Prospective Grant of a Start-up Exclusive Commercial License Agreement: Development of MHC Class II Restricted T Cell Epitopes From the Cancer Antigen, NY ESO-1, for the Treatment of Human Cancers, 59797-59798 [2015-24982]

Download as PDF Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices signal that indicates the blade location with respect to the base plate. Advantageously, this allows for a stage coupled pedestal to be moved accurately from an imaging location on the beam axis to a cutting location off the beam axis. The prospective start-up 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 part 404. 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 start-up 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. 2015–24994 Filed 10–1–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of a Start-up Exclusive Commercial License Agreement: Development of MHC Class II Restricted T Cell Epitopes From the Cancer Antigen, NY ESO–1, for the Treatment of Human Cancers AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404.7, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an start-up exclusive commercial license to Immunova Therapeutics, Inc., which is located in Houston, Texas, to practice the inventions embodied in the following patent applications and applications claiming priority to these applications: mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: E–090–2000 1. U.S. Provisional Patent Application No. 61/179,004 filed January 28, 2000 entitled ‘‘MHC Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO–1’’ (HHS Ref No. E–090–2000/0– VerDate Sep<11>2014 20:43 Oct 01, 2015 Jkt 238001 US–01); 2. U.S. Provisional Patent Application No. 60/237,107 filed September 29, 2000 entitled ‘‘HLA–DP Restricted CD4+ T Cell Epitopes from the Cancer Antigen, NY ESO–1’’ (HHS Ref No. E–227–2000/ 0–US–01 was combined with E–090– 2000/0–US–01 at the PCT stage, creating the E–090–2000/1 technology family and associated applications); 3. PCT Application No. PCT/US01/02765 filed January 26, 2001 entitled ‘‘MHC Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO–1’’ (HHS Ref No. E–090–2000/1–PCT–01); 4. Canadian Patent No. 2398743 issued June 23, 2015 entitled ‘‘MHC Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO–1’’ (HHS Ref No. E–090–2000/1–CA–02); 5. Australian Patent No. 785151 issued January 18, 2007 entitled ‘‘MHC Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO–1’’ (HHS Ref No. E–090–2000/1–AU–03); 6. Japanese Patent No. 5588363 issued August 1, 2014 entitled ‘‘MHC Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO–1’’ (HHS Ref No. E–090–2000/1–JP–12); 7. U.S. Patent No. 7,619,057 issued November 17, 2009 entitled ‘‘MHC Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO–1’’ (HHS Ref No. E–090–2000/1–US–06); 8. U.S. Patent No. 8,754,046 issued June 17, 2014 entitled ‘‘MHC Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO–1’’ (HHS Ref No. E–090–2000/ 1–US–07); 9. U.S. Patent Application No. 12/568,134 filed September 28, 2009 entitled ‘‘MHC Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO–1’’ (HHS Ref No. E–090–2000/1–US–013); 10. European Patent Application No. 10010354.8 filed January 26, 2001 entitled ‘‘MHC Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO–1’’ (HHS Ref No. E–090–2000/1– EP–10); The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective start-up exclusive commercial license territory may be worldwide and the field of use may be limited to the use of the Licensed Patent Rights to develop, manufacture, distribute, sell and use NY–ESO–1 based vaccines and cell therapy products for the treatment of NY–ESO– 1-positive cancers. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before October 19, 2015 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, comments, and other materials relating to the contemplated exclusive evaluation option license should be PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 59797 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: chatterjeesa@mail.nih.gov. SUPPLEMENTARY INFORMATION: NY–ESO– 1 is a known tumor antigen which is expressed on a broad range of tumor types, including melanoma, breast, bladder, ovarian, prostate, head and neck cancers, neuroblastoma, and small cell lung cancer. The above-referenced inventions embody the identification of a number of novel immunogenic peptide epitopes, and analogs thereof, which are derived from the NY–ESO–1 tumor antigen. Specifically, this technology describes novel MHC Class II restricted epitopes of NY–ESO–1 which are recognized by CD4+ T cells. It also embodies the identification of two additional immunogenic peptide epitopes of NY–ESO–1. The latter two epitopes are presented by HLA–DP4, a prevalent MHC Class II allele present in 43–70% of Caucasians. The inventors also determined that the DP allele is highly associated with the NY–ESO–1 antibody production. In addition, one of these epitopes has dual HLA A2 and DP4 specificity, thereby it has the potential to generate both CD4+ and CD8+ tumor specific T cells. These epitopes may be of great value as prophylactic and/or therapeutic cancer vaccines or cell therapy products for use against a number of common cancers. The prospective start-up exclusive commercial license is being considered under the small business initiative launched on October 1, 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 commercial license may be granted unless within fifteen (15) 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 part 404.7. Any additional, properly filed, and 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 commercial 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. E:\FR\FM\02OCN1.SGM 02OCN1 59798 Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices Dated: September 28, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. published under the publication rules of either the United States Patent and Trademark Office or the World Intellectual Property Organization. [FR Doc. 2015–24982 Filed 10–1–15; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Analytical Instruments Utilizing Condensation Particle Counters for the Detection and Analysis of Small Aerosol Particles Public Health Service, National Institutes of Health, HHS. ACTION: Notice. AGENCY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the Public Health Service, Department of Health and Human Services, is contemplating the grant of an exclusive license to Kanomax Japan, Inc. having a principal place of business in Osaka, Japan, to practice the inventions embodied in U.S. Provisional Patent Application No. 62/026,559, filed on 18 July 2014, entitled ‘‘Aerosol Particle Growth Systems for Personal Sampling Applications Using Polymer Electrolyte Membranes’’ [HHS Reference No. E–026–2014/0–US–01]. The patent rights in these inventions have been assigned to the United States of America. The territory of the prospective exclusive patent license may be worldwide, and the field of use may be limited to ‘‘Analytical instruments comprising condensation particle counters (CPCs) for the sampling, detection, counting and analysis of ultrafine and nano-sized aerosol particles.’’ DATES: Only written comments and/or applications for a license that are received by the NIH Office of Technology Transfer on or before November 2, 2015 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Tara L. Kirby, Ph.D., Chief, CDC Unit, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–4426; Facsimile: (301) 402– 0220; Email: tarak@mail.nih.gov. A signed confidential disclosure agreement may be required to receive copies of the patent application assuming it has not already been mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 20:43 Oct 01, 2015 Jkt 238001 Hazardous airborne particles pose a risk for health and safety in a variety of environments and thus detection of these small particles is essential. Current particle magnification systems are bulky and require a lot of power for operation, making them unsuitable to easily detect and analyze small particles in mobile and personal settings. The CDC has developed space-saving miniature instrumentation and methods for the direct sampling and analysis of small particles (diameter <300–400 nm). The systems can effectively sample air at a rate of a few liters per minute and concentrate the particulate matter into microliter or milliliter liquid samples. The novel system uses proton exchange membranes to grow small particles for optical detection using standard methods. Further, these methods allow the system to separate condensation and aerosol flow to enhance user mobility. Moreover, the described methods use inexpensive materials and require low power for operation. 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 part 404. The prospective exclusive license may be granted unless, within thirty (30) days from the date of this published notice, the NIH Office of Technology Transfer receives written evidence and argument that establishes that the grant of the contemplated license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. Properly filed competing applications for a license in the prospective field of use that are filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response 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. Prospective Grant of Exclusive License: Development of a ME–TARP Based Immunotherapy SUPPLEMENTARY INFORMATION: BILLING CODE 4140–01–P SUMMARY: DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: September 28, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015–24985 Filed 10–1–15; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 National Institutes of Health AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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: SUMMARY: 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 ‘‘MultiEpitope 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 E:\FR\FM\02OCN1.SGM 02OCN1

Agencies

[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59797-59798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24982]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of a Start-up Exclusive Commercial License 
Agreement: Development of MHC Class II Restricted T Cell Epitopes From 
the Cancer Antigen, NY ESO-1, for the Treatment of Human Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404.7, that the National Institutes of Health, Department of 
Health and Human Services, is contemplating the grant of an start-up 
exclusive commercial license to Immunova Therapeutics, Inc., which is 
located in Houston, Texas, to practice the inventions embodied in the 
following patent applications and applications claiming priority to 
these applications:

E-090-2000

1. U.S. Provisional Patent Application No. 61/179,004 filed January 
28, 2000 entitled ``MHC Class II Restricted T Cell Epitopes from the 
Cancer Antigen, NY ESO-1'' (HHS Ref No. E-090-2000/0-US-01);
2. U.S. Provisional Patent Application No. 60/237,107 filed 
September 29, 2000 entitled ``HLA-DP Restricted CD4+ T Cell Epitopes 
from the Cancer Antigen, NY ESO-1'' (HHS Ref No. E-227-2000/0-US-01 
was combined with E-090-2000/0-US-01 at the PCT stage, creating the 
E-090-2000/1 technology family and associated applications);
3. PCT Application No. PCT/US01/02765 filed January 26, 2001 
entitled ``MHC Class II Restricted T Cell Epitopes from the Cancer 
Antigen, NY ESO-1'' (HHS Ref No. E-090-2000/1-PCT-01);
4. Canadian Patent No. 2398743 issued June 23, 2015 entitled ``MHC 
Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO-
1'' (HHS Ref No. E-090-2000/1-CA-02);
5. Australian Patent No. 785151 issued January 18, 2007 entitled 
``MHC Class II Restricted T Cell Epitopes from the Cancer Antigen, 
NY ESO-1'' (HHS Ref No. E-090-2000/1-AU-03);
6. Japanese Patent No. 5588363 issued August 1, 2014 entitled ``MHC 
Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO-
1'' (HHS Ref No. E-090-2000/1-JP-12);
7. U.S. Patent No. 7,619,057 issued November 17, 2009 entitled ``MHC 
Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO-
1'' (HHS Ref No. E-090-2000/1-US-06);
8. U.S. Patent No. 8,754,046 issued June 17, 2014 entitled ``MHC 
Class II Restricted T Cell Epitopes from the Cancer Antigen, NY ESO-
1'' (HHS Ref No. E-090-2000/1-US-07);
9. U.S. Patent Application No. 12/568,134 filed September 28, 2009 
entitled ``MHC Class II Restricted T Cell Epitopes from the Cancer 
Antigen, NY ESO-1'' (HHS Ref No. E-090-2000/1-US-013);
10. European Patent Application No. 10010354.8 filed January 26, 
2001 entitled ``MHC Class II Restricted T Cell Epitopes from the 
Cancer Antigen, NY ESO-1'' (HHS Ref No. E-090-2000/1-EP-10);

    The patent rights in these inventions have been assigned to the 
Government of the United States of America. The prospective start-up 
exclusive commercial license territory may be worldwide and the field 
of use may be limited to the use of the Licensed Patent Rights to 
develop, manufacture, distribute, sell and use NY-ESO-1 based vaccines 
and cell therapy products for the treatment of NY-ESO-1-positive 
cancers.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
October 19, 2015 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments, and other materials relating to the contemplated exclusive 
evaluation option 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: 
chatterjeesa@mail.nih.gov.

SUPPLEMENTARY INFORMATION: NY-ESO-1 is a known tumor antigen which is 
expressed on a broad range of tumor types, including melanoma, breast, 
bladder, ovarian, prostate, head and neck cancers, neuroblastoma, and 
small cell lung cancer. The above-referenced inventions embody the 
identification of a number of novel immunogenic peptide epitopes, and 
analogs thereof, which are derived from the NY-ESO-1 tumor antigen. 
Specifically, this technology describes novel MHC Class II restricted 
epitopes of NY-ESO-1 which are recognized by CD4+ T cells. It also 
embodies the identification of two additional immunogenic peptide 
epitopes of NY-ESO-1. The latter two epitopes are presented by HLA-DP4, 
a prevalent MHC Class II allele present in 43-70% of Caucasians. The 
inventors also determined that the DP allele is highly associated with 
the NY-ESO-1 antibody production. In addition, one of these epitopes 
has dual HLA A2 and DP4 specificity, thereby it has the potential to 
generate both CD4+ and CD8+ tumor specific T cells. These epitopes may 
be of great value as prophylactic and/or therapeutic cancer vaccines or 
cell therapy products for use against a number of common cancers.
    The prospective start-up exclusive commercial license is being 
considered under the small business initiative launched on October 1, 
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 commercial 
license may be granted unless within fifteen (15) 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 part 404.7.
    Any additional, properly filed, and 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 
commercial 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 59798]]


    Dated: September 28, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-24982 Filed 10-1-15; 8:45 am]
 BILLING CODE 4140-01-P
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