Government-Owned Inventions; Availability for Licensing, 26791-26792 [2013-10857]

Download as PDF Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Notices Some respondents indicated that the use of certain technology-based platforms may restrict access to the underserved, who might have limited access to smartphones or the internet. One additional concern that was voiced by numerous respondents was confusion regarding the purpose of TXT4Tots and how it is intended to be used. Specifically, it was unclear that this is a library of messages that could be used in a variety of existing platforms and products and not exclusively a text messaging service. Guidance regarding specific details about the use of the TXT4Tots messages has been added to the TXT4Tots Web page (https://www.hrsa.gov/healthit/txt4tots). HRSA appreciates all of the thoughtful comments received either via the RFI or Open Forum. Guidance regarding specific details about the use of the TXT4Tots messages has been added to the TXT4Tots Web page (https://www.hrsa.gov/healthit/txt4tots). It is our hope that the thoughtful recommendations and comments will spur others to explore innovative ways for disseminating the TXT4Tots content. FOR FURTHER INFORMATION CONTACT: Bethany Applebaum, MPH, Health Resources and Services Administration, Office of Women’s Health and Office of Health Information Technology and Quality, 5600 Fishers Lane, Room 7– 100, Rockville, Maryland 20857, or email bapplebaum@hrsa.gov. Dated: May 2, 2013. Mary K. Wakefield, Administrator. [FR Doc. 2013–10968 Filed 5–7–13; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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. 207 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. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:56 May 07, 2013 Jkt 229001 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. Induced Pluripotent Stem Cells Generated Using Lentivirus-Based Reprogramming Description of Technology: Five human induced pluripotent stem cells (iPSC) lines are generated using lentivirus-based reprogramming technology. These lines are pluripotent, meaning they have the potential to differentiate into all cells in the body, and theoretically can proliferate/selfrenew indefinitely. The iPSC lines are: NC1 (derived from female’s fibroblasts), NC2 (derived from female’s fibroblasts), NC3 (derived from male’s HUVECS), NC4 (derived from male’s fibroblasts) and NC5 (derived from female’s fibroblasts). Further details of these cells are available upon request. NC1 uses a retrovirus delivery system incorporating the following vectors: pMIG–hKLF4, pMIG–hOCT4, pMIG–hSOX2, and MSCV h c–MYC IRES GFP. NC2–NC5 use the hSTEMCCA–loxP lentivirus delivery system (a gift from Dr. Gustavo Mostoslavsky). These cell lines will be useful for studies related to stem cell biology, understanding diseases, potential cell therapies, and small molecule screening. Potential Commercial Applications: The iPSCs of this technology are useful: (a) To study the biology of stem cell development, (b) as controls in studies to screen for small molecules to change cell fate and/ or to alleviate the phenotypes of various diseases, and (c) to test different characterization and differentiation assays. Competitive Advantages: • These cells can serve as control cells and, thus, significantly reduce the cost of initiating many research projects. • These cells can be a good source of control cells. Development Stage: • Prototype • Pilot • Early-stage • In vitro data available Inventors: Drs. Guibin Chen and Manfred Boehm (NHLBI) Intellectual Property: HHS Reference No. E–274–2012/0—Research Tools. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 26791 Patent protection is not being pursued for this technology. Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301–435–5020; vepas@mail.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 Induced Pluripotent Stem Cells. For collaboration opportunities, please contact Denise Crooks, OTTAD, at 301–435–0103. Stapled Peptides for Treatment of Cardiovascular Diseases and Inflammation Description of Technology: The invention is directed to small molecule mimetics of apolipoproteins that have an inter-helical hydrocarbon bond, which stabilizes helix formation. Apolipoproteins facilitate the transport of lipids and cholesterol in the body. Mimetics of apolipoproteins have been used to treat cholesterol-related disorders. However, these mimetics are susceptible to degradation in biological fluids and as a result, their ability to bind cholesterol becomes diminished over time. Scientists at NHLBI have devised methods to stabilize and improve the performance of apolipoprotein mimetic peptides, using a modified hydrocarbon chain (‘‘stapled apolipoproteins’’). These stapled apolipoproteins are superior to singular apolipoproteins in that they are more resistant to enzymatic degradation and efflux a greater amount of cellular cholesterol. Stapled apolipoproteins can be used in the treatment of cardiovascular diseases, particularly for treatment of atherosclerosis. Potential Commercial Applications: • Treatment of inflammation and cardiovascular diseases, including hyperlipidemia, atherosclerosis, restenosis, and acute coronary syndrome. • Inclusion in oral, intravenous or transdermal peptide formulations. Competitive Advantages: • Stapled apolipoproteins are more resistant to proteolysis and display enhanced bioavailability. • Stapled apolipoproteins are amenable to oral delivery and have increased permeability to the blood brain barrier. Development Stage: • Pre-clinical • In vitro data available • In vivo data available (animal) Inventors: Alan T. Remaley (CC), Marcelo A. Amar (NHLBI), Imoh Z. E:\FR\FM\08MYN1.SGM 08MYN1 26792 Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES Ikpot (NHLBI), Denis O. Sviridov (NHLBI), David O. Osei-Hwedieh (NHLBI), Scott Turner (KineMed) Publication: Osei-Hwedieh DO, et al. Apolipoprotein mimetic peptides: Mechanisms of action as antiatherogenic agents. Pharmacol Ther. 2011 Apr;130(1):83–91. [PMID 21172387] Intellectual Property: HHS Reference No. E–126–2011/0—US Application No. 61/480,986 filed 29 April 2011; PCT Application No. PCT/US1235870 filed 30 April 2012 Licensing Contact: Lauren NguyenAntczak, Ph.D., J.D.; 301–435–4074; lauren.nguyen-antczak@nih.gov Collaborative Research Opportunity: The NHLBI Lipoprotein Metabolism Section is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize Hydrocarbon-stapled Apolipoprotein Peptide Mimetics for the Treatment of Cardiovascular Diseases and Inflammation. For collaboration opportunities, please contact Denise Crooks, Ph.D. at crooksd@nhlbi.nih.gov. Parvovirus B19 Vaccine Description of Technology: Parvovirus B19 (B19V) infection causes fifth disease, a disease characterized by rashes to the face and other parts of the body that primarily affects children. However, adults can also develop fifth disease and it can lead to more severe conditions. Patients that are immunocompromised, such as those who are HIV infected, organ transplant recipients, and cancer patients, can be particularly susceptible to more severe outcomes from B19V infection. Infection can also cause anemia and in pregnant women, it can lead to hydrops fetalis. The subject technologies are expression vectors for the production of B19V VP1 and VP2 capsid proteins. Coexpression of the two proteins produce empty virus-like particles (VLPs) that can be used to develop a vaccine against parvovirus B19 and a packaging system for infectious B19V virus. Different expression vectors have been developed and optimized for expression in insects cells and more recently in mammalian cell lines such as 293, Cos7, Hela cells and 293T cells. Potential Commercial Applications: Vaccine against parvovirus B19V. Competitive Advantages: There is currently no B19V vaccine on the market. Development Stage: • Early-stage • Pre-clinical • Clinical VerDate Mar<15>2010 17:56 May 07, 2013 Jkt 229001 • In vitro data available • In vivo data available (animal) • In vivo data available (human) Inventors: Neal S. Young, Takashi Shimada, Sachiko Kajigaya, Ning Zhi (NHLBI) Publications: 1. Bernstein DI, et al. Safety and immunogenicity of a candidate parvovirus B19 vaccine. Vaccine. 2011 Oct 6;29(43):7357–63. [PMID 21807052] 2. Zhi N, et al. Codon optimization of human parvovirus B19 capsid genes greatly increases their expression in nonpermissive cells. J Virol. 2010 Dec;84(24):13059–62. [PMID 20943969] Intellectual Property: • HHS Reference No. E–286–1988/ 2—U.S. Patent No. 5,916,563 issued 29 Jun 1999 • HHS Reference No. E–286–1988/ 1—U.S. Patent No. 6,001,371 issued 14 Dec 1999; U.S. Patent No. 6,132,732 issued 17 Oct 2000 • HHS Reference No. E–266–2000/ 0—U.S. Patent No. 6,558,676 issued 06 May 2003 • HHS Reference No. E–011–2010/ 0—International PCT Appl. No. PCT/ US2011/024199 with national stage filings in the U.S. and Europe Licensing Contact: Kevin W. Chang, Ph.D.; 301–435–5018; changke@mail.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 the technology for producing Parvovirus B19 vaccine. For collaboration opportunities, please contact Cecilia Pazman, Ph.D. at pazmance@mail.nih.gov. Dated May 2, 2013. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–10857 Filed 5–7–13; 8:45 am] BILLING CODE 4140–01–P provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; R13 Conference. Date: June 19, 2013. Time: 2:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: D. G. Patel, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 756, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7682, pateldg@niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; NIDDK nGUDMAP U01 Application Review. Date: July 8, 2013. Time: 9:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015. Contact Person: Xiaodu Guo, Md, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 761, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–4719, guox@extra.niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: May 2, 2013. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–10856 Filed 5–7–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 BILLING CODE 4140–01–P National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. E:\FR\FM\08MYN1.SGM 08MYN1

Agencies

[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Pages 26791-26792]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10857]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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. 207 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.

Induced Pluripotent Stem Cells Generated Using Lentivirus-Based 
Reprogramming

    Description of Technology: Five human induced pluripotent stem 
cells (iPSC) lines are generated using lentivirus-based reprogramming 
technology. These lines are pluripotent, meaning they have the 
potential to differentiate into all cells in the body, and 
theoretically can proliferate/self-renew indefinitely. The iPSC lines 
are: NC1 (derived from female's fibroblasts), NC2 (derived from 
female's fibroblasts), NC3 (derived from male's HUVECS), NC4 (derived 
from male's fibroblasts) and NC5 (derived from female's fibroblasts). 
Further details of these cells are available upon request. NC1 uses a 
retrovirus delivery system incorporating the following vectors: pMIG-
hKLF4, pMIG-hOCT4, pMIG-hSOX2, and MSCV h c-MYC IRES GFP. NC2-NC5 use 
the hSTEMCCA-loxP lentivirus delivery system (a gift from Dr. Gustavo 
Mostoslavsky). These cell lines will be useful for studies related to 
stem cell biology, understanding diseases, potential cell therapies, 
and small molecule screening.
    Potential Commercial Applications: The iPSCs of this technology are 
useful:
    (a) To study the biology of stem cell development,
    (b) as controls in studies to screen for small molecules to change 
cell fate and/or to alleviate the phenotypes of various diseases, and
    (c) to test different characterization and differentiation assays.
    Competitive Advantages:
     These cells can serve as control cells and, thus, 
significantly reduce the cost of initiating many research projects.
     These cells can be a good source of control cells.
    Development Stage:
     Prototype
     Pilot
     Early-stage
     In vitro data available
    Inventors: Drs. Guibin Chen and Manfred Boehm (NHLBI)
    Intellectual Property: HHS Reference No. E-274-2012/0--Research 
Tools. Patent protection is not being pursued for this technology.
    Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; vepas@mail.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 Induced Pluripotent Stem Cells. For 
collaboration opportunities, please contact Denise Crooks, OTTAD, at 
301-435-0103.

Stapled Peptides for Treatment of Cardiovascular Diseases and 
Inflammation

    Description of Technology: The invention is directed to small 
molecule mimetics of apolipoproteins that have an inter-helical 
hydrocarbon bond, which stabilizes helix formation.
    Apolipoproteins facilitate the transport of lipids and cholesterol 
in the body. Mimetics of apolipoproteins have been used to treat 
cholesterol-related disorders. However, these mimetics are susceptible 
to degradation in biological fluids and as a result, their ability to 
bind cholesterol becomes diminished over time.
    Scientists at NHLBI have devised methods to stabilize and improve 
the performance of apolipoprotein mimetic peptides, using a modified 
hydrocarbon chain (``stapled apolipoproteins''). These stapled 
apolipoproteins are superior to singular apolipoproteins in that they 
are more resistant to enzymatic degradation and efflux a greater amount 
of cellular cholesterol.
    Stapled apolipoproteins can be used in the treatment of 
cardiovascular diseases, particularly for treatment of atherosclerosis.
    Potential Commercial Applications:
     Treatment of inflammation and cardiovascular diseases, 
including hyperlipidemia, atherosclerosis, restenosis, and acute 
coronary syndrome.
     Inclusion in oral, intravenous or transdermal peptide 
formulations.
    Competitive Advantages:
     Stapled apolipoproteins are more resistant to proteolysis 
and display enhanced bioavailability.
     Stapled apolipoproteins are amenable to oral delivery and 
have increased permeability to the blood brain barrier.
    Development Stage:
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Alan T. Remaley (CC), Marcelo A. Amar (NHLBI), Imoh Z.

[[Page 26792]]

Ikpot (NHLBI), Denis O. Sviridov (NHLBI), David O. Osei-Hwedieh 
(NHLBI), Scott Turner (KineMed)
    Publication: Osei-Hwedieh DO, et al. Apolipoprotein mimetic 
peptides: Mechanisms of action as anti-atherogenic agents. Pharmacol 
Ther. 2011 Apr;130(1):83-91. [PMID 21172387]
    Intellectual Property: HHS Reference No. E-126-2011/0--US 
Application No. 61/480,986 filed 29 April 2011; PCT Application No. 
PCT/US1235870 filed 30 April 2012
    Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; lauren.nguyen-antczak@nih.gov
    Collaborative Research Opportunity: The NHLBI Lipoprotein 
Metabolism Section is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize Hydrocarbon-stapled Apolipoprotein Peptide 
Mimetics for the Treatment of Cardiovascular Diseases and Inflammation. 
For collaboration opportunities, please contact Denise Crooks, Ph.D. at 
crooksd@nhlbi.nih.gov.

Parvovirus B19 Vaccine

    Description of Technology: Parvovirus B19 (B19V) infection causes 
fifth disease, a disease characterized by rashes to the face and other 
parts of the body that primarily affects children. However, adults can 
also develop fifth disease and it can lead to more severe conditions. 
Patients that are immunocompromised, such as those who are HIV 
infected, organ transplant recipients, and cancer patients, can be 
particularly susceptible to more severe outcomes from B19V infection. 
Infection can also cause anemia and in pregnant women, it can lead to 
hydrops fetalis.
    The subject technologies are expression vectors for the production 
of B19V VP1 and VP2 capsid proteins. Co-expression of the two proteins 
produce empty virus-like particles (VLPs) that can be used to develop a 
vaccine against parvovirus B19 and a packaging system for infectious 
B19V virus. Different expression vectors have been developed and 
optimized for expression in insects cells and more recently in 
mammalian cell lines such as 293, Cos7, Hela cells and 293T cells.
    Potential Commercial Applications: Vaccine against parvovirus B19V.
    Competitive Advantages: There is currently no B19V vaccine on the 
market.
    Development Stage:
     Early-stage
     Pre-clinical
     Clinical
     In vitro data available
     In vivo data available (animal)
     In vivo data available (human)
    Inventors: Neal S. Young, Takashi Shimada, Sachiko Kajigaya, Ning 
Zhi (NHLBI)
    Publications:
    1. Bernstein DI, et al. Safety and immunogenicity of a candidate 
parvovirus B19 vaccine. Vaccine. 2011 Oct 6;29(43):7357-63. [PMID 
21807052]
    2. Zhi N, et al. Codon optimization of human parvovirus B19 capsid 
genes greatly increases their expression in nonpermissive cells. J 
Virol. 2010 Dec;84(24):13059-62. [PMID 20943969]
    Intellectual Property:
     HHS Reference No. E-286-1988/2--U.S. Patent No. 5,916,563 
issued 29 Jun 1999
     HHS Reference No. E-286-1988/1--U.S. Patent No. 6,001,371 
issued 14 Dec 1999; U.S. Patent No. 6,132,732 issued 17 Oct 2000
     HHS Reference No. E-266-2000/0--U.S. Patent No. 6,558,676 
issued 06 May 2003
     HHS Reference No. E-011-2010/0--International PCT Appl. 
No. PCT/US2011/024199 with national stage filings in the U.S. and 
Europe
    Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018; 
changke@mail.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 the technology for producing Parvovirus B19 
vaccine. For collaboration opportunities, please contact Cecilia 
Pazman, Ph.D. at pazmance@mail.nih.gov.

     Dated May 2, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-10857 Filed 5-7-13; 8:45 am]
BILLING CODE 4140-01-P
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