[Federal Register Volume 68, Number 52 (Tuesday, March 18, 2003)]
[Notices]
[Pages 12914-12915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6366]


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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 agencies 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.

Development of a Novel High Throughput Assay To Measure Cell Infection 
With Vaccinia Strains Expressing Reporter Genes

Hana Golding (FDA).
U.S. Provisional Patent Application 60/429,767 filed 27 Nov 2002.
Licensing Contact: Peter Soukas; 301/435-4646; [email protected].

    Critical to developing a vaccine against viral infections is an 
assay to measure the neutralizing antibody present in blood of vaccine 
recipients. The currently available tests are labor intensive and 
require 5-6 days to complete. The inventors have designed a high 
throughput vaccinia neutralization assay, which offers several 
advantages over the assays that are currently used. It is completed in 
as little as 24 hours, it is sensitive, highly reproducible, requires 
only 50 [mu]l of plasma and uses automated readout. This assay is based 
on the use of recombinant vaccinia virus (vSC56) expressing a bacterial 
gene coding for the enzyme b-galactosidase (b-Gal) under the control of 
a synthetic early/late promotor. Another recombinant virus expressing 
an inducible reporter gene (EGFP) is also being tested in 
neutralization assay. These assays may be of value in the clinical 
trials of new smallpox vaccines, for evaluations of new vaccinia 
immunoglobulin (VIG) and anti-viral agents under development. The 
technology itself may be adapted for construction of neutralization 
assays for other viruses and intracellular pathogens.

Method of Separating Recombinant Immunotoxin

Hua Jiang et al. (NCI).
DHHS Reference No. E-209-2002/0-US-01 filed 07 Nov 2002.

[[Page 12915]]

Licensing Contact: Jonathan Dixon; 301/435-5559; [email protected].

    Over the past several years, dsFv-immunotoxins have generated 
significant interest in the research and commercial communities, as 
they have been shown to me more useful in certain therapeutic 
applications over intact antibody-immunotoxins and Fv-immunotoxins. 
dsFv-immunotoxins are created when a single-chain variable domain-toxin 
conjugate is associated with the complementary single-chain variable 
domain via one or more disulfide bonds to form a ``disulfide-
stabilized'' Fv (dsFv)-immunotoxin.
    Separation of dsFv-immunotoxin from its single-chain variable 
domain subunits (and any other contaminants) has thus far been achieved 
through a low yielding and relatively expensive process. The present 
invention discloses a new method of purifying dsFv-immunotoxins that 
has shown a three-fold increase in yield while at the same time keeping 
costs at a commercially reasonable level. As the demand for dsFv-
immunotoxins increases, this method will give companies the ability to 
purify sufficient quantities to support their clinical trials and make 
their way to the commercial marketplace.

Optimization of Cardiac Contraction by Novel Human Kinase Mediated 
Differential Phosphorylation of Myosin

Dr. Neal D. Epstein (NHLBI).
DHHS Reference Nos. E-261-00/0 filed 12 Sep 2000 and E-261-00/2 filed 
12 Sep 2001.
Licensing Contact: Fatima Sayyid; 301/435-4521; [email protected].

    This invention relates to the development of drugs that provide 
novel therapeutic interventions to increase the efficiency of failing 
hearts. It describes the cloning of the active cardiac kinase which 
modified the cardiac stretch-activation response and myofiber tension 
via phosphorylation of the beta myosin light chain molecules. These 
molecules are differentially phosphorylated by this kinase as a 
function of location to produce the spatial variation in myofiber 
mechanics that optimize cardiac torsion. The data in this invention 
indicate that targeting this cardiac light chain kinase could yield 
novel therapeutics to increase the efficiency of hearts failing from a 
variety of causes. This approach represents an alternative to present 
day therapeutics such as calcium blocking agents or digoxin, and thus 
may have the added benefit of providing therapeutics that are 
synergistic with present treatments.
    This invention is described, in part, in Davis et al., Cell 2001 
Nov 30; 107(5):631-41.

Methods of Screening for Risk of Cancer Using Human Lactoferrin DNA 
Probe or Primer

Christina Teng and Timothy Panella (NIEHS).
U.S. Patent 5,948,613 issued 07 Sep 1999.
Licensing Contact: Marlene Shinn-Astor; 301/435-4426; 
[email protected].

    While normal breast ductal epithelium and neutrophilic granulocytes 
contain lactoferrin, their malignant counterparts frequently do not. 
The NIH announces primers or probes corresponding to the human 
lactoferrin gene, its promoter region, and its protein product, 
obtained from human breast tissue. The lactoferrin primer or probes can 
be used to screen for malignancy arising from tissues that normally 
secrete lactferrin, or as a test to check the recovery of a patient 
from a malignancy.

    Dated: March 5, 2003.
Steven M. Ferguson,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
[FR Doc. 03-6366 Filed 3-17-03; 8:45 am]
BILLING CODE 4140-01-P