81 FR 62915 - Government-Owned Inventions; Availability for Licensing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 177 (September 13, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 177 (September 13, 2016)
| Page Range | 62915-62916 | |
| FR Document | 2016-21905 |
[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)] [Notices] [Pages 62915-62916] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21905] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development. ADDRESSES: Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850-9702. FOR FURTHER INFORMATION CONTACT: Information on licensing and co- development research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850-9702, Tel. 240-276-5515 or email [email protected]. A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications. SUPPLEMENTARY INFORMATION: Technology description follows. Title of invention: A SNP-based blood test for predicting breast cancer survival and determining treatment strategies. Keywords: SNP Single Nucleotide Polymorphism Array Probe Breast Cancer. Description of Technology Metastasis is a primary cause of patient morbidity and mortality in solid tumors. Although recent advances in genomic technologies have provided major insights into tumor etiology, there is a significant lack of knowledge regarding the factors that contribute to metastasis. Through studying the metastatic susceptibility of tumors, researchers at NCI's Laboratory of Cancer Biology and Genetics have discovered a select panel of single nucleotide polymorphisms (SNPs) and a method for predicting [[Page 62916]] breast cancer patient's survival. In this array, SNPs are analyzed from a patient's genomic DNA (gDNA); the result can be used to predict whether a patient is likely to respond to current breast cancer treatment strategies. This invention can reassure newly diagnosed patients that they have a high probability of responding to treatment and can also identify those patients that require alternative, more aggressive therapeutic strategies. Importantly, this invention has several advantages over the currently-offered gene expression-based breast cancer prognostic tests. Since this array can be completed following routine blood draw, rather than through a tumor biopsy, the samples are more stable, the process is quicker, simpler, less- invasive, and more cost-effective than current methods. Potential Commercial ApplicationsIdentification of patients with higher susceptibility to tumor progression (i.e., metastasis). Prediction of breast cancer survival (less than 10 years, for example) using array and methods. Personalization of patient treatment. Value Proposition: Since the array processes DNA from blood rather than tissue from a standard biopsy or resection of a primary tumor, it is faster, simpler, more stable, more cost-efficient, and less-invasive because gDNA is more stable than tumor mRNA. Development Stage: Pre-clinical (in vivo validation). Inventor(s): Kent W. Hunter, Ph.D. (NCI), Howard H. Yang, Ph.D. (NCI), Maxwell P. Lee, Ph.D. (NCI). Intellectual Property: HHS Reference No. E-082-2015/0-US-01 US Provisional Application 62/297,557 (HHS Reference No. E-082- 2015/0-US-01) filed February 19, 2016 entitled ``SNP-Based Assay to Predict Breast Cancer Survival''. Collaboration Opportunity: Researchers at the NCI seek licensing and/or co-development research collaborations for methods that provide significant improvements in examining additional SNPs for improved prognostics, and to evaluate whether the SNP signature is associated with overall cancer incidence or effective treatment strategies. Contact Information: Requests for copies of the patent application or inquiries about licensing, research collaborations, and co- development opportunities should be sent to John D. Hewes, Ph.D., email [email protected]. Dated: September 5, 2016. John D. Hewes, Technology Transfer Specialist, Technology Transfer Center, National Cancer Institute. [FR Doc. 2016-21905 Filed 9-12-16; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices 62915
93.865, Research for Mothers and Children; Dissemination and Implementation Research DEPARTMENT OF HEALTH AND
93.929, Center for Medical Rehabilitation in Health Study Section. HUMAN SERVICES
Research; 93.209, Contraception and Date: October 12–13, 2016.
Infertility Loan Repayment Program, National Time: 8:00 a.m. to 5:00 p.m. National Institutes of Health
Institutes of Health, HHS) Agenda: To review and evaluate grant
applications. Government-Owned Inventions;
Dated: September 7, 2016.
Place: Bethesda Marriott Suites, 6711
Michelle Trout, Democracy Boulevard, Bethesda, MD 20817.
Availability for Licensing
Program Analyst, Office of Federal Advisory Contact Person: Jessica Bellinger, Ph.D., AGENCY: National Institutes of Health,
Committee Policy. Scientific Review Administrator, Center for HHS.
[FR Doc. 2016–21894 Filed 9–12–16; 8:45 am] Scientific of Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158, ACTION: Notice.
BILLING CODE 4140–01–P
Bethesda, MD 20892, bellingerjd@csr.nih.gov.
SUMMARY: The invention listed below is
Name of Committee: Surgical Sciences, owned by an agency of the U.S.
DEPARTMENT OF HEALTH AND Biomedical Imaging and Bioengineering
Integrated Review Group; Surgery, Government and is available for
HUMAN SERVICES licensing and/or co-development in the
Anesthesiology and Trauma Study Section.
Date: October 12–13, 2016. U.S. in accordance with 35 U.S.C. 209
National Institutes of Health and 37 CFR part 404 to achieve
Time: 8:00 a.m. to 5:00 a.m.
Center for Scientific Review; Notice of Agenda: To review and evaluate grant expeditious commercialization of
applications. results of federally-funded research and
Closed Meetings Place: Residence Inn Bethesda, 7335 development. Foreign patent
Pursuant to section 10(d) of the Wisconsin Avenue, Bethesda, MD 20814. applications are filed on selected
Federal Advisory Committee Act, as Contact Person: Weihua Luo, MD, Ph.D.,
Scientific Review Officer, Center for inventions to extend market coverage
amended (5 U.S.C. App.), notice is Scientific Review, National Institutes of for companies and may also be available
hereby given of the following meetings. Health, 6701 Rockledge Drive, Room 5114, for licensing and/or co-development.
The meetings will be closed to the MSC 7854, Bethesda, MD 20892, (301) 435– ADDRESSES: Invention Development and
public in accordance with the 1170, luow@csr.nih.gov. Marketing Unit, Technology Transfer
provisions set forth in sections Name of Committee: Digestive, Kidney and Center, National Cancer Institute, 9609
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Urological Systems Integrated Review Group; Medical Center Drive, Mail Stop 9702,
as amended. The grant applications and Xenobiotic and Nutrient Disposition and Rockville, MD, 20850–9702.
the discussions could disclose Action Study Section.
Date: October 12, 2016. FOR FURTHER INFORMATION CONTACT:
confidential trade secrets or commercial
Time: 8:00 a.m. to 6:00 p.m. Information on licensing and co-
property such as patentable material,
Agenda: To review and evaluate grant development research collaborations,
and personal information concerning
applications. and copies of the U.S. patent
individuals associated with the grant Place: Handlery Union Square Hotel, 351 applications listed below may be
applications, the disclosure of which Geary Street, San Francisco, CA 94102. obtained by contacting: Attn. Invention
would constitute a clearly unwarranted Contact Person: Martha Garcia, Ph.D., Development and Marketing Unit,
invasion of personal privacy. Scientific Reviewer Officer, Center for
Scientific Review, National Institutes of
Technology Transfer Center, National
Name of Committee: Oncology 1-Basic Cancer Institute, 9609 Medical Center
Translational Integrated Review Group, Health, 6701 Rockledge Drive, Room 2186,
Bethesda, MD 20892, 301–435–1243, Drive, Mail Stop 9702, Rockville, MD,
Tumor Cell Biology Study Section.
garciamc@nih.gov. 20850–9702, Tel. 240–276–5515 or
Date: October 5–6, 2016.
Time: 8:00 a.m. to 5:00 p.m. Name of Committee: Center for Scientific email ncitechtransfer@mail.nih.gov. A
Agenda: To review and evaluate grant Review Special Emphasis Panel; Fellowship: signed Confidential Disclosure
applications. Surgical Sciences Biomedical Imaging and Agreement may be required to receive
Place: Embassy Suites at the Chevy Chase Bioengineering. copies of the patent applications.
Pavilion, 4300 Military Road NW., Date: October 12, 2016. SUPPLEMENTARY INFORMATION:
Washington, DC 20015. Time: 10:30 a.m. to 5:00 p.m.
Technology description follows.
Contact Person: Charles Morrow, MD, Agenda: To review and evaluate grant
applications.
Title of invention: A SNP-based blood
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of Place: National Institutes of Health, 6701 test for predicting breast cancer survival
Health, 6701 Rockledge Drive, Room 6202, Rockledge Drive, Bethesda, MD 20892, and determining treatment strategies.
MSC 7804, Bethesda, MD 20892, 301–408– (Virtual Meeting). Keywords: SNP Single Nucleotide
9850, morrowcs@csr.nih.gov. Contact Person: Jan Li, MD, Ph.D., Polymorphism Array Probe Breast
Name of Committee: Emerging Scientific Review Officer, Center for Cancer.
Technologies and Training Neurosciences Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5106, Description of Technology
Integrated Review Group; Molecular
Neurogenetics Study Section. Bethesda, MD 20892, 301.402.9607, Jan.Li@ Metastasis is a primary cause of
Date: October 6–7, 2016. nih.gov. patient morbidity and mortality in solid
Time: 8:00 a.m. to 5:00 p.m. (Catalogue of Federal Domestic Assistance tumors. Although recent advances in
Agenda: To review and evaluate grant Program Nos. 93.306, Comparative Medicine; genomic technologies have provided
applications. 93.333, Clinical Research, 93.306, 93.333, major insights into tumor etiology, there
Place: Marriott New Orleans, 555 Canal 93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
is a significant lack of knowledge
Street, New Orleans, LA 70130.
Contact Person: Mary G Schueler, Ph.D., Institutes of Health, HHS) regarding the factors that contribute to
Lhorne on DSK30JT082PROD with NOTICES
Scientific Review Officer, Center for metastasis.
Dated: September 7, 2016. Through studying the metastatic
Scientific Review, National Institutes of
David Clary, susceptibility of tumors, researchers at
Health, 6701 Rockledge Drive, Room 5214,
MSC 7846, Bethesda, MD 20892, 301–915– Program Analyst, Office of Federal Advisory NCI’s Laboratory of Cancer Biology and
6301, marygs@csr.nih.gov. Committee Policy. Genetics have discovered a select panel
Name of Committee: Healthcare Delivery [FR Doc. 2016–21893 Filed 9–12–16; 8:45 am] of single nucleotide polymorphisms
and Methodologies Integrated Review Group; BILLING CODE 4140–01–P (SNPs) and a method for predicting
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![62916 Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices
breast cancer patient’s survival. In this Dated: September 5, 2016. trials.1 2 Once the Fv portion of the
array, SNPs are analyzed from a John D. Hewes, immunotoxin binds to its target
patient’s genomic DNA (gDNA); the Technology Transfer Specialist, Technology receptor, the immunotoxin is
result can be used to predict whether a Transfer Center, National Cancer Institute. internalized by endocytosis. Following
patient is likely to respond to current [FR Doc. 2016–21905 Filed 9–12–16; 8:45 am] internalization, Furin cleavage is
breast cancer treatment strategies. This BILLING CODE 4140–01–P critically important for proper cytosolic
invention can reassure newly diagnosed shuttling of the immunotoxin. Early PE-
patients that they have a high containing RITs were effective, but also
probability of responding to treatment DEPARTMENT OF HEALTH AND had issues of off-target toxicity.
and can also identify those patients that HUMAN SERVICES To mitigate off-target toxicity of PE,
require alternative, more aggressive the inventors removed specific
therapeutic strategies. Importantly, this National Institutes of Health sequences of domain II, and connected
invention has several advantages over the Fv domain to domain III (PE24) by
the currently-offered gene expression- Government-Owned Inventions; a furin linker peptide. These PE24–RITs
based breast cancer prognostic tests. Availability for Licensing are very active and better tolerated by
Since this array can be completed AGENCY: National Institutes of Health, mice. However, the PE24-containing
following routine blood draw, rather HHS. RITs could potentially be cleaved and
than through a tumor biopsy, the inactivated before internalization by cell
ACTION: Notice.
samples are more stable, the process is surface furin or other proteases in the
quicker, simpler, less-invasive, and SUMMARY: The invention listed below is bloodstream or the tumor
more cost-effective than current owned by an agency of the U.S. microenvironment, due to the absence
methods. Government and is available for of a key disulfide bond (lost after
licensing and/or co-development in the removal of domain II sequences).
Potential Commercial Applications
U.S. in accordance with 35 U.S.C. 209 Researchers at the National Cancer
• Identification of patients with and 37 CFR part 404 to achieve Institute’s Laboratory of Molecular
higher susceptibility to tumor expeditious commercialization of Biology (NCI LMB) developed and
progression (i.e., metastasis). results of federally-funded research and isolated several de-immunized, low
• Prediction of breast cancer survival development. Foreign patent toxicity, PE24-based RITs with a longer
(less than 10 years, for example) using applications are filed on selected serum half-life. This was enabled by
array and methods. inventions to extend market coverage using a disulfide bond to protect the
• Personalization of patient for companies and may also be available furin cleavage sequence (FCS).
treatment. for licensing and/or co-development. Collectively, the new RITs are
Value Proposition: Since the array designated ‘‘DS–PE24’’ immunotoxins.
ADDRESSES: Invention Development and
processes DNA from blood rather than The goal of the disulfide bond is to
Marketing Unit, Technology Transfer
tissue from a standard biopsy or protect the RIT from cleavage-based
Center, National Cancer Institute, 9609
resection of a primary tumor, it is faster, deactivation before internalization. The
Medical Center Drive, Mail Stop 9702,
simpler, more stable, more cost- most active of these new RITs has longer
Rockville, MD, 20850–9702.
efficient, and less-invasive because serum half-life than an RIT without the
gDNA is more stable than tumor mRNA. FOR FURTHER INFORMATION CONTACT: disulfide bond, has the same anti-tumor
Development Stage: Pre-clinical (in Information on licensing and co- activity, while remaining less cytotoxic
vivo validation). development research collaborations, in vitro. Currently, the inventors are
Inventor(s): Kent W. Hunter, Ph.D. and copies of the U.S. patent working with mouse models to further
(NCI), Howard H. Yang, Ph.D. (NCI), applications listed below may be develop the DS–PE24 RITs towards
Maxwell P. Lee, Ph.D. (NCI). obtained by contacting: Attn. Invention developing an anti-mesothelin RIT for
Intellectual Property: HHS Reference Development and Marketing Unit, treatment of mesothelin-expressing
No. E–082–2015/0–US–01 Technology Transfer Center, National cancers, such as mesothelioma.
US Provisional Application 62/ Cancer Institute, 9609 Medical Center
Drive, Mail Stop 9702, Rockville, MD, Potential Commercial Applications
297,557 (HHS Reference No. E–082–
2015/0–US–01) filed February 19, 2016 20850–9702, Tel. 240–276–5515 or • A more stable cancer therapeutic for
entitled ‘‘SNP-Based Assay to Predict Email ncitechtransfer@mail.nih.gov. A currently used PE-coupled RITs, for
Breast Cancer Survival’’. signed Confidential Disclosure example, anti-mesothelin PE-based
Collaboration Opportunity: Agreement may be required to receive immunotoxins.
Researchers at the NCI seek licensing copies of the patent applications.
Value Proposition
and/or co-development research SUPPLEMENTARY INFORMATION:
collaborations for methods that provide Technology description follows. • Protection of the FCS by a disulfide
significant improvements in examining Title of invention: Immunotoxins with bond results in more stable RIT, which
additional SNPs for improved Increased Stability for Cancer Therapy. can lead to fewer off-target effects.
prognostics, and to evaluate whether the Keywords: Recombinant Development Stage: In-vivo.
SNP signature is associated with overall Immunotoxin, RIT, Antibody, Inventor(s): Ira Pastan M.D. (NCI), et
cancer incidence or effective treatment Mesothelin, Mesothelioma. al.
strategies. Intellectual Property: United States
Description of Technology Provisional Patent Application 62/
Lhorne on DSK30JT082PROD with NOTICES
Contact Information: Requests for
copies of the patent application or Recombinant immunotoxins (RITs) 323,668 (NIH Reference E–157–2016/0–
inquiries about licensing, research are fusions of an antibody-based US–01), entitled ‘‘New, More Stable
collaborations, and co-development targeting moiety and a toxin.
1 Fitzgerald DJ, Kreitman R, et al. Int J Med
opportunities should be sent to John D. Pseudomonas exotoxin A (PE) is a
Microbiol. 2004;293:577–582.
Hewes, Ph.D., email hewesj@ bacterial toxin that has been used in 2 Sampson JH, Akabani G, Archer GE, et al. J
mail.nih.gov. several RITs evaluated in clinical Neurooncol. 2003;65(1):27–35.
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Document Created: 2018-02-09 13:16:39
Document Modified: 2018-02-09 13:16:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Information on licensing and co- development research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850-9702, Tel. 240-276-5515 or email [email protected] A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications. | |
| FR Citation | 81 FR 62915 |
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