[Federal Register Volume 69, Number 190 (Friday, October 1, 2004)]
[Notices]
[Pages 58930-58931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22149]


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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, HHS.

ACTION: Notice.

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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.

Bovine Adeno-Associated Viral (BAAV) Vector and Uses Thereof

John Chiorini et al. (NIDCR)

U.S. Provisional Application No. 60/526,786 Filed 04 Dec 2003 (DHHS 
Reference No. E-329-2003/0-US-01)
    Licensing Contact: Jesse Kindra; (301) 435-5559; 
<a href="/cdn-cgi/l/email-protection#cda6a4a3a9bfaca78da0aca4a1e3a3a4a5e3aaa2bb"><span class="__cf_email__" data-cfemail="6f0406010b1d0e052f020e06034101060741080019">[email protected]</span></a>.
    Adeno-associated viruses (AAVs) are common in humans, but no 
disease has been associated with AAV infections. This, as well as 
several other properties, has made AAVs potentially useful for gene 
therapy. Bovine AAV (BAAV) is serologically distinct from AAVs isolated 
from humans and may not be neutralized by circulating antibodies in 
patients receiving gene therapy. Moreover, BAAV has a unique tropism 
for various cell lines when compared to other AAVs. For instance, 
recombinant BAAV transduced murine submandibular salivary glands about 
ten times more efficiently than AAV-2. Therefore, BAAV may be a useful 
addition to the repertoire of gene transfer tools because of its unique 
serological identity, cell tropism, and efficient gene transfer in 
vivo.
    The present invention describes the isolation, subcloning and 
sequencing of BAAV and provides a vector comprising BAAV viral 
particles, or a vector comprising subparts of the vectors. The 
invention also provides a method of delivering a nucleic acid to a cell 
subject. We note that this vector may also have future application(s) 
in the cattle industry.
    This invention has been described in Schmidt et al. 2004. J. Virol. 
78:6509-16.

Treatments for Inhibiting Development and Progression of Nevi and 
Melanoma Having BRAF Mutations

Paul S. Meltzer (NHGRI)

PCT Application No. PCT/US03/32989 Filed 16 Oct 2003 (DHHS Reference 
No. E-021-2003/0-PCT-01)
    Licensing Contact: Charmaine Richman; (301) 451-7337; 
<a href="/cdn-cgi/l/email-protection#8cfee5efe4e1ede2efcce1ede5e0a2e2e5e4a2ebe3fa"><span class="__cf_email__" data-cfemail="cab8a3a9a2a7aba4a98aa7aba3a6e4a4a3a2e4ada5bc">[email protected]</span></a>.
    The technology encompasses activating mutations in the BRAF gene 
that promote nevi and melanoma proliferation. These mutations produce 
an activated form of B-Raf, a serine/threonine kinase participant in 
the Ras/Raf/MEK/ERK MAPK pathway. In one example of the activating BRAF 
mutations, a 1796 T [rarr] A transversion produces a V599E mutated form 
of B-Raf. This mutated form of B-Raf possesses a tenfold greater basal 
kinase activity and induces focus formation in NIH3T3 cells 138 times 
more efficiently than does wild type B-Raf. Methods of diagnosing BRAF 
mutations in a subject, methods of treating nevi and melanoma in 
subjects having BRAF mutations, methods of selecting treatments, 
methods of screening for agents that influence B-Raf activity, and 
methods of influencing the expression of BRAF or BRAF variants are also 
claimed. Nucleotide sequences for use in the described methods are also 
provided, as are protein-specific binding agents, such as antibodies, 
that bind specifically to at least one epitope of a B-Raf variant 
protein preferentially compared to wild type B-Raf.
    Important publications: Oncogene (2004) 23, 4060-4067; Nature 
(2002) 417(6892), 949-54.

[[Page 58931]]

Lentivirus Vector System

Suresh K. Arya (NCI)

U.S. Provisional Application No. 60/115,247 Filed 07 Jan 1999 (DHHS 
Reference No. E-231-1998/0-US-01)
PCT Application No. PCT/US/00/00390 Filed 06 Jan 2000, which published 
as WO 00/40741 on 13 Jul 2000 (DHHS Reference No. E-231-1998/0-PCT-02)
U.S. Patent Application No. 09/869,588 Filed 28 Jun 2001 (DHHS 
Reference No. E-231-1998/0-US-03)
U.S. Patent Application No. 10/731,988 Filed 09 Dec 2003 (DHHS 
Reference No. E-231-1998/0-US-04)
    Licensing Contact: Jesse Kindra; (301) 435-5559; 
<a href="/cdn-cgi/l/email-protection#22494b4c46504348624f434b4e0c4c4b4a0c454d54"><span class="__cf_email__" data-cfemail="076c6e696375666d476a666e6b29696e6f29606871">[email protected]</span></a>.
    This application relates to the field of gene therapy. More 
particularly the application describes a vector system useful in gene 
therapy. The vectors employed in this system are lentiviral vectors, 
particularly retroviral vectors based on HIV2. Retroviral vectors based 
on HIV2, unlike most other retroviral vectors such as MuLV, are capable 
of infecting non-proliferating cells thereby making them useful in 
situations where other retroviral vectors are not. The vector system 
uses a two vector approach to minimize the possibility of HIV infection 
and comprises a transfer vector, for carrying the foreign gene of 
interest, and a packaging vector. The transfer vector carries a 
specific modification that demonstrates an improved ability to package 
and express the gene of interest when compared to a control. In the 
experimental system this increase was 25 fold. This improved packaging 
and expression ability is one means to address current low viral titers 
which are problematic in the gene therapy field.
    This research has been published, in part, in Human Gene Therapy 
1998 June 10; 9(9): 1371-86.

Food Quality Indicator Device

Dwight W. Miller, Jon G. Wilkes, Eric D. Conte (FDA)

U.S. Provisional Application No. 60/052,674 Filed 17 Jul 1997 (DHHS 
Reference No. E-093-1997/0-US-01)
PCT Application No. PCT/US98/14780 Filed 16 Jul 1998, which published 
as WO 99/04256 on 28 Jan 1999 (DHHS Reference No. E-093-1997/0-PCT-04)
U.S. Patent Application No. 09/116,152 Filed 16 Jul 1998 (DHHS 
Reference No. E-093-1997/0-US-02)
U.S. Patent Application No. 10/005,004 Filed 04 Dec 2001 (DHHS 
Reference No. E-093-1997/0-US-03)
    Licensing Contact: George Pipia; (301) 435-5560; 
<a href="/cdn-cgi/l/email-protection#22524b524b4345624f434b4e0c4c4b4a0c454d54"><span class="__cf_email__" data-cfemail="3b4b524b525a5c7b565a525715555253155c544d">[email protected]</span></a>.
    Scientists at the U.S. Food and Drug Administration have invented 
an effective way to monitor food quality and freshness in real time. 
The major factor for food spoilage is the release of volatile gases due 
to the action of enzymes contained within the food or produced by 
microorganisms, such as bacteria, yeasts and molds growing in the food. 
The rate of release of such gases depends on food's storage history. In 
this technology, a reactive dye locked in a water-repellent material 
reacts with the gases released during food decomposition, and changes 
color. Thus a rapid and informed decision can be made about quality of 
food and its shelf life under the storage conditions used. Since the 
detection is based on biological processes that are the root cause for 
food spoilage, these indicators are much more reliable.
    This technology provides an excellent alternative to the current 
methods for assessing food quality that cannot accurately estimate 
shelf life of food products due to unreliable storage history. This 
technology is also much less expensive than the current methods. These 
indicators have been successfully tested on seafood and meats and can 
be easily adapted to dairy products. This product is fully developed, 
market-tested and ready for full commercial rollout.

    Dated: September 22, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-22149 Filed 9-30-04; 8:45 am]
BILLING CODE 4140-01-P


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