82 FR 11362 - Prospective Grant of Exclusive Patent License: Development of a Gene Signature Predictive of Hepatocellular Carcinoma (HCC) Patient Response to Transcatheter Arterial Chemoembolization (TACE)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 34 (February 22, 2017)

Page Range		11362-11363
FR Document		2017-03402

The National Cancer Institute, an institute of 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 Patents and Patent Applications listed in the Supplementary Information section of this notice to 3D Medicines (``3DMed'') located in Shanghai, China.

Federal Register, Volume 82 Issue 34 (Wednesday, February 22, 2017)

[Federal Register Volume 82, Number 34 (Wednesday, February 22, 2017)]
[Notices]
[Pages 11362-11363]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03402]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Development of a 
Gene Signature Predictive of Hepatocellular Carcinoma (HCC) Patient 
Response to Transcatheter Arterial Chemoembolization (TACE)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, an institute of 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 Patents and Patent Applications listed in 
the Supplementary Information section of this notice to 3D Medicines 
(``3DMed'') located in Shanghai, China.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before March 9, 2017 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Jim Knabb, Ph.D., Technology Transfer and Patent 
Specialist, 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: [email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    United States Provisional Patent Application No. 62/292,789, filed 
February 8, 2016 entitled ``Gene Signature Predictive of Hepatocellular 
Carcinoma Response to Transcatheter Arterial Chemoembolization'' [HHS 
Reference No. E-101-2016/0-US-01]; PCT Patent Application PCT/US2017/
016851, filed February 7, 2017 and entitled ``GENE SIGNATURE PREDICTIVE 
OF HEPATOCELLULAR CARCINOMA RESPONSE TO TRANSCATHETER ARTERIAL 
CHEMOEMBOLIZATION (TACE)'' [HHS Reference No. E-101-2016/0-PCT-02]; 
(and U.S. and foreign patent applications claiming priority to the 
aforementioned applications).
    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 field of use may be limited to ``the Development and 
commercialization of the transcatheter arterial chemoembolization 
(TACE) gene signature as a diagnostic device predictive of TACE 
response in patients with hepatocellular carcinoma (HCC). The field of 
use may be further limited to companion diagnostic tests that are sold 
following Premarket Approval by the FDA or equivalent regulatory agency 
in foreign jurisdictions''.
    This technology discloses a gene expression signature that is 
predictive of HCC patient response to TACE. TACE therapy is a procedure 
whereby the tumor is targeted with both local chemotherapy and 
restriction of local blood supply, and is employed in the treatment of 
locally advanced hepatocellular carcinoma (HCC). Patient biopsies are 
analyzed by Next-Generation Sequencing (NGS) and expression analysis of 
the gene signature can be used to stratify patients for TACE therapy. 
Through the commercialization of this gene signature for TACE efficacy, 
HCC patients can be identified as candidates for TACE

[[Page 11363]]

therapy, or as needing alternative treatment strategies.
    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 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 filed in response to this notice will be treated as objections 
to the grant of the contemplated Exclusive Patent License Agreement. 
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 15, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-03402 Filed 2-21-17; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 82, No. 34 / Wednesday, February 22, 2017 / Notices 11363

therapy, or as needing alternative Contact Person: Paulette S. Gray, Ph.D., DEPARTMENT OF HEALTH AND
treatment strategies. Director, Division of Extramural Activities, HUMAN SERVICES
This notice is made in accordance National Cancer Institute—Shady Grove,
with 35 U.S.C. 209 and 37 CFR part 404. National Institutes of Health, 9609 Medical National Institutes of Health
The prospective exclusive license will Center Drive, 7th Floor, Rm. 7W444,
be royalty bearing, and the prospective Bethesda, MD 20892, 240–276–6340, grayp@ National Cancer Institute; Amended
exclusive license may be granted unless mail.nih.gov. Notice of Meeting
within fifteen (15) days from the date of Name of Committee: National Cancer Notice is hereby given of a change in
this published notice, the National Institute Board of Scientific Advisors. the meeting of the National Cancer
Cancer Institute receives written Date: March 22, 2017. Institute Clinical Trials and Translation
evidence and argument that establishes Time: 8:30 a.m. to 12:00 p.m. Research Advisory Committee, March 8,
that the grant of the license would not Agenda: Acting Director’s Report: Ongoing 2017, 8:00 a.m. to March 8, 2017, 3:00
be consistent with the requirements of and New Business; RFA and RFP Concept p.m., National Institutes of Health,
35 U.S.C. 209 and 37 CFR part 404. Reviews; and Scientific Presentations. Building 31, C-Wing, 6th Floor, Rooms
Complete applications for a license in Place: National Institutes of Health, 31 9 and 10, 31 Center Drive, Bethesda, MD
the prospective field of use that are filed Center Drive, Building 31, C-Wing, 6th Floor, 20892 which was published in the
in response to this notice will be treated Room 10, Bethesda, MD 20892. Federal Register on January 11, 2017, 81
as objections to the grant of the Contact Person: Paulette S. Gray, Ph.D., FR 3342.
contemplated Exclusive Patent License Director, Division of Extramural Activities, This meeting notice is amended to
Agreement. Comments and objections National Cancer Institute—Shady Grove, change the meeting format and start and
submitted to this notice will not be National Institutes of Health, 9609 Medical end times. The meeting will now be
Center Drive, 7th Floor, Rm. 7W444, held virtually from 11:00 a.m. to 1:30
made available for public inspection
Bethesda, MD 20892, 240–276–6340, grayp@ p.m. due to a change in the agenda
and, to the extent permitted by law, will
mail.nih.gov. which reduced the time required for
not be released under the Freedom of
Information Act, 5 U.S.C. 552. Any interested person may file written deliberation and discussion. The
comments with the committee by forwarding meeting will still be held at the National
Dated: February 15, 2017. the statement to the Contact Person listed on Institutes of Health, Building 31, C-
Richard U. Rodriguez, this notice. The statement should include the Wing, 6th Floor, Rooms 9 and 10, 31
Associate Director, Technology Transfer name, address, telephone number and when Center Drive, Bethesda, MD 20892 and
Center, National Cancer Institute. applicable, the business or professional can also be accessed via NIH Videocast
[FR Doc. 2017–03402 Filed 2–21–17; 8:45 am] affiliation of the interested person. at https://videocast.nih.gov. This
BILLING CODE 4140–01–P In the interest of security, NIH has meeting is open to the public.
instituted stringent procedures for entrance
Dated: February 16, 2017.
onto the NIH campus. All visitor vehicles,
DEPARTMENT OF HEALTH AND including taxicabs, hotel, and airport shuttles Melanie J. Gray-Pantoja,
HUMAN SERVICES will be inspected before being allowed on Program Analyst, Office of Federal Advisory
campus. Visitors will be asked to show one Committee Policy.
National Institutes of Health form of identification (for example, a [FR Doc. 2017–03448 Filed 2–21–17; 8:45 am]
government-issued photo ID, driver’s license, BILLING CODE 4140–01–P
National Cancer Institute; Notice of or passport) and to state the purpose of their
Meeting visit.
Information is also available on the DEPARTMENT OF HEALTH AND
Pursuant to section 10(a) of the
Institute’s/Center’s home page: http:// HUMAN SERVICES
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is deainfo.nci.nih.gov/advisory/bsa/bsa.htm,
where an agenda and any additional National Institutes of Health
hereby given of a meeting of the
National Cancer Institute Board of information for the meeting will be posted
National Institute on Aging; Notice of
Scientific Advisors. when available.
Closed Meeting
The meeting will be open to the (Catalogue of Federal Domestic Assistance
public, with attendance limited to space Program Nos. 93.392, Cancer Construction; Pursuant to section 10(d) of the
available. Individuals who plan to 93.393, Cancer Cause and Prevention Federal Advisory Committee Act, as
attend and need special assistance, such Research; 93.394, Cancer Detection and amended (5 U.S.C. App.), notice is
as sign language interpretation or other Diagnosis Research; 93.395, Cancer hereby given of the following meeting.
Treatment Research; 93.396, Cancer Biology The meeting will be closed to the
reasonable accommodations, should
Research; 93.397, Cancer Centers Support; public in accordance with the
notify the Contact Person listed below
93.398, Cancer Research Manpower; 93.399, provisions set forth in sections
in advance of the meeting. The meeting
Cancer Control, National Institutes of Health, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
will also be videocast and can be
HHS) as amended. The grant applications and
accessed from the NIH Videocasting and
the discussions could disclose
Podcasting Web site (http:// Dated: February 15, 2017. confidential trade secrets or commercial
videocast.nih.gov/). Melanie J. Pantoja, property such as patentable material,
Name of Committee: National Cancer Program Analyst, Office of Federal Advisory and personal information concerning
Institute Board of Scientific Advisors.
sradovich on DSK3GMQ082PROD with NOTICES

Committee Policy. individuals associated with the grant
Date: March 21, 2017. applications, the disclosure of which
[FR Doc. 2017–03387 Filed 2–21–17; 8:45 am]
Time: 8:30 a.m. to 5:00 p.m.
Agenda: Acting Director’s Report: Ongoing BILLING CODE 4140–01–P would constitute a clearly unwarranted
and New Business; RFA and RFP Concept invasion of personal privacy.
Reviews; and Scientific Presentations. Name of Committee: National Institute on
Place: National Institutes of Health, 31 Aging Special Emphasis Panel; Second Stage
Center Drive, Building 31, C-Wing, 6th Floor, P01 Review.
Room 10, Bethesda, MD 20892. Date: March 15, 2017.

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Document Created: 2017-02-22 00:08:36
Document Modified: 2017-02-22 00:08:36

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Only written comments and/or applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before March 9, 2017 will be considered.
FR Citation		82 FR 11362

82 FR 11362 - Prospective Grant of Exclusive Patent License: Development of a Gene Signature Predictive of Hepatocellular Carcinoma (HCC) Patient Response to Transcatheter Arterial Chemoembolization (TACE)

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 34 (February 22, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health