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Government-Owned Inventions; Availability for Licensing

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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: (301) 496-7057; fax: (301) 402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Monoclonal Antibody (MP804) That Specifically Binds Stem Cells and Its Use

Neal D. Epstein (NHLBI); U.S. Provisional Application No. 60/565,101 filed 23 Apr 2004 (DHHS Reference No. E-014-2004/0-US-01); Licensing Contact: Fatima Sayyid; (301) 435-4521; sayyidf@mail.nih.gov.

Adult stem cells hold great promise for human disorders that are currently incurable including spinal-cord injury and brain diseases. Although it has been shown that adult stem cells can produce many different tissue types in the body, from blood to muscle to nerve leading hope to their use for repairing or replacing diseased or damaged organs, their use is limited due to lack of reagents for isolation of adult stem cells from tissues. This invention is drawn to antibodies that can detect a subpopulation of primitive stem cells in adult murine skeletal muscle. This subset of cells can be used to repair a variety of neurological disorders, to produce primary and immortalized cell lines for physiologic and pharmaceutical research, and for genomic and proteomic studies focused on the process of neural cell differentiation.

Modulating P38 Kinase Activity

Dr. Jonathan Ashwell (NCI); U.S. Provisional Application No. 60/541,993 filed 05 Feb 2004 (DHHS Reference No. E-010-2004/0-US-01); Licensing Contact: Marlene Shinn-Astor; (301) 435-4426; shinnm@mail.nih.gov.

Protein kinases are involved in various cellular responses to extracellular signals. The protein kinase termed p38 is also known as cytokine suppressive anti-inflammatory drug binding protein (CSBP) and RK. It is believed that p38 has a role in mediating cellular response to inflammatory stimuli, such as leukocyte accumulation, macrophage/monocyte activation, tissue resorption, fever, acute phase responses and neutrophilia. In addition, p38 has been implicated in cancer, thrombin-induced platelet aggregation, immunodeficiency disorders, autoimmune diseases, cell death, allergies, osteoporosis and neurodegenerative disorders.

The NIH announces a new technology that includes compositions and methods for controlling the activity of p38 specifically in T cells through an alternate activation pathway. By controlling p38 activity through Start Printed Page 46171interference with this alternate pathway, the T cells themselves can be controlled which in turn can be a treatment for conditions or diseases characterized by T cell activation such as autoimmune diseases, transplant rejection, graft-versus-host disease, systemic lupus erythematosus, and viral infections such as HIV infections.

Human Neuronal Cells for Therapeutic Uses

Jong-Hoon Kim, Raja Kittappa, and Ronald D. McKay (NINDS); U.S. Provisional Application No. 60/495,346 filed 14 Aug 2003 (DHHS Reference No. E-056-2003/0-US-01); Licensing Contact: Norbert Pontzer; (301) 435-5502; pontzern@mail.nih.gov.

Embryonic stem (ES) cells from various animal models demonstrate pluripotency, the ability to generate the multiple cell types found in the adult body. ES cells can also proliferate indefinitely in an undifferentiated state in vitro. These properties may allow cells derived from ES cells to replace diseased or injured cells and tissue. While the local milieu may direct some naive ES cells into the appropriate fate for that tissue, the formation of teratomas and other unwanted cell types remains an unsolved problem. Thus, the ability to direct the differentiation of embryonic stem (ES) cells into specific fates may be a necessary condition for their use in transplantation therapy for diseases such as Parkinson's.

Using mouse ES cells, this laboratory previously produced a highly enriched population of midbrain neuronal cells that, when transplanted into rat models of Parkinson's disease, improved motor function and demonstrated in vivo electrophysiological properties consistent with functioning dopamine neurons. Using a similar culturing strategy, but with conditions specifically modified for human ES cells, these inventors have now produced a highly enriched population of human neuronal cells that exhibit electrical activity and synaptic vesicle release. Another simplified method differentiates ES cells grown as a monolayer into neurons, without going through an embryoid body stage. This intellectual property provides methods for producing human neuronal cells in general and dopaminergic cells specifically, the cells themselves, and methods of treating diseases caused by neuronal degeneration.

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Dated: July 21, 2004.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. 04-17468 Filed 7-30-04; 8:45 am]

BILLING CODE 4140-01-P