Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1, 4-10, 14-15, 18, 22-23, 34, 38, 41-42, 54, 64-65 and 70-73 are pending and being acted upon in this Office Action.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Objection and Rejection Withdrawn
The objection to the specification is withdrawn in light of the amendment filed November 17, 2025.
The written description rejection of claims 1, 4-10, 14-15, 18, 22-23, 34, 38, 41-42, 54, 64 and 65 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn in view of the claim amendment.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 4-10, 14-15, 18, 22-23, 34, 38, 41-42, 54, 64-65, 70-73 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18, 20 and 21 of U.S. Patent No. 11,492,371. Although the conflicting claims are not identical, they are not patentably distinct from each other because while the ‘371 patent issued from the application which served as the parent for the present case, the examined application was filed as a CON, not a DIV, and therefore no shield against double patenting that might be provided by 35 U.S.C 121 would be applicable here.
Issued claim 1 recites an in vitro method for production of a heterodimeric antibody comprising the following steps: a) incubating in a composition a first homodimeric antibody with a second homodimeric antibody under reducing conditions sufficient to allow reduction of the inter-chain disulfide bonds in the hinge region,
wherein said first homodimeric antibody comprises an Fc region of an immunoglobulin, said Fc region comprising a first human IgG1 CH3 region, and said second homodimeric antibody comprises an Fc region of an immunoglobulin, said Fc region comprising a second human IgG1 CH3 region,
wherein said first homodimeric antibody has a K409R amino acid substitution (numbering according to the EU Index), and said second homodimeric antibody has an amino acid substitution selected from the group consisting of: L368A, L368D, L368E, L368G, L368H, L368I, L368N, L368Q, L368R, L368S, L368T, L368V, L368W, D399A, D399F, D399H, D399K, D399R, D399Y, F405A, F405D, F405E, F405H, F405I, F405K, F405L, F405M, F405N, F405Q, F405S, F405T, F405V, F405W, F405Y, Y407G, Y407L, Y407M, and Y407W (numbering according to the EU Index), and wherein the reducing conditions comprise adding a reducing agent,
b) subjecting the composition obtained from step a) to oxidizing conditions sufficient to allow oxidation of cysteines in the antibodies to inter-chain disulfide bonds, thereby obtaining a heterodimeric antibody.
The issued patent also teaches first homodimeric antibody has K at position 409 substituted for A, D, E, F, G, H, L, Q, S, T, V, W or Y, see Fig. 13A, col. 34, line 48-53, and Leu (L) at position 405, see col. 35, line 45 or K at position 409 substituted for A, G or H (see Table 1) and F405 substituted for I, K, L, S, T, V or W, see Table 10, in particular.
A person of skill in the art, reading the claims of the ‘371 patent, would look to the patent and follow the ‘371 patent’s express instruction on how to make the product within a sample, e.g., Example 39, Tables 1, 10, thereby arriving at the methods of the examined claims.
Issued claim 2 recites the method according to claim 1, wherein the reducing conditions in step a) comprise adding a reducing agent, which corresponds to instant claim 4.
Issued claim 3 recites the method according to claim 2, wherein the reducing agent is selected from the group consisting of: 2-mercaptoethylamine, a chemical derivative of 2-mercaptoethylamine, L-cysteine, and D-cysteine, which corresponds to instant claim 5.
Issued claim 4 recites the method according to claim 1, wherein step a) comprises adding a metal chelating agent, which corresponds to instant claim 6.
Issued claim 5 recites the method according to claim 4, wherein the metal chelating agent is EDTA, EGTA or citric acid, which corresponds to instant claim 7.
Issued claim 6 recites the method according to claim 1, wherein the reducing conditions in step a) comprise reducing the amount of oxygen in the composition in step a), which corresponds to instant claim 8.
Issued claim 7 recites the method according to claim 1, wherein step a) is performed under reducing conditions with a redox potential between −150 and −600 mV, which corresponds to instant claim 9.
Issued claim 8 recites the in vitro method according to claim 1, wherein step a) comprises incubation for at least 30 min at a temperature of at least 20° C. in the presence of at least 25 mM of a reducing agent selected from the group consisting of 2-mercaptoethylamine, L-cysteine and D-cysteine, which corresponds to instant claim 10.
Issued claim 9 recites the method according to claim 1, wherein the first and second homodimeric antibodies are in a buffer selected from the group consisting of a) 8.1 mM sodium phosphate (Na.sub.2HPO.sub.4-7H.sub.2O), 1.5 mM potassium phosphate (KH.sub.2PO.sub.4), 138 mM sodium chloride (NaCl), 2.7 mM potassium chloride (KCl) pH 5.0; b) 8.1 mM sodium phosphate (Na.sub.2HPO.sub.4-7H.sub.2O), 1.5 mM potassium phosphate (KH.sub.2PO.sub.4), 138 mM sodium chloride (NaCl), 2.7 mM potassium chloride (KCl) pH 7.0; and c) 20 mM Tris-HCl, pH 7.8, which corresponds to instant claim 14.
Issued claim 10 recites the method according to claim 1, wherein step b) comprises a pH in the range of 6-8.5, which corresponds to instant claim 15.
Issued claim 11 recites the method according to claim 1, wherein the oxidizing conditions in step b) comprise adding oxygen or an oxidizing agent, which corresponds to instant claim 18.
Issued claim 12 recites the method according to claim 11, wherein the oxidizing agent is dehydroascorbic acid (dhAA), which corresponds to instant claim 22.
Issued claim 13 recites the method according to claim 1, wherein step b) comprises separating the heterodimeric antibody and the reducing agent, which corresponds to instant claim 23.
Issued claim 14 recites the method according to claim 1, wherein the oxidizing conditions in step b) comprise the steps of: I) diafiltration of the composition obtained from step a), II) incubation of the retentate obtained from step I), and III) diafiltration of the composition obtained from step II), which corresponds to instant claim 34.
Issued claim 15 recites the method according to claim 1, wherein the oxidizing conditions in step b) comprise a metal ion or adding a metal ion, which corresponds to instant claim 38.
Issued claim 16 recites the method according to claim 15, wherein the metal ion is selected from the group consisting of: Copper, Manganese, Magnesium, Iron, Nickel and Cobalt, which corresponds to instant claim 41.
Issued claim 17 recites the method according to claim 1, wherein the ratio of first to second homodimeric protein in step a) is in the range of 1:1.01 to 1:2, which corresponds to instant claim 42.
Issued claim 18 recites the method according to claim 1, wherein said first homodimeric antibody has no more than one amino acid substitution in the CH3 region, and the second homodimeric antibody has no more than one amino acid substitution in the CH3 region relative to the wild-type CH3 regions, which corresponds to instant claim 54.
Issued claim 20 recites the method according to claim 1, wherein the first and/or second homodimeric antibody do not contain the c-terminal lysine, which corresponds to instant claim 64.
Issued claim 21 recites the method according to claim 20, wherein the first and/or second homodimeric antibodies are genetically modified to lack the c-terminal lysine in the heavy chain, or wherein the c-terminal lysine is removed from the heavy chain, which corresponds to instant claim 65.
Further, the subject matter claimed in the instant application is fully disclosed in the referenced ‘371 patent.
Regarding claims 70-72, the reference IgG1m of SEQ ID NO: 8 comprises the claimed hinge sequence CPPC of SEQ ID NO: 13.
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Regarding claims 73-71, the reference IgG4-7D8 antibody comprises the claimed CPPC, see Example 15.
A person of skill in the art, reading the claims of the ‘371 patent, would look to the patent and follow the ‘371 patent’s express instruction on how to make the product within the patent, e.g., col. 104 Examples 39, Table 10, examples 19, 45, 47, 49, 50, 59 thereby arriving at the binding molecule of the examined claims.
Applicants’ arguments filed November 17, 2025 have been fully considered but are not found persuasive.
Applicant respectfully traverses these rejections, and maintains that the present claims are directed to a patentably distinct inventions from those claimed in the '371 and '050 patents. As discussed in the previous response, the procedural issue of whether the current application is entitled to the procedural shield provided by 35 U.S.C§ 121 does not automatically give rise to a proper double patenting rejection. Obviousness-type double patenting (ODP) is a judicially created doctrine developed to prohibit the unjustified extension of the term of the "right to exclude" granted by a patent by issuance of a second patent with claims which are not patentably distinct from the first patent. As stated in MPEP 1504.06, double patenting rejections are based on a direct comparison of the subject matter of the claims in the reference patent and subject application.
Thus, if the purpose of the doctrine is used as a guiding principle to prevent a "timewise extension of the right to exclude," it is respectfully submitted that Applicant could not use the claims of either the '371 patent or the '050 patent to prevent a third party from commercializing the subject matter of the presently claimed invention. The issued claims of '371 and '050 patents require that one arm of the heterodimeric antibody contains an Arg at position 409, whereas the presently claimed method excludes Arg at this position in both arms of the heterodimeric antibody.
Claims that do not recite overlapping subject matter do not give rise to OTDP. See, e.g., In re Vogel (CCPA 1970); General Foods v. Studiengesellschaft Kohle (Fed. Cir., 1992). Notably, the Office has not refuted or even addressed these previous arguments in the present Office Action, or explained why the present claims would provide an unfair timewise extension of the right to exclude when clearly the subject matter of the present application and the reference claims do not overlap, as discussed above.
Accordingly, the presently claimed methods are patentably distinct from those of the '371 and '050 patents, and reconsideration and withdrawal of these rejections is respectfully requested.
In response to the argument that issued claims of '371 and '050 patents require that one arm of the heterodimeric antibody contains an Arg at position 409, whereas the presently claimed method excludes Arg at this position in both arms of the heterodimeric antibody is acknowledged.
However, the subject matter claimed in the instant application is fully disclosed in the referenced ‘371 patent. A person of skill in the art, reading the claims of the ‘371 patent, would look to the patent and follow the ‘371 patent’s express instruction on how to make the product within the patent, e.g., col. 104 Examples 39, Table 10, examples 19, 45, 47, 49, 50, 59 thereby arriving at the binding molecule of the examined claims. Regarding claims 70-72, the reference IgG1m of SEQ ID NO: 8 comprises the claimed hinge sequence CPPC of SEQ ID NO: 13.
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Regarding claims 73-71, the reference IgG4-7D8 antibody comprises the claimed CPPC, see Example 15.
Further, this application is a continuation of the parent application 16/426,647 (now U.S. Patent No. 11,492,371), not a dividual application. A continuation application filed under Section 120, is not entitled to the benefit of the safe harbor provision protections afforded by § 121’s safe harbor.” Amgen v. Roche, 580 F.3d 1340, 1354 (Fed. Cir. 2009). Thus, a continuation application drawn to subject matter that is separately patentable from the subject matter of the parent patent is vulnerable to an obviousness-type double patenting rejection from the USPTO and later patent challenge.
The submission of a terminal disclaimer in compliance with 37 CFR 1.321(b) is required to overcome a double patenting rejection because it seeks to prevent the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982) and to prevent
unjustified timewise extension of patent term based on a judicially created doctrine grounded in public policy. “Fundamental to this doctrine is the policy that: ‘[t]he public should … be able to act on the assumption upon the expiration of the patent it will be free to use not only the invention claimed in the patent but also modifications or variants which would have been obvious to those of ordinary skill in the art at the time the invention was made.’” In re Longi, 892-3, citing In re Zickendraht, 319 F.2d 225, 232 (CCPA 1963) (Rich, J., concurring), emphasis in original. See also Singer Mfg. Co. v. June Mfg. Co., 163 U.S. 169, 185 (1896). Without the protection of the safe harbor provision, these public policy concerns apply to all continuation applications and patents filed from a parent patent. See MPEP 1504.06.
A terminal disclaimer over the parent patent can be avoided by satisfying the requirements of a divisional application, where the divisional application is filed from a parent application with claims structured to trigger a restriction requirement. Alternatively, the Applicant can file separate applications to the different inventions where the separate applications do not share a priority claim, thus minimizing the risk of ODP. But in the absence of a restriction requirement and subsequent divisional application, a continuation application filed from a parent patent is an implicit admission that ODP applies to the resulting continuation patent.
For these reasons, the rejection is maintained.
Claims 1, 4-10, 14-15, 18, 22-23, 34, 38, 41-42, 54, 64-65, 70-73 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-26, 36-40, 48, 50-51 of U.S. Patent No. 10,344,050. Although the conflicting claims are not identical, they are not patentably distinct from each other because while the ‘050 patent issued from the application which served as the grandparent for the present case, the examined application was filed as a CON, not a DIV, and therefore no shield against double patenting that might be provided by 35 U.S.C 121 would be applicable here.
Issued claim 1 recites an in vitro method for production of a heterodimeric antibody comprising the following steps: a) incubating a first chimeric, humanized, or human homodimeric antibody with a second chimeric, humanized, or human homodimeric antibody under reducing conditions sufficient to allow reduction of the inter-chain disulfide bonds in the hinge region, and wherein said first homodimeric antibody comprises an Fc region of an immunoglobulin, said Fc region comprising a first human IgG4 CH3 region, and said second homodimeric antibody comprises an Fc region of an immunoglobulin, said Fc region comprising a second human IgG4 CH3 region, wherein said first homodimeric antibody has an Arg at position 409 (numbering according to the EU Index), and said second homodimeric antibody has an amino acid substitution selected from the group consisting of: L368A, L368D, L368E, L368G, L368H, L368I, L368N, L368Q, L368R, L368S, L368T, L368V, L368W, D399A, D399F, D399H, D399K, D399R, D399Y, F405A, F405D, F405E, F405H, F4051, F405K, F405L, F405M, F405N, F405Q, F405S, F405T, F405V, F405W, F405Y, Y407G, Y407L, Y407M, and Y407W (numbering according to the EU Index), wherein the sequences of said first and second CH3 regions are different and are such that the heterodimeric interaction between said first and second CH3 regions is stronger than each of the homodimeric interactions of said first and second CH3 regions, and wherein the reducing conditions comprise adding a reducing agent, b) subjecting the composition obtained from step a) to oxidizing conditions sufficient to allow oxidation of cysteines in the heterodimeric antibody to inter-chain disulfide bonds, and c) obtaining the heterodimeric antibody.
Issued claim 2 recites the method according to claim 1, wherein step b) comprises subjecting at least 10 mL of the composition obtained from step a) to oxidizing conditions sufficient to allow oxidation, which corresponds to instant claim 1.
Issued claim 3 recites the method according to claim 1, wherein the reducing agent is selected from the group consisting of: 2-mercaptoethylamine, a chemical derivative of 2-mercaptoethylamine, L-cysteine, and D-cysteine, which corresponds to instant claim 5.
Issued claim 4 recites the method according to claim 1, wherein step a) comprises adding a metal chelating agent, which corresponds to instant claim 6.
Issued claim 5 recites the method according to claim 4, wherein the metal chelating agent is EDTA, EGTA, or citric acid, which corresponds to instant claim 7.
Issued claim 6 recites the method according to claim 1, wherein the reducing conditions in step a) comprise reducing the amount of oxygen in the composition in step a). which corresponds to instant claim 8.
Issued claim 7 recites the method according to claim 1, wherein step a) is performed under reducing conditions with a redox potential between −150 and −600 mV. which corresponds to instant claim 9.
Issued claim 8 recites the method according to claim 1, wherein step a) comprises incubation for at least 30 min at a temperature of at least 20° C. in the presence of at least 25 mM of a reducing agent selected from the group consisting of 2-mercaptoethylamine, L-cysteine, and D-cysteine, which corresponds to instant claim 10.
Issued claim 9 recites the method according to claim 1, wherein the first and second homodimeric antibodies are in a buffer, which corresponds to instant claim 14.
Issued claim 10 recites the method according to claim 9, wherein the buffer comprises in the range of 1-100 mM phosphate, which corresponds to instant claim 14.
Issued claim 11 recites the method according to claim 9, wherein the buffer has a pH in the range of 4.5-8.5, which corresponds to instant claim 15.
Issued claim 12 recites the method according to claim 9, wherein the buffer is selected from the group consisting of a) 8.1 mM sodium phosphate (Na.sub.2HPO.sub.4-7H.sub.2O), 1.5 mM potassium phosphate (KH.sub.2PO.sub.4), 138 mM sodium chloride (NaCl), 2.7 mM potassium chloride (KCl) pH 5.0; b) 8.1 mM sodium phosphate (Na.sub.2HPO.sub.4-7H.sub.2O), 1.5 mM potassium phosphate (KH.sub.2PO.sub.4), 138 mM sodium chloride (NaCl), 2.7 mM potassium chloride (KCl) pH 7.0; and c) 20 mM Tris-HCl, pH 7.8. which corresponds to instant claim 14.
Issued claim 13 recites the method according to claim 1, wherein step b) comprises a pH in the range of 6-8.5, which corresponds to instant claim 15.
Issued claim 14 recites the method according to claim 1, wherein step b) comprises a redox potential of at least −300 mV, which is a specie within the redox potential between -150 and -600 mV of instant claim 9.
Issued claim 15 recites the method according to claim 1, wherein the oxidizing conditions in step b) comprise the presence of at least 0.05 mM oxygen (species).
Issued claim 16 recites the method according to claim 1, wherein the oxidizing conditions in step b) comprise adding oxygen, which corresponds to instant claim 18.
Issued claim 17 recites the method according to claim 16, wherein adding oxygen is performed mechanically.
Issued claim 18 recites the method according to claim 16, wherein adding oxygen is performed by sparging with oxygen or air or increasing pressure, which corresponds to instant claim 18.
Issued claim 19 recites the method according to claim 1, wherein the oxidizing conditions in step b) comprise an oxidizing agent, which corresponds to instant claim 18.
Issued claim 20 recites the method according to claim 19, wherein the oxidizing agent is dehydroascorbic acid (dhAA), which corresponds to instant claim 22.
Issued claim 21 recites the method according to claim 1, wherein step b) comprises separating the heterodimeric antibody and the reducing agent, which corresponds to instant claim 23.
Issued claim 22 recites the method according to claim 21, wherein step b) comprises subjecting the composition obtained from step a) to chromatography or filtration, which corresponds to instant claim 34.
Issued claim 23 recites the method according to claim 22, wherein the chromatography is column chromatography, which corresponds to instant claim 34.
Issued claim 24 recites the method according to claim 22, wherein the filtration is diafiltration, which corresponds to instant claim 34.
Issued claim 25 recites the method according to claim 24, wherein the diafiltration is tangential flow filtration (TFF) or normal flow filtration (NFF), which is a species of diafiltration (genus).
Issued claim 26 recites the method according to claim 25, wherein the diafiltration is TFF (species), which is a species of diafiltration (genus).
Issued claim 36 recites the method according to claim 1, wherein the oxidizing conditions in step b) comprise a metal ion, which corresponds to instant claim 38.
Issued claim 37 recites the method according to claim 36, wherein the oxidizing conditions in step b) comprise adding a metal ion. which corresponds to instant claim 38.
Issued claim 38 recites the method according to claim 36, wherein the concentration of the metal ion is in the range of 0.1 to 100 μM.
Issued claim 39 recites the method according to claim 36, wherein the metal ion is selected from the group consisting of: Copper, Manganese, Magnesium, Iron, Nickel, and Cobalt, which corresponds to instant claim 41.
Issued claim 40 recites the method according to claim 1, wherein the ratio of first to second homodimeric antibody in step a) is in the range of 1:1.01 to 1:2, which corresponds to instant claim 42.
Issued claim 48 recites the method according to claim 1, wherein said first homodimeric antibody has no more than one amino acid substitution in the CH3 region, and the second homodimeric antibody has no more than one amino acid substitution in the CH3 region relative to the wild-type CH3 regions, which corresponds to instant claim 54.
Issued claim 50 recites the method according to claim 1, wherein the first and/or second homodimeric antibodies do not contain a lysine at the c-terminus, which corresponds to instant claim 64.
Issued claim 51 recites the method according to claim 50, wherein the first and/or second homodimeric antibodies are genetically modified to lack the c-terminal lysine in the heavy chain, which corresponds to instant claim 65.
The issued patent also teaches first homodimeric antibody that has K at position 409 substituted for A, D, E, F, G, H, L, Q, S, T, V, W or Y, see Fig. 13A, col. 34, line 48-53, and Leu (L) at position 405, see col. 35, line 45 or K at position 409 substituted for A, G or H (see Table 1) and F405 substituted for I, K, L, S, T, V or W, see Table 10, in particular.
Regarding claims 70-72, the reference IgG1m of SEQ ID NO: 8 comprises the claimed hinge sequence CPPC of SEQ ID NO: 13.
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Regarding claims 73-71, the reference IgG4-7D8 antibody comprises the claimed CPPC, see Example 15.
A person of skill in the art, reading the claims of the ‘050 patent, would look to the patent and follow the ‘050 patent’s express instruction on how to make the product within the patent, e.g., col. 104 Examples 39, Table 10, examples 19, 45, 47, 49, 50, 59 thereby arriving at the binding molecule of the examined claims.
Applicants’ arguments filed November 17, 2025 have been fully considered but are not found persuasive.
Applicant respectfully traverses these rejections, and maintains that the present claims are directed to a patentably distinct inventions from those claimed in the '371 and '050 patents. As discussed in the previous response, the procedural issue of whether the current application is entitled to the procedural shield provided by 35 U.S.C§ 121 does not automatically give rise to a proper double patenting rejection. Obviousness-type double patenting (ODP) is a judicially created doctrine developed to prohibit the unjustified extension of the term of the "right to exclude" granted by a patent by issuance of a second patent with claims which are not patentably distinct from the first patent. As stated in MPEP 1504.06, double patenting rejections are based on a direct comparison of the subject matter of the claims in the reference patent and subject application.
Thus, if the purpose of the doctrine is used as a guiding principle to prevent a "timewise extension of the right to exclude," it is respectfully submitted that Applicant could not use the claims of either the '371 patent or the '050 patent to prevent a third party from commercializing the subject matter of the presently claimed invention. The issued claims of '371 and '050 patents require that one arm of the heterodimeric antibody contains an Arg at position 409, whereas the presently claimed method excludes Arg at this position in both arms of the heterodimeric antibody.
Claims that do not recite overlapping subject matter do not give rise to OTDP. See, e.g., In re Vogel (CCPA 1970); General Foods v. Studiengesellschaft Kohle (Fed. Cir., 1992). Notably, the Office has not refuted or even addressed these previous arguments in the present Office Action, or explained why the present claims would provide an unfair timewise extension of the right to exclude when clearly the subject matter of the present application and the reference claims do not overlap, as discussed above.
Accordingly, the presently claimed methods are patentably distinct from those of the '371 and '050 patents, and reconsideration and withdrawal of these rejections is respectfully requested.
In response to the argument that issued claims of '050 patents require that one arm of the heterodimeric antibody contains an Arg at position 409, whereas the presently claimed method excludes Arg at this position in both arms of the heterodimeric antibody is acknowledged.
However, the subject matter claimed in the instant application is fully disclosed in the referenced ‘050 patent. The issued patent teaches first homodimeric antibody that has K at position 409 substituted for A, D, E, F, G, H, L, Q, S, T, V, W or Y, see Fig. 13A, col. 34, line 48-53, and Leu (L) at position 405, see col. 35, line 45 or K at position 409 substituted for A, G or H (see Table 1) and second homodimeric antibody that has F405 substituted for I, K, L, S, T, V or W, see Table 10, in particular.
Regarding claims 70-72, the reference IgG1m of SEQ ID NO: 8 comprises the claimed hinge sequence CPPC of SEQ ID NO: 13.
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Regarding claims 73-71, the reference IgG4-7D8 antibody comprises the claimed CPPC, see Example 15.
A person of skill in the art, reading the claims of the ‘050 patent, would look to the patent and follow the ‘050 patent’s express instruction on how to produce heterodimeric antibody in vitro within the patent, e.g., col. 104 Examples 39, Table 10, examples 19, 45, 47, 49, 50, 59 thereby arriving at the binding molecule of the examined claims.
Further, this application is a continuation of the parent application 14/353,962 (now U.S. Patent No. 10,344,050), not a dividual application. A continuation application filed under Section 120, is not entitled to the benefit of the safe harbor provision protections afforded by § 121’s safe harbor.” Amgen v. Roche, 580 F.3d 1340, 1354 (Fed. Cir. 2009). Thus, a continuation application drawn to subject matter that is separately patentable from the subject matter of the parent patent is vulnerable to an obviousness-type double patenting rejection from the USPTO and later patent challenge.
The submission of a terminal disclaimer in compliance with 37 CFR 1.321(b) is required to overcome a double patenting rejection because it seeks to prevent the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982) and to prevent unjustified timewise extension of patent term based on a judicially created doctrine grounded in public policy. “Fundamental to this doctrine is the policy that: ‘[t]he public should … be able to act on the assumption upon the expiration of the patent it will be free to use not only the invention claimed in the patent but also modifications or variants which would have been obvious to those of ordinary skill in the art at the time the invention was made.’” In re Longi, 892-3, citing In re Zickendraht, 319 F.2d 225, 232 (CCPA 1963) (Rich, J., concurring), emphasis in original. See also Singer Mfg. Co. v. June Mfg. Co., 163 U.S. 169, 185 (1896). Without the protection of the safe harbor provision, these public policy concerns apply to all continuation applications and patents filed from a parent patent. See MPEP 1504.06.
A terminal disclaimer over the parent patent can be avoided by satisfying the requirements of a divisional application, where the divisional application is filed from a parent application with claims structured to trigger a restriction requirement. Alternatively, the Applicant can file separate applications to the different inventions where the separate applications do not share a priority claim, thus minimizing the risk of ODP. But in the absence of a restriction requirement and subsequent divisional application, a continuation application filed from a parent patent is an implicit admission that ODP applies to the resulting continuation patent.
For these reasons, the rejection is maintained.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG HUYNH whose telephone number is (571)272-0846. The examiner can normally be reached on 9:00 a.m. to 6:30 p.m. The examiner can also be reached on alternate alternative Friday from 9:00 a.m. to 5:30 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Misook Yu, can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-272-0839.
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/PHUONG HUYNH/ Primary Examiner, Art Unit 1641