CTNF 18/469,342 CTNF 89177 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 § 112 07-36 AIA The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 07-36-01 AIA Claim s 3-5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 depends on claim 1, which recites an anti-HER2 segment capable of binding to a HER2 marker. Claim 3 adds a limitation that such marker is on HER2-positive cell. Location of the marker does not affect the structure of the segment binding to the marker, therefore claim 3 does not further limit claim 1. Claim 4 depends on claim 3 and further specifies that HER2-positive cell is HER2-positive cancer cell. Again, specific definition of location of the marker does not affect the structure of the segment binding to the marker, therefore claim 4 does not further limit claim 1. Claim 5 depends on claim 1, which recites an anti-CD16 segment capable of binding to a CD16 marker. Claim 5 adds a limitation that such marker is on cytotoxic effector cell. Location of the marker does not affect the structure of the segment binding to the marker, therefore claim 5 does not further limit claim 1 . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15-aia AIA Claim(s) 1-5 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Talkhabifard et al (WO 2022/144815, July 2022) . Concerning claims 1-5 Talkhabifard disclose dual-specific aptamer targeting HER2 and CD16 of SEQ ID NO: 14, wherein aptamers targeting HER2 and CD16 are connected with polyA linker of 20 nucleotides (see Table 1 on page 18, Table 3 on page 35, sequence listing). Such SEQ ID NO: 14 is identical to instant SEQ ID NO: 14. Talkhabifard further disclose that the linker can be double-stranded, wherein the polyA linker is hybridized to polyT linker of SEQ ID NO: 7 (see paragraph [00093], sequence listing), identical to instant SEQ ID NO: 7 . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim (s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toleikis et al (WO 2012/076190, June 2012) and in further view of Yarden et al (WO 2014/068553, May 2014) . Toleikis teach dual-specific aptamers binding to tumor-specific antigen and effector cell specific antigen (see Abstract). One of effector cell specific antigens is CD16, present on natural killer cells (see page 6). CD16 aptamer combined with tumor-specific antigen aptamer allows recruitment of natural killer cells to tumor cells (see page 6). Tumor-specific antigen can be HER2 (see page 8). Example 4 demonstrates a number of dual-specific aptamers, which can be connected by a linker of 15 A nucleotides and such linker can be further optimized (see page 21). One of such aptamers of SEQ ID NO: 75 (see page 23) comprises CD16 aptamer of nucleotides 104-144, identical to nucleotides 63-103 of instant SEQ ID NO: 14. Toleikis do not teach aptamer targeting HER2 and comprising nucleotides 1-42 of instant SEQ ID NO: 14. Yarden teach aptamers targeting HER2 (see lines 15-17 on page 8) and specifically aptamer of SEQ ID NO: 7 (see lines 22-24 on page 10), which is identical to nucleotides 1-42 of instant SEQ ID NO: 14. It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to create dual-specific aptamer combining aptamers taught by Toleikis and Yarden, arriving at instant invention. One of the ordinary skill in the art would be motivated to do so, because Toleikis suggest creating dual-specific aptamers targeting HER2 and CD16 and provide example of CD16 aptamer and Yarden provide example of effective HER2 aptamer. Toleikis further suggests connecting aptamers with polyA linker, which can be further optimized to a longer linker. Limitation of instant claim 2 refers to double-stranded linker and such linker is one of the options of claim 1, therefore it does not need to be taught in prior art to reject the claim. Claims 3-5 do not further limit claim 1, therefore they are rejected as well. Conclusion 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 Application/Control Number: 18/469,342 Page 2 Art Unit: 1637 Application/Control Number: 18/469,342 Page 3 Art Unit: 1637 Application/Control Number: 18/469,342 Page 4 Art Unit: 1637 Application/Control Number: 18/469,342 Page 5 Art Unit: 1637 Application/Control Number: 18/469,342 Page 6 Art Unit: 1637