Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Application, Amendments and/or Claims
2. Applicant’s response dated 7/31/2024 is considered and entered into record. Claims 1-6 have been canceled. New claims 7-38 have been added. Claims 7-38 are currently pending.
Specification Objection
3. The disclosure is objected to because of the following informalities:
Internet address:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see, for example, para 0031, last 2 lines). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Objection
4. Claims 21-24 are objected to because of the following informalities: Claims 21-24 are identical to claims 17-20 (see Table below).
Original claims
Duplicate claims
17
21
18
22
19
23
20
24
5. Applicant is advised that should claims 17-20 be found allowable, claims 21-24 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
Appropriate correction is required.
Statutory Basis for Double Patenting
6. A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
7. A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the conflicting claims so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
8. Claims 7, 8, 17 and 21 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 2-3 of prior U.S. Patent No. 8,580,265. Both sets of claims are directed to the same antibody with identical sequences for the H-CDRs, VH and VL (see Appendix 3, 2, 1). This is a statutory double patenting rejection.
Non-Statutory 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).
10. 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).
11. 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.
12. 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.
13. Claims 9-16, 18-20 and 22-38 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7 and 9-10 of US Patent 8,580,265 in view of Masternak et al (WO 2009136286, 2009) and Wang et al (Nature 84: 548-558, 2008).
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to an antibody having the same sequences as stated above (see Appendix 1, 2, 3), and a pharmaceutical composition comprising the same.
The only differences between the 2 sets of claims are:
i) Instant claims recite that the antibody comprises an IgG1 constant region, while the ‘265 patent claims do not have this limitation. However, this would be obvious in view of Masternak et al and Wang et al. Masternak et al teach monoclonal antibodies binding to IL-17F and IL-17A, wherein the antibodies preferably comprise IgG1 (Abstract; claims 14, 15, 20; page 2, para 2, 3). Wang et al teach that most of the commercially available therapeutic monoclonal antibodies comprise a human IgG1 (Table 1), wherein IgG1 antibodies show greater bioavailability (page 550, col 1, para 3). The person of ordinary skill in the art would be motivated to have the antibody comprising IgG1, as it has been shown to be more preferably used in monoclonal antibodies (Masternak et al, Wang et al).
(ii) Instant claims recite that the antibody lacks a C-terminal lysine, while the ‘265 patent claims do not have this limitation. However, the ‘265 patent specification teaches that since C-terminal basic residues like lysine are lost due to carboxypeptidase action, the lysine residue needs to be modified, for example the residue may be absent (col 8, lines 33, 34).
14. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 8,580,265.
15. Claims 7-38 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 4, 9, 11-12, 14, 19, 21-22 and 24-25 of US Patent 9,988,446 in view of Masternak et al (2009) and Wang et al (2008).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the antibody used in the method of the ‘446 patent is identical to the instantly claimed antibody, wherein the antibody in each case is in a pharmaceutical composition and has identical VH and VL sequences. That is the instant VL (SEQ ID NO: 7) and VH (SEQ ID NO: 9) sequences are identical to the corresponding SEQ ID NOs 7 and 9 of the ‘446 patent (Appendix 1, 2).
The only differences between the 2 sets of claims are:
i) Instant claims recite that the antibody comprises an IgG1 constant region, while the ‘446 patent claims do not have this limitation. However, this would be obvious in view of Masternak et al and Wang et al, for reasons set forth above.
(ii) Instant claims recite that the antibody lacks a C-terminal lysine, while ‘446 claims do not have this limitation. However, the ‘446 specification teaches that since C-terminal basic residues (like lysine) are lost due to carboxypeptidase action, the lysine residue is modified by being absent, i.e. the patent contemplates the lack of a C-terminal lysine residue in a heavy chain (col 8, lines 52-57).
16. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 9,988,446.
17. Claims 7-38 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of US Patent 11,492,396 in view of Masternak et al (2009) and Wang et al (2008).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the antibody used in the method of the ‘396 patent is identical to the instantly claimed antibody, wherein the antibody has identical VH and VL sequences. That is the instant VL (SEQ ID NO: 7) and VH (SEQ ID NO: 9) sequences are identical to SEQ ID NOs 10 and 11 (VL and VH) of the ‘396 patent (Appendix 1, 2).
The only differences between the 2 sets of claims are:
i) Instant claims recite that the antibody comprises an IgG1 constant region, while the ‘396 patent claims do not have this limitation. However, this would be obvious in view of Masternak et al and Wang et al, for reasons set forth above.
(ii) Instant claims recite that the antibody lacks a C-terminal lysine, while ‘396 claims do not have this limitation. However, the ‘396 specification teaches that since C-terminal basic residues (like lysine) are lost due to carboxypeptidase action, the lysine residue is modified by being absent, i.e. the patent contemplates the lack of a C-terminal lysine residue (col 23, lines 30-36).
(iii) Instant claims recite a monoclonal antibody, which is not present in the ‘396 claims. However, Bimekizumab of the ‘396 claims is the same monoclonal antibody (CA028_0496.g3) of instant claims (see col 61, lines 47-48 of the ‘396 patent and para 0139; Figs. 1a, 1b of instant application).
18. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 11,492,396.
19. Claims 7-38 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-9 of US Patent 11,857,625 in view of Masternak et al (2009) and Wang et al (2008).
Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are directed to an antibody and a pharmaceutical composition comprising the same, wherein the antibody has identical VH and VL sequences. That is the instant VL (SEQ ID NO: 7) and VH (SEQ ID NO: 9) sequences are identical to SEQ ID NOs 2 and 1 (VL and VH) of the ‘625 patent (Appendix 1, 2).
The only differences between the 2 sets of claims are:
i) Instant claims recite that the antibody comprises an IgG1 constant region, while the ‘625 patent claims do not have this limitation. However, this would be obvious in view of Masternak et al and Wang et al, for reasons set forth above.
(ii) Instant claims recite that the antibody lacks a C-terminal lysine, while ‘625 claims do not have this limitation. However, the ‘625 specification teaches that since C-terminal basic residues (like lysine) are lost due to carboxypeptidase action, the lysine residue is modified by being absent, i.e. the patent contemplates the lack of a C-terminal lysine residue (para spanning cols 9, 10).
20. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 11,857,625.
21. Claims 7-38 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 and 10-16 of co-pending application 18/394,323 in view of Masternak et al (2009) and Wang et al (2008).
Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are directed to an antibody, a pharmaceutical composition comprising the same, and a container comprising the composition, wherein the antibody has identical VH and VL sequences. That is the instant VL (SEQ ID NO: 7) and VH (SEQ ID NO: 9) sequences are identical to SEQ ID NOs: 2 and 1 (VL and VH) of the ‘323 application (Appendix 1, 2).
The only differences between the 2 sets of claims are:
i) Instant claims recite that the antibody comprises an IgG1 constant region, while the ‘323 claims do not have this limitation. However, this would be obvious in view of Masternak et al and Wang et al, for reasons set forth above.
(ii) Instant claims recite that the antibody lacks a C-terminal lysine, while ‘323 claims do not have this limitation. However, the ‘323 specification teaches that since C-terminal basic residues (like lysine) are lost due to carboxypeptidase action, the lysine residue is modified by being absent, i.e. the patent contemplates the lack of a C-terminal lysine residue (para 0072 of the ‘323 PGPB).
22. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
23. Claims 7-38 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 26,125-130,136-143 and 148-156 of co-pending application 18/045,597, in view of Masternak et al (2009) and Wang et al (2008).
Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims recite an antibody, which has identical VL and VH regions with corresponding sequences of instant claims. The ‘597 claims recite using an antibody having VL (SEQ ID NO: 10) and VH (SEQ ID NO: 11) regions identical to the VL and VH sequences of the instantly claimed antibody (SEQ ID NOs 7 and 9) (Appendix 1, 2).
The only differences between the 2 sets of claims are:
i) Instant claims recite that the antibody comprises an IgG1 constant region, while the ‘597 claims do not have this limitation. However, this would be obvious in view of Masternak et al and Wang et al, for reasons set forth above.
(ii) Instant claims recite that the antibody lacks a C-terminal lysine, while ‘597 claims do not have this limitation. However, the ‘597 specification teaches that since C-terminal basic residues (like lysine) are lost due to carboxypeptidase action, the lysine residue is modified by being absent, i.e. the patent contemplates the lack of a C-terminal lysine residue (para 0103 of the ‘597 PGPB).
24. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
25. Claims 7-38 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4-6, 8, 18, 31, 33, 36-37, 44 and 113 of the of co-pending application 18/045,623, in view of Masternak et al (2009) and Wang et al (2008).
Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims recite an antibody, which has identical VL and VH regions with corresponding sequences of instant claims. The ‘623 claims recite using an antibody having VL (SEQ ID NO: 10) and VH (SEQ ID NO: 11) regions identical to the VL and VH sequences of the instantly claimed antibody (SEQ ID NOs 7 and 9) (Appendix 1, 2).
The only differences between the 2 sets of claims are:
i) Instant claims recite that the antibody comprises an IgG1 constant region, while the ‘623 claims do not have this limitation. However, this would be obvious in view of Masternak et al and Wang et al, for reasons set forth above.
(ii) Instant claims recite that the antibody lacks a C-terminal lysine, while ‘623 claims do not have this limitation. However, the ‘623 specification teaches that since C-terminal basic residues (like lysine) are lost due to carboxypeptidase action, the lysine residue is modified by being absent, i.e. the patent contemplates the lack of a C-terminal lysine residue (para 0101 of the ‘623 PGPB).
26. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
27. Claims 7-38 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-9 of the of US patent 9,034,600, in view of Masternak et al (2009) and Wang et al (2008).
Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims recite an antibody, which has identical VL and VH regions with corresponding sequences of instant claims. That is the instant VL (SEQ ID NO: 7) and VH (SEQ ID NO: 9) sequences are identical to the corresponding SEQ ID NOs 7 and 9 of the ‘600 patent (Appendix 1 – highlighted)
The only differences between the 2 sets of claims are:
i) Instant claims recite that the antibody comprises an IgG1 constant region, while the ‘600 patent claims do not have this limitation. However, this would be obvious in view of Masternak et al and Wang et al, for reasons set forth above.
(ii) Instant claims recite that the antibody lacks a C-terminal lysine, while ‘600 claims do not have this limitation. However, the ‘600 specification teaches that since C-terminal basic residues (like lysine) are lost due to carboxypeptidase action, the lysine residue is modified by being absent, i.e. the patent contemplates the lack of a C-terminal lysine residue (col 8, lines 31-37).
(iii) ‘600 claims recite a DNA encoding the antibody, while instant claims do not recite a DNA. However, the making of proteins or antibodies by expressing in a host cell in culture is a well understood standard process.
28. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
29. No claims are allowed.
30. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aditi Dutt whose telephone number is (571)272-9037. The examiner can normally be reached on M-F 9:00am-5:00pm.
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32. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker, can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A. D./
Examiner, Art Unit 1675
8 August 2026
/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675
Prosecution Insights