80 FR 81555 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 250 (December 30, 2015)

Page Range		81555-81556
FR Document		2015-32879

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.

Federal Register, Volume 80 Issue 250 (Wednesday, December 30, 2015)

[Federal Register Volume 80, Number 250 (Wednesday, December 30, 2015)]
[Notices]
[Pages 81555-81556]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-32879]


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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 invention listed below is owned by an agency of the U.S. 
Government and is available for licensing and/or co-development in the 
U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve 
expeditious commercialization of results of federally-funded research 
and development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing and/or co-development.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute, Technology Transfer 
Center on or before January 29, 2016 will be considered.

ADDRESSES: Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD, 20850-9702.

FOR FURTHER INFORMATION CONTACT: Information on licensing and co-
development research collaborations, and copies of the U.S. patent 
applications listed below may be

[[Page 81556]]

obtained by contacting: Attn. Invention Development and Marketing Unit, 
Technology Transfer Center, National Cancer Institute, 9609 Medical 
Center Drive, Mail Stop 9702, Rockville, MD, 20850-9702, Tel. 240-276-
5515 or email [email protected]. A signed Confidential 
Disclosure Agreement may be required to receive copies of the patent 
applications.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of invention: A Novel Fully-Human Anti-CD30 Chimeric Antigen 
Receptor for Treatment of CD30+ Lymphoma.
    Description of Technology: Chimeric antigen receptors (CARs) are 
hybrid proteins that consist of two major components: A targeting 
domain and a signaling domain. The targeting domain allows T cells 
which express the CAR to selectively recognize and bind to diseased 
cells that express a particular protein. Once the diseased cell is 
bound by the targeting domain of the CAR, the signaling domain of the 
CAR activates the T cell, thereby allowing it to kill the diseased 
cell. This is a promising new therapeutic approach known as adoptive 
cell therapy (ACT).
    Researchers at the National Cancer Institute's Experimental 
Transplantation and Immunology Branch developed a CAR that recognizes 
human tumor necrosis factor receptor superfamily member 8 (TNFRSF8, 
also known as CD30). The expression of CD30 is deregulated in a variety 
of human cancers, including many lymphomas. By creating a CAR that 
recognizes CD30, it may be possible to treat these cancers using 
adoptive cell therapy.

Potential Commercial Applications

    --Treatment of human cancers associated with expression of CD30 or 
variants thereof
    --Specific cancers include: Non-Hodgkins Lymphomas, Hodgkin's 
Lymphomas, several solid malignancies

Value Proposition

    --Human components are less likely to cause adverse or neutralizing 
immune response in patients
    --Targeted therapies decrease non-specific killing of healthy cells 
and tissues, resulting in fewer off-target side-effects and healthier 
patients

Development Stage

In vivo/Lead Validation.

Inventor(s)

Jim N. Kochenderfer, M.D. (NCI).

Intellectual Property

HHS Reference No. E-001-2016/0-US-01
US Provisional Application 62/241,896 (HHS Reference No. E-001-2016/0-
US-01) filed October 15, 2015 entitled ``A Novel Fully-Human Anti-CD30 
Chimeric Antigen Receptor for Treatment of CD30+ Lymphoma''
    Licensing Opportunity: Researchers at the NCI seek licensees for a 
chimeric antigen receptor (CAR) that recognizes human tumor necrosis 
factor receptor superfamily member 8 (TNFRSF8, also known as CD30) for 
use as a cancer therapeutic.

Contact Information

    Requests for copies of the patent application or inquiries about 
licensing and/or research collaboration and co-development 
opportunities should be sent to John D. Hewes. Ph.D., email: 
[email protected].

    Dated: December 22, 2015.
Thomas M. Stackhouse,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2015-32879 Filed 12-29-15; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 80, No. 250 / Wednesday, December 30, 2015 / Notices 81555

amended (5 U.S.C. App.), notice is Time: 10:00 a.m. to 4:30 p.m. 092: Bioengineering Research Partnerships
hereby given of the following meeting. Agenda: To review and evaluate grant (BRP).
The meeting will be closed to the applications. Date: January 21, 2016.
public in accordance with the Place: National Institutes of Health, 5601 Time: 11:00 a.m. to 4:00 p.m.
Fishers Lane, Rockville, MD 20892 Agenda: To review and evaluate grant
provisions set forth in sections (Telephone Conference Call). applications.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Contact Person: Zhuqing (Charlie) Li, Place: National Institutes of Health, 6701
as amended. The grant applications and Ph.D., Scientific Review Officer, Scientific Rockledge Drive, Bethesda, MD 20892,
the discussions could disclose Review Program, Division of Extramural (Virtual Meeting).
confidential trade secrets or commercial Activities, Room # 3G41B, National Institutes Contact Person: Mehrdad Mohseni, MD,
property such as patentable material, of Health/NIAID, 5601 Fishers Lane, Scientific Review Officer, Center for
and personal information concerning MSC9823, Bethesda, MD 20892–9823, (240) Scientific Review, National Institutes of
669–5068, zhuqing.li@nih.gov. Health, 6701 Rockledge Drive, Room 5211,
individuals associated with the grant
applications, the disclosure of which Name of Committee: National Institute of MSC 7854, Bethesda, MD 20892, 301–435–
Allergy and Infectious Diseases Special 0484, mohsenim@csr.nih.gov.
would constitute a clearly unwarranted Emphasis Panel; Partnerships for the
invasion of personal privacy. (Catalogue of Federal Domestic Assistance
Development of Host-Targeted Therapeutics Program Nos. 93.306, Comparative Medicine;
Name of Committee: National Institute of to Limit Antimicrobial Resistance (R01). 93.333, Clinical Research, 93.306, 93.333,
Biomedical Imaging and Bioengineering Date: January 28–29, 2016. 93.337, 93.393–93.396, 93.837–93.844,
Special Emphasis Panel; Center for Complex Time: 12:00 p.m. to 4:00 p.m. 93.846–93.878, 93.892, 93.893, National
Tissues (2016/05). Agenda: To review and evaluate grant Institutes of Health, HHS)
Date: February 15, 2016. applications.
Time: 9:00 a.m. to 8:00 p.m. Place: National Institutes of Health, Room Dated: December 23, 2015.
Agenda: To review and evaluate grant 2H 200 A/B, 3F100, 5601 Fishers Lane, David Clary,
applications. Rockville, MD 20892 (Telephone Conference Program Analyst, Office of Federal Advisory
Place: National Institutes of Health, Two Call). Committee Policy.
Democracy Plaza, Suite 920, 6707 Democracy Contact Person: Susana Mendez, DVM,
Ph.D., Scientific Review Officer, Scientific [FR Doc. 2015–32770 Filed 12–29–15; 8:45 am]
Boulevard, Bethesda, MD 20892, (Virtual
Meeting). Review Program, Division of Extramural BILLING CODE 4140–01–P

Contact Person: John K. Hayes, Ph.D., Activities, Room 3G53B, National Institutes
Scientific Review Officer, 6707 Democracy of Health, NIAID, 5601 Fishers Lane Dr.,
Boulevard, Suite 959, Bethesda, MD 20892, MSC 9823, Bethesda, MD 20892–9823, (240) DEPARTMENT OF HEALTH AND
(301)–451–3398, hayesj@mail.nih.gov. 669–5077, mendezs@niaid.nih.gov. HUMAN SERVICES
(Catalogue of Federal Domestic Assistance
Dated: December 23, 2015. Program Nos. 93.855, Allergy, Immunology, National Institutes of Health
David Clary, and Transplantation Research; 93.856,
Program Analyst, Office of Federal Advisory Microbiology and Infectious Diseases Government-Owned Inventions;
Committee Policy. Research, National Institutes of Health, HHS) Availability for Licensing
[FR Doc. 2015–32769 Filed 12–29–15; 8:45 am] Dated: December 23, 2015.
AGENCY: National Institutes of Health,
BILLING CODE 4140–01–P Natasha M. Copeland,
HHS.
Program Analyst, Office of Federal Advisory
Committee Policy. ACTION: Notice.
DEPARTMENT OF HEALTH AND [FR Doc. 2015–32766 Filed 12–29–15; 8:45 am] SUMMARY: The invention listed below is
HUMAN SERVICES BILLING CODE 4140–01–P owned by an agency of the U.S.
National Institutes of Health Government and is available for
licensing and/or co-development in the
DEPARTMENT OF HEALTH AND U.S. in accordance with 35 U.S.C. 209
National Institute of Allergy and
HUMAN SERVICES and 37 CFR part 404 to achieve
Infectious Diseases; Notice of Closed
Meetings National Institutes of Health expeditious commercialization of
results of federally-funded research and
Pursuant to section 10(d) of the Center for Scientific Review; Notice of development. Foreign patent
Federal Advisory Committee Act, as Closed Meeting applications are filed on selected
amended (5 U.S.C. App.), notice is inventions to extend market coverage
hereby given of the following meetings. Pursuant to section 10(d) of the for companies and may also be available
The meetings will be closed to the Federal Advisory Committee Act, as for licensing and/or co-development.
public in accordance with the amended (5 U.S.C. App.), notice is
DATES: Only written comments and/or
provisions set forth in sections hereby given of the following meeting.
applications for a license which are
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., The meeting will be closed to the
public in accordance with the received by the National Cancer
as amended. The grant applications and Institute, Technology Transfer Center on
the discussions could disclose provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., or before January 29, 2016 will be
confidential trade secrets or commercial considered.
property such as patentable material, as amended. The grant applications and
and personal information concerning the discussions could disclose ADDRESSES: Invention Development and
individuals associated with the grant confidential trade secrets or commercial Marketing Unit, Technology Transfer
property such as patentable material, Center, National Cancer Institute, 9609
mstockstill on DSK4VPTVN1PROD with NOTICES

applications, the disclosure of which
would constitute a clearly unwarranted and personal information concerning Medical Center Drive, Mail Stop 9702,
invasion of personal privacy. individuals associated with the grant Rockville, MD, 20850–9702.
applications, the disclosure of which FOR FURTHER INFORMATION CONTACT:
Name of Committee: National Institute of
would constitute a clearly unwarranted Information on licensing and co-
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Investigator Initiated invasion of personal privacy. development research collaborations,
Program Project Applications (P01). Name of Committee: Center for Scientific and copies of the U.S. patent
Date: January 28, 2016. Review Special Emphasis Panel; PAR–14– applications listed below may be

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81556 Federal Register / Vol. 80, No. 250 / Wednesday, December 30, 2015 / Notices

obtained by contacting: Attn. Invention Intellectual Property Institutes of Health, 7201 Wisconsin Avenue,
Development and Marketing Unit, Suite 2c212, Bethesda, MD 20892, 301–402–
HHS Reference No. E–001–2016/0–US– 7705, JOHNSONJ9@NIA.NIH.GOV.
Technology Transfer Center, National 01
Cancer Institute, 9609 Medical Center (Catalogue of Federal Domestic Assistance
US Provisional Application 62/241,896 Program Nos. 93.866, Aging Research,
Drive, Mail Stop 9702, Rockville, MD, (HHS Reference No. E–001–2016/0–
20850–9702, Tel. 240–276–5515 or National Institutes of Health, HHS)
US–01) filed October 15, 2015 entitled
email ncitechtransfer@mail.nih.gov. A Dated: December 23, 2015.
‘‘A Novel Fully-Human Anti-CD30
signed Confidential Disclosure Chimeric Antigen Receptor for Melanie J. Gray,
Agreement may be required to receive Treatment of CD30+ Lymphoma’’ Program Analyst, Office of Federal Advisory
copies of the patent applications. Licensing Opportunity: Researchers at Committee Policy.
SUPPLEMENTARY INFORMATION: the NCI seek licensees for a chimeric [FR Doc. 2015–32773 Filed 12–29–15; 8:45 am]
Technology description follows. antigen receptor (CAR) that recognizes BILLING CODE 4140–01–P

Title of invention: A Novel Fully- human tumor necrosis factor receptor
Human Anti-CD30 Chimeric Antigen superfamily member 8 (TNFRSF8, also
Receptor for Treatment of CD30+ known as CD30) for use as a cancer DEPARTMENT OF HOMELAND
Lymphoma. therapeutic. SECURITY
Description of Technology: Chimeric Contact Information U.S. Citizenship and Immigration
antigen receptors (CARs) are hybrid Requests for copies of the patent Services
proteins that consist of two major application or inquiries about licensing
components: A targeting domain and a [OMB Control Number 1615–0014]
and/or research collaboration and co-
signaling domain. The targeting domain development opportunities should be Agency Information Collection
allows T cells which express the CAR to sent to John D. Hewes. Ph.D., email: Activities: Affidavit of Support, Form
selectively recognize and bind to john.hewes@nih.gov. I–134; Extension, Without Change, of a
diseased cells that express a particular Currently Approved Collection
Dated: December 22, 2015.
protein. Once the diseased cell is bound
by the targeting domain of the CAR, the Thomas M. Stackhouse, AGENCY: U.S. Citizenship and
signaling domain of the CAR activates Associate Director, Technology Transfer Immigration Services, Department of
the T cell, thereby allowing it to kill the Center, National Cancer Institute. Homeland Security.
diseased cell. This is a promising new [FR Doc. 2015–32879 Filed 12–29–15; 8:45 am]
ACTION: 60-day notice.
therapeutic approach known as BILLING CODE 4140–01–P
adoptive cell therapy (ACT). SUMMARY: The Department of Homeland
Researchers at the National Cancer Security (DHS), U.S. Citizenship and
DEPARTMENT OF HEALTH AND Immigration (USCIS) invites the general
Institute’s Experimental Transplantation
HUMAN SERVICES public and other Federal agencies to
and Immunology Branch developed a
CAR that recognizes human tumor comment upon this proposed extension
National Institutes of Health of a currently approved collection of
necrosis factor receptor superfamily
member 8 (TNFRSF8, also known as National Institute on Aging; Notice of information. In accordance with the
CD30). The expression of CD30 is Closed Meeting Paperwork Reduction Act (PRA) of
deregulated in a variety of human 1995, the information collection notice
cancers, including many lymphomas. Pursuant to section 10(d) of the is published in the Federal Register to
By creating a CAR that recognizes CD30, Federal Advisory Committee Act, as obtain comments regarding the nature of
it may be possible to treat these cancers amended (5 U.S.C. App.), notice is the information collection, the
using adoptive cell therapy. hereby given of the following meeting. categories of respondents, the estimated
The meeting will be closed to the burden (i.e. the time, effort, and
Potential Commercial Applications public in accordance with the resources used by the respondents to
provisions set forth in sections respond), the estimated cost to the
—Treatment of human cancers
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., respondent, and the actual information
associated with expression of CD30 or
as amended. The grant applications and collection instruments.
variants thereof
the discussions could disclose DATES: Comments are encouraged and
—Specific cancers include: Non-
confidential trade secrets or commercial will be accepted for 60 days until
Hodgkins Lymphomas, Hodgkin’s
property such as patentable material, February 29, 2016.
Lymphomas, several solid malignancies
and personal information concerning ADDRESSES: All submissions received
Value Proposition individuals associated with the grant must include the OMB Control Number
applications, the disclosure of which 1615–0014 in the subject box, the
—Human components are less likely would constitute a clearly unwarranted agency name and Docket ID USCIS–
to cause adverse or neutralizing immune invasion of personal privacy. 2006–0072. To avoid duplicate
response in patients
Name of Committee: National Institute on submissions, please use only one of the
—Targeted therapies decrease non- Aging Special Emphasis Panel; Alzheimer’s following methods to submit comments:
specific killing of healthy cells and Center. (1) Online. Submit comments via the
tissues, resulting in fewer off-target side- Date: February 4, 2016.
mstockstill on DSK4VPTVN1PROD with NOTICES

Federal eRulemaking Portal Web site at
effects and healthier patients Time: 3:00 p.m. to 4:00 p.m. http://www.regulations.gov under
Agenda: To review and evaluate grant e-Docket ID number USCIS–2006–0072;
Development Stage applications.
Place: Bethesda North Marriott Hotel &
(2) Email. Submit comments to
In vivo/Lead Validation. Conference Center, 5701 Marinelli Road, USCISFRComment@uscis.dhs.gov;
Inventor(s) North Bethesda, MD 20852. (3) Mail. Submit written comments to
Contact Person: Jeannette L. Johnson, DHS, USCIS, Office of Policy and
Jim N. Kochenderfer, M.D. (NCI). Ph.D., National Institutes on Aging, National Strategy, Chief, Regulatory Coordination

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Document Created: 2015-12-30 03:16:03
Document Modified: 2015-12-30 03:16:03

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.
Dates		Only written comments and/or applications for a license which are received by the National Cancer Institute, Technology Transfer Center on or before January 29, 2016 will be considered.
Contact		Information on licensing and co- development research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850-9702, Tel. 240-276- 5515 or email [email protected] A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications.
FR Citation		80 FR 81555

80 FR 81555 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 250 (December 30, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health