Government-Owned Inventions; Availability for Licensing, 76349-76350 [E6-21666]

Download as PDF Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Notices some refinements in protein resolution are still possible which may involve procedural, reagent or equipment modifications. Inventors: B. Alex Merrick (NIEHS), Rachel Patterson (NIEHS), Robert Hall (NIEHS), Chaoying He (NIEHS), James Selkirk (NIEHS). Publication: BA Merrick, RM Patterson, LL Witcher, C He, JK Selkirk. Separation and sequencing of familiar and novel murine proteins using preparative two-dimensional gel electrophoresis. Electrophoresis. 1994 May;15(5):735–745. Patent Status: U.S. Patent No. 5,534,121 issued 09 July 1996, claiming priority to 16 May 1994 (HHS Reference No. E–066–1994/0–US–01). Licensing Status: Available for nonexclusive or exclusive licensing. Licensing Contact: Michael A. Shmilovich; 301/435–5019; shmilovm@mail.nih.gov. Collaborative Research Opportunity: The NIEHS National Center for Toxicogenomics, Proteomics Group, may consider statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this preparative two-dimensional gel electrophoresis system. Please contact John Penta, NIEHS Office of Translational Research, at 919/541–3696 or penta@niehs.nih.gov for additional information. Dated: December 8, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6–21665 Filed 12–19–06; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. sroberts on PROD1PC70 with NOTICES AGENCY: 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. VerDate Aug<31>2005 20:03 Dec 19, 2006 Jkt 211001 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. ADDRESSES: A Method of Immunizing Humans Against Salmonella Typhi Using a VirEPA Conjugate Vaccine Description of Technology: This invention is a method of immunization against typhoid fever using a conjugate vaccine comprising the capsular polysaccharide of Salmonella typhi, Vi, conjugated through an adipic dihydrazide linker to nontoxic recombinant exoprotein A (rEPA) from Pseudomonas aeruginosa. The three licensed vaccines against typhoid fever, attenuated S. typhi Ty21a, killed whole cell vaccines and Vi polysaccharide, have limited efficacy, in particular for children under 5 years of age, which make an improved vaccine desirable. It is generally recognized that an effective vaccine against Salmonella typhi is one that increases serum antiVi IgG eight-fold six weeks after immunization. The conjugate vaccine of the invention increases anti-Vi IgG, 48fold, 252-fold and 400-fold in adults, in 5–14 years old and 2–4 years old children, respectively. Thus this is a highly effective vaccine suitable for children and should find utility in endemic regions and as a traveler’s vaccine. The route of administration can also be combined with routine immunization. In 2–5 years old, the protection against typhoid fever is 90% for 4 years. In school age children and in adults the protection could mount to completer protection according to the immunogenicity data. Application: Immunization against Salmonella typhi for long term prevention of typhoid fever in all ages. Developmental Status: Conjugates have been synthesized and clinical studies have been performed. The synthesis of the conjugates is described by Kossaczka et al. in Infect Immun. 1997 June;65(7):2088–2093. Phase III clinical studies are described by Mai et al. in N Engl J Med. 2003 October 2; 349(14):1390–1391. Dosage studies are described by Canh et al. in Infect Immun. 2004 Nov;72(11):6586–6588. A safety and immunogenicity study in infants are underway. The aim is to administer the conjugate vaccine with routine infant immunization. PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 76349 Preliminary results shows the vaccine is safe in 2 months old infants. Inventors: Zuzana Kossaczka, Shousun C. Szu, and John B. Robbins (NICHD). Patent Status: U.S. Patent 6,797,275 issued 28 Sep 2004 (HHS Reference No. E–020–1999/0–US–02); U.S. Patent Application No. 10/866,343 filed 10 Jun 2004 (HHS Reference No. E–020–1999/ 0–US–03). Licensing Status: Available for nonexclusive licensing. Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The National Institute of Child Health and Human Development, Laboratory of Developmental and Molecular Immunity, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize A Method of Immunizing Humans Against Salmonella Typhi Using a Vi-rEPA Conjugate Vaccine. Please contact Betty Tong, PhD at 301– 594–4263 for more information. Vaccine Against Escherichia Coli O157 Infection, Composed of Detoxified LPS Conjugated to Proteins Description of Technology: This invention is a conjugate vaccine to prevent infection by E. coli O157:H7, particularly in young children under 5 years of age. E. coli O157:H7 is an emerging human pathogen which causes a spectrum of illnesses with high morbidity and mortality, ranging from diarrhea to hemorrhagic colitis and hemolytic-uremic syndrome (HUS). Infection with E. coli O157:H7 occurs as a result of consumption of water, vegetables, fruits or meat contaminated by feces from infected animals, such as cattle. The most recent large outbreak in the U.S. was from contaminated bag spinach. The conjugate is composed of the O-specific polysaccharide isolated from E. coli O157, or other Shiga-toxin producing bacteria, conjugated to carrier proteins, such as non-toxic P. aeruginosa exotoxin A or Shiga toxin 1. A Phase I clinical trial, involving adult humans, showed the vaccine is safe and highly immunogenic. Adults, after one injection containing 25 µg of antigen, responded with high titers of bactericidal antibodies. Similarly in a phase II study, fifty 2 to 5 years-old children in U.S. were injected with the conjugate vaccines. There were only mild local adverse reactions. More than 90% children responded with greater than 10 fold rise of E. coli O157 antibodies of bactericidal ability. Thus the conjugates of the invention are E:\FR\FM\20DEN1.SGM 20DEN1 76350 Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Notices promising vaccines, especially for children and the elderly, who are most likely to suffer serious consequences from infection. Application: Prevention of E. coli O157 infection. Development Status: Clinical studies have been performed and are described in Konadu et al., J Infect Dis. 1998 Feb;177(2):383–387 and Ahmed et al., J Infect Dis. 2006 Feb;193(2):515–526. Inventors: Shousun C. Szu, Edward Konadu, and John B. Robbins (NICHD). Patent Status: U.S. Patent 6,858,211 issued 22 Feb 2005 (HHS Reference No. E–158–1998/0–US–06); U.S. Patent Application No. 10/987,428 filed 12 Nov 2004 (HHS Reference No. E–158– 1998/0–US–07). Licensing Status: Available for nonexclusive or exclusive licensing. Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The National Institute of Child Health and Human Development, Laboratory of Developmental and Molecular Immunity, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Vaccine for E. coli O157 for Children and Adults. Please contact Betty Tong, PhD at 301–594–4263, tongb@mail.nih.gov for more information. Dated: December 8, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6–21666 Filed 12–19–06; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health sroberts on PROD1PC70 with NOTICES National Center for Complementary & Alternative Medicine; Notice of Meeting 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 National Advisory Council for Complementary and Alternative Medicine (NACCAM) meeting. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. VerDate Aug<31>2005 20:03 Dec 19, 2006 Jkt 211001 A portion of the meeting 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/or contract proposals and the discussion could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Council for Complementary and Alternative Medicine. Date: February 2, 2007. Closed: 9 a.m. to 12 p.m. Agenda: To review and evaluate grant applications and/or proposals. Open: 1 p.m. to 4:30 p.m. Agenda: Opening remarks by the Acting Director of National Center for Complementary and Alternative Medicine, presentations of new research initiatives, and other council related business. Place: National Institutes of Health, Neuroscience Building, 6001 Executive Boulevard, Rooms C & D, Rockville, MD 20852. Contact Person: Martin H. Goldrosen, Executive Secretary, National Center for Complementary and Alternative Medicine, National Institutes of Health, 6707 Democracy Blvd., Suite 401, Bethesda, MD 20892. (301) 594–2014. The public comments session is scheduled from 4–4:30 p.m., but could change depending on the actual time spent on each agenda item. Each speaker will be permitted 5 minutes for their presentation. Interested individuals and representatives of organizations are requested to notify Dr. Martin H. Goldrosen, National Center for Complementary and Alternative Medicine, NIH, 6707 Democracy Boulevard, Suite 401, Bethesda, Maryland 20892, 301–594–2014, Fax: 301–480–9970. Letters of intent to present comments, along with a brief description of the organization represented, should be received no later than 5 p.m. on January 31, 2007. Only one representative of an organization may present oral comments. Any person attending the meeting who does not request an opportunity to speak in advance of the meeting may be considered for oral presentation, if time permits, and at the discretion of the Chairperson. In addition, written comments may be submitted to Dr. Martin H. Goldrosen at the address listed above up to ten calendar days (February 12, 2007) following the meeting. Copies of the meeting agenda and roster of members will be furnished upon request by contacting Dr. Martin H. Goldrosen, Executive Secretary, NACCAM, National Center for Complementary and Alternative Medicine, National Institutes of Health, 6707 Democracy Boulevard, Suite 401, Bethesda, Maryland 20892, 301–594–2014, Fax 301– 480–9970, or via e-mail at naccames@mail.nih.gov. PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 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 signin at the security desk upon entering the building. Dated: December 13, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–9773 Filed 12–19–06; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of meetings of the National Advisory Allergy and Infectious Diseases Council. The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. 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. Name of Committee: National Advisory Allergy and Infectious Diseases Council. Date: January 29, 2007. Open: 10:30 a.m. to 11:40 a.m. Agenda: Report from the Institute Director and the Director of Center for Scientific Research. Place: National Institutes of Health, Natcher Building, 45 Center Drive, Conference Rooms E1/E2, Bethesda, MD 20892. Closed: 11:40 a.m. to 12 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: National Institutes of Health, Natcher Building, 45 Center Drive, Conference Rooms E1/E2, Bethesda, MD 20892. Contact Person: Paula S. Strickland, Extramural Science Administrator for Special E:\FR\FM\20DEN1.SGM 20DEN1

Agencies

[Federal Register Volume 71, Number 244 (Wednesday, December 20, 2006)]
[Notices]
[Pages 76349-76350]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21666]


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

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.

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

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.

A Method of Immunizing Humans Against Salmonella Typhi Using a Vi-rEPA 
Conjugate Vaccine

    Description of Technology: This invention is a method of 
immunization against typhoid fever using a conjugate vaccine comprising 
the capsular polysaccharide of Salmonella typhi, Vi, conjugated through 
an adipic dihydrazide linker to nontoxic recombinant exoprotein A 
(rEPA) from Pseudomonas aeruginosa. The three licensed vaccines against 
typhoid fever, attenuated S. typhi Ty21a, killed whole cell vaccines 
and Vi polysaccharide, have limited efficacy, in particular for 
children under 5 years of age, which make an improved vaccine 
desirable.
    It is generally recognized that an effective vaccine against 
Salmonella typhi is one that increases serum anti-Vi IgG eight-fold six 
weeks after immunization. The conjugate vaccine of the invention 
increases anti-Vi IgG, 48-fold, 252-fold and 400-fold in adults, in 5-
14 years old and 2-4 years old children, respectively. Thus this is a 
highly effective vaccine suitable for children and should find utility 
in endemic regions and as a traveler's vaccine. The route of 
administration can also be combined with routine immunization. In 2-5 
years old, the protection against typhoid fever is 90% for 4 years. In 
school age children and in adults the protection could mount to 
completer protection according to the immunogenicity data.
    Application: Immunization against Salmonella typhi for long term 
prevention of typhoid fever in all ages.
    Developmental Status: Conjugates have been synthesized and clinical 
studies have been performed. The synthesis of the conjugates is 
described by Kossaczka et al. in Infect Immun. 1997 June;65(7):2088-
2093. Phase III clinical studies are described by Mai et al. in N Engl 
J Med. 2003 October 2; 349(14):1390-1391. Dosage studies are described 
by Canh et al. in Infect Immun. 2004 Nov;72(11):6586-6588.
    A safety and immunogenicity study in infants are underway. The aim 
is to administer the conjugate vaccine with routine infant 
immunization. Preliminary results shows the vaccine is safe in 2 months 
old infants.
    Inventors: Zuzana Kossaczka, Shousun C. Szu, and John B. Robbins 
(NICHD).
    Patent Status: U.S. Patent 6,797,275 issued 28 Sep 2004 (HHS 
Reference No. E-020-1999/0-US-02); U.S. Patent Application No. 10/
866,343 filed 10 Jun 2004 (HHS Reference No. E-020-1999/0-US-03).
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
soukasp@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of Child 
Health and Human Development, Laboratory of Developmental and Molecular 
Immunity, is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize A Method of Immunizing Humans Against Salmonella Typhi 
Using a Vi-rEPA Conjugate Vaccine. Please contact Betty Tong, PhD at 
301-594-4263 for more information.

Vaccine Against Escherichia Coli O157 Infection, Composed of Detoxified 
LPS Conjugated to Proteins

    Description of Technology: This invention is a conjugate vaccine to 
prevent infection by E. coli O157:H7, particularly in young children 
under 5 years of age. E. coli O157:H7 is an emerging human pathogen 
which causes a spectrum of illnesses with high morbidity and mortality, 
ranging from diarrhea to hemorrhagic colitis and hemolytic-uremic 
syndrome (HUS). Infection with E. coli O157:H7 occurs as a result of 
consumption of water, vegetables, fruits or meat contaminated by feces 
from infected animals, such as cattle. The most recent large outbreak 
in the U.S. was from contaminated bag spinach. The conjugate is 
composed of the O-specific polysaccharide isolated from E. coli O157, 
or other Shiga-toxin producing bacteria, conjugated to carrier 
proteins, such as non-toxic P. aeruginosa exotoxin A or Shiga toxin 1. 
A Phase I clinical trial, involving adult humans, showed the vaccine is 
safe and highly immunogenic. Adults, after one injection containing 25 
[mu]g of antigen, responded with high titers of bactericidal 
antibodies. Similarly in a phase II study, fifty 2 to 5 years-old 
children in U.S. were injected with the conjugate vaccines. There were 
only mild local adverse reactions. More than 90% children responded 
with greater than 10 fold rise of E. coli O157 antibodies of 
bactericidal ability. Thus the conjugates of the invention are

[[Page 76350]]

promising vaccines, especially for children and the elderly, who are 
most likely to suffer serious consequences from infection.
    Application: Prevention of E. coli O157 infection.
    Development Status: Clinical studies have been performed and are 
described in Konadu et al., J Infect Dis. 1998 Feb;177(2):383-387 and 
Ahmed et al., J Infect Dis. 2006 Feb;193(2):515-526.
    Inventors: Shousun C. Szu, Edward Konadu, and John B. Robbins 
(NICHD).
    Patent Status: U.S. Patent 6,858,211 issued 22 Feb 2005 (HHS 
Reference No. E-158-1998/0-US-06); U.S. Patent Application No. 10/
987,428 filed 12 Nov 2004 (HHS Reference No. E-158-1998/0-US-07).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
soukasp@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of Child 
Health and Human Development, Laboratory of Developmental and Molecular 
Immunity, is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize Vaccine for E. coli O157 for Children and Adults. Please 
contact Betty Tong, PhD at 301-594-4263, tongb@mail.nih.gov for more 
information.

    Dated: December 8, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E6-21666 Filed 12-19-06; 8:45 am]
BILLING CODE 4140-01-P

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