81 FR 19984 - Prospective Grant of an Exclusive Patent License for Commercialization: Boron Neutron Capture Therapy for Skin Cancer
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 66 (April 6, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 66 (April 6, 2016)
| Page Range | 19984-19985 | |
| FR Document | 2016-07864 |
[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)] [Notices] [Pages 19984-19985] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-07864] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License for Commercialization: Boron Neutron Capture Therapy for Skin Cancer AGENCY: National Institutes of Health, HHS. 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 worldwide exclusive license to practice the inventions embodied in: HHS Ref. No. E-135-2015/0, U.S. Provisional Patent Application No. 62/ 155,085, filed April 30, 2015, entitled ``Boron Mimics Of Amino Acids And Uses Thereof,'' to Beijing Lanyears Communication Technology, Ltd., a company formed under the laws of the People's Republic of China and having its principle place of business in Beijing, China. The contemplated exclusive license may be limited to boron neutron capture therapy for skin cancer. DATES: Only written comments and/or applications for a license that are received by NIH at the address indicated below on or before April 21, 2016 will be considered. ADDRESSES: Requests for a copy of any unpublished patent application, inquiries, objections to this notice, comments and other requests relating to the contemplated license should be directed to: Michael Shmilovich, Esq., CLP, Senior Licensing and Patent Manager, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892-2479, phone number 301- 435-5019, or [email protected]. SUPPLEMENTARY INFORMATION: The invention pertains to boramino acid compounds that can be used as imaging agents for positron emission tomography of cancer or for boron neutron capture therapy. Mimetics created by substituting the carboxylate group (-COO-) of an amino acid with trifluoroborate (-BF3-) are metabolically stable and allow for the use of fluorine-18 (\18\F) as the radiolabel (e.g., trifluoroborate phenylalanine (B-Phe)). Using boramino acid for \18\F-labeling allows for integrating the \18\F radiolabel into the core molecular backbone rather than the side-chains thus increasing the agent's target specificity. There is a direct relationship between amino acid uptake and cancer cell replication, where the uptake is extensively upregulated in most cancer cells. This uptake increases as cancer progresses, leading to greater uptake in high-grade tumors and metastases. Amino acids act as signaling molecules for proliferation and may also reprogram metabolic networks in the buildup of biomass. This invention provides for an unmet need for traceable amino acid mimics, including those based on naturally-occurring amino acids, which may be non-invasively detected by imaging technology, including for clinical diagnosis or BNCT. Boron neutron capture therapy (BNCT) is based on the nuclear capture and fission reactions that occur when non- radioactive boron-10 (\10\B, approximately 20% of natural elemental boron), is irradiated and thus activated with neutrons of the appropriate energy to yield excited boron-11 (\11\B*). This isotope turn [[Page 19985]] decays into high energy alpha particles (``stripped'' down \4\He nuclei) and high energy lithium-7 (\7\Li) nuclei. Both the emitted alpha particles and the lithium ions are close proximity reactions, i.e., at a range of approximately 5-9 [micro]m; the diameter of a target cell. The energies produced in this ionization and radio-decay is cytotoxic and thus exploited as the basis for cancer radiotherapy. The success of BNCT is dependent on the selective delivery of sufficient amounts of \10\B to the tumor site with only small amounts localized in the surrounding normal tissues thus sparing normal tissue from the nuclear capture and fission reactions. 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 fifteen (15) 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. 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 1, 2016. Michael Shmilovich, Senior Licensing and Patent Manager, Office of Technology Transfer and Development, National Heart, Lung, and Blood Institute. [FR Doc. 2016-07864 Filed 4-5-16; 8:45 am] BILLING CODE 4140-01-P
![19984 Federal Register / Vol. 81, No. 66 / Wednesday, April 6, 2016 / Notices
Technology, Ltd., a company formed emitted alpha particles and the lithium 30, 2015, entitled ‘‘Boron Mimics Of
under the laws of the People’s Republic ions are close proximity reactions, i.e., Amino Acids And Uses Thereof,’’ to
of China and having its principle place at a range of approximately 5–9 mm; the Beijing Lanyears Communication
of business in Beijing, China. diameter of a target cell. The energies Technology, Ltd., a company formed
The contemplated exclusive license produced in this ionization and radio- under the laws of the People’s Republic
may be limited to boron neutron capture decay is cytotoxic and thus exploited as of China and having its principle place
therapy for brain tumors. the basis for cancer radiotherapy. The of business in Beijing, China.
DATES: Only written comments and/or success of BNCT is dependent on the The contemplated exclusive license
applications for a license that are selective delivery of sufficient amounts may be limited to boron neutron capture
received by NIH at the address indicated of 10B to the tumor site with only small therapy for skin cancer.
below on or before April 21, 2016 will amounts localized in the surrounding DATES: Only written comments and/or
be considered. normal tissues thus sparing normal applications for a license that are
ADDRESSES: Requests for a copy of any tissue from the nuclear capture and received by NIH at the address indicated
unpublished patent application, fission reactions. below on or before April 21, 2016 will
inquiries, objections to this notice, The prospective exclusive license will be considered.
comments and other requests relating to be royalty bearing and will comply with ADDRESSES: Requests for a copy of any
the contemplated license should be the terms and conditions of 35 U.S.C. unpublished patent application,
directed to: Michael Shmilovich, Esq., 209 and 37 CFR 404.7. The prospective inquiries, objections to this notice,
CLP, Senior Licensing and Patent exclusive license may be granted unless, comments and other requests relating to
Manager, 31 Center Drive Room 4A29, within fifteen (15) days from the date of the contemplated license should be
MSC2479, Bethesda, MD 20892–2479, this published notice, NIH receives directed to: Michael Shmilovich, Esq.,
phone number 301–435–5019, or written evidence and argument that CLP, Senior Licensing and Patent
shmilovm@mail.nih.gov. establishes that the grant of the license Manager, 31 Center Drive, Room 4A29,
SUPPLEMENTARY INFORMATION: The would not be consistent with the MSC2479, Bethesda, MD 20892–2479,
invention pertains to boramino acid requirements of 35 U.S.C. 209 and 37 phone number 301–435–5019, or
compounds that can be used as imaging CFR 404.7. shmilovm@mail.nih.gov.
agents for positron emission Properly filed competing applications SUPPLEMENTARY INFORMATION: The
tomography of cancer or for boron for a license filed in response to this invention pertains to boramino acid
neutron capture therapy. Mimetics notice will be treated as objections to compounds that can be used as imaging
created by substituting the carboxylate the contemplated license. Comments agents for positron emission
group (-COO-) of an amino acid with and objections submitted in response to tomography of cancer or for boron
trifluoroborate (-BF3-) are metabolically this notice will not be made available neutron capture therapy. Mimetics
stable and allow for the use of fluorine- for public inspection, and, to the extent created by substituting the carboxylate
18 (18F) as the radiolabel (e.g., permitted by law, will not be released group (-COO-) of an amino acid with
trifluoroborate phenylalanine (B-Phe)). under the Freedom of Information Act, trifluoroborate (-BF3-) are metabolically
Using boramino acid for 18F-labeling 5 U.S.C. 552. stable and allow for the use of fluorine-
allows for integrating the 18F radiolabel Dated: April 1, 2016. 18 (18F) as the radiolabel (e.g.,
into the core molecular backbone rather Michael Shmilovich, trifluoroborate phenylalanine (B-Phe)).
than the side-chains thus increasing the Senior Licensing and Patent Manager, Office Using boramino acid for 18F-labeling
agent’s target specificity. There is a of Technology Transfer and Development, allows for integrating the 18F radiolabel
direct relationship between amino acid National Heart, Lung, and Blood Institute. into the core molecular backbone rather
uptake and cancer cell replication, [FR Doc. 2016–07865 Filed 4–5–16; 8:45 am] than the side-chains thus increasing the
where the uptake is extensively BILLING CODE 4140–01–P agent’s target specificity. There is a
upregulated in most cancer cells. This direct relationship between amino acid
uptake increases as cancer progresses, uptake and cancer cell replication,
leading to greater uptake in high-grade DEPARTMENT OF HEALTH AND where the uptake is extensively
tumors and metastases. Amino acids act HUMAN SERVICES upregulated in most cancer cells. This
as signaling molecules for proliferation uptake increases as cancer progresses,
and may also reprogram metabolic National Institutes of Health leading to greater uptake in high-grade
networks in the buildup of biomass. tumors and metastases. Amino acids act
This invention provides for an unmet Prospective Grant of an Exclusive as signaling molecules for proliferation
need for traceable amino acid mimics, Patent License for Commercialization: and may also reprogram metabolic
including those based on naturally- Boron Neutron Capture Therapy for networks in the buildup of biomass.
occurring amino acids, which may be Skin Cancer This invention provides for an unmet
non-invasively detected by imaging AGENCY: National Institutes of Health, need for traceable amino acid mimics,
technology, including for clinical HHS. including those based on naturally-
diagnosis or BNCT. Boron neutron ACTION: Notice. occurring amino acids, which may be
capture therapy (BNCT) is based on the non-invasively detected by imaging
nuclear capture and fission reactions SUMMARY: This is notice, in accordance technology, including for clinical
that occur when non-radioactive boron- with 35 U.S.C. 209(c)(1) and 37 CFR diagnosis or BNCT. Boron neutron
asabaliauskas on DSK3SPTVN1PROD with NOTICES
10 (10B, approximately 20% of natural 404.7(a)(1)(i), that the National capture therapy (BNCT) is based on the
elemental boron), is irradiated and thus Institutes of Health (NIH), Department nuclear capture and fission reactions
activated with neutrons of the of Health and Human Services, is that occur when non-radioactive boron-
appropriate energy to yield excited contemplating the grant of a worldwide 10 (10B, approximately 20% of natural
boron-11 (11B*). This isotope turn exclusive license to practice the elemental boron), is irradiated and thus
decays into high energy alpha particles inventions embodied in: HHS Ref. No. activated with neutrons of the
(‘‘stripped’’ down 4He nuclei) and high E–135–2015/0, U.S. Provisional Patent appropriate energy to yield excited
energy lithium-7 (7Li) nuclei. Both the Application No. 62/155,085, filed April boron-11 (11B*). This isotope turn
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![Federal Register / Vol. 81, No. 66 / Wednesday, April 6, 2016 / Notices 19985
decays into high energy alpha particles update and reissue a current DHS www.regulations.gov, including any
(‘‘stripped’’ down 4He nuclei) and high system of records titled, ‘‘DHS/U.S. personal information provided.
energy lithium-7 (7Li) nuclei. Both the Customs and Border Protection (CBP)– Docket: For access to the docket to
emitted alpha particles and the lithium 014 Regulatory Audit Archive System read background documents or
ions are close proximity reactions, i.e., (RAAS) System of Records’’ (73 FR comments received, please visit http://
at a range of approximately 5–9 mm; the 77807, December 19, 2008). This system www.regulations.gov.
diameter of a target cell. The energies of records allows DHS/CBP to collect FOR FURTHER INFORMATION CONTACT: For
produced in this ionization and radio- and maintain records on individuals general questions, please contact: John
decay is cytotoxic and thus exploited as subject to regulatory audits of customs Connors, (202) 344–1610, Privacy
the basis for cancer radiotherapy. The brokers, importers, and other parties Officer, U.S. Customs and Border
success of BNCT is dependent on the involved in international trade Protection, Privacy and Diversity Office,
selective delivery of sufficient amounts activities. CBP is updating this system 1300 Pennsylvania Ave. NW.,
of 10B to the tumor site with only small of records notice to reflect changes to its Washington, DC 20229. For privacy
amounts localized in the surrounding authorities, category of records, and questions, please contact: Karen L.
normal tissues thus sparing normal routine uses. Specifically, these changes Neuman, (202) 343–1717, Chief Privacy
tissue from the nuclear capture and include expanding the category of Officer, Privacy Office, Department of
fission reactions. records to permit the collection of Homeland Security, Washington, DC
The prospective exclusive license will Employer Identification Numbers (EINs) 20528.
be royalty bearing and will comply with or Social Security numbers (SSNs), also
SUPPLEMENTARY INFORMATION:
the terms and conditions of 35 U.S.C. known as a Federal Taxpayer
209 and 37 CFR 404.7. The prospective Identifying Number, and business I. Background
exclusive license may be granted unless, records associated with the audit from In accordance with the Privacy Act of
within fifteen (15) days from the date of customs brokers, importers, and other 1974, 5 U.S.C. 552a, the Department of
this published notice, NIH receives parties via merchandise entry Homeland Security (DHS)/U.S. Customs
written evidence and argument that documentation. CBP is clarifying the and Border Protection (CBP) proposes to
establishes that the grant of the license authorities section to include updated update and reissue a current DHS
would not be consistent with the and more narrowly tailored authorities system of records titled, ‘‘DHS/CBP–014
requirements of 35 U.S.C. 209 and 37 to permit the collection of EIN or SSN. Regulatory Audit Archive System
CFR 404.7. CBP is making non-substantive edits to (RAAS) System of Records.’’
Properly filed competing applications the Routine Uses A–G to align with DHS/CBP conducts regulatory audits
for a license filed in response to this previously published Departmental in support of its oversight of customs
notice will be treated as objections to Systems of Records Notices (SORNs). brokers licensed by DHS/CBP pursuant
the contemplated license. Comments Lastly, this notice includes non- to 19 U.S.C. 1641 to act as agents for
and objections submitted in response to substantive changes to simplify the importers in the entry of merchandise
this notice will not be made available formatting and text of the previously and payment of duties and fees. This
for public inspection, and, to the extent published notice. system of records covers records about
permitted by law, will not be released Additionally, DHS is issuing a Notice importers and other parties engaged in
under the Freedom of Information Act, of Proposed Rulemaking to reduce the international trade activities that are the
5 U.S.C. 552. current exemptions for this system of subject of a regulatory audit or are
Dated: April 1, 2016. records from certain provisions of the identified in and related to the scope of
Michael Shmilovich, Privacy Act elsewhere in the Federal an audit report.
Senior Licensing and Patent Manager, Office Register. The previously issued Final As a result of a biennial review of this
of Technology Transfer and Development, Rule for DHS/CBP–014 RAAS (Aug. 31, SORN, DHS/CBP is updating the
National Heart, Lung, and Blood Institute. 2009, 74 FR 45076) remains in effect categories of records to include the
[FR Doc. 2016–07864 Filed 4–5–16; 8:45 am] until a new Final Rule is issued. This collection of EINs or SSNs, also known
BILLING CODE 4140–01–P
updated system will be included in the as Federal Taxpayer Identifying
DHS inventory of record systems. Number, pursuant to 19 CFR 24.5, 19
DATES: Submit comments on or before CFR 149.3, and E.O. 9397, as amended
DEPARTMENT OF HOMELAND May 6, 2016. This updated system will by E.O. 13478. DHS/CBP collects this
SECURITY be effective May 6, 2016. additional data to align RAAS with
information provided by importers
ADDRESSES: You may submit comments,
Office of the Secretary through the DHS/CBP Automated
identified by docket number DHS–
Commercial Environment System (ACE)
[Docket No. DHS–2016–0027] 2016–0027 by one of the following
data-source. DHS/CBP is also clarifying
methods:
the category of records to include
Privacy Act of 1974; Department of • Federal e-Rulemaking Portal: http:// business and audit records collected or
Homeland Security, U.S. Customs and www.regulations.gov. Follow the
Border Protection, DHS/CBP–014 created as part of the audit process.
instructions for submitting comments. DHS/CBP is clarifying the authorities
Regulatory Audit Archive System • Fax: 202–343–4010. section to include updated and more
(RAAS) System of Records • Mail: Karen L. Neuman, Chief narrowly tailored authorities to permit
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY: Privacy Office, Department of Privacy Officer, Privacy Office, the collection of EIN or SSN. 19 CFR
Homeland Security. Department of Homeland Security, 24.5 and 19 CFR 149.3 require that
ACTION: Notice of Privacy Act System of
Washington, DC 20528. DHS/CBP collect Federal Taxpayer
Records. Instructions: All submissions received Identifying Numbers in association with
must include the agency name and services resulting in issuance of a bill or
SUMMARY: In accordance with the docket number for this rulemaking. All refund check upon adjustment of a cash
Privacy Act of 1974, the Department of comments received will be posted collection or to document entities that
Homeland Security (DHS) proposes to without change to http:// are liable for payment of all duties and
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Document Created: 2018-02-07 13:51:59
Document Modified: 2018-02-07 13:51:59
| 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. | |
| Dates | Only written comments and/or applications for a license that are | |
| FR Citation | 81 FR 19984 |
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