Prospective Grant of Exclusive License: AAV-Mediated Aquaporin Gene Transfer To Treat Sjögren's Syndrome, 25683 [2016-09978]

Download as PDF Federal Register / Vol. 81, No. 83 / Friday, April 29, 2016 / Notices Application and Submission Information, Requirements for Project and Budget Narratives, A. Project Narrative, Part A: Program Information (3 Page Limitation)’’, the correct subheading and page limit should read as ‘‘Part A: Program Information (10 page limitation)’’. 4. On page 13384, in the first column, under the heading ‘‘V. Application Review Information’’, the correct paragraph should read as ‘‘The instructions for preparing the application narrative also constitute the evaluation criteria for reviewing and scoring the application. Weights assigned to each section are noted in parentheses. The 32 page narrative should include only the first year activities; information for multi-year projects should be included as an appendix. See ‘‘Multi-year Project Requirements’’ at the end of this section for more information. The narrative should be written in a manner that is clear to outside reviewers unfamiliar with prior related activities of the applicant. It should be well organized, succinct, and contain all information necessary for reviewers to understand the project fully. Points will be assigned to each evaluation criteria adding up to a total of 100 points. A minimum score of 60 points is required for funding. Points are assigned as follows:’’ Dated: April 25, 2016. Elizabeth A. Fowler, Deputy Director for Management Operations, Indian Health Service. [FR Doc. 2016–10164 Filed 4–28–16; 8:45 am] BILLING CODE 4165–16–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: AAV-Mediated Aquaporin ¨ Gene Transfer To Treat Sjogren’s Syndrome AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to MeiraGTx, having a principal place of business in New York, New York, U.S.A. to practice the inventions embodied in the following patent applications, entitled ‘‘AAV-mediated aquaporin gene transfer ¨ to treat Sjogren’s syndrome’’: asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:31 Apr 28, 2016 Jkt 238001 1. U.S. Provisional Patent Application No. 61/695,753 filed August 31, 2012 (HHS Ref. No. E–139–2011/1–US–01); 2. PCT Application No. PCT/US2013/ 057632, filed August 30, 2013 (HHS Ref. No. E–139–2011/1–PCT–02); 3. Australia Patent Application No. 2013308470, filed February 25, 2015 (HHS Ref. No. E–139–2011/1–AU–03); 4. Canada Patent Application No. 2882763, filed February 20, 2015 (HHS Ref. No. E– 139–2011/1–CA–04); 5. European Patent Application No. 13773443.0, filed March 30, 2015 (HHS Ref. No. E–139–2011/1–EP–05); 6. U.S. Patent Application No. 14/423,774, filed February 25, 2015 (HHS Ref. No. E– 139–2011/1–US–06). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective license may be worldwide, and the field of use may be limited to adeno-associated virus (AAV) vector mediated gene delivery of human aquaporin-1 (hAQP1) in ¨ Sjogren’s syndrome patients with associated xerostomia and/or xerophthalmia. DATES: Only written comments and/or applications for a license that are received by the National Institute of Dental and Craniofacial Research, Office of Technology Transfer and Innovation Access on or before May 16, 2016 will be considered. FOR FURTHER INFORMATION CONTACT: Requests for a copy of the patent application(s), inquiries, comments and other materials relating to the contemplated license should be directed to: Sally Hu, Ph.D., M.B.A., Senior Licensing and Patenting Manager, Office of Technology Transfer and Innovation Access, National Institute of Dental and Craniofacial Research, National Institutes of Health, BLDG 1 DEM, RM667, 6701 Democracy Blvd., Bethesda, MD 20817; Telephone: (301) 594–2616; Facsimile: (301) 496–1005; Email: sally.hu@nih.gov. A signed confidential disclosure agreement may be required to receive copies of the patent application assuming it has not already been published under the publication rules of either the United States Patent and Trademark Office or the World Intellectual Property Organization. SUPPLEMENTARY INFORMATION: This subject technology is directed to the methods of using AAV vectors to deliver the hAQP gene into a salivary gland or a lachrymal gland in patients who suffer ¨ ¨ from Sjogren’s syndrome. Sjogren’s syndrome is a systemic autoimmune disease in which immune cells attack and destroy the glands that produce saliva and tears, resulting in progressive PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 25683 dry mouth and dry eyes. In a mouse ¨ model of Sjogren’s syndrome, administration of hAQP–1 to salivary glands can restore salivary secretion and reduce inflammation in the glands. 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 Office of Technology Transfer and Innovation Access, National Institute of Dental and Craniofacial Research receives written evidence and argument that establishes that the grant of the contemplated 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 the prospective field of use that are filed 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: April 22, 2016. David W. Bradley, Director, Office of Technology Transfer and Innovation Access, National Institute of Dental and Craniofacial Research, National Institutes of Health. [FR Doc. 2016–09978 Filed 4–28–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel NIH Blueprint Training in Computational E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 81, Number 83 (Friday, April 29, 2016)]
[Notices]
[Page 25683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09978]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: AAV-Mediated Aquaporin 
Gene Transfer To Treat Sj[ouml]gren's Syndrome

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an exclusive license 
to MeiraGTx, having a principal place of business in New York, New 
York, U.S.A. to practice the inventions embodied in the following 
patent applications, entitled ``AAV-mediated aquaporin gene transfer to 
treat Sj[ouml]gren's syndrome'':

    1. U.S. Provisional Patent Application No. 61/695,753 filed 
August 31, 2012 (HHS Ref. No. E-139-2011/1-US-01);
    2. PCT Application No. PCT/US2013/057632, filed August 30, 2013 
(HHS Ref. No. E-139-2011/1-PCT-02);
    3. Australia Patent Application No. 2013308470, filed February 
25, 2015 (HHS Ref. No. E-139-2011/1-AU-03);
    4. Canada Patent Application No. 2882763, filed February 20, 
2015 (HHS Ref. No. E-139-2011/1-CA-04);
    5. European Patent Application No. 13773443.0, filed March 30, 
2015 (HHS Ref. No. E-139-2011/1-EP-05);
    6. U.S. Patent Application No. 14/423,774, filed February 25, 
2015 (HHS Ref. No. E-139-2011/1-US-06).

    The patent rights in these inventions have been assigned to the 
Government of the United States of America. The territory of the 
prospective license may be worldwide, and the field of use may be 
limited to adeno-associated virus (AAV) vector mediated gene delivery 
of human aquaporin-1 (hAQP1) in Sj[ouml]gren's syndrome patients with 
associated xerostomia and/or xerophthalmia.

DATES: Only written comments and/or applications for a license that are 
received by the National Institute of Dental and Craniofacial Research, 
Office of Technology Transfer and Innovation Access on or before May 
16, 2016 will be considered.

FOR FURTHER INFORMATION CONTACT: Requests for a copy of the patent 
application(s), inquiries, comments and other materials relating to the 
contemplated license should be directed to: Sally Hu, Ph.D., M.B.A., 
Senior Licensing and Patenting Manager, Office of Technology Transfer 
and Innovation Access, National Institute of Dental and Craniofacial 
Research, National Institutes of Health, BLDG 1 DEM, RM667, 6701 
Democracy Blvd., Bethesda, MD 20817; Telephone: (301) 594-2616; 
Facsimile: (301) 496-1005; Email: sally.hu@nih.gov. A signed 
confidential disclosure agreement may be required to receive copies of 
the patent application assuming it has not already been published under 
the publication rules of either the United States Patent and Trademark 
Office or the World Intellectual Property Organization.

SUPPLEMENTARY INFORMATION: This subject technology is directed to the 
methods of using AAV vectors to deliver the hAQP gene into a salivary 
gland or a lachrymal gland in patients who suffer from Sj[ouml]gren's 
syndrome. Sj[ouml]gren's syndrome is a systemic autoimmune disease in 
which immune cells attack and destroy the glands that produce saliva 
and tears, resulting in progressive dry mouth and dry eyes. In a mouse 
model of Sj[ouml]gren's syndrome, administration of hAQP-1 to salivary 
glands can restore salivary secretion and reduce inflammation in the 
glands.
    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 Office of 
Technology Transfer and Innovation Access, National Institute of Dental 
and Craniofacial Research receives written evidence and argument that 
establishes that the grant of the contemplated 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 the 
prospective field of use that are filed 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: April 22, 2016.
David W. Bradley,
Director, Office of Technology Transfer and Innovation Access, National 
Institute of Dental and Craniofacial Research, National Institutes of 
Health.
[FR Doc. 2016-09978 Filed 4-28-16; 8:45 am]
 BILLING CODE 4140-01-P