[Federal Register Volume 59, Number 34 (Friday, February 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-3737]
[[Page Unknown]]
[Federal Register: February 18, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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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 U.S. companies and may also be available for licensing.
ADDRESS: Licensing information and copies of the U. S. patent
applications listed below may be obtained by writing to the indicated
Licensing Specialist at the Office of Technology Transfer, National
Institutes of Health, Box OTT, Bethesda, Maryland 20892 (telephone 301/
496-7735; fax 301/402-0220). A signed Confidentiality Agreement will be
required to receive copies of the patent applications. Issued patents
may be obtained from the Commissioner of Patents, U.S. Patent and
Trademark Office, Washington, DC 20231.
Modification of Hepatitis B Virus Infection in Chronic Carriers of
Hepatitis B Surface Antigens
Gerin, J.L., Levy, H.B., Merigan, T.C., Purcell, R.H. (NIAID)
Serial No. 05/786,202 filed 11 Apr 77
U.S. Patent 4,140,761 issued 20 Feb 79
Licensing Contact: Girish C. Barua
Interferon introduced parenterally in a human host or stimulated by
an inducer (PICLC) for a period of greater than 21 days results in
major decrease in all markers of infectivity, such as DNA polymerase,
and such markers remain at a depressed level during the period of
treatment. Long-term treatment with exogenous interferon of greater
than 21 days and up to 14 months results in clinical improvement for
chronic hepatitis B virus (HBV) infection and this long-term treatment
has resulted in sustained improvement even after cessation of treatment
as well as resulting in decrease in infectivity risk to others in close
proximity to the infected human host.
Detection of Non-B Hepatitis Associated Antigens
Tabor, E., Gerety, R.J. (FDA)
Serial No. 06/040,921 filed 21 May 79
U.S. Patent 4,356,164 issued 26 Oct 82
Licensing Contact: Girish C. Barua
A method to detect highly transmittable agent of non-A, non-B
hepatitis using a counterelectrophoresis analysis. The method may also
be applied in the recipients of blood transfusion and for screening
blood donors where the donor had transmitted by transufison non-A, non-
B hepatitis antigens several years previously.
Detection of Non-A, Non-B Hepatitis Associated Antigens
Tabor, E., Gerety, R.J. (FDA)
Serial No. 06/319,995 filed 10 Nov 81 [CIP of 06/192,291 (ABAN),
CIP of 06/060,921]
U.S. Patent 4,395,395 issued 26 Jul 83
Licensing Contact: Girish C. Barua
In the detection of transmittable agent of non-A, non-B hepatitis a
method is described in this invention utilizing antigen-antibody
reaction and preferred counterelectrophoresis technique for detection
of said antigen.
Heat Treatment of Non-A, Non-B Hepatitis Agent To Prepare a Vaccine
Tabor, E., Gerety, R.J. (FDA)
Serial No. 06/343,026 filed 27 Jan 82
U.S. Patent 4,438,098 issued 20 Mar 84
Licensing Contact: Girish C. Barua
A method of treating the agent of human non-A, non-B hepatitis to
render it incapable of causing infection which comprises heating said
agent at about 60 deg. C for about 10 hours and recovering the treated
protective agent, which could be utilized as a vaccine.
Screening Test for Reverse-Transcriptase Containing Virus Such as Non-
A, Non-B Hepatitis, NANBH
Seto, B.P., Gerety, R.J., Coleman, W.G. (FDA)
Serial No. 06/665,400 filed 26 Oct 84
U.S. Patent 4,707,439 issued 17 Nov 87
Licensing Contact: Girish C. Barua
The invention covers a screening test for detecting the presence of
contaminating or infectious agents causing non-A, non-B hepatitis or
AIDS in a blood donor setting. A kit for detecting contaminating agents
belongs to retrovirus is also disclosed. Screening blood or blood
related products so as to prevent spreading of infection or
contamination due to retroviruses is now possible by the present
invention.
Purified Antigens From Non-A, Non-B Hepatitis Causing Factor
Seto, B., Gerety, R.J. (FDA)
Serial No. 06/709,678 filed 8 Mar 85
U.S. Patent 4,673,634 issued 16 Jun 87
Licensing Contact: Girish C. Barua
The invention discloses an isolated and purified antigen specific
to non-A, non-B hepatitis (NANBH) causing agent. The utility of the
antigen as a diagnostic serologic marker and as screening device for
detecting the carrier or source of non-A, non-B hepatitis or infective
factor thereof, particularly in a blood bank or plasmapheresis setting
and preventing transmission of NANBH by isolating the source is
described. Use of the antigens as vaccine to induce protective
antibodies capable of neutralizing NANBH infectivity along with a kit
for detecting the presence or identifying the carriers or sources of
non-A, non-B hepatitis or causative agent thereof is disclosed.
Retrovirus and Related Method Used for Producing a Model for Evaluating
the Anti-Retroviral Effects of Drugs and Vaccines
McClure, H., Fultz, P., Anderson, D. (CDC)
Serial No. 07/200,843
U.S. Patent 5,212,084 issued 18 May 93
Licensing Contact: Steven M. Ferguson
An HIV-like retrovirus (SIV/SMM) isolated from clinically normal
sooty mangabey monkeys provides a rapid means of testing the efficacy
of newly developed anti-retroviral drugs and vaccines. These methods
are based upon the observation that SIV/SMM has been shown to cause
persistent infection and clinical AIDS-like disease when inoculated
into rhesus monkeys and pigtailed macaques. Upon collection and re-
inoculation into simians seronegative for SIV/SMM, acute clinical
disease appears in all recipients within 3 to 5 days that progresses to
death shortly thereafter.
A Sensitive Diagnostic Test for Lyme Disease
Rosa, P.A., Schwan, T.G. (NIAID)
Serial No. 07/885,077 [FWC of 07/361,850 (ABAN)]
Filed 18 May 92
Licensing Contact: Girish C. Barua
The nucleotide sequence of a recombinant clone containing a
specific segment of Borrelia burgdorferi DNA which enables the
identification of the spirochetes causing Lyme disease has been
provided. A diagnostic kit containing oligonucleotide primers derived
from this sequence, suitable for the detection of Borrelia burgdorferi
in a PCR assay, as well as the cloned DNA of the present invention,
allows the detection of Lyme disease sprockets with sensitivity and
specificity not heretofore attained by any other test.
Clones Encoding Mammalian ADP-Ribosylarginine Hydrolases
Moss, J., Stanley, S.J., Nightingale, M.S., Murtagh, J.J.,
Monaco, L., Takada, T. (NHLBI)
Serial No. 07/888,231
Filed 22 May 92
Licensing Contact: Girish C. Barua
The invention relates to the production of mammalian ADP-
ribosylarginine hydrolases. These enzymes can be synthesized using
recombinant DNA technology. The enzymes catalyze the removal of the
ADP-ribose moiety from protein and regulate the ADP-ribose content of
protein.
Specific and Sensitive Diagnostic Test for Lyme Disease
Simpson, W.J., Schwan, T., Garon, C. (NIAID)
Serial No. 07/898,233 [FWC of 07/427,735 (ABAN)]
Filed 12 Jun 92
Licensing Contact: Girish C. Barua
This patent application describes species-specific DNA sequences in
the pathogenic bacterium Borrelia burgdorferi. It includes the use of
these sequences, other related sequences obtained from the bacteria,
and similar DNA sequences generated by recombinant techniques, as DNA
probes for the identification of B. burgdorferi. The target sequences
have been found in multiple locations and are associated with plasmid
molecules. Thus, the natural amplification of these target sequences
may create a sensitivity advantage over other single-site DNA probe
targets.
Recombinant Vaccinia Virus Expressing Human Retorvirus Gene
Moss, B., Chakrabarti, S. (NIAID)
Serial No. 07/919,384
Filed 7 Jul 89
Licensing Contact: Girish C. Barua
A recombinant vaccinia virus carrying the HIV gp-160 env gene under
control of the early/late vaccinia promoter P7.5 and the E. coli lacZ
gene under control of the vaccinia P11 promoter all inserted into the
vaccinia thymidine kinase gene was made. Cells infected with the virus
display the HIV gp 160, gp 120 and gp 41 proteins on their surface.
These proteins reacted with the sera from AIDS patients. The
recombinant vaccinia virus can be used to make these proteins and also
as a vaccine. The recombinant virus and the method of making HIV
envelope proteins are claimed.
Method for Immune Capture and Primary Isolation of Borrelia Burgdorferi
Dorward, D.W., Schwan, T.G., Garon, C.F. (NIAID)
Serial No. 07/929,172 (CIP of 07/485,551, U.S. Patent 5,217,872 issued
8 Jun 93)
Filed 11 Aug 92
Licensing Contact: Girish C. Barua
This invention relates to novel antigens associated with Borrelia
burgdorferi which are exported (or shed) in vivo and whose detection is
a means of diagnosing Lyme disease. The antigens are extracellular
membrane vesicles and other bioproducts including the major
extracellular protein. The invention further provides antibodies,
monoclonal and/or polyclonal, labeled and/or unlabeled, that react with
the antigens. The invention is also directed to a method of diagnosing
Lyme disease by detecting the antigens in a biological sample taken
from a host using the antibodies in conventional immunoassay formats.
The invention further relates to kits, for the diagnosis of Lyme
disease, comprising the antibodies and ancillary reagents. The
advantage of the antibodies used in the invention is that they react
with the antigens from geographically diverse strains of Borrelia
burgdorferi, but do not react with antigens from related Borrelia
spirochetes.
Enzyme Immunoassay for the Detection of a Marker Associated With a
Severe Outcome of Hepatitis Delta Virus Inspection
Fields, H.A., Khudyakov, Y. (CDC)
Serial No. 07/976,358
Filed 17 Nov 92
Licensing Contact: Girish C. Barua
This invention is a method of predicting the development of severe
forms of hepatitis delta virus infection (HDV infection) by detecting
the presence of anti-HDAg' antibody in patients with HDV infection. The
presence of these antibodies is associated with the more severe forms
of HDV infection. The invention additionally encompasses an assay for
detection of HDAg' antibodies in biological samples, and a vaccine
comprising immunologically active HDAg' polypeptides.
Antigenic Protection of Borrelia Burgdorferi
Simpson, W.J., Schwan, T.G. (NIAID)
Serial No. 08/020,245 (FWC of 07/664,731)
Filed 19 Feb 93
Licensing Contact: Girish C. Baura
This patent application describes a 39 Kda protein (P39) that is
species-specific and expressed by all North American and European B.
burgdorferi isolates. The discovery includes the cloning and expression
of the gene for P39 in E. coli and the use of P39 as a diagnostic
antigen for the serodiagnosis of Lyme borreliosis. The P39 described in
this invention report has been found not only to be species-specific,
but reactive only with human Lyme sera. This suggests that any
patient's serum that is shown to react to P39, irrespective of the
patient's clinical picture, can be diagnosed as having Lyme
borreliosis.
Article and Method for Detecting the Presence of Pathogens in Excreta
Dobbins, J., Stewart, J.A., Pellett, P., Koopmans, M. (CDC)
Serial No. 08/048,807
Filed 16 Apr 93
Licensing Contact: Girish C. Barua
The present invention provides a diagnostic diaper capable of
selectively capturing disease causing agents, such as cytomegalovirus
(CMV), from urine. Claims are directed to a diaper with a built in
diagnostic assay for infection detectable in excreta, in particular,
CMV infection in urine. This invention could be used to screen newborns
nationally for infection with CMV since the only current method of
detecting CMV infection is to culture the urine, an unsuitable
procedure for national screening because of expense, the requirement of
special handling, and delayed results.
Immortalized Human Cell Lines Containing Exogenous Cytochrome P450
Genes
Harris, C., Gelboin, H., Gonzalez, F., Mace, L., Pfeifer, A.
(NCI)
Serial No. 08/065,201
Filed 19 May 93
Licensing Contact: Steven M. Ferguson
Stable, non-tumorigenic human bronchial and liver epithelial cell
lines have been developed that are capable of expressing human
cytochrome P450 genes. These immortalized cell lines express
enzymatically active cytochrome P450 enzymes typically involved in
xenobiotic metabolism. Use of these cell lines makes it now possible to
design low-cost in vitro toxicity tests or screens for food-born and
environmental carcinogens, pathogens or mutagens. Previous toxicology
testing methods could only be done in animals, bacteria (Ames test) or
animal cell culture models and could not always be fully extrapolated
to determine human risk.
Regulator of Contact-Medicated Hemolysin of Mycobacterium
Tuberculosis
King, H.C., Sathish, M., Crawford, J.T., Schinnick, T.M. (CDC)
Serial No. 08/066,830
Filed 24 May 93
Licensing Contact: Girish C. Barua
The present invention shows that virulent strains of M.
tuberculosis possess hemolytical activity while avirulent strains do
not. The invention provides the isolation of a contact hemolysin gene
from M. tuberculosis. Claims are directed to the gene, to the protein
produced and to antibodies specifically reactive with the protein.
Claims are also directed to diagnostic tests for infection and tests to
the distinguished virulent from avirulent infection.
Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding
Specificity
Pastan, I., Lee, B., Jung, S-H, Brinkmann, U. (NCI)
Serial No. 08/077,252
Filed 14 Jun 93
Licensing Contact: Daniel R. Passeri
The present invention relates to disulfide-stabilized recombinant
polypeptide molecules which have the binding ability and specificity
for another peptide, such as the variable region of an antibody
molecule. Methods of producing these molecules and nucleic acid
sequences encoding these molecules are also described. In particular,
the invention discloses Fv antibody fragments stabilized by a disulfide
bond connecting the VH and VL regions of the Fv fragment. The
and chains of T cell receptors may be similarly
stabilized by means described in the invention.
Nucleic Acids of a Novel Hantavirus and Reagents for Detection and
Prevention of Infection
Nichol, S.T. (CDC)
Serial No. 08/084,724
Filed 24 Jun 93
Licensing Contact: Girish C. Barua
An outbreak of acute illness in the Four-Corners region of the
United States in the spring of 1993 has been associated with the Muerto
Canyon strain of hantavirus. The identification of specific nucleotide
sequence information for this virus will aid in the development of
diagnostic assays and vaccines.
Diagnostic Reagents and Vaccines for Multiple Genotypes of Hepatitis C
Virus
Bukh, J., Miller, R.H., Purcell, R.H. (NIAID)
Serial No. 08/086,428
Filed 29 Jun 93
Licensing Contact: Girish C. Barua
The invention describes the complete nucleotide and deduced amino
acid sequences of the envelope 1 (E1) gene of 51 hepatitis C virus
(HCV) isolates from around the world and the grouping of these isolates
into twelve distinct HCV genotypes. More specifically, this invention
relates to the oligonucleotides, peptides and recombinant proteins
derived from the envelope 1 gene sequences of these isolates and to
diagnostic methods and vaccines that employ these reagents.
Poliovirus Specific Primers and Methods of Detection Utilizing the Same
Kilpatrick, D.R. (CDC)
Serial No. 08/092,110
Filed 13 Jul 93
Licensing Contact: Girish C. Barua
The ability to rapidly detect wild polioviruses in clinical
specimens is a major concern for the world-wide eradication of
polioviruses. This invention describes a method of detecting
polioviruses of all three serotypes from viral isolates of clinical
specimens using a pair of degenerate PCR primers. These PCR primers do
not recognize nonpoliovirus enteroviruses. All poliovirus serotypes (40
polio vaccine-related genotypes and 120 wild poliovirus genotypes from
around the world) tested positive. The poliovirus-specific PCR primer
will allow for the rapid diagnosis of whether clinical cases of acute
flaccid paralysis are the result of a poliovirus infection.
MRI Coil Having Inductively Coupled and Individually Tuned Elements
Arranged as Free-Pivoting Components
Wen, H., Chesnick, A.S., Balaban, R.S. (NHLBI)
Serial No. 08/104,849
Filed 12 Aug 93
Licensing Contact: John Fahner-Vihtelic
This application describes an MRI probe/transmitter coil that is
composed of concentric cylinders with resonant elements. The probe/
transmitter can be tuned using a plurality of freely rotating resonant
elements radially mounted between the two cylinders. This invention
reduces the effects of subject characteristic variations on the coil
resonant frequency in an MRI system. Further, this apparatus increases
the sensitivity and efficiency in the magnetic resonance system by
raising the Q factor of the probe coil/transmitter. Prototype apparatus
effectively reduces the significant coil-subject coupling at high
frequencies.
Novel and Selective Inhibitors of Biogenic Amine Transporters
Rothman, R.B., Carroll, F.I., Blough, B., Mascarella, S.W. (NIDA)
Serial No. 08/105,747
Filed 12 Aug 93
Licensing Contact: Arthur Cohn
Novel compounds, particularly (2RS, 3aSR, 8aRS)-1,2,3a,8,8a-
Hexahydro-2-Benzyl-1-Methyl-Indeno[1,2-b]pyrrole, bind selectively and
potently to the PCP site 2 associated with biogenic amine transporters
(BAT), and block these transporters. This compound is the first high
affinity ligand to be described which clearly distinguishes between the
two PCP binding sites. It differs from phencyclidine (PCP) in that: (1)
It has no activity at the MK801-sensitive NMDA receptor, (2) it has
considerably higher affinity for the norepinephrin transporter, and (3)
it does not produce PCP-like behavioral effects in rats. The compound
has been shown to raise the extracellular dopamine levels in rats. Thus
it may have utility in treating conditions, like Parkinsons Disease and
depression, that respond to increased dopamine levels. Radiolabeled
compounds of the invention are useful to label PCP site 2.
Method for Proton Magnetic Resonance Spectroscopie Imaging With
Multiple Spin-Echoes
Moonen, C.T., Duyn, J. (NCRR)
Serial No. 08/106,377
Filed 13 Aug 93
Licensing Contact: John Fahner-Vihtelic
This application describes a new method for proton magnetic
resonance spectroscopic imaging. This new method does not have the
limiting disadvantages of the previous techniques. The method combines
multi-slice and multi-spin-echo techniques for high signal-to-noise
ratio per unit time and high efficiency spectroscopic information. This
invention can also produce compound weighted spectroscopic images by
selecting the period between refocusing pulses according to the
coupling constant of a group contained in the compound. Application of
a pulse sequence to conventional MRI imaging apparatus allows for rapid
acquisition of data for generating spectroscopic images.
Orally Active Derivatives of 1,3,5(10)-Estratriene
Kim, H.K, Blye, R.P., Bialy, B. (NICHD)
Serial No. 08/122,853
Filed 17 Sep 93
Licensing Contact: Carol C. Lavrich
Newly developed esters of estradiol which exhibit potent oral and
parenteral estrogenic activity offers a new therapy for replacement of
the natural hormone, estradiol, in hypogonadism and following removal
of the ovaries or cessation of ovarian activity during menopause. The
natural hormones, estradiol and estrone are only weakly active upon
oral administration requiring large dosages. The most frequently used
oral estrogen, 17-alpha-ethenylestradiol, has been associated with a
number of serious dose-related side effects. The novel estrogens of
this patent, lack the ``ethynyl'' group and can be used in lower doses,
thus eliminating the side effects. The compounds are particularly
suitable for use as the estrogenic component of combined oral
contraceptives.
Binding Domains From Plasmodium Vivax and Plasmodium Falciparum
Erythrocyte Binding Proteins
Sim, K.L, Chitnis, C., Miller, L.H. (NIAID)
Serial No. 98/119,677
Filed 10 Sep 93
Licensing Contact: Mark D. Hankins
Despite considerable research efforts worldwide it has not been
possible to design an effective vaccine against malaria. The present
invention provides the basis for an effective vaccine against the blood
state of malaria infections.
This invention relates to the identification of functional domains
of Plasmodium proteins which play a role in erythrocyte binding and
invasion. The inventors have identified the erythrocyte binding domains
of the sialic acid binding protein (SABP) of P. falciparum and the
Duffy antigen binding protein (DABP) of P. vivax. The erythrocyte
binding domains can be used as vaccines to induce immune responses
which block erythrocyte binding and invasion by P. falciparum and P.
vivax merozoites.
Glucose-6-Phosphatase: The Gene Protein and Related Mutations
Chou, J.Y., Lei, K.J. (NICHD)
Serial No. 08/119,773
Filed 10 Sep 93
Licensing Contact: Carol C. Lavrich
This invention describes nucleic acid sequences and methods useful
for producing recombinant glucose-6-phosphatase (c-6-Pase), an enzyme
normally present in the liver, kidney, and intestine and needed in
glycogen metabolism. Specific mutations in the gene human c-6-Pase
cause a shortage or an inactivity of c-6-Pase which results in glycogen
storage disease (GSD), type 1A. The invention further provides a kit
and methods for detecting the mutations and thus diagnosing the genetic
disease that caused GSD type 1A.
Method for Genetating Influenza A Viruses Bearing Attenuating Mutations
in Internal Protein Genes
Murphy, B., Lawson, C.M., Subbarao, K.E. (NIAID)
Serial No. 08/123,933
Filed 20 Sep 93
Licensing Contact: Mark D. Hankins
This patent application describes a method of producing attenuated
Influenza A strains for use as live Influenza A virus vaccine
candidates. The method involves the introduction of one or more
attenuating mutations in the polymerase basic protein 2 (PB2) gene of
Influenza A virus. The attenuating mutations introduced to date are
temperature-sensitive mutations. These mutations are introduced by site
directed mutagenesis at specific sites into a cDNA copy of the PB2
gene. An RNA transcript of this mutant PB2 gene is recovered into an
infectious influenza A virus using a host range restricted helper
virus. This attenuating mutant PB2 gene can be transferred to each new
variant of influenza A virus as it appears in nature. Modifications of
this technology permits introduction of mutations into: Polymerase
basic protein 1 (PB1) genes; polymerase acidic protein (PA) genes;
nuclear protein (NP) genes; membrane protein (M) genes; and non-
structural protein (NS) genes. The patent application covering this
invention is available for licensing and contains claims to: The
methods of producing the attenuated strains; the attenuated strains
produced by the methods; and methods of vaccination using the
attenuated strains. Viruses containing mutant PB2 genes are also
available for licensing.
A Predictive Assay for Suicidal Behavior
Nielsen, D.A., Goldman, D., Linnoila, M., Virkkunen, M. (NIAAA)
Serial No. 08/125,628
Filed 22 Sep 93
Licensing Contact: Arthur Cohn
The present invention describes methods for predicting suicidal and
other abnormal behaviors. In particular, the methods are directed to
the detection of polymorphisms in the tryptophan hydroxylase gene which
are correlated with abnormal serotoninergic function and related
behaviors. Serotoninergic activity is correlated with the concentration
of the serotonin metabolite 5-hydroxyindoleacetic acid (5-HIAA) in the
cerebrospinal fluid (CSF). Indices of decreased serotonin concentration
are connected with anxiety related intolerance to delay and deficient
control of impulses. Low concentrations of 5-HIAA in the CFS have been
associated with risk of suicide in alcoholic, antisocial, and depressed
patients. However, the concentration of CSF 5-HIAA's usefulness as a
marker is limited by the difficulty and expense of obtaining CSF. This
invention fulfills the need for an easily typed marker that is
correlated with 5-HIAA concentration and suicidal behavior.
Target Antigens of Transmission Blocking Antibodies for Malaria
Parasites
Kaslow, D.C., Duffy, P.E. (NIAID)
DHHS Reference No. E-149-92/1
Filed 22 Sep 93
Licensing Contact: Mark D. Hankins
This patent application is a continuation of U.S. Patent
Application 07/912,294 which described Pgs28 a 28 kd protein found in
Plasmodium gallinaceum. The new application describes a unique 28 kd
protein expressed on the surface of ookinetes of Plasmodium Falciparum
(Pfs28). This protein is useful as a malaria transmission blocking
vaccine. The patent application covering this invention is available
for licensing and contains claims to: The Pfs28 protein; Pfs28's amino
acid and nucleic acid sequences; pharmaceutical compositions containing
the polypeptide and nucleic acid sequences; and methods of preventing
transmission of malaria using these pharmaceutical compositions.
Dated: February 3, 1994.
Donald P. Christoferson,
Acting Director, Office of Technology Transfer.
[FR Doc. 94-3737 Filed 2-17-94; 8:45 am]
BILLING CODE 4140-01-M
