83 FR 51969 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 199 (October 15, 2018)

Page Range		51969-51969
FR Document		2018-22359

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development.

Federal Register, Volume 83 Issue 199 (Monday, October 15, 2018)

[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)]
[Notices]
[Page 51969]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22359]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing to achieve expeditious 
commercialization of results of federally-funded research and 
development.

FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained 
by emailing the indicated licensing contact at the National Heart, 
Lung, and Blood, Office of Technology Transfer and Development Office 
of Technology Transfer, 31 Center Drive Room 4A29, MSC2479, Bethesda, 
MD 20892-2479; telephone: 301-402-5579. A signed Confidential 
Disclosure Agreement may be required to receive any unpublished 
information.

SUPPLEMENTARY INFORMATION: Technology description follows.

Antibody Targeting Cell Surface Deposited Complement Protein C3d

    Available for licensing and commercial development is a patent 
estate covering anti-C3d antibodies, antibody fragments, and their 
methods of use for killing cancer cells expressing C3d complement 
protein on their surface, and more particularly for the treatment of 
patients with Chronic Lymphocytic Leukemia (CLL); a malignancy of 
mature B-cells and the most common leukemia in the US. The most 
commonly used monoclonal antibodies (mAbs) are of mouse origin that 
have been chimerized or humanized to carry human constant regions 
(typically the human lgG1 isotype), required for the recruitment of 
human effector mechanisms. The complement system consists of soluble 
plasma proteins and is activated upon binding of a mAb to target cells 
resulting in the deposition of complement components on the cell 
surface and formation of the membrane attack complex (MAC), which can 
kill cells inducing lysis. The invention originated from an observation 
during CLL patient treatment with chemotherapy in combination with an 
anti CD20 mAb (e.g., rituximab or ofatumumab). Upon infusion complement 
is deposited on the cell surface of CLL cells, a subset of cells is 
killed, and other cells escape having lost CD20 expression due to a 
process called trogocytosis by which antibody-CD20 complexes are pulled 
of the CLL cell surface by immune cells that bind the Fc-portion of the 
mAb. It has been noted that C3d is stably attached to the CLL cells 
that escape from further rituximab or ofatumumab targeting and remains 
detectable for weeks on these cells. C3d, thus, could serve as a 
neoantigen that could be targeted with anti C3d specific mAbs to kill 
off escaped tumor cells.
    Potential Commercial Applications:
    Development Stage:
     Mouse data available.
    Inventors: Adrian Wiestner, Martin Skarzynski, Christoph Rader (all 
of NHLBI), and Margaret A. Lindorfer, Ronald P. Taylor, and Berengere 
Vire (all of the University of Virginia School of Medicine).
    Relevant Publications:
     Robinson, et al. Blood. 2018 Aug 2;132(5):521-532. doi: 
10.1182/blood-2018-02-830992.
    Intellectual Property: HHS Reference No. E-758-2013-0 and -1; U.S. 
Provisional Patent Application 61/924,967 filed January 8, 2014 
(converted), International Patent Application PCT/US2015/010620 filed 
January 8, 2015 (nationalized), U.S. Patent Application 15/110, 557 
filed January 8, 2015, Canadian Patent Application 2936346 filed 
January 8, 2015, European Patent Application 15701442.4 filed January 
8, 2015, and U.S. Divisional Patent Application 16/047,929 filed 
January 8, 2015.
    Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019; 
shmilovm@mail.nih.gov.

    Dated: October 4, 2018.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2018-22359 Filed 10-12-18; 8:45 am]
BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Notices 51969

DEPARTMENT OF HEALTH AND commercialization of results of • Mouse data available.
HUMAN SERVICES federally-funded research and Inventors: Adrian Wiestner, Martin
development. Skarzynski, Christoph Rader (all of
National Institutes of Health FOR FURTHER INFORMATION CONTACT:
NHLBI), and Margaret A. Lindorfer,
Ronald P. Taylor, and Berengere Vire
National Institute of Arthritis and Licensing information may be obtained
(all of the University of Virginia School
Musculoskeletal and Skin Diseases; by emailing the indicated licensing
of Medicine).
Notice of Closed Meeting contact at the National Heart, Lung, and Relevant Publications:
Blood, Office of Technology Transfer • Robinson, et al. Blood. 2018 Aug
Pursuant to section 10(d) of the and Development Office of Technology 2;132(5):521–532. doi: 10.1182/blood–
Federal Advisory Committee Act, as Transfer, 31 Center Drive Room 4A29, 2018–02–830992.
amended, notice is hereby given of the MSC2479, Bethesda, MD 20892–2479; Intellectual Property: HHS Reference
following meeting. telephone: 301–402–5579. A signed No. E–758–2013–0 and –1; U.S.
The meeting will be closed to the Confidential Disclosure Agreement may Provisional Patent Application 61/
public in accordance with the be required to receive any unpublished 924,967 filed January 8, 2014
provisions set forth in sections information. (converted), International Patent
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., SUPPLEMENTARY INFORMATION: Application PCT/US2015/010620 filed
as amended. The grant applications and Technology description follows. January 8, 2015 (nationalized), U.S.
the discussions could disclose Patent Application 15/110, 557 filed
confidential trade secrets or commercial Antibody Targeting Cell Surface
January 8, 2015, Canadian Patent
property such as patentable material, Deposited Complement Protein C3d
Application 2936346 filed January 8,
and personal information concerning Available for licensing and 2015, European Patent Application
individuals associated with the grant commercial development is a patent 15701442.4 filed January 8, 2015, and
applications, the disclosure of which estate covering anti-C3d antibodies, U.S. Divisional Patent Application 16/
would constitute a clearly unwarranted antibody fragments, and their methods 047,929 filed January 8, 2015.
invasion of personal privacy. of use for killing cancer cells expressing Licensing Contact: Michael
Name of Committee: Arthritis and C3d complement protein on their Shmilovich, Esq, CLP; 301–435–5019;
Musculoskeletal and Skin Diseases Initial surface, and more particularly for the shmilovm@mail.nih.gov.
Review Group, Arthritis and Musculoskeletal treatment of patients with Chronic Dated: October 4, 2018.
and Skin Diseases Special Grants Review Lymphocytic Leukemia (CLL); a
Committee. Michael A. Shmilovich,
malignancy of mature B-cells and the
Date: November 8–9, 2018. Senior Licensing and Patenting Manager,
most common leukemia in the US. The National Heart, Lung, and Blood Institute,
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
most commonly used monoclonal Office of Technology Transfer and
applications. antibodies (mAbs) are of mouse origin Development.
Place: Canopy by Hilton Washington, DC, that have been chimerized or [FR Doc. 2018–22359 Filed 10–12–18; 8:45 am]
940 Rose Avenue, North Bethesda, MD humanized to carry human constant BILLING CODE 4140–01–P
20852. regions (typically the human lgG1
Contact Person: Helen Lin, Ph.D., isotype), required for the recruitment of
Scientific Review Officer, NIH/NIAMS, 6701 human effector mechanisms. The DEPARTMENT OF HEALTH AND
Democracy Blvd., Suite 800, Plaza One, complement system consists of soluble
Bethesda, MD 20817, 301–594–4952, linh1@
HUMAN SERVICES
plasma proteins and is activated upon
mail.nih.gov.
binding of a mAb to target cells National Institutes of Health
(Catalogue of Federal Domestic Assistance resulting in the deposition of
Program Nos. 93.846, Arthritis, National Human Genome Research
Musculoskeletal and Skin Diseases Research,
complement components on the cell
surface and formation of the membrane Institute; Notice of Closed Meeting
National Institutes of Health, HHS)
attack complex (MAC), which can kill Pursuant to section 10(d) of the
Dated: October 9, 2018. cells inducing lysis. The invention Federal Advisory Committee Act, as
Sylvia L. Neal, originated from an observation during amended, notice is hereby given of a
Program Analyst, Office of Federal Advisory CLL patient treatment with meeting of the Center for Inherited
Committee Policy. chemotherapy in combination with an Disease Research Access Committee.
[FR Doc. 2018–22310 Filed 10–12–18; 8:45 am] anti CD20 mAb (e.g., rituximab or The meeting will be closed to the
BILLING CODE 4140–01–P ofatumumab). Upon infusion public in accordance with the
complement is deposited on the cell provisions set forth in sections
surface of CLL cells, a subset of cells is 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
DEPARTMENT OF HEALTH AND killed, and other cells escape having lost as amended. The grant applications and
HUMAN SERVICES CD20 expression due to a process called the discussions could disclose
trogocytosis by which antibody-CD20 confidential trade secrets or commercial
National Institutes of Health complexes are pulled of the CLL cell property such as patentable material,
surface by immune cells that bind the and personal information concerning
Government-Owned Inventions; Fc-portion of the mAb. It has been noted
Availability for Licensing individuals associated with the grant
that C3d is stably attached to the CLL applications, the disclosure of which
khammond on DSK30JT082PROD with NOTICES

AGENCY: National Institutes of Health, cells that escape from further rituximab would constitute a clearly unwarranted
HHS. or ofatumumab targeting and remains invasion of personal privacy.
ACTION: Notice. detectable for weeks on these cells. C3d,
Name of Committee: Center for Inherited
thus, could serve as a neoantigen that Disease Research Access Committee.
SUMMARY: The inventions listed below could be targeted with anti C3d specific Date: November 9, 2018.
are owned by an agency of the U.S. mAbs to kill off escaped tumor cells. Time: 11:30 a.m. to 12:30 p.m.
Government and are available for Potential Commercial Applications: Agenda: To review and evaluate grant
licensing to achieve expeditious Development Stage: applications.

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Document Created: 2018-10-13 10:04:46
Document Modified: 2018-10-13 10:04:46

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information.
FR Citation		83 FR 51969

83 FR 51969 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 199 (October 15, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health