DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment and Rebuttal Arguments
2. The amendments to the claims filed on May 21, 2026 have been fully considered. The amendments are sufficient to overcome the outstanding rejection under 35 USC 102 over Shikiya et al. and Jisieike et al. These rejections are withdrawn.
3. The amendments to the claims and rebuttal arguments with respect to the 35 USC 103 rejection over Pantziarka et al. in view of CYP!A2 has been fully considered. However, they are not sufficient to overcome the ground of rejection. Below are responses to Applicant’s remarks.
The claims were previously rejected as being unpatentable over Pantziarka et al. in view of CYP1A2. Pantziarka et al. teaches the treatment of cancer by administration of mebendazole with cimetidine. The administration is sequential. The reference suggests possible synergies and that cimetidine increases mebendazole plasma levels. It was determined that the difference between the prior art and the claims is that cimetidine is not a moderate or strong GYP1A2 inhibitor. Based on the guidelines provided by MPEP 2143B, it was determined that the present claims are prima facie obvious. MPEP 2143B provides guidelines that simple substitution of one known element for another to obtain predictable results is a rationale for obviousness. It was determined that Pantziarka et al. does not teach the combination of a moderate or strong CYP1A2 inhibitor with mebendazole for treatment. It was further determined that the prior art differs from the claims by substitution of one CYP1A2 inhibitor for another. For these reasons the present claims were found to be prima facie obvious.
Applicants stated that the reference CYP1A2 cannot be found. This statement has been considered. However, the reference is on the application file as a non patent literature reference dated March 25, 2026.
Applicants argue that the present claims show unexpected results in the clearance of mebendazole in human liver microsomes. This unexpected result is shown and demonstrated for furafylline vs. cimetidine, thiabendazole vs. cimetidine, and for fluvoxamine and for mexiletine. The demonstration of unexpected properties is noted. However, the unexpected results is not shown for the scope of the claims which is directed to the combination of mebendazole with furafylline, enoxacin, fluvoxamine, zafirlukast, 8-phenyltheophylline, methoxsalen, mexiletine. For this reason, the 35 USC103 rejection is maintained. Claims 6, 8, 10, 11, 13-23 remain rejected.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/SUN JAE YOO/Primary Examiner, Art Unit 1621
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