Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 1-14, 19-20 and 31-35 were canceled.
Claims 15-18, 21-30 and 36 are pending and under consideration.
Withdrawn Rejections
Objections of specification and Drawings are withdrawn. Applicant amended the specification and Drawings, thereby obviating the objections.
Objection of claim 18 is withdrawn. Applicant amended the claim 18, thereby obviating this rejection/objection.
Rejection of Claims 15-18 and 21-36 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn. Applicant amended the claims 15-18 to recite specific clones deposited under the accession no. DSM ACC3144 (muAB 43-14A) and DSM ACC3143 (muAB 35-22A). Instant Figure 3 disclosed 6 CDR sequences for muAB 43-14A and muAB 35-22A. Therefore, amended claims 15-18 now define all 6 CDR sequences which are required for specific binding to antigen.
Rejection of Claims 31-34 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn. In the response filed on 10/9/2025, an attorney of record over his or her signature and registration number stated at page 10 that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent.
MAINTAINED - Claim Rejections - 35 USC § 112
(necessitated by amendments)
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.
Claims 18, 26, 30 and 36 are 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.
Amended claim 18 now recites “wherein a quantity of CLDN18.2 or CLDN18.2-expressing cells in the sample indicates that the cancer is treatable by a cancer therapy targeting CLDN18.2.” The wherein-clause is used to add additional description about the claim limitation which was already recited before wherein-clause, and claim 18 does not recite “a quantity of CLDN18.2 or CLDN18.2-expressing cells” before wherein-clause. The step (B) of claim 18 only recites “detecting the formation of a complex”. Therefore, it is unclear how “detecting the formation of a complex” of step (B) relates to “a quantity of CLDN18.2 or CLDN18.2-expressing cells”. How can one of ordinary skill in the art ascertain “a quantity of CLDN18.2 or CLDN18.2-expressing cells” by “detecting the formation of a complex”? For example, can one of ordinary skill in the art ascertain how many nanogram of CLDN18.2 is present in the sample by the presence of the complex between antibody and CLDN18.2?
Dependent claims are also rejected because they depend from claim 18 and therefore contain same claim limitation.
MAINTAINED - Double Patenting
(based on reconsideration)
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 15-18 and 21-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,976,130 (hereinafter patent’130; corresponds to US16/037,759). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Instant application is a divisional of parent case US16/037,759. However, restriction requirement of parent case was withdrawn in Notice of Allowance 1/3/2024 and therefore safe harbor protection does not apply to instant application.
Regarding claim 15, claim 9 of patent’130 claims “A method for detecting CLDN18.2 or determining the quantity of CLDN18.2 in a sample comprising the steps of: (i) contacting a sample with the antibody or the antigen-binding fragment thereof of claim 1; and (ii) detecting the formation of a complex or determining the quantity of a complex between the antibody or the antigen-binding fragment thereof and CLDN18.2 or the peptide fragment thereof”.
Claim 1 of patent’130 claims “An antibody or antigen-binding fragment thereof that binds to claudin 18.2 (CLDN18.2) or a peptide fragment thereof, wherein said peptide fragment comprises the amino acid sequence TEDEVQSYPSKHDYV (SEQ ID NO: 5) or EVQSYPSKHDYV (SEQ ID NO: 6)”.
Regarding newly added limitation “(i) an antibody produced by or obtainable from a clone deposited under the accession no. DSM ACC3144 (muAB 43-14A) or DSM ACC3143 (muAB 35-22A)”, claim 1 of patent’130 claims antibody comprising H-CDR sequences of SEQ ID NO: 8-10 and L-CDR sequences of SEQ ID NO: 12-14. As evidenced by instant figure 3, muAB 43-14A comprises H-CDR sequences of SEQ ID NO: 8-10 and L-CDR sequences of SEQ ID NO: 12-14.
Regarding claim 16, claim 10 of patent’130 claims “A method for determining whether cells express CLDN18.2 comprising the steps of: (i) contacting a cellular sample with the antibody or the antigen-binding fragment thereof of claim 1; and (ii) detecting the formation of a complex between the antibody or the antigen-binding fragment thereof and CLDN18.2 or the peptide fragment thereof expressed by cells in said sample”.
Regarding claim 17, claim 13 of patent’130 claims “A method for diagnosis, detection or monitoring of cancer comprising the steps of: (i) contacting a biological sample with the antibody or the antigen-binding fragment thereof of claim 1; and (ii) detecting the formation of a complex and/or determining the quantity of a complex between the antibody or the antigen-binding fragment thereof and CLDN18.2 or the peptide fragment thereof, wherein the presence of the complex indicates the onset, presence, progression, or recurrence of cancer.”
Regarding claim 18, claim 15 of patent’130 claims “A method for determining whether a cancer is treatable by a cancer therapy targeting CLDN18.2 comprising the steps of: (i) contacting a sample comprising cancer cells with the antibody or the antigen-binding fragment thereof of claim 1; and (ii) detecting the formation of a complex between the antibody or the antigen-binding fragment thereof and CLDN18.2 or the peptide fragment thereof, wherein the presence of the complex indicates that the cancer is treatable by a cancer therapy targeting CLDN18.2.”
Regarding claim 21 and 23, claim 11 of patent’130 claims “The method of claim 10, wherein said sample is derived from a subject having cancer or suspected of having cancer”.
Regarding claim 22 and 24, claim 12 of patent’130 claims “The method of claim 11, wherein said cancer is gastric, esophageal, pancreatic, ear nose and throat (ENT), lung, ovarian, colon, hepatic, head-neck, or gallbladder cancer.”
Regarding claim 25, claim 14 of patent’130 claims “The method of claim 13, wherein said cancer is gastric, esophageal, pancreatic, ear nose and throat (ENT), lung, ovarian, colon, hepatic, head-neck, or gallbladder cancer”.
Regarding claim 26, claim 16 of patent’130 claims “The method of claim 15, wherein said cancer is gastric, esophageal, pancreatic, ear nose and throat (ENT), lung, ovarian, colon, hepatic, head-neck, or gallbladder cancer.”
Claims 15-18 and 27-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 10,053,512 (patent’512; corresponds to US15/227,565; 4/2/2024 35-page IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claim 15, claim 18 of patent’512 claims “A method for detecting CLDN18.2 or determining the quantity of CLDN18.2 in a sample comprising the steps of: (i) contacting a sample with the antibody or antigen-binding fragment of claim 1 and (ii) detecting the formation of a complex or determining the quantity of a complex between the antibody or the antigen-binding fragment and CLDN18.2.”
Claim 1 of patent’512 claims “An antibody or antigen binding fragment thereof that binds to claudin 18.2 (CLDN18.2) or a peptide having the amino acid sequence TEDEVQSYPSKHDYV (SEQ ID NO: 5) or EVQSYPSKHDYV (SEQ ID NO: 6).”
Regarding newly added limitation “(i) an antibody produced by or obtainable from a clone deposited under the accession no. DSM ACC3144 (muAB 43-14A) or DSM ACC3143 (muAB 35-22A)”, claim 1 of patent’512 claims antibody comprising H-CDR sequences of SEQ ID NO: 8-10 and L-CDR sequences of SEQ ID NO: 12-14. As evidenced by instant figure 3, muAB 43-14A comprises H-CDR sequences of SEQ ID NO: 8-10 and L-CDR sequences of SEQ ID NO: 12-14.
Regarding claim 16, claim 19 of patent’512 claims “A method for determining whether cells express CLDN18.2 comprising the steps of: (i) contacting a cellular sample with the antibody or antigen-binding fragment of claim 1 and (ii) detecting the formation of a complex between the antibody or the antigen-binding fragment and CLDN18.2 expressed by cells in said sample.”
Regarding claim 17, claim 20 of patent’512 claims “A method for diagnosis, detection or monitoring of cancer comprising the steps of: contacting a biological sample with the antibody or antigen-binding fragment of claim 1 and (ii) detecting the formation of a complex and/or determining the quantity of a complex between the antibody or the antigen-binding fragment and CLDN18.2.”
Regarding claim 18, claim 21 of patent’512 claims “A method for determining whether a cancer is treatable by a cancer therapy targeting CLDN18.2 comprising the steps of: (i) contacting a sample comprising cancer cells with the antibody or antigen-binding fragment of claim 1 and (ii) detecting the formation of a complex between the antibody or the antigen-binding fragment and CLDN18.2.”
Regarding claim 27-30, claim 22 of patent’512 claims “The method of claim 18, wherein the sample comprises a paraffin embedded tissue section fixed with paraformaldehyde.”
Claims 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,512,232 (hereinafter patent’232; 4/2/2024 35-page IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claim 15, claim 4 of patent’232 claims “A method for detecting CLDN18.2 or determining the quantity of CLDN18.2 in a sample comprising the steps of: (i) contacting a sample with the antibody or antigen-binding fragment thereof of claim 1 and (ii) detecting the formation of a complex or determining the quantity of a complex between the antibody or the antigen-binding fragment thereof and CLDN18.2.” Claim 1 of patent’232 claims “An antibody selected from the group consisting of: (i) an antibody produced by or obtainable from a clone deposited under the accession no. DSM ACC3144 (muAB 43-14A) or DSM ACC3143 (muAB 35-22A)”. As evidenced by example 7 of instant specification, muAB 43-14A and muAB 35-22A antibody binds to SEQ ID NO: 5 or SEQ ID NO: 6.
Regarding claim 16, claim 5 of patent’232 claims “A method for determining whether cells express CLDN18.2 comprising the steps of: contacting a cellular sample with the antibody or antigen-binding fragment thereof of claim 1 and (ii) detecting the formation of a complex between the antibody or the antigen-binding fragment thereof and CLDN18.2 expressed by cells in said sample.”
Regarding claim 17, claim 6 of patent’232 claims “A method for diagnosis, detection or monitoring of cancer comprising the steps of: contacting a biological sample with the antibody or antigen-binding fragment of claim 1 and (ii) detecting the formation of a complex and/or determining the quantity of a complex between the antibody or the antigen-binding fragment or the conjugate and CLDN18.2.”
Regarding claim 18, claim 7 of patent’232 claims “A method for determining whether a cancer is treatable by a cancer therapy targeting CLDN18.2 comprising the steps of: contacting a sample comprising cancer cells with the antibody or antigen-binding fragment thereof of claims 1 and (ii) detecting the formation of a complex between the antibody or the antigen-binding fragment thereof and CLDN18.2.”
Response to Arguments
In the response filed on 10/9/2025, Applicant argued at page 10 as follows.
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Applicant's arguments have been fully considered but they are not persuasive. In previous office action, claims 31-34 were inadvertently omitted. As discussed above, the explanation for claim limitation of now-canceled claims 31-34 were added to above rejections.
Conclusion
No claim is allowed.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674