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
This office action is in response to the amendment filed on 02/19/2026. As directed by the amendment, claims 1, 31 and 49 have been amended. As such, claims 1-10, 13, 30-35 and 49-52 are being examined in this application.
Applicant has amended the specification to address a minor informality; the specification objection has been withdrawn.
Response to Arguments
Applicant’s arguments, see pages 10-13 of Remarks, filed 02/19/2026, pertaining to the 35 USC 101 have not been found persuasive. Applicant argues the claims are directed towards a concrete technological improvement in inhaler dose measurements, not to an abstract idea. However, the examiner is unpersuaded as a person can calculate airflow (using an equation) with pressure data from the pressure sensor and calculate the dose of solid particles (using an equation) using the airflow and power density. Furthermore, it is known within the art for an inhalation device to use a barometric pressure sensor with an optical sensor that detects powder (taught by Calderon), for an aerosol generation system to use a light source and optical detector to measure aerosol particle size (taught by Van Der Mark) and for the optical system to be located in the mouthpiece of a nebulizer (taught by Bentvelsen). All three prior arts use an aerosol device and an optical sensor/system to detect powders. As such, one of ordinary skill in the art would recognize that using an optical sensor arrangement within the mouthpiece. Not to mention, Verjus (US 20180126099 A1) teaches an inhalation apparatus comprising sensor 5 with a light source 12 and detector 14 to detect particles as seen in Figs. 1-2 and [0088]-[0089] and [0098]. Verjus further teaches the sensor 5 integrated at a distal tip of the second end/mouthpiece 3 as seen in Figs. 1-2. The examiner would like to point out there is a lack of practical application within claims 1-10, 13, 30-35, 49 and 51-52.
Applicant's arguments, see pages 13-16 of Remarks, filed 02/19/2026, pertaining to the newly amended limitations have been noted. However, a new ground(s) of rejection has been provided below to address the newly added limitations.
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 1-10, 13, 30-35 and 49 and 51-52 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is directed to “a device,” (i.e. a machine) and claim 31 is directed to “a method,” (i.e. a process), hence the claims are directed to one of the four statutory categories (i.e. process, machine, manufacture, or composition of matter). In other words, Step 1 of the subject-matter eligibility analysis is “Yes.”
However, the claims are drawn to an abstract idea of “detecting an inhalation produced in the inhalation mouthpiece by means of analyzing the pressure of the air inside the outlet conduit” in the form of “mental processes,” in terms of processes that can be performed in the human mind (including an observation, evaluation, judgement or opinion).
The claims are further drawn to an abstract idea of “calculating an airflow going through the outlet conduit using the pressure signal of the barometric pressure sensor and the section of the outlet conduit; and calculating, using the airflow and the powder density, a dose of solid particles suspended in the inhaled air going through the outlet conduit in the detected inhalation” in the form of “mathematical calculations,” an act of calculating using mathematical methods to determine a variable or number.
These limitations simply describe a process of data gathering and manipulation, which is partially analogous to “collecting information, analyzing it, and displaying certain results of the collection analysis” (i.e. Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016)) and an act of calculating using mathematical methods to determine a variable or number, which is partially analogous to “calculating a number representing an alarm limit value using the mathematical formula ‘‘B1=B0 (1.0–F) + PVL(F)’’ (i.e. Parker v. Flook, 437 U.S. 584, 585, 198 USPQ 193, 195 (1978)). Hence, these limitations are akin to an abstract idea which has been identified among non-limiting examples to be an abstract idea. In other words, Step 2A, Prong 1 of the subject-matter eligibility analysis is “Yes.”
Furthermore, the claims do not include additional elements that either alone or in combination are sufficient to claim a practical application because to the extent that, e.g., “an inhalation mouthpiece,” “a powder sensor,” “a barometric pressure sensor,” ”a control unit,” “at least one presence sensor,” “an inhaler” and “a spacing chamber” are merely claimed to generally link the use of a judicial exception (e.g., pre-solution activity of data gathering and post-solution activity of presenting data) to (1) a particular technological environment or (2) field of use, per MPEP §2106.05(h); and are applying the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, per MPEP §2106.05(f). In other words, the claimed ““detecting an inhalation produced in the inhalation mouthpiece by means of analyzing the pressure of the air inside the outlet conduit; calculating an airflow going through the outlet conduit using the pressure signal of the barometric pressure sensor and the section of the outlet conduit; and calculating, using the airflow and the powder density, a dose of solid particles suspended in the inhaled air going through the outlet conduit in the detected inhalation,” is not providing a practical application, thus Step 2A, Prong 2 of the subject-matter eligibility analysis is “No.”
Likewise, the claims do not include additional elements that either alone or in combination are sufficient to amount to significantly more than the judicial exception because to the extent that, e.g. “an inhalation mouthpiece,” “a powder sensor,” “a barometric pressure sensor,” “a control unit,” “at least one presence sensor,” “an inhaler” and “a spacing chamber” are claimed, these are generic, well-known, and conventional elements. As evidence that these are generic, well-known, and a conventional elements (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known, the Applicant’s specification discloses these in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a), per MPEP § 2106.07(a) III (a). As such, this satisfies the Examiner’s evidentiary burden requirement per the Berkheimer memo.
The element of “an inhaler” is described on page 7, lines 11-12, states: “Figure 1 shows a generic inhaler from the state of the art to which the device of the present invention can be coupled.” As such, the element can be any generic inhaler in the art that can be used with the device and therefore can be any generic and conventional inhaler.
Moreover, the element of “a control unit” is described on page 12, lines 15-17 and page 14, lines 4-6, as follows: “(see page 12, lines 15-17) The dose measuring device 1 comprises a control unit 6 (a circuit or hardware element with electronic control functions, implemented for example by means of a microcontroller) …” and “(see page 14, lines 4-6) … the device may include a memory 16 (such as an EEPROM memory, a flash memory, a micro SD card, etc.), which can be incorporated in the actual control unit 6.” This element is reasonably interpreted as a generic hardware, circuit or memory card with no details of anything beyond ubiquitous standard equipment.
Similarly, the element of “a barometric pressure sensor” is described on page 4, lines 24-25, as follows “(see page 4, lines 24-25) Barometric pressure sensor: A digital barometer measuring the air pressure in the inhalation mouthpiece.” This element is a generic barometric sensor used to measure pressure with no description beyond what is otherwise known to be in existence.
The element of “at least one presence sensor” is described on page 23, lines 13-15, as follows: “The device may also comprise at least one presence sensor (implemented by means of at least one pressure sensor, at least one light sensor, at least one impedance sensor or a combination thereof) …” This element is reasonably interpreted as a generic pressure sensor, light sensor or impendence sensor with no details beyond what is known in the art.
The element of “a spacing chamber” is known in the art as taught by Suman (US 20050072421 A1) which recites: “A conventional improvement includes MDI dosing in conjunction with a spacer, which is now recommended for treating young children during acute episodes to partially mitigate against this problem (see [0009]).” As such, a spacer/spacing chamber is known in the art and a conventional equipment.
The element of “a powder sensor” comprises “an optical emitter adapted to emit a first beam of light into the outlet conduit through a first opening located in a periphery of the outlet conduit; and an optical receiver adapted to receive a second beam of light reflected by solid particles suspended in air inside the outlet conduit through a second opening in the periphery of the outlet conduit; wherein the optical emitter is aligned along a first axis and the optical receiver is aligned along a second axis different from the first axis.” However, Van Der Mark teaches the powder sensor (light source 6c and optical detector 8c, see Fig. 1 and [0046] and [0048]) configured for providing a reading of the powder density (Van Der Mark teaches a light source arrangement providing signals at first and second wavelength, recording the detected light signals and processing the light signals to derive the aerosol particle size and aerosol density as seen in [0042], [0024] and [0113]), the powder sensor comprising: an optical emitter (light source 6c, see Fig. 1) adapted to emit a first beam of light (light source 6c introduces a first beam of light signal diagonally into the aerosol flow as seen in Fig. 1 and Van Der Mark’s Annotated Fig. 1 by beam 3c); and an optical receiver (optical detector 8c, see Fig. 1) adapted to receive a second beam of light reflected by solid particles suspended in air (optical detector 8c receives a second beam of light that has been reflected or scattered by the aerosol particles 2 as shown by beam 3c in Fig. 1 and Van Der Mark’s Annotated Fig. 1 and [0048], [0078], and [0083]); wherein the optical emitter is aligned along a first axis and the optical receiver is aligned along a second axis different from the first axis (Van Der Mark’s Annotated Fig. 1 shows light source 6c along a first axis and the optical detector 8c along a second axis different from the first axis). Furthermore, Van der Mark teaches the invention to sense particle size and density in a nebulizer mouthpiece as seen in [0138] and teaches the detectors to be provided in a ring inside the mouthpiece as seen in [0136]. One of ordinary skill in the art, would recognize integrating the powder sensor within a mouthpiece (which is also further taught by Figs.1-5 of Verjus (US 20180126099 A1 as shown in the rejection below). As such, the powder sensor comprising an optical emitter and optical receiver is known within the art.
The element of “an inhalation mouthpiece” is described on page 3, lines 19-20 and page 4, lines 16-17, as follows: “An inhalation mouthpiece, comprising an outlet conduit for the passage of inhaled air (see page 3, lines 19-20)” and “Inhalation mouthpiece which is coupled to the free end of the mouthpiece of an inhaler or of a spacing chamber (see page 4, lines 16-17).” Mouthpieces for inhalers are generic and known in the art as the user requires a mouthpiece to inhale the medication. Furthermore, Suman (US 20050072421 A1) teaches “A conventional improvement includes MDI dosing in conjunction with a spacer, which is now recommended for treating young children during acute episodes to partially mitigate against this problem (see [0009]).” Suman further teaches a space mouthpiece in [0055], especially as Suman teaches inhalers having a common interface between the device and the patient’s mouth (see [0025]). Furthermore, an inhalation mouthpiece comprising an outlet conduit is well known in the art as medication needs to exit through an outlet to enter the user.
As such, the elements of “an inhalation mouthpiece,” “a powder sensor,” “a barometric pressure sensor,”” a control unit,” “at least one presence sensor,” “an inhaler” and “a spacing chamber” are reasonably understood as ubiquitous standard equipment within modern computers/inhalers having generic, well-known, and conventional elements and the elements do not provide anything significantly more. Therefore, Step 2B, of the subject-matter eligibility analysis is “No.”
In addition, dependent claims 2-10, 13, 30, 32-35, 49 and 51-52 do not provide a practical application and are insufficient to amount to significantly more than the judicial exception. As such, dependent claims 2-10, 13, 30, 32-35, 49 and 51-52 are also rejected under 35 U.S.C. § 101, based on their respective dependencies to claim 1 or 31. Therefore, claims 1-10, 13, 30-35, 49 and 51-52are rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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.
Claims 1, 31 and 49-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Calderon (US 20190275267 A1) in view of Van Der Mark (US 20150020804 A1) and Verjus (US 20180126099 A1).
Regarding claim 1, Calderon teaches a dose measuring device for an inhaler (“The inhalation device 100 may include a medication reservoir 110 and a dose delivery mechanism/system.” See [0037] and Figs. 1-4; Calderon teaches a measurement mode 208 in which the sensor system 128 take pressure measurements for a predetermined time period as seen in Fig. 6a and [0070]), comprising:
an inhalation mouthpiece (mouthpiece 106, see Figs. 1-3) comprising an outlet conduit for the passage of inhaled air (there is an outlet conduit for the dose of medication to travel from the flow pathway 119 and out of the mouthpiece 106 to the user as seen in Fig. 2 and [0040]);
a powder sensor configured for providing a reading of the powder density in the inhaled air (Calderon teaches a sensor system 128 which includes an optical sensor for detecting the passage of powder particles past the sensor to monitor drug delivery and to determine the timing of drug delivery, the duration of drug delivery, the amount of drug delivery and/or the like as seen in [0047]. As such, the optical sensor provides a reading of the powder density in the inhaled air);
a barometric pressure sensor configured for measuring the pressure of the air inside the outlet conduit (Calderon teaches a sensor system 128 which includes a barometric pressure sensor as seen in [0047], wherein the pressure sensor is configured to measure a plurality of pressure changes within the inhaler resulting from the user’s inhalation through the mouthpiece as seen in [0016]. Furthermore, the airflow metrics determined/calculated from pressure measurement signals is used to indicate a change of pressure corresponding to inhalation from the mouthpiece 106 as seen in [0049]-[0050]);
a control unit (electronics module 120, see Fig. 2; Calderon teaches an electronics module 120 with a controller as seen in [0045]) configured for:
detecting an inhalation produced in the inhalation mouthpiece by means of analyzing the pressure of the air inside the outlet conduit (The airflow metrics determined/calculated from pressure measurement signals (from the barometric pressure sensor) is used to indicate a change of pressure corresponding to inhalation from the mouthpiece 106 as seen in [0049]-[0050]);
calculating an airflow going through the outlet conduit using the pressure signal of the barometric pressure sensor and the section of the outlet conduit (“The controller may calculate or determine one or more airflow metrics (e.g., a peak flow rate, a time to peak flow rate, an inhaled volume, an inhalation duration, etc.) using the signals received from the sensor system 128. The airflow metrics may be indicative of a profile of airflow through the flow pathway 119 of the inhalation device 100.” See [0049] and Fig. 2); and
calculating, using the airflow and the powder density, a dose of solid particles suspended in the inhaled air going through the outlet conduit in the detected inhalation (Calderon teaches the sensor system 128 with an optical sensor for detecting the passage of powder particles past the sensor to monitor drug delivery and to determine the timing of drug delivery, the duration of drug delivery, the amount of drug delivery and/or the like and a barometric pressure sensor as seen in [0047]. Wherein the barometric pressure sensor is configured to measure a plurality of pressure changes within the inhaler resulting from the user’s inhalation through the mouthpiece as seen in [0016]. Calderon further teaches the controller calculating or determining one or more airflow metrics using the signals received from the sensor system 128 as seen in [0049] and assessing how the inhalation device 100 is being used and whether the use is likely to result in the delivery of a full dose of medication as seen in [0051]. As such, Calderon teaches calculating using sensor data and airflow metrics a dose of particles suspended in the inhaled air through mouthpiece).
But does not teach the powder sensor integrated inside the inhalation mouthpiece and configured for providing a reading of the powder density in the inhaled air inside the outlet conduit of the inhalation mouthpiece,
the powder sensor comprising:
an optical emitter adapted to emit a first beam of light into the outlet conduit through a first opening located in a periphery of the outlet conduit; and
an optical receiver adapted to receive a second beam of light reflected by solid particles suspended in air inside the outlet conduit through a second opening in the periphery of the outlet conduit;
wherein the optical emitter is aligned along a first axis and the optical receiver is aligned along a second axis different from the first axis,
wherein the powder sensor is integrated at a distal tip of the inhalation mouthpiece, at the outlet conduit downstream of the airflow and pressure sensing region.
However, Van Der Mark teaches the powder sensor (light source 6c and optical detector 8c, see Fig. 1 and [0046] and [0048]) configured for providing a reading of the powder density (Van Der Mark teaches a light source arrangement providing signals at first and second wavelength, recording the detected light signals and processing the light signals to derive the aerosol particle size and aerosol density as seen in [0042], [0024] and [0113]), the powder sensor comprising:
an optical emitter (light source 6c, see Fig. 1) adapted to emit a first beam of light (light source 6c introduces a first beam of light signal diagonally into the aerosol flow as seen in Fig. 1 and Van Der Mark’s Annotated Fig. 1 by beam 3c); and
an optical receiver (optical detector 8c, see Fig. 1) adapted to receive a second beam of light reflected by solid particles suspended in air (optical detector 8c receives a second beam of light that has been reflected or scattered by the aerosol particles 2 as shown by beam 3c in Fig. 1 and Van Der Mark’s Annotated Fig. 1 and [0048], [0078], and [0083]);
wherein the optical emitter is aligned along a first axis and the optical receiver is aligned along a second axis different from the first axis (Van Der Mark’s Annotated Fig. 1 shows light source 6c along a first axis and the optical detector 8c along a second axis different from the first axis).
Van Der Mark’s Annotated Fig. 1
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Calderon to replace the optical sensor with the light source and optical detector and include the controller taught by Van Der Mark to know the particle size of the aerosol generating system to give either an indication of the performance or choose certain particular sizes for particular absorption characteristics (see [0013]).
However, Verjus teaches the powder sensor (light source 12 and detector 14, see Figs. 1-2) integrated inside the inhalation mouthpiece (second end 3 and flow measuring apparatus 5, see Figs. 1-2 and [0006] and [0071]-[0072]) (light source 12 and detector 14 is integrated inside the flow measuring apparatus 5 as seen in Figs. 4-5), the powder sensor comprising:
an optical emitter (light source 12, see Figs. 1-5) adapted to emit a first beam of light into the outlet conduit through a first opening located in a periphery of the outlet conduit (Fig. 5 shows light source 12 emitting electromagnetic radiation/light along a light path 16 into the second end 3 through a first opening located in a periphery of the flow measuring apparatus 5 and second end 3 as seen in [0088]-[0089] and [0112]); and
an optical receiver (detector 14, see Figs. 1-5) adapted to receive inside the outlet conduit through a second opening in the periphery of the outlet conduit (Fig. 5 shows detector 14 receiving and measuring the electromagnetic radiation inside second end 3 through a second opening located in a periphery of the flow measuring apparatus 5 and second end 3 as seen in [0088]-[0089]).
wherein the powder sensor is integrated at a distal tip of the inhalation mouthpiece (Verjus teaches light source 12 and detector 14 to be integrated at a distal tip of second end 3 and flow measuring apparatus 5 as seen in Figs. 1-5).
Calderon teaches the optical sensor to be used to detect the passage of powder particles or droplets past the sensor to monitor drug delivery as seen in [0047]. As such, Calderon teaches the sensor to be within the flow pathway. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Calderon in view of Van der Mark to have the powder sensor be integrated into the mouthpiece as taught by Verjus as a known location to place the optical system to detect the mass or amount of drug particles administered to determine if an adequate or inadequate amount of drugs have been delivered for the desired treatment (see [0088]). Furthermore, Van Der Mark teaches the invention to sense particle size and density in a nebulizer mouthpiece as seen in [0138] and teaches the detectors to be provided in a ring inside the mouthpiece as seen in [0136]. Modified Calderon teaches wherein the powder sensor is integrated at a distal tip of the inhalation mouthpiece, at the outlet conduit downstream of the airflow and pressure sensing region (Modified Calderon teaches the light source 6c and optical detector 8c (taught by Van Der Mark) to be integrated at a distal tip of mouthpiece 106 of Calderon (taught by Verjus) such that the outlet conduit is downstream of the airflow and pressure sensing region (the pressure sensing region is where sensor system 128 is within Fig. 3, as only the optical sensor has been moved to the mouthpiece)).
Regarding claim 31, Calderon teaches a dose measuring method in inhalers (Calderon teaches a method applied to a metered-dose inhaler as seen in [0035] and further teaches a measurement mode 208 for the inhalation device 100 in which the sensor system 128 take pressure measurements for a predetermined time period as seen in Fig. 6a and [0068] and [0070]), comprising:
measuring, by means of a barometric pressure sensor, the pressure of the air inside an outlet conduit of an inhalation mouthpiece (mouthpiece 106, see Figs. 1-3) (Calderon teaches a sensor system 128 which includes a barometric pressure sensor as seen in [0047], wherein the pressure sensor is configured to measure a plurality of pressure changes within the inhaler resulting from the user’s inhalation through the mouthpiece as seen in [0016]. Furthermore, the airflow metrics determined/calculated from pressure measurement signals is used to indicate a change of pressure corresponding to inhalation from the mouthpiece 106 as seen in [0049]-[0050]);
detecting an inhalation by means of analyzing the pressure of the air inside the outlet conduit (The airflow metrics determined/calculated from pressure measurement signals (from the barometric pressure sensor) is used to indicate a change of pressure corresponding to inhalation from the mouthpiece 106 as seen in [0049]-[0050]);
obtaining, by means of a powder sensor, a reading of the powder density in the inhaled air (Calderon teaches a sensor system 128 which includes an optical sensor for detecting the passage of powder particles past the sensor to monitor drug delivery and to determine the timing of drug delivery, the duration of drug delivery, the amount of drug delivery and/or the like as seen in [0047]. As such, the optical sensor provides a reading of the powder density in the inhaled air);
calculating an airflow going through the outlet conduit using the pressure signal of the barometric pressure sensor and the section of the outlet conduit (“The controller may calculate or determine one or more airflow metrics (e.g., a peak flow rate, a time to peak flow rate, an inhaled volume, an inhalation duration, etc.) using the signals received from the sensor system 128. The airflow metrics may be indicative of a profile of airflow through the flow pathway 119 of the inhalation device 100.” See [0049] and Fig. 2); and
calculating, using the combined information of the powder sensor and of the barometric pressure sensor, a dose of solid particles suspended in the inhaled air going through the outlet conduit in the detected inhalation (Calderon teaches the sensor system 128 with an optical sensor for detecting the passage of powder particles past the sensor to monitor drug delivery and to determine the timing of drug delivery, the duration of drug delivery, the amount of drug delivery and/or the like and a barometric pressure sensor as seen in [0047]. Wherein the barometric pressure sensor is configured to measure a plurality of pressure changes within the inhaler resulting from the user’s inhalation through the mouthpiece as seen in [0016]. Calderon further teaches the controller calculating or determining one or more airflow metrics using the signals received from the sensor system 128 as seen in [0049] and assessing how the inhalation device 100 is being used and whether the use is likely to result in the delivery of a full dose of medication as seen in [0051]. As such, Calderon teaches calculating using sensor data and airflow metrics a dose of particles suspended in the inhaled air through mouthpiece)
but does not teach wherein obtaining the reading of the powder density in the inhaled air inside the outlet conduit of the inhalation mouthpiece comprises:
emitting, by an optical emitter, a first beam of light into the outlet conduit through a first opening located in a periphery of the outlet conduit; and
receiving, by an optical receiver, a second beam of light reflected by solid particles suspended in air inside the outlet conduit through a second opening in the periphery of the outlet conduit;
wherein the optical emitter is aligned along a first axis and the optical receiver is aligned along a second axis different from the first axis;
wherein the powder sensor is integrated at a distal tip of the inhalation mouthpiece, at the outlet conduit downstream of the airflow and pressure sensing region.
However, Van Der Mark teaches wherein obtaining the reading of the powder density in the inhaled air inside the inhalation mouthpiece (Van Der Mark teaches a light source arrangement providing signals at first and second wavelength, recording the detected light signals and processing the light signals to derive the aerosol particle size and aerosol density as seen in [0042], [0024] and [0113]) comprises:
emitting, by an optical emitter (light source 6c, see Fig. 1), a first beam of light (light source 6c introduces a first beam of light signal diagonally into the aerosol flow as seen in Fig. 1 and Van Der Mark’s Annotated Fig. 1 by beam 3c); and
receiving, by an optical receiver (optical detector 8c, see Fig. 1), a second beam of light reflected by solid particles suspended in air (optical detector 8c receives a second beam of light that has been reflected or scattered by the aerosol particles 2 as shown by beam 3c in Fig. 1 and Van Der Mark’s Annotated Fig. 1 and [0048], [0078], and [0083]);
wherein the optical emitter is aligned along a first axis and the optical receiver is aligned along a second axis different from the first axis (Van Der Mark’s Annotated Fig. 1 shows light source 6c along a first axis and the optical detector 8c along a second axis different from the first axis).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Calderon to replace the optical sensor with the light source and optical detector and include the controller taught by Van Der Mark to know the particle size of the aerosol generating system to give either an indication of the performance or choose certain particular sizes for particular absorption characteristics (see [0013]).
However, Verjus teaches wherein obtaining the reading of the powder in the inhaled air inside the outlet conduit of the inhalation mouthpiece (second end 3 and flow measuring apparatus 5, see Figs. 1-2 and [0006] and [0071]-[0072]) (Verjus teaches a light source 12 and detector 14 is used to detect the mass or amount of drug particles inside second end 3 to determine if a user has been getting the desired treatment a as seen in Figs. 1-5 and [0006] and [0088]), comprises:
the powder sensor (light source 12 and detector 14, see Figs. 1-2) integrated inside the inhalation mouthpiece (light source 12 and detector 14 is integrated inside the flow measuring apparatus 5 as seen in Figs. 4-5), the powder sensor comprising:
an optical emitter (light source 12, see Figs. 1-5) adapted to emit a first beam of light into the outlet conduit through a first opening located in a periphery of the outlet conduit (Fig. 5 shows light source 12 emitting electromagnetic radiation/light along a light path 16 into the second end 3 through a first opening located in a periphery of the flow measuring apparatus 5 and second end 3 as seen in [0088]-[0089] and [0091]); and
an optical receiver (detector 14, see Figs. 1-5) adapted to receive inside the outlet conduit through a second opening in the periphery of the outlet conduit (Fig. 5 shows detector 14 receiving and measuring the electromagnetic radiation inside second end 3 through a second opening located in a periphery of the flow measuring apparatus 5 and second end 3 as seen in [0088]-[0089]).
wherein the powder sensor is integrated at a distal tip of the inhalation mouthpiece (Verjus teaches light source 12 and detector 14 to be integrated at a distal tip of second end 3 and flow measuring apparatus 5 as seen in Figs. 1-5).
Calderon teaches the optical sensor to be used to detect the passage of powder particles or droplets past the sensor to monitor drug delivery as seen in [0047]. As such, Calderon teaches the sensor to be within the flow pathway. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Calderon in view of Van der Mark to have the powder sensor be integrated into the mouthpiece as taught by Verjus as a known location to place the optical system to detect the mass or amount of drug particles administered to determine if an adequate or inadequate amount of drugs have been delivered for the desired treatment (see [0088]). Furthermore, Van Der Mark teaches the invention to sense particle size and density in a nebulizer mouthpiece as seen in [0138] and teaches the detectors to be provided in a ring inside the mouthpiece as seen in [0136]. Modified Calderon teaches wherein the powder sensor is integrated at a distal tip of the inhalation mouthpiece, at the outlet conduit downstream of the airflow and pressure sensing region (Modified Calderon teaches the light source 6c and optical detector 8c (taught by Van Der Mark) to be integrated at a distal tip of mouthpiece 106 of Calderon (taught by Verjus) such that the outlet conduit is downstream of the airflow and pressure sensing region (the pressure sensing region is where sensor system 128 is within Fig. 3, as only the optical sensor has been moved to the mouthpiece)).
Regarding claim 49, modified Calderon teaches the dose measuring device according to claim 1 and modified Calderon further teaches a dose measuring system in inhalers (Fig. 8 of Calderon shows a system 300 including a mobile device 304 and inhalation device 302 (example of inhalation device 100) as seen in [0110]. Calderon further teaches a measurement mode 208 for the inhalation device 100 in which the sensor system 128 take pressure measurements for a predetermined time period as seen in Fig. 6a and [0068] and [0070]), comprising:
a dose measuring device according to claim 1 (see claim 1 above), the dose measuring device further comprising a wireless communication module (wireless communication circuit 129, see Fig. 3 and [0055] of Calderon), and wherein the control unit of the dose measuring device is configured for wirelessly sending, through said wireless communication module, a history of inhalations performed and of measurements of inhaled doses (the wireless communication circuit 129 of the electronics module 120 can be “paired up” with an external device to transmit all the data stored within the memory as seen in [0062] of Calderon, wherein the data can include doses delivered, inhalation events and past usage history as seen in [0111] and [0113] of Calderon); and
a mobile device (mobile device 304, see Fig. 8 of Calderon) configured for:
wirelessly receiving the history of inhalations performed and of measurements of inhaled doses (the wireless communication circuit 129 of the electronics module 120 can be “paired up” with an external device to transmit all the data stored within the memory as seen in [0062] of Calderon, wherein the data can include doses delivered, inhalation events and past usage history as seen in [0111] and [0113] of Calderon);
checking compliance with a predetermined inhalation treatment on the basis of the history of inhalations performed and of measurements of inhaled doses (“The external device may include software (e.g., a mobile application) for processing the received information and for providing compliance and adherence feedback to users of the inhalation device 100 via a graphical user interface (GUI).” See [0052] of Calderon); and
sending at least one notification and/or alert informing about compliance with the inhalation treatment (‘For example, if the electronics module 120 (e.g., and/or a mobile application residing on an external device) determines that six of the twelve most recent inhalation events were a low or no inhalation event, an exhalation event, and/or an air vent block event, then the electronics module 120 (e.g., and/or a mobile application residing on an external device) may provide the user a notification (e.g., an alert, an instructional video, the IFU, etc.) and/or an overview of the past twelve usage events.” See [0103] of Calderon), and
wherein the powder sensor is integrated at a distal tip of the inhalation mouthpiece, at the outlet conduit downstream of the airflow and pressure sensing region (Modified Calderon teaches the light source 6c and optical detector 8c (taught by Van Der Mark) to be integrated at a distal tip of mouthpiece 106 of Calderon (taught by Verjus) such that the outlet conduit is downstream of the airflow and pressure sensing region (the pressure sensing region is where sensor system 128 is within Fig. 3, as only the optical sensor has been moved to the mouthpiece)).
Regarding claim 50, modified Calderon teaches the method of claim 31, and Calderon further teaches further comprising:
wirelessly sending to a mobile device (mobile device 304, see Fig. 8) a history of inhalations performed and of measurements of inhaled doses (the wireless communication circuit 129 of the electronics module 120 can be “paired up” with an external device to transmit all the data stored within the memory as seen in [0062], wherein the data can include doses delivered, inhalation events and past usage history as seen in [0111] and [0113]);
checking, in the mobile device, compliance with a predetermined inhalation treatment on the basis of the history of inhalations performed and of measurements of inhaled doses (“The external device may include software (e.g., a mobile application) for processing the received information and for providing compliance and adherence feedback to users of the inhalation device 100 via a graphical user interface (GUI).” See [0052]); and
sending at least one notification and/or alert informing about compliance with the inhalation treatment (‘For example, if the electronics module 120 (e.g., and/or a mobile application residing on an external device) determines that six of the twelve most recent inhalation events were a low or no inhalation event, an exhalation event, and/or an air vent block event, then the electronics module 120 (e.g., and/or a mobile application residing on an external device) may provide the user a notification (e.g., an alert, an instructional video, the IFU, etc.) and/or an overview of the past twelve usage events.” See [0103]).
Regarding claim 51, modified Calderon teaches the dose measuring device according to claim 1, and Van Der Mark further teaches wherein the first axis and the second axis are not parallel (Van Der Mark’s Annotated Fig. 1 shows light source 6c along a first axis and the optical detector 8c along a second axis different from the first axis, wherein the first axis and the second axis are not parallel).
Regarding claim 52, modified Calderon teaches the dose measuring device according to claim 1, and modified Calderon further teaches wherein:
the first axis is a first central axis of the first opening (Verjus teaches light source 12 to be within the center axis of the opening as shown in Fig. 5. As such, modified Calderon teaches the first axis aligned by the light source 6c (taught by Van Der Mark) to be in a first central axis of the first opening (taught by Verjus));
the second axis is a second central axis of the second opening (Verjus teaches detector 14 to be within the center axis of the opening as shown in Fig. 5. As such, modified Calderon teaches the second axis aligned by the optical detector 8c (taught by Van Der Mark) to be in a second central axis of the second opening (taught by Verjus)); and
an angle defined by an intersection of the first axis and the second axis is less than one hundred eighty (180) degrees (Van Der Mark teaches the angle defined by an intersection of the first axis and the second axis to be less than 180 degrees seen in Fig. 1).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Calderon (US 20190275267 A1) in view of Van Der Mark (US 20150020804 A1) and Verjus (US 20180126099 A1), as applied to claim 1 above, and further in view of Freeman (US 20190247596 A1).
Regarding claim 13, modified Calderon teaches the device of claim 1, and Calderon further teaches “An optical sensor may, for example, be used to detect the passage of powder particles or droplets past the sensor to monitor drug delivery (e.g., to determine the timing of drug delivery, the duration of drug delivery, the amount of drug delivery, and/or the like) (see [0047]).”
But does not teach wherein for calculating the dose of solid particles going through the outlet conduit in a period of time, the control unit is configured for:
- determining, by means of the reading of the powder sensor, the density of solid particles inside the outlet conduit in a plurality of sampling instants (ti) during the period of time;
- calculating the airflow going through the outlet conduit in said plurality of sampling instants (ti) using the pressure signal of the barometric pressure sensor;
- determining the mass flow rate of solid particles going through the outlet conduit in said plurality of sampling instants (ti);
- integrating the mass flow rate in said period of time.
However, Freeman teaches wherein for calculating the dose of solid particles going through the outlet conduit (outlet 30, see Fig. 1A) in a period of time (“For a given amount of time, the processor 214 may, for example, multiply the predetermined interval (e.g., 0.1 seconds) by the vapor factor for that predetermined time interval, for each of the intervals that have occurred, and add each of these products together to derive a total amount consumed. For example, if in the first second of inhalation, 50% of vapor is produced, and assuming 100% of vapor is produced after 1 second, the processor will able to determine that 3 mg has been consumed in 3.5 seconds.” See [0052]), the control unit (processor 14, see Fig. 1A) is configured for:
- determining, by means of the reading of the powder sensor (light emitter 20 and light receiver 22, see Fig. 1A; “…a light emitter 20, which is a light source, a light receiver 22 (which may be or include a light sensor)…” see [0037]), the density of solid particles inside the outlet conduit (“The vapor light sensor may provide light intensity data, which be used to determine density data…” see [0058]) in a plurality of sampling instants during the period of time (Using the timer 18 and processor 14, the timer may be started when a user starts using the inhalation device 1 (see [0042]) and every 0.1 seconds (taken as sampling instant) the density of the particles taken by the light sensor 22 is as seen in [0051]-[0052]);
- calculating the airflow going through the outlet conduit in said plurality of sampling instants using the pressure signal of the pressure sensor (pressure sensor 12 is designed to sense the air pressure in the vicinity of the outlet 30 (see [0057]) where the sensor can sense the volume per unit time of an inhalation (see [0060]-[0061]. The air pressure measured by pressure sensor 12 is also sampled such that the processor 14 can adjust the intensity of heating element 4 based on data from the airflow sensor 12 (see [0061]).
- determining the mass flow rate of solid particles going through the outlet conduit in said plurality of sampling instants (The light sensor, airflow rate and volume of flow is used to derived the mass flow rate of medication (see [0058] and [0063]). Since the density of the particles taken by the light sensor is taken every 0.1 seconds as seen in [0051]-[0052], the processor will determine the mass flow rate using the data from the light sensor every 0.1 seconds as well (see [0052]));
- integrating the mass flow rate in said period of time (“For a given amount of time, the processor 214 may, for example, multiply the predetermined interval (e.g., 0.1 seconds) by the vapor factor for that predetermined time interval, for each of the intervals that have occurred, and add each of these products together to derive a total amount consumed. For example, if in the first second of inhalation, 50% of vapor is produced, and assuming 100% of vapor is produced after 1 second, the processor will able to determine that 3 mg has been consumed in 3.5 seconds.” See [0052]; The data for each time interval is added together to derive a total amount of medication consumed in said period of time as seen in [0052], which is similar to page 15, lines 15-24, where integrating mass flow rate results in mass of solid particles inhaled).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by modified Calderon to include the processor taught by Freeman to help determine the amount of medication consumed by the user in a certain amount of time (see [0052]) to help assure the user is taking the proper amount of medication.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Calderon (US 20190275267 A1) in view of Van Der Mark (US 20150020804 A1) and Verjus (US 20180126099 A1), as applied to claim 1 above, and further in view of Shetty (US 20170270260 A1).
Regarding claim 30, modified Calderon teaches a dose measuring device according to claim 1 but does not teach a spacing chamber for inhalers, wherein the inhalation mouthpiece is an integral part of the spacing chamber.
However, Shetty teaches a spacing chamber (measurement device 100 is an improved spacer with an aerosol holding chamber 140 as seen in Fig. 2 and [0093]) for inhalers (“The chamber 140, if present, is configured to hold aerosolized medicine after it has been expelled from an inhaler into the chamber 140.” See [0121] and [0073]) comprising a measurement device (pressure sensor 124, see Fig. 2 and [0098]) wherein the inhalation mouthpiece (mouthpiece 110, see Fig. 2) is an integral part of the spacing chamber (mouthpiece 110 is an integral part of the spacing chamber 140 as they are directly coupled and share a common lumen 160 as seen in Fig. 2 and [0093]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by modified Calderon to replace the mouthpiece with the spacer taught by Shetty as it known in the art to be coupled with inhalers and allows for a greater delivery of medication into a user’s lungs (see [0073]). Furthermore, it is beneficial for children especially as spacers requires less coordination (see [0003]).
Allowable Subject Matter
Claims 2-10 and 32-35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and overcoming the 35 USC 101 rejections presented above in this office action.
The following is a statement of reasons for the indication of allowable subject matter: Claim 2 cites “The device according to claim 1, wherein the control unit is configured for:
calculating, using the pressure signal of the barometric pressure sensor, the airflow (Xi) going through the outlet conduit in a plurality of sampling instants (ti) during the inhalation;
obtaining, for each sampling instant (ti), a flow distribution coefficient (Ki) depending on the value of the airflow (Xi) in the corresponding sampling instant (ti);
estimating a total dose of medication distributed in the lung (ZT) in the inhalation from the dose of solid particles going through the outlet conduit modified on the basis of the flow distribution coefficients.”
The closest prior arts are Calderon (US 20190275267 A1) and Shetty (US 20170270260 A1).
Calderon teaches wherein the control unit (electronics module 120, see Fig. 2; Calderon teaches an electronics module 120 with a controller as seen in [0045]) is configured for:
calculating, using the pressure signal of the pressure sensor, the airflow (Xi) going through the outlet conduit during the inhalation (Calderon teaches a sensor system 128 which includes a barometric pressure sensor as seen in [0047], wherein the pressure sensor is configured to measure a plurality of pressure changes within the inhaler resulting from the user’s inhalation through the mouthpiece as seen in [0016]. Furthermore, the airflow metrics determined/calculated from pressure measurement signals is used to indicate a change of pressure corresponding to inhalation from the mouthpiece 106 as seen in [0049]-[0050]) but does not teach calculating the airflow in a plurality of sampling instants (ti), obtaining, for each sampling instant (ti), a flow distribution coefficient (Ki) depending on the value of the airflow (Xi) in the corresponding sampling instant (ti); estimating a total dose of medication distributed in the lung (ZT) in the inhalation from the dose of solid particles going through the outlet conduit modified on the basis of the flow distribution coefficients.
Shetty teaches a measurement device 1 (see Fig. 1 and [0075]) wherein the control unit (“…the signal processing component 50 includes an inboard processor…” see [0088] and Fig. 1) is configured for:
calculating, using the pressure signal of the pressure (spirometry component 20, see Fig. 1; “…the spirometry component 20 is formed of a pneumotachometer comprising a fine mesh (i.e., an air-permeable screen) and one or more pressure sensors.” See [0078]), the airflow (Xi) going through the outlet conduit (“The spirometry component 20 of various embodiments includes sensors and/or other components that directly or indirectly sense the flow rate and volume of expired air expressed through the mouthpiece of the measurement device 1.” See [0077]) in a plurality of sampling instants (ti) (Freeman teaches sampling rates for devices as seen in Table 1) during the inhalation;
obtaining a flow distribution coefficient (Ki) depending on the value of the airflow (Xi) (Freeman teaches resistance factor k1 for when airflow moves from a region with a first diameter to a region with a second diameter as seen in [0079]); but does not teach a barometric pressure sensor; estimating a total dose of medication distributed in the lung (ZT) in the inhalation from the dose of solid particles going through the outlet conduit modified on the basis of the flow distribution coefficients.
As a result, because no references of record or reasonable conclusion thereof, could be found which disclose or suggest all features of claim 2, claim 2 is allowable over prior arts. As claim 32 includes the same limitations of claim 2 but for a method, claim 32 is also allowable subject matter. Claims 3-10 and 33-35 depend from claims 2 and 32 and are considered allowable subject matter by virtue of their dependency on claim 2 and 32.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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