DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
If the status of the application as subject to AIA or pre-AIA is incorrect, any correction of the statutory basis (e.g., changing from AIA to pre-AIA ) for a rejection under 35 U.S.C. §§ 102 and/or 103 will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
The listing of claims filed 6 June 2023 has been examined.
Claims 1 and 2 are pending.
Priority
The instant application was filed 6 June 2023, and claims priority to TW 111149673, filed 23 December 2022. Acknowledgment is made of applicant’s claim for foreign priority and a copy of the priority document has been received.
Information Disclosure Statement
An information disclosure statement (IDS) has not been received.
Claim Rejections - 35 U.S.C. § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 2 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”) and Romanowski et al., Antimicrobial Agents and Chemotherapy (1984), 25(4), 455–457 (“Romanowski”).
The claims are directed to a method of administering rosoxacin to 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.32008).
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 are 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).
Conclusion
No claims are allowed.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623