Prospective Grant of an Exclusive Start-Up Patent License for Evaluation: Immunotherapy for Relapsed/Refractory Diffuse Large B Cell Lymphoma, 49387-49388 [2020-17703]

Download as PDF Federal Register / Vol. 85, No. 157 / Thursday, August 13, 2020 / Notices communication/messaging networks, research, training, and subject matter expertise. The dissemination of critical COVID–19 information for tribal communities builds trust, credibility, and integrity of promoting a culturally sensitive public health approach around the information. 2. The JHU CAIH is uniquely positioned to provide culturally specific subject matter expertise drawn from a direct care services or ‘‘boots on the ground’’ approach. The CAIH has nearly 40 years of collaboration with Native American tribes and supports public health interventions in more than 140 tribal communities in over 21 states. The breadth of knowledge and existing partnerships will enhance dissemination of information nationally. Legislative Authority: The Snyder Act, 25 U.S.C. Section 13; the Indian Health Care Improvement Act, 25 U.S.C. Section 1621b; and Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116–136. FOR FURTHER INFORMATION CONTACT: Audrey Solimon at Audrey.Solimon@ ihs.gov or by telephone at 301–590– 5421. Michael D. Weahkee, RADM, Assistant Surgeon General, U.S. Public Health Service, Director, Indian Health Service. [FR Doc. 2020–17516 Filed 8–12–20; 8:45 am] BILLING CODE 4165–16–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council for Biomedical Imaging and Bioengineering. The meeting will be open to the public by videocast as indicated below. 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 and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. VerDate Sep<11>2014 17:16 Aug 12, 2020 Jkt 250001 Name of Committee: National Advisory Council for Biomedical Imaging and Bioengineering. Date: September 15, 2020. Open: 12:00 p.m. to 3:00 p.m. Agenda: Report from the Institute Director and other Institute Staff. Place: National Institutes of Health, Democracy II, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Closed: 3:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Democracy II, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: David T. George, Ph.D., Associate Director, Office of Research Administration, National Institute of Biomedical Imaging and Bioengineering, 6707 Democracy Boulevard, Room 920, Bethesda, MD 20892, georged@mail.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: https:// www.nibib1.nih.gov/about/NACBIB/ NACBIB.htm, where an agenda and any additional information for the meeting will be posted when available. 49387 listed in the Supplementary Information section of this notice. Upon expiration of the evaluation period the granted licenses may be converted into a fully exclusive patent commercialization license for the term of the last to expire of the patent estate upon the company providing NHLBI with a commercial development plan supporting such a conversion. This notice is intended to apprise the public of a aforementioned license and provide a fifteen (15) day notice period for the objection. DATES: Only written comments and/or applications for a license which are received by the National Heart, Lung, and Blood Institute on or before August 28, 2020 will be considered. ADDRESSES: Requests for copies of patent applications (electronic only), inquiries, and comments relating to the contemplated an exclusive patent license should be emailed to: Michael Shmilovich, Esq., Senior Licensing and Patent Manager, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892– 2479, phone number 301–435–5019 shmilovm@nih.gov. SUPPLEMENTARY INFORMATION: Intellectual Property (Patent Estate) HHS Ref. No. E–036–2015–0 and –1, U.S. Provisional Patent Application 62/ 079,975 filed November 14, 2014 Dated: August 7, 2020. (expired), International Patent Miguelina Perez, Application PCT/US2015/060646 filed Program Analyst, Office of Federal Advisory November 13, 2015 (nationalized), U.S. Committee Policy. Patent Application 15/525,921 having [FR Doc. 2020–17678 Filed 8–12–20; 8:45 am] an effective filing date of November 13, 2015, and U.S. Divisional Patent BILLING CODE 4140–01–P Application 16/985,797 filed August 5, 2020, any and all continuation or DEPARTMENT OF HEALTH AND divisional applications claiming priority HUMAN SERVICES to any of the above. The patent rights in these inventions National Institutes of Health have been assigned or exclusively licensed to the Government of the Prospective Grant of an Exclusive United States of America. Start-Up Patent License for Evaluation: The prospective exclusive license Immunotherapy for Relapsed/ territory may be worldwide and in field Refractory Diffuse Large B Cell of use that may be limited to Lymphoma Immunotherapy against relapsed or refractory diffuse large B cell AGENCY: National Institutes of Health, lymphoma, and where the ‘‘Licensed Health and Human Services (HHS). Products’’ may be defined to be limited ACTION: Notice. to transgenically modified allogeneic SUMMARY: The National Heart, Lung, and natural killer cells within the scope of Blood Institute, of the National the Licensed Patent Rights that Institutes of Health, Department of transiently express one or more of a (1) Health and Human Services, is CCR7 receptor, (2) CD16a (HA–CD16), contemplating the grant of an exclusive (3) a DR5 specific TRAIL, or (4) CD19 start-up patent license for evaluation to chimeric antigen receptor. The aforementioned patent estates ONK Therapeutics, a start-up company spun-off from the National University of cover methods of treating a subject with Ireland Galway, and incorporated under a tumor by administering transgenically modified adoptive NK (natural killer the laws of the Republic of Ireland, to cells), methods of generating transgenic practice, for a limited time, the NK cells, and transgenic NK cells per se. inventions covered by the patent estate PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\13AUN1.SGM 13AUN1 49388 Federal Register / Vol. 85, No. 157 / Thursday, August 13, 2020 / Notices In particular, the claims cover include transgenic NKs expressing CCR7 and CD16a (HA–CD16). The treatment methods also include dependent claims where the transgenic NK cells are coadministered with a monoclonal antibody therapeutic (e.g., rituximab). CCR7 is a chemokine receptor (chemokine (C—C motif) receptor 7) known to direct cellular migration to secondary lymphoid tissues, including lymph nodes where hematological malignancies such as diffuse large B cell lymphoma (DLBCL) reside. Normally, CCR7 is expressed by only a small subset of resting primary NK cells. CD16 includes Fc receptors FcgRIIIa (CD16a) and FcgRIIIb (CD16b) found on the surface of natural killer (NK) cells and other leukocytes. CD16a binds to the Fc tail of IgG antibodies which then activates the NK cell for antibodydependent cellular toxicity (ADCC). Human wild type CD16 has a relatively low affinity for IgG1 antibodies. However, a single nucleotide polymorphism (SNP rs396991) in the CD16a gene (F to V at position 158; referred to hereafter as HA–CD16) results in substantially higher IgG1 affinity and superior NK mediated ADCC. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive licenses, both the one granted for the evaluation period and if converted into a full exclusive patent commercialization license, will be royalty bearing. The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Heart, Lung, and Blood 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 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. VerDate Sep<11>2014 17:16 Aug 12, 2020 Jkt 250001 Dated August 5, 2020. Michael Shmilovich, Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2020–17703 Filed 8–12–20; 8:45 am] National Institute of Nursing Research; Notice of Meeting BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; 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: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PAR19–202: High Impact, Interdisciplinary Science in NIDDK Research Areas (RC2 Clinical Trial Optional)—Hematological Diseases. Date: September 28, 2020. Time: 2:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Blvd., Bethesda, MD 20892 (Video Meeting). Contact Person: Najma S. Begum, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7349, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–8894, begumn@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) National Institutes of Health Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council for Nursing Research. The meeting will be open to the public as indicated below. 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: National Advisory Council for Nursing Research. Date: September 15, 2020. Open: 11:30 a.m. to 1:30 p.m. Agenda: Discussion of Program Policies and Issues. Place: https://videocast.nih.gov/ watch=38169, Bethesda, MD 20892 (Virtual Meeting). Closed: 2:00 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Nursing Research, National Institutes of Health, 6701 Democracy Boulevard, One Democracy Plaza, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Kay Wanke, Acting Executive Secretary, National Institute of Nursing Research, National Institutes of Health, 6701 Democracy Boulevard, One Democracy Plaza, Bethesda, MD 20817, (301) 402–0036, kay.wanke@nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: www.nih.gov/ ninr/a_advisory.html, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.361, Nursing Research, National Institutes of Health, HHS) Dated: August 7, 2020. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. Dated: August 10, 2020. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–17677 Filed 8–12–20; 8:45 am] [FR Doc. 2020–17743 Filed 8–12–20; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4140–01–P PO 00000 Frm 00030 Fmt 4703 Sfmt 9990 E:\FR\FM\13AUN1.SGM 13AUN1

Agencies

[Federal Register Volume 85, Number 157 (Thursday, August 13, 2020)]
[Notices]
[Pages 49387-49388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Start-Up Patent License for 
Evaluation: Immunotherapy for Relapsed/Refractory Diffuse Large B Cell 
Lymphoma

AGENCY: National Institutes of Health, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The National Heart, Lung, and Blood Institute, of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an exclusive start-up patent license for 
evaluation to ONK Therapeutics, a start-up company spun-off from the 
National University of Ireland Galway, and incorporated under the laws 
of the Republic of Ireland, to practice, for a limited time, the 
inventions covered by the patent estate listed in the Supplementary 
Information section of this notice. Upon expiration of the evaluation 
period the granted licenses may be converted into a fully exclusive 
patent commercialization license for the term of the last to expire of 
the patent estate upon the company providing NHLBI with a commercial 
development plan supporting such a conversion. This notice is intended 
to apprise the public of a aforementioned license and provide a fifteen 
(15) day notice period for the objection.

DATES: Only written comments and/or applications for a license which 
are received by the National Heart, Lung, and Blood Institute on or 
before August 28, 2020 will be considered.

ADDRESSES: Requests for copies of patent applications (electronic 
only), inquiries, and comments relating to the contemplated an 
exclusive patent license should be emailed to: Michael Shmilovich, 
Esq., Senior Licensing and Patent Manager, 31 Center Drive Room 4A29, 
MSC2479, Bethesda, MD 20892-2479, phone number 301-435-5019 
[email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property (Patent Estate)

    HHS Ref. No. E-036-2015-0 and -1, U.S. Provisional Patent 
Application 62/079,975 filed November 14, 2014 (expired), International 
Patent Application PCT/US2015/060646 filed November 13, 2015 
(nationalized), U.S. Patent Application 15/525,921 having an effective 
filing date of November 13, 2015, and U.S. Divisional Patent 
Application 16/985,797 filed August 5, 2020, any and all continuation 
or divisional applications claiming priority to any of the above.
    The patent rights in these inventions have been assigned or 
exclusively licensed to the Government of the United States of America.
    The prospective exclusive license territory may be worldwide and in 
field of use that may be limited to Immunotherapy against relapsed or 
refractory diffuse large B cell lymphoma, and where the ``Licensed 
Products'' may be defined to be limited to transgenically modified 
allogeneic natural killer cells within the scope of the Licensed Patent 
Rights that transiently express one or more of a (1) CCR7 receptor, (2) 
CD16a (HA-CD16), (3) a DR5 specific TRAIL, or (4) CD19 chimeric antigen 
receptor.
    The aforementioned patent estates cover methods of treating a 
subject with a tumor by administering transgenically modified adoptive 
NK (natural killer cells), methods of generating transgenic NK cells, 
and transgenic NK cells per se.

[[Page 49388]]

In particular, the claims cover include transgenic NKs expressing CCR7 
and CD16a (HA-CD16). The treatment methods also include dependent 
claims where the transgenic NK cells are co-administered with a 
monoclonal antibody therapeutic (e.g., rituximab). CCR7 is a chemokine 
receptor (chemokine (C--C motif) receptor 7) known to direct cellular 
migration to secondary lymphoid tissues, including lymph nodes where 
hematological malignancies such as diffuse large B cell lymphoma 
(DLBCL) reside. Normally, CCR7 is expressed by only a small subset of 
resting primary NK cells.
    CD16 includes Fc receptors Fc[gamma]RIIIa (CD16a) and 
Fc[gamma]RIIIb (CD16b) found on the surface of natural killer (NK) 
cells and other leukocytes. CD16a binds to the Fc tail of IgG 
antibodies which then activates the NK cell for antibody-dependent 
cellular toxicity (ADCC). Human wild type CD16 has a relatively low 
affinity for IgG1 antibodies. However, a single nucleotide polymorphism 
(SNP rs396991) in the CD16a gene (F to V at position 158; referred to 
hereafter as HA-CD16) results in substantially higher IgG1 affinity and 
superior NK mediated ADCC.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive licenses, both the one granted for 
the evaluation period and if converted into a full exclusive patent 
commercialization license, will be royalty bearing. The prospective 
exclusive license may be granted unless within fifteen (15) days from 
the date of this published notice, the National Heart, Lung, and Blood 
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 
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 August 5, 2020.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute.
[FR Doc. 2020-17703 Filed 8-12-20; 8:45 am]
BILLING CODE 4140-01-P
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