80 FR 59798 - Prospective Grant of Exclusive License: Development of a ME-TARP Based Immunotherapy

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 191 (October 2, 2015)

Page Range		59798-59799
FR Document		2015-24989

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404.7, that 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 following U.S. Patents and Patent Applications to PDS Biotechnology Corporation (``PDS'') located in New Brunswick, New Jersey, USA:

Federal Register, Volume 80 Issue 191 (Friday, October 2, 2015)

[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59798-59799]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of a ME-TARP 
Based Immunotherapy

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
404.7, that 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 following U.S. 
Patents and Patent Applications to PDS Biotechnology Corporation 
(``PDS'') located in New Brunswick, New Jersey, USA:

Intellectual Property

1. United States Provisional Patent Application No. 60/476,467, 
filed June 5, 2003, entitled ``Immunogenic Peptides and Peptide 
Derivatives For The Treatment of Prostate And Breast Cancer 
Treatment'' [HHS Reference No. E-116-2003/0-US-01];
2. International Patent Application No. PCT/US2004/17574 filed June 
2, 2004 entitled ``Immunogenic Peptides And Peptide Derivatives For 
The Treatment of Prostate And Breast Cancer Treatment'' [HHS 
Reference No. E-116-2003/0-PCT-02];
3. United States Patent No.7,541,035, issued June 2, 2009, entitled 
``Immunogenic Peptides And Peptide Derivatives For The Treatment of 
Prostate And Breast Cancer Treatment'' [HHS Reference No. E-116-
2003/0-US-03];
4. United States Patent No. 8,043,623, issued 25 Oct 2011, entitled 
``Immunogenic Peptides and Peptide Derivatives For The Treatment of 
Prostate And Breast Cancer Treatment'' [HHS Reference No. E-116-
2003/0-US-04];
5. United States Provisional Patent Application No. 61/915,948, 
filed December 13, 2013, entitled ``Multi-Epitope TARP Peptide 
Vaccine and Uses Thereof'' [HHS Reference No. E-047-2014/0-US-01];
6. International Patent Application No. PCT/US2014/070144 filed 
December 12, 2014 entitled ``Multi-Epitope TARP Peptide Vaccine and 
Uses Thereof'' [HHS Reference No. E-047-2014/0-PCT-02]; and all 
continuation applications, divisional applications and foreign 
counterpart applications claiming priority to the US provisional 
application no. 61/915, 948.

    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

[[Page 59799]]

field of use will be limited to the use of Licensed Patent Rights for 
the following Fields of Use:

1. Development and Commercialization of an ME-TARP-based therapy 
containing at least one cationic lipid within the scope of the 
Licensed Patent Rights.
2. Development and Commercialization of a cell based therapeutic 
product with ME-TARP for Prostate Cancer.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
November 2, 2015 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Sabarni K. Chatterjee, Ph.D., M.B.A. Senior Licensing and 
Patenting 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: This invention concerns the identification 
of immunogenic peptides within TARP, and their use to create an anti-
cancer immune response in patients. By introducing these peptides into 
a patient, an immune response against these cancer cells can be 
initiated by the peptides, resulting in treatment of the cancer. A 
phase I clinical trial in stage D0 prostate cancer patients is nearing 
completion. Initial results indicate a statistically significant 
decrease in the slope of PSA for 48 weeks after vaccination.
    The technology has the potential of being developed into a vaccine 
for various cancer indications or for the treatment of any cancer 
associated with increased or preferential expression of TARP.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless within thirty 
(30) days from the date of this published notice, the NIH 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 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 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.

    Dated: September 28, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-24989 Filed 10-1-15; 8:45 am]
 BILLING CODE 4140-01-P

59798 Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices

Dated: September 28, 2015. published under the publication rules of DEPARTMENT OF HEALTH AND
Richard U. Rodriguez, either the United States Patent and HUMAN SERVICES
Acting Director, Office of Technology Trademark Office or the World
Transfer, National Institutes of Health. Intellectual Property Organization. National Institutes of Health
[FR Doc. 2015–24982 Filed 10–1–15; 8:45 am]
SUPPLEMENTARY INFORMATION: Hazardous Prospective Grant of Exclusive
BILLING CODE 4140–01–P
airborne particles pose a risk for health License: Development of a ME–TARP
and safety in a variety of environments Based Immunotherapy
DEPARTMENT OF HEALTH AND and thus detection of these small
AGENCY: National Institutes of Health,
HUMAN SERVICES particles is essential. Current particle
HHS.
magnification systems are bulky and
National Institutes of Health ACTION: Notice.
require a lot of power for operation,
making them unsuitable to easily detect SUMMARY: This is notice, in accordance
Prospective Grant of Exclusive and analyze small particles in mobile with 35 U.S.C. 209 and 37 CFR 404.7,
License: Analytical Instruments and personal settings. that the National Institutes of Health,
Utilizing Condensation Particle
The CDC has developed space-saving Department of Health and Human
Counters for the Detection and
miniature instrumentation and methods Services, is contemplating the grant of
Analysis of Small Aerosol Particles
for the direct sampling and analysis of an exclusive patent license to practice
AGENCY: Public Health Service, National small particles (diameter <300–400 nm). the inventions embodied in the
Institutes of Health, HHS. The systems can effectively sample air following U.S. Patents and Patent
ACTION: Notice. at a rate of a few liters per minute and Applications to PDS Biotechnology
Corporation (‘‘PDS’’) located in New
SUMMARY: This is notice, in accordance concentrate the particulate matter into
Brunswick, New Jersey, USA:
with 35 U.S.C. 209 and 37 CFR part 404, microliter or milliliter liquid samples.
that the Public Health Service, The novel system uses proton exchange Intellectual Property
Department of Health and Human membranes to grow small particles for 1. United States Provisional Patent
Services, is contemplating the grant of optical detection using standard Application No. 60/476,467, filed June 5,
an exclusive license to Kanomax Japan, methods. Further, these methods allow 2003, entitled ‘‘Immunogenic Peptides
Inc. having a principal place of business the system to separate condensation and and Peptide Derivatives For The
in Osaka, Japan, to practice the aerosol flow to enhance user mobility. Treatment of Prostate And Breast Cancer
Treatment’’ [HHS Reference No. E–116–
inventions embodied in U.S. Provisional Moreover, the described methods use
2003/0–US–01];
Patent Application No. 62/026,559, filed inexpensive materials and require low 2. International Patent Application No. PCT/
on 18 July 2014, entitled ‘‘Aerosol power for operation. US2004/17574 filed June 2, 2004 entitled
Particle Growth Systems for Personal The prospective exclusive license will ‘‘Immunogenic Peptides And Peptide
Sampling Applications Using Polymer be royalty bearing and will comply with Derivatives For The Treatment of
Electrolyte Membranes’’ [HHS Reference the terms and conditions of 35 U.S.C.
Prostate And Breast Cancer Treatment’’
No. E–026–2014/0–US–01]. The patent [HHS Reference No. E–116–2003/0–
209 and 37 CFR part 404. The PCT–02];
rights in these inventions have been
prospective exclusive license may be 3. United States Patent No.7,541,035, issued
assigned to the United States of
granted unless, within thirty (30) days June 2, 2009, entitled ‘‘Immunogenic
America. The territory of the Peptides And Peptide Derivatives For
prospective exclusive patent license from the date of this published notice,
the NIH Office of Technology Transfer The Treatment of Prostate And Breast
may be worldwide, and the field of use Cancer Treatment’’ [HHS Reference No.
may be limited to ‘‘Analytical receives written evidence and argument
E–116–2003/0–US–03];
instruments comprising condensation that establishes that the grant of the 4. United States Patent No. 8,043,623, issued
particle counters (CPCs) for the contemplated license would not be 25 Oct 2011, entitled ‘‘Immunogenic
sampling, detection, counting and consistent with the requirements of 35 Peptides and Peptide Derivatives For
analysis of ultrafine and nano-sized U.S.C. 209 and 37 CFR part 404. The Treatment of Prostate And Breast
aerosol particles.’’ Cancer Treatment’’ [HHS Reference No.
Properly filed competing applications E–116–2003/0–US–04];
DATES: Only written comments and/or for a license in the prospective field of 5. United States Provisional Patent
applications for a license that are use that are filed in response to this Application No. 61/915,948, filed
received by the NIH Office of notice will be treated as objections to December 13, 2013, entitled ‘‘Multi-
Technology Transfer on or before the contemplated license. Comments Epitope TARP Peptide Vaccine and Uses
November 2, 2015 will be considered. and objections submitted in response to Thereof’’ [HHS Reference No. E–047–
ADDRESSES: Requests for a copy of the 2014/0–US–01];
this notice will not be made available 6. International Patent Application No. PCT/
patent application, inquiries, comments for public inspection, and, to the extent US2014/070144 filed December 12, 2014
and other materials relating to the permitted by law, will not be released entitled ‘‘Multi-Epitope TARP Peptide
contemplated license should be directed under the Freedom of Information Act, Vaccine and Uses Thereof’’ [HHS
to: Tara L. Kirby, Ph.D., Chief, CDC 5 U.S.C. 552. Reference No. E–047–2014/0–PCT–02];
Unit, Office of Technology Transfer, and all continuation applications,
National Institutes of Health, 6011 Dated: September 28, 2015. divisional applications and foreign
Richard U. Rodriguez,
mstockstill on DSK4VPTVN1PROD with NOTICES

Executive Boulevard, Suite 325, counterpart applications claiming
Rockville, MD 20852–3804; Telephone: Acting Director, Office of Technology priority to the US provisional
(301) 435–4426; Facsimile: (301) 402– Transfer, National Institutes of Health. application no. 61/915, 948.
0220; Email: tarak@mail.nih.gov. A [FR Doc. 2015–24985 Filed 10–1–15; 8:45 am] The patent rights in these inventions
signed confidential disclosure BILLING CODE 4140–01–P have been assigned to the government of
agreement may be required to receive the United States of America.
copies of the patent application The prospective exclusive license
assuming it has not already been territory may be worldwide and the

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Document Created: 2015-12-15 08:45:29
Document Modified: 2015-12-15 08:45:29

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 NIH Office of Technology Transfer on or before November 2, 2015 will be considered.
FR Citation		80 FR 59798

80 FR 59798 - Prospective Grant of Exclusive License: Development of a ME-TARP Based Immunotherapy

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 191 (October 2, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health