80_FR_10166 80 FR 10129 - Government-Owned Inventions; Availability for Licensing

80 FR 10129 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 37 (February 25, 2015)

Page Range10129-10130
FR Document2015-03779

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Federal Register, Volume 80 Issue 37 (Wednesday, February 25, 2015) 
[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10129-10130]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03779]


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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. in accordance 
with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Licensing information and copies of 
the U.S. patent applications listed below may be obtained by writing to 
the indicated licensing contact at the Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to 
receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology descriptions follow.

HbF Induction Therapy for Sickle Cell Disease and Thalassemias

    Description of Technology: Sickle cell disease and thalassemia are 
hereditary disorders marked by the disruption in the pathways 
responsible for carrying oxygen to red blood cells. Symptoms associated 
with these disorders include anemia, jaundice, and severe pain. It has 
been shown that mutations during the development of fetal to adult 
hemoglobin can contribute to a delay in red blood cell maturity 
underlying sickle cell disease. As a result, there has been an 
increased focus on treatments that promote the induction of fetal 
hemoglobin (HbF) to improve clinical symptoms and ameliorate the 
severity of the diseases. Researchers at the National Institute of 
Diabetes and Digestive and Kidney Diseases have identified methods of 
increasing fetal hemoglobin by increasing the expression of Lin28 or 
decreased expression of let-7 micro-RNAs. The lead inventor and 
colleagues have developed novel lentiviral expression vectors 
containing hemoglobin regulators under the control of erythroid-
specific promoters that can be used to increase Hbf expression without 
affecting the maturity of red blood cells. In addition, they have 
found, through the use of tough decoy inhibition of Let-7 micro-RNAs, a 
selection of Let-7 genes with greater involvement in HbF expression. 
This technology could lead to development of novel HbF induction 
therapies that reactivate and reduce the aberrant pathologies 
associated with human sickle-cell anemia and beta thalassemia.
    Potential Commercial Applications:
     Ex vivo and in vivo therapeutics for treatment of sickle-
cell anemia and beta thalassemias.
     Potential use in combination with other transduction 
methods for unique therapeutic strategies.
    Competitive Advantages:
     Reduced production of symptom-associated adult hemoglobin.
     Lin28 overexpression at defined stage of hematopoietic 
cell development.
     Therapeutic increases in patient HbF expression at lower 
viral titers than current direct transduction methods.
     Improved safety and reduced toxicity as a result of 
erythroid-specific expression.
    Development Stage:
     Early-stage
     In vitro data available
     In vivo data available (animal)
    Inventors: Jeffery L. Miller, Yuanwei T. Lee, Jaira F. de 
Vasconcellos, Colleen K. Byrnes (all of NIDDK)
    Intellectual Property: HHS Reference No. E-249-2014/0--US 
Provisional Application No. 62/046,247 filed September 5, 2014
    Related Technology: HHS Reference No. E-456-2013/2--PCT Application 
No. PCT/US2013/067811 filed October 31, 2013, which published as WO 
2014/200557 on December 18, 2014
    Licensing Contact: Vince Contreras, Ph.D.; 301-435-4711; 
contrerasv@mail.nih.gov
    Collaborative Research Opportunity: The National Institute of 
Diabetes and Digestive and Kidney Diseases is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize this technology. 
For collaboration opportunities, please contact Marguerite J. Miller at 
millermarg@niddk.nih.gov or 301-496-9003.

T Cell-Based Adoptive Transfer Immunotherapy for Polyomavirus-
Associated Pathologies

    Description of Technology: Available for licensing are methods to 
generate T cells responsive to multiple polyomaviruses. The resulting T 
cell populations could be useful in treating immunosuppressed 
individuals with polyomavirus infections or polyomavirus-associated 
pathologies such as Merkel cell carcinoma (MCC), polyomavirus-
associated nephropathy (PVAN), hemorrhagic cystitis,

[[Page 10130]]

progressive multifocal leukoencephalopathy (PML), and trichodysplasia 
spinulosa (TS). The methods could also be used to restore polyomavirus-
specific immunity in immunocompromised individuals.
    Potential Commercial Applications: Immunotherapy for 
immunosuppressed individuals with polyomavirus-associated pathologies.
    Competitive Advantages: Methods allow development of polyomavirus 
antigen-specific T cells.
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: John A. Barrett (NHLBI), Dhanalakshmi Chinnasamy 
(NHLBI), Pawel J. Muranski (NHLBI), Christopher B. Buck (NCI)
    Intellectual Property: HHS Reference No. E-166-2014/0--US 
Application No. 62/075,726 filed November 5, 2014
    Related Technologies:
     HHS Reference No. E-168-2011
     HHS Reference No. E-549-2013
    Licensing Contact: Patrick McCue, Ph.D.; 301-435-5560; 
mccuepat@od.nih.gov
    Collaborative Research Opportunity: The National Heart, Lung, and 
Blood Institute is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize methods to generate T cells responsive to 
multiple polyomaviruses. For collaboration opportunities, please 
contact Dr. Vincent Kolesnitchenko at kolesniv@nhlbi.nih.gov.

\89\Zr-Oxine Complex for In Vivo PET Imaging of Labelled Cells and 
Associated Methods

    Description of Technology: This technology relates to a Zirconium-
89 (\89\Zr)-oxine complex for cell labeling, tracking of labeled cells 
by whole-body positron emission tomography/computed tomography (PET/CT) 
imaging, and associated methods. A long half-life of \89\Zr (78.4 
hours), high sensitivity of PET and absence of background signal in the 
recipient enable tracking cells over a week using low levels of 
labeling radioactivity, without causing cellular toxicity. The \89\Zr-
oxine complex is synthesized quickly by mixing components at room 
temperature and produces high yields. Cell labeling is achieved by a 
short, room temperature incubation. The \89\Zr-oxine complex is capable 
of labeling a wide range of cell types of therapeutic or pathogenic 
relevance (natural, disease, engineered cells), independent of factors 
such as cell cycle or receptor expression. The label is retained during 
cell division. \89\Zr-oxine labeled cells can also be easily cross 
labeled (for example, optically or magnetically) for multi-modality 
imaging and analysis. Labeled cell migration and kinetics can be 
analyzed and quantified in vivo over a week, improving research 
strategies and ability to develop and improve cell therapies and 
diagnostics.
    Potential Commercial Applications: Cell therapies and diagnostics.
    Competitive Advantages: Simple preparation, broadly applicable cell 
label, high resolution imaging and monitoring over period of a week, 
low toxicity, easily combined with labeling technologies and cell 
therapies.
    Development Stage: In vivo data available (animal).
    Inventors: Noriko Sato (NCI), Haitao Wu (NHLBI), Gary L. Griffiths 
(NCI), Peter L. Choyke (NCI)
    Publications:
    1. Sato N, et al. Generation and use of long-lasting cell labeling 
agent for positron emission tomography (PET) imaging. J Nucl Med. May 
2014; 55 (Supplement 1):273.
    2. Sato N, et al. \89\Zr-oxine complex positron emission tomography 
(PET) cell imaging for monitoring cell-based therapies. Radiology, 
2015, In press.
    Intellectual Property: HHS Reference No. E-080-2014/0--US Patent 
Application No. 61/973,706 filed April 1, 2014
    Licensing Contact: Edward (Tedd) Fenn; 424-297-0336; 
Tedd.fenn@nih.gov
    Collaborative Research Opportunity: The National Cancer Institute 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate or commercialize 
cell labeling, cell tracking, cell trafficking, cell-based therapy, PET 
imaging. For collaboration opportunities, please contact John D. Hewes, 
Ph.D. at john.hewes@nih.gov or 240-276-5515.

    Dated: February 18, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-03779 Filed 2-24-15; 8:45 am]
BILLING CODE 4140-01-P

Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10129 This information will help inform this allow external organizations, such as than one response if they have up to strategic planning process and provide cancer centers, to explore what projects three projects. evidence to inform decisions on are being done in which countries, OMB approval is requested for 3 potential investments in grants for which will facilitate collaborations and years. There are no costs to respondents oncology nursing education in LMICs. minimize duplication. The frequency of other than their time. The total Additionally, this information will be the data collection will be once per year estimated annualized burden hours are used in an online, interactive map that although respondents may have more 51. is being developed by CGH which will ESTIMATED ANNUALIZED BURDEN HOURS Average bur- Number of Number of den per re- Total annual Type of respondents respondents/ responses per sponse burden hours year respondent (in hours) Directors of Nursing ......................................................................................... 68 3 15/60 51 Dated: February 19, 2015. disorders marked by the disruption in • Therapeutic increases in patient Karla Bailey, the pathways responsible for carrying HbF expression at lower viral titers than NCI Project Clearance Liaison, National oxygen to red blood cells. Symptoms current direct transduction methods. Institutes of Health. associated with these disorders include • Improved safety and reduced [FR Doc. 2015–03788 Filed 2–24–15; 8:45 am] anemia, jaundice, and severe pain. It has toxicity as a result of erythroid-specific BILLING CODE 4140–01–P been shown that mutations during the expression. development of fetal to adult Development Stage: hemoglobin can contribute to a delay in • Early-stage DEPARTMENT OF HEALTH AND red blood cell maturity underlying • In vitro data available HUMAN SERVICES sickle cell disease. As a result, there has • In vivo data available (animal) been an increased focus on treatments Inventors: Jeffery L. Miller, Yuanwei National Institutes of Health that promote the induction of fetal T. Lee, Jaira F. de Vasconcellos, Colleen hemoglobin (HbF) to improve clinical K. Byrnes (all of NIDDK) Government-Owned Inventions; symptoms and ameliorate the severity of Intellectual Property: HHS Reference Availability for Licensing the diseases. Researchers at the National No. E–249–2014/0—US Provisional AGENCY: National Institutes of Health, Institute of Diabetes and Digestive and Application No. 62/046,247 filed HHS. Kidney Diseases have identified September 5, 2014 ACTION: Notice. methods of increasing fetal hemoglobin Related Technology: HHS Reference by increasing the expression of Lin28 or No. E–456–2013/2—PCT Application SUMMARY: The inventions listed below decreased expression of let-7 micro- No. PCT/US2013/067811 filed October are owned by an agency of the U.S. RNAs. The lead inventor and colleagues 31, 2013, which published as WO 2014/ Government and are available for have developed novel lentiviral 200557 on December 18, 2014 licensing in the U.S. in accordance with expression vectors containing Licensing Contact: Vince Contreras, 35 U.S.C. 209 and 37 CFR part 404 to hemoglobin regulators under the control Ph.D.; 301–435–4711; contrerasv@ achieve expeditious commercialization of erythroid-specific promoters that can mail.nih.gov of results of federally-funded research be used to increase Hbf expression Collaborative Research Opportunity: and development. Foreign patent without affecting the maturity of red The National Institute of Diabetes and applications are filed on selected blood cells. In addition, they have Digestive and Kidney Diseases is inventions to extend market coverage found, through the use of tough decoy seeking statements of capability or for companies and may also be available inhibition of Let-7 micro-RNAs, a interest from parties interested in for licensing. selection of Let-7 genes with greater collaborative research to further FOR FURTHER INFORMATION CONTACT: involvement in HbF expression. This develop, evaluate or commercialize this Licensing information and copies of the technology could lead to development technology. For collaboration U.S. patent applications listed below of novel HbF induction therapies that opportunities, please contact Marguerite may be obtained by writing to the reactivate and reduce the aberrant J. Miller at millermarg@niddk.nih.gov or indicated licensing contact at the Office pathologies associated with human 301–496–9003. of Technology Transfer, National sickle-cell anemia and beta thalassemia. T Cell-Based Adoptive Transfer Institutes of Health, 6011 Executive Potential Commercial Applications: Immunotherapy for Polyomavirus- Boulevard, Suite 325, Rockville, • Ex vivo and in vivo therapeutics for Associated Pathologies Maryland 20852–3804; telephone: 301– treatment of sickle-cell anemia and beta 496–7057; fax: 301–402–0220. A signed Description of Technology: Available thalassemias. Confidential Disclosure Agreement will for licensing are methods to generate T • Potential use in combination with cells responsive to multiple asabaliauskas on DSK5VPTVN1PROD with NOTICES be required to receive copies of the other transduction methods for unique polyomaviruses. The resulting T cell patent applications. therapeutic strategies. populations could be useful in treating SUPPLEMENTARY INFORMATION: Competitive Advantages: immunosuppressed individuals with Technology descriptions follow. • Reduced production of symptom- polyomavirus infections or HbF Induction Therapy for Sickle Cell associated adult hemoglobin. polyomavirus-associated pathologies Disease and Thalassemias • Lin28 overexpression at defined such as Merkel cell carcinoma (MCC), Description of Technology: Sickle cell stage of hematopoietic cell polyomavirus-associated nephropathy disease and thalassemia are hereditary development. (PVAN), hemorrhagic cystitis, VerDate Sep<11>2014 19:36 Feb 24, 2015 Jkt 235001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1

10130 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices progressive multifocal cell division. 89Zr-oxine labeled cells The meetings will be closed to the leukoencephalopathy (PML), and can also be easily cross labeled (for public in accordance with the trichodysplasia spinulosa (TS). The example, optically or magnetically) for provisions set forth in sections methods could also be used to restore multi-modality imaging and analysis. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., polyomavirus-specific immunity in Labeled cell migration and kinetics can as amended. The grant applications and immunocompromised individuals. be analyzed and quantified in vivo over the discussions could disclose Potential Commercial Applications: a week, improving research strategies confidential trade secrets or commercial Immunotherapy for immunosuppressed and ability to develop and improve cell property such as patentable material, individuals with polyomavirus- therapies and diagnostics. and personal information concerning associated pathologies. Potential Commercial Applications: individuals associated with the grant Competitive Advantages: Methods Cell therapies and diagnostics. applications, the disclosure of which allow development of polyomavirus Competitive Advantages: Simple would constitute a clearly unwarranted antigen-specific T cells. preparation, broadly applicable cell invasion of personal privacy. Development Stage: label, high resolution imaging and Name of Committee: Center for Scientific • Early-stage monitoring over period of a week, low Review Special Emphasis Panel; Member • In vitro data available toxicity, easily combined with labeling Conflict: Autoimmunity Transplantation Inventors: John A. Barrett (NHLBI), technologies and cell therapies. Intolerance. Dhanalakshmi Chinnasamy (NHLBI), Development Stage: In vivo data Date: March 11, 2015. Pawel J. Muranski (NHLBI), Christopher available (animal). Time: 3:00 p.m. to 7:00 p.m. B. Buck (NCI) Inventors: Noriko Sato (NCI), Haitao Agenda: To review and evaluate grant Intellectual Property: HHS Reference Wu (NHLBI), Gary L. Griffiths (NCI), applications. No. E–166–2014/0—US Application No. Peter L. Choyke (NCI) Place: National Institutes of Health, 6701 62/075,726 filed November 5, 2014 Publications: Rockledge Drive, Bethesda, MD 20892, Related Technologies: 1. Sato N, et al. Generation and use of (Telephone Conference Call). • HHS Reference No. E–168–2011 long-lasting cell labeling agent for Contact Person: Betty Hayden, Ph.D., Scientific Review Officer, Center for • HHS Reference No. E–549–2013 positron emission tomography (PET) imaging. J Nucl Med. May 2014; 55 Scientific Review, National Institutes of Licensing Contact: Patrick McCue, Health, 6701 Rockledge Drive, Room 4206, Ph.D.; 301–435–5560; mccuepat@ (Supplement 1):273. MSC 7812, Bethesda, MD 20892, 301–435– od.nih.gov 2. Sato N, et al. 89Zr-oxine complex 1223, haydenb@csr.nih.gov. Collaborative Research Opportunity: positron emission tomography (PET) Name of Committee: Center for Scientific The National Heart, Lung, and Blood cell imaging for monitoring cell-based Review Special Emphasis Panel; Topics in Institute is seeking statements of therapies. Radiology, 2015, In press. Drug Discovery and Mechanisms of capability or interest from parties Intellectual Property: HHS Reference Antimicrobial Resistance. interested in collaborative research to No. E–080–2014/0—US Patent Date: March 13, 2015. further develop, evaluate or Application No. 61/973,706 filed April Time: 8:00 a.m. to 6:00 p.m. commercialize methods to generate T 1, 2014 Agenda: To review and evaluate grant cells responsive to multiple Licensing Contact: Edward (Tedd) applications polyomaviruses. For collaboration Fenn; 424–297–0336; Tedd.fenn@ Place: Residence Inn Bethesda, 7335 opportunities, please contact Dr. nih.gov Wisconsin Avenue, Bethesda, MD 20814. Vincent Kolesnitchenko at kolesniv@ Collaborative Research Opportunity: Contact Person: Guangyong Ji, Ph.D., The National Cancer Institute is seeking Scientific Review Officer, Center for nhlbi.nih.gov. Scientific Review, National Institutes of statements of capability or interest from 89Zr-Oxine Complex for In Vivo PET parties interested in collaborative Health, 6701 Rockledge Drive, Room 3211, Imaging of Labelled Cells and research to further develop, evaluate or MSC 7808, Bethesda, MD 20892, 301–435– 1146, jig@csr.nih.gov. Associated Methods commercialize cell labeling, cell tracking, cell trafficking, cell-based Name of Committee: Center for Scientific Description of Technology: This Review Special Emphasis Panel; Skeletal technology relates to a Zirconium-89 therapy, PET imaging. For collaboration Muscle related SBIR/STTR. (89Zr)-oxine complex for cell labeling, opportunities, please contact John D. Date: March 17, 2015. tracking of labeled cells by whole-body Hewes, Ph.D. at john.hewes@nih.gov or Time: 1:00 p.m. to 4:00 p.m. positron emission tomography/ 240–276–5515. Agenda: To review and evaluate grant computed tomography (PET/CT) Dated: February 18, 2015. applications. imaging, and associated methods. A Richard U. Rodriguez, Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, long half-life of 89Zr (78.4 hours), high Acting Director, Office of Technology (Telephone Conference Call). sensitivity of PET and absence of Transfer, National Institutes of Health. Contact Person: Richard Ingraham, Ph.D., background signal in the recipient [FR Doc. 2015–03779 Filed 2–24–15; 8:45 am] Scientific Review Officer, Center for enable tracking cells over a week using BILLING CODE 4140–01–P Scientific Review, National Institutes of low levels of labeling radioactivity, Health, 6701 Rockledge Drive, Room 4116, without causing cellular toxicity. The MSC 7814, Bethesda, MD 20892, 301–496– 89Zr-oxine complex is synthesized DEPARTMENT OF HEALTH AND 8551, ingrahamrh@mail.nih.gov. quickly by mixing components at room HUMAN SERVICES Name of Committee: Center for Scientific temperature and produces high yields. Review Special Emphasis Panel; Program asabaliauskas on DSK5VPTVN1PROD with NOTICES Cell labeling is achieved by a short, National Institutes of Health Project: Regulation of Cell Survival and room temperature incubation. The 89Zr- Death Pathways by Fe-S Proteins. Center for Scientific Review; Notice of Date: March 19–20, 2015. oxine complex is capable of labeling a Closed Meetings Time: 11:00 a.m. to 5:00 p.m. wide range of cell types of therapeutic Agenda: To review and evaluate grant or pathogenic relevance (natural, Pursuant to section 10(d) of the applications. disease, engineered cells), independent Federal Advisory Committee Act, as Place: National Institutes of Health, 6701 of factors such as cell cycle or receptor amended (5 U.S.C. App.), notice is Rockledge Drive, Bethesda, MD 20892, expression. The label is retained during hereby given of the following meetings. (Virtual Meeting). VerDate Sep<11>2014 18:05 Feb 24, 2015 Jkt 235001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1


Document Created: 2015-12-18 13:08:38
Document Modified: 2015-12-18 13:08:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactLicensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402- 0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.
FR Citation80 FR 10129 
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