Submission for OMB Review; Comment Request; Patent Term Extension, 74775 [2016-25951]

Download as PDF Federal Register / Vol. 81, No. 208 / Thursday, October 27, 2016 / Notices DEPARTMENT OF COMMERCE Patent and Trademark Office sradovich on DSK3GMQ082PROD with NOTICES Submission for OMB Review; Comment Request; Patent Term Extension The United States Patent and Trademark Office (USTPO) will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35). Agency: United States Patent and Trademark Office, Commerce. Title: Patent Term Extension. OMB Control Number: 0651–0020. Form Number(s): N/A. Type of Request: Renewal. Number of Respondents: 1,340. Average Hours per Response: 1 hour to 25 hours, depending upon the instrument used. Burden Hours: 6,187 hours. Cost Burden: $351,505.08. Needs and Uses: The patent term restoration portion of the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98– 417), which is codified at 35 U.S.C. 156, permits the United States Patent and Trademark Office (USPTO) to extend the term of protection under a patent to compensate for delay during regulatory review and approval by the Food and Drug Administration (FDA) or Department of Agriculture. Only patents for drug products, medical devices, food additives, or color additives are potentially eligible for extension. The maximum length that a patent may be extended under 35 U.S.C. 156 is five years. The USPTO administers 35 U.S.C. 156 through 37 CFR 1.710–1.791. Separate from the extension provisions of 35 U.S.C. 156, the USPTO may in some cases extend the term of an original patent due to certain delays in the prosecution of the patent application, including delays caused by interference proceedings, secrecy orders, or appellate review by the Patent Trial and Appeal Board or a Federal court in which the patent is issued pursuant to a decision reversing an adverse determination of patentability. The patent term provisions of 35 U.S.C. 154(b), as amended by Title IV, Subtitle D of the Intellectual Property and Communications Omnibus Reform Act of 1999, require the USPTO to notify the applicant of the patent term adjustment in the notice of allowance and give the applicant an opportunity to request reconsideration of the USPTO’s patent term adjustment determination. The USPTO administers 35 U.S.C. 154 through 37 CFR 1.701–1.705. VerDate Sep<11>2014 17:43 Oct 26, 2016 Jkt 241001 The public uses this information collection to file requests related to patent term extensions and reconsideration or reinstatement of patent term adjustments. The information in this collection is used by the USPTO to consider whether an applicant is eligible for a patent term extension or reconsideration of a patent term adjustment and, if so, to determine the length of the patent term extension or adjustment. Affected Public: Businesses or other for-profits; not-for-profit institutions. Frequency: On occasion. Respondent’s Obligation: Required to obtain or retain benefits. OMB Desk Officer: Kimberly R. Keravuori, email: Kimberly_R_ Keravuori@omb.eop.gov. Once submitted, the request will be publicly available in electronic format through reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB. Further information can be obtained by: • Email: InformationCollection@ uspto.gov. Include ‘‘0651–0020 copy request’’ in the subject line of the message. • Mail: Marcie Lovett, Records Management Division Director, OCIO, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450. Written comments and recommendations for the proposed information collection should be sent on or before November 28, 2016 to Kimberly R. Keravuori, OMB Desk Officer, via email to Kimberly_R_ Keravuori@omb.eop.gov, or by fax to 202–395–5167, marked to the attention of Kimberly R. Keravuori. Dated: October 20, 2016. Marcie Lovett, Records Management Division Director, OCIO, United States Patent and Trademark Office. [FR Doc. 2016–25951 Filed 10–26–16; 8:45 am] BILLING CODE 3510–16–P DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No.: PTO–P–2016–0039] Standard ST.26—Request for Comments on the Recommended Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings Using XML (eXtensible Markup Language) United States Patent and Trademark Office, Commerce. AGENCY: PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 ACTION: 74775 Request for comments. Patent applications that contain disclosures of nucleotide and/or amino acid sequences must contain sequence information in a separate part of the disclosure in a specified manner. The United States Patent and Trademark Office (Office) is seeking additional comments to obtain views of the public on the continuing international effort to revise the World Intellectual Property Organization (WIPO) standard for the presentation of nucleotide and/or amino acid sequences and the consequent changes to the United States rules of practice. The revised standard will be known as WIPO Standard ST.26. An interim version of WIPO Standard ST.26 was adopted in March 2016 by the Committee on WIPO Standards (CWS), but has not been implemented pending further consideration by the CWS. Since the adoption of the interim version, efforts have been undertaken to finalize WIPO Standard ST.26 and to improve its effectiveness once implemented. One aspect of that continuing effort is a proposed guidance document annex, which will include a variety of sequence disclosure examples, to ensure understanding and uniform application of standard requirements. Comments may be offered on any aspect of this effort, and in particular, (a) the comprehensiveness and clarity of WIPO Standard ST.26 and the proposed guidance document annex, and (b) the proposed authoring/validation tool for creation of a sequence listing in XML. DATES: Written comments must be received on or before December 27, 2016 to ensure consideration. No public hearing will be held. ADDRESSES: Comments concerning this notice should be sent by electronic mail message over the Internet addressed to seq_listing_xml@uspto.gov. Comments may also be submitted by mail addressed to: Mail Stop Comments— Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Susan C. Wolski, Office of International Patent Legal Administration, Office of the Deputy Commissioner for International Patent Cooperation. Although comments may be submitted by mail, the Office prefers to receive comments via the Internet. The comments will be available for public inspection at the Office of the Commissioner for Patents, located in Madison East, Tenth Floor, 600 Dulany Street, Alexandria, Virginia, and will be available via the Internet (http:// www.uspto.gov). Because comments will be made available for public inspection, information that the submitter does not SUMMARY: E:\FR\FM\27OCN1.SGM 27OCN1

Agencies

[Federal Register Volume 81, Number 208 (Thursday, October 27, 2016)]
[Notices]
[Page 74775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25951]



[[Page 74775]]

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DEPARTMENT OF COMMERCE

Patent and Trademark Office


Submission for OMB Review; Comment Request; Patent Term Extension

    The United States Patent and Trademark Office (USTPO) will submit 
to the Office of Management and Budget (OMB) for clearance the 
following proposal for collection of information under the provisions 
of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
    Agency: United States Patent and Trademark Office, Commerce.
    Title: Patent Term Extension.
    OMB Control Number: 0651-0020.
    Form Number(s): N/A.
    Type of Request: Renewal.
    Number of Respondents: 1,340.
    Average Hours per Response: 1 hour to 25 hours, depending upon the 
instrument used.
    Burden Hours: 6,187 hours.
    Cost Burden: $351,505.08.
    Needs and Uses: The patent term restoration portion of the Drug 
Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-
417), which is codified at 35 U.S.C. 156, permits the United States 
Patent and Trademark Office (USPTO) to extend the term of protection 
under a patent to compensate for delay during regulatory review and 
approval by the Food and Drug Administration (FDA) or Department of 
Agriculture. Only patents for drug products, medical devices, food 
additives, or color additives are potentially eligible for extension. 
The maximum length that a patent may be extended under 35 U.S.C. 156 is 
five years. The USPTO administers 35 U.S.C. 156 through 37 CFR 1.710-
1.791. Separate from the extension provisions of 35 U.S.C. 156, the 
USPTO may in some cases extend the term of an original patent due to 
certain delays in the prosecution of the patent application, including 
delays caused by interference proceedings, secrecy orders, or appellate 
review by the Patent Trial and Appeal Board or a Federal court in which 
the patent is issued pursuant to a decision reversing an adverse 
determination of patentability. The patent term provisions of 35 U.S.C. 
154(b), as amended by Title IV, Subtitle D of the Intellectual Property 
and Communications Omnibus Reform Act of 1999, require the USPTO to 
notify the applicant of the patent term adjustment in the notice of 
allowance and give the applicant an opportunity to request 
reconsideration of the USPTO's patent term adjustment determination. 
The USPTO administers 35 U.S.C. 154 through 37 CFR 1.701-1.705.
    The public uses this information collection to file requests 
related to patent term extensions and reconsideration or reinstatement 
of patent term adjustments. The information in this collection is used 
by the USPTO to consider whether an applicant is eligible for a patent 
term extension or reconsideration of a patent term adjustment and, if 
so, to determine the length of the patent term extension or adjustment.
    Affected Public: Businesses or other for-profits; not-for-profit 
institutions.
    Frequency: On occasion.
    Respondent's Obligation: Required to obtain or retain benefits.
    OMB Desk Officer: Kimberly R. Keravuori, email: 
Kimberly_R_Keravuori@omb.eop.gov.
    Once submitted, the request will be publicly available in 
electronic format through reginfo.gov. Follow the instructions to view 
Department of Commerce collections currently under review by OMB.
    Further information can be obtained by:
     Email: InformationCollection@uspto.gov. Include ``0651-
0020 copy request'' in the subject line of the message.
     Mail: Marcie Lovett, Records Management Division Director, 
OCIO, United States Patent and Trademark Office, P.O. Box 1450, 
Alexandria, VA 22313-1450.
    Written comments and recommendations for the proposed information 
collection should be sent on or before November 28, 2016 to Kimberly R. 
Keravuori, OMB Desk Officer, via email to 
Kimberly_R_Keravuori@omb.eop.gov, or by fax to 202-395-5167, marked to 
the attention of Kimberly R. Keravuori.

    Dated: October 20, 2016.
Marcie Lovett,
Records Management Division Director, OCIO, United States Patent and 
Trademark Office.
[FR Doc. 2016-25951 Filed 10-26-16; 8:45 am]
 BILLING CODE 3510-16-P