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 .
DETAILED ACTION
2. The election filed on 07/12/2026 in response to the Office Action of 05/13/2026 is acknowledged and has been entered.
Applicant has elected Group I, claims 1-5, 10 and 12, drawn to a fusion protein, which comprises the following fused elements: (a) TNF receptor or active fragment thereof; (b) APRIL/BAFF receptor or active fragment thereof, wherein the APRIL/BAFF receptor includes TACI, BCMA, BAFFR, and combinations thereof; and optionally (c) antibody Fc region; wherein, the fusion protein retains the biological activity of above elements (a) and (b).
Because applicant did not distinctly and specifically point out any supposed errors in the restriction requirement, the election has been treated as an election without traverse. See MPEP 818.03(a).
Claims 1-10 and 12-13 are pending in the application. Claims 6-9 and 13 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/12/2026.
Claims 1-5, 10 and 12 are currently under prosecution.
Priority
5. Applicant’s claim under 35 U.S.C. §§ 365(c) for benefit of the earlier filing date of application, is acknowledged.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Objections
7. Claim 1 is objected to because of the following informalities:
Claim 1, “the” in line 1 is duplicated.
8. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
9. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
10. Claims 1-3, 5, 10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lofquist et al. (US 20110152173, published on 06/23/2011) (of record).
Claims 1-3, 5, 10 and 12 are herein drawn to a fusion protein, which comprises the following fused elements: (a) TNF receptor or active fragment thereof; (b) APRIL/BAFF receptor or active fragment thereof, wherein the APRIL/BAFF receptor includes TACI, BCMA, BAFFR, and combinations thereof; and optionally (c) antibody Fc region; wherein, the fusion protein retains the biological activity of above elements (a) and (b).
Lofquist et al. teach a multi-target fusion protein comprises a TNF-α antagonist and a BLyS/APRIL antagonist (e.g., TACI, BCMA, BAFFR); see entire document, e.g., abstract, [0030], [0109]. Lofquist et al. teach the fusion protein further comprising an Fc region at N-terminus or C-terminus of the fusion protein; see [0126-0128].
For claim 2, Lofquist et al. teach the fusion protein can be used to treat a disease associated with TNFα; see [0197].
For claim 5, Lofquist et al. teach amino acids 23-185 of SEQ ID NO:671 of TNFα; see [0033]. Lofquist et al. teach the first 166 amino acids of TACI (SEQ ID NO: 743); see [0111].
SEQ ID NOs: 671 and 743 of Lofquist et al. are 100% identical with the instant claimed SEQ ID NOs: 13-14; see sequence alignment below.
For claim 10, Lofquist et al. teach a pharmaceutical composition comprising the fusion protein and a pharmaceutically acceptable carrier; see [0199].
For claim 12, Lofquist et al. teach the fusion protein can be used to treat an inflammatory, autoimmune diseases; see claims 13-14.
Double Patenting
11. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
12. Claims 1-3, 5, 10 and 12 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 9 and 14-17 of U.S. Patent No. 10,562,954. Although the conflicting claims are not identical, they are not patentably distinct from each other because for the following reasons:
Claims 1-3, 5, 10 and 12 are herein drawn to a fusion protein, which comprises the following fused elements: (a) TNF receptor or active fragment thereof; (b) APRIL/BAFF receptor or active fragment thereof, wherein the APRIL/BAFF receptor includes TACI, BCMA, BAFFR, and combinations thereof; and optionally (c) antibody Fc region; wherein, the fusion protein retains the biological activity of above elements (a) and (b).
Claims 1-4, 9 and 14-17 of U.S. Patent No. 10,562,954 are drawn to a fusion protein, which comprises: (a) an extracellular region of a TNF receptor, wherein the extracellular region comprises amino acids 23-76 of human TNF-R2; (b) an extracellular region of a BAFF receptor, wherein the extracellular region comprises amino acids 30-119 of human TACI; and (c) a human antibody Fc region; wherein (a), (b), and (c) are in the order of, from N-terminus to C-terminus, (a)-(b)-(c) or (b)-(a)-(c); and wherein the fusion protein inhibits the formation of a TACI-BAFF complex, and lowers the concentration of IgE in serum.
Conclusion
13. Claims 1-3, 5, 10 and 12 are rejected. Claim 4 is objected to as being dependent upon a rejected base claim.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YAN XIAO/Primary Examiner, Art Unit 1642
Sequence alignment
US-13-001-087-671
Filing date in PALM: 2011-03-03
Sequence 671, US/13001087
Publication No. US20110152173A1
GENERAL INFORMATION
APPLICANT: Lofquist, Alan Keith
APPLICANT: Mohler, Kendall
APPLICANT: Baum, Peter Robert
APPLICANT: Thompson, Peter Armstrong
APPLICANT: Misher, Lynda
TITLE OF INVENTION: TNF-alpha Antagonist Multi-Target Binding Proteins
FILE REFERENCE: 2479.0940008
CURRENT APPLICATION NUMBER: US/13/001,087
CURRENT FILING DATE: 2011-03-03
PRIOR APPLICATION NUMBER: PCT/US2009/049603
PRIOR FILING DATE: 2009-07-02
PRIOR APPLICATION NUMBER: US 61/180,097
PRIOR FILING DATE: 2009-05-20
PRIOR APPLICATION NUMBER: US 61/134,095
PRIOR FILING DATE: 2008-07-02
PRIOR APPLICATION NUMBER: US 61/134,096
PRIOR FILING DATE: 2008-07-02
PRIOR APPLICATION NUMBER: US 61/134,097
PRIOR FILING DATE: 2008-07-02
PRIOR APPLICATION NUMBER: US 61/134,098
PRIOR FILING DATE: 2008-07-02
PRIOR APPLICATION NUMBER: US 61/134,099
PRIOR FILING DATE: 2008-07-02
PRIOR APPLICATION NUMBER: US 61/134,100
PRIOR FILING DATE: 2008-07-02
PRIOR APPLICATION NUMBER: US 61/134,101
PRIOR FILING DATE: 2008-07-02
NUMBER OF SEQ ID NOS: 834
SEQ ID NO 671
LENGTH: 257
TYPE: PRT
ORGANISM: Human
Query Match 100.0%; Score 1318; Length 257;
Best Local Similarity 100.0%;
Matches 235; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 LPAQVAFTPYAPEPGSTCRLREYYDQTAQMCCSKCSPGQHAKVFCTKTSDTVCDSCEDST 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 23 LPAQVAFTPYAPEPGSTCRLREYYDQTAQMCCSKCSPGQHAKVFCTKTSDTVCDSCEDST 82
Qy 61 YTQLWNWVPECLSCGSRCSSDQVETQACTREQNRICTCRPGWYCALSKQEGCRLCAPLRK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 83 YTQLWNWVPECLSCGSRCSSDQVETQACTREQNRICTCRPGWYCALSKQEGCRLCAPLRK 142
Qy 121 CRPGFGVARPGTETSDVVCKPCAPGTFSNTTSSTDICRPHQICNVVAIPGNASMDAVCTS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 143 CRPGFGVARPGTETSDVVCKPCAPGTFSNTTSSTDICRPHQICNVVAIPGNASMDAVCTS 202
Qy 181 TSPTRSMAPGAVHLPQPVSTRSQHTQPTPEPSTAPSTSFLLPMGPSPPAEGSTGD 235
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 203 TSPTRSMAPGAVHLPQPVSTRSQHTQPTPEPSTAPSTSFLLPMGPSPPAEGSTGD 257
US-13-001-087-743
Filing date in PALM: 2011-03-03
Sequence 743, US/13001087
Publication No. US20110152173A1
GENERAL INFORMATION
APPLICANT: Lofquist, Alan Keith
APPLICANT: Mohler, Kendall
APPLICANT: Baum, Peter Robert
APPLICANT: Thompson, Peter Armstrong
APPLICANT: Misher, Lynda
TITLE OF INVENTION: TNF-alpha Antagonist Multi-Target Binding Proteins
FILE REFERENCE: 2479.0940008
CURRENT APPLICATION NUMBER: US/13/001,087
CURRENT FILING DATE: 2011-03-03
PRIOR APPLICATION NUMBER: PCT/US2009/049603
PRIOR FILING DATE: 2009-07-02
PRIOR APPLICATION NUMBER: US 61/180,097
PRIOR FILING DATE: 2009-05-20
PRIOR APPLICATION NUMBER: US 61/134,095
PRIOR FILING DATE: 2008-07-02
PRIOR APPLICATION NUMBER: US 61/134,096
PRIOR FILING DATE: 2008-07-02
PRIOR APPLICATION NUMBER: US 61/134,097
PRIOR FILING DATE: 2008-07-02
PRIOR APPLICATION NUMBER: US 61/134,098
PRIOR FILING DATE: 2008-07-02
PRIOR APPLICATION NUMBER: US 61/134,099
PRIOR FILING DATE: 2008-07-02
PRIOR APPLICATION NUMBER: US 61/134,100
PRIOR FILING DATE: 2008-07-02
PRIOR APPLICATION NUMBER: US 61/134,101
PRIOR FILING DATE: 2008-07-02
NUMBER OF SEQ ID NOS: 834
SEQ ID NO 743
LENGTH: 166
TYPE: PRT
ORGANISM: Human
Query Match 55.9%; Score 909; Length 166;
Best Local Similarity 100.0%;
Matches 166; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MSGLGRSRRGGRSRVDQEERFPQGLWTGVAMRSCPEEQYWDPLLGTCMSCKTICNHQSQR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSGLGRSRRGGRSRVDQEERFPQGLWTGVAMRSCPEEQYWDPLLGTCMSCKTICNHQSQR 60
Qy 61 TCAAFCRSLSCRKEQGKFYDHLLRDCISCASICGQHPKQCAYFCENKLRSPVNLPPELRR 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 TCAAFCRSLSCRKEQGKFYDHLLRDCISCASICGQHPKQCAYFCENKLRSPVNLPPELRR 120
Qy 121 QRSGEVENNSDNSGRYQGLEHRGSEASPALPGLKLSADQVALVYST 166
||||||||||||||||||||||||||||||||||||||||||||||
Db 121 QRSGEVENNSDNSGRYQGLEHRGSEASPALPGLKLSADQVALVYST 166
Prosecution Insights