[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13352-13354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04443]


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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.

FOR FURTHER INFORMATION CONTACT: 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.

Java Software for Investigational Drug Clinical Research

    Description of Technology: A Java based software application 
available for academic use and on a royalty-bearing basis for 
commercial licensing. The Investigational Drug Management System (IDMS) 
supports the operational needs of the investigation drug section of a 
pharmacy providing inventory management functions which fulfill the 
recordkeeping requirements defined in the Code of Federal Regulations 
related to the storage, labeling, handling, and dispensing of 
investigational drugs. The internet/browser based application 
interfaces with the Computerized Provider Order Entry (CPOE) system for

[[Page 13353]]

tracking patients and prescriptions for investigational drugs. The IDMS 
supports the prescription filling process by capturing real-time data 
during the dispensing activity where automated safety checks are 
performed, ensuring the ``five rights'' of medication use are 
satisfied. The system supports randomized double-blind clinical trials 
by generating complex, multi-tiered randomization schemes that produce 
patient-specific treatment assignments along with industry standard 
labels containing barcodes. IDMS serves as the book of record providing 
end-to-end traceability for the receipt of raw materials from their 
source to the dispensing of finished pharmaceutical dosage forms to 
patients.
    Potential Commercial Applications:

 Clinical data management
 Clinical Trials
 Investigational new drug trials

    Competitive Advantages:

 Web based
 User friendly
 Data portability
 Randomization tables

    Development Stage:

 Prototype
 Clinical

    Inventors: Richard O. DeCederfelt, George J. Grimes, Stephen M. 
Bergstrom, Jon W. McKeeby (all of NIH-CC).
    Intellectual Property: HHS Reference No. E-063-2013/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Michael Shmilovich; 301-435-5019; 
[email protected].

Software To Improve the Quality of Microscopy Images

    Description of Technology: Available for licensing and commercial 
use is software based on an iterative deconvolution procedure that 
recovers images that have been blurred by a known point spread 
function. The software provides superior results when multiple 
independent observations of the same specimen are obtained. An example 
of such observations might be the multiple views of a specimen 
collected by a selective illumination plane microscope (SPIM). By using 
the blurring function and observations (raw images) corresponding to 
each view in sequential order through the iteration loop, the resulting 
output contains higher resolution, contrast, and signal than would 
result if any single observation alone was used, or if the output from 
single deconvolution operations on each image are combined, e.g. by 
averaging. In its current form, the software has been tested on the 
Richardson-Lucy deconvolution (RLD) procedure. Preliminary data 
indicate that the algorithm provides an isotropic resolution of 350 nm, 
greatly improving the raw data (lateral resolution 0.5 microns, axial 
resolution 1.5 microns) on nematode embryos. In vivo data illustrating 
the power of the algorithm are available upon request.
    Potential Commercial Applications:

 Image Resolution
 Sub-micron microscopy

    Competitive Advantages:

 Enables isotopic resolution
 Iterative deconvolution algorithm that can readily be applied 
to SPIM datasets

    Development Stage:

 Prototype
 In vitro data available
 In vivo data available (animal)

    Inventors: Hari Shroff, Andrew York, Yicong Wu (all of NIBIB).
    Publications:

1. Swoger J, et al. Multi-view image fusion improves resolution in 
three-dimensional microscopy. Opt Express. 2007 Jun 25;15(13):8029-
42. [PMID 19547131]
2. Verveer PJ, et al. High-resolution three-dimensional imaging of 
large specimens with light sheet-based microscopy. Nat Methods. 2007 
Apr;4(4):311-3. [PMID 17339847]

    Intellectual Property: HHS Reference No. E-062-2013/0--Software 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Michael Shmilovich; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The NIBIB Section on High 
Resolution Optical Imaging is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize our algorithm, especially with 
respect to multiview microscopes. For collaboration opportunities, 
please contact Hari Shroff at [email protected].

Background-Free Fluorescent Nanodiamond Imaging

    Description of Technology: Available for licensing and commercial 
development are intellectual property rights covering a method of 
imaging a biological specimen (e.g., human tissue) using fluorescent 
nanodiamonds implanted into the subject of interest, applying a 
magnetic field to said subject and producing a resultant image by a net 
juxtaposition of a second acquired image. This process suppresses the 
background and permits selective imaging of the nanodiamonds in the 
presence of background fluorescence that exceeds the signal from the 
nanodiamonds. Another aspect of the invention provides an imaging 
method in which the resulting image is acquired by applying time-
varying magnetic fields using one or more secondary image averaged 
against the first. The technique relies on imposing a small (~100 
Gauss) magnetic field on the sample of interest during optical imaging 
combined with post-processing of the acquired images to remove the 
background. This technology can readily be added onto any commercial 
optical imaging platform to achieve background-free images of the 
nanodiamonds in a biological specimen.
    Potential Commercial Applications:
 In vitro and in vivo optical imaging and diagnostics
 MRI imaging

    Competitive Advantages:

 Improved resolution through composite imagery
 Background elimination
 Indefinite tracking due to the exceptional stability of the 
fluorescent nanodiamonds
 Wide excitation band (~500-600 nm)
 Broad-band Near IR emission (600-700 nm)
 Nanodiamonds are stable in aqueous solution
 In related technologies we have developed a method to 
specifically coat and functionalize nanodiamonds for targeting and 
labeling applications

    Development Stage:

 Prototype
 In vitro data available
 In vivo data available (animal)

    Inventors: Susanta Sarkar, Ambika Bumb, Keir Neuman (all of NHLBI).
    Intellectual Property: HHS Reference No. E-261-2012/0--US 
Provisional Application No. 61/711,702 filed 09 Oct 2012.
    Related Technology: HHS Reference No. E-175-2012/0--US Provisional 
Application No. 61/672,996 filed 18 Jul 2012, ``Method of Preparing 
Silica-coated Nanodiamonds.''
    Licensing Contact: Michael Shmilovich; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The NHLBI Laboratory of Single 
Molecule Biophysics is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize background-free imaging of fluorescent 
nanodiamonds for in vivo and in vitro applications. For collaboration 
opportunities, please contact Keir C. Neuman, Ph.D. at 
[email protected] or 301-496-3376.

[[Page 13354]]

Silica-Coated Nanodiamonds for Imaging and the Delivery of Therapeutic 
Agents

    Description of Technology: NIH investigators invented a robust and 
easily implemented method of synthesizing silica-coated nanodiamonds 
for imaging and therapeutic applications. A patent estate covering 
these methods is offered for licensing to commercial entities. The 
method generally includes coating nanodiamonds with a silica precursor, 
e.g., tetraethylorthosilicate (TEOS), inside liposomes. The liposomes 
are then removed to yield a final product that is stable, monodisperse, 
and easy to functionalize.
    Potential Commercial Applications:
 Imaging
 Drug delivery

    Competitive Advantages:
 Small size
 Physiologically inert carrier
 Monodisperse
 Stable in aqueous solution
 Readily functionalized

    Development Stage: Prototype.
    Inventors: Ambika Bumb (NHLBI), Susanta Kumar Sarkar (NHLBI), Keir 
Neuman (NHLBI), Martin Brechbiel (NCI).

    Publications:

1. Yu SJ, et al. Bright fluorescent nanodiamonds: no photobleaching 
and low cytotoxicity. J Am Chem Soc. 2005 Dec 21;127(50):17604-5. 
[PMID 16351080]
2. Wilson RM. Nanodiamonds are promising quantum probes of living 
cells. Phys Today 2011 Aug;64(8):17. [doi 10.1063/PT.3.1204]
3. Chow EK, et al. Nanodiamond therapeutic delivery agents mediate 
enhanced chemoresistant tumor treatment. Sci Transl Med. 2011 Mar 
9;3(73):73ra21. [PMID 21389265]
4. Krueger A. New carbon materials: biological applications of 
functionalized nanodiamond materials. Chemistry 2008;14(5):1382-90. 
[PMID 18033700]

    Intellectual Property: HHS Reference No. E-175-2012/0--US 
Provisional Application No. 61/672,996 filed 18 Jul 2012.
    Related Technology: HHS Reference No. E-261-2012/0--US Provisional 
Application No. 61/711,702 filed 09 Oct 2012, ``Imaging Methods and 
Computer-Readable Media for Background-Free imaging of Fluorescent 
Nanodiamonds.''
    Licensing Contact: Michael Shmilovich; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The NHLBI Laboratory of Single 
Molecule Biophysics is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate or commercialize fluorescent nanodiamonds for use as in vivo 
and in vitro optical tracking probes. For collaboration opportunities, 
please contact Keir C. Neuman, Ph.D. at [email protected] or 301-
496-3376.

     Dated February 20, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-04443 Filed 2-26-13; 8:45 am]
BILLING CODE 4140-01-P