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8862 Federal Register / Vol. 71, No.

34 / Tuesday, February 21, 2006 / Notices

Licensing Contact: Jesse Kindra; 301/ DEPARTMENT OF HEALTH AND [Human Mutation 26, 199–204; HHS
435–5559; kindraj@mail.nih.gov HUMAN SERVICES Ref. No. E–222–2003/0] and have now
extended their studies to the sweet and
Disclosed are methods of using National Institutes of Health umami receptors in global populations.
previously unknown soluble forms of The group of Dr. Dennis Drayna at
CD22 (sCD22) present in the serum of Government-Owned Inventions; NIDCD have now discovered novel
subjects with B-cell leukemias and Availability for Licensing coding sequence polymorphisms in the
lymphomas to assess tumor burden in human TAS1R genes. These genes
AGENCY: National Institutes of Health,
the subjects. Also disclosed are methods encode dimeric receptors that sense
Public Health Service, HHS.
of diagnosing or prognosing sweet taste (as TAS1R2+TAS1R3) and
ACTION: Notice.
development or progression of a B-cell the taste of umami (as
lymphoma or leukemia in a subject, SUMMARY: The inventions listed below TAS1R1+TAS1R3). To achieve
including detecting sCD22 in a body are owned by an agency of the U.S. maximum genetic diversity, TAS1R
fluid sample taken or derived from the Government and are available for receptors from a panel of 30 Europeans,
subject, for instance serum. In some licensing in the U.S. in accordance with 20 East Asian, 10 Native Americans, 8
embodiments, soluble CD22 levels are 35 U.S.C. 207 to achieve expeditious South Asians and 20 sub-Saharan
quantified. By way of example, the B- commercialization of results of Africans were sequenced.
cell lymphoma or leukemia can be hairy federally-funded research and Approximately 60% of the identified
cell leukemia, chronic lymphocytic development. Foreign patent SNPs caused an amino acid substitution
leukemia, or non-Hodgkin’s lymphoma. applications are filed on selected in the encoded receptor protein. This
Soluble CD22 in some embodiments is inventions to extend market coverage variation may account for individual
detected by a specific binding agent, for companies and may also be available preferences in sweet and umami tastes
and optionally, the specific binding for licensing. in foods and could be of use in the
agent can be detectably labeled. ADDRESSES: Licensing information and understanding and control of dietary
copies of the U.S. patent applications preferences that lead to obesity and
Also disclosed are methods of diabetes.
listed below may be obtained by writing
selecting a B-cell lymphoma or These novel variants and methods of
to the indicated licensing contact at the
leukemia therapy that include detecting use are available for licensing and
Office of Technology Transfer, National
an increase or decrease in sCD22 levels should be of particular use to those
Institutes of Health, 6011 Executive
in a subject compared to a control, and, Boulevard, Suite 325, Rockville, using sensorial analysis in the food and
if such increase or decrease is Maryland 20852–3804; telephone: 301/ flavoring industry where the use of
identified, selecting a treatment to 496–7057; fax: 301/402–0220. A signed taster panels in the development of
prevent or reduce B-cell lymphoma or Confidential Disclosure Agreement will flavors and flavor enhancers for
leukemia or to delay the onset of B-cell be required to receive copies of the different foods is key to the
lymphoma or leukemia. patent applications. development of new food products and
Other embodiments are kits for taste masking compounds. The ability,
Human Sweet and Umami Taste for example, to genetically match taster
measuring a soluble CD22 level, which Receptor Variants
kits include a specific binding molecule individuals employed by industry with
that selectively binds to the CD22, e.g. Dennis Drayna and Un-Kyung Kim the target consumer populations can
an antibody or antibody fragment that (NIDCD) both guide improved formulations and
U.S. Provisional Application No. 60/ marketing decisions as well as reducing
selectively binds CD22.
671,173 filed 13 Apr 2005 (HHS the total sample size in the testing of
Further disclosed methods are Reference No. E–099–2005/0–US–01) new products in this highly competitive
methods for screening for a compound Licensing Contact: Susan Carson; 301/ industry.
useful in treating, reducing, or 435–5020; carsonsu@mail.nih.gov The Human Taste Receptor Haplotype
preventing B-cell lymphomas or The complexity of taste patent portfolio is also available for
leukemias, or development or discrimination (salty, sour, sweet, licensing and includes: HHS Ref No. E–
progression of B-cell lymphomas or umami and bitter) varies between 169–2001/0–PCT–02,
leukemias, which methods include human individuals and populations. Phenylthiocarbamide Taste Receptor,
determining if application of a test Sweet and umami (the taste of International Publication No. WO 2003/
compound lowers soluble CD22 levels glutamate) tastes play a major role in the 008627, PCT filed 19 July 2002 and
in a subject, and selecting a compound perception of calorically-rich and global IP and HHS Ref. No 222–2003/1:
that so lowers sCD22 levels. essential nutrients and there are well- Variants of Human Taste Receptor
documented differences in individual Genes, International Publication No.
In addition to licensing, the
perception of sweet and umami WO 2005/007891, PCT filed 18 June
technology is available for further
flavorings, many of which appear to be 2004 and global IP.
development through collaborative
genetic in origin. Studies of individuals In addition to licensing, the
research opportunities with the
within and between populations that technology is available for further
inventors. vary in any of the taste receptors should development through collaborative
Dated: February 10, 2006. be of direct interest to the multi-billion research opportunities with the
Steven M. Ferguson, dollar food and flavoring industry as the inventors.
Director, Division of Technology Development characterization of such variants could
Genes for Niemann-Pick Type C
rmajette on PROD1PC67 with NOTICES1

and Transfer, Office of Technology Transfer, be used to aid in the development of a


Disease
National Institutes of Health. variety of taste improvements in foods
[FR Doc. E6–2362 Filed 2–17–06; 8:45 am] and orally administered medications. Eugene D. Carstea (NINDS) et al.
NIH researchers previously U.S. Patent No. 6,426,198 issued 30 Jul
BILLING CODE 4140–01–P
characterized bitter taste receptor 2002 (HHS Reference No. E–122–
variants in world wide populations 1997/0–US–03)

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Federal Register / Vol. 71, No. 34 / Tuesday, February 21, 2006 / Notices 8863

U.S. Patent Application No. 10/208,731 Driscoll for more information E–171–2002/0, ‘‘Cell Culturing and
filed 29 Jul 2002, allowed (HHS (telephone: 301/594–2235; e-mail: Storage Systems, Devices and Methods;’’
Reference No. E–122–1997/0–US–04) cdriscol@mail.nih.gov). The invention pertains to a closed
Licensing Contact: Marlene Astor; 301/ Dated: February 10, 2006. chamber that provides an environment
435–4426; shinnm@mail.nih.gov Steven M. Ferguson, for long-term culture of cells such as
Niemann-Pick disease is a class of Director, Division of Technology Development stems cells of central nervous system
inherited lipid storage diseases. and Transfer, Office of Technology Transfer, (CNS) origin, embryonic stem cells, and
Niemann-Pick Type C disease is an National Institutes of Health. other cells. The chamber is designed
autosomal recessive neurovisceral lipid [FR Doc. E6–2363 Filed 2–17–06; 8:45 am] with top and bottom mounted cover
storage disorder which leads to systemic BILLING CODE 4140–01–P slips that permit the observation of cells
and neurological abnormalities in culture under an optical microscope.
including ataxia, seizures, and loss of This chamber has the ability to control
speech. Patients with the disease DEPARTMENT OF HEALTH AND volume and pressure of liquids and
typically die as children. The HUMAN SERVICES gases by an inlet tube and outlet tubes
biochemical hallmark of Niemann-Pick at two different vertical positions. The
Type C cells is the abnormal National Institutes of Health chamber also includes a ball joint
accumulation of unesterified cholesterol assembly that allows for the
Prospective Grant of Exclusive
in lysosomes, which results in the manipulation of a glass microcapillary/
License: Device for Cell Culturing,
delayed homeostatic regulation of both microelectrode to come in close contact
Monitoring and Containment
uptake and esterification of low density with the developing cells. This
lipoprotein (LDL) cholesterol. Niemann- AGENCY: National Institutes of Health, microcapillary/microelectrode assembly
Pick Type C is characterized by Public Health Service, HHS. can be used to either administer growth
phenotypic variability. The disease ACTION: Notice. factors (e.g., monitoring growth factor
appears at random in families that have levels such as BMP and CNTF) and also
no history of the disorder, making SUMMARY: This is notice, in accordance
for electrical recording from the cells.
diagnosis problematic. This invention with 35 U.S.C. 209(c)(1) and 37 CFR The prospective exclusive license will
provides the human gene for Niemann- 404.7(a)(1)(i), that the National be royalty bearing and will comply with
Pick Type C disease and the nucleic Institutes of Health (NIH), Department the terms and conditions of 35 U.S.C.
acid sequences corresponding to the of Health and Human Services, is
209 and 37 CFR 404.7. The prospective
human gene for Niemann-Pick Type C contemplating the grant of an exclusive
exclusive license may be granted unless,
disease. Also provided is the mouse worldwide license to practice the
within sixty (60) days from the date of
homolog of the human gene. The invention embodied in: E–171–2002,
this published notice, NIH receives
invention could lead to improved ‘‘Cell Culturing and Storage Systems,
written evidence and argument that
diagnosis and the design of therapies for Devices and Methods’’ U.S. Patent
establishes that the grant of the license
the disease and improved means of Application 10/334,565 filed December
would not be consistent with the
detection of carriers of the gene. In 30, 2002; European Patent Application
requirements of 35 U.S.C. 209 and 37
addition, this invention may contribute 03808601.3; rights are also pending in
CFR 404.7.
to the understanding and development Canada and Australia; to KW Company,
LLC, a New York company having its Properly filed competing applications
of treatments for atherosclerosis, a more for a license filed in response to this
common disorder associated with headquarters in Woodstock, New York.
The United States of America is the notice will be treated as objections to
cholesterol buildup that involves the the contemplated license. Comments
accumulation of fatty tissue inside assignee of the patent rights of the above
invention. The contemplated exclusive and objections submitted in response to
arteries that blocks blood flow, leading this notice will not be made available
to heart disease and stroke. The license may be granted in the field of
sales of devices for cell culturing, for public inspection, and, to the extent
invention may also lead to additional permitted by law, will not be released
discoveries concerning how cholesterol monitoring and containment.
under the Freedom of Information Act,
is processed in the body. DATES: Only written comments and/or
5 U.S.C. 552.
This invention is described, in part, applications for a license received by
the NIH Office of Technology Transfer Dated: February 10, 2006.
in: S.K. Loftus et al., ‘‘Murine model of
Niemann-Pick C disease: Mutation in a on or before April 24, 2006 will be Steven M. Ferguson,
cholesterol homeostasis gene,’’ Science considered. Director, Division of Technology Development
277(5323):232–235, 1997; S.K. Loftus et ADDRESSES: Requests for a copy of the and Transfer, Office of Technology Transfer.
al., ‘‘Rescue of neurodegeneration in patent application, inquiries, comments [FR Doc. E6–2360 Filed 2–17–06; 8:45 am]
Niemann Pick-C mice by a prion- and other materials relating to the BILLING CODE 4140–01–P
promoter driven Npc1 cDNA contemplated license should be directed
transgene,’’ Human Molec. Genet. to: Michael A. Shmilovich, Esq., Office
11(24):3107–14, 2002. of Technology Transfer, National DEPARTMENT OF HOUSING AND
The NHGRI Genetic Disease Research Institutes of Health, 6011 Executive URBAN DEVELOPMENT
Branch is seeking statements of Boulevard, Suite 325, Rockville, MD
capability or interest from parties 20852–3804; Telephone: (301) 435– [Docket No. FR–5037–N–08]
interested in collaborative research to 5019; Facsimile: (301) 402–0220; E-mail:
Notice of Submission of Proposed
further develop, evaluate or shmilovm@mail.nih.gov. A signed
Information Collection to OMB;
confidentiality nondisclosure agreement
rmajette on PROD1PC67 with NOTICES1

commercialize Niemann-Pick Type C Universities Rebuilding America


disease diagnostics and therapies as will be required to receive copies of the
Partnerships: Community Design
well as potential applications of the patent applications.
Program
Niemann-Pick Type C gene related to SUPPLEMENTARY INFORMATION: The patent
atherosclerosis and cholesterol applications intended for licensure AGENCY: Office of the Chief Information
processing. Please contact Claire T. disclose and/or cover the following: Officer, HUD.

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