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
The Amendments and Remarks filed 1/16/26 in response to the Office Action of 10/16/25 are acknowledged and have been entered.
Claims 52-53 have been added by Applicant.
Claims 1-3, 7, 9, 12, 15, 17, 20, 22, 24, 25, 29-36, 52 and 53 are pending.
Claims 1, 2, 3, 22, 24, 25, 29, and 30 have been amended by Applicant.
Claims 1-3, 7, 9, 12, 15, 17, 20, 22, 24, 25, 29-36, 52 and 53 are currently under examination.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections Withdrawn
The rejections of claims under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
The rejection of claims under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn.
The rejections of claims under 35 U.S.C. 103(a) are withdrawn.
Rejections Maintained
Double Patenting
Claims 1-3, 7, 9, 12, 15, 17, 20, 22, 24, 25, and 29-36 remain and claims 52-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 11-13, 20, 21, 28, and 29 of U.S. Patent No. 12435154 B2 in view of Saville et al (US 2017/0349657 A1; 12/7/17) and Gnaoui et al (Annals of Oncology, 2007, 18: 1363-1368). The instant claims and the patent claims are both drawn to methods of treating DLBCL comprising administering the bispecific antibody that binds CD3 and CD20 epcoritamab. The instant claims differ from the patent claims in that the instant claims require administering gemcitabine and oxaliplatin. Further, the instant claims require administration of epcoritamab at additional time points beyond those specified by the patent claims. However, one of skill in the art would have been motivated with an expectation of success to perform the patent method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks with epcoritamb administration and wherein subcutaneous administration of 24 or 48 mg of epcoritamab is continued at just any time-points after those specified in the patent claims because: (1) Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular); and (2) patent claim 1 recites “after day (8) of treatment epcoritabmab is subcutaneously administered in intervals to the subject until progressive disease develops or unacceptable toxicity occurs”, patent claim 2 identifies 48 mg of epcoritamab as a dose to be administered after day (8), and patent claim 11 identifies 24 mg of epcoritamab as a dose to be administered after day (8).
“[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” In the instant case, given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
Response to Arguments
In the Reply of 1/16/26, Applicant argues the patent does not disclose administering epcoritamab in combination with gemcitabine and oxaliplatin, the patent fails to provide any motivation which would have led the skilled artisan to combine teachings with those of Saville and Gnaoui, and the combination of cited references fail to render obvious the claimed 28-day dosage regimen where epcoritamab, gemcitabine, and oxaliplatin are administered at specific dosages and frequencies.
The amendments to the claims and the arguments found in the Reply of 1/16/26 have been carefully considered, but are not deemed persuasive. The examiner agrees that the patent does not disclose administering epcoritamab in combination with gemcitabine and oxaliplatin. However, one of skill in the art would have been motivated with an expectation of success to perform the patent method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks with epcoritamb administration and wherein subcutaneous administration of 24 or 48 mg of epcoritamab is continued at just any time-points after those specified in the patent claims because: (1) Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular); and (2) patent claim 1 recites “after day (8) of treatment epcoritabmab is subcutaneously administered in intervals to the subject until progressive disease develops or unacceptable toxicity occurs”, patent claim 2 identifies 48 mg of epcoritamab as a dose to be administered after day (8), and patent claim 11 identifies 24 mg of epcoritamab as a dose to be administered after day (8). Given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
Double Patenting
Claims 1-3, 7, 9, 12, 15, 17, 20, 22, 24, 25, and 29-36 remain and claims 52-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 6, and 13-25 of U.S. Patent No. 11548952 B2 in view of Saville et al (US 2017/0349657 A1; 12/7/17) and Gnaoui et al (Annals of Oncology, 2007, 18: 1363-1368). The instant claims and the patent claims are both drawn to methods of treating DLBCL comprising administering the bispecific antibody that binds CD3 and CD20 epcoritamab. The instant claims differ from the patent claims in that the instant claims require administering gemcitabine. However, one of skill in the art would have been motivated with an expectation of success to perform the patent method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine alongside 100 mg/m2 of oxaliplatin of the patent claims every two weeks and wherein subcutaneous administration of 24 or 48 mg of epcoritamab is continued at just any time-points after those specified in the patent claims because: (1) Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular); and (2) patent claims 1-3 identify 24 and 48 mg of the bispecific antibody as a dose to be administered after day 8.
“[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” In the instant case, given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
Response to Arguments
In the Reply of 1/16/26, Applicant argues the patent does not disclose administering epcoritamab in combination with gemcitabine and oxaliplatin, the patent fails to provide any motivation which would have led the skilled artisan to combine teachings with those of Saville and Gnaoui, and the combination of cited references fail to render obvious the claimed 28-day dosage regimen where epcoritamab, gemcitabine, and oxaliplatin are administered at specific dosages and frequencies.
The amendments to the claims and the arguments found in the Reply of 1/16/26 have been carefully considered, but are not deemed persuasive. The examiner agrees that the patent does not disclose administering epcoritamab in combination with gemcitabine and oxaliplatin. However, one of skill in the art would have been motivated with an expectation of success to perform the patent method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine alongside 100 mg/m2 of oxaliplatin of the patent claims every two weeks and wherein subcutaneous administration of 24 or 48 mg of epcoritamab is continued at just any time-points after those specified in the patent claims because: (1) Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular); and (2) patent claims 1-3 identify 24 and 48 mg of the bispecific antibody as a dose to be administered after day 8. Given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
Double Patenting
Claims 1-3, 7, 9, 12, 15, 17, 20, 22, 24, 25, and 29-36 remain and claims 52-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-13, and 15-33 of U.S. Patent No. 11845805 B2 in view of Saville et al (US 2017/0349657 A1; 12/7/17) and Gnaoui et al (Annals of Oncology, 2007, 18: 1363-1368). The instant claims and the patent claims are both drawn to methods of treating DLBCL comprising administering the bispecific antibody that binds CD3 and CD20 epcoritamab. The instant claims differ from the patent claims in that the instant claims require administering gemcitabine and oxaliplatin. However, one of skill in the art would have been motivated with an expectation of success to perform the patent method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks alongside epcoritamab and wherein subcutaneous administration of 24 or 48 mg of epcoritamab is continued at just any time-points after those specified in the patent claims because Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular).
“[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” In the instant case, given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
Response to Arguments
In the Reply of 1/16/26, Applicant argues the patent does not disclose administering epcoritamab in combination with gemcitabine and oxaliplatin, the patent fails to provide any motivation which would have led the skilled artisan to combine teachings with those of Saville and Gnaoui, and the combination of cited references fail to render obvious the claimed 28-day dosage regimen where epcoritamab, gemcitabine, and oxaliplatin are administered at specific dosages and frequencies.
The amendments to the claims and the arguments found in the Reply of 1/16/26 have been carefully considered, but are not deemed persuasive. The examiner agrees that the patent does not disclose administering epcoritamab in combination with gemcitabine and oxaliplatin. However, one of skill in the art would have been motivated with an expectation of success to perform the patent method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks alongside epcoritamab and wherein subcutaneous administration of 24 or 48 mg of epcoritamab is continued at just any time-points after those specified in the patent claims because Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular). Given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
Double Patenting
Claims 1-3, 7, 9, 12, 15, 17, 20, 22, 24, 25, and 29-36 remain and claims 52-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 7, 11, 14, 46-50, and 67-68 of copending Application No. 18/160391 in view of Saville et al (US 2017/0349657 A1; 12/7/17) and Gnaoui et al (Annals of Oncology, 2007, 18: 1363-1368). The instant claims and the copending claims are both drawn to methods of treating DLBCL comprising administering the bispecific antibody that binds CD3 and CD20 epcoritamab. The instant claims differ from the copending claims in that the instant claims require administering gemcitabine and oxaliplatin. However, one of skill in the art would have been motivated with an expectation of success to perform the copending method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks with epcoritamab and wherein subcutaneous administration of 24 or 48 mg of epcoritamab is continued at just any time-points after those specified in the copending claims because Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular).
“[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” In the instant case, given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
This is a provisional nonstatutory double patenting rejection.
Request
In the Reply of 1/16/26, Applicant requests that this rejection be held in abeyance. The request has been considered, but is not granted. The Office does not hold rejections or provisional rejections in abeyance.
Double Patenting
Claims 1-3, 7, 9, 12, 15, 17, 20, 22, 24, 25, and 29-36 remain and claims 52-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, 11, 14, 16, 17, 29-31, 33-35, 40-43, and 48 of copending Application No. 18/160386 in view of Saville et al (US 2017/0349657 A1; 12/7/17) and Gnaoui et al (Annals of Oncology, 2007, 18: 1363-1368). The instant claims and the copending claims are both drawn to methods of treating DLBCL comprising administering the bispecific antibody that binds CD3 and CD20 epcoritamab. The instant claims differ from the copending claims in that the instant claims require administering gemcitabine and oxaliplatin. However, one of skill in the art would have been motivated with an expectation of success to perform the copending method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks with epcoritamab and wherein subcutaneous administration of 24 or 48 mg of epcoritamab is continued at just any time-points after those specified in the copending claims because Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular).
“[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” In the instant case, given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
This is a provisional nonstatutory double patenting rejection.
Request
In the Reply of 1/16/26, Applicant requests that this rejection be held in abeyance. The request has been considered, but is not granted. The Office does not hold rejections or provisional rejections in abeyance.
Double Patenting
Claims 1-3, 7, 9, 12, 15, 17, 20, 22, 24, 25, and 29-36 remain and claims 52-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 69, 70, 72, 73, 80-83, 98-100, 107, and 108 of copending Application No. 17/923317 in view of Saville et al (US 2017/0349657 A1; 12/7/17) and Gnaoui et al (Annals of Oncology, 2007, 18: 1363-1368). The instant claims and the copending claims are both drawn to methods of treating DLBCL comprising administering the bispecific antibody that binds CD3 and CD20 epcoritamab. The instant claims differ from the copending claims in that the instant claims require administering gemcitabine and oxaliplatin. Further, the instant claims require administration of epcoritamab at additional time points beyond those specified by the copending claims. However, one of skill in the art would have been motivated with an expectation of success to perform the copending method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks with epcoritamab and wherein subcutaneous administration of 48 mg of epcoritamab is continued at just any time-points after those specified in the copending claims because: (1) Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular); and (2) copending claim 69 recites “after day (8) of treatment a dose of 48 mg of epcoritabmab is subcutaneously administered in intervals to the subject until progressive disease develops or unacceptable toxicity occurs.”
“[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” In the instant case, given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
In the Reply of 1/16/26, Applicant argues the copending application does not disclose administering epcoritamab in combination with gemcitabine and oxaliplatin, the copending application fails to provide any motivation which would have led the skilled artisan to combine teachings with those of Saville and Gnaoui, and the combination of cited references fail to render obvious the claimed 28-day dosage regimen where epcoritamab, gemcitabine, and oxaliplatin are administered at specific dosages and frequencies.
The amendments to the claims and the arguments found in the Reply of 1/16/26 have been carefully considered, but are not deemed persuasive. The examiner agrees that the copending application does not disclose administering epcoritamab in combination with gemcitabine and oxaliplatin. However, one of skill in the art would have been motivated with an expectation of success to perform the copending method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks with epcoritamab and wherein subcutaneous administration of 48 mg of epcoritamab is continued at just any time-points after those specified in the copending claims because: (1) Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular); and (2) copending claim 69 recites “after day (8) of treatment a dose of 48 mg of epcoritabmab is subcutaneously administered in intervals to the subject until progressive disease develops or unacceptable toxicity occurs.” Given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
Double Patenting
Claims 1-3, 7, 9, 12, 15, 17, 20, 22, 24, 25, and 29-36 remain and claims 52-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-16, 28, 29, 34, 35, 37-39, 47-53, and 67-70 of copending Application No. 18/025206 in view of Saville et al (US 2017/0349657 A1; 12/7/17) and Gnaoui et al (Annals of Oncology, 2007, 18: 1363-1368). The instant claims and the copending claims are both drawn to methods of treating DLBCL comprising administering the bispecific antibody that binds CD3 and CD20 epcoritamab. The instant claims differ from the copending claims in that the instant claims require administering gemcitabine. However, one of skill in the art would have been motivated with an expectation of success to perform the copending method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine alongside 100 mg/m2 of oxaliplatin with epcoritamab of the copending claims every two weeks and wherein subcutaneous administration of 24 or 48 mg of epcoritamab is continued at just any time-points after those specified in the patent claims because: (1) Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular); and (2) copending claim 1 identifies 24 and 48 mg of the bispecific antibody as a full dose of the bispecific antibody.
“[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” In the instant case, given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
In the Reply of 1/16/26, Applicant argues the copending application does not disclose administering epcoritamab in combination with gemcitabine and oxaliplatin, the copending application fails to provide any motivation which would have led the skilled artisan to combine teachings with those of Saville and Gnaoui, and the combination of cited references fail to render obvious the claimed 28-day dosage regimen where epcoritamab, gemcitabine, and oxaliplatin are administered at specific dosages and frequencies.
The amendments to the claims and the arguments found in the Reply of 1/16/26 have been carefully considered, but are not deemed persuasive. The examiner agrees that the copending application does not disclose administering epcoritamab in combination with gemcitabine and oxaliplatin. However, one of skill in the art would have been motivated with an expectation of success to perform the copending method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine alongside 100 mg/m2 of oxaliplatin with epcoritamab of the copending claims every two weeks and wherein subcutaneous administration of 24 or 48 mg of epcoritamab is continued at just any time-points after those specified in the patent claims because: (1) Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular); and (2) copending claim 1 identifies 24 and 48 mg of the bispecific antibody as a full dose of the bispecific antibody. Given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
Double Patenting
Claims 1-3, 7, 9, 12, 15, 17, 20, 22, 24, 25, and 29-36 remain and claims 52-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-8, 12, 15, 33-38, 47-50, and 64-67 of copending Application No. 18/500799 in view of Saville et al (US 2017/0349657 A1; 12/7/17) and Gnaoui et al (Annals of Oncology, 2007, 18: 1363-1368). The instant claims and the copending claims are both drawn to methods of treating DLBCL comprising administering the bispecific antibody that binds CD3 and CD20 epcoritamab. The instant claims differ from the copending claims in that the instant claims require administering gemcitabine and oxaliplatin. Further, the instant claims require administration of epcoritamab at additional time points beyond those specified by the copending claims. However, one of skill in the art would have been motivated with an expectation of success to perform the copending method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin with epcoritamab every two weeks and wherein subcutaneous administration of 24 or 48 mg of epcoritamab is continued at just any time-points after those specified in the copending claims because: (1) Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular); and (2) copending claim 1 recites “wherein administration of the combination continues at least until the subject exhibits a complete metabolic response (CMR), a partial metabolic response or stable disease, or until progressive disease develops or unacceptable toxicity.”
“[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” In the instant case, given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
In the Reply of 1/16/26, Applicant argues the copending application does not disclose administering epcoritamab in combination with gemcitabine and oxaliplatin, the copending application fails to provide any motivation which would have led the skilled artisan to combine teachings with those of Saville and Gnaoui, and the combination of cited references fail to render obvious the claimed 28-day dosage regimen where epcoritamab, gemcitabine, and oxaliplatin are administered at specific dosages and frequencies.
The amendments to the claims and the arguments found in the Reply of 1/16/26 have been carefully considered, but are not deemed persuasive. The examiner agrees that the copending application does not disclose administering epcoritamab in combination with gemcitabine and oxaliplatin. However, one of skill in the art would have been motivated with an expectation of success to perform the copending method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin with epcoritamab every two weeks and wherein subcutaneous administration of 24 or 48 mg of epcoritamab is continued at just any time-points after those specified in the copending claims because: (1) Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular); and (2) copending claim 1 recites “wherein administration of the combination continues at least until the subject exhibits a complete metabolic response (CMR), a partial metabolic response or stable disease, or until progressive disease develops or unacceptable toxicity.” Given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
Double Patenting
Claims 1-3, 7, 9, 12, 15, 17, 20, 22, 24, 25, and 29-36 remain and claims 52-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 3, 12, 15, 33-38, 47-50, and 64-67 of copending Application No. 18/025203 in view of Saville et al (US 2017/0349657 A1; 12/7/17) and Gnaoui et al (Annals of Oncology, 2007, 18: 1363-1368). The instant claims and the copending claims are both drawn to methods of treating DLBCL comprising administering the bispecific antibody that binds CD3 and CD20 epcoritamab. The instant claims differ from the copending claims in that the instant claims require administering gemcitabine and oxaliplatin. However, one of skill in the art would have been motivated with an expectation of success to perform the copending method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin with epcoritamab every two weeks and wherein subcutaneous administration of 24 or 48 mg of epcoritamab is continued at just any time-points after those specified in the copending claims because Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular).
“[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” In the instant case, given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
In the Reply of 1/16/26, Applicant argues the copending application does not disclose administering epcoritamab in combination with gemcitabine and oxaliplatin, the copending application fails to provide any motivation which would have led the skilled artisan to combine teachings with those of Saville and Gnaoui, and the combination of cited references fail to render obvious the claimed 28-day dosage regimen where epcoritamab, gemcitabine, and oxaliplatin are administered at specific dosages and frequencies.
The amendments to the claims and the arguments found in the Reply of 1/16/26 have been carefully considered, but are not deemed persuasive. The examiner agrees that the copending application does not disclose administering epcoritamab in combination with gemcitabine and oxaliplatin. However, one of skill in the art would have been motivated with an expectation of success to perform the copending method wherein the subject is just any subject with DLBCL and the method further comprises intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin with epcoritamab every two weeks and wherein subcutaneous administration of 24 or 48 mg of epcoritamab is continued at just any time-points after those specified in the copending claims because Saville et al identifies gemcitabine and/or oxaliplatin as chemotherapeutics to be administered to DLBCL patients with a bispecific antibody that binds CD3 and CD20 ([0156]-[0157], in particular) and Gnaoui et al teaches methods of therapeutically treating subjects with B-cell lymphoma, including subjects with DLBCL, comprising intravenously administering 1000 mg/m2 of gemcitabine and 100 mg/m2 of oxaliplatin every two weeks (left column on page 1364 and page 1365, in particular). Given the known function of each administered reagent to treat DLBCL, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination is expected to provide therapeutic DLBCL treatment. Further, varying dosage amounts and dosage schedules of the administered therapeutic reagents of the combined method are “result-effective variables” wherein the results are therapeutic benefit weighed against dose-limiting toxicities and the variables are the varying amounts and dosage schedules of the administered therapeutic reagents.
Conclusion
THIS ACTION IS MADE FINAL. 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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/SEAN E AEDER/Primary Examiner, Art Unit 1642