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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/21/2025 has been entered.
Status of the Claims
Claims 1 and 4-19 are pending and are subject to this Office Action. Claims 10-19 have been withdrawn.
Response to Amendment
The Examiner acknowledges Applicant’s response filed on 10/21/2025 containing
amendments and remarks to the claims.
Response to Arguments
Applicant's arguments, see pages 8-10, filed 10/21/2025, with respect to the rejection(s) of claims 1-9 under 35 USC 101 have been fully considered but they are not persuasive.
The Applicant argues that the claimed steps of (i) and (ii) require physical changes to real-world hardware, and as such does not relate to mental processes. The Applicant further argues step (i) requires the amount of power supplied to a heater changes in order to adjust an amount of aerosol generated by the heater for user inhalation, and as such a physically different amount of aerosol if generated by the heater. Further, step (ii) requires the supply of power to a heater is prevented in order to stop aerosol generation, which will have an impact both on the state of the aerosol provision system and the user who is using the aerosol provision system. The Examiner does not find this to be persuasive because the step of adjusting a power supplied to a heater in order to adjust an amount of aerosol generated by the heater for user inhalation is an additional element that is just linking the mental process to a field of use, aerosol generation, and applying it. The courts have yielded that merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instruction to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, does not integrate the abstract idea into a practical application. See MPEP § 2106.05(f).
The Applicant further argues that in step (i), a real-world result is produced, in that the physical amount of aerosol which will be received by the user inhalation is changed, and in step (ii) the physical material produced by the aerosol provision system clearly changes, due to no electrical heating being produced by a heater. As such, they clearly have a practical impact that applies to the real world. The Examiner does not find this to be persuasive because the courts have yielded that simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, have found not to be enough to qualify as “significantly more”. See MPEP 2106.05(I)(A). As such, adjusting power to the heater to affect aerosol generation, including decreasing, increasing, or stopping power to the heater, is well understood and routine in the art, and therefore does not amount to significantly more.
Applicant’s arguments, see pages 10-13, filed 10/21/2025, with respect to the rejection(s) of claim(s) 1, 4-5, and 8-9 under 35 USC 102 have been fully considered and are persuasive. The Applicant has amended the claim to require the session being a period of more intense use of the aerosol provision system to generate aerosol, which occurs between periods of less intense use of the aerosol provision system to generate aerosol, whereas previously this was not required. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found art.
The following is a modified rejection made based on amendments made to the claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 4-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 1, the claim(s) recite(s) an aerosol provision system configured to generate aerosol from an aerosol generating material for user inhalation, the aerosol provision system comprising: a computer configured to: derive user profile data indicating a user's usage of the aerosol provision system as a function of time, the user profile data indicating an amount of consumption by usage of the aerosol provision system; obtain data of a target usage profile indicating a target usage of the aerosol provision system as a function of time; estimate a difference between a total consumption by usage of the aerosol provision system over a predetermined period of time corresponding to a session, the session being a period of more intense use of the aerosol provision system to generate aerosol which occurs between periods of less intense use of the aerosol provision system to generate aerosol, as indicated by the user profile data, and a target usage of the aerosol provision system for the session as indicated by the target usage profile; and adjust one or more operational parameters of the aerosol provision system to at least partially map the user's usage over the session, as indicated by the user profile data to the target usage of the aerosol provision system for the session, wherein adjusting the one or more operational parameters of the aerosol provision system to at least partially map the user's usage over the session, as indicated by the user profile data, to the target usage of the aerosol provision system for the session comprises, if the total consumption by usage of the aerosol provision system over the session has reached the target usage of the aerosol provision system for the session, at least one of: (i) adjusting a power supplied to a heater by the aerosol provision system in order to adjust an amount of aerosol generated by the heater for user inhalation; and (ii) stopping the generation of aerosol by the aerosol provision system by preventing a supply of power to a heater by the aerosol provision system.
A claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, is considered to recite mental processes. See MPEP 2106.04(a)(2)(III)(A). The limitation of derive user profile data indicating a user's usage of the aerosol provision system as a function of time, the user profile data indicating an amount of consumption by usage of the aerosol provision system; obtain data of a target usage profile indicating a target usage of the aerosol provision system as a function of time; estimate a difference between a total consumption by usage of the aerosol provision system over a predetermined period of time corresponding to a session, the session being a period of more intense use of the aerosol provision system to generate aerosol which occurs between periods of less intense use of the aerosol provision system to generate aerosol, as indicated by the user profile data, and a target usage of the aerosol provision system for the session as indicated by the target usage profile; and at least partially map the user's usage over the session as indicated by the user profile data to the target usage of the aerosol provision system for the session, as drafted, is a process that, under its broadest reasonable interpretation, merely covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a computer configured to” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “computer configured to” language, “derive” in the context of this claim merely encompasses collecting information; “obtain” in the context of this claim merely encompasses collecting information; “estimate” in the context of this claim merely encompasses analyzing information; “map the user’s usage” in the context of this claim merely encompasses displaying certain results of the collection and analysis and is a process that can be practically performed in the human mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the additional elements of an aerosol provision system and aerosol-generating material, a computer, adjust one or more operational parameters of the aerosol provision system, adjusting or stopping power supplied to a heater by the aerosol provision system, which are generic parts of an electronic cigarette and thus do nothing more than link the use of an abstract idea to the field of electronic cigarettes. The courts have yielded that merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, do not integrate a judicial exception into a practical application. See MPEP 2106.04(d)(I). Thus, claim 1 does not integrate the abstract idea into a practical application.
In specific regards to the claim limitation of wherein adjusting the one or more operational parameters of the aerosol provision system to at least partially map the user's usage over the session, as indicated by the user profile data, to the target usage of the aerosol provision system for the session comprises, if the total consumption by usage of the aerosol provision system over the session has reached the target usage of the aerosol provision system for the session, at least one of: (i) adjusting a power supplied to a heater by the aerosol provision system in order to adjust an amount of aerosol generated by the heater for user inhalation; and (ii) stopping the generation of aerosol by the aerosol provision system by preventing a supply of power to a heater by the aerosol provision system, this requires “if” the total consumption has reached the target usage. However, “if” the total consumption does not reach the target usage then there would be no adjustment and therefore no particular practical application.
The claim(s) does/do not include additional elements that are sufficient to amount
to significantly more than the judicial exception because the courts have yielded that
simply appending well-understood, routine, conventional activities previously known to
the industry, specified at a high level of generality, to the judicial exception, e.g., a claim
to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, have found not to be enough to qualify as “significantly
more”. See MPEP 2106.05(I)(A). The additional elements are known in the art as shown
by Wensley (US2015/0216237):
An aerosol provision system ([0378], device for generating a condensation
aerosol).
An aerosol generating material ([0378], pharmaceutically active agent).
A computer ([0378], controller).
Adjusting one or more operational parameters of the aerosol provision system ([0378], wherein the dosage, frequency of administration and/or delivery schedule can be adjusted based the monitored data of a user).
Therefore, the claim is not patent eligible.
The dependent claims do not further incorporate the abstract ideas into
significantly more and just provide additional details to an abstract idea. Therefore
dependent claims 4-9 are also rejected under 101.
Regarding claim 4, the claim recites “in which the one or more operational parameters are adjusted to change the amount of an active ingredient delivered per unit volume of air inhaled”. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional element is known in the art as shown by Wensley ([0409], adjust dose). Therefore, the claim is not patent eligible.
Regarding claim 5, the claim recites “in which the computer is configured to: at least partially map the user's usage as indicated by the user profile data to the target usage of the aerosol provision system, wherein the mapping distributes the total delivered active ingredient indicated by the target usage profile across the user's usage for the predetermined period of time as indicated by the user profile data”. “map the user’s usage” and “distributes” in the context of this claim merely encompasses displaying certain results of the collection and analysis and is a process that can be practically performed in the human mind. Accordingly, the claim recites an abstract idea.
Regarding claim 6, the claim recites “in which the computer is further configured to: at least partially map the user's usage as indicated by the user profile data to the target usage of the aerosol provision system, wherein the mapping distributes delivery of an active ingredient within user inhalations responsive to a schedule of inhalations within the target usage of the aerosol provision system”. “map the user’s usage” and “distributes” in the context of this claim merely encompasses displaying certain results of the collection and analysis and is a process that can be practically performed in the human mind. Accordingly, the claim recites an abstract idea.
Regarding claim 7, the claim recites “in which the computer is further configured to: at least partially map the user's usage as indicated by the user profile data to the target usage of the aerosol provision system, wherein the mapping distributes delivery of an active ingredient during a respective user inhalation responsive to the difference between an expected inhalation duration indicated by the user profile data and a corresponding target inhalation duration”. “map the user’s usage” and “distributes” in the context of this claim merely encompasses displaying certain results of the collection and analysis and is a process that can be practically performed in the human mind. Accordingly, the claim recites an abstract idea.
Regarding claim 8, the claim recites “in which the computer is further configured to: receive from a user interface an indication from the user to commence mapping”. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional element is known in the art as shown by Wensley ([[0412], the collection and/or communication with the user device can be triggered by an event on the delivery device…the event can include a click on a portion (e.g., a button or a link) of a user display on the delivery device)). Therefore, the claim is not patent eligible.
Regarding claim 9, the claim recites “in which the operations of the computer are located within one or more of: i. the aerosol provision system; ii. a remote server operable to communicate with the aerosol provision system; iii. a mobile computing device operable to communicate with the aerosol provision system; and iv. a remote server operable to communicate with a mobile computing device operable to communicate with the aerosol provision system”. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional element is known in the art as shown by Wensley:
the aerosol provision system ([0408], wherein the delivery device can comprise a controller).
ii. a remote server operable to communicate with the aerosol provision system (network 3904, figure 39, [0408]).
iii. a mobile computing device operable to communicate with the aerosol provision system (user devices 3902 can include…mobile phones, figure 39, [0408]).
iv. a remote server operable to communicate with a mobile computing device operable to communicate with the aerosol provision system (network, figure 39, [0408]).
Therefore, the claim is not patent eligible.
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.
Claim(s) 1, 4-5, and 8-9 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bowen (US2019/0158938).
Regarding claim 1, Bowen discloses:
An aerosol provision system (vaporizer system) configured to generate aerosol from an aerosol generating material for user inhalation ([0025]) the aerosol provision system comprising:
A computer (controller 105, [0034]) configured to:
Derive user profile data indicating a user's usage of the aerosol provision system as a function of time, the user profile data indicating an amount of consumption by usage of the aerosol provision system (the current operation of the vaporizer where the parameter of dosage/exposure is compared, [0125])
Obtain data of a target usage profile indicating a target usage of the aerosol provision system as a function of time (Recording of a use profile which may include dosage/exposure, [0125]).
Estimate a difference between a total consumption by usage of the aerosol provision system over a predetermined period of time (the vaporizer may compare the use parameter to the current operation of the vaporizer, wherein the use parameter may be dosage/exposure, [0125]) corresponding to a session, the session being a period of more intense use of the aerosol provision system to generate aerosol which occurs between periods of less intense use of the aerosol provision system to generate aerosol (draw events [0125] and session control [0138]), as indicated by the user profile data (current operation of the vaporizer), and a target usage of the aerosol provision system for the session as indicated by the target usage profile (use profile, [0124]-[0125]).
Adjust one or more operational parameters of the aerosol provision system to at least partially map the user's usage over the session, as indicated by the user profile data, to the target usage of the aerosol provision system for the session (adjust the operational parameter accordingly to match the use profile, [0125]).
Wherein adjusting the one or more operational parameters of the aerosol provision system to at least partially map the user’s usage over the session, as indicated by the user profile data, to the target usage of the aerosol provision system for the session comprises, if the total consumption by usage of the aerosol provision system over the session has reached the target usage of the aerosol provision system for the session, at least one of: (i) adjusting a power supplied to a heater by the aerosol provision system in order to adjust an amount of aerosol generated by the heater or user inhalation; and (ii) stopping the generation of aerosol by the aerosol provision system by preventing a supply of power to a heater by the aerosol provision system (where the heater may be controlled based on the recorded profile [0125]).
Regarding claim 4, Bowen discloses:
In which the one or more operational parameters are adjusted to change the amount of an active ingredient delivered per unit volume of air inhaled (dosage, [0125]).
Regarding claim 5, Bowen further teaches:
In which the computer is configured to: at least partially map the user's usage as indicated by the user profile data to the target usage of the aerosol provision system (where the vaporizer may include session control, and where there is a suggested dosage limit per period of time (i.e. target usage) based on user data such as previous vaping consumption (i.e. use profile data), [0138]).
Wherein the mapping distributes the total delivered active ingredient indicated by the target usage profile across the user's usage for the predetermined period of time as indicated by the user profile data (controlling consumption of the vaporizable material for consumption over one session [0138]).
Regarding claim 8, Bowen discloses:
In which the computer is further configured to: receive from a user interface an indication from the user to commence mapping (where the recorded operational profile may be played back later by pressing the icon; the vaporizer may compare the use parameter to the current operation of the vaporizer and may adjust the operational parameter accordingly to match the use profile, [0125]).
Regarding claim 9, Bowen further discloses in which the operations of the computer are located within one or more of:
i. the aerosol provision system (controller 105 located in the vaporizer 100, [0038]).
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.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bowen (US2019/0158938) as applied to claim 1 above, and further in view of Selby (WO2016/198879, cited previously).
Regarding claim 6, Bowen further teaches:
In which the computer is configured to: at least partially map the user's usage as indicated by the user profile data to the target usage of the aerosol provision system (where the vaporizer may include session control, and where there is a suggested dosage limit per period of time (i.e. target usage) based on user data such as previous vaping consumption (i.e. use profile data), [0138]).
Bowen does not appear to explicitly disclose wherein the mapping distributes delivery of an active ingredient within user inhalations responsive to a schedule of inhalations within the target usage of the aerosol provision system.
Selby, directed to a spray delivery device, teaches:
A controller that can determine a proportionality constant K such that the rate of delivery (of the fluid) is tuned to be completed within the expected inhalation event (Pg. 12, first paragraph).
By successively adjusting the K value in this way over inhalation events allows tuning of the delivery to the anticipated inhalation profile for the user. This can all act to refine the delivery profile, such that the dose is delivered in a desired manner during a typical inhalation of a user (Pg. 13, first paragraph).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to configure the controller of Bowen to tune the rate of delivery of each dose to be completed within the inhalation event, as taught by Selby, and thus the mapping distributing delivery of an active ingredient within user inhalations responsive to a schedule of inhalations within the target usage of the aerosol provision system, because both Bowen and Selby are directed to electronic aerosol delivery systems, Selby teaches this allows the dose to be delivered in a desired manner during a typical inhalation, and this merely involves incorporating a known way to administer a dose (i.e. tuned to an inhalation profiles) to a similar electronic aerosol delivery system to yield predictable results.
Regarding claim 7, Bowen further teaches:
In which the computer is configured to: at least partially map the user's usage as indicated by the user profile data to the target usage of the aerosol provision system (where the vaporizer may include session control, and where there is a suggested dosage limit per period of time (i.e. target usage) based on user data such as previous vaping consumption (i.e. use profile data), [0138]).
Bowen does not appear to explicitly disclose wherein the mapping distributes delivery of an active ingredient during a respective user inhalation responsive to the difference between an expected inhalation duration indicated by the user profile data and a corresponding target inhalation duration.
Selby, directed to a spray delivery device, teaches:
A controller that can determine a proportionality constant K such that the rate of delivery (of the fluid) is tuned to be completed within the expected inhalation event (Pg. 12, first paragraph). The expected inhalation event defined an expected inhalation duration.
By successively adjusting the K value in this way over inhalation events allows tuning of the delivery to the anticipated inhalation profile for the user. This can all act to refine the delivery profile, such that the dose is delivered in a desired manner during a typical inhalation of a user (Pg. 13, first paragraph).
As Bowen teaches the vaporizer providing a suggested dosage limit per period of time based on user data such as previous vaping consumption, it would be obvious to configure the controller to deliver the entire dose within an expected inhalation, as taught by Selby, based on a difference between the user’s previous vaping consumption (i.e. expected inhalation duration indicated by the user profile data) and the suggested dosage limit per period of time (i.e. corresponding target inhalation duration).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to configure the controller of Bowen to tune the rate of delivery of each dose to be completed within a respective user inhalation event, as taught by Selby, and thus the mapping distributing delivery of an active ingredient during a respective user inhalation responsive to the difference between an expected inhalation duration indicated by the user profile data and a corresponding target inhalation duration, because both Bowen and Selby are directed to electronic aerosol delivery systems, Selby teaches this allows the dose to be delivered in a desired manner during a typical inhalation, and this merely involves incorporating a known way to administer a dose (i.e. tuned to an inhalation profile) to a similar electronic aerosol delivery system to yield predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole A Szumigalski whose telephone number is (703)756-1212. The examiner can normally be reached Monday - Friday: 8:00 - 4:30 EST.
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/N.A.S./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755