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 .
Response to Amendment
Claims 1-3 and 22 have been cancelled. Claims 4, 5, 7, 10-12, 15-20 have been amended and Claim 22 has been newly added as requested in the amendment filed on 30 June 2026. Following the amendment, claims 4-21 and 23-24 are pending in the instant application, and are under examination in the instant office action.
Claim Objections
Claim 4 is objected to because of the following informalities: The word “or” at the end of antibody (8) needs to be removed. Appropriate correction is required.
Claim Rejections - 35 USC § 112 (Maintained)
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.
Claim 5 and 7 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.
In Remarks filed 30 June 2026, applicant argues, “Both claims 5 and 7 depend from claim 4, directly or indirectly. Claim 4 recites specific CDR sequences. Thus, contrary to the Examiner's statements, claims 5 and 7 require that the antibody or antigen-binding fragment thereof possess the CDR sequences as recited in claim 4. In other words, any amino acid residue change(s) of claims 5 or 7 would only occur in a region outside the CDRs”.
This is not persuasive for the following reasons.
Claims 5 and 7 at least 90% identity or at least 85% identity. The claims are drawn to a genus of molecules that are not defined by the claims themselves. The disclosure as filed does not identify those residues outside of the CDRs that must be conserved for activity; or conversely, those residues that may be changed yet the anti-CD3 binding affinity remains.
It is well established in the art that the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs that provide the majority of the contact residues for the binding of the antibody to its target epitope. Even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function as evidenced by Rudikoff et al (Proc Natl Acad Sci USA 1982 Vol 79 page 1979). Rudikoff et al. teach that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function. MacCallum et al. J. Mol. Biol. (1996) 262, 732-745, analyzed many different antibodies for interactions with antigen and state that although CDR3 of the heavy and light chain dominate, a number of residues outside the standard CDR definitions make antigen contacts (see page 733, right col) and non-contacting residues within the CDRs coincide with residues as important in defining canonical backbone conformations (see page 735, left col.). Vajdos et al. (2002) 320, 415-428, additionally state that while antigen binding is primarily mediated by the CDRs, more highly conserved framework segments which connect the CDRs are mainly involved in supporting the CDR loop conformations and in some cases framework residues also contact antigen (page 416, left col.). Wu et al. J. Mol. Biol. (1999) 294, 151-162. state that it is difficult to predict which framework residues serve a critical role in maintaining affinity and specificity due in part to the large conformational change in antibodies that accompany antigen binding (page 152 left col.) but certain residues have been identified as important for maintaining conformation.
Therefore, absent adequate description of those residues outside of the CDRs that can be altered such that anti-CD3 binding remains, or a representative number of species from the genus that fall within 85% or 90% identity, the disclosure fails to provide adequate written description for the genus claimed. The rejection is maintained.
Claim Rejections - 35 USC § 102 (New)
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
As currently amended, Claim 4 is rejected under 35 U.S.C. 102(a)(1), or in the alternative 102(a)(2), as being anticipated by WO 2019104075 (hereafter the WO ‘075 publication).
Regarding claim 4, the WO ‘075 publication teaches an antibody consisting of:
SEQ ID NO: 1
GFTFNTYAMN (see pg. 71, SEQ ID NO: 81 of the reference; pg. 72, SEQ ID NOs: 94 & 95; pg. 73, SEQ ID NOs: 104 & 106; pg. 74, SEQ ID NOs: 114 & 116; pg. 76, SEQ ID NOs: 106 & 128; pg. 194, SEQ ID NO: 732; pg. 197, SEQ ID NOs: 114 & 116; pg. 198, SEQ ID NO: 738; and pg. 200, SEQ ID NO: 732).
SEQ ID NO: 2
RIRSKYNNYATYYADSVKD (see pg. 71, SEQ ID NO: 81 of the reference; and pg. 72, SEQ ID NO: 95; pg. 73, SEQ ID NO: 98; pg. 193, SEQ ID NOs: 114 & 116; pg. 194 SEQ ID NO: 732; pg. 197 SEQ ID NOs: 114 & 116; and pg. 200, SEQ ID NO: 732).
SEQ ID NO: 8
HGNFGQSYVSWFAY (see pg. 82, SEQ ID NO: 194 of the reference).
SEQ ID NO: 29
RSSTGAVTTSNYAN (see pg. 193 SEQ ID NO: 132; SEQ ID NO: 115; and SEQ ID NO: 116 of the reference; pg. 194, SEQ ID NO: 732; pg. 197, SEQ ID NOs: 132, 115 & 116; pg. 198, SEQ ID NO: 738; and pg. 200, SEQ ID NO: 732).
SEQ ID NO: 30
GTNKRAP (see pg. 71, SEQ ID NO: 82; pg. 72, SEQ ID NO: 91; pg. 73, SEQ ID NO: 82, 103, 105 and 107; pg. 74, SEQ ID NO: 109, 115, and 116; pg. 75, SEQ ID NO: 109, 117, 119, and 121; pg. 76, SEQ ID NO: 123, 109, 125, 127, 107 and 128; pgs. 77-95, SEQ ID NO: 176, 187 and 196; pg. 193, SEQ ID NO: 152 , 728, 115 and 116; pg. 194, SEQ ID NO: 732; and pg. 197, SEQ ID NO: 152, 728, 115 and 116; pg. 198, SEQ ID NO: 738; pg. 200, SEQ ID NO: 732; pgs. 207 and 211, SEQ ID NO: 738; pg. 208, SEQ ID NO: 743; pg. 209, SEQ ID NO: 743; pg. 213, SEQ ID NO: 750; pg. 214, SEQ ID NO: 751; pg. 215, SEQ ID NO: 752; pg. 216, SEQ ID NO: 243; pg. 217, SEQ ID NO: 753; pg. 218, SEQ ID NO: 755; pgs. 227 and 230, SEQ ID NO: 792 and 793; pg. 231, SEQ ID NO: 814; pg. 232, SEQ ID NO: 738 of the reference).
SEQ ID NO: 31
ALWYSNLWV (see pg. 77-96, SEQ ID NO: 176; pg. 193, SEQ ID NO: 176 and 115; pg. 194, SEQ ID NO: 732; pg. 197, SEQ ID NO: 176 and 115; pg. 198, 207 and 232, SEQ ID NO: 738; pgs. 208, 209 and 216, SEQ ID NO: 743; pg. 212, SEQ ID NO: 748; pg. 215, SEQ ID NO: 752; pg. 230, SEQ ID NO: 792 of the reference).
Double Patenting (New)
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 4-21 and 23-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-27 of copending Application No. 18294212
(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because some of the antibodies that fall within the scope of instant claim 4 are also claimed within the co-pending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4-21 and 23-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7-10, and 13-24 of copending Application No. 18850651 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application encompass the VH of SEQ ID NOs: 50, 52-75 and the VL of SEQ ID NO: 80; as well as SEQ ID NO: 101 of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4-21 and 23-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 5-6, 8-15, 18-19, 21-22 of copending Application No. 18294212 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application read upon
the VH of SEQ ID NOs: 50, 52-75 and the VL of SEQ ID NO: 80, of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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/STACEY N MACFARLANE/Examiner, Art Unit 1675
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