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 .
Terminal Disclaimer
The terminal disclaimer filed on 10/08/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of the full statutory term of prior patent numbers 9580710, 10047110, 1004711, 10358647, 10792299, 11045488, 11352628, 11390871, 11926831, RE49229, RE49431 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 23-24, 26-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shapiro et al (WO 2013/075140, May 2013, cited from IDS) taken with the evidence of https://cansar.isr.ac.uk/cansar/cell-lines/A549/mutations/, cited from IDS, and in further view of Wagner et al (Am J Clin Pathol 2009;132:500-505, cited from IDS).
Shapiro et al teach chimeric nanoparticles forming siRNA targeting GSTP1 (same as GST-
π
) of instant SEQ ID NO: 287 (see Abstract, lines 6-11 on page 46), which can be administered to humans (see lines 25-27 on page 31, lines 10-12 on page 57) for treatment of breast cancer (see lines 1-5 on page 6) or lung adenocarcinoma (see lines 20-25 on page 27, Figure 53), decreasing expression of GSTP1 (see Figure 53). Shapiro et al teach administering such nanoparticles into A549 lung adenocarcinoma cells (see lines 13-16 on page 57), such A549 cells are KRAS mutant cells with a missense mutation at position 12 (see https://cansar.icr.ac.uk/cansar/cell- lines/A549/mutations/). Concerning claims 28-29 and 35-37, their limitations are functional and are expected to happen upon siRNA administration in the absence of evidence to the contrary.
Shapiro et al do not teach that the tumor cells comprise an increased level of expression of wild type KRAS protein compared to non-tumor cells and identifying such tumor cell.
Wagner et al teach that lung adenocarcinoma cells express higher level of KRAS than non-cancer cells (see Abstract).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to identify lung adenocarcinoma cells overexpressing KRAS and treat cancer with KRAS overexpression by administering siRNA targeting GST-π as taught by Shapiro et al and Wagner et al. One of the ordinary skill in the art would be motivated to do so because Wagner et al teach that lung adenocarcinoma cells overexpress KRAS and Shapiro et al teach administering nanoparticles forming siRNA, making it obvious to try administering siRNA by itself and treating the same cancer by administering siRNA targeting GST-π.
Response to Arguments
Applicant's arguments filed 10/08/2025 have been fully considered but they are not persuasive.
Previous 102 rejections are withdrawn in view of new amendments, arguments are moot.
Concerning Shapiro et al reference Applicant argues that the reference does not teach siRNA by itself, but teach nanoparticles forming such siRNA. In response the reference makes obvious to administer siRNA by itself, because it teaches nanoparticles forming such siRNA. Therefore amended 103 rejection is maintained.
Double patenting rejections are withdrawn in view of filing proper terminal disclaimer.
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.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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