[Federal Register Volume 71, Number 156 (Monday, August 14, 2006)]
[Notices]
[Pages 46487-46489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-6872]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

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

ACTION: Notice.

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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.

Real-Time Correction of Magnetic Field Fluctuations in MIR

    Description of Technology: Available for licensing is a new MRI 
technique that will markedly improve the diagnostic potential of the 
rendered images. This is a method for applying real-time corrections to 
prevent image distortions caused by field variations that are due to 
the patient's respiratory cycle or instrument instability. These field 
variations reduce the B0 homogeneity in a non-uniform and 
spatially-dependent manner. They may lead to a variety of image 
artifacts such as ghosting and blurring. This method provides a way of 
calculating the correct electrical currents that must be applied to a 
set of gradients and shims, smaller magnets that are used to make fine-
tune adjustments to the magnetic field in a spatially-dependent manner. 
As the MRI subject breathes, changes in the B0 field occur. 
During a brief training session, the amplitude of these changes as a 
function of chest motion is recorded in a phase map. Similarly, changes 
in B0 as a function of chest motion is recorded in a phase 
map. Similarly, changes in B0 as a function of current 
intensity is available from calibration data containing B0 
as a function of coil current. As the subject undergoes a scan, 
compensatory currents are applied to the x, y, or z axis of the 
gradients and the shims coils in order to correct for the effect of 
respiration on the B0 homogeneity. The shim values can be 
updated every 10 to 80 milliseconds

[[Page 46488]]

during an experiment. This method results in a substantial decrease in 
artifacts that can obscure the overall image quality. It can be used 
for virtually all types of scans and MRI instruments.
    Applications: (1) Real-time correction of magnetic fluctuations in 
MRI experiments; (2) Improved MRI image precision.
    Market: MRI manufacturers, hospitals, medical research centers, and 
universities.
    Development Status: The technology is ready to be used and requires 
no further testing or development.
    Inventors: Jozef H. Duyn (NINDS), Peter van Gelderen (NINDS), et 
al.
    Related Publication: P van Gelderen, JA de Zwart, P Starewicz, RS 
Hinks, JH Duyn. Real time shimming for compensation of respiration 
induced field changes. Proceedings ISMRM 2006, page 752.
    Patent Status: U.S. Provisional Application No. 60/781,246 filed 10 
Mar 2006 (HHS Reference No. E-085-2006/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Chekesha Clingman, Ph.D.; 301/435-5018; 
[email protected]
    Collaborative Research Opportunity: The National Institute of 
Neurological Disorders and Stroke is seeking statements of capability 
or interest from parties interested in collaorative research to further 
develop, evaluate, or commercialize this technology. Please contact 
Martha Lubet at 301/435-3120 or [email protected] for more 
information.

Microdialysis Probe for Musculoskeletal Tissue Stimulation and 
Biochemical Analysis

    Description of Technology: Available for licensing and commercial 
development is a microdialysis probe made from a small-bore (32 gauge) 
needle containing both a fluid delivery and recovery tube within the 
bore. A molecular exchange membrane is positioned about 200 microns 
from the tip. Fluid flows across the membrane removing diffused 
molecules to a collection device. The rounded tip of the needle is 
designed to cause minimal tissue damage while allowing investigations 
to be performed on local tissue fluids. Additionally, this device 
allows simultaneous delivery of small concentrations of drug to the 
area immediately surrounding the device tip. The device is actively 
used to study the pathophysiology of myofascial trigger points (MTrPs), 
a very common physical finding and cause of musculoskeletal pain and 
disability. The device allows for safe in situ exploration of 
myofascial pain biochemistry with minimal system perturbation.
    Applications: (1) Muscular stimulation; (2) Musculoskeletal pain; 
(3) Myofascial Trigger Points.
    Market: (1) Drug Discovery; (2) Pain management.
    Inventors: Jay Shah (NIHCC), Terence Martyn Phillips (ORS), Jerome 
V. Danoff (NIHCC), Lynn Gerber (NIHCC).
    Patent Status: U.S. Provisional Application No. 60/795,176 filed 27 
Apr 2006 (HHS Reference No. E-024-2006/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Michael A. Shmilovich, Esq.; 301/435-5019; 
[email protected]

Novel Infrared (IR)-Transparent Hydrophilic Membrane That Can be Used 
for Filtration, Printing or Microarrays, and Cultivation of Bacteria 
and Other Microorganisms for Reagent-Free IR Spectroscopic 
Identification

    Description of Technology: Available for licensing and commercial 
development is a novel, disposable infrared (IR)-transparent, 
microporous, plasma treated polyethylene hydrophilic membrane, as well 
as methods for making and using this membrane to identify bacterial and 
other micoorganism impurities in food using IR spectroscopy. Further 
applications include: filtering dilute aqueous bacterial suspensions, 
and growing bacterial colonies when the PE membrane is placed over an 
agar medium and incubated. The patent also describes a novel high-
throughout technique, as an alternative to manual filtration, where the 
PE membrane is used for microarray printing of intact microorganisms in 
pre-enriched medium on the treated PE substrate. Furthermore, the 
invention relates to a method of detecting mixtures of food-borne 
pathogens E. sakazakii and K. pneumonia, by using the treated PE 
membranes. Because this unique membrane is transparent to infrared 
light, isolated microcolonies of bacterial cells grown on this PE 
substrate can be fingerprinted directly by IR microspectroscopy, 
followed by multivariate analysis for the identification of the 
pathogens. The method can be applied to other cell types as well.
    This novel membrane and its applications offer an advantage over 
existing tests in that it can be used to rapidly identify presumptive 
pathogen colonies, and can be used in screening tests for a large 
number of pathogens, as well as various microorganisms and cell types. 
It can also be used to isolate microorganisms from aqueous suspensions 
as well as spores, including airborne ones.
    Inventors: Magdi M. Mossoba and Sufian Al-Khaldi (FDA).
    Patent Status: U.S. Patent Application No. 11/343,561 filed 30 Jan 
2006, entitled ``Hydrophilic IR transparent membrane, spectroscopic 
sample holder comprising same and methods of using same'' (HHS 
Reference No. E-174-2005/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contract: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301/
435-4507; [email protected].

Porcine Rotavirus Reassortant Compositions

    Description of Technology: Rotaviruses are the predominant cause of 
severe diarrhea and dehydration in infants and young children and are 
associated with approximately 600,000 deaths each year worldwide. 
Although death from rotavirus infection occurs more frequently in 
developing countries an estimated 55,000-70,000 hospitalizations and 20 
to 60 deaths occur yearly in the United States. Thus, accelerating the 
availability of a safe and effective rotavirus vaccine represents a 
global public health priority.
    Available for licensing and commercial development are newly 
developed human rotavirus-porcine rotavirus reassortant vaccine 
compositions and methodology for their use in humans. This technology 
provides immunogenic compositions of reassortant human-porcine 
rotaviruses with VP7 specificity of the most clinically prevalent 
serotypes of human rotavirus found in various regions of the world. 
These compositions, which need clinical evaluation, should be able to 
induce an immunogenic response specific to human rotavirus serotypes 
that is protective against symptoms of serious rotaviral disease, such 
as severe diarrhea and dehydration. Porcine rotaviruses are genetically 
more closely related to human rotavirus strains compared to rhesus and 
bovine rotaviruses.
    Applications: (1) Resistance to developing severe human rotaviral 
disease; (2) Safe and effective global infant vaccinations.
    Market: (1) Rotaviral infections result in approximately 600,000 
deaths yearly; (2) Anti-rotavirus technology has a projected market of 
more than 1.0 billion dollars by 2010.

[[Page 46489]]

    Development Status: Preclinical data is available at this time.
    Inventors: Yasutaka Hoshino and Albert Z. Kapikian (NIAID).
    Related Publications:
    1. Y Hoshino, RW Jones, J Ross, AZ Kapikian. Porcine rotavirus 
strain Gottfried-based human rotavirus candidate vaccines: construction 
and characterization. Vaccine 2005 May 31;23(29):3791-3799.
    2. M Gorziglia, K Nishikawa, Y Hoshino, K Taniguchi. Similarity of 
the outer capsid protein VP4 of the Gottfried strain of porcine 
rotavirus to that asymptomatic human rotavirus strains. J Virology, 
1990 Jan;64(1):414-418.
    Patent Status: U.S. Provisional Application No. 60/698,572 filed 11 
Jul 2005 (HHS Reference No. E-056-2005/0-US-01)
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Chekesha Clingman, Ph.D.; 301/435-5018; 
[email protected].

Adoptive T-Cell Transfer After Lymphodepletion Promotes Tumor 
Regression

    Description of Technology: Available for licensing is a method of 
adoptive cell transfer (ACT) immunotherapy. Since its first 
description, ACT is now being developed for the supportive treatment of 
a variety of infectious diseases and cancer.
    Current ACT methods to treat cancer are based on the ex vivo 
selection of lymphocytes with high avidity for recognition of tumor 
antigens, and their activation and numerical expansion before re-
infusion to the autologous tumor-bearing host. The current invention 
improves ACT by including a pre-treatment regimen to ensure permissive 
conditions in the host for in vivo proliferation of the transferred 
cells. Specifically, the immune system is suppressed by pre-treatment 
with lymphodepleting chemotherapy. Two separate clinical trials have 
demonstrated that using this approach, ACT can induce lasting tumor 
shrinkage.
    Lymphodepleting chemotherapy followed by ACT resulted in tumor 
shrinkage of at least 50 percent in 6 out of 13 treated patients 
suffering from refractory melanoma. Several patients remained cancer 
free for more than a year after treatment. The usefulness of combined 
ACT and lymphodepleting therapy for cancer treatment was confirmed when 
this study was extended to include 35 melanoma patients. Eighteen of 
the 35 patients (51%) responded to the treatment, including 3 patients 
who experienced ongoing complete disappearance of cancer and 15 
patients had tumor shrinkage of at least 50 percent with a mean 
duration of almost a year after treatment. In a recent clinical trial 
that is not yet published, using a modified protocol to treat 23 
patients, a similar response rate (56%) was seen.
    This approach to ACT offers a potentially significant improvement 
in the treatment of many types of cancer. In addition, this method 
might be applicable in treating other diseases such as AIDS, 
immunodeficiency, or other autoimmunity for which immune effector cells 
can impact the clinical outcome.
    Inventors: Mark E. Dudley, Steven A. Rosenberg, John R. Wunderlich 
(NC).
    Publications:
    1. Dudley ME, et al. ``Adoptive cell transfer therapy following 
non-myeloablative but lymphodepleting chemotherapy for the treatment of 
patients with refractory metastatic melanoma.'' J Clin Oncol. 2005 Apr 
1;23(10):2346-2357.
    2. Dudley ME, et al. ``Cancer regression and autoimmunity in 
patients after clonal repopulation with antitumor lymphocytes.'' 
Science. 2002 Oct 25;298(5594):850-854.
    Patent Status: U.S. Provisional Application No. 60/408,681 filed 06 
Sep 2002 (HHS Reference No. E-275-2002/0-US-01); PCT Application No. 
PC/US03/27873 filed 05 Sep 2003, which published as WO 2004/021995 on 
18 Mar 2004 (HHS Reference No. E-275-2002/1-PCT-01); U.S. Patent 
Application No. 10/526,697 filed 05 May 2005 (HHS Reference No. E-275-
2002/1-US-02).
    Licensing Status: Available for exclusive and non-exclusive 
licensing.
    Licensing Contact: Michelle A. Booden, Ph.D.; 301/451-7337; 
[email protected].
    Collaborative Research Opportunity: The NCI Surgery Branch is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
ACT therapy. Please contact Steven A. Rosenberg, M.D., Ph.D. at 301/
496-4164 for more information.

    Dated: July 28, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 06-6872 Filed 8-11-06 8:45 am]
BILLING CODE 4140-01-M