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. Election/Restrictions Applicant’s election with traverse of Group I (claims 2-3, 6-7, 14, 16-17, 19, 48-49, and 51) and Applicant’s election without traverse of the below-listed species in the reply filed on 11/11/2025 is acknowledged. Elected Species: Anti-CLDN18.2 antibody 14G11 comprising HCDRs 1-3, LCDRs 1-3, VH, and VL sequences corresponding to SEQ ID NOs: 1/3/5, 2/4/6, 13, and 14, respectively. CLDN18.2 associated disease and disease subtype: cancer and gastric cancer, respectively. CLDN18.2-targeting agent for use as therapeutic agent: therapeutic anti-CLDN18.2 antibody. With regard to the election of Group I with traverse, Applicant argues that invention groups I-III all share the special technical feature of an isolated antibody or an antigen binding fragment thereof that specifically binds to CLDN18.2 comprising: A heavy chain CDR1 comprising the amino acid sequence of X 1 X 2 YX 3 H (SEQ ID NO: 8), a heavy chain CDR2 comprising the amino acid sequence of WIYPX4GX 5 X 6 X 7 X 8 YX 9 EKFKG (SEQ ID NO: 12), and a heavy chain CDR3 comprising the amino acid sequence of NYX 10 STFGY (SEQ ID NO: 24); and/or A light chain CDRI1 comprising the amino acid sequence of RSSQNIVHSNGNTYLE (SEQ ID NO: 2), a light chain CDR2 comprising the amino acid sequence of KX 11 SNRFS (SEQ ID NO: 25), and a light chain CDR3 comprising the amino acid sequence of FQGSHVPFT (SEQ ID NO: 6); wherein X 1 is R or T, X 2 is N or Y, X 3 is F or I, X 4 is G or R, X 5 is F or G, X 6 is D or N, X 7 is I or T, X 8 is E or V, X 9 is S or N, X 10 is G or R, and X 11 is V or I. Applicant argues that such an antibody with the consensus CDR amino acid sequences is not disclosed, taught, or suggested by US 2018/0117174 A1 (previously cited on PTO-892) and thus constitutes a special technical feature and groups I-III therefore have unity of invention. Applicant’s argument has been fully considered, but is deemed not persuasive. Particularly, it is noted that technical feature argued by applicant is variable and represents hundreds of possible CDR sets. It is well established in the art and that CDR variability is highly unpredictable , and Applicant has not demonstrated that the consensus sequences are the core CDR sequences that are sufficient to convey the ability of an antibody having as few as three CDRs (heavy or light chain CDRs1-3) the ability to specifically bind CLDN18.2, regardless of the variability of the other CDR residues . Thus, the shared feature of groups I-III is, more generally, an antibody or antigen binding fragment thereof that specifically binds to CLDN18.2, which is taught by US 2018/0117174 A1 . As such, the Restriction/Election requirement is deemed proper and is made FINAL. Claim Status Claims 1, 4-5, 8-13, 15, 18, 20-22, 27, 34, 36-38, 40-41, 44, 46, 50, and 52-54 have been cancelled and c laims 6-7, 14, 16-17, 19, 23, 26, 28-33, 35, 39, 42-43, 45, 47-49, and 51 have been amended, as requested in the preliminary amendment filed on 09/12/2023. Following the amendment, claims 2-3, 6-7, 14, 16-17, 19, 23-26, 28-33, 35, 39, 42-43, 45, 47-49, and 51 are pending in the instant application. Claims 23-26, 28-33, 35, 39, 42-43, 45, and 47 stand as withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions in the Response filed 11/11/2025 , there being no allowable generic or linking claim. Claims 2-3, 6-7, 14, 16-17, 19, 48-49, and 51 are under examination in the instant office action. Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. It is noted that the claim to foreign priority has been perfected. Claims 2-3, 6-7, 14, 16-17, 19, 48-49, and 51 have an effective filing date of May 25, 2020 corresponding to PCT/CN2020/092092 . Information Disclosure Statement The information disclosure statement s (IDS) submitted on FILLIN "Enter date IDS was filed" \* MERGEFORMAT 11/25/2022, 10/15/2024, 01/03/2025, 02/13/2025, 07/17/2025, and 11/23/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statemen t s are being considered by the examiner. Specification Applicant is reminded of the proper content of an abstract of the disclosure. A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art. If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives. Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps. Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts. The abstract of the disclosure is objected to because FILLIN "Enter appropriate information" \* MERGEFORMAT it is less than 50 words in length . A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). The disclosure i s objected to because of the following informalities: The use of the term FILLIN "Identify the term that is a trade name or mark used in commerce." \d "[ 1 ]" nanobody which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Appropriate correction is required. Claim Objections Claims 6-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim FILLIN "Enter claim indentification information" \* MERGEFORMAT 17 is objected to because of the following informalities: FILLIN "Enter appropriate explanation" \* MERGEFORMAT the claim recites the limitation of "a multispecific antibody" twice at lines 3 and 9 . Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—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 or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 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. Claim FILLIN "Enter claim identification information" \* MERGEFORMAT s 2-3, 14, 16-17, 19, 48-49, and 51 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. 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. The claims are drawn to a genus of antibodies that specifically bind CLDN18.2, which may comprise one of many possible combinations of heavy chain CDRs1-3 and/or one of the possible recited combinations of light chain CDRs1-3, see claim 2 . Heavy chain CDR1 and CDR2 also encompass an exponential number of possible sequence variants. Thus, the genus of antibodies claimed and required to specifically bind CLDN18.2 is vast. At Pages 36-37 of the Specification, two species of CLDN18.2 antibodies have been adequately described; specifically, the antibodies with the secondary identifiers 14G11 and 69H2. These two antibodies have been adequately described by the recitation of six CDRs (heavy chain CDRs1-3 and light chain CDRs1-3). See Table 1: However, even though Applicant has disclosed two species of antibodies that specifically bind CLDN18.2, Applicant is claiming a large and structurally diverse genus of CLDN18.2 antibody species, each of which comprise one of numerous possible combinations of the recited CDRs and CDR sequence variants. Absent empirical determination, one skilled in the art would be unable to immediately envision, recognize, or distinguish at least most of the members comprised within the genus claimed, specifically which variations and subsequent combinations of the recited CDRs yield antibodies that are capable of specifically binding CLDN18.2 . Accordingly, Applicant’s disclosure is not sufficient to demonstrate possession of the entire claimed genus, and Applicant’s disclosure does not satisfy the written description requirement of 35 U.S.C. 112(a). 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, reduction to drawings, 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 Eli Lilly , 119 F.3d at 1568, 43 USPQ2d at 1406 ; and see Enzo Biochem , Inc. V. Gen-Probe Inc . A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. As previously indicated, Applicant has disclosed two species within the genus claimed. However, given the large number of species encompassed by the genus claimed as well as the high level of structure variation that would be displayed by members of the claimed genus, the disclosure of said two adequately described species is not sufficiently representative of the entire genus. Furthermore, other than the six defined CDR sequences for each of antibodies 14G11 and 69H2 (See Table 1 above), Applicant has not disclosed relevant, identifying characteristics of CDR amino acid sequences (or variations/combinations thereof) that confer upon an antibody the ability to specifically bind CLDN18.2 . It is well-known in the art that antibodies generally comprise six CDRs. The amino acid sequences of the CDRs are hypervariable, and the amino acid residues contained within the six CDRs determine the antigen specificity of a particular antibody . Absent a description of the at least minimal structural features correlating with a functional ability to specifically bind CLDN18.2 which are shared by members of a genus of antibodie s commonly sharing this function, it is submitted that the skilled artisan could not immediately envision, recognize, or distinguish which CDR amino acid sequences (or variants/ combinations thereof) may be combined such that the resultant antibody comprises six defined CDR sequences that confer the ability to specifically bind CLDN18.2 . Applicants have not established any reasonable structure-function correlation with regards to the sequences in the CDRs that can be altered and still maintain CLDN18.2 binding function. Furthermore, it is noted that claim 17 encompasses single domain antibodies (e.g., N anobody ® , camelized , bivalent domain, and domain antibodies); however the instant specification does not provide any exemplary species of such single domain antibodies which may comprise as few as three CDRs that have the ability to specifically bind CLDN18.2. The instant specification only discloses antibodies that require six defined CDRs, three heavy chain and three light chain CDRs , critical to the CLDN18.2 binding function . Thus, regarding claim 17, the specification fails to provide a representative number of species of single domain antibodies and fails to provide a structure-function correlation between which CDRs/sequences of a single domain antibody function to specifically bind CLDN18.2. Although screening techniques can be used to isolate antibodies that possess the ability to specifically bind CLDN18.2 , Applicant is reminded that the written description requirement of 35 U.S.C. 112 is severable from the enablement provision. As stated in Vas-Cath Inc. v. Mahurkar (CA FC) 19 USPQ2d 1111, 935 F2d 1555, “The purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’; the applicant must also convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” Applicant is informed that, as indicated below, the elected CDR , VH, and VL set (corresponding to antibody 14G11) elected by Applicant has been fully examined and is free of the prior art . Therefore, the rejection of the claims under 35 U.S.C. 112(a) as failing to meet the written description requirement may be overcome by amending claims 1 and 15 to recite all six elected CDRs . The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.— The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: 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. Claim FILLIN "Enter claim indentification information" \* MERGEFORMAT s 14 and 16-17 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim FILLIN "Enter claim identification information" \* MERGEFORMAT 14 , the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention . The claim currently recites “an immunoglobulin constant region, optionally comprising a heavy chain constant region of IgG and/or a light chain constant region”, and it is unclear if the antibody of claim 14 is required to comprise an IgG heavy chain constant domain and/or a light chain constant domain, or if an IgG heavy chain constant domain and/or light chain constant domain are only exemplary embodiments and are not a requirement of the claim. Claim 16 is included in this rejection as it depends from claim 14. Regarding claim FILLIN "Enter claim identification information" \* MERGEFORMAT 17 , the phrase " e.g. " renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The claim currently recites “a modified antibody (e.g. glycosylated antibody)”, and it is unclear if a modified antibody is required to be a glycosylated antibody or if a glycosylated antibody is only an exemplary embodiment of a modified antibody and is not a requirement of the claim. Claim 17 is also indefinite in the use of the expression in parenthesis “(e.g. glycosylated antibody)” in that it is not clear whether this recitation is intended to be part of the claim or not. Further regarding c laim FILLIN "Enter claim identification information" \* MERGEFORMAT 17 , it is noted that the claim contains the trademark/trade name FILLIN "Enter appropriate name" \* MERGEFORMAT N anobody ® . Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph. See Ex parte Simpson , 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe FILLIN "Enter appropriate information" \* MERGEFORMAT a single domain antibody and, accordingly, the identification/description is indefinite. Art-Free Subject Matter It is noted that the elected 14G11 antibody comprising HCDRs 1-3, LCDRs 1-3, VH, and VL sequences corresponding to SEQ ID NOs: 1/3/5, 2/4/6, 13, and 14, respectively, has been thoroughly searched and is free of the prior art. However, as noted above , claims 6-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Conclusion Claims 2-3, 6-7, 14, 16-17, 19, 23-26, 28-33, 35, 39, 42-43, 45, 47-49, and 51 are pending. Claims 23-26, 28-33, 35, 39, 42-43, 45, and 47 are withdrawn. Claims 2-3 , 14, 16-17, 19, 48-49, and 51 are rejected. Claims 6-7 are objected to. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ALYSSA RAE STONEBRAKER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-0863 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Thursday 7:00 am - 5:00 pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT Samira Jean-Louis can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)270-3503 . 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. /ALYSSA RAE STONEBRAKER/ Examiner, Art Unit 1642 /Laura B Goddard/ Primary Examiner, Art Unit 1642