DETAILED ACTION
Previous Rejections
Applicants' arguments, filed 20 July 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 1-3, 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). This microemulsion has water and oil phases present in amounts which read upon the instantly recited ranges.
Sintov et al. further teaches that 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]). This is also the elected species of antiviral agent, and has a lop P value less than 2.
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 and 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.
Response to Arguments
The Applicant argues that the rejection is not proper. The Applicant argues that the microemulsions taught by Sintov et al. do not meet the limitations for the amounts of the phases as recited by instant claim 1. In particular, comparative example 1 is not a water-in-oil emulsion, and comparative example 2 has amounts outside the instantly claimed range.
The Applicant also argues that one of ordinary skill in the art would not reasonably expect that compounds having a lop P value under 2 could be successfully administered intranasally. The focus of Sintov et al. is on diazepam and insulin, which have higher log P values.
The Applicant also argues that there are unexpected results present as supported by evidence in the instant specification. In particular, the claimed method provides foe improved efficacy.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. With respect to the amounts of the phases in the microemulsion, the rejection rationale cited (and still cites) example 1 disclosed by Sintov et al. (and not the comparative examples).
With respect to the arguments relating to the lop P values, Sintov et al. does not discuss log P values, so there is no support for the conclusion that one of ordinary skill in the art would expect such antivirals with the log P instantly recited would not be able to be intranasally administered. Further, Dahl et al. discloses antiviral therapy useful for treating HIV infections using active agents such as tenofovir disoproxil fumarate (abstract). And Dahl et al. states that the disclosed antiviral (anti-HIV) agents can be delivered nasally (paragraph [86]). Thus, there is support for a reasonable expectation that tenofovir disoproxil fumarate (which has a lop P value under 2) could be administered nasally.
With respect to the unexpected results, the Examiner acknowledges the arguments and evidence presented. The evidence evaluated and compared a single microemulsion with tenofovir disoproxil fumarate, and the administration via oral and nasal routes. The nasal route was significantly more concentrated in the brain after nasal administration. However, it is not clear that this is unexpected. As stated by Sintov et al., nasal delivery can lead to increased penetration of compounds to the CNS (paragraph [14]).
Even if the effect is unexpected in magnitude, the rejection would not be overcome. Once unexpectedness has been established, the probative value of the evidence as compared to the invention as claimed must be determined, i.e., claims must be “commensurate in scope” with the showing. See MPEP 716.02(d). In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range or whether or not there is adequate basis for reasonably concluding that the number and variety of species included by the claims would behave in the same manner as those tested. And the claims are not so limited in scope, as only one antiviral agent in one particular microemulsion was evaluated.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian Gulledge whose telephone number is (571)270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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