[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Notices]
[Pages 72729-72730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29650]
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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.
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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 Omega Diagnostics Group PLC (``Omega''), a company
incorporated under the laws of the United Kingdom, having an office in
Alva, Scotland, an exclusive patent 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]; and US Patent Application No. 14/421,732, filed 13 Feb
2015, [HHS Ref No E-260-2012/0-US-05].
The patent rights in these inventions have been assigned to the
United States of America. Omega is seeking a worldwide territory for
this license. The field of use may be limited to use of the Patent
Rights for the development and sale of trans-cyclopentane-modified
peptide nucleic acids (PNA) in a diagnostic system incorporating an
enzyme-linked immunosorbent assay or Omega's proprietary
VISITECT[supreg] technology for the detection of 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 December 7, 2015 will be considered.
ADDRESSES: Requests for copies of the patent application, patents,
inquiries,
[[Page 72730]]
comments, and other materials relating to the contemplated exclusive
license should be directed to: The Patrick McCue, Ph.D., Senior
Licensing and Patenting 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: November 17, 2015.
Anna Z. Amar,
Acting Deputy Director, Technology Advancement Office, NIDDK.
[FR Doc. 2015-29650 Filed 11-19-15; 8:45 am]
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