[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Notices]
[Pages 18833-18834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7419]


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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.

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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:
    <bullet> Devices--Weight management diagnostic.
    <bullet> 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; 
<a href="/cdn-cgi/l/email-protection#0e7d666367626178634e636f67622060676620696178"><span class="__cf_email__" data-cfemail="7f0c171216131009123f121e16135111161751181009">[email protected]</span></a>.
    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 
<a href="/cdn-cgi/l/email-protection#b7dadedbdbd2c5dad6c5d0f7d9ded3d3dc99d9dedf99d0d8c1"><span class="__cf_email__" data-cfemail="bfd2d6d3d3dacdd2decdd8ffd1d6dbdbd491d1d6d791d8d0c9">[email protected]</span></a>.

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

[[Page 18834]]

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:
    <bullet> Pathogen detection,
    <bullet> QA/QC (of drugs, food or cosmetic ingredients),
    <bullet> Continuous monitoring of (airborne) Biological Warfare 
Agents and the like.
    Competitive Advantages:
    <bullet> Rapid, specific, sensitive and reproducible identification 
of microbiological analytes.
    <bullet> Systematic acquisition of reproducible spectra among same 
bacterial species.
    <bullet> Whole cell analysis of food-borne pathogens is rapid, 
safer and micro-reliable.
    <bullet> Characteristic mass spectra obtained and reproduced for 
food-borne pathogens.
    <bullet> Unique DISI device with gas cylinder chamber.
    Development Stage:
    <bullet> Prototype.
    <bullet> 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:
    <bullet> HHS Reference No. E-169-2000/0--U.S. Patent Application 
No. 09/975,530 filed 10 Oct 2001.
    <bullet> 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; 
<a href="/cdn-cgi/l/email-protection#3c4f54515550534a517c515d555012525554125b534a"><span class="__cf_email__" data-cfemail="34475c595d585b42597459555d581a5a5d5c1a535b42">[email protected]</span></a>.
    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 <a href="/cdn-cgi/l/email-protection#5b1a3732383e750c3e3738331b3d3f3a75333328753c342d"><span class="__cf_email__" data-cfemail="03426f6a60662d54666f606b436567622d6b6b702d646c75">[email protected]</span></a>.

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 anti-HCV 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:
    <bullet> Early-stage.
    <bullet> Pre-clinical.
    <bullet> In vitro data available.
    <bullet> 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'-
Diacetyldiphenylurea-bis(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{time} -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 gatekeeper-dependent 
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; 
<a href="/cdn-cgi/l/email-protection#f3909b929d949896b39e929a9fdd9d9a9bdd949c85"><span class="__cf_email__" data-cfemail="5e3d363f3039353b1e333f37327030373670393128">[email protected]</span></a>.

     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


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