69866 Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Development of Autologous 

Tumor Infiltrating Lymphocyte 

Adoptive Cells for the Treatment of 

Metastatic Melanoma 

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, 

that the National Institutes of Health, 

Department of Health and Human 

Services, is contemplating the grant of 

an exclusive patent license to the 

current licensee, Lion Biotechnologies, 

Inc., which is located in Woodland 

Hills, California to practice the 

inventions embodied in the following 

patent applications and applications 

claiming priority to these applications: 

1. U.S. Provisional Patent Application No. 

61/237,889, filed August 26, 2009 entitled 

‘‘Adoptive cell therapy with young T cells’’ 

(HHS Ref No. E–273–2009/0–US–01); 

2. U.S. Patent No. 8,383,099 issued 

February 26, 2013 entitled ‘‘Adoptive cell 

therapy with young T cells’’ (HHS Ref No. E– 

273–2009/0–US–02); 

3. U.S. Patent Application No. 13/742,541 

filed January 16, 2013 entitled ‘‘Adoptive cell 

therapy with young T cells’’ (HHS Ref No. E– 

273–2009/0–US–03); 

4. U.S. Provisional Patent Application No. 

61/466,200 filed March 22, 2011 entitled 

‘‘Methods of growing tumor infiltrating 

lymphocytes in gas-permeable containers’’ 

(HHS Ref No. E–114–2011/0–US–01); 

5. PCT Application No. PCT/US2012/

029744 filed March 20, 2012 entitled 

‘‘Methods of growing tumor infiltrating 

lymphocytes in gas-permeable containers’’ 

(HHS Ref No. E–114–2011/0–US–01); 

6. U.S. Patent Application No. 13/424,646 

filed May 20, 2012 entitled ‘‘Methods of 

growing tumor infiltrating lymphocytes in 

gas-permeable containers’’ (HHS Ref No. E– 

114–2011/0–US–01); 

The patent rights in these inventions 

have been assigned to the United States 

of America. 

The prospective exclusive 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 autologous tumor infiltrating 

lymphocyte adoptive cell therapy 

products for the treatment of metastatic 

melanoma as a stand-alone therapy. 

DATES: Only written comments and/or 

applications for a license which are 

received by the NIH Office of 

Technology Transfer on or before 

December 24, 2014 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated exclusive license should 

be directed to: Whitney A. Hastings, 

Ph.D., Senior Licensing and Patenting 

Manager, Office of Technology Transfer, 

National Institutes of Health, 6011 

Executive Boulevard, Suite 325, 

Rockville, MD 20852–3804; Telephone: 

(301) 451–7337; Facsimile: (301) 402– 

0220; Email: hastingw@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: Isolating 

cells from the tumor infiltrating 

lymphocytes (TIL) of a patient tumor 

sample provides a suitable initial 

lymphocyte culture for further in vitro 

manipulations. NIH scientists have 

discovered that taking the isolated cells 

through one cycle of rapid expansion 

(including exposure to IL–2), rather than 

multiple cycles, yields lymphocyte 

cultures with higher affinity and longer 

persistence in patients. In addition, they 

have found that through the use of gas 

permeable (GP) flasks, they could obtain 

large quantities of highly reactive TIL 

from patient tumor samples for anticancer immunotherapy. If an adoptive T 

cell transfer immunotherapy is to gain 

regulatory approval and successfully 

treat a wide array of patients, it will 

need to be rapid, reliable, and 

technically simple. One of the most 

critical factors to this approach is the 

generation of effective lymphocyte 

cultures that will rapidly and repeatedly 

attack the target cells when infused into 

patients. 

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 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 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: November 17, 2014. 

Richard U. Rodriguez, 

Acting Director, Office of Technology 

Transfer, National Institutes of Health. 

[FR Doc. 2014–27680 Filed 11–21–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable materials, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel 

Production, Analysis, and Distribution of 

Cannabis and Related Materials (7793). 

Date: December 2, 2014. 

Time: 10:00 a.m. to 12:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call). 

Contact Person: Lyle Furr, Scientific 

Review Officer, Office of Extramural Affairs, 

National Institute on Drug Abuse, NIH, 

DHHS, Room 4227, MSC 9550, 6001 

Executive Boulevard, Bethesda, MD 20892– 

9550, (301) 435–1439, lf33c.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos.: 93.279, Drug Abuse and 

Addiction Research Programs, National 

Institutes of Health, HHS) 

Dated: November 18, 2014. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–27669 Filed 11–21–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 


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