[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