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. DETAILED ACTION Restriction/Election 1 . Applicant’s election without traverse of Invention Group II (claims 37, 47, and 58) in the reply filed on 11/11/2025 is acknowledged. 2. Claims 1, 5, 7, 9-10, 12, 15, 17, 22-23, 26-27, 37, 47, 58- 59, 65-66, 69, 76-77, 79-83, and 84-88 are pending. Claims 37, 47, and 58 are currently under consideration. Claims 1, 5, 7, 9-10, 12, 15, 17, 22-23, 26-27, 59, 65-66, 69, 76-77, 79-83, and 84-88 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention . Information Disclosure Statement 3. The information disclosure statement filed on 11/11/2025 and 12/29/2022 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to th is communication. Drawings 4. The drawing filed on 09/29/2022 are accepted by the examiner. Claim Rejections 35 USC § 112 (a) 5 . The following is a quotation of the first paragraph of 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention. 6 . Claims 37, 47, and 58 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba , B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar , 935 F.2d at 1563, 19 USPQ2d at 1116. Claim 37 is drawn to a method comprising administering a pharmaceutical composition of claim 5 to a subject suffering from a CLDN-18.2-positive solid tumor , whereas non-elected claim 5 is drawn to a pharmaceutical composition comprising: a ) at least one single-stranded RNA comprising one or more coding regions that encode an antibody agent that binds preferentially to a Claudin-18.2 (CLDN-18.2) polypeptide relative to a Claudin-18.1 (CLDN-18.1) polypeptide; and b) lipid nanoparticles; wherein the at least one single-stranded RNA is encapsulated within at least one of the lipid nanoparticles . Claims 37 and 47depend from claim 27. The claim s do not require that the anti- Claudin-18.2 antibody or single-stranded RNA possess any particular conserved structure nor other disclosed distinguishing feature. C laims encompass a genus of anti-Claudin-18.2 antibodies or single-stranded RNA without any structural features. For each claim drawn to a genus, MPEP §2163 II.A.3(a) ii) (page 2100-189) states, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i )(A), above), reduction to drawings (see i )(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i )( C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”. In the instant case, the specification discloses that a RiboMab format may be useful for RNA that delivers a CLDN-18.2 -targeting antibody (page 2, paragraph [6]). The specification discloses an anti-Claudin-18.2 antibod y , Zolbetuximab (development code IMAB362) (page 3, paragraph [8] ; page 446, paragraphs [140]-[141] ) . The specification also cite s a number of publications and discloses a number of anti-Claudin-18.2 antibod ies (page 45, paragraph [132]-page 47, paragraph [139]). However, such an instant disclosure is insufficient to support the broad genus of anti-Claudin-18.2 antibod ies and the single-stranded RNA s encoding the anti-Claudin-18.2 antibodies . Moreover, claims 37 and 47 recite a chemotherapeutic agent. There is no sufficient support for the broad genus of chemotherapeutic agents that can be used with the pharmaceutical composition used in the method of claim 27. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of anti-Claudin-18.2 antibodies or genus of single-stranded RNA s, and thus the instantly claimed method of using the same. Claim Rejections 35 USC § 112 (b) 7 . The following is a quotation of the second paragraph of 35 U.S.C. 112: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 8 . A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 37 recites the broad recitation “ a subject suffering from a CLDN-18.2-positive solid tumor” , and the claim also recites the narrower statement of the range/limitation “ optionally wherein the CLDN-18.2-positive tumor is: a) a pancreatic tumor, a gastric tumor, or a biliary tract tumor; and/or b) is locally advanced, unresectable, or metastatic ” and the narrower statement of the range/limitation “ optionally wherein: c) the subject has received a pre-treatment sufficient to increase CLDN-18.2 level such that a solid tumor from which the subject is suffering is characterized as a CLDN-18.2-positive solid tumor, d) the CLDN-18.2-positive tumor is characterized in that >50% of tumor cells show >2+ CLDN-18.2 protein staining intensity as assessed by an immunohistochemistry assay in formalin-fixed, paraffin-embedded neoplastic tissue from the subject, d) the pharmaceutical composition is administered as monotherapy, e) he pharmaceutical composition is administered as part of combination therapy comprising the pharmaceutical composition and a chemotherapeutic agent, and/or f) the subject has received the chemotherapeutic agent ” . Likewise, claim 47 is rejected on the same basis. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. 9. Claim s 37 , 47, and 58 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. ( i ). Claim 37 is drawn to a method comprising administering a pharmaceutical composition of claim 5 to a subject suffering a CLDN-18.2-positive solid tumor. Claim 37 is indefinite because it does not particularly point out and distinctly claim the subject matter. Claim 5 does not point out whether it is a method of treating a CLDN-18.2-positive solid tumor or it merely requires administering a pharmaceutical composition of claim 5 to a subject suffering a CLDN-18.2-positive solid tumor. (ii). Claim 37 recites “a pretreatment” in line 7 and “a chemotherapeutic agent” in lines 15-16. Claim 47 recites “ the chemotherapeutic agent ” in line 2. It is unclear what the pretreatment and the chemotherapeutic agent refer to. (i i ). Claim 58 reads: In a method of delivering a CLDN-18.2-targeting antibody for cancer treatment in a subject, the improvement comprising administering to the subject the pharmaceutical composition of claim 47. It is unclear if the claim is drawn to a method of cancer treatment or a method of delivering a CLDN-18.2-targeting antibody . It is unclear if “ the improvement ” refers to the improvement of treatment or improvement of delivery of a a CLDN-18.2-targeting antibody . Claim Rejections under 35 USC § 103(a) 1 0 . The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. 1 1 . Claims 37, 47, and 58 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tran et al. ( EMBO 9 (10), 1434-1447, 2017) in view of Türeci et al . ( Oncoimmunology , V ol . 8, N o . 1, e1523096 , 10 pages , published online, 10 Nov 2018). Tran et al. teach a pharmaceutical composition comprising mRNA that encodes an antibody and lipid nanoparticles (see, e.g., Abstract). Tran et al. teach that various antibodies using different designs were expressed and characterized in vitro and in vivo in the fields of cancer immunotherapies and that therapeutic mRNA ‐ mediated antibody expression allowed mice to survive an otherwise lethal tumor challenge. (Abstract). Tran et al. do not teach a pharmaceutical composition comprising a single-stranded RNA encoding an antibody that specifically binds Claudin-18.2 and lipid nanoparticles and a method comprising administering the composition to a subject suffering from a CLDN-18.2-positive solid tumor. Türeci et al teach an antibody that specifically binds Claudin-18.2 (CLDN18.2) (see, e.g., Abstract). It would have been obvious to one having ordinary skill in the art at the time the invention was made to make a p harmaceutical composition comprising a single-stranded RNA encoding an anti- Claudin-18.2 antibody taught by Türeci et al . and lipid nanoparticles , and to treat a CLDN-18.2-positive solid tumor with a reasonable expectation of success. One would have been motivated to do so because such a pharmaceutical composition allows expression of the encoded antibody without inducing an adverse immune response against the encoded antibody as taught by Tran et al. (Abstract). It would also have been obvious to one having ordinary skill in the art at the time the invention was made to administer to a subject a pharmaceutical composition taught by Tran et al. and Türeci et al . in combination with a chemotherapeutic agent with a reasonable expectation of success. One would have been motivated to do so because such a combination therapy with chemotherapeutic agent is well-known in the art and routinely practiced by one of skill in the art. Cl aim Objections 1 2 . Claim 37 is objected to because ( i ). it depends from a non-elected claim (claim 5) ; and (ii) . “ any one of claim 5” should be amended to – of claim 5 --. Conclusion 1 3 . No claims are allowed. Advisory Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov . Should you have questions on access to the Private PAIR system, please contact the Electronic Business Center (EBC) at the toll-free phone number 866-217-9197. /RUIXIANG LI/ Primary Examiner, Art Unit 16 74 December 1 7 , 2025