[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Notices]
[Pages 8082-8083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03187]


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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 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]
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