81_FR_59115 81 FR 58949 - Government-Owned Inventions; Availability for Licensing

81 FR 58949 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 166 (August 26, 2016)

Page Range58949-58950
FR Document2016-20444

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 166 (Friday, August 26, 2016) 
[Federal Register Volume 81, Number 166 (Friday, August 26, 2016)]
[Notices]
[Pages 58949-58950]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20444]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing 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 
[email protected]. A signed Confidential Disclosure 
Agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of invention:
    Detection of Colorectal Cancer Using Two Heme-Related Molecules in 
Human Feces.
    Description of Technology:
    Mortality from colorectal cancer (CRC) can be reduced by detecting 
the cancer or its precursor, colorectal adenoma (CRA), so that it can 
be removed at an early stage. Current tests involve screening stool 
specimens for blood, especially for hemoglobin. The fecal 
immunochemical test (FIT) for hemoglobin is positive in stool for about 
60% of early-stage and 85% of advanced CRC cases, with a false-positive 
rate of less than 10%. Assays with better accuracy are still needed.
    The subject technology is a novel assay that detects the presence 
or absence of one or both of two heme-related peptides, X-18565 and X-
19549 in stool samples. The presence of one, and especially both, of 
these peptides within the stool sample indicates a high likelihood that 
CRC or CRA is present within the patient. X-18565 was detected in 67% 
of CRC cases and the specificity of X-18565 was 99%, as it was detected 
in only 1% of control patients who did not have CRC (e.g., false 
positives). X-19549 was detected in 48% of CRC cases and the 
specificity of X-19549 was 97%, as it was detected in only 3% of 
controls patients who did not have CRC (e.g., false positives). The 
absence of both X-18565 and X-19549 from the stool sample (or extract) 
indicates a greater than 95% likelihood that CRC or CRA is not present 
within the patient from which the stool sample is obtained. The assay 
can be performed on fresh or frozen samples.

[[Page 58950]]

Potential Commercial Applications:

     Diagnostic for colorectal cancer.

Value Proposition:

     Assay has high specificity.
     Fresh and frozen samples can be utilized by this assay.

Development Stage:

    Pre-clinical (in vivo validation).
    Inventor(s):
    James J. Goedert (NCI) and Rashmi Sinha (NCI).

Intellectual Property:

    HHS Reference No. E-198-2014/0-PCT-02.
    International PCT Application No. PCT/US2015/038299 (HHS Reference 
No. E-198-2014/0-PCT-02) filed June 29, 2015 entitled, ``Detection of 
Colorectal Cancer with Two Novel Heme-Related Molecules in Human 
Feces.''

Publications:

1. J.J. Goedert et al. Fecal Metabolomics: Assay Performance and 
Association with Colorectal Cancer. Carcinogenesis. 2014 
Sep;35(9):2089-96. [PMID: 25037050].

Collaboration Opportunity

    The NCI seeks licensing or co-development collaborations the would 
enable eventual commercialization of the diagnostic technology.

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: [email protected].

    Dated: August 17, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-20444 Filed 8-25-16; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Notices 58949 applications, the disclosure of which Bethesda, MD 20892–2542, 301–594–7682, for companies and may also be available would constitute a clearly unwarranted campd@extra.niddk.nih.gov. for licensing and/or co-development. invasion of personal privacy. Name of Committee: National Institute of ADDRESSES: Invention Development and Diabetes and Digestive and Kidney Diseases Name of Committee: National Institute of Special Emphasis Panel; The NIDDK–KUH- Marketing Unit, Technology Transfer Diabetes and Digestive and Kidney Diseases Fellowship Review SEP. Center, National Cancer Institute, 9609 Special Emphasis Panel; NIDDK Ancillary Date: October 7, 2016. Medical Center Drive, Mail Stop 9702, Studies. Time: 8:00 a.m. to 5:00 p.m. Rockville, MD 20850–9702. Date: September 9, 2016. Agenda: To review and evaluate grant Time: 2:00 p.m. to 3:00 p.m. FOR FURTHER INFORMATION CONTACT: applications. Information on licensing and co- Agenda: To review and evaluate grant Place: Kinzie Hotel, 20 W Kinzie Street, applications. Chicago, IL 60654. development research collaborations, Place: National Institutes of Health, Two Contact Person: Xiaodu Guo, MD, Ph.D., and copies of the U.S. patent Democracy Plaza, 6707 Democracy Scientific Review Officer, Review Branch, applications listed below may be Boulevard, Bethesda, MD 20892 (Telephone DEA, NIDDK, National Institutes of Health, obtained by contacting: Attn. Invention Conference Call). Room 7023, 6707 Democracy Boulevard, Development and Marketing Unit, Contact Person: Elena Sanovich, Ph.D., Bethesda, MD 20892–5452, (301) 594–4719, Technology Transfer Center, National Scientific Review Officer, Review Branch, guox@extra.niddk.nih.gov. Cancer Institute, 9609 Medical Center DEA, NIDDK, National Institutes of Health, Room 7351, 6707 Democracy Boulevard, Name of Committee: National Institute of Drive, Mail Stop 9702, Rockville, MD Diabetes and Digestive and Kidney Diseases 20850–9702, Tel. 240–276–5515 or Bethesda, MD 20892–2542, 301–594–8886, Special Emphasis Panel; The NIDDK–DDK–D email ncitechtransfer@mail.nih.gov. A sanoviche@mail.nih.gov. Member Conflict SEP. signed Confidential Disclosure Name of Committee: National Institute of Date: October 7, 2016. Diabetes and Digestive and Kidney Diseases Time: 9:00 a.m. to 4:00 p.m. Agreement may be required to receive Special Emphasis Panel; NIDDK DEM Agenda: To review and evaluate grant copies of the patent applications. Fellowship Grant Applications Review. applications. SUPPLEMENTARY INFORMATION: Date: October 3, 2016. Place: Kinzie Hotel, 20 W Kinzie Street, Technology description follows. Time: 8:00 a.m. to 5:00 p.m. Chicago, IL 60654. Agenda: To review and evaluate grant Title of invention: Contact Person: Xiaodu Guo, MD, Ph.D., applications. Scientific Review Officer, Review Branch, Detection of Colorectal Cancer Using Place: Residence Inn Bethesda, 7335 DEA, NIDDK, National Institutes of Health, Two Heme-Related Molecules in Human Wisconsin Avenue, Bethesda, MD 20814. Room 7023, 6707 Democracy Boulevard, Feces. Contact Person: Carol J. Goter-Robinson, Bethesda, MD 20892–5452, (301) 594–4719, Description of Technology: Ph.D., Scientific Review Officer, Review guox@extra.niddk.nih.gov. Mortality from colorectal cancer Branch, DEA, NIDDK, National Institutes of (Catalogue of Federal Domestic Assistance (CRC) can be reduced by detecting the Health, Room 7347, 6707 Democracy Program Nos. 93.847, Diabetes, cancer or its precursor, colorectal Boulevard, Bethesda, MD 20892–5452, (301) Endocrinology and Metabolic Research; 594–7791, goterrobinsonc@ adenoma (CRA), so that it can be 93.848, Digestive Diseases and Nutrition removed at an early stage. Current tests extra.niddk.nih.gov. Research; 93.849, Kidney Diseases, Urology Name of Committee: National Institute of involve screening stool specimens for and Hematology Research, National Institutes Diabetes and Digestive and Kidney Diseases of Health, HHS) blood, especially for hemoglobin. The Special Emphasis Panel; PAR–15–067: fecal immunochemical test (FIT) for NIDDK Multi-Center Clinical Study Dated: August 22, 2016. hemoglobin is positive in stool for about Cooperative Agreement (U01). David Clary, 60% of early-stage and 85% of advanced Date: October 3, 2016. Program Analyst, Office of Federal Advisory CRC cases, with a false-positive rate of Time: 12:00 p.m. to 2:00 p.m. Committee Policy. less than 10%. Assays with better Agenda: To review and evaluate grant [FR Doc. 2016–20445 Filed 8–25–16; 8:45 am] accuracy are still needed. applications. Place: National Institutes of Health, Two BILLING CODE 4140–01–P The subject technology is a novel Democracy Plaza, 6707 Democracy assay that detects the presence or Boulevard, Bethesda, MD 20892 (Telephone absence of one or both of two heme- Conference Call). DEPARTMENT OF HEALTH AND related peptides, X–18565 and X–19549 Contact Person: Dianne Camp, Ph.D., HUMAN SERVICES in stool samples. The presence of one, Scientific Review Officer, Review Branch, and especially both, of these peptides DEA, NIDDK, National Institutes of Health, National Institutes of Health within the stool sample indicates a high Room 7013, 6707 Democracy Boulevard, likelihood that CRC or CRA is present Bethesda, MD 20892–2542, 301–594–7682, Government-Owned Inventions; Availability for Licensing within the patient. X–18565 was campd@extra.niddk.nih.gov. detected in 67% of CRC cases and the Name of Committee: National Institute of National Institutes of Health, AGENCY: specificity of X–18565 was 99%, as it Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; RFA–DK–16–002: HHS. was detected in only 1% of control Understanding Barriers and Facilitators to ACTION: Notice. patients who did not have CRC (e.g., Type 1 Diabetes Management in Adults. false positives). X–19549 was detected Date: October 6, 2016. SUMMARY: The invention listed below is in 48% of CRC cases and the specificity Time: 1:00 p.m. to 4:30 p.m. owned by an agency of the U.S. of X–19549 was 97%, as it was detected Agenda: To review and evaluate grant Government and is available for in only 3% of controls patients who did applications. licensing and/or co-development in the not have CRC (e.g., false positives). The mstockstill on DSK3G9T082PROD with NOTICES Place: National Institutes of Health, Two U.S. in accordance with 35 U.S.C. 209 absence of both X–18565 and X–19549 Democracy Plaza, 6707 Democracy and 37 CFR part 404 to achieve from the stool sample (or extract) Boulevard, Bethesda, MD 20892 (Telephone Conference Call). expeditious commercialization of indicates a greater than 95% likelihood Contact Person: Dianne Camp, Ph.D., results of federally-funded research and that CRC or CRA is not present within Scientific Review Officer, Review Branch, development. Foreign patent the patient from which the stool sample DEA, NIDDK, National Institutes of Health, applications are filed on selected is obtained. The assay can be performed Room 7013, 6707 Democracy Boulevard, inventions to extend market coverage on fresh or frozen samples. VerDate Sep<11>2014 21:17 Aug 25, 2016 Jkt 238001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\26AUN1.SGM 26AUN1

58950 Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Notices Potential Commercial Applications: attendance limited to space available. DEPARTMENT OF HEALTH AND • Diagnostic for colorectal cancer. Individuals who plan to attend and HUMAN SERVICES need special assistance, such as sign Value Proposition: language interpretation or other National Institutes of Health • Assay has high specificity. reasonable accommodations, should • Fresh and frozen samples can be National Heart, Lung, and Blood notify the Contact Person listed below utilized by this assay. Institute; Notice of Closed Meeting in advance of the meeting. Development Stage: The meeting will be closed to the Pursuant to section 10(d) of the public in accordance with the Federal Advisory Committee Act, as Pre-clinical (in vivo validation). provisions set forth in sections amended (5 U.S.C. App.), notice is Inventor(s): James J. Goedert (NCI) and Rashmi 552b(c)(4) and 552b(c)(6), title 5 U.S.C., hereby given of the following meeting. Sinha (NCI). as amended. The grant applications The meeting will be closed to the public in accordance with the Intellectual Property: and/or contract proposals and the provisions set forth in sections discussions could disclose confidential HHS Reference No. E–198–2014/0– 552b(c)(4) and 552b(c)(6), title 5 U.S.C., trade secrets or commercial property as amended. The grant applications and PCT–02. such as patentable material, and International PCT Application No. the discussions could disclose personal information concerning confidential trade secrets or commercial PCT/US2015/038299 (HHS Reference No. E–198–2014/0–PCT–02) filed June individuals associated with the grant property such as patentable material, 29, 2015 entitled, ‘‘Detection of applications and/or contract proposals, and personal information concerning Colorectal Cancer with Two Novel the disclosure of which would individuals associated with the grant Heme-Related Molecules in Human constitute a clearly unwarranted applications, the disclosure of which Feces.’’ invasion of personal privacy. would constitute a clearly unwarranted Name of Committee: National Advisory invasion of personal privacy. Publications: Council for Biomedical Imaging and Name of Committee: National Heart, Lung, 1. J.J. Goedert et al. Fecal Metabolomics: Bioengineering. and Blood Institute Special Emphasis Panel; Assay Performance and Association Date: September 15, 2016. Zika R21 Rapid Review. with Colorectal Cancer. Open: 8:30 a.m. to 12:00 p.m. Date: September 21, 2016. Carcinogenesis. 2014 Sep;35(9):2089– Agenda: Report from the Institute Director, Time: 1:00 p.m. to 2:00 p.m. 96. [PMID: 25037050]. other Institute Staff and scientific Agenda: To review and evaluate grant presentation. applications. Collaboration Opportunity Place: National Institutes of Health, 6701 Place: The William F. Bolger Center, The NCI seeks licensing or co- Rockledge Drive, Room 7189, Bethesda, MD Franklin Building, Classroom 15/16, 9600 20892, (Telephone Conference Call). development collaborations the would Newbridge Drive, Potomac, MD 20854. Contact Person: Stephanie L Constant, enable eventual commercialization of Closed: 1:30 p.m. to 3:30 p.m. Ph.D., Scientific Review Officer, Office of the diagnostic technology. Agenda: To review and evaluate grant Scientific Review/DERA, National Heart, Contact Information applications and/or proposals. Lung, and Blood Institute, 6701 Rockledge Place: The William F. Bolger Center, Drive, Room 7189, Bethesda, MD 20892, 301– Requests for copies of the patent Franklin Building, Classroom 15/16, 9600 443–8784, constantsl@nhlbi.nih.gov. application or inquiries about licensing, Newbridge Drive, Potomac, MD 20854. (Catalogue of Federal Domestic Assistance research collaborations, and co- Contact Person: David T. George, Ph.D., Program Nos. 93.233, National Center for development opportunities should be Acting Associate Director, Office of Research Sleep Disorders Research; 93.837, Heart and sent to John D. Hewes, Ph.D., email: Administration, National Institute of Vascular Diseases Research; 93.838, Lung john.hewes@nih.gov. Biomedical Imaging, and Bioengineering, Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes Dated: August 17, 2016. 6707 Democracy Boulevard, Room 920, of Health, HHS) John D. Hewes, Bethesda, MD 20892. Technology Transfer Specialist, Technology Any interested person may file written Dated: August 22, 2016. Transfer Center, National Cancer Institute. comments with the committee by forwarding Michelle Trout, [FR Doc. 2016–20444 Filed 8–25–16; 8:45 am] the statement to the Contact Person listed on Program Analyst, Office of Federal Advisory BILLING CODE 4140–01–P this notice. The statement should include the Committee Policy. name, address, telephone number and when [FR Doc. 2016–20438 Filed 8–25–16; 8:45 am] applicable, the business or professional BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND affiliation of the interested person. HUMAN SERVICES Information is also available on the Institute’s/Center’s home page: http:// DEPARTMENT OF HEALTH AND National Institutes of Health www.nibib1.nih.gov/about/NACBIB/ HUMAN SERVICES NACBIB.htm, where an agenda and any National Institute of Biomedical additional information for the meeting will National Institutes of Health Imaging and Bioengineering; Notice of be posted when available. Meeting National Institute of Allergy and Dated: August 22, 2016. Infectious Diseases; Notice of Closed Pursuant to section 10(d) of the mstockstill on DSK3G9T082PROD with NOTICES David Clary, Meeting Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is Program Analyst, Office of Federal Advisory Pursuant to section 10(d) of the hereby given of a meeting of the Committee Policy. Federal Advisory Committee Act, as National Advisory Council for [FR Doc. 2016–20437 Filed 8–25–16; 8:45 am] amended (5 U.S.C. App.), notice is Biomedical Imaging and Bioengineering. BILLING CODE 4140–01–P hereby given of the following meeting. The meeting will be open to the The meeting will be closed to the public as indicated below, with public in accordance with the VerDate Sep<11>2014 21:17 Aug 25, 2016 Jkt 238001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\26AUN1.SGM 26AUN1


Document Created: 2016-08-26 10:40:59
Document Modified: 2016-08-26 10:40:59
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 58949 
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