DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The claim listing filed on October 7, 2025 is acknowledged.
Claims 3, 6-10, 12, 14-17, 20, 27, 29, 30, 37-41, 53, 54, and 56-72 are canceled.
Claims 1, 2, 4, 5, 11, 13, 18, 19, 21-26, 28, 31-36, 42-52, 55, and 73 are pending and under consideration.
In view of the applicant’s amendment filed October 7, 2025, the previous rejections set forth in the Office Action mailed May 19, 2025 have been withdrawn and the following objections and rejections are set forth.
Claim Objections
Claims 24 and 26 objected to because of the following informalities:
Claim 24 recites the term “IgGI” where it should be “IgG1” in line 2.
Claim 26 recites the term “L235A2” where it should be “L235A” in line 5.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Indefinite Language
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
This is a New Ground of Rejection necessitated by applicant's amendment. Claims 11 and 28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 11 and 28 recite that “the first/second moiety is a Fab, a single-chain Fab, a VH domain, a VL domain, an immunoglobulin new antigen receptor (IgNAR), a single-chain variable fragment (scFv), or a T cell receptor domain” in lines 1-3. Claims 11 and 28 are dependent on claim 11 which recites that the first and second moieties comprise six CDRs. However, it is noted that the VH domain, VL domain, and immunoglobulin new antigen receptor (IgNAR) all individually comprise only three CDRs. Thus, if the first and second moieties are “a VH domain, a VL domain, or an immunoglobulin new antigen receptor (IgNAR),” then the moieties do not comprise all six CDRs recited in claim 11 and therefore lack antecedent basis.
Amending claims 11 and 28 to delete the phrase “a VH domain, a VL domain, an immunoglobulin new antigen receptor (IgNAR)” would obviate this part of the rejection.
Written Description - New Matter
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.
This is a New Ground of Rejection necessitated by the Applicant’s amendment. Claims 1, 2, 4, 5, 11, 13, 18, 19, 21-26, 28, 31-36, 42-52, 55, and 73 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 Written Description, New Matter rejection.
Claim 11 recites “wherein the first moiety comprises:
(a) a heavy chain complementarity determining region 1 (HCDR1) of SYTMH (SEQ ID NO: 113), a heavy chain complementarity determining region 2 (HCDR2) of IINPSGGSTSYAQKFQG(SEQ ID NO: 114), a heavy chain complementarity determining region 3 (HCDR3) of QEITTEFDY (SEQ ID NO:115), a light chain complementarity determining region 1 (LCDR1) of RASQSVSSYANSYLH (SEQ ID NO: 116), a light chain complementarity determining region 2 (LCDR2) of RGSTRES (SEQ ID NO: 117), and a light chain complementarity determining region 3 (LCDR3) of QQSKSEPLT(SEO ID NO: 118);
(b) a HCDR1 of NYYIF (SEQ ID NO: 119), a HCDR2 of IINPVDGDTNYNPSFQG (SEQ ID NO: 120), a HCDR3 of GGYTMDR (SEQ ID NO: 121), a LCDR1 of RSSQSLLHSNGYNYLH (SEQ ID NO: 122), a LCDR2 of KVSNRLS (SEQ ID NO: 123), and a LCDR 3 of FQNTHTPRT (SEQID NO: 124);
(c) a HCDR1 of DTYIH (SEQ ID NO: 125), a HCDR2 of RIYPTNGYTRYADSVKG (SEQ ID NO: 126), a HCDR3 of WGGDGFYAMDY (SEQ ID NO: 127), a LCDR1 of RASQDVNTAVA (SEQ ID NO: 128), a LCDR2 of SASFLYS (SEQ ID NO: 129), and a LCDR3 QQHYTTPPT (SEQ ID NO: 130); or
(d) a HCDR1 of RYTMH (SEQ ID NO: 131), a HCDR2 of YINPSRGYTNYNQKFKD (SEQ ID NO: 132), a HCDR3 of YYDDHYCLDY (SEQ ID NO: 133), a LCDR1 of SASSSVSYMN (SEQ ID NO: 134), a LCDR2 of DTSKLAS (SEQ ID NO: 135), and a LCDR3 of QQWSSNPFT (SEQ ID NO:136); and
wherein the second moiety comprises:
(a) a HCDR1 of SYTMH(SEQ ID NO: 113), a HCDR2 of IINPSGGSTSYAQKFQG (SEQ ID NO: 114), a HCDR3 of QEITTEFDY (SEQ ID NO: 115), a LCDR1 of RASQSVSSYANSYLH (SEQ ID NO: 116), a LCDR2 of RGSTRES (SEQ ID NO: 117), and a LCDR3 of QQSKSEPLT (SEQ ID NO:118);
(b) a HCDR1 of NYYIF (SEQ ID NO: 119), a HCDR2 of IINPVDGDTNYNPSFQG (SEQ ID NO: 120), a HCDR3 of GGYTMDR (SEP ID NO: 121), a LCDR1 of RSSQSLLHSNGYNYLH (SEQ ID NO: 122), a LCDR 2 of KVSNRLS (SEQ ID NO: 123), and a LCDR3 of FQNTHTPRT (SEQID NO: 124);
(c) a HCDR1 of DTYIH (SEQ ID NO: 125), a HCDR2 of RIYPTNGYTRYADSVKG (SEQ ID NO: 126), a HCDR3 of WGGDGFYAMDY (SEQ ID NO: 127), a LCDR1 of RASQDVNTAVA (SEQ ID NO: 128), a LCDR2 of SASFLYS (SEQ ID NO: 129), and a LCDR3 QQHYTTPPT (SEQ ID NO: 130); or
(d) a HCDR1 of RYTMH (SEQ ID NO: 131), a HCDR2 of YINPSRGYTNYNQKFKD (SEQ ID NO: 132), a HCDR3 of YYDDHYCLDY(SEQ ID NO: 133), a LCDR1 of SASSSVSYMN (SEQ ID NO: 134), a LCDR2 of DTSKLAS (SEQ ID NO: 135), and a LCDR3 of QQWSSNPFT (SEQ ID NO:136)” in lines 22-67.
These limitations are not supported by the original disclosure or claim as filed.
Applicant’s amendment, filed October 7, 2025, asserts that no new matter has been added by the amendments, Replacement Sequence Listing, or the Substitute Specification.
However, the specification as filed does not provide sufficient written description of the above-mentioned limitations. The specification does not provide sufficient support for the CDRs recited in claims 1 and 73. The only first and second moieties with sufficient structure (amino acid sequences) for the binding domains are recited claims 43-52 and in Tables 3-9, 13, 14, 19, 20, and 22 of the specification. It is noted that while these amino acids sequences presumably comprise the CDRs recited in the claims, nowhere in the disclosure has the Applicant explicitly pointed out these CDR amino acid sequence or provided guidance for how they have been identified.
The instant claims now recite that the first and second moieties comprise HCDRs1-3 and LCDRs1-3 with their corresponding amino acid sequences and SEQ ID NOs. However, these CDR amino acid sequence have not been clearly disclosed in the specification. Therefore, the claims represent a departure from the specification and claims originally filed. Applicant’s reliance on full length amino acid sequences for the binding domains of the first and second moieties do not provide sufficient direction and guidance to the features currently claimed, namely the specific CDR amino acid sequences.
The Examiner acknowledges that in the Office Action mailed on 05/19/2025, the Examiner suggested limiting the scope of the claims to proteins comprising first and second moieties comprising “a complete set of six CDRs, such as the first and second polypeptide chains recited in claims 43-55 or those found on pages 92-102, 105, and 108-114, in tables 3-9, 13, 14, 19, 20, 22, and 23 of the specification” on page 7. However, the Examiner did not realize that the CDRs of these disclosed amino acid sequences had not been explicitly identified nor did the Applicant provide guidance on how to identify the CDRs anywhere in the disclosure.
Such limitations recited in the instant claims, which did not appear in the specification as filed, introduce new concepts and violate the written description requirement of the first paragraph of 35 U.S.C. 112.
Applicant is required to cancel the new matter in the response to this Office Action.
Alternatively, applicant is invited to provide sufficient written support for the “limitations” indicated above. See MPEP 714.02, 2163.05-06 and 2173.05 (i).
Amending claims 1 and 73 to recited the full length amino acid sequences recited in claims 43-52 or those found on pages 92-102, 105, and 108-114, in tables 3-9, 13, 14, 19, 20, 22, and 23 of the specification would obviate this part of the rejection.
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 Grace H. Lunde whose telephone number is (703)756-1851. The examiner can normally be reached Monday - Thursday 6:00 a.m. - 3:00 p.m. (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GRACE H LUNDE/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641