6704 Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 

analysis. This method has been used in 

S. cerevisiae for many yeast 

chromosomal genes and the human gene 

p53 and has obvious potential for use 

with YAC and TAR clones. Claims are 

directed to several methods for 

generating DNA nucleic acid mutations 

in vivo and are applicable to any 

organism that has a homologous 

recombination system, as well as to kits. 

This methodology is available for 

licensing and is a highly versatile tool 

of direct use to drug discovery, pharma 

and research reagent companies as well 

as to companies working with industrial 

yeast strains. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research with the inventors via a 

Cooperative Research and Development 

Agreement (CRADA). 

Related technologies also available for 

licensing include: DHHS Ref. No. E–

121–1996/0–US–06, TransformationAssociated Recombination Cloning (U.S. 

Patent No. 6,391,642 issued 21 May 

2002); and DHHS Ref. No. E–262–1984/

0–US–03, Process for Site Specific 

Mutagenesis Without Phenotypic 

Selection (U.S. Patent No. 4,873,192 

issued 10 Oct 1989). 

The Whey Acidic Protein (WAP) 

Promoter and Its Use to Express 

Therapeutic Proteins in the Milk of 

Transgenic Mammals 

Lothar Hennighausen (NIDDK), Heiner 

Westphal (NICHD), et al. U.S. Patent 

No. 6,727,405 issued 27 Apr 2004 

(DHHS Reference No. E–411–1987/0–

US–03). 

Licensing Contact: Susan Carson; 301/

435–5020; carsonsu@mail.nih.gov.

Transgenic animals can be engineered 

to express complex human proteins at 

high concentrations in milk. Protein 

replacement therapy is often the only 

treatment available for congenital 

diseases such as hemophilia or 

lysosomal storage disease, and the cost 

of treatment can be high with the 

therapeutic protein market estimated to 

reach more than $50 billion by 2010. 

U.S. Patent No. 6,727,405 has recently 

been issued (expiry date 2021) to NIH 

scientists and their collaborators. This 

patent provides for a non-human 

mammal such as mouse, sheep, pig, goat 

and cow whose genome contains a DNA 

sequence comprising a milk serum 

protein (whey acidic protein) promoter 

linked to a heterologous gene sequence 

and secretory peptide, as well as 

methods for producing a secreted 

protein into the transgenic animal’s 

milk and claims directed to the DNA 

construct. The invention permits the 

production of any desired protein in an 

easily maintained, stable, mammalian 

bioreactor, which is capable not only of 

producing the desired protein in milk, 

but can also pass the ability to do so to 

its female offspring. Although other 

methods of obtaining recombinant 

protein products are available, these 

require inefficient, expensive 

purification of the protein from the 

blood or from cell culture media and 

there remains a need for an efficient and 

cost effective method for producing 

therapeutic proteins. 

This WAP promoter platform 

technology provides a viable alternative 

to other milk protein promoters and is 

available for non-exclusive licensing.

Dated: January 31, 2005. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health.

[FR Doc. 05–2364 Filed 2–7–05; 8:45 am] 

BILLING CODE 4140–01–P

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 

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. 

A3 Adenosine Receptor Agonists 

Kenneth A. Jacobson et al. (NIDDK). 

U.S. Provisional Patent Application No. 

60/608,823 filed 09 Sep 2004 (DHHS 

Reference No. E–248–2004/0–US–01). 

Licensing Contact: Marlene Shinn-Astor; 

(301) 435–4426; 

shinnm@mail.nih.gov.

Researchers have been pursuing 

compounds that activate or inhibit 

adenosine A3 receptors because these 

cell membrane proteins have a wide 

range of physiological and diseaserelated effects and are thus considered 

to be promising drug targets. The 

adenosine A3 receptors are G-proteincoupled receptors and are found mostly 

in brain, lung, liver, heart, kidney, and 

testis. When this receptor is activated 

moderately, a cytoprotective effect is 

observed, such as reducing damage to 

heart cells from lack of oxygen. 

However, at high levels of stimulation 

they can cause cell death. Both agonists 

and antagonists are being tested for 

therapeutic potential, for example, 

treatment of cancer, heart conditions, 

neurological conditions, pain, asthma, 

inflammation and other immune 

implications. 

Adenosine receptors have provided 

fertile leads for pharmaceutical 

development, and there are currently a 

variety of adenosinergic compounds 

advancing toward clinical trials. 

Therapeutics which target the adenosine 

A3 receptors is now an emerging focus 

that the major pharmaceutical 

companies are developing. Smaller 

companies are also developing drugs 

that stem from proprietary technology 

targeting adenosine A3 receptors. These 

companies have products in clinical 

trials for colorectal cancer and 

rheumatoid arthritis. 

This invention pertains to highly 

potent A3 adenosine receptor agonists, 

pharmaceutical compositions 

comprising such nucleosides, and a 

method of use of these nucleosides. 

This research has been published, in 

part, in S. Tchilibon, B.V. Joshi, S.-K. 

Kim, H.T. Duong, Z.-G. Gao, and K.A. 

Jacobson, ‘‘N-methano adenosine 

derivatives as A3 receptor agonists,’’ J. 

Med. Chem., ASAP web release date 23 

Sep 2004, doi: 10.1021/jm049580r. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research with the inventors via a 

Cooperative Research and Development 

Agreement (CRADA). 

Apparatus for Multifocal Deposition 

and Analysis 

Bradford Wood, Alexander Gorbach, Ziv 

Neeman, Julia Hvisda (all of NIHCC), 

et al. U.S. Provisional Patent 

Application No. 60/403,875 filed 16 

Aug 2002 (DHHS Reference No. E–

248–2001/0–US–01); International 

Application Number PCT/US03/

25575 filed 14 Aug 2003, which 

Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 6705

published as WO 2004/016155 A3 on 

26 Feb 2004 (DHHS Reference No. E–

248–2001/0–PCT–02). 

Licensing Contact: Michael Shmilovich; 

(301) 435–5019; 

shmilovm@mail.nih.gov.

Available for licensing and 

commercial development is a multifocal 

apparatus for delivering an agent or for 

gathering information about a biological 

tissue, such as optical spectroscopy for 

tissue characterization (nuclear 

chromatic density). The apparatus 

includes a needle or catheter having a 

lumen extending longitudinally at least 

partially through it and a deployment 

port within the distal portion of the 

catheter. A plurality of extendableretractable needles are housed within 

the catheter lumen, when deployed, 

extend through the deployment port. 

The needles may be solid or hollow and 

may deliver an agent to the tissue, 

include a mechanism for gathering 

information about the tissue, or both. 

Optical spectroscopy in a needle-based 

system provides in vivo tissue 

characterization without removal of 

tissue for microscopic analysis, which 

may be helpful during surgery or image 

guided therapies to localize cancerous 

tissue. 

Figure 1 is a schematic diagram of one 

embodiment of the apparatus in use. 

The distal end of the apparatus is shown 

within a neoplasm and the needles are 

in a deployed state. 

Figure 2 is an enlarged, longitudinal 

section through the distal end of an 

embodiment of the apparatus, showing 

several extendable-retractable needles in 

a non-deployed, or retracted, state.

In addition to licensing, the 

technology is available for further 

development through collaborative 

research with the inventors via a 

Cooperative Research and Development 

Agreement (CRADA).

Dated: February 1, 2005. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health.

[FR Doc. 05–2365 Filed 2–7–05; 8:45 am] 

BILLING CODE 4140–01–P

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 

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. 

Monoclonal Antibody 90.12 Recognizes 

a Novel B Cell Surface Antigen 

Upregulated on Both Activated and 

Apoptotic Lymphocytes 

Marjorie A. Shapiro et al. (FDA). 

DHHS Reference No. E–195–2004/0—

Research Tool. 

Licensing Contact: Cristina 

Thalhammer-Reyero; 301/435-4507; 

thalhamc@mail.nih.gov.

Monoclonal antibody 90.12 

recognizes a molecule expressed on the 

surface of a subset of B lymphocytes and 

on all types of blood cells. This antigen 

is increased upon stimulation of B and 

T lymphocytes as well as on cells 

undergoing programmed cell death. 

Amino acid sequencing of the beginning 

of the protein suggests that it is a 

member of the S100 family of calcium 

binding proteins. The antibody is 

further described in ‘‘Characterization of 

a B cell surface antigen with homology 

to the S100 protein MRP8’’ by Shapiro 

MA, Fitzsimmons SP, Clark KJ, Biochem 

Biophys Res Commun. 1999 Sep 

16;263(1):17–22 and ‘‘A novel activation 

induced lymphocyte surface antigen, 

90.12, is also expressed on apoptotic 

cells’’ by Clark KJ, Monser M, Stein KE, 

Shapiro MA, Scand J Immunol. 2000 

Feb;51(2):155–63. 

Methods for Analyzing High 

Dimensional Data for Classifying, 

Diagnosing, Prognosticating, and/or 

Predicting Diseases and Other 

Biological States 

Javed Khan and Paul S. Meltzer 

(NHGRI), et al.

U.S. Patent Application No. 10/133,937 

filed 25 Apr 2002 (DHHS Reference 

No. E–324–2001/0–US–01). 

Licensing Contact: Cristina 

Thalhammer-Reyero; 301/435–4507; 

thalhamc@mail.nih.gov.

This invention relates to a method of 

using supervised pattern recognition 

methods to classifying, diagnosing, 

predicting, or prognosticating various 

diseases. The method includes 


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