Office Action 1: Non-Final Rejection (2024-10-22)
Rejection types: Double Patenting

CLAIMS:
CLAIMS

WHAT IS CLAIMED:
-20038.03

1\. A variant TACI-Fc fusion protein set forth in SEQ ID NO: 167.

2\. A variant TACI-Fc fusion protein homodimer, wherein each polypeptide of the homodimer is set forth in SEQ ID NO:167.

3\. A pharmaceutical composition comprising the variant TACI-Fc fusion protein of claim 1 and a pharmaceutically acceptable excipient.

4\. A pharmaceutical composition comprising the variant TACI-Fc fusion protein homodimer of claim 2 and a pharmaceutically acceptable excipient.
sf-6088142 159

OFFICE ACTION:
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 .
Claims 1-4 are pending and under examination.
Information Disclosure Statement
The Information Disclosure Statement filed on 8/29/2024 has been considered.
Double Patenting
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 Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention 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.
Claims 1-4 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 18-19 and 29-30 of prior U.S. Patent No. 11,274,140. This is a statutory double patenting rejection.
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.
Claims 1-4 are rejected provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-27 and 30 of copending Application No. 17364095 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because a variant TACI-Fc fusion protein set forth in SEQ ID NO: 167, a variant TACI-Fc fusion protein homodimer, wherein each polypeptide of the homodimer is set forth in SEQ ID NO:167 and a pharmaceutical composition comprising the variant TACI-Fc fusion protein of claim 1 or 2 are taught by claims 26-27 and 30 of copending Application No. 17364095.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.


NEXT OFFICE ACTION: 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 .
Applicant’s response filed on 1/22/2025 is acknowledged and fully considered.
Status of Application, Amendments, And/Or Claims
The amendments of claims 1-2, and 4, and the addition of claim 5 have been made of record.
Claims 1-5 are pending and under consideration.
Information Disclosure Statement
The Information Disclosure Statement filed on 1/16/2025 has been considered.
EXAMINER’S COMMENT
Double Patenting--withdrawn
The rejection of claims 1-4 under 35 U.S.C. 101 as claiming the same invention as that of claims 18-19 and 29-30 of prior U.S. Patent No. 11,274,140. This is a statutory double patenting rejection is withdrawn in view of applicant’s amendments to claims 1-2 and 4 and the filing of a terminal disclosure on 1/22/2025 which was approved by the office on 1/23/2025.
The provisional rejection of claims 1-4 on the ground of nonstatutory double patenting as being unpatentable over claims 26-27 and 30 of copending Application No. 17346095 (17364095 was a typo) is withdrawn as the application No. 17/346,095 is now US Pat. No. 11,274,140 (see above). Applicants have filed a TD on 1/22/2025 to overcome with the rejection.
Conclusion
Claims 1-5 are allowed.

CITED REFERENCE SUMMARIES: Ref US11274140: Claims:
1. An immunomodulatory protein homodimer comprising two identical copies of a TACI-Fc fusion protein, wherein the TACI-Fc fusion protein comprises a variant TACI polypeptide, an Fc region, and a linker between the variant TACI polypeptide and the Fc region, wherein the variant TACI polypeptide comprises the amino acid substitutions K77E, F78Y, and Y102D in the sequence set forth in SEQ ID NO:13, wherein the numbering of positions corresponds to numbering of positions set forth in SEQ ID NO:122.
2. The immunomodulatory protein homodimer of claim 1, wherein the variant TACI polypeptide has increased binding affinity to one or both of APRIL and BAFF compared to the reference TACI polypeptide.
3. The immunomodulatory protein homodimer of claim 1, wherein the variant TACI polypeptide has at least 90% sequence identity to SEQ ID NO:13.
4. The immunomodulatory protein homodimer of claim 1, wherein the variant TACI polypeptide has at least 92% sequence identity to SEQ ID NO:13.
5. The immunomodulatory protein homodimer of claim 1, wherein the variant TACI polypeptide is set forth in SEQ ID NO: 26.
6. The immunomodulatory protein homodimer of claim 1, wherein the linker comprises a peptide linker and the peptide linker is selected from GSGGS (SEQ ID NO: 76), GGGGS (G45; SEQ ID NO: 77), GSGGGGS (SEQ ID NO: 74), GGGGSGGGGS (2×GGGGS; SEQ ID NO: 78), GGGGSGGGGSGGGGS (3×GGGGS; SEQ ID NO: 79), GGGGSGGGGSGGGGSGGGGS (4×GGGGS, SEQ ID NO:84), GGGGSGGGGSGGGGSGGGGSGGGGS (5×GGGGS, SEQ ID NO: 91), GGGGSSA (SEQ ID NO: 80), or GSGGGGSGGGGS (SEQ ID NO:194) or combinations thereof.
7. The immunomodulatory protein homodimer of claim 1, wherein the linker is GSGGGGS (SEQ ID NO: 74).
8. The immunomodulatory protein homodimer of claim 7, wherein the Fc region is an IgG1 Fc domain comprising the amino acid substitutions L234A, L235E an G237A by EU numbering.
9. The immunomodulatory protein homodimer of claim 8, wherein the Fc region is set forth in SEQ ID NO:73.
10. The immunomodulatory protein homodimer of claim 1, wherein the Fc region is an IgG1 Fc domain.
11. The immunomodulatory protein homodimer of claim 10, wherein the Fc region is set forth in SEQ ID NO:81.
12. The immunomodulatory protein homodimer of claim 1, wherein the Fc region is a variant IgG1 Fc domain that exhibits reduced effector function.
13. The immunomodulatory protein homodimer of claim 12, wherein the variant IgG1 Fc domain comprises the amino acid substitutions L234A, L235E, and G237A by EU numbering.
14. The immunomodulatory protein homodimer of claim 13, wherein the Fc region is set forth in SEQ ID NO:73.
15. The immunomodulatory protein homodimer of claim 1, wherein the Fc region is an Fc domain of IgG2.
16. The immunomodulatory protein homodimer of claim 1, wherein the Fc region is an Fc domain of IgG4 or is a variant IgG4 Fc domain containing the S228P mutation.
17. The immunomodulatory protein homodimer of claim 1, wherein the TACI-Fc fusion protein is set forth in SEQ ID NO: 168.
18. The immunomodulatory protein homodimer of claim 1, wherein the TACI-Fc fusion protein is set forth in SEQ ID NO: 167.
19. A pharmaceutical composition comprising the immunomodulatory protein homodimer of claim 1 and a pharmaceutically acceptable excipient.
20. An immunomodulatory protein homodimer comprising two identical copies of a TACI-Fc fusion protein of the formula TACI polypeptide (TACI)-Linker-Fc region, wherein the TACI polypeptide is a variant TACI polypeptide set forth in SEQ ID NO:26.
21. The immunomodulatory protein homodimer of claim 20, wherein the linker comprises a peptide linker and the peptide linker is selected from GSGGS (SEQ ID NO: 76), GGGGS (G45; SEQ ID NO: 77), GSGGGGS (SEQ ID NO: 74), GGGGSGGGGS (2×GGGGS; SEQ ID NO: 78), GGGGSGGGGSGGGGS (3×GGGGS; SEQ ID NO: 79), GGGGSGGGGSGGGGSGGGGS (4×GGGGS, SEQ ID NO:84), GGGGSGGGGSGGGGSGGGGSGGGGS (5×GGGGS, SEQ ID NO: 91), GGGGSSA (SEQ ID NO: 80), or GSGGGGSGGGGS (SEQ ID NO:194) or combinations thereof.
22. The immunomodulatory protein homodimer of claim 20, wherein the linker is GSGGGGS (SEQ ID NO: 74).
23. The immunomodulatory protein homodimer of claim 20, wherein the Fc region is an IgG1 Fc domain.
24. The immunomodulatory protein homodimer of claim 23, wherein the Fc region is set forth in SEQ ID NO:81.
25. The immunomodulatory protein homodimer of claim 20, wherein the Fc region is a variant IgG1 Fc domain that exhibits reduced effector function.
26. The immunomodulatory protein homodimer of claim 25, wherein the Fc region comprises the amino acid substitutions L234A, L235E, and G237A by EU numbering.
27. The immunomodulatory protein homodimer of claim 26, wherein the Fc region is set forth in SEQ ID NO:73.
28. A pharmaceutical composition comprising the immunomodulatory protein homodimer of claim 20 and a pharmaceutically acceptable excipient.
29. An immunomodulatory protein that is a homodimer comprising two identical copies of the TACI-Fc fusion protein set forth in SEQ ID NO:167 or SEQ ID NO: 168 linked by a covalent disulfide bond.
30. A pharmaceutical composition comprising the immunomodulatory protein of claim 29 and a pharmaceutically acceptable excipient.