[Federal Register Volume 84, Number 192 (Thursday, October 3, 2019)]
[Notices]
[Pages 52889-52890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21520]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Compositions, 
Devices and Processes for Production and Delivery of Cell Grafts of 
Manufactured Retinal Pigment Epithelium Cell(s) Alone, or in 
Combination With Photoreceptor Cells, and on a Biodegradable Support 
Scaffold Transplanted Subretinally for Intra-Ocular Ophthalmic 
Treatment of Conditions of Degeneration, Dysfunction or Terminal Injury 
of Retinal Pigment Epithelium and/or Photoreceptors in Humans

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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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 Opsis 
Therapeutics, LLC, (``Opsis'') located in Madison Wisconsin and its 
affiliate, FUJIFILM Cellular Dynamics, Inc.

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 October 18, 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. 01717003244, 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); Australia Patent App. 
No. 2016321170, filed 03/21/18 (NIH Ref. E-212-2015-0-AU-03); Canada 
Patent App. No. 2997952, filed 09/07/16 (NIH Ref. E-212-2015-0-CA-04); 
EPC Patent App. No. 16766444.0, filed 09/07/16 (NIH Ref. E-212-2015-0-
EP-05); Japan Patent App. No. 2018-512373, filed 03/07/18 (NIH Ref. E-
212-2015-0-JP-06); United States Patent App. No. 15/758,314, filed 03/
07/18 (NIH Ref. E-212-2015-0-US-07); China patent application No. 
201680060872.4, filed 04/18/2018 (NIH Ref. pending); Korea patent 
application No. 1020187009942, file 04/06/2018 (NIH Ref. pending); 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. pending (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)

[[Page 52890]]

entitled ``Devices for Tissue Cryopreservation and Recovery'' and; 
United States Patent App. No. pending (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. pending (NIH Ref. E-094-2016-0-
CA-05); EPC Patent App. No. pending (NIH Ref. E-094-2016-0-EP-06); 
Japan Patent App. No. pending (NIH Ref. E-094-2016-0-JP-07); each ``A 
Self-contained Cryopreservation and Recovery Device for Tissue Storage, 
Shipping and Recovery'';
     United States Provisional Patent App. No. 62/644,175, 
filed 03/16/18 (NIH Ref. E-058-2018-0-US-01) entitled ``Using Machine 
Learning And/or Neural Networks to Validate Stem Cells and Their 
Derivatives for Use in Cell Therapy, Drug Discovery and Diagnostics''; 
PCT Patent App. No. pending (NIH Ref. E-058-2018-0-PCT-02) entitled 
``Using Machine Learning And/or Neural Networks to Validate Stem Cells 
and Their Derivatives (2-D Cells And 3-D Tissues) for Use in Cell 
Therapy And Tissue Engineered Products'';
     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 to the 
government of the United States of America.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to the following:
    ``The development, production and commercialization of allogeneic 
cell grafts of manufactured Retinal Pigment Epithelium cell(s) alone, 
or in combination with photoreceptor cells, and on a biodegradable 
support scaffold transplanted subretinally for intra-ocular ophthalmic 
treatment of conditions of degeneration, dysfunction or terminal injury 
of retinal pigment epithelium and/or photoreceptors in humans.''
    The technologies relate to development of compositions, devices and 
processes for production and delivery of RPE-containing tissue graft 
therapies for treating a range of retinal function disorders, including 
retinal degenerative conditions 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: September 26, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2019-21520 Filed 10-2-19; 8:45 am]
BILLING CODE 4140-01-P