Notice (A): Government-Owned Inventions; Availability for Licensing

Federal Register: March 5, 2008 (Volume 73, Number 44)           
                  Page 11930-11932

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

ACTION: Notice.

SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

PSM Peptides as Vaccine Targets Against Methicillin-Resistant

Staphylococcus aureus

    Description of Technology: Available for licensing and commercial 
development are compositions and methods for the treatment and 
inhibition of Methicillin-resistant Staphylococcus aureus (MRSA), a 
dangerous human pathogen. The invention concerns immunogenic peptides 
that can be used to induce protective immunity against MRSA, including 
phenol-soluble modulin (PSM) peptides.
    In addition to the MRSA infections that occur in immunocompromised 
patients in hospitals, new MRSA strains have recently emerged that can 
cause severe infections (such as necrotizing fasciitis) or death in 
otherwise healthy adults. These strains are increasingly involved in 
community-associated (CA)-MRSA infections, and can be contracted 
outside of the health care settings. The incidence of CA-MRSA 
infections is increasing and the majority of infections in patients 
reporting to emergency departments in the U.S. is now due to CA-MRSA.
    The invention describes a class of secreted staphylococcal peptides 
with an extraordinary ability to recruit, activate, and subsequently 
lyse human neutrophils, thus eliminating the main cellular defense 
against S. aureus infection. The peptides are encoded by the PSM gene 
cluster and include PSM[alpha]1, PSM[alpha]2, PSM[alpha]3, and 
PSM[alpha]4, all of which activate and subsequently lyse neutrophils. 
These peptides are produced at especially high levels in CA-MRSA and to 
a large extent determine their aggressive behavior and ability to cause 
disease in animal models of infection. Thus, the peptides represent a 
set of virulence factors of S. aureus that account for the enhanced 
virulence of CA-MRSA. The identification of these peptides enables the 
production of vaccines and other preventative and/or therapeutic agents 
for use in subjects infected with MRSA.
    Applications: Development of new classes of antibiotics and 
vaccines against Methicillin-resistant Staphylococcus aureus 
infections.
    Inventors: Michael Otto and Rong Wang (NIAID).
    Publication: R Wang et al. Identification of novel cytolytic 
peptides as key virulence determinants for community-associated MRSA. 
Nat Med. 2007. Dec;13(12):1510-1514.
    Patent Status: U.S. Provisional Application No. 60/933,573 filed 06 
Jun 2007 (HHS Reference No. E-239-2007/0-US-01); U.S. Provisional 
Application

[[Page 11931]]

No. 60/983,141 filed 26 Oct 2007 (HHS Reference No. E-239-2007/1-US-
01).
    Development Status: Early stage.
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Cristina Thalhammer-Reyero, PhD., M.B.A.; 301-
435-4507; thalhamc@mail.nih.gov.
    Collaborative Research Opportunity: The NIAID Laboratory of Human 
Bacterial Pathogenesis is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize this technology. Please contact William 
Ronnenberg at 301-451-3522 or wronnenberg@mail.nih.gov for more 
information.

Active MRI Compatible and Visible iMRI Catheter

    Description of Technology: MRI is a promising imaging modality that 
provides superior soft tissue contrast and multi planar real-time 
imaging without harmful ionizing radiation for therapeutic procedures. 
Interventional magnetic resonance imaging (iMRI) has gained important 
popularity in many fields such as interventional cardiology and 
radiology, owing to the development of minimally invasive techniques 
and visible catheters under MRI for conducting MRI-guided procedures 
and therapies. This invention relates to a novel MRI compatible and 
active visible catheter for conducting interventional and 
intraoperative procedures under the guidance of MRI. The catheter 
features a non conductive transmission line and the use of ultrasonic 
transducers that transform RF signals to ultrasonic signals for 
transmitting RF signal to the MRI scanner. The unique design of this 
catheter overcomes the concern of patient/sample heating (due to the 
coupling between RF transmission energy and long conductors within 
catheter) associated with the design of conventional active MRI 
catheters.
    Inventor: Ozgur Kocaturk (NHLBI).
    Patent Status: U.S. Provisional Application No. 60/716,503 filed 14 
Sep 2005 (HHS Reference No. E-298-2005/0-US-01); PCT Application No. 
PCT/US2006/035636 filed 13 Sep 2006, which published as WO 2007/033240 
on 22 Mar 2007 (HHS Reference No. E-298-2005/0-PCT-02).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Michael Shmilovich, Esq.; 301/435-5019; 
shmilovm@mail.nih.gov.
    Collaborative Research Opportunity: The National Heart, Lung, and 
Blood Institute, Cardiac Catheterization Lab is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize the alternative 
Active MRI compatible and visible catheters using ultrasonic 
technology. Please contact Peg Koelble at koelblep@nhlbi.nih.gov for 
more information.

Immunoglobulins With Potent and Broad Antiviral (HIV) Activity Based on 
scFv Joined by Flexible Linker to Fc

    Description of Technology: This invention describes methods of 
inhibiting viral infection (e.g., HIV-1 infection). The method 
comprises administering a fusion protein comprising a small size, 
single chain Fv (scFv) antibody binding domain joined to an Fc region 
by a long flexible linker. In particular, scFv m6 or m9, the single 
chain variable fragments that were previously identified from a phage 
display library for binding to gp14089.6, 
gp120JRFL, gp140IIIB, and their complex with two-
domain soluble CD4 is joined to Fc by a long flexible linker to provide 
a new agent for the inhibition of HIV infection or immunotherapy of 
HIV-infected individuals. The Fc region provides stability, long half-
life, and biological effector functions. The scFv-Fc fragment provides 
antigen recognition and neutralizing activity. The small size of the 
scFv-Fc fusion molecule provides easy access to conserved viral 
epitopes exposed before or during viral entry. In addition, these 
fusion molecules exhibit neutralization activity that is higher than 
that of whole IgGs. Thus, this invention may offer a novel approach to 
treat and prevent HIV-1 infection and/or AIDS.
    Inventors: Dimiter Dimitrov (NCI) and Mei-Yun Zhang (NCI/SAIC).
    Patent Status: U.S. Patent Application No. 10/573,962 filed 29 Mar 
2006, claiming priority to 29 Sep 2003 (HHS Reference No. E-316-2003/0-
US-03).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Sally Hu; 301/435-5606; hus@mail.nih.gov.

Modulators of Nuclear Hormone Receptor Activity: Novel Compounds, 
Diverse Applications for Infectious Diseases, Including Anthrax (B. 
anthracis)

    Description of Technology: Nuclear hormones such as glucocorticoids 
dampen inflammatory responses, and thus provide protection to mammals 
against inflammatory disease and septic shock. The Anthrax lethal 
factor represses nuclear hormone receptor activity, and thus may 
contribute to the infectious agent causing even more damage to the 
host. This observation can be exploited to find new means of studying 
and interfering with the normal function of nuclear hormone receptors. 
Scientists at NIH have shown that under the appropriate conditions, 
these molecules can be used to modulate the activity of various nuclear 
hormone receptors. Identifying useful agents that modify these 
important receptors can provide relief in several human disorders such 
as inflammation, autoimmune disorders, arthritis, malignancies, shock 
and hypertension.
    Applications: This invention provides novel agents that can 
interfere with the action of nuclear hormone receptors. It is well 
known that malfunction or overdrive of these receptors can lead to a 
number of diseases such as enhanced inflammation; worse sequelae of 
infection including shock; diabetes; hypertension and steroid 
resistance. Hence a means of controlling or fine-tuning the activity of 
these receptors can be of great benefit. Current means of affecting 
steroid receptor activity are accompanied by undesirable side-effects. 
Since the conditions for which these treatments are sought tend to be 
chronic, there is a critical need for safer drugs that will have 
manageable side-effects.
    Advantages: The observation that the lethal factor from Anthrax has 
a striking effect on the activity of nuclear hormone receptors opens up 
new routes to controlling their activity. The means of action of this 
repressor is sufficiently different from known modulators of hormone 
receptors (i.e., the classical antagonists). For instance, the 
repression of receptor activity is non-competitive, and does not affect 
hormone binding or DNA binding. Also, the efficacy of nuclear hormone 
receptor repression by Anthrax lethal factor is sufficiently high that 
the pharmacological effect of this molecule is seen at vanishingly 
small concentrations. Taken together, these attributes may satisfy some 
of the golden rules of drug development such as the uniqueness or 
novelty of the agent's structure, a low threshold for activity, high 
level of sophistication and knowledge in the field of enquiry, and the 
leeway to further refine the molecule by rational means.
    Development Status: In vitro studies have been completed, and a 
limited number of animal studies have been carried out.
    Inventors: Esther M. Sternberg (NIMH), Jeanette Webster (NIMH), 
Leonardo H. Tonelli (NIMH), Stephen H. Leppla (NIAID), Mahtab Moayeri 
(NIAID).
    Patent Status: U.S. Patent Application No. 10/530,254 filed 04 Apr 
2005,

[[Page 11932]]

claiming priority to 04 Oct 2002 (HHS Reference No. E-247-2002/1-US-
02).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Peter Soukas; 301/435-4646; 
soukasp@mail.nih.gov.

    Dated: February 27, 2008.
Bonny Harbinger,
Deputy Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. E8-4187 Filed 3-4-08; 8:45 am]

BILLING CODE 4140-01-P