SUPPLEMENTARY INFORMATION:

The following and all continuing U.S. and foreign patents/patent applications thereof are the intellectual properties to be licensed under the prospective license to AntaraCore Systems, Inc.:

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The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive patent license territory may be worldwide and in a field of use limited to catheter-based intramyocardial ablation, for treating ventricular arrhythmia in a human.

This patent license covers two patent estates as shown above, namely the invention described in the E-017-2024 estate, and the invention described in the E-061-2022 estate. “Intramural substrates” are the crux of the clinical challenge addressed by the subject patent estates and the proposed field of use. Specifically, these intramural substrates are the electrically conducting and hard-to-reach arrhythmogenic tissue located within the depth of the myocardial wall—the mid-myocardium—rather than on the endocardial (inner) or epicardial (outer) surfaces. The inventions being exclusively licensed herein provide a catheter-based system and method to access these intramyocardium tissues, and a synchronous circumferential intramyocardial resynchronization and pacing (SCIRP) system intended to improve cardiac resynchronization therapy. Both of these inventions together provide a new and improved device, system and method to enable electrophysiologists to access and treat arrhythmogenic intramural substrates located within the ventricular myocardial wall, which currently is not systematized.

The invention described in E-017-2024, for which we have 3 provisional applications, 3 PCT applications, a pending U.S. national stage application and a pending European national stage application, covers a catheter-based system and method for performing ablation directly within the intramyocardium and particularly targeting ventricular tachycardia that is otherwise difficult to reach using existing ablation devices and methods. The system, referred to as VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms), principally uses a small flexible ablation microcatheter that tracks coaxially over a steerable, electrically insulated guidewire. Proximal to the catheter tip are mapping electrodes and a conductive ablation electrodes with perforations that can elute irrigants directly into the surrounding myocardial tissue. The physician navigates to the desired deep target using fluoroscopy, ultrasound, electroanatomic mapping and/or electrogram-based depth navigation (EDEN); once the ablation electrode reaches the target, irrigant is delivered through its openings and radiofrequency energy applied while irrigation continues, producing a controlled lesion in the abnormal tissue responsible for the arrhythmia. The irrigant may be an electrolyte acting to alter the electrical and/or physicochemical characteristics of the target myocardial substrate (such as increasing ionic conductivity), act as a thermo-conductive “virtual ablation electrode”, or may alternatively be a caustic agent intended to effect adjunctive chemoablation.

The invention described in E-061-2022, for which we have a PCT application, a pending U.S. national stage application, a pending Isreali national stage application and a pending European application, covers a synchronous circumferential intramyocardial resynchronization and pacing (SCIRP) system intended to improve cardiac resynchronization therapy by placing a flexible, multi-electrode pacing lead inside the ventricular myocardium rather than on an endocardial or epicardial surface. The lead contains multiple small ring electrodes and is implanted along a curved trajectory that can extend at least 180 degrees—and potentially substantially around the circumference—of the left ventricle, including through the interventricular septum near the His bundle or left bundle branch. Of particular import is the ability to introduce these electrodes into the ventricular intramural spaces through a navigated guidewire introduced through the myocardium using electrograms or pace mapping, and leaving the electrode-bearing lead embedded in the heart muscle. A multichannel pulse generator then energizes selected myocardium implanted electrodes in unipolar or bipolar configurations directly stimulate ventricular muscle and, where appropriately positioned, the native His/LBB conduction system. In essence, instead of trying to resynchronize the ventricle from a few conventional surface pacing sites, the invention creates an intramyocardial array of pacing sites distributed around the ventricle, intended to re homogenize synchronization.

This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent license will be royalty bearing and may be granted unless within thirty (30) days from the date of this published notice, the NHLBI receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act,5 U.S.C. 552.

91 FR 68963