[Federal Register Volume 78, Number 25 (Wednesday, February 6, 2013)]
[Notices]
[Pages 8547-8549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02516]


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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, HHS.

ACTION: Notice.

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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.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION:

Mutations in the G Protein Coupled Receptor (GPCR) Gene Family in 
Melanoma

    Description of Technology: Using exon capture and next generation 
sequencing approaches to analyze the entire G protein coupled receptor 
(GPCR) gene family in melanoma, the researchers at the NIH have 
identified several novel somatic (e.g., tumor-specific) alterations. 
GPCRs play an integral part in regulating physiological functions and 
the importance of these molecules is evident by the fact that 
approximately half of the current FDA approved therapeutics target 
GPCRs or their direct downstream signaling components.
    Many of the GPCR gene mutations identified by the NIH researchers 
were mutated in a large portion of melanoma patients and already have 
inhibitors, the most notable being the Glutamate Receptor Metabotropic 
3 (GRM3) mutation which could be functionally signification for 
melanoma tumorigenesis. Therefore, this technology could aid in the 
development of specific inhibitors of GRM3 as well as the pathway it 
activates, mitogen-activated protein kinase (MEK), for the treatment of 
melanoma patients with these mutations. To complement these findings, 
human melanoma metastatic cell lines harboring GRM3 mutations are also 
available for licensing.
    Potential Commercial Applications:
     Diagnostic array for the detection of GRM3 mutations.
     Method of identifying GRM3 inhibitors as therapeutic 
agents to treat malignant melanoma patients.
     In vitro and in vivo cell model for the GRM3 mutation in 
melanoma. This is a useful tool for investigating GRM3 phenotype 
biology, including growth, motility, invasion, and metabolite 
production.
    Competitive Advantages:
     GPCR mutations, GRM3 in particular, are frequent in 
melanomas.
     Several inhibitors to GPCR and MEK are already in clinical 
trials, thus this technology may prove useful for the development of 
novel diagnostic tests and therapeutics.
     Associated cell lines derived from melanoma patients are 
available.
    Development Stage: Pre-clinical.
    Inventors: Yardena Samuels (NHGRI), Todd Prickett (NHGRI), and 
Steven Rosenberg (NCI).
    Publication: Prickett TD, et al. Exon capture analysis of G-protein 
coupled receptors reveals activating mutations in GRM3 in melanoma. Nat 
Genet. 2011 Sep 25;43(11):1119-26. [PMID 21946352].

[[Page 8548]]

    Intellectual Property:
     HHS Reference No. E-244-2010/0--U.S. Provisional 
Application No. 61/462,471 filed 23 Sep 2010; PCT Application No. PCT/
US2011/052032 filed 16 Sep 2011.
     HHS Reference No. E-029-2012/0--Research Tool. Patent 
protection is not being pursued for the GRM3 melanoma metastatic cell 
lines.
    Related Technologies: HHS Reference Nos.--E-013-2011/0 (patent app: 
PCT); E-024-2012/0 (research tool); E-272-2008/0 (patent app: US, EP); 
E-229-2010/0 (research tool); E-232-2010/0 (research tool).
    Licensing Contact: Whitney Hastings; 301-451-7337; 
[email protected].
    Collaborative Research Opportunity: The NHGRI is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize this technology. 
For collaboration opportunities, please contact Claire Driscoll, 
Director, NHGRI Technology Transfer Office, at [email protected] or 
301-594-2235.

Human Melanoma Metastasis Cell Lines Harboring GRM3 Mutations

    Description of Technology: Using exon capture and next generation 
sequencing approaches to analyze the entire G protein coupled receptor 
(GPCR) gene family in melanoma, the researchers at the NIH have 
identified several novel somatic (e.g., tumor-specific) alterations. 
GPCRs play an integral part in regulating physiological functions and 
the importance of these molecules is evident by the fact that 
approximately half of the current FDA approved therapeutics target 
GPCRs or their direct downstream signaling components. Many of the GPCR 
gene mutations identified by the NIH researchers were mutated in a 
large portion of melanoma patients and already have inhibitors, the 
most notable being the Glutamate Receptor Metabotropic 3 (GRM3) 
mutation which could be functionally signification for melanoma 
tumorigenesis.
    Available for licensing are several melanoma cell lines that harbor 
GRM3 mutations. These cell lines provide useful and efficient tools for 
studying melanoma and can be used in the development of specific 
inhibitors of GRM3 as well as the pathway it activates, mitogen-
activated protein kinase (MEK), for the treatment of melanoma patients 
with these mutations.
    Potential Commercial Applications:
     Diagnostic array for the detection of GRM3 mutations
     Method of identifying GRM3 inhibitors as therapeutic 
agents to treat malignant melanoma patients.
     In vitro and in vivo cell model for the GRM3 mutation in 
melanoma. This is a useful tool for investigating GRM3 phenotype 
biology, including growth, motility, invasion, and metabolite 
production.
     Tool for testing the activity of GRM3 inhibitors and 
generating GRM3 mutation knock-outs.
    Competitive Advantages:
     Cell lines are derived from melanoma patients.
     GRM3 mutations are highly frequent and/or highly mutated 
in melanomas.
     Several inhibitors to GPCR and MEK are already in clinical 
trials, thus this technology may prove useful for the development of 
novel diagnostic tests and therapeutics.
    Development Stage: Pre-clinical
    Inventors: Yardena Samuels (NHGRI), Todd Prickett (NHGRI), and 
Steven Rosenberg (NCI)
    Publication: Prickett TD, et al. Exon capture analysis of G-protein 
coupled receptors reveals activating mutations in GRM3 in melanoma. Nat 
Genet. 2011 Sep 25;43(11):1119-26. [PMID 21946352]
    Intellectual Property: HHS Reference No. E-029-2012/0--Research 
Tool. Patent protection is not being pursued for the GRM3 melanoma 
metastatic cell lines.
    Related Technologies: HHS Reference Nos.--E-244-2010/0 (patent app: 
PCT); E-013-2011/0 (patent app: PCT); E-024-2012/0 (research tool); E-
272-2008/0 (patent app: US, EP); E-229-2010/0 (research tool); E-232-
2010/0 (research tool)
    Licensing Contact: Whitney Hastings; 301-451-7337; 
[email protected]
    Collaborative Research Opportunity: The NHGRI is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize this technology. 
For collaboration opportunities, please contact Claire Driscoll, 
Director, NHGRI Technology Transfer Office, at [email protected] or 
301-594-2235.

Human Melanoma Metastasis Cell Lines Harboring MITF Mutations

    Description of Technology: Researchers at the NIH have found 
recurrent somatic mutations in the microphthalmia-associated 
transcription factor (MITF). Previous studies have linked the MITF 
pathway to the progression of melanoma, however, little is known about 
somatic gene mutations in the MITF pathway that could contribute to 
this progression. The NIH researchers evaluated primary and metastatic 
melanoma samples for the presence of somatic mutations in two genes of 
the MITF pathway, MITF and SRY (sex determining region Y)-box 10 
(SOX10). They identified 16 previously unidentified somatic mutations 
in these genes. These studies suggest that MITF and SOX10 genes could 
be used as diagnostic markers in human metastatic melanoma. 
Consequently, these cell lines could be used to further investigate the 
effects of MITF and SOX10 in melanoma and to develop therapeutics 
targeting this gene and protein.
    Potential Commercial Applications:
     Diagnostic array for the detection of MITF mutations.
     In vitro and in vivo cell model for the MITF mutations in 
melanoma. This is a useful tool for investigating MITF phenotype 
biology, including growth, motility, invasion, and metabolite 
production.
    Competitive Advantages:
     Cell lines are derived from melanoma patients.
     The MITF mutation is frequent in melanomas.
    Development Stage: Pre-clinical
    Inventors: Yardena Samuels (NHGRI) and Steven Rosenberg (NCI)
    Publication: Cronin JC, et al. Frequent mutations in the MITF 
pathway in melanoma. Pigment Cell Melanoma Res. 2009 Aug;22(4):435-44. 
[PMID 19422606]
    Intellectual Property: HHS Reference No. E-023-2012/0--Research 
Tool. Patent protection is not being pursued for the MITF melanoma 
metastatic cell lines.
    Related Technologies: HHS Reference Nos.--E-029-2012/0 (research 
tool); E-013-2011/0 (patent app: PCT); E-024-2012/0 (research tool); E-
272-2008/0 (patent app: US, EP); E-229-2010/0 (research tool); E-232-
2010/0 (research tool)
    Licensing Contact: Whitney Hastings; 301-451-7337; 
[email protected]
    Collaborative Research Opportunity: The NHGRI is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize this technology. 
For collaboration opportunities, please contact Claire Driscoll, 
Director, NHGRI Technology Transfer Office, at [email protected] or 
301-594-2235.

Human Melanoma Metastasis Cell Lines Harboring TRRAP, GRIN2A, and PLCB4 
Mutations

    Description of Technology: Researchers at the NIH have identified

[[Page 8549]]

several novel somatic (e.g., tumor-specific) alterations, many of which 
have not previously been known to be genetically altered in tumors or 
linked to melanoma. In particular, the researchers identified a 
recurrent ``hotspot'' mutation in the transformation/transcription 
domain-associated protein (TRRAP) gene, identified the glutamate 
receptor ionotropic N-methyl D-aspartate 2A (GRIN2A) gene as a highly 
mutated in melanoma, and have shown that the majority of melanoma 
tumors have alternations in genes encoding members of the glutamate 
signaling pathway, such as phospholipase C, beta 4 (PLCB4). Therefore, 
this technology not only provides a comprehensive map of genetic 
alterations in melanoma, but has important diagnostic and therapeutic 
applications.
    Available for licensing are several melanoma cell lines that harbor 
TRRAP, GRIN2A, and PLCB4 mutations. These cell lines provide useful and 
efficient tools for studying melanoma and can be used in the 
development of specific therapeutics for patients harboring these 
mutations. Specifically, these cell lines could be used to develop 
inhibitors to limit tumor growth and further understand melanoma and 
the biology of these genes.
    Potential Commercial Applications:
     Diagnostic array for the detection of TRRAP, GRIN2A, and 
PLCB4 mutations.
     Method of identifying TRRAP, GRIN2A, and PLCB4 inhibitors 
as therapeutic agents to treat malignant melanoma patients.
     In vitro and in vivo cell model for understanding the 
biology of TRRAP, GRIN2A, and PLCB4, including growth, motility, 
invasion, and metabolite production.
    Competitive Advantages:
     Cell lines are derived from melanoma patients.
     TRRAP, GRIN2A, and PLCB4 mutations are highly frequent 
and/or highly mutated in melanomas.
     Glutamate antagonists have already been shown to inhibit 
tumor growth. Thus, this technology may prove useful for the 
development of novel diagnostic tests and therapeutics.
    Development Stage: Pre-clinical
    Inventors: Yardena Samuels (NHGRI) and Steven Rosenberg (NCI)
    Publication: Wei X, et al. Exome sequencing identifies GRIN2A as 
frequently mutated in melanoma. Nat Genet. 2011 May; 43(5):442-6. [PMID 
21499247]
    Intellectual Property: HHS Reference No. E-024-2012/0--Research 
Tool. Patent protection is not being pursued for the TRRAP, GRIN2A, 
PLCB4 melanoma metastatic cell lines.
    Related Technologies: HHS Reference Nos.--E-013-2011/0 (patent 
apps. PCT); E-272-2008/0 (patent apps. US, EP); E-229-2010/0 (research 
tool); E-232-2010/0 (research tool); E-029-2012/0 (research tool); E-
244-2012/0 (patent app: PCT)
    Licensing Contact: Whitney Hastings; 301-451-7337; 
[email protected]
    Collaborative Research Opportunity: The NHGRI is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize this technology. 
For collaboration opportunities, please contact Claire Driscoll, 
Director, NHGRI Technology Transfer Office, at [email protected] or 
301-594-2235.

     Dated: January 31, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-02516 Filed 2-5-13; 8:45 am]
BILLING CODE 4140-01-P