Federal Register / Vol. 69, No. 243 / Monday, December 20, 2004 / Notices 75989

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments To OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, New Executive 

Office Building, Room 10235, 

Washington, DC 20503, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Dr. Paul 

Sorlie, NIH, NHLBI, 6701 Rockledge 

Drive, MSC 7934, Bethesda, MD 20892–

7934, or call non-toll-free number (301) 

435–0707 or E-mail your request, 

including your address to: 

SorlieP@nhlbi.nih.gov.

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of the date of 

this publication.

Dated: December 7, 2004. 

Peter Savage, 

Director, DECA, NHLBI.

[FR Doc. 04–27724 Filed 12–17–04; 8:45 am] 

BILLING CODE 4167–01–M

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.

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. 

Human Monoclonal Antibodies Against 

Hendra and Nipah Viruses 

Dimiter S. Dimitrov et al. (NCI). U.S. 

Provisional Application filed 1 Nov 

2004 (DHHS Reference No. E–004–2005/

0–US–01); Related to the Phage Display 

Library described in DHHS Reference 

No. E–005–2005/0. 

Licensing Contact: Michael 

Shmilovich; 301/435–5019; 

shmilovm@mail.nih.gov.

Available for licensing are 

neutralizing human monoclonal 

antibodies against the envelope proteins 

(Envs) of Hendra virus (HeV) and Nipah 

virus (NiV) for uses in immunotherapy, 

vaccine development and as diagnostic 

or research reagents. Monoclonal 

antibody variable region fragments (Fabs 

and scFvs) have been isolated from 

screening a human phage display library 

against the Envs. The phage display 

library (DHHS Ref. No. E–005–2005) is 

useful for screening other viral or cancer 

antigens and can be licensed from 

DHHS under a biological materials 

license. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research with the inventors via a 

Cooperative Research and Development 

Agreement (CRADA). 

Human Antibody Phage Display 

Library 

Dimiter S. Dimitrov et al. (NCI). 

DHHS Reference No. E–005–2005/0—

Research Tool; Related to the 

Monoclonal Antibodies Against Hendra 

and Nipah Viruses described in U.S. 

Provisional Application filed 1 Nov 

2004 (DHHS Reference No. E–004–2005/

0–US–01).

Licensing Contact: Michael 

Shmilovich; 301/435–5019; 

shmilovm@mail.nih.gov.

Available for licensing as a biological 

material for either internal use or 

commercial distribution is a human Fab

immunoglobulin/antibody fragment 

phage display library. The library 

contains 1010 Fabs derived from the 

peripheral blood of ten (10) healthy 

human donors. The high quality of the 

library was demonstrated in the 

successful selection of high affinity 

antibodies specific for Hendra and 

Nipah viruses; however, the library is 

useful for selecting a variety of antigen 

specific immunoglobulin/antibody Fab

fragments especially for cancer or 

viruses. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research with the inventors via a 

Cooperative Research and Development 

Agreement (CRADA). 

Vaccines Against Crimean-Congo 

Hemorrhagic Fever 

Dimiter Dimitrov and Xiadong Xiao 

(NCI). U.S. Provisional Patent 

Application filed 3 Nov 2004 (DHHS 

Reference Nos. E–299–2004/0–US–01 

and E–299–2004/1–US–01). 

Licensing Contact: Michael 

Shmilovich; 301/435–5019; 

shmilovm@mail.nih.gov.

Crimean-Congo hemorrhagic fever 

(CCHF) is a tick-borne public health 

concern in many regions of the world 

including Africa, the Middle East, 

Europe, and Western Asia. The disease 

is etiologically linked to Crimean-Congo 

hemorrhagic fever virus (CCHFV) from 

the Nairovirus genus of the 

Bunyaviridae family of viruses and is 

transmitted primarily through the bite of 

Ixodid ticks. Available for licensing and 

commercial development are antigens, 

immunogens, and nucleic acid 

constructs for the development of 

vaccines against CCHFV. The antigens 

and immunogens are peptides 

corresponding to the soluble 

ectodomains of CCHFV G1 (Gc) and G2 

(Gn) glycoproteins. Also provided are 

coupled proteins that include soluble 

peptide fragments derived from the G1 

(Gc) or G2 (Gn) ectodomains or portions 

thereof; peptidomimetics; vaccines; 

immunogenic compounds methods for 

vaccination and inhibitors of CCHFV 

cell entry. Expression vectors and DNA 

vaccines encoding these peptides are 

also within the scope of the invention 

as well as antibodies, aptamers and kits 

containing antibodies or aptamers that 

bind to these peptides. CCHFV has been 

implicated as a pathogen of biodefense 

significance. 

Intracellular Contrast Agents for 

Magnetic Resonance Imaging 

Mrinal K. Dewanjee (NIHCC). U.S. 

Provisional Patent Application filed 8 

Oct 2004 (DHHS Reference No. E–291–

2004/0–US–01). 

Licensing Contact: Michael 

Shmilovich; 301/435–5019; 

shmilovm@mail.nih.gov.

Available for licensing and 

commercial development are contrast 

agents for magnetic resonance imaging 

(MRI). These agents are composed of 

charge neutral and lipid-soluble 

complexes of paramagnetic cations 

bound by chelators. Unlike 

conventional extra-cellular contrast 

agents, these agents of the present 

75990 Federal Register / Vol. 69, No. 243 / Monday, December 20, 2004 / Notices 

invention penetrate into the cells and 

thus permit higher spatial resolution in 

MRI. The paramagnetic cation is 

preferably Gd∂3, Dy∂3 and Fe∂3 with 

three equivalents of a charge 

neutralizing chelator that provides a 

neutral lipid-soluble complex of the 

paramagnetic cation. The complex is 

extracted rapidly and retained 

intracellularly, when mammalian cells 

are incubated in buffer or plasma media. 

Hence, they may be used in imaging 

vascular plaque after intra-arterial 

injection and tracking the distribution 

patterns of injected immune cells in 

localizing the inflammatory disease or 

implanted stem cells in regenerative 

medicine. 

Electromagnetically Tracked Tissue 

Ablation Device 

Bradford J. Wood (NIHCC). U.S. 

Provisional Patent Application filed 5 

Nov 2004 (DHHS Reference No. E–278–

2004/0–US–01). 

Licensing Contact: Michael 

Shmilovich; 301/435–5019; 

shmilovm@mail.nih.gov.

Available for licensing, development, 

manufacturing and commercial 

distribution is an ablation device 

coupled with electromagnetic tracking 

for procedural navigation. Minimally 

invasive interventions exemplified by 

devices like this are rapidly increasing 

in popularity. This device improves 

accuracy and may improve outcomes by 

using pre-procedural imaging (like CT, 

MRI, PET) during procedures, to assist 

with guidance of ablation probes to a 

target that shows up on pre-procedural 

imaging. This allows use of exquisite 

diagnostic imaging during 

interventional procedures, that 

otherwise would not be available. This 

device is similar to having a 

miniaturized version of an automobile 

GPS (global positioning system) on the 

tip of a small needle. Image guided 

surgery is not truly ‘‘image guided’’

without being able to use all preoperative imaging during the procedure. 

One example allows accurate 

identification and treatment of a tumor 

that is only briefly seen on CT scan, 

then disappears, or is only seen with 

PET. Tissue burns during thermal 

ablation, releasing gas that obscures the 

real-time ultrasound image. This device 

allows use of CT and other enhanced 

imaging during repositioning of ablation 

needles, which is the most difficult part 

of the procedure. 

One design can include a guidance 

needle and grid to direct the ablation 

needle. Another design includes a plate 

with an aperture and button coupled to 

the plate wherein the plate has a 

beveled surface and a slideable hub 

coupled to the plate by a rod. An added 

advantage is an inclusion of a plurality 

of guide apertures to focus the needle. 

The needle is inserted into and guided 

by one of the guide apertures of the grid 

as the needle is introduced into a body 

of a patient to a target site. The device 

is useful for therapy or for biopsy and 

includes a button defining an aperture, 

a hub defining an aperture being 

slideably coupled to the button by a rod, 

and a lock mechanism configured to 

lock the hub relative to the button on 

the rod. The system also includes a 

removable probe inserted through the 

hub and the button and a miniature 

magnetically trackable sensor coil that 

fits inside a 22 Gauge needle. A pictorial 

representation of the device is shown 

here.

In addition to licensing, the 

technology is available for further 

development through collaborative 

research with the inventors via a 

Cooperative Research and Development 

Agreement (CRADA). 

Grid Etcher for Generating Defined 

Growth Areas 

Rea Ravin, James Sullivan, Daniel 

Hoeppner, David Munno, Ronald 


EN20DE04.136</GPH>
Federal Register / Vol. 69, No. 243 / Monday, December 20, 2004 / Notices 75991

McKay (NINDS). U.S. Patent 

Application filed 14 Oct 2004 (DHHS 

Reference No. E–125–2004/0–US–01). 

Licensing Contact: Michael 

Shmilovich; 301/435–5019; 

shmilovm@mail.nih.gov.

Available for licensing and 

commercial development is a cell 

culture tool kit for etching confined 

growth areas on substrates coated with 

tissue culture growth matrix, such as 

fibronectin. The kit includes three 

components: an etching comb (etcher) 

with rectangular teats, a back plate, and 

an open chamber with guides to direct 

the etcher. 

Overview: Cells are plated over a glass 

cover slide previously coated with 

growth matrix. Perpendicular channels 

are etched into the culture, removing 

both growth matrix and plated cells, 

resulting in rectangular growth areas 

containing only the cells plated 

originally to each growth area. This 

protocol allows high-density cultures to 

grow freely within a confined growth 

area. Specifically, this procedure 

prevents emigration out of the growth 

area and also prevents immigration from 

individual cells or sphere clusters into 

the growth area, common if cells are 

plated on pre-defined surfaces. 

Method: A coated cover slide is plated 

with cells. The cover slide is then 

sandwiched between the back plate, and 

open chamber with etching guides, then 

secured in place. The chamber is filled 

with media and the etcher is drawn 

across the cover slip to generate a first 

set of channels. The etcher is then 

drawn across the cover slip in a 

perpendicular direction to generate a 

second set of channels, resulting in 

rectangular growth areas. The number of 

the teats on the etcher determines the 

number of squares in the grid, the width 

of each teat will determine the distance 

between the squares and the gap 

between the teats will determine the 

size of the squares. 

This tool kit enables the production of 

a slide for monitoring dynamic cell 

processes especially for the proliferation 

and migration of stem cells or other 

migratory cells. Beside complexity, a 

significant problem with existing 

containment systems is the inability to 

keep cells within the field of 

observation and to keep out cells not 

present in the field of view at the onset 

of the experiment. The present 

invention provides a simple and flexible 

solution that enables long-term cell 

culture in a defined growth area. 

Chlorine Dioxide Gas Decontamination 

Apparatus 

Deborah E. Wilson, D.Ph. (ORS). U.S. 

Provisional Application 60/620,095 

filed 18 Oct 2004 (DHHS Reference No. 

E–190–2004/0-US–01). 

Licensing Contact: Michael 

Shmilovich; 301/435–5019; 

shmilovm@mail.nih.gov.

Available for licensing and 

commercial development is an 

apparatus for decontaminating articles 

and areas contaminated with one or 

more biosafety level 2, 3, or 4 

pathogens. Particularly, the focus of 

decontamination is a piece of laboratory 

equipment, such as a biological safety 

cabinet. The apparatus is portable, and 

includes a moveable cart, a source of 

chlorine dioxide gas, a humidification 

means, an inlet conduit for introducing 

a flow of chlorine dioxide gas from the 

source of chlorine dioxide gas into the 

environment and for simultaneously 

humidifying the environment, and an 

outlet conduit for withdrawing gas from 

the environment. The apparatus further 

includes a blower for circulating gas 

between the environment to the 

humidifier and vice versa. Of particular 

advantage, the moveable cart weighs 

less than 200 pounds. The patent 

application covering this apparatus can 

be reviewed under a confidentiality 

nondisclosure agreement.

Dated: December 9, 2004. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health.

[FR Doc. 04–27723 Filed 12–17–04; 8:45 am] 

BILLING CODE 4140–01–P

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.

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. 

Methods and Compositions for 

Protecting Cells From UltrasoundMediated Cytolysis 

Joe Z. Sostaric (NCI), Norio Miyoshi 

(EM), Peter Riesz (NCI). 

U.S. Provisional Application No. 60/

620,258 filed 19 Oct 2004 (DHHS 

Reference No. E–311–2004/0–US–01). 

Licensing Contact: Michael Shmilovich; 

301/435–5019; 

shmilovm@mail.nih.gov.

Available for licensing and 

commercial development are methods 

for protecting cells from ultrasoundmediated cytolysis. Therapeutic uses of 

ultrasound (e.g., sonoporation, 

thrombolysis, HIFU, sonophoresis, 

acoustic hemostasis) may induce 

changes in tissue state, including 

apoptosis and cytolysis, through 

thermal effects (e.g., hyperthermia), 

mechanical effects (e.g., acoustic 

cavitation or through radiation force, 

acoustic streaming and other ultrasound 

induced forces), and chemical effects 

(via sonochemistry or by the activation 

of solutes by sonoluminescence). 

Furthermore, ultrasound exposure 

conditions in biological processes, e.g.

ultrasound bioreactors, are limited by 

the need to decrease cytolysis of 

microbes or animal and plant cells. 

Accordingly, the protecting molecules 

used to carry out the methods of the 

invention possess the ability to protect 

cells against ultrasound mediated 

cytolysis, without hindering ultrasound 

induced physical effects that could be 

utilized to create beneficial effects. The 

protecting solutes are surface active and 

possess at least one ‘‘carbohydrate unit’’

as described. The solutes include, but 

are not limited to: alkyl-b-Dthioglucopyranoside, alkyl-b-Dthiomaltopyranoside, alkyl-b-Dgalactopyranoside, alkyl-b-Dthiogalactopyranoside, or alkyl-b-Dmaltrioside, hexyl-b-D-glucopyranoside, 

heptyl-b-D-glucopyranoside, octyl-b-Dglucopyranoside, nonyl-b-Dglucopyranoside, hexyl-b-Dmaltopyranoside, n-octyl-b-Dmaltopyranoside, n-octyl-b-Dthioglucopyranoside, 2-propyl-1-pentylb-D-maltopyranoside, methyl-6-O-(Nheptylcarbamoyl)-a-D-glucopyranoside, 

3-cyclohexyl-1-propyl-b-D-glucoside, 6-

O-methyl-n-heptylcarboxyl-a-Dglucopyranoside. 

In addition to licensing, the 

technology is available for further