Prospective Grant of Exclusive License: Treatment of Cardiovascular Conditions With Nitrite Therapy, 77418-77419 [E5-8139]

Download as PDF 77418 Federal Register / Vol. 70, No. 250 / Friday, December 30, 2005 / Notices Place: National Library of Medicine, Building 38, Board Room, 2nd Floor, 8600 Rockville Pike, Bethesda, MD 20894. Closed: February 24, 2006, 8:30 a.m. to 2 p.m. Agenda: To review and evaluate journals as potential titles to be indexed by the National Library of Medicine. Place: National Library of Medicine, Building 38, Board Room, 2nd Floor, 8600 Rockville Pike, Bethesda, MD 20894. Contact Person: Sheldon Kotzin, MLS, Chief, Bibliographic Services Division, Division of Library Operations, National Library of Medicine, 8600 Rockville Pike, Bldg 38A/Room 4N419, Bethesda, MD 20894, 301–496–6217, Sheldon_Kotzin@nlm.nih.gov. Any interested person may file written comments with the Committee by forwarding the statement to the Contact Person listed on this Notice. The statement should include the name, address, telephone number and, when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance into the building by nongovernment employees. Persons without a government I.D. will need to show a photo I.D. and sign in at the security desk upon entering the building. (Catalogue of Federal Domestic Assistance Program No. 93.879, Medical Library Assistance, National Institutes of Health, HHS) Dated: December 19, 2005. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy, NIH. [FR Doc. 05–24649 Filed 12–29–05; 8:45 am] Name of Committee: Center for Scientific Review Special Emphasis Panel; Cardiovascular Development. Date: January 3, 2006. Time: 2:30 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call). Contact Person: Larry Pinkus, PhD., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4132, MSC 7802, Bethesda, MD 20892. (301) 435– 1214. pinkus@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; High Performance Computing Infrastructure. Date: January 27, 2006. Time: 9 a.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Marc Rigas, PhD., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4194, MSC 7826, Bethesda, MD 20892. (301) 402– 1074. rigasm@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846– 93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: December 22, 2005. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–24658 Filed 12–29–05; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4140–01–M National Institutes of Health wwhite on PROD1PC61 with NOTICES Center for Scientific Review; Notice of Closed Meetings DEPARTMENT OF HEALTH AND HUMAN SERVICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. National Institutes of Health VerDate Aug<31>2005 18:16 Dec 29, 2005 Jkt 208001 Prospective Grant of Exclusive License: Treatment of Cardiovascular Conditions With Nitrite Therapy National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the invention embodied in PCT patent applications PCT/US2004/21985 and PCT/US2004/ PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 22232, filed July 9, 2004, both entitled ‘‘Use of Nitrite Salts for the Treatment of Cardiovascular Conditions’’ [HHS Reference Number: E–254–2003/2–3– PCT–01], to Hope Medical Enterprises, Inc., dba Hope PharmaceuticalsTM, an Arizona S-Corporation having a principle place of business in Scottsdale, Arizona. The field of use may be limited to the use of nitrite salts for the treatment of cerebral vasospasm following subarachnoid hemorrhage and/or cardiovascular conditions. The United States of America is an assignee of the patent rights in these inventions. DATES: Only written comments and/or application for a license, which are received by the NIH Office of Technology Transfer on or before February 28, 2006 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Susan Carson, D.Phil., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; E-mail: carsonsu@od.nih.gov; Telephone: (301) 435–5020; Facsimile: (301) 402–0220. SUPPLEMENTARY INFORMATION: A wide variety of disease indications, including cardiovascular and respiratory diseases, have been treated by different therapeutic classes of compounds that are able to increase blood flow and act as vasodilators. The core invention is the unexpected finding that low, physiological and non-toxic concentrations of sodium nitrite are able to increase blood flow and produce vasodilation by infused and nebulized routes of administration. Proof of concept data has been obtained in animal models for (1) myocardial and hepatic ischemia and reperfusion injury [J. Clin. Invest. (2005) 115, 1232–1240], (2) neonatal pulmonary hypertension in a neonate lamb model [Nature Medicine (2004) 10, 1122–1127] and (3) control of delayed cerebral vasospasm following subarachnoid hemorrhage in a primate model [JAMA (2005) 293, 1477–1484]. The implications of these results point to the use of nitrite as a potential costeffective platform therapy for a wide variety of disease indications characterized broadly by constricted blood flow or hypoxia. Method of use claims for nitrite salt formulations are directed to conditions associated with high blood pressure, decreased blood flow or hemolytic disease and for the treatment of specific conditions such as pulmonary hypertension, cerebral artery vasospasm and hepatic, cardiac or brain ischemia-reperfusion injury. E:\FR\FM\30DEN1.SGM 30DEN1 Federal Register / Vol. 70, No. 250 / Friday, December 30, 2005 / Notices The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 60 days from the date of this published Notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: December 22, 2005. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E5–8139 Filed 12–29–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Software for Predicting Molecular Properties and Pathogen Detection National Institutes of Health, Public Health Service, HHS. ACTION: Notice. wwhite on PROD1PC61 with NOTICES AGENCY: SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in E–169–2000/0 ‘‘Drift Compensation Method for Fingerprint Spectra,’’ U.S. Patent Application No. 09/975,530 filed October 10, 2001; E–297–2001/0 ‘‘Methods For Predicting Properties of Molecules,’’ U.S. Patent Application No. 10/383,602 filed March 7, 2003; and E– 017–2003/0 ‘‘Improved Pattern Recognition Of Whole Cell Mass Spectra Via Separation Of Specific Charge States,’’ U.S. Patent Application No. 10/ 863,745 filed June 7, 2004; to Litmus, LLC an Arkansas corporation having its headquarters in Little Rock, Arkansas. The United States of America is the assignee of the patent rights of the above inventions. VerDate Aug<31>2005 18:16 Dec 29, 2005 Jkt 208001 The contemplated exclusive license may be granted in the field of providing software solutions for pathogen detection and for predicting molecular properties. DATES: Only written comments and/or applications for a license received by the NIH Office of Technology Transfer on or before February 28, 2006 will be considered. ADDRESSES: Requests for a copy of the patent applications, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael A. Shmilovich, Esq., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–5019; Facsimile: (301) 402– 0220; E-mail: shmilovm@mail.nih.gov. A signed confidentiality nondisclosure agreement may be required to receive copies of the patent applications. SUPPLEMENTARY INFORMATION: The patent applications intended for licensure disclose and/or cover the following: E–297–2001 ‘‘Methods For Predicting Properties of Molecules’’ Quantitative Spectral data-activity relationships (QSDAR) The invention relates to methods for predicting the biological, chemical, and physical properties of molecules from their chemical shift through bond and through spatial distance connectivity patterns. This invention is related to E– 209–1999 (related to the SDAR patent that could use chemical shift through bond correlated data); however, here predicted NMR chemical shift data is used that has already been structurally assigned. The invention uses the carbon or other heteronuclear molecular skeleton atom to atom connectivity of the molecule instead of proton to proton or proton to carbon connectivity that can be obtained from NMR experimental spectra of unlabeled molecules. This allows a model to be built using a complete molecular connectivity pattern instead of a pattern developed from a set of individual 2 or 3 atom pieces of a molecule. A 2D through bond connectivity spectrum is produced with a cross peak bin ‘‘hit’’ occurring when there is an atom to atom bond connection. Only half of the spectrum is used because the spectrum is symmetrical. A 2D through space connectivity spectrum is simulated is produced with a cross peak bin ‘‘hit’’ occurring when there is a atom to atom distance r is within a certain specified range. The through bond and through space spectra can be reduced to principal PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 77419 components. The biological, chemical, and physical endpoints are added to the connectivity patterns and multiple linear regression (OVILS) or artificial neural networks (ANN) methods are applied to produce and validate the model. This provides a very rapid, reliable ability to model many different compounds. The model uses the structurally assigned chemical shifts from predicted NMR spectra. The through bond and through space connectivity patterns uses the structural assignment of the chemical shifts. The through bond connectivity pattern gives a local description of the atoms and the through space connectivity pattern gives a non-local description of the atoms. The combination of the through bond and through space molecular connectivity pattern provides a very precise pattern that can be used by pattern recognition software to produce a model. All parts of this model can be completely computerized. The ideas used in this model may be able to produce the highest cross-validated models of ‘‘endpoints’’ that are important to the public health service. E–169–2000 ‘‘Microbial Identification Databases’’ The invention is a method for, based on an assembled coherent database, containing an essentially unlimited number of pyrolysis mass spectra to enable rapid chemotaxonomy of unknown microbial samples. The invention corrects for short- and longterm drift of microbial pyrolysis mass spectra by using spectra of similar microbes as internal standards. The invention provides a way to assemble a coherent database containing an essentially unlimited number of pyrolysis mass spectra or other instrumental ‘‘fingerprints,’’ where one or more is representative of each relevant strain, and representative of additional strains as they are added to the pool of microbial agents. Microorganisms can be identified using the invention from their fingerprint spectra regardless of the growth medium used to culture the bacteria. This is a result of the discovery that corrections made to the fingerprint spectrum of one type of bacterium to compensate for changes in growth medium may be applied successfully to metabolically similar bacteria. Fingerprint spectra to which the method of the invention may be applied include pyrolysis MALDI or other types of mass spectra, infrared spectra, chromatograms, NMR spectra and ion-mobility spectra. The present invention is especially useful for the rapid identification of microorganisms, including human pathogens. E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 70, Number 250 (Friday, December 30, 2005)]
[Notices]
[Pages 77418-77419]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-8139]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Treatment of 
Cardiovascular Conditions With Nitrite Therapy

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 
404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services (HHS), is contemplating the 
grant of an exclusive license to practice the invention embodied in PCT 
patent applications PCT/US2004/21985 and PCT/US2004/22232, filed July 
9, 2004, both entitled ``Use of Nitrite Salts for the Treatment of 
Cardiovascular Conditions'' [HHS Reference Number: E-254-2003/2-3-PCT-
01], to Hope Medical Enterprises, Inc., dba Hope 
PharmaceuticalsTM, an Arizona S-Corporation having a 
principle place of business in Scottsdale, Arizona. The field of use 
may be limited to the use of nitrite salts for the treatment of 
cerebral vasospasm following subarachnoid hemorrhage and/or 
cardiovascular conditions. The United States of America is an assignee 
of the patent rights in these inventions.

DATES: Only written comments and/or application for a license, which 
are received by the NIH Office of Technology Transfer on or before 
February 28, 2006 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Susan Carson, D.Phil., Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; E-mail: carsonsu@od.nih.gov; 
Telephone: (301) 435-5020; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: A wide variety of disease indications, 
including cardiovascular and respiratory diseases, have been treated by 
different therapeutic classes of compounds that are able to increase 
blood flow and act as vasodilators. The core invention is the 
unexpected finding that low, physiological and non-toxic concentrations 
of sodium nitrite are able to increase blood flow and produce 
vasodilation by infused and nebulized routes of administration. Proof 
of concept data has been obtained in animal models for (1) myocardial 
and hepatic ischemia and reperfusion injury [J. Clin. Invest. (2005) 
115, 1232-1240], (2) neonatal pulmonary hypertension in a neonate lamb 
model [Nature Medicine (2004) 10, 1122-1127] and (3) control of delayed 
cerebral vasospasm following subarachnoid hemorrhage in a primate model 
[JAMA (2005) 293, 1477-1484]. The implications of these results point 
to the use of nitrite as a potential cost-effective platform therapy 
for a wide variety of disease indications characterized broadly by 
constricted blood flow or hypoxia. Method of use claims for nitrite 
salt formulations are directed to conditions associated with high blood 
pressure, decreased blood flow or hemolytic disease and for the 
treatment of specific conditions such as pulmonary hypertension, 
cerebral artery vasospasm and hepatic, cardiac or brain ischemia-
reperfusion injury.

[[Page 77419]]

    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless, within 60 days 
from the date of this published Notice, NIH receives written evidence 
and argument that establishes that the grant of the license would not 
be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response to 
this notice will not be made available for public inspection, and, to 
the extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: December 22, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E5-8139 Filed 12-29-05; 8:45 am]
BILLING CODE 4140-01-P