83_FR_20172 83 FR 20084 - Government-Owned Inventions; Availability for Licensing

83 FR 20084 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 88 (May 7, 2018)

Page Range20084-20085
FR Document2018-09660

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

Federal Register, Volume 83 Issue 88 (Monday, May 7, 2018) 
[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Notices]
[Pages 20084-20085]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-09660]


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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 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.

FOR FURTHER INFORMATION CONTACT: Peter Soukas, J.D., 301-594-8730; 
peter.soukas@nih.gov. Licensing information and copies of the patent 
applications 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unpublished patent applications.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.

Mononegavirales Vectors Expressing Chimeric Antigens

Description of Technology

    Human respiratory syncytial virus (RSV) continues to be the leading 
viral cause of severe acute lower respiratory tract disease in infants 
and children

[[Page 20085]]

worldwide. A licensed vaccine or antiviral drug suitable for routine 
use remains unavailable. This invention relates to the use of murine 
pneumonia virus (MPV), a virus to which humans normally are not exposed 
to and that is not cross-protected with RSV, as a vector to express the 
RSV fusion (F) glycoprotein as an RSV vaccine candidate. The RSV F ORF 
was codon optimized. The RSV F ORF was placed under the control of MPV 
transcription signals and inserted at the first (rMPV-F1), third 
(rMPV29 F3), or fourth (rMPV-F4) gene position of a version of the MPV 
genome that contained a codon pair optimized L polymerase gene. The 
recovered viruses replicated in vitro as efficiently as the empty 
vector, with stable expression of RSV F protein. Replication and 
immunogenicity of rMPV-F1 and rMPV-F3 were evaluated in rhesus macaques 
following administration by the combined intranasal and intratracheal 
routes. Both viruses replicated at low levels in the upper and lower 
respiratory tract, maintained stable RSV F expression, and induced 
similar high levels of RSV-neutralizing serum antibodies that reached 
peak titers by fourteen (14) days post-vaccination. rMPV provides a 
highly attenuated yet immunogenic vector for the expression of RSV F 
protein, with potential application in RSV-na[iuml]ve and RSV 
experienced populations.
    The invention relates to live, chimeric non-human Mononegavirales 
vectors that allow a cell to express at least one protein from at least 
one human pathogen as well as compositions comprising the vectors, 
methods and kits for eliciting an immune response in a host, and 
methods of making the vectors.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.

Potential Commercial Applications

 Viral diagnostics
 Vaccine research

Competitive Advantages

 Ease of manufacture
 Multivalent live attenuated vaccines
 B cell and T cell activation
 Low-cost vaccines

Development Stage

 In vivo data assessment (animal)
    Inventors: Shirin Munir (NIAID), Linda Brock (NIAID), Ursula 
Buchholz (NIAID), Peter Collins (NIAID).
    Publications: None.
    Intellectual Property: HHS Reference No. E-018-2018/0--U.S. 
Provisional Application No. 62/661,320, filed April 23, 2018 (pending).
    Licensing Contact: Peter Soukas, J.D., 301-594-8730; 
peter.soukas@nih.gov.
    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 further 
develop, evaluate or commercialize for development of a vaccine for 
respiratory or other infections. For collaboration opportunities, 
please contact Peter Soukas, J.D., 301-594-8730; peter.soukas@nih.gov.

    Dated: April 26, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-09660 Filed 5-4-18; 8:45 am]
 BILLING CODE 4140-01-P

20084 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Notices FOR FURTHER INFORMATION CONTACT: Potential Commercial Applications: Date: June 6–7, 2018. Licensing information and copies of the Time: 1:00 p.m. to 2:00 p.m. • Prevention of iatrogenic left Agenda: To review and evaluate grant patent applications listed below may be ventricular outflow tract obstruction applications. obtained by emailing the indicated following transcatheter mitral valve Place: Embassy Suites, Denver Airport, licensing contact at the National Heart, replacement 7001 Yampa Street, Denver, CO 80249. Lung, and Blood, Office of Technology • Bioprosthetic aortic scallop Contact Person: Transfer and Development Office of intentional laceration Kimberly Firth, Ph.D., National Institute on Technology Transfer, 31 Center Drive Aging, Gateway Building, 7201 Wisconsin Room 4A29, MSC2479, Bethesda, MD Development Stage: Avenue, Suite 2C212, Bethesda, MD 20892, 301–402–7702, kimberly.firth@nih.gov. 20892–2479; telephone: 301–402–5579. • In vivo data available A signed Confidential Disclosure Inventors: Robert Lederman, Jaffar (Catalogue of Federal Domestic Assistance Khan, Toby Rogers (all of NHLBI). Program Nos. 93.866, Aging Research, Agreement may be required to receive National Institutes of Health, HHS) copies of the patent applications. Intellectual Property: HHS Reference No. E–064–2018/0–US–01; U.S. Dated: May 2, 2018. SUPPLEMENTARY INFORMATION: This Provisional Patent Application 62/ Melanie J. Pantoja, notice is in accordance with 35 U.S.C. 633,791 filed February 22, 2018. Program Analyst, Office of Federal Advisory 209 and 37 CFR part 404 to achieve Licensing Contact: Michael Committee Policy. commercialization of results of Shmilovich, Esq, CLP; 301–435–5019; [FR Doc. 2018–09658 Filed 5–4–18; 8:45 am] federally-funded research and shmilovm@nih.gov. BILLING CODE 4140–01–P development. Foreign patent Collaborative Research Opportunity: applications are filed on selected The National Institute of Environmental inventions to extend market coverage Health Sciences seeks statements of DEPARTMENT OF HEALTH AND for companies and may also be available capability or interest from parties HUMAN SERVICES for licensing. A description of the interested in collaborative research to technology follows. further develop and evaluate, please National Institutes of Health Inner Curvature Charge Concentration contact Peg Koelble, Technology Government-Owned Inventions; Development Specialist, Office of Device For Tissue Laceration Availability for Licensing Technology Transfer, National Heart, Description of Technology: Left Lung, and Blood Institute, Phone: AGENCY: National Institutes of Health, ventricular outflow tract obstruction is a 301.594.4095; koelblep@nhlbi.nih.gov. HHS. life-threatening complication of Dated: April 26, 2018. ACTION: Notice. transcatheter mitral valve replacement Michael A. Shmilovich, caused by septal displacement of the SUMMARY: The invention listed below is Senior Licensing and Patenting Manager, owned by an agency of the U.S. anterior mitral leaflet (AML). The AML National Heart, Lung, and Blood Institute, is a mobile structure that physically Government and is available for Office of Technology Transfer and separates inflow and outflow zones of Development. licensing to achieve expeditious the left ventricle. Preserving the AML commercialization of results of [FR Doc. 2018–09656 Filed 5–4–18; 8:45 am] federally-funded research and during surgical mitral valve replacement BILLING CODE 4140–01–P development. Foreign patent can cause left ventricular outflow tract applications are filed on selected obstruction, either when the prosthesis DEPARTMENT OF HEALTH AND inventions to extend market coverage struts protrude into the left ventricular HUMAN SERVICES for companies and may also be available outflow tract or when along redundant for licensing. anterior leaflet prolapses into the left National Institutes of Health FOR FURTHER INFORMATION CONTACT: ventrical outflow tract. The invention relates to devices having monopolar or Peter Soukas, J.D., 301–594–8730; National Institute on Aging; Notice of peter.soukas@nih.gov. Licensing bipolar tissue lacerators for efficiently Closed Meeting information and copies of the patent and safely cutting AMLs percutaneously by vaporizing target tissue with applications listed below may be Pursuant to section 10(d) of the electrical energy. Exemplary devices obtained by communicating with the Federal Advisory Committee Act, as include a wire partially covered by indicated licensing contact at the amended, notice is hereby given of the electrical insulation, where the wire is Technology Transfer and Intellectual following meeting. kinked and where the wire is exposed The meeting will be closed to the Property Office, National Institute of through the insulation at one or more public in accordance with the Allergy and Infectious Diseases, 5601 exposed regions along or near the inner provisions set forth in sections Fishers Lane, Rockville, MD, 20852; tel. curvature of the kink. The wire is 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 301–496–2644. A signed Confidential configured to conduct electrical energy as amended. The grant applications and Disclosure Agreement will be required through the exposed region(s) and the discussions could disclose to receive copies of unpublished patent through a tissue target positioned confidential trade secrets or commercial applications. adjacent the inner curvature to lacerate property such as patentable material, SUPPLEMENTARY INFORMATION: the tissue target via the electrical and personal information concerning Technology description follows. energy. The tissue target can be a native individuals associated with the grant Mononegavirales Vectors Expressing daltland on DSKBBV9HB2PROD with NOTICES or prosthetic heart valve leaflet in a applications, the disclosure of which Chimeric Antigens patient’s heart. An optional feature of would constitute a clearly unwarranted the device also includes an irrigation invasion of personal privacy. Description of Technology catheter to displace blood from the Name of Committee: National Institute on Human respiratory syncytial virus electrode, concentrating current at the Aging Initial Review Group; Behavior and (RSV) continues to be the leading viral tissue and reducing char and coagulum Social Science of Aging Review Committee cause of severe acute lower respiratory formation. NIA—S. tract disease in infants and children VerDate Sep<11>2014 17:38 May 04, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\07MYN1.SGM 07MYN1

Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Notices 20085 worldwide. A licensed vaccine or Intellectual Property: HHS Reference overseeing compliance with antiviral drug suitable for routine use No. E–018–2018/0—U.S. Provisional environmental concerns in the remains unavailable. This invention Application No. 62/661,320, filed April operation of crude oil terminals and oil relates to the use of murine pneumonia 23, 2018 (pending). tankers. virus (MPV), a virus to which humans Licensing Contact: Peter Soukas, J.D., The President has delegated his normally are not exposed to and that is 301–594–8730; peter.soukas@nih.gov. authority under 33 U.S.C 2732(o) not cross-protected with RSV, as a Collaborative Research Opportunity: respecting certification of advisory vector to express the RSV fusion (F) The National Institute of Allergy and councils, or groups, subject to the Act to glycoprotein as an RSV vaccine Infectious Diseases is seeking statements the Secretary of the Department of candidate. The RSV F ORF was codon of capability or interest from parties Homeland Security. Section 8(g) of optimized. The RSV F ORF was placed interested in collaborative research to Executive Order 12777, (56 FR 54757, under the control of MPV transcription further develop, evaluate or October 22, 1991), as amended by signals and inserted at the first (rMPV– commercialize for development of a section 34 of Executive Order 13286 (68 F1), third (rMPV29 F3), or fourth vaccine for respiratory or other FR 10619, March 5, 2003). The Secretary (rMPV–F4) gene position of a version of infections. For collaboration redelegated that authority to the the MPV genome that contained a codon opportunities, please contact Peter Commandant of the USCG. Department pair optimized L polymerase gene. The Soukas, J.D., 301–594–8730; of Homeland Security Delegation No. recovered viruses replicated in vitro as peter.soukas@nih.gov. 0170.1, paragraph 80 of section II. The efficiently as the empty vector, with Dated: April 26, 2018. Commandant redelegated that authority stable expression of RSV F protein. to the Chief, Office of Marine Safety, Suzanne M. Frisbie, Replication and immunogenicity of Security and Environmental Protection Deputy Director, Technology Transfer and (G–M) on March 19, 1992 (letter #5402). rMPV–F1 and rMPV–F3 were evaluated Intellectual Property Office, National Institute in rhesus macaques following The Assistant Commandant for of Allergy and Infectious Diseases. administration by the combined Marine Safety and Environmental [FR Doc. 2018–09660 Filed 5–4–18; 8:45 am] Protection (G–M), redelegated intranasal and intratracheal routes. Both viruses replicated at low levels in the BILLING CODE 4140–01–P recertification authority for advisory upper and lower respiratory tract, councils, or groups, to the Commander, maintained stable RSV F expression, Seventeenth Coast Guard District on DEPARTMENT OF HOMELAND February 26, 1999 (letter #16450). and induced similar high levels of RSV- SECURITY On July 7, 1993, the USCG published neutralizing serum antibodies that a policy statement, ‘‘Alternative reached peak titers by fourteen (14) days Coast Guard Voluntary Advisory Groups, Prince post-vaccination. rMPV provides a [Docket No. USCG–2017–0289] William Sound and Cook Inlet’’ (58 FR highly attenuated yet immunogenic 36504), to clarify the factors considered vector for the expression of RSV F Cook Inlet Regional Citizens’ Advisory in making the determination as to protein, with potential application in Council (CIRCAC) Recertification whether advisory councils, or groups, RSV-naı̈ve and RSV experienced should be certified in accordance with populations. AGENCY: Coast Guard, DHS. the Act. The invention relates to live, chimeric ACTION: Notice of recertification. On September 16, 2002, the USCG non-human Mononegavirales vectors published a policy statement, 67 FR that allow a cell to express at least one SUMMARY: This notice informs the public 58440, which changed the protein from at least one human that the Coast Guard has completed its recertification procedures such that pathogen as well as compositions triennial recertification of the Cook Inlet applicants are required to provide the comprising the vectors, methods and Regional Citizens’ Advisory Council USCG with comprehensive information kits for eliciting an immune response in (CIRCAC) as an alternative voluntary every three years (triennially). For each a host, and methods of making the advisory group for Cook Inlet, Alaska. of the two years between the triennial vectors. The certification allows the CIRCAC to application procedures, applicants This technology is available for monitor the activities of terminal submit a letter requesting recertification licensing for commercial development facilities and crude oil tankers under an that includes a description of any in accordance with 35 U.S.C. 209 and 37 alternative composition other than substantive changes to the information CFR part 404, as well as for further prescribed Cook Inlet Program provided at the previous triennial development and evaluation under a established by statute. recertification. Further, public comment research collaboration. DATES: This recertification is effective is only solicited during the triennial Potential Commercial Applications for the period from September 1st, 2017, comprehensive review. through August 31st, 2018. • Viral diagnostics Discussion of Comments FOR FURTHER INFORMATION CONTACT: LT • Vaccine research Jonathan Dale, Seventeenth Coast Guard On June 29th, 2017, the USCG Competitive Advantages District (dpi), by phone at (907)463– published a ‘‘Notice; request for • Ease of manufacture 2812, email at jonathan.dale@uscg.mil. comments for recertification of Cook • Multivalent live attenuated vaccines SUPPLEMENTARY INFORMATION: Inlet Regional Citizens’ Advisory • B cell and T cell activation Council’’ in the Federal Register (82 FR Background and Purpose • Low-cost vaccines 29572). We received 43 letters daltland on DSKBBV9HB2PROD with NOTICES As part of the Oil Pollution Act of commenting on the proposed action. No Development Stage 1990, Congress passed the Oil Terminal public meeting was requested. One • In vivo data assessment (animal) and Oil Tanker Environmental comment was received questioning Inventors: Shirin Munir (NIAID), Oversight and Monitoring Act of 1990 CIRCAC’s recent changes to its by laws Linda Brock (NIAID), Ursula Buchholz (the Act), 33 U.S.C. 2732, to foster a governing the Tourism Group. Through (NIAID), Peter Collins (NIAID). long-term partnership among industry, coordination of the involved parties, the Publications: None. government, and local communities in Coast Guard is satisfied that the concern VerDate Sep<11>2014 17:38 May 04, 2018 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\07MYN1.SGM 07MYN1


Document Created: 2018-05-05 02:48:47
Document Modified: 2018-05-05 02:48:47
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.
ContactPeter Soukas, J.D., 301-594-8730; [email protected] Licensing information and copies of the patent applications 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 20084 
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