Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices 18833 

Competitive Advantages: 

• These T cell clones were isolated 

and selected from the bulk TIL cultures 

of the respective patients from which 

they were derived due to their superior 

reactivity to their TAA antigen. 

• Significant data has been collected 

on their characteristics, including 

identification of the tumor associated 

antigen and specific cancer peptide 

recognized by the T cell receptor of each 

clone. 

Development Stage: 

• Pre-clinical 

• Clinical 

• In vitro data available 

• In vivo data available (human) 

Inventors: Mark E. Dudley and Steven 

A. Rosenberg (both of NCI). 

Publications: 

1. Dudley M, et al. Cancer regression 

and autoimmunity in patients after 

clonal repopulation with antitumor 

lymphocytes. Science. 2002 Oct 

25;298(5594):850–854. [PMID 12242449] 

2. Dudley M, et al. Adoptive transfer 

of cloned melanoma-reactive T 

lymphocytes for the treatment of 

patients with metastatic melanoma. J 

Immunother. 2001 Jul–Aug;24(4):363– 

373. [PMID 11565838] 

Intellectual Property: HHS Reference 

No. E–267–2010/0—Research Tool. 

Patent protection is not being pursued 

for this technology. 

Related Technologies: 

• HHS Reference No. E–057–1994— 

elanoma Antigens and Their Use in 

Diagnostic and Therapeutic Methods 

• HHS Reference No. E–086–2001— 

Peptides of a Melanoma Antigen and 

Their Use in Diagnostic, Prophylactic, 

and Therapeutic Methods 

• HHS Reference No. E–106–2004— 

Compositions Comprising T cell 

Receptors and Methods of Use Thereof 

• HHS Reference No. E–304–2006— 

Modified T cell Receptors and Related 

Materials and Methods 

• HHS Reference No. E–059–2007— 

gp100-specific T cell Receptors and 

Related Materials and Methods 

• HHS Reference No. E–312–2007— 

Modified T cell Receptors and Related 

Materials and Methods 

• HHS Reference No. E–257–2008— 

Melanoma Associated Peptide 

Analogues and Vaccines Against 

Melanoma 

• HHS Reference No. E–261–2008— 

Melanoma Associated Antigenic 

Polypeptide, Epitopes Thereof and 

Vaccines Against Melanoma 

Licensing Contact: Samuel E. Bish, 

Ph.D.; 301–435–5282; 

bishse@mail.nih.gov. 

Dated: March 22, 2012. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2012–7420 Filed 3–27–12; 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. 

Personalized Body Weight Management 

System Using Monitoring Devices and 

Mathematical Models of Metabolism 

Description of Technology: Attempts 

to manage body weight are often 

unsuccessful or only temporary. This is, 

in part, due to antiquated dieting 

methods that attempt to address calorie 

consumption while ignoring metabolic 

and physical changes. It is becoming 

clear that personalized methods to 

manage body weight must be developed. 

Scientists at the NIH have developed 

new methods for prescribing and 

monitoring personalized weight 

management interventions. The system 

uses validated mathematical models of 

human metabolism to set weight 

management goals and predict 

individual body weight outcomes in the 

context of changing metabolic needs 

and calorie consumption. The system 

uses repeated monitoring of a patient’s 

body weight to assess progress and 

provide specific feedback to the patient 

and health care professional. Projected 

outcomes and body weight goals can be 

revised over time along with required 

prescription modifications to meet the 

body weight goals. The system is 

integrated into a network of one or more 

devices that may additionally monitor 

various physiological parameters, 

physical activities, food intake, or other 

behaviors. Such an enhanced 

personalized weight management 

program has great promise in the 

management of obesity. 

Potential Commercial Applications: 

• Devices—Weight management 

diagnostic. 

• Software for the integration of 

multiple devices. 

Competitive Advantages: Integrated 

system provides feedback to health care 

professional and patient with more 

accurate predictors of weight loss 

outcomes. Combined with other 

devices, patient receives encouragement 

to stay on track. 

Inventor: Kevin D. Hall (NIDDK). 

Publications: 

1. Hall KD, Sacks G, Chandramohan 

D, Chow CC, Wang YC, Gortmaker SL, 

Swinburn BA. Quantification of the 

effect of energy imbalance on 

bodyweight. Lancet. 2011 378 

(9793):826–837. [PMID 21872751] 

2. Hall KD and Chow CC. Estimating 

changes in free-living energy intake and 

its confidence interval. Am J Clin Nutr. 

2011 Jul;94(1):66–74. [PMID 21562087] 

3. Hall KD. Predicting metabolic 

adaptation, body weight change, and 

energy intake in humans. Am J Physiol 

Endocrinol Metab. 2010 

Mar;298(3):E449–466. [PMID 19934407] 

Intellectual Property: HHS Reference 

No. E–063–2012/0—U.S. Provisional 

Application No. 61/592,325 filed 30 Jan 

2012. 

Licensing Contact: Michael A. 

Shmilovich, Esq., CLP; 301–435–5019; 

shmilovm@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIDDK Laboratory of Biological 

Modeling is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate or 

commercialize this technology. For 

collaboration opportunities, please 

contact Marguerite J. Miller at 301–496– 

9003 or millermarg@niddk.nih.gov. 

Direct Impact Spark Ionization (DISI) 

Mass Spectrometry (MS) for 

Identification of Microbes 

Description of Technology: Generating 

reproducible mass spectra from bacterial 

samples in a timely fashion at 

atmospheric pressure remained 

problematic for many years. FDA/NCTR 


tkelley on DSK3SPTVN1PROD with NOTICES
18834 Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices 

inventors designed a rapid mass 

spectrometry device using direct impact 

spark ionization source for microbial 

analytes identification via spectral 

pattern recognition. The device design 

includes a rapid mass spectrometer 

suitable for analyzing microbiological 

samples that was earlier used to analyze 

low volatile organic compounds. The 

device employs a solid needle for 

electrode discharge. It includes a gear 

plate that introduces stainless steel pins 

carrying bacterial samples. The pins 

also act as counter electrodes and are 

targeted by controlled arcs. The small 

custom-made glass cylinder that is 

meant to shut out oxygen and prevent 

the introduction of ambient moisture 

into the analyte is unique from other 

DISI device. The examination revealed 

enormous peak intensity and spectral 

information with normal ionization 

mode on the same instrument. This 

device can be employed in fields such 

as pathogen determination in clinical 

settings, QA/QC (of drugs, food or 

cosmetic ingredients), continuous 

monitoring of (airborne) Biological 

Warfare Agents and the like. 

Potential Commercial Applications: 

• Pathogen detection, 

• QA/QC (of drugs, food or cosmetic 

ingredients), 

• Continuous monitoring of (airborne) 

Biological Warfare Agents and the like. 

Competitive Advantages: 

• Rapid, specific, sensitive and 

reproducible identification of 

microbiological analytes. 

• Systematic acquisition of 

reproducible spectra among same 

bacterial species. 

• Whole cell analysis of food-borne 

pathogens is rapid, safer and microreliable. 

• Characteristic mass spectra 

obtained and reproduced for food-borne 

pathogens. 

• Unique DISI device with gas 

cylinder chamber. 

Development Stage: 

• Prototype. 

• In vitro data available. 

Inventors: Peter Alusta, Cameron 

Dorey, Ryan Parker, Dan A. Buzatu, Jon 

G. Wilkes (all of FDA/NCTR). 

Intellectual Property: HHS Reference 

No. E–258–2011/0—U.S. Patent 

Application No. 13/271,182 filed 11 Oct 

2011. 

Related Technologies: 

• HHS Reference No. E–169–2000/ 

0—U.S. Patent Application No. 09/ 

975,530 filed 10 Oct 2001. 

• HHS Reference No. E–259–2011/ 

0—U.S. Provision Application No. 61/ 

564,926 filed 30 Nov 2011. 

Licensing Contact: Michael A. 

Shmilovich, Esq., CLP; 301–435–5019; 

shmilovm@mail.nih.gov. 

Collaborative Research Opportunity: 

The NCTR/FDA inventors are seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate or 

commercialize this device. For 

collaboration opportunities, please 

contact Alice Y. Welch, Ph.D. at 

Alice.Welch@fda.hhs.gov. 

Method of Treating Hepatitis C Virus 

Infection With a Small Molecule CHK2 

Inhibitor 

Description of Technology: DNA 

damage sensors such as Checkpoint 

Kinase 2 (Chk2) are key regulators of the 

cellular DNA damage response that 

limits cell-cycle progression in response 

to DNA damage. It has been reported 

that these DNA damage sensors also 

play a key role in Hepatitis C virus 

(HCV) replication. The subject 

technology are small molecule CHK2 

kinase inhibitors that have been shown 

to have promising activity against HCV 

replication. The compounds were 

discovered by high throughput 

screening of chemical libraries with 

more than 150,000 compounds. These 

novel compounds can potentially be 

used in combination with other antiHCV drugs or interferon and represent 

a novel target for treating HCV. In vitro 

antiviral assay data, as well as 

preliminary in vitro and in vivo 

pharmokinetic data are available upon 

request. 

Potential Commercial Applications: 

The subject technology can potentially 

be developed into anti-HCV 

therapeutics, particularly in 

combination with other anti-HCV 

therapeutics. 

Competitive Advantages: The subject 

technology represents a novel and 

promising target for treating HCV 

infection and thus, has the potential to 

increase the efficacy of other HCV 

antivirals that directly target HCV in a 

multi-drug formulation. Furthermore, 

since the subject technology targets a 

cellular protein necessary for HCV 

replication and not the virus itself, the 

emergence of viral resistance against the 

subject technology could be low or more 

delayed. 

Development Stage: 

• Early-stage. 

• Pre-clinical. 

• In vitro data available. 

• In vivo data available (animal). 

Inventors: Yves G. Pommier, Robert H. 

Shoemaker, Dominic A. Scudiero, 

Andrew G. Jobson, David S. Waugh, 

George T. Lountos (all of NCI) 

Publications: 

1. Jobson AG, et al. Identification of 

a Bis-guanylhydrazone [4,4′- 

Diacetyldiphenylureabis(guanylhydrazone); NSC 109555] as a 

novel chemotype for inhibition of Chk2 

kinase. Mol Pharmacol 2007 

Oct;72(4):876–884. [PMID 17616632] 

2. Jobson AG, et al. Cellular inhibition 

of checkpoint kinase 2 (Chk2) and 

potentiation of camptothecins and 

radiation by the novel Chk2 inhibitor 

PV1019 [7-nitro-1H-indole-2-carboxylic 

acid {4-[1-(guanidinohydrazone)-ethyl]- 

phenyl}-amide]. J Pharmacol Exp Ther. 

2009 Dec;331(3):816–826. [PMID 

19741151] 

3. Lountos GT, et al. Crystal structure 

of checkpoint kinase 2 in complex with 

NSC 109555, a potent and selective 

inhibitor. Protein Sci. 2009 

Jan;18(1):92–100. [PMID 19177354] 

4. Lountos GT, et al. X-ray structures 

of checkpoint kinase 2 in complex with 

inhibitors that target its gatekeeperdependent hydrophobic pocket. FEBS 

Lett. 2011Oct 20;585(20):3245–3249. 

[PMID 21907711] 

5. Lountos GT, et al. Structural 

characterization of inhibitor complexes 

with checkpoint kinase 2 (Chk2), a drug 

target for cancer therapy. J Struct Biol. 

2011 Dec;176(3):292–301. [PMID 

21963792] 

Intellectual Property: HHS Reference 

No. E–224–2011/0—U.S. Provisional 

Patent Application No. 61/551,742 filed 

26 Oct 2011. 

Related Technology: HHS Reference 

No. E–211–2005/0—U.S. Patent 

Application No. 11/989,737 filed 29 Jan 

2008, with corresponding applications 

in Europe, Canada, and Australia. 

Licensing Contact: Kevin W. Chang, 

Ph.D.; 301–435–5018; 

changke@mail.nih.gov. 

Dated: March 22, 2012. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2012–7419 Filed 3–27–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–4057– 

DR; Docket ID FEMA–2012–0002] 

Kentucky; Amendment No. 5 to Notice 

of a Major Disaster Declaration 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This notice amends the notice 

of a major disaster declaration for the 


tkelley on DSK3SPTVN1PROD with NOTICES