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 Status
The remarks filed 07/31/2025 are acknowledged.
Claims 1-24 are pending.
Claims 1-3, 7-15, and 19 are amended.
Claims 21-24 are new.
Claims 17 and 19-20 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/18/2024.
Therefore, claims 1-16, 18, and 21-24 are under examination.
Withdrawn
The objection to the specification is withdrawn. Applicant has amended the specification to overcome the objection.
The objections to claims 11 and 12 are withdrawn. Applicant has amended the claims to overcome the objections.
The rejections of claims 11-14 under 35 U.S.C. 112(b) are withdrawn. Applicant has amended the claims to overcome the rejections.
The rejections of claims 1-6, 9-10, 15, and 18 under 35 U.S.C. 112(a) written description are withdrawn. Applicant has amended claim 1 to overcome the rejections.
The rejections of claims 11-13 under 35 U.S.C. 112(a) written description are withdrawn. Applicant has amended claim 1 to overcome the rejections.
The rejections of claims 1, 3, 5-6, 9-10, and 15 under 35 U.S.C. 102 are withdrawn. Applicant has amended claim 1 to overcome the rejections.
The rejections of claims 1-6, 9-10, 15, and 18 under 35 U.S.C. 103 are withdrawn. Applicant has amended claim 1 to overcome the rejections.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/31/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1-3 and 15 are objected to because of the following informalities: Claim 1 recites the limitation “at least two second binding agents”, claim 2 recites “another second binding agent” and claims 3 and 15 make reference to said “second binding agents”. While not indefinite, the language of “at least two second binding agents” is confusing because in a technical sense, these “two second binding agents” would be a second and third binding agent, as claimed in instant claim 1, and the “another second binding agent” would be a fourth binding agent, as set forth in instant claim 2. The Examiner recommends amending the “second binding agent” language to be “additional binding agent”. Appropriate correction is required.
Maintained Rejections
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.
This rejection has been modified solely to address the claim amendments to claim 1 requiring that one of said second binding agents binds to CD33 and comprising an amino acid sequence that is at least 85% identical to any one of SEQ ID NOs: 15, 67 to 70, 111, and 112, wherein another of said second binding agents specifically binds to CD123 and comprises an amino acid sequence that it is at least 85% identical to any one of SEQ ID NOs: 6, 65, 66, and 102 to 106 and to address newly added claims 21-24.
Claims 1-16, 18, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16, 18, and 20 of U.S. Patent No. 11,834,504 (‘504). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1, 6-8, 13, and 21-24 of the instant application, claim 1 of ‘504 teaches a recombinant protein (1) comprising a first binding agent that specifically binds to a protein expressed on the surface of an immune cell, and (2) at least two binding agents that specifically bind to a tumor-associated antigen, wherein said two binding agents specifically bind to different tumor-associated antigens, and wherein said first binding agent is a designed ankyrin repeat domain with binding specificity for CD3, and wherein said ankyrin repeat domain with binding specificity for CD3 comprises an amino acid sequence that is at least 85% identical to any one of the amino acid sequence of SEQ ID NOs: 1 to 5, claim 16 of ‘504 teaches the recombinant protein of claim 1, wherein said recombinant protein comprises a polypeptide having the amino acid sequence of SEQ ID NO: 95, and claim 12 of ‘504 teaches the recombinant protein of claim 1, wherein said recombinant protein comprises a polypeptide having an amino acid sequence that is at least 80% identical to the amino acid sequence of SEQ ID NO: 96.
SEQ ID NO: 95 of ‘504 comprises a sequence (i.e. residues 297 to 421 of SEQ ID NO: 95) with 100% sequence identity to SEQ ID NO: 111 of instant claim 1 and also comprises a sequence (i.e. residues 446 to 569 of SEQ ID NO: 95) with 100% sequence identity to SEQ ID NO: 105 of the instant claim. SEQ ID NO: 96 of ‘504 comprises a sequence (i.e. residues 593 to 717 of SEQ ID NO: 96) with 100% sequence identity to SEQ ID NO: 112 of instant claim 1 and also comprises a sequence (i.e. residues 445 to 567 of SEQ ID NO: 96) with 100% sequence identity to SEQ ID NO: 106 of the instant claim. Since the sequences comprised in SEQ ID NO: 95 and SEQ ID NO: 96 of ‘504 are 100% identical to the claimed second binding agents that bind to CD33 and CD123, then SEQ ID NO: 95 and SEQ ID NO: 96 must each comprise two second binding agents that bind to CD33 and CD123 since function flows from structure. See MPEP 2112.01(II).
Additionally, SEQ ID NOs: 1 to 5 of ‘504 have 100% sequence identity to SEQ ID NOs: 1 to 5 of instant claims 7 and 8, respectively.
Regarding claim 2 of the instant application, claim 2 of ‘504 teaches the recombinant protein of claim 1, wherein said protein comprises at least three binding agents that specifically bind to a tumor-associated antigen, wherein said three binding agents specifically bind to different tumor-associated antigens.
Regarding claim 3 of the instant application, claim 3 of ‘504 teaches the recombinant protein of claim 1, wherein said recombinant protein is capable of binding with a lower dissociation constant (KD) to a surface displaying said tumor-associated antigens, when compared to a recombinant protein comprising only one of said binding agents that specifically bind to a tumor-associated antigen.
Regarding claim 4 of the instant application, claim 4 of ‘504 teaches the recombinant protein of claim 3, wherein said surface displaying said tumor-associated antigens is the surface of a tumor cell.
Regarding claim 5 of the instant application, claim 5 of ‘504 teaches the recombinant protein of claim 1, wherein said protein expressed on the surface of an immune cell is CD3.
Regarding claim 9 of the instant application, claim 7 of ‘504 teaches the recombinant protein of claim 1, wherein said recombinant protein binds human CD3 in PBS with a dissociation constant (KD) below 10-6 M.
Regarding claim 10 of the instant application, claim 8 of ‘504 teaches the recombinant protein of claim 1, wherein said recombinant protein binds human CD3 with an EC50 ranging from 1 to 400 nM.
Regarding claim 11 of the instant application, claim 9 of ‘504 teaches the recombinant protein of claim 1, wherein said recombinant protein comprises a polypeptide having an amino acid sequence that is at least 80% identical to any one
of the amino acid sequences of SEQ ID NOs: 11 to 14, 78 to 86 and 95 to 101 and claim 14 of ‘504 teaches the recombinant protein of claim 1, wherein said recombinant protein comprises a polypeptide having the amino acid sequence of any one of SEQ ID NOs: 11 to 14, 78 to 86 and 95 to 101.
SEQ ID NOs: 11 to 14, 78 to 86 and 95 to 101 of ‘504 have 100% sequence identity to SEQ ID NOs: 11 to 14, 78 to 86 and 95 to 101 of the instant claim, respectively.
Regarding claim 12 of the instant application, claim 10 of ‘504 teaches the recombinant protein of claim 1, wherein said recombinant protein comprises a polypeptide having an amino acid sequence that is at least 80% identical to any one
of the amino acid sequences of SEQ ID NOs: 95 to 101 and claim 15 of ‘504 teaches the recombinant protein of claim 1, wherein said recombinant protein comprises a polypeptide having the amino acid sequence of any one of SEQ ID NOs: 95 to 101.
SEQ ID NOs: 95 to 101 of ‘504 have 100% sequence identity to SEQ ID NOs: 95 to 101 of the instant claim, respectively.
Regarding claim 13 of the instant application, claim 11 of ‘504 teaches the recombinant protein of claim 1, wherein said recombinant protein comprises a polypeptide having an amino acid sequence that is at least 80% identical to the amino acid sequence of SEQ ID NO: 95 and claim 16 of ‘504 teaches the recombinant protein of claim 1, wherein said recombinant protein comprises a polypeptide having the amino acid sequence of SEQ ID NO: 95.
SEQ ID NO: 95 of ‘504 has 100% sequence identity to SEQ ID NO: 95 of the instant claim.
Regarding claim 14 of the instant application, claim 12 of ‘504 teaches the recombinant protein of claim 1, wherein said recombinant protein comprises a polypeptide having an amino acid sequence that is at least 80% identical to the amino acid sequence of SEQ ID NO: 96.
SEQ ID NO: 96 of ‘504 has 100% sequence identity to SEQ ID NO: 96 of the instant claim.
Regarding claim 15 of the instant application, claim 13 of ‘504 teaches the recombinant protein of claim 1, wherein said recombinant protein is capable of binding simultaneously to said protein expressed on the surface of an immune cell, which is specifically bound by said first binding agent, and to said tumor-associated antigens, which are specifically bound by said at least two binding agents that specifically bind to a tumor-associated antigen.
Regarding claim 16 of the instant application, claim 18 of ‘504 teaches a recombinant protein comprising a polypeptide having the amino acid sequence of SEQ ID NO: 95 or SEQ ID NO: 96.
SEQ ID NOs: 95 and 96 of ‘504 has 100% sequence identity to SEQ ID NOs: 96 and 96 of the instant claim, respectively.
Regarding claim 18 of the instant application, claim 20 of ‘504 teaches a pharmaceutical composition comprising the recombinant protein of claim 1, and a pharmaceutically acceptable carrier and/or diluent.
Response to Arguments
The double patenting rejections over U.S. Patent No. 11,834,504 (‘504) are maintained. Applicant did not set forth any arguments against the double patenting rejections nor did Applicant file a Terminal Disclaimer. As such, the double patenting rejections are maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (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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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675