80_FR_14193 80 FR 14141 - Government-Owned Inventions; Availability for Licensing

80 FR 14141 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 52 (March 18, 2015)

Page Range14141-14142
FR Document2015-06123

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

Federal Register, Volume 80 Issue 52 (Wednesday, March 18, 2015)
[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Pages 14141-14142]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06123]


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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. 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.

FOR FURTHER INFORMATION CONTACT: Licensing information and copies of 
the U.S. patent applications listed below may be obtained by writing to 
the indicated licensing contact at the Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to 
receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology descriptions follow.

GTF2I Mutations as Genetic Marker for Prognosis of Thymic Malignancies

    Description of Technology: The present invention describes the 
presence of a mutation in the general transcription factor IIi (GTF2I) 
gene in indolent thymic tumors that is rarely found in more aggressive 
thymic tumors.
    The invention provides a method of determining the prognosis of 
thymic cancer in a patient by assaying (for example using PCR based 
methods) the genetic material obtained from the patient tissue to 
detect a mutation in at least one copy of GTF2I genetic sequence; and 
correlating the presence of a GTF2I mutation with the prognosis of a 
thymic cancer patient, the presence of the mutation indicating that the 
thymic cancer is indolent.
    A genetic test will complement the diagnostic assessment, 
facilitate development of a molecular classification and assessment for 
the clinical management of thymic cancers.
    Potential Commercial Applications:
     A diagnostic test kit for the prognosis and clinical 
management of thymic cancer.
     Clinical decision whether treatment is needed (for 
example, additional treatment after surgery).
     Therapeutic decision making, between an aggressive course 
of

[[Page 14142]]

treatment for more aggressive cancers versus non aggressive treatment.
    Competitive Advantages: The PCR based method is more advantageous 
and more objective than currently available histological classification 
and staging systems.
    Development Stage:
     Early-stage.
     In vitro data available.
     In vivo data available (human).
    Inventors: Guiseppe Giaccone and Yisong Wang (NCI).
    Publication: Petrini I, et al. A specific missense mutation in 
GTF2I occurs at high frequency in thymic epithelial tumors. Nat Genet. 
2014 Aug;46(8):844-9. [PMID 24974848].
    Intellectual Property: HHS Reference No. E-109-2014/0--US 
Provisional Application No. 61/975,222 filed April 4, 2014.
    Licensing Contact: Sabarni Chatterjee, Ph.D., MBA; 301-435-5587; 
chatterjeesa@mail.nih.gov.
    Collaborative Research Opportunity: For collaboration 
opportunities, please contact Dr. Guiseppe Giaccone at 
gg496@georgetown.edu.

Systems and Devices for Training and Imaging an Awake Test Animal

    Description of Technology: The invention pertains to an apparatus 
and training system for rodents to maintain its head substantially 
motionless during an imaging procedure. The system includes a frame 
defining an enclosure for enclosing an animal therein during the 
imaging procedure which has a head post attached to the head of the 
animal and a treadmill having a plurality of rollers that the animal 
walks on such that one or more of the plurality of wheels rotate when 
the animal is in walking motion and stop rotating when the animal is in 
a substantially motionless state. This arrangement trains the animal to 
remain substantially motionless when disposed within an imaging 
apparatus. This invention permits prolonged imaging of awake rodents 
with minimal confinement and reduces stress.
    Potential Commercial Applications:
     Imaging test rodents.
     Imaging pharmacological agent distribution in rodents.
     Imaging the therapeutically effects of pharmacological 
agent.
    Competitive Advantages: Imaging while animal is awake.
    Development Stage:
     Early-stage.
     Prototype.
    Inventors: Hanbing Lu, Yihong Yang, Elliot Stein (all of NIDA).
    Intellectual Property: HHS Reference No. E-043-2015/0--US Patent 
Application 14/589,725 filed January 5, 2015.
    Licensing Contact: Michael Shmilovich; 301-435-5019; 
shmilovm@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute on Drug 
Abuse is seeking statements of capability or interest from parties 
interested in collaborative research to further develop apparatus and/
or the training system; commercialize with pharmaceutical industry. For 
collaboration opportunities, please contact Vio Conley, M.S. at 
conleyv@mail.nih.gov.

Miniature System for Manipulating Small Animals in High-Throughput 
Screening Small Molecules

    Description of Technology: The invention pertains to a miniaturized 
plating and feeding system based on a 96-well microplate base and is 
intended to reduce manipulation of organisms as well as amounts of test 
drug/anesthetic, thereby mitigating waste. The kit comprises a feeder 
plate, transfer adaptor and receiver plate. The feeder plate is defined 
by, for example, a plastic 96-well plate with rounded wells. The 
rounded bottoms can dispense to or permit access to the test organism 
of liquid food or drug through about 7 holes of approximately 350 
microns in diameter. A top portion of the well provides test organisms 
(e.g., drosophila, daphnia) with sufficient space to enjoy normal life-
cycles without confinement stress. The feeder plate includes means for 
interfacing with complementary components of the transfer and receiver 
plates through receiving holes and complementary dowels or pins. A 
transfer adapter allows the interconnection of the feeder plate to the 
receiver plate. The transfer plate can be configured to be square or 
rounded for the transfer of organisms from the feeder plate to the 
receiver plate.
    Potential Commercial Applications:
     Drug Development.
     Toxicity Studies.
     Drug Design.
    Competitive Advantages:
     Small animals.
     High Throughput.
     Space efficiency.
     Resource economy.
    Development Stage:
     Early stage.
     Prototype.
    Inventors: Maria De Los Angeles Jaime and Brian Oliver (NIDDK).
    Intellectual Property: HHS Reference No. E-034-2015/0--US 
Provisional Application No. 62/080,181 filed November 14, 2014.
    Licensing Contact: Michael Shmilovich, Esq.; 301-435-5019; 
shmilovm@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Diabetes and Digestive and Kidney Diseases is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize High-Throughput 
Small Animal Manipulation for Drug Design. For collaboration 
opportunities, please contact Marguerite J. Miller at 
millermarg@niddk.nih.gov.
    This abstract replaces one published on Thursday, January 29, 2015 
(80 FR 4935) to correct the patent application filing date.

    Dated: March 12, 2015.
Richard U. Rodriguez, M.B.A.,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-06123 Filed 3-17-15; 8:45 am]
 BILLING CODE 4140-01-P



                                                                                       Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices                                                                14141

                                                  information collection. This is a one-                                 for managing patients with chronic                                  voluntary and all responses CDC will
                                                  time data collection effort.                                           conditions and to improve the quality of                            de-identify all responses. There are no
                                                    CDC will use the information to                                      care delivered. NCHS and CDC will also                              costs to respondents other than their
                                                  examine health systems and                                             use the results to improve technical                                time. The total estimated annualized
                                                  dissemination of health systems                                        assistance to public health partners.                               burden hours are 429.
                                                  technology. Primary care practices will                                  OMB approval is requested for two
                                                  use the results to inform their systems                                years. Participation in the survey is

                                                                                                                        ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                             Average
                                                                                                                                                                                                               Number
                                                                                                                                                                                             Number of                     burden per
                                                                     Type of respondent                                                         Form name                                                  responses per
                                                                                                                                                                                            respondents                     response
                                                                                                                                                                                                             respondent     (in hours)

                                                  Physician .........................................................   Cognitive Testing Screener ............................                       25               1           5/60
                                                  Physician .........................................................   Cognitive Testing Protocol .............................                      15               1           1.25
                                                  Medical Secretary ...........................................         NSPCP Screener ...........................................                 1,500               1          10/60
                                                  Physician .........................................................   NSPCP ...........................................................            473               1          20/60



                                                  Leroy A. Richardson,                                                   Arthritis & Musculoskeletal and Skin                                may be obtained by writing to the
                                                  Chief, Information Collection Review Office,                           Diseases, Building 10, Room 9N228, MSC                              indicated licensing contact at the Office
                                                  Office of Scientific Integrity, Office of the                          1820, Bethesda, MD 20892, (301) 496–2612,                           of Technology Transfer, National
                                                  Associate Director for Science, Office of the                          osheaj@arb.niams.nih.gov.                                           Institutes of Health, 6011 Executive
                                                  Director, Centers for Disease Control and                                 Any interested person may file written                           Boulevard, Suite 325, Rockville,
                                                  Prevention.                                                            comments with the committee by forwarding                           Maryland 20852–3804; telephone: 301–
                                                  [FR Doc. 2015–06159 Filed 3–17–15; 8:45 am]                            the statement to the Contact Person listed on
                                                                                                                         this notice. The statement should include the
                                                                                                                                                                                             496–7057; fax: 301–402–0220. A signed
                                                  BILLING CODE 4163–18–P                                                                                                                     Confidential Disclosure Agreement will
                                                                                                                         name, address, telephone number and when
                                                                                                                         applicable, the business or professional                            be required to receive copies of the
                                                                                                                         affiliation of the interested person.                               patent applications.
                                                  DEPARTMENT OF HEALTH AND
                                                  HUMAN SERVICES                                                         (Catalogue of Federal Domestic Assistance                           SUPPLEMENTARY INFORMATION:
                                                                                                                         Program Nos. 93.846, Arthritis,                                     Technology descriptions follow.
                                                  National Institutes of Health                                          Musculoskeletal and Skin Diseases Research,
                                                                                                                         National Institutes of Health, HHS).                                GTF2I Mutations as Genetic Marker for
                                                  National Institute of Arthritis and                                      Dated: March 12, 2015.
                                                                                                                                                                                             Prognosis of Thymic Malignancies
                                                  Musculoskeletal and Skin Diseases;                                     Carolyn Baum,                                                          Description of Technology: The
                                                  Notice of Closed Meeting                                               Program Analyst, Office of Federal Advisory                         present invention describes the
                                                    Pursuant to section 10(d) of the                                     Committee Policy.                                                   presence of a mutation in the general
                                                  Federal Advisory Committee Act, as                                     [FR Doc. 2015–06122 Filed 3–17–15; 8:45 am]                         transcription factor IIi (GTF2I) gene in
                                                  amended (5 U.S.C. App.), notice is                                     BILLING CODE 4140–01–P
                                                                                                                                                                                             indolent thymic tumors that is rarely
                                                  hereby given of a meeting of the Board                                                                                                     found in more aggressive thymic
                                                  of Scientific Counselors, NIAMS.                                                                                                           tumors.
                                                    The meeting will be closed to the                                    DEPARTMENT OF HEALTH AND                                               The invention provides a method of
                                                  public as indicated below in accordance                                HUMAN SERVICES                                                      determining the prognosis of thymic
                                                  with the provisions set forth in section                                                                                                   cancer in a patient by assaying (for
                                                  552b(c)(6), Title 5 U.S.C., as amended                                 National Institutes of Health                                       example using PCR based methods) the
                                                  for the review, discussion, and                                                                                                            genetic material obtained from the
                                                                                                                         Government-Owned Inventions;                                        patient tissue to detect a mutation in at
                                                  evaluation of individual intramural                                    Availability for Licensing
                                                  programs and projects conducted by the                                                                                                     least one copy of GTF2I genetic
                                                  National Institute of Arthritis and                                    AGENCY:        National Institutes of Health,                       sequence; and correlating the presence
                                                  Musculoskeletal and Skin Diseases,                                     HHS.                                                                of a GTF2I mutation with the prognosis
                                                  including consideration of personnel                                   ACTION:      Notice.                                                of a thymic cancer patient, the presence
                                                  qualifications and performance, and the                                                                                                    of the mutation indicating that the
                                                  competence of individual investigators,                                SUMMARY:   The inventions listed below                              thymic cancer is indolent.
                                                  the disclosure of which would                                          are owned by an agency of the U.S.                                     A genetic test will complement the
                                                  constitute a clearly unwarranted                                       Government and are available for                                    diagnostic assessment, facilitate
                                                  invasion of personal privacy.                                          licensing in the U.S. in accordance with                            development of a molecular
                                                                                                                         35 U.S.C. 209 and 37 CFR part 404 to                                classification and assessment for the
                                                    Name of Committee: Board of Scientific
                                                  Counselors, NIAMS.                                                     achieve expeditious commercialization                               clinical management of thymic cancers.
                                                    Date: April 15–16, 2015.                                             of results of federally-funded research                                Potential Commercial Applications:
                                                                                                                         and development. Foreign patent                                        • A diagnostic test kit for the
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                                                    Time: 6:00 p.m. to 3:45 p.m.
                                                    Agenda: To review and evaluate personal                              applications are filed on selected                                  prognosis and clinical management of
                                                  qualifications and performance, and                                    inventions to extend market coverage                                thymic cancer.
                                                  competence of individual investigators.                                for companies and may also be available                                • Clinical decision whether treatment
                                                    Place: National Institutes of Health,                                for licensing.
                                                  Building 31, Room 4C32, 31 Center Drive,
                                                                                                                                                                                             is needed (for example, additional
                                                  Bethesda, MD 20892.                                                    FOR FURTHER INFORMATION CONTACT:                                    treatment after surgery).
                                                    Contact Person: John J. O’Shea, MD, Ph.D.,                           Licensing information and copies of the                                • Therapeutic decision making,
                                                  Scientific Director, National Institute of                             U.S. patent applications listed below                               between an aggressive course of


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                                                  14142                       Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices

                                                  treatment for more aggressive cancers                   Application 14/589,725 filed January 5,                  Licensing Contact: Michael
                                                  versus non aggressive treatment.                        2015.                                                 Shmilovich, Esq.; 301–435–5019;
                                                     Competitive Advantages: The PCR                        Licensing Contact: Michael                          shmilovm@mail.nih.gov.
                                                  based method is more advantageous and                   Shmilovich; 301–435–5019; shmilovm@                      Collaborative Research Opportunity:
                                                  more objective than currently available                 mail.nih.gov.                                         The National Institute of Diabetes and
                                                  histological classification and staging                   Collaborative Research Opportunity:                 Digestive and Kidney Diseases is
                                                  systems.                                                The National Institute on Drug Abuse is               seeking statements of capability or
                                                     Development Stage:                                   seeking statements of capability or                   interest from parties interested in
                                                     • Early-stage.                                       interest from parties interested in                   collaborative research to further
                                                     • In vitro data available.                           collaborative research to further develop             develop, evaluate or commercialize
                                                     • In vivo data available (human).                    apparatus and/or the training system;                 High-Throughput Small Animal
                                                     Inventors: Guiseppe Giaccone and                     commercialize with pharmaceutical                     Manipulation for Drug Design. For
                                                  Yisong Wang (NCI).                                      industry. For collaboration                           collaboration opportunities, please
                                                     Publication: Petrini I, et al. A specific            opportunities, please contact Vio                     contact Marguerite J. Miller at
                                                  missense mutation in GTF2I occurs at                    Conley, M.S. at conleyv@mail.nih.gov.                 millermarg@niddk.nih.gov.
                                                  high frequency in thymic epithelial
                                                  tumors. Nat Genet. 2014 Aug;46(8):844–                  Miniature System for Manipulating                        This abstract replaces one published
                                                  9. [PMID 24974848].                                     Small Animals in High-Throughput                      on Thursday, January 29, 2015 (80 FR
                                                     Intellectual Property: HHS Reference                 Screening Small Molecules                             4935) to correct the patent application
                                                  No. E–109–2014/0—US Provisional                                                                               filing date.
                                                                                                             Description of Technology: The
                                                  Application No. 61/975,222 filed April                  invention pertains to a miniaturized                    Dated: March 12, 2015.
                                                  4, 2014.                                                plating and feeding system based on a                 Richard U. Rodriguez, M.B.A.,
                                                     Licensing Contact: Sabarni Chatterjee,               96-well microplate base and is intended               Acting Director, Office of Technology
                                                  Ph.D., MBA; 301–435–5587;                               to reduce manipulation of organisms as                Transfer, National Institutes of Health.
                                                  chatterjeesa@mail.nih.gov.                              well as amounts of test drug/anesthetic,              [FR Doc. 2015–06123 Filed 3–17–15; 8:45 am]
                                                     Collaborative Research Opportunity:                  thereby mitigating waste. The kit                     BILLING CODE 4140–01–P
                                                  For collaboration opportunities, please                 comprises a feeder plate, transfer
                                                  contact Dr. Guiseppe Giaccone at                        adaptor and receiver plate. The feeder
                                                  gg496@georgetown.edu.                                   plate is defined by, for example, a                   DEPARTMENT OF HEALTH AND
                                                  Systems and Devices for Training and                    plastic 96-well plate with rounded                    HUMAN SERVICES
                                                  Imaging an Awake Test Animal                            wells. The rounded bottoms can
                                                                                                          dispense to or permit access to the test              National Institutes of Health
                                                     Description of Technology: The
                                                                                                          organism of liquid food or drug through
                                                  invention pertains to an apparatus and                                                                        Center for Scientific Review; Notice of
                                                                                                          about 7 holes of approximately 350
                                                  training system for rodents to maintain                                                                       Closed Meetings
                                                                                                          microns in diameter. A top portion of
                                                  its head substantially motionless during
                                                                                                          the well provides test organisms (e.g.,                 Pursuant to section 10(d) of the
                                                  an imaging procedure. The system
                                                                                                          drosophila, daphnia) with sufficient                  Federal Advisory Committee Act, as
                                                  includes a frame defining an enclosure
                                                                                                          space to enjoy normal life-cycles                     amended (5 U.S.C. App.), notice is
                                                  for enclosing an animal therein during
                                                                                                          without confinement stress. The feeder                hereby given of the following meetings.
                                                  the imaging procedure which has a head
                                                                                                          plate includes means for interfacing
                                                  post attached to the head of the animal                                                                         The meetings will be closed to the
                                                                                                          with complementary components of the
                                                  and a treadmill having a plurality of                                                                         public in accordance with the
                                                                                                          transfer and receiver plates through
                                                  rollers that the animal walks on such                                                                         provisions set forth in sections
                                                                                                          receiving holes and complementary
                                                  that one or more of the plurality of                                                                          552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
                                                                                                          dowels or pins. A transfer adapter
                                                  wheels rotate when the animal is in                                                                           as amended. The grant applications and
                                                                                                          allows the interconnection of the feeder
                                                  walking motion and stop rotating when                                                                         the discussions could disclose
                                                                                                          plate to the receiver plate. The transfer
                                                  the animal is in a substantially                                                                              confidential trade secrets or commercial
                                                                                                          plate can be configured to be square or
                                                  motionless state. This arrangement                                                                            property such as patentable material,
                                                                                                          rounded for the transfer of organisms
                                                  trains the animal to remain substantially                                                                     and personal information concerning
                                                                                                          from the feeder plate to the receiver
                                                  motionless when disposed within an                                                                            individuals associated with the grant
                                                                                                          plate.
                                                  imaging apparatus. This invention                                                                             applications, the disclosure of which
                                                                                                             Potential Commercial Applications:
                                                  permits prolonged imaging of awake                                                                            would constitute a clearly unwarranted
                                                                                                             • Drug Development.
                                                  rodents with minimal confinement and                                                                          invasion of personal privacy.
                                                                                                             • Toxicity Studies.
                                                  reduces stress.
                                                     Potential Commercial Applications:                      • Drug Design.                                       Name of Committee: Center for Scientific
                                                                                                             Competitive Advantages:                            Review Special Emphasis Panel; PAR Panel:
                                                     • Imaging test rodents.                                                                                    Cancer Health Disparities/Diversity in Basic
                                                     • Imaging pharmacological agent                         • Small animals.                                   Cancer Research.
                                                  distribution in rodents.                                   • High Throughput.                                   Date: April 13–14, 2015.
                                                     • Imaging the therapeutically effects                   • Space efficiency.                                  Time: 8:00 a.m. to 5:00 p.m.
                                                  of pharmacological agent.                                  • Resource economy.                                  Agenda: To review and evaluate grant
                                                     Competitive Advantages: Imaging                         Development Stage:                                 applications.
                                                                                                             • Early stage.                                       Place: Embassy Suites at the Chevy Chase
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                                                  while animal is awake.
                                                     Development Stage:                                      • Prototype.                                       Pavilion, 4300 Military Road, NW.,
                                                                                                                                                                Washington, DC 20015.
                                                     • Early-stage.                                          Inventors: Maria De Los Angeles Jaime
                                                                                                                                                                  Contact Person: Nywana Sizemore, Ph.D.,
                                                     • Prototype.                                         and Brian Oliver (NIDDK).                             Scientific Review Officer, Center for
                                                     Inventors: Hanbing Lu, Yihong Yang,                     Intellectual Property: HHS Reference               Scientific Review, National Institutes of
                                                  Elliot Stein (all of NIDA).                             No. E–034–2015/0—US Provisional                       Health, 6701 Rockledge Drive, Room 6204,
                                                     Intellectual Property: HHS Reference                 Application No. 62/080,181 filed                      MSC 7804, Bethesda, MD 20892, 301–435–
                                                  No. E–043–2015/0—US Patent                              November 14, 2014.                                    1718, sizemoren@csr.nih.gov.



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Document Created: 2018-02-21 09:39:41
Document Modified: 2018-02-21 09:39:41
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 U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402- 0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.
FR Citation80 FR 14141 

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