Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices 10375 

Licensing Contacts 

• Uri Reichman, PhD, MBA; 301– 

435–4616; UR7a@nih.gov. 

• John Stansberry, PhD; 301–435– 

5236; Stansbej@mail.nih.gov. 

Meningococcal and Pneumococcal 

Conjugate Vaccine and Method of Using 

Same 

Description of Invention: 

Pneumococcal diseases are a major 

public health problem all over the 

world. The etiological agent, 

Streptococcus pneumoniae (the 

pneumococcus) is surrounded by a 

polysaccharide capsule. Differences in 

the composition of this capsule permit 

serological differentiation between 

about 90 capsular types, some of which 

are frequently associated with 

pneumococcal disease, others rarely. 

Invasive pneumococcal infections 

include pneumonia, meningitis and 

febrile bacteremia; among the common 

non-invasive manifestations are otitis 

media, sinusitis and bronchitis. At least 

1 million children die of pneumococcal 

disease every year, most of these being 

young children in developing countries. 

Vaccination is the only available tool to 

prevent pneumococcal disease. The 

recent development of widespread 

microbial resistance to essential 

antibiotics underlines the urgent need 

for more efficient pneumococcal 

vaccines. 

Meningococcal disease is a contagious 

bacterial disease caused by the 

meningococcus (Neisseria meningitidis). 

It is spread by person-to-person contact 

through respiratory droplets of infected 

people. There are 3 main clinical forms 

of the disease: the meningeal syndrome, 

the septic form and pneumonia. The 

onset of symptoms is sudden and death 

can follow within hours. In as many as 

10–15% of survivors, there are 

persistent neurological defects, 

including hearing loss, speech 

disorders, loss of limbs, mental 

retardation and paralysis. Up to 5–10% 

of a population may be asymptomatic 

carriers. These carriers are crucial to the 

spread of the disease as most cases are 

acquired through exposure to 

asymptomatic carriers. Waning 

immunity among the population against 

a particular strain favors epidemics, as 

do overcrowding and climatic 

conditions such as dry seasons or 

prolonged drought and dust storms. The 

disease mainly affects young children, 

but is also common in older children 

and young adults. The disease occurs 

sporadically throughout the world with 

seasonal variations and accounts for a 

proportion of endemic bacterial 

meningitis. However, the highest 

burden of the disease is due to the 

cyclic epidemics occurring in the 

African meningitis belt. 

With the burden of S. pneumoniae 

and N. meningitidis infection on the 

public health system at a global scale, it 

is desirable to have a single vaccine that 

is effective to prevent disease resulting 

from the infection of both pathogens. 

This application claims immunogenic 

compositions for inducing an immune 

response to two different 

microorganisms, S. pneumoniae and N. 

meningitidis. The application also 

claims conjugate vaccines comprising at 

least one N. meningitidis capsular 

polysaccharide conjugated to a 

recombinant pneumococcal protein. 

Applications: Conjugate vaccine for 

the prevention and/or therapy of 

meningococcal and pneumococcal 

infections. 

Advantages 

• Rapid production time. 

• Higher-yielding manufacturing 

method. 

• Low manufacturing cost. 

Development Status: Preclinical 

studies have been conducted by the 

inventors. 

Inventors 

• Stanley S. Tai (Howard University). 

• Che-Hung Robert Lee (FDA). 

Patent Status: HHS Reference No. E– 

030–2010/0— 

• U.S. Patent Application No. 12/ 

425,232 filed 16 Apr 2009. 

• PCT/US2010/031083 filed 14 Apr 

2010. 

Licensing Status: Available for 

licensing. 

Licensing Contact: Daniel G. McCabe; 

Associate General Counsel for Business 

Transactions; Howard University, Office 

of the General Counsel; 2400 6th Street, 

NW., Suite 321; Washington, DC 20059; 

Office: (202) 806–2650; Fax: (202) 806– 

6357; E-mail: dmccabe@howard.edu. 

Dated: February 16, 2011. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2011–4171 Filed 2–23–11; 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. 

Terahertz Spatial Light Modulator 

System for Adaptive Near-Field 

Imaging 

Description of Technology: The 

invention offered for licensing is in the 

field of imaging microscopes and relates 

to a terahertz light modulator system, 

and in particular to a terahertz spatial 

light modulator system for adaptive 

near-field imaging. 

More specifically, the invention 

relates to a spatial light modulator 

system for adaptive near-field imaging 

having an optical source for transmitting 

an optical beam through a filter which 

is controlled to convert the optical light 

beam into a filtered optical light beam 

to define one or more transmission 

pathways through a photoconductive 

material. The system further includes a 

terahertz light source for transmitting a 

terahertz beam through one or more 

transmission pathways defined by the 

filtered optical light beam through the 

photoconductive material for 

illuminating and scanning the sample 

without the use of moving structural 

components. The device would allow 

micron-scale spatial resolution, would 

remove the need to mechanically scan a 

sample, and would allow automatic 

adjustment of image resolution and 

transmitted terahertz power. The nearfield terahertz microscope of the 

invention could have a compact, fibercoupled sensor head with no moving 

parts—ideal for scientific, medical, and 

industrial applications like crystal 

growth optimization, skin cancer 

diagnosis, and semiconductor chip 

inspection. In one application, such as 

‘‘one-cut’’ surgery, the compact sensor 


emcdonald on DSK2BSOYB1PROD with NOTICES
10376 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices 

head of the terahertz imaging system has 

the capability of distinguishing healthy 

cells from cancerous cells with micronscale spatial resolution by immediately 

identifying a skin cancer margin 

without the need for laboratory work or 

additional surgery. In another 

application, the terahertz imaging 

system may be used in nondestructive 

semiconductor chip inspection since the 

terahertz imaging system provides 

micron-scale spatial resolution. 

Applications: 

• Biomedical research applications 

(living tissues have distinctive terahertz 

absorption signals) 

• Clinical applications like 

diagnostics of skin cancer (skin cancer 

and normal skin reflect terahertz 

radiation differently) 

• Industrial applications like crystal 

growth optimization 

• Industrial applications like 

semiconductor chip inspection. 

Advantages: The system provides 

micron-scale spatial resolution, while 

removing any need to mechanically 

scan samples (it is equipped with a 

fiber-coupled sensor head), and at the 

same time allows automatic adjustment 

of image resolution and transmitted 

terahertz power. 

Development Status: In development. 

Prototype is being built. 

Inventors: Hari Shroff et al. (NIBIB). 

Relevant Publications: 

1. Mair S, Gompf B, Dressel M. 

Microspectroscopy and imaging in the 

THz range using coherent CW radiation. 

Phys Med Biol. 2002 Nov 

7;47(21):3719–3725. [PubMed: 

12452559] 

2. Chen Q, Jiang Z, Xu GX, Zhang XC. 

Near-field terahertz imaging with a 

dynamic aperture. Opt Lett. 2000 Aug 

1;25(15):1122–1124. [PubMed: 

18064291] 

3. Wallace VP, Fitzgerald AJ, Shankar 

S, Flanagan N, Pye R, Cluff J, Arnone 

DD. Terahertz pulsed imaging of basal 

cell carcinoma ex vivo and in vivo. Br 

J Dermatol. 2004 Aug;151(2):424–432. 

[PubMed: 15327550] 

4. Hu BB, Nuss MC. Imaging with 

terahertz waves. Opt Lett. 1995 Aug 

15;20(16):1716–1718. 

Patent Status: U.S. Provisional 

Application No. 61/425,007 filed 20 Dec 

2010 (HHS Reference No. E–243–2010/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: 

• Uri Reichman, PhD, MBA; 301– 

435–4616; UR7a@nih.gov. 

• Michael Shmilovich, Esq.; 301– 

435–5019; ShmilovichM@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Biomedical 

Imaging and Bioengineering is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize this technology. Please 

contact Hari Shroff at 

hari.shroff@nih.gov or 301–435–1995 for 

more information. 

Versatile Melanoma Antigen Family A3 

(MAGE–A3) Specific Human T Cell 

Receptors To Treat Cancer That Also 

Recognize Other MAGE–A Antigen 

Superfamily Members 

Description of Technology: Current 

approaches for treating cancer can also 

generate harsh side effects in patients 

and many cancer patients do not 

respond to generalized chemotherapy 

and radiation. New and improved 

therapeutic strategies need to be 

characterized by reduced side-effects 

and enhancements in specific antitumor activity in individual patients. 

Adoptive immunotherapy is a 

promising new approach to cancer 

treatment that engineers an individual’s 

innate and adaptive immune system to 

fight against specific diseases, such as 

cancer. Scientists are aiming to improve 

cell transfer therapies by targeting an 

increasing collection of tumor antigens 

with more effective immune cell 

cultures. 

T cell receptors (TCRs) are specialized 

proteins that recognize antigens in the 

context of infected or transformed cells 

and activate T cells to mediate an 

immune response and destroy abnormal 

cells. TCRs consist of a variable domain 

that recognizes the antigen and a 

constant region that anchors the TCR to 

the membrane and transmits recognition 

signals by interacting with other 

proteins. When a TCR is activated by 

recognizing its antigen, such as a tumor 

antigen, signaling pathways are 

triggered in the cell to produce 

cytokines that mediate the immune 

response. 

Scientists at the National Institutes of 

Health (NIH) have developed T cells 

genetically engineered to recognize 

melanoma antigen family A3 (MAGE– 

A3) peptide antigens. MAGE–A 

superfamily antigens, including MAGE– 

A3, are expressed primarily by tumor 

cells from a variety of cancers. Other 

than germ cells of the testis, normal 

cells do not express MAGE–A3 and 

other MAGE–A proteins, which makes 

these antigens ideal targets for 

developing cancer immunotherapies. 

There are twelve (12) known MAGE–A 

genes designated A1–A12. The normal 

function of MAGE–A3 is not completely 

known, but in cancerous cells it appears 

to mediate fibronectin-controlled tumor 

growth and spreading. MAGE–A3 is one 

of the most widely expressed cancer 

testis antigens (CTAs) on human tumors 

and its expression increases as the 

cancer progresses to more advanced 

stages. The T cell receptors (TCRs) 

developed by these NIH scientists have 

specificity for MAGE–A3 and MAGE– 

A12 and deliver a robust immune 

response when they encounter tumor 

cells expressing these antigens. These 

TCRs also recognize MAGE–A2 and/or 

MAGE–A6, but to a lesser extent that 

MAGE–A3 and MAGE–A12. The ability 

to recognize antigens from multiple 

MAGE–A family members could allow 

these TCRs to be utilized in the 

treatment of multiple types of cancer in 

a wide array of cancer patients. Infusing 

cancer patients with MAGE–A3 specific 

T cells via adoptive immunotherapy 

could prove to be a powerful approach 

for selectively attacking tumors without 

generating toxicity against 

noncancerous cells. 

Applications: 

• Immunotherapeutics to treat and/or 

prevent the recurrence of a variety of 

human cancers, including melanoma, 

lung cancers, head and neck cancers, 

liver cancers, and multiple myeloma, by 

adoptively transferring the genemodified T cells into patients whose 

tumors express a MAGE–A family 

member protein recognized by this TCR. 

• A drug component of a combination 

immunotherapy regimen aimed at 

targeting specific tumor-associated 

antigens, including MAGE–A3, MAGE– 

A12, and MAGE–A2 and/or MAGE–A6 

expressed by cancer cells within 

individual patients. 

• A research tool to investigate 

signaling pathways in MAGE–A antigen 

expressing cancer cells. 

• An in vitro diagnostic tool to screen 

for cells expressing a MAGE–A antigens. 

Advantages: 

• Selective toxicity for tumor cells— 

MAGE–A3 and other MAGE–A proteins 

are only expressed on testis germ cells 

and tumor cells. Thus, infused cells 

expressing an anti-MAGE–A3 TCR 

should target MAGE–A3-expressing 

tumor cells with little or no toxicity to 

normal cells. Immunotherapy with these 

T cells should yield little or no harsh 

side effects to patients. 

• Ability to recognize multiple 

MAGE–A antigens—Since these MAGE– 

A3 directed TCRs can also recognize up 

to three (3) additional MAGE–A 

antigens (MAGE–A12, A2, and A6), 

cells expressing these TCRs are 

expected to be able to fight a larger 

range of tumor types. During treatment, 

if an infused anti-MAGE–A3 T cell 

culture encounters tumor cells 

expressing other recognized MAGE–A 

antigens, these T cells would not only 


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Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices 10377 

be capable of eliminating the MAGE–A3 

expressing tumor cells, but MAGE–A12, 

MAGE–A2, and MAGE–A6 expressing 

cells as well. This versatility should 

allow these TCRs to be utilized to treat 

a broader range of cancer patients. 

• Expression on a majority of tumors 

—MAGE–A3 is one of the most highly 

expressed cancer testis antigens (CTAs) 

on human tumors. For example, over 

half of melanoma tumors and non-small 

cell lung cancer cells express MAGE– 

A3. A large spectrum of cancer patients 

should be eligible for treatment with 

these MAGE–A3 TCRs should they 

prove successful in clinical studies. 

Development Status: This technology 

is in an early clinical stage of 

development. 

Inventors: Richard A. Morgan, et al. 

(NCI). 

Publications: 

1. N Chinnasamy et al. A TCR 

Targeting the HLA–A*0201–Restricted 

Epitope of MAGE–A3 Recognizes 

Multiple Epitopes of the MAGE–A 

Antigen Superfamily in Several Types 

of Cancer. J Immunol. 2011 Jan 

15;186(2):685–696. [PubMed: 21149604] 

2. V Cesson et al. MAGE–A3 and 

MAGE–A4 specific CD4(+) T cells in 

head and neck cancer patients: 

Detection of naturally acquired 

responses and identification of new 

epitopes. Cancer Immunol Immunother. 

2010 Sept. 21, E-pub ahead of print, doi: 

10.1007/s00262–010–0916-z. [PubMed: 

20857101] 

Patent Status: U.S. Provisional 

Application No. 61/405,668 filed 22 

October 2010 (HHS Reference No. E– 

236–2010/0–US–01). 

Related Technologies: T cell receptor 

technologies developed against other 

CTAs: E–304–2006/0 and E–312–2007/1 

(anti-NY–ESO–1) and E–269–2010/0 

(anti-SSX–2). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Samuel E. Bish, 

PhD; 301–435–5282; 

bishse@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute Surgery 

Branch is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize the use of anti-MAGE–A 

T-cell receptors for the adoptive 

immunotherapy of cancer. Please 

contact John Hewes, PhD at 301–435– 

3121 or hewesj@mail.nih.gov for more 

information. 

Selective 12–Human Lipoxygenase 

Inhibitors for the Treatment of Diabetes 

and Clotting 

Description of Technology: This 

invention discloses small molecule 

inhibitors of human 12-lipoxygenase 

(12-hLO). 12-lipoxygenase expression, 

activation, and lipid metabolites have 

been implicated in type 1 and type 2 

diabetes, cardiovascular disease, 

hypertension, Alzheimer’s, and 

Parkinson’s disease. The development 

of 12-hLO inhibitors may be a potent 

intracellular approach to decreasing the 

ability of platelets to form large clots in 

response to vessel injury or activation of 

the coagulation pathway. Thus, 12-hLO 

inhibition has the potential to attenuate 

platelet-mediated clot formation caused 

by diabetes and/or cardiovascular 

disease and significantly decrease the 

occurrence of myocardial infarction and 

death. Moreover, Type 1 and Type 2 

diabetes are serious disorders that can 

lead to major complications and 

reduced lifespan. An unmet medical 

need is to identify new ways to protect 

beta cells in these metabolic disorders. 

A selective 12-hLO inhibitor could 

provide a new therapeutic approach to 

prevent or treat either form of diabetes. 

Applications: 

• Therapeutic developments (blood 

clots; Type 1 and Type 2 diabetes, 

cardiovascular disease, and 

neurodegenerative diseases) 

• Inflammatory responses 

Advantages: 

• Small molecule (series of analogs 

can be derived in search of improved 

performances and/or different 

functions) 

• Selective inhibitor of human 12- 

lipoxygenase 

Market: 

• Metabolic disorders 

• Neurodegeneration 

• Research tool—screening for 12- 

lipoxygenase-mediated responses in 

various human cell lines 

Development Status: Pre-clinical; no 

animal data. 

Inventors: David J Maloney (NHGRI); 

Ajit Jadhav (NHGRI); Ganesha Rai 

(NHGRI); Anton Simeonov (NHGRI); 

Theodore Holman (University California 

Santa Cruz); Jerry Nadler (Eastern 

Virginia Medical School); Michael 

Holinstat (Thomas Jefferson University). 

Patent Status: U.S. Provisional 

Application No. 61/345,708 filled 18 

May 2010 (HHS Reference No. E–134– 

2010/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Steven H. 

Standley, PhD 301–435–4074; 

sstand@mail.nih.gov. 

Gene Expressed in Prostate Cancer and 

Methods of Use 

Description of Technology: Prostate 

cancer is the second leading cause of 

cancer-related deaths among males in 

the United States. There are 

approximately two hundred and fifteen 

thousand (215,000) newly diagnosed 

cases of prostate cancer and thirty 

thousand (30,000) prostate cancerrelated deaths each year, underscoring 

the importance of addressing this 

deadly disease. Although there are 

diagnostic tests in place for identifying 

the potential for developing prostate 

cancer, even the most widely accepted 

diagnostic for detecting cancer (prostatespecific antigen or PSA) is capable of 

producing a false negative result. 

Furthermore, current treatments are 

invasive and may produce deleterious 

side-effects. Therefore, there is a clear 

need to identify and develop new and 

effective diagnostics and treatments for 

prostate cancer. 

This technology concerns the 

identification of a novel protein that is 

specifically expressed on prostate 

tissue: Novel Gene Expressed in Prostate 

(NGEP). Because of its selective 

expression on prostate tissue, NGEP 

represents a potential target in the fight 

against prostate cancer. Monoclonal 

antibodies that specifically recognize 

NGEP have been developed in 

conjunction with the identification of 

the protein. These antibodies can be 

used as both diagnostic agents and 

therapeutic agents. 

Applications: 

• Antibodies to NGEP can be used as 

diagnostic agents to identify metastatic 

prostate tissue, either alone or in 

combination with other diagnostic 

antibodies 

• Antibodies to NGEP can also be 

used therapeutically to specifically 

target cytotoxic agents to prostate cancer 

cells or to induce antibody-dependent 

cell-mediated cytotoxicity (ADCC) 

• Antibodies to NGEP can be used as 

research reagents for identifying 

prostate tissue, including cancerous 

tissue 

Advantages: 

• The selective expression of NGEP 

allows the specific detection and 

recognition of prostate tissue, which is 

useful in both diagnostic and 

therapeutic applications 

• Combining the detection of NGEP 

with other prostate cancer diagnostic 

agents may reduce the incidence of a 

false negative diagnosis 

• The use of NGEP antibodies in 

targeted therapy can decrease the nonspecific killing of non-cancerous cells, 

thereby decreasing side-effects 


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10378 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices 

associated with current prostate cancer 

therapies 

Development Status: Preclinical stage 

of development. 

Inventors: Pastan (NCI) et al. 

Patent Status: 

• US Patent 7,816,087 (E–005–2002/ 

0–US–03)—Issued 

• US Patent Application 12/193,604 

(E–005–2002/0–US–05)—Allowed 

• EP Patent Application 02795643.2 

(E–005–2002/0–EP–04)—Pending 

For more information, see: 

• Das et al. ‘‘Topology of NGEP, a 

prostate-specific cell:cell junction 

protein widely expressed in many 

cancers of different grade level.’’ Cancer 

Res. 2008 Aug 1; 68(15):6306–12 

• Das et al. ‘‘NGEP, a prostate-specific 

plasma membrane protein that promotes 

the association of LNCaP cells.’’ Cancer 

Res. 2007 Feb 15; 67(4):1594–601 

• Bera et al. ‘‘NGEP, a gene encoding 

a membrane protein detected only in 

prostate cancer and normal prostate.’’ 

Proc Natl Acad Sci U S A. 2004 Mar 2; 

101(9):3059–64. 

Licensing Status: Available for 

licensing 

Licensing Contact: David A. 

Lambertson, PhD; 301–435–4632; 

lambertsond@mail.nih.gov. 

Stem Cells That Transform To Beating 

Cardiomyocytes 

Description of Technology: Many 

people die each year of congestive heart 

failure occurring from a variety of 

causes including cardiomyopathy, 

myocardial ischemia, congenital heart 

disease and valvular heart disease 

resulting in cardiac cell death and 

myocardial dysfunction. When 

cardiomyocytes are not replaced in 

adult myocardial tissue, physiologic 

demands on existing, healthy 

cardiomyocytes can lead to 

hypertrophy. Heart transplants have 

been the only recourse for patients in 

end-stage heart disease however this is 

complicated by lack of donors, tissue 

incompatibility and high cost. 

An alternative approach to heart 

transplantation is to generate 

cardiomyocytes from stem cells in vitro 

that can be used in the treatment of 

cardiac diseases characterized by 

myocardial cell death or dysfunction. 

This invention discloses a novel 

isolated population of stem cells, called 

spoc cells, isolated from skeletal 

muscle, that can be induced, either in 

vivo or in vitro, to differentiate into 

cardiomyocytes. Spoc cells may be 

differentiated and utilized for screening 

agents that affect cardiomyocytes and as 

therapeutic agents in the treatment of 

cardiac MI. 

Potential Applications and 

Advantages: This invention is an 

alternative approach to heart 

transplantation which is typically 

complicated by lack of donors, tissue 

incompatibility and high cost. 

Inventors: Neal D. Epstein (NHLBI), et 

al. 

Related Publication: SO Winitsky, et 

al. Adult murine skeletal muscle 

contains cells that can differentiate into 

beating cardiomyocytes in vitro. PLoS 

Biol. 2005 Apr;3(4):e87, doi:10.1371/ 

journal.pbio.0030087. [PubMed: 

15757365] 

Patent Status: 

• Issued Australian Patent No. 

2002337949 (HHS Ref. No. E–329–2001/ 

0–AU–03) 

• Issued Japanese Patent No. 4377690 

(HHS Ref. No. E–329–2001/0–JP–04) 

• Allowed Canadian Patent Appl. No. 

2464088 (HHS Ref. No. E–329–2001/0– 

CA–05) 

Licensing Status: Available for 

licensing. 

Licensing Contact: Fatima Sayyid, 

M.H.P.M.; 301–435–4521; 

Fatima.Sayyid@nih.hhs.gov. 

Dated: February 16, 2011. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2011–4170 Filed 2–23–11; 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. 

Recombinant BoCPB: An Enzymatic 

Reagent for Removing Disordered, 

Positively Charged C-terminal Residues 

From Recombinant Proteins 

Description of Technology: Affinity 

tags are commonly used to facilitate the 

purification of recombinant proteins, 

but concerns about the potential impact 

of the tags on the biological activity of 

the target proteins makes it necessary to 

remove them in most cases. Proteases 

with high sequence specificity, such as 

tobacco etch virus (TEV) protease, are 

typically used for this purpose. Affinity 

tags on the amino-terminus (N-terminal 

tag) can be cleaved by TEV protease to 

yield a recombinant protein product 

with only one nonnative residues on its 

C-terminus (usually G or S). In contrast, 

removal by TEV protease of tags added 

to the carboxy-terminus (C-terminal tag) 

of proteins has proven to be somewhat 

problematic, yielding a recombinant 

protein product with six nonnative 

residues on its C-terminus (ENLYFQ). 

Since C-terminal affinity tags are 

potentially very useful, particularly 

when used in combination with Nterminal tags in an ‘‘affinity sandwich’’ 

format, it would be very desirable to 

have a reagent to remove the C-terminal 

affinity tags without leaving extra 

nonnative residues behind. 

Previously, the NIH inventors created 

a tagged version of a fungal 

carboxypeptidase from Metarhizium 

anisopliae (MeCPA) that is capable of 

removing histidine residues and many 

other types of amino acids from the Ctermini of recombinant proteins. The 

only limitation of the MeCPA enzyme is 

that it does not remove positively 

charged residues (arginine and lysine). 

To overcome this drawback of MeCPA, 

the NIH inventors have now cloned, 

expressed and purified bovine 

carboxypeptidase B (BoCPB), which is 

specific for the removal of these 

positively charged residues. Like the 

genetically engineered MeCPA, the 

recombinant BoCPB has a C-terminal 

polyhistidine tag. This feature facilitates 

the purification of the enzyme, and, 

because this His-tag as been engineered 

to be immune to the action of MeCPA 

and BoCPB, it can be used to separate 

the enzymes from the products of a 

carboxypeptidase digest. By using a 

mixture of MeCPA and BoCPB, it should 

be possible to remove any short affinity 

tag along with disordered C-terminal 

residues of a recombinant protein with 

the exception of proline, which can be 

used as a ‘‘stop sign’’ to facilitate the 


emcdonald on DSK2BSOYB1PROD with NOTICES