DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This Office Action is in response to the amendments filed on 10/09/2025, as directed by the Non-Final Rejection on 07/16/2025. Claims 1 and 9 are amended. Claim 20 is new. Claims 1-18 and 20 are pending in the instant application. The previous rejections under 35 U.S.C 103 are withdrawn as necessitated by amendment. However, new rejections are made below.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-18, 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 pre-AIA 35 U.S.C. 103(a) 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 negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 1-3, 5, 7, 9-10, 12-13, 15 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kilis (U.S 5,167,506 A) in view of Jongejan (U.S 2007/0023034 A1) and Bonney (U.S 6,651,651 B1) and Mishelevich (U.S 5,363,842 A) and Kofoed (U.S 6,367,475 B1).
Regarding claim 1, Kilis discloses a method of training a subject to properly use an inhalation system (Abstract) comprising:
a) providing a subject with a dry powder inhaler (Fig. 1, Col. 4 lines 56-66; The device can be used with a dry powder inhaler; Col. 3 lines 44 – Col. 4 line 10, the patient is provided with the inhaler) with a mouthpiece (mouthpiece 10, Col. 5 line 33-35) and a cartridge for delivering a dry powder formulation (canister 18, Fig. 1; Col. 4 lines 56-66, the inhaler can instead be a dry powder inhaler and thus would include a dry powder cartridge with dry powder formulation) and the dry powder inhaler having at least one sensor (flow sensor 14, Fig. 1 and Col. 5 lines 33-42), wherein the at least one sensor can detect at least one signal generated from the dry powder inhaler upon an inhalation (Col. 5 lines 36-39, Col. 2 lines 40-56 and Col. 3 lines 1-25; The sensor detects a flow signal upon inhalation) and transmit the at least one signal to at least one external device in real time for analysis of the at least one signal to generate data for real-time display of an inhalation concurrently being performed by the subject (Col. 5 lines 36-39; Col. 6 line 37 – Col. 7 line 47 and Figs. 2-5; The signal is passed to an external computer for analysis of the patient inhalation flow data and for display of the signal; The display can show comparison or color-coded prompts for improving specific areas of the inhalation maneuver; This is noted to be able to be performed in real-time for the patient to try and match an idealized pattern);
b) monitoring the subject's inhalation on a display of the external device (Col. 7 lines 1-36; The patient’s inhalation is monitored/tracked on the display of the external device for comparison with an idealized pattern);
c) repeating the inhalation (Col. 7 lines 24-47 and Fig. 2; The different training or tutorial steps can be repeated to allow the patient to practice before moving to a next step); and
d) comparing the curves attained until a preferred flow profile for the subject is displayed so that maximal delivery of a dry powder formulation can be achieved (Col. 7 lines 1-7, Col. 6 lines 61-65, Col. 7 lines 48-68; The curves can be compared with an idealized pattern to allow the subject to achieve this profile for best inhalation results based on a predetermined level; The results can also be used to correlate inhalation performance with overall drug administration efficacy and thus for a maximal delivery of dry powder formulation).
Kilis is silent regarding wherein a time versus pressure curve is generated and shown on the display.
However, Kilis teaches that a flow rate versus time curve is generated and shown on the display (Col. 6 lines 56-65 and Claim 1), and further that differential pressure can be used to detect inhalation (Col. 4 lines 48-55, Col. 8 lines 19-45, 53-63; Pressure transducers can detect the differentials caused by inhalation for monitoring of inhalation maneuvers).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Kilis to include monitoring/displaying a time versus pressure curve, such as that taught by Kilis, in order to monitor a known property which varies with inhalation (Col. 4 lines 48-55 and Col. 8 lines 19-45, 53-63).
Kilis is silent regarding wherein an interactive training device is attachable to the dry powder inhaler comprising a microprocessor and at least one sensor, or wherein the sensor is within the mouthpiece and in communication with air conduits of the dry powder inhaler.
However, Jongejan teaches a compliance monitoring device which is attachable to an inhaler and includes a microprocessor and a sensor unit for inhalation monitoring (Fig. 2 and Paragraph 0045, 0011; The compliance monitor is removably attachable to the inhaler device and includes sensors for monitoring compliance/usage; Paragraphs 0014-0018, 0022, 0041, the compliance monitor uses a sensor to pass information to the microprocessor to record/determine usage of the inhaler). Jongejan further teaches wherein the microprocessor converts the inhalation signals from the sensor into usage data/signals (Paragraph 0022, analog signals of the sensor are passed to the processor).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Kilis to have included the interactive monitoring device attachable to the dry powder inhaler with a microprocessor and sensor, such as that taught by Kilis, in order to prevent FDA reappraisal of an entirely new inhaler and instead allow coupling of a sensor/compliance monitor to a regular inhaler (Paragraph 0011-0012).
Alternatively, Bonney teaches wherein a sensor is located attachable to the mouthpiece of the inhaler and is in communication with air conduits of said dry powder inhaler (Col. 5 lines 23-42, the inhaler includes a sensor tube 20 and 30 which are disposed in the mouthpiece and allow for measurement of flow signals through the inhaler).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Kilis to include a sensor attachable to the mouthpiece and in communication with air conduits of said dry powder inhaler, such as that taught by Bonney, in order to measure the airflow delivered/generated by the patient as it exits the device (Col. 5 lines 23-42).
Kilis is silent regarding wherein the signal is transmitted to an external device by wireless communication.
However, Mishelevich teaches transmission of signals wirelessly for compliance monitoring (Claim 26, Claim 29; The inspiration pattern value data can be measured and wirelessly sent/retrieved by a remote computer for compliance monitoring).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Kilis to include transmitting the signals wirelessly to an external device, such as that taught by Mishelevich, in order to use a known alternative for communicating data (Claim 26, 29) and to monitor the data at other points or by medical practitioners.
Kilis is silent regarding wherein the time versus pressure curve includes a green acceptable region, a yellow warning region, and a red failed region.
However, Kofoed teaches a respiratory monitoring system wherein the respiratory flow signal can include a green acceptable region, yellow warning region, and a red failed region (Col. 1 line 63 – Col. 2 line 3; Zones can be established for regions of respiratory flow that meet 80% of a personal best or predictive norm, a yellow zone for values from 80-50% and thus a warning of below predictive norm, and a red zone of below 50% and thus failure; The zones can be used to indicate a status of the user and for appropriate corrective treatment).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Kilis to have included green/yellow/red regions on the graph indicative of user performance such as that that taught by Kofoed, in order to provide an assessment of user respiration compared to a predictive norm, and to provide a color-coded indication of the status of the user for corrective treatment (Col. 1 line 63 – Col. 2 line 3).
Regarding claim 2, the modified method of Kilis discloses the device of claim 1.
Kilis further discloses wherein the inhalation is for a period of 4 to 5 seconds (It is noted that the inhalation is merely one or more inhalation events of the patient, which is itself variable and applicant has not defined any particular measurements or periods of the inhalation event; see Fig. 4-5; Col. 2 lines 49-56, Col. 5 lines 3-10; A length of inspiration can be monitored for each patient, which is patient-dependent and variable across multiple breaths and thus can be for a period of 4-5 seconds; also see Fig. 4-5, where the inhalation can be measured or prompted to be held for longer and thus across feedback/training can be for a duration of 4-5 seconds).
Regarding claim 3, the modified method of Kilis discloses the device of claim 1.
Kilis further discloses wherein said at least one sensor is a pressure sensor (Col. 4 lines 48-55, Col. 8 lines 53-67; The sensor is a differential air pressure sensor).
Regarding claim 5, the modified method of Kilis discloses the device of claim 1.
Kilis further discloses wherein the sensor detects at least one signal generated from said dry powder inhaler (Col. 5 lines 36-39, Col. 2 lines 40-56 and Col. 3 lines 1-25; The sensor detects a flow signal upon inhalation) and transmits in real-time said at least one signal to at least one external device (Col. 5 lines 36-39; Col. 6 line 37 – Col. 7 line 47 and rejection of claim 1 above; The signal is transmitted in real time to the external device) by wireless communication (see rejection of claim 1 above; Per the modification, the transmission of the signal is wireless) for analysis of said at least one signal to generate a data set for real-time display of the inhalation maneuver concurrently being performed by said subject (Col. 5 lines 36-39; Col. 6 line 37 – Col. 7 line 47 and Figs. 2-5; The signal is passed to an external computer for analysis of the patient inhalation flow data and for display of the signal; The display can show comparison or color-coded prompts for improving specific areas of the inhalation maneuver; This is noted to be able to be performed in real-time for the patient to try and match an idealized pattern).
Regarding claim 7, the modified method of Kilis discloses the device of claim 5.
Kilis further discloses wherein said at least one sensor is configured to further measure said at least one signal (Col. 5 lines 36-39, Col. 2 lines 40-56 and Col. 3 lines 1-25; The sensor detects a flow signal upon inhalation; The sensor measures the signal).
Regarding claim 9, Kilis discloses a method of training a patient to properly monitor an inhalation maneuver in real-time corresponding to characteristic patterns of a patient's use of a dry powder inhalation system (Abstract), comprising:
a) providing a dry powder inhaler to the patient (Fig. 1, Col. 4 lines 56-66; The device can be used with a dry powder inhaler; Col. 3 lines 44 – Col. 4 line 10, the patient is provided with the inhaler), said dry powder inhaler includes a mouthpiece (mouthpiece 10, Col. 5 line 33-35), a cartridge containing a dry powder formulation and structurally configured for said dry powder inhaler (canister 18, Fig. 1; Col. 4 lines 56-66, the inhaler can instead be a dry powder inhaler and thus would include a dry powder cartridge with dry powder formulation), and at least one sensor attached to or within the mouthpiece and in communication with air conduits of said dry powder inhaler (flow sensor 14, Fig. 1 and Col. 5 lines 33-42), wherein the at least one sensor detects at least one signal generated from said dry powder inhaler (Col. 5 lines 36-39, Col. 2 lines 40-56 and Col. 3 lines 1-25; The sensor detects a flow signal upon inhalation) and transmits in real-time said at least one signal to at least one external device comprising a microprocessor for analysis of said at least one signal to generate data for real-time display of an inhalation maneuver concurrently being performed by the patient (Col. 5 lines 36-39; Col. 6 line 37 – Col. 7 line 47 and Figs. 2-5; The signal is passed to an external computer for analysis of the patient inhalation flow data and for display of the signal; The display can show comparison or color-coded prompts for improving specific areas of the inhalation maneuver; This is noted to be able to be performed in real-time for the patient to try and match an idealized pattern; Col. 8 lines 58-61; The computer includes a processor),
b) coaching the patient during the inhalation maneuver to take a deep breath for a period of 4 to 5 seconds and having the patient exhale normally thereafter (see Col. 6 lines 40 – Col. 7 lines 55 and Col. 2 lines 40-67; The patient is directed or prompted to inhale and is given feedback to inhale for a certain time or duration; A length of inspiration can be monitored for each patient, which is patient-dependent and variable across multiple breaths and thus can be for a period of 4-5 seconds; also see Fig. 4-5, where the inhalation can be measured or prompted to be held for longer and thus across feedback/training can be for a duration of 4-5 seconds), wherein a graph is generated on a display of the external device (Col. 6 lines 56-65 and Claim 1; also see Col. 7 lines 1-36);
c) repeating and monitoring the patient's inhalation maneuver (Col. 7 lines 24-47 and Fig. 2; The different training or tutorial steps can be repeated to allow the patient to practice the inhalation maneuvers before moving to a next step);
d) comparing the curves to attain a preferred flow profile for that individual compared to a control curve provide in the display so that maximal delivery of the dry powder formulation can be achieved (Col. 7 lines 1-7, Col. 6 lines 61-65, Col. 7 lines 48-68; The curves can be compared with an idealized pattern to allow the subject to achieve this profile for best inhalation results based on a predetermined level; The results can also be used to correlate inhalation performance with overall drug administration efficacy and thus for a maximal delivery of dry powder formulation; Figs. 4-5 the patients inhalation is compared to a representative/control curve for adjustment to an idealized inhalation maneuver).
Kilis is silent regarding wherein a time versus pressure curve is generated and shown on the display.
However, Kilis teaches that a flow rate versus time curve is generated and shown on the display (Col. 6 lines 56-65 and Claim 1), and further that differential pressure can be used to detect inhalation (Col. 4 lines 48-55, Col. 8 lines 19-45, 53-63; Pressure transducers can detect the differentials caused by inhalation for monitoring of inhalation maneuvers).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Kilis to include monitoring/displaying a time versus pressure curve, such as that taught by Kilis, in order to monitor a known property which varies with inhalation (Col. 4 lines 48-55 and Col. 8 lines 19-45, 53-63).
Kilis is silent regarding wherein an interactive training device is attachable to the dry powder inhaler comprising a microprocessor and at least one sensor, or wherein the sensor is within the mouthpiece and in communication with air conduits of the dry powder inhaler.
However, Jongejan teaches a compliance monitoring device which is attachable to an inhaler and includes a microprocessor and a sensor unit for inhalation monitoring (Fig. 2 and Paragraph 0045, 0011; The compliance monitor is removably attachable to the inhaler device and includes sensors for monitoring compliance/usage; Paragraphs 0014-0018, 0022, 0041, the compliance monitor uses a sensor to pass information to the microprocessor to record/determine usage of the inhaler). Jongejan further teaches wherein the microprocessor converts the inhalation signals from the sensor into usage data/signals (Paragraph 0022, analog signals of the sensor are passed to the processor).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Kilis to have included the interactive monitoring device attachable to the dry powder inhaler with a microprocessor and sensor, such as that taught by Kilis, in order to prevent FDA reappraisal of an entirely new inhaler and instead allow coupling of a sensor/compliance monitor to a regular inhaler (Paragraph 0011-0012).
Alternatively, Bonney teaches wherein a sensor is located attachable to the mouthpiece of the inhaler and is in communication with air conduits of said dry powder inhaler (Col. 5 lines 23-42, the inhaler includes a sensor tube 20 and 30 which are disposed in the mouthpiece and allow for measurement of flow signals through the inhaler).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Kilis to include a sensor attachable to the mouthpiece and in communication with air conduits of said dry powder inhaler, such as that taught by Bonney, in order to measure the airflow delivered/generated by the patient as it exits the device (Col. 5 lines 23-42).
Kilis is silent regarding wherein the signal is transmitted to the external device by wireless communication.
However, Mishelevich teaches transmission of signals wirelessly for compliance monitoring (Claim 26, Claim 29; The inspiration pattern value data can be measured and wirelessly sent/retrieved by a remote computer for compliance monitoring).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kilis to include transmitting the signals wirelessly to an external device, such as that taught by Mishelevich, in order to use a known alternative for communicating data (Claim 26, 29).
Kilis is silent regarding wherein the time versus pressure curve includes a green acceptable region, a yellow warning region, and a red failed region.
However, Kofoed teaches a respiratory monitoring system wherein the respiratory flow signal can include a green acceptable region, yellow warning region, and a red failed region (Col. 1 line 63 – Col. 2 line 3; Zones can be established for regions of respiratory flow that meet 80% of a personal best or predictive norm, a yellow zone for values from 80-50% and thus a warning of below predictive norm, and a red zone of below 50% and thus failure; The zones can be used to indicate a status of the user and for appropriate corrective treatment).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Kilis to have included green/yellow/red regions on the graph indicative of user performance such as that that taught by Kofoed, in order to provide an assessment of user respiration compared to a predictive norm, and to provide a color-coded indication of the status of the user for corrective treatment (Col. 1 line 63 – Col. 2 line 3).
Regarding claim 10, the modified method of Kilis discloses the device of claim 9.
Kilis further discloses wherein said at least one signal is derived from a pressure differential generated in said dry powder inhaler (Col. 4 lines 48-55, Col. 8 lines 53-67; The sensor is a differential air pressure sensor which provides the change in flow rates based on differential pressure changes during inhalation).
Regarding claim 12, the modified method of Kilis discloses the device of claim 9.
Kilis further discloses wherein said at least one sensor is a pressure sensor (Col. 4 lines 48-55, Col. 8 lines 53-67; The sensor is a differential air pressure sensor).
Regarding claim 13, the modified method of Kilis discloses the device of claim 9.
Kilis further discloses wherein said dry powder formulation is for pulmonary delivery (Fig. 1; Col. 4 lines 56-66, the inhaler can instead be a dry powder inhaler and thus would include a dry powder cartridge with dry powder formulation).
Regarding claim 15, the modified method of Kilis discloses the device of claim 9.
Kilis further disclose wherein the dry powder formulation comprises at least one active ingredient (Abstract, Col. 4 lines 56-66; The inhaler delivers medicament and thus must include at least one active ingredient to affect health/act as medicine; Additionally the inhaler device can deliver powder, as mentioned in the rejection of claim 9 above).
Regarding claim 18, the modified method of Kilis discloses the device of claim 9.
Kilis further discloses wherein said at least one external device comprises an analog to digital converter (Col. 4 line 66-67, Col. 8 lines 14-26, 58-65; The external system includes an analog to digital board; The analog signal of the pressure drop is converted to digital for the computer).
Claims 4, 6, 11 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kilis (U.S 5,167,506) in view of Jongejan (U.S 2007/0023034 A1) and Bonney (U.S 6,651,651 B1) and Mishelevich (U.S 5,363,842 A) and Kofoed (U.S 6,367,475 B1), as applied to claims 1, 5, 9 and 12, in further view of Wolf (U.S 5,505,195 A).
Regarding claim 4, the modified method of Kilis discloses the device of claim 1.
Kilis is silent regarding wherein said at least one sensor is a microphone.
However, Wolf teaches wherein an inhaler can include a microphone to sense signals indicative of inhalation (Col. 10 lines 56 – Col. 11 lines 16; An audio element can detect change in sound as air passes through the device to produce wave forms indicative of inhalation).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Kilis to include a microphone to provide inhalation waveforms, such as that taught by Wolf, in order to provide a known alternative sensor which provides varied output with inhalation (Col. 10 lines 56 – Col. 11 lines 16).
Regarding claim 6, the modified method of Kilis discloses the device of claim 5.
Kilis is silent regarding wherein said at least one signal is a sound signal.
However, Wolf teaches wherein an inhaler can include a microphone to sense sound signals indicative of inhalation (Col. 10 lines 56 – Col. 11 lines 16; An audio element can detect change in sound as air passes through the device to produce wave forms indicative of inhalation).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Kilis to include a microphone to measure sound signal waveforms, such as that taught by Wolf, in order to provide a known alternative sensor which provides varied output with inhalation (Col. 10 lines 56 – Col. 11 lines 16).
Regarding claim 11, the modified method of Kilis discloses the device of claim 9.
Kilis is silent regarding wherein said at least one signal is a sound signal.
However, Wolf teaches wherein an inhaler can include a microphone to sense sound signals indicative of inhalation (Col. 10 lines 56 – Col. 11 lines 16; An audio element can detect change in sound as air passes through the device to produce wave forms indicative of inhalation).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Kilis to include a microphone to measure sound signal waveforms, such as that taught by Wolf, in order to provide a known alternative sensor which provides varied output with inhalation (Col. 10 lines 56 – Col. 11 lines 16).
Regarding claim 17, the modified method of Kilis discloses the device of claim 12.
Kilis further discloses wherein an analog to digital converter communicates at least one signal from the sensor to the microprocessor configured to analyze and process said at least one signal for said characteristic pattern (Col. 4 line 66-67, Col. 8 lines 14-26, 58-65; The external system includes an analog to digital board; The analog signal of the pressure drop is converted to digital for the computer to analyze the inhalation waveform; Col. 8 lines 58-61; The computer includes a processor; Col. 5 lines 36-39; Col. 6 line 37 – Col. 7 line 47 and Figs. 2-5 regarding analysis and processing of the signal for characteristic shape/magnitude/duration compared to an idealized waveform).
Kilis is silent regarding wherein the sensor is a sound sensor which communicates a sound signal with a characteristic pattern.
However, Wolf teaches wherein an inhaler can include a sound sensor to sense sound signals with a characteristic pattern indicative of inhalation (Col. 10 lines 56 – Col. 11 lines 16; An audio element can detect change in sound as air passes through the device to produce wave forms indicative of inhalation).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Kilis to include a sound sensor to measure sound signal waveforms, such as that taught by Wolf, in order to provide a known alternative sensor which provides varied output with inhalation (Col. 10 lines 56 – Col. 11 lines 16).
Claims 8 and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kilis (U.S 5,167,506) in view of Jongejan (U.S 2007/0023034 A1) and Bonney (U.S 6,651,651 B1) and Mishelevich (U.S 5,363,842 A) and Kofoed (U.S 6,367,475 B1), as applied to claims 1 and 9, in further view of Zierenberg (U.S 2003/0235538 A1).
Regarding claim 8, the modified method of Kilis discloses the device of claim 1.
Kilis is silent regarding wherein said dry powder inhaler has a resistance value between about 0.065 (√kPa)/liter per minute and about 0.200 (√kPa)/liter per minute.
However, Zierenberg teaches that a dry powder inhaler should have a low flow resistance for efficient delivery of medicament (Paragraph 0022) and further wherein the resistance is advantageously in the range of 0.01 to 0.1 (√kPa)/liter per minute (Paragraphs 0027-0028).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Kilis to include an inhaler resistance between 0.065 (√kPa)/liter per minute and about 0.200 (√kPa)/liter per minute, such as that taught by Zierenberg, in order to provide efficient delivery of powdered medicament to the user (Paragraph 0022).
Regarding claim 16, the modified method of Kilis discloses the device of claim 9.
Kilis is silent regarding wherein said dry powder inhaler has a resistance value between about 0.065 (√kPa)/liter per minute and about 0.200 (√kPa)/liter per minute.
However, Zierenberg teaches that a dry powder inhaler should have a low flow resistance for efficient delivery of medicament (Paragraph 0022) and further wherein the resistance is advantageously in the range of 0.01 to 0.1 (√kPa)/liter per minute (Paragraphs 0027-0028).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Kilis to include an inhaler resistance between 0.065 (√kPa)/liter per minute and about 0.200 (√kPa)/liter per minute, such as that taught by Zierenberg, in order to provide efficient delivery of powdered medicament to the user (Paragraph 0022).
Richardson (US 20090110647)
Claims 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kilis (U.S 5,167,506) in view of Jongejan (U.S 2007/0023034 A1) and Bonney (U.S 6,651,651 B1) and Mishelevich (U.S 5,363,842 A) and Kofoed (U.S 6,367,475 B1), as applied to claims 1 and 9, in further view of Richardson (U.S 2009/0110647 A1).
Regarding claim 14, the modified method of Kilis discloses the device of claim 9.
Kilis is silent regarding wherein the dry powder formulation comprises diketopiperazine microparticles.
However, Richardson teaches wherein a dry powder formulation can include diketopiperazine (Paragraphs 0010-0011, 0017-0018, 0046).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Kilis to include delivering diketopiperazine in the dry powder, such as that taught by Richardson, in order to facilitate drug delivery and absorption into circulation and improve drug stability (Paragraph 0046).
Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kilis (U.S 5,167,506) in view of Jongejan (U.S 2007/0023034 A1) and Bonney (U.S 6,651,651 B1) and Mishelevich (U.S 5,363,842 A) and Kofoed (U.S 6,367,475 B1), as applied to claims 9, 12 and 17, in further view of Lanpher (U.S 5,333,106 A).
Regarding claim 20, the modified method of Kilis discloses the device of claim 17.
Kilis is silent regarding wherein the attachable interactive training device further comprises additional circuitry to condition, filter, and amplify the at least one signal.
However, Kilis teaches wherein the inhalation training device system can include an amplifier to enhance the signal received from a pressure transducer (Col. 8 lines 14-26; An amplifier can be included to enhance/boost the signal from a differential pressure transducer which measures the inhalation).
Lanpher additionally teaches wherein an inhalation training device can further include additional circuitry to condition and filter the respiratory signal (Col. 14 lines 5-11; The circuitry can further smooth the signal to remove noise from interference or vibration and thus conditions and filters the input data before analysis; Additionally, see Col. 19 line 61 – Col. 20 line 6; The data can be weighted or filtered and thus can do both conditioning and filtering).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Kilis to have included additional circuitry to amplify, condition and filter the signal, such as that taught by Kilis and Lanpher, in order to increase the clarity of the signal for better analysis and to remove interference (Col. 8 lines 14-26 of Kilis and Col. 14 lines 5-11 of Lanpher).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS WILLIAM GREIG whose telephone number is (571)272-5378. The examiner can normally be reached Monday - Thursday: 7:30AM - 5:00PM.
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/THOMAS W GREIG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785