81 FR 8082 - Prospective Grant of Exclusive License: Development of In Vitro Diagnostics for the Detection of Diseases or Pathogenic Agents
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 31 (February 17, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 31 (February 17, 2016)
| Page Range | 8082-8083 | |
| FR Document | 2016-03187 |
[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)] [Notices] [Pages 8082-8083] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03187] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Development of In Vitro Diagnostics for the Detection of Diseases or Pathogenic Agents AGENCY: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Public Health Service, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), at the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to Altra Tech, Ltd. (``AltraTech''), a company incorporated under the laws of the Ireland, having an office in Shannon, Ireland, an exclusive patent commercialization license to practice the following inventions embodied in the following patent applications: US Provisional Patent Application No.60/846,354, entitled, ``(S,S)-trans- 1,2-cyclopentane Diamine-modified and Gamma-lysine-modified Peptide Nucleic Acids as Probes for Nucleic Acid Detection: Synthesis and Applications,'' filed 22 Sep 2006 [HHS Ref No. E-308-2006/0-US-01]; US Provisional Patent Application No. 60/896,667, entitled, ``Synthesis of Trans-tert-butyl-2-aminocyclopentylcarbamate,'' filed 23 Mar 2007 [HHS Ref No. E-308-2006/1-US-01]; International Application PCT/US2007/ 020466, entitled, ``Synthesis of Trans-tert-butyl-2- aminocyclopentylcarbamate,'' filed 21 Sep 2007 [HHS Ref No. E-308-2006/ 2-PCT-01]; US Patent Application No. 12/441,925, filed 21 Sep 2007, [HHS Ref No. E-308-2006/2-US-02]; US Patent Application No. 12/409,159, entitled, ``Cross-Coupled Peptide Nucleic Acids for Detection of Nucleic Acids of Pathogens,'' filed 23 Mar 2009 [HHS Ref No. E-308- 2006/3-US-01]; US Patent No. 9,156,778, entitled, ``Cross-Coupled Peptide Nucleic Acids for Detection of Nucleic Acids of Pathogens,'' issued 13 Oct 2015 [HHS Ref No. E-308-2006/3-US-02]; US Provisional Patent Application No. 61/684,354, entitled, Cyclopentane-peptide Nucleic Acids for Qualitative and Quantitative Detection of Nucleic Acids,'' filed 17 Aug 2012 [HHS Ref No. E-260-2012/0-US-01]; International Application PCT/US2013/055252, filed 16 Aug 2013 [HHS Ref No. E-260-2012/0-PCT-02]; European Patent Application No. 13753962.3, filed 11 Feb 2015, [HHS Ref No E-260-2012/0-EP-03]; Korea Patent Application No. 10-2015-7006286, filed 11 Mar 2015, [HHS Ref No E-260- 2012/0-KR-04]; US Patent Application No. 14/421,732, filed 13 Feb 2015, [HHS Ref No E-260-2012/0-US-05]; US Provisional Patent Application No. 61/333,442, filed 11 May 2010, [HHS Ref No E-129-2010/0-US-01]; International Patent Application No. PCT/US2011/036090, filed 11 May 2011, [HHS Ref No. E-129-2010/0-PCT-02]; European Patent Application No. 11721899.0, filed 11 May 2011, [HHS Ref No. E-129-2010/0-EP-03]; and US Patent Application No. 13/697,123, filed 9 Nov 2012, [HHS Ref No. E-129-2010/0-US-04]. The patent rights in these inventions have been assigned to the United States of America. AltraTech is seeking a worldwide territory for this license. The field of use may be limited to exclusive use of the licensed patent rights limited to the development and sale of trans-cyclopentane-modified peptide nucleic acids (PNA) in a diagnostic test system incorporating AltraTech's proprietary sample preparation and AltraTech's proprietary semiconductor sensor technology for the detection of infectious diseases or pathogenic agents including viruses and microorganisms. DATES: Only written comments or applications for a license (or both) which are received by the Technology Advancement Office, NIDDK, on or before March 3, 2016 will be considered. ADDRESSES: Requests for copies of the patent application, patents, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Patrick McCue, Ph.D., Senior Licensing and Patenting [[Page 8083]] Manager, Technology Advancement Office, The National Institutes of Diabetes and Digestive and Kidney Diseases, 12A South Drive, Bethesda, MD 20892, Telephone: (301) 451-5560; Email: [email protected]. A signed confidentiality non-disclosure agreement will be required to receive copies of any patent applications that have not been published by the United States Patent and Trademark Office or the World Intellectual Property Organization. SUPPLEMENTARY INFORMATION: These technologies, and the corresponding patent applications, are directed to cyclopentane-peptide nucleic acids (PNA) and their use in qualitative and quantitative detection of nucleic acids. The technologies overcome a stability problem and sensitivity to outside contamination that is inherent to PCR-based detection systems, wherein the PNA probes bind to DNA with greater stability and selectivity compared to a complementary DNA sequence. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the Technology Advancement Office, NIDDK, receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. Properly filed competing applications for a license in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: February 10, 2016. Anna Amar, Acting Deputy Director, Technology Advancement Office, NIDDK. [FR Doc. 2016-03187 Filed 2-16-16; 8:45 am] BILLING CODE 4140-01-P
![8082 Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices
(Catalogue of Federal Domestic Assistance 9609 Medical Center Drive, Room 7W412, PCT–01]; US Patent Application No. 12/
Program Nos. 93.233, National Center for Bethesda, MD 20892–9750, 240–276–6438 441,925, filed 21 Sep 2007, [HHS Ref
Sleep Disorders Research; 93.837, Heart and smallm@mail.nih.gov. No. E–308–2006/2–US–02]; US Patent
Vascular Diseases Research; 93.838, Lung (Catalogue of Federal Domestic Assistance Application No. 12/409,159, entitled,
Diseases Research; 93.839, Blood Diseases Program Nos. 93.392, Cancer Construction;
and Resources Research, National Institutes
‘‘Cross-Coupled Peptide Nucleic Acids
93.393, Cancer Cause and Prevention for Detection of Nucleic Acids of
of Health, HHS) Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Pathogens,’’ filed 23 Mar 2009 [HHS Ref
Dated: February 10, 2016. No. E–308–2006/3–US–01]; US Patent
Treatment Research; 93.396, Cancer Biology
Michelle Trout, No. 9,156,778, entitled, ‘‘Cross-Coupled
Research; 93.397, Cancer Centers Support;
Program Analyst, Office of Federal Advisory 93.398, Cancer Research Manpower; 93.399, Peptide Nucleic Acids for Detection of
Committee Policy. Cancer Control, National Institutes of Health, Nucleic Acids of Pathogens,’’ issued 13
[FR Doc. 2016–03121 Filed 2–16–16; 8:45 am] HHS) Oct 2015 [HHS Ref No. E–308–2006/3–
BILLING CODE 4140–01–P Dated: February 10, 2016. US–02]; US Provisional Patent
Melanie J. Gray,
Application No. 61/684,354, entitled,
Cyclopentane-peptide Nucleic Acids for
DEPARTMENT OF HEALTH AND Program Analyst, Office of Federal Advisory
Committee Policy.
Qualitative and Quantitative Detection
HUMAN SERVICES of Nucleic Acids,’’ filed 17 Aug 2012
[FR Doc. 2016–03124 Filed 2–16–16; 8:45 am]
[HHS Ref No. E–260–2012/0–US–01];
National Institutes of Health BILLING CODE 4140–01–P
International Application PCT/US2013/
055252, filed 16 Aug 2013 [HHS Ref No.
National Cancer Institute; Notice of
E–260–2012/0–PCT–02]; European
Closed Meetings DEPARTMENT OF HEALTH AND
Patent Application No. 13753962.3,
HUMAN SERVICES
Pursuant to section 10(d) of the filed 11 Feb 2015, [HHS Ref No E–260–
Federal Advisory Committee Act, as National Institutes of Health 2012/0–EP–03]; Korea Patent
amended (5 U.S.C. App.), notice is Application No. 10–2015–7006286, filed
hereby given of the following meetings. Prospective Grant of Exclusive 11 Mar 2015, [HHS Ref No E–260–2012/
The meetings will be closed to the License: Development of In Vitro 0–KR–04]; US Patent Application No.
public in accordance with the Diagnostics for the Detection of 14/421,732, filed 13 Feb 2015, [HHS Ref
provisions set forth in sections Diseases or Pathogenic Agents No E–260–2012/0–US–05]; US
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Provisional Patent Application No. 61/
as amended. The grant applications and AGENCY: National Institute of Diabetes 333,442, filed 11 May 2010, [HHS Ref
the discussions could disclose and Digestive and Kidney Diseases, No E–129–2010/0–US–01]; International
confidential trade secrets or commercial National Institutes of Health, Public Patent Application No. PCT/US2011/
property such as patentable material, Health Service, HHS. 036090, filed 11 May 2011, [HHS Ref
and personal information concerning ACTION: Notice. No. E–129–2010/0–PCT–02]; European
individuals associated with the grant SUMMARY: This notice, in accordance Patent Application No. 11721899.0,
applications, the disclosure of which with 35 U.S.C. 209(c)(1) and 37 CFR filed 11 May 2011, [HHS Ref No. E–129–
would constitute a clearly unwarranted part 404.7(a)(1)(i), that the National 2010/0–EP–03]; and US Patent
invasion of personal privacy. Institute of Diabetes and Digestive and Application No. 13/697,123, filed 9 Nov
Name of Committee: National Cancer Kidney Diseases (NIDDK), at the 2012, [HHS Ref No. E–129–2010/0–US–
Institute Special Emphasis Panel; Omnibus National Institutes of Health, 04].
SEP–12. Department of Health and Human The patent rights in these inventions
Date: March 15, 2016. Services, is contemplating the grant to have been assigned to the United States
Time: 8:00 a.m. to 5:00 p.m.
Altra Tech, Ltd. (‘‘AltraTech’’), a of America. AltraTech is seeking a
Agenda: To review and evaluate grant worldwide territory for this license. The
applications. company incorporated under the laws of
the Ireland, having an office in field of use may be limited to exclusive
Place: Residence Inn Bethesda, Downtown, use of the licensed patent rights limited
7335 Wisconsin Avenue, Bethesda, MD Shannon, Ireland, an exclusive patent
20814. commercialization license to practice to the development and sale of trans-
Contact Person: Timothy C. Meeker, MD, the following inventions embodied in cyclopentane-modified peptide nucleic
Ph.D., Scientific Review Officer, Resources the following patent applications: US acids (PNA) in a diagnostic test system
and Training Review Branch, Division of Provisional Patent Application No.60/ incorporating AltraTech’s proprietary
Extramural Activities, National Cancer 846,354, entitled, ‘‘(S,S)-trans-1,2- sample preparation and AltraTech’s
Institute, NIH, 9609 Medical Center Drive,
cyclopentane Diamine-modified and proprietary semiconductor sensor
Room 7W624, Rockville, MD 20850, 240– technology for the detection of
276–6464 meekert@mail.nih.gov. Gamma-lysine-modified Peptide
Nucleic Acids as Probes for Nucleic infectious diseases or pathogenic agents
Name of Committee: National Cancer including viruses and microorganisms.
Institute Special Emphasis Panel; Planning Acid Detection: Synthesis and
Applications,’’ filed 22 Sep 2006 [HHS DATES: Only written comments or
Grants for Global Research Infrastructure in
Non-Communicable Disease. Ref No. E–308–2006/0–US–01]; US applications for a license (or both)
Date: April 27–28, 2016. Provisional Patent Application No. 60/ which are received by the Technology
Time: 8:00 a.m. to 5:00 p.m. 896,667, entitled, ‘‘Synthesis of Trans- Advancement Office, NIDDK, on or
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Agenda: To review and evaluate grant tert-butyl-2- before March 3, 2016 will be
applications. aminocyclopentylcarbamate,’’ filed 23 considered.
Place: Marriott Courtyard Gaithersburg Mar 2007 [HHS Ref No. E–308–2006/1– ADDRESSES: Requests for copies of the
Washingtonian Center, 204 Boardwalk Place,
Gaithersburg, MD 20878.
US–01]; International Application PCT/ patent application, patents, inquiries,
Contact Person: Michael B. Small, Ph.D., US2007/020466, entitled, ‘‘Synthesis of comments, and other materials relating
Chief, Program & Review Extramural Staff Trans-tert-butyl-2- to the contemplated exclusive license
Training Office, Division of Extramural aminocyclopentylcarbamate,’’ filed 21 should be directed to: Patrick McCue,
Activities, National Cancer Institute, NIH, Sep 2007 [HHS Ref No. E–308–2006/2– Ph.D., Senior Licensing and Patenting
VerDate Sep<11>2014 19:05 Feb 16, 2016 Jkt 238001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\17FEN1.SGM 17FEN1](https://thefederalregister.org/doc/81_FR_8113/page/1.svg)
![Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices 8083
Manager, Technology Advancement The meetings will be closed to the DEPARTMENT OF HEALTH AND
Office, The National Institutes of public in accordance with the HUMAN SERVICES
Diabetes and Digestive and Kidney provisions set forth in sections
Diseases, 12A South Drive, Bethesda, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., National Institutes of Health
MD 20892, Telephone: (301) 451–5560; as amended. The grant applications and
Email: patrick.mccue@nih.gov. A signed the discussions could disclose Center for Scientific Review; Notice of
confidentiality non-disclosure confidential trade secrets or commercial Closed Meetings
agreement will be required to receive property such as patentable material, Pursuant to section 10(d) of the
copies of any patent applications that and personal information concerning Federal Advisory Committee Act, as
have not been published by the United individuals associated with the grant amended (5 U.S.C. App.), notice is
States Patent and Trademark Office or applications, the disclosure of which hereby given of the following meetings.
the World Intellectual Property would constitute a clearly unwarranted The meetings will be closed to the
Organization. invasion of personal privacy. public in accordance with the
SUPPLEMENTARY INFORMATION: These Name of Committee: National Heart, Lung, provisions set forth in sections
technologies, and the corresponding and Blood Institute Special Emphasis Panel; 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
patent applications, are directed to Collaborative Projects in Organ Fibrosis. as amended. The grant applications and
cyclopentane-peptide nucleic acids Date: March 8, 2016. the discussions could disclose
(PNA) and their use in qualitative and Time: 8:30 a.m. to 4:30 p.m. confidential trade secrets or commercial
quantitative detection of nucleic acids. Agenda: To review and evaluate grant property such as patentable material,
The technologies overcome a stability applications. and personal information concerning
Place: Courtyard by Marriott, 5520 individuals associated with the grant
problem and sensitivity to outside
Wisconsin Avenue, Chevy Chase, MD 20815.
contamination that is inherent to PCR- applications, the disclosure of which
Contact Person: Kristen Page, Ph.D.,
based detection systems, wherein the Scientific Review Officer, Office of Scientific would constitute a clearly unwarranted
PNA probes bind to DNA with greater Review/DERA, National Heart, Lung, and invasion of personal privacy.
stability and selectivity compared to a Blood Institute, 6701 Rockledge Drive, Room Name of Committee: Center for Scientific
complementary DNA sequence. 7185, Bethesda, MD 20892, 301–435–0725, Review Special Emphasis Panel, PAR–14–
The prospective exclusive license will kristen.page@nih.gov. 166: Early Phase Clinical Trials in Imaging
be royalty bearing and will comply with Name of Committee: National Heart, Lung, and Image-Guided Interventions (R01).
the terms and conditions of 35 U.S.C. and Blood Institute Special Emphasis Panel; Date: February 29, 2016.
209 and 37 CFR part 404. The Small Business Point of Care. Time: 1:00 p.m. to 4:00 p.m.
prospective exclusive license may be Date: March 9, 2016. Agenda: To review and evaluate grant
Time: 9:00 a.m. to 11:00 a.m. applications.
granted unless within fifteen (15) days
Agenda: To review and evaluate grant Place: National Institutes of Health, 6701
from the date of this published notice, Rockledge Drive, Bethesda, MD 20892,
the Technology Advancement Office, applications.
(Telephone Conference Call).
NIDDK, receives written evidence and Place: Bethesda Marriott Suites, 6711
Contact Person: David L Williams, Ph.D.,
Democracy Boulevard, Bethesda, MD 20817.
argument that establishes that the grant Scientific Review Officer, Center for
Contact Person: Kristin Goltry, Ph.D.,
of the license would not be consistent Scientific Review, National Institutes of
Scientific Review Officer, Office of Scientific Health, 6701 Rockledge Drive, Room 5110,
with the requirements of 35 U.S.C. 209 Review/DERA, National Heart, Lung, and
and 37 CFR part 404. MSC 7854, Bethesda, MD 20892, (301) 435–
Blood Institute, 6701 Rockledge Drive, Room 1174, williamsdl2@csr.nih.gov.
Properly filed competing applications 7198, Bethesda, MD 20892, 301–435–0297,
for a license in response to this notice Name of Committee: Center for Scientific
goltrykl@mail.nih.gov.
will be treated as objections to the Review Special Emphasis Panel, Topics in
Name of Committee: National Heart, Lung, Bacterial Pathogenesis.
contemplated license. Comments and and Blood Institute Special Emphasis Panel; Date: March 9, 2016.
objections submitted in response to this Small Business Point of Care. Time: 8:00 a.m. to 6:00 p.m.
notice will not be made available for Date: March 9–10, 2016. Agenda: To review and evaluate grant
public inspection and, to the extent Time: 11:00 a.m. to 5:00 p.m. applications.
permitted by law, will not be released Agenda: To review and evaluate grant Place: Residence Inn Bethesda, 7335
under the Freedom of Information Act, applications. Wisconsin Avenue, Bethesda, MD 20814.
5 U.S.C. 552. Place: Bethesda Marriott Suites, 6711 Contact Person: Richard G Kostriken,
Democracy Boulevard, Bethesda, MD 20817. Ph.D., Scientific Review Officer, Center for
Dated: February 10, 2016. Contact Person: Kristin Goltry, Ph.D., Scientific Review, National Institutes of
Anna Amar, Scientific Review Officer, Office of Scientific Health, 6701 Rockledge Drive, Room 3192,
Acting Deputy Director, Technology Review/DERA, National Heart, Lung, and MSC 7808, Bethesda, MD 20892, 240–519–
Advancement Office, NIDDK. Blood Institute, 6701 Rockledge Drive, Room 7808, kostrikr@csr.nih.gov.
[FR Doc. 2016–03187 Filed 2–16–16; 8:45 am]
7198, Bethesda, MD 20892, 301–435–0297, Name of Committee: Center for Scientific
goltrykl@mail.nih.gov. Review Special Emphasis Panel; Small
BILLING CODE 4140–01–P
Business: Digestive Sciences.
(Catalogue of Federal Domestic Assistance
Date: March 9, 2016.
Program Nos. 93.233, National Center for
Time: 8:00 a.m. to 7:00 p.m.
DEPARTMENT OF HEALTH AND Sleep Disorders Research; 93.837, Heart and
Agenda: To review and evaluate grant
HUMAN SERVICES Vascular Diseases Research; 93.838, Lung applications.
Diseases Research; 93.839, Blood Diseases Place: Cambria Hotel & Suites, 1 Helen
asabaliauskas on DSK5VPTVN1PROD with NOTICES
National Institutes of Health and Resources Research, National Institutes Heneghan Way, Rockville, MD 20850.
of Health, HHS) Contact Person: Martha Garcia, Ph.D.,
National Heart, Lung, and Blood Dated: February 10, 2016. Scientific Reviewer Officer, Center for
Institute; Notice of Closed Meetings Michelle Trout, Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2186,
Pursuant to section 10(d) of the Program Analyst, Office of Federal Advisory MSC 7818, Bethesda, MD 20892, 301–435–
Federal Advisory Committee Act, as Committee Policy. 1243, garciamc@nih.gov.
amended (5 U.S.C. App.), notice is [FR Doc. 2016–03122 Filed 2–16–16; 8:45 am] Name of Committee: Center for Scientific
hereby given of the following meetings. BILLING CODE 4140–01–P Review Special Emphasis Panel;
VerDate Sep<11>2014 19:05 Feb 16, 2016 Jkt 238001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\17FEN1.SGM 17FEN1](https://thefederalregister.org/doc/81_FR_8113/page/2.svg)
Document Created: 2016-02-17 01:16:33
Document Modified: 2016-02-17 01:16:33
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Only written comments or applications for a license (or both) which are received by the Technology Advancement Office, NIDDK, on or before March 3, 2016 will be considered. | |
| FR Citation | 81 FR 8082 |
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