2020-07707. Prospective Grant of an Exclusive Patent License: Interinstitutional Agreement-Institution Lead: Graphene Oxide-Polycarbonate Track-Etched Nanosieve Platform for Sensitive Detection of Human Immunodeficiency Virus Envelope Glycoprotein

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

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 Indian Patent Applications listed in the Supplementary Information section of this notice to Chaudhary Charan Singh Haryana Agricultural University (CCSHAU) located in Hisar, India.

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 April 28, 2020 will be considered.

ADDRESSES:

Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Jasmine J. Yang, 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: [phone]; Facsimile: (240)-276-5504 Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Intellectual Property

Indian Patent Application Serial No. 201711002764, filed February 24, 2017 entitled “Graphene oxide-polycarbonate track-etched nanosieve platform for sensitive detection of human immunodeficiency virus envelope glycoprotein.”

The patent rights in these inventions have been assigned and/or exclusively licensed to the CCS Haryana Agricultural University and Government of the United States of America as represented by the Secretary, Department of Health & Human Services.

The prospective patent license will be for the purpose of consolidating the patent rights to CCSHAU, the 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 will be an exclusive in India 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 CCSHAU will be subject to the provisions of 37 CFR part 401 and 404.

This technology discloses a graphene oxide-polycarbonate nanosieve electrochemical biosensor for the detection of HIV envelope glycoprotein. The nanosieve is comprised of a polycarbonate membrane layered with graphene oxide laminate, which is conjugated to a bispecific tetravalent antibody, “2Dm2m”, comprised of CD4 fused to a human domain targeting HIV-1 coreceptor binding domain that has high affinity to the HIV envelope glycoprotein gp140. The nanosieve is fitted between two Ag/AgCl electrodes to form an electrochemical nanobiosensor capable of detecting HIV virus (see attached figures). Binding of the HIV gp140 to 2Dm2m reduces the ionic current through the nanosieve biosensors, which functions as the marker of HIV presence. The biosensor has the potential to be a low-cost, portable and quick method for HIV viral load detection.

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.

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.

Dated: April 2, 2020.

Richard U. Rodriguez,

Associate Director, Technology Transfer Center, National Cancer Institute.