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 .
1. The Amendment filed April 14, 2026 in response to the Office Action of January 14, 2026, is acknowledged and has been entered. Claims 20 and 22-38 are now pending and being examined. Claims 20, 22, 23, 28 are amended.
Claim Objections
2. Claim 20 is objected to because of the following informalities: Claim 20 as amended contains sequences that lack SEQ ID NO identifiers. 37 CFR 1.831 (c) requires that a reference to a particular sequence identifier (i.e., SEQ ID NO:#) be made in the specification and claims wherever a reference is made to that sequence:
(c) Where the description or claims of a patent application discuss a sequence that is set forth in the "Sequence Listing XML" in accordance with paragraph (a) of this section, reference must be made to the sequence by use of the sequence identifier, preceded by "SEQ ID NO:" or the like in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application
Appropriate correction is required.
New Rejection
(necessitated by amendments)
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
3. Claims 20 and 22-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a NEW MATTER REJECTION.
Claim 20 is amended to recite the exclusion limitation:
“…wherein the first antigen-binding portion does not comprise (i) a first light chain comprising CDR1, CDR2 and CDR3 comprising the amino acid sequences RASQSVSSYLA, DASNRAT, and QQRSNWPIT, respectively, and a first heavy chain comprising CDR1 comprising the amino acid sequence NDYAMH or DYAMH, CDR2 comprising the amino acid sequence TISWNSGSIGYADSVKG, and CDR3 comprising the amino acid sequence DIQYGNYYYGMDY; or
(ii) a first light chain comprising CDR1 comprising the amino acid sequence RSSQSIVHSNYNTYLE or RSSQSIVHSNGNTYLE, CDR2 comprising the amino acid sequence KVSNRFS and CDR3 comprising the amino acid sequence LQVTHVPLT, and a first heavy chain comprising CDR1, CDR2 and CDR3 comprising the amino acid sequences ADYEIH, AIHPGSGGTAYAOKFQG and YYSFAY, respectively.
This exclusion limitation has no clear support in the specification and the claims as originally filed.
Applicant points to the original claims and specification in general to support the newly added claim limitation. However, a review of the original claims and specification fail to reveal support for this exclusion limitation.
The instant specification does not disclose the specific CDR sequences: RASQSVSSYLA, DASNRAT, QQRSNWPIT, NDYAMH, DYAMH, TISWNSGSIGYADSVKG, DIQYGNYYYGMDY, RSSQSIVHSNYNTYLE, RSSQSIVHSNGNTYLE, KVSNRFS, LQVTHVPLT, ADYEIH, AIHPGSGGTAYAOKFQG and YYSFAY anywhere in the instant specification or original claims. Nowhere, are these CDR sequences specifically identified. Nowhere, are these select CDR sequences disclosed as excluded from a bispecific antibody.
The specification neither states nor demonstrates bispecific antibodies excluding these specific CDR sequences. The subject matter claimed in claim 20 alters the scope of the invention as originally disclosed in the specification.
Claim Interpretation
4. Claim 20 is amended to recite the exclusion limitation:
“…wherein the first antigen-binding portion does not comprise:
(i) a first light chain comprising CDR1, CDR2 and CDR3 comprising the amino acid sequences RASQSVSSYLA, DASNRAT, and QQRSNWPIT, respectively, and a first heavy chain comprising CDR1 comprising the amino acid sequence NDYAMH or DYAMH, CDR2 comprising the amino acid sequence TISWNSGSIGYADSVKG, and CDR3 comprising the amino acid sequence DIQYGNYYYGMDY; or
(ii) a first light chain comprising CDR1 comprising the amino acid sequence RSSQSIVHSNYNTYLE or RSSQSIVHSNGNTYLE, CDR2 comprising the amino acid sequence KVSNRFS and CDR3 comprising the amino acid sequence LQVTHVPLT, and a first heavy chain comprising CDR1, CDR2 and CDR3 comprising the amino acid sequences ADYEIH, AIHPGSGGTAYAOKFQG and YYSFAY, respectively.
Therefore, the first antigen-binding portion can exclude either the CDRs listed in (i) or the CDRs listed in (ii), and the claim does not require that both sets of CDRs listed in (i) and (ii) have to be excluded.
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.
5. Claims 20 and 22-37 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-18 of copending Application No. 18/023,332 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application is claiming a CD3xCD20 bispecific antibody, wherein the CD3 heavy chain comprises SEQ ID NO:92 or 50 that comprises 100% of instant CDR SEQ ID Nos:26+27+28, wherein SEQ ID NO:92 comprises Gln39Lys mutation; and the CD3 light chain comprises SEQ ID NO:90 or 18 that comprises 100% of instant CDR SEQ ID NOs:7+8+21 and λ light chain region; wherein SEQ ID NO:90 comprises Gln40Glu mutation; wherein the CD20 light chain sequence is SEQ ID NO:98 that comprises a κ chain sequence; nucleic acids and vectors encoding the bispecific antibody, cell containing the nucleic acid, a composition comprising the bispecific antibody, the bispecific antibody conjugated covalently to a therapeutic agent; a kit comprising the bispecific antibody; and methods of treating a subject with a CD20-related cancer by administering the bispecific antibody, wherein the cancer is selected from non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), multiple myeloma (MM), and Hodgkin lymphoma (HL). Thus, the copending claimed species of bispecific antibody anticipates and renders obvious the instantly claimed bispecific antibody and limitations utilizing or comprising the antibody.
The CD3xCD20 bispecific antibody of the copending application excludes the instantly claimed CDR sequences of claim 20 part (ii) directed to a GPC3-bidning portion, therefore satisfies the criteria of instant claim 20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
6. Claims 20, 22-36 and 38 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/265,114 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application is claiming a CD3xGPC3 bispecific antibody, wherein the CD3 heavy chain comprises SEQ ID NO:168 that is 100% identical to instant SEQ ID NO:68 and comprises instant CDR SEQ ID NOs:26, 27, and 28; and the CD3 light chain comprises SEQ ID NO:166 that is 100% identical to instant SEQ ID NO:66 comprises a λ light chain region and comprises instant CDR SEQ ID NOs:7, 8, and 21; the bispecific antibody comprising a CD3 lambda chain with Gln40Glu mutation and CD3 heavy chain Gln39Lys mutation; the antibody comprising knobs-into-holes format; nucleic acids and vectors encoding the bispecific antibody, cell containing the nucleic acid, a composition comprising the bispecific antibody, the bispecific antibody conjugated covalently to a therapeutic agent; a kit comprising the bispecific antibody; and methods of treating a subject with a GPC3-related cancer by administering the bispecific antibody, wherein the cancer is liver cancer, pancreatic, hepatocellular, lung, colon, breast, or prostate cancer, leukemia or lymphoma. Thus, the copending claimed species of bispecific antibody anticipates and renders obvious the instantly claimed bispecific antibody and limitations utilizing or comprising the antibody.
The CD3xGPC3 bispecific antibody of the copending application excludes the instantly claimed CDR sequences of claim 20 part (i) directed to a CD20-bidning portion, therefore satisfies the criteria of instant claim 20. The copending application also lists alternative CDR sequences for the GPC3-binding portion in claim 1(a) that exclude the CDR sequences listed in instant claim 20 part (ii). Therefore, the copending application claim 1 satisfies the criteria of excluded sequences as recited in instant claim 20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
7. Applicants argue that claim 20 is amended to exclude the CDR sequences of the first antigen-binding portion recited in the claims of the copending applications.
Applicants additionally argue that copending application 18/265,114 had a species restriction requirement where Applicants elected first antigen-binding portion CDR SEQ ID NOs:11+106+13 and 60+17+61. Applicants argue that instant claim 20 as amended excludes this antibody.
8. The arguments have been considered but are not persuasive for the reasons stated in the rejections and claim interpretation above. Further, although Applicants elected a species for examination in copending application 18/265,114, the claims in copending application 18/265,114 still recite alternative CDR sequences for the GPC3-binding portion in claim 1(a) that exclude the CDR sequences listed in instant claim 20 part (ii). Additionally, the CD3xGPC3 bispecific antibody of copending application 18/265,114 excludes the instantly claimed CDR sequences of claim 20 part (i) directed to a CD20-bidning portion, therefore satisfies the criteria of instant claim 20.
9. All other objections and rejections recited in the Office Action mailed January 14, 2026 are hereby withdrawn in view of amendments. The rejection of claims under 35 U.S.C. 102(a)(2) as being anticipated by US Patent Application Publication 20230330257, Wang is withdrawn in view of the exception filed under 102(b)(2)(A) and the Xu and Chen declarations filed under 37 CFR 1.130(a) stating the claimed invention was derived from them, and Ying Wang did not make an inventive contribution.
The rejection of claims under 35 U.S.C. 112(a) written description is withdrawn in view of claim 20 amended to require the six defined CDR SEQ ID NOs of the inventive anti-CD3 antibody.
The rejections of claims under 35 USC 103 as being obvious over US Patent 10,544,220, Engelberts, are withdrawn in view of amendments. US Patent 10,544,220, Engelberts does not teach light chain variable region CDR3 SEQ ID NO:21 (VLWYSNLWV), of the CD3 antibody, and instead teaches SEQ ID NO:9 (ALWYSNLWV), see sequence alignment below:
ALIGNMENT:
Query Match 83.0%; Score 139.4; Length 109;
Best Local Similarity 39.0%;
Matches 30; Conservative 0; Mismatches 1; Indels 46; Gaps 2;
Qy 1 RSSTGAVTTSNYAN--------------GGTNKRAP------------------------ 22
|||||||||||||| ||||||||
Db 23 RSSTGAVTTSNYANWVQQTPGQAFRGLIGGTNKRAPGVPARFSGSILGNKAALTITGAQA 82
Qy 23 --------VLWYSNLWV 31
||||||||
Db 83 DDESIYFCALWYSNLWV 99
10. Conclusion: No claim is allowed.
Conclusion
11. 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.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA B GODDARD whose telephone number is (571)272-8788. The examiner can normally be reached Mon-Fri, 7am-3:30pm.
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/Laura B Goddard/Primary Examiner, Art Unit 1642
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