83 FR 28002 - Prospective Grant of Exclusive Patent Commercialization License: Streptococcus Pneumonia PSAA Peptide for Treatment of Sepsis and Infection

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 116 (June 15, 2018)

Page Range		28002-28003
FR Document		2018-12838

The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, on behalf of the Centers for Disease Control and Prevention, Department of Health and Human Services, is contemplating the grant of an exclusive patent commercialization license to The University of Liverpool, located in Liverpool, UK, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.

Federal Register, Volume 83 Issue 116 (Friday, June 15, 2018)

[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Notices]
[Pages 28002-28003]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12838]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent Commercialization License: 
Streptococcus Pneumonia PSAA Peptide for Treatment of Sepsis and 
Infection

AGENCY: National Institutes of Health, Centers for Disease Control and 
Prevention, Department of Health and Human Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Institute of Allergy and Infectious Diseases, an 
institute of the National Institutes of Health, Department of Health 
and Human Services, on behalf of the Centers for Disease Control and 
Prevention, Department of Health and Human Services, is contemplating 
the grant of an exclusive patent commercialization license to The 
University of Liverpool, located in Liverpool, UK, to practice the 
inventions embodied in the patent applications listed in the 
Supplementary Information section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases on or 
before July 2, 2018 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated exclusive patent 
commercialization license should be directed to: Karen Surabian, 
Licensing and Patenting Manager, Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Suite 6D, MSC9804, Rockville, MD 20852-9804, phone 
number 301-496-2644, or karen.surabian@nih.gov.

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement: United States 
Provisional Patent Application Number 61/085,208, filed 07/31/2008, 
entitled ``Methods of Enhancing Opsonophagocytosis in Response to a 
Pathogen'' (HHS Reference No. E-329-2013/0-US-01); PCT Patent 
Application Number PCT/US2009/052384, filed 07/31/2009, entitled 
``Methods of Enhancing Opsonophagocytosis in Response to a Pathogen'' 
(HHS Reference No. E-329-2013/0-PCT-02); China Patent Number 
200980137625.X, issued 11/26/2014, entitled ``Methods of Enhancing 
Opsonophagocytosis in Response to a Pathogen'' (HHS Reference No. E-
329-2013/0-CN-03); European Patent Number 2323684, issued 05/21/2014, 
entitled ``Use of a Pneumococcal P4 Peptide for Enhancing 
Opsonophagocytosis in Response to a Pathogen'' (HHS Reference No. E-
329-2013/0-EP-04), and validated in Germany, Spain, France, the United 
Kingdom, and Ireland; Hong Kong Patent Number 1160391, issued 07/31/
2015, entitled ``Methods of Enhancing Opsonophagocytosis in Response to 
a Pathogen'' (HHS Reference No. E-329-2013/0-HK-05); United States 
Patent Number 8,431,134, issued 04/30/2013, entitled ``Use of a 
Pneumococcal P4 Peptide for Enhancing Opsonophagocytosis in Response to 
a Pathogen'' (HHS Reference No. E-329-2013/0-US-06); United States 
Patent Number 9,101,582, issued 08/11/2015, entitled ``Use of a 
Pneumococcal P4 Peptide for Enhancing Opsonophagocytosis in Response to 
a Pathogen'' (HHS Reference No. E-329-2013/0-US-07); United States 
Provisional Patent Application Number 60/682,495, filed 05/19/2005, 
entitled ``Functional Epitopes of Streptococcus Pneumonia PSAA Antigen 
and Uses Thereof'' (HHS Reference No. E-338-2013/0-US-01); PCT Patent 
Application Number PCT/US2005/027290, filed 07/29/2005, entitled 
``Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses 
Thereof'' (HHS Reference No. E-338-2013/0-PCT-02); Australia Patent 
Number 2005332058, issued 03/15/2012, entitled ``Functional Epitopes of 
Streptococcus Pneumonia PSAA Antigen and Uses Thereof'' (HHS Reference 
No. E-338-2013/0-AU-03); European Patent Number 1931700, issued 07/17/
2003, entitled ``Functional Epitopes of Streptococcus Pneumonia PSAA 
Antigen and Uses Thereof'' (HHS Reference No. E-338-2013/0-EP-04), and 
validated in: Germany, Spain, France, the United Kingdom, and Ireland; 
Hong Kong Patent Number 1115144, issued 02/14/2014, entitled 
``Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses 
Thereof'' (HHS Reference No. E-338-2013/0-HK-05); United States Patent 
Number 7,919,104, issued 04/05/2011, entitled ``Functional Epitopes of 
Streptococcus Pneumonia PSAA Antigen and Uses Thereof'' (HHS Reference 
No. E-338-2013/0-US-06); Canada Patent Application Number 2,631,556, 
filed 09/15/2014, entitled ``Functional Epitopes of Streptococcus 
Pneumonia PSAA Antigen and Uses Thereof'' (HHS Reference No. E-338-
2013/0-CA-07); Australia Patent Number 2012201107, issued 06/06/2013, 
entitled ``Functional Epitopes of Streptococcus Pneumonia PSAA Antigen 
and Uses Thereof'' (HHS Reference No. E-338-2013/0-AU-08); Hong Kong 
Patent Number HK1163113, issued 06/05/2015, entitled ``Functional 
Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses Thereof'' 
(HHS Reference No. E-338-2013/0-HK-09); European Patent Number 2371843, 
issued 09/17/2014, entitled ``Functional Epitopes of Streptococcus 
Pneumonia PSAA Antigen and Uses Thereof'' (HHS Reference No. E-338-
2013/0-EP-10), and validated in: Germany, France, and the United 
Kingdom.
    All rights in these inventions have been assigned to the Government 
of the United States of America.
    The prospective exclusive patent commercialization license 
territory may be worldwide and the field of use may be limited to: 
``Development, manufacture, and sale of a P4 peptide therapeutic for 
the treatment of infection and sepsis.''
    These inventions, developed within the National Center for 
Immunization and Respiratory Diseases (NCIRD), at the Centers for 
Disease Control and Prevention (CDC), describe methods to bolster the 
human body's own mechanisms to fight infection by enhancing an innate 
immune response, opsonophagocytosis. The specific 24 amino acid peptide 
sequence (P4) acts as a polymorphonuclear cell activator. P4 can be 
administered in vivo along with disease-specific antibodies to enhance 
systemic bacterial clearance,

[[Page 28003]]

thus leading to prolonged survival. This technology enhances the body's 
response to a variety of bacterial infections, including S. pneumoniae 
and S. aureus.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent commercialization license 
will be royalty bearing and may be granted unless within fifteen (15) 
days from the date of this published notice, the National Institute of 
Allergy and Infectious Diseases 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 timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent 
commercialization license. In response to this Notice, the public may 
file comments or objections. Comments and objections, other than those 
in the form of a license application, will not be treated 
confidentially, and may be made publicly available. License 
applications submitted in response to this Notice will be presumed to 
contain business confidential information, and any release of 
information in these license applications will be made only as required 
and upon a request under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: June 11, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-12838 Filed 6-14-18; 8:45 am]
 BILLING CODE 4140-01-P

28002 Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices

Conflict: Healthcare Delivery and comments relating to the contemplated issued 03/15/2012, entitled ‘‘Functional
Methodologies. exclusive patent commercialization Epitopes of Streptococcus Pneumonia
Date: July 16, 2018. license should be directed to: Karen PSAA Antigen and Uses Thereof’’ (HHS
Time: 2:00 p.m. to 5:00 p.m.
Surabian, Licensing and Patenting Reference No. E–338–2013/0–AU–03);
Agenda: To review and evaluate grant
applications. Manager, Technology Transfer and European Patent Number 1931700,
Place: National Institutes of Health, 6701 Intellectual Property Office, National issued 07/17/2003, entitled ‘‘Functional
Rockledge Drive, Bethesda, MD 20892 Institute of Allergy and Infectious Epitopes of Streptococcus Pneumonia
(Telephone Conference Call). Diseases, 5601 Fishers Lane, Suite 6D, PSAA Antigen and Uses Thereof’’ (HHS
Contact Person: Karin F. Helmers, Ph.D., MSC9804, Rockville, MD 20852–9804, Reference No. E–338–2013/0–EP–04),
Scientific Review Officer, Center for phone number 301–496–2644, or and validated in: Germany, Spain,
Scientific Review, National Institutes of France, the United Kingdom, and
karen.surabian@nih.gov.
Health, 6701 Rockledge Drive, Room 3166,
SUPPLEMENTARY INFORMATION: The Ireland; Hong Kong Patent Number
MSC 7770, Bethesda, MD 20892, 301–254–
9975, helmersk@csr.nih.gov. following represents the intellectual 1115144, issued 02/14/2014, entitled
(Catalogue of Federal Domestic Assistance property to be licensed under the ‘‘Functional Epitopes of Streptococcus
Program Nos. 93.306, Comparative Medicine; prospective agreement: United States Pneumonia PSAA Antigen and Uses
93.333, Clinical Research, 93.306, 93.333, Provisional Patent Application Number Thereof’’ (HHS Reference No. E–338–
93.337, 93.393–93.396, 93.837–93.844, 61/085,208, filed 07/31/2008, entitled 2013/0–HK–05); United States Patent
93.846–93.878, 93.892, 93.893, National ‘‘Methods of Enhancing Number 7,919,104, issued 04/05/2011,
Institutes of Health, HHS) entitled ‘‘Functional Epitopes of
Opsonophagocytosis in Response to a
Dated: June 8, 2018. Pathogen’’ (HHS Reference No. E–329– Streptococcus Pneumonia PSAA
Sylvia L. Neal, 2013/0–US–01); PCT Patent Application Antigen and Uses Thereof’’ (HHS
Program Analyst, Office of Federal Advisory Number PCT/US2009/052384, filed 07/ Reference No. E–338–2013/0–US–06);
Committee Policy. 31/2009, entitled ‘‘Methods of Canada Patent Application Number
[FR Doc. 2018–12839 Filed 6–14–18; 8:45 am] Enhancing Opsonophagocytosis in 2,631,556, filed 09/15/2014, entitled
Response to a Pathogen’’ (HHS ‘‘Functional Epitopes of Streptococcus
BILLING CODE 4140–01–P
Pneumonia PSAA Antigen and Uses
Reference No. E–329–2013/0–PCT–02);
Thereof’’ (HHS Reference No. E–338–
China Patent Number 200980137625.X,
DEPARTMENT OF HEALTH AND 2013/0–CA–07); Australia Patent
issued 11/26/2014, entitled ‘‘Methods of
HUMAN SERVICES Number 2012201107, issued 06/06/
Enhancing Opsonophagocytosis in
2013, entitled ‘‘Functional Epitopes of
Response to a Pathogen’’ (HHS
National Institutes of Health Streptococcus Pneumonia PSAA
Reference No. E–329–2013/0–CN–03);
Antigen and Uses Thereof’’ (HHS
European Patent Number 2323684,
Prospective Grant of Exclusive Patent Reference No. E–338–2013/0–AU–08);
issued 05/21/2014, entitled ‘‘Use of a
Commercialization License: Hong Kong Patent Number HK1163113,
Pneumococcal P4 Peptide for Enhancing
Streptococcus Pneumonia PSAA issued 06/05/2015, entitled ‘‘Functional
Opsonophagocytosis in Response to a Epitopes of Streptococcus Pneumonia
Peptide for Treatment of Sepsis and
Pathogen’’ (HHS Reference No. E–329– PSAA Antigen and Uses Thereof’’ (HHS
Infection
2013/0–EP–04), and validated in Reference No. E–338–2013/0–HK–09);
AGENCY: National Institutes of Health, Germany, Spain, France, the United European Patent Number 2371843,
Centers for Disease Control and Kingdom, and Ireland; Hong Kong issued 09/17/2014, entitled ‘‘Functional
Prevention, Department of Health and Patent Number 1160391, issued 07/31/ Epitopes of Streptococcus Pneumonia
Human Services. 2015, entitled ‘‘Methods of Enhancing PSAA Antigen and Uses Thereof’’ (HHS
ACTION: Notice. Opsonophagocytosis in Response to a Reference No. E–338–2013/0–EP–10),
Pathogen’’ (HHS Reference No. E–329– and validated in: Germany, France, and
SUMMARY: The National Institute of 2013/0–HK–05); United States Patent
Allergy and Infectious Diseases, an the United Kingdom.
Number 8,431,134, issued 04/30/2013, All rights in these inventions have
institute of the National Institutes of entitled ‘‘Use of a Pneumococcal P4 been assigned to the Government of the
Health, Department of Health and Peptide for Enhancing United States of America.
Human Services, on behalf of the Opsonophagocytosis in Response to a The prospective exclusive patent
Centers for Disease Control and Pathogen’’ (HHS Reference No. E–329– commercialization license territory may
Prevention, Department of Health and 2013/0–US–06); United States Patent be worldwide and the field of use may
Human Services, is contemplating the Number 9,101,582, issued 08/11/2015, be limited to: ‘‘Development,
grant of an exclusive patent entitled ‘‘Use of a Pneumococcal P4 manufacture, and sale of a P4 peptide
commercialization license to The Peptide for Enhancing therapeutic for the treatment of
University of Liverpool, located in Opsonophagocytosis in Response to a infection and sepsis.’’
Liverpool, UK, to practice the Pathogen’’ (HHS Reference No. E–329– These inventions, developed within
inventions embodied in the patent 2013/0–US–07); United States the National Center for Immunization
applications listed in the Provisional Patent Application Number and Respiratory Diseases (NCIRD), at the
Supplementary Information section of 60/682,495, filed 05/19/2005, entitled Centers for Disease Control and
this notice. ‘‘Functional Epitopes of Streptococcus Prevention (CDC), describe methods to
DATES: Only written comments and/or Pneumonia PSAA Antigen and Uses bolster the human body’s own
applications for a license which are Thereof’’ (HHS Reference No. E–338– mechanisms to fight infection by
sradovich on DSK3GMQ082PROD with NOTICES

received by the Technology Transfer 2013/0–US–01); PCT Patent Application enhancing an innate immune response,
and Intellectual Property Office, Number PCT/US2005/027290, filed opsonophagocytosis. The specific 24
National Institute of Allergy and 07/29/2005, entitled ‘‘Functional amino acid peptide sequence (P4) acts
Infectious Diseases on or before July 2, Epitopes of Streptococcus Pneumonia as a polymorphonuclear cell activator.
2018 will be considered. PSAA Antigen and Uses Thereof’’ (HHS P4 can be administered in vivo along
ADDRESSES: Requests for copies of the Reference No. E–338–2013/0–PCT–02); with disease-specific antibodies to
patent applications, inquiries, and Australia Patent Number 2005332058, enhance systemic bacterial clearance,

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Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices 28003

thus leading to prolonged survival. This Subcommittee meetings. The National to be used in preparing the report on
technology enhances the body’s Cancer Advisory Board Ad Hoc best practices’’ and to consider
response to a variety of bacterial Subcommittee Population Science, categories including but not limited to
infections, including S. pneumoniae Epidemiology and Disparities meeting the following:
and S. aureus. on June 25, 2018, 5:30 p.m. to 7:30 p.m., Category #1: Sixteen specific
This notice is made in accordance will be held at the Gaithersburg Marriott underage drinking laws/regulations
with 35 U.S.C. 209 and 37 CFR part 404. Washingtonian Center in Salons A and enacted at the state level (e.g., laws
The prospective exclusive patent B. The National Cancer Advisory Board prohibiting sales to minors; laws related
commercialization license will be Ad Hoc Subcommittee on Global Cancer to minors in possession of alcohol).
royalty bearing and may be granted Research meeting on June 25, 2018, 7:30 Note that ten additional policies have
unless within fifteen (15) days from the p.m. to 9:00 p.m., will be held at the been added to the Report to Congress
date of this published notice, the Gaithersburg Marriott Washingtonian pursuant to Congressional
National Institute of Allergy and Center in Salon C. appropriations language or the
Infectious Diseases receives written Secretary’s authority granted by the
Dated: June 11, 2018.
evidence and argument that establishes STOP Act;
Melanie J. Pantoja, Category #2: Enforcement and
that the grant of the license would not
Program Analyst, Office of Federal Advisory educational programs to promote
be consistent with the requirements of Committee Policy.
35 U.S.C. 209 and 37 CFR part 404. compliance with these laws/regulations;
Complete applications for a license in [FR Doc. 2018–12837 Filed 6–14–18; 8:45 am] Category #3: Programs targeted to
the prospective field of use that are BILLING CODE 4140–01–P youths, parents, and caregivers to deter
timely filed in response to this notice underage drinking and the number of
will be treated as objections to the grant individuals served by these programs;
DEPARTMENT OF HEALTH AND Category #4: The amount that each
of the contemplated exclusive patent
HUMAN SERVICES state invests, per youth capita, on the
commercialization license. In response
to this Notice, the public may file prevention of underage drinking broken
Substance Abuse and Mental Health into five categories: (a) Compliance
comments or objections. Comments and Services Administration
objections, other than those in the form check programs in retail outlets; (b)
of a license application, will not be Checkpoints and saturation patrols that
Agency Information Collection
treated confidentially, and may be made include the goal of reducing and
Activities: Submission for OMB
publicly available. License applications deterring underage drinking; (c)
Review; Comment Request
submitted in response to this Notice Community-based, school-based, and
will be presumed to contain business Periodically, the Substance Abuse and higher-education-based programs to
confidential information, and any Mental Health Services Administration prevent underage drinking; (d)
(SAMHSA) will publish a summary of Underage drinking prevention programs
release of information in these license
information collection requests under that target youth within the juvenile
applications will be made only as
OMB review, in compliance with the justice and child welfare systems; and
required and upon a request under the
Paperwork Reduction Act (44 U.S.C. (e) Any other state efforts or programs
Freedom of Information Act, 5 U.S.C.
chapter 35). To request a copy of these that target underage drinking.
552. Congress’ purpose in mandating the
documents, call the SAMHSA Reports
Dated: June 11, 2018. Clearance Officer on (240) 276–1243. collection of data on state policies and
Suzanne M. Frisbie, programs through the State Survey is to
Deputy Director, Technology Transfer and Project: Survey of State Underage provide policymakers and the public
Intellectual Property Office, National Institute Drinking Prevention Policies and with otherwise unavailable but much
of Allergy and Infectious Diseases. Practices—(OMB No. 0930–0316)— needed information regarding state
[FR Doc. 2018–12838 Filed 6–14–18; 8:45 am] Revision underage drinking prevention policies
BILLING CODE 4140–01–P The Sober Truth on Preventing and programs. SAMHSA and other
Underage Drinking Act (the ‘‘STOP Federal agencies that have underage
Act’’) (Pub. L. 109–422, reauthorized in drinking prevention as part of their
DEPARTMENT OF HEALTH AND 2016 by Pub. L. 114–255) states that the mandate use the results of the State
HUMAN SERVICES ‘‘Secretary [of Health and Human Survey to inform federal programmatic
Services] shall . . . annually issue a priorities, as do other stakeholders,
National Institutes of Health report on each state’s performance in including community organizations.
enacting, enforcing, and creating laws, The information gathered by the State
National Cancer Institute; Amended
regulations, and programs to prevent or Survey has established a resource for
Notice of Meeting
reduce underage drinking.’’ The state agencies and the general public for
Notice is hereby given of a change in Secretary has delegated responsibility assessing policies and programs in their
the meeting of the joint meeting of the for this report to SAMHSA. Therefore, own state and for becoming familiar
National Cancer Advisory Board and SAMHSA has developed a Survey of with the programs, policies, and
NCI Board of Scientific Advisors, June State Underage Drinking Prevention funding priorities of other states.
26, 2018, 8:30 a.m. to June 27, 2018, Policies and Practices (the ‘‘State Because of the broad scope of data
12:00 p.m., National Cancer Institute Survey’’) to provide input for the state- required by the STOP Act, SAMHSA
relies on existing data sources where
sradovich on DSK3GMQ082PROD with NOTICES

Shady Grove, 9609 Medical Center by-state report on prevention and
Drive, Conference Room TE 406/408, enforcement activities related to possible to minimize the survey burden
Rockville, MD 20850 which was underage drinking component of the on the states. SAMHSA uses data on
published in the Federal Register on Annual Report to Congress on the state underage drinking policies from
June 05, 2018, 83 FR 26069. Prevention and Reduction of Underage the National Institute of Alcohol Abuse
This meeting notice is being amended Drinking (‘‘Report to Congress’’). and Alcoholism’s Alcohol Policy
to update the meeting locations for the The STOP Act also requires the Information System (APIS), an
National Cancer Advisory Board Ad Hoc Secretary to develop ‘‘a set of measures authoritative compendium of state

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Document Created: 2018-11-02 12:01:18
Document Modified: 2018-11-02 12:01:18

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 Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases on or before July 2, 2018 will be considered.
FR Citation		83 FR 28002

83 FR 28002 - Prospective Grant of Exclusive Patent Commercialization License: Streptococcus Pneumonia PSAA Peptide for Treatment of Sepsis and Infection

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 116 (June 15, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health