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 .
Election/Restrictions
2. Applicant’s election of species of 2-S rimantadine HCl, and head and neck cancer, in the reply filed on January 12, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
3. Examination followed guidelines provided by MPEP 803.02. The elected species appeared to be obvious over the prior art. Therefore, the Markush claims were rejected and claims to nonelected species were withdrawn from further consideration.
Status of Claims
4. Claims 1-11, 22-27 and 75-77 are pending and elected. Claim 1 is independent.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on December 8, 2025 was in compliance with the provisions of 37 CFR 1.97 and37 CFR 1.98. The IDS was considered. A signed copy of form 1449 is enclosed herewith.
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.
6. Claim(s) 1-11, 22-27 and 75-77 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020118096 as applied to claims 1-11, 22-27 and 75-77 further in view of Moreno et al.
Determining the scope and contents of the prior art
WO 2020118096 teaches methods of treating cancer using rimantadine or pharmaceutically acceptable salt. See abstract. The reference teaches hydrochloride salt, paragraph [0050]. Regarding claims 5-9, the reference teaches the treating of head and neck cancer, paragraph [0022] and also the treatment of HPV associated cancer such as HPV 16 which is an alpha genus HPV, paragraph [0017], claims 10-11. The reference teaches the administration of an additional agent such as carboplatin, immunotherapy, immune checkpoint that tragets CTLA-4, eg. ipilimumab or pembrolizamub, paragraph [0023] – claims 22-27 and 75-77.
Ascertaining the differences between the prior art and the claims at issue
The difference between the reference and Applicant’s elected species is that the reference administers racemic mixture of rimantadine HCl while the claims require the administration of enantiomerically pure 2-S rimantadine.
Moreno et al. teaches the preparation of enantiopure 2-S rimantadine.
Resolving the level of ordinary skill in the pertinent art and considering objective evidence present in the application indicating obviousness
MPEP 2144.04 VII provides guidelines for the examination of claims using legal precedent as a source of supporting rationale. Thus, the purification of an old product (ie. 2-S enantiomer vs. racemic mixture) to result in an enantiomerically pure product does not impart patentability. For a purified product that has no structural or functional difference the purity does not give rise to patentability. As it applies to the present claims, Applicants have provided an enantiomerically pure product which has no functional difference in that both the racemic mixture and enantiomer has utility in the treatment of head and neck cancer. One of ordinary skill has the motivation and reasonable expectation of success in preparing enantiopure 2-S enantiomer of rimantadine and administer it for the treatment of head and neck cancer. The motivation is to practice an alternate method of treatment wherein activity and side effects could be advantageous as compared to the racemic mixture.
It is noted that the specification provides the following:
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. Therefore, based on the disclosure that 2R rimantadine and 2S rimantadine both results in a higher incidence of central nervous system adverse effects, it does not appear that the enantiopure 2S rimantadine has unexpected results relative to the racemic mixture.
For the reasons provided above, the skilled artisan has a reasonable expectation of success in practicing the present invention. It is determined that the present claims are prima facie obvious over the prior art.
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621