DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
1. Claims 1-20 as filed on August 17, 2023 are pending and under consideration.
Priority
2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
It is noted that the examiner has established a priority date of March 03, 2022 for claims 1-20 of the instant application because the priority of the instantly claimed invention is based on the prior filed applications CN 202110235660.8 which are written Chinese. The prior filed applications have not been translated and the Examiner is unable to determine the information in the document.
If applicant disagrees with any rejection set forth in this action based on examiner's establishment of a priority date of March 03, 2022 for claims 1-20, then Applicants are invited to submit a proper translation of the priority document and to point to page and line where support can be found establishing an earlier priority date. If Applicants choose to file a translation, then the translation must be filed together with a statement that the translation of the certified copy is accurate. See 35 U.S.C. 119 (b)(3), 37 C.F.R. 1.55(g)(3)(4), 37 C.F.R. 1.78(d)(7), and MPEP 1895.01.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
3. Claims 3, 6, 8, 10, 11, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 3, 6, 8, 10, 11, and 18, the phrases "preferably", more "preferably" and most preferably renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Additionally, claim 18 recites “(d) 100 mM to 1000 mM of mannitol, and/or 100 mM to 1000 mM of arginine or a pharmaceutically acceptable salt thereof, or proline;.” The use of “and/or” and “or” in part (d) makes it unclear if the components are limited to being in combination or are only in the alternative. Thus, this renders the claim indefinite.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
4a. Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/043221 A1 (Chen et al. March 11, 2021, IDS), “Chen-221” in view of US 2019/0111129 A1 (Ikdea et al. April 28, 2019), “Ikdea”.
4b. Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0289833 A1 (Chen et al Sep. 15, 2022), “Chen-833” in view of US 2019/0111129 A1 (Ikdea et al. April 28, 2019), “Ikdea”.
Chen-833 is the publication of the national stage application of Chen-221. Thus, Chen-833 and Chen-221 have the same disclosure. Chen-833 will be cited for both Chen-833 and Chen-221 in both rejections.
Chen-833 teaches in the claims:.
1. An isolated monoclonal antibody, or an antigen-binding portion thereof, binding to thymic stromal lymphopoietin (TSLP), comprising (i) a heavy chain variable region comprising a VH CDR1 region, a VH CDR2 region and a VH CDR3 region, wherein the VH CDR1 region, the VH CDR2 region and the VH CDR3 region comprise amino acid sequences of (1) SEQ ID NOs: 1, 2 and 3, respectively; (2) SEQ ID Nos: 37, 38, and 39, respectively; or (3) SEQ ID Nos: 47, 48, and 49, respectively, and/or (ii) a light chain variable region comprising a VL CDR1 region, a VL CDR2 region and a VL CDR3 region, wherein the VL CDR1 region, the VL CDR2 region and the VL CDR3 region comprise amino acid sequences of (1) SEQ ID NOs: 4, 5 and 6, respectively; (2) SEQ ID NOs: 40, 41 and 42, respectively; or (3) SEQ ID NOs: 50, 51 and 52, respectively.
2. The isolated monoclonal antibody, or the antigen-binding portion thereof, of claim 1, wherein the heavy chain variable region comprises an amino acid sequence having at least 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94% 95%, 96%, 97%, 98%, 99% or 100% identity to SEQ ID NOs: 7, 8, 9 (X1=R, X2=V, X3=R; X1=R, X2=V, X3=V; X1=R, X2=A, X3=R; X1=K, X2=A, X3=R; X1=K, X2=A, X3=V), 43 or 53.
3. The isolated monoclonal antibody, or the antigen-binding portion thereof, of claim 1, wherein the light chain variable region comprises an amino acid sequence having at least 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94% 95%, 96%, 97%, 98%, 99% or 100% identity to SEQ ID NOs: 10, 11 (X1=S, X2=V; X1=A, X2=I; X1=S, X2=I), 44 or 54.
4. The isolated monoclonal antibody, or an antigen-binding portion thereof, of claim 1, wherein the heavy chain variable region and the light chain variable region comprise amino acid sequences having at least 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90°/a, 91%, 92%, 93%, 94% 95%, 96%, 97%, 98%, 99% or 100% identity to (1) SEQ ID NOs: 7 and 10, respectively; (2) SEQ ID NOs: 8 and 11 (X1=S, X2=V), respectively; (3) SEQ ID NOs: 9 (X1=R, X2=V, X3=R) and 11 (X1=S, X2=V), respectively; (4) SEQ ID NOs: 9 (X1=R, X2=V, X3=V) and 11 (X1=S, X2=V), respectively; (5) SEQ ID NOs: 9 (X1=R, X2=A, X3=R) and 11 (X1=S, X2=V), respectively; (6) SEQ ID NOs: 9 (X1=K, X2=A, X3=R) and 11 (X1=S, X2=V), respectively; (7) SEQ ID NOs: 9 (X1=K, X2=A, X3=V) and 11 (X1=S, X2=V), respectively; (8) SEQ ID NOs: 8 and 11 (X1=A, X2=I), respectively; (9) SEQ ID NOs: 9 (X1=R, X2=V, X3=R) and 11 (X1=A, X2=I), respectively; (10) SEQ ID NOs: 9 (X1=R, X2=V, X3=V) and 11 (X1=A, X2=I), respectively; (11) SEQ ID NOs: 9 (X1=R, X2=A, X3=R) and 11 (X1=A, X2=I), respectively; (12) SEQ ID NOs: 9 (X1=K, X2=A, X3=R) and 11 (X1=A, X2=I), respectively; (13) SEQ ID NOs: 9 (X1=K, X2=A, X3=V) and 11 (X1=A, X2=I), respectively; (14) SEQ ID NOs: 8 and 11 (X1=S, X2=I), respectively; (15) SEQ ID NOs: 9 (X1=R, X2=V, X3=R) and 11 (X1=S, X2=I), respectively; (16) SEQ ID NOs: 9 (X1=R, X2=V, X3=V) and 11 (X1=S, X2=I), respectively; (17) SEQ ID NOs: 9 (X1=R, X2=A, X3=R) and 11 (X1=S, X2=I), respectively; (18) SEQ ID NOs: 9 (X1=K, X2=A, X3=R) and 11 (X1=S, X2=I), respectively; (19) SEQ ID NOs: 9 (X1=K, X2=A, X3=V) and 11 (X1=S, X2=I), respectively; (20) SEQ ID NOs: 43 and 44, respectively; or (21) SEQ ID NOs: 53 and 54, respectively.
5. The isolated monoclonal antibody, or an antigen-binding portion thereof, of claim 1, comprising a heavy chain constant region having an amino acid sequence of SEQ ID NOs: 12, 13 or 57, linked to the heavy chain variable region, and a light chain constant region having an amino acid sequence of SEQ ID NO: 14, linked to the light chain variable region.
6. The isolated monoclonal antibody, or the antigen-binding portion thereof, of claim 1, which (i) binds human TSLP; (ii) binds to monkey TSLP; and/or (iii) blocks human TSLP-human TSLPR/IL7R interaction.
7. The isolated monoclonal antibody, or the antigen-binding portion thereof, of claim 1, which is a mouse, chimeric or humanized antibody.
8. The isolated monoclonal antibody, or the antigen-binding portion thereof, of claim 1, which is an IgG1, IgG2 or IgG4 isotype.
12. A pharmaceutical composition comprising a therapeutically effective amount of the isolated monoclonal antibody, or antigen-binding portion thereof, of claim 1, and a pharmaceutically acceptable carrier.
15. A method for treating a disease associated with TSLP overexpression in a subject in need thereof, comprising administering to the subject the pharmaceutical composition of claim 12.
16. The method of claim 15, wherein the disease is asthma, ulcerative colitis, atopic dermatitis or psoriasis.
17. The method of claim 16, wherein the disease is asthma.
SEQ ID NOs: 1-11 of Chen-833 comprise the claimed SEQ ID NOs: 1-11. See Table 1 of Chen-833 and Appendix.
Chen-833 teaches the heavy chain constant region may comprise human IgG1 constant region having the amino acid sequences set forth in SEQ ID NOs: 12 or 57, or human IgG4 constant region having the amino acid sequence set forth in SEQ ID NO: 13, or a fragment thereof. The light chain constant region may comprise human kappa constant region having the amino acid sequence set forth in SEQ ID NO: 14, or a fragment thereof. See ¶ 0018.
SEQ ID NO: 14 of Chen-833 comprises the claimed SEQ ID NO: 14. See Appendix.
SEQ ID NO: 57 of Chen-833 comprises the claimed SEQ ID NO: 37. See Appendix.
Chen-833 teaches as set forth above, but does that the pharmaceutical compositions comprises a buffering agent, a surfactant and a stabilizer or a lyophilized formulation.
Ikdea teaches stable pharmaceutical composition comprising an anti-human TSLP receptor antibody, capable of inhibiting the generation of chemically modified substances, such as deamidated forms and oxidized forms, or degradants, or multimers. The pharmaceutical composition comprises an anti-human TSLP receptor antibody, a pharmaceutically acceptable buffer, arginine (a stabilizer as claimed) or a pharmaceutically acceptable salt thereof, and a surfactant. See abstract and ¶¶ 0012-0014.
Regarding claim 3, Ikdea teaches when the pharmaceutical composition is a liquid state (liquid preparation), the concentration of the antibody is, for example, 1 mg/mL to 300 mg/mL (about 0.007 mmol/L to 2 mmol/L) as an embodiment, 1 mg/mL to 200 mg/mL (about 0.007 mmol/L to 1 mmol/L) as one embodiment, 1 mg/mL to 100 mg/mL (about 0.007 mmol/L to 0.7 mmol/L) as still another embodiment, and 10 mg/mL to 50 mg/mL (about 0.07 mmol/L to 0.3 mmol/L) as still another embodiment. See ¶ 0042.
Regarding claims 4 and 18, Ikdea teaches the pharmaceutically acceptable buffer is one, or two or more selected from the group consisting of phosphoric acid, citric acid, acetic acid, succinic acid, histidine, ascorbic acid, glutamic acid, lactic acid, maleic acid, trometamol, and gluconic acid. See ¶¶ 0013, 0046 and 0047.
Regarding claims 5 and 18, Ikdea teaches sodium phosphate buffers See ¶¶ 0013, 0047, 0099 and 0137 and Table 3-1.
Regarding claims 6 and 18, Ikdea teaches the buffers are a concentration of 5 to 100 mM. See ¶¶ 0013 and 0049,
Regarding claims 7, 8, and 18, Ikdea teaches the surfactant is polysorbate 20 or 80 and wherein a content of the surfactant is 0.001 to 1% , 0.01 to 0.1% or 0.01 to 0.2% (w/v). See ¶¶ 0007, 0013 and 0056-0058.
Regarding claims 9, 10 and 18, Ikdea teaches arginine or arginine hydrochloride in an amount of 50 to 200 mM or about 700 mM, 500 mM, 210 mM or 140 mM or less. See ¶¶ 0007, 0013, 0051-0053.
Regarding claims 11 and 18, Ikdea teaches a pH ranging from 5.5 to 7.0 or a pH of 5 to 6. See ¶¶ 0007, 0013, 0046 and 0047.
Regarding claims 12 and 13, Ikdea teaches making lyophilized forms of the pharmaceutical compositions. See ¶¶ 0013, 0040, 0047, and 0050.
Regarding claim 14, Ikdea teaches containers containing the pharmaceutical compositions. See ¶¶ 0013 and 0059.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Chen-221 or Chen-833 and Ikdea make pharmaceutical compositions of the TSLP antibodies of Chen-221 or Chen-833 with the pharmaceutical composition components of Ikdea or a lyophilized formulation thereof because Ikdea teaches the pharmaceutical compositions stabilize the TSLP antibodies and lyophilized formulations thereof. Thus, one would have been motivated to make pharmaceutical compositions of the TSLP antibodies of Chen-221 or Chen-833 with the pharmaceutical composition components of Ikdea to inhibit the degradation of the antibodies and increase their stability.
The applied Chen-833 reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
The Chen-833 rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
5. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,479,912 B2 (Chen et al. Nov. 25, 2025) in view of US 2019/0111129 A1 (Ikdea et al. April 28, 2019), “Ikdea”.
The ‘912 claims are drawn to
1. An isolated monoclonal antibody, or an antigen-binding portion thereof, which binds to thymic stromal lymphopoietin (TSLP), comprising (i) a heavy chain variable region (VH) comprising a VH CDR1 region, a VH CDR2 region and a VH CDR3 region, wherein the VH CDR1 region, the VH CDR2 region and the VH CDR3 region comprise amino acid sequences of (1) SEQ ID NOs: 1, 2 and 3, respectively; (2) SEQ ID Nos: 37, 38, and 39, respectively; or (3) SEQ ID NOs: 47, 48, and 49, respectively, and/or (ii) a light chain variable region (VL) comprising a VL CDR1 region, a VL CDR2 region and a VL CDR3 region, wherein the VL CDR1 region, the VL CDR2 region and the VL CDR3 region comprise amino acid sequences of (1) SEQ ID NOs: 4, 5 and 6, respectively; (2) SEQ ID NOs: 40, 41 and 42, respectively; or (3) SEQ ID NOs: 50, 51 and 52, respectively.
2. The isolated monoclonal antibody, or the antigen-binding portion thereof, of claim 1, wherein the heavy chain variable region comprises an amino acid sequence having at least 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94% 95%, 96%, 97%, 98%, 99% or 100% identity to SEQ ID NOs: 7, 8, 9, 43 or 53.
3. The isolated monoclonal antibody, or the antigen-binding portion thereof, of claim 1, wherein the light chain variable region comprises an amino acid sequence having at least 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94% 95%, 96%, 97%, 98%, 99% or 100% identity to SEQ ID NOs: 10, 11, 44 or 54.
4. The isolated monoclonal antibody, or an antigen-binding portion thereof, of claim 1, wherein the heavy chain variable region and the light chain variable region comprise amino acid sequences having at least 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94% 95%, 96%, 97%, 98%, 99% or 100% identity to (1) SEQ ID NOs: 7 and 10; (2) SEQ ID NOs: 8 and 11; or (3) SEQ ID NOs: 9 and 11.
5. The isolated monoclonal antibody, or an antigen-binding portion thereof, of claim 1, comprising a heavy chain constant region having an amino acid sequence of SEQ ID NOs: 12, 13 or 57, linked to the heavy chain variable region, and a light chain constant region having an amino acid sequence of SEQ ID NO: 14, linked to the light chain variable region.
6. The isolated monoclonal antibody, or the antigen-binding portion thereof, of claim 1, which (i) binds human TSLP; (ii) binds to monkey TSLP; and/or (iii) blocks human TSLP-human TSLPR/IL7R interaction.
7. The isolated monoclonal antibody, or the antigen-binding portion thereof, of claim 1, which is a mouse, chimeric or humanized antibody.
8. The isolated monoclonal antibody, or the antigen-binding portion thereof, of claim 1, which is an IgG1, IgG2 or IgG4 isotype.
9. The isolated antibody of claim 1, wherein the VH region comprises the amino acid sequence of SEQ ID NO. 9, wherein X1=R or K, X2=V or A, and X3=R or V.
10. The isolated antibody of claim 9, wherein the VH region comprises the amino acid sequence of SEQ ID NO. 9, wherein X1=R, X2=V, and X3=R.
11. The isolated antibody of claim 1, wherein the VL region comprises the amino acid sequence of SEQ ID NO. 11, wherein X1=S or A and X2=V or I.
12. The isolated antibody of claim 11, wherein the VL region comprises the amino acid sequence of SEQ ID NO. 11, wherein X1=A and X2=I.
13. The isolated antibody of claim 1, wherein the VH region comprises the amino acid sequence of SEQ ID NO. 9, wherein X1=R or K, X2=V or A, and X3=R or V and wherein the VL region comprises the amino acid sequence of SEQ ID NO. 11, wherein X1=A and X2=I.
14. A polynucleotide encoding the isolated monoclonal antibody, or the antigen-binding portion thereof, of claim 1.
15. A vector containing the polynucleotide according to claim 14.
16. An isolated host cell having its genome integrated with the polynucleotide according to claim 14.
17. An isolated host cell containing the vector according to claim 15.
18. A pharmaceutical composition comprising a therapeutically effective amount of the isolated monoclonal antibody, or antigen-binding portion thereof, of claim 1, and a pharmaceutically acceptable carrier.
19. The pharmaceutical composition of claim 18, further comprising an anti-asthma agent, anti-ulcerative colitis drug, anti-atopic dermatitis drug, or anti-psoriasis drug.
20. The pharmaceutical composition of claim 19, wherein the anti-asthma agent is an antibody selected from the group consisting of an anti-TSLPR/IL7R antibody, an anti-IL4 antibody, an anti-IL4R antibody, an anti-IL-5 antibody, an anti-IL5R antibody, an anti-IL13 antibody, an anti-IL13R antibody and an anti-IgE antibody.
21. A method for treating a disease associated with TSLP overexpression in a subject in need thereof, comprising administering to the subject the pharmaceutical composition of claim 18.
22. The method of claim 21, wherein the disease is asthma, ulcerative colitis, atopic dermatitis or psoriasis.
23. The method of claim 22, wherein the disease is atopic dermatitis.
24. The method of claim 22, wherein the disease is asthma.
SEQ ID NOs: 1-11 of the ‘912 claims comprise the claimed SEQ ID NOs: 1-11. See Table 1 of ‘912 and Appendix.
SEQ ID NO: 14 comprises the claimed SEQ ID NO: 14. See Appendix.
SEQ ID NO: 57 comprises the claimed SEQ ID NO: 37. See Appendix.
The ‘912 claims teach as set forth above, but do not teach that the pharmaceutical compositions comprises a buffering agent, a surfactant and a stabilizer or a lyophilized formulation.
Ikdea teaches as set forth above.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of the ‘912 claims and Ikdea make pharmaceutical compositions of the TSLP antibodies of the ‘912 claims with the pharmaceutical composition components of Ikdea or a lyophilized formulation thereof because Ikdea teaches the pharmaceutical compositions stabilize the TSLP antibodies and lyophilized formulations thereof. Thus, one would have been motivated to make pharmaceutical compositions of the TSLP antibodies of the ‘912 claims with the pharmaceutical composition components of Ikdea to inhibit the degradation of the antibodies and increase their stability.
6. Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-21 of co-pending Application No. 19/388,619 (Chen et al.) in view of US 2019/0111129 A1 (Ikdea et al. April 28, 2019), “Ikdea”.
The ‘619 claims are drawn to
1. A bispecific antibody comprising two antigen-binding portions, comprising: (a) a first antibody or antigen-binding portion or fragment thereof that binds TSLP comprising a heavy chain variable region (VH) comprising a VH CDR1 region, a VH CDR2 region and a VH CDR3 region, wherein the VH CDR1 region, the VH CDR2 region and the VH CDR3 region comprise amino acid sequences of SEQ ID NOs: 1, 2 and 3, respectively, and a light chain variable region (VL) comprising a VL CDR1 region, a VL CDR2 region and a VL CDR3 region, wherein the VL CDR1 region, the VL CDR2 region and the VL CDR3 region comprise amino acid sequences of SEQ ID NOs: 4, 5 and 6, respectively, and (b) a second antibody or antigen-binding portion or fragment thereof that binds to a disease-specific protein.
2. The bispecific antibody of claim 1, wherein the second antibody or antigen-binding portion or fragment thereof comprises an antigen-binding portion of an anti-IgE antibody, an anti-IL4 antibody, an anti-IL4R antibody, an anti-IL13 antibody, an anti-IL13R antibody, an anti-IL5 antibody, an anti-IL5R antibody, an anti-IL17 antibody or an anti-TSLPR antibody.
3. The bispecific antibody of claim 1, which binds to TSLP and another disease-specific protein selected from the group consisting of IgE, Il-4, IL-13, IL-13R, Il-5, IL-5R, IL-17 or TSLPR.
4. The bispecific antibody of claim 1, which is a mouse, chimeric, humanized, or human antibody.
5. The bispecific antibody according to claim 1, wherein the first antibody further comprises: (c) a heavy chain constant region comprising an amino acid sequence of SEQ ID NOs: 12, 13 or 57, linked to the heavy chain variable region; and (d) a light chain constant region having an amino acid sequence of SEQ ID NO: 14, linked to the light chain variable region.
6. The bispecific antibody according to claim 5, wherein a C-terminus of the heavy chain variable region is linked to an N-terminus of the heavy chain constant region, and a C-terminus of the light chain variable region is linked to an N-terminus of the light chain constant region.
7. The bispecific antibody according to claim 5, wherein the heavy chain constant region comprises an amino acid sequence of SEQ ID NO: 12.
8. The bispecific antibody according to claim 5, wherein the first antibody is an IgG1 isotype.
9. The bispecific antibody according to claim 5, wherein the first antibody or antigen-binding portion or fragment thereof is an scFv.
10. The bispecific antibody according to claim 5, wherein the second antibody or antigen-binding portion or fragment thereof is an scFv.
11. A pharmaceutical composition comprising a therapeutically effective amount of the bispecific antibody, or antigen-binding portion thereof, of claim 1, and a pharmaceutically acceptable carrier.
12. The pharmaceutical composition of claim 11, further comprising an anti-asthma agent, anti-ulcerative colitis drug, anti-atopic dermatitis drug, anti-allergic drug or anti-psoriasis drug.
13. The pharmaceutical composition of claim 12, wherein the anti-asthma agent is an antibody selected from the group consisting of an anti-TSLPR/IL7R antibody, an anti-IL4 antibody, an anti-IL4R antibody, an anti-IL-5 antibody, an anti-IL5R antibody, an anti-IL13 antibody, an anti-IL13R antibody, am anti-IL-17 antibody and an anti-IgE antibody.
14. A method for treating a disease associated with TSLP overexpression in a subject in need thereof, comprising administering to the subject the pharmaceutical composition of claim 11.
15. The method of claim 14, wherein the disease is asthma.
16. A vector containing a polynucleotide encoding the bispecific antibody, or the antigen-binding portion thereof, according to claim 1.
17. An isolated host cell containing the vector according to claim 16.
18. An isolated monoclonal antibody, or an antigen-binding portion thereof, which binds to thymic stromal lymphopoietin (TSLP), comprising (a) a heavy chain variable region (VH) comprising a VH CDR1 region, a VH CDR2 region and a VH CDR3 region, wherein the VH CDR1 region, the VH CDR2 region and the VH CDR3 region comprise amino acid sequences of SEQ ID NOs: 1, 2 and 3, respectively, and a light chain variable region (VL) comprising a VL CDR1 region, a VL CDR2 region and a VL CDR3 region, wherein the VL CDR1 region, the VL CDR2 region and the VL CDR3 region comprise amino acid sequences of SEQ ID NOs: 4, 5 and 6, respectively; or (b) the VH region comprising an amino acid sequence of SEQ ID NO. 9, wherein X1=R, X2=V, and X3=R, and the VL region comprising an amino acid sequence of SEQ ID NO. 11, wherein X1=A and X2=I.
19. The isolated monoclonal antibody, or the antigen-binding portion thereof, of claim 18, which (i) binds human TSLP; (ii) binds to monkey TSLP; and/or (iii) blocks human TSLP-human TSLPR/IL7R interaction.
20. The isolated monoclonal antibody, or the antigen-binding portion thereof, of claim 18, which is a mouse, chimeric, or humanized antibody.
21. The isolated monoclonal antibody, or the antigen-binding portion thereof, of claim 18, which is an IgGl, IgG2 or IgG4 isotype.
SEQ ID NOs: 1-6, 9 and 11 of the ‘619 claims comprise the claimed SEQ ID NOs: 1-6, 9 and 11 of. See Table 1 of ‘619 and Appendix.
SEQ ID NO: 14 comprises the claimed SEQ ID NO: 14. See Appendix.
SEQ ID NO: 57 comprises the claimed SEQ ID NO: 37. See Appendix.
The ‘619 claims teach as set forth above, but do not teach that the pharmaceutical compositions comprises a buffering agent, a surfactant and a stabilizer or a lyophilized formulation.
Ikdea teaches as set forth above.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of the ‘619 claims and Ikdea make pharmaceutical compositions of the TSLP antibodies of the ‘619 claims with the pharmaceutical composition components of Ikdea or a lyophilized formulation thereof because Ikdea teaches the pharmaceutical compositions stabilize the TSLP antibodies and lyophilized formulations thereof. Thus, one would have been motivated to make pharmaceutical compositions of the TSLP antibodies of the ‘619 claims with the pharmaceutical composition components of Ikdea to inhibit the degradation of the antibodies and increase their stability.
This is a provisional nonstatutory double patenting rejection.
Conclusion
7. No claims allowed.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached M-F 8:30-5:30 Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Greg Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PETER J REDDIG/Primary Examiner, Art Unit 1646
APPENDIX
Alignment of SEQ ID NOs: 1, 2, 3 with SEQ ID NO: 7 of Chen-833
Sequence 7, US/17636089
Publication No. US20220289833A1
GENERAL INFORMATION
APPLICANT: BIOSION INC.
APPLICANT: CHIA TAI TIANQING PHARMACEUTICALS GROUP CO., LTD.
TITLE OF INVENTION: ANTIBODIES BINDING TSLP AND USES THEREOF
FILE REFERENCE: 55532 00020
CURRENT APPLICATION NUMBER: US/17/636,089
CURRENT FILING DATE: 2022-02-17
PRIOR APPLICATION NUMBER: US62/895,984
PRIOR FILING DATE: 2019-09-04
NUMBER OF SEQ ID NOS: 58
SEQ ID NO 7
LENGTH: 117
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: VH for mouse and chimeric 1C5F12E9 antibodies
Query Match 85.9%; Score 149.4; Length 117;
Best Local Similarity 39.5%;
Matches 30; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 TYWMH--------------VIDPSDSDTTYNQKFKG------------------------ 22
||||| |||||||||||||||||
Db 31 TYWMHWVKQRPGQGLEWIGVIDPSDSDTTYNQKFKGKATLTVDTSSSTAYMQLSSLTSED 90
Qy 23 --------SLDGYYDY 30
||||||||
Db 91 SAVYYCTRSLDGYYDY 106
Alignment of SEQ ID NO: 7 with SEQ ID NO: 7 of Chen-833
Sequence 7, US/17636089
Publication No. US20220289833A1
GENERAL INFORMATION
APPLICANT: BIOSION INC.
APPLICANT: CHIA TAI TIANQING PHARMACEUTICALS GROUP CO., LTD.
TITLE OF INVENTION: ANTIBODIES BINDING TSLP AND USES THEREOF
FILE REFERENCE: 55532 00020
CURRENT APPLICATION NUMBER: US/17/636,089
CURRENT FILING DATE: 2022-02-17
PRIOR APPLICATION NUMBER: US62/895,984
PRIOR FILING DATE: 2019-09-04
NUMBER OF SEQ ID NOS: 58
SEQ ID NO 7
LENGTH: 117
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: VH for mouse and chimeric 1C5F12E9 antibodies
Query Match 100.0%; Score 628; Length 117;
Best Local Similarity 100.0%;
Matches 117; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLQQPGTELVKPGASVKMSCKASGYTFTTYWMHWVKQRPGQGLEWIGVIDPSDSDTTY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLQQPGTELVKPGASVKMSCKASGYTFTTYWMHWVKQRPGQGLEWIGVIDPSDSDTTY 60
Qy 61 NQKFKGKATLTVDTSSSTAYMQLSSLTSEDSAVYYCTRSLDGYYDYWGQGTTLTVSS 117
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NQKFKGKATLTVDTSSSTAYMQLSSLTSEDSAVYYCTRSLDGYYDYWGQGTTLTVSS 117
Alignment of SEQ ID NO: 10 with SEQ ID NO: 10 of Chen-833
Sequence 10, US/17636089
Publication No. US20220289833A1
GENERAL INFORMATION
APPLICANT: BIOSION INC.
APPLICANT: CHIA TAI TIANQING PHARMACEUTICALS GROUP CO., LTD.
TITLE OF INVENTION: ANTIBODIES BINDING TSLP AND USES THEREOF
FILE REFERENCE: 55532 00020
CURRENT APPLICATION NUMBER: US/17/636,089
CURRENT FILING DATE: 2022-02-17
PRIOR APPLICATION NUMBER: US62/895,984
PRIOR FILING DATE: 2019-09-04
NUMBER OF SEQ ID NOS: 58
SEQ ID NO 10
LENGTH: 107
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: VL for mouse and chimeric 1C5F12E9 antibodies
Query Match 100.0%; Score 575; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPASLSASVGETVTITCRPTENIYSYLAWYQQKQGKSPHLLVYFARTLAEGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPASLSASVGETVTITCRPTENIYSYLAWYQQKQGKSPHLLVYFARTLAEGVPS 60
Qy 61 RFSGSGSGTQFSLKINSLQPEDFGIYYCQHHYGTPWTFGGGTKLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTQFSLKINSLQPEDFGIYYCQHHYGTPWTFGGGTKLEIK 107
Alignment of SEQ ID NOs: 4, 5, 6 with SEQ ID NO: 10 of Chen-833
Sequence 10, US/17636089
Publication No. US20220289833A1
GENERAL INFORMATION
APPLICANT: BIOSION INC.
APPLICANT: CHIA TAI TIANQING PHARMACEUTICALS GROUP CO., LTD.
TITLE OF INVENTION: ANTIBODIES BINDING TSLP AND USES THEREOF
FILE REFERENCE: 55532 00020
CURRENT APPLICATION NUMBER: US/17/636,089
CURRENT FILING DATE: 2022-02-17
PRIOR APPLICATION NUMBER: US62/895,984
PRIOR FILING DATE: 2019-09-04
NUMBER OF SEQ ID NOS: 58
SEQ ID NO 10
LENGTH: 107
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: VL for mouse and chimeric 1C5F12E9 antibodies
Query Match 83.9%; Score 128.3; Length 107;
Best Local Similarity 36.5%;
Matches 27; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 RPTENIYSYLA---------------FARTLAE--------------------------- 18
||||||||||| |||||||
Db 24 RPTENIYSYLAWYQQKQGKSPHLLVYFARTLAEGVPSRFSGSGSGTQFSLKINSLQPEDF 83
Qy 19 -----QHHYGTPWT 27
|||||||||
Db 84 GIYYCQHHYGTPWT 97
Alignment of SEQ ID NO: 37 with SEQ ID NO: 10 of Chen-833
ALIGNMENT:
Query Match 100.0%; Score 1767; Length 330;
Best Local Similarity 100.0%;
Matches 330; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 60
Qy 61 GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG 120
Qy 121 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYN 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYN 180
Qy 181 STYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDE 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 STYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDE 240
Qy 241 LTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 LTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW 300
Qy 301 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 330
||||||||||||||||||||||||||||||
Db 301 QQGNVFSCSVMHEALHNHYTQKSLSLSPGK 330
Alignment of SEQ ID NO: 14 with SEQ ID NO: 14 of Chen-833
ALIGNMENT:
Query Match 100.0%; Score 553; Length 108;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2 RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQD 61
Qy 61 SKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 62 SKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 108
Prosecution Insights