[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Pages 81626-81628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32669]


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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.

Engineered Biological Pacemakers

    Description of Technology: A common symptom of many heart diseases 
is an abnormal heart rhythm or arrhythmia. While effectively improving 
the lives of many patients, implantable pacemakers have significant 
limitations such as limited power sources, risk of infections, 
potential for interference from other devices, and absence of autonomic 
rate modulation.
    The technology consists of biological pacemakers engineered to 
generate normal heart rhythm. The biological pacemakers include cardiac 
cells or cardiac-like cells derived from embryonic stem cells or 
mesenchymal stem cells. The biological pacemakers naturally integrate 
into the heart. Their generation of rhythmic electric impulses involves 
coupling factors, such as cAMP-dependent PKA and Ca\2+\ -dependent CaMK 
II, which are regulatory proteins capable of modulating/enhancing 
interactions (i.e. coupling) of the sarcoplasmic reticulum-based, 
intracellular Ca\2+\ clock and the surface membrane voltage clock, 
thereby converting irregularly or rarely spontaneously active cells 
into pacemakers generating rhythmic excitations.

[[Page 81627]]

    Applications: This technology can be utilized in heart disease 
characterized by arrhythmia or situations requiring an implantable 
cardiac pacemaker.
    Advantages: In contrast to current implantable cardiac pacemaker 
technology, this technology is not externally powered, has a lower risk 
of infection, has decreased potential for interference from other 
devices, and has full autonomic rate modulation.
    Development Status: Early stage.
    Inventors: Victor A. Maltsev et al. (NIA)
    Publications:
    1. VA Maltsev and EG Lakatta. Synergism of coupled subsarcolemmal 
Ca\2+\ clocks and sarcolemmal voltage clocks confers robust and 
flexible pacemaker function in a novel pacemaker cell model. Am J 
Physiol Heart Circ Physiol. 2009 Mar;296(3):H594-H615. [PubMed: 
19136600]
    2. VA Maltsev and EG Lakatta. Dynamic interactions of an 
intracellular Ca\2+\ clock and membrane ion channel clock underlie 
robust initiation and regulation of cardiac pacemaker function. 
Cardiovasc Res. 2008 Jan 15;77(2):274-284. [PubMed: 18006441]
    Patent Status: PCT Application No. PCT/US2010/035823 filed 21 May 
2010 (HHS Reference No. E-134-2009/0-PCT-02).
    Licensing Status: Available for licensing.
    Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521; 
[email protected].
    Collaborative Research Opportunity: The National Institute on 
Aging, Cellular Biophysics Section, is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize this technology. Please 
contact Vio Conley at 301-496-0477 or [email protected] for more 
information.

Method of Detecting and Quantifying Contaminants in Heparin 
Preparations

    Description of Technology: Heparin is a naturally occurring acidic 
carbohydrate produced commercially from extracts of animal tissues 
(such as bovine lung or porcine intestine) and is used in the treatment 
of a wide range of diseases in addition to their classic anticoagulant 
activity. Heparin is also used to coat many medical devices, such as 
catheters, syringes, stents and filters. Recently, certain lots of 
heparin were associated with serious side effects and adverse events. 
Recalls were issued in multiple countries and it became evident that 
there was an extensive problem with heparin manufacture.
    Traditional tests may not be able to determine the presence of 
contaminant(s) without lyophilizing and concentrating each sample and 
may not be suitable for testing finished medical devices. Therefore, 
there is a demonstrated need to develop other assay methods for 
detecting contaminating oversulfated compounds of any source in heparin 
and heparin derived products.
    This technology relates to methods for detecting and/or quantifying 
oversulfated glycosaminoglycans based on inhibition of nucleic acid 
polymerases and resistance to enzymatic degradation. It also relates to 
the use of these methods to screen and quantify pharmaceutical 
preparations such as heparin preparations for oversulfated 
contaminants.
    Potential Applications: Robust, simple and effective method for 
detecting and optionally quantifying oversulfated contaminants in 
heparin preparations.
    Development Status: The method has been developed and qualified for 
sensitivity and identity, but full validation and commercialization 
have not been undertaken.
    Inventor: Daniela Verthelyi et al. (FDA)
    Publication: C Tami, M Puig, JC Reepmeyer, H Ye, DA D'Avignon, L 
Buhse, D Verthelyi. Inhibition of Taq polymerase as a method for 
screening heparin for oversulfated contaminants. Biomaterials 2008 
Dec;29(36):4808-4814. [PubMed: 18801571]
    Patent Status: PCT Application No. PCT/US2009/056263 filed 08 Sep 
2009, which published as WO 2010/030608 on 18 Mar 2010 (HHS Reference 
No. E-227-2008/0-PCT-02).
    Licensing Status: Available for licensing.
    Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521; 
[email protected].
    Collaborative Research Opportunity: The FDA, Division of 
Therapeutic Proteins, Laboratory of Immunology, is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize this high 
throughput screening test for oversulfated glycosamineglycan 
contaminants in heparin. Please contact Daniela Verthelyi at 
[email protected] or Alice Welch at [email protected] 
for more information.

Method for the Diagnosis and Prognosis of Age-Related Cardiovascular 
Disorders

    Description of Technology: NIH investigators have discovered a 
method for the diagnosis and prognosis of cardiovascular aging. Current 
methodologies include the measurement of patient lipid profiles or 
expression of up to two proteins. In contrast, this technology utilizes 
the expression levels of a panel of proteins not previously known to be 
related to cardiovascular aging and may prove to be a more accurate 
diagnostic or prognostic of cardiovascular aging than currently 
available tests or it may improve the accuracy of currently available 
tests when used in concert.
    The technology relates to methods for determining susceptibility to 
having an extremely common age-associated vascular disorder. It also 
describes the subsequent use of these proteins as markers for disease. 
While the underlying cellular and molecular mechanisms of age-related 
vascular disease remain largely undefined, the expression levels of the 
genes described in this technology have been empirically determined to 
differ between healthy and age-inflamed arterial tissue. Further, this 
technology includes a companion mass spectroscopic-based methodology 
for reproducible quantification of specific expression levels of 
interest.
    Application: Diagnosis of age-related vascular disorder.
    Development Status: Early stage.
    Inventors: Mingyi Wang et al. (NIA).
    Patent Status: PCT Application No. PCT/US2010/024816 filed 19 Feb 
2010, which published as WO 2010/096713 on 26 Aug 2010 (HHS Reference 
No. E-219-2008/0-PCT-02).
    Licensing Status: Available for licensing.
    Licensing Contact: Fatima Sayyid, MHPM; 301-435-4521; 
[email protected].
    Collaborative Research Opportunity: The National Institute on 
Aging, Cardiovascular Biology Unit--Vascular Group, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
idea of how to assess and retard accelerated arterial aging and its 
attendant risks for atherosclerosis and hypertension. Please contact 
Vio Conley at 301-496-0477 or [email protected] for more 
information.

[[Page 81628]]

Identification of Subjects Likely To Benefit From Copper Treatment

    Description of Technology: Menkes disease is an infantile onset X-
linked recessive neurodegenerative disorder caused by deficiency or 
dysfunction of a copper-transporting ATPase, ATP7A. The clinical and 
pathologic features of this condition reflect decreased activities of 
enzymes that require copper as a cofactor, including dopamine-[beta]-
hydrolase, cytochrome c oxidase and lysyl oxidase. Recent studies 
indicate that ATP7A normally responds to N-methyl-D-aspartate receptor 
activation in the brain, and an impaired response probably contributes 
to the neuropathology of Menkes disease. Affected infants appear 
healthy at birth and develop normally for 6 to 8 weeks. Subsequently, 
hypotonia, seizures and failure to thrive occur and death by 3 years of 
age is typical. Occipital horn syndrome (OHS) is also caused by 
mutations in the copper transporting ATPase ATP7A, although its 
symptoms are milder than Menkes syndrome, including occipital horns and 
lax skin and joints.
    Treatment with daily copper injections may improve the outcome in 
Menkes disease if commenced within days after birth; however, newborn 
screening for this disorder is not available and early detection is 
difficult because clinical abnormalities in affected newborns are 
absent or subtle. Moreover, the usual biochemical markers (low serum 
copper and ceruloplasmin) are unreliable predictors in the neonatal 
period, since levels in healthy newborns are low and overlap with those 
in infants with Menkes disease. Although molecular diagnosis is 
available, its use is complicated by the diversity of mutation types 
and the large size of ATP7A (about 140kb). Thus, there is a need for 
improved methods for early detection of infants with Menkes disease or 
OHS in order to improve outcomes.
    This technology relates to methods of identifying individuals who 
may benefit from treatment with copper, particularly those having 
Menkes disease or Occipital Horn Syndrome.
    Inventor: Stephen G. Kaler (NICHD).
    Publication: SG Kaler, CS Holmes, DS Goldstein, JR Tang, SC Godwin, 
A Donsante, CJ Liew, S Sato, N Patronas. Neonatal diagnosis and 
treatment of Menkes disease. N Engl J Med. 2008 Feb 7;358(6):605-614. 
[PubMed: 18256395]
    Patent Status: PCT Application No. PCT/US2008/078966 filed 06 Oct 
2008, which published as WO 2010/042102 on 15 Apr 2010 (HHS Reference 
No. E-186-2008/0-PCT-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521; 
[email protected].
    Collaborative Research Opportunity: The National Institute of Child 
Health and Human Development, Division of Intramural Research, 
Molecular Medicine Program, Unit on Pediatric Genetics, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
population-based newborn screening for Menkes disease and related 
disorders of copper transport in order to identify subjects likely to 
benefit from copper injections and other treatments. Please contact 
Alan Hubbs, PhD at 301-594-4263 or [email protected] for more 
information.

    Dated: December 21, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-32669 Filed 12-27-10; 8:45 am]
BILLING CODE 4140-01-P