DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sah et al (US 2007/0105806, May 2007, cited from IDS) and in further view of Tzabazis et al (Laboratory Investigations, 2007, vol.106, 1196-1203, cited from IDS), Kovacevic et al (US 2012/0294797, November 2012, of record) and GenBank X02330.1 (GenBank, 2016, pages 1-3, of record).
Sah et al teach methods of treating pain in subjects by administering dsRNA (see paragraph [0025]). Such dsRNA can be administered with the reporter gene (see paragraph [0318]) and dsRNA is a gene expression modifier, because it blocks gene expression (see paragraph [0015]). Disease to treat can be fibromyalgia (see paragraph [0150]) and other pain - related disorders (see paragraph [0152]), therefore inherently including complex regional pain syndrome. dsRNA can be delivered in a vector under polymerase Il control (see paragraph [0315]). Sah et al further teach designing dsRNAs targeting specific protein based on the protein mRNA sequence, such dsRNAs comprising two sequences complementary to each other (see paragraphs [0018-0019, 0049, 0056-0057]).
Sah et al do not teach gene expression modifiers comprising any of SEQ ID NOs: 15-30.
Tzabazis et al teach that antisense inhibition of CGRP reduces sensitivity to pain and can be used for pain treatment (see Abstract).
Kovacevich et al teach that anti-CGRP antibodies can be administered for treatment of fibromyalgia and complex regional pain syndrome (see paragraphs [0314-0315]).
GenBank X02330.1 provides mRNA sequence of CGRP (see page 3), comprising sequences complementary to at least instant SEQ ID NOs: 15-17.
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to treat pain disorders such as fibromyalgia and complex regional pain syndrome by administering vectors comprising dsRNAs, gene expression modifiers, targeting CGRP to a subject based on teachings of Sah et al, Tzabazis et al, Kovacevich et al and GenBank X02330.1. One of the ordinary skill in the art would be motivated to do so, because Tzabazis et al and Kovacevich et al teach that inhibition of CGRP can be used to treat pain disorders such as fibromyalgia and complex regional pain syndrome. Further one of the ordinary skill in the art can design dsRNAs as inhibitors of CGRP based on teachings of Sah et al and GenBank X02330.1, arriving at instant SEQ ID NOs: 15-17, and deliver them as vectors taught by Sah et al.
Response to Arguments
Applicant's arguments filed 02/04/2026 have been fully considered but they are not persuasive.
Concerning 103 rejection Applicant argues that none of the references teach any of instant SEQ ID NOs: 15-30. In response the references make obvious at least instant SEQ ID NOs: 15-17, which are complementary to mRNA sequence of CGRP.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571)272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637