83_FR_24423 83 FR 24321 - Government-Owned Inventions; Availability for Licensing

83 FR 24321 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 102 (May 25, 2018)

Page Range24321-24322
FR Document2018-11256

The invention listed below is owned by an agency of the U.S. Government and is available for licensing.

Federal Register, Volume 83 Issue 102 (Friday, May 25, 2018) 
[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)]
[Notices]
[Pages 24321-24322]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-11256]


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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, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing.

FOR FURTHER INFORMATION CONTACT: Dr. Amy Petrik, 240-627-3721; 
[email protected]. Licensing information and copies of the U.S. patent 
application listed below may be obtained by communicating with the 
indicated licensing contact at the Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Rockville, MD, 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Antibodies and Methods for the Diagnosis and Treatment of Epstein-Barr 
Virus Infection

Description of Technology

    According to the World Health Organization, over 90% of the 
worldwide population is infected with Epstein-Barr virus by adulthood. 
In most cases, the disease accompanying initial infection is 
subclinical though some individuals who are infected as adolescents or 
adults do experience infectious mononucleosis. However, once infected, 
individuals carry latent EBV for their remaining lifespan. In such 
individuals, immune suppression can result in reactivation of the EBV 
and consequently, EBV-associated lymphoproliferative disease. 
Currently, there is no prophylactic to prevent primary EBV infection 
and additional therapeutics would be useful to treat EBV-associated B-
cell driven lymphoproliferative disease.
    Scientists at the NIAID are developing neutralizing antibodies, 
originally isolated from humans or non-human primates, that could be 
useful in preventing primary infection or reactivation of EBV in 
immunocompromised individuals. These antibodies are 10-100 times more 
potent than the most potent EBV neutralizing antibody identified to 
date (72A1). The antibodies target epitopes on either the gp350 surface 
glycoprotein of EBV or the gH/gL heterodimer. In vitro experiments have 
demonstrated that the antibodies effectively inhibit EBV infection of B 
cells and epithelial cells as well as cell-to-cell fusion of cells 
expressing the viral proteins gH/gL.

Potential Commercial Applications

     Treatment of individuals with compromised immune systems 
to prevent EBV-associated lymphoproliferative diseases.
     Prevention of primary EBV infection in individuals with 
compromised immune systems to prevent EBV-associated 
lymphoproliferative diseases.

Competitive Advantages

     No EBV therapeutics or prophylactics currently exist.

Development Stage

     In vitro
    Inventors: Masaru Kanekiyo (NIAID), W. Gordon Joyce (WRAIR), Wei Bu 
(NIAID), Jeffrey Cohen (NIAID).
    Publications: N/A.
    Intellectual Property: HHS Reference Number E-001-2017 includes 
U.S. Provisional Patent Application No. 62/490,023 filed April 25, 2017 
(Pending); PCT Application No. PCT/US2018/29463 filed April 25, 2018.
    HHS Reference Number E-079-2018 includes U.S. Provisional Patent 
Application No. 62/665,977 filed May 2, 2018.
    Related Intellectual Property: HHS Reference Number E-001-2017; E-
079-2018.
    Licensing Contact: Dr. Amy Petrik, 240-627-3721; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to

[[Page 24322]]

further develop, evaluate or commercialize Epstein-Barr monoclonal 
antibody technologies. For collaboration opportunities, please contact 
Dr. Amy Petrik, 240-627-3721; [email protected].

    Dated: May 10, 2018.
Suzanne M. Frisbie
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-11256 Filed 5-24-18; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices 24321 DEPARTMENT OF HEALTH AND Contact Person: Amir E. Zeituni, Ph.D., can result in reactivation of the EBV and HUMAN SERVICES Scientific Review Officer Scientific Review consequently, EBV-associated Program Division of Extramural Activities lymphoproliferative disease. Currently, National Institutes of Health NIAID/NIH/DHHS, 5601 Fishers Lane, MSC– there is no prophylactic to prevent 9834, Rockville, MD 20852, 301–496–2550, amir.zeituni@nih.gov. primary EBV infection and additional National Institute of Allergy and therapeutics would be useful to treat Infectious Diseases; Notice of Closed (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, EBV-associated B-cell driven Meetings lymphoproliferative disease. and Transplantation Research; 93.856, Pursuant to section 10(d) of the Microbiology and Infectious Diseases Scientists at the NIAID are developing Federal Advisory Committee Act, as Research, National Institutes of Health, HHS) neutralizing antibodies, originally amended, notice is hereby given of the isolated from humans or non-human Dated: May 21, 2018. following meetings. primates, that could be useful in Natasha M. Copeland, The meetings will be closed to the preventing primary infection or Program Analyst, Office of Federal Advisory reactivation of EBV in public in accordance with the Committee Policy. provisions set forth in sections immunocompromised individuals. [FR Doc. 2018–11215 Filed 5–24–18; 8:45 am] These antibodies are 10–100 times more 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., BILLING CODE 4140–01–P potent than the most potent EBV as amended. The grant applications and the discussions could disclose neutralizing antibody identified to date confidential trade secrets or commercial (72A1). The antibodies target epitopes DEPARTMENT OF HEALTH AND on either the gp350 surface glycoprotein property such as patentable material, HUMAN SERVICES and personal information concerning of EBV or the gH/gL heterodimer. In individuals associated with the grant National Institutes of Health vitro experiments have demonstrated applications, the disclosure of which that the antibodies effectively inhibit would constitute a clearly unwarranted Government-Owned Inventions; EBV infection of B cells and epithelial invasion of personal privacy. Availability for Licensing cells as well as cell-to-cell fusion of Name of Committee: National Institute of cells expressing the viral proteins gH/ AGENCY: National Institutes of Health, gL. Allergy and Infectious Diseases Special HHS. Emphasis Panel; Next Generation Potential Commercial Applications Multipurpose Prevention Technologies ACTION: Notice. (NGM) (R61/R33 Clinical Trial Optional). • Treatment of individuals with SUMMARY: The invention listed below is Date: June 12, 2018. compromised immune systems to Time: 10:00 a.m. to 6:00 p.m. owned by an agency of the U.S. prevent EBV-associated Agenda: To review and evaluate grant Government and is available for lymphoproliferative diseases. applications. licensing. • Prevention of primary EBV Place: National Institutes of Health, 5601 FOR FURTHER INFORMATION CONTACT: Dr. infection in individuals with Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Amy Petrik, 240–627–3721; compromised immune systems to Contact Person: Audrey O. Lau, Ph.D., amy.petrik@nih.gov. Licensing prevent EBV-associated MPH, Scientific Review Officer AIDS information and copies of the U.S. lymphoproliferative diseases. REVIEW BRANCH SRP, RM 3E70, National patent application listed below may be Institutes of Health, NIAID, 5601 Fishers Competitive Advantages obtained by communicating with the Lane, MSC 9834, Rockville, MD 20852–9834, indicated licensing contact at the • No EBV therapeutics or 240–669–2081, audrey.lau@nih.gov. Technology Transfer and Intellectual prophylactics currently exist. Name of Committee: National Institute of Property Office, National Institute of Allergy and Infectious Diseases Special Development Stage Allergy and Infectious Diseases, 5601 Emphasis Panel; Partnerships for Fishers Lane, Rockville, MD, 20852; tel. • In vitro Countermeasures against Select Pathogens Inventors: Masaru Kanekiyo (NIAID), (R01). 301–496–2644. A signed Confidential Date: June 28–29, 2018. Disclosure Agreement will be required W. Gordon Joyce (WRAIR), Wei Bu Time: 9:00 a.m. to 5:00 p.m. to receive copies of unpublished patent (NIAID), Jeffrey Cohen (NIAID). Agenda: To review and evaluate grant applications. Publications: N/A. applications. Intellectual Property: HHS Reference SUPPLEMENTARY INFORMATION: Place: National Institutes of Health 5601 Number E–001–2017 includes U.S. Technology description follows. Fishers Lane, Rockville, MD 20892 Provisional Patent Application No. 62/ (Telephone Conference Call). Antibodies and Methods for the 490,023 filed April 25, 2017 (Pending); Contact Person: Amir E. Zeituni, Ph.D., Diagnosis and Treatment of Epstein- PCT Application No. PCT/US2018/ Scientific Review Officer, Scientific Review 29463 filed April 25, 2018. Barr Virus Infection Program, Division of Extramural Activities NIAID/NIH/DHHS, 5601 Fishers Lane, MSC– HHS Reference Number E–079–2018 Description of Technology includes U.S. Provisional Patent 9834, Rockville, MD 20852, 301–496–2550, amir.zeituni@nih.gov. According to the World Health Application No. 62/665,977 filed May 2, Name of Committee: National Institute of Organization, over 90% of the 2018. Allergy and Infectious Diseases Special worldwide population is infected with Related Intellectual Property: HHS Emphasis Panel; Partnerships for Epstein-Barr virus by adulthood. In Reference Number E–001–2017; E–079– Countermeasures against Select Pathogens most cases, the disease accompanying 2018. amozie on DSK3GDR082PROD with NOTICES1 (R01). initial infection is subclinical though Licensing Contact: Dr. Amy Petrik, Date: July 10–11, 2018. some individuals who are infected as 240–627–3721; amy.petrik@nih.gov. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant adolescents or adults do experience Collaborative Research Opportunity: applications. infectious mononucleosis. However, The National Institute of Allergy and Place: National Institutes of Health 5601 once infected, individuals carry latent Infectious Diseases is seeking statements Fishers Lane, Rockville, MD 20892 EBV for their remaining lifespan. In of capability or interest from parties (Telephone Conference Call). such individuals, immune suppression interested in collaborative research to VerDate Sep<11>2014 18:28 May 24, 2018 Jkt 241001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\25MYN1.SGM 25MYN1

24322 Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices further develop, evaluate or monoclonal antibodies (nMAbs) against Infectious Diseases is seeking statements commercialize Epstein-Barr monoclonal the MERS-CoV. This invention of capability or interest from parties antibody technologies. For collaboration describes antibodies that target the interested in collaborative research to opportunities, please contact Dr. Amy Spike (S) glycoprotein on the further develop, evaluate or Petrik, 240–627–3721; amy.petrik@ coronavirus surface, which mediates commercialize MERS-CoV monoclonal nih.gov. viral entry into host cells. These novel antibodies. For collaboration Dated: May 10, 2018. antibodies target different regions of the opportunities, please contact Amy S protein, and when administered in Petrik, Ph.D., 240–627–3721; Suzanne M. Frisbie combination, reduce the possibility of amy.petrik@nih.gov. Deputy Director, Technology Transfer and Intellectual Property Office, National Institute viral escape. In preclinical testing, these Dated: May 14, 2018. of Allergy and Infectious Diseases. nMAbs have demonstrated potent Suzanne M. Frisbie, [FR Doc. 2018–11256 Filed 5–24–18; 8:45 am] protective effects, preventing death, Deputy Director, Technology Transfer and viral replication in the lower airways Intellectual Property Office, National Institute BILLING CODE 4140–01–P and severe disease in challenge studies of Allergy and Infectious Diseases. with mice. In addition, these nMAbs [FR Doc. 2018–11255 Filed 5–24–18; 8:45 am] DEPARTMENT OF HEALTH AND have potential application for use in BILLING CODE 4140–01–P HUMAN SERVICES assays for detecting MERS-CoV S protein in infected patients or animals. National Institutes of Health This technology is available for DEPARTMENT OF HEALTH AND licensing for commercial development HUMAN SERVICES Government-Owned Inventions; in accordance with 35 U.S.C. 209 and 37 Availability for Licensing CFR part 404, as well as for further National Institutes of Health development and evaluation under a AGENCY: National Institutes of Health, research collaboration. National Eye Institute; Amended Notice HHS. of Meeting ACTION: Notice. Potential Commercial Applications Notice is hereby given of a change in Monoclonal antibodies developed the meeting of the National Advisory SUMMARY: The invention listed below is against multiple regions of the owned by an agency of the U.S. Eye Council, June 14, 2018, 08:30 a.m. coronavirus spike protein have potential to June 14, 2018, 05:00 p.m., NIH, Government and is available for application in the prevention and licensing to achieve expeditious National Eye Institute, 5635 Fishers treatment of MERS-CoV. There is also Lane, Terrace Level Conference Rooms, commercialization of results of potential application for their use as a federally-funded research and Rockville, MD 20852 which was diagnostic tool of infection. published in the Federal Register on development. Foreign patent applications are filed on selected Competitive Advantages May 04, 2018, 83 FR 19791. This meeting is being amended to inventions to extend market coverage • In vitro models, the combinations of change the Open and Close times. The for companies and may also be available antibodies have been demonstrated to for licensing. Closed portion is now from 8:30 a.m. to be effective in reducing viral escape. 10:30 a.m. The Open portion is now FOR FURTHER INFORMATION CONTACT: • In vivo data in animal models from 10:45 a.m. to 3:00 p.m. The Amy Petrik, Ph.D., 240–627–3721; demonstrated a potent ability to control meeting is partially Closed to the public. amy.petrik@nih.gov. Licensing infection. information and copies of the U.S. • Applicable in diagnostic assays. Dated: May 21, 2018. patent applications listed below may be Natasha M. Copeland, Development Stage Program Analyst, Office of Federal Advisory obtained by communicating with the indicated licensing contact at the • In vivo data available (animal) Committee Policy. Technology Transfer and Intellectual Inventors: Barney Graham (NIAID), [FR Doc. 2018–11211 Filed 5–24–18; 8:45 am] Property Office, National Institute of Wing-Pui Kong (NIAID), Kayvon BILLING CODE 4140–01–P Allergy and Infectious Diseases, 5601 Modjarrad (NIAID), Lingshu Wang Fishers Lane, Rockville, MD 20852; tel. (NIAID), Wei Shi (NIAID), Michael 301–496–2644. A signed Confidential Gordon Joyce (NIAID), Masaru Kanekiyo DEPARTMENT OF HEALTH AND Disclosure Agreement will be required (NIAID), John Mascola (NIAID). HUMAN SERVICES to receive copies of unpublished patent Intellectual Property: HHS Reference No. E–239–2014, U.S. Provisional Patent National Institutes of Health applications. Application Number 62/120,353 filed SUPPLEMENTARY INFORMATION: National Institute of Allergy and February 25, 2015, PCT Patent Technology description follows. Infectious Diseases; Notice of Closed Application PCT/US2016/019395 filed Meetings Middle East Respiratory Syndrome February 24, 2016, Europe Patent Coronavirus Antibodies Application Number 16711059.2 filed Pursuant to section 10(d) of the February 24, 2016, South Korea Patent Federal Advisory Committee Act, as Description of Technology Application Number 10–2017–7027105 amended, notice is hereby given of the Middle East Respiratory Syndrome filed September 25, 2017, Saudi Arabia following meetings. coronavirus (MERS-CoV) causes a Patent Application Number 5173382168 The meetings will be closed to the amozie on DSK3GDR082PROD with NOTICES1 highly lethal pulmonary infection with filed August 21, 2017, and U.S. Patent public in accordance with the ∼35% mortality. Currently there are no Application Number 15/553,466 filed provisions set forth in sections prophylactic measures or effective August 24, 2017. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., therapies. Inventors at the Vaccine Licensing Contact: Amy Petrik Ph.D., as amended. The grant applications and Research Center of the National Institute 240–627–3721; amy.petrik@nih.gov. the discussions could disclose of Allergy and Infectious Diseases have Collaborative Research Opportunity: confidential trade secrets or commercial identified and developed neutralizing The National Institute of Allergy and property such as patentable material, VerDate Sep<11>2014 18:28 May 24, 2018 Jkt 241001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\25MYN1.SGM 25MYN1


Document Created: 2018-05-25 02:12:51
Document Modified: 2018-05-25 02:12:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactDr. Amy Petrik, 240-627-3721; [email protected] Licensing information and copies of the U.S. patent application listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD, 20852; tel. 301-496-2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.
FR Citation83 FR 24321 
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