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
Claims 25-28, 30-37, and 39-78 are pending in the instant application.
Claims 77-78 are new.
Claims 40, 49-51, and 54 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/25/2026.
Claim Status
Applicant’s election with traverse of the antibody-drug conjugate Formula (I) species of
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in the reply filed on 1/25/2026 was addressed and made final in the Non-Final Rejection filed on 3/24/2026. Claims 25-28, 30-37, and 39, 41-48, 52-53, and 55-78 are pending on the Applicant elected species. In view of the certified translation of the foreign priority document CN202010410633.5 the Applicant elected species
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is free of prior art.
The Examiner further included the species of
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. Claims 25-28, 30-37 and 56-67, and 77-78 are pending on the Examiner elected species.
Claims 40, 49-51, and 54 remain withdrawn
Claim Objects and Rejections Withdrawn
The objections and rejections to claims 29 and 38 are moot in view of claim cancelation.
The objection to claims 25-28, 30-37, 39, 41-48, 52-53, and 55-68 is withdrawn in view of claim amendment.
The rejection to claims 27, 31, 39, 41-48, 52, 66, and 72-76 under 35 USC § 112(b) is withdrawn in view of claim amendment.
The rejection to claims 25-28, 30-34, 36-37, 39, 41-48, 52-53, and 55-68 under 35 USC § 112(a) is withdrawn in view of claim amendment.
The rejection to claims 25-28, 30-37, 39, 41-48, 52-53, and 55-76 under 35 USC § 103 is withdrawn in view of 35 U.S.C. § 102(b)(2)(C) exception of the enabled claimed subject matter present in the certified translated priority document of CN202010410633.5 filed 6/21/2026 with a foreign priority date to 5/15/2020, which is less than one year from the publishing date of Applicant filed WO 2020/135201 (Tian H et al.).
The provisional rejection to claims 25-28, 30-37, 39, 41-48, 52-53, and 55-70 under nonstatutory double patenting is withdrawn in view of 18/000,174 is not Applicant or inventor owned.
For the Applicant elected species, the rejection to claims 25-28, 30-37, 39, 41-48, 52-53, and 58-76 under nonstatutory double patenting against Patent No. 12,297,265 is withdrawn in view of 35 U.S.C. § 102(b)(2)(C) exception of WO 2020/135201 (Tian H et al.).
For the Examiner elected species, the rejection to claims 25-28, 30-37, 56-67 under nonstatutory double patenting against Patent No. 12,297,265 is withdrawn in view of claim amendment.
Objections to the Claims
Claims 40, 49-51, and 54 are objected to because of the following informalities:
Regarding claims 40, 49-51, and 54, the text of the withdrawn claims has been removed but the claims are indicated as withdrawn not canceled. Thus, the claims do not comply with 37 CFR 1.121 which requires a canceled claim to be labeled “canceled”. The claim is required to be canceled or the text present in the withdrawn claim.
Appropriate correction is required.
Double Patenting
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.
Regarding the species
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Claims 25-28, 30-37, 56-67, and 77-78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of U.S. Patent No. 12,297,265 in view of WO 2014/092804 (Govindan SV et al.).
‘265 taught antibody or antigen-binding fragment thereof that specifically bind to CLDN18.2 in patented claims 1-11, wherein the antibody comprises a VH of SEQ ID NO:40 and a VL of SEQ ID NO:41 in patented claim 1 and:
further comprises a heavy chain constant region (CH) having a sequence as set forth in SEQ ID NO: 42 and a light chain constant region (CL) having a sequence as set forth in SEQ ID NO: 43 in patented claim 23;
wherein the VH and/or VL of the antibody or antigen binding fragment thereof comprises Framework Regions (FR) derived from a human or a mouse immunoglobulin in patented claim 28;
wherein the heavy chain constant region is an IgG1 heavy chain constant region in patented claim 30;
wherein the antibody has a detectable label of biotin in patented claim 33;
in a conjugate with a small molecule toxin in patented claim 12;
in a multispecific antibody in claim 14;
in a pharmaceutical composition which comprises a pharmaceutically acceptable carrier and/or an excipient in patented claim 15;
in a pharmaceutical composition which further comprises a second antibody that specifically binds to PD-1 in patented claim 16;
is in a method for treating a tumor in a subject, wherein the tumor is CLDN18.2 positive, the method comprising administering to the subject in need thereof an effective amount of the pharmaceutical composition of claim 15, which further comprises administering an immunotherapy in patented claim 18-19;
is in a method for treating a tumor in a subject, wherein the tumor is CLDN18.2 positive, the method comprising administering to the subject in need thereof an effective amount of the pharmaceutical composition of patented claims 15 and 18, wherein the tumor is a solid cancer in patented claim 20, and a non-small cell lung cancer in patented claim 42;
wherein the tumor is a solid tumor of gastric cancer in patented claims 20 and 22,
The claims of ‘265 did not teach: 1) a conjugate wherein the linker drug is
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, but this is obvious in view of ‘804.
804 taught an effective method of treating pancreatic cancer that expressed EGP-1, comprising administering a pharmaceutical composition comprising of the ADC hRS7-CL2A-SN-38 (page 89, [0232] and Fig. 2) and a pharmaceutically acceptable excipient, wherein the antibody was conjugated to the CLA2A-SN-38 linker of
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(page 85 and pages 87-88 [0231]), wherein hRS7-CL2A-SN-38 had a DAR of 5.8 (page 88, Table 7, [0231]).
Regarding instant claims 25-28, 30-37, 56-67, and 77-78, it would have been obvious for a person having ordinary skill in the art to take ‘265 patented claims 1, 6, 12, 14-16, 18-20, 22-23, 28, 30, 33, and 42 of a method for treating a gastric tumor or non-small cell lung cancer tumor in a subject, wherein the tumor is CLDN18.2 positive, the method comprising administering to the subject in need thereof an effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a multispecific conjugate in a conjugate with a small molecule toxin, wherein the antibody comprises a VH of ‘265 SEQ ID NO:40 and a VL of ‘265 SEQ ID NO:41 and a CH of ‘265 SEQ ID NO: 42 and a CL of ‘265 SEQ ID NO: 43, with human framework sequences, wherein the antibody has a human IgG1 heavy chain constant region, wherein the antibody has a detectable label of biotin, in combination a second antibody that specifically binds to PD-1 as an immunotherapy – and modify the method by: 1) including the CLA2A-SN-38 linker of
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, wherein antibody-CL2A-SN-38 had a DAR of 5.8 and γ is between 5-6 of ’804.
This is obvious because: 1) ‘804 taught an effective method of treating pancreatic cancer that expressed EGP-1, comprising administering a pharmaceutical composition comprising of the ADC hRS7-CL2A-SN-38 and a pharmaceutically acceptable excipient, wherein the antibody was conjugated to the CLA2A-SN-38 linker of
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, wherein hRS7-CL2A-SN-38 had a DAR of 5.8.
There is a reasonable expectation of success because the claims of ‘265 taught the CLDN18.2 antibody was useful in a method of treating cancer and as a conjugate bound to a cytotoxin and: 1) the linker drug
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was effective against cancer cells.
This would produce a method for treating a gastric cancer (instant claim 66) or non-small cell lung cancer (NSCLC) (instant claim 78), which are solid tumors (instant claim 65), in a subject, wherein the tumor is CLDN18.2 positive (instant claim 67), the method comprising administering to the subject in need thereof an effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable carrier (instant claim 61) and a multispecific (instant claim 37) conjugate, wherein the structure is:
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, wherein the antibody comprises a VH of ‘265 SEQ ID NO:40 and a VL of ‘265 SEQ ID NO:41 and a CH of ‘265 SEQ ID NO: 42 and a CL of ‘265 SEQ ID NO: 43, which is identical to the instantly claimed heavy chain of SEQ ID NO:19 and light chain of SEQ ID NO:20 (instant claim 36) and is further comprised of a heavy chain with instant SEQ ID NO:14 (instant claim 26), and instant SEQ ID NO:1, 21, 3 and an IgG1 CH of instant SEQ ID NO:16 (instant claims 27, 31-32, and 77) and a light chain with instant SEQ ID NO:15, and instant SEQ ID NO:4-6 and kappa light chain CL of instant SEQ ID NO:17 (instant claims 33-34) which have human frameworks (instant claim 30), wherein the DAR is 6.9 and γ is between 6-7 (instant claims 28 and 58-60), wherein the antibody has a detectable label of biotin (instant claims 56-57), in combination a second antibody that specifically binds to PD-1 as an immunotherapy (instant claim 63-64) (instant claims 25, 35, and 62).
Response to Arguments
Regarding the non-statutory double patenting rejections referencing the '265 patent, as the present application is currently undergoing examination, Applicant respectfully requests that the Office hold the double patenting rejection in abeyance. Should the claims in the present application be found allowable, Applicant requests that the Examiner review at that point the propriety of the double patenting rejection.
In response, Applicant's arguments filed 6/21/2026 have been fully considered but they are not persuasive. Applicant requests that the double patenting rejection over the ‘265 patent be held in abeyance (Remarks p. 24). A request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see 37 CFR 1.111(b) and MPEP §714.02). The double patenting rejection is above.
Conclusion
Claims 25-28, 30-37, 56-67, and 77-78 are rejected.
Claims 40, 49-51, and 54 are objected to.
Claims 39, 41-48, 52-53, and 55, and 68-76 are objected to because other species are still under examination.
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 JOHN J SKOKO III whose telephone number is (571)272-1107. The examiner can normally be reached M-F 8:30 - 5:00.
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, Julie Z Wu can be reached at (571)272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.J.S./Examiner, Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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