Government-Owned Inventions; Availability for Licensing, 3440-3441 [2013-00737]

Download as PDF 3440 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Notices Dated: January 10, 2013. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–00738 Filed 1–15–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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. mstockstill on DSK4VPTVN1PROD with SUMMARY: Transmission-Blocking Malaria Vaccine Description of Technology: There is no vaccine for malaria, and there is growing resistance to existing antimalarial drugs. Sexual stage-specific antigens are of interest as vaccine candidates because disruption of these antigens would reduce the fertility and, thus, the infectivity of the parasite. This invention claims methods and compositions for delivering a Plasmodium P47 vaccine or antibody to P47 to prevent Plasmodium falciparum or Plasmodium vivax malaria. P47 and other antigens have been mentioned as potential transmission-blocking vaccines due to their surface location on gametes. The gene for P47 antigens is also well characterized. Recent discoveries have noted that P47 allows the parasite to suppress or evade the immune system, thereby ensuring the VerDate Mar<15>2010 17:01 Jan 15, 2013 Jkt 229001 mosquitoes’ survival. Recent discoveries have also shown the mechanism by which P47 enables survival of the parasite by manipulation of the mosquito immune system. Based on the critical role of P47 antigens in transmission, the disruption of the function of P47 by various means can be an innovative and forceful means to control and/or reduce the prevalence of malaria. Potential Commercial Applications: Malaria vaccine, diagnostic and therapeutic. Competitive Advantages: • Single protein malaria transmission-blocking vaccine. • Cost-effective, simple manufacturing process for vaccine. • Potentially lower-cost malarial vaccine for developing/developed countries. Development Stage: • Pre-clinical. • In vitro data available. • In vivo data available (animal). Inventors: Carolina Barillas-Mury and Alvaro Molina-Cruz (NIAID). Publication: Molina-Cruz A, et al. Some strains of Plasmodium falciparum, a human malaria parasite, evade the complement-like system of Anopheles gambiae mosquitoes. Proc Natl Acad Sci U S A. 2012 Jul 10;109(28):E1957–62. [PMID 22623529] Intellectual Property: HHS Reference No. E–222–2012/0 — US Application No. 61/684,333 filed 17 Aug 2012. Licensing Contact: Peter A. Soukas; 301–435–4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases (NIAID) is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize malaria vaccines, diagnostics and therapeutics. For collaboration opportunities, please contact Tristan J. Mahyera at tristan.mahyera@nih.gov or 301–827– 0251. Methods and Composition for Identification of Variants of JC Virus DNA; An Etiologic Agent for Progressive Multifocal Leukoencephalopathy (PML) Description of Technology: JC Virus causes a fatal disease in the brain called progressive multifocal leukoencephalopathy (PML) that occurs in many patients with immunocompromised conditions. The finding of JCV DNA in the patients with neurological symptoms of PML is a diagnostic criterion and is needed to confirm the diagnosis of PML to rule out other neurological conditions. Certain PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 JC virus variants are known to have a greater association with PML. For example, ‘‘Prototype’’ JC virus is far more pathogenic than ‘‘Archetype’’ JC virus. This invention claims novel assays for identifying Archetype and/or Prototype JC virus by detecting the presence or absence of the unique Archetype nucleic acid sequence in the non-coding regulatory region of JC virus. While the sequences of Archetype and Prototype JC virus are known, these are the first assays that allow discrimination between Prototype and Archetype JC virus in a simple assay without the need for DNA sequencing. The identification of a JC virus as a prototype can lead to early treatment of infected individuals. Potential Commercial Applications: • JCV diagnostic kits. • JCV diagnostics. Competitive Advantages: • DNA sequencing not required. • Single assay format using same template to identify prototype and archetype with 10c/ml sensitivity. Development Stage: • Clinical. • In vitro data available. • In vivo data available (human). Inventors: Eugene O. Major and Caroline F. Ryschkewitsch (NINDS). Publication: Perkins MR, et al. Changes in JC Virus-Specific T Cell Responses during Natalizumab Treatment and in NatalizumabAssociated Progressive Multifocal Leukoencephalopathy. PLoS Pathog. 2012 Nov;8(11):e1003014. [PMID 23144619] Intellectual Property: HHS Reference No. E–088–2012—US Application No. 61/661,289 filed 18 Jun 2012. Related Technology: HHS Reference No. E–152–2009/0—Research Material. Patent protection is not being pursued for this technology. Licensing Contact: Peter A. Soukas; 301–435–4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The National Institute of Neurological Disorders and Stroke is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize assays for the detection of JC Virus. For collaboration opportunities, please contact Melissa Maderia at maderiam@mail.nih.gov or 301–451–3943. Cross-Reactive Dengue Fully Human Monoclonal Antibodies Description of Technology: Among the arthropod-borne flaviviruses, the four dengue virus serotypes, dengue type 1 virus (DENV–1), dengue type 2 virus (DENV–2), dengue type 3 virus (DENV– E:\FR\FM\16JAN1.SGM 16JAN1 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Notices 3), and dengue type 4 virus (DENV–4) are most important in terms of human morbidity and geographic distribution. Dengue viruses cause dengue outbreaks and major epidemics in most tropical and subtropical areas where Aedes albopictus and Aedes aegypti mosquitoes are abundant. A safe and effective vaccine against dengue is currently not available. Passive immunization with monoclonal antibodies from non-human primates or humans represents a possible alternative to vaccines for prevention of illness caused by dengue virus. This invention claims fully human monoclonal antibodies that bind and neutralize dengue type 1, 2, 3 and 4 viruses. It also claims fragments of such antibodies and nucleic acids encoding the antibodies of the invention as well as prophylactic, therapeutic and diagnostic methods employing the antibodies and nucleic acids of the invention. Potential Commercial Applications: • Prophylaxis/therapy against dengue serotypes 1, 2, 3, and 4. • Dengue diagnostics. Competitive Advantages: • Antibodies are cross-reactive with all four serotypes of dengue. • Antibodies are fully human. Development Stage: • Pre-clinical. • In vitro data. Inventors: Dimiter S. Dimitrov and Zhongyu Zhu (NCI). Intellectual Property: HHS Reference No. E–273–2011/0—US Application No. 61/646,638 filed 14 May 2012. Related Technologies: HHS Reference No. E–066–2003/5—US Patent 7,622,133 issued 24 Nov 2009; US Application No. 12/607,035 filed 27 Oct 2009. Licensing Contact: Peter A. Soukas; 301–435–4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The NCI/CCR/NP is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize Cross-Reactive Dengue Fully Human Monoclonal A. For collaboration opportunities, please contact John Hewes, Ph.D. at hewesj@mail.nih.gov. mstockstill on DSK4VPTVN1PROD with Typhoid-Plague Bivalent Vaccine Description of Technology: Yersinia pestis (Y. pestis) bacteria is the causative agent of plague, typically transmitted from animals to humans by the bite of an infected flea. Y. pestis infection of the lungs leads to pneumonic plague, which is highly contagious and generally fatal. Y. pestis is a potential bioterrorist threat agent for which no vaccine yet exists. VerDate Mar<15>2010 17:01 Jan 15, 2013 Jkt 229001 This invention claims the generation and development of a candidate oral vaccine against plague. The vaccine consists of a synthetic gene construct that expresses a Y. pestis F1–V fusion antigen linked to a secretion signal, resulting in the production of large amounts of the F1–V antigen. The F1– V synthetic gene fusion is housed within Ty21a, an attenuated typhoid fever strain that is licensed for human use as a live oral bacterial vaccine. Ty21a serves as a carrier to deliver the F1–V fusion antigens of the plague bacteria; the combined F1–V fusion in the Ty21a carrier has been shown to stimulate a robust immune response in mice. The possibility of combining the oral plague vaccine of this invention with FDA’s candidate oral anthrax vaccine exists and would result in an easy-to-administer oral delivery system to streamline administration of the vaccine to large numbers of recipients in emergency situations. Potential Commercial Applications: Plague vaccines, therapeutics and diagnostics. Competitive Advantages: • Vector is well-characterized. • Simple manufacturing process. • Potential low-cost vaccine. Development Stage: • Pre-clinical. • In vitro data available. • In vivo data available (animal). Inventors: Dennis J. Kopecko, Manuel A. Osorio, Monica R. Foote (FDA/ CBER). Intellectual Property: HHS Reference No. E–105–2011/0—US Application No. 61/650,676 filed 23 May 2012. Related Technologies: HHS Reference No. E–344–2003/1—US Patent 7,758,855 issued 20 Jul 2010; US Patent 8,247,225 issued 21 Aug 2012. Licensing Contact: Peter A. Soukas; 301–435–4616; soukasp@mail.nih.gov. Collaborative Research Opportunity: The FDA Center for Biologics Evaluation and Research, Lab of Enteric and Sexually Transmitted Diseases, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize oral plague vaccine. For collaboration opportunities, please contact Dennis Kopecko at dennis.kopecko@fda.hhs.gov. Dated: January 10, 2013. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–00737 Filed 1–15–13; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 3441 DEPARTMENT OF HOMELAND SECURITY Office of the Secretary [Docket No. DHS–2012–0076] Privacy Act of 1974; Department of Homeland/U.S. Customs and Border Protection—002 Global Enrollment System (GES), System of Records Department of Homeland Security, Privacy Office. ACTION: Notice of Privacy Act System of Records. AGENCY: In accordance with the Privacy Act of 1974, as amended, the Department of Homeland Security proposes to update and reissue the Department of Homeland Security system of records titled, ‘‘Department of Homeland Security/U.S. Customs and Border Protection—002 Global Enrollment System’’ system of records. This system of records allows the Department of Homeland Security/U.S. Customs and Border Protection to collect and maintain records on individuals who voluntarily provide personally identifiable information to U.S. Customs and Border Protection in return for enrollment in a program that will make them eligible for expedited processing at designated U.S. border ports of entry, including all trusted traveler and registered traveler programs. This system of records notice is being re-published to update the categories of records, authorities, purposes, routine uses, retrievability, retention and disposal, notification procedures, record sources, and exemptions sections of the system. Additionally, this notice includes nonsubstantive changes to simplify the formatting and text of the previously published notice. The Global Enrollment System will now maintain law enforcement information as part of the vetting results, therefore the Department of Homeland Security is issuing a Notice of Proposed Rulemaking, to exempt this system of records from certain provisions of the Privacy Act of 1974, as amended, elsewhere in the Federal Register. This updated system will be included in the Department of Homeland Security’s inventory of record systems. DATES: Submit comments on or before February 15, 2013. This updated system will be effective February 15, 2013. ADDRESSES: You may submit comments, identified by docket number DHS– 2012–0076 by one of the following methods: SUMMARY: E:\FR\FM\16JAN1.SGM 16JAN1

Agencies

[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Notices]
[Pages 3440-3441]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00737]


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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, Public Health Service, 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.

Transmission-Blocking Malaria Vaccine

    Description of Technology: There is no vaccine for malaria, and 
there is growing resistance to existing anti-malarial drugs. Sexual 
stage-specific antigens are of interest as vaccine candidates because 
disruption of these antigens would reduce the fertility and, thus, the 
infectivity of the parasite.
    This invention claims methods and compositions for delivering a 
Plasmodium P47 vaccine or antibody to P47 to prevent Plasmodium 
falciparum or Plasmodium vivax malaria. P47 and other antigens have 
been mentioned as potential transmission-blocking vaccines due to their 
surface location on gametes. The gene for P47 antigens is also well 
characterized. Recent discoveries have noted that P47 allows the 
parasite to suppress or evade the immune system, thereby ensuring the 
mosquitoes' survival. Recent discoveries have also shown the mechanism 
by which P47 enables survival of the parasite by manipulation of the 
mosquito immune system. Based on the critical role of P47 antigens in 
transmission, the disruption of the function of P47 by various means 
can be an innovative and forceful means to control and/or reduce the 
prevalence of malaria.
    Potential Commercial Applications: Malaria vaccine, diagnostic and 
therapeutic.
    Competitive Advantages:
     Single protein malaria transmission-blocking vaccine.
     Cost-effective, simple manufacturing process for vaccine.
     Potentially lower-cost malarial vaccine for developing/
developed countries.
    Development Stage:
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Carolina Barillas-Mury and Alvaro Molina-Cruz (NIAID).
    Publication: Molina-Cruz A, et al. Some strains of Plasmodium 
falciparum, a human malaria parasite, evade the complement-like system 
of Anopheles gambiae mosquitoes. Proc Natl Acad Sci U S A. 2012 Jul 
10;109(28):E1957-62. [PMID 22623529]
    Intellectual Property: HHS Reference No. E-222-2012/0 -- US 
Application No. 61/684,333 filed 17 Aug 2012.
    Licensing Contact: Peter A. Soukas; 301-435-4646; 
soukasp@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases (NIAID) is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize malaria 
vaccines, diagnostics and therapeutics. For collaboration 
opportunities, please contact Tristan J. Mahyera at 
tristan.mahyera@nih.gov or 301-827-0251.

Methods and Composition for Identification of Variants of JC Virus DNA; 
An Etiologic Agent for Progressive Multifocal Leukoencephalopathy (PML)

    Description of Technology: JC Virus causes a fatal disease in the 
brain called progressive multifocal leukoencephalopathy (PML) that 
occurs in many patients with immunocompromised conditions. The finding 
of JCV DNA in the patients with neurological symptoms of PML is a 
diagnostic criterion and is needed to confirm the diagnosis of PML to 
rule out other neurological conditions. Certain JC virus variants are 
known to have a greater association with PML. For example, 
``Prototype'' JC virus is far more pathogenic than ``Archetype'' JC 
virus.
    This invention claims novel assays for identifying Archetype and/or 
Prototype JC virus by detecting the presence or absence of the unique 
Archetype nucleic acid sequence in the non-coding regulatory region of 
JC virus. While the sequences of Archetype and Prototype JC virus are 
known, these are the first assays that allow discrimination between 
Prototype and Archetype JC virus in a simple assay without the need for 
DNA sequencing. The identification of a JC virus as a prototype can 
lead to early treatment of infected individuals.
    Potential Commercial Applications:
     JCV diagnostic kits.
     JCV diagnostics.
    Competitive Advantages:
     DNA sequencing not required.
     Single assay format using same template to identify 
prototype and archetype with 10c/ml sensitivity.
    Development Stage:
     Clinical.
     In vitro data available.
     In vivo data available (human).
    Inventors: Eugene O. Major and Caroline F. Ryschkewitsch (NINDS).
    Publication: Perkins MR, et al. Changes in JC Virus-Specific T Cell 
Responses during Natalizumab Treatment and in Natalizumab-Associated 
Progressive Multifocal Leukoencephalopathy. PLoS Pathog. 2012 
Nov;8(11):e1003014. [PMID 23144619]
    Intellectual Property: HHS Reference No. E-088-2012--US Application 
No. 61/661,289 filed 18 Jun 2012.
    Related Technology: HHS Reference No. E-152-2009/0--Research 
Material. Patent protection is not being pursued for this technology.
    Licensing Contact: Peter A. Soukas; 301-435-4646; 
soukasp@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Neurological Disorders and Stroke is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate or commercialize assays for the detection of 
JC Virus. For collaboration opportunities, please contact Melissa 
Maderia at maderiam@mail.nih.gov or 301-451-3943.

Cross-Reactive Dengue Fully Human Monoclonal Antibodies

    Description of Technology: Among the arthropod-borne flaviviruses, 
the four dengue virus serotypes, dengue type 1 virus (DENV-1), dengue 
type 2 virus (DENV-2), dengue type 3 virus (DENV-

[[Page 3441]]

3), and dengue type 4 virus (DENV-4) are most important in terms of 
human morbidity and geographic distribution. Dengue viruses cause 
dengue outbreaks and major epidemics in most tropical and subtropical 
areas where Aedes albopictus and Aedes aegypti mosquitoes are abundant.
    A safe and effective vaccine against dengue is currently not 
available. Passive immunization with monoclonal antibodies from non-
human primates or humans represents a possible alternative to vaccines 
for prevention of illness caused by dengue virus. This invention claims 
fully human monoclonal antibodies that bind and neutralize dengue type 
1, 2, 3 and 4 viruses. It also claims fragments of such antibodies and 
nucleic acids encoding the antibodies of the invention as well as 
prophylactic, therapeutic and diagnostic methods employing the 
antibodies and nucleic acids of the invention.
    Potential Commercial Applications:
     Prophylaxis/therapy against dengue serotypes 1, 2, 3, and 
4.
     Dengue diagnostics.
    Competitive Advantages:
     Antibodies are cross-reactive with all four serotypes of 
dengue.
     Antibodies are fully human.
    Development Stage:
     Pre-clinical.
     In vitro data.
    Inventors: Dimiter S. Dimitrov and Zhongyu Zhu (NCI).
    Intellectual Property: HHS Reference No. E-273-2011/0--US 
Application No. 61/646,638 filed 14 May 2012.
    Related Technologies: HHS Reference No. E-066-2003/5--US Patent 
7,622,133 issued 24 Nov 2009; US Application No. 12/607,035 filed 27 
Oct 2009.
    Licensing Contact: Peter A. Soukas; 301-435-4646; 
soukasp@mail.nih.gov.
    Collaborative Research Opportunity: The NCI/CCR/NP is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate or commercialize 
Cross-Reactive Dengue Fully Human Monoclonal A. For collaboration 
opportunities, please contact John Hewes, Ph.D. at hewesj@mail.nih.gov.

Typhoid-Plague Bivalent Vaccine

    Description of Technology: Yersinia pestis (Y. pestis) bacteria is 
the causative agent of plague, typically transmitted from animals to 
humans by the bite of an infected flea. Y. pestis infection of the 
lungs leads to pneumonic plague, which is highly contagious and 
generally fatal. Y. pestis is a potential bioterrorist threat agent for 
which no vaccine yet exists.
    This invention claims the generation and development of a candidate 
oral vaccine against plague. The vaccine consists of a synthetic gene 
construct that expresses a Y. pestis F1-V fusion antigen linked to a 
secretion signal, resulting in the production of large amounts of the 
F1-V antigen. The F1-V synthetic gene fusion is housed within Ty21a, an 
attenuated typhoid fever strain that is licensed for human use as a 
live oral bacterial vaccine. Ty21a serves as a carrier to deliver the 
F1-V fusion antigens of the plague bacteria; the combined F1-V fusion 
in the Ty21a carrier has been shown to stimulate a robust immune 
response in mice. The possibility of combining the oral plague vaccine 
of this invention with FDA's candidate oral anthrax vaccine exists and 
would result in an easy-to-administer oral delivery system to 
streamline administration of the vaccine to large numbers of recipients 
in emergency situations.
    Potential Commercial Applications: Plague vaccines, therapeutics 
and diagnostics.
    Competitive Advantages:
     Vector is well-characterized.
     Simple manufacturing process.
     Potential low-cost vaccine.
    Development Stage:
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Dennis J. Kopecko, Manuel A. Osorio, Monica R. Foote 
(FDA/CBER).
    Intellectual Property: HHS Reference No. E-105-2011/0--US 
Application No. 61/650,676 filed 23 May 2012.
    Related Technologies: HHS Reference No. E-344-2003/1--US Patent 
7,758,855 issued 20 Jul 2010; US Patent 8,247,225 issued 21 Aug 2012.
    Licensing Contact: Peter A. Soukas; 301-435-4616; 
soukasp@mail.nih.gov.
    Collaborative Research Opportunity: The FDA Center for Biologics 
Evaluation and Research, Lab of Enteric and Sexually Transmitted 
Diseases, is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate or 
commercialize oral plague vaccine. For collaboration opportunities, 
please contact Dennis Kopecko at dennis.kopecko@fda.hhs.gov.

    Dated: January 10, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-00737 Filed 1-15-13; 8:45 am]
BILLING CODE 4140-01-P