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
The amendment filed June 30, 2025 in response to the Office Action of March 28, 2025 is acknowledged and has been entered.
Claims 42-55 are pending.
Claims 47-55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim.
Claims 42-46 are currently under consideration as drawn to the elected invention.
Terminal Disclaimer (TD) filed June 30, 2025 has been acknowledged.
The Double Patenting rejection over Pat. 11,459,394 is hereby withdrawn in view of the TD. However, the Terminal Disclaimer over Pat. 11,942,149 was disapproved because the disclaimer fee under 37 CFR 1.20(d) has not been submitted nor is there any pre authorization in the application to charge to a deposit account.
The 112(d) rejection for claim 43 is withdrawn in view of Applicant’s argument.
MAINTAINED 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 42-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,942,149 (hereinafter Pat. 149, corresponding Appl. 17/883,158, of record). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Pat. 149 teach:
1. A method for treating cancer, comprising administering to a subject in need thereof a therapeutically effective amount of a composition comprising a CD137×TA Binding Molecule; wherein:
the CD137×TA Binding Molecule comprises a CD137 binding domain capable of specific binding to an epitope of CD137; and the CD137 binding domain comprises a first Light Chain Variable Domain that comprises a CDRL1, CDRL2 and CDRL3, and a first Heavy Chain Variable Domain that comprises a CDRH1, CDRH2 and CDRH3, and:
(A) (1) the first Light Chain Variable Domain CDRL1, CDRL2, and CDRL3 are the Light Chain CDRs of CD137 MAB-3 VL (SEQ ID NO:75); and (2) the first Heavy Chain Variable Domain CDRH1, CDRH2, and CDRH3 are the Heavy Chain CDRs of CD137 MAB-3 VH1B (SEQ ID NO:84); or
(B) (1) the first Light Chain Variable Domain CDRL1, CDRL2, and CDRL3 are the Light Chain CDRs of CD137 MAB-3 VL15 (SEQ ID NO:222); and (2) the first Heavy Chain Variable Domain CDRH1, CDRH2, and CDRH3 are the Heavy Chain CDRs of CD137 MAB-3 VH1B (SEQ ID NO:84); or
(C) (1) the first Light Chain Variable Domain CDRL1, CDRL2, and CDRL3 are the Light Chain CDRs of CD137 MAB-3 VL14 (SEQ ID NO:221); and (2) the first Heavy Chain Variable Domain CDRH1, CDRH2, and CDRH3 are the Heavy Chain CDRs of CD137 MAB-3 VH1B (SEQ ID NO:84); or
(D) (1) the first Light Chain Variable Domain CDRL1, CDRL2, and CDRL3 are the Light Chain CDRs of CD137 MAB-3 VL11 (SEQ ID NO:218); and (2) the first Heavy Chain Variable Domain CDRH1, CDRH2, and CDRH3 are the Heavy Chain CDRs of CD137 MAB-3 VH1B (SEQ ID NO:84); or
(E) (1) the first Light Chain Variable Domain CDRL1, CDRL2, and CDRL3 are the Light Chain CDRs of CD137 MAB-3 VL10 (SEQ ID NO:217); and (2) the first Heavy Chain Variable Domain CDRH1, CDRH2, and CDRH3 are the Heavy Chain CDRs of CD137 MAB-3 VH1B (SEQ ID NO:84); or
(F) (1) the first Light Chain Variable Domain CDRL1, CDRL2, and CDRL3 are the Light Chain CDRs of CD137 MAB-3 VL6 (SEQ ID NO:213); and (2) the first Heavy Chain Variable Domain CDRH1, CDRH2, and CDRH3 are the Heavy Chain CDRs of CD137 MAB-3 VH1B (SEQ ID NO:84); or
(G) (1) the first Light Chain Variable Domain CDRL1, CDRL2, and CDRL3 are the Light Chain CDRs of CD137 MAB-3 VL4 (SEQ ID NO:211); and (2) the first Heavy Chain Variable Domain CDRH1, CDRH2, and CDRH3 are the Heavy Chain CDRs of CD137 MAB-3 VH1B (SEQ ID NO:84); or
(H) (1) the first Light Chain Variable Domain CDRL1, CDRL2, and CDRL3 are the Light Chain CDRs of CD137 MAB-3 VL (SEQ ID NO:75); and (2) the first Heavy Chain Variable Domain CDRH1, CDRH2, and CDRH3 are the Heavy Chain CDRs of CD137 MAB-3 VII (SEQ ID NO:74); or
(I) (1) the first Light Chain Variable Domain CDRL1, CDRL2, and CDRL3 are the Light Chain CDRs of CD137 MAB-4 VL (SEQ ID NO:91); and (2) the first Heavy Chain Variable Domain CDRH1, CDRH2, and CDRH3 are the Heavy Chain CDRs of CD137 MAB-4 VII (SEQ ID NO:90); or
(J) (1) the first Light Chain Variable Domain CDRL1, CDRL2, and CDRL3 are the Light Chain CDRs of CD137 MAB-5 VL (SEQ ID NO:97); and (2) the first Heavy Chain Variable Domain CDRH1, CDRH2, and CDRH3 are the Heavy Chain CDRs of CD137 MAB-5 VII (SEQ ID NO:96); or
(K) (1) the first Light Chain Variable Domain CDRL1, CDRL2, and CDRL3 are the Light Chain CDRs of CD137 MAB-3 VL (SEQ ID NO:75); and (2) the first Heavy Chain Variable Domain CDRH1, CDRH2, and CDRH3 are the Heavy Chain CDRs of CD137 MAB-3 VH1A (SEQ ID NO:83); or
(L) (1) the first Light Chain Variable Domain CDRL1, CDRL2, and CDRL3 are the Light Chain CDRs of CD137 MAB-3 VL (SEQ ID NO:75); and (2) the first Heavy Chain Variable Domain CDRH1, CDRH2, and CDRH3 are the Heavy Chain CDRs of CD137 MAB-3 VH1C (SEQ ID NO:85); or
(M) (1) the first Light Chain Variable Domain CDRL1, CDRL2, and CDRL3 are the Light Chain CDRs of CD137 MAB-3 VL (SEQ ID NO:75); and (2) the first Heavy Chain Variable Domain CDRH1, CDRH2, and CDRH3 are the Heavy Chain CDRs of CD137 MAB-3 VH1D (SEQ ID NO:86); and …; and wherein the cancer is characterized by the expression of the TA.
It is noted that Appl. 17/883,158 shares the same disclosure as the instant application. Thus, same SEQ ID NO in the two applications would have the same sequences. The CD137×TA Binding Molecule of Pat. 149 would read on the CD137 Binding Molecule of the instant claim 42, because the CD137×TA Binding Molecule of Pat. 149 can bind CD137 and comprises the same CDR combinations as the instantly claimed CD137 Binding Molecule.
2. The method of claim 1, wherein:
(A) the first Light Chain Variable Domain comprises the amino acid sequence of CD137 MAB-3 VL15 (SEQ ID NO:222), and the first Heavy Chain Variable Domain comprises the amino acid sequence of hCD137 MAB-3 VH1B (SEQ ID NO:84); or
(B) the first Light Chain Variable Domain comprises the amino acid sequence of CD137 MAB-3 VL14 (SEQ ID NO:221), and the first Heavy Chain Variable Domain comprises the amino acid sequence of hCD137 MAB-3 VH1B (SEQ ID NO:84); or
(C) the first Light Chain Variable Domain comprises the amino acid sequence of CD137 MAB-3 11 (SEQ ID NO:218), and the first Heavy Chain Variable Domain comprises the amino acid sequence of hCD137 MAB-3 VH1B (SEQ ID NO:84); or
(D) the first Light Chain Variable Domain comprises the amino acid sequence of CD137 MAB-3 VL10 (SEQ ID NO:217), and the first Heavy Chain Variable Domain comprises the amino acid sequence of hCD137 MAB-3 VH1B (SEQ ID NO:84); or
(E) the first Light Chain Variable Domain comprises the amino acid sequence of CD137 MAB-3 VL6 (SEQ ID NO:213), and the first Heavy Chain Variable Domain comprises the amino acid sequence of hCD137 MAB-3 VH1B (SEQ ID NO:84); or
(F) the first Light Chain Variable Domain comprises the amino acid sequence of CD137 MAB-3 VL4 (SEQ ID NO:211), and the first Heavy Chain Variable Domain comprises the amino acid sequence of hCD137 MAB-3 VH1B (SEQ ID NO:84).
Claim 2 of Pat. 149 reads on instant claims 43 and 44 because it teaches the same heavy chain variable domain e.g SEQ ID NO: 84 and the same light chain variable domain e.g. SEQ ID NO: 222.
Regarding claim 45, as evidenced by claims 1 and 2 of Pat. 149, the light chain variable domain and heavy chain variable domain are antigen binding fragments of antibodies; e.g. CD137 MAB-3; CD137 MAB-3 VH1B; hCD137 MAB03 VH1B.
Regarding claim 46, claim 9 of Pat. 149 teach: wherein the composition comprising a CD137×TA Binding Molecule is a pharmaceutical composition comprising a physiologically acceptable carrier.
Response to Arguments
For the Double Patenting rejection over Pat. 11,942,149, Applicant argues:
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Applicant’s arguments have been fully considered but they are not persuasive. As set forth above, the Terminal Disclaimer over Pat. 11,942,149 was disapproved. Thus, the rejection is maintained for the reasons of record.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 CHENG LU whose telephone number is (571)272-0334. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (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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/CHENG LU/ Examiner, Art Unit 1642
/PETER J REDDIG/Primary Examiner, Art Unit 1646