DETAILED ACTION
A non-final Office action was mailed 27 January 2026 (“Office Action”).
Applicant’s reply to the Office Action was received 27 April 2026 (“Reply”).
Status of the Claims
The listing of claims filed with the Reply has been examined.
Claims 1–3 are pending. Claim 1 is amended. Claim 3 is new.
Status of Rejections and Objections
The text of those sections of Title 35, U.S. Code and/or text providing the basis for non-statutory double patenting rejections not included in this action are set forth in the Office Action.
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
Claim Rejections - 35 U.S.C. § 103
Claims 1–3 are rejected under 35 U.S.C. § 103 as being unpatentable over Ding in view of Ruszczyk et al., Cancer Causes Control (2016), 27, 183–198 (“Ruszczyk”) Romanowski et al., Antimicrobial Agents and Chemotherapy (1984), 25(4), 455–457 (“Romanowski”), and Mannu et al., BMJ (2020), 369:m1570 (13 pages) (“Mannu”).
The claims are directed to a method of administering rosoxacin a subject in need thereof, which in view of the claim preamble is a subject with triple-negative breast cancer.
Ding suggests using rosoxacin for the treatment of ductal carcinoma in situ (DCIS). (Ding, Abstract, p.62008).
Ruszczyk discloses a study of 831 women having invasive ductal carcinoma (IDC) with (n = 650) or without (n = 181) a DCIS component. (Ruszczyk, p.183). Table 5 shows there is a patient population having a DCIS component and who also tested negative for ER, PR, and HER2 (i.e., the three genes indicative of triple-negative breast cancer). (Id., p.194).
A person having ordinary skill in the art following the teachings of Ding would have found it prima facie obvious to treat triple negative breast cancer patients because Ding suggests treating subjects having DCIS with rosoxacin and some of the subjects with DCIS were demonstrated by Ruszczyk to have triple-negative breast cancer. Thus, the instantly claimed method is suggested by and therefore is unpatentable over Ding in view of Ruszczyk.
Regarding claim 2, Romanowski discloses the administration of rosoxacin in an oral dosage form. (Romanowski, p.455).
Regarding claim 3, Ding states DCIS is “confined to the breast ducts” and “does not exhibit stromal invasion into adjacent breast stroma under microscopic examination.” (Ding, p.61998). The statement in Ding appears to be based on references 1 and 2, which were published in 2015. Mannu, however, was subsequently published in 2020. Mannu studied the long-term consequence of DCIS to ascertain, inter alia, the risks of invasive breast cancer “among all women diagnosed as having DCIS detected by screening in England.” (Mannu, p.2). The extensive study included 32,024 women who were diagnosed with DCIS between 1988 and March 2014. (Id., p.3). Mannu discloses the rate of invasive breast cancer was 8.82 per 1000 women per year. (Id.). Thus, one of skill in the art would appreciate that DCIS can be invasive and metastasize. Based on the disclosures of Ding, Ruszczyk, and Mannu, a person having ordinary skill in the art would have found the method in claim 3 prima facie obvious and would have had a reasonable expectation of success using rosoxacin for the treatment of metastatic triple-negative breast cancer.
Response to Arguments
Applicant’s arguments submitted with the Reply have been fully considered but are not persuasive. Applicant first argues against the references individually. Applicant asserts, inter alia, Ding is “purely computational . . . and does not provide any guidance as to which drug to choose from for the treatment of DCIS among plurality of drugs identified.” (Remarks, p.4). Applicant argues, inter alia, “Ruszczyk does not support the assertion that a skilled physician would administer rosoxacin to a patient with IDC/DCIS.” (Id.). Applicant argues: “Romanowski is silent as to the treatment of breast cancers in any forms.” (Id., pp.4–5). With respect to the combination of references—which is the basis for the rejection—Applicant argues a person of skill in the art “would not have expected the beneficial effects of claim 1 that a metastasis of a triple-negative breast cancer can be inhibited, as the Applicant’s data show that not all drugs predicted by Ding are effective (Declaration submitted herewith), and not all quinolone antibiotics are effective to inhibit metastasis (Figure 1 of the present specification).” (Id., p.5).
After considering Applicant’s arguments, Examiner notes the Declaration referred to in the Remarks for rebutting Ding has not been received. As such, any supplemental data therein cannot be considered. And attorney argument is not a substitute for factual evidence. Thus, Applicant’s arguments against the combination of references fails.
The arguments against Ding are not persuasive either. Applicant’s characterization of Ding as prophetic or computational does not diminish the fact that Ding suggests rosoxacin (and two other drugs) may have pharmacological value in treating breast cancer. And Applicant’s argument that Ding does not provide guidance as to which of the “plurality of drugs” to use for treating DCIS is misplaced because Ding suggests only three drugs for further study to treat breast cancer. It would have been obvious for one of skill in the art to select each of those suggested drugs to investigate further. Indeed, Ding states: “Complmentarity between CDK1 and three drugs, Aminophenazone, Pomalidomide, and the Rosoxacin, implies novel pharmacological value of those drugs in breast cancer.” (Ding, p.62008).
Conclusion
No claims are allowed.
Applicant’s 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 C.F.R. § 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 C.F.R. § 1.17(a)) pursuant to 37 C.F.R. § 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.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to submit an Automated Interview Request: http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674.
/J.M.N./Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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