Prospective Grant of an Exclusive Patent License for: Ointments for the Topical Administration To Treat Neuropathic and/or Ischemic Skin Ulcers in Humans, 59394 [2019-23993]

Download as PDF 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]
[Page 59394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23993]


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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.

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

SUMMARY: 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: [email protected].

SUPPLEMENTARY INFORMATION:

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 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

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