82_FR_11963 82 FR 11926 - Prospective Grant of Exclusive Patent License: The Development of an Anti-Mesothelin Recombinant Immunotoxin (RIT) for the Treatment of Human Cancers.

82 FR 11926 - Prospective Grant of Exclusive Patent License: The Development of an Anti-Mesothelin Recombinant Immunotoxin (RIT) for the Treatment of Human Cancers.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 37 (February 27, 2017)

Page Range11926-11927
FR Document2017-03823

The National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Selecta Biosciences (``Selecta'') located in Watertown, Massachusetts to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.

Federal Register, Volume 82 Issue 37 (Monday, February 27, 2017) 
[Federal Register Volume 82, Number 37 (Monday, February 27, 2017)]
[Notices]
[Pages 11926-11927]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03823]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: The Development of 
an Anti-Mesothelin Recombinant Immunotoxin (RIT) for the Treatment of 
Human Cancers.

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Cancer Institute, National Institutes of Health, 
Department of Health and Human Services, is contemplating the grant of 
an Exclusive Patent License to Selecta Biosciences (``Selecta'') 
located in Watertown, Massachusetts to practice the inventions embodied 
in the patent applications listed in the Supplementary Information 
section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NCI Technology Transfer Center on or before March 
14, 2017 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: David A. Lambertson, Ph.D., 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)-276-6467; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement:

U.S. Patent Application 61/535,668 (HHS Ref. E-263-2011/0-US-01), 
PCT Application PCT/US2012/055034 (HHS reference E-263-2011/0-PCT-
02), Australian Patent Application 2012308591 (HHS reference E-263-
2011/0-AU-03), Canadian Patent Application 2846608 (HHS reference E-
263-2011/0-CA-04), European Patent Application 12766780.6 (HHS 
reference E-263-2011/0-EP-05), US Patent 9,206,240 (HHS reference E-
263-2011/0-US-06), Hong Kong Patent Application 14111650.2 (HHS 
reference E-263-2011/0-HK-07), and US Patent Application 14/927,645 
(HHS reference E-263-2011/0-US-08);
U.S. Patent Application 61/495,085 (HHS Ref. E-174-2011/0-US-01), 
PCT Application PCT/US2012/041234 (HHS reference E-174-2011/0-PCT-
02), Australian Patent Application 2012268013 (HHS reference E-174-
2011/0-AU-03), Brazilian Patent Application 112013031262-9 (HHS 
reference E-174-2011/0-BR-04), Canadian Patent Application 2838013 
(HHS reference E-174-2011/0-CA-05), Chinese Patent Application 
201280039071.1 (HHS reference E-174-2011/0-CN-06), European Patent 
Application 12727074.2 (HHS reference E-174-2011/0-EP-07), Hong Kong 
Patent Application 14105911.9 (HHS reference E-174-2011/0-HK-08), 
Japanese Patent Application 2014-514616 (HHS reference E-174-2011/0-
JP-09), South Korean Patent Application 2013-7032402 (HHS reference 
E-174-2011/0-KR-10), Mexican Patent Application MX/a/2013/014388 
(HHS reference E-174-2011/0-MX-11), Russian Patent Application 
2013151655 (HHS reference E-174-2011/0-RU-12), US Patent 9,346,859 
(HHS reference E-174-2011/0-US-13), Hong Kong Patent Application 
14106689.7 (HHS reference E-174-2011/0-HK-14), and US Patent 
Application 15/095,470 (HHS reference E-174-2011/0-US-15);
U.S. Patent Application 61/483,531 (HHS Ref. E-117-2011/0-US-01), 
PCT Application PCT/US2012/036456 (HHS reference E-117-2011/0-PCT-
02), Australian Patent Application 2012253896 (HHS reference E-117-
2011/0-AU-03), Brazilian Patent Application 112013028537-0 (HHS 
reference E-117-2011/0-BR-04), Canadian Patent Application 2835070 
(HHS reference E-117-2011/0-CA-05), Chilean Patent Application 
03182-2013 (HHS reference E-117-2011/0-CL-06), Ecuadorian Patent 
Application SP-13-13067 (HHS reference E-117-2011/0-EC-07), Egyptian 
Patent Application PCT 1697/2013 (HHS reference E-117-2011/0-EG-08), 
European Patent Application 12722586.0 (HHS reference E-117-2011/0-
EP-09), Hong Kong Patent Application 14105586.3 (HHS reference E-
117-2011/0-HK-10), South Korean Patent Application 2013-7032247 (HHS 
reference E-117-2011/0-KR-11), Mexican Patent Application MX/a/2013/
012905 (HHS reference E-117-2011/0-MX-12), Malaysian Patent 
Application PI2013702094 (HHS reference E-117-2011/0-MY-13), New 
Zealand Patent Application 617386 (HHS reference E-117-2011/0-NZ-
14), Philippines Patent Application 1-2013-502264 (HHS reference E-
117-2011/0-PH-15), Russian Patent Application 2013148919 (HHS 
reference E-117-2011/0-RU-16), Singapore Patent Application 
201308179-9 (HHS reference E-117-2011/0-SG-17), Thailand Patent 
Application 1301006329 (HHS reference E-117-2011/0-TH-18), Ukrainian 
Patent Application 201313011 (HHS reference E-117-2011/0-UA-19), 
Vietnamese Patent Application 1-2013-03855 (HHS reference E-117-
2011/0-VN-20), South African Patent Application 2013/08270 (HHS 
reference E-117-2011/0-ZA-21), US Patent Application 14/115,131 (HHS 
reference E-117-2011/0-US-22), Japanese Patent Application 2014-
509467 (HHS reference E-117-2011/0-JP-23), Chinese Patent 
201280033583.7 (HHS reference E-117-2011/0-CN-24), Colombian Patent 
Application 13-274.153 (HHS reference E-117-2011/0-CO-25), Costa 
Rican Patent Application 2013-0571 (HHS reference E-117-2011/0-CR-
26), Indonesian Patent Application W-00201305198 (HHS reference E-
117-2011/0-ID-27), Israeli Patent Application 229198 (HHS reference 
E-117-2011/0-IL-28), Indian Patent Application 8854/CHENP/2013 (HHS 
reference E-117-2011/0-IN-29), Peruvian Patent Application 2456.13 
(HHS reference E-117-2011/0-PE-30), Algerian Patent Application 
130758 (HHS reference E-117-2011/0-DZ-31), Moroccan Patent 
Application 36534 (HHS reference E-117-2011/0-MA-32), and Hong Kong 
Patent Application 14108273.5 (HHS reference E-117-2011/0-HK-33);
U.S. Patent Application 61/241,620 (HHS Ref. E-269-2009/0-US-01), 
PCT Application PCT/US2010/048504 (HHS reference E-269-2009/0-PCT-
02), Australian Patent 2010292069 (HHS reference E-269-2009/0-AU-
03), Canadian Patent Application 2773665 (HHS reference E-269-2009/
0-CA-04), Chinese Patent 201080049559.3 (HHS reference E-269-2009/0-
CN-05), European Patent 2475398 (HHS reference E-269-2009/0-EP-06), 
as validated in France, Germany, Italy, Spain and the United 
Kingdom, Indian Patent Application 3197/CHENP/2012 (HHS reference E-
269-2009/0-IN-07), Japanese Patent 5795765 (HHS reference E-269-
2009/0-JP-08), Russian Patent Application 2012114005 (HHS

[[Page 11927]]

reference E-269-2009/0-RU-09), and US Patent 8,936,792 (HHS 
reference E-269-2009/0-US-10);
U.S. Patent Application 60/969,929 (HHS Ref. E-292-2007/0-US-01), 
PCT Application PCT/US2008/075296 (HHS reference E-292-2007/0-PCT-
02), Australian Patent 2008296194 (HHS reference E-292-2007/0-AU-
03), Canadian Patent Application 2698357 (HHS reference E-292-2007/
0-CA-04), European Patent 2197903 (HHS reference E-292-2007/0-EP-05) 
as validated in Austria, Belgium, Bulgaria, Switzerland, Cyprus, 
Germany, Denmark, Estonia, Spain, Finland, France, the United 
Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, 
Luxembourg, Latvia, Monaco, Malta, the Netherlands, Norway, Poland, 
Portugal, Romania, Slovenia, Slovakia, and Turkey, US Patent 
8,871,906 (HHS reference E-292-2007/0-US-06), European Patent 
Application 12184319.7 (HHS reference E-292-2007/0-EP-07), and Hong 
Kong Patent Application 13106628.2 (HHS reference E-292-2007/0-HK-
08);
U.S. Patent Application 60/703,798 (HHS Ref. E-262-2005/0-US-01), 
PCT Application PCT/US2006/028986 (HHS reference E-262-2005/0-PCT-
02), Australian Patent 2006275865 (HHS reference E-262-2005/0-AU-
03), Canadian Patent 2616987 (HHS reference E-262-2005/0-CA-04), 
European Patent 1910407 (HHS reference E-262-2005/0-EP-05) as 
validated in Switzerland, Germany, Spain, France, the United 
Kingdom, and Italy, US Patent 8,907,060 (HHS reference E-262-2005/0-
US-06), European Patent 2311854 (HHS reference E-262-2005/0-EP-07) 
as validated in Switzerland, Germany, Spain, France, the United 
Kingdom, and Italy, European Patent 2332970 (HHS reference E-262-
2005/0-EP-08) as validated in Germany, Spain, France, the United 
Kingdom, and Italy, Australian Patent 2012216642 (HHS reference E-
262-2005/0-AU-15), Australian Patent 2014208269 (HHS reference E-
262-2005/0-AU-22), European Patent Application 15191388.6 (HHS 
reference E-262-2005/0-EP-28), European Patent Application 
15191391.0 (HHS reference E-262-2005/0-EP-29), European Patent 
Application 15191395.1 (HHS reference E-262-2005/0-EP-30), 
Australian Patent Application (HHS reference E-262-2005/0-AU-31), 
and Canadian Patent Application (HHS reference E-262-2005/0-CA-32);
U.S. Patent Application 60/160,071 (HHS Ref. E-139-1999/0-US-01), 
PCT Application PCT/US00/14829 (HHS reference E-139-1999/0-PCT-02), 
Canadian Patent 2374398 (HHS reference E-139-1999/0-CA-03), European 
Patent 1180123 (HHS reference E-139-1999/0-EP-04) as validated in 
Belgium, Switzerland, Germany, Denmark, France, The United Kingdom, 
Italy, The Netherlands, and Sweden, Japanese Patent 5683766 (HHS 
reference E-139-1999/0-JP-05), Mexican Patent 270476 (HHS reference 
E-139-1999/0-MX-06); and U.S. Patent 7,081,518 (HHS reference E-139-
1999/0-US-07);
U.S. Patent Application 60/067,175 (HHS Ref. E-021-1998/0-US-01), 
PCT Application PCT/US98/25270 (HHS reference E-021-1998/0-PCT-02), 
Australian Patent 760120 (HHS reference E-021-1998/0-AU-03), 
Canadian Patent 2318576 (HHS reference E-021-1998/0-CA-04), European 
Patent 1025230 (HHS reference E-021-1998/0-EP-05) as validated in 
Switzerland, Germany, France, Italy, Spain and the United Kingdom, 
Israeli Patent 135775 (HHS reference E-021-1998/0-IL-06), US Patent 
6,809,184 (HHS reference E-021-1998/0-US-07), US Patent 7,368,110 
(HHS reference E-021-1998/0-US-08), and US Patent 7,709,252 (HHS 
reference E-021-1998/0-US-15),
U.S. Patent Application 60/010,166 (HHS Ref. E-002-1996/0-US-01), 
PCT Application PCT/US97/00224 (HHS Ref. E-002-1996/1-PCT-01), U.S. 
Patent 6,083,502 (HHS reference E-002-1996/1-US-02), Australian 
Patent 703769 (HHS reference E-002-1996/1-AU-03), Canadian Patent 
2241604 (HHS reference E-002-1996/1-CA-04), European Patent 0871492 
(HHS reference E-002-1996/1-EP-05) as validated in Switzerland, 
Germany, France, Italy Spain and the United Kingdom, U.S. Patent 
6,153,430 (HHS reference E-002-1996/1-US-14), and U.S. Patent 
7,375,183 (HHS reference E-002-1996/1-US-15);

and all continuing applications and foreign counterparts.
    With respect to persons who have an obligation to assign their 
right, title and interest to the Government of the United States of 
America, the patent rights in these inventions have been assigned to 
the Government of the United States of America.
    The prospective Exclusive Patent License territory may be worldwide 
for the following field of use:
    ``The use of anti-mesothelin targeted immunotoxins for the 
treatment of mesothelin-expressing cancers, wherein the immunotoxins 
have:
    (1) A targeting domain containing the complementary determining 
regions (CDRs) of the SS1 antibody; and
    (2) A Pseudomonas exotoxin A (PE) toxin domain that lacks at least 
one B cell or T cell epitope due to the alteration or deletion of one 
or more amino acids.
    For purposes of clarity, the immunotoxin may include additional 
alterations to B cell and T cell epitopes for the reduction of 
immunogenicity, a peptide linker sequence, and/or polyethylene glycol 
molecule(s). The immunotoxins may also be combined with the use of 
synthetic vaccine particle (SVP)-rapamycin.''
    The present inventions to be licensed concern RITs which are 
targeted to mesothelin-expressing cancer cells, and methods of using 
the immunotoxins for the treatment of mesothelin-expressing cancers 
(such as mesothelioma, ovarian cancer and pancreatic cancer). The 
specific immunotoxin will have an antibody targeting domain that 
contains the CDRs of the antibody identified as SS1, which was invented 
at the NIH. The specific immunotoxin will also have a toxin domain 
derived from PE that is resistant to lysosomal proteases due to the 
deletion of a large portion of the exotoxin, and which lacks at least 
one major B-cell epitope due to the alteration an amino acid. 
Ultimately, the PE used in the immunotoxin may lack multiple B-cell 
epitopes, as well as multiple T-cell epitopes, in an effort to minimize 
immunogenicity.
    Alterations to the toxin that reduce immunogenicity improve the 
therapeutic value of the immunotoxin while maintaining its ability to 
trigger cell death. Since mesothelin is preferentially expressed on 
certain types of cancer cells, the immunotoxins selectively bind and 
kill only those cancer cells, allowing healthy, essential cells to 
remain unharmed. This may result in an effective therapeutic strategy 
with fewer side effects, especially when combined with agents that can 
suppress the formation of neutralizing antibodies.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective Exclusive Patent License will be royalty 
bearing and may be granted unless within fifteen (15) days from the 
date of this published notice, the National Cancer Institute 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 prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated Exclusive Patent 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: February 21, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-03823 Filed 2-24-17; 8:45 am]
 BILLING CODE 4140-01-P

11926 Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Notices The meeting will be open to the ADDRESSES: Requests for copies of the Application 03182–2013 (HHS reference public, with attendance limited to space patent applications, inquiries, and E–117–2011/0–CL–06), Ecuadorian Patent available. Individuals who plan to comments relating to the contemplated Application SP–13–13067 (HHS reference E–117–2011/0–EC–07), Egyptian Patent attend and need special assistance, such Exclusive Patent License should be Application PCT 1697/2013 (HHS as sign language interpretation or other directed to: David A. Lambertson, Ph.D., reference E–117–2011/0–EG–08), European reasonable accommodations, should Senior Licensing and Patenting Patent Application 12722586.0 (HHS notify the Contact Person listed below Manager, NCI Technology Transfer reference E–117–2011/0–EP–09), Hong in advance of the meeting. Center, 9609 Medical Center Drive, RM Kong Patent Application 14105586.3 (HHS 1E530 MSC 9702, Bethesda, MD 20892– reference E–117–2011/0–HK–10), South Name of Committee: Sickle Cell Disease 9702 (for business mail), Rockville, MD Korean Patent Application 2013–7032247 Advisory Committee. 20850–9702 Telephone: (240)–276– (HHS reference E–117–2011/0–KR–11), Date: March 29, 2017. Mexican Patent Application MX/a/2013/ Time: 8:30 a.m. to 1:45 p.m. 6467; Email: lambertsond@mail.nih.gov. 012905 (HHS reference E–117–2011/0– Agenda: Presentations and Discussion of SUPPLEMENTARY INFORMATION: The MX–12), Malaysian Patent Application Training the Next Generation of Researchers following represents the intellectual PI2013702094 (HHS reference E–117– in Sickle Cell Disease. property to be licensed under the 2011/0–MY–13), New Zealand Patent Place: National Institutes of Health 6701 prospective agreement: Application 617386 (HHS reference E– Rockledge Drive, 9th Floor, Room 9100/9104, 117–2011/0–NZ–14), Philippines Patent Bethesda, MD 20892. U.S. Patent Application 61/535,668 (HHS Application 1–2013–502264 (HHS Contact Person: W. Keith Hoots, MD, Ref. E–263–2011/0–US–01), PCT reference E–117–2011/0–PH–15), Russian Director, Division of Blood Diseases and Application PCT/US2012/055034 (HHS Patent Application 2013148919 (HHS Resources, National Heart, Lung, and Blood reference E–263–2011/0–PCT–02), reference E–117–2011/0–RU–16), Institute, 6701 Rockledge Drive, Suite 9030, Australian Patent Application 2012308591 Singapore Patent Application 201308179– Bethesda, MD 20892, 301–435–0080, (HHS reference E–263–2011/0–AU–03), 9 (HHS reference E–117–2011/0–SG–17), hootswk@nhlbi.nih.gov. Canadian Patent Application 2846608 Thailand Patent Application 1301006329 (HHS reference E–263–2011/0–CA–04), (Catalogue of Federal Domestic Assistance (HHS reference E–117–2011/0–TH–18), European Patent Application 12766780.6 Program Nos. 93.233, National Center for Ukrainian Patent Application 201313011 (HHS reference E–263–2011/0–EP–05), US Sleep Disorders Research; 93.837, Heart and (HHS reference E–117–2011/0–UA–19), Patent 9,206,240 (HHS reference E–263– Vascular Diseases Research; 93.838, Lung Vietnamese Patent Application 1–2013– 2011/0–US–06), Hong Kong Patent Diseases Research; 93.839, Blood Diseases 03855 (HHS reference E–117–2011/0–VN– Application 14111650.2 (HHS reference E– and Resources Research, National Institutes 20), South African Patent Application 263–2011/0–HK–07), and US Patent of Health, HHS) Application 14/927,645 (HHS reference E– 2013/08270 (HHS reference E–117–2011/ 263–2011/0–US–08); 0–ZA–21), US Patent Application 14/ Dated: February 21, 2017. U.S. Patent Application 61/495,085 (HHS 115,131 (HHS reference E–117–2011/0– Michelle Trout, US–22), Japanese Patent Application 2014– Ref. E–174–2011/0–US–01), PCT Program Analyst, Office of Federal Advisory 509467 (HHS reference E–117–2011/0–JP– Application PCT/US2012/041234 (HHS Committee Policy. 23), Chinese Patent 201280033583.7 (HHS reference E–174–2011/0–PCT–02), [FR Doc. 2017–03706 Filed 2–24–17; 8:45 am] Australian Patent Application 2012268013 reference E–117–2011/0–CN–24), BILLING CODE 4140–01–P (HHS reference E–174–2011/0–AU–03), Colombian Patent Application 13–274.153 Brazilian Patent Application (HHS reference E–117–2011/0–CO–25), 112013031262–9 (HHS reference E–174– Costa Rican Patent Application 2013–0571 2011/0–BR–04), Canadian Patent (HHS reference E–117–2011/0–CR–26), DEPARTMENT OF HEALTH AND Indonesian Patent Application W– HUMAN SERVICES Application 2838013 (HHS reference E– 174–2011/0–CA–05), Chinese Patent 00201305198 (HHS reference E–117–2011/ Application 201280039071.1 (HHS 0–ID–27), Israeli Patent Application National Institutes of Health 229198 (HHS reference E–117–2011/0–IL– reference E–174–2011/0–CN–06), European Patent Application 12727074.2 (HHS 28), Indian Patent Application 8854/ Prospective Grant of Exclusive Patent CHENP/2013 (HHS reference E–117–2011/ reference E–174–2011/0–EP–07), Hong License: The Development of an Anti- 0–IN–29), Peruvian Patent Application Kong Patent Application 14105911.9 (HHS Mesothelin Recombinant Immunotoxin reference E–174–2011/0–HK–08), Japanese 2456.13 (HHS reference E–117–2011/0– (RIT) for the Treatment of Human Patent Application 2014–514616 (HHS PE–30), Algerian Patent Application Cancers. reference E–174–2011/0–JP–09), South 130758 (HHS reference E–117–2011/0–DZ– Korean Patent Application 2013–7032402 31), Moroccan Patent Application 36534 AGENCY: National Institutes of Health, (HHS reference E–174–2011/0–KR–10), (HHS reference E–117–2011/0–MA–32), HHS. Mexican Patent Application MX/a/2013/ and Hong Kong Patent Application ACTION: Notice. 014388 (HHS reference E–174–2011/0– 14108273.5 (HHS reference E–117–2011/0– MX–11), Russian Patent Application HK–33); SUMMARY: The National Cancer Institute, 2013151655 (HHS reference E–174–2011/ U.S. Patent Application 61/241,620 (HHS National Institutes of Health, 0–RU–12), US Patent 9,346,859 (HHS Ref. E–269–2009/0–US–01), PCT Department of Health and Human reference E–174–2011/0–US–13), Hong Application PCT/US2010/048504 (HHS Kong Patent Application 14106689.7 (HHS reference E–269–2009/0–PCT–02), Services, is contemplating the grant of reference E–174–2011/0–HK–14), and US Australian Patent 2010292069 (HHS an Exclusive Patent License to Selecta Patent Application 15/095,470 (HHS reference E–269–2009/0–AU–03), Biosciences (‘‘Selecta’’) located in reference E–174–2011/0–US–15); Canadian Patent Application 2773665 Watertown, Massachusetts to practice U.S. Patent Application 61/483,531 (HHS (HHS reference E–269–2009/0–CA–04), the inventions embodied in the patent Ref. E–117–2011/0–US–01), PCT Chinese Patent 201080049559.3 (HHS applications listed in the Application PCT/US2012/036456 (HHS reference E–269–2009/0–CN–05), European mstockstill on DSK3G9T082PROD with NOTICES SUPPLEMENTARY INFORMATION section of reference E–117–2011/0–PCT–02), Patent 2475398 (HHS reference E–269– this notice. Australian Patent Application 2012253896 2009/0–EP–06), as validated in France, (HHS reference E–117–2011/0–AU–03), Germany, Italy, Spain and the United DATES: Only written comments and/or Kingdom, Indian Patent Application 3197/ Brazilian Patent Application applications for a license which are 112013028537–0 (HHS reference E–117– CHENP/2012 (HHS reference E–269–2009/ received by the NCI Technology 2011/0–BR–04), Canadian Patent 0–IN–07), Japanese Patent 5795765 (HHS Transfer Center on or before March 14, Application 2835070 (HHS reference E– reference E–269–2009/0–JP–08), Russian 2017 will be considered. 117–2011/0–CA–05), Chilean Patent Patent Application 2012114005 (HHS VerDate Sep<11>2014 20:23 Feb 24, 2017 Jkt 241001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\27FEN1.SGM 27FEN1

Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Notices 11927 reference E–269–2009/0–RU–09), and US U.S. Patent Application 60/067,175 (HHS cancer and pancreatic cancer). The Patent 8,936,792 (HHS reference E–269– Ref. E–021–1998/0–US–01), PCT specific immunotoxin will have an 2009/0–US–10); Application PCT/US98/25270 (HHS antibody targeting domain that contains U.S. Patent Application 60/969,929 (HHS reference E–021–1998/0–PCT–02), Ref. E–292–2007/0–US–01), PCT Australian Patent 760120 (HHS reference the CDRs of the antibody identified as Application PCT/US2008/075296 (HHS E–021–1998/0–AU–03), Canadian Patent SS1, which was invented at the NIH. reference E–292–2007/0–PCT–02), 2318576 (HHS reference E–021–1998/0– The specific immunotoxin will also Australian Patent 2008296194 (HHS CA–04), European Patent 1025230 (HHS have a toxin domain derived from PE reference E–292–2007/0–AU–03), reference E–021–1998/0–EP–05) as that is resistant to lysosomal proteases Canadian Patent Application 2698357 validated in Switzerland, Germany, France, (HHS reference E–292–2007/0–CA–04), due to the deletion of a large portion of Italy, Spain and the United Kingdom, European Patent 2197903 (HHS reference Israeli Patent 135775 (HHS reference E– the exotoxin, and which lacks at least E–292–2007/0–EP–05) as validated in 021–1998/0–IL–06), US Patent 6,809,184 one major B-cell epitope due to the Austria, Belgium, Bulgaria, Switzerland, (HHS reference E–021–1998/0–US–07), US alteration an amino acid. Ultimately, the Cyprus, Germany, Denmark, Estonia, Patent 7,368,110 (HHS reference E–021– PE used in the immunotoxin may lack Spain, Finland, France, the United 1998/0–US–08), and US Patent 7,709,252 multiple B-cell epitopes, as well as Kingdom, Greece, Croatia, Hungary, (HHS reference E–021–1998/0–US–15), Ireland, Italy, Lithuania, Luxembourg, U.S. Patent Application 60/010,166 (HHS multiple T-cell epitopes, in an effort to Latvia, Monaco, Malta, the Netherlands, Ref. E–002–1996/0–US–01), PCT minimize immunogenicity. Norway, Poland, Portugal, Romania, Application PCT/US97/00224 (HHS Ref. Alterations to the toxin that reduce Slovenia, Slovakia, and Turkey, US Patent E–002–1996/1–PCT–01), U.S. Patent 8,871,906 (HHS reference E–292–2007/0– immunogenicity improve the 6,083,502 (HHS reference E–002–1996/1– US–06), European Patent Application therapeutic value of the immunotoxin US–02), Australian Patent 703769 (HHS 12184319.7 (HHS reference E–292–2007/0– reference E–002–1996/1–AU–03), while maintaining its ability to trigger EP–07), and Hong Kong Patent Application Canadian Patent 2241604 (HHS reference cell death. Since mesothelin is 13106628.2 (HHS reference E–292–2007/0– E–002–1996/1–CA–04), European Patent preferentially expressed on certain types HK–08); 0871492 (HHS reference E–002–1996/1– of cancer cells, the immunotoxins U.S. Patent Application 60/703,798 (HHS EP–05) as validated in Switzerland, Ref. E–262–2005/0–US–01), PCT selectively bind and kill only those Germany, France, Italy Spain and the Application PCT/US2006/028986 (HHS cancer cells, allowing healthy, essential United Kingdom, U.S. Patent 6,153,430 reference E–262–2005/0–PCT–02), (HHS reference E–002–1996/1–US–14), cells to remain unharmed. This may Australian Patent 2006275865 (HHS and U.S. Patent 7,375,183 (HHS reference result in an effective therapeutic reference E–262–2005/0–AU–03), E–002–1996/1–US–15); strategy with fewer side effects, Canadian Patent 2616987 (HHS reference E–262–2005/0–CA–04), European Patent and all continuing applications and especially when combined with agents 1910407 (HHS reference E–262–2005/0– foreign counterparts. that can suppress the formation of EP–05) as validated in Switzerland, With respect to persons who have an neutralizing antibodies. Germany, Spain, France, the United obligation to assign their right, title and This notice is made in accordance Kingdom, and Italy, US Patent 8,907,060 interest to the Government of the United (HHS reference E–262–2005/0–US–06), with 35 U.S.C. 209 and 37 CFR part 404. States of America, the patent rights in The prospective Exclusive Patent European Patent 2311854 (HHS reference E–262–2005/0–EP–07) as validated in these inventions have been assigned to License will be royalty bearing and may Switzerland, Germany, Spain, France, the the Government of the United States of be granted unless within fifteen (15) United Kingdom, and Italy, European America. days from the date of this published Patent 2332970 (HHS reference E–262– The prospective Exclusive Patent notice, the National Cancer Institute 2005/0–EP–08) as validated in Germany, License territory may be worldwide for Spain, France, the United Kingdom, and receives written evidence and argument the following field of use: Italy, Australian Patent 2012216642 (HHS ‘‘The use of anti-mesothelin targeted that establishes that the grant of the reference E–262–2005/0–AU–15), immunotoxins for the treatment of license would not be consistent with the Australian Patent 2014208269 (HHS mesothelin-expressing cancers, wherein requirements of 35 U.S.C. 209 and 37 reference E–262–2005/0–AU–22), CFR part 404. European Patent Application 15191388.6 the immunotoxins have: (HHS reference E–262–2005/0–EP–28), (1) A targeting domain containing the Complete applications for a license in European Patent Application 15191391.0 complementary determining regions the prospective field of use that are (HHS reference E–262–2005/0–EP–29), (CDRs) of the SS1 antibody; and timely filed in response to this notice European Patent Application 15191395.1 (2) A Pseudomonas exotoxin A (PE) will be treated as objections to the grant (HHS reference E–262–2005/0–EP–30), toxin domain that lacks at least one B of the contemplated Exclusive Patent Australian Patent Application (HHS cell or T cell epitope due to the reference E–262–2005/0–AU–31), and License. Comments and objections alteration or deletion of one or more Canadian Patent Application (HHS submitted to this notice will not be amino acids. reference E–262–2005/0–CA–32); For purposes of clarity, the made available for public inspection U.S. Patent Application 60/160,071 (HHS immunotoxin may include additional and, to the extent permitted by law, will Ref. E–139–1999/0–US–01), PCT not be released under the Freedom of Application PCT/US00/14829 (HHS alterations to B cell and T cell epitopes for the reduction of immunogenicity, a Information Act, 5 U.S.C. 552. reference E–139–1999/0–PCT–02), Canadian Patent 2374398 (HHS reference peptide linker sequence, and/or Dated: February 21, 2017. E–139–1999/0–CA–03), European Patent polyethylene glycol molecule(s). The Richard U. Rodriguez, 1180123 (HHS reference E–139–1999/0– immunotoxins may also be combined EP–04) as validated in Belgium, Associate Director, Technology Transfer with the use of synthetic vaccine mstockstill on DSK3G9T082PROD with NOTICES Switzerland, Germany, Denmark, France, Center, National Cancer Institute. particle (SVP)-rapamycin.’’ The United Kingdom, Italy, The [FR Doc. 2017–03823 Filed 2–24–17; 8:45 am] The present inventions to be licensed Netherlands, and Sweden, Japanese Patent BILLING CODE 4140–01–P 5683766 (HHS reference E–139–1999/0– concern RITs which are targeted to JP–05), Mexican Patent 270476 (HHS mesothelin-expressing cancer cells, and reference E–139–1999/0–MX–06); and U.S. methods of using the immunotoxins for Patent 7,081,518 (HHS reference E–139– the treatment of mesothelin-expressing 1999/0–US–07); cancers (such as mesothelioma, ovarian VerDate Sep<11>2014 20:23 Feb 24, 2017 Jkt 241001 PO 00000 Frm 00037 Fmt 4703 Sfmt 9990 E:\FR\FM\27FEN1.SGM 27FEN1


Document Created: 2017-02-25 01:06:07
Document Modified: 2017-02-25 01:06:07
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 NCI Technology Transfer Center on or before March 14, 2017 will be considered.
FR Citation82 FR 11926 
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