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
Amendment filed 7/16/2025 has been entered and fully considered. Claims 17-29 are pending. Claims 1-17 are cancelled. Claim 29 is amended. No new matter is added.
Response to Arguments
Applicant's arguments filed 7/16/2025 have been fully considered but they are not persuasive.
Applicant argues that Nielson does not clearly disclose the detection of a second phase of an inhalation. This is because Nielson merely discloses that a flow sensor may be used to detect when threshold values related to airflow are reached. It is therefore unclear which aspect of detection the Examiner deems to correspond to a first and second phase of inhalation and how this directly corresponds to the production of the first and second versions of aerosol respectively.
Examiner respectfully disagrees. Nielson discloses that the flow sensor detects the level of reduced pressure and the aerosol is adapted to the level of reduced pressure (Paragraph [0139]). Thus, the flow sensor must be able to detect each level of air flow based on the level of reduced pressure. Any two levels of reduced pressure detected by the flow sensor is a detection of the claimed first and second phases of inhalation. Even if there are more levels of detection, there are at least two.
Applicant argues that the Examiner appears to interpret the first activation signal and second activation signal in Nielson to correspond to the generation of a first and second version of aerosol with modified properties. However, this is not clear from the disclosure of Nielson, which simply discusses that the first and second atomizers used may have different velocities, without teaching that a property of the aerosol generated itself is modified.
Examiner respectfully disagrees. Nielson explicitly discloses that the first and second atomizers, FA and SA, are activated by the first activation signal, FASI, and the second activation signal, SASI (Paragraph [0273]). Thus, each atomizer is necessarily activated and generates aerosol based on the respective activation signal. The types of aerosol generated varies based on particle size and are controlled for each atomizer (Paragraphs [0010], [0013], [0207], [0225]). The different aerosol sizes represent a first property modified to a first version during the first phase, such as going from a first initial size, or even a liquid state, to a defined particle size set by the first atomizer, which is then modified to a second version having a different particle size while in the second phase of inhalation. The timing between phases is determined by the threshold levels in which FASI and SASI are activated (Paragraphs [0286]; Figures 11B and 11C).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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Claim(s) 17, 19-25, 28 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over NIELSEN (US 2017/0251727) in view of HEIDL et al. (US 2019/0289915)
With respect to claim 17, NIELSEN discloses an aerosol delivery system (Abstract). The system comprising a delivery device (Figure 1; Abstract; Paragraph [0021]) an electronic control arrangement that controls the atomizers (Paragraphs [0203]-[0206]); Figure 1 and 9). The controller is configured to generate (FASI) a first version (Figures 11A-11C; Paragraphs [0273]-[0276]) of an aerosol having a first property of constituents being vaporized (Abstract; Paragraphs [0033], [0078], [0016], [0149], [0189], [0219]), such as a particular particle size or the use of nicotine; and the controller is configured to generate (SASI) a second aerosol having a second property (Abstract; Paragraphs [0033], [0149], [0189], [0219]), such as a particular particle size or the use of a buffer or other additive, that is different than the first version.
NIELSEN further discloses a flow sensor (e.g., detection means) (Paragraphs [0138], [0139]) for detecting more than one phase of inhalation, whereby the activation of first and section versions are activated according to different threshold levels of the air flow (Paragraph [0284]-[0286]; Figure 11C).
As seen in figure 11C, the first version may include both the first vapor and second vapor, until a threshold phase of inhalation is reached (e.g., detecting a second phase of inhalation), at which point the amount of section vapor is increase to create a different version of the aerosol (e.g., second version of aerosol having a second property at the detection of the second phase of inhalation).
While NIELSEN discloses a controller, a processor for the controller and detection means is not mentioned. HEIDL et al. discloses a vaporizer device (Abstract). The device includes one or more controllers and processors for controlling the aspects of the device (Paragraph [0047], [0064]) by executing program instruction. The processor may also retrieve information from the cartridge, and then detect a puff event so that the proper vaporizing profile can be achieved (Paragraph [0113]). It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention, to provide at least one processor with the controller of NIELSEN, as taught by HEIDL et al., so that the controller can detect the pressure sensor of NIELSEN, as well as determine the aerosol being currently generated, thereby allowing the proper heating and vapor profile to be generated using programmed instructions.
The processor of the controller also detects the pressure sensor, and thus represents both a control process or and detection processor.
Claim 17 requires that the ingredient of the first version has an active effect that occurs upon absorption, while the second version has an ingredient whose active effect occurs when tasted. The ingredients themselves are materials worked upon by the claimed apparatus. The courts have generally held that "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). MPEP 2115. Thus, the specific ingredients of the various phases of different vapors does not impart patentability to the claims. Specifically, the device of NIELSEN is capable of providing two different versions of aerosols having different constituents within each aerosol phase. Changing the types of ingredients does not change the structure of the device claimed, or the manner of controlling the device claimed.
With respect to claim 19, NIELSEN discloses that the device comprises two aerosol generators (e.g., first atomizer and second atomizer) (Paragraph [0183]), with each being connected to a respective payload source (Paragraph [0189]). These atomizers are selectively activated to generate their respective payloads (Abstract; Paragraphs [0033], [0149], [0189], [0219], [0203]-[0206]).
With respect to claim 20, NIELSEN discloses that the first property is aerosol particle size (Paragraphs [0133], [0149]-[0158]).
With respect to claim 21, NIELSEN discloses that the particle size of the first aerosol is smaller than the second aerosol (Paragraph [0133]). Thus, when the FASI ends and the SASI is still activated, the second version particle size is greater than the first (See figure 11C).
With respect to claim 22, NIELSEN discloses that the particles size of the first and second version is changed by adjusting the temperature of the atomizers (Paragraph [0012], [0199], [0200]))
With respect to claim 23, NIELSEN discloses that inhalation is detected as an airflow using an airflow detector (Paragraphs [0193], [0203], [0228]-[0235).
With respect to claim 24, NIELSEN discloses that the first and second atomizers are activated according to threshold levels of the air flow (Paragraphs [0285], [0286]). As seen in figure 11C, the first phase occurs until above a fist threshold.
[AltContent: connector][AltContent: textbox (Start of second phase above threshold, thus end of first phase)][AltContent: arrow][AltContent: textbox (Threshold)][AltContent: arrow]
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With respect to claim 25, NIELSEN discloses that the second phase is occurring with peak airflow level.
With respect to claim 28, HEIDL et al. discloses that the device includes a communication network that wirelessly communicated with a smart phone (e.g. mobile communications device) (Paragraph [0039]). The communication device comprises an app that executes (e.g., processes and therefore representing a processor) the information and provides the device with the vaporizing profiles (e.g., control processor) (Paragraphs [0041]-[0044]l Figure 2).
With respect to claim 29, NIELSEN discloses a first payload for aerosolizing by the first delivery device (Paragraph [0189]).
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Claim(s) 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over NIELSEN (US 2017/0251727) in view of HEIDL et al. (US 2019/0289915) as applied to claims 17, 19-25, 28 and 29 above, and further in view of THORENS (US 2017/0318861).
With respect to claim 26, NIELSEN does not explicitly disclose that the controller is configured to measure airflow during a plurality of inhalations and model those inhalation airflow profiles.
THORENS discloses a method of controlling an inhalation device (Abstract) comprising a controller for recording a user puff signature based on signals from a gas flow sensor during a set-up procedure (Paragraph [0012], [0034]-[0036]). The set-up procedure involves the user providing a series of puffs (e.g., inhalations) that are measured and recorded (Paragraphs [0082], [0083]; Figures 2, 3 and 4). The puffs are used to create a temporal profile (e.g., model) of the inhalation profile based on the measurements, that are stored in the memory of the device (Paragraphs [0081], [0085], [0086], [0089]). This allows the inhalation device to authenticate a user based on their puff profile.
The profiles made in figure 2 represent a model that is formed from an inhalation airflow profile.
It would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to configured the controller of NIELSEN to measure airflow during a plurality of inhalations of the user, and to model the one or more inhalation airflow profiles based on the measurements, as taught by THORENS, so that the inhalation device is able to authenticate the user based on puff profile.
With respect to claim 27, THORENS discloses a method of controlling an inhalation device (Abstract) comprising recording a user puff signature based on signals from a gas flow sensor during a set-up procedure (Paragraph [0012]). The set-up procedure involves the user providing a series of puffs (e.g., inhalations) that are measured and recorded (Paragraphs [0082], [0083]; Figures 2, 3 and 4). The puffs are used to create a temporal profile (e.g., model) of the inhalation profile based on the measurements, that are stored in the memory of the device (Paragraphs [0081], [0085], [0086], [0089]).
The profiles made in figure 2 represent a model that is formed from an inhalation airflow profile.
THORENS then compares the subsequent airflow measurements from the user to the model in order to create a correlation score (e.g., matching airflow measurements to a modelled profile) to determine if the inhalation measurement is within a tolerance (Paragraphs [0015], [0017], [0085], [0088], [0091]).
The stored data is then used to predict the course of the smoking session based on this profile (Paragraph [0090]). While not explicitly disclosing that the predictions are of the end of the first phase of inhalation and the start of the second phase, with the smoking session being predicted, it would have been obvious to one having ordinary skill in the art, to predict all of the course of the smoking session, such as the start and end of each phase, so that the device operation is optimized.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX B EFTA whose telephone number is (313)446-6548. The examiner can normally be reached 8AM-5PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Philip Tucker can be reached at 571-272-1095. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEX B EFTA/Primary Examiner, Art Unit 1745