83 FR 44281 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 169 (August 30, 2018)

Page Range		44281-44282
FR Document		2018-18779

The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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.

Federal Register, Volume 83 Issue 169 (Thursday, August 30, 2018)

[Federal Register Volume 83, Number 169 (Thursday, August 30, 2018)]
[Notices]
[Pages 44281-44282]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-18779]


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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, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing 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: Yogikala Prabhu, Ph.D., 301-761-7789; 
[email protected]. Licensing information and copies of the patent 
applications listed below may be obtained by communicating with the 
indicated licensing contact at the Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Methods of Diagnosing and Treating CHAPLE, a Newly Identified Orphan 
Disease Description of Technology

    This technology is directed towards a potential treatment for a new 
disease, CHAPLE (Complement Hyperactivation, Angiopathic thrombosis, 
and Protein-Losing Enteropathy), identified by NIAID researchers. 
CHAPLE is associated with GI symptoms and vascular thrombosis and is 
caused by loss-of-function variants in the gene encoding the complement 
regulatory protein CD55. The disease is caused by enhanced activation 
of the complement pathway and complement-mediated induction of 
intestinal lymphangiectasia and protein-losing enteropathy. There is no 
current therapy for the newly described heritable genetic disorder and 
the symptoms are poorly controlled. CHAPLE is similar to other 
complement activating diseases that can be fatal, particularly for 
patients who develop severe thrombosis. Recent off-label use of a 
complement inhibiting drug, eculizumab (CD55 inhibitor) was shown to 
provide a dramatic benefit in patients with CHAPLE disease with an 
immediate correction of gastrointestinal protein loss. Thus, 
identification of CD55 deficiency in CHAPLE patients, and the 
possibility to use complement inhibitory drugs provide opportunities 
for treatment.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.

Potential Commercial Applications

     Diagnostic.
     Therapeutic.

Competitive Advantages

     There is no therapy currently approved for CHAPLE disease, 
and

[[Page 44282]]

patients face a debilitating and often time fatal course of the 
disease.
     Anti-complement drugs (including eculizumab) has the 
potential to treat CHAPLE disease.

Development Stage

     Pre-clinical.
     Clinical.

Inventors

    Dr. Michael J. Lenardo (NIAID), Dr. Helen Su (NIAID), Ahmet Ozen 
(NIAID), William A. Comrie (NIAID), Mr. Rico C. Ardy (CeMM, Austria), 
and Dr. Kaan Boztug (CeMM, Austria).

Intellectual Property

    HHS Reference No. E-251-2016/0, U.S. Provisional Patent Application 
Number 62/394,630, filed September 14, 2016, and PCT/US2017/051413 
filed September 13, 2017.

Licensing Contact

    Yogikala Prabhu, Ph.D., 301-761-7789; [email protected].

Collaborative Research Opportunity

    The National Institute of Allergy and Infectious Diseases is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate or commercialize 
the use of Eculizumab or other complement inhibitory drugs for the 
treatment of CHAPLE. For collaboration opportunities, please contact 
Yogikala Prabhu, Ph.D., 301-761-7789; [email protected].

    Dated: August 18, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-18779 Filed 8-29-18; 8:45 am]
BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices 44281

SUPPLEMENTARY INFORMATION: The BSC ntp.niehs.nih.gov/go/165) and will be for companies and may also be available
will provide input to the NTP on updated one week before the meeting. for licensing.
programmatic activities and issues. Individuals are encouraged to access the FOR FURTHER INFORMATION CONTACT:
Preliminary agenda topics include meeting web page to stay abreast of the Yogikala Prabhu, Ph.D., 301–761–7789;
discussions on strategic realignment of most current information regarding the prabhuyo@niaid.nih.gov. Licensing
NTP and updates on peer reviews. meeting. information and copies of the patent
Please see the preliminary agenda for Background Information on the BSC: applications listed below may be
information about the specific The BSC is a technical advisory body obtained by communicating with the
presentations. The preliminary agenda, comprised of scientists from the public indicated licensing contact at the
roster of BSC members, background and private sectors that provides Technology Transfer and Intellectual
materials, public comments, and any primary scientific oversight to the NTP. Property Office, National Institute of
additional information, when available, Specifically, the BSC advises the NTP Allergy and Infectious Diseases, 5601
will be posted on the BSC meeting on matters of scientific program content, Fishers Lane, Rockville, MD 20852; tel.
website (http://ntp.niehs.nih.gov/go/ both present and future, and conducts 301–496–2644. A signed Confidential
165) or may be requested in hardcopy periodic review of the program for the Disclosure Agreement will be required
from the Designated Federal Official for purpose of determining and advising on to receive copies of unpublished patent
the BSC. Following the meeting, the scientific merit of its activities and applications.
summary minutes will be prepared and their overall scientific quality. Its SUPPLEMENTARY INFORMATION:
made available on the BSC meeting members are selected from recognized Technology description follows.
website. authorities knowledgeable in fields such
Meeting and Registration: The Methods of Diagnosing and Treating
as toxicology, pharmacology, pathology, CHAPLE, a Newly Identified Orphan
meeting is open to the public with time biochemistry, epidemiology, risk
scheduled for oral public comments. Disease Description of Technology
assessment, carcinogenesis,
Registration to view the webcast is by mutagenesis, molecular biology, This technology is directed towards a
October 9, 2018, at http:// behavioral toxicology, neurotoxicology, potential treatment for a new disease,
ntp.niehs.nih.gov/go/165. Registration is immunotoxicology, reproductive CHAPLE (Complement Hyperactivation,
required to view the webcast; the URL Angiopathic thrombosis, and Protein-
toxicology or teratology, and
for the webcast will be provided in the Losing Enteropathy), identified by
biostatistics. Members serve overlapping
email confirming registration. TTY users NIAID researchers. CHAPLE is
terms of up to four years. The BSC
should contact the Federal TTY Relay associated with GI symptoms and
usually meets biannually. The authority
Service at 800–877–8339. Requests vascular thrombosis and is caused by
for the BSC is provided by 42 U.S.C.
should be made at least five business loss-of-function variants in the gene
217a, section 222 of the Public Health
days in advance of the event. encoding the complement regulatory
Written Public Comments: NTP Service Act (PHS), as amended.
protein CD55. The disease is caused by
invites written and oral public The BSC is governed by the
enhanced activation of the complement
comments on the agenda topics. provisions of the Federal Advisory
pathway and complement-mediated
Guidelines for public comments are Committee Act, as amended (5 U.S.C.
induction of intestinal lymphangiectasia
available at https://ntp.niehs.nih.gov/ app.), which sets forth standards for the
and protein-losing enteropathy. There is
ntp/about_ntp/guidelines_public_ formation and use of advisory
no current therapy for the newly
comments_508.pdf. The deadline for committees.
described heritable genetic disorder and
submission of written comments is Dated: August 20, 2018 the symptoms are poorly controlled.
October 1, 2018. Written public Brian R. Berridge, CHAPLE is similar to other complement
comments should be submitted through Associate Director, National Toxicology activating diseases that can be fatal,
the meeting website. Persons submitting Program. particularly for patients who develop
written comments should include name, [FR Doc. 2018–18778 Filed 8–29–18; 8:45 am] severe thrombosis. Recent off-label use
affiliation, mailing address, phone, of a complement inhibiting drug,
BILLING CODE 4140–01–P
email, and sponsoring organization (if eculizumab (CD55 inhibitor) was shown
any). Written comments received in to provide a dramatic benefit in patients
response to this notice will be posted on DEPARTMENT OF HEALTH AND with CHAPLE disease with an
the NTP website, and the submitter will HUMAN SERVICES immediate correction of gastrointestinal
be identified by name, affiliation, and protein loss. Thus, identification of
sponsoring organization (if any). National Institutes of Health CD55 deficiency in CHAPLE patients,
Oral Public Comments: Registration
and the possibility to use complement
for oral comments is on or before Government-Owned Inventions;
inhibitory drugs provide opportunities
October 1, 2018, at http:// Availability for Licensing
for treatment.
ntp.niehs.nih.gov/go/165. Oral This technology is available for
comments will be received only during AGENCY: National Institutes of Health,
HHS. licensing for commercial development
the formal public comment periods in accordance with 35 U.S.C. 209 and 37
indicated on the preliminary agenda. ACTION: Notice. CFR part 404, as well as for further
Oral comments may be by development and evaluation under a
teleconference line. The access number SUMMARY: The invention listed below is
research collaboration.
for the teleconference line will be owned by an agency of the U.S.
amozie on DSK3GDR082PROD with NOTICES1

provided to registrants by email prior to Government and is available for Potential Commercial Applications
the meeting. Each organization is licensing to achieve expeditious • Diagnostic.
allowed one time slot, and five minutes commercialization of results of • Therapeutic.
will be allotted to each time slot. federally-funded research and
Meeting Materials: The preliminary development. Foreign patent Competitive Advantages
meeting agenda is available on the applications are filed on selected • There is no therapy currently
meeting web page (http:// inventions to extend market coverage approved for CHAPLE disease, and

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44282 Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices

patients face a debilitating and often individuals associated with the contract DEPARTMENT OF HEALTH AND
time fatal course of the disease. proposals, the disclosure of which HUMAN SERVICES
• Anti-complement drugs (including would constitute a clearly unwarranted
eculizumab) has the potential to treat invasion of personal privacy. National Institutes of Health
CHAPLE disease.
Name of Committee: Center for Scientific
National Center for Advancing
Development Stage Review Special Emphasis Panel; Shared and
Translational Sciences; Notice of
• Pre-clinical. High-end Mass Spectrometers.
Closed Meeting
• Clinical. Date: September 20–21, 2018.
Time: 11:00 a.m. to 4:00 p.m.
Inventors Pursuant to section 10(d) of the
Agenda: To review and evaluate grant
applications.
Federal Advisory Committee Act, as
Dr. Michael J. Lenardo (NIAID), Dr.
Place: Hotel Nikko San Francisco, 222 amended, notice is hereby given of the
Helen Su (NIAID), Ahmet Ozen (NIAID),
William A. Comrie (NIAID), Mr. Rico C. Mason Street, San Francisco, CA 94102. following meeting.
Ardy (CeMM, Austria), and Dr. Kaan Contact Person: Sudha Veeraraghavan, The meeting will be closed to the
Boztug (CeMM, Austria). Ph.D., Scientific Review Officer, Center for public in accordance with the
Scientific Review, National Institutes of provisions set forth in sections
Intellectual Property Health, 6701 Rockledge Drive, Bethesda, MD 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
HHS Reference No. E–251–2016/0, 20892, 301–435–1504, as amended. The grant applications and
U.S. Provisional Patent Application sudha.veeraraghavan@nih.gov. the discussions could disclose
Number 62/394,630, filed September 14, Name of Committee: Surgical Sciences, confidential trade secrets or commercial
2016, and PCT/US2017/051413 filed Biomedical Imaging and Bioengineering property such as patentable material,
September 13, 2017. Integrated Review Group; Surgery, and personal information concerning
Anesthesiology and Trauma Study Section. individuals associated with the grant
Licensing Contact
Date: September 26–27, 2018
Yogikala Prabhu, Ph.D., 301–761– applications, the disclosure of which
Time: 8:00 a.m. to 5:00 p.m.
7789; prabhuyo@niaid.nih.gov. would constitute a clearly unwarranted
Agenda: To review and evaluate grant
applications
invasion of personal privacy.
Collaborative Research Opportunity
Place: Residence Inn Bethesda, 7335 Name of Committee: National Center for
The National Institute of Allergy and Wisconsin Avenue, Bethesda, MD 20814. Advancing Translational Sciences Special
Infectious Diseases is seeking statements Contact Person: Weihua Luo, MD, Ph.D., Emphasis Panel CTSA.
of capability or interest from parties Scientific Review Officer, Center for Date: September 13–14, 2018.
interested in collaborative research to Scientific Review, National Institutes of Time: 8:00 a.m. to 5:00 p.m.
further develop, evaluate or Health, 6701 Rockledge Drive, Room 5114, Agenda: To review and evaluate grant
commercialize the use of Eculizumab or MSC 7854, Bethesda, MD 20892, (301) 435– applications.
other complement inhibitory drugs for 1170, luow@csr.nih.gov. Place: Bethesda North Marriott Hotel &
the treatment of CHAPLE. For Name of Committee: Center for Scientific Conference Center, Brookside Conference
collaboration opportunities, please Review Special Emphasis Panel; PAR Panel: Rooms A & B, 5701 Marinelli Road,
contact Yogikala Prabhu, Ph.D., 301– Neural regulation of Cancer. Rockville, MD 20852.
761–7789; prabhuyo@niaid.nih.gov. Date: September 26, 2018. Contact Person: Victor Henriquez, Ph.D.,
Dated: August 18, 2018. Time: 12:00 p.m. to 4:00 p.m. Scientific Review Officer, Office of Scientific
Suzanne M. Frisbie, Agenda: To review and evaluate grant Director, National Center for Advancing
applications. Translational Sciences (NCATS), National
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute Place: National Institutes of Health, 6701 Institutes of Health, 6701 Democracy Blvd.,
of Allergy and Infectious Diseases. Rockledge Drive, Bethesda, MD 20892 Democracy 1, Room 1080, Bethesda, MD
(Virtual Meeting). 20892–4878, 301–435–0813, henriquv@
[FR Doc. 2018–18779 Filed 8–29–18; 8:45 am]
Contact Person: Rolf Jakobi, Ph.D., mail.nih.gov.
BILLING CODE 4140–01–P
Scientific Review Officer, Center for (Catalogue of Federal Domestic Assistance
Scientific Review, National Institutes of Program Nos. 93.859, Pharmacology,
DEPARTMENT OF HEALTH AND Health, 6701 Rockledge Drive, Room 6187, Physiology, and Biological Chemistry
HUMAN SERVICES MSC 7806, Bethesda, MD 20892, 301–495– Research; 93.350, B—Cooperative
1718, jakobir@mail.nih.gov. Agreements; 93.859, Biomedical Research
National Institutes of Health (Catalogue of Federal Domestic Assistance and Research Training, National Institutes of
Program Nos. 93.306, Comparative Medicine; Health, HHS)
Center for Scientific Review; Notice of 93.333, Clinical Research, 93.306, 93.333, Dated: August 23, 2018.
Closed Meetings 93.337, 93.393–93.396, 93.837–93.844, David D. Clary,
Pursuant to section 10(d) of the 93.846–93.878, 93.892, 93.893, National
Program Analyst, Office of Federal Advisory
Federal Advisory Committee Act, as Institutes of Health, HHS)
Committee Policy.
amended, notice is hereby given of the Dated: August 23, 2018. [FR Doc. 2018–18773 Filed 8–29–18; 8:45 am]
following meetings. David D. Clary, BILLING CODE 4140–01–P
The meetings will be closed to the
public in accordance with the Program Analyst, Office of Federal Advisory
amozie on DSK3GDR082PROD with NOTICES1

Committee Policy.
provisions set forth in sections
[FR Doc. 2018–18772 Filed 8–29–18; 8:45 am]
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and BILLING CODE 4140–01–P
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning

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Document Created: 2018-08-30 01:21:31
Document Modified: 2018-08-30 01:21:31

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		Yogikala Prabhu, Ph.D., 301-761-7789; [email protected] Licensing information and copies of the patent applications listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.
FR Citation		83 FR 44281

83 FR 44281 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 169 (August 30, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health