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 .
Claims 5-7, 11, 13-22 have been canceled. Claims 1, 8, 9, 10 and 12 have been amended. Claims 23-34 have been added. Claims 1-4, 8-10, 12 and 23-34 are pending and under consideration.
The rejection of claims 10 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of applicant’s amendment.
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 24 is 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.
Claim 24 is vague and indefinite in the recitation of “at least one” selected from the group consisting of pleural, peritoneal, pericardial mesothelioma and tunica It is unclear if this refers to a subject having more than one primary mesothelioma site, or if this refers to a subject with a primary mesothelioma and mesothelioma at secondary sites due to metastases.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The rejection of claims 1-4, 8-10, 12 under 35 U.S.C. 102(a)(1) as being anticipated by Kamii et al (WO2019/039483) as evidenced by Kamii et al (U.S. 2021/0128741, English Language translation) is maintained for reasons of record.. Kamii et al (translation) disclose a pharmaceutical composition comprising an ADC having the drug linker of formula I, wherein A represents a connecting position to an antibody which is conjugated to the drug-linker via a thioether bond(claim 1 of ‘741), which meets the structural limitations of instant claims 1 and 12 for the drug-linker. Kamii et al disclose that the antibody is an anti-B7H3 antibody (claim 7 of ‘741) comprising a heavy chain consisting of amino acid residues 20-471 of SEQ ID NO:7 and a light chain consisting of amino acid residues 21-233 of SEQ ID NO:4, or a variant thereof comprising the heavy chain wherein a lysine residue at the carboxyl terminus is deleted (claim 27 of ‘741) which meets the limitations of instant claims 10 and 21 for the deletion of a lysine residue at the carboxy terminus of the heavy chain; instant claims 5 and 16, wherein the heavy chain CDRs are at residues 50-54, 69-85 and 118-130 of SEQID NO: 3; the limitations of instant claims 6, 7, 17 and 18 wherein the heavy chain variable regions consists of residues 20-141 of SEQ ID NO:3 and the light chain variable region consists of residues 21-128 of SEQ ID NO:4; the limitations of instant claims 8, 9, 19 and 20 wherein the anti-B7H3 antibody consists of a heavy chain of amino acid residues 20-471 of SEQ ID NO:3 and a light chain of residues 21-233 of SEQ ID NO:4 because
SEQ ID NO: 7 of ‘483 is identical to the instant SEQ ID NO: 3:
GenCore version 6.5.2
Copyright (c) 1993 - 2025 Biocceleration Ltd.
OM protein - protein search, using sw model
Run on: December 11, 2025, 23:48:49 ; Search time 1 Seconds
(without alignments)
0.222 Million cell updates/sec
Title: AASEQ1_12112025_234844
Perfect score: 2533
Sequence: 1 MKHLWFFLLLVAAPRWVLSQ..........MHEALHNHYTQKSLSLSPGK 471
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 1 seqs, 471 residues
Total number of hits satisfying chosen parameters: 1
Minimum DB seq length: 0
Maximum DB seq length: inf
Post-processing: Minimum Match 0%
Maximum Match 100%
Listing first 1 summaries
Database : US-18-036-290-3.pep:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 2533 100.0 471 1 US-18-036-290-3 TREATMENT OF MESOT
ALIGNMENTS
RESULT 1
US-18-036-290-3
Query Match 100.0%; Score 2533; DB 1; Length 471;
Best Local Similarity 100.0%;
Matches 471; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKHLWFFLLLVAAPRWVLSQVQLVQSGAEVKKPGSSVKVSCKASGYTFTNYVMHWVRQAP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKHLWFFLLLVAAPRWVLSQVQLVQSGAEVKKPGSSVKVSCKASGYTFTNYVMHWVRQAP 60
Qy 61 GQGLEWMGYINPYNDDVKYNEKFKGRVTITADESTSTAYMELSSLRSEDTAVYYCARWGY 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GQGLEWMGYINPYNDDVKYNEKFKGRVTITADESTSTAYMELSSLRSEDTAVYYCARWGY 120
Qy 121 YGSPLYYFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 YGSPLYYFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV 180
Qy 181 SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVE 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVE 240
Qy 241 PKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFN 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 PKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFN 300
Qy 301 WYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTI 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 WYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTI 360
Qy 361 SKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPP 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 SKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPP 420
Qy 421 VLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 471
|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 VLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 471
Search completed: December 11, 2025, 23:48:49
Job time : 1 secs
and SEQ ID NO: 8 of ‘483 is identical to the instant SEQ ID NO: 4:
GenCore version 6.5.2
Copyright (c) 1993 - 2025 Biocceleration Ltd.
OM protein - protein search, using sw model
Run on: December 11, 2025, 23:52:40 ; Search time 1 Seconds
(without alignments)
0.054 Million cell updates/sec
Title: AASEQ1_12112025_235238
Perfect score: 1211
Sequence: 1 MVLQTQVFISLLLWISGAYG..........EVTHQGLSSPVTKSFNRGEC 233
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 1 seqs, 233 residues
Total number of hits satisfying chosen parameters: 1
Minimum DB seq length: 0
Maximum DB seq length: inf
Post-processing: Minimum Match 0%
Maximum Match 100%
Listing first 1 summaries
Database : US-18-036-290-4.pep:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 1211 100.0 233 1 US-18-036-290-4 TREATMENT OF MESOT
ALIGNMENTS
RESULT 1
US-18-036-290-4
Query Match 100.0%; Score 1211; DB 1; Length 233;
Best Local Similarity 100.0%;
Matches 233; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MVLQTQVFISLLLWISGAYGEIVLTQSPATLSLSPGERATLSCRASSRLIYMHWYQQKPG 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MVLQTQVFISLLLWISGAYGEIVLTQSPATLSLSPGERATLSCRASSRLIYMHWYQQKPG 60
Qy 61 QAPRPLIYATSNLASGIPARFSGSGSGTDFTLTISSLEPEDFAVYYCQQWNSNPPTFGQG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 QAPRPLIYATSNLASGIPARFSGSGSGTDFTLTISSLEPEDFAVYYCQQWNSNPPTFGQG 120
Qy 121 TKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQE 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQE 180
Qy 181 SVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 233
|||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 233
Search completed: December 11, 2025, 23:52:40
Job time : 1 secs
Kamii et al disclose that the anti-B7H3 conjugate has an average number of drug-linker conjugated to the antibody of 3 to 5 (claim 28 of ‘741) which meets the limitations of “n” in instant claim 12, and 3.5-4.5 in instant claim 22.
It is noted that the limitation “for mesothelioma” in claim 1 occurs in the preamble.
A preamble is generally not accorded any patentable weight where it merely recites the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding claims 2-4, the recitation of the subtypes of mesothelioma encompassed by the intended use of the therapeutic agent of claim 1 are also not accorded any patentable weight, applying only to the intended use of the therapeutic agent
Thus, Kamii et al (WO2019/039483) as evidenced by Kamii et al (U.S. 2021/0128741) anticipates the instant claims.
Applicant argues that the independent claims 1 and 12 generally recite therapeutic agents for mesothelioma, comprising as an active component is the anti-B7-H3 antibody comprising a drug linker. This has been considered but not found persuasive. Kamii et al disclose the same antibody conjugate as claimed.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 8-10, 12, 23, 27, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Kamii et al (WO2019/039483) as evidenced by Kamii et al (U.S. 2021/0128741 in view of Matsumura et al (Pathology International, 2020, Vol. 70, pp. 999-1008, ePub October 7, 2020).
Kamii et al (translation) teach a pharmaceutical composition comprising an ADC having the drug linker of formula I, wherein A represents a connecting position to an antibody which is conjugated to the drug-linker via a thioether bond(claim 1 of ‘741), which meets the structural limitations of instant claims 1 and 12 for the drug-linker. Kamii et al disclose that the antibody is an anti-B7H3 antibody (claim 7 of ‘741) comprising a heavy chain consisting of amino acid residues 20-471 of SEQ ID NO:7 and a light chain consisting of amino acid residues 21-233 of SEQ ID NO:4, or a variant thereof comprising the heavy chain wherein a lysine residue at the carboxyl terminus is deleted (claim 27 of ‘741) which meets the limitations of instant claims 10 and 32 for the deletion of a lysine residue at the carboxy terminus of the heavy chain; instant claim 27, wherein the heavy chain CDRs are at residues 50-54, 69-85 and 118-130 of SEQID NO: 3; the limitations of instant claims 28-31, wherein the heavy chain variable regions consists of residues 20-141 of SEQ ID NO:3 and the light chain variable region consists of residues 21-128 of SEQ ID NO:4; the limitations of instant claims 28-32, wherein the anti-B7H3 antibody consists of a heavy chain of amino acid residues 20-471 of SEQ ID NO:3 and a light chain of residues 21-233 of SEQ ID NO:4 because
SEQ ID NO: 7 of ‘483 is identical to the instant SEQ ID NO: 3:
GenCore version 6.5.2
Copyright (c) 1993 - 2025 Biocceleration Ltd.
OM protein - protein search, using sw model
Run on: December 11, 2025, 23:48:49 ; Search time 1 Seconds
(without alignments)
0.222 Million cell updates/sec
Title: AASEQ1_12112025_234844
Perfect score: 2533
Sequence: 1 MKHLWFFLLLVAAPRWVLSQ..........MHEALHNHYTQKSLSLSPGK 471
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 1 seqs, 471 residues
Total number of hits satisfying chosen parameters: 1
Minimum DB seq length: 0
Maximum DB seq length: inf
Post-processing: Minimum Match 0%
Maximum Match 100%
Listing first 1 summaries
Database : US-18-036-290-3.pep:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 2533 100.0 471 1 US-18-036-290-3 TREATMENT OF MESOT
ALIGNMENTS
RESULT 1
US-18-036-290-3
Query Match 100.0%; Score 2533; DB 1; Length 471;
Best Local Similarity 100.0%;
Matches 471; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKHLWFFLLLVAAPRWVLSQVQLVQSGAEVKKPGSSVKVSCKASGYTFTNYVMHWVRQAP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKHLWFFLLLVAAPRWVLSQVQLVQSGAEVKKPGSSVKVSCKASGYTFTNYVMHWVRQAP 60
Qy 61 GQGLEWMGYINPYNDDVKYNEKFKGRVTITADESTSTAYMELSSLRSEDTAVYYCARWGY 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GQGLEWMGYINPYNDDVKYNEKFKGRVTITADESTSTAYMELSSLRSEDTAVYYCARWGY 120
Qy 121 YGSPLYYFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 YGSPLYYFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV 180
Qy 181 SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVE 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVE 240
Qy 241 PKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFN 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 PKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFN 300
Qy 301 WYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTI 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 WYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTI 360
Qy 361 SKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPP 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 SKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPP 420
Qy 421 VLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 471
|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 VLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 471
Search completed: December 11, 2025, 23:48:49
Job time : 1 secs
and SEQ ID NO: 8 of ‘483 is identical to the instant SEQ ID NO: 4:
GenCore version 6.5.2
Copyright (c) 1993 - 2025 Biocceleration Ltd.
OM protein - protein search, using sw model
Run on: December 11, 2025, 23:52:40 ; Search time 1 Seconds
(without alignments)
0.054 Million cell updates/sec
Title: AASEQ1_12112025_235238
Perfect score: 1211
Sequence: 1 MVLQTQVFISLLLWISGAYG..........EVTHQGLSSPVTKSFNRGEC 233
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 1 seqs, 233 residues
Total number of hits satisfying chosen parameters: 1
Minimum DB seq length: 0
Maximum DB seq length: inf
Post-processing: Minimum Match 0%
Maximum Match 100%
Listing first 1 summaries
Database : US-18-036-290-4.pep:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 1211 100.0 233 1 US-18-036-290-4 TREATMENT OF MESOT
ALIGNMENTS
RESULT 1
US-18-036-290-4
Query Match 100.0%; Score 1211; DB 1; Length 233;
Best Local Similarity 100.0%;
Matches 233; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MVLQTQVFISLLLWISGAYGEIVLTQSPATLSLSPGERATLSCRASSRLIYMHWYQQKPG 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MVLQTQVFISLLLWISGAYGEIVLTQSPATLSLSPGERATLSCRASSRLIYMHWYQQKPG 60
Qy 61 QAPRPLIYATSNLASGIPARFSGSGSGTDFTLTISSLEPEDFAVYYCQQWNSNPPTFGQG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 QAPRPLIYATSNLASGIPARFSGSGSGTDFTLTISSLEPEDFAVYYCQQWNSNPPTFGQG 120
Qy 121 TKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQE 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQE 180
Qy 181 SVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 233
|||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 233
Search completed: December 11, 2025, 23:52:40
Job time : 1 secs
Kamii et al disclose that the anti-B7H3 conjugate has an average number of drug-linker conjugated to the antibody of 3 to 5 (claim 28 of ‘741) which meets the limitations of “n” in instant claim 12, and 3.5-4.5 and instant claims 33 and 34.
Kamii et al teach a pharmaceutical composition comprising an inventive conjugate for the treatment of various cancers (paragraph [0459]). Kamii et al do not specifically teach the conjugates comprising the anti-B7H3 antibody for the treatment of mesothelioma.
Matsumura et al teach that mesothelioma samples from patients classified as epithelioid type exhibited 90.9% positivity for B7-H3 expression and samples from patient classified as non-epithelioid type exhibited B7-H3 expression (page 1004, Table 3). Thus B7-H3 is expressed in both the epithelioid and non-epithelioid histological types of mesothelioma. Matsumura et al suggest that the findings provide motivation for the development of single-agent drugs for targeting B7-H3 on mesothelioma (page 1005, second column, last sentence ion the bottom full paragraph).
It would have been prima facie obvious at the time prior to the effective filing date to treat mesothelioma expressing B7H3 with the anti-B7H3 conjugates of Kamii et al\. One of skill in the art would have been motivated to dos o because Kamii et al teach the treatment of cancers by administering the pharmaceutical compositions comprising the antibody drug conjugates. One of skill in the art would understand that it would be necessary for the targeted cancer tissue to express the B7H3 target antigen in order for specific tumor delivery. Matsumura et al teach that ~90% of both histological subtypes of mesothelioma express B7-H3, and Matumura et al suggest the development of single-agent drugs targeting B7-H3 for the treatment of mesothelioma.
Claims 1-4, 8-10, 12, 23-28 are rejected under 35 U.S.C. 103 as being unpatentable over Kamii et al (‘483) as evidenced by Kamii et al (‘741) and Matsumura et al as applied to claims 1-4, 8-10, 12, 23, 27, 28 above, and further in view of Guazzelli et al (Expert Opinion on Investigational New Drugs, 2017, Vol. 26, pp. 933-944).
The combined teachings of Kamii et al (‘483) and Matsumura et al render obvious the limitations of claims 1, 4, 8-10, 12, 23, 27, and 28 for the reasons set forth above. Neither Kamii et al nor Matsumura et al specifically teach the treatment of a subject with pleural mesothelioma, peritoneal mesothelioma, pericardial mesothelioma or tunica vaginalis testis mesothelioma.
Guazzelli et al teach that ~80% of mesotheliomas are pleural, ~20% are peritoneal, while less than 1% occur in the pericardium and tunica vaginalis (page 933, first column, lines 1-6).
It would have been prima facie obvious at the time prior to the effective filing date to treat mesotheliomas arising in the pleural cavity, the peritoneum, pericardium or tunica- vaginalis that express B7H3 in the method rendered obvious by the combined teachings of Kamii et al (‘483) and Matsumura et al. One of skill in the art would have been motivated to so do by the teachings of Guazzelli et al on the locations for development of mesotheliomas.
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 1-4, 8-10 and 12 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 20-23 and 40-52 of U.S. Patent No. 12,220,604 is maintained for reasons of record. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims. Claim 1 anticipates the drug-linker of instant claim 1. Claim 7 of ‘604 as drawn to the conjugate comprising an anti-B7-H3 antibody anticipates the antibody of instant claims 1. Claim 21 of ‘604 disclosing the anti-B7-H3 antibody as comprising the heavy chain of residues 20-471 of SEQ ID NO: 7 and a light chain comprising residues 21-233 of SEQ ID NO: 8, meets the limitations of instant claims 8 and 9, because SEQ ID NO: 7 of ‘914 is identical to the instant SEQ ID NO: 3 and SEQ ID NO: 8 of ‘914 is identical to the instant SEQ ID NO: 4. Claim 22 of ‘604 discloses that the heavy chain consists of residues 20-470 of SEQ ID NO: 7 anticipates instant claim 10 for deletion of the terminal lysine residue. Claim 23 discloses that the ratio of drug to antibody is in the range of 3.5 to 4.5 meets the limitations of instant claims 11, and 22 and “n” in the structure of claim 12.
It is noted that the limitation “for mesothelioma” in claims 1 and 12 occurs in the preamble. A preamble is generally not accorded any patentable weight where it merely recites the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding claims 2-4, the recitation of the subtypes of mesothelioma encompassed by the intended use of the therapeutic agent of claims 1and 12 are also not accorded any patentable weight, applying only to the intended use of the therapeutic agent
The provisional rejection of claims 1-4, 8-10 and 12 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 26-31, 43, 44 and 52-58 of copending Application No. 16/640,914(reference application) is maintained for reasons of record. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘914 application anticipate the instant claims. Claim 1 of ‘914 anticipates the drug-linker of instant claims 1 and 12, with the exception of the value of “n” in claim 12. Claim 7 as drawn to the conjugate comprising ananti-B7-H3 antibody in claim 7 and claim 26 of ‘914 anticipates the antibody of instant claims 1 and 12. Claim 27 disclosing the anti-B7-H3 antibody as comprising the heavy chain of residues 20-471 of SEQ ID NO: 7 and a light chain comprising residues 21-233 of SEQ ID NO: 8, meets the limitations of instant claims 5-9 and because SEQ ID NO: 7 of ‘914 is identical to the instant SEQ ID NO: 3 and SEQ ID NO: 8 of ‘914 is identical to the instant SEQ ID NO: 4. Claim 27 of ‘914 anticipates instant claim 10. Claim 28 of ‘914 meets the limitations of “n” in claim 12.
It is noted that the limitation “for mesothelioma” in claims 1 and 12 occurs in the preamble. A preamble is generally not accorded any patentable weight where it merely recites the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding claims 2-4 and 13-15, the recitation of the subtypes of mesothelioma encompassed by the intended use of the therapeutic agent of claims 1and 12 are also not accorded any patentable weight, applying only to the intended use of the therapeutic agent
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The provisional rejection of claims 1-4, 8-10 and 12 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 20-23, 32-38, 51-54 of copending Application No. 19/001,254(reference application) is maintained for reasons of record. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘001 application anticipate the instant claims. The claims of the ‘001 application anticipate the instant claims due to the identical structure of the drug-linker and the sequence of the anti-B7-H3 antibody of the antibody-drug conjugate.
It is noted that the limitation “for mesothelioma” in claims 1 and 12 occurs in the preamble. A preamble is generally not accorded any patentable weight where it merely recites the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding instant claims 2-4, the recitation of the subtypes of mesothelioma encompassed by the intended use of the therapeutic agent of claims 1 and 12 are also not accorded any patentable weight, applying only to the intended use of the therapeutic agent.
Thus, said claims of the ‘254 application anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 8-10, 12, 23, 27, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31, 33-48, 50-53, 55, 57of copending Application No. 19/353,836 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘836 application either anticipate the instant claims. The claims of the ‘836 application anticipate the instant claims 1-4, 8-10 and 12 due to the identical structure of the drug-linker and the sequence of the anti-B7-H3 antibody of the antibody-drug conjugate.
It is noted that the limitation “for mesothelioma” in claims 1 and 12 occurs in the preamble. A preamble is generally not accorded any patentable weight where it merely recites the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding instant claims 2-4 the recitation of the subtypes of mesothelioma encompassed by the intended use of the therapeutic agent of claims 1 and 12 are also not accorded any patentable weight, applying only to the intended use of the therapeutic agent.
Claims 33-36 of the ‘836 application teach the sequence limitations of instant claims 27-30. Claims 37 and 38 teach the limitations of instant claims 31 and 32. Claim 39 of ‘836 teaches the limitation of the average number of drug units in instant claims 33 and 34.
Claim 59 of ‘836 specifies that the cancer to be treated is mesothelioma.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 8-10, 12, 23-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31, 33-48, 50-53, 55, 57 of copending Application No. 19/353,836 (reference application) in view of Matsumura et al (Pathology International, 2020, Vol. 70, pp. 999-1008) and Guazzelli et al (Expert Opinion on Investigational New Drugs, 2017, Vol. 26, pp. 933-944).
Matsumura et al teach that mesothelioma samples from patients classified as epithelioid type exhibited 90.9% positivity for B7-H3 expression and samples from patients classified as non-epithelioid type exhibited 88.9% B7-H3 expression (page 1004, Table 3). Thus, B7-H3 is expressed in both the epithelioid and non-epithelioid histological types of mesothelioma.
Guazzelli et al teach that ~80% of mesotheliomas are pleural, ~20% are peritoneal, while less than 1% occur in the pericardium and tunica vaginalis (page 933, first column, lines 1-6).
It would have been prima facie obvious at the time prior to the effective filing date to treat mesotheliomas arising in the pleural cavity, the peritoneum, pericardium or tunica- vaginalis that express B7H3 in the method of treating mesothelioma in claim 59 of the ‘836 application. One of skill in the rt would have been motivated to do so by the combined teachings of Matsumura et al who demonstrated that histological subtype did not significantly alter the percentage of mesotheliomas expressing B7H3 and the teachings of Guazzelli et al on the locations for development of mesotheliomas. One of skill in the art would understand that mesothelioma expressing B7H3 at any site would be amendable to treatment by the method of claim 59 of the ‘836 application
Claims 1-4, and 8-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 52, 65-68 of copending Application No. 18/440,920(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the claims of the ‘920 application..
Claim 3 of the ‘920 application teaches a method of producing an ADC comprising the drug-linker of formula 19, which meets the structure of the instant ADC comprising the same drug-linker in instant claim 1. Claims 52 and 65 specify that the antibody of the ADC is an anti-B6-H3 antibody. Claims 66-67 of the ‘920 application teach that the anti-B6-H3 antibody comprising the identical heavy and light chains as the heavy chain of residues 20-471 of SEQ ID NO:3 paired with a light chain comprising residues 21-233 of SEQ ID NO: 4 in instant claims 8 and 9. Claims 66 and 68 of the ‘920 application include a heavy chain of residues 20-479n of SEQ ID NO: 7 paired with a light chain consisting of residues 21-233 of SEQ ID NO: 8 which meets the limitations of instant claim 10 wherein the terminal lysine of the heavy chain is deleted.
It is noted that the limitation “for mesothelioma” in claim 1 occurs in the preamble.
A preamble is generally not accorded any patentable weight where it merely recites the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding instant claims 2-4, the recitation of the subtypes of mesothelioma encompassed by the intended use of the therapeutic agent of claim 1 are also not accorded any patentable weight, applying only to the intended use of the therapeutic agent.
Thus, the instant therapeutic agent is obvious over the method of producing the antibody-drug conjugate of claims 3, 52, 65-68 of the ‘920 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant argues that the pending clams are patentably distinct from US12,220,604, 16/640,914, 19/001,254 and 18/440,920 because none of the aforesaid teach therapeutic agents for treating mesothelioma. This has been considered but not found persuasive because the antibody-drug conjugates of US12,220,604, 16/640,914, 19/001,254 and 18/440,920 are the same as the instant antibody drug conjugates recited with the intended use of treating mesothelioma. The intended use does not impart any structural alterations t the antibody drug conjugates, thus the claims of US12,220,604, 16/640,914, 19/001,254 and 18/440,920 anticipate the instant claims.
Applicant argues that 19/353,836 has a later filing date than the instant application and so, the provisional rejection should be withdrawn. This has been considered but not found persuasive. Section 804IB(b) states that if the provisional nonstatutory double patenting rejection is the only rejection remaining in a utility or plant application, the provisional rejection can be withdrawn so that the claims can pass to issue. However, in the instant case, all claims remain rejected.
All claims are rejected.
All other rejections and/or objection as set forth in the previous Office action are withdrawn.
Conclusion
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.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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