71 FR 156 pgs. 46487-46489 - Government-Owned Inventions; Availability for Licensing

Type: NOTICEVolume: 71Number: 156Pages: 46487 - 46489
FR document: [FR Doc. 06-6872 Filed 8-11-06 8:45 am]
Agency: Health and Human Services Department
Sub Agency: National Institutes of Health
Official PDF Version:  PDF Version

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.

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 B 0 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 B 0 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 B 0 as a function of chest motion is recorded in a phase map. Similarly, changes in B 0 as a function of current intensity is available from calibration data containing B 0 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 B 0 homogeneity. The shim values can be updated every 10 to 80 milliseconds 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; clingmac@mail.nih.gov

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 lubetm@mail.nih.gov 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; shmilovm@mail.nih.gov

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; thalhamc@mail.nih.gov.

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.

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; clingmac@mail.nih.gov.

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; boodenm@mail.nih.gov.

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