[Federal Register Volume 88, Number 87 (Friday, May 5, 2023)]
[Notices]
[Pages 29141-29142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09566]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Predicting 
Patient Response to Cancer Therapy via Histopathology Images

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute (NCI), an institute of the 
National Institutes of Health, Department of Health and Human Services, 
is contemplating the grant of an exclusive, sublicensable patent 
license to Australian National University (``ANU''), a non-profit 
research institution located in Canberra, Australia for NCI's rights to 
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 National Cancer Institute's Technology Transfer 
Center on or before May 22, 2023 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: Kevin Chang, Ph.D., Senior Technology Transfer 
Manager, NCI Technology Transfer Center, at: email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    The following and all continuing U.S. and foreign patents/patent 
applications thereof are the intellectual properties to be licensed 
under the prospective agreement to ANU: United States Provisional 
Patent Application No. 63/349,829, filed June 7, 2022, entitled 
``Predicting Patient Response to Cancer Therapy via Histopathology 
Images'' (HHS Ref. No. E-186-2022-0-US-01).
    The Government of the United States of America and ANU are 
assignees of the patent rights in these inventions. The prospective 
license will be for the purpose of consolidating NCI's patent rights to 
ANU, co-owners of said rights, for commercial development and 
marketing. Consolidation of these co-owned rights is intended to 
expedite development of the invention, consistent with the goals of the 
Bayh-Dole Act codified as 35 U.S.C. 200-212.
    The prospective patent license territory will be worldwide, 
exclusive, and may be limited to those fields of use commensurate in 
scope with the patent rights. It will be sublicensable, and any 
sublicenses granted by ANU will be subject to the provisions of 37 CFR 
part 401 and 404.
    This technology discloses a computational based method to predict 
whether a cancer patient will respond to targeted and immunotherapies 
against cancer using hematoxylin and eosin (H&E) slides from the 
patient's tumor.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will include terms for the 
sharing of royalty income with NCI from commercial sublicenses of the 
patent rights. 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 that are timely filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive patent license. In response to this Notice, 
the public may file comments or objections. Comments and objections, 
other than those in the form of a license application, will not be 
treated confidentially, and may be made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.


[[Page 29142]]


    Dated: May 1, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2023-09566 Filed 5-4-23; 8:45 am]
BILLING CODE 4140-01-P