81 FR 31250 - Prospective Grant of Start-up Exclusive License: Development of Virus Like Particles for the Treatment of Breast Cancer, Lung Cancer, Melanoma, Pancreatic Cancer, and Hepatocellular Cancer
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 96 (May 18, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 96 (May 18, 2016)
| Page Range | 31250-31251 | |
| FR Document | 2016-11661 |
[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)] [Notices] [Pages 31250-31251] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11661] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-up Exclusive License: Development of Virus Like Particles for the Treatment of Breast Cancer, Lung Cancer, Melanoma, Pancreatic Cancer, and Hepatocellular Cancer AGENCY: National Institutes Of Health, Public Health Service, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7, that the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Patent License to practice the inventions embodied in the following patent applications to Chimeron Bio Corporation, a company incorporated under the laws of Delaware and having an office in Philadelphia, PA. Intellectual Property: U.S. Provisional Patent Application No.: 61/ 615,687 Entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-US-01 Filed March 26, 2012; International Patent Application No.: PCT/US2013/031876 Entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-PCT-02 Filed March 15, 2013; Australian Patent Application No.: 2013-240248 Entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264- 2011/0-AU-03 Filed October 17, 2014; European Patent Application No.: 13712661.1 Entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-EP-04 Filed October 24, 2014; Japanese Patent Application No.: 2015-503322 entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-JP-05 Filed September 25, 2014; U.S. Patent Application No.: 14/388,441 Entitled Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-US-06 Filed September 26, 2014; U.S. Provisional Patent Application No.: 61/ 916,394 Entitled ``Cancer Immunotherapy: Delivery HLA-11 using VLP- Replicon'' HHS Ref. No.: E-050-2014/0-US-01 Filed December 16, 2013; International Patent Application No.: PCT/US2014/070552 Entitled ``Cancer Immunotherapy: Delivery HLA-11 using VLP-Replicon'' HHS Ref. No.: E-050-2014/0-PCT-02 Filed December 16, 2014; The patent rights to these inventions have been assigned to the Government of the United States of America. The prospective exclusive start-up licensed territory may be worldwide and the field of use may be limited to: ``Use of virus like particles comprising MHCII and CD80 for the treatment of breast cancer, lung cancer, melanoma, pancreatic cancer, and hepatocellular cancer.'' DATES: Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before June 2, 2016 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated exclusive license should be directed to: Lauren Nguyen-Antczak, Ph.D., J.D., Sr. Licensing and Patenting Manager, Technology Transfer Center, National Cancer Institute, 8490 Progress Drive, Riverside 5, Suite 400, Frederick, MD 21701; Telephone: (301) 624-8752; Email: lauren.nguyen-antczak@nih.gov. SUPPLEMENTARY INFORMATION: The invention is directed to virus-like particles (``VLPs'') that serve to induce transgene expression of at least one recombinant protein of interest in specific, targeted cells. This technology can be used to treat a variety of diseases, depending on the cell type to be targeted. Preferably, invention VLPs may be used to treat tumor bearing cancers, including breast cancer, lung cancer, melanoma, pancreatic cancer, and hepatocellular cancer. The prospective Start-Up Exclusive Patent License, which will be royalty bearing, is being considered under the small business initiative launched on 1 October 2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404.7. The prospective Start-Up Exclusive Patent License may be granted unless the NIH receives written evidence and argument, within fifteen (15) days from the date of this published notice, 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 404.7. Complete applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive start-up license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. [[Page 31251]] Dated: May 12, 2016. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2016-11661 Filed 5-17-16; 8:45 am] BILLING CODE 4140-01-P
![31250 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
Scientific Review, National Institutes of DEPARTMENT OF HEALTH AND The patent rights to these inventions
Health, 6701 Rockledge Drive, Room 2204, HUMAN SERVICES have been assigned to the Government
MSC 7890, Bethesda, MD 20892, (301) 435– of the United States of America.
1045, corsaroc@csr.nih.gov. National Institutes of Health The prospective exclusive start-up
Name of Committee: Center for Scientific licensed territory may be worldwide
Review Special Emphasis Panel; Electrical Prospective Grant of Start-up
and the field of use may be limited to:
Signaling, Ion Transport and Arrhythmias Exclusive License: Development of
‘‘Use of virus like particles comprising
Special Panel. Virus Like Particles for the Treatment
MHCII and CD80 for the treatment of
Date: June 16, 2016. of Breast Cancer, Lung Cancer,
breast cancer, lung cancer, melanoma,
Time: 11:00 a.m. to 1:00 p.m. Melanoma, Pancreatic Cancer, and
pancreatic cancer, and hepatocellular
Agenda: To review and evaluate grant Hepatocellular Cancer
cancer.’’
applications.
Place: Bethesda North Marriott Hotel & AGENCY: National Institutes Of Health, DATES: Only written comments and/or
Conference Center, 5701 Marinelli Road, Public Health Service, HHS. applications for a license which are
Bethesda, MD 20852. ACTION: Notice. received by the NCI Technology
Contact Person: Abdelouahab Aitouche, Transfer Center on or before June 2,
Ph.D., Scientific Review Officer, Center for SUMMARY: This notice, in accordance 2016 will be considered.
Scientific Review, National Institutes of with 35 U.S.C. 209(c)(1) and 37 CFR
Health, 6701 Rockledge Drive, Room 4222,
ADDRESSES: Requests for copies of the
part 404.7, that the National Cancer patent application, inquiries, and
MSC 7814, Bethesda, MD 20892, 301–435– Institute, National Institutes of Health,
2365, aitouchea@csr.nih.gov. comments relating to the contemplated
Department of Health and Human exclusive license should be directed to:
Name of Committee: Center for Scientific Services, is contemplating the grant of a Lauren Nguyen-Antczak, Ph.D., J.D., Sr.
Review, Special Emphasis Panel; SBIB Start-Up Exclusive Patent License to Licensing and Patenting Manager,
Clinical Pediatric and Fetal Applications. practice the inventions embodied in the Technology Transfer Center, National
Date: June 16, 2016. following patent applications to Cancer Institute, 8490 Progress Drive,
Time: 11:00 a.m. to 5:00 p.m. Chimeron Bio Corporation, a company Riverside 5, Suite 400, Frederick, MD
Agenda: To review and evaluate grant incorporated under the laws of 21701; Telephone: (301) 624–8752;
applications. Delaware and having an office in
Place: National Institutes of Health, 6701
Email: lauren.nguyen-antczak@nih.gov.
Philadelphia, PA.
Rockledge Drive, Bethesda, MD 20892. SUPPLEMENTARY INFORMATION: The
Intellectual Property: U.S. Provisional
Contact Person: John Firrell, Ph.D., invention is directed to virus-like
Patent Application No.: 61/615,687
Scientific Review Officer, Center for particles (‘‘VLPs’’) that serve to induce
Entitled ‘‘Delivery of Packaged RNA in
Scientific Review, National Institutes of transgene expression of at least one
Health, 6701 Rockledge Drive, Room 5118,
Mammalian Cells’’ HHS Ref. No.: E–
recombinant protein of interest in
MSC 7854, Bethesda, MD 20892, 301–435–
264–2011/0–US–01 Filed March 26,
specific, targeted cells. This technology
2598, firrellj@csr.nih.gov.
2012; International Patent Application
can be used to treat a variety of diseases,
No.: PCT/US2013/031876 Entitled
Name of Committee: Center for Scientific depending on the cell type to be
‘‘Delivery of Packaged RNA in
Review, Special Emphasis Panel, Member targeted. Preferably, invention VLPs
Mammalian Cells’’ HHS Ref. No.: E–
Conflict: Neural Trauma and Neurovascular may be used to treat tumor bearing
264–2011/0–PCT–02 Filed March 15,
Pathology. cancers, including breast cancer, lung
2013; Australian Patent Application
Date: June 17, 2016. cancer, melanoma, pancreatic cancer,
No.: 2013–240248 Entitled ‘‘Delivery of
Time: 1:30 p.m. to 5:00 p.m. and hepatocellular cancer.
Packaged RNA in Mammalian Cells’’
Agenda: To review and evaluate grant The prospective Start-Up Exclusive
applications.
HHS Ref. No.: E–264–2011/0–AU–03
Filed October 17, 2014; European Patent Patent License, which will be royalty
Place: National Institutes of Health, 6701 bearing, is being considered under the
Rockledge Drive, Bethesda, MD 20892
Application No.: 13712661.1 Entitled
‘‘Delivery of Packaged RNA in small business initiative launched on 1
(Telephone Conference Call). October 2011 and will comply with the
Contact Person: Alexei Kondratyev, Ph.D., Mammalian Cells’’ HHS Ref. No.: E–
264–2011/0–EP–04 Filed October 24, terms and conditions of 35 U.S.C. 209
Scientific Review Officer, Center for
2014; Japanese Patent Application No.: and 37 CFR part 404.7. The prospective
Scientific Review, National Institutes of
2015–503322 entitled ‘‘Delivery of Start-Up Exclusive Patent License may
Health, 6701 Rockledge Drive, Room 5200,
Packaged RNA in Mammalian Cells’’ be granted unless the NIH receives
MSC 7846, Bethesda, MD 20892, 301–435–
HHS Ref. No.: E–264–2011/0–JP–05 written evidence and argument, within
1785, kondratyevad@csr.nih.gov.
Filed September 25, 2014; U.S. Patent fifteen (15) days from the date of this
(Catalogue of Federal Domestic Assistance published notice, that establishes that
Program Nos. 93.306, Comparative Medicine;
Application No.: 14/388,441 Entitled
Delivery of Packaged RNA in the grant of the license would not be
93.333, Clinical Research, 93.306, 93.333, consistent with the requirements of 35
93.337, 93.393–93.396, 93.837–93.844, Mammalian Cells’’ HHS Ref. No.: E–
264–2011/0–US–06 Filed September 26, U.S.C. 209 and 37 CFR part 404.7.
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS) 2014; U.S. Provisional Patent Complete applications for a license in
Application No.: 61/916,394 Entitled the field of use filed in response to this
Dated: May 12, 2016. ‘‘Cancer Immunotherapy: Delivery notice will be treated as objections to
HLA–11 using VLP-Replicon’’ HHS Ref. the grant of the contemplated exclusive
sradovich on DSK3TPTVN1PROD with NOTICES
David Clary,
No.: E–050–2014/0–US–01 Filed start-up license. Comments and
Program Analyst, Office of Federal Advisory
Committee Policy.
December 16, 2013; International Patent objections submitted to this notice will
Application No.: PCT/US2014/070552 not be made available for public
[FR Doc. 2016–11662 Filed 5–17–16; 8:45 am]
Entitled ‘‘Cancer Immunotherapy: inspection and, to the extent permitted
BILLING CODE 4140–01–P Delivery HLA–11 using VLP-Replicon’’ by law, will not be released under the
HHS Ref. No.: E–050–2014/0–PCT–02 Freedom of Information Act, 5 U.S.C.
Filed December 16, 2014; 552.
VerDate Sep<11>2014 17:10 May 17, 2016 Jkt 238001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\18MYN1.SGM 18MYN1](https://thefederalregister.org/doc/81_FR_31346/page/1.svg)
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31251
Dated: May 12, 2016. Dated: May 12, 2016. exclusively licensed to the Government
Richard U. Rodriguez, Natasha M. Copeland, of the United States of America.
Associate Director, Technology Transfer Program Analyst, Office of Federal Advisory The prospective exclusive licensed
Center, National Cancer Institute. Committee Policy. territory may be the United States,
[FR Doc. 2016–11661 Filed 5–17–16; 8:45 am] [FR Doc. 2016–11663 Filed 5–17–16; 8:45 am] Australia, Canada, the European Union,
BILLING CODE 4140–01–P Russia, China, Hong Kong, Japan,
BILLING CODE 4140–01–P
Taiwan, South Korea and Singapore,
and the field of use may be limited to:
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND ‘‘The development of a glypican-3
HUMAN SERVICES HUMAN SERVICES (GPC3) chimeric antigen receptor (CAR)-
based immunotherapy using autologous
National Institutes of Health National Institutes of Health (meaning one individual is both the
donor and the recipient) primary human
National Institute of Dental & Prospective Grant of an Exclusive lymphocytes (T cells or NK cells)
License: The Development of an Anti- transfected with a lentiviral or retroviral
Craniofacial Research; Notice of
GPC3 Chimeric Antigen Receptor vector, wherein the vector expresses a
Closed Meetings
(CAR) Based on YP7 for the Treatment CAR having (1) a single antigen
Pursuant to section 10(d) of the of Human Cancers specificity and (2) comprising at least:
Federal Advisory Committee Act, as AGENCY: Public Health Service, National (a) The complementary determining
amended (5 U.S.C. App.), notice is Institutes of Health, HHS. region (CDR) sequences of the anti-GPC3
hereby given of the following meetings. ACTION: Notice. antibody known as YP7; and (b) a T cell
signaling domain; for the prophylaxis
The meetings will be closed to the
SUMMARY: This notice, in accordance and treatment of GPC3-expressing
public in accordance with the
with 35 U.S.C. 209(c)(1) and 37 CFR cancers.’’
provisions set forth in sections
Part 404.7(a)(1)(i), that the National DATES: Only written comments and/or
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Institutes of Health, Department of applications for a license which are
as amended. The grant applications and
Health and Human Services, is received by the NCI Technology
the discussions could disclose
contemplating the grant of an exclusive Transfer Center on or before June 2,
confidential trade secrets or commercial
license to practice the inventions 2016 will be considered.
property such as patentable material,
embodied in:
and personal information concerning ADDRESSEES: Requests for copies of the
individuals associated with the grant Intellectual Property patent application, inquiries, comments,
applications, the disclosure of which U.S. Provisional Patent Application and other materials relating to the
would constitute a clearly unwarranted 61/654,232 entitled ‘‘High-affinity contemplated exclusive license should
invasion of personal privacy. Monoclonal Antibodies To Glypican-3 be directed to: David A. Lambertson,
Name of Committee: National Institute of And Use Thereof’’ [HHS Ref. E–136– Ph.D., Senior Licensing and Patenting
Dental and Craniofacial Research Special 2012/0–US–01]; PCT Patent Application Manager, National Cancer Institute,
Emphasis Panel; NIDCR Data Analysis and PCT/US2013/043633 entitled ‘‘High- 9609 Medical Center Drive, Rm 1–E530
Statistical Methodology PARs. affinity Monoclonal Antibodies To MSC9702, Rockville, MD 20850–9702,
Date: June 10, 2016. Glypican-3 And Use Thereof’’ [HHS Ref. Email: david.lambertson@nih.gov.
Time: 11:00 a.m. to 4:00 p.m. E–136–2012/0–PCT–02]; Chinese Patent SUPPLEMENTARY INFORMATION: This
Agenda: To review and evaluate grant Application 201380039993.7 entitled invention concerns an anti-GPC3
applications. ‘‘High-affinity Monoclonal Antibodies (Glypican-3) chimeric antigen receptor
Place: National Institutes of Health, One To Glypican-3 And Use Thereof’’ [HHS (CAR) and methods of using the CAR for
Democracy Plaza, 6701 Democracy Ref. E–136–2012/0–CN–03]; Japanese the treatment of GPC3-expressing
Boulevard, Bethesda, MD 20892. Patent Application 2015–515243 cancers. GPC3 is a cell surface antigen
Contact Person: Victor Henriquez, Ph.D., entitled ‘‘High-affinity Monoclonal that is preferentially expressed on
Scientific Review Officer DEA/SRB/NIDCR, Antibodies To Glypican-3 And Use certain types of cancer cells, particularly
6701 Democracy Blvd., Room 668, Bethesda, liver cancers such as hepatocellular
Thereof’’ [HHS Ref. E–136–2012/0–JP–
MD 20892–4878, 301–451–2405, henriquv@ carcinoma (HCC). The anti-GPC3 CARs
04]; South Korea Patent Application 10–
nidcr.nih.gov.
2014–7037046 entitled ‘‘High-affinity of this technology contain (1) antigen
Name of Committee: NIDCR Special Grants Monoclonal Antibodies To Glypican-3 recognition sequences that bind
Review Committee. And Use Thereof’’ [HHS Ref. E–136– specifically to GPC3 and (2) signaling
Date: June 16–17, 2016. domains that can activate the cytotoxic
2012/0–KR–05]; Singapore Patent
Time: 8:00 a.m. to 12:00 p.m.
Application 11201407972R entitled functions of a T cell. The anti-GPC3
Agenda: To review and evaluate grant
‘‘High-affinity Monoclonal Antibodies CAR can be transduced into T cells that
applications.
Place: Wyndham San Antonio Riverwalk
To Glypican-3 And Use Thereof’’ [HHS are harvested from a donor, followed by
111 East Pecan Street, San Antonio, TX Ref. E–136–2012/0–SG–06]; United (a) selection and expansion of the T
78205 States Patent Application 14/403,896 cells expressing the anti-GPC3 CAR, and
Contact Person: Marilyn Moore-Hoon, entitled ‘‘High-affinity Monoclonal (b) reintroduction of the T cells into the
Ph.D., Scientific Review Officer, Scientific Antibodies To Glypican-3 And Use patient. Once the anti-GPC3 CAR-
Thereof’’ [HHS Ref. E–136–2012/0–US– expressing T cells are reintroduced into
sradovich on DSK3TPTVN1PROD with NOTICES
Review Branch, National Institute of Dental
and Craniofacial Research, 6701 Democracy 07]; the patient, the T cells can selectively
Blvd., Rm. 676, Bethesda, MD 20892–4878, and all continuing U.S. and foreign bind to GPC3-expressing cancer cells
301–594–4861, mooremar@nidcr.nih.gov. patents/patent applications for the through its antigen recognition
(Catalogue of Federal Domestic Assistance technology family, to Lentigen sequences, thereby activating the T cell
Program Nos. 93.121, Oral Diseases and Technology, Inc. through its signaling domains to
Disorders Research, National Institutes of The patent rights to these inventions selectively kill the cancer cells. Through
Health, HHS) have been assigned to and/or this mechanism of action, the selectivity
VerDate Sep<11>2014 17:10 May 17, 2016 Jkt 238001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\18MYN1.SGM 18MYN1](https://thefederalregister.org/doc/81_FR_31346/page/2.svg)
Document Created: 2016-05-18 00:06:53
Document Modified: 2016-05-18 00:06:53
| 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 NCI Technology Transfer Center on or before June 2, 2016 will be considered. | |
| FR Citation | 81 FR 31250 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR