[Federal Register Volume 70, Number 170 (Friday, September 2, 2005)]
[Notices]
[Pages 52403-52405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17517]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

[[Page 52404]]

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.

Method for Inducing T-Cell Proliferation

Warren J. Leonard et al. (NHLBI).
U.S. Provisional Application No. 60/555,898 filed 23 Mar 2004 (HHS 
Reference No. E-104-2004/0-US-01); U.S. Utility Application No. 11/
084,408, filed 18 Mar 2005 (HHS Reference No. E-104-2004/0-US-02).

Licensing Contact: Susan Ano; 301/435-5515; [email protected].
    This technology relates to the use of thymic stromal lymphopoietin 
(TSLP) or TSLP agonists to induce CD4+ T cell proliferation as well as 
the use of TSLP antagonists to treat IgE-mediated disorders such as 
asthma or allergies. The T cell proliferation application of this 
technology could be of particular relevance for patients in whom this 
cell population has been significantly reduced by e.g., HIV/AIDS 
infection or another condition resulting in immunodeficiency. The 
patent application describes methods of treating individuals afflicted 
with an immunodeficiency by administering CD4+ T cells that have been 
isolated and induced to proliferate using TSLP or by direct 
administration of TSLP or a nucleic acid encoding TSLP. The need for 
appropriate treatment methods for conditions such as asthma and 
allergies are well recognized. The patent application describes 
administration of a TSLP antagonist to an individual suffering from an 
IgE-mediated disorder to remove or lessen the symptoms. TSLPR knockout 
mice are also described in the patent application and available for 
licensing through a biological materials license agreement.

Vaccines Using Universally Inactivated Viruses, Parasites, and Tumor 
Cells

Yossef Raviv et al. (NCI).
U.S. Provisional Application filed 22 Mar 2004 (HHS Reference No. E-
303-2003/0-US-01); PCT Application filed 22 Mar 2005 (HHS Reference No. 
E-303-2003/0-PCT-02).
Licensing Contact: Susan Ano; 301/435-5515; [email protected].

    The current technology describes the universal inactivation of 
viruses, parasites, and tumor cells by hydrophobic, photoactivatable 
compounds. These non-toxic compounds, such as 1,5-iodoanpthylazide 
(INA), will selectively accumulate in the innermost regions of 
biological membrane bilayers, where the compounds will bind to proteins 
and lipids upon irradiation with light, thus inactivating deeply 
embedded proteins while maintaining integrity and activity of the 
proteins on the surface. This inactivation preserves the structural and 
conformational integrity and therefore immunogenicity of the agent in 
question, which overcomes a potential problem associated with some 
other vaccines such as those containing killed pathogens. As 
representative examples, the patent application describes experimental 
results obtained using HIV, SIV, and Ebola viruses. The inactivation 
approach presented in this technology provides for a safe, non-
infectious composition for vaccination against the corresponding agent, 
whereas some vaccines, such as those involving live-attenuated 
microbial agents, still have a risk of infectivity associated with 
them.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

High Expression Level Vectors Combining of mRNA Transport Elements for 
Use in Mammalian Cells

Barbara K. Felber et al. (NCI).
U.S. Provisional Application No. 60/471,988 filed 19 May 2003 (HHS 
Reference No. E-223-2003/0-US-01); U.S. Provisional Application No. 60/
472,223, filed 20 May 2003 (HHS Reference No. E-258-2003/0-US-01); PCT 
Application No. PCT/US04/15776 filed 19 May 2004, which published as 
WO2004/113547 on 29 Dec 2004 (HHS Reference No. E-223-2003/1-PCT-01).
Licensing Contact: Susan Ano; 301/435-5515; [email protected].

    This technology relates to improving levels of gene expression 
using a combination of a constitutive RNA transport element (CTE) with 
a mutant form of another RNA transport element (RTE). The combination 
of these elements results in a synergistic effect on stability of mRNA 
transcripts, which in turn leads to increased expression levels. Using 
HIV-1 gag as reporter mRNA, one mutated RTE in combination with a CTE 
was found to improve expression of unstable mRNA by about 500-fold. 
Similarly this combination of elements lead to synergistically elevated 
levels of HIV-1 Env expression. The function of CTEs and RTEs is 
conserved in mammalian cells, so this technology is a simple and useful 
way of obtaining high levels of expression of otherwise poorly 
expressed genes and can be used in a number of applications such as but 
not limited to improvements of gene therapy vectors, expression vectors 
for mammalian cells.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Recombinant Plasmids Containing HIV Reverse Transcriptase

Stephen H. Hughes and Paul L. Boyer (NCI).
HHS Reference Nos. E-034-1991/0, /1, /2, /3, and /4--Research Tools.
Licensing Contact: Sally Hu; 301/435-5606; [email protected].

    NIH offers below HIV-1 Reverse Transcriptase (RT) Expression 
plasmids that are available for licensing via biological material 
licenses (BML). In an appropriate strain of E. coli, these plasmids 
cause the expression of an HIV-1 RT heterodimer (p66/p51). In the 
expression plasmid, the RT coding region is flanked by synthetic 
initiation and termination codons. The amino terminus of the RT made in 
E. coli has two additional amino acids relative to the viral enzyme 
(MV); these have no obvious effect on enzymatic activity. The carboxy 
terminus of p66 carries a 6-histidine tag that facilitates 
purification. The plasmid also causes the expression of a low level of 
HIV-1 protease; this leads to the conversion of the approximately half 
of the p66 synthesized in E. coli to p51. The p66/p51 heterodimer can 
be easily extracted from the E. coli host and purified by metal-chelate 
chromatography. Expression constructs for many of the common drug-
resistant versions of HIV-1 RT (a partial list is given below) and for 
a number of other mutants are available. Alternate RT expression 
plasmids that encode versions of HIV-1 RT that do not have his tags and 
plasmids that separately encode p51 and p66 (allowing subunit selective 
mutagenesis) are also available. The HIV-1 RT expression plasmids can 
be used to generate wild-type and drug resistant RTs that can be used 
in both biological and medical research. The RTs are particularly 
useful in the screening and development of RT

[[Page 52405]]

inhibitors in vitro and can be used to test drug candidates for their 
effectiveness against common drug resistant mutants of HIV-1 RT. Please 
contact Dr. Hughes directly ([email protected]) if you want additional 
information about RT expression plasmids that are not listed below.

------------------------------------------------------------------------
            Vector                   Description         Reference No.
------------------------------------------------------------------------
Wild-type HIV-1 RT............  full length, wild           E-034-1991/0
                                 type.
L100I.........................  NNRTI resistant......       E-034-1991/1
K103N.........................  NNRTI resistant......       E-034-1991/1
V106A.........................  NNRTI resistant......       E-034-1991/1
V108I.........................  .....................  .................
E138K.........................  NNRTI resistant......       E-034-1991/1
Y181I.........................  .....................  .................
Y181C.........................  NNRTI resistant......       E-034-1991/1
Y188L.........................  .....................  .................
Y188H.........................  NNRTI resistant......       E-034-1991/1
G190A.........................  .....................  .................
G190S.........................  .....................  .................
P236L.........................  NNRTI resistant......       E-034-1991/1
-------------------------------
 
 RTs that carry some combinations of NNRTI mutations, e.g., K103N+Y181I,
                           are also available.
------------------------------------------------------------------------
K65R..........................  NRTI resistant.......       E-034-1991/2
T69G..........................  .....................  .................
L74V..........................  NRTI resistant.......       E-034-1991/1
M184I.........................  Lamivudine (3TC)       .................
                                 resistant.
M184V.........................  Lamivudine (3TC)            E-034-1991/1
                                 resistant.
AZT-R (5 mutations)...........  AZT resistant........       E-034-1991/1
[Delta]67 complex.............  Multi-NRTI resistant.       E-034-1991/4
Q151M.........................  Multi-NRTI resistant.       E-034-1991/4
Q151M Complex.................  Multi-NRTI resistant.       E-034-1991/4
SSGR/T215Y....................  Multi-NRTI resistant.       E-034-1991/4
SSSR/T215Y....................  Multi-NRTI resistant.       E-034-1991/4
------------------------------------------------------------------------


    Dated: August 20, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-17517 Filed 9-1-05; 8:45 am]
BILLING CODE 4140-01-P