Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Notices 21405

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 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.

Enhanced Homologous Recombination

Mediated by Lambda Recombination

Proteins

Drs. E. Lee, N. Copeland, N. Jenkins,

and D. Court (NCI)

DHHS Reference No. E–077–01/0 filed

Feb 26, 2001

Licensing Contact: John Rambosek; 301/

496–7056 ext. 270; e-mail:

rambosej@od.nih.gov

The present invention concerns a

method to enhance homologous

recombination in bacteria using the Red

recombination system derived from a

defective lambda prophage. This lambda

system, like the RecET system, uses

homologous recombination proteins to

protect and recombine the

electroporated linear DNA. However,

the lambda system is at least 50 to 100

times more efficient than the RecET

system. The high recombination

efficiency offered by this system makes

it possible to manipulate DNA without

drug selection. Point mutations,

deletions, or insertions can be

engineered into any gene on plasmids or

bacterial artificial chromosomes (BACs)

for gene functional analysis. This

recombination system also can be used

to subclone DNA fragments as large as

80 kb from BACs by gap repair.

Targeting vectors for embryonic stem

cells or transgenic constructs by BAC

engineering can now be subcloned with

ease, and virtually any region of the

engineered BAC may be included in the

final subclone. The ability to efficiently

and precisely modify genes or

regulatory sequences on BACs,

combined with the ability to include or

exclude them during the subcloning

process, should make it possible to

dissect the function of these sequences

in the whole animal at a high-throughput level not previously possible.

This lambda recombination system

has been used to introduce a Cre

recombinase gene into the coding region

of the mouse neural-specific enolase

gene carried on a 250 kb mouse BAC

after transfer of the mouse BAC into

DY380 E. coli cells which carry the

lambda recombination system.

Transgenic mice that were subsequently

generated which carry this modified

BAC specifically expressed Cre in all

mature neurons and Cre expression

mirrored that of the mouse neuralspecific enolase gene.

This abstract modifies an abstract for

this technology published in the

Federal Register on Thursday, April 5,

2001 (66 FR 18098).

Use of Endogenous Vertebrate Phytase

to Increase Capacity To Utilize Phytic

Acid in Livestock Feed

Stephen Shears (NIEHS), Paul Reynolds,

Jim Petitte

DHHS Reference No. E–139–00/0 filed

Aug 11, 2000

Licensing Contact: John Rambosek; 301/

496–7056 ext. 270; e-mail:

rambosej@od.nih.gov

This invention discloses the concept

of creating transgenic farm animals that

secrete a native phytase enzyme into

their digestive tracts. It has long been

recognized that monogastric animals

(e.g. pigs and chickens) do not utilize

dietary phosphorus as efficiently as

possible. This is because a high

percentage of total phosphorus (70% in

cereals, 50% in legume seeds) is present

as phytic acid and its salts—phytate.

Monogastric animals utilize phytate

inefficiently because they lack the

enzyme phytase in their digestive

systems. Phytase liberates the

phosphorus from phytate, thereby

making dietary phosphorus available to

the animals. This has the dual effect of

both promoting more efficient growth of

the animals, as well as imposing less of

an environmental burden in the form of

excess phosphorus in water streams.

Use of phytase as a growth feed

supplement is well known. However, in

the past the focus has always been on

adding exogenous phytase to animal

feed, or to increase the level of phytase

expression in the seeds making up the

feed. The inventors’ novel concept is to

redirect expression of a naturally

occurring phytase gene so that the

enzyme will be secreted into the

intestinal lumen. This will create farm

animals that can more efficiently utilize

unsupplemented feeds. Another

problem with existing phytases that the

present invention overcomes is that

phytase tends to be unstable during the

heat treatment used to process feed.

This invention overcomes this

limitation because the phytase does not

have to incorporated into feed at all.

Cloning of the Human Nuclear Receptor

Co-Repressor Gene

Dr. Johnson M. Liu (NHLBI)

DHHS Reference Number E–088–99/0

filed Aug 3, 1999

Licensing Contact: John Rambosek; 301/

496–7056 ext. 270; e-mail:

rambosej@od.nih.gov

Alteration in the expression of human

genes is critical to the development and

progression of many diseases. These

include, among others, cancer,

inflammation, cardiovascular disease,

hypercholesterolemia, blood pressure,

and diabetes. The Human Nuclear

Receptor Co-Repressor (HuN-Cor) gene

represents a technology that may be

used to alter the transcription of genes.

It provides a general mechanism by

which many genes may be modulated

throughout the entire range of being

turned on to being completely turned

off. The HuN-Cor gene encodes for a

ubiquitously expressed protein that

silences other genes. It does this by

specifically recruiting an enzyme

complex that causes local folding of

chromatin, not allowing other

transcription factors to access the DNA.

HuN-Cor represents a powerful research

tool that can be used to study gene

expression and characterization of many

different genes. It may ultimately have

great utility in controlling gene

expression via gene therapy technology,

and may also be useful as a target for the

isolation of pharmaceutical compounds

that enhance or inhibit expression of

genes. For example, it may be possible

to engineer mutations of the HuN-Cor

gene that dominantly inhibit its

function; these mutants could then be

expressed in appropriate target tissues

or cells in order to control gene

expression. Finally, the gene product

may have utility in the discovery of

therapeutic compounds that modulate

gene expression via HuN-Cor.

Antibodies That Selectively Detect the

Human Nestin Protein

Conrad Messam et al. (NINDS)

21406 Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Notices

DHHS Reference Nos. E–145–99/0 and

E–009–01/0

Licensing Contact: Norbert Pontzer; 301/

496–7736, ext. 284; e-mail:

pontzern@od.nih.gov

Nestin is an intermediate filament

protein first described in early

embryonic neuroepithelial stem cells.

Although not found in most cells of the

mature CNS, nestin is the predominant

marker used to detect the small

population of undifferentiated cells. The

presence of nestin identifies stem,

progenitor and some tumor cells in the

CNS, and also labels areas of reactive

gliosis in the CNS. Available methods to

detect nestin use antibodies generated

against rat nestin protein. Since rat and

human nestin have only about fifty

percent sequence homology, these

antibodies may not be optimal for

detecting nestin in human cells.

NIH scientists used a novel human

nestin immunogen to generate

polyclonal and monoclonal antibodies

that bind with high affinity and

specificity to human nestin. The

immunogen was expressed from a 450

base-pair segment of human nestin

mRNA, which has 11 nucleotide

differences from previously published

human nestin. These antibodies

increase the specificity to accurately

detect human nestin in all stages of

brain development and will increase our

understanding of glial differentiation. In

addition, this technology may be useful

for detecting glioblastomas or other

early stage neuroectodermal tumors and

for following transplanted stem cells.

Dated: April 20, 2001.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer,

National Institutes of Health.

[FR Doc. 01–10580 Filed 4–27–01; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Statement of Organization, Functions,

and Delegations of Authority

Part N, National Institutes of Health,

of the Statement of Organization,

Functions, and Delegations of Authority

for the Department of Health and

Human Services (40 FR 22859), May 27,

1975, as amended most recently at 66

FR 6617, January 22, 2001, and

redesignated from Part HN as Part N at

60 FR 56605, November 9, 1995), is

amended as set forth below to

reorganize the Office of the Director,

NIH, as follows: (1) Abolish the Office

of Bioengineering, Bioimaging, and

Bioinformatics.

Section N–B, Organization and

Functions, under the heading Office of

the Director (NA, formerly HNA), is

amended as follows:

(1) Immediately following the

statement for the Executive Office (NAR,

formerly HNAR), the title and functional

statement of the Office of

Bioengineering, Bioimaging, and

Bioinformatics (NAC, formerly HNAC)

as deleted in their entirety.

DELEGATIONS OF AUTHORITY

STATEMENT: All delegations and

redelegations of authority to officers and

employees of NIH which were in effect

immediately prior to the effective date

of this reorganization and are consistent

with this reorganization shall continue

in effect, pending further redelegation.

Dated: March 6, 2001.

Ruth L. Kirschstein,

Acting Director, National Institutes of Health.

[FR Doc. 01–10581 Filed 4–27–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Prospective Grant of Exclusive

License: Bacteriophage Having

Multiple Host Range

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: This is notice, in accordance

with 35 U.S.C. 209(c)(1) and 37 CFR

404.7(a)(1)(i), that the National

Institutes of Health (NIH), Department

of Health and Human Services, is

contemplating the grant of a an

exclusive license to practice the

invention embodied in: United States

Patent Application 60/220,987 entitled

‘‘Bacteriophage Having Multiple Host

Range’’ filed on July 25, 2000, to

BioPhage, Inc., having a place of

business in Montreal, Quebec. The

patent rights in this invention have been

assigned to the United States of

America.

DATES: Only written comments and/or

application for a license which are

received by the NIH Office of

Technology Transfer on or before June

29, 2001 will be considered.

ADDRESSES: Requests for a copy of the

patent applications, inquiries,

comments and other materials relating

to the contemplated license should be

directed to: Peter Soukas, Office of

Technology Transfer, National Institutes

of Health, 6011 Executive Boulevard,

Suite 325, Rockville, MD 20852–3804;

Email: ps193c@nih.gov; Telephone:

(301) 496–7056, ext. 268; Facsimile:

(301) 402–0220.

SUPPLEMENTARY INFORMATION: This

invention concerns bacteriophage with

specificity to more than one bacterial

species and the ability to make such

bacteriophages. The specificity is

broadened and/or changed by genetic

engineering of the phage tail proteins.

The phage can be used to kill

pathogenic bacteria in both animals and

humans. The use of phages as

antibacterials may be one answer to the

problem of antibiotic resistant bacteria.

The prospective exclusive license will

be royalty bearing and will comply with

the terms and conditions of 35 U.S.C.

209 and 37 CFR 404.7. The prospective

exclusive license may be granted unless,

within 60 days from the date of this

published Notice, NIH receives written

evidence and argument that establishes

that the grant of the license would not

be consistent with the requirements of

35 U.S.C. 209 and 37 CFR 404.7.

The field of use may be limited to

prophylaxis and/or treatment of

bacterial infections in non-human

animals and treatment and/or

prophylaxis of antibiotic resistant

bacteria in humans.

Properly filed competing applications

for a license filed in response to this

notice will be treated as objections to

the contemplated license. Comments

and objections submitted in response to

this notice will not be made available

for public inspection, and, to the extent

permitted by law, will not be released

under the Freedom of Information Act,

5 U.S.C. 552.

Dated: April 20, 2001.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer.

[FR Doc. 01–10576 Filed 4–27–01; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Prospective Grant of Exclusive

License: MHC Class II Restricted

Melanoma Antigens and Their Use in

Therapeutic Methods

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice

SUMMARY: This is notice, in accordance

with 35 U.S.C. 209(c)(1) and 37 CFR

404.7(a)(1)(i), that the National