82 FR 41970 - Prospective Grant of an Exclusive Patent License: Apparatus for Microarray Binding Sensors Having Biological Probe Materials Using Carbon Nanotube Transistors
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 170 (September 5, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 170 (September 5, 2017)
| Page Range | 41970-41971 | |
| FR Document | 2017-18668 |
[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)] [Notices] [Pages 41970-41971] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18668] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Apparatus for Microarray Binding Sensors Having Biological Probe Materials Using Carbon Nanotube Transistors AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Nanobernetics, LLC (``Nanobernetics'') located in Maryland. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before September 20, 2017 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated Exclusive Commercialization Patent License should be directed to: Jaime M. Greene, Senior Licensing and Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, Rm. 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-9702 Telephone: (240)-276-5530; [[Page 41971]] Facsimile: (240)-276-5504 Email: [email protected]. SUPPLEMENTARY INFORMATION: Intellectual Property EP Patent 1999277 (Application No. 07753436.0) filed 19 March 2007, titled ``Apparatus for biosensor microarrays based on carbon nanotube transistors having biological probe materials, method for its production and method of electronically detecting a biological target material'', validated in FR, DE, IE, and GB, HHS Reference No.: E-056-2007/0-EP-04; Australia Patent 2007227415 (Application No. 2007227415) filed 10/16/08, titled ``Apparatus for microarray binding sensors having biological probe materials using carbon nanotube transistors'', HHS Reference No.: E-056-2007/0-AU-05; Canada Patent 2646465 (Application No. 2646465) filed 03/19/07, titled ``Apparatus for microarray binding sensors having biological probe materials using carbon nanotube transistors'', HHS Reference No.: E-056-2007/0-CA-06; Japan Patent 5048752 (Application No. 2009-501490) filed 03/19/ 07, titled ``Apparatus for microarray binding sensors having biological probe materials using carbon nanotube transistors'', HHS Reference No.: E-056-2007/0-JP-07; EP Patent 2570490 (Application No. 12160369.0) filed 03/19/07, titled ``Apparatus for microarray binding sensors having biological probe materials using carbon nanotube transistors'', validated in FR, DE, and GB. HHS Reference No.: E-056-2007/0-EP-08; U.S. Patent 8,017,938 (Application No. 11/723,369), filed 19 March 2007, titled ``Apparatus for Microarray Binding Sensors Having Biological Probe Materials Using Carbon Nanotube Transistors'', HHS Ref. No.: E-056-2007/0-US-03; and PCT Application No. PCT/US2007/06809, filed 19 March 2007, now abandoned, titled ``Apparatus for Microarray Binding Sensors Having Biological Probe Materials Using Carbon Nanotube Transistors'', HHS Ref. No.: E-056-2007/0-PCT-02. U.S. Provisional Patent Application No. 60/743,524, filed 17 March 2006, now abandoned, titled ``Apparatus for Microarray DNA Binding Sensors Using Carbon Nanotube Transistors'', HHS Ref. No.: E-056-2007/0-US-01. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to: ``The development of an FDA- approved or cleared in vitro diagnostic for the detection of hematological malignancies, wherein nucleic acids encoding one or more of the following genes are detected: (1) BCR-ABL, (2) FLT3, (3) Btk, (4) Alk, (5) Bcl-2, (6) Akt, and (7) PI3K.'' This technology discloses a microarray apparatus that uses carbon nanotubes transistors and electronic circuitry to quantitatively measure changes in gene expression levels. Typically, microarrays are microscope glass slides spotted with thousands of different genes. The array does not have built-in reader, and the detection is performed using a fluorescence scanner after hybridization with fluorescent- tagged target DNA. For simple nucleic acid detection, current methods rely upon various combinations of enzymatic amplification of nucleic acids and fluorescent labeling of targets, which entail enzymatic manipulation of the nucleic acid being tested and chemical labeling, respectively. These methods are both time consuming and afford limited sensitivity. In cases where microarray technology is used as a tool for monitoring gene expression patterns and profiling of micro RNA (miRNA) in normal and cancerous tissue, quantification of changes has typically been optically-based. While this technique is highly sensitive, use of optical methods impedes progress in both system miniaturization and in direct interfacing with data collection electronics. To overcome the limitation of current microarray technologies, the inventors have developed a highly sensitive microarray apparatus that uses carbon nanotube transistors for the electronic detection of biological probe-target binding. The present invention provides an apparatus for biological target material detection which uses an array of carbon nanotube transistors, with each being operated as a field effect transistor. A single carbon nanotube transistor is associated with a distinct biological probe material. The current versus voltage characteristics or transconductance between the source and drain electrodes is measured before and after a binding event between the biological probe and target materials. By using a mathematical relationship, the exact amount of target binding can be extracted. Importantly, the present apparatus offers a significant advantage in simplicity of protocol as the method used therewith does not require chemical or enzymatic manipulation of the target being detected. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute 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 part 404. Complete applications for a license in the prospective field of use that are filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Commercialization Patent License Agreement. Comments and objections submitted 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: August 25, 2017. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2017-18668 Filed 9-1-17; 8:45 am] BILLING CODE 4140-01-P
![41970 Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices
• For written/paper comments and/or go to the Dockets Management 5. EMSAM (selegiline transdermal
submitted to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, system)
Staff, FDA will post your comment, as Rockville, MD 20852. 6. LATISSE (bimatoprost ophthalmic
well as any attachments, except for FOR FURTHER INFORMATION CONTACT: solution) 0.03%
information submitted, marked and Kenneth Quinto, Office of the 7. NAMENDA (memantine
identified, as confidential, if submitted Commissioner, Food and Drug hydrochloride) and NAMENDA XR
as detailed in ‘‘Instructions.’’ Administration, 10903 New Hampshire (memantine hydrochloride)
Instructions: All submissions received Ave., Bldg. 32, Rm. 5145, Silver Spring, extended-release
must include the Docket No. FDA– MD 20993, 240–402–2221, email: 8. PRIFTIN (rifapentine)
2017–N–4866 for the ‘‘Pediatric Post- 9. REYATAZ (atazanavir)
kenneth.quinto@fda.hhs.gov. 10. TACLONEX (betamethasone
Marketing Pharmacovigilance and Drug
SUPPLEMENTARY INFORMATION: FDA is dipropionate/calcipotriene hydrate)
Utilization Reviews’’ that have been
posted on FDA’s Web site between responsible for protecting the public Topical Suspension 0.064%/
March 11, 2017, and September 12, health by assuring the safety, efficacy, 0.005% and TACLONEX
2017, but not presented at the and security of human and veterinary (betamethasone dipropionate/
September 12, 2017, PAC meeting. drugs, biological products, medical calcipotriene hydrate) Topical
Received comments, those filed in a devices, our Nation’s food supply, Ointment 0.064%/0.005%
timely manner (see ADDRESSES), will be cosmetics, and products that emit 11. ZETONNA (ciclesonide)
placed in the docket and, except for radiation.
Dated: August 30, 2017.
those submitted as ‘‘Confidential FDA is establishing a public docket,
Anna K. Abram,
Submissions,’’ publicly viewable at Docket No. FDA–2017–N–4866, to
receive input on pediatric post- Deputy Commissioner for Policy, Planning,
https://www.regulations.gov or at the Legislation, and Analysis.
Dockets Management Staff office marketing pharmacovigilance and drug
utilization reviews posted between [FR Doc. 2017–18690 Filed 9–1–17; 8:45 am]
between 9 a.m. and 4 p.m., Monday
through Friday. March 11, 2017, and September 12, BILLING CODE 4164–01–P
• Confidential Submissions—To 2017, available on FDA’s Web site at
submit a comment with confidential https://www.fda.gov/
AdvisoryCommittees/ DEPARTMENT OF HEALTH AND
information that you do not wish to be HUMAN SERVICES
made publicly available, submit your CommitteesMeetingMaterials/
comments only as a written/paper PediatricAdvisoryCommittee/ National Institutes of Health
submission. You should submit two ucm510701.htm, but not presented at
copies total. One copy will include the the September 12, 2017, PAC meeting. Prospective Grant of an Exclusive
information you claim to be confidential FDA welcomes comments by members Patent License: Apparatus for
with a heading or cover note that states of the PAC, as mandated by the Best Microarray Binding Sensors Having
‘‘THIS DOCUMENT CONTAINS Pharmaceuticals for Children Act (Pub. Biological Probe Materials Using
CONFIDENTIAL INFORMATION.’’ The L. 107–109) and the Pediatric Research Carbon Nanotube Transistors
Agency will review this copy, including Equity Act (Pub. L. 108–155), interested
the claimed confidential information, in parties (such as academic researchers, AGENCY: National Institutes of Health,
its consideration of comments. The regulated industries, consortia, and HHS.
second copy, which will have the patient groups), and the general public. ACTION: Notice.
claimed confidential information The docket number is FDA–2017–N–
SUMMARY: The National Cancer Institute,
redacted/blacked out, will be available 4866. The docket will open on October
an institute of the National Institutes of
for public viewing and posted on 9, 2017, and remain open until October
Health, Department of Health and
https://www.regulations.gov. Submit 20, 2017. These pediatric post-
Human Services, is contemplating the
both copies to the Dockets Management marketing pharmacovigilance and drug
grant of an Exclusive Commercialization
Staff. If you do not wish your name and utilization reviews are for the following
Patent License to practice the inventions
contact information to be made publicly products from the following centers at
embodied in the Patents and Patent
available, you can provide this FDA:
Applications listed in the
information on the cover sheet and not
Center for Biologics Evaluation and SUPPLEMENTARY INFORMATION section of
in the body of your comments and you
Research this notice to Nanobernetics, LLC
must identify this information as
‘‘confidential.’’ Any information marked 1. GRASTEK (Timothy Grass Pollen (‘‘Nanobernetics’’) located in Maryland.
as ‘‘confidential’’ will not be disclosed Allergen Extract) Tablet for DATES: Only written comments and/or
except in accordance with 21 CFR 10.20 Sublingual Use applications for a license which are
and other applicable disclosure law. For 2. ORALAIR (Sweet Vernal, Orchard, received by the National Cancer
more information about FDA’s posting Perennial Rye, Timothy, and Institute’s Technology Transfer Center
of comments to public dockets, see 80 Kentucky Blue Grass Mixed Pollens on or before September 20, 2017 will be
FR 56469, September 18, 2015, or access Allergen Extract) Tablet for considered.
the information at: https://www.gpo.gov/ Sublingual Use ADDRESSES: Requests for copies of the
fdsys/pkg/FR-2015-09-18/pdf/2015- patent application, inquiries, and
Center for Drug Evaluation and comments relating to the contemplated
23389.pdf.
Docket: For access to the docket to Research Exclusive Commercialization Patent
mstockstill on DSK30JT082PROD with NOTICES
read background documents or the 1. ALOXI (palonosetron hydrochloride) License should be directed to: Jaime M.
electronic and written/paper comments 2. ARNUITY ELLIPTA (fluticasone Greene, Senior Licensing and Patenting
received, go to https:// furoate) Manager, NCI Technology Transfer
www.regulations.gov and insert the 3. ASMANEX HFA and ASMANEX Center, 9609 Medical Center Drive, Rm.
docket number, found in brackets in the TWISTHALER (mometasone furoate 1E530 MSC 9702, Bethesda, MD 20892–
heading of this document, into the inhalation) 9702 (for business mail), Rockville, MD
‘‘Search’’ box and follow the prompts 4. CYMBALTA (duloxetine) 20850–9702 Telephone: (240)-276–5530;
VerDate Sep<11>2014 17:43 Sep 01, 2017 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\05SEN1.SGM 05SEN1](https://thefederalregister.org/doc/82_FR_42140/page/1.svg)
![Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices 41971
Facsimile: (240)-276–5504 Email: nanotubes transistors and electronic Complete applications for a license in
greenejaime@mail.nih.gov. circuitry to quantitatively measure the prospective field of use that are filed
SUPPLEMENTARY INFORMATION: changes in gene expression levels. in response to this notice will be treated
Typically, microarrays are microscope as objections to the grant of the
Intellectual Property glass slides spotted with thousands of contemplated Exclusive
EP Patent 1999277 (Application No. different genes. The array does not have Commercialization Patent License
07753436.0) filed 19 March 2007, titled built-in reader, and the detection is Agreement. Comments and objections
‘‘Apparatus for biosensor microarrays based performed using a fluorescence scanner submitted to this notice will not be
on carbon nanotube transistors having after hybridization with fluorescent- made available for public inspection
biological probe materials, method for its
tagged target DNA. For simple nucleic and, to the extent permitted by law, will
production and method of electronically
detecting a biological target material’’, acid detection, current methods rely not be released under the Freedom of
validated in FR, DE, IE, and GB, HHS upon various combinations of Information Act, 5 U.S.C. 552.
Reference No.: E–056–2007/0–EP–04; enzymatic amplification of nucleic acids Dated: August 25, 2017.
Australia Patent 2007227415 (Application and fluorescent labeling of targets,
No. 2007227415) filed 10/16/08, titled Richard U. Rodriguez,
which entail enzymatic manipulation of
‘‘Apparatus for microarray binding sensors the nucleic acid being tested and Associate Director, Technology Transfer
having biological probe materials using Center, National Cancer Institute.
chemical labeling, respectively. These
carbon nanotube transistors’’, HHS Reference [FR Doc. 2017–18668 Filed 9–1–17; 8:45 am]
methods are both time consuming and
No.: E–056–2007/0–AU–05;
Canada Patent 2646465 (Application No. afford limited sensitivity. In cases where BILLING CODE 4140–01–P
2646465) filed 03/19/07, titled ‘‘Apparatus microarray technology is used as a tool
for microarray binding sensors having for monitoring gene expression patterns
biological probe materials using carbon and profiling of micro RNA (miRNA) in DEPARTMENT OF HEALTH AND
nanotube transistors’’, HHS Reference No.: E– normal and cancerous tissue, HUMAN SERVICES
056–2007/0–CA–06; quantification of changes has typically
Japan Patent 5048752 (Application No. National Institutes of Health
been optically-based. While this
2009–501490) filed 03/19/07, titled
technique is highly sensitive, use of Proposed Collection; 60-Day Comment
‘‘Apparatus for microarray binding sensors
having biological probe materials using optical methods impedes progress in Request; NCI Cancer Genetics
carbon nanotube transistors’’, HHS Reference both system miniaturization and in Services Directory Web-Based
No.: E–056–2007/0–JP–07; direct interfacing with data collection Application and Update Mailer
EP Patent 2570490 (Application No. electronics. (National Cancer Institute)
12160369.0) filed 03/19/07, titled ‘‘Apparatus To overcome the limitation of current
for microarray binding sensors having microarray technologies, the inventors AGENCY: National Institutes of Health,
biological probe materials using carbon have developed a highly sensitive HHS.
nanotube transistors’’, validated in FR, DE, microarray apparatus that uses carbon
and GB. HHS Reference No.: E–056–2007/0– ACTION: Notice.
EP–08;
nanotube transistors for the electronic
U.S. Patent 8,017,938 (Application No. 11/ detection of biological probe-target SUMMARY: In compliance with the
723,369), filed 19 March 2007, titled binding. The present invention provides requirement of the Paperwork
‘‘Apparatus for Microarray Binding Sensors an apparatus for biological target Reduction Act of 1995 to provide
Having Biological Probe Materials Using material detection which uses an array opportunity for public comment on
Carbon Nanotube Transistors’’, HHS Ref. No.: of carbon nanotube transistors, with proposed data collection projects, the
E–056–2007/0–US–03; and each being operated as a field effect National Cancer Institute (NCI) will
PCT Application No. PCT/US2007/06809, transistor. A single carbon nanotube publish periodic summaries of propose
filed 19 March 2007, now abandoned, titled transistor is associated with a distinct projects to be submitted to the Office of
‘‘Apparatus for Microarray Binding Sensors
Having Biological Probe Materials Using
biological probe material. The current Management and Budget (OMB) for
Carbon Nanotube Transistors’’, HHS Ref. No.: versus voltage characteristics or review and approval.
E–056–2007/0–PCT–02. transconductance between the source DATES: Comments regarding this
U.S. Provisional Patent Application No. and drain electrodes is measured before information collection are best assured
60/743,524, filed 17 March 2006, now and after a binding event between the of having their full effect if received
abandoned, titled ‘‘Apparatus for Microarray biological probe and target materials. By within 60 days of the date of this
DNA Binding Sensors Using Carbon using a mathematical relationship, the publication.
Nanotube Transistors’’, HHS Ref. No.: E–056– exact amount of target binding can be
2007/0–US–01. extracted. Importantly, the present FOR FURTHER INFORMATION CONTACT: To
The patent rights in these inventions apparatus offers a significant advantage obtain a copy of the data collection
have been assigned and/or exclusively in simplicity of protocol as the method plans and instruments, submit
licensed to the government of the used therewith does not require comments in writing, or request more
United States of America. chemical or enzymatic manipulation of information on the proposed project,
The prospective exclusive license the target being detected. contact: Margaret Beckwith, Office of
territory may be worldwide and the This notice is made in accordance Cancer Content, Office of
field of use may be limited to: ‘‘The with 35 U.S.C. 209 and 37 CFR part 404. Communications and Public Liaison
development of an FDA-approved or The prospective exclusive license will (OCPL), 9609 Medical Center Drive,
cleared in vitro diagnostic for the be royalty bearing, and the prospective Rockville, MD 20892 or call non-toll-
detection of hematological exclusive license may be granted unless free number 240–276–6600 or email
mstockstill on DSK30JT082PROD with NOTICES
malignancies, wherein nucleic acids within fifteen (15) days from the date of your request, including your address to:
encoding one or more of the following this published notice, the National nciocpl@mail.nih.gov. Formal requests
genes are detected: (1) BCR–ABL, (2) Cancer Institute receives written for additional plans and instruments
FLT3, (3) Btk, (4) Alk, (5) Bcl–2, (6) Akt, evidence and argument that establishes must be requested in writing.
and (7) PI3K.’’ that the grant of the license would not SUPPLEMENTARY INFORMATION: Section
This technology discloses a be consistent with the requirements of 3506(c)(2)(A) of the Paperwork
microarray apparatus that uses carbon 35 U.S.C. 209 and 37 CFR part 404. Reduction Act of 1995 requires: Written
VerDate Sep<11>2014 17:43 Sep 01, 2017 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\05SEN1.SGM 05SEN1](https://thefederalregister.org/doc/82_FR_42140/page/2.svg)
Document Created: 2017-09-02 03:25:01
Document Modified: 2017-09-02 03:25:01
| 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 which are received by the National Cancer Institute's Technology Transfer Center on or before September 20, 2017 will be considered. | |
| FR Citation | 82 FR 41970 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR