82_FR_47950 82 FR 47753 - Government-Owned Inventions; Availability for Licensing

82 FR 47753 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 197 (October 13, 2017)

Page Range47753-47754
FR Document2017-22146

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.

Federal Register, Volume 82 Issue 197 (Friday, October 13, 2017)
[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)]
[Notices]
[Pages 47753-47754]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22146]


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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 inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S.

FOR FURTHER INFORMATION CONTACT: Licensing information and copies of 
the patent applications listed below may be obtained by emailing the 
indicated licensing contact at the National Heart, Lung, and Blood, 
Office of Technology Transfer and Development Office of Technology 
Transfer, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479; 
telephone: 301-402-5579. A signed Confidential Disclosure Agreement may 
be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: This notice is 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. A description of 
the technology follows.

Derivatives of Docosahexaenoylethanolamide (DEA) for Neurogenesis

    The invention pertains to derivatives of 
docosahexaenoylethanolamide (synaptamide or DEA) and their use in 
inducing neurogenesis, neurite growth, and/or synaptogenesis. As such, 
these DEA derivatives can be used as therapeutics for neurodegenerative 
diseases such as traumatic brain injury, spinal cord injury, peripheral 
nerve injury, stroke, multiple sclerosis, autism, Alzheimer's disease, 
Huntington's disease, Parkinson's disease, amyotrophic lateral 
sclerosis. The DEA derivatives of the invention have increased potency 
and hydrolysis resistance as compared to native DEA. Docosahexaenoic 
acid (DHA), an n-3

[[Page 47754]]

polyunsaturated fatty acid accumulates in the brain during development, 
and has been implicated in learning and memory development. DEA, a 
metabolite derived from DHA, also has been shown to accelerate neuronal 
growth and development. In vitro studies in which neural progenitor 
cells were treated with DEA derivatives showed an increase in the 
number of somatic neurons produced after differentiation.

Potential Commercial Applications

     Neurogenesis,
     Neurite growth,
     Synaptogenesis,
     Therapeutics for traumatic brain injury, spinal cord 
injury, peripheral nerve injury, stroke, multiple sclerosis, autism, 
Alzheimer's disease, Huntington's disease, Parkinson's disease, and 
amyotrophic lateral sclerosis.
    Inventors: Erika Englund (NCATS), Juan Marugan (NCATS), Samarjit 
Patnaik (NCATS), Hee-Yong Kim (NIAAA).
    Intellectual Property: HHS Reference No. E-070-2012/0, U.S. 
Provisional Patent Application 61/624,741 filed April 16, 2012 
(expired), International Patent Application PCT/US2013/032333 filed 
March 15, 2013 (expired), U.S. Patent 9,422,308; German Patent 
602013016154.2, French Patent 2847178, and UK Patent 2847178.
    Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019; 
[email protected].

    Dated: October 5, 2017.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development .
[FR Doc. 2017-22146 Filed 10-12-17; 8:45 am]
 BILLING CODE 4140-01-P



                                                                                  Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices                                               47753

                                                    SUMMARY:   The Food and Drug                            than 2 business days before the meeting.                Dated: October 6, 2017.
                                                    Administration (FDA) announces a                        If FDA is unable to post the background               Anna K. Abram,
                                                    forthcoming public advisory committee                   material on its Web site prior to the                 Deputy Commissioner for Policy, Planning,
                                                    meeting of the Orthopaedic and                          meeting, the background material will                 Legislation, and Analysis.
                                                    Rehabilitation Devices Panel of the                     be made publicly available at the                     [FR Doc. 2017–22174 Filed 10–12–17; 8:45 am]
                                                    Medical Devices Advisory Committee.                     location of the advisory committee                    BILLING CODE 4164–01–P
                                                    The general function of the committee is                meeting, and the background material
                                                    to provide advice and recommendations                   will be posted on FDA’s Web site after
                                                    to the Agency on FDA’s regulatory                       the meeting. Background material is                   DEPARTMENT OF HEALTH AND
                                                    issues. The meeting will be open to the                 available at https://www.fda.gov/                     HUMAN SERVICES
                                                    public.                                                 AdvisoryCommittees/Calendar/
                                                    DATES: The meeting will be held on                      default.htm. Scroll down to the                       National Institutes of Health
                                                    December 12, 2017, from 8 a.m. to 6                     appropriate advisory committee meeting
                                                    p.m.                                                    link.                                                 Government-Owned Inventions;
                                                                                                               Procedure: Interested persons may                  Availability for Licensing
                                                    ADDRESSES: Hilton Washington DC
                                                    North/Gaithersburg, salons A, B, C, and                 present data, information, or views,                  AGENCY:    National Institutes of Health,
                                                    D, 620 Perry Pkwy., Gaithersburg, MD                    orally or in writing, on issues pending               HHS.
                                                    20877. The hotel’s telephone number is                  before the committee. Written                         ACTION:   Notice.
                                                    301–977–8900.                                           submissions may be made to the contact
                                                    FOR FURTHER INFORMATION CONTACT: Sara                   person on or before December 1, 2017.                 SUMMARY:    The inventions listed below
                                                    J. Anderson, Center for Devices and                     Oral presentations from the public will               are owned by an agency of the U.S.
                                                    Radiological Health, Food and Drug                      be scheduled between approximately 1                  Government and are available for
                                                    Administration, 10903 New Hampshire                     p.m. and 2 p.m. Those individuals                     licensing in the U.S.
                                                    Ave., Bldg. 66, Rm. G616, Silver Spring,                interested in making formal oral                      FOR FURTHER INFORMATION CONTACT:
                                                    MD 20993–0002, 301–796–7047,                            presentations should notify the contact               Licensing information and copies of the
                                                    Sara.Anderson@fda.hhs.gov, or FDA                       person and submit a brief statement of                patent applications listed below may be
                                                    Advisory Committee Information Line,                    the general nature of the evidence or                 obtained by emailing the indicated
                                                    1–800–741–8138 (301–443–0572 in the                     arguments they wish to present, the                   licensing contact at the National Heart,
                                                    Washington, DC area). A notice in the                   names and addresses of proposed                       Lung, and Blood, Office of Technology
                                                    Federal Register about last minute                      participants, and an indication of the                Transfer and Development Office of
                                                    modifications that impact a previously                  approximate time requested to make                    Technology Transfer, 31 Center Drive
                                                    announced advisory committee meeting                    their presentation on or before                       Room 4A29, MSC2479, Bethesda, MD
                                                    cannot always be published quickly                      November 3, 2017. Time allotted for                   20892–2479; telephone: 301–402–5579.
                                                    enough to provide timely notice.                        each presentation may be limited. If the              A signed Confidential Disclosure
                                                    Therefore, you should always check the                  number of registrants requesting to                   Agreement may be required to receive
                                                    Agency’s Web site at https://                           speak is greater than can be reasonably               copies of the patent applications.
                                                    www.fda.gov/AdvisoryCommittees/                         accommodated during the scheduled                     SUPPLEMENTARY INFORMATION: This
                                                    default.htm and scroll down to the                      open public hearing session, FDA may                  notice is in accordance with 35 U.S.C.
                                                    appropriate advisory committee meeting                  conduct a lottery to determine the                    209 and 37 CFR part 404 to achieve
                                                    link, or call the advisory committee                    speakers for the scheduled open public                expeditious commercialization of
                                                    information line to learn about possible                hearing session. The contact person will              results of federally-funded research and
                                                    modifications before coming to the                      notify interested persons regarding their             development. Foreign patent
                                                    meeting.                                                request to speak by November 9, 2017.                 applications are filed on selected
                                                    SUPPLEMENTARY INFORMATION:
                                                                                                               Persons attending FDA’s advisory                   inventions to extend market coverage
                                                       Agenda: On December 12, 2017, the                    committee meetings are advised that the               for companies and may also be available
                                                    committee will discuss, make                            Agency is not responsible for providing               for licensing. A description of the
                                                    recommendations, and vote on                            access to electrical outlets.                         technology follows.
                                                    information regarding the premarket                        FDA welcomes the attendance of the
                                                                                                            public at its advisory committee                      Derivatives of
                                                    approval application (PMA) for the
                                                                                                            meetings and will make every effort to                Docosahexaenoylethanolamide (DEA)
                                                    Barricaid Anular Closure Device by
                                                                                                            accommodate persons with disabilities.                for Neurogenesis
                                                    Intrinsic Therapeutics. The proposed
                                                    Indication for Use, as stated in the PMA,               If you require accommodations due to a                  The invention pertains to derivatives
                                                    is as follows: The Barricaid is intended                disability, please contact AnnMarie                   of docosahexaenoylethanolamide
                                                    to be implanted following a limited                     Williams at Annmarie.Williams@                        (synaptamide or DEA) and their use in
                                                    discectomy, to prevent reherniation and                 fda.hhs.gov or 301–796–5966 at least 7                inducing neurogenesis, neurite growth,
                                                    the recurrence of pain or dysfunction.                  days in advance of the meeting.                       and/or synaptogenesis. As such, these
                                                    The Barricaid is indicated for patients                    FDA is committed to the orderly                    DEA derivatives can be used as
                                                    with radiculopathy (with or without                     conduct of its advisory committee                     therapeutics for neurodegenerative
                                                    back pain), a posterior or posterolateral               meetings. Please visit our Web site at                diseases such as traumatic brain injury,
                                                                                                            https://www.fda.gov/
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    herniation, characterized by                                                                                  spinal cord injury, peripheral nerve
                                                    radiographic confirmation of neural                     AdvisoryCommittees/                                   injury, stroke, multiple sclerosis,
                                                    compression using magnetic resonance                    AboutAdvisoryCommittees/                              autism, Alzheimer’s disease,
                                                    imaging, and a large anular defect (e.g.,               ucm111462.htm for procedures on                       Huntington’s disease, Parkinson’s
                                                    between 4–6 mm tall and between 6–12                    public conduct during advisory                        disease, amyotrophic lateral sclerosis.
                                                    mm wide) post discectomy, at one level                  committee meetings.                                   The DEA derivatives of the invention
                                                    between L4 and S1.                                         Notice of this meeting is given under              have increased potency and hydrolysis
                                                       FDA intends to make background                       the Federal Advisory Committee Act (5                 resistance as compared to native DEA.
                                                    material available to the public no later               U.S.C. app. 2).                                       Docosahexaenoic acid (DHA), an n-3


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                                                    47754                         Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices

                                                    polyunsaturated fatty acid accumulates                  property such as patentable material,                 Improving Smoking Cessation in
                                                    in the brain during development, and                    and personal information concerning                   Socioeconomically Disadvantaged
                                                    has been implicated in learning and                     individuals associated with the grant                 Populations via Scalable Interventions.
                                                                                                                                                                    Date: November 7, 2017.
                                                    memory development. DEA, a                              applications, the disclosure of which                   Time: 1:00 p.m. to 5:00 p.m.
                                                    metabolite derived from DHA, also has                   would constitute a clearly unwarranted                  Agenda: To review and evaluate grant
                                                    been shown to accelerate neuronal                       invasion of personal privacy.                         applications.
                                                    growth and development. In vitro                          Name of Committee: Center for Scientific              Place: National Institutes of Health, 6701
                                                    studies in which neural progenitor cells                Review Special Emphasis Panel; Immune                 Rockledge Drive, Bethesda, MD 20892
                                                    were treated with DEA derivatives                       System Plasticity in Dental, Oral, and                (Telephone Conference Call).
                                                    showed an increase in the number of                     Craniofacial Diseases.                                  Contact Person: Kristen Prentice, Ph.D.,
                                                                                                              Date: November 1, 2017.                             Scientific Review Officer, Center for
                                                    somatic neurons produced after                                                                                Scientific Review, National Institutes of
                                                    differentiation.                                          Time: 2:00 p.m. to 6:00 p.m.
                                                                                                              Agenda: To review and evaluate grant                Health, 6701 Rockledge Drive, Room 3112,
                                                    Potential Commercial Applications                       applications.                                         MSC 7808, Bethesda, MD 20892, 301–496–
                                                                                                              Place: National Institutes of Health, 6701          0726, prenticekj@mail.nih.gov.
                                                       • Neurogenesis,                                      Rockledge Drive, Bethesda, MD 20892                     Name of Committee: Center for Scientific
                                                       • Neurite growth,                                    (Virtual Meeting).                                    Review Special Emphasis Panel; Small
                                                       • Synaptogenesis,                                      Contact Person: Yi-Hsin Liu, Ph.D.,                 Business: Digestive Sciences.
                                                       • Therapeutics for traumatic brain                   Scientific Review Officer, Center for                   Date: November 8–9, 2017.
                                                    injury, spinal cord injury, peripheral                  Scientific Review, National Institutes of               Time: 8:00 a.m. to 5:00 p.m.
                                                    nerve injury, stroke, multiple sclerosis,               Health, 6701 Rockledge Drive, Room 4214,                Agenda: To review and evaluate grant
                                                    autism, Alzheimer’s disease,                            MSC 7814, Bethesda, MD 20892, 301–435–                applications.
                                                                                                            1781, liuyh@csr.nih.gov.                                Place: Residence Inn Bethesda, 7335
                                                    Huntington’s disease, Parkinson’s                                                                             Wisconsin Avenue, Bethesda, MD 20814.
                                                    disease, and amyotrophic lateral                          Name of Committee: Center for Scientific
                                                                                                            Review Special Emphasis Panel; PAR–17–                  Contact Person: Martha Garcia, Ph.D.,
                                                    sclerosis.                                              263: Innovation for HIV Vaccine Discovery.            Scientific Reviewer Officer, Center for
                                                       Inventors: Erika Englund (NCATS),                      Date: November 3, 2017.                             Scientific Review, National Institutes of
                                                    Juan Marugan (NCATS), Samarjit                            Time: 10:00 a.m. to 5:00 p.m.                       Health, 6701 Rockledge Drive, Room 2186,
                                                    Patnaik (NCATS), Hee-Yong Kim                             Agenda: To review and evaluate grant                MSC 7818, Bethesda, MD 20892, 301–435–
                                                    (NIAAA).                                                applications.                                         1243, garciamc@nih.gov.
                                                       Intellectual Property: HHS Reference                   Place: National Institutes of Health, 6701            Name of Committee: Center for Scientific
                                                    No. E–070–2012/0, U.S. Provisional                      Rockledge Drive, Bethesda, MD 20892                   Review Special Emphasis Panel; Small
                                                                                                            (Virtual Meeting).                                    Business: Computational, Modeling, and
                                                    Patent Application 61/624,741 filed                       Contact Person: Barna Dey, Ph.D.,                   Biodata Management.
                                                    April 16, 2012 (expired), International                 Scientific Review Officer, Center for                   Date: November 8, 2017.
                                                    Patent Application PCT/US2013/032333                    Scientific Review, National Institutes of               Time: 8:00 a.m. to 6:00 p.m.
                                                    filed March 15, 2013 (expired), U.S.                    Health, 6701 Rockledge Drive, Room 3184,                Agenda: To review and evaluate grant
                                                    Patent 9,422,308; German Patent                         Bethesda, MD 20892, 301–451–2796, bdey@               applications.
                                                    602013016154.2, French Patent                           mail.nih.gov.                                           Place: Embassy Suites at the Chevy Chase
                                                    2847178, and UK Patent 2847178.                           Name of Committee: Center for Scientific            Pavilion, 4300 Military Road NW.,
                                                       Licensing Contact: Michael                           Review Special Emphasis Panel; Member                 Washington, DC 20015.
                                                    Shmilovich, Esq, CLP; 301–435–5019;                     Conflict: Epidemiology, Ethical and                     Contact Person: Allen Richon, Ph.D.,
                                                                                                            Population Sciences.                                  Scientific Review Officer, Center for
                                                    shmilovm@nih.gov.                                                                                             Scientific Review, National Institutes of
                                                                                                              Date: November 3, 2017.
                                                      Dated: October 5, 2017.                                 Time: 2:30 p.m. to 4:30 p.m.                        Health, 6701 Rockledge Drive, Room 6184,
                                                    Michael Shmilovich,                                       Agenda: To review and evaluate grant                MSC 7892, Bethesda, MD 20892, 301–379–
                                                                                                            applications.                                         9351, allen.richon@nih.hhs.gov.
                                                    Senior Licensing and Patenting Manager,
                                                                                                              Place: National Institutes of Health, 6701            Name of Committee: Center for Scientific
                                                    National Heart, Lung, and Blood Institute,
                                                                                                            Rockledge Drive, Bethesda, MD 20892                   Review Special Emphasis Panel; Member
                                                    Office of Technology Transfer and
                                                                                                            (Telephone Conference Call).                          Conflict: Pathophysiology of
                                                    Development .
                                                                                                              Contact Person: Gniesha Yvonne                      Neurodevelopmental Disorders.
                                                    [FR Doc. 2017–22146 Filed 10–12–17; 8:45 am]            Dinwiddie, Ph.D., Scientific Review Officer,            Date: November 8, 2017.
                                                    BILLING CODE 4140–01–P                                  Center for Scientific Review, National                  Time: 11:00 a.m. to 2:00 p.m.
                                                                                                            Institutes of Health, 6701 Rockledge Drive,             Agenda: To review and evaluate grant
                                                                                                            Room 3137, Bethesda, MD 20892,                        applications.
                                                    DEPARTMENT OF HEALTH AND                                dinwiddiegy@csr.nih.gov.                                Place: National Institutes of Health, 6701
                                                    HUMAN SERVICES                                            Name of Committee: Center for Scientific            Rockledge Drive, Bethesda, MD 20892
                                                                                                            Review Special Emphasis Panel; PAR Panel:             (Telephone Conference Call).
                                                    National Institutes of Health                           Systems Science and Health in the                       Contact Person: Boris P Sokolov, Ph.D.,
                                                                                                            Behavioral and Social Science.                        Scientific Review Officer, Center for
                                                    Center for Scientific Review; Notice of                   Date: November 7, 2017.                             Scientific Review, National Institutes of
                                                    Closed Meetings                                           Time: 1:00 p.m. to 5:00 p.m.                        Health, 6701 Rockledge Drive, Room 5217A,
                                                                                                              Agenda: To review and evaluate grant                MSC 7846, Bethesda, MD 20892, 301–408–
                                                      Pursuant to section 10(d) of the                      applications.                                         9115, bsokolov@csr.nih.gov.
                                                    Federal Advisory Committee Act, as                        Place: National Institutes of Health, 6701            Name of Committee: Center for Scientific
                                                                                                            Rockledge Drive, Bethesda, MD 20892
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                                                    amended, notice is hereby given of the                                                                        Review Special Emphasis Panel; PAR–17–
                                                    following meetings.                                     (Telephone Conference Call).                          171: Cancer Tissue Engineering Collaborative
                                                                                                              Contact Person: Ping Wu, Ph.D., Scientific          Research.
                                                      The meetings will be closed to the
                                                                                                            Review Officer, HDM IRG, Center for                     Date: November 8, 2017.
                                                    public in accordance with the                           Scientific Review, National Institutes of               Time: 12:00 p.m. to 4:30 p.m.
                                                    provisions set forth in sections                        Health, 6701 Rockledge Drive, Room 3166,                Agenda: To review and evaluate grant
                                                    552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              Bethesda, MD 20892, 301–451–8428, wup4@               applications.
                                                    as amended. The grant applications and                  csr.nih.gov.                                            Place: National Institutes of Health, 6701
                                                    the discussions could disclose                            Name of Committee: Center for Scientific            Rockledge Drive, Bethesda, MD 20892
                                                    confidential trade secrets or commercial                Review Special Emphasis Panel; PAR Panel:             (Virtual Meeting).



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Document Created: 2017-10-13 04:33:52
Document Modified: 2017-10-13 04:33:52
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.
ContactLicensing information and copies of the patent applications listed below may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications.
FR Citation82 FR 47753 

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