.
Summary: It was improper for the district court to find patent claims indefinite without considering the specification and prosecution history.
Medtronic announced that its Intellis™ neurostimulator and the Vanta™ neurostimulator have both received approval from the U.S. Food and Drug Administration (FDA) for the treatment of chronic pain associated with diabetic peripheral neuropathy (DPN), in a January 24, 2022 press release. The approval grants patients suffering from DPN access to both products within Medtronic’s spinal cord stimulation (SCS) portfolio. The IntellisTM neurostimulator is rechargeable whereas the VantaTM neurostimulator is recharge-free .
Surgeons at the University of Maryland School of Medicine performed the first successful porcine (pig) to human heart transplant, a procedure referred to as “xenotransplantation.” The patient, 57 year old David Bennett, was recovering and doing well three days after the procedure. The surgical team continues to monitor Mr. Bennett’s condition.
