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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 calls to determining that “the canister is moved back to the first position” however claim 1 defines the first position as a position of the pressure sensor, thus it is unclear if the canister or the pressure sensor is in the first position. The claim is being interpreted as calling to --- the pressure sensor moved back to the first position upon the release of the canister ---.
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.
Claims 1-2, 6-7, 9, 19, 22 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farina (US 2019/0224426 A1).
Regarding claim 1, Farina discloses an inhaler (par 0013, fig 4A-4B, 5A-5B) comprising: a housing (#403 fig 4A-4B, 5A-5B) that comprises a mouthpiece (see Farina annotated fig 4B below), a medication canister (#401 fig 4A-4B, 5A-5B), and an airflow channel (par 0080, "air flowing in between the inhaler canister 401 and actuator body 403 during inhalation") formed between an air inlet (see Farina annotated fig 4B below, par 0080) and the mouthpiece (see Farina annotated fig 4B below, par 0080); a pressure sensor (#320 fig 3B, par 0080 “barometer”, see also full sensor device #300 fig 5A-5B) configured to measure a pressure indicative of the pressure in the airflow channel (par 0080), wherein the pressure sensor is configured to be in a first position relative to the airflow channel when the medication canister is not actuated (see position in fig 5b), and in a second position relative to the airflow channel when the medication canister is in an actuated position (as the sensor is attached to the medication canister, when the canister is depressed for actuation the sensor moves closer to the airflow channel/air inlet); and a processor that is configured to: receive pressure measurements from the pressure sensor (par 0078); and determine that the medication canister was actuated based on the pressure measurements (par 0084, 0092).
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Farina annotated fig 4B
Regarding claim 2, Farina discloses the inhaler of claim 1. Farina further discloses the processor is configured to determine the position of the pressure sensor or the medication canister based on the pressure measurements received from the pressure sensor while a user is inhaling through the mouthpiece of the inhaler (par 0092 discloses measuring actuation hold time thus disclosing determining when actuation starts and concludes thus disclosing determining the sensor being in both first and second positions, par 0084 discloses determining actuation and inhalation parameters in combination thus disclosing actuation parameters being measured during inhalation through the mouthpiece).
Regarding claim 6, Farina discloses the inhaler of claim 1. Farina further discloses the sensor is connected to the medication canister (see fig 1, 4, 5, par 0060).
Regarding claim 7, Farina discloses the inhaler of claim 1. Farina further discloses the pressure sensor comprises a differential pressure sensor or a barometric pressure sensor (par 0076 “barometer”).
Regarding claim 9, Farina discloses the inhaler of claim 1. Farina further discloses the processor is configured to determine an inhalation event based on the pressure measurements received from the pressure sensor exceeding an inhalation threshold, and determine a canister actuation event based on the pressure measurements exceeding a canister actuation threshold (par 0084 discloses inhalation parameters and actuation parameters being determined based on the sensors meeting thresholds).
Regarding claim 19, Farina discloses the inhaler of claim 1. Farina further discloses the pressure sensor comprises a pressure port (par 0080 disclosing using pressure tap tubes and ports with the pressure sensor), and wherein the pressure sensor is configured such that it does not extend into the inhaler housing when the pressure sensor is in the first position or the second position (see fig 5B showing sensor device being wider than inlet and thus does not enter housing when in the second position, and par 0080 instead disclosing the pressure tap tube entering the housing for pressure communication with the sensor).
Regarding claim 22, Farina discloses the inhaler of claim 1. Farina further discloses a capillary tube connected to a sensor port of the pressure sensor, wherein the capillary tube is configured to extend from the pressure sensor into the housing (#410 fig 4A-7, par 0080).
Regarding claim 29, Farina discloses the inhaler of claim 1. Farina further discloses the processor is configured to determine that the medication canister was manually actuated based on the pressure measurements (par 0092 disclosing actuation involves compressing the canister thus disclosing manual actuation).
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.
Claims 3-5, 14-17 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Farina as applied to claims 1 and 9 above, and further in view of Samson (US 2016/0325058 A1).
Regarding claim 3, Farina discloses the inhaler of claim 1. Farina is silent to the processor is configured to generate an error event based on a slope of the received pressure measurements not exceeding a slope threshold that is indicative of the canister actuation during an inhalation; and send, via a transmitter, the error event to an external device for display via a user interface of the external device. Farina does discloses using thresholds for determining proper actuations and inhalations (par 0084, 0130).
Samson teaches a similar inhaler device wherein a processor is configured to generate an error event based on a slope of the received pressure measurements not exceeding a slope threshold that is indicative of the canister actuation during an inhalation (par 0165 discloses using slope of flow data to determine proper actuation occurring during inhalation, par 0031 discloses using a pressure sensor for obtaining actuation data, par 0047 disclosing using the same pressure sensor for flow and actuation detection, par 0033 discloses using the pressure sensor for obtaining flow data); and send, via a transmitter, the error event to an external device for display via a user interface of the external device (par 0149 discloses generating patient instructions on actuation timing, par 0005 discloses transmitting from the inhaler to a computing device/mobile phone).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize compliance monitoring as taught by Samson on the device of Farina as doing so allows a user to improve actuation and/or inhalation technique (Samson: par 0064).
Regarding claim 4, Farina discloses the inhaler of claim 1. Farina is silent to the processor is configured to generate a late inhalation error event based on the determination that the actuation of the medication canister did not occur during an inhalation; and send, via a transmitter, the late inhalation error event to an external device for display via a user interface of the external device. Farina does discloses using thresholds for determining proper actuations and inhalations (par 0084, 0130).
Samson teaches a similar inhaler device wherein a processor is configured to generate a late inhalation error event based on the determination that the actuation of the medication canister did not occur during an inhalation (par 0148-0149); and send, via a transmitter, the late inhalation error event to an external device for display via a user interface of the external device (par 0149, 0005).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize compliance monitoring as taught by Samson on the device of Farina as doing so allows a user to improve actuation and/or inhalation technique (Samson: par 0064).
Regarding claim 5, Farina discloses the inhaler of claim 1. Farina is silent to the processor is configured to generate a good inhalation event based on a slope of the received pressure measurements exceeding a slope threshold that is indicative of the canister actuation during an inhalation; and send, via a transmitter, the good inhalation event to an external device for display via a user interface of the external device. Farina does discloses using thresholds for determining proper actuations and inhalations (par 0084, 0130).
Samson teaches a similar inhaler device wherein a processor is configured to generate a good inhalation event based on a slope of the received pressure measurements exceeding a slope threshold that is indicative of the canister actuation during an inhalation (par 0165 discloses using slope of flow data to determine proper actuation occurring during inhalation, par 0031 discloses using a pressure sensor for obtaining actuation data, par 0033 discloses using the pressure sensor for obtaining flow data, par 0047 disclosing using the same pressure sensor for flow and actuation detection, par 0166 discloses interface indicating good inhalation); and send, via a transmitter, the good inhalation event to an external device for display via a user interface of the external device (par 0166 discloses interface indicating good inhalation, par 0005 discloses transmitting from the inhaler to a computing device/mobile phone).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize compliance monitoring as taught by Samson on the device of Farina as doing so allows a user to improve actuation and/or inhalation technique (Samson: par 0064).
Regarding claim 14, Farina discloses the inhaler of claim 9. Farina is silent to the processor is configured to determine a duration of an inhalation event based on the pressure measurements received from the pressure sensor.
Samson teaches a similar inhaler device that determine a duration of an inhalation event based on the pressure measurements received from the pressure sensor (par 0087 discloses detecting inhalation based on pressure changes, par 0066 discloses determining the total inhalation times, par 0044 discloses determining inhalation vs non-inhalation air movement).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine inhalation duration as taught by Samson on the inhaler of Farina as doing so allows for the inhaler to generate predicative alerts for improving actuation timing (Samson: par 0066).
Regarding claim 15, modified Farina discloses the inhaler of claim 14. Samson further discloses the duration of the inhalation event starts at the time of the canister actuation event and ends when the parameters return to a predetermined value (par 0148 discloses measuring inhalation in relation to canister actuation this disclosing measuring a time between actuation and the end of inhalation, par 0044 disclosing detecting non-inhalation movement).
Regarding claim 16, Farina discloses the inhaler of claim 1. Farina is silent to the processor is configured to determine a peak inspiratory flow (PIF) based on the received pressure measurements, and generate a late actuation error event based on the PIF exceeding a threshold prior to the determination that the canister is actuated.
Samson teaches a similar inhaler device wherein a processor is configured to determine a peak inspiratory flow (PIF) based on the received pressure measurements (par 0033 discloses using the pressure sensor for obtaining flow data, par 0164 discloses determining PIF), and generate a late actuation error event based on the PIF exceeding a threshold prior to the determination that the canister is actuated (par 0164-0165 discloses good inhalation being when the actuation aligns with the peak inhalation flow and thus bad inhalation being when they do not align/actuation is late).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize compliance monitoring as taught by Samson on the device of Farina as doing so allows a user to improve actuation and/or inhalation technique (Samson: par 0064).
Regarding claim 17, Farina discloses the inhaler of claim 1. Farina further discloses using thresholds for determining proper actuation and inhalations (par 0084, 0130) including monitoring measurements to see if they exceed a value for a period of time (par 0092, 0105). Farina is silent to the processor is configured to generate a late actuation error event based on a slope of the pressure measurements exceeding a threshold for a period of time that exceeds a duration threshold prior to the determination that the canister is actuated.
Samson teaches a similar inhaler device wherein a processor is configured to generate a late actuation error event based on a slope of the pressure measurements exceeding a threshold for a period of time that exceeds a duration threshold prior to the determination that the canister is actuated (par 0165 discloses using slope of flow data to determine proper actuation occurring during inhalation by monitoring if the actuation happened within a predetermined threshold time from the beginning of the inhalation, par 0069 discloses determining appropriate timing by determining the time between the start of inhalation to the actuation being within a threshold par 0031 discloses using a pressure sensor for obtaining actuation data, par 0033 discloses using the pressure sensor for obtaining flow data, par 0047 disclosing using the same pressure sensor for flow and actuation detection, par 0166 discloses interface indicating good inhalation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize compliance monitoring as taught by Samson on the device of Farina as doing so allows a user to improve actuation and/or inhalation technique (Samson: par 0064).
Regarding claim 28, Farina discloses the inhaler of claim 1. Farina does not expressly disclose the processor is configured to determine a start time of the user's inhalation based on the pressure measurements, determine an end time of the user's inhalation based on a determination that an exhalation occurred using the pressure measurements, and determine a duration of the user's inhalation based on the start time and the end time; wherein the processor is configured to send data indicating the duration of the user's inhalation to an external device for display to the user.
Samson teaches a similar inhaler that is configured to determine a start time of the user's inhalation based on the pressure measurements (par 0087 discloses detecting inhalation based on pressure changes, par 0066 discloses determining the total inhalation time thus disclosing determining the start and the end, par 0044 discloses determining inhalation vs non-inhalation air movement), determine an end time of the user's inhalation based on a determination that an exhalation occurred using the pressure measurements (par 0044 discloses a non-inhalation air movement thus disclosing exhalation), and determine a duration of the user's inhalation based on the start time and the end time (par 0066); wherein the processor is configured to send data indicating the duration of the user's inhalation to an external device for display to the user (par 0066-0067).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to monitor inhalation time as taught by Samson on the inhaler of Farina as doing so allows for a user to observe their inhalation and better coordinate actuation (Samson: par 0066-0067).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Farina as applied to claim 9 above, and further in view of Shah (US 2021/0220586 A1).
Regarding claim 10, Farina discloses the inhaler of claim 10. Farina is silent to the canister actuation threshold is a slope threshold.
Shah teaches the use of slope thresholds for improved accuracy compared to thresholds (par 0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize slope thresholds as taught by Shah for the canister actuation threshold of Farina as doing so can provide improved accuracy (Shah: par 0047).
Regarding claim 11, Farina discloses the inhaler of claim 9. Farina further discloses the processor is configured to determine that the canister moved back to the first position upon the release of the canister based on the pressure measurements exceeding a canister released threshold (par 0084 discloses actuation parameters being determined based on the sensors meeting thresholds, par 0092 discloses detecting actuation hold time thus disclosing both the canister being actuated and released in order to determine the hold time).
Farina is silent to a slope of the pressure measurements being used to determine canister release.
Shah teaches the use of slope thresholds for improved accuracy compared to thresholds (par 0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize slope thresholds as taught by Shah for the canister release threshold of Farina as doing so can provide improved accuracy (Shah: par 0047).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Farina as applied to claim 1 above, and further in view of Decker (US 2024/0023631 A1).
Regarding claim 24, Farina discloses the inhaler of claim 1. Farina is silent to the processor is configured with a first flow rate calibration curve for when the pressure sensor is in the first position, and a second flow rate calibration curve for when the pressure sensor is in the second position.
Decker teaches utilizing different calibration models based on the location of components (par 0051 disclosing different calibration models, par 0046 disclosing element 134 as discussed on par 0051 to be a pressure sensor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize different calibration models dependent on sensor position as taught by Decker on the inhaler of Farina as doing so improves the accuracy of the barometric pressure sensor, since in the second position the pressure tap tube of Farina is deeper within the canister housing thus impacting the pressure and flow, as pressure and flow are known to be affected by a change in flow area (see for example Bernoulli’s equation).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Farina as applied to claim 1 above, and further in view of Biswas (US 2016/0144141 A1).
Regarding claim 27, Farina discloses the inhaler of claim 1. Farina further discloses the processor is configured to determine a shake event of the inhaler (par 0084). However, Farina is silent to the shake event being determined based on the pressure measurements received from the pressure sensor.
Biswas teaches an inhaler configured to determine a shake event of the inhaler based on the pressure measurements received from the pressure sensor (par 0076).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the pressure sensor of farina to detect a shake event as taught by Biswas, as doing so allows the shake detection sensor of Farina to be removed, decreasing the components needed on Farina and thus reducing weight.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mishelevich (US 5,363,842) discloses a compliance monitoring inhaler
Morrison (US 2017/0290527 A1) discloses an inhaler with a pressure sensor monitoring pressure via a capillary tube
Ciancone (US 2021/0268212 A1) discloses an inhaler interface for monitoring usage
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIRA B DAHER whose telephone number is (571)270-0190. The examiner can normally be reached M-F 8am-5pm.
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/KIRA B DAHER/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799