[Federal Register Volume 75, Number 56 (Wednesday, March 24, 2010)]
[Notices]
[Pages 14168-14170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6433]


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

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.

Novel Regulatory B Cells for Treatment of Cancer and Autoimmune Disease

    Description of Invention: The manner by which cancers evade the 
immune response is not well-understood. What is known is that the 
manner is an active process that regulates immune responses employing 
at least two types of suppressive cells, myeloid-derived suppressive 
cells and regulatory T cells (Tregs), a key subset of CD4\+\ T cells 
that controls peripheral tolerance to self- and allo-antigens. Tregs 
are considered to play a key role in the escape of cancer cells from 
anti-tumor effector T cells.
    Cancer cells have been found to directly activate resting B cells 
to form suppressive regulatory B cells (tBregs) and utilize them to 
evade immune surveillance and mediate metastasis. tBregs directly 
inhibit CD4\+\ and CD8\+\ T cell activity in a cell contact-dependent

[[Page 14169]]

manner, induce FoxP3\+\ T cell activity, and promote Treg-dependent 
metastasis.
    Researchers from the National Institute on Aging (NIA), NIH, have 
developed methods for the generation of tBregs, and for using tBregs to 
produce Tregs, and methods that inactivate or deplete tBregs. These 
methods have significant therapeutic value in the combat with cancer 
immune escape and metastasis, and in the control of harmful autoimmune 
diseases.
    Applications:
     Production of cellular cancer vaccines.
     Treatments for immune-mediated disorders.
     Treatments for cancer.
     Treatments for chronic viral infections.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Arya Biragyn and Purevdorj Olkhanud (NIA).
    Patent Status: U.S. Provisional Application No. 61/302,074 filed 05 
Feb 2010 (HHS Reference No. E-101-2010/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Patrick P. McCue, Ph.D.; 301-435-5560; 
[email protected].
    Collaborative Research Opportunity: The Immunotherapeutics Unit, 
National Institute on Aging, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize the utilization of regulatory B 
cells to control autoimmune diseases and strategies that inactivate 
tBregs to control cancer immune escape. Please contact Nicole Darack, 
Ph.D. at 301-435-3101 or [email protected] for more information.

A New Transmission Blocking Vaccine for Leishmania Infection

    Description of Invention: A novel transmission blocking vaccine has 
been developed that can eliminate or reduce the number of Leishmania 
chagasi parasites in the gut of the sand fly species, Lutzomyia 
longipalpis. The vaccine involves the production of antibodies to the 
sand fly midgut protein, LP1, which is normally expressed in the midgut 
of the sand fly during a blood meal. This vaccine could potentially 
block parasite transmission from the sand fly to mammalian hosts and 
significantly reduce the incidence of leishmaniasis in endemic areas of 
the world such as Brazil, India, and Indonesia where leishmaniasis 
accounts for over 58,000 deaths annually.
    Studies have shown that LP1 antibodies produced by immunized mice 
are able to reduce the number of L. chagasi parasites that develop in 
the midgut of Lu. longipalpis. These results illustrate the potential 
use of the protein as a vaccine to immunize dogs and protect humans 
from visceral leishmaniasis transmitted by the sand flies that feed on 
the infected, vaccinated dogs. In endemic areas such as Brazil where 
dogs are the principal reservoir for L. chagasi, the LPl antigen alone 
or in combination with other sand fly midgut proteins could be used to 
immunize household pets and stray dogs. Vaccinated dogs will produce 
antibodies to LPl, and once a sand fly feeds on blood from the infected 
and vaccinated dogs, the antibodies will inhibit development of the 
parasite in the gut of the sand fly. This approach can effectively 
block Leishmania transmission to human hosts. Such vaccines have the 
potential to reduce the risk of humans acquiring leishmaniasis without 
the risks involved in human vaccination.
    Applications:
     Transmission blocking vaccine for Leishmania infection.
     Vaccination of dogs as reservoirs for the Leishmania 
parasite.
    Development Status: Early stage.
    Market: 500,000 cases of visceral leishmaniasis annually worldwide 
and 58,000 deaths in Brazil, Bangladesh and Nepal.
    Inventors: Ryan C. Jochim and Jesus G. Valenzuela (NIAID).
    Related Publication: Jochim RC, Teixeira CR, Laughinghouse A, Mu J, 
Oliveira F, Gomes RB, Elnaiem DE, Valenzuela JG. The midgut 
transcriptome of Lutzomyia longipalpis: comparative analysis of cDNA 
libraries from sugar-fed, blood-fed, post-digested and Leishmania 
infantum chagasi-infected sand flies. BMC Genomics. 2008 Jan 
14;9(1):15. [PubMed: 18194529]
    Patent Status: U.S. Provisional Application No. 61/265.250 filed 29 
Oct 2009 (HHS Reference No. E-305-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Jeffrey A. James; 301-435-5474; 
[email protected].
    Collaborative Research Opportunity: The NIAID, OTD is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
``A New Transmission Blocking Vaccine for Leishmania Infection''. 
Please contact Dana Hsu at 301-496-2400 for more information.

A Composition for Cyropreservation and Storage of Human Cellular 
Products

    Description of Invention: This technology is directed to an 
enhanced composition for the freezing and storage of human cellular 
products for future use. The inventors have discovered optimal ratios 
of an extracellular cryoprotectant (low molecular weight pentastarch), 
an intracellular cryoprotectant (dimethyl sulfoxide, DMSO), and human 
serum albumin in a plasmalyte A solution. In comparison to currently 
available products, utilization of this composition results in a 
cryopreserved product with higher cell yield, longer period of 
viability and decreased incidence of dimethyl sulfoxide-related adverse 
effects.
    Applications and Advantages:
     Cryopreservation and storage of human and other mammalian 
cellular products.
     Higher cell yield.
     Extended post-thaw viability.
     Decreased incidence of DMSO-related adverse effects.
    Development Status: Early stage.
    Market: This invention may be of interest to cell processing and 
storage companies, hospitals, and research institutions.
    Inventors: Joseph F. Gallelli (CC) et al.
    Patent Status: U.S. Provisional Application No. 61/256,075 filed 29 
Oct 2009 (HHS Reference No. E-285-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521; 
[email protected].

Polarization Adapter for Colposcope

    Description of Invention: The invention offered for licensing is 
directed to a polarization adaptor for colposcopes. The colposcope is a 
medical diagnostic device that examines an illuminated magnified view 
of a patient's cervical, vaginal, and vulva tissues during a colposcopy 
procedure. Specifically, the invention provides for a specialized 
polarized camera (polarization adaptor) for integration into 
commercially available colposcopes. The addition of polarization to 
currently available colposcope results in an enhanced image video 
output that allows the user to view hidden subsurface tissue structures 
and textures, thereby allowing for better diagnosis of pathological 
conditions.
    The device which can readily be adapted to commercial colposcope 
enables the separation of specularly

[[Page 14170]]

reflected light from diffusely backscattered light, coming from deeper 
tissue layers. In combination with suggested data processing algorithm, 
based on correlation analysis, this allows one to enhance imaging of 
the hidden subsurface tissue structure (texture).
    Applications:
     The polarization adaptor of the invention can enhance the 
quality of imaging and diagnostics of conventional colposcope and thus 
improve early detection of pathologies, especially the status of the 
collagen network beneath the surface of the cervix.
     Screening and diagnostics of cervical abnormalities which 
can lead to cancer or pre-term delivery.
    Advantages:
     Improved characterization of cervical tissue for better 
diagnosis of abnormalities in cervical, vaginal, and vulva tissues. 
Minimally invasive measurement and analysis of diffusely backscattered 
light using specific image processing procedures as provided in the 
invention, may contribute useful information about internal structures 
of biological tissues in more detail as compared with existing methods.
     The device can improve early detection of cervical cancer 
and thus save lives. Recent large-scale National Cancer Institute-
sponsored clinical trial demonstrated that colposcopy failed to detect 
33% of high-grade precancerous lesions in women referred with 
questionable Pap results. An improvement in detection capabilities is 
thus very much needed (http://biomedreports.com/articles/most-popular/12449-non-invasive-device-for-cervical-cancer).
     Enhanced diagnostics may result in the reduction of repeat 
examinations usually used for a definitive diagnostics for cervical 
cancer. Thus it may have favorable impact on healthcare costs.
     Can be readily adapted to any conventional colposcope.
    Development Status:
     A working prototype was built.
     Need to gather clinical data and demonstrate clinical 
utility.
    Market:
     Colposcopy is now routinely used for diagnostics of 
cervical cancer and other tissue abnormalities in female organs.
     In the U.S. alone, over $6 billion is spent annually on 
the screening, diagnosis and treatment of women with cervical cancer. 
Diagnosing cervical cancer is often a long and uncertain process 
requiring repeat visits to the Doctor's office. Approximately three (3) 
million colposcopy procedures are performed annually, with many repeat 
exams aimed at a definitive diagnosis. The U.S. colposcopy market alone 
is approximately $1 billion annually (http://biomedreports.com/articles/most-popular/12449-non-invasive-device-for-cervical-cancer).
     The repeat examinations typically required to arrive at a 
definitive determination are both stressful and expensive. For women 
with precancerous lesions, the long diagnostic cycle can allow the 
disease to progress and develop into invasive, life-threatening 
cancers. By providing a more definitive test, the device offered in 
this invention will allow clinicians to more effectively manage and 
treat millions of women who are at risk of cervical cancer.
    In light of the above it is evident that a device that can be 
adapted to conventional instruments and provide for improved 
diagnostics will also be commercially rewarding.
    Inventors: Amir H. Gandjbakhche et al. (NICHD).
    Related Publications:
    1. Jacques SL, Roman JR, Lee K. Imaging superficial tissues with 
polarized light. Lasers Surg Med. 2000;26(2):119-129. [PubMed: 
10685085].
    2. Jacques SL, Ramella-Roman JC, Lee K. Imaging skin pathology with 
polarized light. J Biomed Opt. 2002 Jul 7;7(3):329-340. [PubMed: 
12175282].
    3. Ramella-Roman JC, Lee K, Prahl SA, Jacques SL. Design, testing, 
and clinical studies of a handheld polarized light camera. J Biomed 
Opt. 2004 Nov-Dec;9(6):1305-1310. [PubMed: 15568952].
    4. Sviridov AP, Ulissi Z, Chernomordik V, Hassan M, Boccara AC, 
Gandjbakhche A, ``Analysis of Biological Tissue Textures Using 
Measurements of Backscattered Polarized Light''; OSA Topical Meeting on 
Biomedical Optics, c.WD8 (2006).
    5. Sviridov AP, Ulissi Z, Chernomordik V, Hassan M, Gandjbakhche A. 
Visualization of biological texture using correlation coefficient 
images. J Biomed Opt. 2006 Nov-Dec;11(6):060504. [PubMed: 17212522].
    6. Sviridov AP, Chernomordik V, Hassan M, Boccara AC, Russo A, 
Smith P, Gandjbakhche A. Enhancement of hidden structures of early skin 
fibrosis using polarization degree patterns and Pearson correlation 
analysis. J Biomed Opt. 2005 Sep-Oct;10(5):051706. [PubMed: 16292958].
    Patent Status: U.S. Provisional Application No. 61/242,652 filed 15 
Sep 2009, entitled ``Polarization Adapter for Colposcope'' (HHS 
Reference No. E-161-2009-0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contacts: Uri Reichman, Ph.D., MBA; 301-435-4616; 
[email protected]; or Michael Shmilovich, J.D.; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The Eunice Shriver National 
Institute of Child Health and Human Development, Section on Analytical 
and Functional Biophotonics, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize the polarization camera for 
cervical tissue characterization. Please contact Joseph Conrad, Ph.D. 
at 301-435-3107 or [email protected] for more information.

    Dated: March 16, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-6433 Filed 3-23-10; 8:45 am]
BILLING CODE 4140-01-P