[Federal Register Volume 79, Number 183 (Monday, September 22, 2014)]
[Notices]
[Page 56591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22454]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Direct Impact Corona 
Ionization Mass Spectrometry

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the Food and Drug Administration, an agency within the 
Department of Health and Human Services, through the National 
Institutes of Health Office of Technology Transfer is contemplating the 
grant of an exclusive worldwide license to practice the inventions 
embodied in HHS Ref. No. E-258-2011/0, ``Direct Impact Corona 
Ionization (DICI) Mass Spectrometry;'' U.S. Patent 8,704,169, to 
Vivione Biosciences, Inc., a corporation incorporated under the laws of 
the State of Arkansas, having a principle place of business at 515 W. 
Matthews Ave., Jonesboro, AR 72401.
    The United States of America is the assignee of the patent rights 
pertaining to this invention.
    The exclusivity period of the contemplated license may be granted 
for no more than seven (7) years, may be territorially limited to the 
United States and may be limited to a field of use directed to direct 
impact corona ionization mass spectrometry pattern recognition devices 
and systems for detection of small molecules and microbiological 
agents.

DATES: Only written comments and/or applications for a license that are 
received by the NIH Office of Technology Transfer on or before October 
22, 2014 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, CLP, Senior Licensing 
and Patent Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-5019; Facsimile: (301) 402-0220; Email: 
[email protected]. A signed confidential disclosure agreement may 
be required to receive copies of the patent application assuming it has 
not already been published under the publication rules of either the 
U.S. Patent and Trademark Office or the World Intellectual Property 
Organization.

SUPPLEMENTARY INFORMATION: E-258-2011/0 (U.S. Patent 8,704,169)--The 
invention relates to the uses of an AccuTOF DART (time-of-flight mass 
spectrometer coupled to direct analysis in real time) mass spectrometer 
for qualitatively analyzing samples (originally designed for microbes) 
based on the serendipitous discovery that glowing direct impact corona 
ionization greatly enhances sensitivity of identification. This direct 
impact corona ionization occurred while repositioning the stainless 
steel pin too close to the grid of the ion source gun. Examination 
revealed that not only did the peak intensity increase by 490 fold but 
the spectral information was well beyond anything seen before with only 
the normal ionization mode on the same instrument. Initially, pyrolysis 
was considered necessary for vaporizing low volatility components of 
microbiological analytes, a prerequisite for ionizing and introducing 
samples into the mass spectrometer. However, pyrolysis introduced 
particles from burned electrical wiring insulation because of the high 
current necessary. As an alternative, the inventors replaced the 
pyrolysis device with a power generator used for direct corona ionizing 
microbiological analytes in a controlled fashion. Furthermore, a small 
custom-made glass cylinder with two juxtaposing holes on each side was 
set up within the sample introduction chamber to exclude oxygen thus 
preventing oxidation of microbiological analytes. Additionally, the 
insulation provided by this cylinder kept out ambient moisture thus 
ensuring proton transfer from water molecules would not contribute to 
irreproducible ionization of the analyte.
    The prospective exclusive license will be royalty-bearing and 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 
404. The prospective exclusive license may be granted unless, within 
thirty (30) days from the date of this published notice, the National 
Institutes of Health Office of Technology Transfer 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.
    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: September 18, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-22454 Filed 9-19-14; 8:45 am]
BILLING CODE 4140-01-P