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[Federal Register Volume 66, Number 38 (Monday, February 26, 2001)]
[Notices]
[Pages 11592-11594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4616]

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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

[[Page 11593]]

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.

Coupled Calcium/Citrate Delivery System and Method for Apheresis 
Devices

Charles D. Bolan (CC), Susan F. Leitman (CC), Herb Cullis
DHHS Reference No. E-001-01/0 filed 03 Nov 2000
Licensing Contact: Dale Berkley; 301/496-7735 ext. 223; e-mail: 
[email protected]

    The invention is a method and device for eliminating the long 
recognized physiologic symptoms caused by the use of citrate 
anticoagulant in apheresis procedures. The adverse effects caused by 
citrate anticoagulants can be prevented by administration of an 
intravenous calcium infusion through the return line, coupled to the 
rate of the citrate infusion administered into the draw line of 
apheresis devices. The invention automatically couples the calcium 
infusion rate to the citrate anticoagulant rate. The device calculates 
and administers the appropriate amount of intravenous elemental calcium 
to neutralize citrate symptoms, and replaces calcium for donors and 
patients receiving citrate infusions during the performance of 
apheresis procedures. The invention fills a long standing need to make 
apheresis procedures safer, more economical, and more universally 
applicable to a wider range of donors. In addition, the invention 
significantly shortens the amount of time necessary for the apheresis 
procedure, by allowing higher flow rates.

Adaptive Sensitivity Encoding Incorporating Temporal Filtering 
(TSENSE)

Peter Kellman, Elliot McVeigh (NHLBI)
DHHS Reference No. E-200-00/0
Licensing Contact: Dale Berkley; 301/496-7735 ext. 223; e-mail: 
[email protected]

    The invention is an accelerated magnetic resonance imaging method 
developed to reduce the total imaging time for gated, segmented cine 
imaging or to increase the frame rate when imaging dynamic activity, 
such as heart motion or brain activity. The invention combines temporal 
filtering (e.g., the UNFOLD method) with a known spatial sensitivity 
encoding technique (SENSE or SMASH) to achieve a new technique that is 
the subject of the invention (TSENSE) having a higher degree of alias 
artifact rejection than could be obtained using either temporal or 
spatial filtering individually. The new technique tracks changing coil 
sensitivities over time, which may arise due to chest wall or other 
body motions, and provides time saving by eliminating a separate 
reference acquisition. The invention is thus a robust accelerated 
imaging method that tolerates body motion or change in scan plane 
without the need to reacquire additional reference images, and the 
method may be used to reconstruct the full field-of-view with a large 
temporal bandwidth.

Endoluminal Radiofrequency Cauterization System

Bradford J. Wood (CC)
DHHS Reference No. E-244-00/0 filed 07 Dec 2000
Licensing Contact: Dale Berkley; 301/496-7735 ext. 223; e-mail: 
[email protected]

    The invention is a device for occluding the lumen of a hollow 
organ, vessel or aneurysm by delivering radio frequency energy to its 
inner wall. The apparatus uses specialized electrodes that contact the 
walls of the organ to substantially conform to the inner surface. RF 
energy is then applied to the electrode at any of a broad range of 
desired frequencies for selected times at power levels of from 20 to 
200 watts. Delivery of RF energy may be regulated by monitoring 
temperature, tissue impedance or other parameters at or near the site 
of the electrode. A temperature sensor located near the electrode 
allows microprocessor-based control of the power delivered to the 
electrode site as a function of tissue temperature. The device has 
applications in therapeutic thrombosis of an aneurysm, stopping blood 
flow to a tumor or bleeding vessel, or reducing stricture or stenosis 
in, for example, a bronchus, esophagus, intestine segment or a blood 
vessel. The invention also may be useful in reducing stenosis in a 
coronary artery or to reduce a restenotic lesion from intimal 
hyperplasia that may occur after angioplasty.

Radio Frequency Probes for Tissue Treatment and Methods of Use

Bradford J. Wood (CC)
DHHS Reference No. E-186-00/0 filed 10 Jul 2000
Licensing Contact: Dale Berkley; 301/496-7735 ext. 223; e-mail: 
[email protected]

    The invention is a device and method for radio frequency (RF) 
treatment of tissue that is designed to destroy or damage selected 
tissue areas without damaging surrounding material. Improvements upon 
currently available techniques include: easier percutaneous deployment 
and placement, easier imaging visualization, less bleeding 
complications, and one-handed deployment. Applications include the 
treatment of metastatic cancer lesions in the liver, kidney or other 
solid internal organ. The invention can be used for minimally invasive 
procedures. For example, RF electrodes may be placed percutaneously to 
treat a cancer lesion in the liver. Standard medical imaging techniques 
such as ultrasound can be used to guide the RF electrode into the 
proper position, and surface markings made on the electrode improve the 
ultrasound visibility of the instrument. This invention is easily 
operated using only one hand, allowing the operator's other hand to be 
free to operate a medical imaging device or manage the delivery of the 
RF energy. The RF probe has an introducer that carries it to the 
desired site where a number of RF electrodes are deployed from the 
introducer into the subject's tissue. The RF electrodes may be deployed 
by a spring mechanism. The introducer has a biodegradable occluder that 
reduces tissue injury as the device is inserted into the subject. The 
occluder is displaced from the distal end of the introducer as the 
device transitions to a deployed state.

Modifications of HIV Env, Gag and Pol Enhance Immunogenicity for 
Genetic Immunization

Chakrabarti et al. (NIAID)
DHHS Reference Nos. E-275-00/0 filed 14 Aug 2000 and E-275-00/1 
filed 14 Nov 2000
Licensing Contact: Carol Salata; 301/496-7735 ext. 232; e-mail: 
[email protected]

    Protective immunity against human immunodeficiency virus-1 (HIV-1) 
is likely to require recognition of linear and conformation epitopes 
from multiple HIV antigens. This invention relates to modified HIV Env, 
Gag and Pol DNA and proteins with improved ability to elicit antibody 
and CTL responses. The Env DNA has been modified to expose the core 
protein for optimal antigen presentation and recognition. This 
invention also relates to a Gag-Pol fusion protein that is a 
polyprotein designed to maximize epitope presentation. The effect of

[[Page 11594]]

specific mutations in HIV-1 Env on humoral and cellular immune 
responses after DNA vaccination has been investigated. The 
modifications of Env enhance antibody production to this viral protein 
that may facilitate the generation of broadly neutralizing antibodies 
to HIV. In addition, the immune response to HIV-1 Gag and Pol after 
plasmid DNA immunization with Rev-independent expression vectors 
encoding various forms of these proteins has been examined. The Gag-Pol 
fusion protein induced the most broad and potent CTL responses to Gag 
and Pol in DNA-vaccinated mice. These DNA sequences and proteins may be 
important immunogens for the treatment and prevention of HIV infection.

Mucosal Cytotoxic T Lymphocyte Responses

Jay A. Berzofsky (NCI), Igor M. Belyakov (NCI), Michael A. Derby 
(NCI), Brian L. Kelsall (NIAID), Warren Strober (NIAID)
Serial Number 09/508,552 filed June 12, 2000; DHHS Reference No. E-
268-97/4 filed January 10, 2001
Licensing Contact: Peter Soukas; 301/496-7056, ext. 268; e-mail: 
[email protected]

    This invention claims methods and compositions for inducing a 
protective mucosal cytotoxic T lymphocyte (CTL) response in a mammal 
involving administering a soluble antigen or a soluble antigen with one 
or more active agents such as a cytokine or co-stimulatory molecule to 
a mucosal surface or tissue. As a preferred embodiment, the invention 
contemplates intrarectal administration of the peptide vaccine because 
the inventors have shown that there is a greater CTL response through 
intrarectal administration rather than intranasal administration. The 
synthetic peptide vaccines utilized in the invention to elicit 
protective immune responses after mucosal infection comprise a 
multideterminant helper peptide containing a cluster of overlapping 
helper epitopes (a PCLUS or cluster peptide) colinearly synthesized 
with a peptide epitope target for neutralizing antibodies and CTL. The 
inventors have generated data showing that an intrarectally 
administered synthetic multiepitope HIV/SIV peptide vaccine 
administered to macaques in conjunction with mutant E. coli heat labile 
enterotoxin as an adjuvant induces mucosal CTL responses that provide 
better protection against intrarectal SHIV infection when compared to a 
subcutaneously administered vaccine comprising the same peptides 
inducing as high or higher systemic CTL responses. The invention is 
further described in Belyakov et al., Proc. Natl. Acad. Sci. USA 1998 
Feb 17;95(4):1709-14 and Belyakov et al., J. Clin. Invest. 102: 2072-
2081, 1998.

A Novel Chimeric Protein for Prevention and Treatment of HIV 
Infection

Edward A. Berger (NIAID), Christie M. Del Castillo
Serial No. 60/124,681 filed 16 Mar 1999 and PCT/US00/06946 filed 16 
Mar 2000
Licensing Specialist: Peter Soukas; 301/496-7056 ext. 268; e-mail: 
[email protected]

    This invention relates to bispecific fusion proteins effective in 
viral neutralization. Specifically, the invention is a genetically 
engineered chimeric protein containing a soluble extracellular region 
of human CD4 attached via a flexible polypeptide linker to a single 
chain human monoclonal antibody directed against a CD4-induced, highly 
conserved HIV gp120 determinant involved in coreceptor interaction. 
Binding of the sCD4 moiety to gp120 induces a conformational change 
that enables the antibody moiety to bind, thereby blocking Env function 
and virus entry. This novel bispecific protein displays neutralizing 
activity against genetically diverse primary HIV-1 isolates, with 
potency at least 10-fold greater than the best described HIV-1 
neutralizing monoclonal antibodies. The agent has considerable 
potential for prevention of HIV-1 infection, both as a topical 
microbicide and as a systemic agent to protect during and after acute 
exposure (e.g. vertical transmission; post-exposure prophylaxis). It 
also has potential utility for treatment of chronic infection. Such 
proteins, nucleic acid molecules encoding them, and their production 
and use in preventing or treating viral infections are claimed.

Antimicrobial Magainin Peptides

Michael A. Zasloff, Hao-Chia Chen, Judith H. Brown, John L. Morell, 
Charng-Ming Huang (NICHD)
Serial No. 07/280,363 filed 12/06/1988, now U.S. Patent 5,221,732; 
Serial No. 07/021,493 filed 03/04/1987, now U.S. Patent 4,810,777; 
Serial No. 07/834,992 filed 02/14/1992, now U.S. Patent 5,567,681; 
Serial No. 07/963,007 filed 10/19/1992, now U.S. Patent 5,643,876
Licensing Contact: Peter Soukas; 301/496-7056 ext. 268; e-mail: 
[email protected]

    First isolated from the skin of the African clawed frog Xenopus 
laevis, magainin peptides have been shown by the inventors to have 
broad-spectrum antimicrobial properties. Both synthetic and natural 
magainin peptides are active against many species of bacteria and fungi 
and induce osmotic lysis of protozoa. Magainin peptides are water 
soluble, nonhemolytic at effective antimicrobial concentrations, have 
molecular weights of 2500 or less and are amphiphilic. Compositions and 
methods for their use are claimed in the patents. These inventions are 
available for nonexclusive or exclusive licensing. The inventions are 
further described in Zasloff et al., P.N.A.S. USA 1987 
Aug.;84(15):5449-53; Marion et al., FEBS Lett. 1988 Jan.18;227(1):21-6; 
Soravia et al., FEBS Lett. 1988 Feb. 15;228(2):337-40; Westerhoff et 
al., P.N.A.S. USA 1989 Sep.;86(17):6597-601; and Gwadz et al., Infect. 
Immun. 1989 Sep.; 57(9):2628-33.

    Dated: February 15, 2001.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 01-4616 Filed 2-23-01; 8:45 am]
BILLING CODE 4140-01-P
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