[Federal Register Volume 67, Number 144 (Friday, July 26, 2002)]
[Notices]
[Pages 48928-48929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18944]


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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, DHHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by agencies 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.

Suppressing Unencoded MRI Signal Contribution in Multi-Phase 
Myocardial Tagging and Phase-Contrast Based Methods

Anthony H. Aletras (NHLBI)
DHHS Reference No. E-079-02/0
Licensing Contact: Dale Berkley; 301/496-7735 ext. 223; e-mail: 
[email protected].

    The invention is a method for obtaining clear functional magnetic 
resonance (MR) cardiac images without significantly increasing signal 
acquisition time. During functional magnetic resonance imaging (MRI) 
the specimen magnetization is spatially encoded by application of one 
or more radio frequency pulses (RF) and gradient magnetic fields. This 
spatially encoded magnetization is then read out to produce images that 
can be used to assess specimen motion. During this process the contrast 
decreases from the beginning of the cardiac cycle as the magnetization 
decays or relaxes, making the images more difficult to process and 
interpret over time. This is currently solved by acquiring the images 
twice (with a modified signal excitation phase) to suppress unwanted 
unencoded MRI signal contributions; therefore improving the contrast. 
Unfortunately, this prolongs the acquisition by a factor of two. In the 
invention, an RF inversion pulse is used to suppress the undesirable 
unencoded MRI signal contributions, thereby improving the contrast. 
This RF frequency drives the undesired signal to an equilibrium around 
zero, while preserving the desired encoded signal. The application of 
the RF inversion pulse doubles the resolution of the image and does not 
increase acquisition time. It allows for immediate evaluation of 
myocardial contractility throughout the whole cardiac cycle without 
requiring user intervention during phase-based data processing. There 
is also the possibility that this method could be used in other areas 
of the body, including the spinal cord, and the invention may be 
applicable to the study of brain motion. This new method speeds up the 
quantification of datasets, suppresses undesired signal contributions, 
and doubles the resolution of the images without doubling acquisition 
time.

ELISA Assay of Serum Soluble CD22 to Assess Tumor Burden/Relapse in 
Subjects with Leukemia and Lymphoma

Robert Kreitman et al. (NCI)
DHHS Reference No. E-065-02/0 filed May 20, 2002
Licensing Contact: Richard Rodriguez; 301/496-7056 ext. 287; e-mail: 
[email protected].

    Disclosed are methods of using previously unknown soluble forms of 
CD22 (sCD22) present in the serum of subjects with B-cell leukemias and 
lymphomas to assess tumor burden in the subjects. Also disclosed are 
methods of diagnosing or prognosing development or progression of a B-
cell lymphoma or leukemia in a subject, including detecting sCD22 in a 
body fluid sample taken or derived from the subject, for instance 
serum. In some embodiments, soluble CD22 levels are quantified. By way 
of example, the B-cell lymphoma or leukemia can be hairy cell leukemia, 
chronic lymphocytic leukemia, or non-Hodgkin's lymphoma. Soluble CD22 
in some embodiments is detected by a specific binding agent, and 
optionally, the specific binding agent can be detectably labeled.
    Also disclosed are methods of selecting a B-cell lymphoma or 
leukemia therapy that include detecting an increase or decrease in 
sCD22 levels in a subject compared to a control, and, if such increase 
or decrease is identified, selecting a treatment to prevent or reduce 
B-cell lymphoma or leukemia or to delay the onset of B-cell lymphoma or 
leukemia.
    Other embodiments are kits for measuring a soluble CD22 level, 
which kits include a specific binding molecule that selectively binds 
to the CD22, e.g. an antibody or antibody fragment that selectively 
binds CD22.
    Further disclosed methods are methods for screening for a compound 
useful in treating, reducing, or preventing B-cell lymphomas or 
leukemias, or development or progression of B-cell lymphomas or 
leukemias, which methods include determining if application of a test 
compound lowers soluble CD22 levels in a subject, and selecting a 
compound that so lowers sCD22 levels.

Mutated Anti-CD22 Antibodies with Increased Affinity to CD22-
Expressing Leukemia Cells

Ira Pastan et al. (NCI)
HHS Reference No. E-129-01/0 filed Sep 26, 2001
Licensing Contact: Richard Rodriguez; 301/496-7056 ext. 287; e-mail: 
[email protected].

    The present invention provides improved antibodies for binding to 
CD22-expressing cells (CD22 is expressed on B cells and B-cell 
malignancies), especially cancer cells that express CD22 on their 
exterior surface. In this regard, the invention provides anti-CD22 
antibodies with a variable light (VL) chain having the 
sequence of antibody RFB4 and a variable heavy (VH) chain 
having the sequence of antibody RFB4, but in which residues 100, 100A 
and 100B of CDR3 of said VH chain (as numbered by the Kabat 
and Wu numbering system)

[[Page 48929]]

have an amino acid sequence selected from the group consisting of: THW, 
YNW, TTW, and STY. The antibody can be a full length antibody molecule, 
but is preferably a single chain Fv (``scFv''), a disulfide stabilized 
Fv (``dsFv''), an Fab, or an F(ab').
    The invention further provides compositions comprising these 
antibodies conjugated or fused to a therapeutic moiety or a detectable 
label. The therapeutic moiety can be a cytotoxin, a drug, a 
radioisotope, or a liposome loaded with a drug or a cytotoxin. In 
preferred embodiments, the effector moiety is a cytotoxin. The 
cytotoxin can be selected from the group consisting of ricin A, abrin, 
ribotoxin, ribonuclease, saporin, calicheamycin, diphtheria toxin or a 
cytotoxic subunit or mutant thereof, a Pseudomonas exotoxin, a 
cytotoxic portion thereof, a mutated Pseudomonas exotoxin, a cytotoxic 
portion thereof, and botulinum toxins A through F. In preferred forms, 
the cytotoxin is a Pseudomonas exotoxin or cytotoxic fragment thereof, 
or a mutated Pseudomonas exotoxin or a cytotoxic fragment thereof. In 
particularly preferred forms, the Pseudomonas exotoxin is selected from 
the group consisting of PE35, PE38, PE38KDEL, PE40, PE4E, and PE38QQR. 
In the most preferred embodiment, the Pseudomonas exotoxin is PE38. The 
compositions may further comprise a pharmaceutically acceptable 
carrier.

    Dated: July 19, 2002.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 02-18944 Filed 7-25-02; 8:45 am]
BILLING CODE 4140-01-Py