83_FR_46123 83 FR 45947 - Prospective Grant of an Exclusive Patent License: Photoactivatable Liposomal Nanoparticle for the Delivery of an Immunotherapeutic or Immunotherapeutic-Enabling Agent

83 FR 45947 - Prospective Grant of an Exclusive Patent License: Photoactivatable Liposomal Nanoparticle for the Delivery of an Immunotherapeutic or Immunotherapeutic-Enabling Agent

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 176 (September 11, 2018)

Page Range45947-45948
FR Document2018-19604

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 Nano Red LLC (``Nano Red'') located in Milwaukee, Wisconsin.

Federal Register, Volume 83 Issue 176 (Tuesday, September 11, 2018) 
[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Notices]
[Pages 45947-45948]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19604]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: 
Photoactivatable Liposomal Nanoparticle for the Delivery of an 
Immunotherapeutic or Immunotherapeutic-Enabling Agent

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 Nano Red LLC 
(``Nano Red'') located in Milwaukee, Wisconsin.

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 September 26, 2018 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

1. U.S. Provisional Patent Application (Application No. 61/845,861) 
filed July 12, 2013, HHS Reference No.: E-482-2013/0-US-01
2. PCT Application (Application No. PCT/US2014/045922) filed July 
09, 2014, HHS Reference No.: E-482-2013/0-PCT-02
3. Canada Patent Application (Application No. 2917545) filed 09 July 
2014, HHS Reference No.: E-482-2013/0-CA-03
4. European Patent Application (Application No. 14745037.3) filed 09 
July 2014, HHS Reference No.: E-482-2013/0-EP-04
5. U.S. Patent Application (Allowed Application No. 14/904,385) 
filed January 11, 2016, HHS Reference No.: E-482-2013/0-US-05

    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 where patent 
applications are filed and the field of use may be limited to 
``Photoactivatable liposomal nanoparticle for the delivery of an 
immunotherapeutic or immunotherapeutic-enabling agent''. Additional 
licensable fields of use are available (e.g. encapsulating imaging 
agent).
    This technology discloses a photoactivatable, lipid-based 
nanoparticles containing at least one hydrophilic agent, wherein the 
agent could be an anti-cancer agent, an imaging agent, or an anti-
inflammatory agent and the lipid bilayer wall of the nanoparticle is 
comprised of (i) a lipid bilayer comprising (a) 1,2-bis(tricosa-10,12-
diynoyl)-sn-glycero-3-phosphocholine (DC8,9PC), (b) 1,2-distearoyl-sn-
glycero-3-phosphoethanolamine-N-methoxy(polyethylene glycol) (DSPE-PEG) 
and (c) dipalmitoylphosphatidylcholine (DPPC), and (ii) a tetrapyrollic 
photosensitizer, 2-[1-hexyloxyethyl]-2-devinyl pyropheophorbide-a 
(HPPH), and wherein the encapsulated agent is released by exposure to 
near-infrared light.
    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.

[[Page 45948]]

    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: August 31, 2018.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2018-19604 Filed 9-10-18; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 45947 Agenda: The committee will be asked meetings and will make every effort to SUPPLEMENTARY INFORMATION: to discuss new drug application (NDA) accommodate persons with disabilities. Intellectual Property 209128, sufentanil sublingual tablets, If you require accommodations due to a submitted by AcelRx Pharmaceuticals, disability, please contact Moon Hee V. 1. U.S. Provisional Patent Application Inc., for the management of moderate-to- Choi (see FOR FURTHER INFORMATION (Application No. 61/845,861) filed July severe acute pain severe enough to CONTACT) at least 7 days in advance of 12, 2013, HHS Reference No.: E–482– require an opioid analgesic and for the meeting. 2013/0–US–01 which alternative treatments are FDA is committed to the orderly 2. PCT Application (Application No. PCT/ inadequate, in adult patients in a conduct of its advisory committee US2014/045922) filed July 09, 2014, medically supervised setting. The meetings. Please visit our website at HHS Reference No.: E–482–2013/0–PCT– committee will also be asked to discuss https://www.fda.gov/Advisory 02 risk-benefit considerations and whether Committees/AboutAdvisoryCommittees/ 3. Canada Patent Application (Application No. 2917545) filed 09 July 2014, HHS this product should be approved. ucm111462.htm for procedures on Reference No.: E–482–2013/0–CA–03 FDA intends to make background public conduct during advisory 4. European Patent Application (Application material available to the public no later committee meetings. No. 14745037.3) filed 09 July 2014, HHS than 2 business days before the meeting. Notice of this meeting is given under Reference No.: E–482–2013/0–EP–04 If FDA is unable to post the background the Federal Advisory Committee Act (5 5. U.S. Patent Application (Allowed material on its website prior to the U.S.C. app. 2). Application No. 14/904,385) filed meeting, the background material will Dated: September 4, 2018. January 11, 2016, HHS Reference No.: E– be made publicly available at the 482–2013/0–US–05 Leslie Kux, location of the advisory committee Associate Commissioner for Policy. The patent rights in these inventions meeting, and the background material have been assigned and/or exclusively [FR Doc. 2018–19668 Filed 9–10–18; 8:45 am] will be posted on FDA’s website after licensed to the government of the BILLING CODE 4164–01–P the meeting. Background material is United States of America. available at https://www.fda.gov/ The prospective exclusive license AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND territory may be where patent default.htm. Scroll down to the HUMAN SERVICES applications are filed and the field of appropriate advisory committee meeting use may be limited to ‘‘Photoactivatable link. National Institutes of Health liposomal nanoparticle for the delivery Procedure: Interested persons may of an immunotherapeutic or present data, information, or views, Prospective Grant of an Exclusive immunotherapeutic-enabling agent’’. orally or in writing, on issues pending Patent License: Photoactivatable before the committee. All electronic and Additional licensable fields of use are Liposomal Nanoparticle for the available (e.g. encapsulating imaging written submissions submitted to the Delivery of an Immunotherapeutic or Docket (see ADDRESSES) on or before agent). Immunotherapeutic-Enabling Agent October 4, 2018, will be provided to the This technology discloses a committee. Oral presentations from the AGENCY: National Institutes of Health, photoactivatable, lipid-based public will be scheduled between HHS. nanoparticles containing at least one approximately 1 p.m. and 2 p.m. Those ACTION: Notice. hydrophilic agent, wherein the agent individuals interested in making formal could be an anti-cancer agent, an SUMMARY: The National Cancer Institute, imaging agent, or an anti-inflammatory oral presentations should notify the an institute of the National Institutes of contact person and submit a brief agent and the lipid bilayer wall of the Health, Department of Health and nanoparticle is comprised of (i) a lipid statement of the general nature of the Human Services, is contemplating the evidence or arguments they wish to bilayer comprising (a) 1,2-bis(tricosa- grant of an Exclusive Patent License to 10,12-diynoyl)-sn-glycero-3- present, the names and addresses of practice the inventions embodied in the proposed participants, and an phosphocholine (DC8,9PC), (b) 1,2- Patents and Patent Applications listed distearoyl-sn-glycero-3- indication of the approximate time in the Supplementary Information requested to make their presentation on phosphoethanolamine-N- section of this notice to Nano Red LLC methoxy(polyethylene glycol) (DSPE– or before September 26, 2018. Time (‘‘Nano Red’’) located in Milwaukee, allotted for each presentation may be PEG) and (c) Wisconsin. dipalmitoylphosphatidylcholine limited. If the number of registrants requesting to speak is greater than can DATES: Only written comments and/or (DPPC), and (ii) a tetrapyrollic be reasonably accommodated during the applications for a license which are photosensitizer, 2-[1-hexyloxyethyl]-2- scheduled open public hearing session, received by the National Cancer devinyl pyropheophorbide-a (HPPH), FDA may conduct a lottery to determine Institute’s Technology Transfer Center and wherein the encapsulated agent is the speakers for the scheduled open on or before September 26, 2018 will be released by exposure to near-infrared public hearing session. The contact considered. light. person will notify interested persons ADDRESSES: Requests for copies of the This notice is made in accordance regarding their request to speak by patent application, inquiries, and with 35 U.S.C. 209 and 37 CFR part 404. September 27, 2018. comments relating to the contemplated The prospective exclusive license will Persons attending FDA’s advisory an Exclusive Patent License should be be royalty bearing, and the prospective committee meetings are advised that directed to: Jasmine Yang, Sr. Licensing exclusive license may be granted unless daltland on DSKBBV9HB2PROD with NOTICES FDA is not responsible for providing and Patenting Manager, NCI Technology within fifteen (15) days from the date of access to electrical outlets. Transfer Center, 9609 Medical Center this published notice, the National For press inquiries, please contact the Drive, RM 1E530 MSC 9702, Bethesda, Cancer Institute receives written Office of Media Affairs at fdaoma@ MD 20892–9702 (for business mail), evidence and argument that establishes fda.hhs.gov or 301–796–4540. Rockville, MD 20850–9702 Telephone: that the grant of the license would not FDA welcomes the attendance of the (240) 276–5530; Facsimile: (240) 276– be consistent with the requirements of public at its advisory committee 5504 Email: jasmine.yang@nih.gov. 35 U.S.C. 209 and 37 CFR part 404. VerDate Sep<11>2014 18:49 Sep 10, 2018 Jkt 244001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\11SEN1.SGM 11SEN1

45948 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices In response to this Notice, the public Closed: 1:00 p.m. to 5:00 p.m. Emphasis Panel; NIAID Clinical Trial may file comments or objections. Agenda: To review and evaluate grant Implementation Cooperative Agreement (U01 Comments and objections, other than applications. Clinical Trial Required) and NIAID SBIR Place: NIH, National Eye Institute, 6700B Phase II Clinical Trial Implementation those in the form of a license Rockledge Drive, First Floor Conference Cooperative Agreement (U44 Clinical Trial application, will not be treated Rooms, Bethesda, MD 20817. confidentially, and may be made Required). Contact Person: Paul A. Sheehy, Ph.D., publicly available. Director, Division of Extramural Affairs, Date: October 10, 2018. License applications submitted in National Eye Institute, National Institutes of Time: 11:00 a.m. to 3:00 p.m. response to this Notice will be Health, 5635 Fishers Lane, Suite 12300, Agenda: To review and evaluate grant presumed to contain business Bethesda, MD 20892, 301–451–2020, ps32h@ applications. confidential information and any release nih.gov. Place: National Institutes of Health, 5601 of information in these license Information is also available on the Fishers Lane, Rockville, MD 20892 applications will be made only as Institute’s/Center’s home page: (Telephone Conference Call). required and upon a request under the www.nei.nih.gov, where an agenda and any Contact Person: Brenda Lange-Gustafson, additional information for the meeting will Ph.D., Scientific Review Officer, NIAID/NIH/ Freedom of Information Act, 5 U.S.C. be posted when available. 552. DHHS, Scientific Review Program,5601 (Catalogue of Federal Domestic Assistance Fishers Lane, Room 3G13, Rockville, MD Dated: August 31, 2018. Program Nos. 93.867, Vision Research, 20852, 240–669–5047, bgustafson@ Richard U. Rodriguez, National Institutes of Health, HHS) niaid.nih.gov. Associate Director, Technology Transfer Dated: September 5, 2018. (Catalogue of Federal Domestic Assistance Center, National Cancer Institute. Natasha M. Copeland, Program Nos. 93.855, Allergy, Immunology, [FR Doc. 2018–19604 Filed 9–10–18; 8:45 am] Program Analyst, Office of Federal Advisory and Transplantation Research; 93.856, BILLING CODE 4140–01–P Committee Policy. Microbiology and Infectious Diseases [FR Doc. 2018–19606 Filed 9–10–18; 8:45 am] Research, National Institutes of Health, HHS) BILLING CODE 4140–01–P Dated: September 5, 2018. DEPARTMENT OF HEALTH AND HUMAN SERVICES Natasha M. Copeland, DEPARTMENT OF HEALTH AND Program Analyst, Office of Federal Advisory National Institutes of Health Committee Policy. HUMAN SERVICES National Eye Institute; Notice of [FR Doc. 2018–19607 Filed 9–10–18; 8:45 am] Meeting National Institutes of Health BILLING CODE 4140–01–P Pursuant to section 10(d) of the National Institute of Allergy and Federal Advisory Committee Act, as Infectious Diseases; Notice of Closed DEPARTMENT OF HEALTH AND amended, notice is hereby given of a Meetings HUMAN SERVICES meeting of the National Advisory Eye Pursuant to section 10(d) of the Council. Federal Advisory Committee Act, as National Institutes of Health The meeting will be open to the amended, notice is hereby given of the public as indicated below, with National Institute on Drug Abuse following meetings. attendance limited to space available. The meetings will be closed to the Amended; Notice of Meeting Individuals who plan to attend and public in accordance with the need special assistance, such as sign provisions set forth in sections Notice is hereby given of a change in language interpretation or other 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., the meeting of the National Institute on reasonable accommodations, should as amended. The grant applications and Drug Abuse Special Emphasis Panel, notify the Contact Person listed below the discussions could disclose September 25, 2018, 10:00 a.m. to in advance of the meeting. confidential trade secrets or commercial September 25, 2018, 12:00 p.m., The meeting will be closed to the National Institutes of Health, property such as patentable material, public in accordance with the Neuroscience Center, 6001 Executive and personal information concerning provisions set forth in sections Boulevard, Rockville, MD 20852 which individuals associated with the grant 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., applications, the disclosure of which was published in the Federal Register as amended. The grant applications and would constitute a clearly unwarranted on August 15, 2018, 83 159 FR 2018– the discussions could disclose invasion of personal privacy. 17674. confidential trade secrets or commercial property such as patentable material, Name of Committee: National Institute of The meeting date was changed to and personal information concerning Allergy and Infectious Diseases Special October 9, 2018. The meeting time did Emphasis Panel; NIAID Peer Review Meeting. individuals associated with the grant not change. The meeting is closed to the Date: October 10, 2018. applications, the disclosure of which Time: 10:30 a.m. to 6:00 p.m. public. would constitute a clearly unwarranted Agenda: To review and evaluate contract Dated: September 5, 2018. invasion of personal privacy. proposals. Natasha M. Copeland, Name of Committee: National Advisory Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 Program Analyst, Office of Federal Advisory Eye Council. Date: October 12, 2018. (Telephone Conference Call). Committee Policy. daltland on DSKBBV9HB2PROD with NOTICES Open: 8:30 a.m. to 12:00 p.m. Contact Person: Chelsea D. Boyd, Ph.D., [FR Doc. 2018–19608 Filed 9–10–18; 8:45 am] Agenda: Following opening remarks by the Scientific Review Officer, Scientific Review BILLING CODE 4140–01–P Director, NEI, there will be presentations by Program, DEA/NIAID/NIH/DHHS, 5601 the staff of the Institute and discussions Fishers Lane, MSC–9823, Rockville, MD concerning Institute programs. 20852–9834, 240–669–2081, chelsea.boyd@ Place: NIH, National Eye Institute, 6700B nih.gov. Rockledge Drive, First Floor Conference Name of Committee: National Institute of Rooms, Bethesda, MD 20817. Allergy and Infectious Diseases Special VerDate Sep<11>2014 18:49 Sep 10, 2018 Jkt 244001 PO 00000 Frm 00074 Fmt 4703 Sfmt 9990 E:\FR\FM\11SEN1.SGM 11SEN1


Document Created: 2018-09-11 01:02:40
Document Modified: 2018-09-11 01:02:40
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly written comments and/or applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before September 26, 2018 will be considered.
FR Citation83 FR 45947 
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