Prospective Grant of an Exclusive Patent License for: Autologous Cell Graft of Manufactured Retinal Pigment Epithelium Cell(s) on a Biodegradable Support Scaffold Transplanted Sub-Retinally for Intra-Ocular Ophthalmic Treatment of Age-Related Macular Degeneration in Humans, 59393-59394 [2019-23995]

Download as PDF Federal Register / Vol. 84, No. 213 / Monday, November 4, 2019 / Notices Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PAR–18–423: NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34). Date: November 18, 2019. Time: 2:00 p.m. to 4:00 p.m. Agenda: To review and evaluate applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Ann A. Jerkins, Ph.D., Scientific Review Officer, Review Branch, Division of Extramural Activities, National Institutes of Health, Room 7119, 6707 Democracy Boulevard, Bethesda, MD 20892– 5452, (301) 594–2242, jerkinsa@ niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: October 29, 2019. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–23996 Filed 11–1–19; 8:45 am] BILLING CODE 4140–01–P Contact Person: Lindsay M. Garvin, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Suite 7189, Bethesda, MD 20892, 301–827–7911, lindsay.garvin@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: October 29, 2019. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–23997 Filed 11–1–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License for: Autologous Cell Graft of Manufactured Retinal Pigment Epithelium Cell(s) on a Biodegradable Support Scaffold Transplanted SubRetinally for Intra-Ocular Ophthalmic Treatment of Age-Related Macular Degeneration in Humans AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health, HHS. ACTION: National Institutes of Health Notice. The National Eye Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to CellRay, LLC, (‘‘CellRay’’) located in New York, New York and its affiliates. DATES: Only written comments and/or complete applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before November 19, 2019 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Edward Fenn., Senior Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892–9702 (for business mail), Rockville, MD 20850– 9702; Telephone: (240)-276–5530; Facsimile: (240)-276–5504 Email: Tedd.Fenn@nih.gov. SUPPLEMENTARY INFORMATION: SUMMARY: National Heart, Lung, and Blood Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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: Heart, Lung, and Blood Initial Review Group; NHLBI Institutional Training Mechanism Review Committee. Date: December 13, 2019. Time: 9:30 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). VerDate Sep<11>2014 20:48 Nov 01, 2019 Jkt 250001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 59393 Intellectual Property • PCT Patent App. No. PCT/US2015/ 039932, filed 07/10/15 (NIH Ref. E–192– 2014–1–PCT–01); United States Patent App. No. 15/325,584, filed 01/11/17 (NIH Ref. E–192–2014–1–US–02); Australia Patent App. No. 2015287692, filed 07/10/15 (NIH Ref. E–192–2014–1– AU–03); Canada Patent App. No. 2954762, filed 07/10/15 (NIH Ref. E– 192–2014–1–CA–04); PEC Patent App. No. 15741462.4, filed 07/10/15 (NIH Ref. E–192–2014–1–EP–05); India Patent App. No. 21717003244, filed 01/30/17 (NIH Ref. E–192–2014–1–IN–06); Japan Patent App. No. 2017–501212 Filed 01/ 10/17 (NIH Ref. E–192–2014–1–JP–07); each entitled ‘‘Surgical Tool and Method for Ocular Tissue Transplantation’’ • United States Patent App. No. 62/ 215,579, filed 09/08/15 (NIH Ref. E– 212–2015–0–US–01); PCT Patent App. No. PCT/US2016/050543, filed 09/07/16 (NIH Ref. E–212–2015–0–PCT–02); United States Patent App. No. 15/ 758,314, filed 03/07/18 (NIH Ref. E– 212–2015–0–US–07); each entitled ‘‘Method for Reproducible Differentiation of Clinical-Grade Retinal Pigment Epithelium Cells’’ • United States Provisional Patent App. No. 62/419,804, filed 11/09/16 (NIH Ref. E–293–2016–0–US–01); PCT Patent App. No. PCT/US2017/060672, filed 11/08/17 (NIH Ref. E–293–2016–0– PCT–02); Australia Patent App. No. 2017359336, filed 11/08/17 (NIH Ref. E– 293–2016–0–AU–04); Canada Patent App. No. 3043174, filed 11/08/17 (NIH Ref. E–293–2016–0–CA–05); EPC Patent App. No. 17801272.0, filed 11/08/17 (NIH Ref. E–293–2016–0–EP–06); Japan Patent App. No. 2017–545900 (NIH Ref. E–293–2016–0–JP–07); United States Patent App. No. 16/348,855, filed 05/09/ 2019 (NIH Ref. E–293–2016–0–US–03); each entitled ‘‘A Surgical Clamp to Gate Large Scleral Surgery Port and Suture Alignment Tool’’; • United States Patent App. No. 62/ 453,148, filed 02/01/17 (NIH Ref. E– 094–2016–0–US–01); PCT Patent App. No. PCT/US2018/016101, Filed 01/31/ 18 (NIH Ref. E–094–2016–0–PCT–02) entitled ‘‘Devices for Tissue Cryopreservation and Recovery’’ and; United States Patent App. No. 16/ 478,093 (NIH Ref. E–094–2016–0–US– 03); Australia Patent App. No. 2018214954 filed 01/31/18 (NIH Ref. E– 094–2016–0–AU–04); Canada Patent App. No. 3048523 (NIH Ref. E–094– 2016–0–CA–05); EPC Patent App. No. 18704773.3 (NIH Ref. E–094–2016–0– EP–06); Japan Patent App. No. 2019– 538157 (NIH Ref. E–094–2016–0–JP–07); each ‘‘A Self-contained E:\FR\FM\04NON1.SGM 04NON1 59394 Federal Register / Vol. 84, No. 213 / Monday, November 4, 2019 / Notices Cryopreservation and Recovery Device for Tissue Storage, Shipping and Recovery’’ • United States Patent App. No 62/ 769,484, filed 11/19/18 (NIH Ref. E– 015–2019–0–US–01) entitled ‘‘Biodegradable Tissue Replacement Implant and its Use’’; and all U.S. and foreign patent applications claiming priority to the aforementioned applications. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be limited to the United States for certain of the rights, or worldwide, and the field of use may be limited to the following: ‘‘The development, production and commercialization of an autologous cell graft of manufactured Retinal Pigment Epithelium cell(s) on a biodegradable support scaffold transplanted sub-retinally for intra-ocular ophthalmic treatment of age-related macular degeneration in humans’’. The technologies relate to development of compositions, devices and processes for production and delivery of RPE-containing tissue graft therapies for treating age-related macular degeneration in humans. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute 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. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a completed license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: October 24, 2019. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2019–23995 Filed 11–1–19; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 20:48 Nov 01, 2019 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License for: Ointments for the Topical Administration To Treat Neuropathic and/or Ischemic Skin Ulcers in Humans AGENCY: National Institutes of Health, HHS. ACTION: Notice. The Clinical Center and National Heart Lung and Blood Institute, each an institute of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to TeamedOn International Inc., (‘‘TeamedOn’’), a Delaware corporation with offices in Gaithersburg, Maryland. DATES: Only written comments and/or complete applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before November 19, 2019 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Edward Fenn., Senior Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892–9702 (for business mail), Rockville, MD 20850– 9702; Telephone: (240) 276–5530; Facsimile: (240) 276–5504 Email: Tedd.Fenn@nih.gov. SUPPLEMENTARY INFORMATION: SUMMARY: Intellectual Property I. United States Provisional Patent Application No. 62/077,622 filed Nov. 10, 2014, ‘‘Topical Sodium Nitrite Formulations’’, [HHS Ref. No. E–149– 2014–0–US–01]; II. International Patent Application No. PCT/US2015/060015 filed Nov. 10, 2015, ‘‘Topical Sodium Nitrite Formulations’’, [HHS Reference No. E– 149–2014–0–PCT–02]; III. European National Stage Patent Application No. 15798623.3, filed Nov. 10, 2015, ‘‘Topical Sodium Nitrite Formulations’’, [HHS Ref. No. E–149– 2014–0–EP–03]; IV. U.S. National Stage Patent Application No. 15/525,557 filed May 9, 2017, ‘‘Topical Sodium Nitrite PO 00000 Frm 00044 Fmt 4703 Sfmt 9990 Formulations’’, [HHS Ref. No. E–149– 2014–0–US–04]; and all U.S. and foreign patent applications claiming priority to the aforementioned applications. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be limited to the United States for certain of the rights, or worldwide, and the field of use may be limited to the following: ‘‘Treatment of neuropathic and/or ischemic skin ulcers in human. The technology relates to topical ointment formulations comprising about .5% to 3.0% by weight non-acidified sodium nitrite dispersed in white petrolatum, mineral oil and bisabolol for topical administration. Nitrite anions may act as a vasodilator in vivo by generating nitric oxide (NO) in tissues with lower oxygen tension and pH. Therapeutic application of sodium nitrite through this specific topical formulation may provide selective vasodilation to hypoxemic tissue that treat ulcers associated with chronic ischemic and neuropathic ulcer conditions associated with several diseases. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute 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. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a completed license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: October 24, 2019. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2019–23993 Filed 11–1–19; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\04NON1.SGM 04NON1

Agencies

[Federal Register Volume 84, Number 213 (Monday, November 4, 2019)]
[Notices]
[Pages 59393-59394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23995]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License for: Autologous 
Cell Graft of Manufactured Retinal Pigment Epithelium Cell(s) on a 
Biodegradable Support Scaffold Transplanted Sub-Retinally for Intra-
Ocular Ophthalmic Treatment of Age-Related Macular Degeneration in 
Humans

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Eye Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice the 
inventions embodied in the Patents and Patent Applications listed in 
the Supplementary Information section of this notice to CellRay, LLC, 
(``CellRay'') located in New York, New York and its affiliates.

DATES: Only written comments and/or complete applications for a license 
which are received by the National Cancer Institute's Technology 
Transfer Center on or before November 19, 2019 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: Edward Fenn., Senior Technology Transfer 
Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 
1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, 
MD 20850-9702; Telephone: (240)-276-5530; Facsimile: (240)-276-5504 
Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

     PCT Patent App. No. PCT/US2015/039932, filed 07/10/15 (NIH 
Ref. E-192-2014-1-PCT-01); United States Patent App. No. 15/325,584, 
filed 01/11/17 (NIH Ref. E-192-2014-1-US-02); Australia Patent App. No. 
2015287692, filed 07/10/15 (NIH Ref. E-192-2014-1-AU-03); Canada Patent 
App. No. 2954762, filed 07/10/15 (NIH Ref. E-192-2014-1-CA-04); PEC 
Patent App. No. 15741462.4, filed 07/10/15 (NIH Ref. E-192-2014-1-EP-
05); India Patent App. No. 21717003244, filed 01/30/17 (NIH Ref. E-192-
2014-1-IN-06); Japan Patent App. No. 2017-501212 Filed 01/10/17 (NIH 
Ref. E-192-2014-1-JP-07); each entitled ``Surgical Tool and Method for 
Ocular Tissue Transplantation''
     United States Patent App. No. 62/215,579, filed 09/08/15 
(NIH Ref. E-212-2015-0-US-01); PCT Patent App. No. PCT/US2016/050543, 
filed 09/07/16 (NIH Ref. E-212-2015-0-PCT-02); United States Patent 
App. No. 15/758,314, filed 03/07/18 (NIH Ref. E-212-2015-0-US-07); each 
entitled ``Method for Reproducible Differentiation of Clinical-Grade 
Retinal Pigment Epithelium Cells''
     United States Provisional Patent App. No. 62/419,804, 
filed 11/09/16 (NIH Ref. E-293-2016-0-US-01); PCT Patent App. No. PCT/
US2017/060672, filed 11/08/17 (NIH Ref. E-293-2016-0-PCT-02); Australia 
Patent App. No. 2017359336, filed 11/08/17 (NIH Ref. E-293-2016-0-AU-
04); Canada Patent App. No. 3043174, filed 11/08/17 (NIH Ref. E-293-
2016-0-CA-05); EPC Patent App. No. 17801272.0, filed 11/08/17 (NIH Ref. 
E-293-2016-0-EP-06); Japan Patent App. No. 2017-545900 (NIH Ref. E-293-
2016-0-JP-07); United States Patent App. No. 16/348,855, filed 05/09/
2019 (NIH Ref. E-293-2016-0-US-03); each entitled ``A Surgical Clamp to 
Gate Large Scleral Surgery Port and Suture Alignment Tool'';
     United States Patent App. No. 62/453,148, filed 02/01/17 
(NIH Ref. E-094-2016-0-US-01); PCT Patent App. No. PCT/US2018/016101, 
Filed 01/31/18 (NIH Ref. E-094-2016-0-PCT-02) entitled ``Devices for 
Tissue Cryopreservation and Recovery'' and; United States Patent App. 
No. 16/478,093 (NIH Ref. E-094-2016-0-US-03); Australia Patent App. No. 
2018214954 filed 01/31/18 (NIH Ref. E-094-2016-0-AU-04); Canada Patent 
App. No. 3048523 (NIH Ref. E-094-2016-0-CA-05); EPC Patent App. No. 
18704773.3 (NIH Ref. E-094-2016-0-EP-06); Japan Patent App. No. 2019-
538157 (NIH Ref. E-094-2016-0-JP-07); each ``A Self-contained

[[Page 59394]]

Cryopreservation and Recovery Device for Tissue Storage, Shipping and 
Recovery''
     United States Patent App. No 62/769,484, filed 11/19/18 
(NIH Ref. E-015-2019-0-US-01) entitled ``Biodegradable Tissue 
Replacement Implant and its Use'';

and all U.S. and foreign patent applications claiming priority to the 
aforementioned applications.
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.
    The prospective exclusive license territory may be limited to the 
United States for certain of the rights, or worldwide, and the field of 
use may be limited to the following:

    ``The development, production and commercialization of an 
autologous cell graft of manufactured Retinal Pigment Epithelium 
cell(s) on a biodegradable support scaffold transplanted sub-
retinally for intra-ocular ophthalmic treatment of age-related 
macular degeneration in humans''.

    The technologies relate to development of compositions, devices and 
processes for production and delivery of RPE-containing tissue graft 
therapies for treating age-related macular degeneration in humans.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Cancer Institute 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.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
completed license application, will not be treated confidentially, and 
may be made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

    Dated: October 24, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2019-23995 Filed 11-1-19; 8:45 am]
 BILLING CODE 4140-01-P
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