DETAILED ACTION
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 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.
Election/Restrictions
Applicant's election with traverse of the species of HIV (neurotropic virus) and tenofovir disoproxil fumarate (antiviral agent) in the reply filed on 11 December 2025 is acknowledged. The traversal is on the ground(s) that the art cited does not address the newly added limitation to claim 15, and thus does not support the conclusion that there is not unity of invention. This is not found persuasive because the art cited did address the claims presented, and the combination of US Patent Application Publications 2010/0034880 and 2004/0224917 addresses the presently claimed invention. The requirement is still deemed proper and is therefore made FINAL.
Claims 6 and 8-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species of neurotropic virus, there being no allowable generic or linking claim.
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.
Claims 1-5, 7, 10-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Sintov et al. (US Patent Application Publication 2010/0034880) in view of Dahl et al. (US Patent Application Publication 2004/0224917).
Sintov et al. discloses transmucosal compositions for delivering biologically active substances to a membrane (abstract). The composition can be a microemulsion (claim 2), with the examples being this form as well (examples 1-3). More specifically, the microemulsion is a water-in-oil emulsion (example 1). The compositions can be used nasally (paragraph [25] and example 3). And the biologically active substance can be an antiviral agent (paragraph [49]).
Thus, Sintov et al. discloses most of the limitations recited by independent instant claim 1. However, the use for treating a virus that is a neurotropic virus using an antiviral agent is not taught (no specific viral conditions are taught, nor are the antiviral agents taught necessarily useful for such a treatment).
Dahl et al. discloses antiviral therapy useful for treating HIV infections using active agents such as tenofovir disoproxil fumarate (abstract). HIV is a neurotropic virus, and a specific HIV suggested as treatable by Dahl et al. is HIV-1 (paragraph [43]). This antiviral (anti-HIV) agent can be delivered nasally (paragraph [86]).
Dahl et al. does not disclose delivering the antiviral agent (as tenofovir disoproxil fumarate) in a microemulsion.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have incorporated the antiviral agent tenofovir disoproxil fumarate into the microemulsion taught by Sintov et al. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. The use of this agent to treat HIV would thus render prima facie obvious the method recited by independent instant claim 1.
Instant claims 2 and 10-12 recite limitations to the manner in which the antiviral works. Since the same antiviral active agent is taught by Dahl et al. as instantly elected, the resultant method would possess the same properties upon administration.
Instant claims 3-5 limit the antiviral agent, and are read upon by the tenofovir disoproxil fumarate disclosed by Dahl et al.
Instant claims 7 and 16 further limit the virus treated, and the HIV-1 disclosed by Dahl et al. reads upon these limitations.
Instant claims 13-14 further limit the pharmaceutical composition. The emulsion disclosed by Sintov et al. has oil and water (vehicles) as well as surfactant (abstract), thus reading upon these limitations.
Conclusion
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/Brian Gulledge/Primary Examiner, Art Unit 1699