[Federal Register Volume 69, Number 46 (Tuesday, March 9, 2004)]
[Notices]
[Pages 11027-11029]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 04-5224]


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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, DHHS.

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.

Carbohydrate-Encapsulated Quantum Dots For Cell-Specific Biological 
Imaging

Joseph Barchi, Sergey Svarovsky (NCI).

[[Page 11028]]

PCT Application No. PCT/US03/34897 filed 05 Nov 2003 (DHHS Reference 
No. E-325-2003/0-PCT-01).
Licensing Contact: Michael Shmilovich; 301/435-5019; 
shmilovm@mail.nih.gov.

    Available for licensing is intellectual property covering 
carbohydrate-encapsulated quantum dots (QD) for use in medical imaging 
and methods of making the same. Certain carbohydrates, especially those 
included on tumor glycoproteins are known to have affinity for certain 
cell types. One notable glycan used in the present invention is the 
Thomsen-Freidenreich disaccharide (Gal[beta]1-3GalNAc) that is readily 
detectable in 90% of all primary human carcinomas and their metastases. 
These glycans can be exploited for medical imaging. Quantum Dots (QDs) 
are semiconductor nanocrystals (CdSe or CdTe) with detectable 
luminescent properties. Encapsulating luminescent QDs with target-
specific glycans permits efficient imaging of the tissue to which the 
glycans bind with high affinity. Accurate imaging of diseased cells 
(e.g., primary and metastatic tumors) is of primary importance in 
disease management. The inventors describe the only stable synthesis of 
glycan encapsulated Qds and the Qds per se.

Method and Apparatus for Bioweapon Decontamination

Deborah S. Wilson (ORS).
U.S. Provisional Application filed 16 Jan 2004 (DHHS Reference No. E-
218-2003/0-US-01).
Licensing Contact: Michael Shmilovich; 301/435-5019; 
shmilovm@mail.nih.gov.

    It is in the interest of the public health and national security 
that the Public Health Service find a licensee for the commercial 
development and rapid dissemination of the apparatus and method of this 
invention.
    The apparatus enables the decontamination of articles contaminated 
with bioweapons, more particularly sporolated bioweapons of which 
anthrax (Bacillus anthracis) is of notable concern. The system includes 
enclosing the article to be decontaminated in a humidified environment 
thus enhancing the susceptibility of spores to decontamination gases 
such as chlorine dioxide. Vacuum sealing the chamber and exposing the 
contaminated article to decontamination gases kills 100% of the spores.

Methods and Devices for Intramuscular Stimulation in Dysphonia

Christy L. Ludlow, Eric Mann, Theresa Burnett, Steve Bielamowicz 
(NINDS).
U.S. Provisional Application No. 60/413,733 filed 27 Sep 2002 (DHHS 
Reference No. E-181-2002/0-US-01); PCT Application No. PCT/US03/30032 
filed 27 Sep 2003 (DHHS Reference No. E-181-2002/0-PCT-02).
Licensing Contact: Michael Shmilovich; 301/435-5019; 
shmilovm@mail.nih.gov.

    The invention is presently being licensed to two entities for 
treating dysphagia. The method and device of the invention can also be 
used for treating dysphonia, and the Public Health Service seeks a 
licensee to commercially develop this invention for that purpose. 
Qualified applicants are preferably those having implantable 
stimulators capable of inducing intramuscular stimulation of the 
laryngeal musculature to improve voice in humans. This invention will 
assist those persons who have chronic long-standing dysphonia. The 
invention comprises three unique components: (1) Intramuscular 
implantation to produce two synergistic actions; (2) independent long 
term control of stimulation during speech by patients; and, (3) a 
unique system of combining indwelling intramuscular electrodes and 
controllers.

Methods and Compositions To Detect Nucleic Acid

Dougbeh C. Nyan (NIDDK).
U.S. Provisional Application No. 60/468,341 filed 06 May 2003 (DHHS 
Reference No. E-146-2002/0-US-01).
Licensing Contact: Michael Ambrose; 301/594-6565; 
ambrosem@mail.nih.gov.

    This technology involves the isolation and identification of 
Helicobacter within fecal matter. The technology provides for the 
methods and nucleic acid primer reagents and sequences specific for H. 
pylori. Specifically, it addresses the identification of the common 
human species of H. pylori. H. pylori is a major infectious agent of 
the human gastric intestinal tract, affecting about 50% of the world 
population with various degrees of severity. H. pylori infection is 
associated with 95% of duodenal ulcers and 80% of gastric ulcers. 
Without treatment, 80% of duodenal ulcers will return. Further, gastric 
ulcers have been linked as precursors to the more life-threatening 
gastric cancers.
    Current diagnostics are expensive, invasive, or require the patient 
to ingest radioactive substances. The technology presented provides for 
a quick, specific, inexpensive, non-invasive method for diagnosis of H. 
pylori infection as well the ability to repeat such tests for patient 
follow up on treatment effectiveness. Also included is the ability to 
develop kits for commercial purposes.

Novel Spore Wall Proteins and Genes From Microsporidia

Russell J. Hayman, John T. Conrad, Theodore Nash (NIAID).
PCT Application No. PCT/US01/47182 filed 04 Dec 2001, which published 
as WO 03/048299 on 12 Jun 2003 (DHHS Reference No. E-125-2001/0-PCT-
02).
Licensing Contact: Michael Ambrose; 301/594-6565; 
ambrosem@mail.nih.gov.

    Microsporidia are obligate, intracellular organisms that infect a 
wide range of hosts, including humans. Disease occurs mostly in 
immunosuppressed individuals, particularly those with AIDS, but 
infections have been documented in immunocompetent persons with 
diarrhea. Effective treatment is available for disease caused by some 
species. However, the most common type can only be treated with an 
experimental drug that is not available.
    The invention presented here involves the isolation and use of two 
spore wall proteins of E. intestinalis, spore wall protein 1 (SWP-1) 
and spore wall protein 2 (SWP-2). These form the wall of the spore and 
enable the parasite to survive outside the host and therefore enable 
transmission. Although infection occurs after the spore contents are 
injected through the cell membrane into the host cell, proximity to the 
cell and a high likelihood of infection occurs because the spore wall 
attaches to the cell. Therefore, prevention of binding by antibodies, 
for instance, is likely to prevent infection. Some spores may also be 
infectious after being taken up by certain host cells. After infection, 
multiplication by merogony and sporogony occurs, releasing more 
infectious spores into the host and/or environment.
    The invention claims SWP-1 and SWP-2 as isolate proteins and as 
immunogenic fragments of these parent proteins. Further claims include 
the nucleic acids that encode the whole proteins as well as the 
immunogenic fragments. A second series of claims include the methods 
and use of these reagents for diagnostic kit development as well as 
prevention of infectivity using

[[Page 11029]]

the proteins as well as nucleic acid constructs of SWP-1 and SWP-2. A 
third series of claims covers the administration and use of SWP-1 and 
SWP-2, either as whole proteins, immunogenic fragments or nucleic acid 
expression constructs along with a pharmaceutically acceptable carrier 
for the treatment of microsporidiosis. A final set of claims include 
the administration of certain ligands to SWP-2 in pharmaceutically 
acceptable carriers for the prevention and treatment of 
microsporidiosis.

    Dated: March 2, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-5224 Filed 3-8-04; 8:45 am]
BILLING CODE 4140-01-P