[Federal Register Volume 69, Number 125 (Wednesday, June 30, 2004)]
[Notices]
[Pages 39488-39489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14777]


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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.

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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.

Antibody (Anti-Allergen) Microarray

Jay E. Slater, William J. Finlay, Nicolette DeVore (FDA)
DHHS Reference No. E-044-2004/0--Research Tool
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected]

    Available for licensing as a biological material or by material 
transfer is a microarray with immobilized antibodies specific to 
particular allergens or allergen epitopes and specifically allergens 
from an allergen vaccine or extract. Allergen extracts are manufactured 
and sold worldwide for the diagnosis and treatment of IgE-mediated 
allergic disease. Each extract contains a variety of active allergenic 
components (e.g., proteins, carbohydrates and other small molecules) in 
varying concentrations and immugenicities. Most allergen extracts are 
non-standardized. These extracts have been labeled either with a 
designation of extraction ratio (w/v) or with a protein unit 
designation determined using the Kjeldahl method (protein nitrogen 
units/mL). There appears to be little correlation between these two 
designations and biological measures of allergen potency. At

[[Page 39489]]

present, there are nineteen standardized allergen extracts available 
from U.S. manufacturers. Each extract is assigned a potency value for 
sale to the public. Potency value is an arbitrary measurement based on 
quantitation of the total protein content and specific allergen content 
within the allergen extracts (as measured with hyperimmune sheep sera), 
or by the inhibition of the binding of IgE from pooled allergic sera to 
reference allergen. These methods are generally crude and provide only 
integral averages. These averages are non-characteristics of the 
concentration of individual allergens in the extract and their 
respective immunoglobulin binding affinities. By contrast, this 
microarray uses large numbers of engineered antibodies to 
``fingerprint'' the test extract. The present invention provides 10-100 
allergen specific scFV or Fab immunoglobulins imprinted on a 
solid matrix in multiple concentrations. The allergen mixture is 
applied to the array and the pattern of protein binding to each spot is 
analyzed quantitatively and qualitatively. Thus, large numbers of 
component allergenic proteins can be assayed quickly and 
simultaneously.

Epitopes of Ebola Virus Glycoproteins Useful for Vaccine Development

Carolyn A. Wilson et al. (FDA)
U.S. Provisional Application No. 60/532,677 filed 23 Dec 2003 (DHHS 
Reference No. E-271-2003/0-US-01)
Licensing Contact: Susan Ano; 301/435-5515; [email protected]

    The current technology describes the identification of amino acid 
residues on Ebola glycoprotein (GP) critical for virus infection 
through mutation of residues in the glycoprotein-1 (GP1) of Ebola virus 
(Zaire strain). The amino acid residues identified through mutational 
analysis are conserved and can be found in all published sequences of 
strains of Ebola and Marburg viruses, making them a good target for 
development into a cross-protective vaccine or antiviral therapy. The 
mutations could be used to generate non-infectious Ebola viral 
particles for use in vaccines. These residues in wild-type filoviruses 
could also be targeted by compounds to prevent viral entry into cells 
or could potentially represent an epitope (or part of an epitope) for 
use as an immunogen in a vaccine. Vaccines utilizing these non-
infectious particles may be safer than vaccines that use other common 
approaches, e.g. live-attenuated virus vaccines. In addition to the 
non-infectious particles, this technology describes the polypeptides 
that form them, the polynucleotide sequences encoding the polypeptides, 
and vectors comprising the polynucleotides. These additional materials 
could also form the basis of an Ebola vaccine or antiviral therapy. 
Also claimed are kits for detection of antibodies to Ebola involving 
contacting the sample containing antibodies to the polypeptides 
described in the invention.

Haplotypes of Human Bitter Taste Receptor Genes

Dennis Drayna, Un-Kyung Kim (NIDCD)
U.S. Provisional Application No. 60/480,035 filed 11 Jul 2003 (DHHS 
Reference No. E-222-2003/0-US-01); PCT Application filed 18 Jun 2004 
(DHHS Reference No. E-222-2003/1-PCT-01)
Licensing Contact: Susan Carson; 301/435-5020; [email protected]

    Bitter taste has evolved in mammals as a crucial, important warning 
signal against ingestion of poisonous or toxic compounds. However, many 
beneficial compounds are also bitter and taste masking of bitter 
tasting pharmaceutical compounds is a billion dollar industry. The 
diversity of compounds that elicit bitter-taste sensations is very 
large and more than two dozen members of the T2R bitter taste receptor 
gene family have been identified. How individuals are genetically 
predisposed to respond or not to respond to the bitter taste of 
substances like nicotine and certain foods like broccoli may have broad 
implications for nutritional status and tobacco use. Large individual 
differences in the perception of bitterness of these compounds have 
been well documented, and common allelic variants of a member of the 
T2R bitter taste receptor gene family have been shown to underlie 
variation in the ability to taste the bitter compound 
phenylthiocarbamide (PTC) [DHHS Ref. No. E-169-2001/0-PCT-02].
    Scientists at the NIDCD have extended these results to other bitter 
taste receptors and have sequenced 22 of the 24 known T2R genes in a 
series of populations worldwide, including Hungarians, Japanese, 
Cameroonians, Pygmies and South American Indians, and the present 
invention includes these isolated sequences and their variants. This 
includes a total of 127 SNPs and 109 different protein coding 
haplotypes, including those defined for the PTC Receptor (T2R38) [E-
169- 2001/0]. The inventors showed that 77% of the SNPs identified 
caused an amino acid substitution in the encoded receptor protein, 
giving rise to a high degree of receptor protein variation in the 
population. The frequencies of these different haplotypes have been 
shown to differ in different populations which will aid in population-
specific studies, such as those targeting differences in taste 
perception between Europeans and Asians, for example.
    The invention available for licensing includes these novel SNPs and 
haplotypes and methods of use, which can be used to better identify and 
characterize different groups of individuals within and between 
populations that vary in the their bitter taste abilities. This is 
important to the food and flavoring industry, for example, where these 
variants can be used to aid in the development of a variety of taste 
improvements in foods and orally administered medications.
    A related technology also available for licensing is DHHS Ref. No. 
E-169- 2001/0-PCT-02, Phenylthiocarbamide Taste Receptor, International 
Publication No. WO 03/008627.

    Dated: June 24, 2004.
Mark L. Rohrbaugh,
Director, Office of Technology Transfer, National Institutes of Health.
[FR Doc. 04-14777 Filed 6-29-04; 8:45 am]
BILLING CODE 4140-01-P