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 .
Election/Restrictions
Applicant’s election without traverse of group I (claims 1-26) in the reply filed on 10/09/2025 is acknowledged.
Claims 27-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups/inventions, there being no allowable generic or linking claim. Election was made without traverse as noted above.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 10-23, 25, and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pradeep (US 20120291791A1).
Regarding claims 1, 2, and 16, Pradeep discloses an automatic nicotine delivery reduction system that has a processor to intelligently vary a reduction program upon learning user behaviors. The processor and software are disclosed as:
Processor 205 may be used to intelligently vary a reduction program upon learning user behaviors. In some examples, if a user all too frequently inhales at a rapid rate, slightly higher nicotine levels may still not be delivered and instead a different nicotine solution or different flavoring solution may be used or suggested. [0025]
The processor described above is considered to be an estimation processor adapted to identify at least a first feedback action (changing the nicotine or flavoring solution) based upon one or more user factors (user all too frequently inhales at a rapid rate). Changing the nicotine or flavoring solution is considered to be relating to an amount or nature of an active ingredient delivered by the delivery device. Pradeep also discloses that, “[T]he breath monitor continuously tracks nicotine solution usage, usage frequency, and breath characteristic…The flow controller can alter the concentration or amount of nicotine solution provided for each breath or during each session according to a nicotine reduction plan…” [0027].
Regarding claim 3, the processor of Pradeep changes the amount of nicotine based on increased or decreased breath rate or breath depth [0027]. This is considered to be adjusting the concentration or amount of active ingredient in response to an output value (i.e. breath rate or breath depth) of the processor which is based on one or more user factors (i.e. breathing rate or breathing depth).
Regarding claim 5 and 10-12, Pradeep discloses that adjustments to concentration and/or amount are made over a sequence of inhalation actions and for a predetermined period of time (i.e. morning and/or afternoon, [0028]) and anticipates a user’s state at different predetermined times (morning and afternoon).
Regarding claim 13, the system of Pradeep prompts user feedback (i.e. breathing rate and depth) to the processor in relation to the actions of the system.
Regarding claim 14, Pradeep indicates that the system may provide the user the ability to make lifestyle (i.e. behavioral) modifications to reduce stress or other periodic triggers [0021].
Regarding claim 15, although not disclosed by Pradeep, but it would be inherent that the system would not operate if the system was not available (i.e. no solution to vaporize or no power).
Regarding claim 17, Pradeep discloses that “a different nicotine solution or different flavoring solution may be used or suggested” [0025]. This is considered to be asking for user consent.
Regarding claim 18, Pradeep discloses, “According to various embodiments, the nicotine reduction plan is tailored based on user preference…and dynamically modifiable based on user feeback.” [0026].
Regarding claim 19, Pradeep discloses that the system, “can also include an interface…that allows a user to program new schemes or receive feedback about nicotine reduction progress. The reports may indicate that a user feels the need for more nicotine during particular days or hours.” [0021].
Regarding claims 20-22, Pradeep discloses that user data such as EEG measurements undergoes data analysis to obtain factors indicative of a state of the user to formulate a nicotine delivery reduction scheme [0032-0047].
Regarding claim 23, Pradeep discloses the nicotine delivery is disclosed to be adapted directly based on breathing patterns, without an explicit estimation of nicotine withdrawal symptoms (i.e. user state).
Regarding claim 25 and 26, Pradeep discloses system 600 operates over a network (i.e. remote server ([0047] and figure 6) to implement particular embodiments and also discloses the processor within the delivery device (figure 1, processor 205).
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-9, 19, and 24 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cohen (US 20190387796 A1).
Regarding claims 1, 2, and 3, Cohen discloses an aerosol generation system with user feedback, stating:
In some implementations, the controller 105, 205, a connected application (e.g., an app on the user device 305 and/or in the cloud), and/or the processor 610 may be configured to toggle between reservoirs and/or chambers and/or mix the different nicotine concentration vaporizable material. This toggling and/or mixing may beneficially allow the vaporizer and/or vaporizer system to control a concentration of nicotine in each puff of the user. [0108]
Regarding claims 4 and 5, Cohen discloses replacing the nicotine with non-nicotine over time, implying that nicotine will be eventually be absent. [0118]-[0119].
Regarding claim 6, Cohen discloses that the device may lock the user out [0095].
Regarding claims 7-9, Cohen discloses that:
Cartridges with lower nicotine concentration may have a higher citric acid, or other non-nicotine sensory agent, concentration than cartridges with a higher nicotine concentration. The concentration of nicotine may be sufficient to protonate the nicotine [...] The vaporizer and/or vaporizer system may be configured to toggle, on a puff by puff basis, between nicotine and non-nicotine puffs. In some aspects, the vaporizer and/or vaporizer system may also be configured to dynamically mix of non-nicotine vaporizable material (e.g., citric acid) with the nicotine-containing vaporizable material to adjust a nicotine ratio/concentration in the inhalable vapor.
Citric acid can either be considered the second active agent, or addition of citric acid inherently produces protonated nicotine (due to addition of an acid).
Regarding claim 19, Cohen discloses notifications that may include information on how users may purchase their first cartridge and how to begin the program [0112].
Regarding claim 24, Cohen discloses using the vaporizer with hand-held mobile devices such as a smartphone (mobile terminal), smartwatch (wearable), or a remote server [0048].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J FELTON whose telephone number is (571)272-4805. The examiner can normally be reached Monday, Thursday-Friday 7:00-4:30, Wednesday 7:00-1:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H Wilson can be reached at 571-270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael J Felton/Primary Examiner, Art Unit 1747