[Federal Register Volume 76, Number 111 (Thursday, June 9, 2011)]
[Pages 33769-33771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14261]



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.

X-Clometer: Optimizing Portable Radiography

    Description of Technology: The technology offered for licensing and 
commercial development relates to a method and apparatus that can 
significantly improve the diagnostic performance of portable chest 
(CXR) and abdominal x-rays. This device quantifies angulation of a 
patient to provide for a better comparison of day-to-day improvement.
    The portable CXR is one of the most commonly requested diagnostic 
medical tests around the world. They are performed nearly daily on some 
of the sickest patients in hospitals. Paradoxically, it is well 
documented that portable radiography of the chest is inconsistent and 
often inadequate.
    An upright projection best evaluates effusions, rules out free air, 
or detects air-fluid levels. Optimally, the images are obtained at 
similar angles each day, even if not erect, to allow accurate 
comparisons and assessment of change. It is well documented that 
portable radiography of the chest is inconsistent and often inadequate. 
To achieve optimal quality of the exam the technologist attempts the 
most upright projection; balanced with patient condition and ability to 
achieve this often impossible task.
    Applications: Portable chest and abdominal x-rays performed at 
patient's hospital bedside.


     Currently, there is no quantitative marker to indicate 
degree of the upright position. Prior markers with small ball bearings 
sinking to a small circle only indicate if the patient is supine or 
not. This technology introduces a simple dynamic marker that can 
quantify the angle at a glance for the radiologist to best compare 
patient condition over time. This device objectively quantifies 
cassette angle with a ball bearing in a cylindrical tube with markers 
to indicate upright position in degrees.
     The technology improves performance of CXR, allowing 
reliable comparisons of patient condition over time. Thus, better 
therapies can be planned and unnecessary CT (Computerized Tomography) 
can be prevented.
     The technology improves care for Intensive Care Unit 
patients, as developing effusion and the need for immediate drainage 
(as one of many examples) can be more effectively assessed with the 
present apparatus. A widespread use of the device will save lives 
through improved diagnosis and comparison of effusions.

Development Status

     A performance of a visual prototype was demonstrated. The 
visual prototype was imaged at 5 selected angles with a chest phantom. 
Initial in-vitro results demonstrate that angles can be quantified to 
within 30 degrees.
     Improved prototypes with more accuracy are currently being 
manufactured for patient use. In-vivo studies will soon be underway to 
validate clinical utility.
    Inventors: Les R. Folio (CC) and Lucas S. Folio.

Relevant Publications

    1. Wandtke JC. Bedside chest radiography. Radiology. 1994; 190:1-
10. [PMID: 8043058]
    2. Pneumatikos I, Bouros D. Pleural effusions in critically ill 
patients. Respiration. 2008; 76(3):241-248. [PMID: 18824883]
    3. Mattison LE, et al. Pleural effusions in the medical ICU: 
prevalence, causes, and clinical implications. Chest. 1997 
Apr;111(4):1018-1023. [PMID: 9106583]
    4. Fartoukh M, et al. Clinically documented pleural effusions in 
medical ICU patients: how useful is routine thoracentesis? Chest. 2002 
Jan;121(1):178-184. [PMID: 11796448]
    5. Bekemeyer WB, et al. Efficacy of chest radiography in a 
respiratory intensive care unit. A prospective study. Chest. 1985 Nov; 
88(5): 691-696. [PMID: 4053711]
    6. Tocino I. Chest imaging in intensive care unit. Eur J Radiol 
1996 Aug;23(1):46-57. [PMID: 8872073]
    Patent Status: U.S. Provisional Application No. 61/452,364 filed 
March 14, 2011 (HHS Reference No. E-063-2011/0-US-01).
    Licensing Status: Available for licensing.

Licensing Contacts

     Uri Reichman, PhD, MBA; 301-435-4616; [email protected].
     Michael Shmilovich, Esq.; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The NIH Clinical Center, 
Radiology and

[[Page 33770]]

Imaging Sciences, is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize X-Clometer. Please contact Ken Rose, PhD at 
301-435-3132 or [email protected] for more information.

HIF1[alpha]-Targeted Therapy for Diabetes and Obesity

    Description of Technology: This technology describes the use of 
hypoxia inducible factor 1 alpha (HIF1[alpha]) inhibitors for the 
reduction of body weight and treatment of diabetes.
    In obesity, the rapid expansion of adipose tissue outpaces the 
oxygen supply, resulting in hypoxia. HIF1[alpha], a transcription 
factor that plays an essential role in cellular and systemic responses 
to low oxygen levels, is activated in these tissues, and causes 
inflammation that has been linked to insulin resistance and other 
metabolic dysfunction.
    To examine the role of hypoxia in obesity and insulin resistance, 
investigators at the National Cancer Institute disrupted the 
HIF1[alpha] gene (or its dimerization partner, the HIF1[beta]) in the 
adipose tissue of transgenic mice, and found that these mice were 
protected from obesity and insulin resistance when fed a high-fat 
(western) diet. In further experiments, administration of an 
HIF1[alpha] inhibitor to wild-type mice achieved similar reductions in 
fat mass and insulin resistance, as well as other indicators of 
metabolic disease. Thus, HIF1[alpha] inhibitors represent promising new 
leads for obesity and diabetes therapeutics.
    Applications: HIF1[alpha]-targeted therapies for type 2 diabetes 
and obesity.
    Development Status: Proof of concept has been demonstrated in mouse 
    Inventors: Frank J. Gonzalez and Changtao Jiang (NCI).
    Relevant Publications: In preparation.
    Patent Status: U.S. Provisional Application No. 61/423,936, filed 
December 16, 2010 (HHS Reference No. E-018-2011/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Tara L. Kirby, PhD; 301-435-4426; 
[email protected]
    Collaborative Research Opportunity: The Center for Cancer Research, 
Laboratory of Metabolism (LM), is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize HIF1[alpha] inhibitors that can be 
used for the treatment of obesity and type 2 diabetes. The LM will be 
willing to collaborate with parties to evaluate potential inhibitors 
using the HIF1[alpha] adipose-specific knockout mice. Please contact 
John Hewes, PhD at 301-435-3121 or [email protected] for more 

Synergistic Combination Agent (Ceramide and Vinca Alkaloids) for Cancer 

    Description of Technology: Work by the Nanotechnology 
Characterization Laboratory (NCL), a joint initiative of NCI, NIST, and 
the FDA, has led to the discovery of a novel combination chemotherapy. 
This combination is shown to have synergistic effects on cytotoxicity 
to cancer cells in vitro, and to cause a substantial decrease in tumor 
growth in preclinical tumor models in vivo. Combination therapy using 
these agents may enhance the response rate of different cancers to 
these drugs and may significantly reduce side effects by permitting a 
lower therapeutic dose to be administered.
    The instant invention relates to a novel combination of ceramide 
and vinca alkaloids, which synergistically decrease cancer cell growth 
without increasing the toxicity profile compared to the individual 
drugs. The drug combination has been rigorously evaluated in both in 
vitro and in vivo models of cancer, and a dose range-finding toxicology 
study has been conducted in rodents.
    This combination induces cell death via a novel mechanism 
(induction of autophagy with simultaneous blockade of autophagy flux). 
This mechanism appears to impart selectivity of the therapy to cancer 
    Available for licensing are methods to use the combination therapy 
for cancer treatment.
    Applications: Cancer treatment, especially for cancers sensitive to 
treatment with vinca alkaloids such as breast cancer, testicular 
cancer, head and neck cancer, Hodgkin's lymphoma, and non-small cell 
lung cancer.
    Advantages: Vinca alkaloids alone at therapeutic doses produce the 
standard side effects of cancer chemotherapy. The vinca alkaloid-
ceramide combination can be administered at lower doses with comparable 
efficacy and may allow for more frequent dosing (metronomic dosing). 
The novel mechanism of action of this combination appears to be 
selective to cancer cells.
    Development Status: The drug combination has been evaluated in both 
human hepatocarcinoma models (in vitro cell culture assays) and human 
colon cancer models (in vivo mouse xenografts). Additional in vivo 
studies with other cancer types and early stage preclinical toxicology 
studies are being planned.
    Inventors: Stephan T. Stern, Scott E. McNeil, Pavan Adiseshaiah 
    Patent Status: U.S. Provisional Patent Application No. 61/451,925 
filed March 11, 2011 (HHS Reference No. E-007-2011/0-US-01)
    Licensing Status: Available for licensing or partnering for further 
    Licensing Contact: Betty B. Tong, PhD; 301-594-6565; 
[email protected]
    Collaborative Research Opportunity: The SAIC Frederick, 
Nanotechnology Characterization Laboratory, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize a ceramide and 
vinca alkaloid combination therapy for treatment of cancer. Please 
contact John Hewes, PhD at 301-435-3121 or [email protected] for more 

Novel Small Molecule Inhibitors for the Treatment of Huntington's 

    Description of Technology: This technology is a collection of small 
molecules screened for their ability to prevent or reduce the cytotoxic 
effects of the protein, Huntingtin. Huntington's disease is a 
neurodegenerative disorder due to a dominantly acting expansion of a 
CAG trinucleotide repeat in exon 1 of the Huntington (HTT) gene 
resulting in production of the altered (mutant) protein Huntingtin, 
which has a long chain of polyglutamine (poly Q) attached to the exon 1 
encoded protein sequence. Clinical and statistical analyses have shown 
that an increased number of poly Q repetition correlates with the 
probability of developing the disease, with 36 to 40 being the accepted 
cut off number for developing the disorder with high probability. It is 
known that poly Q repetitions impact the physical properties of 
Huntingtin and cause it to produce aggregates that precipitate and form 
inclusion bodies, which are toxic to the neuronal cells. The compounds 
of this invention have been screened multiply in a neuronal cell model 
of Huntington's disease containing an HTT with an expanded repeat in 
exon 1 of 103 Qs for their ability to inhibit cytotoxicity and protein 
    Applications: Treatment of Huntington's disease.
    Development Status: Early development.

[[Page 33771]]

    Inventors: Juan Marugan, Joshua McCoy, Samarjit Patnaik, Steven 
Titus, Wei Zheng, Noel T. Southall, Wenwei Huang (NHGRI).
    Relevant Publications: None.
    Patent Status: U.S. Provisional Application No. 61/388,482 filed 
September 30, 2010 (HHS Reference No. E-258-2010/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Steve Standley, PhD; 301-435-4074; 
[email protected].
    Collaborative Research Opportunity: The National Center for 
Translational Therapeutics is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize this technology further. Please 
contact Ms. Lili Portilla at [email protected] for more information.

    Dated: June 3, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-14261 Filed 6-8-11; 8:45 am]