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 46-69 are pending in the instant application and being examined on the merit.
*Note: No terminal disclaimer has been filed for US Patent No. 11,795,225 (Application 17/471723).
Claim Rejections Withdrawn
The rejections to claims 60-69 under 35 USC §112(b) are withdrawn in view of claim amendment.
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. Applicant has not
complied with one or more conditions for receiving the benefit of an earlier filing date
under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention
which is also disclosed in the prior application (the parent or original nonprovisional
application or provisional application). The disclosure of the invention in the parent
application and in the later-filed application must be sufficient to comply with the
requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112,
except for the best mode requirement. See Transco Products, Inc. v. Performance
Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed priority application, 63/077,207, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Analysis of priority documents, 17/471,723 (9/10/2021) and the Provisional application 63/077,207 (9/11/2020), showed that the instant claims have different support in these priority documents. The provisional application ‘207 specifically lacks support for a method of treatment of a cancer cell that has a homologous recombination DNA repair defect and BRCA1 mutation, which is first described in 17/471,723. Claims 64-69 therefore contain subject matter introduced for the first time in 17/471,723. Thus, claims 64-69 have a priority date of 9/10/2021. Claims 46-63 are present in the original disclosure of the provisional application and have the priority date of 9/11/2020.
New Claim Objections and Rejections Necessitated by Amendment
Claim Objections
Claims 49-51 and 54 are objected to because of the following informalities: claims 49-51 and 54 do not comply with 37 CFR 1.121 which requires an amended claim to be labeled “currently amended”. The resolution of the chemical structures for: 1) SG4057 in claims 49-51; and 2) SG3932 in claim 54, have been changed when compared to the claim set filed 2/7/2024 in a manner that makes it difficult to determine the number of PEG linkers present in the structures.
Appropriate correction is required.
Claim Rejections – 35 USC § 112(b)
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 49-51, 54, and 57-69 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.
The resolution of the chemical structures for: 1) SG4057 in claims 49-51; and 2) SG3932 in claim 54, is too low to determine the number of PEG linkers present in the structures. It is unclear if the number of PEG linkers present in the structures is 8 or another number. Thus, the meets and bounds of the claims are unclear and the claims are indefinite. Claims 57-69 are dependent on claim 54 and also include the indefinite subject matter and thus are also rejected.
Maintained Claim Rejections
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.
The rejection of claims 46-59 on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 11,795,225 is maintained. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claims 46-59, claim 32 of ‘225 taught a method of treatment of cancer comprising administering to the patient in need thereof an antibody that binds B7-H4, wherein the antibody is conjugated to SG3932, and wherein the ADC has a drug to antibody ratio (DAR) of about 8, and wherein the antibody is comprised of a heavy chain of SEQ ID NO: 51 and a light chain of SEQ ID NO:44, wherein the cancer has a homologous recombination DNA repair defect and is mutated in BRCA1 in patented claims 36-37. This would meet the claim limitations of the ADC compositions of instant claims 46-57 and the method of treatment of instant claims 58-59.
Regarding instant claims 46-57, the claims of ‘225 further taught: 1) a pharmaceutical composition of an antibody drug conjugate that binds B7-H4 comprised of (i) a heavy chain of SEQ ID NO: 51 and a light chain of SEQ ID NO:44, (ii) a cleavable mp-PEG8-val-ala linker; and (iii) a cytotoxic agent wherein the cleavable mp-PEG8-val-ala linker and the cytotoxic agent are SG3932, and wherein the ADC has a drug to antibody ratio (DAR) of about 8 in claims 17-19, 22, wherein the structure of SG3932 is taught in patented claim 11 as
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The claims of ‘225 further taught: 1) the B7-H4 antibody or its nucleotide sequence without conjugates in claims 1-2, 4, 12, and 23-25; 2) heterologous agents conjugated to the antibody in claims 5-11; and 3) methods for producing the B7-H4 antibody, treating cancer, and detecting B7-H4 in a sample in claims 13-16 and 26-38.
Response to Arguments
Applicant argues a terminal disclaimer over U.S. Patent No. 11,795,225 has been filed to overcome the nonstatutory double patenting rejection.
In response, Applicant's arguments filed 10/29/2025 have been fully considered but they are not persuasive. No terminal disclaimer has been filed.
The rejection of claims 46-69 on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 11,795,225 is maintained.
The claims of the ‘225 patent teach the limitations of claims 46-59 for the reasons set forth above.
The claims of ‘225 are described above.
Regarding instant claims 60-69, the claims of ‘225 further taught in patented claim 14 a method of treating a cancer which expresses B7-H4, the method comprising administering to the patient in need thereof an antibody which binds to B7-H4 comprising a VH of SEQ ID NO:7-9 and a VL of SEQ ID NO:10-12 conjugated to SG3932 with the structure:
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, wherein the cancer is breast cancer or endometrial in claim 15.
The claims of ‘225 do not describe a single embodiment of a method for treating cancer with an ADC with SG3932 conjugated with a DAR of 8 that binds B7-H4 comprising a VH of SEQ ID NO:51 and VL of SEQ ID NO:44, wherein the cancer has a homologous recombination DNA repair defect and is mutated in BRCA1 wherein: 1) the cancer is breast cancer or endometrial cancer, but this is obvious in view of other dependent claims that describe the DAR and full sequence comprising the claimed VH and VL CDR.
Regarding instant claims 60-69, it would have been obvious for a person having ordinary skill in the art to take the method of patented claims 32 and 36-37 in ‘225 for:
a method of treatment of cancer comprising administering to the patient in need thereof an antibody that binds B7-H4, wherein the antibody is conjugated to SG3932, wherein the DAR is about 8, and wherein the antibody is comprised of a heavy chain of SEQ ID NO: 51 and a light chain of SEQ ID NO:44, wherein the cancer has a homologous recombination DNA repair defect and is mutated in BRCA1 – and:
Include breast cancer and endometrial cancer in the treatment as taught by patented claim 15.
This is obvious with a reasonable expectation of success because: 1) ‘225 patented claim 15 taught treatment of breast cancer or endometrial cancer with an ADC with an identical VH and VL and both CDRs would target the ADC to B7-H4 expressed on the cancer cells. Thus, the targeting ADC would be expected to target cancer cells expressing the target with the same conjugated drug. This meets the claim limitations of instant claims 60-69.
Response to Arguments
Applicant argues a terminal disclaimer over U.S. Patent No. 11,795,225 has been filed to overcome the nonstatutory double patenting rejection.
In response, Applicant's arguments filed 10/29/2025 have been fully considered but they are not persuasive. No terminal disclaimer has been filed.
The provisional rejection of claims 46-48 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20, 39, 59, 80, and 98 of copending Application No. 18/025,883 is maintained. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claims 46-48, copending claim 1 taught a method using a composition of an ADC with a payload, wherein the antibody targets a protein on cancer cells, wherein the protein is B7-H4, wherein in copending claim 10 the ADC antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 12; and a light chain comprising the amino acid sequence of SEQ ID NO: 13, which is identical to the VH of instant SEQ ID NO:51 and VL of instant SEQ ID NO:44 (instant claims 46-48). This meets the claim limitations of the composition of instant claims 46-48.
The claims of ‘883 further taught: 1) the VH and VL and CDR of the antibody above in claims 8-9, 2) the ADC is a humanized IgG1 monoclonal antibody and further details of ADC payloads in claims 12-13 and 17-19; 3) cancer types being treated in claims 15-16; 4) methods for prediction of a response to the ADC in claims 2-7, 11, 14, 20, 39, 59, 80, and 98.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that the co-pending '883, '497, and '542 applications all have filing dates later than the present application. Applicants respectfully request that the
provisional nonstatutory double patenting rejections be held in abeyance until such time when allowable subject matters are identified.
In response, Applicant's arguments filed 10/29/2025 have been fully considered but they are not persuasive. While '883, '497, and '542 applications all have filing dates later than the present application, other rejections remain for the instant claims.
According to the MPEP 804 section I.B.1.B.i., if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
The provisional rejection of claims 46-54 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20, 39, 59, 80, and 98 of copending Application No. 18/025,883 is maintained.
The claims of the ‘883 patent teach the limitations of claims 46-48 for the reasons set forth above.
The claims of ‘883 further taught the ADC is SG3932 with the structure:
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in copending claim 18.
The claims of the ‘883 do not described a single embodiment of an ADC with the sequence and SG3932 conjugated, but this is obvious in view of separate dependent claims that describe the antibody sequence of the ADC and the SG3932 conjugate.
Regarding instant claims 49-54, it would have been obvious for a person having ordinary skill in the art to take the method of using an ADC payload targeting B7-H4 composition with a claimed antibody sequence of copending claims 1 and 10 of ‘883 – and:1) combine it with the method using an ADC payload composition of the ADC targeting B7-H4 with a claimed drug conjugate structure of SG3932 of copending claim 18 of ‘883.
This is obvious with a reasonable expectation of success because: 1) The ADC antibody claimed would require a drug conjugate and the ADC drug conjugate would require an antibody to target the B7-H4 target claimed. This meets the claim limitations of instant claims 49-54.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant argues that the co-pending '883, '497, and '542 applications all have filing dates later than the present application. Applicants respectfully request that the
provisional nonstatutory double patenting rejections be held in abeyance until such time when allowable subject matters are identified.
In response, Applicant's arguments filed 10/29/2025 have been fully considered but they are not persuasive. While '883, '497, and '542 applications all have filing dates later than the present application, other rejections remain for the instant claims.
According to the MPEP 804 section I.B.1.B.i., if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
The provisional rejection of claims 46-48 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-8, 11-13, 16, 18, 21-25, 27, 29, 46, and 55 of copending Application No. 18/169,497 is maintained. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claims 46-48, copending claim 1 taught a method of treating cancer in a human subject in need thereof, comprising administering to the human subject: A) an antibody-drug conjugate (ADC) comprising an antibody or antigen binding fragment thereof which binds to a B7-H4 polypeptide comprising VH HCDR1-3 of SEQ ID NO:7-9 and a VL LCDR1-3 of SEQ ID NO:10-12 and a cleavable linker and cytotoxic agent; wherein in copending claim 18 the antibody or antigen binding fragment comprises a VH of copending SEQ ID NO: 51; and a VL of copending SEQ ID NO: 44, which is identical to a VH of instant SEQ ID NO: 51 and VL of instant SEQ ID NO:44. This meets the claim limitations of the composition of instant claims 46-48.
The claims of ‘497 taught further details of the method of treating cancer with: 1) an additional agent included in claim 2; 2) details of the cancers in claims 4, 6-8, and 55; 3) the antibody CDRs, constant region, and VH and VL in claims 11-13, 16, and 21; and 4) further details of the linker and ADC payload in claims 22-25, and 27. The claims of ‘497 taught the ADC in a kit in claim 29. The claims of ‘497 further taught a method of treating cancer with a B7-H4 targeting ADC in claim 46.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that the co-pending '883, '497, and '542 applications all have filing dates later than the present application. Applicants respectfully request that the
provisional nonstatutory double patenting rejections be held in abeyance until such time when allowable subject matters are identified.
In response, Applicant's arguments filed 10/29/2025 have been fully considered but they are not persuasive. While '883, '497, and '542 applications all have filing dates later than the present application, other rejections remain for the instant claims.
According to the MPEP 804 section I.B.1.B.i., if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
The provisional rejection of claims 49-61 and 64-69 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-8, 11-13, 16, 18, 21-25, 27, 29, 46, and 55 of copending Application No. 18/169,497 is maintained.
The claims of the ‘497 patent teach the limitations of claims 46-48 for the reasons set forth above.
Regarding instant claims 49-61 and 64-69, the claims of ‘497 further taught in copending claim 1 a method of treating cancer in a human subject in need thereof, comprising administering to the human subject: A) an antibody-drug conjugate (ADC) comprising an antibody or antigen binding fragment thereof which binds to a B7-H4 polypeptide comprising VH HCDR1-3 of SEQ ID NO:7-9 and a VL LCDR1-3 of SEQ ID NO:10-12 and a cleavable linker and cytotoxic agent;
wherein in copending claim 7 the cancer is a breast cancer;
wherein in copending claim 8 the cancer is homologous recombination deficient (HRD) and comprises a mutation in BCRA1;
wherein in copending claim 25 the cleavable linker and cytotoxic agent are SG3932 :
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wherein in copending claim 27 the ADC has a drug to antibody ratio (DAR) of between about 1 and about 8.
The claims of ‘497 do not describe a single embodiment of a method for treating cancer with an ADC that binds B7-H4 comprising a VH of SEQ ID NO:51 and VL of SEQ ID NO:44, wherein the cancer has a homologous recombination DNA repair defect and is mutated in BRCA1 wherein: 1) the cancer is breast cancer: 2) the cancer is homologous recombination deficient (HRD) and comprises a mutation in BCRA1; 3) the ADC comprised SG3932; and 4) the ADC is conjugated with a DAR of 8, but this is obvious in view of other dependent claims that describe the ADC can comprise these components.
Regarding instant claims 49-61 and 64-69, it would have been obvious for a person having ordinary skill in the art to take the method of treating cancer with an ADC targeting B7-H4 with a claimed full length antibody sequence of copending claims 1 and 18 of ‘497 – and combine it with the ADC targeting B7-H4 which contains an identical CDR region wherein:
breast cancer is claimed in copending claim 7 of ‘497;
the cancer is homologous recombination deficient (HRD) and comprises a mutation in BCRA1 in copending claim 8 of ‘497;
the ADC comprised SG3932 in copending claim 25 of ‘497; and
the ADC is conjugated with a DAR of 8 in copending claim 27 of ‘497.
This is obvious with a reasonable expectation of success because: 1)-4) The full length ADC sequence claimed has an identical VH and VL CDR binding region compared to the dependent claims; and the full length ADC antibody sequence claimed would require a drug conjugate. Further, the antibody would target the same B7-H4 target with the same CDR. This meets the claim limitations of instant claims 49-54.
This would produce a method of treating breast cancer (instant claims 60-61) that was homologous recombination deficient (HRD) (instant claims 64-67) and comprises a mutation in BCRA1 (instant claims 68-69), wherein an ADC targeting B7-H4 comprising a VH of copending SEQ ID NO: 51; and a VL of copending SEQ ID NO: 44, which is identical to a VH of instant SEQ ID NO: 51 and VL of instant SEQ ID NO:44 was administered to the human subject, wherein the ADC comprised SG3932 (instant claims 49-55) and a DAR of 1-8, which overlaps with about 8 (instant claims 55-57) (instant claims 58-59)
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant argues that the co-pending '883, '497, and '542 applications all have filing dates later than the present application. Applicants respectfully request that the
provisional nonstatutory double patenting rejections be held in abeyance until such time when allowable subject matters are identified.
In response, Applicant's arguments filed 10/29/2025 have been fully considered but they are not persuasive. While '883, '497, and '542 applications all have filing dates later than the present application, other rejections remain for the instant claims.
According to the MPEP 804 section I.B.1.B.i., if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
The provisional rejection of claims 46-48 on the ground of nonstatutory double patenting as being unpatentable over claims 108-127 of copending Application No. 18/360,542 is maintained. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claims 46-48, copending claim 108 taught a method of treating cancer in a human subject in need thereof, comprising administering to the human subject: a) an antibody-drug conjugate (ADC) comprising: i) an antibody or antigen binding fragment thereof, ii) a cleavable linker, and iii) a cytotoxic agent; wherein the cytotoxic agent is a compound of formula I is claimed;
wherein in copending claim 111 the antibody or antigen binding fragment comprises a VH of copending SEQ ID NO: 45; and a VL of copending SEQ ID NO: 34 which is identical to a VH of instant SEQ ID NO: 45 and VL of instant SEQ ID NO:34.
This meets the claim limitations of the composition of instant claims 46-47.
The claims of ‘542 taught further details of the method of treating cancer with: 1) an additional agent included in claims 109 and 115-123; 2) the antibody CDRs in claim 110; 3) further details of the linker and ADC payload in claims 112-114; and 4) details of the cancers in claims 124-126. The claims of ‘497 taught a pharmaceutical composition comprising an ADC with a drug linker of:
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in claim 127.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that the co-pending '883, '497, and '542 applications all have filing dates later than the present application. Applicants respectfully request that the
provisional nonstatutory double patenting rejections be held in abeyance until such time when allowable subject matters are identified.
In response, Applicant's arguments filed 10/29/2025 have been fully considered but they are not persuasive. While '883, '497, and '542 applications all have filing dates later than the present application, other rejections remain for the instant claims.
According to the MPEP 804 section I.B.1.B.i., if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
The provisional rejection of claims 46-48 on the ground of nonstatutory double patenting as being unpatentable over claims 108-127 of copending Application No. 18/360,542 is maintained.
The claims of the copending ‘542 teach the limitations of claims 46-47 for the reasons set forth above.
Regarding instant claims 49-50 and 52-53, copending claim 108 taught a method of treating cancer in a human subject in need thereof, comprising administering to the human subject: a) an antibody-drug conjugate (ADC) comprising: i) an antibody or antigen binding fragment thereof, ii) a cleavable linker, and iii) a cytotoxic agent; wherein the cytotoxic agent is a compound of formula I is claimed; and
wherein in copending claim 114 the cleavable linker and cytotoxic agent are SG3932.
The claims of ‘542 do not describe a single embodiment of a method for treating cancer with an ADC that binds B7-H4 comprising a VH of SEQ ID NO:45 and VL of SEQ ID NO:34 wherein: 1) the cancer is breast cancer: 2) the cancer is homologous recombination deficient (HRD) and comprises a mutation in BCRA1; 3) the ADC comprised SG3932.
Regarding instant claims 49-50 and 52-53, it would have been obvious for a person having ordinary skill in the art to take the method of treating cancer with an ADC with an antibody sequence of copending claims 108 and 111 of ‘542 – and combine it with the other ADC components claimed in ‘542 wherein:
the ADC comprised SG3932 in copending claim 114 of ‘542.
This is obvious because: 1) ‘542 taught the ADC components of the linker drug conjugate SG3932 could be used for treating cancer. When combined, the ADC would target B7-H4 with the linker conjugated toxic payload to cancer cells. This meets the claim limitations of instant claims 49-50 and 52-53.
This would produce a method of treating cancer, wherein an ADC targeting B7-H4 comprising a VH of copending SEQ ID NO: 45; and a VL of copending SEQ ID NO: 34, which is identical to a VH of instant SEQ ID NO: 45 and VL of instant SEQ ID NO:34 was administered to the human subject, wherein the ADC comprised SG3932 (instant claims 49-50 and 52-53).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant argues that the co-pending '883, '497, and '542 applications all have filing dates later than the present application. Applicants respectfully request that the
provisional nonstatutory double patenting rejections be held in abeyance until such time when allowable subject matters are identified.
In response, Applicant's arguments filed 10/29/2025 have been fully considered but they are not persuasive. While '883, '497, and '542 applications all have filing dates later than the present application, other rejections remain for the instant claims.
According to the MPEP 804 section I.B.1.B.i., if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
Conclusion
Claims 46-69 are rejected.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Z Wu can be reached on (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
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643