Notice2024-11796
Government-Owned Inventions; Availability for Licensing
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 30, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
Full Text
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<title>Federal Register, Volume 89 Issue 105 (Thursday, May 30, 2024)</title>
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[Federal Register Volume 89, Number 105 (Thursday, May 30, 2024)]
[Notices]
[Pages 46895-46896]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-11796]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. to achieve
expeditious commercialization of results of federally-funded research
and development.
FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained
by emailing the licensing contact Michael Shmilovich, Esq, MS, CLP;
301-435-5019; <a href="/cdn-cgi/l/email-protection#0964606a61686c65277a61646065667f606a6149676061276e667f"><span class="__cf_email__" data-cfemail="a2cfcbc1cac3c7ce8cd1cacfcbcecdd4cbc1cae2cccbca8cc5cdd4">[email protected]</span></a> at the National Heart, Lung,
and Blood, Office of Technology Transfer and Development Office of
Technology Transfer, 31 Center Drive, Room 4A25, MSC2479, Bethesda, MD
20892-2479. A signed Confidential Disclosure Agreement may be required
to receive any unpublished information.
SUPPLEMENTARY INFORMATION: This notice is in accordance with 35 U.S.C.
209 and 37 CFR part 404. Technology description follows.
Next generation MRI platform Signal Amplification by Reversible
Exchange (SABRE) hyperpolarization:
Hyperpolarized magnetic resonance imaging (MRI) is an emerging
molecular imaging method for metabolic imaging for detecting cancer,
cardiovascular disease, stroke, and traumatic brain injury and
monitoring therapy with no Gadolinium or Iron. Available for licensing
and commercial development is a patent estate covering a perfluorinated
single amplification by reversible exchange (SABRE) catalyst for
generating MRI agents that includes a d-block element and a
perfluorinated ligand hyperpolarized substrate comprising a \1/2\ spin
nucleus or nuclei using the perfluorinated SABRE catalysts, and
isolating the resulting hyperpolarized substrate for administration.
The invention also provides methods for separating a hyperpolarized
substrate from the SABRE catalyst and/or hyperpolarized SABRE catalyst
complex containing a
[[Page 46896]]
heavy metal. These changes can be observed in patients in real time
with a specialized MRI approach called hyperpolarization. By
transiently changing the nuclear spin of naturally occurring
intermediates in cellular energy production, the metabolic fate can be
observed with greater than 10,000-fold sensitivity. Current methods of
hyperpolarization require expensive machines with limited throughput.
Potential Commercial Applications:
<bullet> MRI imaging
<bullet> Hyperpolarization
<bullet> Infusion Device for imaging reagents
<bullet> Cancer diagnostics
<bullet> Cardiovascular disease diagnostics
Development Stage:
<bullet> Early stage
Inventors: Rolf E. Swenson (NHLBI), Jessica H. Ettedgui-Benjamini
(NHLBI), Carolyn Woodroofe Hitko (NCI), Murali K. Cherukuri (NCI), and
Natarajan Raju (NHLBI).
Intellectual Properties:
<bullet> HHS Reference No. E-035-2022-0 ``Preparation Of
Isotopically Labeled Ketoglutarates And Methods Of Hyperpolarization
Through Signal Amplification By Reversible Exchange (SABRE)''; U.S.
Provisional Patent Application No. 63/303,190 filed January 26, 2022;
Patent Cooperation Treaty Application PCT/US2023/011640 filed January
26, 2023.
<bullet> HHS Reference No. E-036-2022 ``Sabre Catalysts Containing
Fluorinated Carbon Chains For Delivery Of Metal-Free MRI Contrast
Agents''; U.S. Provisional Patent Application 63/328,545 filed April 7,
2022; Patent Cooperation Treaty Application PCT/US2023/017885 filed
April 7, 2023, U.S. Patent Application 18/410,773 filed January 11,
2024, Applications also pending in Japan, Canada, Israel, China, and
Europe.
<bullet> HHS Reference No. E-052-2022 ``Infusion device for the
preparation and delivery of MRI probes,'' U.S. Provisional Patent
Application 63/328,556 filed April 7, 2022, Patent Cooperation Treaty
Application PCT/US2023/017895 filed April 7, 2023.
<bullet> HHS Reference No. E-069-2020 ``Real-time Monitoring Of In
Vivo Free Radical Scavengers Through Hyperpolarized [1-\13\C] N-acetyl
Cysteine,'' U.S. Provisional Patent Application 62/961,855 filed
January 16, 2020, Patent Cooperation Treaty Application PCT/US2021/
013634 filed January 15, 2021, European Patent Application 21741034.9
filed January 15, 2021, Israeli Patent Application 294365 filed January
15, 2021, European Patent Application 17/793,083 filed January 15,
2021.
<bullet> HHS Reference No. E-070-2020 ``Isotopes Of Alpha
Ketoglutarate And Related Compounds For Hyperpolarized MRI Imaging,''
U.S. Provisional Patent Application 62/962,473 filed January 17, 2020,
Patent Cooperation Treaty Application PCT/US2021/013658 filed January
15, 2021, European Patent Application 21741941.5 filed January 15,
2021, Israeli Patent Application 294464 filed January 15, 2021, U.S.
Patent Application 17/793,089 filed January 15, 2021.
<bullet> HHS Reference No. E-039-2022 ``Temperature Cycling Method
for Hyperpolarization of Target Molecules and Contrast Agents using
Parahydrogen,'' US Provisional Patent Application 63/203591 filed July
27, 2021. Patent Cooperation Treaty Application PCT/US2022/074122 filed
July 26, 2022, U.S. Application 18/291,681.
Publications:
<bullet> Perfluorinated Iridium catalyst for signal amplification
by reversible exchange provides metal-free aqueous hyperpolarized [1-
<SUP>13</SUP>C]-Pyruvate. J. Ettedgui, B. Blackman, N. Raju, S. Kotler,
E. Chekmenev, B. Goodson, H. Merkle, C. Woodroofe, C. LeClair, K.
Murali, R. Swenson J. Am. Chem. Soc. 2024, 146, 946-953.
<bullet> Monitoring response to a clinically relevant IDH inhibitor
in glioma--Hyperpolarized <SUP>13</SUP>C magnetic resonance
spectroscopy approaches. D. Hong, Y. Kim, C. Mushti, N. Minami, J. Wu,
M. K. Cherukuri, R. E. Swenson, D. B. Vigneron, S. M. Ronen. Neuro-
Oncology Advances 2023, DOI: <a href="https://academic.oup.com/noa/article/5/1/vdad143/7337326">https://academic.oup.com/noa/article/5/1/vdad143/7337326</a>.
<bullet> Catalyst-Free Aqueous Hyperpolarized \13\C-Pyruvate
Obtained by Re-Dissolution Signal Amplification by Reversible Exchange
A. B. Schmidt; H. de Maissin; I. Adelabu; S. Nantogma; J. Ettedgui; P.
TomHon; B. M Goodson.; T. Theis; E. Y. Chekmenev. ACS Sensors 2022, 7
(11), 3430-3439.
<bullet> Rapid <SUP>13</SUP>C Hyperpolarization of the TCA-Cycle
Intermediate [alpha]-Ketoglutarate via SABRE-SHEATH. I. Adelabu,
Isaiah; Ettedgui, Jessica; Joshi, Sameer; Nantogma, Shiraz; Chowdhury,
Md Raduanul; McBride, Stephen; Theis, Thomas; Sabbasani, Venkata;
Chandrasekhar, Mushti; Sail, Deepak; Yamamoto, Kazutoshi; Swenson,
Rolf; Krishna, Murali; Goodson, Boyd; Chekmenev, Eduard. Anal. Chem.
2022, 94, 13422-13431.
<bullet> Order-Unity <SUP>13</SUP>C Nuclear Polarization of [1-
<SUP>13</SUP>C]Pyruvate in Seconds and the Interplay of Water and SABRE
Enhancement. I. Adelabu, P. TomHon, M. S. H. Kabir, S Nantogma, M.
Abdulmojeed, I. Mandzhieva, J. Ettedgui, R. E. Swenson, M. C. Krishna,
T. Theis, B. M. Goodson, and E. Y. Chekmenev. ChemPhysChem. 2022, 23,
131-136.
<bullet> Simple esterification of [1-<SUP>13</SUP>C]-alpha-
ketoglutarate enhances membrane permeability and allows for non-
invasive tracing of glutamate and glutamine production. J. AbuSalim, K.
Yamamoto, N. Miura, B. Blackman, J. Brender, C. Mushti, T. Seki, K.
Camphausen, R. Swenson, M. Krishna, A. Kesarwala. ACS Chem. Biol. 2021,
16, 2144-2150. DOI: 10.1021/acschembio.1c00561
<bullet> Synthesis of [1-<SUP>13</SUP> C-5-12 C]-alpha-
ketoglutarate enables non-invasive detection of 2-hydroxyglutarate. N.
Miura, C. Mushti, D. Sail, J. E. Bingham, K. Yamamoto, J. R. Brender,
T. Seki, D. I. AbuSalim, S. Matsumoto, K. A. Camphausen, M. C. Krishna,
R. E. Swenson, A. H. Kesarwala. NMR in Biomedicine 2021, 34, e4588.
<a href="https://doi.org/10.1002/nbm.4588">https://doi.org/10.1002/nbm.4588</a>.
<bullet> Low-cost High-Pressure Clinical-Scale 50% Parahydrogen
Generator Using Liquid Nitrogen at 77 K. B. Chapman, B. Joalland, C.
Meersman, J. Ettedgui, R. E. Swenson, M. C. Krishna, P. Nikolaou, K.V.
Kovtunov, O. G. Salnikov, I. V. Koptyug, M. E. Gemeinhardt, B. M.
Goodson, R. V. Shchepin, and E. Y. Chekmenev. Anal. Chem. 2021, 93,
8476-8483.
<bullet> Real Time Insight into In Vivo Redox Status utilizing
Hyperpolarized [1-\13\C] N-Acetyl Cysteine. K. Yamamoto, A. Opina, D.
Sail, B. Blackman, K. Saeito, J. R. Brender, R. M. Malinowski, T. Seki,
N. Oshima, D. R. Crooks, S. Kishimoto, Y. Saida, Y. Otowa, P. L.
Choyke, J. H. Ardenkjaer-Larsen, J. B. Mitchell, W. M. Linehan, R. E.
Swenson, M. C. Krishna. Sci. Reports 2021, 11, 12155.
Dated: May 23, 2024.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood
Institute, Office of Technology Transfer and Development.
[FR Doc. 2024-11796 Filed 5-29-24; 8:45 am]
BILLING CODE 4140-01-P
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