DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s election without traverse of Group III (new claims 198-217) and species of (i)(A), (ii) a CDR3 according to SEQ ID NO:3, (iii) CDR1 according to SEQ ID NO:1 and (iv) a CDR2 according to SEQ ID NO: 2 in the reply filed on June 18, 2026 is acknowledged.
3. Claims 198-217 are pending. Claims 1-197 are canceled.
4. Claims 198-217 are under examination.
Priority
5. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/821,287, filed on 03/17/2020.
Information Disclosure Statement
6. The information disclosure statements (IDS) submitted on 6/26/2023, 11/22/2023, 6/28/2024, 5/20/2025 and 6/18/2026 have been considered by the examiner.
Specification
7. The disclosure is objected to because of incorrect page numbers. The page after page 77 is numbered as page 111.
Claim Objections
8. Claims 198, 202, 205 and 208 are objected to because of the following informalities:
Claim 198 recites a phrase “an immunoglobulin chain variable domain”. The phrase encompasses an antibody light chain variable domain. However, the specification discloses that all sequences in claim 197 are sequences of heavy chain antibodies (VHH).
To avoid ambiguity, claim 202 should be amended to recite “an amino acid sequence comprising SEQ ID NO” or “the amino acid sequence of SEQ ID NO”. Claims 205 and 208 should be amended to recite “a nucleic acid sequence comprising SEQ ID NO” or “the nucleic acid sequence of SEQ ID NO”. The phrase “a sequence according to SEQ ID NO” reads on a fragment of SEQ ID NO.
Double Patenting
9. 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
10. Claims 198-202 and 209-217 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,633,438, in view of Yayon et al. (US 2005/0147612, pub. date: 7/7/2005), and Dombrecht et al. (US 2014/0228546, pub. date 8/14/2014, effectively filed date: 6/23/2011).
Claim 1 of U.S. Patent No. 10,633,438 discloses a VH or VHH which binds to TNF-alpha and comprises a set of three complementarity determining regions (CDRs) comprising CDR1, CDR2 and CDR3, wherein the respective SEQ ID NOs of CDR1, CDR2 and CDR3 of said set are selected from the group consisting of:
(a) SEQ ID NO: 1, SEQ ID NO: 2 and SEQ ID NO: 3,
(b) SEQ ID NO: 1, SEQ ID NO: 63 and SEQ ID NO: 70,
(c) SEQ ID NO: 1, SEQ ID NO: 64 and SEQ ID NO: 70,
(d) SEQ ID NO: 1, SEQ ID NO: 65 and SEQ ID NO: 70,
(e) SEQ ID NO: 59, SEQ ID NO: 66 and SEQ ID NO: 71,
(f) SEQ ID NO: 60, SEQ ID NO: 67, and SEQ ID NO: 70,
(g) SEQ ID NO: 1, SEQ ID NO: 67 and SEQ ID NO: 70,
(h) SEQ ID NO: 1, SEQ ID NO: 68 and SEQ ID NO: 72,
(i) SEQ ID NO: 1, SEQ ID NO: 69 and SEQ ID NO: 70,
(j) SEQ ID NO: 1, SEQ ID NO: 62 and SEQ ID NO: 70,
(k) SEQ ID NO: 1, SEQ ID NO: 69 and SEQ ID NO: 3,
(l) SEQ ID NO: 1, SEQ ID NO: 2 and SEQ ID NO: 70,
(m) SEQ ID NO: 1, SEQ ID NO: 61 and SEQ ID NO: 70 and
(n) SEQ ID NO: 1, SEQ ID NO: 62 and SEQ ID NO: 3.
Claim 2 of the patent further limits claim 1, wherein the VH or VHH comprises SEQ ID NO: 8. The amino acid sequence of SEQ ID NO:8 is 100% identical to the instant SEQ ID NO:8.
The claims of the patent do not disclose a nucleic acid encoding the VH or VHH, a vector comprising the nucleic acid, and a host cell comprising the nucleic acid. The claims of the patent do not disclose that the host cell is a yeast cell or a bacterial cell.
Yayon et al. teach that a nucleic acid encoding an antibody can be placed in an expression vector, and the vector can be introduced into a host cell allowing expression in eukaryotic or prokaryotic cells ([0195] and [0196]). Yayon et al. teaches that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made a nucleic acid encoding the antibody of the patent, a vector comprising the nucleic acid, and a host cell comprising the vector in view of Yayon. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Yayon et al teach that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used yeast cell or bacterial cell in view of Dombrecht. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
11. Claims 198-202 and 209-217 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 10,772,839, in view of Yayon et al. (US 2005/0147612, pub. date: 7/7/2005), and Dombrecht et al. (US 2014/0228546, pub. date 8/14/2014, effectively filed date: 6/23/2011).
Claim 19 of U.S. Patent No. 10,772,839 discloses a pharmaceutical composition comprising a polypeptide comprising or consisting of any one of SEQ ID NOs: 1 to 28. Each of the amino acid sequences of SEQ ID NOs: 26 and 28 comprise three CDRs of instant SEQ ID NOs: 1, 2 and 3. SEQ ID NO: 28 is 100% identical to instant SEQ ID NO:8.
Claim 19 of the patent does not disclose a nucleic acid encoding the VH or VHH, a vector comprising the nucleic acid, and a host cell comprising the nucleic acid. The claim of the patent does not disclose that the cell is a yeast cell or a bacterial cell.
Yayon et al. teach that a nucleic acid encoding an antibody can be placed in an expression vector, and the vector can be introduced into a host cell allowing expression in eukaryotic or prokaryotic cells ([0195] and [0196]). Yayon et al. teaches that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made a nucleic acid encoding the antibody of the patent, a vector comprising the nucleic acid, and a host cell comprising the vector in view of Yayon. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Yayon et al teach that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used yeast cell or bacterial cell in view of Dombrecht. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
12. Claims 198-202 and 209-217 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-22 of U.S. Patent No. 10,980,748, in view of Yayon et al. (US 2005/0147612, pub. date: 7/7/2005), and Dombrecht et al. (US 2014/0228546, pub. date 8/14/2014, effectively filed date: 6/23/2011).
Claims 21-22 of U.S. Patent No. 10,980,748 disclose a pharmaceutical composition comprising a polypeptide comprising or consisting of any one of SEQ ID NOs: 1 to 28. Each of the amino acid sequences of SEQ ID NOs: 26 and 28 comprise three CDRs of instant SEQ ID NOs: 1, 2 and 3. SEQ ID NO: 28 is 100% identical to instant SEQ ID NO:8.
Claims 21-22 of U.S. Patent No. 10,980,748 of the patent do not disclose a nucleic acid encoding the VH or VHH, a vector comprising the nucleic acid, and a host cell comprising the nucleic acid. The claims of the patent do not disclose that the cell is a yeast cell or a bacterial cell.
Yayon et al. teach that a nucleic acid encoding an antibody can be placed in an expression vector, and the vector can be introduced into a host cell allowing expression in eukaryotic or prokaryotic cells ([0195] and [0196]). Yayon et al. teaches that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made a nucleic acid encoding the antibody of the patent, a vector comprising the nucleic acid, and a host cell comprising the vector in view of Yayon. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Yayon et al teach that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used yeast cell or bacterial cell in view of Dombrecht. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
13. Claims 198-199 and 209-217 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,684,677, in view of Yayon et al. (US 2005/0147612, pub. date: 7/7/2005), and Dombrecht et al. (US 2014/0228546, pub. date 8/14/2014, effectively filed date: 6/23/2011).
The claims of the patent disclose a composition comprising: (a) an TNF-alpha-binding VHH, said TNF-alpha-binding VHH comprising three complementarity determining regions (CDR1-CDR3), wherein CDR1 comprises SEQ ID NO: 1, CDR2 comprises SEQ ID NO: 2 and CDR3 comprises SEQ ID NO: 3; and (b) an IL-6R-binding VHH, said IL-6R-binding VHH comprising three complementarity determining regions (CDR1-CDR3), wherein CDR1 comprises SEQ ID NO: 9, CDR2 comprises SEQ ID NO: 10 and CDR3 comprises SEQ ID NO: 11. The amino acid sequences of SEQ ID NOs: 1, 2, 3 are 100% identical to instant SEQ ID NOs: 1, 2, 3, respectively.
The claims of the patent do not disclose a nucleic acid encoding the TNF-alpha-binding VHH, a vector comprising the nucleic acid, and a host cell comprising the nucleic acid. The claims of the patent do not disclose that the cell is a yeast cell or a bacterial cell.
Yayon et al. teach that a nucleic acid encoding an antibody can be placed in an expression vector, and the vector can be introduced into a host cell allowing expression in eukaryotic or prokaryotic cells ([0195] and [0196]). Yayon et al. teaches that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made a nucleic acid encoding the antibody of the patent, a vector comprising the nucleic acid, and a host cell comprising the vector in view of Yayon. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Yayon et al teach that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used yeast cell or bacterial cell in view of Dombrecht. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
14. Claims 198-202 and 209-217 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-19 of U.S. Patent No. 12,559,552, in view of Yayon et al. (US 2005/0147612, pub. date: 7/7/2005), and Dombrecht et al. (US 2014/0228546, pub. date 8/14/2014, effectively filed date: 6/23/2011).
The claims of the patent disclose a polypeptide binding to TNF-alpha and comprising SEQ ID NO: 46 or 47. Each of the amino acid sequences of SEQ ID NOs: 46 and 47 comprises the 3 CDR sequences of instant SEQ ID NOs: 1, 2 and 3 and is 100% identical to instant SEQ ID NO:8.
The claims of the patent do not disclose a nucleic acid encoding the TNF-alpha-binding VHH, a vector comprising the nucleic acid, and a host cell comprising the nucleic acid. The claims of the patent do not disclose that the cell is a yeast cell or a bacterial cell.
Yayon et al. teach that a nucleic acid encoding an antibody can be placed in an expression vector, and the vector can be introduced into a host cell allowing expression in eukaryotic or prokaryotic cells ([0195] and [0196]). Yayon et al. teaches that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made a nucleic acid encoding the antibody of the patent, a vector comprising the nucleic acid, and a host cell comprising the vector in view of Yayon. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Yayon et al teach that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used yeast cell or bacterial cell in view of Dombrecht. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
15. Claims 198-202 and 209-217 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 14 of U.S. Patent No. 11,623,952, in view of Yayon et al. (US 2005/0147612, pub. date: 7/7/2005), and Dombrecht et al. (US 2014/0228546, pub. date 8/14/2014, effectively filed date: 6/23/2011).
The claims of the patent Claims 15 and 22 of copending Application No 17/750,112 disclose an immunoglobulin heavy chain variable domain that binds to TNF-alpha and comprises SEQ ID NO: 46 or 67. Each of the amino acid sequences of SEQ ID NOs: 46 and 67 comprises the 3 CDR sequences of instant SEQ ID NOs: 1, 2 and 3 is 100% identical to instant SEQ ID NO:8
The claims of the patent do not disclose a nucleic acid encoding the TNF-alpha-binding VHH, a vector comprising the nucleic acid, and a host cell comprising the nucleic acid. The claims of the patent do not disclose that the cell is a yeast cell or a bacterial cell.
Yayon et al. teach that a nucleic acid encoding an antibody can be placed in an expression vector, and the vector can be introduced into a host cell allowing expression in eukaryotic or prokaryotic cells ([0195] and [0196]). Yayon et al. teaches that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made a nucleic acid encoding the antibody of the patent, a vector comprising the nucleic acid, and a host cell comprising the vector in view of Yayon. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Yayon et al teach that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used yeast cell or bacterial cell in view of Dombrecht. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
16. Claims 198-202 and 209-217 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-7 and 15-17 of U.S. Patent No. 12,570,736, in view of Yayon et al. (US 2005/0147612, pub. date: 7/7/2005), and Dombrecht et al. (US 2014/0228546, pub. date 8/14/2014, effectively filed date: 6/23/2011).
The claims of the patent disclose a TNF-alpha binding polypeptide comprising SEQ ID NO: 8 or 26. Each of the amino acid sequences of SEQ ID NOs: 8 and 26 comprises the 3 CDR sequences of instant SEQ ID NOs: 1, 2 and 3 and is 100% identical to instant SEQ ID NO:8
The claims of the patent do not disclose a nucleic acid encoding the TNF-alpha-binding VHH, a vector comprising the nucleic acid, and a host cell comprising the nucleic acid. The claims of the patent do not disclose that the cell is a yeast cell or a bacterial cell.
Yayon et al. teach that a nucleic acid encoding an antibody can be placed in an expression vector, and the vector can be introduced into a host cell allowing expression in eukaryotic or prokaryotic cells ([0195] and [0196]). Yayon et al. teaches that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made a nucleic acid encoding the antibody of the patent, a vector comprising the nucleic acid, and a host cell comprising the vector in view of Yayon. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Yayon et al teach that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used yeast cell or bacterial cell in view of Dombrecht. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
17. Claims 198-202 and 209-217 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of copending Application No. 19/354,206, in view of Dombrecht et al. (US 2014/0228546, pub. date 8/14/2014, effectively filed date: 6/23/2011).
This is a provisional nonstatutory double patenting rejection.
Claim 16 of copending Application No.19/354,206 disclose an engineered cell comprising a heterologous polynucleotide that encodes nanobody V565 having a sequence at least 95% identical to SEQ ID NO:7. The amino acid sequences of SEQ ID NO: 7 comprises the 3 CDR sequences of instant SEQ ID NOs: 1, 2 and 3 and is 100% identical to instant SEQ ID NO:8.
The claim of the copending application does not disclose that the cell is a yeast cell or a bacterial cell.
Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used yeast cell or bacterial cell in view of Dombrecht. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
18. Claims 198-202 and 209-217 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
(i) claims 31-32 of copending Application No. 19/525,934, and
(ii) claims 47-48 of copending Application No 19/509,037,
in view of Yayon et al. (US 2005/0147612, pub. date: 7/7/2005), and Dombrecht et al. (US 2014/0228546, pub. date 8/14/2014, effectively filed date: 6/23/2011).
This is a provisional nonstatutory double patenting rejection.
(i) Claims 31-32 of copending Application No 19/525,934 disclose a first antigen binding domain that binds to TNF-alpha and comprising SEQ ID NO: 118. The amino acid sequences of SEQ ID NO: 118 comprises the 3 CDR sequences of instant SEQ ID NOs: 1, 2 and 3 and is 100% identical to instant SEQ ID NO:8.
(ii) claims 47-48 of copending Application No 19/509,037 disclose a VHH that binds to TNF-alpha and comprising SEQ ID NO: 118. The amino acid sequences of SEQ ID NO: 118 comprises the 3 CDR sequences of instant SEQ ID NOs: 1, 2 and 3 and is 100% identical to instant SEQ ID NO:8.
The claims of the above copending applications do not disclose a nucleic acid encoding the TNF-alpha-binding VHH, a vector comprising the nucleic acid, and a host cell comprising the nucleic acid. The claims of the copending applications do not disclose that the cell is a yeast cell or a bacterial cell.
Yayon et al. teach that a nucleic acid encoding an antibody can be placed in an expression vector, and the vector can be introduced into a host cell allowing expression in eukaryotic or prokaryotic cells ([0195] and [0196]). Yayon et al. teaches that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made a nucleic acid encoding the antibody of the copending applications, a vector comprising the nucleic acid, and a host cell comprising the vector in view of Yayon. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Yayon et al teach that methods for construction of nucleic acid molecules (encoding antibodies), for construction of vectors comprising said nucleic acid molecules, for introduction of said vectors into appropriately chosen host cells, for causing or achieving the expression are well-known in the art ([0198]).
Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used yeast cell or bacterial cell in view of Dombrecht. One would have been motivated to do so for recombinant production of the antibody. One of ordinary skill in the art would have had a reasonable expectation of success because Dombrecht et al. teaches that immunoglobulin single variable domains such as Nanobodies, VHHs, single domain antibodies can be expressed in a number of host cells and host organisms, such as bacterial cells such as E. coli, yeast strains such as Pichia and Saccharomyces, and various mammalian cells or cell lines ([0016]).
Conclusion
19. No claims are allowed.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-5pm.
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/HONG SANG/Primary Examiner, Art Unit 1643
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