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 .
Terminal Disclaimer
The terminal disclaimer filed on 5/5/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of the full statutory term of prior US patent No. 11,833,213 and US patent No. 11,510,992 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Status
Claims 1-16, 18-33, 36-39, 41-62, and 65-94 were canceled.
Claims 17, 34-35, 40, 63-64 and 95 are pending and under consideration.
Withdrawn Rejections
Rejection of Claims 17-18, 20-22, 24-25, 27-28, 32, 34-35, 40, 63-64 and 95 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn. Applicant amended the claim 17 to recite specific sequences, thereby obviating this rejection/objection.
Rejection of Claim(s) 17-18, 20-22, 24-25, 27-28, 32, 34-35, 63-64 and 95 under 35 U.S.C. 102(a)(2) as being anticipated by Balkovec et al (WO2020/051498) is withdrawn. Applicant made a statement “Applicant submits that the disclosure of WO 2020/051498 and the subject matter claimed in the present application were, as of the effective filing date of the present application, commonly owned and subject to a common obligation of assignment to Cidara Therapeutics, Inc. Pursuant to 35 U.S.C. § 102(b)(2)(C), WO 2020/051498 is thus not eligible as prior art under 35 U.S.C. § 102(a)(2) against the subject matter claimed in the instant application” (Document code R3.73 filed 5/5/2026).
Rejection of Claims 17-18, 20-22, 24-25, 27-28, 32, 34-35 and 63 on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,833,213 is withdrawn.
Rejection of Claims 17-18, 20-22, 24-25, 27-28, 32, 34-35 and 63 on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 11,510,992 is withdrawn.
Application filed Terminal Disclaimer to overcome these rejections.
NEW - Claim Objections
(necessitated by amendments)
Claim 95 is objected to because of the following informalities: claim 95 recites “further comprises substitutions”. However, amended claim 17 does not recite “substitution” any more. Because SEQ ID NO: 23-29 and 31 recited by instant claim 17 comprises variable X at position 297, it is suggested that Applicant amend wherein-clause of claim 95 to
“wherein the variant Fc domain monomer comprises amino acid alanine at position 297” or
“wherein the variant Fc domain monomer comprises asparagine to alanine substitution (N297A) at position 297”.
Appropriate correction is required.
NEW - Claim Rejections - 35 USC § 112
(necessitated by amendments)
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.
Claim 95 is 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.
Claim 95 recites amino acid position number 297, but does not recite which numbering system is used. Because claim 17 now recites specific SEQ ID NOs, it is unclear whether position number 297 is according to standard numbering system for Fc domain or whether the position numbering is according to the recited SEQ ID NOs.
NEW - Claim Rejections - 35 USC § 102
(necessitated by amendments)
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.
Claim(s) 17, 34-35, 40, 63-64 and 95 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu (WO2018107116; published 6/14/2018; PTO-892).
Regarding claim 17, Liu teaches Fc region mutant/ Mut J-N297A, SEQ ID 387 which has 329 amino acid (corresponds to 36.19 kD as recited by instant claim 17 because average molecular weight of amino acid is 0.11 kD) and comprises instant SEQ ID NO: 23 (SCV; result 3 of 23.rag; see below for sequence alignment). Instant SEQ ID NO: 23 defines amino acid at following positions as follows: X1= N or absent; X52= M or Y; X54= S or T; X56= T or E; X97= any amino acid; X156= D or E; X158= L or M; X247= K or absent. As shown below, SEQ ID NO: 387 of Liu corresponds to instant SEQ ID NO: 23 wherein X1= absent; X52= M; X54= S; X56= T; X97= A; X156= D; X158= L; and X247= absent.
result 3 of 23.rag
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257
1010
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405
1024
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Regarding claims 34-35, Liu teaches “This application provides antibodies, immunoreactive fragments thereof, having modifications such as amino acid deletions and/or substitutions within their constant region (Fc), and antibody drug conjugates (ADCs) comprising said modified antibodies or immunoreactive fragments, having effective anti-cancer activity while exhibiting improved pharmacokinetic and toxicity profiles” (abstract). ADC of Liu corresponds to conjugate of instant claims 34-35.
Regarding claim 40, Liu teaches “For example, antibodies or fusion constructs with increased in vivo half- lives can be generated by attaching relatively high molecular weight polymer molecules such as commercially available polyethylene glycol (PEG) or similar biocompatible polymers”. Therefore, Liu teaches fusion protein of claim 40.
Regarding claim 63, claim 63 describes functional property of the variant Fc domain. Liu teaches the variant Fc domain comprises same sequence as instant invention, and therefore the variant Fc domain of Liu will also have same function.
Regarding claim 64, Liu teaches pharmaceutical composition comprising an antibody drug conjugate and a pharmaceutically acceptable carrier (claim 48).
Regarding claim 95, as shown above in sequence alignment, the variant Fc domain of Liu comprises alanine at position 297 (i.e. position 97 according to SEQ ID NO: 23).
Conclusion
No claim is 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 CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 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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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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