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 .
DETAILED ACTION
Priority and Status of the Claims
1. This application is a 371 of PCT/CN2022/114247 08/23/2022, which claims benefit of the foreign application: CHINA CN202110997973.7 08/27/2021.
2. Amendment of claims 11-20, 22-25 and 27 in the amendment filed on 7/28/2026 is acknowledged. Claims 11-29 are pending in the application.
Responses to Amendments/Arguments
3. The rejection of claims 11-29 under 35 U.S.C. 112 (a) has been overcome in the amendment filed on 7/28/2026.
4. Applicant's arguments regarding the rejection of claims 11 and 27 under 35 U.S.C. 103(a) have been fully considered but they are not persuasive.
Applicants state “D1 (US2019108729) merely discloses that antibiotics in the tetracycline family (including tigecycline) may be chemically modified to form repurposcins having efficacy as anti-cancer therapeutics. If the present application sought protection for the use of tigecycline in inhibiting traditional "named tumors" defined by tissue-origin (e.g., breast cancer, etc.), D1 would undermine the novelty and inventiveness of this application.
However, this present application does not seek to protect tigecycline's inhibitory effects on conventionally defined tumors; rather, this application seeks to protect tigecycline's targeted anticancer activity against a novel tumor classification defined by specific biomarker. In fact, D1 did not disclose any information on which particular subtype of tumor is more sensitive to these antibiotics, nor did it provide any technical guidance on how to apply them in precision cancer therapy to achieve improved therapeutic effects.”, see page 20.
However, Lisanti et al. ‘018 discloses methods of use for treating breast cancer using six compounds, see RN: 60-54-8, 127-33-3, 564-25-0, 10118-90-8, 149934-19-0, and220620-09-7. Lisanti et al. ‘018 compounds read on the instant compound of formula (I), wherein W1 and W2 are O or S , R1-R16 are hydrogen, halogen, substituted or unsubstituted alkyl, hydroxyl, amino, nitro, -COOH, cycloalkyl, alkoxyl, ester group, amide, -N(R17)(R18)- and R18 or R18 is hydrogen or alkyl or cycloalkyl.
The difference between instant claims and Lisanti et al. ‘018 is that Lisanti et al. ‘018 is silent on the instant high expression of DNA methylase, UHRF1 and/or high methylation level of nucleotide site of NNMT gene. Without instant gene or enzyme alteration, Lisanti et al. ‘018 methods of use still are for treating breast caner. It is noted that methods of use of Lisanti et al. ‘018 are broader than the instant invention.
Additionally, the discovery of a new property or use, i.e., instant gene or enzyme alteration for treating cancer in a patient, even when that property and use are unobvious from the prior art, cannot impart patentability to claims to the known compounds of, see In re Spada, 15 USPQ2d 1655 (Fed. Cir. 1990), and MPEP 2112.01. Therefore Lisanti et al. ‘018 still render obviousness over the instant invention. The rejection of claims 11 and 27 under 35 U.S.C. 103 (a) over Lisanti et al. ‘018 is maintained. Additional steps (e.g. diagnosis steps before treatments) supported by specification into instant methods of use of claim 11 would obviate the rejection.
Claim Objections
5. Claim 27 is objected to as having a typographic error. Claim 27 shall depend on claim 11. Correction is required.
6. Claims 12-26 and 28-29 are objected to as being dependent on rejected claim 11.
7. THIS ACTION IS MADE FINAL. Applicants are 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 extension fee 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is (571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
August 25, 2026
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