DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submissions filed on 9/8/26 and 7/29/26 have been entered.
Claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, 73, 74, and 80 are pending.
Claims 1, 7,3, and 80 have been amended by Applicant.
Claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, 73, 74, and 80 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Rejections Withdrawn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 rejection of claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, and 80 under 35 U.S.C. 103(a) as being unpatentable over Altintas et al (US 2020/0062853 A1; 2/27/2020) is withdrawn.
The rejection of claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, and 80 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11091557 B2 in view of Altintas et al (US 2020/0062853 A1; 2/27/2020) is withdrawn.
The rejection of claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, and 80 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11084882 B2 in view of Altintas et al (US 2020/0062853 A1; 2/27/2020) is withdrawn.
The rejection of claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, and 80 on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11440966 B2 in view of Altintas et al (US 2020/0062853 A1; 2/27/2020) is withdrawn.
The rejection of claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, and 80 on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11939388 B2 in view of Altintas et al (US 2020/0062853 A1; 2/27/2020) is withdrawn.
The rejection of claims on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12077596 B2 in view of Altintas et al (US 2020/0062853 A1; 2/27/2020) is withdrawn.
The provisional rejection of claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, and 80 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 15, 42, 47, 81, 83-90, and 92-95 of copending Application No. 17/817033 in view of Altintas et al (US 2020/0062853 A1; 2/27/2020) is withdrawn.
The provisional rejection of claims on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 15, 20, 23, 24, 26, 30, 35, 41, 46, 48, 70, 74, 78, 79, 81, 85, and 86 of copending Application No. 18/579086 in view of Altintas et al (US 2020/0062853 A1; 2/27/2020) is withdrawn.
Rejections Maintained
Claim Rejections - 35 USC § 103
Claims 73-74 remain rejected under 35 U.S.C. 103(a) as being unpatentable over Altintas et al (US 2020/0062853 A1; 2/27/2020).
Instant claims 73-74 are drawn to compositions comprising amounts of bispecific antibodies of Altintas et al.
Altintas et al teaches bispecific antibodies comprising a first binding region to human CD40 and a second binding region to human CD137 ([0055], in particular). Altintas et al further teaches the bispecific antibodies as comprising a first heavy chain (HC) polypeptide comprising a first VH region comprising SEQ ID NO:117 (same as instant SEQ ID NO:9) and first CH region; a first light chain (LC) polypeptide comprising a first VL region comprising SEQ ID NO:121 (same as instant SEQ ID NO:10) and a first CL region; a second heavy chain (HC) polypeptide comprising a second VH region comprising SEQ ID NO:123 (same as instant SEQ ID NO:19) and a second CH region; and a second light chain (LC) polypeptide comprising a second VL region and a second CL region comprising SEQ ID NO:127 (same as instant SEQ ID NO:20) ([0441]-[0443], in particular). Altintas et al further teaches the bispecific antibodies as comprising hinge, CH2, and CH3 regions in each heavy chain ([0120], in particular). Altintas et al further teaches the bispecific antibodies as comprising asymmetrical mutations in said CH3 regions ([0120], in particular). Altintas et al further teaches methods of treating infectious disease comprising administering a composition comprising the bispecific antibodies to subjects ([0825], in particular). Altintas et al further teaches said methods wherein the bispecific antibodies are administered by any suitable route, including intravenously ([0807], in particular). Altintas et al further teaches dosages used in said method should be optimized ([0845], in particular). Altintas et al further teaches dosages and dosage regimens for the bispecific antibodies depend on disease or condition to be treated and may be determined by persons skilled in the art ([0846], in particular). Altintas et al further teaches 0.001-30 mg/kg as an exemplary, non-limiting range for a therapeutically effective amount of the bispecific antibodies ([0846], in particular). Altintas et al further teaches the bispecific antibodies may be administered by infusion in a weekly dosage of calculated by mg/m2 and/or such doses can be based on the mg/kg dosages provided above according to the following: dose (mg/kg)×70: 1.8 and that such administration may be repeated, e.g., 1 to 8 times, such as 3 to 5 times ([0847], in particular). Altintas et al further teaches the bispecific antibodies may be administered in a weekly dosage of calculated as a fixed dose for up to 8 times, such as from 4 to 6 times when given once a week and such regimen may be repeated one or more times as necessary, for example, after 6 months or 12 months ([0848], in particular).
Altintas et al does not specifically demonstrate generating dosages, such as 3-100 mg of the bispecific antibodies. However, one of skill in the art would have been motivated with an expectation of success to perform the method of Altintas et al wherein the subject is just any subject with just any infectious disease of Altintas et al and the method comprises intravenously administering compositions at any doses of the bispecific antibodies (including any doses between 0.001-30 mg/kg; 0.07-2100 mg for a 70 kg subject) and dosing schedules encompassed by those of Altintas et al. “[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 expected therapeutic benefit of the bispecific antibodies , 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 cancer treatment. Further, varying dosage amounts and dosage schedules of the administered bispecific antibodies of the 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 bispecific antibodies. Further, this is an example of some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference to arrive at the claimed invention. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Response to Arguments
In the Reply of 7/29/26, Applicant argues the claims are non-obvious because the application provides unexpected results with improved properties for methods of treating a human subject for cancer with a claimed antibody at recited doses.
The amendments to the claims and the arguments found in the Reply of 7/29/26 have been carefully considered, but are not deemed persuasive. As stated at MPEP 716.02(d), the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In the instant case, the evidence of non-obviousness is for methods of treating a human subject for cancer with a claimed antibody at recited doses. Claims 73-74 are product claims and are not drawn to methods of treating a human subject for cancer with a claimed antibody at recited doses. Therefore, disclosed evidence of unexpected results with improved properties for methods of treating a human subject for cancer with a claimed antibody at recited doses is not commensurate in scope with the products of instant claims 73-74. Further, the above rejection is based on obviousness of methods of treating subjects for infectious diseases with a claimed antibody at recited doses and unexpected result of such methods have not been presented.
Double Patenting
Claims 73-74 remain rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-20 of U.S. Patent No. 11091557 in view of Altintas et al (US 2020/0062853 A1; 2/27/2020);
claims 1-11 of U.S. Patent No. 11084882 in view of Altintas;
claims 1-21 of U.S. Patent No. 11440966 in view of Altintas; and
claims 1-13 of U.S. Patent No. 11939388 in view of Altintas;
The patent claims are drawn to bispecific antibodies of Altintas et al; a method for making the bispecific antibodies of Altintas et al; or nucleic acids encoding the bispecific antibodies of Altintas et al.
The patent claims do not recite compositions of the bispecific antibodies at recited concentrations. However, one of skill in the art would have been motivated with an expectation of success to use host cells expressing the bispecific bispecific antibodies of patent claims of U.S. Patent No. 11939388 to generate the bispecific antibodies of the patent claims (and of Altintas) and use said bispecific antibodies or the bispecific bispecific antibodies of any of patent claims U.S. Patent No. 11091557, 11084882, or 11440966 (all the same bispecific antibodies as Altintas) to generate compositions to administer to subjects with infectious diseases in methods of Altintas of treating subjects with infectious diseases comprising intravenously administering compositions at any doses of the bispecific antibodies (including any doses between 0.001-30 mg/kg; 0.07-2100 mg for a 70 kg subject) and dosing schedules encompassed by those of Altintas et al. “[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 expected therapeutic benefit of the bispecific antibodies , 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 cancer treatment. Further, varying dosage amounts and dosage schedules of the administered bispecific antibodies of the 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 bispecific antibodies.
Response to Arguments
In the Reply of 7/29/26, Applicant repeats arguments addressed above.
Again, as stated at MPEP 716.02(d), the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In the instant case, the evidence of non-obviousness is for methods of treating a human subject for cancer with a claimed antibody at recited doses. Claims 73-74 are product claims and are not drawn to methods of treating a human subject for cancer with a claimed antibody at recited doses. Therefore, disclosed evidence of unexpected results with improved properties for methods of treating a human subject for cancer with a claimed antibody at recited doses is not commensurate in scope with the products of instant claims 73-74. Further, the above rejections are based on obviousness of methods of treating subjects for infectious diseases with an antibody at recited doses and unexpected result of such methods have not been presented.
Double Patenting
Claims 73-74 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 15, 42, 47, 81, 83-90, and 92-95 of copending Application No. 17/817033 in view of Altintas et al (US 2020/0062853 A1; 2/27/2020).
The copending claims are drawn to bispecific antibodies of Altintas et al.
The copending claims do not recite compositions of the bispecific antibodies at recited concentrations. However, one of skill in the art would have been motivated with an expectation of success to generate compositions comprising bispecific antibodies of the copending claims to administer to subjects with infectious diseases in methods of Altintas of treating subjects with infectious diseases comprising intravenously administering compositions at any doses of the bispecific antibodies (including any doses between 0.001-30 mg/kg; 0.07-2100 mg for a 70 kg subject) and dosing schedules encompassed by those of Altintas et al. “[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 expected therapeutic benefit of the bispecific antibodies , 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 cancer treatment. Further, varying dosage amounts and dosage schedules of the administered bispecific antibodies of the 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 bispecific antibodies.
Response to Arguments
In the Reply of 7/29/26, Applicant repeats arguments addressed above.
Again, as stated at MPEP 716.02(d), the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In the instant case, the evidence of non-obviousness is for methods of treating a human subject for cancer with a claimed antibody at recited doses. Claims 73-74 are product claims and are not drawn to methods of treating a human subject for cancer with a claimed antibody at recited doses. Therefore, disclosed evidence of unexpected results with improved properties for methods of treating a human subject for cancer with a claimed antibody at recited doses is not commensurate in scope with the products of instant claims 73-74. Further, the above rejections are based on obviousness of methods of treating subjects for infectious diseases with an antibody at recited doses and unexpected result of such methods have not been presented.
Allowable Subject Matter
Claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, and 80 are allowed.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642
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