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 .
Response to Amendment
The office action is in response to Applicant’s amendment filed on 12/20/2025.
Claims 1, 3, 5-12, 14-20, and 22-27 are pending.
Claim 1 is amended.
Claims 2, 4, 13, and 21 are cancelled.
Claims 23-27 are withdrawn as being directed to a non-elected invention.
Response to Arguments
Applicant' s arguments, see pages 7-13, filed 12/20/2025, with respect to the rejection of claims 1-3, 5-12, 14-20, and 22-27 and 14-19 under 35 U.S.C. 102 and 103, respectively, have been fully considered and are persuasive. However, a new ground of rejection based on a different interpretation of previously cited prior art, Freeman, is provided below.
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.
(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.
Claims 1, 3, 6-12, 14, 18-20, and 22 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Freeman et al. (US-20190261691-A1, as cited in the IDS dated 11/07/2022).
In regards to claim 1, Freeman directed to an inhalation device, discloses the inhalation device (i.e., non-combustible aerosol provision system) comprising a processor or circuit (i.e., control circuitry) to perform a metering method (abstract; [0041]; [0042]).
Freeman further discloses the device comprises a batter to provide electrical power to a heating element (i.e., vaporizer) to generate a vapor/aerosol ([0008] and [0037]-[0038]).
Freeman further discloses the method comprising:
The metering method is performed in response to a signal indicating a puff has been detected (i.e., user input) and activates the heating element (i.e., vaporizer) to begin vaporizing the substance (i.e., aerosol generation event) ([0008]; [0051]); and
Determining an amount of vaporized substance that has been generated in response to the user input (puff), based on the extracted known flow rate (i.e., determined rate of aerosol generation) and the determined rate of aerosol generation is adjusted based on the length of the puff duration (i.e., an intra-puff duration - dynamic factor) ([0008] and [0052]).
Specifically, Freeman teaches as the puff-duration increases (i.e., intra-puff duration - a dynamic factor), the rate of aerosol-generation also increases. Freeman teaches this by teaching during the first two seconds of aerosol generation, the rate of generation is 1.5mg/2seconds([0052]), which would result in 0.75mg/sec, for 3.5 seconds, the amount generated is 3 mg/3.5seconds, which is 0.85mg/sec, and for 4.5 seconds, the vapor factor and intervals would give you 4mg/4.5seconds which is 0.88mg/sec, for example. Therefore, Freeman teaches the determined rate of aerosol generation is adjusted (increased) based on the length of the intra-puff duration, which is a dynamic factor. Since the rate of aerosol generation starts slower and increases over time, the rate of the aerosol generation is directly dependent on how long the puff duration (i.e., intra-puff duration) lasts.
In regards to claim 3, Freeman discloses the vaporization rate (i.e., determined rate of aerosol generation) is an average rate of aerosol generation during the aerosol generation event ([0052]).
In regards to claims 6-7, Freeman discloses the method of claim 1 comprises a static factor with at least one factor related to one or more of:
the time it takes the heating element to heat up (i.e., energy delivered to the aerosol generator) ([0052]);
The control circuitry can store additional vapor characteristics of the vaporizable substance (i.e., composition of the aerosolizable material) ([0053]);
Rate of vaporization depends on the heating element (i.e., aerosol generator is a static factor) ([0052]-[0053]); and
The air flowing through the inlet (i.e., airway configuration) ([0053]-[0054]).
In regards to claim 8, Freeman discloses the metering method is performed in response to a signal indicating a puff (i.e., user input) has been detected ([0008]).
Freeman further discloses the device determines when the user stops inhaling by using a pressure sensor (i.e., activation of a user input mechanism - a sensor is described as a user input mechanism in the instant specification, page 27) ([0046]).
Freeman further discloses the device measures the amount of substance inhaled in real time (i.e., user input is an inhalation) ([0085]).
In regards to claim 9, The Examiner notes that the “intra-puff duration” is not a required dynamic factor of the method. However, Freeman discloses the total amount of the aerosolizable material can be calculated based on the duration of a puff alone (i.e., intra-puff duration) ([0079]).
The puff is the user input and therefore the intra-puff duration is equivalent to a duration of the user input.
In regards to claim 10, Freeman discloses the method of claim 1 further comprises calculating the vapor produced during the duration of the inhalation (i.e., usage amount) ([0052]).
Freeman further discloses the usage amount is a remaining amount of aerosol that can be generated from the aerosolizable material during a user’s inhalation ([0052]).
Freeman further discloses the method can determine the amount of vaporized substance that has been produced as a total amount (i.e., a cumulative amount of aerosol generated from the aerosolizable material) ([0008]).
In regards to claim 11, Freeman discloses the method further comprises:
a function of the device that when the accumulated total amount produced (i.e., usage amount) reaches a predetermined threshold dosage amount (i.e., comparing the usage amount to a threshold) the device either shuts off the heating element or can send a signal to an indicator or display that the predetermined threshold amount of the vaporized substance has been consumed (i.e., controlling an aspect of system based on the comparison of the usage amount to the threshold) ([0009]).
In regards to claim 12, Freeman discloses the method of claim 11 comprises controlling the aerosol provision system based on the comparison to the usage characteristic by shutting off the heating element (i.e., modulating delivery of power to the aerosol generator) or by sending a signal to an indicator or display that the predetermined threshold amount of the vaporized substance has been consumed and alerting the user (i.e., alerts the user that the aerosol generator is operating under abnormal conditions) ([0008] and [0042]).
In regards to claim 14, The Examiner notes that the limitation discussed in claim 14 is an option limitation and not a necessary one.
Freeman discloses variations in current/resistance in the temperature and current drawn in the device may be measured and included in the calculations of the usage amount (i.e., a resistance-based detection mechanism) ([0084]).
Freeman further discloses the indicator informs the user when a dose of the substance has been inhaled, and the indicator includes at least one of: an audio signal, a visual signal, a visual display, a vibration and a transmitter that sends a signal to an external device (i.e., optical-based).
In regards to claim 18, Freeman discloses the usage amount in milligrams (i.e., a mass) ([0052]).
In regards to claims 19-20, Freeman discloses the device sends a signal to an indicator or display that the predetermined threshold amount of the vaporized substance has been consumed and alerts the user (i.e., provides an indication to a user in relation to the usage amount) ([0008] and [0042]).
Freeman further discloses the indicator informs the user when a dose of the substance has been inhaled, and the indicator includes at least one of: an audio signal, a visual signal, a visual display, a vibration and a transmitter that sends a signal to an external device ([0015]).
In regards to claim 22, Freeman discloses the device comprises a sensor that the control circuitry records information from the sensor to the memory and can provide information about the vapor concentration to the user ([0049]).
Freeman further discloses the control circuitry can also store the heating and temperature variations during different inhalation profiles. For example, if a user inhales at a high rate, the air flowing through the inlet and into the device can cool the heating element. The control circuitry can store, in the memory, information on different rates of inhalation to adjust, for example, the temperature of the heating element (i.e., the memory is configured to write a record of the aerosol generation event) ([0053]).
Claim Rejections - 35 USC § 103
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 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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. (US-20190261691-A1, as cited in the IDS dated 11/07/2022).
In regards to claim 15, Freeman discloses a predetermined threshold for the usage amount ([0009]) but does not explicitly disclose an upper and a lower estimate for the usage amount.
However, since Freeman discloses a predetermined threshold, it would be obvious that a value below that threshold would be a lower estimate and a value above the threshold would be an upper estimate of the usage amount, therefore it would be obvious to one of ordinary skill in the art that Freeman would have a lower and an upper estimate for the usage amount since the device is already taking measurements to determine if the threshold is met/exceeded.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. (US-20190261691-A1, as cited in the IDS dated 11/07/2022) as applied to claim 1 above, and further in view of Bilat et al. (US-20190274361-A1 as cited in the IDS dated 11/07/2022).
In regards to claim 5, Freeman discloses the control circuitry powers the aerosol generator from the battery ([0038]), but does not explicitly disclose the power is delivered at a first substantially constant average level during a first phase and at a second substantially constant average level during a subsequent phase of the aerosol generation event.
Bilat, directed to an electrically operated aerosol-generating system (i.e., non-combustible aerosol provision system), discloses the aerosol-generating system comprising a power source, an aerosol-generating device (i.e., aerosol generator for generating an aerosol), and electric circuitry (i.e., control circuitry) for controlling power to the electric heater ([0013]).
Bilat further discloses a method of controlling the non-combustible aerosol provision system ([0017]).
Bilat further discloses the control circuitry powers pulses of 6 Watts to the heater during a puff (i.e., average constant level of a first phase). When an adverse condition is determined during a puff, the power supply may be limited to pulses of 5 Watts for the remainder of the puff (i.e., an average constant level for a subsequent phase of the aerosol generation event) ([0089]).
Bilat further discloses the control circuitry may be configured to supply non-limited 6 Watt pulses to the heater in subsequent puffs, until further adverse conditions are determined or in other example embodiments, the control circuitry may be configured to supply limited 5 Watt pulses to the heater in subsequent puffs, until the heater or aerosol-forming substrate is replaced ([0089]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Freeman by making the control circuitry of Freeman further comprise a constant average level of power for a first phase and a second phase of aerosol generation, as taught by Bilat, because both are directed to methods of generating an aerosol, Bilat teaches the subsequent second phase can be adjusted if an adverse condition is determined ([0089]), and this merely involves applying a known technique of having two constant average power levels during aerosol generation of a similar device to yield predictable results.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. (US-20190261691-A1, as cited in the IDS dated 11/07/2022) as applied to claim 6 above, and further in view of Bowen et al. (US-20190261689-A1).
In regards to claim 16, Freeman discloses the control circuitry can also store the heating and temperature variations during different inhalation profiles in the memory. For example, if a user inhales at a high rate, the air flowing through the inlet and into the device can cool the heating element. The control circuitry can store, in the memory, information on different rates of inhalation to adjust, for example, the temperature of the heating element (i.e., the memory stores historical data) ([0053]).
Freeman further discloses the total amount of the aerosolizable material can be calculated based on the duration of a puff ([0079]), the total amount of vaporized product can be determined by calculating a total amount that has been consumed by accumulation each puff over a predetermined amount of time ([0011]), and can calculate how much a particular amount of substance is expected to be produced per unit of time ([0053]).
Freeman does not explicitly disclose a prediction of a remaining total during aerosol generation events or a remaining number of aerosol generation events for the aerosolizable material, wherein the prediction is based on the usage amount and a historical data set relating to measured durations of previous aerosol generation events.
Bowen, directed to a mass output controlled vaporizer, discloses a vaporizer device comprising a resistive heating element; circuitry configured to control delivery of electrical power to the resistive heating element from a power source, the resistive heating element configured to provide heat to a vaporizable material to produce an aerosol (claim 1 and [0028]).
Bowen further discloses the vaporizer is controlled by predicting an amount of evaporation of the vaporizable material is left (i.e., prediction a remaining total duration of aerosol generation events or remaining number of aerosol generation events) (claim 1 and [0028]-[0029]).
Bowen further discloses the target aerosol yield depends on a user-adjustable parameter, such as a desired output target based on a desired evaporation rate, a desired number of puffs, a particular time period, and/or a daily output target (claims 5-6).
Bowen further discloses predicting the amount of evaporation includes executing an algorithm using received inputs from the user, such as one or more user behaviors (claims 16-17 and [0007]).
Bowen further discloses the device can adjust the heater output depending on user behaviors such as utilizing a sample of users and history of one or more devices (i.e., historical data set related to measured durations of previous aerosol generation events) and therefore the mass output rate may be automatically adjusted based on the data obtained to suit the user ([0058]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Freeman by making the method of Freeman further comprise a prediction of the remaining aerosol generation events based on historical data, as taught by Bowen, because both are directed to methods of generating an aerosol, Bowen teaches the historical data allows for the output rate to be automatically adjusted to a predetermined user parameter based on the data obtained ([0007] and [0028]), and this merely involves applying a known technique of predicting a number of aerosol generation events remaining based on historical data of a similar device to yield predictable results.
In regards to claim 17, Freeman in view of Bowen discloses a controller implements a control law based on received inputs (Freeman [0005]).
Bowen further discloses the control law uses the aerosol yield measurement (the predicted amount of evaporation of the vaporizable material from the predictor) as a control signal to attenuate the amount of power delivered to the heater. The controller may set the control target to be a constant or a user adjustable parameter. The control target for instantaneous aerosol may be adjusted over the course of a puff, over the course of successive puffs, or in response to other user behaviors, preferences, and/or goals. For example, a user may set one or more of the following as a desired output target: a desired evaporation rate (such as 1 mg/s), a desired number of puffs per a particular time period, and/or a particular program to achieve a daily goal ([0057]).
Bowen further discloses the control law is adjusted in response to user behaviors and can utilize a sample of users and history of one or more devices to automatically adjust the output rate of the aerosol ([0058]).
While Bowen does not explicitly disclose the prediction of based on the historical data set is based on: “a duration of a most recent previous aerosol generation event, an average duration of a plurality of previous aerosol generation events, or a predicted usage for a plurality of subsequent puff aerosol generation events.” Bowen does disclose the use of historical data and does not limit or teach away from using historical data of what is claimed. Further, Bowen teaches puff duration as a user behavior ([0057]) and therefore it would be obvious that the historical data of Bowen could include “a duration of a most recent previous aerosol generation event, an average duration of a plurality of previous aerosol generation events, or a predicted usage for a plurality of subsequent puff aerosol generation events” and is considered prima facie obvious.
Conclusion
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/MADELEINE P DELACRUZ/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755