[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59794-59796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24987]


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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, 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. 209 and 37 CFR part 404 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.

FOR FURTHER INFORMATION CONTACT: Licensing information and copies of 
the U.S. patent applications listed below may be obtained by writing to 
the

[[Page 59795]]

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.

SUPPLEMENTARY INFORMATION: Technology descriptions follow.

Novel Radio-Labeled Agents for Imaging Alzheimer's Disease-Associated 
Amyloid

    Description of Technology: This technology introduces novel radio-
labeled agents for imaging amyloid deposits in the brains of 
Alzheimer's disease patients. These are small molecule, radio-ligand 
compounds that are analogs of benzo[d]thiazole. They are highly 
specific to amyloid, have low background noise, do not undergo rapid 
defluoridation and do not produce residual radioactivity in the brain. 
In addition, the compounds are stable and may be readily synthesized 
from commercially available starting materials. These compounds may be 
used in many noninvasive imaging techniques including: Magnetic 
resonance spectroscopy (MRS) or imaging (MRI) or positron emission 
tomography (PET) or single-photon emission computed tomography (SPECT) 
to measure amyloid. Non-invasive detection of Alzheimer's disease-
associated amyloid plaques in the brain would be valuable for early 
diagnosis, monitoring, and for clinical development of therapeutic 
drugs.
    Potential Commercial Applications: Imaging agents for use in 
magnetic resonance spectroscopy (MRS), or imaging (MRI), positron 
emission tomography (PET) or single -photon emission computed 
tomography (SPECT).
    Competitive Advantages: Highly specificity to amyloid, low 
background, do not undergo rapid defluoridation and do not produce 
residual radioactivity in the brain.
    Development Stage: Early-stage.
    Inventors: Lisheng Cai and Victor W. Pike (NIMH).
    Publications:
    1. Cai L, et al. Synthesis and structure-affinity relationships of 
new 4-(6-iodo-H-imidazo[1,2-a]pyridin-2-yl)-N-dimethylbenzeneamine 
derivatives as ligands for human beta-amyloid plaques. J Med Chem. 2007 
Sep 20;50(19):4746-58. [PMID 17722900]
    2. Cai L, et al. Synthesis and evaluation of N-methyl and S-methyl 
11C-labeled 6-methylthio-2-(4'-N,N-dimethylamino)phenylimidazo[1,2-
a]pyridines as radioligands for imaging beta-amyloid plaques in 
Alzheimer's disease. J Med Chem. 2008 Jan 10;51(1):148-58. [PMID 
18078311]

Intellectual Property:
 HHS Reference No. E-225-2011/0--US Provisional Application No. 
61/535,569 filed 16 Sep 2011
 HHS Reference No. E-225-2011/1--PCT Application No. PCT/
US2012/055124 filed 13 Sep 2012, which published as WO 2013/0401830 on 
21 Mar 2013; US Patent Application No. 14/345,004 filed 23 Apr 2014

    Related Technology: HHS Reference No. E-156-2006/0--US Patent No. 
8,703,096 issued 22 Apr 2014; US Patent Application No. 14/223,782 
filed 24 Mar 2014; Various international patents/applications issued/
pending.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Mental Health (NIMH) is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate or commercialize Beta-amyloid Imaging Agents. For 
collaboration opportunities, please contact Suzanne L. Winfield, Ph.D. 
at [email protected] or 301-402-4324.

Human Research Information System (HuRIS)

    Summary: Researchers at the National Institute on Drug Abuse (NIDA) 
seek licensing or co-development of a Human Research Information System 
(HuRIS) software that automates all major functions of a clinical-
research entity. The system is designed for commercial healthcare 
providers, community treatment centers, and clinical research 
facilities.
    Description of Technology: The available system is the Human 
Research Information System (HuRIS), an integrated advanced clinical/
research informatics series of systems--that is, an intelligent 
electronic environment for the collection, organization and retrieval 
of information in clinical/scientific decision support--which enables 
data and resource sharing in real time among authorized users at our 
clinics. (Individual systems or subsystems may be licensable.) Users on 
both the clinical side (e.g. doctors writing medication orders or 
nurses recording participants' vital signs) and on the research side 
(e.g. researchers conducting data analysis or completing reporting 
requirements) have access to the information on demand. At the core of 
this informatics infrastructure reside the clinical charts and research 
records of participants compiled over the entire history of their study 
participation, and sometimes across multiple studies. The computerized 
recording of participants' information starts from the time of their 
initial consent for screening. Data collected by our intake personnel 
under a screening protocol become part of the participants' clinical 
research records. This recording continues as participants are admitted 
to a clinical trial and persists throughout their progress within the 
prescribed activities until they are discharged. The electronic 
recording of participants' activities enables the use of this 
information as a research resource to different groups at different 
locations, in current and future protocols, as permitted by human 
subjects' protection regulations. The HuRIS has a number of intelligent 
decision systems built-in for real-time or on-demand query as well as 
HL-7 communications with external laboratories for data exchange, and 
it seamlessly communicates with our Human Biospecimen Tracking System. 
User permissions to access various components of the system are 
centrally controlled and all access is logged.
    Potential Commercial Applications:

 Hospital Information Management
 Clinical Research Information Management
 Pharmacy Management System
 Biospecimens Tracking System
 Laboratory Information Management
 Behavioral Modification/Addiction Treatment

    Competitive Advantages:

 Mature solution developed with contributions by numerous 
physicians, scientists, and treatment professionals at all levels
 Low-cost mechanism
 Proven advantage in prior clinical studies

    Development Stage:

 Ready for commercialization
 Prototype
 Clinical

    Inventors: Massoud R. Vahabzadeh, Mustapha Mezghanni, Jia-Ling Lin, 
Michelle K. Leff (all of NIDA)
    Publications:
    1. Massoud Vahabzadeh, Jia-Ling Lin, Mustapha Mezghanni, Carlo 
Contoreggi, and Michelle Leff, ``An EHR-Based Multi-Site Recruiting 
System for Clinical Trials,'' Proc. 20th IEEE International Symposium 
on Computer-Based Medical Systems, June 2007, pages 331-6.
    2. Massoud Vahabzadeh, Jia-Ling Lin, Mustapha Mezghanni, David 
Epstein, and Kenzie Preston, ``Automation in an Addiction Treatment 
Research Clinic:

[[Page 59796]]

Computerized Contingency Management, Ecological Momentary Assessment, 
and a Protocol Workflow System,'' Drug and Alcohol Review, 28(1):3-11, 
January 2009.
    Intellectual Property: HHS Reference No. E-266-2014/0--Software. No 
patent protection is being sought.
    Contact Information: Vio Conley, M.S.; NCI Technology Transfer 
Center; Phone: 240-276-5531; Email: [email protected].
    Keywords: Software, Clinical Information System, Research 
Information System, Medical Decision Support System (DSS), Electronic 
Hospital Records (EHR), Physicians Order Entry (POE), Pharmacy 
Information System, Laboratory Information Management (LIM), 
Biospecimen Tracking System, Substance abuse, Drug addiction, Mental 
health, mPAL, HuRIS.

Optimized Gene Therapy Vector for the Treatment of Glycogen Storage 
Disease Type Ia

    Description of Technology: NIH researchers have developed an adeno-
associated viral (AAV) vector for the treatment of glycogen storage 
disease type Ia (GSD-Ia). GSD-Ia is an inherited disorder of metabolism 
associated with life-threatening hypoglycemia, hepatic malignancy, and 
renal failure caused by the deficiency of glucose-6-phosphatase-alpha 
(G6Pase-alpha or G6PC). This new AAV vector that expresses human 
G6Pase-alpha directed by the tissue-specific human G6PC promoter/
enhancer incorporates two improvements: (1) It expresses a variant of 
G6Pase-alpha with enhanced enzymatic activity; (2) it is codon 
optimized to achieve higher enzyme expression levels and enhanced 
enzymatic activity.
    Current therapy, which primarily consists of dietary modification, 
fails to prevent long-term complications in many patients, including 
growth failure, gout, pulmonary hypertension, renal dysfunction, 
osteoporosis, and hepatocellular adenomas (HCA). Gene therapy-based 
techniques, which directly address the underlying genetic deficiency 
driving the disorder, offer the prospect of long-term remission in 
patients with GSD-Ia.
    Potential Commercial Applications: Gene therapy vector for the 
treatment of GSD-Ia.
    Competitive Advantages:
     Protein coding sequence modified for enhanced enzymatic 
activity.
     Codon optimized for increased enzyme expression in target 
organs.
    Inventor: Janice J. Chou (NICHD)
    Development Stage: In vivo data available (animal).
    Publications:
    1. Lee YM et al. Prevention of hepatocellular adenoma and 
correction of metabolic abnormalities in murine glycogen storage 
disease type Ia by gene therapy. Hepatology 2012 Nov;56(5):1719-29. 
[PMID 22422504].
    2. Lee YM, et al. The upstream enhancer elements of the G6PC 
promoter are critical for optimal G6PC expression in murine glycogen 
storage disease type Ia. Mol Genet Metab. 2013 Nov;110(3):275-80. [PMID 
23856420].
    Intellectual Property: HHS Reference No. E-039-2015/0-US-01--US 
Provisional Patent Application 62/096,400 filed December 23, 2014.
    Related Technologies: HHS Reference No. E-552-2013/0--US 
Provisional Patent Application No. 61/908,861 filed November 26, 2013; 
PCT Application No. PCT/US2014/067415 filed November 25, 2014.
    Licensing Contact: Surekha Vathyam, Ph.D.; 301-435-4076; 
[email protected].
    Collaborative Research Opportunity: The National Institute of Child 
Health and Human Development is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize gene therapy vectors for the 
treatment of glycogen storage disease type Ia. For collaboration 
opportunities, please contact Joseph M. Conrad, III, Ph.D., J.D. at 
[email protected].

    Dated: September 25, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-24987 Filed 10-1-15; 8:45 am]
BILLING CODE 4140-01-P