[Federal Register Volume 74, Number 136 (Friday, July 17, 2009)]
[Notices]
[Pages 34766-34767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-17038]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Use of CD47 Antibodies, 
Antisense Oligonucleotides, and Small Molecules To Treat Disease 
Affecting the Vascular System

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR part 404.7(a)(1)(i), that 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 U.S. 
Provisional Patent Application No. 60/850,132, filed October 6, 2006, 
now abandoned (HHS Ref. No. E-227-2006/0-US-01); U.S. Provisional 
Patent Application No. 60/864,153, filed November 02, 2006, now 
abandoned (HHS Ref. No. E-227-2006/1-US-01); U.S. Provisional Patent 
Application No. 60/888,754, filed February 07, 2007, now abandoned (HHS 
Ref. No. E-227-2006/2-US-01); U.S. Provisional Patent Application No. 
60/910,549, filed April 06, 2007, now abandoned (HHS Ref. No. E-227-
2006/3-US-01); U.S. Provisional Patent Application No. 60/956,375, 
filed August 16, 2007, now abandoned (HHS Ref. No. E-227-2006/4-US-01); 
PCT Patent Application No. PCT/2007/080647, filed October 5, 2007, now 
abandoned (HHS Ref. No. E-227-2006/5-PCT-01); U.S. Patent Application 
No. 12/444,364, filed October 5, 2007 (HHS Ref. No. E-227-2006/5-US-
02); Canadian Patent Application (not yet determined) (HHS Ref. No. E-
227-2006/5-CA-03); Australian Patent Application No. 2007319576, filed 
October 5, 2007 (HHS Ref. No. E-227-2006/5-AU-04); and European Patent 
Application No. 07868382.8, filed October 5, 2007 (HHS Ref. No. E-227-
2006/5-EP-05), all of which are entitled ``Prevention of Tissue 
Ischemia, Related Methods and Compositions'', developed by Dr. David 
Roberts (NCI), Dr. Jeffrey Isenberg, and Dr. William Frazier. The 
patent rights in these inventions have been assigned to the United 
States of America. The prospective exclusive license territory may be 
``worldwide'', and the field of use may be limited to: (1) ``The use of 
antibodies including humanized antibodies reacting with CD47 or related 
antigens, precursors, or molecules, and isolated and/or recombinant 
fragments, and conjugates

[[Page 34767]]

with an affinity for CD47 for the preservation or resuscitation of 
organs and tissues for transplantation''; (2) ``the use of antibodies 
including humanized antibodies reacting with CD47 or related antigens, 
precursors, or molecules, and isolated and/or recombinant fragments, 
and conjugates with an affinity for CD47 for treating or preventing 
vascular diseases, including but not limited to, pulmonary 
hypertension, sickle cell disease, myocardial infarction, stroke, and 
tissue ischemia resulting from trauma and surgical procedures''; (3) 
``the use of antisense oligonucleotides or RNA formulations of 
stabilized composition to reduce expression of CD47 for treating wounds 
and/or burns and for use in reconstructive surgery''; and (4) ``use of 
small molecules antagonists of CD47 for treating or preventing vascular 
diseases including, but not limited to, thrombosis, hypertension, 
peripheral artery disease, renal artery disease, and ischemia resulting 
from atherosclerosis'' to Vasculox, Inc., having an office in at least 
St. Louis, Missouri, U.S.A. The patent rights in these inventions have 
been assigned to the United States of America.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
September 15, 2009 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Charlene A. Sydnor, Ph.D., Licensing and 
Patenting Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-4689; Facsimile: (301) 402-0220; E-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Nitric Oxide (NO) plays an important role as 
a major intrinsic vasodilator, and increases blood flow to tissues and 
organs. Disruption of this process leads to peripheral vascular 
disease, ischemic heart disease, stroke, diabetes and many more 
significant diseases. The inventors have discovered that the matrix 
protein thrombospondin1 (TSP1) blocks the beneficial effects of NO, and 
prevents it from dilating blood vessels and increasing blood flow to 
organs and tissues. Additionally, they discovered that this regulation 
requires TSP1 interaction with its cell receptor, CD47. Relief of this 
inhibition in genetically altered mice lacking either TSP1 or CD47 
results in dramatically improved blood flow and increased tissue 
oxygenation. Further, by using reagents such as monoclonal antibodies 
and peptides that block TSP1-CD47 interaction, or agents such as 
antisense oligonucleotides or morpholinos that reduce the level of CD47 
or TSP1, blood flow can dramatically increase to ischemic tissues in 
vivo. Inhibition of TSP1 signaling at the level of CD47 expression and/
or activation significantly improves the survival of tissue in an 
ischemic environment.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 
404.7. The prospective exclusive license may be granted unless within 
sixty (60) days from the date of this published notice, the 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 404.7.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated exclusive license. Comments and objections submitted 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 10, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-17038 Filed 7-16-09; 8:45 am]
BILLING CODE 4140-01-P