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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/JP2022/024418 filed 06/17/2022, which claims the benefit of the priority of Japan Patent Application No. 2021-101016 filed 06/17/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements submitted on 08/17/2023 and 07/02/2025 have been considered by the examiner.
Claim Status
Claims 1-6 are being examined on the merits in this office action.
Claim Objections
Claims 5-6 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
Claim Rejections - 35 USC § 112
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.
Claims 1-4 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.
Regarding claim 1, the claim contain a parenthesis in line 8 and 15. It is unclear whether the limitations in the parenthesis are a required part of the claimed invention. Claims 2-4 depend on claim 1 and are similarly rejected.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. (WO2019208731A1 – hereinafter “Yamamoto”).
Yamamoto teaches a production method comprising reacting the compound 1
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with the compound 2
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to produce the compound
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(Page 1-2).
Yamamoto teaches R1, R2, R4, and R5 each independently represent a hydrogen atom, halogen atom, hydroxy group, carboxyl group, nitro group, cyano group, or thiol group, or monovalent hydrocarbon group or heterocyclic group, which may have one, two, or more substituents, A1 to A4 each independently represent a divalent aliphatic hydrocarbon group having 1 to 3 carbon atoms, which may have one, two, or more substituents (Page 2), p1 to p4 each independently represent 0 or 1 (Page 2), m and n are each independently an integer of 1 or higher (Page 2), PG2 represents a protecting group of the carboxyl group, PG1 represents a protecting group of the amino group (Page 2). Examiner notes that the circled group on the product compound above is a bivalent group and represents instant L1, wherein q1 is 0.
Yamamoto does not explicitly teach that compound 1 is a lactam ring, however, Yamamoto teaches that R 1 and R 3 are bonded to each other to form a heterocyclic ring which may have one or more substituents together with the carbon atom to which R 1 is bonded and the nitrogen atom to which R 3 is bonded (Page 2) and that the Lewis acid catalyst is suitable for the compound being a seven-membered ring compound (Page 17, 7th paragraph). Examiner notes that the teachings of Yamamoto read on the instant Formula 1-3, and read on Formula 1 being a lactam ring.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Yamamoto and make the compound 1 a lactam ring since Yamamoto teaches that the Lewis acid catalyst used in the method is suitable for the compound being a seven-membered ring compound (Page 17, 7th paragraph). Thus, one of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using modifying compound 1 to a ring compound for efficient production of the polypeptide. The disclosure renders obvious claim 1.
Regarding claim 2, Yamamoto teaches that specific examples of the amino protecting group PG1 include tert-butoxycarbonyl group (Boc), benzyloxycarbonyl group (Cbz), benzoyl group (Bz), 2,2,2-trichloroethoxycarbonyl group (Troc), allyloxycarbonyl group (Alloc), phthaloyl group (Phth), paramethoxybenzoyl group (PMPCO), cinnamoyl group, toluenesulfonyl group (Ts), 2 or 4-nitrobenzenesulfonyl group (Ns), cyanomethyl group, 9-fluorenylmethyloxycarbonyl group (Fmoc) (Page 15, 1st paragraph).
Regarding claim 3, Yamamoto teaches A1 represent a divalent aliphatic hydrocarbon group having 1 to 3 carbon atoms, which may have one, two, or more substituents (Page 2), p1 to p4 each independently represent 0 or 1 (Page 2). Examiner notes that the circled group on the product compound above is a bivalent group and represents instant L1, wherein q1 is 0.
Regarding claim 4, Yamamoto teaches the compound
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(Page 1-2).
wherein R1, R2, R4, and R5 each independently represent a hydrogen atom, halogen atom, hydroxy group, carboxyl group, nitro group, cyano group, or thiol group, or monovalent hydrocarbon group or heterocyclic group, which may have one, two, or more substituents. Yamamoto teaches A1 represent a divalent aliphatic hydrocarbon group having 1 to 3 carbon atoms, which may have one, two, or more substituents (Page 2), p1 to p4 each independently represent 0 or 1 (Page 2). Examiner notes that the disclosure reads on L1 is —C(═O)—N—. Further, Yamamoto teaches linking groups such as
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(Page 13, last paragraph) which reads on —C(═O)—N—.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654