81 FR 37579 - Grant of Interim Extension of the Term of U.S. Patent No. 5,912,231; LOCILEX® (pexiganan)

DEPARTMENT OF COMMERCE
United States Patent and Trademark Office

Federal Register Volume 81, Issue 112 (June 10, 2016)

Page Range		37579-37580
FR Document		2016-13764

The United States Patent and Trademark Office has issued an order granting interim extension under 35 U.S.C. 156(d)(5) for a one- year interim extension of the term of U.S. Patent No. 5,912,231.

Federal Register, Volume 81 Issue 112 (Friday, June 10, 2016)

[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37579-37580]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13764]


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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

[Docket No.: PTO-P-2016-00014]


Grant of Interim Extension of the Term of U.S. Patent No. 
5,912,231; LOCILEX[supreg] (pexiganan)

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Notice of Interim Patent Term Extension.

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SUMMARY: The United States Patent and Trademark Office has issued an 
order granting interim extension under 35 U.S.C. 156(d)(5) for a one-
year interim extension of the term of U.S. Patent No. 5,912,231.

FOR FURTHER INFORMATION CONTACT: Mary C. Till by telephone at (571) 
272-7755; by mail marked to her attention and addressed to the 
Commissioner for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, 
Alexandria, VA 22313-1450; by fax marked to her attention at (571) 273-
7755; or by email to [email protected].

SUPPLEMENTARY INFORMATION: Section 156 of Title 35, United States Code, 
generally provides that the term of a patent may be extended for a 
period of up to five years if the patent claims a product, or a method 
of making or using a product, that has been subject to certain defined 
regulatory review, and that the patent may be extended for interim 
periods of up to one year if the regulatory review is anticipated to 
extend beyond the expiration date of the patent.
    On May 26, 2016, Scripps Research Institute, the patent owner of 
record, timely filed an application under 35 U.S.C. 156(d)(5) for an 
interim extension of the term of U.S. Patent No. 5,912,231. The patent 
claims a composition of the active ingredient pexiganan of the human 
drug product LOCILEX[supreg]. The application for patent term extension 
indicates that New Drug Application (NDA) 29-930 was submitted to the 
Food and Drug Administration (FDA) on July 24, 1998.
    Review of the patent term extension application indicates that, 
except for permission to market or use the product commercially, the 
subject patent would be eligible for an extension of the patent term 
under 35 U.S.C. 156, and that the patent should be extended for one 
year as required by 35 U.S.C. 156(d)(5)(B). Because the regulatory 
review period will continue beyond the original expiration date of the 
patent, June 15, 2016, interim extension of the patent term under 35 
U.S.C. 156(d)(5) is appropriate.
    An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. 
Patent No. 5,912,231 is granted for a period of one year from the 
original expiration date of the patent.


[[Page 37580]]


    Dated: June 6, 2016.
Robert Bahr,
Deputy Commissioner for Patent Examination Policy, United States Patent 
and Trademark Office.
[FR Doc. 2016-13764 Filed 6-9-16; 8:45 am]
BILLING CODE 3510-16-P

Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices 37579

(Assistant Regional Administrator), has fishing in the Western GOM Closure ACTION: Notice of Interim Patent Term
made a preliminary determination that Area and from retaining undersized Extension.
an exempted fishing permit application groundfish. The vessel would use four
contains all of the required information electric rod and reels each day and fish SUMMARY: The United States Patent and
and warrants further consideration. This for at least 4 to 6 hours, with an Trademark Office has issued an order
permit would allow one commercial additional 5 to 6 hours of steaming, for granting interim extension under 35
fishing vessel to test the economic a total trip of approximately 12 hours. U.S.C. 156(d)(5) for a one-year interim
viability of using electric rod and reel Fishing would primarily occur within extension of the term of U.S. Patent No.
gear to target pollock in the Western the Western GOM Closure Area, in the 5,912,231.
Gulf of Maine Closure Area, and to area known as ‘‘The Fingers,’’ with
temporarily retain undersized catch for some effort being conducted outside the FOR FURTHER INFORMATION CONTACT:
measurement and data collection. The area. The researcher is requesting access Mary C. Till by telephone at (571) 272–
privately-funded study would be to the Western GOM Closure Area based 7755; by mail marked to her attention
conducted by a commercial fisherman on his belief that pollock is and addressed to the Commissioner for
as a pilot demonstration project. concentrated in this area, and that they Patents, Mail Stop Hatch-Waxman PTE,
Regulations under the Magnuson- can be targeted with minimal catch of P.O. Box 1450, Alexandria, VA 22313–
Stevens Fishery Conservation and non-target species. 1450; by fax marked to her attention at
Management Act require publication of A research technician would (571) 273–7755; or by email to
this notification to provide interested accompany all trips that occur under Mary.Till@uspto.gov.
parties the opportunity to comment on this EFP to measure and document fish
applications for proposed exempted caught (retained and discarded), SUPPLEMENTARY INFORMATION: Section
fishing permits. document fishing gear, bait, location, 156 of Title 35, United States Code,
DATES: Comments must be received on and fishing conditions to evaluate gear generally provides that the term of a
or before June 27, 2016. performance. Undersized fish would be patent may be extended for a period of
ADDRESSES: You may submit written discarded as quickly as possible after up to five years if the patent claims a
comments by any of the following sampling. All Northeast multispecies of product, or a method of making or using
methods: legal size would be landed, with all a product, that has been subject to
• Email: NMFS.GAR.EFP@noaa.gov. catch being attributed to the sector certain defined regulatory review, and
Include in the subject line ‘‘Comments vessel’s annual catch entitlement. that the patent may be extended for
on Rod and Reel Fishing in WGOM Proceeds from the sales would be interim periods of up to one year if the
Closed Area EFP.’’ retained by the vessel. The participating regulatory review is anticipated to
• Mail: John K. Bullard, Regional vessel would not be exempt from any extend beyond the expiration date of the
Administrator, NMFS, Greater Atlantic sector monitoring or reporting patent.
Regional Fisheries Office, 55 Great requirements.
If approved, the applicant may On May 26, 2016, Scripps Research
Republic Drive, Gloucester, MA 01930.
Mark the outside of the envelope request minor modifications and Institute, the patent owner of record,
‘‘Comments Rod and Reel Fishing in extensions to the EFP throughout the timely filed an application under 35
WGOM Closed Area EFP.’’ year. EFP modifications and extensions U.S.C. 156(d)(5) for an interim extension
FOR FURTHER INFORMATION CONTACT: may be granted without further notice if of the term of U.S. Patent No. 5,912,231.
Elizabeth Scheimer, Fisheries they are deemed essential to facilitate The patent claims a composition of the
Management Specialist, 978–281–9236, completion of the proposed research active ingredient pexiganan of the
Elizabeth.scheimer@noaa.gov. and have minimal impacts that do not human drug product LOCILEX®. The
SUPPLEMENTARY INFORMATION: A
change the scope or impact of the application for patent term extension
commercial fisherman submitted a initially approved EFP request. Any indicates that New Drug Application
complete application for an exempted fishing activity conducted outside the (NDA) 29–930 was submitted to the
fishing permit (EFP) on May 4, 2016, to scope of the exempted fishing activity Food and Drug Administration (FDA) on
conduct commercial fishing activities would be prohibited. July 24, 1998.
that the regulations would otherwise Authority: 16 U.S.C. 1801 et seq. Review of the patent term extension
restrict. The EFP would authorize one Dated: June 6, 2016. application indicates that, except for
vessel to use electric rod and reel gear Alan D. Risenhoover, permission to market or use the product
in the Western Gulf of Maine (GOM) Director, Office of Sustainable Fisheries, commercially, the subject patent would
Closure Area and to temporarily retain National Marine Fisheries Service. be eligible for an extension of the patent
undersized catch for measurement and [FR Doc. 2016–13728 Filed 6–9–16; 8:45 am] term under 35 U.S.C. 156, and that the
data collection. patent should be extended for one year
BILLING CODE 3510–22–P
The project, titled ‘‘Utilization of as required by 35 U.S.C. 156(d)(5)(B).
Electric Rod and Reel to Target Pollock
Because the regulatory review period
in WGOM Closed Area,’’ is privately DEPARTMENT OF COMMERCE will continue beyond the original
funded by a commercial fisherman as a
expiration date of the patent, June 15,
pilot study to test the economic viability United States Patent and Trademark
of using electric rod and reel gear to 2016, interim extension of the patent
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Office term under 35 U.S.C. 156(d)(5) is
target pollock while avoiding non-target
catch. The study would take place in the [Docket No.: PTO–P–2016–00014] appropriate.
Western GOM Closure Area, from June An interim extension under 35 U.S.C.
Grant of Interim Extension of the Term
through August 2016, with one vessel 156(d)(5) of the term of U.S. Patent No.
of U.S. Patent No. 5,912,231; LOCILEX®
planning to fish up to 5 days per month. 5,912,231 is granted for a period of one
(pexiganan)
The exemptions are necessary because year from the original expiration date of
groundfish vessels on commercial AGENCY:United States Patent and the patent.
groundfish trips are prohibited from Trademark Office, Commerce.

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37580 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices

Dated: June 6, 2016. for the Patent Public Advisory Order No. 13490, 74 FR 4673 (January
Robert Bahr, Committee, or TPACnominations@ 21, 2009) (While Executive Order 13490
Deputy Commissioner for Patent Examination uspto.gov for the Trademark Public does not specifically apply to federally
Policy, United States Patent and Trademark Advisory Committee. registered lobbyists appointed by agency
Office. FOR FURTHER INFORMATION CONTACT: or department heads, it sets forth the
[FR Doc. 2016–13764 Filed 6–9–16; 8:45 am] Vikrum D. Aiyer, Chief of Staff, Office Administration’s general policy of
BILLING CODE 3510–16–P of the Under Secretary of Commerce for decreasing the influence of special
Intellectual Property and Director of the interests in the Federal Government).
USPTO, at (571) 272–8600. Procedures and Guidelines of the
DEPARTMENT OF COMMERCE
SUPPLEMENTARY INFORMATION: The Patent and Trademark Public Advisory
United States Patent and Trademark Advisory Committees’ duties include: Committees
Office • Review and advise the Under
Secretary of Commerce for Intellectual Each newly appointed member of the
[Docket No. PTO–P–2016–0020] Property and Director of the USPTO on Patent and Trademark Public Advisory
matters relating to policies, goals, Committees will serve for a three-year
Patent and Trademark Public Advisory term that begins on December 1, 2015,
performance, budget, and user fees of
Committees and ends on December 1, 2018. As
the USPTO relating to patents and
AGENCY: United States Patent and trademarks, respectively; and required by the 1999 Act, members of
Trademark Office, Commerce. • Within 60 days after the end of each the Patent and Trademark Public
ACTION: Notice and request for fiscal year: (1) Prepare an annual report Advisory Committees will receive
nominations for the Patent and on matters listed above; (2) transmit the compensation for each day (including
Trademark Public Advisory report to the Secretary of Commerce, the travel time) while the member is
Committees. President, and the Committees on the attending meetings or engaged in the
Judiciary of the Senate and the House of business of that Advisory Committee.
SUMMARY: On November 29, 1999, the Representatives; and (3) publish the The enabling statute states that members
President signed into law the Patent and report in the Official Gazette of the are to be compensated at the daily
Trademark Office Efficiency Act (the USPTO. equivalent of the annual rate of basic
‘‘Act’’), Public Law 106–113, which, pay in effect for level III of the Executive
among other things, established two Advisory Committees Schedule under section 5314 of Title 5,
Public Advisory Committees to review The Public Advisory Committees are United States Code. Committee
the policies, goals, performance, budget each composed of nine (9) voting members are compensated on an hourly
and user fees of the United States Patent members who are appointed by the basis, calculated at the daily rate. While
and Trademark Office (USPTO) with Secretary of Commerce (the ‘‘Secretary’’) away from home or regular place of
respect to patents, in the case of the and serve at the pleasure of the business, each member shall be allowed
Patent Public Advisory Committee, and Secretary for three-year terms. Members travel expenses, including per diem in
with respect to trademarks, in the case are eligible for reappointment for a lieu of subsistence, as authorized by
of the Trademark Public Advisory second consecutive three-year term. The Section 5703 of Title 5, United States
Committee, and to advise the Director Public Advisory Committee members Code.
on these matters (now codified at 35 must be citizens of the United States Applicability of Certain Ethics Laws
U.S.C. 5). The America Invents Act and are chosen to represent the interests
Technical Corrections Act made several of diverse users of the United States Public Advisory Committee Members
amendments to the 1999 Act, including Patent and Trademark Office with are Special Government Employees
the requirement that the terms of the respect to patents, in the case of the within the meaning of Section 202 of
USPTO Public Advisory Committee Patent Public Advisory Committee, and Title 18, United States Code. The
members be realigned by 2014, so that with respect to trademarks, in the case following additional information
December 1 be used as the start and end of the Trademark Public Advisory includes several, but not all, of the
date, with terms staggered so that each Committee. Members must represent ethics rules that apply to members, and
year three existing terms expire and small and large entity applicants located assumes that members are not engaged
three new terms begin on December 1. in the United States in proportion to the in Public Advisory Committee business
Through this Notice, the USPTO is number of applications filed by such more than 60 days during any period of
requesting nominations for up to three applicants. The Committees must 365 consecutive days.
(3) members of the Patent Public include individuals with ‘‘substantial • Each member will be required to
Advisory Committee, and for up to three background and achievement in finance, file a confidential financial disclosure
(3) members of the Trademark Public management, labor relations, science, form within thirty (30) days of
Advisory Committee, for terms of three technology, and office automation.’’ 35 appointment. 5 CFR 2634.202(c),
years that begin on December 1, 2016. U.S.C. 5(b)(3). Each of the Public 2634.204, 2634.903, and 2634.904(b).
DATES: Nominations must be Advisory Committees also includes • Each member will be subject to
postmarked or electronically three (3) non-voting members many of the public integrity laws,
transmitted on or before July 25, 2016. representing each labor organization including criminal bars against
ADDRESSES: Persons wishing to submit recognized by the USPTO. representing a party in a particular
asabaliauskas on DSK3SPTVN1PROD with NOTICES

nominations should send the nominee’s Administration policy discourages the matter that came before the member’s
resumé by postal mail to Vikrum D. appointment of federally registered committee and that involved at least one
Aiyer, Chief of Staff, Office of the Under lobbyists to agency advisory boards and specific party. 18 U.S.C. 205(c); see also
Secretary of Commerce for Intellectual commissions (Lobbyists on Agency 18 U.S.C. 207 for post-membership bars.
Property and Director of the USPTO, Boards and Commissions, http:// A member also must not act on a matter
Post Office Box 1450, Alexandria, www.whitehouse.gov/blog/2009/09/23/ in which the member (or any of certain
Virginia 22313–1450 or by electronic lobbyist-agency-boards-and- closely related entities) has a financial
mail to: PPACnominations@uspto.gov commissions (Sept. 23, 2009)); cf. Exec. interest. 18 U.S.C. 208.

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Document Created: 2018-02-08 07:35:56
Document Modified: 2018-02-08 07:35:56

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 of Interim Patent Term Extension.
Contact		Mary C. Till by telephone at (571)
FR Citation		81 FR 37579

81 FR 37579 - Grant of Interim Extension of the Term of U.S. Patent No. 5,912,231; LOCILEX® (pexiganan)

DEPARTMENT OF COMMERCEUnited States Patent and Trademark Office

Federal Register Volume 81, Issue 112 (June 10, 2016)

DEPARTMENT OF COMMERCE
United States Patent and Trademark Office