Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Notices 23729 

the control of the cell cycle and 

alterations in CDK expression, function, 

or regulation and are associated with 

diseases characterized by cellular 

proliferation. Increasing CDK activity 

has been reported in many cancers. 

Likewise, the loss of inhibitory activity 

has been observed in a wide variety of 

primary human tumors and human 

tumor-derived cell lines, including lung, 

breast, brain, bone, skin, bladder, 

kidney, ovary, liver, colon, and pancreas 

as well as in leukemia. These 

compounds have also been found to 

potently inhibit GSK3beta activity 

which has recently been linked to a 

variety of cellular processes and several 

disparate areas of biology. In particular, 

GSK3beta activity has been strongly 

implicated in Alzheimer’s as well as 

cardiac failure. Thus, the compounds of 

this invention offer unique 

opportunities for a variety of 

indications. 

Applications: CDK/GSK3beta 

inhibitor therapeutics for the treatment 

of several indications including various 

cancers, neurodegenerative diseases, 

and cardiac conditions. 

Development: Pre-clinical stage of 

development. 

Inventors: Daniel W. Zaharevitz et al. 

(NCI). 

Publication: DW Zaharevitz et al. 

Discovery and initial characterization of 

the paullones, a novel class of smallmolecule inhibitors of cyclin-dependent 

kinases. Cancer Res. 1999 Jun 

1;59(11):2566–2569. 

Patent Status: HHS Reference No. E– 

025–1998/0— 

• U.S. Patent No. 6,610,684, issued 

August 26, 2003; 

• Australian Patent Nos. 780528 and 

778735, issued March 24, 2005 and 

December 16, 2004; 

• Canada Patent Application No. 

2335115, filed June 16, 1999; 

• Japanese Patent Application No. 

2000–554735, filed June 16, 1999; 

• United Kingdom Patent No. 

1086105, validated March 01, 2006 ((E– 

025–1998/0–GB–09); 

• French Patent No. 1086105, 

validated March 01, 2006 (E–025–1998/ 

0–FR–10); and 

• German Patent No. 69930120.3, 

validated March 16, 2006 (E–025–1998/ 

0–DE–11). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Whitney A. 

Hastings; 301–451–7337; 

hastingw@mail.nih.gov. 

Dated: May 13, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–11706 Filed 5–19–09; 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. 

Antibody and Immunotoxin Treatments 

for Mesothelin-Expressing Cancers 

Description of Technology: 

Mesothelin is a cell surface protein that 

is highly expressed in aggressive 

cancers such as malignant 

mesothelioma, ovarian cancer and 

pancreatic cancer. As a result, 

mesothelin is an excellent candidate for 

tumor targeted immunotherapeutics. 

However, the antibodies against 

mesothelin that are available for clinical 

trials are of murine origin. These 

antibodies have the potential to elicit 

immune responses in patients, which 

may adversely affect the ability to 

provide patients with repeated doses. 

Thus, the clinical application of the 

antibodies may be limited. 

In order to address the issue of 

immunogenicity in patients, NIH 

inventors have generated antimesothelin antibody variable fragments 

(Fv) of human origin. These antibody 

fragments (HN1 and HN2) have the 

ability to efficiently recognize 

mesothelin on the surface of numerous 

cancer cells. As a result, these antibody 

fragments represent an attractive 

therapeutic alternative to the murine 

anti-mesothelin antibodies currently 

being tested in clinical trials. 

Application: 

• Use as an antibody therapeutic for 

mesotheliomas, pancreatic tumors and 

ovarian tumors. 

• Use in an immunotoxin therapeutic 

for mesotheliomas, pancreatic tumors 

and ovarian tumors. 

• Diagnostic for the detection of 

mesothelin positive tumors. 

• Research agent for the detection of 

mesothelin. 

Advantages: 

• Fully human antibody reduces 

potential immunogenicity, thereby 

allowing repeated dosing. 

• Antibody specificity improves the 

therapeutic efficacy of the agent. 

Development Status: Preclinical stage 

of development with some pre-clinical 

data available. 

Inventors: Mitchell Ho et al. (NCI). 

Patent Status: U.S. Provisional 

Application No. 61/162,778, filed 24 

Mar 2009 (HHS Reference E–091–2009/ 

0–US–01) 

Related Technologies/Publications: 

• U.S. Patent 6,083,502 entitled 

‘‘Mesothelium Antigen and Methods 

and Kits For Targeting It.’’ 

• PCT Application PCT/US97/0224 

entitled ‘‘Mesothelium Antigen and 

Methods and Kits For Targeting It.’’ 

• U.S. Patent 6,809,184 entitled 

‘‘Antibodies, Including Fv Molecules, 

and Immunoconjugates Having High 

Binding Affinity for Mesothelin and 

Methods for Their Use.’’ 

• PCT Application PCT/US98/25270 

entitled ‘‘Antibodies, Including Fv 

Molecules, and Immunoconjugates 

Having High Binding Affinity for 

Mesothelin and Methods for Their Use.’’ 

• U.S. Patent 7,081,518 entitled 

‘‘Anti-mesothelin antibodies having 

high binding affinity.’’ 

• PCT Application PCT/US00/14829 

entitled ‘‘Immunoconjugates Having 

High Binding Affinity Improvement of 

scFVsr Ab’s with Higher Affinity for 

Mesothelin.’’ 

Licensing Status: Available for 

licensing. 

Licensing Contact: David A. 

Lambertson, Ph.D.; 301–435–4632; 

lambertsond@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute 

Laboratory of Molecular Biology is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

23730 Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Notices 

develop, evaluate, or commercialize 

antibody-based treatments of 

mesothelin-expressing cancers. Please 

contact John D. Hewes, Ph.D. at 301– 

435–3121 or hewesj@mail.nih.gov for 

more information. 

Simple Biosensors Based on Electrical 

Percolation Biological Semiconductors 

Description of Technology: The 

invention offered for licensing is in the 

field of biosensors with application in 

diagnostics and in regulation of 

implantable biomedical devices. More 

specifically, it is related to biological 

semiconductors based on the electrical 

percolation of single-walled carbon 

nanotubes (SWNTs). The nanotubes are 

embedded with biological ligands (e.g., 

antibodies). The electrical resistance of 

a semiconducting SWNT is found to 

dramatically increase upon the 

actuation by a specific antigen. 

Measurement of the change in resistance 

correlates with the concentration of the 

specific antigen and thus provides for 

quantitative determination and 

diagnostics of biological samples. The 

simple printing fabrication of electrical 

percolation biological semiconductors 

(EPBSC) can facilitate assembly of 

numerous types of gates (e.g., 

antibodies, DNA, etc.) and print many of 

such gates on the same chip for the 

creation of biological CPUs for various 

biomedical applications, including 

direct biodetection and regulation of 

implantable biomedical devices. 

Applications: 

(a) Miniaturized biosensors for 

various biomedical applications, 

including: (i) Direct biodetection of 

microbial pathogens and their toxins ii) 

diagnostics and prognostics of human 

diseases (e.g., cancer, cardiovascular, or 

other biomarkers) (iii) detection and 

analysis of nucleic acids (e.g., DNA, 

RNA) (iv) detection and analysis of 

other analytes (carbohydrates, fatty 

acids, organic or inorganic compounds). 

—Point of Care (POC) diagnostics (e.g., 

Physician’s office, home-use) 

—Military applications (e.g., remote 

sensing of biowarfare agents) 

(b) Monitor food safety and detection 

of environmental pollution. 

(c) Regulation of implantable 

biomedical devices such as insulin 

pumps or artificial hearts. 

(d) New generation of personal 

detectors (e.g., food allergens, 

cardiovascular event, etc.). 

Advantages: 

(a) The electrical percolation 

biological semiconductors (EPBSC) are 

relatively simple to assemble, and do 

not require specialized fabrication 

facilities or experience which may 

broaden the use of EPBSC in a similar 

way that PDMS (Polydimethylsiloxane) 

technology has broadened the use of 

lab-on-a-chip. 

(b) Many EPBSC can be fabricated 

into the same chip enabling 

simultaneous detection of many 

analytes. 

(c) Electronic based EPBS detection 

enable simple digital signal 

amplification and analysis. 

(d) EPBSC can be relatively stable 

with respect to retention of biological 

viability and thus can be stored for a 

long period of time before use. 

(e) EPBSC enable device 

miniaturization. 

(f) EPBSC are relatively simple to use 

and may not require special equipment 

or a skilled operator. Thus, these 

biosensors can be utilized in a Physician 

Office setting, for military applications 

and for possibly remote sensing for 

detections of biowarfare materials. 

(g) EPBSC devices will offer speed of 

detection, ease of use, and it will be 

inexpensive to make. 

Development Status: Proof of concept 

was demonstrated. For example, using 

anti-Staphylococcal Enterotoxin B (SEB) 

IgG antibodies as a gate, and the SEB 

antigen as an actuator, the inventors 

could detect as little as 0.1 ng/mL of 

SEB. 

Market: According to market research 

reports from 2003–2004 the global 

market for biosensors was projected to 

grow from approximately $7.0 billion in 

2004 to approximately $9.5 billion in 

2009, an average annual growth of about 

7.0%. Ninety-nine percent (99%) of the 

biosensor’s market is dominated by 

biomedical and life sciences, while only 

one percent (1.0%) with applications in 

environmental monitoring. 

Because of the unique advantages 

offered by this technology (i.e., diversity 

of applications, simplicity of use and 

low cost), there is a good probability 

that if technically successful it will 

become commercially successful and 

financially rewarding. 

Inventors: Avraham Rasooly (NCI) et 

al. 

Patent Status: U.S. Provisional 

Application No. 61/115,546 filed 18 

Nov 2008, entitled ‘‘Electrical 

Percolation Biomedical 

Semiconductors’’ (HHS Reference No. 

E–040–2009/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contacts: Uri Reichman, 

Ph.D., MBA; 301–435–4616; 

UR7a@nih.gov; Michael Shmilovich, JD; 

301–435–5019; shmilovm@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute, Cancer 

Diagnostic Program, and the Food and 

Drug Administration, the Center for 

Devices and Radiological Health, Office 

of Science and Engineering 

Laboratories, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize Electrical Percolation 

Biological Semiconductors for 

biodetection. Please contact John D. 

Hewes, Ph.D. at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

C57BL/6J Embryonic Stem Cell Lines 

Generated Using Serum-Free Media 

Description of Technology: NIH 

investigators have generated Embryonic 

Stem (ES) cell clones from C57BL/6J 

mice in a defined medium. These cell 

lines enable direct genetic alteration of 

mice in a pure genetic background. 

Using a defined media supplement, 

knockout serum replacement (KSR) with 

knockout DMEM (KSR–KDMEM), the 

investigators established ES cell lines 

from blastocysts of C57BL/6J mice. One 

specific cell line, HGTC–8 was found to 

be karyotypically stable and germline 

competent, both prior to manipulation 

and after gene targeting. These cell lines 

transfected more efficiently, and 

exhibited increased efficiencies of cell 

cloning and chimera generation, when 

maintained in KSR–KDMEM. 

Applications: 

• Generation of knockout mice 

without the need to backcross. 

• Generation of mice via targeted 

mutations. 

Inventors: Jun Cheng, Lisa GarrettBeal, and Pamela L. Schwartzberg 

(NHGRI). 

Publication: J Cheng, A Dutra, A 

Takesono, L Garrett-Beal, PL 

Schwartzberg. Improved generation of 

C57BL/6J mouse embryonic stem cells 

in a defined serum-free media. Genesis. 

2004 June; 39(2):100–104. 

Patent Status: HHS Reference No. E– 

038–2009/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

licensing under a Biological Materials 

License Agreement. 

Licensing Contact: Suryanarayana 

(Sury) Vepa, Ph.D., J.D.; 301–435–5020; 

vepas@mail.nih.gov. 

Identification of Renal Cell Carcinoma 

Biomarkers 

Description of Technology: This 

invention describes the identification of 

potential renal cancer biomarkers which 

could be utilized in the development of 

a renal cancer diagnostics. The 

invention identified cancer protein 

biomarkers from clinically relevant 

samples including peripheral blood and 

Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Notices 23731 

fresh frozen tissues. Vast availability of 

fresh frozen tissues and peripheral 

blood specimens that are easily obtained 

could lead to clinical tests amenable to 

therapeutic, prognostic and even early 

screening tests for renal cell carcinoma 

and other malignancies. 

Applications: Renal cell carcinoma 

diagnostics, therapeutics and 

prognostics. 

Market: 

• Cancer is the second leading cause 

of death in the U.S.A. There is an acute 

need for cancer biomarkers that can be 

detected from clinically relevant 

samples and used for early diagnosis, 

therapeutic follow-up and prognosis of 

malignant diseases. 

• The incidence of renal cell cancer 

has been rising steadily. Renal Cell 

Carcinoma is the most common type of 

kidney cancer, and the most common 

type in adults, responsible for 

approximately 80% of cases. 

Inventors: Josip Blonder et al. (NCI). 

Patent Status: PCT Application No. 

PCT/US2009/037855 filed 20 Mar 2009 

(HHS Reference No. E–317–2008/0– 

PCT–01) 

Licensing Status: Available for 

licensing. 

Licensing Contact: Betty B. Tong, 

Ph.D.; 301–594–6565; 

tongb@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute 

Laboratory of Proteomics and Analytical 

Technologies is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize diagnostic, therapeutic 

and prognostic cancer biomarkers from 

clinical specimens. Please contact John 

D. Hewes, Ph.D. at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

Dated: May 13, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–11705 Filed 5–19–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary 

and Alternative Medicine 

Announcement of Workshop on the 

Non-Pharmacological Management of 

Back Pain 

ACTION: Notice. 

SUMMARY: The National Center for 

Complementary and Alternative 

Medicine (NCCAM) invites the research 

community to participate in an online 

Workshop on Non-Pharmacological 

Management of Back Pain. The purpose 

of this workshop is to identify and 

explore a range of important and timely 

clinical research questions related to 

non-pharmacological interventions to 

treat back pain. This information will 

help inform future research directions 

for NIH and the biomedical scientific 

field. This workshop will be split into 

three sessions that will feature 

presentations and discussions focusing 

on the current understanding and 

complexity of chronic back pain, 

promising questions associated with 

testable hypotheses, and the relevant 

outcome measures. 

The Workshop will take place on May 

27, 2009. Those interested in CAM 

research are particularly encouraged to 

view and participate. 

Background: The National Center for 

Complementary and Alternative 

Medicine (NCCAM) was established in 

1999 with the mission of exploring 

complementary and alternative healing 

practices in the context of rigorous 

science, training CAM researchers, and 

disseminating authoritative information 

to the public and professionals. NCCAM 

funds research grants that explore the 

science of CAM. For more information, 

see http://nccam.nih.gov/grants/ 

whatnccamfunds/. 

Participating: The Workshop will be 

broadcast on the Internet and archived 

on http://www.videocast.nih.gov/. 

Viewers may submit questions for the 

presenters and panelists by e-mailing 

nccambkpnwkshp@mail.nih.gov with 

questions or comments. For more 

information about what will be covered 

at the workshop, see http:// 

nccam.nih.gov/news/events/. 

FOR FURTHER INFORMATION CONTACT: To 

request more information, visit the 

NCCAM Web site at http:// 

nccam.nih.gov/news/events/, call 301– 

594–3391 (Edward Culhane) or e-mail at 

culhanee@mail.nih.gov. 

Dated: May 12, 2009. 

Richard Nahin, 

Senior Advisor for Scientific Coordination 

and Outreach, National Center for 

Complementary and Alternative Medicine, 

National Institutes of Health. 

[FR Doc. E9–11679 Filed 5–19–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Gastroenterology and Urology Devices 

Panel of the Medical Devices Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Gastroenterology 

and Urology Devices Panel of the 

Medical Devices Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on Wednesday, June 10, 2009, from 

8 a.m. to 5 p.m. 

Location: Holiday Inn, Ballroom, Two 

Montgomery Village Ave., Gaithersburg, 

MD. 

Contact Person: Megan Mickal, Center 

for Devices and Radiological Health 

(HFZ–470), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 240–276–4151, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512523. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: The committee will discuss 

and make recommendations regarding 

general issues related to the use of 

ultrafiltration devices in the treatment 

of extracellular body fluid overload in 

patients experiencing heart failure. 

Specifically, the committee will address 

the use of these devices in patients 

experiencing heart failure in the 

following terms: Identifying the most 

appropriate heart failure patients for 

whom these treatments should be 

indicated, determining where these 

treatments fit within the spectrum of 

treatment options, and defining what 

level of clinical evidence is necessary to