[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Notices]
[Pages 38352-38353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15204]


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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 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.

Predicting Age of Onset of Niemann-Pick Disease

    Description of Technology: Niemann-Pick disease (NPD) refers to a 
group of fatal inherited metabolic disorders. Children with type A or B 
NPD usually die within the first few months or years of life, while NPD 
type C progresses more slowly, and affected individuals may survive 
into their seventies. The lifespan of patients with NPD is related to 
the age of onset. At present, however, there is no effective diagnostic 
method to predict the age of NPD disease onset.
    The instant invention presents diagnostic compositions and 
efficient methods for predicting the age of onset of a lysosomal 
storage disease (e.g., NPD) and of diseases associated with lysosomal 
of autophagic defects (e.g., Parkinson's disease and Alzheimer's 
disease) in patients. It can also be used to screen for agents useful 
in treating NPD patients.
    Potential Commercial Applications:
     Predicting the age of disease onset in patients with 
Niemann-Pick disease, and other diseases associated with lysosomal or 
autophagic defects.
     Identifying agents for treating NPD patients.
    Competitive Advantages: A new method for predicting the age of NPD 
disease onset.
    Development Stage:
     Early-stage.
     Pre-clinical.
     In vitro data available.
    Inventors: William J. Pavan, et al. (NHGRI).
    Intellectual Property: HHS Reference No. E-060-2013/0--U.S. 
Provisional Application No. 61/781,807 filed 14 Mar 2013.
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected].
    Collaborative Research Opportunity: The National Human Genome 
Research Institute (NHGRI) is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize diagnostic methods for predicting 
the age of onset of lysosomal disorders, such as NPD and Parkinson's. 
For collaboration opportunities, please contact Dr. William J. Pavan at 
[email protected].

Rat Model for Alzheimer's Disease

    Description of Technology: The present invention is directed to a 
transgenic rat model of Alzheimer's Disease (AD) termed TgF344-19+/-. 
The invention rat overexpresses two human genes (APPswe and 
PS1[Delta]E9 genes), each of which are believed to be independent 
dominant causes of early-onset AD. The hemizygote exhibits major 
features of AD pathology (i.e., dense and diffuse amyloid plaques, 
neurofibrillary tangles, cerebral amyloid angiopathy, 
hyperphosphorylated tau, paired-helical filaments, Hirano bodies, 
granulovacuolar degeneration, cognitive impairment, and cortical 
neuronal loss).
    The invention rat is superior to AD mice models because the rat has 
a larger sized brain to accommodate in vivo imaging studies and complex 
behavioral

[[Page 38353]]

testing. Further, the invention rat has a longer life span so that 
studies of longer duration or studies involving serial sampling can be 
conducted. The invention rat can be used to evaluate potential 
treatments for AD and to further investigate AD physiology.
    Potential Commercial Applications:
     In vivo validation of AD therapeutics.
     Development and validation of imaging methods to diagnose 
AD.
     Detailed investigation of AD pathology and physiology.
    Competitive Advantages:
     Rat model in contrast to available mice models.
     Rat model based on over-expression of genes responsible 
for early onset AD.
    Development Stage:
     Prototype.
     In vivo data available (animal).
    Inventors: Robert M. Cohen, et al. (NIMH).
    Publication: Borchelt DR, et al. Familial Alzheimer's disease-
linked presenilin 1 variants elevate Abeta1-42/1-40 ratio in vitro and 
in vivo. Neuron. 1996 Nov; 17(5):1005-13. [PMID 8938131]
    Intellectual Property: HHS Reference No. E-211-2012/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; [email protected].

Prognostic Biomarkers for Patients With Early Stage Lung Cancer

    Description of Technology: Investigators at the National Cancer 
Institute have discovered a set of biomarkers that can identify 
patients with early stage lung cancer who have a high risk of relapse. 
Available for licensing are prognostic assays based on these 
biomarkers, which can enable clinicians to select more effective 
therapy and post-operative follow-up strategies.
    Surgery is the standard care for patients with stage I lung cancer. 
Despite successful surgery, 20-30% of patients will relapse. 
Chemotherapy can improve patient survival; however, it is controversial 
if early stage cancer patients should be treated with chemotherapy 
since, for many cases, it will harm quality of life with little 
therapeutic benefit. Utilizing patient samples, the investigators 
conducted a retrospective study in eight patient cohorts that validated 
the gene classifier set. These prognostic methods can guide physicians 
to select appropriate treatment and follow-up while sparing other 
patients of unnecessary treatment and negative side-effects of 
chemotherapy.
    Potential Commercial Applications:
     Method to determine the prognosis of patients with lung 
cancer.
     Method to select more effective treatment and post-
operative follow-up for patients with early stage lung cancer.
    Competitive Advantages: Assays were validated in human tissue 
samples and eight different patient cohorts.
    Development Stage:
     Early-stage.
     In vivo data available (human).
    Inventors: Curt Harris (NCI), Aaron Schetter (NCI), Ichiro Akagi 
(Nippon Medical School), and Hirokazu Okayama (Fukushima Medical 
University).
    Publication: Akagi I, et al. Combination of protein coding and non-
coding gene expression as a robust prognostic classifier in stage I 
lung adenocarcinoma. Cancer Res. 2013 May 2; Epub ahead of print. [PMID 
23639940]
    Intellectual Property: HHS Reference No. E-048-2012/0--U.S. 
Provisional Application No. 61/691,118 filed 20 Aug 2012.
    Related Technology: HHS Reference No. E-181-2006/0--U.S. Patent 
Nos. 7,943,318 and 8,377,637 and Australian Patent No. 2007205234, and 
related patent applications pending in Australia, Canada, China, 
Europe, Japan and the U.S.
    Licensing Contact: Jennifer Wong, M.S.; 301-435-4633; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate or commercialize 
an early detection test for lung cancer. For collaboration 
opportunities, please contact John Hewes, Ph.D. at [email protected].

Retroviral and Lentiviral Vectors To Increase Efficiency of Inducible 
Pluripotent Stem Cell (iPSC) Production

    Description of Technology: Researchers at the National Cancer 
Institute have discovered that modulating a specific p53 isoform 
increases the number of inducible pluripotent stem cells that can be 
obtained from cells that are being re-programmed to obtain pluripotent 
cells. It is known that the activity of p53 regulates the self-renewal 
and pluripotency of normal and cancer stem cells, and also affects re-
programming efficiency of iPS cells. This p53 isoform-based technology 
provides a more natural process of increasing iPS cell production than 
previous methods of decreasing p53.
    Potential Commercial Applications:
     Stem cell-based regenerative medicine.
     Cancer therapeutic that targets cancer stem cells.
    Competitive Advantages: The retroviral and lentiviral vectors in 
this invention allow more selective control of p53 activities than 
siRNA or mutant p53 methods.
    Development Stage: Early-stage.
    Inventors: Curtis C. Harris (NCI) et al.
    Intellectual Property: HHS Reference No. E-239-2010/0--
     U.S. Provisional Patent Application No. 61/389,134 filed 
01 Oct 2010.
     International Patent Application PCT/US2011/054304 filed 
30 Sep 2011, which published as WO/2012/044979 on 05 Apr 2012.
     Australian Patent Application 2011308567 filed 30 Sep 
2011.
     US Patent Application No. 13/877,100 filed 29 Mar 2013.
     Applications also pending in CA, EP, JP (filing nos. 
unknown).
    Related Technologies:
     HHS Reference No. E-033-2008/0--Therapeutic Applications 
of a p53 Isoform in Regenerative Medicine, Aging, and Cancer.
     HHS Reference No. E-137-2010/0--Research Tool. Patent 
protection is not being pursued for this technology.
    Licensing Contact: Patrick McCue, Ph.D.; 301-435-5560; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Laboratory of Human Carcinogenesis, is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate or commercialize Retroviral and Lentiviral 
Vectors. For collaboration opportunities, please contact John D. Hewes, 
Ph.D. at [email protected].

    Dated: June 20, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-15204 Filed 6-25-13; 8:45 am]
BILLING CODE 4140-01-P