[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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