[Federal Register Volume 67, Number 247 (Tuesday, December 24, 2002)]
[Notices]
[Pages 78479-78481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32348]


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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.

Improved Non-Viral Mammalian Expression Vector

Gary Nabel, Zhi-yong Yang (NIAID/VRC).
DHHS Reference No. E-318-2002/0 filed 24 Sep 2002.
Licensing Contact: Carol Salata; 301/435-5018; [email protected].

    This invention provides an improved expression vector that 
generates a higher level of protein than vectors currently in use. The 
expression vector is unique in that it uses a specific translational 
enhancer in combination with specific enhancer/promoters to yield high 
levels of protein expression and enhanced immunogenicity for DNA 
vaccines. This is particularly important because the potency of these 
vaccines in humans is marginal and this type of improvement can 
increase the effectiveness of various DNA vaccines. The expression 
vector cassettes can be used in other gene based vaccines as well, or 
for production of recombinant proteins from eukaryotic expression 
vectors. The invention may be useful in the production of genetic 
vaccines and gene therapies for a wide variety of diseases, including 
cancer and viral diseases such as HIV.

[[Page 78480]]

Contiguous Capillary Separation and Electrospray Ionization Sources and 
Analytical Devices

George Janini et al. (NCI)
DHHS Reference No. E-307-2002/0 filed 21 Oct 2002
Licensing Contact: Dale Berkley; 301/435-5019; [email protected]

    The invention is a device that acts as an interface between micro-
scale separation instruments and electrospray ionization (ESI) mass 
spectrometers (MS), thus facilitating the separation and MS 
characterization of almost any type of analyte such as proteins, 
peptides, and small molecules. The device may be used as an interface 
between ESI-MS and any micro-scale separation technology such as 
capillary zone electrophoresis (CZE) capillary electrochromatography 
(CEC), capillary isoelectric focusing (cIEF), capillary 
isotachophoresis (cITF), electrokinetic chromatography (EKC), and high 
performance liquid chromatography (HPLC). The invention integrates a 
separation column, an electrical junction and a spray tip on a single 
piece of fused silica capillary. This invention offers advantages over 
existing ESI-MS interfaces, including ease of fabrication, ruggedness 
and a true zero dead volume junction between the separation column and 
the ESI tip.

Methods and Devices for Intramuscular Stimulation of Upper Airway and 
Swallowing Muscle Groups

Christy Ludlow et al. (NINDS)
DHHS Reference No. E-181-2002/0 filed 27 Sep 2002
Licensing Contact: Dale Berkley; 301/435-5019; [email protected]

    The invention is a method and device that induces intramuscular 
stimulation of the extrinsic and intrinsic laryngeal musculature to 
improve swallowing and voice and upper esophageal sphincter opening in 
humans. The device may be used to augment airway protection in persons 
with swallowing problems (dysphagia) who are at risk of aspiration. 
This invention will assist those persons who have chronic long-standing 
dysphagia and have not been benefited from early rehabilitative 
efforts, putting them at chronic risk of developing life-threatening 
pneumonia because of repeated aspiration. Limiting the entry of food or 
liquids into the lungs while swallowing, which is the objective of this 
invention, can prevent aspiration. Patients at risk of aspiration 
pneumonia currently require enteric (tube) feeding, a costly method for 
sustaining nutrition and one that greatly reduces quality of life. The 
invention comprises three unique components for preventing aspiration 
during swallowing for some persons now requiring enteric feeding: (1) 
Intramuscular implantation to produce two synergistic actions; (2) 
independent long term control of stimulation during swallowing by 
patients; and, (3) a unique system of combining indwelling 
intramuscular electrodes and controllers.

Assays for Assembly of Ebola Virus Pseudoparticles Relevant to 
Antiviral Therapy and Vaccines

Gary Nabel, Yue Huang (NIAID/VRC)
DHHS Reference No. E-090-2002/0 filed 12 Jul 2002
Licensing Contact: Carol Salata; 301/435-5018; [email protected]

    This invention relates to assays for the identification of 
compounds that inhibit assembly of NP, VP35, and VP24, or inhibit the 
glycosylation of NP, required for nucleocapsid formation for the use as 
anti-viral agents. The invention also relates to assays for the 
identification of compounds that block glycosylation of proteins having 
a glycosylation domain that is substantially homologous to a 
glycosylation domain of NP required for polymerization. The invention 
further relates to pseudoparticles for presentation of antigens or 
antigenic epitopes for immunogenic or vaccination purposes especially 
filovirus vaccines such as Ebola.

Dengue Tetravalent Vaccine Containing a Common 30 Nucleotide Deletion 
in the 3'-UTR of Dengue Types 1, 2, 3, and 4

Stephen S. Whitehead (NIAID), Brian R. Murphy (NIAID), Lewis Markoff 
(FDA), Barry Falgout (FDA)
DHHS Reference No. E-089-2002/0 filed 03 May 2002
Licensing Contact: Carol Salata; 301/435-5018; [email protected]

    The invention relates to a dengue virus tetravalent vaccine 
containing a common 30-nucleotide deletion ([Delta]30) in the 3'-
untranslated region (UTR) of the genome of dengue virus serotypes 1, 2, 
3, and 4. The previously identified [Delta]30 attenuating mutation, 
created in dengue virus type 4 (DEN4) by the removal of 30 nucleotides 
from the 3'-UTR, is also capable of attenuating a wild-type strain of 
dengue virus type 1 (DEN1). Removal of 30 nucleotides from the DEN1 3'-
UTR in a highly conserved region homologous to the DEN4 region 
encompassing the [Delta]30 mutation yielded a recombinant virus 
attenuated in rhesus monkeys to a level similar to recombinant virus 
DEN4[Delta]30. This established the transportability of the [Delta]30 
mutation and its attenuation phenotype to a dengue virus type other 
than DEN4. The effective transferability of the [Delta]30 mutation 
establishes the usefulness of the [Delta]30 mutation to attenuate and 
improve the safety of commercializable dengue virus vaccines of any 
serotype.
    A tetravalent dengue virus vaccine containing dengue virus types 1, 
2, 3, and 4 each attenuated by the [Delta]30 mutation is being 
developed. The presence of the [Delta]30 attenuating mutation in each 
virus component precludes the reversion to a wild-type virus by 
intertypic recombination. In addition, because of the inherent genetic 
stability of deletion mutations, the [Delta]30 mutation represents an 
excellent alternative for use as a common mutation shared among each 
component of a tetravalent vaccine.

VAC-BAC Shuttle Vector System

Bernard Moss, Arban Domi (NIAID)
DHHS Reference No. E-355-2001/0 filed 10 Apr 2002
Licensing Contact: Carol Salata; 301/435-5018; [email protected]

    This invention relates to a VAC-BAC shuttle vector system for the 
creation of recombinant poxviruses from DNA cloned in a bacterial 
artificial chromosome. A VAC-BAC is a bacterial artificial chromosome 
(BAC) containing a vaccinia virus genome (VAC) that can replicate in 
bacteria and produce infectious virus in mammalian cells.
    The following are some of the uses for a VAC-BAC:
    1.VAC-BACs can be used to modify vaccinia virus DNA by deletion, 
insertion or point mutation or add new DNA to the VAC genome with 
methods developed for bacterial plasmids, rather than by recombination 
in mammalian cells.
    2. It can be used to produce recombinant vaccinia viruses for gene 
expression.
    3. It can be used for the production of modified vaccinia viruses 
that have improved safety or immunogenicity.
    Advantages of the VAC-BAC shuttle system:
    1. VAC-BACs are clonally purified from bacterial colonies before 
virus reconstitution in mammalian cells.
    2. Manipulation of DNA is much simpler and faster in bacteria than 
in mammalian cells.
    3. Modified genomes can be characterized prior to virus 
reconstitution.
    4. Only virus with modified genomes will be produced so that virus 
plaque isolations are not needed.
    5. Generation of a stock of virus from a VAC-BAC is accomplished 
within a week rather than many weeks.

[[Page 78481]]

    6. Multiple viruses can be generated at the same time since plaque 
purification is unnecessary.

    Dated: December 13, 2002.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 02-32348 Filed 12-23-02; 8:45 am]
BILLING CODE 4140-01-P