Prospective Grant of an Exclusive License: Human Papillomavirus 16 E2 and E6 Peptides for Cervical Cancer Vaccine Development, 42530-42531 [2013-16949]

Download as PDF 42530 Federal Register / Vol. 78, No. 136 / Tuesday, July 16, 2013 / Notices 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel Review of the Diversity Program Date: July 23, 2013. Time: 2:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Raul A. Saavedra, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS, NIH, NSC, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892– 9529, 301–496–9223, saavedrr@ninds.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel P30 and R24 Review. Date: August 7, 2013. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites Chicago—O’Hare/ Rosemont, 550 North River Road, Rosemont, IL 60018. Contact Person: William C. Benzing, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research NINDS, NIH, NSC, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892– 9529, 301–496–0660, benzingw@mail.nih.gov. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel Stroke Trials Network NCCC SEP. Date: August 15, 2013. Time: 8:00 a.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. Place: The Fairmont Washington, DC, 2401 M Street NW., Washington, DC 20037. Contact Person: Shanta Rajaram, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research NINDS, NIH, NSC, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892– 9529, 301–435–6033, rajarams@mail.nih.gov. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel Stroke Trial Network Sites. Date: August 15–16, 2013. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: The Fairmont Washington, DC, 2401 M Street NW., Washington, DC 20037. Contact Person: Shanta Rajaram, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research NINDS, NIH, NSC, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892– 9529, 301–435–6033, rajarams@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: July 10, 2013. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–16945 Filed 7–15–13; 8:45 am] emcdonald on DSK67QTVN1PROD with NOTICES Ref. Ref. Ref. Ref. Ref. Ref. Ref. Ref. Ref. Ref. Ref. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial 18:49 Jul 15, 2013 Jkt 229001 Dated: July 10, 2013. Carolyn A. Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–16943 Filed 7–15–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive License: Human Papillomavirus 16 E2 and E6 Peptides for Cervical Cancer Vaccine Development AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the inventions embodied in: SUMMARY: Patent application No. E–126–2001/0–AU–06 ................................................................ E–126–2001/0–CA–04 ................................................................ E–126–2001/0–EP–05 ................................................................. E–126–2001/0–PCT–02 .............................................................. E–126–2001/0–US–01 ................................................................ E–126–2001/0–US–03 ................................................................ E–126–2001/0–US–07 ................................................................ E–155–2005/0–US–01 ................................................................ E–155–2005/1–US–01 ................................................................ E–155–2005/2–US–01 ................................................................ E–155–2005/3–AU–04 ................................................................ VerDate Mar<15>2010 Name of Committee: National Institute on Alcohol Abuse and Alcoholism Initial Review Group; Clinical, Treatment and Health Services Research Review Subcommittee. Date: October 15, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, NIAAA, 5635 Fishers Lane, T508 Rockville, MD 20852. Contact Person: Katrina L Foster, Ph.D., Scientific Review Officer, National Institute on Alcohol Abuse & Alcoholism, National Institutes of Health, 5635 Fishers Lane, Rm. 2019, Rockville, MD 20852, 301–443–4032, katrina@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.273, Alcohol Research Programs; National Institutes of Health, HHS) BILLING CODE 4140–01–P NIH Ref. No. NIH NIH NIH NIH NIH NIH NIH NIH NIH NIH NIH property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. PO 00000 Frm 00045 Fmt 4703 Filing date Issued patent no. (if any) 2002258614 2441947 2728570.9 PCT/US02/09261 60/278,520 10/472,661 11/685,632 60/671,463 60/680,000 60/724,783 2006236905 March 22, 2002 .................. March 22, 2002 .................. March 22, 2002 .................. March 22, 2002 .................. March 23, 2001 .................. September 23, 2003 .......... March 13, 2007 .................. April 15, 2005 ..................... May 12, 2005 ..................... October 11, 2005 ............... April 11, 2006 ..................... 2002258614 .............................. .............................. (Expired) (Expired) 7,189,513 7,507,538 (Expired) (Expired) (Expired) .............................. Sfmt 4703 E:\FR\FM\16JYN1.SGM 16JYN1 Federal Register / Vol. 78, No. 136 / Tuesday, July 16, 2013 / Notices Patent application No. NIH Ref. No. NIH NIH NIH NIH Ref. Ref. Ref. Ref. E–155–2005/3–CA–05 ................................................................ E–155–2005/3–EP–03 (CH, DE, FR, GB, and IE) ..................... E–155–2005/3–PCT–01 .............................................................. E–155–2005/3–US–02 ................................................................ to Georgia Health Sciences University Research Institute, Inc. having a principal place of business in Augusta, Georgia. The United States of America is an assignee to the patent rights of these inventions. The contemplated exclusive license may be in a field of use directed to cervical cancer vaccines. DATES: Only written comments and/or applications for a license that are received by the NIH Office of Technology Transfer on or before August 15, 2013 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael Shmilovich, Esq, CLP, Senior Licensing and Patent Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 5019; Facsimile: (301) 402–0220; Email: shmilovm@od.nih.gov. A signed confidential disclosure agreement may be required to receive copies of patent applications assuming it has not already issued or been published under either the publication rules of either the US Patent and Trademark Office or World Intellectual Property Organization. SUPPLEMENTARY INFORMATION: emcdonald on DSK67QTVN1PROD with NOTICES NIH Ref. No. E–155–2005/0–3 (as Above) The invention pertains primarily to CD8+ T cell epitopes from HPV16 E2. These epitopes generated from amino acid positions 69–77 (ALQAIELQL) and 138–147 (YICEEASVTV) bind to HLA.A2 and elicit CD8+ cytotoxic T cell responses that lyse tumor cells of lowgrade cervical neoplasia (wart). NIH Ref. No. E–126–2001/0 (as Above) Immunogenic peptides from the HPV– 18E6 (X1KLPDLCTELX2;, wherein X2 and X1 are peptides of 0–11 amino acids in length comprising contiguous HPV 18 E6 amino acid sequences) protein that comprise class I restricted T cell epitopes and methods of administering the same. The HPV–18E6 peptide crossreacts immunologically with both HPV type 16 and HPV type 18 with higher affinity than most common human lymphocyte antigen (HLA), HLA–A2 VerDate Mar<15>2010 18:49 Jul 15, 2013 Jkt 229001 42531 Filing date Issued patent no. (if any) 2604909 6749659.6 PCT/US2006/1331 11/918,557 April 11, 2006 ..................... April 11, 2007 ..................... April 11, 2006 ..................... October 11, 2006 ............... .............................. 1877087 (Expired) 7,691,579 than the homologous peptide from HPV 16. E6 peptide vaccines are potentially prophylactic or therapeutic for cervical cancer, other genital cancers, head and neck cancers, and upper digestive tract cancers. It could also be potentially used in the treatment of patients presenting with pre-malignant cervical disease, especially in underdeveloped countries with no access to surgical treatment or to completely avoid surgical treatment. The prospective exclusive license will be royalty-bearing and comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license may be granted unless, within thirty (30) days from the date of this published notice, NIH 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. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response 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: July 9, 2013. Richard Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–16949 Filed 7–15–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Ophthalmic Diagnostic Devices AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human SUMMARY: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Services (HHS), is contemplating the grant of a worldwide exclusive start-up patent license, to practice the inventions embodied in U.S. Patent 8,132,911 (HHS Ref. No. E–279–2006/0) to OptoBiometrics Designs, Inc., a company incorporated under the laws of the State of California having its headquarters in Pleasant Hill, California. The United States of America is the assignee of the rights of the above inventions. The contemplated exclusive license may be granted in a field of use limited to ocular fundus examination devices and systems. DATES: Only written comments and/or applications for a license received by the NIH Office of Technology Transfer on or before July 31, 2013 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael A. Shmilovich, Esq., CLP, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 5019; Facsimile: (301) 402–0220; Email: shmilovm@mail.nih.gov. A signed confidentiality nondisclosure agreement will be required to receive copies of any patent applications that have not been published by the United States Patent and Trademark Office or the World Intellectual Property Organization. SUPPLEMENTARY INFORMATION: The issued patent covers an optical system that permits targeted photo-stimulation of the retina by positioning a stimulus location under visual guidance through a fundus camera. The instant system is designed to elicit, under direct infrared (IR) visual control of stimulus size and position in the retina, electroretinograms (ERGs) in response to photo-stimulation from selected regions of the retina, as well as to present small light stimuli to a selected area to explore visual sensitivity properties. For example, the detected ERGs can be the basis for diagnosing or characterizing patient retina with early stage retinal disease versus healthy retina from the opposite eye. The system can be mounted on commercially available fundus cameras that have IR capabilities (or would accept IR bandpass filtering of E:\FR\FM\16JYN1.SGM 16JYN1

Agencies

[Federal Register Volume 78, Number 136 (Tuesday, July 16, 2013)]
[Notices]
[Pages 42530-42531]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16949]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive License: Human Papillomavirus 
16 E2 and E6 Peptides for Cervical Cancer Vaccine Development

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health (NIH), Department of 
Health and Human Services, is contemplating the grant of an exclusive 
worldwide license to practice the inventions embodied in:

----------------------------------------------------------------------------------------------------------------
                                          Patent                                               Issued patent no.
           NIH Ref. No.              application No.                 Filing date                    (if any)
----------------------------------------------------------------------------------------------------------------
NIH Ref. E-126-2001/0-AU-06.......         2002258614  March 22, 2002........................         2002258614
NIH Ref. E-126-2001/0-CA-04.......            2441947  March 22, 2002........................  .................
NIH Ref. E-126-2001/0-EP-05.......          2728570.9  March 22, 2002........................  .................
NIH Ref. E-126-2001/0-PCT-02......     PCT/US02/09261  March 22, 2002........................          (Expired)
NIH Ref. E-126-2001/0-US-01.......         60/278,520  March 23, 2001........................          (Expired)
NIH Ref. E-126-2001/0-US-03.......         10/472,661  September 23, 2003....................          7,189,513
NIH Ref. E-126-2001/0-US-07.......         11/685,632  March 13, 2007........................          7,507,538
NIH Ref. E-155-2005/0-US-01.......         60/671,463  April 15, 2005........................          (Expired)
NIH Ref. E-155-2005/1-US-01.......         60/680,000  May 12, 2005..........................          (Expired)
NIH Ref. E-155-2005/2-US-01.......         60/724,783  October 11, 2005......................          (Expired)
NIH Ref. E-155-2005/3-AU-04.......         2006236905  April 11, 2006........................  .................

[[Page 42531]]

 
NIH Ref. E-155-2005/3-CA-05.......            2604909  April 11, 2006........................  .................
NIH Ref. E-155-2005/3-EP-03 (CH,            6749659.6  April 11, 2007........................            1877087
 DE, FR, GB, and IE).
NIH Ref. E-155-2005/3-PCT-01......    PCT/US2006/1331  April 11, 2006........................          (Expired)
NIH Ref. E-155-2005/3-US-02.......         11/918,557  October 11, 2006......................          7,691,579
----------------------------------------------------------------------------------------------------------------

to Georgia Health Sciences University Research Institute, Inc. having a 
principal place of business in Augusta, Georgia.
    The United States of America is an assignee to the patent rights of 
these inventions.
    The contemplated exclusive license may be in a field of use 
directed to cervical cancer vaccines.

DATES: Only written comments and/or applications for a license that are 
received by the NIH Office of Technology Transfer on or before August 
15, 2013 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Michael Shmilovich, Esq, CLP, Senior Licensing 
and Patent Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-5019; Facsimile: (301) 402-0220; Email: 
shmilovm@od.nih.gov. A signed confidential disclosure agreement may be 
required to receive copies of patent applications assuming it has not 
already issued or been published under either the publication rules of 
either the US Patent and Trademark Office or World Intellectual 
Property Organization.

SUPPLEMENTARY INFORMATION:

NIH Ref. No. E-155-2005/0-3 (as Above)

    The invention pertains primarily to CD8+ T cell epitopes from HPV16 
E2. These epitopes generated from amino acid positions 69-77 
(ALQAIELQL) and 138-147 (YICEEASVTV) bind to HLA.A2 and elicit CD8+ 
cytotoxic T cell responses that lyse tumor cells of low-grade cervical 
neoplasia (wart).

NIH Ref. No. E-126-2001/0 (as Above)

    Immunogenic peptides from the HPV-18E6 
(X1KLPDLCTELX2;, wherein X2 and 
X1 are peptides of 0-11 amino acids in length comprising 
contiguous HPV 18 E6 amino acid sequences) protein that comprise class 
I restricted T cell epitopes and methods of administering the same. The 
HPV-18E6 peptide cross-reacts immunologically with both HPV type 16 and 
HPV type 18 with higher affinity than most common human lymphocyte 
antigen (HLA), HLA-A2 than the homologous peptide from HPV 16. E6 
peptide vaccines are potentially prophylactic or therapeutic for 
cervical cancer, other genital cancers, head and neck cancers, and 
upper digestive tract cancers. It could also be potentially used in the 
treatment of patients presenting with pre-malignant cervical disease, 
especially in underdeveloped countries with no access to surgical 
treatment or to completely avoid surgical treatment.
    The prospective exclusive license will be royalty-bearing and 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 
404. The prospective exclusive license may be granted unless, within 
thirty (30) days from the date of this published notice, NIH 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.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response 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: July 9, 2013.
Richard Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-16949 Filed 7-15-13; 8:45 am]
BILLING CODE 4140-01-P
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