Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1, 21-29, 31-33, 35-38, 40 and 41 are pending.
Claim 1 is withdrawn from further consideration by the examiner, 37 C.F.R. 1.142(b) as being drawn to non-elected inventions.
Claims 21-29, 31-33, 35-38, 40 and 41, drawn to a method of making an antibody, are being acted upon in this Office Action.
Priority
Applicant’ claim priority to provisional application 61/657,556, filed June 8, 2012, and 61/725,433, filed November 12, 2012 is acknowledged.
Rejection Withdrawn
The new matter rejection of claims 21, 22, 23, 24, 26, 29, 32, 35, 36 and 40 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn in view of the claim amendment.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 21-29, 31-32, 35-38, 40 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 14 and 18 of U.S. Patent No. 11,958,909. Although the claims at issue are not identical, they are not patentably distinct from each other because while the ‘909 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 a method of detecting an antigen, comprising: contacting a sample comprising the antigen with an antibody conjugate or a pharmaceutical composition comprising the antibody conjugate, wherein the antibody conjugate comprises an isolated antibody of the IgG1 class comprising a heavy chain and a light chain, wherein the antibody conjugate binds to the antigen, and wherein: the heavy chain comprises at least one non-natural amino acid residue at a specific site selected from the group consisting of heavy chain residues 19, 25, 40, 52, and 70 according to the Kabat numbering scheme and heavy chain residues 119, 121, 180, 190, 222, 241, and 404 according to the EU index of Kabat; or the light chain comprises a non-natural amino acid residue at a specific site selected from the group consisting of the light chain residues 7, 22, and 152 according to the Kabat numbering scheme; or a combination thereof; or an aglycosylated variant thereof; wherein each non-natural amino acid residue is independently selected from the group consisting of ortho-substituted tyrosine, meta-substituted tyrosine, para-substituted phenylalanine, ortho-substituted phenylalanine, and meta-substituted phenylalanine; wherein at least one of the non-natural amino acids is linked to a payload capable of being detected; and detecting a complex formed between the antibody and the antigen, which corresponds to instant claim 21.
A person of skill in the art, reading the claims of the ‘909 patent, would look to the patent and follow the ‘909 patent’s express instruction on how to make the product within the patent, e.g., Examples 1, 2, 6, 13, thereby arriving at the method of the examined claims.
Issued claim 2 recites the method of claim 1, wherein the antibody is aglycosylated, which corresponds to instant claim 22.
Issued claim 3 recites the method of claim 1, wherein the light chain is selected from λ, and κ, which corresponds to instant claim 23.
Issued claim 4 recites the method of claim 1, wherein said non-natural amino acid residue comprises a moiety selected from the group consisting of amino, carboxy, acetyl, hydrazino, hydrazido, semicarbazido, sulfanyl, azido, and alkynyl, which corresponds to instant claim 24.
Issued claim 5 recites the method of claim 1, wherein each non-natural amino acid residue is according to the formula
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wherein each L is independently a phenylene; and each R is independently a functional group selected from the group consisting of a labeling moiety, amino, carboxy, acetyl, hydrazino, hydrazido, semicarbazido, sulfanyl, azido, and alkynyl, which corresponds to instant claim 25.
Issued claim 6 recites the method of claim 1, wherein the non-natural amino acid residue is selected from a group consisting of p-acetyl-L-phenylalanine, O-methyl-L-tyrosine, 3-methyl-phenylalanine, O-4-allyl-L-tyrosine, 4-propyl-L-tyrosine, fluorinated phenylalanine, isopropyl-L-phenylalanine, p-azido-L-phenylalanine, p-acyl-L-phenylalanine, p-benzoyl-L-phenylalanine, p-iodo-phenylalanine, p-bromophenylalanine, p-amino-L-phenylalanine, isopropyl-L-phenylalanine, p-propargyloxy-phenylalanine, and p-azidomethyl-L-phenylalanine, which corresponds to instant claim 26.
Issued claim 7 recites the method of claim 6, wherein the non-natural amino acid residue is a p-azido-L-phenylalanine residue, which corresponds to instant claim 27.
Issued claim 8 recites the method of claim 6, wherein the non-natural amino acid residue is a p-azidomethyl-L-phenylalanine residue, which corresponds to instant claim 28.
Issued claim 9 recites the method of claim 1, wherein said payload is linked to the non-natural amino acid, or a residue thereof, via one or more linkers, which corresponds to instant claim 21.
Issued claim 10 recites the method of claim 1, wherein the pharmaceutical composition comprises the antibody that is at least 95% by mass of the total antibody mass of said composition, which corresponds to instant claim 34.
Issued claim 14 recites the method of claim 1, wherein the payload is selected from a label, dye, radioactive moiety, nanoparticle, and fluorophore, which corresponds to instant claim 30.
Issued claim 18 recites the method of claim 1, wherein payload is selected from a nanoparticle, a spin label, a fluorophore, a metal-containing moiety, a radioactive moiety, or a photocaged moiety, which corresponds to instant claim 30.
Applicants’ arguments filed September 25, 2026 have been fully considered but are not found persuasive.
Applicant’s indication of willingness to consider filing a terminal disclaimer as appropriate once all pending claims are otherwise allowable is acknowledged. As such, the rejection is maintained.
Claims 21-29, 31-32, 35-38, 40 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 15-16 of U.S. Patent No. 10,669,347. Although the claims at issue are not identical, they are not patentably distinct from each other because while the ‘347 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 isolated antibody of the IgG class comprising a heavy chain and a light chain, wherein: the heavy chain comprises at least one non-natural amino acid residue at a specific site selected from the group consisting of heavy chain residue 52 according to the Kabat numbering scheme and heavy chain residues 119, 222, and 241 according to the EU index of Kabat; or the light chain comprises a non-natural amino acid residue at the light chain residue 152; or a combination thereof; or an aglycosylated variant thereof, wherein each non-natural amino acid residue is independently selected from the group consisting of ortho-substituted tyrosine, meta substituted tyrosine, para-substituted phenylalanine, ortho-substituted phenylalanine, and meta-substituted phenylalanine, which corresponds to instant claim 21.
A person of skill in the art, reading the claims of the ‘347 patent, would look to the patent and follow the ‘347 patent’s express instruction on how to make the product within the patent, e.g., Examples 1 for Synthesis of Exemplary Antibodies Containing Non-Natural Amino Acids, Examples 3, 6, 13 for Transfer of Sites of Non-Natural Amino Acid Incorporation to Another Antibody, thereby arriving at the method of the examined claims.
Issued claim 2 recites the antibody of claim 1, wherein the antibody is a glycosylated, which corresponds to instant claim 22.
Issued claim 3 recites antibody of claim 2, wherein the light chain is selected from λ, and κ.
Issued claim 4 recites antibody of claim 2, that is of a class or subclass selected from the group consisting of IgG1, IgG2, IgG3, and IgG4, which corresponds to instant claim 23.
Issued claim 5 recites the antibody of claim 2,. wherein said non-natural amino acid residue comprises a moiety selected from the group consisting of amino, carboxy, acetyl, hydrazino, hydrazido, semicarbazido, sulfanyl, azido and alkynyl, which corresponds to instant claim 24.
Issued claim 6 recites the antibody of claim 2, wherein each non-natural amino acid residue is according to the formula
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wherein each L is independently a phenylene; and each R is independently a functional group selected from the group consisting of a therapeutic moiety, a labeling moiety, amino, carboxy, acetyl, hydrazino, hydrazido, semicarbazido, sulfanyl, azido, and alkynyl, which corresponds to instant claim 25.
Issued claim 7 recites antibody of claim 2, wherein the non-natural amino acid residue is selected from the group consisting of p-acetyl-L-phenylalanine, O-methyl-L-tyrosine, 3-methyl-phenylalanine, O-4-allyl-L-tyrosine, 4-propyl-L-tyrosine, fluorinated phenylalanine, isopropyl-L-phenylalanine, p-azido-L-phenylalanine, p-acyl-L-phenylalanine, p-benzoyl-L-phenylalanine, p-iodo-phenylalanine, p-bromophenylalanine, p-amino-L-phenylalanine, isopropyl-L-phenylalanine, p-propargyloxy-phenylalanine, and p-azidomethyl-L-phenylalanine, which corresponds to instant claim 26.
Issued claim 8 recites antibody of claim 2, wherein the non-natural amino acid residue is p-azido-L-phenylalanine, which corresponds to instant claim 27.
Issued claim 9 recites antibody of claim 2, wherein the non-natural amino acid residue is p-azidomethyl-L-phenylalanine, which corresponds to instant claim 28.
Applicants’ arguments filed September 25, 2026 have been fully considered but are not found persuasive.
Applicant’s indication of willingness to consider filing a terminal disclaimer as appropriate once all pending claims are otherwise allowable is acknowledged. As such, the rejection is maintained.
Claims 21-29, 31-32, 35-38, 40 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 18-28, 34 and 35 of U.S. Patent No. 9,738,724. Although the claims at issue are not identical, they are not patentably distinct from each other because while the ‘724 patent issued from the application which served as the great 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 isolated antibody of the IgG class comprising a heavy chain and a light chain wherein:
a. the light chain has one or more non-natural amino acid residue residues at specific sites selected from the group consisting of light chain residues 7 and 22 according to the Kabat numbering scheme; and/or
b. the heavy chain has one or more non-natural amino acid residue residues at specific sites selected form the group consisting of heavy chain residues 19, 25, 40, and 70 according to the Kabat numbering scheme and heavy chain residues 121, 180, and 190 according to the EU index of Kabat; or an aglycosylated variant thereof, wherein each non-natural amino acid residue is independently selected from the group consisting of ortho-substituted tyrosine, meta substituted tyrosine, para-substituted phenylalanine, ortho-substituted phenylalanine, and meta-substituted phenylalanine, which corresponds to instant claim 21.
A person of skill in the art, reading the claims of the ‘724 patent, would look to the patent and follow the ‘724 patent’s express instruction on how to make the product within the patent, e.g., Examples 1, 2, 13, thereby arriving at the method of the examined claims.
Issued claim 2 recites the antibody of claim 1 wherein the antibody is aglycosylated, which corresponds to instant claim 22.
Issued claim 3 recites an isolated antibody of the IgG class comprising a heavy chain and a light chain wherein the heavy chain has a non-natural amino acid residue at site 404 according to the EU index of Kabat, or an aglycosylated variant thereof, wherein the non-natural amino acid residue is independently selected from the group consisting of ortho-substituted tyrosine, meta substituted tyrosine, para-substituted phenylalanine, ortho-substituted phenylalanine, and meta-substituted phenylalanine, which corresponds to instant claim 21.
Issued claim 4 recites the antibody of claim 3, wherein the antibody is aglycosylated, which corresponds to instant claim 22.
Issued claim 5 recites the antibody of claim 4, wherein the antibody has a higher thermal stability (T.sub.m1) compared to the corresponding wild-type antibody following conjugation of a linker-drug to the non-natural amino acid, which corresponds to instant claim 31.
Issued claim 6 recites the antibody of claim 4, wherein the light chain is selected from λ and κ, which corresponds to instant claim 23.
Issued claim 7 recites the antibody of claim 4, wherein the heavy chain is selected from the group consisting of IgG1, IgG2, IgG3, and IgG4, which corresponds to instant claim 32.
Issued claim 8 recites the antibody of claim 4, wherein the non-natural amino acid residue is substituted with a moiety selected from the group consisting of amino, carboxy, acetyl, hydrazino, hydrazido, semicarbazido, sulfanyl, azido, and alkynyl, which corresponds to instant claim 24.
Issued claim 9 recites the antibody of claim 4, wherein the non-natural amino acid residue is according to the formula
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wherein each L is independently a phenylene; and each R is independently a functional group selected from the group consisting of a therapeutic moiety, a labeling moiety, amino, carboxy, acetyl, hydrazino, hydrazido, semicarbazido, sulfanyl, azido, and alkynyl, which corresponds to instant claim 25.
Issued claim 10 recites the antibody of claim 4, wherein the non-natural amino acid residue is selected from the group consisting of p-acetyl-L-phenylalanine, O-methyl-L-tyrosine, 3-methyl-phenylalanine, O-4-allyl-L-tyrosine, 4-propyl-L-tyrosine, fluorinated phenylalanine, isopropyl-L-phenylalanine, p-azido-L-phenylalanine, p-acyl-L-phenylalanine, p-A benzoyl-L-phenylalanine, p-iodo-phenylalanine, p-bromophenylalanine, p-amino-L-phenylalanine, isopropyl-L-phenylalanine, p-propargyloxy-phenylalanine, and p-azidomethyl-L-phenyl alanine, which corresponds to instant claim 26.
Issued claim 11 recites the antibody of claim 4, wherein the non-natural amino acid residue is p-azido-L-phenylalanine, which corresponds to instant claim 27.
Issued claim 12 recites the antibody of claim 4, wherein the non-natural amino acid residue is p-azidomethyl-L-phenyl alanine, which corresponds to instant claim 28.
Issued claim 19 recites a composition comprising the antibody of claim 4, wherein said antibody is at least 95% by mass of the total antibody mass of said composition, which corresponds to instant claim 34.
Issued claim 20 recites the antibody of claim 2 wherein the one or more non-natural amino acid residues are at specific sites selected from the group consisting of heavy chain residues 25 and 40 according to the Kabat numbering scheme, heavy chain residues 121, 180, and 190 according to the EU index of Kabat, and light chain residues 7 and 22, according to the Kabat numbering scheme, which corresponds to instant claim 21.
Issued claim 21 recites the antibody of claim 2 wherein the one or more non-natural amino acid residues are at specific sites selected from the group consisting of light chain residues 7 and 22 according to the Kabat numbering scheme and heavy chain residues 121 and 180, according to the EU index of Kabat, which corresponds to instant claim 21.
Issued claim 22 recites the antibody of claim 2, wherein the light chain is selected from λ and κ, which corresponds to instant claim 23.
Issued claim 23 recites the antibody of claim 2, wherein the heavy chain is selected from the group consisting of IgG1, IgG2, IgG3, and IgG4, which corresponds to instant claim 32.
Issued claim 24 recites the antibody of claim 2, wherein said one or more non-natural amino acid residue is substituted with a moiety selected from the group consisting of amino, carboxy, acetyl, hydrazino, hydrazido, semicarbazido, sulfanyl, azido, and alkynyl, which corresponds to instant claim 24.
Issued claim 25 recites the antibody of claim 2, wherein each of the one or more non-natural amino acid residues is according to the formula
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wherein each L is independently a phenylene; and each R is independently a functional group selected from the group consisting of a therapeutic moiety, a labeling moiety, amino, carboxy, acetyl, hydrazino, hydrazido, semicarbazido, sulfanyl, azido, and alkynyl, which corresponds to instant claim 23.
Issued claim 26 recites the antibody of claim 2, wherein the one or more non-natural amino acid residues are selected from the group consisting of p-acetyl-L-phenylalanine, O-methyl-L-tyrosine, 3-methyl-phenylalanine, O-4-allyl-L-tyrosine, 4-propyl-L-tyrosine, fluorinated phenylalanine, isopropyl-L-phenylalanine, p-azido-L-phenylalanine, p-acyl-L-A phenylalanine, p-benzoyl-L-phenylalanine, p-iodo-phenylalanine, p-bromophenylalanine, p-amino-L-phenylalanine, isopropyl-L-phenylalanine, p-propargyloxy-phenylalanine, and p-azidomethyl-L-phenylalanine, which corresponds to instant claim 26.
Issued claim 27 recites the antibody of claim 2, wherein at least one non-natural amino acid residue is p-azido-L-phenylalanine, which corresponds to instant claim 27.
Issued claim 28 recites the antibody of claim 2, wherein at least one non-natural amino acid residue is p-azidomethyl-L-phenylalanine, which corresponds to instant claim 29.
Issued claim 34 recites a composition comprising the antibody of claim 2, wherein said composition is substantially pure.
Issued claim 35 recites a composition comprising the antibody of claim 2 wherein said antibody is at least 95% by mass of the total antibody mass of said composition.
Applicants’ arguments filed September 25, 2026 have been fully considered but are not found persuasive.
Applicant’s indication of willingness to consider filing a terminal disclaimer as appropriate once all pending claims are otherwise allowable is acknowledged. As such, the rejection is maintained.
Claims 21-29, 31-32, 35-38, 40 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,764,039. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims and the disclosure of the ‘039 patent teaches the claim method; the examined application was voluntary filed by the applicant and not in response to an Office requirement for restriction and therefore no shield against double patenting that might be provided by 35 U.S.C 121 would be applicable here, see MPEP 804.1.
Issued claim 1. An antibody of the IgG class comprising six or fewer site-specific non-natural amino acid residues, wherein at least one of said site-specific non-natural amino acid residues comprises an azide moiety and at least one of said site-specific non-natural amino acid residues comprises a tetrazine moiety, wherein at least one of the said site-specific non-natural amino acid residues comprising the azide moiety or the tetrazine moiety is at heavy chain site 404 according to the EU index of Kabat which corresponds to instant claim 21.
2. The antibody of claim 1, wherein the six or fewer site-specific non-natural amino acid residues are in a single heavy chain or heavy chain variable domain, which corresponds to instant claim 21.
3. The antibody of claim 1, wherein at least one site-specific non-natural amino acid is in a light chain or light chain variable domain, which corresponds to instant claim 21.
4. The antibody of claim 1, wherein at least one site-specific non-natural amino acid is in a light chain or light chain variable domain and a site-specific non-natural amino acid at site 404 is in each of two heavy chains, which corresponds to instant claim 21.
5. The antibody of claim 1, wherein at least one site-specific non-natural amino acid is in each of two light chains or light chain variable domains and a site-specific non-natural amino acid at site 404 is in a heavy chain, which corresponds to instant claim 21.
6. The antibody of claim 1, wherein at least one site-specific non-natural amino acid is in each of two light chain or light chain variable domains, which corresponds to instant claim 21.
7. The antibody of claim 1, wherein said site-specific non-natural amino acid residues are not one of the 20 common amino acids or pyrrolysine or selenocysteine, or post-translationally modified variants thereof, which corresponds to instant claims 21, 26-29.
8. The antibody of claim 1 comprising two to six site-specific non-natural amino acid residues, wherein said site-specific non-natural amino acid residues are not one of the 20 common amino acids or pyrrolysine or selenocysteine, or post-translationally modified variants thereof which corresponds to instant claims 21, 26-29.
9. The antibody of claim 1, wherein at least one of said site-specific non-natural amino acid residue is at one or more sequence positions selected from the group consisting of light chain residues 7 and 22 according to the Kabat numbering scheme, light chain residue 152 according to the EU index of Kabat, heavy chain residues 19, 25, 40, 52, 70, and 110 according to the Kabat numbering scheme, and heavy chain residues 119, 121, 136, 180, 190, 221, and 222 according to the EU index of Kabat, which corresponds to instant claim 21.
10. The antibody of claim 1, wherein the antibody comprises a heavy chain according to SEQ ID NO:1.
11. The antibody of claim 1, wherein the antibody comprises a light chain according to SEQ ID NO:2.
12. The antibody of claim 1, comprising a light chain of a type selected from λ, and κ, which corresponds to instant claim 23.
13. The antibody of claim 1, that is of a class or subclass selected from the group consisting of IgG1, IgG2, IgG3 and IgG4, which corresponds to instant claim 32.
14. The antibody of claim 9, wherein each further site-specific non-natural amino acid residue comprises a moiety selected from the group consisting of amino, carboxy, acetyl, hydrazino, hydrazido, semicarbazido, sulfanyl, and alkynyl, wherein said site-specific non-natural amino acid residue is not one of the 20 amino acids or pyrrolysine or selenocysteine, or post-translationally modified variant thereof, which corresponds to instant claims 24, 25.
15. The antibody of claim 1, wherein said antibody is a full-length antibody, which corresponds to instant claims 21, 32.
16. The antibody of claim 1, wherein each site-specific non-natural amino acid residue is according to the formula
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wherein each L is independently a divalent linker; and each R is independently a reactive group, a therapeutic moiety, or a labeling moiety, wherein R of the site-specific non-natural amino acid residue at site 404 and R of a second site-specific non-natural amino acid residue are independently selected from azido and tetrazine, and wherein R of the second site-specific non-natural amino acid residue is different from R of the site-specific non-natural amino acid residue at site 404, which corresponds to instant claims 21, 25.
17. The antibody of claim 16 wherein each further non-natural amino acid residue comprises an R that comprises a reactive group selected from the group consisting of amino, carboxy, acetyl, hydrazino, hydrazido, semicarbazido, sulfanyl, azido, alkynyl, and tetrazine, which corresponds to instant claim 24.
18. The antibody claim 16 wherein each L is a divalent linker selected from the group consisting of a bond, alkylene, substituted alkylene, heteroalkylene, substituted heteroalkylene, arylene, substituted arylene, heteroarlyene and substituted heteroarylene.
A person of skill in the art, reading the claims of the ‘039 patent, would look to the patent and follow the ‘039 patent’s express instruction on how to perform the method to make the product within the patent, e.g., Examples 1, 2, 3, 6, 9, 11, 17, thereby arriving at the method of the examined claims.
Applicants’ arguments filed September 25, 2026 have been fully considered but are not found persuasive.
Applicant’s indication of willingness to consider filing a terminal disclaimer as appropriate once all pending claims are otherwise allowable is acknowledged. As such, the rejection is maintained.
Claims 21-29, 31-32, 35-38, 40 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,344,626. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims and the disclosure of the ‘626 patent teaches the claim method; the examined application was voluntary filed by the applicant and not in response to an Office requirement for restriction and therefore no shield against double patenting that might be provided by 35 U.S.C 121 would be applicable here, see MPEP 804.1.
Issued claim 1. An antibody of the IgG class comprising: a first site-specific non-natural amino acid residue and a second site-specific non-natural amino acid residue, wherein at least one non-natural amino acid is at a residue position selected from the list consisting of: a. heavy chain residues 136, 404, 190, 180, and 121, according to the EU index of Kabat; b. heavy chain residue 70, according to the Kabat numbering scheme; and c. light chain residues 7 and 22 according to the Kabat numbering scheme; wherein the first and the second site specific non-natural amino acid residues comprise a moiety selected from the group consisting of amino, carboxyl, acetyl, hydrazino, hydrazido, semicarbazido, sulfanyl, azido, alkynyl, tetrazine, and strained alkene, wherein the first site-specific non-natural amino acid residue is different from the second-specific non-natural amino acid residue, and wherein the first and second site specific non-natural amino acid residues have different reactive groups that are capable of mutually non-overlapping site-specific conjugations in the same reaction, which corresponds to instant claims 21, 24.
2. The antibody of claim 1 comprising one or more site-specific non-natural amino acid residues in a single light chain polypeptide.
3. The antibody of claim 1 comprising two or more site-specific non-natural amino acid residues in a single heavy chain polypeptide.
4. The antibody of claim 1 comprising at least one site-specific non-natural amino acid in a light chain polypeptide and at least one site-specific non-natural amino acid in each of two heavy chain polypeptides, which corresponds to instant claim 21.
5. The antibody of claim 1 comprising at least one site-specific non-natural amino acid in each of two light chain polypeptides and at least one site-specific non-natural amino acid in a heavy chain polypeptide, which corresponds to instant claim 21.
6. The antibody of claim 1 comprising at least one site-specific non-natural amino acid in each of two light chain polypeptides and at least one site-specific non-natural amino acid in each of two heavy chain polypeptides, which corresponds to instant claim 21.
7. The antibody of claim 1 comprising three, four, five, six, seven, eight, nine, or ten site-specific non-natural amino acid residues, which corresponds to instant claim 21.
8. The antibody of claim 1 comprising two to six non-natural amino acid residues.
9. The antibody of claim 1 comprising the light chain is selected from the group consisting of from λ, and κ, which corresponds to instant claim 23.
10. The antibody of claim 1 wherein the IgG is selected from the group consisting of IgG1, IgG2, and IgG3, which corresponds to instant claim 32.
11. The antibody of claim 1 wherein the antibody is selected from the group consisting of Fv, Fab, (Fab′).sub.2, single chain Fv (scFv), single chain Fv-Fc (scFv-Fc) and full-length antibody, which corresponds to instant claim 33.
12. The antibody of claim 1 wherein at least one of said non-natural amino acid residues comprises an azide moiety, which corresponds to instant claims 21, 26, 27, 28.
13. The antibody of claim 1 wherein at least one of said non-natural amino acid residues comprises an acetyl moiety, which corresponds to instant claims 21, 26, 29.
14. The antibody of claim 1 wherein at least one of said non-natural amino acid residues comprises an azide moiety and at least one of said non-natural amino acid residues comprises an acetyl moiety.
15. The antibody of claim 1 wherein each non-natural amino acid residue is according to the formula
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wherein each L is independently a divalent linker; and each R independently comprises a moiety selected from the group consisting of amino, carboxyl, acetyl, hydrazino, hydrazido, semicarbazido, sulfanyl, azido, alkynyl, tetrazine, and strained alkene, which corresponds to instant claim 25.
16. The antibody of claim 15 wherein each R is a reactive group selected from the group consisting of amino, carboxy, acetyl, hydrazino, hydrazido, semicarbazido, sulfanyl, azido, alkynyl, tetrazine, and a strained alkene, which corresponds to instant claims 24, 25.
17. The antibody of claim 15 wherein each L is a divalent linker selected from the group consisting of a bond, alkylene, substituted alkylene, heteroalkylene, substituted heteroalkylene, arylene, substituted arylene, heteroarlyene and substituted heteroarylene.
A person of skill in the art, reading the claims of the ‘626 patent, would look to the patent and follow the ‘626 patent’s express instruction on how to perform the claimed method to make the product within the patent, e.g., Examples 1, 2, 3, 6, 9, 11, 17, thereby arriving at the method of the examined claims.
Applicants’ arguments filed September 25, 2026 have been fully considered but are not found persuasive.
Applicant’s indication of willingness to consider filing a terminal disclaimer as appropriate once all pending claims are otherwise allowable is acknowledged. As such, 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 571-272-0839. 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
