46604 Federal Register / Vol. 74, No. 174 / Thursday, September 10, 2009 / Notices 

Dated: September 3, 2009. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. E9–21718 Filed 9–9–09; 8:45 am] 

BILLING CODE 4184–01–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, HHS. 

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. 

Use of a Modified Adaptor Molecule 

LAT to Improve Immunotherapy for 

Cancer and Other Diseases 

Description of Technology: One 

problem with the development of 

immunotherapy for cancer or other 

diseases is the inability to stimulate a 

sufficient immune response in patients 

to tumor associated antigens. The Linker 

Adapted for T Cell Signaling molecule 

(LAT) has been shown to be an 

important molecule in T cell signaling. 

The inventions described and claimed 

in this patent application illustrate a 

new supportive role for LAT which may 

be harnessed to improve a patient’s 

immune response to tumor-associated 

antigens. 

A number of approaches to improving 

the immune response in cancer 

immunotherapy have been investigated. 

One such approach is to be able to 

influence the potency of T Cell 

Signaling. This invention exploits the 

role of LAT in T Cell signaling and 

provides a means to create a more 

intense and effective T Cell response. 

This would have the end result of 

improving the overall response of a 

patient’s immune system to the 

presence of tumor-associated antigens. 

With T Cell signaling being important 

in the body’s immune response to 

bacterial and viral antigens it may also 

be possible to harness the modified LAT 

molecules to improve the immune 

response in developing immunotherapy 

for infectious disease. 

Applications 

• As an adjuvant with 

immunotherapeutic agents to improve 

the overall response of a patient’s 

immune system to tumor associated 

antigens. 

• As an adjuvant with 

immunotherapeutic agents to improve 

the overall response of a patient’s 

immune system to bacterial associated 

antigens. 

• As an adjuvant with 

immunotherapeutic agents to improve 

the overall response of a patient’s 

immune system to viral associated 

antigens. 

Advantages: Enhanced T Cell 

Signaling should improve the overall 

effectiveness of immunotherapy 

producing a more robust patient 

response. 

Development Status: Early stage, 

significant development efforts required 

to reach proof of principle. 

Inventors: Lawrence E. Samelson et 

al. (NCI). 

Publication: This work has not yet 

been published. 

Patent Status 

• U.S. Provisional Application No. 

61/176,231 filed May 7, 2009 (HHS 

Reference No. E–159–2009/0–US–01). 

• Interested parties wishing to review 

the U.S. Patent Application will need to 

sign a CDA. 

Related Technologies: The NIH also 

has three patents related to the basic 

LAT molecule (HHS Reference No. E– 

010–1998)—US 7,118,889, AU 750543, 

and AU 776495—and several pending 

applications in the US published as 

20060073562 A1 and 20070134749 A1 

and corresponding applications in 

Canada (2316769) and Europe (1 141 

281 A1). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Susan S. Rucker; 

301–435–4478; ruckersu@mail.nih.gov. 

Immunogenic Tumor-Associated 

Antigen SPANX–B for Selective Cancer 

Immunotherapy 

Description of Technology: 

Researchers at the National Institutes of 

Health (NIH) have characterized a novel 

tumor-associated antigen, SPANX–B, 

that is naturally immunogenic and is 

expressed in a variety of human 

malignancies, including melanoma and 

lung, colon, renal, ovarian and breast 

carcinomas. In melanoma specifically, 

SPANX–B expression is associated with 

advanced and metastatic disease. 

Moreover, the researchers have found 

several agonist epitope peptides from 

SPANX–B which can be used to activate 

the immune system to eradicate tumors 

utilizing T cells. SPANX–B peptides 

have significant clinical and 

immunotherapeutic potential for the 

development of cancer diagnostic assays 

and potent protective and/or therapeutic 

vaccines to combat a wide-range of 

cancers. 

Applications 

• In vitro diagnostic assays for highlymetastatic melanomas or other cancers. 

• Therapeutic monoclonal antibodies. 

• Cancer vaccine development. 

Advantages 

• Immunogenic: SPANX–B peptides 

are naturally able to elicit immune 

response. 

• Expressed in a wide-range of 

cancers. 

• Use of epitope peptides facilitates 

the activation of cells of the more 

therapeutically effective branch of the 

immune system. 

• Small epitope peptides: Can be 

more easily manufactured in contrast to 

recombinant proteins. 

Development Status: Pre-clinical. 

Market: Cancer; Cancer, Therapy; 

Cancer, Diagnostics/Prognostics. 

Inventors: Arya Biragyn (NIA) and 

Vladimir Larionov (NCI). 

Publication: G Almanzar et al. Spermderived SPANX–B is a clinically 

relevant tumor antigen that is expressed 

in human tumors and readily 

recognized by human CD4+ and CD8+ T 

cells. Clin Cancer Res. 2009 Mar 

15;15(6):1954–1963. 

Patent Status: U.S. Provisional 

Application No. 61/156,435 filed 

February 27, 2009 (HHS Reference No. 

E–089–2009/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Patrick P. McCue, 

Ph.D.; 301–435–5560; 

mccuepat@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute on Aging, 

Laboratory of Immunology, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize the use of SPANX–Bbased therapeutic approaches to combat 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 74, No. 174 / Thursday, September 10, 2009 / Notices 46605 

cancers. Please contact John D. Hewes, 

PhD at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

Biomarkers for Sjo ̈gren’s Syndrome 

Description of Technology: This 

technology provides differentiallyexpressed microRNAs that may be 

utilized for the development of 

diagnostics and therapeutics for 

Sjo ̈gren’s syndrome. 

Sjo ̈gren’s syndrome is an autoimmune 

disorder in which immune cells attack 

and destroy the glands that produce 

tears and saliva. The hallmark 

symptoms of this disorder are dry 

mouth and dry eyes, but it can also 

cause serious complications throughout 

the body. Sjo ̈gren’s syndrome affects as 

many as four million people in the 

United States, making it the second 

most common autoimmune rheumatic 

disease. Unfortunately, there is 

currently no cure for Sjo ̈gren’s 

syndrome, nor is there a specific 

treatment to restore gland secretion. 

Treatment is generally symptomatic and 

supportive, including moisture 

replacement therapies and the use of 

non-steroidal anti-inflammatory drugs 

to treat musculoskeletal symptoms. For 

individuals with severe complications, 

corticosteroids or immunosuppressive 

drugs are often prescribed, but these 

drugs can have serious side effects. 

The inventors have identified 

microRNAs that are differentially 

expressed in patients with Sjo ̈gren’s 

syndrome compared to the normal 

population; these biomarkers can be 

used to diagnose Sjo ̈gren’s syndrome, 

and are potential targets for treatment of 

this disease. The inventors have also 

identified microRNAs associated with 

high or low salivary flow in this patient 

population; these markers may serve as 

targets for therapeutics that restore 

salivary flow. 

Applications: Development of 

diagnostics and therapeutics for 

Sjo ̈gren’s syndrome. 

Development Status: Discovery stage. 

Market: Sjo ̈gren’s syndrome affects 

four million people in the United States. 

Inventors: Ilias Alevizos and Gabor G. 

Illei (NIDCR). 

Related Publication: A Michael et al. 

Exosomes from human saliva as a 

source of microRNA biomarkers. Oral 

Dis. 2009 Jul 15. Epub ahead of print, 

doi: 10.1111/j.1601–0825.2009.01604.x. 

Patent Status: U.S. Provisional 

Application No. 61/165,142 filed March 

31, 2009 (HHS Reference No. E–018– 

2009/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Tara Kirby, PhD; 

301–435–4426; tarak@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIDCR is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize differentially-expressed 

microRNAs. Please contact David 

Bradley at bradleyda@nidcr.nih.gov. 

Treatment of Airway Diseases, 

Including Asthma and COPD, by 

Targeting Airway Hyperresponsiveness 

Description of Technology: This 

technology provides methods of 

treatment for airway diseases, including 

asthma and chronic obstructive 

pulmonary disease (COPD), utilizing 

molecules that target the airway 

hyperresponsiveness (AHR) pathway. 

Airway diseases are a major health 

burden in the developed world. A major 

component of airway disease is airway 

hyperresponsiveness (AHR), defined as 

the exaggerated airway constrictive 

response to external triggers. The 

inventors have shown that inter-alphatrypsin inhibitor (IaI), a mammalian 

protein involved in tissue inflammation 

and repair, is necessary for the 

development of AHR, and that 

inhibitors of IaI prevent the 

development of AHR. Specifically, the 

inventors tested their hypothesis that IaI 

inhibition or absence modifies airway 

smooth muscle cell binding to 

hyaluronan, a molecule known to 

contribute to the response to noninfectious lung injury, which also 

mediates induced AHR. 

Claims in the provisional patent 

application are directed to methods of 

treating an airway disease or disorder by 

administering an inhibitor of IaI, such as 

an antibody, a polypeptide, a 

carbohydrate, a small molecule, or an 

antisense compound. 

Applications: Development of 

therapeutics for airway diseases, 

including asthma and COPD. 

Development Status: Discovery stage. 

Market: Asthma affects over six 

percent of the U.S. population, and 

COPD affects approximately five 

percent. The combined asthma/COPD 

market is expected to reach over $25 

billion in 2017. 

Inventors: Stavros Garantziotis 

(NIEHS) et al. 

Related Publication: S Garantziotis et 

al. Hyaluronan mediates ozone-induced 

airway hyperresponsiveness in mice. J 

Biol Chem. 2009 Apr 24;284(17):11309– 

11317. 

Patent Status: PCT Application Serial 

No. PCT/US09/039157 filed April 1, 

2009 (HHS Reference No. E–009–2009/ 

0–PCT–02). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Tara Kirby, PhD; 

301–435–4426; tarak@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIEHS Division of Intramural 

Research is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize this technology. Please 

contact Dr. Elizabeth M. Denholm, 

Director of the Office of Technology 

Transfer, at denholme@neihs.nih.gov for 

more information. 

MRI Coil Holder for Both Dynamic and 

Static Imaging of Joints 

Description of Technology: Two new 

designs of the MRI coil, each of which 

can be used for both dynamic and static 

imaging of joints, particularly knee and 

ankle joints, have been developed. The 

first design is based on the current 

cylindrical coil designs: While 

maintaining the overall shape, the top 

portion of the coil can slide, providing 

room for joint movement during a 

dynamic exam. To improve the signalto-noise ratio, the adjustable section 

would be able to transmit and receive 

the MRI signal. The second design 

describes a coil in the form of a 

rectangular prism. The sides would be 

adjustable so that the size and 

proportion of the coil can be changed. 

The top of the coil can slide, providing 

room for a bent knee. All four sides of 

the coil would be able to transmit and 

receive the MRI signal. 

Applications: MRI (human and 

veterinary). 

Advantages: Allows for higher quality 

dynamic imaging while maintaining 

current quality of static imaging, 

particularly useful for imaging knee and 

ankle joints while they move. Housing 

is adjustable to allow for bent joints 

while maintaining a favorable signal-tonoise ratio. 

Development Status: Detailed design 

drawings have been completed. 

Inventors: Frances T. (Sheehan) 

Gavelli and Nicole A. Wilson (NIHCC). 

Patent Status: U.S. Provisional 

Application No. 61/151,300 filed 

February 10, 2009 (HHS Reference No. 

E–298–2008/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Bruce Goldstein, 

J.D., M.S.; 301–435–5470; 

goldsteb@mail.nih.gov. 


erowe on DSK5CLS3C1PROD with NOTICES
46606 Federal Register / Vol. 74, No. 174 / Thursday, September 10, 2009 / Notices 

Dated: September 1, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–21786 Filed 9–9–09; 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, HHS. 

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. 

Rapid Diagnostic Applications of Phage 

Description of Technology: The NIH 

has available for licensing two 

techniques for rapid detection of a 

particular bacteria strain. Similar 

detection using currently available 

technologies take 1–2 days; this 

technology reduces the time to less than 

one hour. These technologies utilize 

phage, which has no pathogenic effect 

on higher plants and animals and are 

part of approved food-preparation 

formulations, indicating their known 

safety profile and an existing regulatory 

pathway. The first technique involves a 

phage that incorporates a reporter gene 

(e.g., luciferase) that will be expressed 

only when the phage successfully 

infects a bacterium. This technique is 

particularly useful where only bacteriakilling (‘‘lytic’’) phages are known 

because the method also deactivates the 

lytic genes, enabling infection and 

subsequent detection. The second 

technique involves an engineered phage 

that will bind with quantum dots upon 

infection of bacteria; if a sample is 

treated first with this phage and then 

with quantum dots, the sample will 

only respond if the bacteria are present. 

Both techniques can be used to diagnose 

a clinical sample (tissue, blood, etc.) or 

an environmental isolate. 

Applications 

• Bacterial detection and diagnostics, 

including clinical or environment 

samples. 

• Food safety and biodefense. 

Advantages 

• Detection methods are novel, rapid, 

and potentially applicable in many 

contexts (e.g., clinic, food preparation, 

bioterror response). 

• Phage is easy and inexpensive to 

cultivate. 

• Phage is on sale in the US for foodpreparation formulations and thus has a 

known regulatory pathway. 

Development Status: A range of 

phages have been synthesized, many of 

which have been tested proof-ofprinciple using major standardized 

testing systems. 

Inventors: Dr. Carl Merrill (NIMH), Dr. 

Sankar Adhya (NCI), et al. 

Publications 

1. R Edgar et al. High-sensitivity 

bacterial detection using biotin-tagged 

phage and quantum-dot nanocomplexes. 

Proc Natl Acad Sci. USA 2006 Mar 

28;103(13):4841–4845. 

2. C Merril et al. The prospect for 

bacteriophage therapy in Western 

medicine. Nat Rev Drug Discov. 2003 

Jun;2(6):489–497. 

Patent Status 

HHS Reference No. E–169–2004—U.S. 

Patent Application No. 11/547,587 filed 

05 Oct 2006. 

HHS Reference No. E–281–2005—U.S. 

Patent Application No. 11/884,604 filed 

17 Aug 2007. 

HHS Reference No. E–318–2000— 

Research Materials (patent protection is 

not being pursued for this technology): 

‘‘Method for Determining Sensitivity to 

a Bacteriophage.’’ 

Licensing Status: Technologies are 

available for licensing, either 

individually or as a package. 

Licensing Contact: Bruce Goldstein, 

J.D., M.S.; 301–435–5470; 

goldsteb@mail.nih.gov. 

Collaborative Research Opportunity: 

The NCI Laboratory of Molecular 

Biology is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize this technology. Please 

contact John D. Hewes, PhD at 301–435– 

3121 or hewesj@mail.nih.gov for more 

information. 

Therapeutic Antibacterial Applications 

of Phage 

Description of Technology: The NIH, 

in collaboration with others, has 

developed three groups of inventions 

related to the use of bacteriophages in 

therapeutic situations. The first group is 

a method of adapting phages to survive 

in the body substantially longer than 

wild-type phages, using serial passaging 

and/or genetic engineering. The second 

group involves phages designed to bind 

the toxins and cytokines that killed 

bacteria release into the bloodstream, 

reducing the pathogenic properties of 

the bacteria. The third group is a 

method of engineering a phage to have 

multiple binding sites, such that a single 

phage can target multiple types of 

bacteria. 

Application: Therapeutic applications 

of phage to treat bacterial infection. 

Advantages 

• Improved efficacy through longer 

circulation. 

• Additional antibacterial functions. 

• Can be used independently or as an 

adjuvant to another antibacterial 

therapy. 

Development Status: A range of 

phages have been synthesized and 

tested in vivo. A Phase 1 study of a 

phage targeting vancomycin-resistant 

Enterococcus faecium was completed by 

Exponential Biotherapies, Inc., with no 

adverse effects reported. 

Inventors: Dr. Carl Merrill (NIMH), Dr. 

Sankar Adhya (NCI), et al. 

Publications 

1. C Merril et al. The prospect for 

bacteriophage therapy in Western 

medicine. Nat Rev Drug Discov. 2003 

Jun;2(6):489–497. 

2. B Biswas et al. Bacteriophage 

therapy rescues mice bacteremic from a 

clinical isolate of vancomycin-resistant 

Enterococcus faecium. Infect Immun. 

2002 Jan;70(1):204–210. 

3. C Merrill et al. Long-circulating 

bacteriophage as antibacterial agents. 

Proc Natl Acad Sci. USA 1996 Apr 

16;93(8):3188–3192. 

Patent Status 

HHS Reference No. E–110–1993—U.S. 

Patent No. 5,688,601 issued 19 Jun 

1997; U.S. Patent No. 7,332,307 issued 

19 Feb 2008. 

HHS Reference No. E–257–2000—U.S. 

Patent No. 7,163,818 issued 16 Jan 2007. 

HHS Reference No. E–178–1996— 

Research Materials (patent protection is 


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