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 .
Information Disclosure Statement
2. The information disclosure statements (dated July 17, 2026 and May 30, 2026 and April 6, 2026) were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The statements were considered. Signed copies of form 1449 are enclosed herewith.
Response to Amendment
3. The rebuttal arguments filed on June 24, 2026 have been fully considered, however, they are not found to be persuasive. Below are responses to Applicant’s remarks.
The claims were previously rejected as being unpatentable over WO 2020118096 in view of Moreno et al. WO 202011809 teaches the administration of racemic rimantadine HCl for the treatment of cancer which includes head and neck cancer. It was determined that the purification of an old product to result in an enantiomerically pure product does not impart patentability. MPEP 2144.04 VII. The skilled artisan has the motivation and reasonable expectation of success in preparing and administering enantiopure 2S rimantadine HCl for the treatment of head and neck cancer.
Applicants have traversed the rejection by providing arguments and a declaration that shows unexpected results of 2S rimantadine HCl vs. 2R rimantadine. The arguments are noted. However, the declaration does not show unexpected results of 2S rimantadine HCl vs. the racemic mixture. As such, the declaration is not persuasive in overcoming the outstanding rejection. Applicants are invited to show unexpected results of the enantiopure 2S rimantadine vs. the racemic mixture.
For the reasons stated above, it is maintained that the 35 USC 103 rejection is proper. All claims remain rejected. This ground of rejection is hereby made FINAL.
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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