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
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 13 November 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Status of Application
2. Applicants’ arguments/remarks filed 17 February 2026 are acknowledged. Claims 1-3, 7-15, and 17-23 are currently pending. Claims 4-6 and 16 are cancelled. Claims 20-23 are newly added. Claims 1-3, 7-15, and 17-19 are currently amended. Claims 1-3, 7-15, and 17-23 are examined on the merits within.
Withdrawn Rejections
3. Applicants’ arguments, filed 17 February 2026, with respect to the 35 U.S.C. 112(a) Rejections have been fully considered and are persuasive. The 35 U.S.C. 112(a) Rejections of claims 2-3, 7-15, and 17-19 have been withdrawn in view of the claim amendments. The 35 U.S.C. 112(b) Rejection of claim 19 has been withdrawn in view of the claim amendments. The 35 U.S.C. 102(a)(1) Rejections are withdrawn in view of the claim amendments. However, upon further review, a new rejection is made in view of Liu (WO2016/074203). The 35 U.S.C. 103 Rejections of Takamori et al. (U.S. Patent Application Publication No. 2018/0369798) in view of Alliger (U.S. Patent Application Publication No. 2019/0000875) are withdrawn in view of the claim amendments. However, upon further review a new rejection is made in view of Liu (WO2016/074203) and Takamori et al. (U.S. Patent Application Publication No. 2018/0369798). The Obviousness Double Patenting Rejections over Application 17/766127 have been withdrawn in view of applicant’s arguments.
New Rejections
Claim Rejections – 35 U.S.C. 102
4. 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
5. Claim(s) 1-3, 7, 15, and 17-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu (WO2016/074203).
Liu discloses a cell apoptosis inducer kit containing a solution of a chlorine dioxide precursors and an aqueous solution of an acidity pH adjuster. See abstract. The chlorine dioxide precursor is selected from sodium chlorite or potassium chlorite. See page 4. The chlorine dioxide precursor is dissolved in water. See page 5. The composition is used to treat tumors such as bladder cancer, breast cancer, etc. See page 24. The apoptosis inducing agent comprises chlorine dioxide dissolved in water with a chlorine dioxide concentration of 500 to 2900 ppm. See page 4. Example 1 shows a final concentration of 1 µg/ml and an apoptosis rate was determined.
Thus the instant claims are anticipated by Liu.
Claim Rejections – 35 U.S.C. 103
6. 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.
7. Claim(s) 1-3, 7-15, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu (WO2016/074203) in view of Takamori et al. (U.S. Patent Application Publication No. 2018/0369798)
Liu discloses a cell apoptosis inducer kit containing a solution of a chlorine dioxide precursors and an aqueous solution of an acidity pH adjuster. See abstract. The chlorine dioxide precursor is selected from sodium chlorite or potassium chlorite. See page 4. The chlorine dioxide precursor is dissolved in water. See page 5. The composition is used to treat tumors such as bladder cancer, breast cancer, etc. See page 24. The apoptosis inducing agent comprises chlorine dioxide dissolved in water with a chlorine dioxide concentration of 500 to 2900 ppm. See page 4. Example 1 shows a final concentration of 1 µg/ml and an apoptosis rate was determined.
Liu does not teach a radical generating catalyst.
Takamori et al. teach a radical producing method comprising halogen ions, halite ions, halite ion, or an oxoacid or salt thereof, such as halogen oxoacid. Halogen oxoacid acid includes chlorous acid or chloric acid. See paragraph [0146]. The Lewis acidity of the radical generating catalyst is 0.4 eV or more. See paragraph [0060]. Ammonium serves as a radical generating catalyst. See paragraph [0059]. Examples include benzalkonium chloride. See paragraph [0063].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to use the halogen oxoacid and benzalkonium chloride of Takamori et al. in the treatment of epithelial cancer as taught by Liu because Liu teaches that chlorine dioxide treats cancerous tumors and Takamori et al. teach the combination is a highly safe formulation that overcomes the safety and storage stability issues of chlorine dioxide (see paragraphs [0016-0019], i.e., a composition that behaves like chlorine dioxide without the drawbacks. It would have been obvious to substitute one ammonium compound for another to yield predictable results.
Conclusion
8. Applicants’ 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.
Correspondence
9. No claims are allowed at this time.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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