81_FR_52852 81 FR 52699 - Government-Owned Inventions; Availability for Licensing

81 FR 52699 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 153 (August 9, 2016)

Page Range52699-52700
FR Document2016-18862

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development.

Federal Register, Volume 81 Issue 153 (Tuesday, August 9, 2016)
[Federal Register Volume 81, Number 153 (Tuesday, August 9, 2016)]
[Notices]
[Pages 52699-52700]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18862]


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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

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

SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing and/or co-development in the 
U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development.

ADDRESSES: Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD, 20850-9702.

FOR FURTHER INFORMATION CONTACT: Information on licensing and co-
development research collaborations, and copies of the U.S. patent 
applications listed below may be obtained by contacting: Attn. 
Invention Development and Marketing Unit, Technology Transfer Center, 
National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, 
Rockville, MD, 20850-9702, Tel. 240-276-5515 or email 
ncitechtransfer@mail.nih.gov. A signed Confidential Disclosure 
Agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of invention: Methods of Treating or Preventing Demyelination 
Using Thrombin Inhibitors and Methods of Detecting Demyelination Using 
Neurofascin 155.
    Description of Technology: Neurofascin 155 is a cell adhesion 
molecule that attaches myelin to axolemma. Contactin-associated protein 
(Caspr) is a major component of the perinodes. Perinodal astrocytes 
regulate nodal structure and myelin thickness by regulating thrombin-
dependent cleavage of axo-glial junction attaching the outermost 
paranodal loops of myelin to the axon membrane. Agents which inhibit 
the cleavage of Neurofascin 155 or the cleavage of Caspr1 stabilize the 
node and may impede the immunological attack of myelin where the 
paranodes are attached to the axon.
    The technology is directed to methods of treating diseases 
characterized by demyelination (such as Multiple sclerosis), white 
matter injury, or conditions associated with myelin remodeling by 
administering an agent that inhibits cleavage of Neurofascin 155 or 
Caspr1. The agent could be a thrombin inhibitor, an agent that inhibits 
thrombin expression, an anti-thrombin antibody that specifically 
inhibits thrombin mediated cleavage of Neurofascin 155, a mutated 
version or fragment of Neurofascin 155 or Caspr1, antibodies to 
Neurofascin 155 or Caspr1.
    The technology also includes methods of detecting remodeling of 
myelin by detecting changes in levels of Neurofascin 125 and 
Neurofascin 30 in a biological sample, such as central spinal fluid or 
blood.
    Potential Commercial Applications: Treatment of demyelinating 
diseases, such as Multiple sclerosis.
    Treatment of diseases characterized by white matter injury or 
myelin remodeling.
    Monitoring the amount of or rate of remodeling of myelin to 
determine the efficacy of agents used demyelinating diseases.
    Value Proposition: Agents which inhibit cleavage of Neurofascin 155 
or Caspr1 or inhibit thrombin activity are a novel approach to treating 
demyelinating diseases or diseases characterized by white matter 
injury.
    The methods of detecting modification in the amount or rate of 
remodeling of myelin can be used to determine the efficacy of 
treatments of neurological disorders and are less expensive than other 
methods currently used.
    Development Stage: Pre-clinical (in vivo validation).
    Inventor(s): R. Douglas Fields https://science.nichd.nih.gov/confluence/display/snsdp/Home.
    Intellectual Property: HHS Reference No. E-151-2015/0-PCT-02.
    PCT application, PCT/US2016/027776, filed April 15, 2016 entitled 
``Methods of Treating or Preventing Demyelination Using Thrombin 
Inhibitors and Methods of Detecting Demyelination Using Neurofascin 
155''.
    Publications: 1. In preparation.
    Collaboration Opportunity: Researchers at the Eunice Kennedy 
Shriver National Institute of Child Health and Human Development 
(``NICHD''), seek CRADA partner or collaboration for development of 
agents to treat multiple sclerosis or other conditions associated with 
myelin remodeling by administering an agent that inhibits cleavage of 
Neurofascin 155 or Caspr1. The agent could be a

[[Page 52700]]

thrombin inhibitor, an agent that inhibits thrombin expression, an 
anti-thrombin antibody that specifically inhibits thrombin mediated 
cleavage of Neurofascin 155, a mutated version or fragment of 
Neurofascin 155 or Caspr1, or antibodies to Neurofascin 155 or Caspr1.
    Contact Information: Requests for copies of the patent application 
or inquiries about licensing, research collaborations, and co-
development opportunities should be sent to John D. Hewes, Ph.D., 
email: john.hewes@nih.gov.

    Dated: August 2, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-18862 Filed 8-8-16; 8:45 am]
 BILLING CODE 4140-01-P



                                                                                  Federal Register / Vol. 81, No. 153 / Tuesday, August 9, 2016 / Notices                                           52699

                                                      Contact Person: William C. Benzing, Ph.D.,            DEPARTMENT OF HEALTH AND                                 The technology is directed to methods
                                                    Scientific Review Officer, Scientific Review            HUMAN SERVICES                                        of treating diseases characterized by
                                                    Branch, Division of Extramural Research,                                                                      demyelination (such as Multiple
                                                    NINDS/ NIH/DHHS, Neuroscience Center,                   National Institutes of Health                         sclerosis), white matter injury, or
                                                    6001 Executive Blvd., Suite 3204, MSC 9529,                                                                   conditions associated with myelin
                                                    Bethesda, MD 20892–9529, 301–496–0660,                  Government-Owned Inventions;                          remodeling by administering an agent
                                                    Benzingw@mail.nih.gov.                                  Availability for Licensing                            that inhibits cleavage of Neurofascin
                                                      This notice is being published less than 15                                                                 155 or Caspr1. The agent could be a
                                                    days prior to the meeting due to the timing             AGENCY:    National Institutes of Health,
                                                                                                            HHS.                                                  thrombin inhibitor, an agent that
                                                    limitations imposed by the review and                                                                         inhibits thrombin expression, an anti-
                                                    funding cycle.                                          ACTION:   Notice                                      thrombin antibody that specifically
                                                      Name of Committee: National Institute of                                                                    inhibits thrombin mediated cleavage of
                                                    Neurological Disorders and Stroke Special               SUMMARY:     The invention listed below is
                                                                                                            owned by an agency of the U.S.                        Neurofascin 155, a mutated version or
                                                    Emphasis Panel; Clinician Training Program                                                                    fragment of Neurofascin 155 or Caspr1,
                                                    R25 Application Review.                                 Government and is available for
                                                                                                            licensing and/or co-development in the                antibodies to Neurofascin 155 or Caspr1.
                                                      Date: August 17, 2016.                                                                                         The technology also includes methods
                                                      Time: 2:00 p.m. to 8:00 p.m.                          U.S. in accordance with 35 U.S.C. 209
                                                                                                                                                                  of detecting remodeling of myelin by
                                                      Agenda: To review and evaluate grant                  and 37 CFR part 404 to achieve
                                                                                                                                                                  detecting changes in levels of
                                                    applications.                                           expeditious commercialization of
                                                                                                                                                                  Neurofascin 125 and Neurofascin 30 in
                                                      Place: National Institutes of Health,                 results of federally-funded research and
                                                                                                                                                                  a biological sample, such as central
                                                    Neuroscience Center, 6001 Executive                     development. Foreign patent
                                                                                                                                                                  spinal fluid or blood.
                                                    Boulevard, Rockville, MD 20852 (Telephone               applications are filed on selected
                                                                                                                                                                     Potential Commercial Applications:
                                                    Conference Call).                                       inventions to extend market coverage
                                                                                                                                                                  Treatment of demyelinating diseases,
                                                      Contact Person: William C. Benzing, Ph.D.,            for companies and may also be available
                                                                                                                                                                  such as Multiple sclerosis.
                                                    Scientific Review Officer, Scientific Review            for licensing and/or co-development.                     Treatment of diseases characterized
                                                    Branch, Division of Extramural Research,                ADDRESSES: Invention Development and                  by white matter injury or myelin
                                                    NINDS/NIH/DHHS, Neuroscience Center,                    Marketing Unit, Technology Transfer                   remodeling.
                                                    6001 Executive Blvd, Suite MSC 9529,                    Center, National Cancer Institute, 9609                  Monitoring the amount of or rate of
                                                    Bethesda, MD 20892–9529, 301–496–0660,                  Medical Center Drive, Mail Stop 9702,                 remodeling of myelin to determine the
                                                    Benzingw@mail.nih.gov.
                                                                                                            Rockville, MD, 20850–9702.                            efficacy of agents used demyelinating
                                                      This notice is being published less than 15
                                                    days prior to the meeting due to the timing             FOR FURTHER INFORMATION CONTACT:                      diseases.
                                                                                                            Information on licensing and co-                         Value Proposition: Agents which
                                                    limitations imposed by the review and
                                                                                                            development research collaborations,                  inhibit cleavage of Neurofascin 155 or
                                                    funding cycle.
                                                                                                            and copies of the U.S. patent                         Caspr1 or inhibit thrombin activity are
                                                      Name of Committee: National Institute of                                                                    a novel approach to treating
                                                    Neurological Disorders and Stroke Special               applications listed below may be
                                                                                                            obtained by contacting: Attn. Invention               demyelinating diseases or diseases
                                                    Emphasis Panel; Biorepository Resource
                                                                                                            Development and Marketing Unit,                       characterized by white matter injury.
                                                    Access Committee (BRAC) X01 Meeting.
                                                                                                            Technology Transfer Center, National                     The methods of detecting
                                                      Date: August 18, 2016.
                                                                                                            Cancer Institute, 9609 Medical Center                 modification in the amount or rate of
                                                      Time: 1:00 p.m. to 3:00 p.m.
                                                                                                            Drive, Mail Stop 9702, Rockville, MD,                 remodeling of myelin can be used to
                                                      Agenda: To review and evaluate grant
                                                    applications.                                           20850–9702, Tel. 240–276–5515 or                      determine the efficacy of treatments of
                                                      Place: National Institutes of Health,                 email ncitechtransfer@mail.nih.gov. A                 neurological disorders and are less
                                                    Neuroscience Center, 6001 Executive                     signed Confidential Disclosure                        expensive than other methods currently
                                                    Boulevard, Rockville, MD 20852 (Telephone               Agreement may be required to receive                  used.
                                                    Conference Call).                                       copies of the patent applications.                       Development Stage: Pre-clinical (in
                                                      Contact Person: Joel A. Sayoff, Ph.D.,                                                                      vivo validation).
                                                                                                            SUPPLEMENTARY INFORMATION:                               Inventor(s): R. Douglas Fields https://
                                                    Scientific Review Officer, Scientific Review            Technology description follows.
                                                    Branch, Division of Extramural Research,                                                                      science.nichd.nih.gov/confluence/
                                                                                                               Title of invention: Methods of                     display/snsdp/Home.
                                                    NINDS/NIH/DHHS, Neuroscience Center,
                                                                                                            Treating or Preventing Demyelination                     Intellectual Property: HHS Reference
                                                    6001 Executive Blvd., Suite 3204, MSC 9529,
                                                    Bethesda, MD 20892–9529, 301–496–9223,
                                                                                                            Using Thrombin Inhibitors and Methods                 No. E–151–2015/0–PCT–02.
                                                    joel.saydoff@nih.gov.                                   of Detecting Demyelination Using                         PCT application, PCT/US2016/
                                                      This notice is being published less than 15           Neurofascin 155.                                      027776, filed April 15, 2016 entitled
                                                    days prior to the meeting due to the timing                Description of Technology:                         ‘‘Methods of Treating or Preventing
                                                    limitations imposed by the review and                   Neurofascin 155 is a cell adhesion                    Demyelination Using Thrombin
                                                    funding cycle.                                          molecule that attaches myelin to                      Inhibitors and Methods of Detecting
                                                    (Catalogue of Federal Domestic Assistance               axolemma. Contactin-associated protein                Demyelination Using Neurofascin 155’’.
                                                    Program Nos. 93.853, Clinical Research                  (Caspr) is a major component of the                      Publications: 1. In preparation.
                                                    Related to Neurological Disorders; 93.854,              perinodes. Perinodal astrocytes regulate                 Collaboration Opportunity:
                                                    Biological Basis Research in the                        nodal structure and myelin thickness by               Researchers at the Eunice Kennedy
                                                                                                            regulating thrombin-dependent cleavage                Shriver National Institute of Child
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    Neurosciences, National Institutes of Health,
                                                    HHS)                                                    of axo-glial junction attaching the                   Health and Human Development
                                                                                                            outermost paranodal loops of myelin to                (‘‘NICHD’’), seek CRADA partner or
                                                      Dated: August 3, 2016.
                                                                                                            the axon membrane. Agents which                       collaboration for development of agents
                                                    Sylvia L. Neal,                                         inhibit the cleavage of Neurofascin 155               to treat multiple sclerosis or other
                                                    Program Analyst, Office of Federal Advisory             or the cleavage of Caspr1 stabilize the               conditions associated with myelin
                                                    Committee Policy.                                       node and may impede the                               remodeling by administering an agent
                                                    [FR Doc. 2016–18863 Filed 8–8–16; 8:45 am]              immunological attack of myelin where                  that inhibits cleavage of Neurofascin
                                                    BILLING CODE 4140–01–P                                  the paranodes are attached to the axon.               155 or Caspr1. The agent could be a


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                                                    52700                         Federal Register / Vol. 81, No. 153 / Tuesday, August 9, 2016 / Notices

                                                    thrombin inhibitor, an agent that                       organizations such as schools,                        United States, as well as associated
                                                    inhibits thrombin expression, an anti-                  universities, and exchange visitor                    organizations and individuals, who
                                                    thrombin antibody that specifically                     programs being investigated by CTCEU                  overstay their period of admission or
                                                    inhibits thrombin mediated cleavage of                  and information about individuals,                    otherwise violate the terms of their visa,
                                                    Neurofascin 155, a mutated version or                   including designated school officials                 immigrant, or non-immigrant status
                                                    fragment of Neurofascin 155 or Caspr1,                  (DSOs), and associates of suspected                   (collectively, ‘‘status violators’’). Using
                                                    or antibodies to Neurofascin 155 or                     status violators.                                     the LeadTrac information technology
                                                    Caspr1.                                                   Additionally, DHS/ICE is issuing a                  (IT) system, ICE Homeland Security
                                                       Contact Information: Requests for                    Notice of Proposed Rulemaking to                      Investigations (HSI), Counterterrorism
                                                    copies of the patent application or                     exempt this system of records from                    and Criminal Exploitation Unit (CTCEU)
                                                    inquiries about licensing, research                     certain provisions of the Privacy Act,                collects PII from key DHS databases and
                                                    collaborations, and co-development                      elsewhere in the Federal Register. This               analyzes it to identify suspected status
                                                    opportunities should be sent to John D.                 newly established system will be                      violators. This system of records
                                                    Hewes, Ph.D., email: john.hewes@                        included in the Department of                         contains records from Arrival and
                                                    nih.gov.                                                Homeland Security’s inventory of                      Departure Information System (ADIS),
                                                      Dated: August 2, 2016.                                record systems.                                       Student and Exchange Visitor
                                                                                                            DATES: Submit comments on or before                   Information System (SEVIS),
                                                    John D. Hewes,
                                                                                                            September 8, 2016.This new system will                Enforcement Integrated Database (EID/
                                                    Technology Transfer Specialist, Technology                                                                    ENFORCE), TECS, Consular
                                                    Transfer Center, National Cancer Institute.             be effective September 8, 2016.
                                                                                                                                                                  Consolidated Database (CCD),
                                                    [FR Doc. 2016–18862 Filed 8–8–16; 8:45 am]              ADDRESSES: You may submit comments,
                                                                                                                                                                  Computer—Linked Application
                                                                                                            identified by docket number DHS–
                                                    BILLING CODE 4140–01–P                                                                                        Information Management System
                                                                                                            2016–0053 by one of the following
                                                                                                                                                                  (CLAIMS 3), Automated Biometric
                                                                                                            methods:
                                                                                                                                                                  Identification System (IDENT), and from
                                                                                                              • Federal e-Rulemaking Portal: http://
                                                    DEPARTMENT OF HOMELAND                                                                                        commercial databases and public
                                                                                                            www.regulations.gov. Follow the
                                                    SECURITY                                                                                                      sources. CTCEU will also use LeadTrac
                                                                                                            instructions for submitting comments.
                                                                                                              • Fax: 202–343–4010.                                to collect information about
                                                    Office of the Secretary                                                                                       organizations such as schools,
                                                                                                              • Mail: Jonathan R. Cantor, Acting
                                                    [Docket No. DHS–2016–0053]                              Chief Privacy Officer, Privacy Office,                universities, and exchange visitor
                                                                                                            Department of Homeland Security,                      programs being investigated by CTCEU,
                                                    Privacy Act of 1974; Department of                      Washington, DC 20528–0655.                            and information about individuals,
                                                    Homeland Security/ICE–015 LeadTrac                        Instructions: All submissions received              including designated school officials
                                                    System of Records                                       must include the agency name and                      (DSOs) and associates of suspected
                                                                                                            docket number for this rulemaking. All                status violators.
                                                    AGENCY:  Privacy Office, Department of                                                                           ICE collects information in LeadTrac
                                                    Homeland Security (DHS).                                comments received will be posted
                                                                                                                                                                  about suspected status violators and
                                                    ACTION: Notice of Privacy Act system of
                                                                                                            without change to http://
                                                                                                                                                                  organizations to help enforce
                                                    records.                                                www.regulations.gov, including any
                                                                                                                                                                  compliance with U.S. immigration laws.
                                                                                                            personal information provided.                        Specifically, the information is collected
                                                    SUMMARY:    In accordance with the                        Docket: For access to the docket to
                                                                                                                                                                  and used to support the following DHS
                                                    Privacy Act of 1974, the Department of                  read background documents or
                                                                                                                                                                  activities: Investigating and determining
                                                    Homeland Security (DHS) proposes to                     comments received, please visit http://
                                                                                                                                                                  immigration status of individuals;
                                                    establish a new DHS system of records                   www.regulations.gov.                                  identifying fraudulent schools and/or
                                                    titled, ‘‘DHS/ICE–015 LeadTrac System                   FOR FURTHER INFORMATION CONTACT: For                  organizations and the people affiliated
                                                    of Records.’’ This new system of records                general questions, please contact:                    with those schools or organizations;
                                                    is being created from a previously                      Amber Smith, Privacy Officer, (202)                   providing HSI and Enforcement and
                                                    issued system of records, DHS/ICE 009–                  732–3300, U.S. Immigration and                        Removal Operations (ERO) with
                                                    External Investigations SORN. 73 FR                     Customs Enforcement, 500 12th Street                  information to further investigate
                                                    75452 (Dec. 11, 2008). This system of                   SW., Mail Stop 5004, Washington, DC                   suspected status violators; and carrying
                                                    records allows DHS to collect and                       20536, email: ICEPrivacy@dhs.gov. For                 out the required enforcement activity.
                                                    maintain records gathered by and in the                 privacy questions, please contact:                       Some of the individuals about whom
                                                    possession of U.S. Immigrations and                     Jonathan R. Cantor, (202) 343–1717,                   ICE collects information in LeadTrac,
                                                    Customs Enforcement (ICE), Homeland                     Acting Chief Privacy Officer, Privacy                 such as DSOs and associates of
                                                    Security Investigations (HSI),                          Office, Department of Homeland                        suspected status violators, may have
                                                    Counterterrorism and Criminal                           Security, Washington, DC 20528–0655.                  lawful permanent resident (LPR) status
                                                    Exploitation Unit (CTCEU) and ICE field                 SUPPLEMENTARY INFORMATION:                            or be U.S. citizens. CTCEU and Overstay
                                                    offices for appropriate enforcement                                                                           Analysis Unit (OAU) personnel query a
                                                    action, used in the course of their duties              I. Background                                         variety of DHS and non-DHS
                                                    in identifying, investigating, and taking                  In accordance with the Privacy Act of              information systems and enter the
                                                    enforcement action against foreign                      1974, 5 U.S.C. 552a, the Department of                results into LeadTrac to build a unified
                                                    students, exchange visitors, and other                  Homeland Security (DHS)/U.S.                          picture of an individual’s entry/exit,
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    non-immigrant visitors to the United                    Immigration and Customs Enforcement                   visa, criminal, and immigration history,
                                                    States who overstay their period of                     (ICE) proposes to establish a new DHS                 and will comparably process
                                                    admission or otherwise violate the terms                system of records titled, ‘‘DHS/ICE–015               information about associated
                                                    of their visa, immigrant, or non-                       LeadTrac System of Records.’’                         individuals and organizations. Using
                                                    immigrant status (collectively, status                     This record system allows DHS to                   this assembled information, CTCEU
                                                    violators) through the LeadTrac system.                 collect and maintain information about                personnel will determine which
                                                    This SORN also allows DHS to collect                    foreign students, exchange visitors, and              individuals and organizations warrant
                                                    information in LeadTrac about                           other non-immigrant visitors to the                   additional investigation for possible


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Document Created: 2016-08-09 01:10:19
Document Modified: 2016-08-09 01:10:19
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
ContactInformation on licensing and co- development research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850-9702, Tel. 240-276-5515 or email [email protected] A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications.
FR Citation81 FR 52699 

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