83_FR_16449 83 FR 16376 - Government-Owned Inventions; Availability for Licensing

83 FR 16376 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 73 (April 16, 2018)

Page Range16376-16377
FR Document2018-07822

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 73 (Monday, April 16, 2018) 
[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16376-16377]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-07822]


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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: Amy Petrik., Ph.D., 240-627-3721; 
[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unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Prefusion Coronavirus Spike Proteins and Their Use

Description of Technology

    Coronaviruses (CoVs) can cause severe respiratory disease with high 
fatality rates in humans. The 2002-2003 SARS-CoV epidemic resulted in 
8098 cases and 744 deaths, and MERS-CoV, which emerged in 2012, has 
resulted in 2144 cases and over 750 deaths as of March 2018. Currently, 
there are no effective prophylactic or therapeutic measures, and 
because other CoVs are poised to emerge as new human pathogens, there 
is a need to define a general CoV vaccine solution. Past efforts to 
develop CoV vaccines have used whole-inactivated virus, live-attenuated 
virus, recombinant protein subunit, or genetic approaches.
    CoV spike (S) proteins mediate cellular attachment and membrane 
fusion and are therefore the target of protective antibodies. Inventors 
at the Vaccine Research Center of the National Institute of Allergy and 
Infectious Diseases have developed a novel CoV S protein vaccine 
antigen. This

[[Page 16377]]

technology employs protein engineering to stabilize S in its prefusion 
conformation, preventing structural rearrangement, and exposing 
antigenically preferable surfaces. The technology has been applied to 
several CoV spikes, including those from human-relevant viruses, such 
as HKU1-CoV, SARS-CoV, and MERS-CoV. Particularly for MERS-COV, 
stabilized S proteins have been shown to elicit superior neutralizing 
antibody responses up to 10-fold higher in animal models and protect 
mice against lethal MERS-CoV infection. This technology is applicable 
for delivery via other platforms, such as mRNA.
    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: The stabilized prefusion 
coronavirus spike protein can be used as a vaccine antigen to elicit 
robust neutralizing antibody responses.
    Competitive Advantages:
     Improved immunogenicity compared to other coronavirus S 
vaccine formulations.
     Increased protein expression, stability, and 
manufacturability compared to wild-type CoV S.
    Development Stage:
     In vivo data available (animal).
    Inventors: Barney Graham (NIAID), Masaru Kanekiyo (NIAID), M. 
Gordon Joyce (NIAID), Kizzmekia Corbett (NIAID), Hadi Yassine (NIAID), 
Andrew Ward (Scripps), Robert Kirchdoefer (Scripps), Christopher 
Cottrell (Scripps), Jesper Pallesen (Scripps), Hannah Turner (Scripps), 
Nianshuang Wang (Dartmouth), Jason McLellan (Dartmouth),
    Intellectual Property: HHS Reference No. E-234-2016/0, U.S. 
Provisional Patent Application Number 62/412,703, filed October 25, 
2016, PCT Patent Application PCT/US2017/058370 filed October 25, 2017.
    Licensing Contact: Amy Petrik, Ph.D., 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 further 
develop, evaluate or commercialize norovirus diagnostics or vaccines. 
For collaboration opportunities, please contact Amy Petrik, Ph.D., 240-
627-3721; [email protected].

    Dated: April 5, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-07822 Filed 4-13-18; 8:45 am]
 BILLING CODE 4140-01-P

16376 Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices request a leave of absence the first • Change in Graduation Date DEPARTMENT OF HEALTH AND academic year. HUMAN SERVICES The following reports must be sent to Any time that a change occurs in a the IHSSP at the identified time frame. scholarship awardee’s expected National Institutes of Health Each scholarship awardee will have graduation date, they must notify their access to online Student and Service Scholarship Program Analyst Government-Owned Inventions; Commitment Handbooks and required immediately in writing. Justification Availability for Licensing program forms and instructions on must be attached from the school AGENCY: National Institutes of Health, when, how, and to whom these must be advisor. Approvals must be made by the HHS. submitted, by logging into the IHSSP Branch Chief of Scholarships. ACTION: Notice. website at www.ihs.gov/scholarship. If a scholarship awardee fails to submit VII. Agency Contacts SUMMARY: The invention listed below is these forms and reports as required, owned by an agency of the U.S. 1. Questions on the application they will be ineligible for continuation Government and is available for process may be directed to the of scholarship support and scholarship licensing to achieve expeditious award payments will be discontinued. appropriate IHS Area Scholarship commercialization of results of Coordinator. federally-funded research and A. Recipient’s and Initial Progress 2. Questions on other programmatic Report development. Foreign patent matters may be addressed to: Ms. Reta applications are filed on selected Within thirty (30) days from the Brewer, Chief, Scholarship Program, inventions to extend market coverage beginning of each semester/trimester/ 5600 Fishers Lane, Mail Stop: OHR for companies and may also be available quarter, scholarship awardees must (11E53A), Rockville, Maryland 20857, for licensing. submit a Recipient’s Initial Program Telephone: (301) 443–6197 (This is not FOR FURTHER INFORMATION CONTACT: Progress Report (Form IHS–856–8, a toll-free number). Amy Petrik., Ph.D., 240–627–3721; found on the IHS Scholarship Program amy.petrik@nih.gov. Licensing website at: http://www.ihs.gov/ 3. Questions on payment information may be directed to: Mr. Craig Boswell, information and copies of the patent scholarship/programresources/ applications listed below may be studentforms/). Grants Scholarship Coordinator, Division of Grants Management, Indian obtained by communicating with the B. Transcripts indicated licensing contact at the Health Service, 5600 Fishers Lane, Mail Within thirty (30) days from the end Technology Transfer and Intellectual Stop: (09E65A), Rockville, Maryland of each academic period, i.e., semester/ Property Office, National Institute of 20857, Telephone: (301) 443–0056 (This Allergy and Infectious Diseases, 5601 trimester/quarter, or summer session, is not a toll-free number). scholarship awardees must submit an Fishers Lane, Rockville, MD 20852; tel. Official Transcript showing the results VIII. Other Information 301–496–2644. A signed Confidential of the classes taken during that period. Disclosure Agreement will be required The Public Health Service (PHS) is to receive copies of unpublished patent C. Notification of Academic Problem committed to achieving the health applications. If at any time during the semester/ promotion and disease prevention SUPPLEMENTARY INFORMATION: trimester/quarter, scholarship awardees objectives of Healthy People 2020, a Technology description follows. are advised to reduce the number of PHS-led activity for setting priority Prefusion Coronavirus Spike Proteins credit hours for which they are enrolled areas. This program announcement is and Their Use below the minimum of the 12 (or the related to the priority area of Education number of hours considered by their and Community-Based Programs. Description of Technology school as full-time) for a full-time Potential applicants may download a Coronaviruses (CoVs) can cause student or at least 6 hours for part-time copy of Healthy People 2020 from severe respiratory disease with high students, or if they experience academic http://www.healthypeople.gov. fatality rates in humans. The 2002–2003 problems, they must submit this report Interested individuals are reminded SARS-CoV epidemic resulted in 8098 (Form IHS–856–9, found on the IHS that the list of eligible IHSSP health and cases and 744 deaths, and MERS-CoV, Scholarship Program website at: which emerged in 2012, has resulted in allied professions is effective for www.ihs.gov/scholarship/ 2144 cases and over 750 deaths as of applicants for the 2018–2019 academic programresources/studentforms/). March 2018. Currently, there are no year. These priorities will remain in D. Change of Status effective prophylactic or therapeutic effect until superseded. Applicants who measures, and because other CoVs are • Change of Academic Status apply for health career categories not poised to emerge as new human listed as a priorities during the current pathogens, there is a need to define a Scholarship awardees must scholarship cycle will not be considered general CoV vaccine solution. Past immediately notify their Scholarship Program Analyst if they are placed on for a scholarship award. efforts to develop CoV vaccines have academic probation, dismissed from Dated: April 5, 2018. used whole-inactivated virus, live- school, or voluntarily withdraw for any Michael Weahkee, attenuated virus, recombinant protein reason (personal or medical). Assistant Surgeon General, U.S. Public Health subunit, or genetic approaches. CoV spike (S) proteins mediate srobinson on DSK3G9T082PROD with NOTICES • Change of Health Discipline Service, Acting Director, Indian Health cellular attachment and membrane Service. Scholarship awardees may not change fusion and are therefore the target of [FR Doc. 2018–07797 Filed 4–13–18; 8:45 am] from the approved IHSSP health protective antibodies. Inventors at the BILLING CODE 4165–16–P discipline during the school year. If an Vaccine Research Center of the National unapproved change is made, Institute of Allergy and Infectious scholarship payments will be Diseases have developed a novel CoV S discontinued. protein vaccine antigen. This VerDate Sep<11>2014 19:42 Apr 13, 2018 Jkt 244001 PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 E:\FR\FM\16APN1.SGM 16APN1

Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices 16377 technology employs protein engineering Dated: April 5, 2018. Dated: April 10, 2018. to stabilize S in its prefusion Suzanne M. Frisbie, Michelle D. Trout, conformation, preventing structural Deputy Director, Technology Transfer and Program Analyst, Office of Federal Advisory rearrangement, and exposing Intellectual Property Office, National Institute Committee Policy. antigenically preferable surfaces. The of Allergy and Infectious Diseases. [FR Doc. 2018–07820 Filed 4–13–18; 8:45 am] technology has been applied to several [FR Doc. 2018–07822 Filed 4–13–18; 8:45 am] BILLING CODE 4140–01–P CoV spikes, including those from BILLING CODE 4140–01–P human-relevant viruses, such as HKU1- CoV, SARS-CoV, and MERS-CoV. DEPARTMENT OF HEALTH AND Particularly for MERS–COV, stabilized S DEPARTMENT OF HEALTH AND HUMAN SERVICES proteins have been shown to elicit HUMAN SERVICES superior neutralizing antibody National Institutes of Health responses up to 10-fold higher in animal National Institutes of Health models and protect mice against lethal Government-Owned Inventions; MERS-CoV infection. This technology is National Heart, Lung, and Blood Availability for Licensing applicable for delivery via other Institute; Notice of Meeting AGENCY: National Institutes of Health, platforms, such as mRNA. HHS. This technology is available for Pursuant to section 10(d) of the Federal Advisory Committee Act, as ACTION: Notice. licensing for commercial development in accordance with 35 U.S.C. 209 and 37 amended, notice is hereby given of a SUMMARY: The invention listed below is CFR part 404, as well as for further meeting of the Sleep Disorders Research owned by an agency of the U.S. development and evaluation under a Advisory Board. Government and is available for research collaboration. This meeting is open to the public but licensing to achieve expeditious Potential Commercial Applications: is being held by virtual/teleconference. commercialization of results of The stabilized prefusion coronavirus No physical meeting location is federally-funded research and spike protein can be used as a vaccine provided for any interested individuals development. Foreign patent antigen to elicit robust neutralizing to listen to and/or participate in the applications are filed on selected antibody responses. meeting. Any individual interested in inventions to extend market coverage listening to the meeting discussions for companies and may also be available Competitive Advantages: for licensing. must: access the website https:// • Improved immunogenicity nih.webex.com/nih/onstage/ FOR FURTHER INFORMATION CONTACT: Dr. compared to other coronavirus S g.php?MTID=e9a4cbcaac003afd915c2c Amy Petrik, 240–627–3721; vaccine formulations. 94a8c787585 and enter Event Password: amy.petrik@nih.gov. Licensing • Increased protein expression, sdrab or call-in toll number 1–650–479– information and copies of the U.S. stability, and manufacturability 3208 and enter access code: 625 446 patent application listed below may be compared to wild-type CoV S. 354, for access to the meeting. obtained by communicating with the Development Stage: Individuals require special assistance, indicated licensing contact at the • In vivo data available (animal). should notify the Contact Person listed Technology Transfer and Intellectual below in advance of the meeting. Property Office, National Institute of Inventors: Barney Graham (NIAID), Masaru Kanekiyo (NIAID), M. Gordon Name of Committee: Sleep Disorders Allergy and Infectious Diseases, 5601 Joyce (NIAID), Kizzmekia Corbett Research Advisory Board. Fishers Lane, Rockville, MD, 20852; tel. (NIAID), Hadi Yassine (NIAID), Andrew Date: April 27, 2018. 301–496–2644. A signed Confidential Ward (Scripps), Robert Kirchdoefer Time: 2:00 p.m. to 4:00 p.m. Disclosure Agreement will be required (Scripps), Christopher Cottrell (Scripps), Agenda: Discussion of NIH Sleep Disorders to receive copies of unpublished patent Jesper Pallesen (Scripps), Hannah Research Plan Revision. applications. Place: National Institutes of Health, Two SUPPLEMENTARY INFORMATION: Turner (Scripps), Nianshuang Wang Rockledge Center, Conference Room 10167, Technology description follows. (Dartmouth), Jason McLellan 6701 Rockledge Drive, Bethesda, MD 20892 (Dartmouth), (Virtual Meeting). Novel Multivalent Nanoparticle Intellectual Property: HHS Reference Contact Person: Michael J. Twery, Ph.D., Vaccines No. E–234–2016/0, U.S. Provisional Director, National Center on Sleep Disorders Description of Technology: Current Patent Application Number 62/412,703, Research Division of Lung Diseases, National seasonal influenza vaccines are filed October 25, 2016, PCT Patent Heart, Lung, and Blood Institute, National designed to elicit immunity to Application PCT/US2017/058370 filed Institutes of Health, 6701 Rockledge Drive, circulating strains of influenza each October 25, 2017. Suite 10042, Bethesda, MD 20892–7952, 301– 435–0199, twerym@nhlbi.nih.gov. year. The targeted strains are selected Licensing Contact: Amy Petrik, Ph.D., based on predictions of which strains 240–627–3721; amy.petrik@nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing are likely to be predominant in the Collaborative Research Opportunity: limitations of receiving input from committee human population for a given year. This The National Institute of Allergy and members prior to presenting the plan to other prediction must be made well ahead of Infectious Diseases is seeking statements audiences for comment and meeting a the influenza season to allow time for of capability or interest from parties legislative reporting deadline. vaccine production and can be srobinson on DSK3G9T082PROD with NOTICES interested in collaborative research to (Catalogue of Federal Domestic Assistance inaccurate. further develop, evaluate or Program Nos. 93.233, National Center for Scientists at NIAID’s Vaccine commercialize norovirus diagnostics or Sleep Disorders Research; 93.837, Heart and Research Center are developing an vaccines. For collaboration Vascular Diseases Research; 93.838, Lung alternative approach for design and opportunities, please contact Amy Diseases Research; 93.839, Blood Diseases production of seasonal influenza Petrik, Ph.D., 240–627–3721; and Resources Research, National Institutes vaccines. The design includes amy.petrik@nih.gov. of Health, HHS) recombinant fusion proteins that self- VerDate Sep<11>2014 19:42 Apr 13, 2018 Jkt 244001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 E:\FR\FM\16APN1.SGM 16APN1


Document Created: 2018-04-14 02:19:18
Document Modified: 2018-04-14 02:19:18
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.
ContactAmy Petrik., Ph.D., 240-627-3721; [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 16376 
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