03-26357. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

The invention listed below is owned by an agency of the U.S. Government and is 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 application 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 application.

Method and Device for Catheter-Based Repair of Cardiac Valves

Robert J. Lederman (NHLBI), U.S. Provisional Application No. 60/426,984 filed 15 Nov 2002 (DHHS Reference No. E-010-2003/0-US-01).

Licensing Contact: Michael Shmilovich; 301/435-5019; [e-mail].

The invention provides a system and method for catheter-based repair of cardiac valves. The technique may permit non-surgical repair of regurgitant valves using percutaneous catheters in awake patients. The intervention is intended to discontinue/lessen regurgitation of the mitral valve and should provide a viable alternative to the conventional treatment with vasodilator medications and open heart surgery. The technology involves re-apposing of mitral valve leaflets by percutaneous annuloplasty delivering circumferential tensioning devices. Under appropriate imaging guidance (such as fluoroscopic MRI) a circumferential device trajectory is navigated through anatomic (coronary sinus) and non-anatomic spaces to deliver a circumferential tensioning device. As an adjunct, redundant or otherwise disrupted valvar tissue may be oversewn by catheter-based capture, alignment, and suture of valve leaflets. Provided are also designs of various catheters, systems that would be necessary to perform the repair of cardiac valves. Imaging methods, like fluoroscopic (real time MRI), could be used to assist the operator for placement and orientation purposes.

Variable Curve Catheter

Robert J. Lederman, Parag Karmarkar (NHLBI), U.S. Provisional Application No. 60/426,542 filed 15 Nov 2002 (DHHS Reference No. E-035-2003/0-US-01).

Licensing Contact: Michael Shmilovich; 301/435-5019; [e-mail].

The invention provides a deflectable tip guiding device, such as a catheter, that enables the operator to vary the radius of curvature of the tip of the catheter. This is a novel variation on the classic “fixed fulcrum” tip deflectors used in minimally invasive procedures in open surgical treatments. The described device would permit more comprehensive ability to navigate complex geometric pathways in patient's body and would enable better access to the target structures (e.g., to all endomyocardial walls from a transaortic approach). The guiding device can be made compatible with imaging methods like MRI. The described technology can be used as a platform for a wide variety of interventional devices for delivery of drugs, cells, energy, or sutures through complex trajectories of the body.

Recombinant Plasmids for Soluble Immunoreceptors

Peter Sun (NIAID), DHHS Reference No. E-305-2003/0.

Licensing Contact: Cristina Thalhammer-Reyero; 301/435-4507; [e-mail].

Immunoreceptors initiate signals leading to the activation of immune system against invasion pathogens. A number of soluble receptors, representing the extracellular ligand binding domains of the immunoreceptors, have been expressed using a recombinant bacteria expression and reconstitution system. This set of 21 plasmids, which can be used as immunological research reagents or to develop diagnostic tools, comprise the following:

Plasmid	Description
CD16-28b	Soluble CD16.
CD94 (S34)-30a	Soluble CD94 truncated at S34.
CD94 (E51)-30a	Soluble CD94 truncated at E51.
NKG2A (109R)-30a	Soluble NKG2A 109R construct.
NKG2A (117G)-30a	Soluble NKG2A 117G construct.
TBRII-30a	Soluble type II TGF-beta receptor.
C143-30a	Soluble KIR2DL2 receptor.
NKG2D-22b	Soluble NKG2D receptor.
ULBP-1-22-b	Soluble ULBP-1.
ULBP-2-22-b	Soluble ULBP-2.
ULBP-3-22b	Soluble ULBP-3.
HLA-E-30a	Soluble HLA-E heavy chain.
HLA-Cw3	Soluble HLA-Cw3 heavy chain.
TREM-1-22b	Soluble TREM-1 receptor.
TREM-2-22b	Soluble TREM-2 receptor.
NKp30-22b	Soluble NKp30.
NKp46-22b	Soluble NKp46.
NKp44-22b	Soluble NKp44.
Siglec-3-30a	Soluble Siglec-3.
Siglec-5-30a	Soluble Siglec-5.
Siglec-7-30a	Soluble Siglec-7.

Methods and Materials for Controlling Stem Cell and Cancer Cell Proliferation and Differentiation. ea /01)./

Robert Tsai and Ronald McKay (NCI), U.S. Provisional Application No. 60/442,005 filed 22 Jan 2003 (DHHS Reference No. E-019-2003/0-US-01); U.S. Provisional Application No. 60/415,867 filed 02 Oct 2002 (DHHS Reference No. E-001-2003/0-US-01)

Licensing Contact: Norbert Pontzer; 301/435-5502; [e-mail].

This work describes a novel nucleolar mechanism that controls the cell-cycle progression in CNS stem cells and cancer cells. The inventors identified a novel peptide, nucleostemin, found in the nucleoli of CNS stem cells, embryonic stem cells, and several cancer cell lines and preferentially expressed by other stem cell-enriched populations. When stem cells differentiate, nucleostemin expression decreases rapidly prior to cell-cycle exit both in vitro and in vivo. Depletion or overexpression of nucleostemin reduces cell proliferation in CNS stem cells and transformed cells.

Nucleic acids encoding the polypeptide, vectors incorporating the nucleic acids, and host cells transfected with these nucleic acids are disclosed and claimed. The claimed invention includes methods for regulating cell differentiation, cell proliferation, or both using nucleostemin. Methods for inducing differentiation, inhibiting proliferation, and inducing senescence of a cell by altering the level of a nucleostemin polypeptide and related amino acid sequences are disclosed and claimed. Methods for screening for agents that affect proliferation, differentiation, or senescence of cells are also disclosed and claimed. Further information can be found in Genes Dev. 2002 Dec 1;16 (23):2991-3003.

Dated: October 7, 2003.

Steven M. Ferguson,

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