DETAILED ACTION
This Office Action is in response to the filing of preliminary amendment to the claims on 10/24/2024. As per the preliminary amendments, claims 1-19 and 24 have been amended, claims 20-23 and 25-35 have been cancelled, and no claims have been added. Thus, claims 1-19 and 24 are pending in the application.
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 .
Drawings
The drawings are objected to because Fig. 1 fails to comply with 37 CFR 1.83(a) whereby empty boxes should be labeled in order to give full detail of the figure at a glance. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it recites the implied phrase “is disclosed” at the end of the first sentence, which should be omitted. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 2-4, 12, 14, and 18-19 are objected to because of the following informalities:
Claim 2 lines 2-3 recites the term “comprises to determine.” Examiner suggests changing to read –comprises determining—in order to improve clarity of the claim language.
Claim 3 line 2 recites the term “comprises to determine.” Examiner suggests changing to read –comprises determining—in order to improve clarity of the claim language.
Claim 4 line 3 recites the term “comprises to determine.” Examiner suggests changing to read –comprises determining—in order to improve clarity of the claim language.
Claim 12 lines 2-3 recites the term “comprises to obtain.” Examiner suggests changing to read –comprises obtaining—in order to improve clarity of the claim language.
Claim 14 lines 2-3 recites the term “comprises to perform.” Examiner suggests changing to read –comprises performing—in order to improve clarity of the claim language.
Claim 18 line 2 recites the term “comprises to split.” Examiner suggests changing to read –comprises splitting—in order to improve clarity of the claim language.
Claim 19 line 2 recites the term “comprises to shuffle.” Examiner suggests changing to read –comprises shuffling—in order to improve clarity of the claim language.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 1-2, 5-6, 12-13, 18 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thomason (GB 2589395).
Regarding claim 1, Thomason discloses an electronic device for at least one of characterizing or monitoring an operation of an inhaler device (see page 13 lines 14-29 where the inhaler system can use software to detect parameters of the inhaler for monitoring/ feedback), the electronic device comprising: a memory; an interface; and a processor (see page 14 lines 5-18 where a computer performs the monitoring method, which is understood to have an memory, and interface, and a processor) including predictor circuitry configured to operate according to a prediction model (see page 13 lines 14-18 where the system makes a determination as to whether the user is using the inhaler correctly, which is a prediction that comes from prediction circuitry, and acts according to some algorithm that is a prediction model), wherein the processor is configured to obtain operation data, wherein the operation data is indicative of an audio signal representing an operation of the inhaler device (see page 14 lines 5-9), determine, based on the operation data, using the predictor circuitry, a predicted operation parameter indicative of a prediction of an operation of the inhaler device (see page 13 lines 14-18 where the software outputs a prediction of inhaler usage based on the monitored parameters), determine, based on the predicted operation parameter, an operation representation (see page 13 lines 14-18 where the software outputs a prediction of inhaler usage based on the monitored parameters), and output, via the interface, the operation representation (see page 13 lines 19-29 where the output is done via some application/ mobile device/ speaker as feedback).
Regarding claim 2, Thomason discloses wherein the determination of the predicted operation parameter comprises to determine one or more of: an inhalation parameter, an inhaler device status parameter, an activation parameter, a coordination parameter, or a container status parameter (see page 13 lines 14-29 where the prediction includes analyzing breathing patterns and whether the inhaler is used correctly, which are parameters regarding the inhalation and state of the inhaler).
Regarding claim 5, Thomason discloses wherein the processor is configured to determine, based on the predicted operation parameter, one or more of: a duration of the operation, a coordination of the operation, an inhalation volume, an average inhalation flow, a maximum inhalation flow, a minimum inhalation flow, median inhalation flow, an inhalation flow acceleration, an inhalation pattern, or one or more exhalation parameters (see page 13 lines 14-18 where an outputted determination as to whether the device is properly being used is a coordination of the operation, and the inhalation pattern regarding frequency is also considered).
Regarding claim 6, Thomason discloses wherein the operation representation is indicative of a performance of the operation of the inhaler device (see page 13 lines 14-29 where the feedback output is representative of the usage of the device by the user, and their performance during usage).
Regarding claim 12, Thomason discloses wherein the obtaining of the operation data comprises to obtain, based on the audio signal, sound data of the audio signal, and wherein the determination of the predicted operation parameter is based on the sound data (see page 13 lines 14-18 where the processing relies on audible signal data from the open tube whistle).
Regarding claim 13, Thomason discloses wherein the sound data comprises one or more of: a frequency signature, an amplitude signature, or a duration signature (see page 14 lines 21-30 where a frequency, duration, or harmony is able to be detected).
Regarding claim 18, Thomason discloses wherein the obtaining of operation data comprises to split the audio signal into a plurality of audio samples, and wherein the determination of the predicted operation parameter is based on one or more audio samples of the plurality of audio samples (see page 13 lines 14-29, where each inhalation that the device is being used can be considered an “audio signal” which is a split from the full duration of usage of the inhaler, each relying on the collected audio signals).
Regarding claim 24, Thomason discloses a method for at least one of characterizing or monitoring an operation of an inhaler device (see page 13 lines 14-29 where the inhaler system can use software to detect parameters of the inhaler for monitoring/ feedback), the method comprising: obtaining operation data , wherein the operation data is indicative of an audio signal representing an operation of the inhaler device (see page 14 lines 5-9); determining, based on the operation data, a predicted operation parameter indicative of a prediction of an operation of the inhaler device (see page 13 lines 14-18 where the software outputs a prediction of inhaler usage based on the monitored parameters); determining, based on the predicted operation parameter, an operation representation (see page 13 lines 14-18 where the software outputs a prediction of inhaler usage based on the monitored parameters); and outputting the operation representation (see page 13 lines 19-29 where the output is done via some application/ mobile device/ speaker as feedback).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Thomason as applied to claim 2 above, and further in view of Eicher et al. (US Pub. 2020/0384216).
Regarding claim 3, Thomason discloses the inhaler device.
Thomason lacks a detailed description of wherein the determination of the container status parameter comprises to determine whether a container is present in the inhaler device.
However, Eicher teaches a similar control and monitoring system for an inhaler, where a sensor system can be used to detect the state or tension state of the container of the inhaler, in order to determine a presence or position of the container (see [0209]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the detection software of Thomason to include a sensor and necessary software to monitor the position of the container as taught by Eicher, as it would provide additional information with regards to the physical state of the inhaler and the container, to better monitor the system.
Claims 4, 7-11, 14-15 and 19 rejected under 35 U.S.C. 103 as being unpatentable over Thomason as applied to claims 1 and 2 above, respectively, and further in view of Alizoti et al. (US Pub. 2017/0333645).
Regarding claim 4, Thomason discloses the inhaler device.
Thomason lacks a detailed description of wherein the determination of the container status parameter comprises to determine a content of a container of the inhaler device.
However, Alizoti teaches a control system for monitoring an inhaler, where the flow rate and the inhaled volume of the medicament can be monitored and determined (see [0119]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the detection software of Thomason to include a sensor and necessary software to monitor the flow and volume of the medicament in the container as taught by Alizoti, as it would provide additional information with regards to the medicament being inhaled, to better monitor the system.
Regarding claim 7, Thomason discloses the processor.
Thomason lacks a detailed description of wherein the processor is configured to: determine whether the predicted operation parameter satisfies a first criterion; in accordance with the predicted operation parameter satisfying the first criterion, determine a first recommendation; and output, via the interface, the first recommendation.
However, Alizoti teaches a processing system for an inhaler, where the system can output a prediction based on feedback with regards to how the user should operate the device, and provide a recommendation on how to proceed using the device (see [0119]-[0121]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the feedback of the control system of Thomason to give a recommendation as to how to proceed as taught by Alizoti, as it would condition the user to improve their compliance with the inhaler, improving efficacy.
Regarding claim 8, the modified Thomason device has wherein the first criterion comprises one or more of: a coordination criterion, an activation criterion, an inhaler status criterion, inhalation criterion, or a container status criterion (Alizoti; see [0119] where feedback on when to activate is activation criterion).
Regarding claim 9, the modified Thomason device has wherein the first recommendation is comprised in the operation representation (Alizoti; see [0119] where the recommendation is provided via a feedback that can be visual or auditory).
Regarding claim 10, the modified Thomason device has wherein the first recommendation comprises one or more of: an inhaler device maintenance recommendation, a container recommendation, a coordination recommendation, an inhalation depth recommendation, an inhalation duration recommendation, an inhalation flow rate recommendation, or an inhalation preparation recommendation (Alizoti; see [0119] where a recommendation can be for the inhalation flow rate).
Regarding claim 11, Thomason discloses the electronic device.
Thomason lacks a detailed description of wherein the electronic device comprises one or more microphones for obtaining the audio signal.
However, Alizoti teaches a control system for an inhaler, where an input device for the audio signal can be a microphone (see [0127]-[0129]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the collection of audio signals of Thomason to be done via a microphone as taught by Alizoti, as it would be a simple substation of one audio signal gathering sensor for another, to yield the predictable result of gathering audio signals.
Regarding claim 14, Thomason discloses the operation data.
Thomason lacks a detailed description of wherein the obtaining of the operation data comprises to perform pre-processing of the audio signal.
However, Alizoti teaches an inhaler control system, where the audio signals can be filtered according to different filtering bands, before being further processed (see [0150]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the signal processing of Thomason to filter the audio signals as taught by Alizoti, as it would help reduce noise.
Regarding claim 15, the modified Thomason device has obtaining of the operation data.
Thomason lacks a detailed description of wherein the obtaining of the operation data comprises to identify a background noise from the audio signal.
However, Alizoti teaches an inhaler control system, where the audio signals can be filtered according to different filtering bands, to remove ambient noise (see [0150] where filtering the audio data includes identifying and removing ambient noise).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the signal processing of Thomason to filter the audio signals as taught by Alizoti, as it would help reduce noise.
Regarding claim 19, Thomason discloses the obtaining of operation data.
Thomason lacks a detailed description of wherein the obtaining of operation data comprises to shuffle the plurality of audio samples and wherein the determination of the predicted operation parameter is based on the shuffled audio samples.
However, Alizoti teaches an inhaler control system, where the audio signals can be filtered according to different filtering bands, the filtering resulting in some amount of change to the sequence of audio signals as some are filtered out, and thus results in a shuffling (see [0150] where filtering the audio data includes identifying and removing ambient noise).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the signal processing of Thomason to filter the audio signals as taught by Alizoti, as it would help reduce noise.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Thomason as applied to claim 1 above, and further in view of Haussermann et al. (US Pub. 2021/0110905).
Regarding claim 16, Thomason discloses the predictor circuitry.
Thomason lacks a detailed description of wherein the predictor circuitry comprises a neural network module configured to operate according to a neural network.
However, Haussermann teaches a control system for an inhaler, where analysis of audio signals can be done with an artificial neural network (see [0024]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the circuitry of the Thomason device to use a neural network as taught by Haussermann, as it would be a simple matter of design choice for a person of ordinary skill in the art to choose a different style of processing circuitry.
Regarding claim 17, the modified Thomason device has wherein the neural network is a deep neural network, configured to operate according to a classification model (Haussermann; see [0039] and [0045] where the neural network is pre-trained as a classifier).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Cameron et al. (US Pat. 10,244,791), and Costella et al. (US Pat. 10,894,142) are cited to show similar control systems for monitoring and detecting respiratory parameters.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Fri 10:00-6:00.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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