Government-Owned Inventions; Availability for Licensing, 55069-55070 [2011-22688]

Download as PDF Federal Register / Vol. 76, No. 172 / Tuesday, September 6, 2011 / Notices Medical Applications Draft Guidance.’’ The document was published with an outdated address in the section entitled ‘‘Will there be transcripts of the meeting?’’ This document corrects that error. FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3208, Silver Spring, MD 20993–0002, 301– 796–9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2011–20574, appearing on page 50231 in the Federal Register of Friday, August 12, 2011, the following correction is made: 1. On page 50233, in the second column, under the section entitled ‘‘Will there be transcripts of the meeting?’’ the address for the Division of Freedom of Information is corrected to read ‘‘Division of Freedom of Information (ELEM–1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.’’ Dated: August 31, 2011. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. [FR Doc. 2011–22674 Filed 9–2–11; 8:45 am] BILLING CODE 4160–01–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. ADDRESSES: 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:00 Sep 02, 2011 Jkt 223001 55069 be required to receive copies of the patent applications. Fully Automated Bone Mineral Densitometry on Routine CT Scans Description of Technology: The invention relates to an improved system for measuring bone mineral density (BMD). BMD measurement is an important tool for the diagnosis of osteopenia- and osteoporosis-related fractures, a significant national health problem primarily affecting the elderly and women after menopause. More specifically, the invention relates to an algorithm and software for fully automating BMD measurement, using routine CT data and eliminating the need for a reference phantom or a specialized imaging protocol. The current standard methods not only require reference phantom to be placed underneath the patient and a specialized imaging protocol, but they also require manually placed regions of interest (ROI) to identify the appropriate bone structures. The benefit of the automated method provided in the invention is that with this system BMD measurement will be available for every patient with chest/abdominal CT scan (millions are done every year) so that the potential low bone mineral density can be discovered. Potential Commercial Applications: • The technique can be integrated to a CT scanner to provide automated measurement of BMD for every CT scan. • The technique can be integrated into PACS (Picture Archiving and Communication Systems) to report BMD at the time of image interpretation by the radiologist or clinician. Competitive Advantages: The technique can be readily integrated to existing medical imaging systems such as CT scanners (to provide BMD measurement with every CT scan) or PACS (to report BMD at the time of image interpretation). Development Stage: • Prototype • In vivo data available (human) Inventors: Ronald M. Summers et al. (NIH–CC) Publication: Summers RM, et al. Feasibility of simultaneous computed tomographic colonography and fully automated bone mineral densitometry in a single examination. J Comput Assist Tomogr. 2011 Mar–Apr;35(2):212–216. [PMID 21412092] Intellectual Property: HHS Reference No. E–218–2011/0—Research Tool. Patent protection is not being pursued for this technology. Licensing Contact: Michael Shmilovich, Esq.; 301–435–5019; shmilovm@mail.nih.gov. Filovirus Vaccines and Diagnostics Based on Glycoprotein-Fc Fusion Proteins Description of Technology: Ebola virus is a member of the Filoviridae, a family of viruses classified as ‘‘Category A’’ bioterrorism agents that cause severe hemorrhagic fever in humans and nonhuman primates with high morbidity and mortality rates up to 90%. This invention provides an efficacious Filovirus subunit vaccine based on a recombinant protein consisting of the extracellular domain of the Filovirus glycoprotein fused to an Fc Fragment of human immunoglobulin (FiloGP-Fc). Vaccination with FiloGP-Fc elicited humoral and cellular immunity against Filoviruses. The FiloGP-Fc vaccine induced antibodies that bound and neutralized replication-competent recombinant G-deleted Vesicular Stomatitis Virus containing the Filovirus GP (rVSV-FiloGP), and protected animals against Filovirus lethal challenge. Also described are cellular and humoral immunity tests as well as rVSV-FiloGP neutralization tests to evaluate anti-Filovirus immune responses in individuals. Potential Commercial Applications: • Vaccines for protection against infections by Ebola Virus and other Filoviruses. • Diagnostic tests for cellular and humoral immunity based on FiloGP-Fc and rVSV-FiloGP to evaluate antiFilovirus immune responses in vaccinated and infected animals and individuals. Competitive Advantages: Filovirus vaccine candidates based on virus-like particles and virus vectors are currently under development by others. However, efficacious subunit vaccines have not yet been developed. The FiloGP-Fc fusion protein described in this invention has the advantage of resembling the native glycoprotein expressed at the surface of cells and viral particles. Thus, in addition to vaccines, the soluble FiloGP-Fc fusion proteins are ideal substrates to evaluate immune responses in animals and vaccinees. Development Stage: • Early-stage • Pre-clinical • In vitro data available • In vivo data available (animal) Inventors: Geraldo Kaplan (FDA), Krishnamurthy Konduru (FDA), et al. Publication: Konduru K, et al. Ebola virus glycoprotein Fc fusion protein confers protection against lethal challenge in vaccinated mice. Vaccine 2011 Apr 5;29(16):2968–2977. [PMID 21329775] PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1 55070 Federal Register / Vol. 76, No. 172 / Tuesday, September 6, 2011 / Notices Intellectual Property: HHS Reference No. E–222–2010/0—U.S. Patent Application No. 61/407,842 filed 28 October 2010. Licensing Contact: Cristina Thalhammer-Reyero, PhD, MBA; 301– 435–4507; thalhamc@mail.nih.gov. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2011–22688 Filed 9–2–11; 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. ADDRESSES: 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 NOTICES SUMMARY: Vaccine To Prevent BK Polyomavirusassociated Kidney and Bladder Infections in Organ Transplant Recipients Description of Technology: Nearly all adults have chronic urinary tract infections with one or more strains of BK polyomavirus (BKV). In healthy persons, the infection is controlled by the immune system and no symptoms are apparent. However, immunosuppressed persons, such as organ transplant recipients, can suffer from bladder disease or kidney disease caused by uncontrolled BKV growth. BKV causes cancer in animals; it is unknown if the same is true in humans. VerDate Mar<15>2010 18:00 Sep 02, 2011 Jkt 223001 A significant need remains for a means of preventing BKV infection and associated pathologies. Researchers at the National Cancer Institute, NIH, have developed compositions and therapeutic methods for pre-vaccination of organ transplant recipients against BKV and prognostic methods to identify patients that may benefit from the vaccination. Methods for producing a BKV vaccine against all four known BKV serotypes are in development. Potential Commercial Applications: • An effective multivalent BKV vaccine to prevent BKV-associated pathologies of the urinary tract and bladder. • A prognostic kit to determine clinical benefit. • Tests for identifying renal transplant donors and recipients. Competitive Advantages: • A successful proof-of-principle study in mice has been conducted. • The inventors have identified the major virulent BKV serotype. • No vaccine for BKV infection currently exists. • If BKV is linked to cancer, the technology might be relevant to vaccines applicable to the general public. Development Stage: • Early-stage. • Pre-clinical. • In vitro data available. • In vivo data available (animal). Inventors: Christopher Buck and Diana Pastrana (NCI). Publication: In preparation. Intellectual Property: HHS Reference No. E–168–2011/0—U.S. Patent Application No. 61/508,897 filed 18 July 2011. Licensing Contact: Patrick McCue, PhD; 301–435–5560; mccuepat@mail.nih.gov. Collaborative Research Opportunity: The NCI Center for Cancer Research, Laboratory of Cellular Oncology, 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 John Hewes, PhD at hewesj@mail.nih.gov. Gas Permeable Flasks To Grow Tumor Infiltrating Lymphocytes (TIL) for More Effective Anti-Cancer Immunotherapy Description of Technology: Scientists at NIH have developed a strategy to obtain large quantities of highly reactive tumor infiltrating lymphocytes (TIL) from patient tumor samples for anticancer immunotherapy by making use of gas permeable (GP) flasks. This PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 advancement in personalized anticancer immunotherapy involves culturing a tumor sample in a series of GP containers to isolate and rapidly expand TIL. The process provides suitable quantities of TIL for adoptive transfer into the cancer patient more reliably than previous approaches. Culturing and growing TIL in the GP containers permits efficient gas exchange between TIL cells and the air to promote optimal respiration, growth, and viability of the patient’s TIL throughout the process. Using GP flasks in the TIL expansion process provides for better circulation of the growth media and larger surface area so more TIL can grow per unit volume. Therefore, less reagents and fewer numbers of culture containers are need to generate the required number of TIL for adoptive immunotherapy protocols to treat cancer patients. NIH researchers have demonstrated the advantages of this GP TIL growth process in comparison to their more established TIL expansion protocols using human patient tumor samples. This new TIL production method should enable TIL therapy to become more GMP compliant and allow it to become more standardized for widespread utilization as a cancer treatment option outside of NIH. Potential Commercial Applications: • Adoptive cell transfer therapy (immunotherapy) for a variety of human cancers. • Growing TIL in gas permeable cultureware has the potential to become the new standard for obtaining suitable quantities of TIL for use in adoptive immunotherapy. • GMP grade TIL manufacture process to allow for regulatory approval of TIL therapy so that it can become a more widely available personalized cancer treatment option. Competitive Advantages: • Simpler, faster, less laborious, less reagent intensive, and less equipment intensive TIL growth process compared to methods of obtaining TIL without gas permeable cultureware. • Reduces risks of microbial contamination versus comparable methodologies. • More GMP-compliant than other TIL growing processes. • Capable of producing larger quantities of TIL more reliably than other TIL methodologies. • Potential to expand the number of patients and types of cancers treatable by TIL. Development Stage: • Pre-clinical. • In vitro data available. • In vivo data available (human). E:\FR\FM\06SEN1.SGM 06SEN1

Agencies

[Federal Register Volume 76, Number 172 (Tuesday, September 6, 2011)]
[Notices]
[Pages 55069-55070]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22688]


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

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.

ADDRESSES: 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.

Fully Automated Bone Mineral Densitometry on Routine CT Scans

    Description of Technology: The invention relates to an improved 
system for measuring bone mineral density (BMD). BMD measurement is an 
important tool for the diagnosis of osteopenia- and osteoporosis-
related fractures, a significant national health problem primarily 
affecting the elderly and women after menopause. More specifically, the 
invention relates to an algorithm and software for fully automating BMD 
measurement, using routine CT data and eliminating the need for a 
reference phantom or a specialized imaging protocol. The current 
standard methods not only require reference phantom to be placed 
underneath the patient and a specialized imaging protocol, but they 
also require manually placed regions of interest (ROI) to identify the 
appropriate bone structures. The benefit of the automated method 
provided in the invention is that with this system BMD measurement will 
be available for every patient with chest/abdominal CT scan (millions 
are done every year) so that the potential low bone mineral density can 
be discovered.
    Potential Commercial Applications:
     The technique can be integrated to a CT scanner to provide 
automated measurement of BMD for every CT scan.
     The technique can be integrated into PACS (Picture 
Archiving and Communication Systems) to report BMD at the time of image 
interpretation by the radiologist or clinician.
    Competitive Advantages: The technique can be readily integrated to 
existing medical imaging systems such as CT scanners (to provide BMD 
measurement with every CT scan) or PACS (to report BMD at the time of 
image interpretation).
    Development Stage:
     Prototype
     In vivo data available (human)
    Inventors: Ronald M. Summers et al. (NIH-CC)
    Publication: Summers RM, et al. Feasibility of simultaneous 
computed tomographic colonography and fully automated bone mineral 
densitometry in a single examination. J Comput Assist Tomogr. 2011 Mar-
Apr;35(2):212-216. [PMID 21412092]
    Intellectual Property: HHS Reference No. E-218-2011/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Michael Shmilovich, Esq.; 301-435-5019; 
shmilovm@mail.nih.gov.

Filovirus Vaccines and Diagnostics Based on Glycoprotein-Fc Fusion 
Proteins

    Description of Technology: Ebola virus is a member of the 
Filoviridae, a family of viruses classified as ``Category A'' 
bioterrorism agents that cause severe hemorrhagic fever in humans and 
nonhuman primates with high morbidity and mortality rates up to 90%. 
This invention provides an efficacious Filovirus subunit vaccine based 
on a recombinant protein consisting of the extracellular domain of the 
Filovirus glycoprotein fused to an Fc Fragment of human immunoglobulin 
(FiloGP-Fc). Vaccination with FiloGP-Fc elicited humoral and cellular 
immunity against Filoviruses. The FiloGP-Fc vaccine induced antibodies 
that bound and neutralized replication-competent recombinant G-deleted 
Vesicular Stomatitis Virus containing the Filovirus GP (rVSV-FiloGP), 
and protected animals against Filovirus lethal challenge. Also 
described are cellular and humoral immunity tests as well as rVSV-
FiloGP neutralization tests to evaluate anti-Filovirus immune responses 
in individuals.
    Potential Commercial Applications:
     Vaccines for protection against infections by Ebola Virus 
and other Filoviruses.
     Diagnostic tests for cellular and humoral immunity based 
on FiloGP-Fc and rVSV-FiloGP to evaluate anti-Filovirus immune 
responses in vaccinated and infected animals and individuals.
    Competitive Advantages: Filovirus vaccine candidates based on 
virus-like particles and virus vectors are currently under development 
by others. However, efficacious subunit vaccines have not yet been 
developed. The FiloGP-Fc fusion protein described in this invention has 
the advantage of resembling the native glycoprotein expressed at the 
surface of cells and viral particles. Thus, in addition to vaccines, 
the soluble FiloGP-Fc fusion proteins are ideal substrates to evaluate 
immune responses in animals and vaccinees.
    Development Stage:
     Early-stage
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Geraldo Kaplan (FDA), Krishnamurthy Konduru (FDA), et 
al.
    Publication: Konduru K, et al. Ebola virus glycoprotein Fc fusion 
protein confers protection against lethal challenge in vaccinated mice. 
Vaccine 2011 Apr 5;29(16):2968-2977. [PMID 21329775]

[[Page 55070]]

    Intellectual Property: HHS Reference No. E-222-2010/0--U.S. Patent 
Application No. 61/407,842 filed 28 October 2010.
    Licensing Contact: Cristina Thalhammer-Reyero, PhD, MBA; 301-435-
4507; thalhamc@mail.nih.gov.

Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-22688 Filed 9-2-11; 8:45 am]
BILLING CODE 4140-01-P
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