DETAILED ACTION
Notice of Pre-AIA or 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 .
Status of the Application
Claims 2-4 and 7-30 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 02/09/2026 are acknowledged. Claims 8-27, and 30 remain withdrawn, as being drawn to an unelected invention or specie. Claims 8, 18, and 28 are amended. Claims under consideration in the instant office action are claims 2-4, 7, and 28-29.
Applicants' arguments, filed 02/09/2026, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-4, 7, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Boyer et al. (US 2010/0209542) in view of Weinstein et al. (US 8,327,845).
Claim Interpretation
The claimed invention is drawn towards a composition comprising at least 10% of a compound of formula (I) and/or at least 10% of a compound of formula (II). Since the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the language recited in the preamble of “A vaporizing device” merely states the purpose or intended use of the invention, the preamble is not considered a limitation of the claimed invention. "If the claim preamble, when read in the context of the entire claim, recites limitations of the claim, or, if the claim preamble is ‘necessary to give life, meaning, and vitality’ to the claim, then the claim preamble should be construed as if in the balance of the claim." See MPEP 2111.02.
Rejection
Boyer et al. teaches “Compounds isolated from Kratom leaf extracts may be capable of allowing a patient to cease the administration of addictive compounds without experiencing physically debilitating withdrawal symptoms.” (paragraph 0002). Boyer et al. teaches 7-hydroxymitragynine as a preferred embodiment (paragraph 0007). Boyer et al. teaches such compounds in an amount of about 50% or more in a composition (paragraph 0030). Boyer et al. teaches that such compounds can be administered via a medical device such as a catheter, applicator gun, or syringe (paragraph 0020). Boyer et al. teaches that such compositions “may contain additional materials useful in physically formulating various dosage forms of the compositions of the present invention, such as dyes, flavoring agents, preservatives, antioxidants, opacifiers, thickening agents and stabilizers.” (paragraph 0209). Boyer et al. teaches that administration can be provided via inhalation by a nebulizer (paragraph 0201).
Boyer et al. does not teach a vaporizing device comprising a heating element.
Weinstein et al. is drawn towards vaporizer systems for use in drug delivery systems including nebulizers (see abstract; col. 1, lines 18-26). Weinstein et al. teaches such systems comprising a heating device (col. 2, lines 36-49).
It would have been obvious to one of ordinary skill in the art to formulate a vaporizing device comprising a heating element, as suggested by Weinstein et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since such a system provides a convenient and efficient delivery system for the drug as taught by Weinstein et al. (col. 2, lines 31-49), with a reasonable expectation of success absent evidence of criticality of the particular formulation.
Conclusion
Claims 2-4, 7, and 28-29 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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