enNotice 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
Claims 1-5, 7-16 and 65-67 are pending in the instant application.
Claims 1, 4, 8, and 10-16 have been amended.
Claims 6 and 33-36 have been cancelled.
Claims 65-67 are new.
Claims 3, 9, 14-16, and 65-67 are withdrawn from consideration.
Claims 1-2, 4-5, 7-8, and 10-13 are examined herein.
Priority
The instant application claims benefit of priority to U.S. Provisional Application No. 63/013270, filed on 21 April 2020 and PCT/US2021/028492, filed on 21 April 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 21 April 2020.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 12 August 2025, 20 August 2025, and 12 December 2025 are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 12 December 2025 has been entered.
In view of applicant amendment to claim 1, the Improper Markush rejection of record is withdrawn. Applicant has limited claimed genus to be representative of the disclosed embodiments.
In view of applicant amendment to claim 1, the 102(a)(1) rejection of record over DeJesus is withdrawn. Applicant has added the proviso that the compound is not the previously elected species; (2S)-2-amino-2-[(3-fluoranyl-4-hydroxyphenyl)methyl] -3-fluoropropanoic acid.
In addition, new 1020(a)(1) rejections are necessitated by amendment (see below).
All rejections and objections not found below have been withdrawn.
Election/Restrictions
Applicant has amended the claims such that the previously elected species, (2S)-2-amino-2-[(3-fluoranyl-4-hydroxyphenyl)methyl] -3-fluoropropanoic acid, is no longer a claimed compound. As such, the search has been expanded to the next compound listed in claim 13; 2-amino-3-(3-fluoro-4-hydroxyphenyl)propanoic acid.
NEW REJECTIONS FACILITATED BY AMENDMENT
Claim Rejections - 35 USC § 102
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 –
Claims 1-2, 4-5, 7-8, and 10-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ciba Geigy (BE 636257) (hereinafter referred to as “Ciba”).
Regarding claims 1 and 13, Ciba discloses compounds of the formula pictured below (claim 22), which is a species of the instant genus when the reference R and R’ are hydrogen. This corresponds to the instant Formula (I) where:
X1 is -C(R7)=, wherein R7 is halogen
X2 is -C(R11)=, wherein R11 is hydrogen
X3 is -C(R8)=, wherein R8 is hydrogen
X4 is =C(R12)-, wherein R12 is hydrogen
X5 is =C(R4), wherein R4 is hydroxyl
R1 is hydrogen
R2 is hydrogen
R3 is
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; wherein R9 is hydrogen; R10 is amino; and R14 is hydrogen
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92
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Regarding claim 2, Ciba discloses the substituent corresponding to the instant R14 is H (claim 22).
Regarding claim 4, Ciba discloses the substituent corresponding to the instant R4 is hydroxyl and the substituent corresponding to the instant R10 is amino (claim 22).
Regarding claim 5, Ciba discloses a compound of claim 1 that is not one of the three excluded compounds of claim 5.
Regarding claim 7, Ciba teaches the racemic form which would include the S isomer of claim 7.
Regarding claim 8, Ciba discloses the substituents corresponding to X1, X2, X3, and X4 are CR7, CR11, CR8, and CR12, respectively (claim 22).
Regarding claim 10, Ciba discloses the substituent corresponding to the instant R4 is hydroxyl (claim 22).
Regarding claim 11, Ciba discloses the substituent corresponding to the instant R1 is H (claim 22).
Regarding claim 12, Ciba discloses the substituent corresponding to the instant R7 is halogen (claim 22).
Conclusion
Claims 1-2, 4-5, 7-8, and 10-13 are rejected.
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 Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621