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
The instant application, filed on 06 April, 2023, is a 371 of PCT/CN2021/122823 filed 09 October, 2021.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to CN 202011086123.3 filed on 12 October, 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of Application, Amendments, and/or Claims
The response filed on 04 June, 2026 has been entered in full. The response is an amendment due to a restriction requirement of claim set filed on 06 February, 2024. In the amendment, claims 22 and 23 are amended, and claims 1-8 and 24-28 are withdrawn, however claims 1-8 and 24-28 speak upon the elected species and the elected invention and are therefore rejoined for examination on their merits. Therefore, claims 1-28 are pending and are the subject of this Office Action.
Election/Restrictions
Election was made without traverse in the reply filed on 04 June, 2026.
It is noted in the reply the applicant elected the species wherein the linker drug-conjugate has the following structure:
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Which subsequently elect the linker structure:
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Specification
The use of the terms such as Adcetris and Enhertu, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 4-6 and 9-28 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim must contain a reference in the alternative only, to more than one claim previously set forth and then specify a further limitation, and a multiple dependent claim shall not serve as a basis for any other multiple dependent claims. See MPEP § 608.01(n). It is noted that claim 4 uses the language, “in accordance with claims 1-3,” and does not appear to be in the alternative and is thus withdrawn. Claims 5 and 6 depend on claim 4 and are also withdrawn. Accordingly, claims 4-6 and 9-28 will not be further treated on the merits.
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Ogitani et al. (2016) DS-8201a, A Novel HER2-Targeting ADC with a Novel DNA Topoisomerase I Inhibitor, Demonstrates a Promising Antitumor Efficacy with Differentiation from T-DM1 Clin Cancer Res; 22(20) 5097-5108 in view of Ali et al. (2015) Synthesis of Ciprofloxacin Lactate Procainamide as Mutual Prodrug International Journal of Engineering and Applied Sciences 6(5); 14-22.
In regards to claims 1-3, 7 and 8 Ogitani teaches a camptothecin derivative with the structure shown below in examiner Figure 1, which the chiral carbon connected to the -NH group has absolute chirality of R configuration, the R1 group is alkyl, the R2 group is the halogen fluorine, the R group if hydrogen, and the X group is -C(O)-CRaRb-(CR3R4)m-O-, where in Ra and Rb are hydrogen and m=0 (Ogitani figure 1A).
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Examiner Figure 1: Camptothecin derivative
Ogitani fails to teach the methyl group on the camptothecin derivative of the elected species in regards to claims 1, 7 and 8 as shown in the comparison below in examiner figure 3.
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Examiner Figure 2: Missing methyl group of Ogitani in comparison with the elected species circled.
Ali, however, in regards to claims 1, 7, and 8 using a lactamide linker between two drugs for dual delivery (Scheme 1). Further Ali teaches the lactic acid could hydrolyze and release the drugs as the same biological agent with release in a specific site to prevent side effects (pg.17, col 2, lines 2-7).
Thus, Ogitani discloses a camptothecin drug conjugate comprising almost the exact structure of the elected species without the methyl group, and Ali teaches a lactamide linker group to allow for targeted cleavage in the body to prevent side effects. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the teachings of Ogitani’s antibody drug conjugate, with the simple substitution of the spacer groups of Ali with a reasonable expectation of success to develop a camptothecin derivative with a cleavable linker spacer that allows for attachment to another structure and prevent side effects by targeted delivery.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DASIA A ALDARONDO whose telephone number is (571)272-1977. The examiner can normally be reached on Monday – Friday from 8:30am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached at telephone number (571)272-2911. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/D.A.A/Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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