81_FR_72798 81 FR 72595 - Government-Owned Invention; Availability for Licensing

81 FR 72595 - Government-Owned Invention; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 203 (October 20, 2016)

Page Range72595-72596
FR Document2016-25343

The invention listed below is owned by an agency of the U.S. Government and is 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.

Federal Register, Volume 81 Issue 203 (Thursday, October 20, 2016) 
[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Notices]
[Pages 72595-72596]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25343]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Invention; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is 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.

FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained 
by emailing the indicated licensing contact at the National Heart, 
Lung, and Blood, Office of Technology Transfer and Development Office 
of Technology

[[Page 72596]]

Transfer, 31 Center Drive Room 4A29, MSC 2479, Bethesda, MD 20892-2479; 
telephone: 301-402-5579. A signed Confidential Disclosure Agreement may 
be required to receive any unpublished information.

SUPPLEMENTARY INFORMATION: Technology description follows.

Capsid-Free AAV Vectors for Gene Delivery and Their Use for Gene 
Therapy

    Description of Technology: The invention concerns novel capsid-free 
AAV vectors that can be used for gene delivery and gene therapy 
applications. The invention provides for a linear nucleic acid molecule 
comprising in this order: A first adeno-associated virus (AAV) inverted 
terminal repeat (ITR), a nucleotide sequence of interest, and a second 
AAV ITR, wherein said nucleic acid molecule is devoid of AAV capsid 
protein coding sequences. The said nucleic acid molecule can be applied 
to a host at repetition without eliciting an immune response. Methods 
of producing and purifying this nucleic acid molecule, as well as its 
use for gene transfer and gene therapy are also described.
    Potential Commercial Applications: The commercial applications of 
the technology relate to the field of gene therapy. It may offer 
significant advantages compared to existing methods of gene delivery 
and gene therapy.
    Competitive Advantages:
     The AAV vectors described in the invention devoid the AAV 
capsid proteins and thus are not exposed to the adverse effects caused 
by immunogenicity.
     In contrast to the use of plasmid DNA for gene delivery, 
the AAV DNA of the invention seems to confer greater stability in cell 
nuclei, allowing prolonged expression compared to plasmid DNA.
     The vector DNA of the invention is not limited in size to 
the packageable size genome.
     The production of the AAV DNA vector is economical, simple 
and provides high yields.
    Development Stage: Early-stage; In vitro data available
    Inventors: Drs. Luis Garcia, Cyriaque Beley, and Thomas Voit 
(INSERM Paris); Drs. Robert M. Kotin and Lina Li (NHLBI).
    Publication: Li L, Dimitriadis EK, Yang Y, Li J, Yuan Z, Qiao C, 
Beley C, Smith RH, Garcia L, Kotin RM. Production and characterization 
of novel recombinant adeno-associated virus replicative-form genomes: A 
eukaryotic source of DNA for gene transfer. PLoS One. 2013 Aug 
1;8(8):e69879. doi: 10.1371/journal.pone.0069879.
    Intellectual Property: NIH Reference No. E-241-2010/0--US Patent 
Application No. 14/004,379 (Publication No. 2014-0107186 A), and its 
foreign counterparts in Europe (11 157986.8; 12 708035.6), Canada 
(2,829,518), Australia (2012228376), Brazil (BR 1 1 2013 023185 8), 
China (201280022523.5), Israel (228328), India (8000/DELNP/2013), Japan 
(2013-557138), and South Korea (10-2013-7026982).
    Licensing Contact: Uri Reichman, Ph.D., M.BA.; Phone: 301-435-4616; 
Email: [email protected].

    Dated: October 13, 2016.
Uri Reichman,
Senior Advisor for Licensing, Office of Technology Transfer and 
Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2016-25343 Filed 10-19-16; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Notices 72595 and QSRS for 2016–2020 and data will Health, 6701 Rockledge Drive, Room 1108, amended (5 U.S.C. App.), notice is be adjusted accordingly. MPSMS did MSC 7890, Bethesda, MD 20892, (301) 435– hereby given of the following meeting. not include an opioids specific measure 1219, currieri@csr.nih.gov. The meeting will be closed to the and QSRS now allows AHRQ to now This notice is being published less than 15 public in accordance with the days prior to the meeting due to the timing track inpatient opioids adverse drug provisions set forth in sections limitations imposed by the review and events. funding cycle. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Descriptions of the surveillance as amended. The grant applications and Name of Committee: Center for Scientific systems, measures, and targets can be Review Special Emphasis Panel; the discussions could disclose found here: https://health.gov/hcq/ade- Fellowships: Risk, Prevention, and Health confidential trade secrets or commercial measures.asp. Behavior. property such as patentable material, Interested persons or organizations Date: October 31–November 1, 2016. and personal information concerning are invited to submit written comments Time: 8:00 a.m. to 5:00 p.m. individuals associated with the grant in response to the proposed measures Agenda: To review and evaluate grant applications, the disclosure of which and targets. Written comments should applications. would constitute a clearly unwarranted not exceed more than two pages per Place: Embassy Suites at the Chevy Chase invasion of personal privacy. ADE measure. The comments should Pavilion, 4300 Military Road NW., Washington, DC 20015. Name of Committee: National Institute of reference the specific measure or target Allergy and Infectious Diseases Special Contact Person: Martha M. Faraday, Ph.D., to which feedback refers. To be Scientific Review Officer, Center for Emphasis Panel Rapid Assessment of Zika considered, the person or representative Scientific Review, National Institutes of Virus (ZIKV) Complications (R21). from an organization must self-identify Health, 6701 Rockledge Drive, Room 3110, Date: November 14, 2016 and submit the written comments by MSC 7808, Bethesda, MD 20892, (301) 435– Time: 1:00 p.m. to 5:00 p.m. close of business on November 21, 2016. 3575, faradaym@csr.nih.gov. Agenda: To review and evaluate grant This notice is being published less than 15 applications. Dated: September 30, 2016. Place: National Institutes of Health, 5601 days prior to the meeting due to the timing Don Wright, limitations imposed by the review and Fishers Lane, Rockville, MD 20892, Deputy Assistant Secretary for Health, (Telephone Conference Call). funding cycle. Director, Office of Disease Prevention and Contact Person: Travis J. Taylor, Ph.D., Name of Committee: Center for Scientific Scientific Review Officer Scientific, Review Health Promotion Office of the Assistant Review Special Emphasis Panel; Member Secretary for Health. Program, Division of Extramural Activities, Conflict: Brain injury. Room 3G62B, 5601 Fishers Lane, MSC 9823, [FR Doc. 2016–25424 Filed 10–19–16; 8:45 am] Date: November 7, 2016. Bethesda, MD 20892–9823, (240) 669–5082, BILLING CODE 4150–32–P Time: 11:00 a.m. to 12:00 p.m. Travis.Taylor@nih.gov. Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance applications. Program Nos. 93.855, Allergy, Immunology, DEPARTMENT OF HEALTH AND Place: National Institutes of Health, 6701 and Transplantation Research; 93.856, HUMAN SERVICES Rockledge Drive, Bethesda, MD 20892, Microbiology and Infectious Diseases (Telephone Conference Call). Research, National Institutes of Health, HHS) National Institutes of Health Contact Person: Samuel C. Edwards, Ph.D., IRG CHIEF, Center for Scientific Review, Dated: October 14, 2016. National Institutes of Health, 6701 Rockledge Natasha M. Copeland, Center for Scientific Review; Notice of Drive, Room 5210, MSC 7846, Bethesda, MD Program Analyst, Office of Federal Advisory Closed Meetings 20892, (301) 435–1246, edwardss@ Committee Policy. Pursuant to section 10(d) of the csr.nih.gov. [FR Doc. 2016–25339 Filed 10–19–16; 8:45 am] Federal Advisory Committee Act, as This notice is being published less than 15 BILLING CODE 4140–01–P amended (5 U.S.C. App.), notice is days prior to the meeting due to the timing hereby given of the following meetings. limitations imposed by the review and The meetings will be closed to the funding cycle. DEPARTMENT OF HEALTH AND public in accordance with the (Catalogue of Federal Domestic Assistance HUMAN SERVICES provisions set forth in sections Program Nos. 93.306, Comparative Medicine; 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 93.333, Clinical Research, 93.306, 93.333, National Institutes of Health 93.337, 93.393–93.396, 93.837–93.844, as amended. The grant applications and 93.846–93.878, 93.892, 93.893, National the discussions could disclose Government-Owned Invention; Institutes of Health, HHS) Availability for Licensing confidential trade secrets or commercial property such as patentable material, Dated: October 14, 2016. AGENCY: National Institutes of Health, and personal information concerning Anna Snouffer, HHS. individuals associated with the grant Deputy Director, Office of Federal Advisory Committee Policy. ACTION: Notice. applications, the disclosure of which would constitute a clearly unwarranted [FR Doc. 2016–25336 Filed 10–19–16; 8:45 am] SUMMARY: The invention listed below is invasion of personal privacy. BILLING CODE 4140–01–P owned by an agency of the U.S. Name of Committee: Center for Scientific Government and is available for Review Special Emphasis Panel; Member licensing in the U.S. in accordance with Conflicts: Genetics and Genomics. DEPARTMENT OF HEALTH AND 35 U.S.C. 209 and 37 CFR part 404 to Date: October 25, 2016. HUMAN SERVICES achieve expeditious commercialization Time: 3:30 p.m. to 6:30 p.m. of results of federally-funded research mstockstill on DSK3G9T082PROD with NOTICES Agenda: To review and evaluate grant National Institutes of Health and development. applications. National Institute of Allergy and FOR FURTHER INFORMATION CONTACT: Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, Infectious Diseases; Notice of Closed Licensing information may be obtained (Telephone Conference Call). Meeting by emailing the indicated licensing Contact Person: Richard A. Currie, Ph.D., contact at the National Heart, Lung, and Scientific Review Officer, Center for Pursuant to section 10(d) of the Blood, Office of Technology Transfer Scientific Review, National Institutes of Federal Advisory Committee Act, as and Development Office of Technology VerDate Sep<11>2014 16:40 Oct 19, 2016 Jkt 241001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM 20OCN1

72596 Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Notices Transfer, 31 Center Drive Room 4A29, transfer. PLoS One. 2013 Aug Date: November 15, 2016. MSC 2479, Bethesda, MD 20892–2479; 1;8(8):e69879. doi: 10.1371/ Time: 1:00 p.m. to 2:00 p.m. telephone: 301–402–5579. A signed journal.pone.0069879. Agenda: To review and evaluate grant applications. Confidential Disclosure Agreement may Intellectual Property: NIH Reference Place: National Institutes of Health, 6701 be required to receive any unpublished No. E–241–2010/0—US Patent Rockledge Drive, Bethesda, MD 20892 information. Application No. 14/004,379 (Publication (Telephone Conference Call). SUPPLEMENTARY INFORMATION: No. 2014–0107186 A), and its foreign Contact Person: Dominique Lorang-Leins, Technology description follows. counterparts in Europe (11 157986.8; 12 Ph.D., Scientific Review Officer, Center for 708035.6), Canada (2,829,518), Australia Scientific Review, National Institutes of Capsid-Free AAV Vectors for Gene (2012228376), Brazil (BR 1 1 2013 Health, 6701 Rockledge Drive, Room 5108, Delivery and Their Use for Gene 023185 8), China (201280022523.5), MSC 7766, Bethesda, MD 20892, 301–326– Therapy 9721, Lorangd@mail.nih.gov. Israel (228328), India (8000/DELNP/ Description of Technology: The Name of Committee: Center for Scientific 2013), Japan (2013–557138), and South Review Special Emphasis Panel; Small invention concerns novel capsid-free Korea (10–2013–7026982). Business: Non-HIV Diagnostics, Food Safety, AAV vectors that can be used for gene Licensing Contact: Uri Reichman, Sterilization/Disinfection, and delivery and gene therapy applications. Ph.D., M.BA.; Phone: 301–435–4616; Bioremediation. The invention provides for a linear Email: uri.reichman@nih.gov. Date: November 17–18, 2016. nucleic acid molecule comprising in Time: 8:00 a.m. to 5:30 p.m. Dated: October 13, 2016. this order: A first adeno-associated virus Agenda: To review and evaluate grant Uri Reichman, applications. (AAV) inverted terminal repeat (ITR), a Senior Advisor for Licensing, Office of Place: Bethesda North Marriott Hotel & nucleotide sequence of interest, and a Conference Center, 5701 Marinelli Road, Technology Transfer and Development, second AAV ITR, wherein said nucleic National Heart, Lung, and Blood Institute. Bethesda, MD 20852. acid molecule is devoid of AAV capsid Contact Person: Gagan Pandya, Ph.D., [FR Doc. 2016–25343 Filed 10–19–16; 8:45 am] protein coding sequences. The said Scientific Review Officer, National Institutes BILLING CODE 4140–01–P nucleic acid molecule can be applied to of Health, Center for Scientific Review, 6701 a host at repetition without eliciting an Rockledge Drive, RM 3200, MSC 7808, immune response. Methods of Bethesda, MD 20892, 301–435–1167, DEPARTMENT OF HEALTH AND pandyaga@mail.nih.gov. producing and purifying this nucleic HUMAN SERVICES acid molecule, as well as its use for gene Name of Committee: Center for Scientific transfer and gene therapy are also Review Special Emphasis Panel; Small National Institutes of Health Business: Medical Imaging. described. Date: November 17–18, 2016. Potential Commercial Applications: Center for Scientific Review; Notice of Time: 8:00 a.m. to 5:00 p.m. The commercial applications of the Closed Meetings Agenda: To review and evaluate grant technology relate to the field of gene applications. therapy. It may offer significant Pursuant to section 10(d) of the Place: Hilton Alexandria Mark Center, advantages compared to existing Federal Advisory Committee Act, as 5000 Seminary Road, Alexandria, VA 22311. methods of gene delivery and gene amended (5 U.S.C. App.), notice is Contact Person: Leonid V. Tsap, Ph.D., therapy. hereby given of the following meetings. Scientific Review Officer, Center for Competitive Advantages: The meetings will be closed to the Scientific Review, National Institutes of • The AAV vectors described in the public in accordance with the Health, 6701 Rockledge Drive, Room 5128, provisions set forth in sections MSC 7854, Bethesda, MD 20892, (301) 435– invention devoid the AAV capsid 2507, tsapl@csr.nih.gov. proteins and thus are not exposed to the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and Name of Committee: Center for Scientific adverse effects caused by Review Special Emphasis Panel; Member immunogenicity. the discussions could disclose Conflict: Biological Chemistry and • In contrast to the use of plasmid confidential trade secrets or commercial Macromolecular Biophysics. DNA for gene delivery, the AAV DNA property such as patentable material, Date: November 17–18, 2016. of the invention seems to confer greater and personal information concerning Time: 8:00 a.m. to 6:00 p.m. stability in cell nuclei, allowing individuals associated with the contract Agenda: To review and evaluate grant prolonged expression compared to proposals, the disclosure of which applications. plasmid DNA. would constitute a clearly unwarranted Place: National Institutes of Health, 6701 • The vector DNA of the invention is invasion of personal privacy. Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). not limited in size to the packageable Name of Committee: Center for Scientific Contact Person: Sergei Ruvinov, Ph.D., size genome. Review Special Emphasis Panel; PAR16–297: Scientific Review Officer, Center for • The production of the AAV DNA Native American Research Centers for Health Scientific Review, National Institutes of vector is economical, simple and (NARCH). Health, 6701 Rockledge Drive, Room 4158, provides high yields. Date: November 14–16, 2016. MSC 7806, Bethesda, MD 20892, 301–435– Development Stage: Early-stage; In Time: 8:00 a.m. to 5:00 p.m. 1180, ruvinser@csr.nih.gov. vitro data available Agenda: To review and evaluate grant Name of Committee: Center for Scientific Inventors: Drs. Luis Garcia, Cyriaque applications. Review Special Emphasis Panel; PAR Panel: Beley, and Thomas Voit (INSERM Place: Crowne Plaza Tyson’s Corner, 1960 Basic Research in Cancer Health Disparities/ Paris); Drs. Robert M. Kotin and Lina Li Chain Bridge Road, Mclean, VA 22102. Diversity. Contact Person: Delia Olufokunbi Sam, Date: November 17–18, 2016. (NHLBI). mstockstill on DSK3G9T082PROD with NOTICES Ph.D., Scientific Review Officer, Center for Time: 8:00 a.m. to 6:00 p.m. Publication: Li L, Dimitriadis EK, Scientific Review, National Institutes of Yang Y, Li J, Yuan Z, Qiao C, Beley C, Agenda: To review and evaluate grant Health, 6701 Rockledge Drive, Room 3158, applications. Smith RH, Garcia L, Kotin RM. MSC 7770, Bethesda, MD 20892, 301–435– Place: Hyatt Regency Bethesda, One Production and characterization of 0684, olufokunbisamd@csr.nih.gov. Bethesda Metro Center, 7400 Wisconsin novel recombinant adeno-associated Name of Committee: Center for Scientific Avenue, Bethesda, MD 20814. virus replicative-form genomes: A Review Special Emphasis Panel; Member Contact Person: Arnold Revzin, Ph.D., eukaryotic source of DNA for gene Conflict: Genetic Diseases. Scientific Review Officer, Center for VerDate Sep<11>2014 16:40 Oct 19, 2016 Jkt 241001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM 20OCN1


Document Created: 2016-10-21 09:58:54
Document Modified: 2016-10-21 09:58:54
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 may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive Room 4A29, MSC 2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information.
FR Citation81 FR 72595 
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