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
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. Claims 1-72 have an effective filing date of 30JUN2022.
Election/Restrictions
In the response filed on 1/16/2026 Applicant elected, without traverse:
Species
A distinct species of cancer
Gastric cancer
A distinct species of first and second domains that specifically bind to EGFR and c-Met
SEQ ID NOs: 1-3, 4-6, 7-9, 10-12
A distinct species of administration route
Intravenous
A distinct species of dosage amount
A dosage amount of 1050 mg
A distinct species of administration frequency
An administration frequency of once in two weeks
A distinct species of prior treatment
Chemotherapy
A distinct species of chemotherapy
A fluoropyrimidine-based chemotherapy
A distinct species of fluoropyrimidine-based chemotherapy
A 5-fluorouracil as fluoropyrimidine-based chemotherapy
A distinct species of platinum-based chemotherapy
Cisplatin
A distinct species of targeted therapy
Anti-HER2 therapy
A distinct species of anti-VEGF/VEGFR therapy
Bevacizumab
A distinct species of additional therapeutics
Glucocorticosteroid
Status of Claims
Claims 1-72 are currently pending and presented for examination on the merits.
Claims 50-53 are amended.
Claims 11-18, 21-22, 29-31, and 37-72 are withdrawn from further consideration by Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1, 5-10, 19-20, 23, and 35-36 is rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Chui et al (US 20140141000 A1).
With regards to claim 1, Chui et al teaches a bispecific epidermal growth factor receptor (EGFR) and hepatocyte growth factor receptor (c-Met) antibody [0012]. Chui et al further teaches a method of treating cancer comprising administering the bispecific EGFR/c-Met antibody to a patient [0034]. Chui et al further teaches exemplary cancers that are amendable to this treatment, including gastric cancer [0509].
With regards to claim 5, Chui et al teaches a bispecific EGFR and c-Met antibody comprising SEQ ID NO: 199. A comparison of instant SEQ ID NO: 17 and SEQ ID NO: 199 of Chui et al is shown below.
Instant SEQ ID NO: 17 and SEQ ID NO: 199 of Chui et al.
Query Match 100.0%; Score 2434; Length 455;
Best Local Similarity 100.0%;
Matches 455; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSTYGMHWVRQAPGKGLEWVAVIWDDGSYKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSTYGMHWVRQAPGKGLEWVAVIWDDGSYKYY 60
Qy 61 GDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDGITMVRGVMKDYFDYWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDGITMVRGVMKDYFDYWGQGTL 120
Qy 121 VTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPA 180
Qy 181 VLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAP 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 VLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAP 240
Qy 241 ELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPR 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 ELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPR 300
Qy 301 EEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLP 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 EEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLP 360
Qy 361 PSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFLLYSKLTV 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 PSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFLLYSKLTV 420
Qy 421 DKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 455
|||||||||||||||||||||||||||||||||||
Db 421 DKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 455
Chui et al teaches a bispecific EGFR and c-Met antibody comprising SEQ ID NO: 200. A comparison of instant SEQ ID NO: 18 and SEQ ID NO: 200 of Chui et al is shown below.
Instant SEQ ID NO: 18 and SEQ ID NO: 200 of Chui et al.
Query Match 100.0%; Score 1098; Length 214;
Best Local Similarity 100.0%;
Matches 214; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AIQLTQSPSSLSASVGDRVTITCRASQDISSALVWYQQKPGKAPKLLIYDASSLESGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AIQLTQSPSSLSASVGDRVTITCRASQDISSALVWYQQKPGKAPKLLIYDASSLESGVPS 60
Qy 61 RFSGSESGTDFTLTISSLQPEDFATYYCQQFNSYPLTFGGGTKVEIKRTVAAPSVFIFPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSESGTDFTLTISSLQPEDFATYYCQQFNSYPLTFGGGTKVEIKRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
Chui et al teaches a bispecific EGFR and c-Met antibody comprising SEQ ID NO: 201. A comparison of instant SEQ ID NO: 19 and SEQ ID NO: 201 of Chui et al is shown below.
Instant SEQ ID NO: 19 and SEQ ID NO: 201 of Chui et al.
Query Match 100.0%; Score 2403; Length 449;
Best Local Similarity 100.0%;
Matches 449; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCETSGYTFTSYGISWVRQAPGHGLEWMGWISAYNGYTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKVSCETSGYTFTSYGISWVRQAPGHGLEWMGWISAYNGYTNY 60
Qy 61 AQKLQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARDLRGTNYFDYWGQGTLVTVSSA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AQKLQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARDLRGTNYFDYWGQGTLVTVSSA 120
Qy 121 STKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 STKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG 180
Qy 181 LYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGP 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 LYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGP 240
Qy 241 SVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNS 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 SVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNS 300
Qy 301 TYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEM 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 TYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEM 360
Qy 361 TKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQ 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 TKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQ 420
Qy 421 QGNVFSCSVMHEALHNHYTQKSLSLSPGK 449
|||||||||||||||||||||||||||||
Db 421 QGNVFSCSVMHEALHNHYTQKSLSLSPGK 449
Chui et al teaches a bispecific EGFR and c-Met antibody comprising SEQ ID NO: 202. A comparison of instant SEQ ID NO: 20 and SEQ ID NO: 202 of Chui et al is shown below.
Instant SEQ ID NO: 20 and SEQ ID NO: 202 of Chui et al.
Query Match 100.0%; Score 1106; Length 214;
Best Local Similarity 100.0%;
Matches 214; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSVSASVGDRVTITCRASQGISNWLAWFQHKPGKAPKLLIYAASSLLSGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSVSASVGDRVTITCRASQGISNWLAWFQHKPGKAPKLLIYAASSLLSGVPS 60
Qy 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQQANSFPITFGQGTRLEIKRTVAAPSVFIFPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQQANSFPITFGQGTRLEIKRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
With regards to claim 6, Chui et al further teaches the antibody has a biantennary glycan structure with a fucose content of about between 1-15% [0488].
With regards to claims 7 and 19, Chui et al further teaches administering the bispecific antibody intravenously [0539].
With regards to claims 8-10, Chui et al further teaches a therapeutic dosage of between 0.1-10 mg/kg [0541].
With regards to claim 20, Chui et al further teaches administration once in two weeks [0541].
With regards to claim 23, Chui et al further teaches the cancer expresses EGFR and/or c-Met [0025].
With regards to claim 35, Chui et al further teaches treating gastric cancer [0326]. Furthermore, Chui et al teaches the cancer treated is metastatic [0323].
12. With regards to claim 36, Chui et al further teaches the treatment of humans [0321].
Claim Rejections - 35 USC § 103
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.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10, 19-20, 23-28, and 32-36 are rejected under 35 U.S.C. 103 as being unpatentable over Chui et al (US 20140141000 A1) as applied to claims 1, 5-10, 19-20, 23, and 35-36 above, and further in view of Van De Winkel et al (WO 02100348 A2) and Neijssen et al (WO 2011110642 A2).
Chui et al does not specifically teach the EGFR antibody comprising SEQ ID NOs: 1-3, 4-6. However, this deficiency is made up in the teachings of Van De Winkel et al.
With regards to claim 2, Van De Winkel teaches the treatment of EGFR-related diseases including cancer [Line 15, pg. 9]. Van De Winkel further teaches an EGFR antibody 2F8 VH. A comparison of instant SEQ ID NOs: 1,2,3 and EGFR antibody 2F8 VH are shown below.
Instant SEQ ID NOs: 1,2,3 and EGFR antibody 2F8 VH of Van De Winkel.
Query Match 88.6%; Score 191.4; Length 125;
Best Local Similarity 45.2%;
Matches 38; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 TYGMH--------------VIWDDGSYKYYGDSVKG------------------------ 22
||||| |||||||||||||||||
Db 31 TYGMHWVRQAPGKGLEWVAVIWDDGSYKYYGDSVKGRFTISRDNSKNTLYLQMNSLRAED 90
Qy 23 --------DGITMVRGVMKDYFDY 38
||||||||||||||||
Db 91 TAVYYCARDGITMVRGVMKDYFDY 114
Van De Winkel further teaches an EGFR antibody 2F8 VL. A comparison of instant SEQ ID NOs: 4,5,6 and EGFR antibody 2F8 VL of Van De Winkel is shown below.
Instant SEQ ID NOs: 4,5,6 and EGFR antibody 2F8 VL of Van De Winkel.
Query Match 80.7%; Score 103.3; Length 107;
Best Local Similarity 36.5%;
Matches 27; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 RASQDISSALV---------------DASSLES--------------------------- 18
||||||||||| |||||||
Db 24 RASQDISSALVWYQQKPGKAPKLLIYDASSLESGVPSRFSGSESGTDFTLTISSLQPEDF 83
Qy 19 -----QQFNSYPLT 27
|||||||||
Db 84 ATYYCQQFNSYPLT 97
Chui et al does not specifically teach a c-Met antibody comprising SEQ ID NOs: 7,8,9 and 10,11,12. However, this deficiency is made up in the teachings of Neijssen et al.
Neijssen et al teaches an anti-c-Met antibody used in the treatment of cancer [3rd Paragraph, pg. 38]. Neijssen et al further teaches the treatment of gastric cancer [4th Paragraph, pg. 38]. Neijssen et al further teaches an c-Met antibody comprising SEQ ID NOs: 98,99,100. A comparison of instant SEQ ID NOs: 7,8,9 and SEQ ID NO: 97 of Neijssen et al is shown below.
Instant SEQ ID NOs: 7,8,9 and SEQ ID NO: 97 of Neijssen et al.
Query Match 86.3%; Score 154.4; Length 119;
Best Local Similarity 41.0%;
Matches 32; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 SYGIS--------------WISAYNGYTNYAQKLQG------------------------ 22
||||| |||||||||||||||||
Db 31 SYGISWVRQAPGHGLEWMGWISAYNGYTNYAQKLQGRVTMTTDTSTSTAYMELRSLRSDD 90
Qy 23 --------DLRGTNYFDY 32
||||||||||
Db 91 TAVYYCARDLRGTNYFDY 108
Neijssen et al teaches an c-Met antibody comprising SEQ ID NO: 101. A comparison of instant SEQ ID NOs: 10,11,12 and SEQ ID NO: 101 of Neijssen et al is shown below.
Instant SEQ ID NOs: 10,11,12 and SEQ ID NO: 101 of Neijssen et al.
Query Match 81.1%; Score 106.3; Length 107;
Best Local Similarity 36.5%;
Matches 27; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 RASQGISNWLA---------------AASSLLS--------------------------- 18
||||||||||| |||||||
Db 24 RASQGISNWLAWFQHKPGKAPKLLIYAASSLLSGVPSRFSGSGSGTDFTLTISSLQPEDF 83
Qy 19 -----QQANSFPIT 27
|||||||||
Db 84 ATYYCQQANSFPIT 97
One of ordinary skill in the art, before the effective filing date would have been motivated to use Chui’s method of treating gastric cancer comprising administering a bispecific EGFR and c-Met antibody, with Van De Winkel’s method of treating cancer comprising administering the EGFR antibody 2F8 VH and VL, with Neijssen’s method of treating gastric cancer comprising administering c-Met antibody comprising SEQ ID NOs: 97 and 101. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Chui, Van De Winkel, and Neijssen’s methods for a method of treating gastric cancer comprising administering an EGFR and c-Met bispecific antibody, because Chui, Van De Winkel, and Neijssen all show these therapeutics treating gastric cancer.
With regards to claims 3, Van De Winkel further teaches an EGFR antibody 2F8 VH. A comparison of instant SEQ ID NO: 13 and EGFR antibody 2F8 VH are shown below.
Instant SEQ ID NO: 13 and EGFR antibody 2F8 VH of Van De Winkel.
Query Match 100.0%; Score 669; Length 125;
Best Local Similarity 100.0%;
Matches 125; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSTYGMHWVRQAPGKGLEWVAVIWDDGSYKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSTYGMHWVRQAPGKGLEWVAVIWDDGSYKYY 60
Qy 61 GDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDGITMVRGVMKDYFDYWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDGITMVRGVMKDYFDYWGQGTL 120
Qy 121 VTVSS 125
|||||
Db 121 VTVSS 125
Van De Winkel further teaches an EGFR antibody 2F8 VL. A comparison of instant SEQ ID NO: 14 and EGFR antibody 2F8 VL are shown below.
Instant SEQ ID NO: 14 and EGFR antibody 2F8 VL of Van De Winkel.
Query Match 100.0%; Score 545; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AIQLTQSPSSLSASVGDRVTITCRASQDISSALVWYQQKPGKAPKLLIYDASSLESGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AIQLTQSPSSLSASVGDRVTITCRASQDISSALVWYQQKPGKAPKLLIYDASSLESGVPS 60
Qy 61 RFSGSESGTDFTLTISSLQPEDFATYYCQQFNSYPLTFGGGTKVEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSESGTDFTLTISSLQPEDFATYYCQQFNSYPLTFGGGTKVEIK 107
Neijssen et al teaches an c-Met antibody comprising SEQ ID NO: 97. A comparison of instant SEQ ID NO: 15 and SEQ ID NO: 97 of Neijssen et al is shown below.
Instant SEQ ID NO: 15 and SEQ ID NO: 97 of Neijssen et al.
Query Match 100.0%; Score 636; Length 119;
Best Local Similarity 100.0%;
Matches 119; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCETSGYTFTSYGISWVRQAPGHGLEWMGWISAYNGYTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKVSCETSGYTFTSYGISWVRQAPGHGLEWMGWISAYNGYTNY 60
Qy 61 AQKLQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARDLRGTNYFDYWGQGTLVTVSS 119
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AQKLQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARDLRGTNYFDYWGQGTLVTVSS 119
Neijssen et al teaches an c-Met antibody comprising SEQ ID NO: 101. A comparison of instant SEQ ID NO: 16 and SEQ ID NO: 101 of Neijssen et al is shown below.
Instant SEQ ID NO: 16 and SEQ ID NO: 101 of Neijssen et al.
Query Match 100.0%; Score 553; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSVSASVGDRVTITCRASQGISNWLAWFQHKPGKAPKLLIYAASSLLSGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSVSASVGDRVTITCRASQGISNWLAWFQHKPGKAPKLLIYAASSLLSGVPS 60
Qy 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQQANSFPITFGQGTRLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQQANSFPITFGQGTRLEIK 107
With regards to claim 4, Van De Winkle further teaches the antibody is IgG1 isotype [Line 25, pg. 3].
With regards to claims 24-26, and 28, Van De Winkle further teaches administering chemotherapeutic agents before or after treatment, such as cisplatin [Line 6-12, pg. 8].
With regards to claim 27, Van De Winkel further teaches administering the additional therapeutic 5-fluorouracil [Line 12, pg. 51].
With respect to claim 32, one of ordinary skill in the art would have been motivated to administer the bispecific antibody of Chui, Van De Winkel, and Neijssen to patients that are treatment naïve, as well as patients that have received prior cancer treatment, such as chemotherapy, because there would have been a reasonable expectation that said bispecific antibody would provide a therapeutic benefit to both treatment naïve patients and patients that have received prior cancer treatment.
With regards to claim 33-34, Neijssen et al further teaches the administration of an additional therapeutic, glucocorticoids [4th Paragraph, pg. 30].
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.
Claims 1-10, 19-20, 23-28, and 32-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9593164 ('164) in view of Van De Winkel et al (WO 02100348 A2), and Neijssen et al (WO 2011110642 A2).
Claims 1 and 5 are not patentably distinct from claim 1 of ‘164. Specifically, a bispecific antibody that binds EGFR and c-Met. Furthermore, a bispecific EGFR and c-Met antibody comprising SEQ ID NOs: 199, 200, 201, & 202.
Furthermore, ‘164 teaches a bispecific EGFR and c-Met antibody comprising SEQ ID NO: 199. A comparison of instant SEQ ID NO: 17 and SEQ ID NO: 199 of ‘164 is shown below.
Instant SEQ ID NO: 17 and SEQ ID NO: 199 of ‘164.
Query Match 100.0%; Score 2434; Length 455;
Best Local Similarity 100.0%;
Matches 455; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSTYGMHWVRQAPGKGLEWVAVIWDDGSYKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSTYGMHWVRQAPGKGLEWVAVIWDDGSYKYY 60
Qy 61 GDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDGITMVRGVMKDYFDYWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDGITMVRGVMKDYFDYWGQGTL 120
Qy 121 VTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPA 180
Qy 181 VLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAP 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 VLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAP 240
Qy 241 ELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPR 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 ELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPR 300
Qy 301 EEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLP 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 EEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLP 360
Qy 361 PSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFLLYSKLTV 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 PSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFLLYSKLTV 420
Qy 421 DKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 455
|||||||||||||||||||||||||||||||||||
Db 421 DKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 455
Furthermore, ‘164 teaches a bispecific EGFR and c-Met antibody comprising SEQ ID NO: 200. A comparison of instant SEQ ID NO: 18 and SEQ ID NO: 200 of ‘164 is shown below.
Instant SEQ ID NO: 18 and SEQ ID NO: 200 of ‘164.
Query Match 100.0%; Score 1098; Length 214;
Best Local Similarity 100.0%;
Matches 214; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AIQLTQSPSSLSASVGDRVTITCRASQDISSALVWYQQKPGKAPKLLIYDASSLESGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AIQLTQSPSSLSASVGDRVTITCRASQDISSALVWYQQKPGKAPKLLIYDASSLESGVPS 60
Qy 61 RFSGSESGTDFTLTISSLQPEDFATYYCQQFNSYPLTFGGGTKVEIKRTVAAPSVFIFPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSESGTDFTLTISSLQPEDFATYYCQQFNSYPLTFGGGTKVEIKRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
Furthermore, ‘164 teaches a bispecific EGFR and c-Met antibody comprising SEQ ID NO: 201. A comparison of instant SEQ ID NO: 19 and SEQ ID NO: 201 of ‘164 is shown below.
Instant SEQ ID NO: 19 and SEQ ID NO: 201 of ‘164.
Query Match 100.0%; Score 2403; Length 449;
Best Local Similarity 100.0%;
Matches 449; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCETSGYTFTSYGISWVRQAPGHGLEWMGWISAYNGYTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKVSCETSGYTFTSYGISWVRQAPGHGLEWMGWISAYNGYTNY 60
Qy 61 AQKLQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARDLRGTNYFDYWGQGTLVTVSSA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AQKLQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARDLRGTNYFDYWGQGTLVTVSSA 120
Qy 121 STKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 STKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG 180
Qy 181 LYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGP 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 LYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGP 240
Qy 241 SVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNS 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 SVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNS 300
Qy 301 TYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEM 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 TYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEM 360
Qy 361 TKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQ 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 TKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQ 420
Qy 421 QGNVFSCSVMHEALHNHYTQKSLSLSPGK 449
|||||||||||||||||||||||||||||
Db 421 QGNVFSCSVMHEALHNHYTQKSLSLSPGK 449
Furthermore, ‘164 teaches a bispecific EGFR and c-Met antibody comprising SEQ ID NO: 202. A comparison of instant SEQ ID NO: 20 and SEQ ID NO: 202 of ‘164 is shown below.
Instant SEQ ID NO: 20 and SEQ ID NO: 202 of ‘164.
Query Match 100.0%; Score 1106; Length 214;
Best Local Similarity 100.0%;
Matches 214; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSVSASVGDRVTITCRASQGISNWLAWFQHKPGKAPKLLIYAASSLLSGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSVSASVGDRVTITCRASQGISNWLAWFQHKPGKAPKLLIYAASSLLSGVPS 60
Qy 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQQANSFPITFGQGTRLEIKRTVAAPSVFIFPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQQANSFPITFGQGTRLEIKRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
The teachings of Van De Winkel et al and Neijssen et al are discussed above. Based on the teachings of Van De Winkel et al, one of ordinary skill in the art would have been motivated to modify the conflicting claims to recite a method of treating cancer comprising administering the EGFR antibody 2F8 VH and VL, and based on the teachings of Neijssen et al, one of ordinary skill would have been motivated to modify the conflicting claims to recite a method of treating gastric cancer comprising administering c-Met antibody comprising SEQ ID NOs: 98,99,100 and 101.
With regards to claim 2, Van De Winkel teaches the treatment of EGFR-related diseases including cancer [Line 15, pg. 9]. Van De Winkel further teaches an EGFR antibody 2F8 VH. A comparison of instant SEQ ID NOs: 1,2,3 and EGFR antibody 2F8 VH are shown below.
Instant SEQ ID NOs: 1,2,3 and EGFR antibody 2F8 VH of Van De Winkel.
Query Match 88.6%; Score 191.4; Length 125;
Best Local Similarity 45.2%;
Matches 38; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 TYGMH--------------VIWDDGSYKYYGDSVKG------------------------ 22
||||| |||||||||||||||||
Db 31 TYGMHWVRQAPGKGLEWVAVIWDDGSYKYYGDSVKGRFTISRDNSKNTLYLQMNSLRAED 90
Qy 23 --------DGITMVRGVMKDYFDY 38
||||||||||||||||
Db 91 TAVYYCARDGITMVRGVMKDYFDY 114
Van De Winkel further teaches an EGFR antibody 2F8 VL. A comparison of instant SEQ ID NOs: 4,5,6 and EGFR antibody 2F8 VL of Van De Winkel is shown below.
Instant SEQ ID NOs: 4,5,6 and EGFR antibody 2F8 VL of Van De Winkel.
Query Match 80.7%; Score 103.3; Length 107;
Best Local Similarity 36.5%;
Matches 27; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 RASQDISSALV---------------DASSLES--------------------------- 18
||||||||||| |||||||
Db 24 RASQDISSALVWYQQKPGKAPKLLIYDASSLESGVPSRFSGSESGTDFTLTISSLQPEDF 83
Qy 19 -----QQFNSYPLT 27
|||||||||
Db 84 ATYYCQQFNSYPLT 97
Neijssen et al teaches an anti-c-Met antibody used in the treatment of cancer [3rd Paragraph, pg. 38]. Neijssen et al further teaches the treatment of gastric cancer [4th Paragraph, pg. 38]. Neijssen et al further teaches an c-Met antibody comprising SEQ ID NOs: 98,99,100. A comparison of instant SEQ ID NOs: 7,8,9 and SEQ ID NOs: 98,99,100 of Neijssen et al is shown below.
Instant SEQ ID NOs: 7,8,9 and SEQ ID NOs: 98,99,100 of Neijssen et al.
Query Match 86.3%; Score 154.4; Length 119;
Best Local Similarity 41.0%;
Matches 32; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 SYGIS--------------WISAYNGYTNYAQKLQG------------------------ 22
||||| |||||||||||||||||
Db 31 SYGISWVRQAPGHGLEWMGWISAYNGYTNYAQKLQGRVTMTTDTSTSTAYMELRSLRSDD 90
Qy 23 --------DLRGTNYFDY 32
||||||||||
Db 91 TAVYYCARDLRGTNYFDY 108
Neijssen et al teaches an c-Met antibody comprising SEQ ID NO: 101. A comparison of instant SEQ ID NOs: 10,11,12 and SEQ ID NO: 101 of Neijssen et al is shown below.
Instant SEQ ID NOs: 10,11,12 and SEQ ID NO: 101 of Neijssen et al.
Query Match 81.1%; Score 106.3; Length 107;
Best Local Similarity 36.5%;
Matches 27; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 RASQGISNWLA---------------AASSLLS--------------------------- 18
||||||||||| |||||||
Db 24 RASQGISNWLAWFQHKPGKAPKLLIYAASSLLSGVPSRFSGSGSGTDFTLTISSLQPEDF 83
Qy 19 -----QQANSFPIT 27
|||||||||
Db 84 ATYYCQQANSFPIT 97
With regards to claim 3, Van De Winkel further teaches an EGFR antibody 2F8 VH. A comparison of instant SEQ ID NO: 13 and EGFR antibody 2F8 VH are shown below.
Instant SEQ ID NO: 13 and EGFR antibody 2F8 VH of Van De Winkel.
Query Match 100.0%; Score 669; Length 125;
Best Local Similarity 100.0%;
Matches 125; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSTYGMHWVRQAPGKGLEWVAVIWDDGSYKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSTYGMHWVRQAPGKGLEWVAVIWDDGSYKYY 60
Qy 61 GDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDGITMVRGVMKDYFDYWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDGITMVRGVMKDYFDYWGQGTL 120
Qy 121 VTVSS 125
|||||
Db 121 VTVSS 125
Van De Winkel further teaches an EGFR antibody 2F8 VL. A comparison of instant SEQ ID NO: 14 and EGFR antibody 2F8 VL are shown below.
Instant SEQ ID NO: 14 and EGFR antibody 2F8 VL of Van De Winkel.
Query Match 100.0%; Score 545; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AIQLTQSPSSLSASVGDRVTITCRASQDISSALVWYQQKPGKAPKLLIYDASSLESGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AIQLTQSPSSLSASVGDRVTITCRASQDISSALVWYQQKPGKAPKLLIYDASSLESGVPS 60
Qy 61 RFSGSESGTDFTLTISSLQPEDFATYYCQQFNSYPLTFGGGTKVEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSESGTDFTLTISSLQPEDFATYYCQQFNSYPLTFGGGTKVEIK 107
Neijssen et al teaches an c-Met antibody comprising SEQ ID NO: 97. A comparison of instant SEQ ID NO: 15 and SEQ ID NO: 97 of Neijssen et al is shown below.
Instant SEQ ID NO: 15 and SEQ ID NO: 97 of Neijssen et al.
Query Match 100.0%; Score 636; Length 119;
Best Local Similarity 100.0%;
Matches 119; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCETSGYTFTSYGISWVRQAPGHGLEWMGWISAYNGYTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKVSCETSGYTFTSYGISWVRQAPGHGLEWMGWISAYNGYTNY 60
Qy 61 AQKLQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARDLRGTNYFDYWGQGTLVTVSS 119
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AQKLQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARDLRGTNYFDYWGQGTLVTVSS 119
Neijssen et al teaches an c-Met antibody comprising SEQ ID NO: 101. A comparison of instant SEQ ID NO: 16 and SEQ ID NO: 101 of Neijssen et al is shown below.
Instant SEQ ID NO: 16 and SEQ ID NO: 101 of Neijssen et al.
Query Match 100.0%; Score 553; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSVSASVGDRVTITCRASQGISNWLAWFQHKPGKAPKLLIYAASSLLSGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSVSASVGDRVTITCRASQGISNWLAWFQHKPGKAPKLLIYAASSLLSGVPS 60
Qy 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQQANSFPITFGQGTRLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQQANSFPITFGQGTRLEIK 107
With regards to claim 4, Van De Winkle et al further teaches the antibody is IgG1 isotype [Line 25, pg. 3].
With regards to claim 6, Chui et al further teaches the antibody has a biantennary glycan structure with a fucose content of about between 1-15% [0488].
With regards to claims 7 and 19, Chui et al further teaches administering the bispecific antibody intravenously [0539].
With regards to claims 8-10, Chui et al further teaches a therapeutic dosage of between 0.1-10 mg/kg [0541].
With regards to claim 20, Chui et al further teaches administration once in two weeks [0541].
With regards to claim 23, Chui et al further teaches the cancer expresses EGFR and/or c-Met [0025].
With regards to claims 24-26, and 28, Van De Winkle further teaches administering chemotherapeutic agents before or after treatment, such as cisplatin [Line 6-12, pg. 8].
With regards to claim 27, Van De Winkel further teaches administering the additional therapeutic 5-fluorouracil [Line 12, pg. 51].
With respect to claim 32, one of ordinary skill in the art would have been motivated to administer the bispecific antibody of ‘164, Van De Winkel, and Neijssen to patients that are treatment naïve, as well as patients that have received prior cancer treatment, such as chemotherapy, because there would have been a reasonable expectation that said bispecific antibody would provide a therapeutic benefit to both treatment naïve patients and patients that have received prior cancer treatment.
With regards to claim 33-34, Neijssen et al further teaches the administration of an additional therapeutic, glucocorticoids [4th Paragraph, pg. 30].
With regards to claim 35, Chui et al further teaches treating gastric cancer [0326]. Furthermore, Chui et al teaches the cancer treated is metastatic [0323].
With regards to claim 36, Chui et al further teaches the treatment of humans [0321].
Claims 1-4, 6-10, 19-20, 23-28, and 32-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9725497 ('497) in view of Chui et al (US 20140141000 A1), Van De Winkel et al (WO 02100348 A2), and Neijssen et al (WO 2011110642 A2).
Claims 1 is not patentably distinct from claim 1 of ‘497. Specifically, a bispecific antibody that binds to EGFR and c-Met.
The teachings of Chui et al, Van De Winkel et al, and Neijssen et al are discussed above. Based on the teachings of Chui et al, one of ordinary skill would have been motivated to modify the conflicting claims to recite a method of treating metastatic gastric cancer that expresses EGFR and/or c-Met comprising administering a bispecific EGFR and c-Met antibody, and based upon the teachings of Van De Winkel et al, one of ordinary skill in the art would have been motivated to modify the conflicting claims to recite a method of treating cancer comprising administering the EGFR antibody 2F8 VH and VL, and based on the teachings of Neijssen et al, one of ordinary skill would have been motivated to modify the conflicting claims to recite a method of treating gastric cancer comprising administering c-Met antibody comprising SEQ ID NOs: 98,99,100 and 101.
With regards to claim 2, Van De Winkel teaches the treatment of EGFR-related diseases including cancer [Line 15, pg. 9]. Van De Winkel further teaches an EGFR antibody 2F8 VH. A comparison of instant SEQ ID NOs: 1,2,3 and EGFR antibody 2F8 VH are shown below.
Instant SEQ ID NOs: 1,2,3 and EGFR antibody 2F8 VH of Van De Winkel.
Query Match 88.6%; Score 191.4; Length 125;
Best Local Similarity 45.2%;
Matches 38; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 TYGMH--------------VIWDDGSYKYYGDSVKG------------------------ 22
||||| |||||||||||||||||
Db 31 TYGMHWVRQAPGKGLEWVAVIWDDGSYKYYGDSVKGRFTISRDNSKNTLYLQMNSLRAED 90
Qy 23 --------DGITMVRGVMKDYFDY 38
||||||||||||||||
Db 91 TAVYYCARDGITMVRGVMKDYFDY 114
Van De Winkel further teaches an EGFR antibody 2F8 VL. A comparison of instant SEQ ID NOs: 4,5,6 and EGFR antibody 2F8 VL of Van De Winkel is shown below.
Instant SEQ ID NOs: 4,5,6 and EGFR antibody 2F8 VL of Van De Winkel.
Query Match 80.7%; Score 103.3; Length 107;
Best Local Similarity 36.5%;
Matches 27; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 RASQDISSALV---------------DASSLES--------------------------- 18
||||||||||| |||||||
Db 24 RASQDISSALVWYQQKPGKAPKLLIYDASSLESGVPSRFSGSESGTDFTLTISSLQPEDF 83
Qy 19 -----QQFNSYPLT 27
|||||||||
Db 84 ATYYCQQFNSYPLT 97
Neijssen et al teaches an anti-c-Met antibody used in the treatment of cancer [3rd Paragraph, pg. 38]. Neijssen et al further teaches the treatment of gastric cancer [4th Paragraph, pg. 38]. Neijssen et al further teaches an c-Met antibody comprising SEQ ID NOs: 98,99,100. A comparison of instant SEQ ID NOs: 7,8,9 and SEQ ID NOs: 98,99,100 of Neijssen et al is shown below.
Instant SEQ ID NOs: 7,8,9 and SEQ ID NOs: 98,99,100 of Neijssen et al.
Query Match 86.3%; Score 154.4; Length 119;
Best Local Similarity 41.0%;
Matches 32; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 SYGIS--------------WISAYNGYTNYAQKLQG------------------------ 22
||||| |||||||||||||||||
Db 31 SYGISWVRQAPGHGLEWMGWISAYNGYTNYAQKLQGRVTMTTDTSTSTAYMELRSLRSDD 90
Qy 23 --------DLRGTNYFDY 32
||||||||||
Db 91 TAVYYCARDLRGTNYFDY 108
Neijssen et al teaches an c-Met antibody comprising SEQ ID NO: 101. A comparison of instant SEQ ID NOs: 10,11,12 and SEQ ID NO: 101 of Neijssen et al is shown below.
Instant SEQ ID NOs: 10,11,12 and SEQ ID NO: 101 of Neijssen et al.
Query Match 81.1%; Score 106.3; Length 107;
Best Local Similarity 36.5%;
Matches 27; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 RASQGISNWLA---------------AASSLLS--------------------------- 18
||||||||||| |||||||
Db 24 RASQGISNWLAWFQHKPGKAPKLLIYAASSLLSGVPSRFSGSGSGTDFTLTISSLQPEDF 83
Qy 19 -----QQANSFPIT 27
|||||||||
Db 84 ATYYCQQANSFPIT 97
With regards to claims 3, Van De Winkel further teaches an EGFR antibody 2F8 VH. A comparison of instant SEQ ID NO: 13 and EGFR antibody 2F8 VH are shown below.
Instant SEQ ID NO: 13 and EGFR antibody 2F8 VH of Van De Winkel.
Query Match 100.0%; Score 669; Length 125;
Best Local Similarity 100.0%;
Matches 125; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSTYGMHWVRQAPGKGLEWVAVIWDDGSYKYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFTFSTYGMHWVRQAPGKGLEWVAVIWDDGSYKYY 60
Qy 61 GDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDGITMVRGVMKDYFDYWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDGITMVRGVMKDYFDYWGQGTL 120
Qy 121 VTVSS 125
|||||
Db 121 VTVSS 125
Van De Winkel further teaches an EGFR antibody 2F8 VL. A comparison of instant SEQ ID NO: 14 and EGFR antibody 2F8 VL are shown below.
Instant SEQ ID NO: 14 and EGFR antibody 2F8 VL of Van De Winkel.
Query Match 100.0%; Score 545; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AIQLTQSPSSLSASVGDRVTITCRASQDISSALVWYQQKPGKAPKLLIYDASSLESGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AIQLTQSPSSLSASVGDRVTITCRASQDISSALVWYQQKPGKAPKLLIYDASSLESGVPS 60
Qy 61 RFSGSESGTDFTLTISSLQPEDFATYYCQQFNSYPLTFGGGTKVEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSESGTDFTLTISSLQPEDFATYYCQQFNSYPLTFGGGTKVEIK 107
Neijssen et al teaches an c-Met antibody comprising SEQ ID NO: 97. A comparison of instant SEQ ID NO: 15 and SEQ ID NO: 97 of Neijssen et al is shown below.
Instant SEQ ID NO: 15 and SEQ ID NO: 97 of Neijssen et al.
Query Match 100.0%; Score 636; Length 119;
Best Local Similarity 100.0%;
Matches 119; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCETSGYTFTSYGISWVRQAPGHGLEWMGWISAYNGYTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKVSCETSGYTFTSYGISWVRQAPGHGLEWMGWISAYNGYTNY 60
Qy 61 AQKLQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARDLRGTNYFDYWGQGTLVTVSS 119
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AQKLQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARDLRGTNYFDYWGQGTLVTVSS 119
Neijssen et al teaches an c-Met antibody comprising SEQ ID NO: 101. A comparison of instant SEQ ID NO: 16 and SEQ ID NO: 101 of Neijssen et al is shown below.
Instant SEQ ID NO: 16 and SEQ ID NO: 101 of Neijssen et al.
Query Match 100.0%; Score 553; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSVSASVGDRVTITCRASQGISNWLAWFQHKPGKAPKLLIYAASSLLSGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSVSASVGDRVTITCRASQGISNWLAWFQHKPGKAPKLLIYAASSLLSGVPS 60
Qy 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQQANSFPITFGQGTRLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQQANSFPITFGQGTRLEIK 107
With regards to claim 4, Van De Winkle et al further teaches the antibody is IgG1 isotype [Line 25, pg. 3].
With regards to claim 6, Chui et al further teaches the antibody has a biantennary glycan structure with a fucose content of about between 1-15% [0488].
With regards to claims 7 and 19, Chui et al further teaches administering the bispecific antibody intravenously [0539].
With regards to claims 8-10, Chui et al further teaches a therapeutic dosage of between 0.1-10 mg/kg [0541].
With regards to claim 20, Chui et al further teaches administration once in two weeks [0541].
With regards to claim 23, Chui et al further teaches the cancer expresses EGFR and/or c-Met [0025].
With regards to claims 24-26, and 28, Van De Winkle further teaches administering chemotherapeutic agents before or after treatment, such as cisplatin [Line 6-12, pg. 8].
With regards to claim 27, Van De Winkel further teaches administering the additional therapeutic 5-fluorouracil [Line 12, pg. 51].
With respect to claim 32, one of ordinary skill in the art would have been motivated to administer the bispecific antibody of Chui et al, Van De Winkel, and Neijssen to patients that are treatment naïve, as well as patients that have received prior cancer treatment, such as chemotherapy, because there would have been a reasonable expectation that said bispecific antibody would provide a therapeutic benefit to both treatment naïve patients and patients that have received prior cancer treatment.
With regards to claim 33-34, Neijssen et al further teaches the administration of an additional therapeutic, glucocorticoids [4th Paragraph, pg. 30].
With regards to claim 35, Chui et al further teaches treating gastric cancer [0326]. Furthermore, Chui et al teaches the cancer treated is metastatic [0323].
With regards to claim 36, Chui et al further teaches the treatment of humans [0321].
Claims 1-4, 6-10, 19-20, 23-28, and 32-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 12, 16, 18, 21, and 27 of U.S. Patent No. 11459391 ('391) in view of Chui et al (US 20140141000 A1), Van De Winkel et al (WO 02100348 A2), and Neijssen et al (WO 2011110642 A2).
Claims 1-2, and 23 are not patentably distinct from claims 1 and 18 of ‘391. Specifically, a method of treating gastric cancer comprising a bispecific antibody that binds EGFR and c-Met comprising SEQ ID NOs: 1-3, 4-6, 7-9, 10-12.
Claim 3 is not patent ably distinct from claim 2 of ‘391. Specifically, a method of treating cancer comprising a bispecific antibody that binds EGFR and c-Met comprising SEQ ID NOs: 13, 14, 15, 16.
Claim 4 is not patentably distinct from claim 3 of ‘391. Specifically, the bispecific antibody is an IgG1 isotype.
Claim 6 is not patentably distinct from claim 27 of ‘391. Specifically, a fucose content of about 15% or less.
Claims 24-25 are not patentably distinct from claims 12 and 16 of ‘391. Specifically, the subject has received prior treatment of chemotherapy.
Claim 33 is not patentably distinct from claim 21 of ‘391. Specifically, administering at least one additional therapeutic to the subject.
The teachings of Chui et al, Van De Winkel et al, and Neijssen et al are discussed above. Based on the teachings of Chui et al, one of ordinary skill would have been motivated to modify the conflicting claims to recite a method of treating metastatic gastric cancer that expresses EGFR and/or c-Met comprising administering a bispecific EGFR and c-Met antibody and administering it intravenously at a dose of 0.1-10 mg/kg once in two weeks, and based upon the teachings of Van De Winkel et al one of ordinary skill in the art would have been motivated to modify the conflicting claims to recite a method of treating cancer after the chemotherapeutic cisplatin, and based on the teachings of Neijssen et al, one of ordinary skill would have been motivated to modify the conflicting claims to recite a method of treating gastric cancer comprising the additional therapeutic glucocorticoid.
With regards to claims 7 and 19, Chui et al further teaches administering the bispecific antibody intravenously [0539].
With regards to claims 8-10, Chui et al further teaches a therapeutic dosage of between 0.1-10 mg/kg [0541].
With regards to claim 20, Chui et al further teaches administration once in two weeks [0541].
With regards to claims 26, and 28, Van De Winkle further teaches administering chemotherapeutic agents before or after treatment, such as cisplatin [Line 6-12, pg. 8].
With regards to claim 27, Van De Winkel further teaches administering the additional therapeutic 5-fluorouracil [Line 12, pg. 51].
With respect to claim 32, one of ordinary skill in the art would have been motivated to administer the bispecific antibody of Chui et al, Van De Winkel, and Neijssen to patients that are treatment naïve, as well as patients that have received prior cancer treatment, such as chemotherapy, because there would have been a reasonable expectation that said bispecific antibody would provide a therapeutic benefit to both treatment naïve patients and patients that have received prior cancer treatment.
With regards to claim 34, Neijssen et al further teaches the administration of an additional therapeutic, glucocorticoids [4th Paragraph, pg. 30].
With regards to claim 35, Chui et al further teaches treating gastric cancer [0326]. Furthermore, Chui et al teaches the cancer treated is metastatic [0323].
With regards to claim 36, Chui et al further teaches the treatment of humans [0321].
Claims 1-4, 6-10, 19-20, 23-28, and 32-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 23, 25-27, and 29 of U.S. Patent No. 11879013 ('013) in view of Chui et al (US 20140141000 A1), Van De Winkel et al (WO 02100348 A2), and Neijssen et al (WO 2011110642 A2).
Claims 1, 23, and 33 are not patentably distinct from claims 1 and 23 of ‘013. Specifically, a method of treating gastric cancer expressing EGFR and/or c-Met comprising administering a bispecific EGFR and c-Met antibody and an additional therapeutic.
Claim 2 is not patentably distinct from claim 2 of ‘013. Specifically, an bispecific EGFR and c-Met antibody comprising SEQ ID NOs: 1-3, 4-6, 7-9, and 10-12.
Claim 3 is not patentably distinct from claim 3 of ‘013. Specifically, a bispecific EGFR and c-Met antibody comprising SEQ ID NOs: 13, 14, 15, and 16.
Claim 4 is not patentably distinct from claim 4 of ‘013. Specifically, the antibody is IgG1 isotype.
Claim 6 is not patentably distinct from claim 6 of ‘013. Specifically, the antibody is with a fucose structure content of between about 1% and 15%.
Claims 8-10 are not patentably distinct from claims 25-27 of ‘013. Specifically, the bispecific EGFR and c-Met antibody is administered at a dosage of about 350-3400 mg.
Claim 20 is not patentably distinct from claim 29 of ‘013. Specifically, the bispecific EGFR and c-Met antibody is administered once every two weeks.
The teachings of Chui et al, Van De Winkel et al, and Neijssen et al are discussed above. Based on the teachings of Chui et al, one of ordinary skill would have been motivated to modify the conflicting claims to recite a method of treating metastatic gastric cancer in humans that expresses EGFR and/or c-Met comprising administering a bispecific EGFR and c-Met antibody and administering it intravenously, and based upon the teachings of Van De Winkel et al one of ordinary skill in the art would have been motivated to modify the conflicting claims to recite a method of treating cancer after the chemotherapeutic cisplatin, and based on the teachings of Neijssen et al, one of ordinary skill would have been motivated to modify the conflicting claims to recite a method of treating gastric cancer comprising the additional therapeutic glucocorticoid.
With regards to claims 7 and 19, Chui et al further teaches administering the bispecific antibody intravenously [0539].
With regards to claims 24-26, and 28, Van De Winkle further teaches administering chemotherapeutic agents before or after treatment, such as cisplatin [Line 6-12, pg. 8].
With regards to claim 27, Van De Winkel further teaches administering the additional therapeutic 5-fluorouracil [Line 12, pg. 51].
With respect to claim 32, one of ordinary skill in the art would have been motivated to administer the bispecific antibody of Chui et al, Van De Winkel, and Neijssen to patients that are treatment naïve, as well as patients that have received prior cancer treatment, such as chemotherapy, because there would have been a reasonable expectation that said bispecific antibody would provide a therapeutic benefit to both treatment naïve patients and patients that have received prior cancer treatment.
With regards to claim 34, Neijssen et al further teaches the administration of an additional therapeutic, glucocorticoids [4th Paragraph, pg. 30].
With regards to claim 35, Chui et al further teaches treating gastric cancer [0326]. Furthermore, Chui et al teaches the cancer treated is metastatic [0323].
With regards to claim 36, Chui et al further teaches the treatment of humans [0321].
Claims 1-4, 6-10, 19-20, 23-28, and 32-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7-10, 14, 16, 22-24, 26-27, 29-33, 39, and 45-47 of U.S. Patent No. 12215160 ('160) in view of Chui et al (US 20140141000 A1), Van De Winkel et al (WO 02100348 A2), and Neijssen et al (WO 2011110642 A2).
Claims 1-2 are not patentably distinct from claims 1, 14, 26, and 37 of ‘160. Specifically, a method of treating gastric cancer expressing EGFR and/or c-Met comprising administering a bispecific EGFR and c-Met antibody and an additional therapeutic. Furthermore, an bispecific EGFR and c-Met antibody comprising SEQ ID NOs: 1-3, 4-6, 7-9, and 10-12.
Claim 3 is not patentably distinct from claims 2 and 27 of ‘160. Specifically, a bispecific EGFR and c-Met antibody comprising SEQ ID NOs: 13, 14, 15, and 16.
Claim 4 is not patentably distinct from claims 3 and 29 of ‘160. Specifically, the bispecific EGFR and c-Met antibody is IgG1 isotype.
Claim 6 is not patentably distinct from claim 5 of ‘160. Specifically, the antibody is with a fucose structure content of between about 1% and 15%.
Claims 8-10 are not patentably distinct from claims 22-23 and 45-46 of ‘160. Specifically, the bispecific EGFR and c-Met antibody is administered at a dosage of about 350-3400 mg.
Claim 20 is not patentably distinct from claims 24 and 47 of ‘160. Specifically, the bispecific EGFR and c-Met antibody is administered once every two weeks.
Claims 24-26, and 28 are not patentably distinct from claims 7-9 and 30-32 of ‘160. Specifically, the subject has received the prior treatment of a chemotherapeutic, cisplatin.
Claim 32 is not patentably distinct from claims 10 and 33 of ‘160. Specifically, the subject if treatment naïve.
Claim 33 is not patentably distinct from claims 16 and 39. Specifically, administering an additional therapeutic.
The teachings of Chui et al, Van De Winkel et al, and Neijssen et al are discussed above. Based on the teachings of Chui et al, one of ordinary skill would have been motivated to modify the conflicting claims to recite a method of treating metastatic gastric cancer in humans that expresses EGFR and/or c-Met comprising administering a bispecific EGFR and c-Met antibody and administering it intravenously, and based on the teachings of Neijssen et al, one of ordinary skill would have been motivated to modify the conflicting claims to recite a method of treating gastric cancer comprising the additional therapeutic glucocorticoid.
With regards to claims 7 and 19, Chui et al further teaches administering the bispecific antibody intravenously [0539].
With regards to claim 23, Chui et al further teaches the cancer expresses EGFR and/or c-Met [0025].
With regards to claim 27, Van De Winkel further teaches administering the additional therapeutic 5-fluorouracil [Line 12, pg. 51].
With regards to claim 34, Neijssen et al further teaches the administration of an additional therapeutic, glucocorticoids [4th Paragraph, pg. 30].
With regards to claim 35, Chui et al further teaches treating gastric cancer [0326]. Furthermore, Chui et al teaches the cancer treated is metastatic [0323].
With regards to claim 36, Chui et al further teaches the treatment of humans [0321].
Claims 1-4, 6-10, 19-20, 23-28, and 32-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 6-7, 16, and 18 of U.S. Patent No. 12528869 ('869) in view of Chui et al (US 20140141000 A1), Van De Winkel et al (WO 02100348 A2), and Neijssen et al (WO 2011110642 A2).
The teachings of Chui et al, Van De Winkel et al, and Neijssen et al are discussed above. Based on the teachings of Chui et al, one of ordinary skill would have been motivated to modify the conflicting claims to recite a method of treating metastatic gastric cancer in humans that expresses EGFR and/or c-Met comprising administering a bispecific EGFR and c-Met antibody and administering it intravenously, and based upon the teachings of Van De Winkel et al one of ordinary skill in the art would have been motivated to modify the conflicting claims to recite a method of treating cancer after the chemotherapeutic cisplatin, and based on the teachings of Neijssen et al, one of ordinary skill would have been motivated to modify the conflicting claims to recite a method of treating gastric cancer comprising the additional therapeutic glucocorticoid. The invention of the conflicting claims, Chui, Van De Winkel, and Neijssen meets the limitations of claims 1-2, 8-10, 20, 23-26,
Claim 3 is not patentably distinct from claims 3, 16, and 18. Specifically, the bispecific EGFR and c-Met antibody comprise SEQ ID NOs: 13, 14, 15, and 16.
Claim 4 is not patentably distinct from claim 4 of ‘869. Specifically, the antibody is isotype IgG1.
Claim 6 is not patentably distinct from claim 6 of ‘869. Specifically, a biantennary glycan structure with a fucose content of about 1% to about 15%
Claim 33 is not patentably distinct from claim 7 of ‘869. Specifically, the subject is administered an additional therapeutic.
With regards to claims 7 and 19, Chui et al further teaches administering the bispecific antibody intravenously [0539].
With regards to claims 28, Van De Winkle further teaches administering chemotherapeutic agents before or after treatment, such as cisplatin [Line 6-12, pg. 8].
With regards to claim 27, Van De Winkel further teaches administering the additional therapeutic 5-fluorouracil [Line 12, pg. 51].
With respect to claim 32, one of ordinary skill in the art would have been motivated to administer the bispecific antibody of Chui et al, Van De Winkel, and Neijssen to patients that are treatment naïve, as well as patients that have received prior cancer treatment, such as chemotherapy, because there would have been a reasonable expectation that said bispecific antibody would provide a therapeutic benefit to both treatment naïve patients and patients that have received prior cancer treatment.
With regards to claim 34, Neijssen et al further teaches the administration of an additional therapeutic, glucocorticoids [4th Paragraph, pg. 30].
With regards to claim 35, Chui et al further teaches treating gastric cancer [0326]. Furthermore, Chui et al teaches the cancer treated is metastatic [0323].
With regards to claim 36, Chui et al further teaches the treatment of humans [0321].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
Prosecution Insights