Prosecution Insights
Last updated: April 19, 2026
Application No. 18/549,346

MULTISPECIFIC BINDING AGENTS AGAINST CD40 AND CD137 IN THERAPY

Non-Final OA §103§112§DP
Filed
Sep 06, 2023
Examiner
AEDER, SEAN E
Art Unit
1642
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
BIONTECH SE
OA Round
1 (Non-Final)
57%
Grant Probability
Moderate
1-2
OA Rounds
3y 2m
To Grant
76%
With Interview

Examiner Intelligence

Grants 57% of resolved cases
57%
Career Allow Rate
793 granted / 1395 resolved
-3.2% vs TC avg
Strong +20% interview lift
Without
With
+19.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
81 currently pending
Career history
1476
Total Applications
across all art units

Statute-Specific Performance

§101
13.8%
-26.2% vs TC avg
§103
25.4%
-14.6% vs TC avg
§102
20.2%
-19.8% vs TC avg
§112
24.5%
-15.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1395 resolved cases

Office Action

§103 §112 §DP
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, 73, 74, and 80 are pending and currently under consideration. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim s 34 and 45 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Step ( i ) of claim 34 recites “…a) the sequence…b) a subsequence of the sequence in a)….” Steps (ii)-(vi) of claim 34 each further recite “…a) the sequence…b) a subsequence of the sequence in a) …the sequence defined in a)…the amino acid sequence defined in a) or b)…. ” There is insufficient antecedent basis for “ the sequence in a) ”, “t he sequence defined in a) ”, and “ the amino acid sequence defined in a) or b ” in steps (ii)-(vi) of claim 34. Step ( i ) of claim 45 recites “…a) the sequence…b) a subsequence of the sequence in a)….” Step (ii) of claim 45 further recite s “…a) the sequence…b) a subsequence of the sequence in a)…the sequence defined in a)…the amino acid sequence defined in a) or b)….” There is insufficient antecedent basis for “the sequence in a)”, “the sequence defined in a)”, and “the amino acid sequence defined in a) or b” in step (ii) of claim 45 . 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. Claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, 73, 74, and 80 are rejected u nder 35 U.S.C. 103(a) as being unpatentable over Altintas et al (US 2020/0062853 A1; 2/27/2020) . 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 the bispecific antibodies wherein (a) the position corresponding to F405 in a human IgG1 heavy chain according to EU numbering of the first CH is L, and the position corresponding to K409 in a human IgG1 heavy chain according to EU numbering of the second CH chain is R; or (b) the position corresponding to K409 in a human IgG1 heavy chain according to EU numbering of the first CH chain is R, and the position corresponding to F405 in a human IgG1 heavy chain according to EU numbering of the second CH chain is L ([0446], in particular) . Altintas et al further teaches the bispecific antibodies wherein said first and second heavy chains are modified so that the bisp ecific antibodies induce and/or enhances Fc-mediated effector function to a lesser extent compared to a bisp ecific antibod y which is identical except for comprising non-modified first and second heavy chains ([0579], in particular) . Altintas et al further teaches the bispecific antibodies wherein the modified heavy chains have reduced C1q binding as compared to wild-type antibody ([0581], in particular). Altintas et al further teaches the bispecific antibodies wherein in at least one of said first and second heavy chains one or more amino acids in the positions corresponding to positions L234, L235, D265, N297, and P331 in a human IgG1 heavy chain according to EU numbering, are not L, L, D, N, and P, respectively ([0592], in particular) . Altintas et al further teaches the bispecific antibodies wherein in at least one of said first and second heavy chains the amino acids in the positions corresponding to positions L234 and L235 in a human IgG1 heavy chain according to EU numbering, are F and E ; or A and A, respectively ([0656], in particular) . Altintas et al further teaches the bispecific antibodies wherein the positions corresponding to positions L234, L235, and D265 in the human IgG1 heavy chain of SEQ ID NO:109 (same as instant SEQ ID NO:21) of both the first heavy chain and the second heavy chain are F, E, and A, respectively. Altintas et al further teaches the bispecific antibodies wherein a LC comprises SEQ ID NO:114 ([0740], in particular ; identical to instant SEQ ID NO:27 ), which is a kappa constant region Table 1, in particular). Altintas et al further teaches the bispecific antibodies as IgG1 ([0116], in particular). Altintas et al further teaches methods of treating cancer comprising administering the bispecific antibodies to subjects with cancer ([0003], [0825], and [0835]-[0837], 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 said methods wherein the cancer is a solid cancerous tumor, such as breast cancer ([0813], 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). Altinta et al further teaches the bispecific antibodies may be administered by infusion in a weekly dosage of calculated by mg/m 2 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). Altinta 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). Altinta et al does not specifically demonstrate administering the bispecific antibodies to subjects at recited doses and/or dosing cycles . However, one of skill in the art would have been motivated with an expectation of success to perform the method of Altinta et al wherein the subject is just any subject with cancer of Altinta et al and the method comprises intravenously administering at any doses of the bispecific antibodies (including any doses between 0.001-30 mg/kg; 0.07-210 mg for a 70 kg subject) and/or dosing schedules (including weekly for 8 weeks) encompassed by those of Altinta 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, t his is an example of s ome 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. 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, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, 73, 74, and 80 are rejected on the ground of nonstatutory double patenting a s 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) . The patent claims are drawn to a method for making the bispecific antibodies of Altintas et al ; the patent claims do not recite administering the bispecific antibodies at recited doses and/or dosing times. However , one of skill in the art would have been motivated with an expectation of success to perform the patented method to generate bispecific antibodies for the method of Altinas et al and then perform the method of Altinta et al with the bispecific antibodies wherein the subject is just any subject with cancer of Altinta et al and the method comprises intravenously administering at any doses of the bispecific antibodies (including any doses between 0.001-30 mg/kg; 0.07-210 mg for a 70 kg subject) and/or dosing schedules (including weekly for 8 weeks) encompassed by those of Altinta 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. Claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, 73, 74, and 80 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1- 11 of U.S. Patent No. 11 084882 B2 in view of Altintas et al (US 2020/0062853 A1; 2/27/2020) . The patent claims are drawn to the bispecific antibodies of Altintas et al ; the patent claims do not recite administering the bispecific antibodies at recited doses and/or dosing times. However, one of skill in the art would have been motivated with an expectation of success to perform the method of Altinta et al with the bispecific antibodies of the patent (same as those of Altina et al) wherein the subject is just any subject with cancer of Altinta et al and the method comprises intravenously administering at any doses of the bispecific antibodies (including any doses between 0.001-30 mg/kg; 0.07-210 mg for a 70 kg subject) and/or dosing schedules (including weekly for 8 weeks) encompassed by those of Altinta 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. Claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, 73, 74, and 80 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1- 21 of U.S. Patent No. 11 440966 B2 in view of Altintas et al (US 2020/0062853 A1; 2/27/2020) . The patent claims are drawn to the bispecific antibodies of Altintas et al ; the patent claims do not recite administering the bispecific antibodies at recited doses and/or dosing times. However, one of skill in the art would have been motivated with an expectation of success to perform the method of Altinta et al with the bispecific antibodies of the patent (same as those of Altina et al) wherein the subject is just any subject with cancer of Altinta et al and the method comprises intravenously administering at any doses of the bispecific antibodies (including any doses between 0.001-30 mg/kg; 0.07-210 mg for a 70 kg subject) and/or dosing schedules (including weekly for 8 weeks) encompassed by those of Altinta 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. Claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, 73, 74, and 80 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-1 3 of U.S. Patent No. 11 939388 B2 in view of Altintas et al (US 2020/0062853 A1; 2/27/2020) . The patent claims are drawn to nucleic acid encoding the bispecific antibodies of Altintas et al and host cells comprising expression vectors comprising said nucleic acid ; the patent claims do not recite administering the bispecific antibodies at recited doses and/or dosing times. However, one of skill in the art would have been motivated with an expectation of success to use the host cells expressing the bispecific bispecific antibodies of the copending claims to generate the bispecific antibodies and then perform the method of Altinta et al with the bispecific antibodies wherein the subject is just any subject with cancer of Altinta et al and the method comprises intravenously administering at any doses of the bispecific antibodies (including any doses between 0.001-30 mg/kg; 0.07-210 mg for a 70 kg subject) and/or dosing schedules (including weekly for 8 weeks) encompassed by those of Altinta 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. Claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, 73, 74, and 80 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1- 20 of U.S. Patent No. 1 2077596 B2 in view of Altintas et al (US 2020/0062853 A1; 2/27/2020) . The patent claims are drawn to methods of administering the bispecific antibodies of Altintas et al ; the patent claims do not recite administering the bispecific antibodies at recited doses and/or dosing times. However, one of skill in the art would have been motivated with an expectation of success to perform the method of Altinta et al with the bispecific antibodies wherein the subject is just any subject with cancer of Altinta et al and the method comprises intravenously administering at any doses of the bispecific antibodies (including any doses between 0.001-30 mg/kg; 0.07-210 mg for a 70 kg subject) and/or dosing schedules (including weekly for 8 weeks) encompassed by those of Altinta 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. Claim s 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, 73, 74, and 80 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 12, 15, 19, 42, 47, 81, and 83-95 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 a l; the copending claims do not recite administering the bispecific antibodies at recited doses and/or dosing times. However, one of skill in the art would have been motivated with an expectation of success to perform the method of Altinta et al with the bispecific antibodies wherein the subject is just any subject with cancer of Altinta et al and the method comprises intravenously administering at any doses of the bispecific antibodies (including any doses between 0.001-30 mg/kg; 0.07-210 mg for a 70 kg subject) and/or dosing schedules (including weekly for 8 weeks) encompassed by those of Altinta 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. This is a provisional nonstatutory double patenting rejection. Claims 1, 4, 10, 14, 19, 22-24, 28-30, 34, 40, 45, 47, 51, 69, 73, 74, and 80 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8, 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) . The copending claims are drawn to bispecific antibodies of Altintas et a l and methods comprising those of Altintas et al ; the copending claims do not recite administering the bispecific antibodies at recited doses and/or dosing times. However, one of skill in the art would have been motivated with an expectation of success to perform the method of Altinta et al with the bispecific antibodies wherein the subject is just any subject with cancer of Altinta et al and the method comprises intravenously administering at any doses of the bispecific antibodies (including any doses between 0.001-30 mg/kg; 0.07-210 mg for a 70 kg subject) and/or dosing schedules (including weekly for 8 weeks) encompassed by those of Altinta 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. This is a provisional nonstatutory double patenting rejection. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SEAN E AEDER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-8787 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9am-6pm ET . 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, FILLIN "SPE Name?" \* MERGEFORMAT Samira Jean-Louis can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (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. /SEAN E AEDER/ Primary Examiner, Art Unit 1642
Read full office action

Prosecution Timeline

Sep 06, 2023
Application Filed
Feb 12, 2026
Non-Final Rejection — §103, §112, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
57%
Grant Probability
76%
With Interview (+19.5%)
3y 2m
Median Time to Grant
Low
PTA Risk
Based on 1395 resolved cases by this examiner. Grant probability derived from career allow rate.

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