52758 Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices 

Patent Status: PCT Application No. 

PCT/US2009/66867 filed 04 Dec 2009 

(HHS Reference No. E–054–2009/0– 

PCT–02). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Charlene Sydnor, 

Ph.D.; 301–435–4689; sydnorc@mail.

nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Mental Health 

Clinical Brain Disorders Branch is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize the 

development of PIK3CD inhibitors for 

the treatment of CNS disorders 

including schizophrenia, psychosis, and 

cognitive deficiency. Please contact 

Amanda Law at lawa@mail.nih.gov for 

more information. 

Fast Electron Paramagnetic Resonance 

Imaging (EPRI) Using CW–EPR 

Spectrometer With Sinusoidal RapidScan and Digital Signal Processing 

Description of Invention: Electron 

Paramagnetic Resonance (EPR) Imaging 

is an indispensable tool that may be 

applied to a variety of disciplines for 

evaluation of chemical species having 

unpaired electrons such as free radicals 

and transition metal ions. In Continuous 

Wave (CW)–EPR the sample is 

continuously irradiated with weak RF 

radiation while sweeping the magnetic 

field relatively slowly. Existing CW– 

EPR techniques utilize a signal 

detection method known as phasesensitive detection which results in data 

acquisition times that are too long for in 

vivo applications. The present 

technology represents significant 

improvements on conventional CW– 

EPR. 

The subject technology includes three 

approaches to collecting image data 

with increased spatial, temporal and 

spectral resolution and improved 

sensitivity. Spectral data acquisition is 

performed by a direct detection strategy 

involving mixing a signal to base-band 

and acquiring data with a fast-digitizer. 

Projection data is acquired using a 

sinusoidal magnetic field sweep under 

gradient magnetic fields. Data collection 

times are decreased with the utility of 

rotating gradients. 

Further improvement to the present 

technology includes optimized DSP 

(digital signal processing) transmit and 

receive systems that decrease the analog 

background noise and allow optimizing 

the extent of signal averaging for 

improved image quality. 

Increased speed and sensitivity make 

CW–EPR a potentially useful and 

complementary tool to proton Magnetic 

Resonance Imaging for in vivo imaging. 

The presently described improvements 

to CW–EPR will allow changes of blood 

perfusion and oxygenation in tumors to 

be observed in nearly real-time, while 

improved resolution will permit 

angiogenesis in and around tumors to be 

monitored in a non-invasive manner. 

Additionally, rapid scan imaging 

provides excellent temporal resolution 

and will help quantify pharmacokinetics and metabolic degradation 

kinetics of bioactive and redox sensitive 

free radicals such as nitroxides. 

Applications 

• Enhanced spatial, temporal, and 

spectral resolution of Continuous WaveElectron Paramagnetic Resonance 

Imaging. 

• Real-time assessment of changes in 

blood perfusion and oxygenation. 

Development Status: Preliminary 

experiments have been conducted and 

the technology has been tested for 

feasibility. 

Inventors: Sankaran Subramanian et 

al. (NCI). 

Relevant Publication: Subramanian S, 

Koscielniak JW, Devasahayam N, 

Pursley RH, Pohida TJ, Krishna MC. A 

new strategy for fast radiofrequency CW 

EPR imaging: Direct detection with 

rapid scan and rotating gradients. J 

Magn Reson. 2007 Jun; 186(2):212–219. 

[PubMed: 17350865]. 

Patent Status 

• U.S. Provisional Application No. 

60/818,052 filed 30 Jun 2006 (HHS 

Reference No. E–221–2005/0–US–01). 

• PCT Application No. PCT/US07/ 

00072371 filed 02 Jul 2007, which 

published as WO 2008/091365 on 31 Jul 

2008 (HHS Reference No. E–221–2005/ 

1–PCT–01). 

• U.S. Patent Application No. 12/ 

306,514 filed 23 Dec 2008 (HHS 

Reference No. E–221–2005/1–US–02). 

• U.S. Patent Application No. 12/ 

564,006 filed 21 Sep 2009 (HHS 

Reference No. E–221–2005/2–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contacts 

• Uri Reichman, PhD, MBA; 301– 

435–4616; UR7a@nih.gov. 

• John Stansberry, PhD; 301–435– 

5236; js852e@nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute, Radiation 

Biology Branch, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop improved hardware in 

terms of higher gradient & sweep 

frequencies and compatible AC 

amplifiers and evaluate, or 

commercialize the above rapid scanrotating gradients strategy for 

performing routine in vivo 

radiofrequency CW EPR imaging in 

small animals. Please contact John D. 

Hewes, PhD, at 301–435–3121 or hewesj

@mail.nih.gov for more information. 

Dated: August 20, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–21347 Filed 8–26–10; 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. 

An XMRV Tool Box: Expression 

Plasmids, Genes, and Proteins for All 

Components of the Xenotropic Murine 

Leukemia Virus-Related Virus (XMRV) 

Description of Invention: The 

xenotropic murine leukemia virusrelated virus (XMRV) has been 

implicated as a possible causative agent 

of prostate cancer and chronic fatigue 

syndrome (CFS). Scientists at the 

National Institutes of Health (NIH) and 

Science Applications International 

Corporation in Frederick, MD (SAIC– 

Frederick) have developed sixty four 

(64) protein expression plasmids for 

components of XMRV. One or more 

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Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices 52759 

XMRV proteins made available through 

these expression plasmids could have 

clinical relevance to diagnosing or 

treating human disease. The work to 

develop this technology was performed 

in the Protein Expression Laboratory at 

SAIC–Frederick in collaboration with 

expert retrovirologists from the National 

Cancer Institute’s Frederick, MD 

campus, a site well-positioned to 

develop these expression plasmids from 

initial cloning to final validations. The 

development of these XMRV tools is 

expected to save researchers months in 

laboratory production time and 

thousands of dollars in labor costs. 

The XMRV strain utilized to generate 

these expression plasmids is a reference 

strain isolated from a human patient. 

Each expression plasmid encodes one of 

the ten proteins that comprise the 

XMRV retrovirus (matrix, p12, capsid, 

nucleocapsid, protease, reverse 

transcriptase, integrase, surface, 

transmembrane, and envelope). Nine of 

the ten XMRV proteins expressed by 

these clones have been successfully 

purified in large quantities using scaleup processes. The expression vectors 

were generated utilizing the Gateway®

cloning system and consist of Gateway®

entry clones, bacterial (Escherichia coli) 

expression clones, baculovirus 

expression clones, and mammalian 

expression clones. Expression of the 

appropriate XMRV protein from its 

corresponding expression clone has 

been confirmed. The entry clones have 

been validated for Gateway® subcloning 

and the baculovirus clones have been 

validated for baculovirus production 

and can be transposed into baculoviral 

genomes. The plasmids have been fully 

mapped and sequenced and contain one 

or more elements to facilitate laboratory 

use, such as antibiotic resistance genes, 

specialized promoter sequences, 

maltose-binding protein and His tags, 

TEV protease sites, Kozak-ATG 

sequences, signal peptides, and other 

elements. 

Applications: 

• Research tool whose large-scale 

production capability can be utilized to 

develop serological assays for detecting 

XMRV and other retroviruses to 

possibly establish these viruses as 

causative agents for CFS, prostate 

cancer, and other diseases with 

unknown origins. 

• Collection of research tools that 

could be utilized to develop a complete 

set of diagnostic assays for detecting 

each of these XMRV proteins in patient 

samples. 

• Research tool to serve as a platform 

for developing therapeutic moieties, 

such as neutralizing antibodies and 

other biologics, for treating prostate 

cancer, chronic fatigue syndrome, and 

any other disease where XMRV is later 

identified as the causative agent. 

• A logical starting point for 

generating clinical-grade XMRV 

constructs for use in clinical vaccine, 

immunotherapy, and gene therapy 

studies. 

Advantages: 

• First complete set of plasmids 

available for the expression of each 

XMRV protein individually: Researchers 

looking to study XMRV can save months 

of time and thousands of dollars by 

using this set of XMRV tools. The 

plasmids have been fully-mapped and 

validated for protein expression. This 

plasmid portfolio offers a variety of 

vectors for expressing these XMRV 

proteins including Gateway® entry 

clones, bacterial vectors, baculoviral 

vectors, and mammalian expression 

systems. 

• Clones were developed from an 

XMRV isolate taken from a patient with 

a confirmed XMRV infection: The 

proteins produced by these expression 

plasmids are anticipated to have direct 

clinical applicability to human XMRV 

diseases. 

• Launching pad for any commercial 

entity desiring to develop diagnostics or 

therapeutics for XMRV: This technology 

is likely to give companies in the 

prostate cancer arena or the emerging 

chronic fatigue syndrome market a 

competitive advantage for developing 

anti-XMRV products faster than 

competitors. The molecular targets 

needed as a starting point for 

therapeutic development are provided 

by this technology. 

Market: Apart from cancers of the 

skin, prostate cancer is the most 

common form of cancer found in men, 

especially in men over the age of 65. In 

the United States, an estimated 200,000 

men are diagnosed with prostate cancer 

each year and around 100 men die of 

the disease daily. About $5 billion 

dollars is spent annually on treatments 

for prostate cancer. 

The Center for Disease Control (CDC) 

estimates that over 1 million Americans 

are living with chronic fatigue 

syndrome and approximately 80% of 

these individuals are undiagnosed. This 

debilitating disease likely affects over 17 

million people worldwide and the cause 

of CFS is currently unknown. Those 

individuals diagnosed with CFS are a 

vocal patient group desiring expanded 

research into the cause of CFS and 

possible treatments and/or cures. In the 

United States alone, an estimated $9 

billion dollars is lost annually due to 

CFS-induced decreases in worker 

productivity. 

Inventors: Dominic Esposito (SAIC), 

Alan Rein (NCI), Stuart Le Grice (NCI), 

James Hartley (SAIC), William Gillette 

(SAIC), Ralph Hopkins III (SAIC), Troy 

Taylor (SAIC). 

Selected Publications: 

1. VC Lombardi, et al. Detection of an 

infectious retrovirus, XMRV, in blood 

cells of patients with chronic fatigue 

syndrome. Science 2009 Oct 

23;326(5952):585–589. [PubMed: 

19815723] 

2. A Urisman, et al. Identification of 

a novel Gammaretrovirus in prostate 

tumors of patients homozygous for 

R462Q RNASEL variant. PLoS Pathog. 

2006 Mar;2(3):e25. [PubMed: 16609730] 

Patent Status: HHS Reference No. E– 

155–2010/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

licensing under a Biological Materials 

License Agreement. 

Licensing Contact: Samuel E. Bish, 

Ph.D.; 301–435–5282; bishse@ 

mail.nih.gov. 

Tempol: A Commercially Available 

Nitroxide as Cancer Therapeutics 

Description of Invention: The 

invention is the discovery that a 

commercially available stable nitroxide, 

namely TEMPOL can effectively reduce 

the level of hypoxia-inducible 

transcription factor (HIF)–2a. Elevated 

HIF–2a is associated with clear cell 

kidney cancer characterized by 

mutation of the VHL tumor suppressor 

gene and with many other cancers. 

Therefore, TEMPOL can potentially be 

developed into a cancer drug to treat 

patients with elevated HIF–2a, whether 

due to compromised VHL function or 

not. 

Applications: Known compound 

(TEMPOL) found to be effective in 

treating several cancers. 

Advantages: Animal data confirms 

effectiveness of TEMPOL against cancer 

support. 

Development Status: Pre-clinical, In 

vivo animal data available. 

Target Market: The potential drug will 

target a population that suffers from 

genetic diseases such as inherited von 

Hippel-Lindau (VHL) disease, which is 

associated with elevated expression of 

HIF–2a and patients with kidney and 

other cancers characterized by elevation 

of HIF–2a. Inherited VHL disease is a 

cancer syndrome caused by germ line 

mutations of the VHL tumor suppressor 

gene. VHL is characterized by angiomas 

and hemangioblastomas of the brain, 

spinal cord, and retina. These can lead 

to cysts and/or tumors of the kidney, 

pancreas, and adrenal glands (e.g., 

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52760 Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices 

pheochromocytoma and endolymphatic 

sac tumors). 

Renal clear cell carcinoma (RCC) 

develops in approximately 75% of VHL 

patients by age 60 and is a leading cause 

of death in this population. Inactivation 

(mutation or methylation) of the VHL 

gene is associated with greater than 90% 

of all clear cell RCC (including sporadic 

cases) (Nickerson et al. Clin Cancer Res 

2008;14:4726–34). Thus, subjects with 

compromised VHL function represent a 

significant population that has or is at 

risk for developing cancer, including 

RCC. There is data that HIF–2a may be 

important in all or most cancers 

(Franovic et al. Proc Natl Acad Sci U S 

A 2009;106:21306–11). 

Inventors: W. Marston Linehan (NCI), 

Tracey A. Rouault (NICHD), James B. 

Mitchell (NCI), Murali K. Cherukuri 

(NCI). 

Patent Status: U.S. Provisional 

Application No. 61/265,194 filed 30 

Nov 2009 (HHS Reference No. E–133– 

2009/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Sabarni Chatterjee, 

Ph.D.; 301–435–5587; chatterjeesa@

mail.nih.gov. 

Collaborative Research Opportunity: 

The Center for Cancer Research, 

Urologic Oncology Branch, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize the use of Tempol to 

target HIF–2a in cancer. Please contact 

John Hewes, Ph.D. at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

Chimeric Anti-human ROR1 

Monoclonal Antibodies 

Description of Invention: Available for 

licensing are mouse anti-human 

receptor tyrosine kinase-like orphan 

receptor 1 (ROR1) monoclonal 

antibodies (mAbs). ROR1 is a signature 

cell surface antigen for B-cell chronic 

lymphocytic leukemia (B–CLL) and 

mantle cell lymphoma (MCL) cells, two 

incurable B-cell malignancies that are 

newly diagnosed in approximately 

15,000 and 3,500 patients per year, 

respectively, in the United States. 

Currently, there are no therapeutic 

mAbs that specifically target B–CLL or 

MCL cells. Anti-ROR1 mAbs may be 

linked to chemical drugs or biological 

toxins thus providing cytotoxic delivery 

to malignant B-cells and not normal 

cells. Additionally, these antibodies can 

be fused to radioisotopes and can be 

used to diagnose B–CLL and MCL 

malignancies. 

Applications: 

• B–CLL and MCL antibody 

therapeutics. 

• Method to diagnose B–CLL and 

MCL. 

Advantages: Selective targeting to 

malignant B–CLL and MCL cells. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Market: 

• The monoclonal antibody market is 

one of the fastest growing sectors of the 

pharmaceutical industry with a 48.1% 

growth between 2003 and 2004 and the 

potential to reach $30.3 billion in 2010. 

This growth rate is driven by the 

evolution of chimeric and humanized to 

fully humanized antibody therapeutics. 

• Approximately 18,500 patients with 

ROR1-expressing B-cell malignancies 

are newly diagnosed annually in the 

United States. 

Inventors: Christoph Rader and 

Sivasubramanian Baskar (NCI). 

Related Publications: 

1. S Baskar et al. Unique cell surface 

expression of receptor tyrosine kinase 

ROR1 in human B-cell chronic 

lymphocytic leukemia. Clin Cancer Res. 

2008 Jan 15;14(2):396–404. [PubMed: 

18223214] 

2. M Hudecek et al. The B-cell tumor 

associated antigen ROR1 can be targeted 

with T-cells modified to express a 

ROR1-specific chimeric antigen 

receptor. Blood. 2010 Aug 11; Epub 

ahead of print. [PubMed: 20702778] 

Patent Status: 

• U.S. Provisional Application No. 

61/172,099 filed 23 Apr 2009 (HHS 

Reference No. E–097–2009/0–US–01). 

• PCT Application No. PCT/US10/ 

32208 filed 23 Apr 2010 (HHS Reference 

No. E–097–2009/0–PCT–02). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jennifer Wong; 

301–435–4633; wongje@mail.nih.gov. 

Collaborative Research Opportunity: 

The Center for Cancer Research, 

Experimental Transplantation and 

Immunology Branch is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize anti-ROR1 mAbs, 

antibody-drug conjugates, 

radioimmunoconjugates, bispecific 

antibodies, and other therapeutic or 

diagnostic modalities. Please contact 

John D. Hewes, Ph.D. at 301–435–3121 

or hewesj@mail.nih.gov for more 

information. 

Dated: August 23, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–21349 Filed 8–26–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–0031–N] 

Medicare Program; Listening Session 

Regarding the Implementation of 

Section 10332 of the Patient Protection 

and Affordable Care Act, Availability of 

Medicare Data for Performance 

Measurement 

DATE: September 20, 2010. 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces a 

listening session to receive comments 

regarding implementation of section 

10332 of the Patient Protection and 

Affordable Care Act (the Affordable Care 

Act), which amended section 1874 of 

the Social Security Act: Availability of 

Medicare Data for Performance 

Measurement. The purpose of the 

listening session is to solicit input from 

potential stakeholders on key 

components of the design of the 

program. We are soliciting input on the 

types of organizations that may be 

interested in receiving data as qualified 

entities under this provision; the criteria 

such organizations will have to meet for 

participation; procedures for CMS to 

approve interested organizations for 

participation; provider communities 

and geographic areas that might be 

served by these entities; data elements 

required, and the sources and types of 

other data that these organizations 

might match to Medicare claims; 

challenges in calculating performance 

measures from the data, and issues 

related to the identification, selection, 

and reporting of the performance 

measures. 

DATES: Meeting Date: The listening 

session will be held on Monday, 

September 20, 2010 from 9 a.m. until 1 

p.m. Eastern Daylight Time (e.d.t.). 

Deadline for Meeting Registration and 

Request for Special Accommodations: 

Registration opens on August 27, 2010. 

Registration must be completed by 5 

p.m. e.d.t. on September 16, 2010. 

Requests for special accommodations 

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