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
Claims 1-2, 14-18, and 23-26 are pending in the instant application.
Claim 1 has been amended.
Claims 1-2, 14-18, and 23-26 are examined herein.
Priority
The instant application claims benefit of foreign priority to EP20184760, filed on 08 July 2020, and the benefit of priority to PCT/EP2021/065313, filed on 08 July 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 08 July 2020.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 06 January 2023. 12 March 2024, 20 February 2025, 25 April 2025, and 25 April 2025, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 07 November 2025 has been entered.
In view of applicant amendment to claim 1, the objection of record is withdrawn.
In view of applicant argument, the 103 rejection of record over Adams in view of Wosikowski is withdrawn. Applicant argues that one skilled in the art would not be motivated to substituted one platinum complex for another as the art demonstrates distinct activity profiles across the compounds.
With respect to the 103 rejection of Pollard over Wosikowski, Applicant’s arguments have been considered but are not found persuasive for the following reasons. Wosikowski demonstrates the cytotoxicity of satraplatin in the SR cell line. The SR cell line models anaplastic large cell lymphoma (ALCL) as evidenced by Creative Bioarray (https://www.creative-bioarray.com/SR-786-CSC-C0418-item-1215.htm#:~:text=If%20you%20use%20this%20products,promoting%20cellular%20transformation%20and%20proliferation.). While most primary CNS lymphomas are diffuse large B-cell lymphomas, ALCL is a rare PCNSL (Nomura et al. Mol Clin Oncol. 2013;1(4):655–660). As such, it falls within the broadest reasonable interpretation of PCNSL recited in claim 1. The activity profile presented by Wosikowski would guide the skilled artisan to satraplatin in the work of Pollard. Therefore the rejection is maintained.
All rejections and objections not found below have been withdrawn.
MAINTAINED REJECTIONS
Claim Rejections - 35 USC § 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 1-2, 14-18, and 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pollard et al. (US20180303829A1) in view of Wosikowski et al. (cited above).
Regarding claim 1, Pollard discloses a method of treating a proliferative disorder in a subject comprising administering a DNA damaging agent (claim 1). Pollard discloses malignant lymphoma as a proliferative disease (claim 12) and satraplatin as a DNA damaging agent (claim 4).
Pollard fails to teach administering satraplatin as a monotherapy, rather Pollard discloses administering the DNA damaging agent with an ATR kinase inhibitor.
Wosikowski teaches the antitumor activity of satraplatin against several cancer lines including the SR cell line (Table 4), a human lymphoma cell line.
It would be prima facie obvious to one of ordinary skill in the art to administer satraplatin as a monotherapy in view of Wosikowski teaching its cytotoxicity.
Regarding claim 2, Pollard discloses the subject to be human (paragraph [0302].
Regarding claim 14, Pollard (paragraph [0309]) and Wosikowski (Abstract) teach the oral administration of satraplatin.
Regarding claims 15 and 23, Pollard discloses the dose between 0.001 mg/kg to 1000 mg/kg, which is .037 mg/m2 to 37000 mg/m2, encompassing the claimed dose range. One skilled in the art would be expected to optimize the frequency of the dose. (Conversion Factors compiled from Cancer Chemother Rep.1966;50(4):219-244.)
Regarding claims 16, 25, and 26, Wosikowski teaches the inhibition of growth of satraplatin in the SR cell line (Table 4).
Regarding claim 17, Pollard discloses the method of administering a DNA damaging agent with an ATR kinase inhibitor (claim 1).
Regarding claim 18, Pollard does not disclose the co-administration of a DNA damaging agent and another therapeutic agent however, combination therapy is well known in the art, as is concurrent administration. It would be prima facie obvious to one of ordinary skill in the art to administer satraplatin concurrently with an additional agent with a reasonable expectation of success as Pollard demonstrates a successful combination therapy.
Regarding claim 24, Pollard discloses an effective amount of a compound is an amount necessary to ameliorate or reverse one of more symptoms of the proliferative disease (paragraph [0307]).
Conclusion
Claims 1-2, 14-18, and 23-26 are rejected.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 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 use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621