2013-13628. Prospective Grant of Start-up Exclusive Evaluation License: Portable Device and Method for Detecting Hematomas

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a worldwide exclusive evaluation option license to practice the inventions embodied in: HHS Ref. No. E-010-2010/0, U.S. Provisional Patent Application No. 61/286,626, filed December 15, 2009, International Patent Application PCT/US2010/060506 filed December 15, 2010 (published as WO2011084480), European Patent Application 10798422.1 filed December 15, 2010, and U.S. Patent Application 13/516,480 filed June 15, 2012, to ArcheOptix, having its principle place of business in Kingston, Ontario (Canada).

The United States of America is an assignee to the patent rights of these inventions.

The contemplated exclusive license may be limited to devices for the detection of hematomas. Upon the expiration or termination of the start-up exclusive evaluation license, ArcheOptix will have the right to execute a start-up exclusive patent commercialization license with no greater field of use and territory than granted in the evaluation license.

DATES:

Only written comments and/or applications for a license that are received by the NIH Office of Technology Transfer on or before June 25, 2013 will be considered.

ADDRESSES:

Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael Shmilovich, Esq., Senior Licensing and Patent Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

The invention is a device and method for detecting hematomas based on near infrared light emitted perpendicularly into a tissue from a non-stationary emitter and on continuous detection of the reflected light with a non-stationary probe. The device is designed as a handheld detector that can be used either in an ER or at the scene of an accident, which will allow the Doctor or EMT to diagnose hematoma for patients with a traumatic brain injury at the scene. Furthermore, this device can be utilized to discriminate between subdural, epidural and bi-lateral hematomas. The specific combination and sequences of data analysis are performed to discriminate healthy tissue from tissue perfused with blood. This invention will result in a better triage and treatment for patients with traumatic brain injury (TBI) and fills a must filled gap in TBI health care.

The prospective exclusive evaluation option license is being considered under the small business initiative launched on October 1, 2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive evaluation option license, and a subsequent exclusive patent commercialization license, may be granted unless within fifteen (15) days from the date of this published notice, the NIH 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 404.7.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response 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.

Dated: June 4, 2013.

Richard Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.