DETAILED ACTION
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 .
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.
Current Status of 17/735,271
This Office Action is responsive to the amended claims received 7 August 2026.
Claims 1-2, 5-7, and 9-23 are currently pending.
Priority
Applicant has not claimed the benefit of any prior-filed patent applications.
Response to Amendments
The 35 U.S.C. 112 rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments. A new rejection under 35 U.S.C. 112 is presented herein due to Applicant’s amendments.
The 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments.
The 35 U.S.C. 103 rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments. New rejections are presented herein, as necessitated by Applicant’s submission.
Response to Arguments
Applicant argues against the 112 rejections present in the previous office action. The Examiner has withdrawn the previous 112 rejections due to Applicant’s amendments. Applicant argues that claim 4 was not rejected under GYNTHER or NEXAVAR in the previous action, and the limitations of claim 4 have been incorporated into the current text of claims 1 and 13. The Examiner does not rely on the GYNTHER or NEXAVAR references herein.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 depends upon a cancelled claim. This renders claim 5 indefinite. Applicant may choose to amend claim 5 so that it depends upon claim 1.
Claim Rejections - 35 USC § 103
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, 5-7, 9-17, 20-21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over:
NORTH (North, W.G.; Liu, F.; Tian, R.; et al. “NMDA receptors are expressed in human ovarian cancer tissues and human ovarian cancer cell lines” Clinical Pharmacology: Advances and Applications 2015:7 111–117)
in view of:
CHEKEROV (Chekerov, R.; Hilpert, F.; Mahner, S.; et al. “Sorafenib plus topotecan versus placebo plus topotecan for platinum-resistant ovarian cancer (TRIAS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial” Lancet Oncol 2018; 19: 1247–58).
NORTH teaches that ifenprodil, being an NMDAR antagonist, was able to significantly decrease tumor growth in a mouse model of ovarian cancer (abstract). NORTH also teaches that ifenprodil caused a 2-3 fold reduction in ovarian tumor growth in a mouse model (discussion section). NORTH teaches that the findings therein could be used in the treatment of ovarian cancers (abstract). NORTH teaches the daily administration of 2.5 mg ifenprodil per kg of body weight per day for 8 days (4th paragraph Pg. 113). A 40 kg patient would require 88 mg of ifenprodil/day based upon this teaching.
NORTH does not specifically teach sorafenib.
CHEKEROV teaches the results of a clinical trial treating platinum-resistant ovarian cancer with a combination of topotecan and sorafenib (summary section). CHEKEROV teaches that 400 mg of sorafenib was orally administered twice daily (3rd paragraph, Pg. 1249). CHEKEROV teaches that the combination of sorafenib and topotecan showed a significant improvement in progression-free survival in women with platinum-resistant ovarian cancer (summary interpretation section). The discussion section of CHEKEROV specifically teaches that the group treated with sorafenib showed a median survival of 17 months with sorafenib, compared to 10 months in the placebo group. CHEKEROV mentions that to be included in the trial, the patients must have been more than 4 weeks past any recent surgery (last paragraph, Pg. 1248).
It would have been obvious to one of ordinary skill in the art, before the instant effective filing date, to combine the method of treating ovarian cancer through administration of ifenprodil (taught by NORTH) with the known ovarian chemotherapy treatment of sorafenib and topotecan taught by CHEKEROV, for the purpose of increasing the efficacy of the anti-cancer therapy. The artisan would have expected success in this combination, because both NORTH and CHEKEROV teach compounds capable of treating ovarian cancer and the concept of using multiple chemotherapy agents is well known in the art, as shown by CHEKEROV.
Regarding claims 2, 14, 20-21, and 23: The outcomes within instant claims 2, 14, 20-21, and 23 are solely the result of administering the combination of claim 1 or 13 to the subject having cancer. There are no positive steps recited therein that would alter these outcomes unrelated to administering the combination of instant claim 1 or 13 to the subject having cancer. Therefore, because the method of administering the combination of claim 1 or 13 to the subject has been found to be rendered obvious, these direct outcomes must also be rendered obvious.
Regarding claims 11-12: Claims 11-12 recite an intended use of the claimed pharmaceutical composition of claim 1. Nothing within the cited references precludes the intended uses described within these claims.
Regarding claims 15-16: CHEKEROV and NORTH do not explicitly teach the hourly timing of the ifenprodil and sorafenib doses. It would have been obvious to one of ordinary skill in the art to test the administration of ifenprodil and sorafenib at various times of the day within human patients, for the purpose of decreasing the overlap of any side effects. In other words, it would have been obvious to the artisan to test various administration times of each drug to increase the tolerability of any potential side effects from the drugs.
Claims 1-2, 5-7, 9-23 are rejected under 35 U.S.C. 103 as being unpatentable over:
NORTH (North, W.G.; Liu, F.; Tian, R.; et al. “NMDA receptors are expressed in human ovarian cancer tissues and human ovarian cancer cell lines” Clinical Pharmacology: Advances and Applications 2015:7 111–117)
in view of:
CHEKEROV (Chekerov, R.; Hilpert, F.; Mahner, S.; et al. “Sorafenib plus topotecan versus placebo plus topotecan for platinum-resistant ovarian cancer (TRIAS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial” Lancet Oncol 2018; 19: 1247–58)
as evidenced by:
LIU (Liu, W.; Zhang, J.; Gan, X.; et al. “LGR5 promotes epithelial ovarian cancer proliferation, metastasis, and epithelial–mesenchymal transition through the Notch1 signaling pathway” Cancer Medicine 2018; 7(7): 3132–3142).
Teachings of NORTH and CHEKEROV are discussed above.
Regarding claims 18-19 and 22: LIU provides evidence that Lgr5 is overexpressed in ovarian cancer (abstract).
Conclusion
No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 PM.
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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
