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

Federal Register: Volume 76, Number 172 (Tuesday, September 6, 2011)
                  Pages 55070-55071

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.

Vaccine To Prevent BK Polyomavirus-associated Kidney and Bladder 
Infections in Organ Transplant Recipients

    Description of Technology: Nearly all adults have chronic urinary 
tract infections with one or more strains of BK polyomavirus (BKV). In 
healthy persons, the infection is controlled by the immune system and 
no symptoms are apparent. However, immunosuppressed persons, such as 
organ transplant recipients, can suffer from bladder disease or kidney 
disease caused by uncontrolled BKV growth. BKV causes cancer in 
animals; it is unknown if the same is true in humans. A significant 
need remains for a means of preventing BKV infection and associated 
pathologies.
    Researchers at the National Cancer Institute, NIH, have developed 
compositions and therapeutic methods for pre-vaccination of organ 
transplant recipients against BKV and prognostic methods to identify 
patients that may benefit from the vaccination. Methods for producing a 
BKV vaccine against all four known BKV serotypes are in development.
    Potential Commercial Applications:
     An effective multivalent BKV vaccine to prevent BKV-
associated pathologies of the urinary tract and bladder.
     A prognostic kit to determine clinical benefit.
     Tests for identifying renal transplant donors and 
recipients.
    Competitive Advantages:
     A successful proof-of-principle study in mice has been 
conducted.
     The inventors have identified the major virulent BKV 
serotype.
     No vaccine for BKV infection currently exists.
     If BKV is linked to cancer, the technology might be 
relevant to vaccines applicable to the general public.
    Development Stage:
     Early-stage.
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Christopher Buck and Diana Pastrana (NCI).
    Publication: In preparation.
    Intellectual Property: HHS Reference No. E-168-2011/0--U.S. Patent 
Application No. 61/508,897 filed 18 July 2011.
    Licensing Contact: Patrick McCue, PhD; 301-435-5560; 
mccuepat@mail.nih.gov.
    Collaborative Research Opportunity: The NCI Center for Cancer 
Research, Laboratory of Cellular Oncology, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize this technology. 
For collaboration opportunities, please contact John Hewes, PhD at 
hewesj@mail.nih.gov.

Gas Permeable Flasks To Grow Tumor Infiltrating Lymphocytes (TIL) for 
More Effective Anti-Cancer Immunotherapy

    Description of Technology: Scientists at NIH have developed a 
strategy to obtain large quantities of highly reactive tumor 
infiltrating lymphocytes (TIL) from patient tumor samples for anti-
cancer immunotherapy by making use of gas permeable (GP) flasks. This 
advancement in personalized anti-cancer immunotherapy involves 
culturing a tumor sample in a series of GP containers to isolate and 
rapidly expand TIL. The process provides suitable quantities of TIL for 
adoptive transfer into the cancer patient more reliably than previous 
approaches.
    Culturing and growing TIL in the GP containers permits efficient 
gas exchange between TIL cells and the air to promote optimal 
respiration, growth, and viability of the patient's TIL throughout the 
process. Using GP flasks in the TIL expansion process provides for 
better circulation of the growth media and larger surface area so more 
TIL can grow per unit volume. Therefore, less reagents and fewer 
numbers of culture containers are need to generate the required number 
of TIL for adoptive immunotherapy protocols to treat cancer patients. 
NIH researchers have demonstrated the advantages of this GP TIL growth 
process in comparison to their more established TIL expansion protocols 
using human patient tumor samples. This new TIL production method 
should enable TIL therapy to become more GMP compliant and allow it to 
become more standardized for widespread utilization as a cancer 
treatment option outside of NIH.
    Potential Commercial Applications:
     Adoptive cell transfer therapy (immunotherapy) for a 
variety of human cancers.
     Growing TIL in gas permeable cultureware has the potential 
to become the new standard for obtaining suitable quantities of TIL for 
use in adoptive immunotherapy.
     GMP grade TIL manufacture process to allow for regulatory 
approval of TIL therapy so that it can become a more widely available 
personalized cancer treatment option.
    Competitive Advantages:
     Simpler, faster, less laborious, less reagent intensive, 
and less equipment intensive TIL growth process compared to methods of 
obtaining TIL without gas permeable cultureware.
     Reduces risks of microbial contamination versus comparable 
methodologies.
     More GMP-compliant than other TIL growing processes.
     Capable of producing larger quantities of TIL more 
reliably than other TIL methodologies.
     Potential to expand the number of patients and types of 
cancers treatable by TIL.
    Development Stage:
     Pre-clinical.
     In vitro data available.
     In vivo data available (human).

[[Page 55071]]

    Inventors: Steven A. Rosenberg (NCI), Mark E. Dudley (NCI), Robert 
P. Somerville (NCI), Jianjian Jin (CC), Marianna V. Sabatino (CC), 
David F. Stroncek (CC).
    Intellectual Property: HHS Reference No. E-114-2011/0--U.S. Patent 
Application No. 61/466,200 filed 22 March 2011.
    Related Technologies:
     HHS Reference No. E-275-2002/1--U.S. Patent Application 
No. 10/526,697 filed 5 May 2005 (and foreign counterparts).
     HHS Reference No. E-273-2009/0--U.S. Patent Application 
No. 12/869,390 filed 26 August 2010.
    Licensing Contact: Samuel E. Bish, PhD; 301-435-5282; 
bishse@mail.nih.gov.
    Collaborative Research Opportunity: The National Cancer Institute 
Surgery Branch is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize gas permeable flasks for cell and gene 
therapy applications and multicenter clinical trials. For collaboration 
opportunities, please contact John Hewes, PhD, at hewesj@mail.nih.gov.

A Novel Optomechanical Module that Enables a Conventional inverted 
Microscope To Provide Selective Plane Illumination Microscopy (iSPIM)

    Description of Technology: The invention describes an 
optomechanical module that, when engaged with a conventional inverted 
microscope, provides selective plane illumination microscopy (iSPIM). 
The module is coupled to the translational base of the microscope 
whereby a SPIM excitation objective is engaged to one portion of the 
mount body, and a SPIM detection objective (having a longitudinal axis 
perpendicular to that of the excitation objective) is engaged to 
another portion of the mount body. Such a system offers the advantages 
of SPIM (optically sectioned, high-speed volumetric interrogation of 
living samples, enabling, for example, the study of developmental or 
neuronal dynamics at high frame rates), while maintaining the 
flexibility and sample geometry of commercially available inverted 
microscopes (thus additionally allowing wide-field, TIRF, confocal, or 
2 photon imaging of samples).
    Potential Commercial Applications: The microscope can be used for:
     Imaging of live whole animals (e.g. worms) (demonstrated 
already).
     Superresolution (photoactivated localization microscopy) 
with minimal bleaching of dye molecules.
     High speed investigation of neuronal dynamics at high 
frame rates.
    Competitive Advantages:
     The system offers the advantages of SPIM, while 
maintaining the flexibility and sample geometry of commercially 
available inverted microscopes.
     In this system the sample can be easily mounted on a 
rectangular coverslip and may be translated using an automated 3D 
mechanical stage and additionally imaged using the conventional light 
path built into the inverted microscope frame.
    Development Stage:
     Prototype.
     In vivo data available (animal).
    Inventors: Hari Shroff (NIBIB) et al.
    Publication: A publication is under review at PNAS.
    Intellectual Property: HHS Reference No. E-078-2011/0--U.S. 
Provisional Patent Application No. 61/449,422 filed 04 Mar 2011.
    Licensing Contact: Michael Shmilovich, Esq.; 301-435-5019; 
shmilovm@mail.nih.gov.
    Collaborative Research Opportunity: The NIBIB is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize applications of 
the invention. For collaboration opportunities, please contact Hari 
Shroff at 301-435-1995 or hari.shroff@nih.gov.

A Vaccine for Shigella sonnei for Both Children and Adults

    Description of Technology: There is currently no vaccine widely 
available for shigellosis, which affects over 150 million people 
worldwide and causes over 1 million deaths a year, mostly children. The 
present invention discloses a novel immunogen to be used in a vaccine 
for both children and adults. The immunogen, a low-molecular mass O-SP-
core fragment, generates high antibody responses in animal studies, 
which means reduced number of vaccinations. The immunogen is easy to 
isolate for ease of manufacturing. Additionally, the methods of 
manufacturing vaccines and protocols of preventing and/or treating 
Shigellosis had been carried out in the present invention.
    Potential Commercial Applications: Shigella sonnei vaccines and 
diagnostics.
    Competitive Advantages:
     Vaccine can be used in both children and adults.
     Doses of vaccine are reduced.
     Immunogen is easy to isolate for easy vaccine production.
    Development Stage:
     Prototype.
     Pilot.
     Early-stage.
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: John B. Robbins, Rachel Schneerson, Joanna Kubler-Kielb, 
Christopher P. Mocca (NICHD).
    Publications:
    1. Robbins JB, et al. Synthesis, characterization, and 
immunogenicity in mice of Shigella sonnei O-specific oligosaccharide-
core-protein conjugates. Proc Natl Acad Sci U S A. 2009 May 
12;106(19):7974-7978. [PMID 19346477]
    2. Kubler-Kielb J, et al. The elucidation of the structure of the 
core part of the LPS from Plesiomonas shigelloides serotype O17 
expressing O-polysaccharide chain identical to the Shigella sonnei O-
chain. Carbohydr Res. 2008 Dec 8;343(18):3123-3127. [PMID 18954864].
    Intellectual Property: HHS Reference No. E-308-2008/0--
     PCT Application No. PCT/US2009/053897 filed 14 Aug 2009.
     U.S. Application No. 13/059,051 filed 14 Feb 2011.
    Licensing Contact: Susan Ano, PhD; 301-435-5515; anos@mail.nih.gov.

    Dated: August 29, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-22693 Filed 9-2-11; 8:45 am]
BILLING CODE 4140-01-P