04-5224. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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: [phone]; fax: [phone]. 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).

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; [e-mail].

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 (Galβ1-3GalNAc) 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; [e-mail].

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; [e-mail].

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; [e-mail].

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; [e-mail].

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 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.