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Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices
Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Jim Knabb, Senior Technology Transfer Manager, at Telephone: 2402767856; or at Email:
jim.knabb@nih.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:

Intellectual Property E08020120: Human Monoclonal Antibodies Specific for CD22
1. US Provisional Patent Application 61/042,329, filed April 4, 2008 E080
20080US01;
2. International Patent Application PCT/US2009/039,080, Filed April 1, 2009 E0802008/0PCT02;
3. US Patent Application: 12/934,214, filed September 23, 2010 E0802008
0US03;
4. US Patent Application 13/959,061, filed August 5, 2015 E08020080
US04;
5. US Patent Application 15/012,023, filed February 1, 2016 E08020080
US05;
6. US Patent Application 15/424,238, filed February 3, 2017 E08020080
US06.

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E29120120: M971 Chimeric Antigen Receptors 1. US Provisional Patent Application 61/717,960, filed October 24, 2012 E
29120120US01;
2. International Patent Application PCT/US2013/060332, filed September 18, 2013 E29120120PCT02;
3. Australia Patent Application No:
2019235926, filed September 2, 2020
E29120120AU03;
4. Brazil Patent Application BR1120150090036, filed April 22, 2015
E29120120BR04;
5. Canada Application No: 2889055, filed September 18, 2013 E2912012
0CA05;
6. China Application No:
201380061387.5, filed May 25, 2015 E
29120120CN06;
7. European Patent Application No:
13773468.7, filed September 18, 2013
E29120120EP07;
8. India Patent Application No: 2344/
CHENP/2015, filed September 18, 2013
E29120120IN08;
9. Japan Application No: 539602/
2015, filed April 24, 2015 E2912012
0JP09;
10. Russia Patent Application:
2015117237, filed May 7, 2015 E291
20120RU10;
11. US Patent Application: 14/
437,889, filed April 23, 2015 E291
20120US11;

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12. Hong Kong Patent Application:
16101891.0, filed February 19, 2016 E
29120120HK12;
13. Russia Patent Application:
2018116582, filed May 4, 2018 E291
20120RU13;
14. Japan Patent Application: 2018
088908, filed May 2, 2018, E291
20120JP14;
15. Australia Patent Application:
2018204257, filed June 14, 2018 E
29120120AU16;
16. US Patent Application: 16/
107,271, filed August 21, 2018 E291
20120US17;
17. Germany Patent Application:
13773468.7, filed April 22, 2015 E
29120120DE18;
18. Spain Patent Application:
13773468.7, filed April 22, 2015 E
29120120ES19;
19. France Patent Application:
13773468.7, filed April 22, 2015 E
29120120FR20;
20. Great Britain Patent Application:
13773468.7, filed April 22, 2015 E
29120120GB21;
21. Italy Patent Application:
13773468.7, filed April 22, 2015 E
29120120IT22;
22. China Patent Application:
201910500128.7, filed June 11, 2019 E
29120120CN23;
23. US Patent Application: 16/
869,792, filed May 8, 2020 E291
20120US24.
E10620150: Chimeric Antigen Receptors Targeting Both CD19 and CD22
1. US Provisional Patent Application No.: 62/135,442, filed March 19, 2015
E10620150US01;
2. International Patent Application PCTUS2016/023055, Filed March 18, 2016 E10620150PCT02;
3. US Patent Application: 15/559,485.
Filed September 19, 2017 E1062015
0US03.
E01720170: CD19/CD22 Bicistronic CAR Targeting Human B-Cell Malignancies 1. US Provisional Patent Application No.: 62/135,442, filed May 15, 2017 E
01720170US01;
2. International Patent Application PCT/US2018/032,809, filed May 15, 2018 E01720170PCT02;
3. Australia Patent Application No.:
2018269194, filed October 28, 2019 E
01720170AU03;
4. Canada Patent Application No:
3062433, filed May 15, 2018 E017
20170CA04;
5. China Patent Application No.:
201880032676.5, filed Date: May 15, 2018 E01720170CN05;

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6. European Patent Application No.:
18733012.1, filed May 15, 2018 E017
20170EP06;
7. Japan Patent Application No.:
2019563082, filed November 13, 2019
E01720170JP07;
8. Korea Patent Application No.:
20197017289, filed December 13, 2019, E01720170KR08;
9. Singapore Patent Application No.:
11201910499V, filed November 11, 2019
E01720170SG09;
10. United States Patent Application No.: 16/613,187, filed November 13, 2019 E01720170US10.
The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America.
The prospective exclusive license territory may be worldwide, and the fields of use may be limited to the following:
Field 1: Ex vivo allogeneic CART
The development, manufacture and commercialization of chimeric antigen receptor T cells CART cells for the treatment of B cell malignancies, wherein the CART cells are engineered to express a CAR
that comprises the m971 binder and is monospecific for CD22, or is specific to both CD22
and CD19 but are not engineered to bind to any other B cell antigen, and the engineered CART cells are generated ex vivo using allogeneic T cells that are engineered to overexpress CD47.
Field 2: In vivo gene therapy vector The development, manufacture and commercialization of gene therapy vectors encoding a chimeric antigen receptor construct CAR construct, wherein the CAR
construct comprises either i a CD22 binder m971 or ii the CD22 binder m971 and a CD19 binder, but, in each case i and ii, comprises no other binder against a B cell antigen. For the avoidance of doubt, the field of use excludes development, manufacture and commercialization of genetically modified autologous T cells made by obtaining a patients T cells via a standard leukapheresis procedure, genetically modifying the T cells ex vivo, expanding the T cells in cell culture, and formulating the T
cells for later administration to the patient.

This technology discloses CAR
therapies that target CD22 alone or in combination with CD19 by utilizing the anti-CD22 binder known as m971. CD22
and CD19 are expressed on the surface of B cells in B cell malignancies and CART utilizing binders targeting CD 19
and CD22 have shown early promise in clinical trials for B cell malignancies.
This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen 15 days from the date of this published Notice, the National Cancer Institute receives written
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