80_FR_59988 80 FR 59797 - 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

80 FR 59797 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

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

Page Range59797-59798
FR Document2015-24982

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:

Federal Register, Volume 80 Issue 191 (Friday, October 2, 2015) 
[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59797-59798]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24982]


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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.

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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

Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices 59797 signal that indicates the blade location US–01); directed to: Sabarni K. Chatterjee, Ph.D., with respect to the base plate. 2. U.S. Provisional Patent Application No. M.B.A., Senior Licensing and Patenting Advantageously, this allows for a stage 60/237,107 filed September 29, 2000 Manager, NCI Technology Transfer entitled ‘‘HLA–DP Restricted CD4+ T coupled pedestal to be moved Center, 9609 Medical Center Drive, RM Cell Epitopes from the Cancer Antigen, accurately from an imaging location on NY ESO–1’’ (HHS Ref No. E–227–2000/ 1E530 MSC 9702, Bethesda, MD 20892– the beam axis to a cutting location off 0–US–01 was combined with E–090– 9702 (for business mail), Rockville, MD the beam axis. 2000/0–US–01 at the PCT stage, creating 20850–9702; Telephone: (240) 276– The prospective start-up exclusive the E–090–2000/1 technology family and 5530; Facsimile: (240) 276–5504; Email: license may be granted unless within associated applications); chatterjeesa@mail.nih.gov. thirty (30) days from the date of this 3. PCT Application No. PCT/US01/02765 SUPPLEMENTARY INFORMATION: NY–ESO– published notice, the NIH receives filed January 26, 2001 entitled ‘‘MHC Class II Restricted T Cell Epitopes from 1 is a known tumor antigen which is written evidence and argument that expressed on a broad range of tumor the Cancer Antigen, NY ESO–1’’ (HHS establishes that the grant of the license Ref No. E–090–2000/1–PCT–01); types, including melanoma, breast, would not be consistent with the 4. Canadian Patent No. 2398743 issued June bladder, ovarian, prostate, head and requirements of 35 U.S.C. 209 and 37 23, 2015 entitled ‘‘MHC Class II neck cancers, neuroblastoma, and small CFR part 404. Restricted T Cell Epitopes from the cell lung cancer. The above-referenced Complete applications for a license in Cancer Antigen, NY ESO–1’’ (HHS Ref inventions embody the identification of the field of use filed in response to this No. E–090–2000/1–CA–02); a number of novel immunogenic notice will be treated as objections to 5. Australian Patent No. 785151 issued January 18, 2007 entitled ‘‘MHC Class II peptide epitopes, and analogs thereof, the grant of the contemplated start-up which are derived from the NY–ESO–1 exclusive license. Comments and Restricted T Cell Epitopes from the Cancer Antigen, NY ESO–1’’ (HHS Ref tumor antigen. Specifically, this objections submitted to this notice will No. E–090–2000/1–AU–03); technology describes novel MHC Class not be made available for public 6. Japanese Patent No. 5588363 issued II restricted epitopes of NY–ESO–1 inspection and, to the extent permitted August 1, 2014 entitled ‘‘MHC Class II which are recognized by CD4+ T cells. by law, will not be released under the Restricted T Cell Epitopes from the It also embodies the identification of Freedom of Information Act, 5 U.S.C. Cancer Antigen, NY ESO–1’’ (HHS Ref two additional immunogenic peptide 552. No. E–090–2000/1–JP–12); 7. U.S. Patent No. 7,619,057 issued epitopes of NY–ESO–1. The latter two Dated: September 28, 2015. November 17, 2009 entitled ‘‘MHC Class epitopes are presented by HLA–DP4, a Richard U. Rodriguez, II Restricted T Cell Epitopes from the prevalent MHC Class II allele present in Acting Director, Office of Technology Cancer Antigen, NY ESO–1’’ (HHS Ref 43–70% of Caucasians. The inventors Transfer, National Institutes of Health. No. E–090–2000/1–US–06); also determined that the DP allele is [FR Doc. 2015–24994 Filed 10–1–15; 8:45 am] 8. U.S. Patent No. 8,754,046 issued June 17, highly associated with the NY–ESO–1 2014 entitled ‘‘MHC Class II Restricted T antibody production. In addition, one of BILLING CODE 4140–01–P Cell Epitopes from the Cancer Antigen, these epitopes has dual HLA A2 and NY ESO–1’’ (HHS Ref No. E–090–2000/ DP4 specificity, thereby it has the 1–US–07); DEPARTMENT OF HEALTH AND 9. U.S. Patent Application No. 12/568,134 potential to generate both CD4+ and HUMAN SERVICES filed September 28, 2009 entitled ‘‘MHC CD8+ tumor specific T cells. These Class II Restricted T Cell Epitopes from epitopes may be of great value as National Institutes of Health the Cancer Antigen, NY ESO–1’’ (HHS prophylactic and/or therapeutic cancer Ref No. E–090–2000/1–US–013); vaccines or cell therapy products for use Prospective Grant of a Start-up 10. European Patent Application No. against a number of common cancers. Exclusive Commercial License 10010354.8 filed January 26, 2001 The prospective start-up exclusive Agreement: Development of MHC entitled ‘‘MHC Class II Restricted T Cell commercial license is being considered Class II Restricted T Cell Epitopes Epitopes from the Cancer Antigen, NY under the small business initiative From the Cancer Antigen, NY ESO–1, ESO–1’’ (HHS Ref No. E–090–2000/1– EP–10); launched on October 1, 2011 and will for the Treatment of Human Cancers comply with the terms and conditions The patent rights in these inventions of 35 U.S.C. 209 and 37 CFR part 404.7. AGENCY: National Institutes of Health, have been assigned to the Government The prospective start-up exclusive HHS. of the United States of America. The commercial license may be granted ACTION: Notice. prospective start-up exclusive unless within fifteen (15) days from the SUMMARY: This is notice, in accordance commercial license territory may be date of this published notice, the NIH with 35 U.S.C. 209 and 37 CFR part worldwide and the field of use may be receives written evidence and argument 404.7, that the National Institutes of limited to the use of the Licensed Patent that establishes that the grant of the Health, Department of Health and Rights to develop, manufacture, license would not be consistent with the Human Services, is contemplating the distribute, sell and use NY–ESO–1 requirements of 35 U.S.C. 209 and 37 grant of an start-up exclusive based vaccines and cell therapy CFR part 404.7. commercial license to Immunova products for the treatment of NY–ESO– Any additional, properly filed, and Therapeutics, Inc., which is located in 1-positive cancers. complete applications for a license in Houston, Texas, to practice the DATES: Only written comments and/or the field of use filed in response to this inventions embodied in the following applications for a license which are notice will be treated as objections to received by the NIH Office of mstockstill on DSK4VPTVN1PROD with NOTICES patent applications and applications the grant of the contemplated exclusive claiming priority to these applications: Technology Transfer on or before commercial license. Comments and E–090–2000 October 19, 2015 will be considered. objections submitted to this notice will 1. U.S. Provisional Patent Application No. ADDRESSES: Requests for copies of the not be made available for public 61/179,004 filed January 28, 2000 patent applications, inquiries, inspection and, to the extent permitted entitled ‘‘MHC Class II Restricted T Cell comments, and other materials relating by law, will not be released under the Epitopes from the Cancer Antigen, NY to the contemplated exclusive Freedom of Information Act, 5 U.S.C. ESO–1’’ (HHS Ref No. E–090–2000/0– evaluation option license should be 552. VerDate Sep<11>2014 20:43 Oct 01, 2015 Jkt 238001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\02OCN1.SGM 02OCN1

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 VerDate Sep<11>2014 20:43 Oct 01, 2015 Jkt 238001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\02OCN1.SGM 02OCN1


Document Created: 2015-12-15 08:45:29
Document Modified: 2015-12-15 08:45:29
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly 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.
FR Citation80 FR 59797 
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