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 


EN08FE05.002</GPH>
6706 Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 

obtaining high dimensional 

experimental data, such as gene 

expression profiling data, filtering the 

data, reducing the dimensionality of the 

data through use of one or more 

methods, training a supervised pattern 

recognition method, ranking individual 

data points from the data, choosing 

multiple data points from the data based 

on the relative ranking, and using the 

multiple data points to determine if an 

unknown set of experimental data 

indicates a diseased condition, a 

predilection for a diseased condition, or 

a prognosis about a diseased condition. 

Artificial neural networks (ANNs) are 

computer-based algorithms capable of 

pattern recognition particularly suited 

to making diagnoses. ANNs do not 

require explicit encoding of process 

knowledge in a set of rules and can be 

trained from examples to recognize and 

categorize complex patterns. ANNs 

learn more efficiently when the data to 

be input into the neural network is 

preprocessed. Various ANN approaches 

to the analysis of data have seen 

extensive application to biomedical 

problems, including those in the areas 

of diagnosis and drug development. 

Unsupervised neural networks are also 

extensively used for the analysis of DNA 

microarray data. 

The technology is further described in 

J. Khan et al., ‘‘Classification and 

diagnostic prediction of cancers using 

gene expression profiling and artificial 

neural networks,’’ Nature Medicine, 

7(6):673–679, June 2001. 

Selections of Genes 

Javed Khan and Paul S. Meltzer 

(NHGRI), et al.

U.S. Patent Application No. 10/159,563 

filed 31 May 2002 (DHHS Reference 

No. E–324–2001/1–US–01). 

Licensing Contact: Cristina 

Thalhammer-Reyero; 301/435–4507; 

thalhamc@mail.nih.gov.

The invention provides selections of 

genes expressed in a cancer cell that 

function to characterize such cancer, 

and methods of using the same for 

diagnosis and for targeting the therapy 

of selected cancers. In particular, 

methods are provided to classify cancers 

belonging to distinct diagnostic 

categories, which often present 

diagnostic dilemmas in clinical practice, 

such as the small round blue cell tumors 

(SRBCTs) of childhood, including 

neuroblastoma (NB), 

rhabdomyosarcoma RMS), Burkitt’s 

lymphoma (BL), and the Ewing family 

of tumors (EWS). More specifically, the 

invention is an application of Artificial 

Neural Networks (ANNs) for the 

diagnostic classification of cancers 

based on gene expression profiling data 

derived from cDNA microarrays. The 

ANNs were trained using as models. 

The ANNs then correctly classified all 

samples tested and identified the genes 

most relevant to the classification. Their 

study demonstrated the potential 

applications of these methods for tumor 

diagnosis and for the identification of 

candidate targets for therapy. The 

uniqueness of this method is taking 

gene expression data generated by 

microarrays, minimizing the genes from 

the original 1000s to less than 100, 

identifying which genes are the most 

relevant to a classification, which gives 

an immediate clue to the actual 

biological processes involved, not just 

surrogate markers which have no 

bearing on the biology. 

The technology is further described in 

J. Khan et al., ‘‘Classification and 

diagnostic prediction of cancers using 

gene expression profiling and artificial 

neural networks,’’ Nature Medicine 7(6): 

673–679, June 2001.

Dated: February 1, 2005. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health.

[FR Doc. 05–2366 Filed 2–7–05; 8:45 am] 

BILLING CODE 4140–01–U

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. 

Methods for Prophylaxis and Treatment 

of HER–2/neu Tumors 

John C Morris, Jay A. Berzofsky, Yoshio 

Sakai, Jong-Myun Park, Masake 

Terabe (all of NCI). 

Serial Nos. PCT/US2003/034362 filed 

29 Oct 2003 (DHHS Reference No. E–

025–2003/1–PCT–1) and 60/422,395 

filed 30 Oct 2002 (DHHS Reference 

No. E–025–2003/0–US–01). 

Licensing Contact: Susan S. Rucker; 

(301) 435–4478; 

ruckersu@mail.nih.gov.

This application relates to methods 

for cancer prophylaxis and treatment. 

More particularly, the application 

relates to methods for the treatment and 

prophylaxis of cancers caused by the 

activity of the HER–2/neu/erbB–2 gene 

employing immunotherapy. Such 

cancers include breast cancers, cancers 

of the female genital tract and some 

cancers of the gastrointestinal tract. 

The methods claimed involve the use 

of a HER–2/neu vaccine employing 

recombinant non-replicating adenovirus 

expressing a HER–2/neu/erbB–2 gene. 

In a preferred embodiment the vaccine 

comprises a recombinant nonreplicating adenoviral vector encoding a 

HER–2/neu/erbB–2 gene that is 

expressed as a truncated HER–2/neu/

erbB–2 protein. Antigen presenting 

cells, such as dendritic cells infected 

with the recombinant adenoviral vector, 

process and present the truncated HER–

2/neu/erbB–2 protein, thereby 

stimulating an immune response. 

Preferred HER–2/neu/erbB–2 proteins 

contain regions of the extracellular 

domain and the transmembrane domain 

of the intact HER–2/neu/erbB–2 gene 

product and do not contain any tyrosine 

kinase domains. 

This work has been published in part 

in Sakai, Y, et al. Cancer Research 

64(21): 8022 (Nov 1 2004) and as WO 

2004/041065 (May 21 2004). 

Antibodies and Polypeptides to AAMP–

1 for Use in Diagnosis and Therapy of 

AAMP–1–Expressing Cancers 

Lance Liotta et al. (NCI). 

U.S. Patent No. 6,274,134 issued 14 Aug 

2001 (DHHS Reference No. E–084–

1991/1–US–01); Australian Patent No. 

684806 issued 23 Apr 1998 (DHHS 

Reference No. E–084–1991/1–AU–05). 

Licensing Contact: Thomas Clouse; (301) 

435–4076; clousetp@mail.nih.gov.

Angio-associated migratory cell 

protein (AAMP–1) was first isolated 

from a human melanoma cell line as a 

motility-associated cell protein. AAMP–

1 contains two immunoglobin domains,