DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
2. The Amendment filed 03/30/2026 is acknowledged.
3. Claims 1-3, 5-7, and 9-12 are pending and under examination. Claims 4 and 8 are cancelled.
Response to Amendment
4. In view of the amendment filed on 03/30/2026, only the following rejections remain.
Claim Rejections - 35 USC § 112
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.
Claims 1-3, 5-7, and 9-12 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention for the same reasons set forth in the previous Office Action mailed 12/31/2025.
Applicant’s arguments, filed 03/30/2026, have been fully considered, but have not been found convincing.
Applicant asserts in their response that the catenator polypeptide is not required to have any common core sequence or structural motif, and later states that limiting the scope of the invention to the specific polypeptides of SEQ ID NOs 1-3 would unduly restrict the scope of the claimed invention in view of the novel and inventive technical concept presented herein. This argument is not persuasive. There must be a common core structure claimed, and/or specific SEQ ID NOs for each part of the conjugate claimed, as well as the entire structure of the conjugate. Examiner maintains their position from the previous Office Action.
Declaration
5. The rejection under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (Publication date: 07/13/2022, IDS NPL #11 - filed 7/25/2023) is hereby withdrawn in view of applicant’s declaration.
6. The rejection under 35 U.S.C. 103 as being unpatentable over Song et al above as applied to claim 1 above, and further in view of US 5601819 A (the ‘819 patent) Publication date: 1997-02-11) is hereby withdrawn in view of applicant’s declaration.
The Byung-Ha Oh declaration under 37 CFR 1.130(a) filed on 03/30/2026 is sufficient to overcome the rejections based on Song et al. (Publication date: 07/13/2022, IDS NPL #11 - filed 7/25/2023).
Applicant states that Wonki Cho and Myung-Ju Ahn are not listed as inventors and did not contribute to the conception of the claimed invention, but rather provided technical assistance related to the work.
The applicant further states that the disclosure was made by Byung-Ha Oh, Bo-Seong Jeong, Seong-Woo Kim, Seong-Bin Im, and Jinyeop Song less than one year before the effective filing date of the claimed invention.
Conclusion
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN ALFANO whose telephone number is (571)272-3092. The examiner can normally be reached M-F 8-5 EST.
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/ALAN ALFANO/Examiner, Art Unit 1641
/MAHER M HADDAD/Primary Examiner, Art Unit 1641
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