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###### Department of Health and Human Services

###### National Institutes of Health

# 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 Patent Applications listed in the Supplementary Information section of this notice to Sixfold Biosciences Inc., (“Sixfold”) of Walnut, California.

# 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 January 7, 2019 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 Yang, Sr. 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: (240)-276-5530; Facsimile: (240)-276-5504 Email:                         *jasmine.yang@nih.gov.*

# SUPPLEMENTARY INFORMATION:

## Intellectual Property

### A. Multifunctional RNA Nanoparticles and Methods of Uses

1. U.S. Provisional Patent Application (Application No. 61/878,758) filed September 17, 2013, HHS Reference No.: E-765-2013-0-US-01

2. PCT Application (Application No. PCT/US2014/056007) filed September 17, 2014, HHS Reference No.: E-765-2013-0-US-02

3. European Patent Application (Application No. 14780963.6) filed September 17, 2014, HHS Reference No.: E-765-2013-0-EP-03

4. Australian Patent Application (Application No. 2014321443) filed September 17, 2014, HHS Reference No.: E-765-2013-0-AU-04

5. Canadian Patent Application (Application No. 2,924,509) filed September 17, 2014, HHS Reference No.: E-765-2013-0-CA-05

6. Japanese. Patent Application (Application No. 2016-543964) filed September 17, 2014, HHS Reference No.: E-765-2013-0-JP-05

7. US Patent Application (Application No. 15/022,530) filed March 16, 2016, HHS Reference No.: E-765-2013-0-US-07

### B. RNA/DNA Hybrid Nanoparticles Modified with Single Stranded RNA Toeholds and Uses Thereof

1. U.S. Provisional Patent Application (Application No. 62/294,848) filed February 12, 2016, HHS Reference No.: E-078-2016-0-US-01

2. PCT Application (Application No. PCT/US2017/017661) filed February 13, 2017, HHS Reference No.: E-078-2016-0-US-02

3. US Patent Application (Application No. 16/076,878) filed August 9, 2018, HHS Reference No.: E-078-2016-0-US-03

4. European Patent Application (Application No. 17706653.7) filed September 12, 2018, HHS Reference No.: E-078-2016-0-EP-04

                    The patent rights in these inventions have been assigned and/or exclusively                           ( print page 65695)                        licensed to the government of the United States of America.                

                    The prospective exclusive license territory may be where patent applications are filed and the field of use may be limited to “Multifunctional RNA nanoparticle functionalized by RNA toeholds as a drug delivery agent carrying gene therapeutic or gene-editing cargo and/or aptamers”. Additional licensable fields of use are available (                    *e.g.*                     functionalized with proteins or imaging agent).                

The technologies disclose RNA and RNA/DNA (“R/DNA”) nanoparticles in the form of a hexameric ring that have arms attached off the sides of the ring in which the arms could be siRNAs, RNA aptamers, fluorescent dyes, imaging agents and/or proteins in various combinations and use of single-stranded RNA toeholds of lengths of 12 nucleotides or less contained in nucleic acid-based nanoparticles, such as the nanoring, which trigger the association of these nanoparticles and activates multiple functionalities such as gene silencing and/or cell-specific targeting. 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; December 11, 2018. 

Richard U. Rodriguez,

Associate Director, Technology Transfer Center, National Cancer Institute.

[FR Doc. 2018-27671 Filed 12-20-18; 8:45 am]

 BILLING CODE 4140-01-P