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
The amendments filed 6/26/2026 have been entered. Accordingly, claims 1-4, 7-9, 11-14 are pending in the current application. The amendments have overcome the 112b rejections previously presented in the non-final office action dated 3/24/2026. However, the Examiner notes the newly added 112b rejections as necessitated by the recent amendments.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 7-9, 11-14 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, as necessitated by the recent amendments. Regarding Applicant’s arguments on page 5 of the remarks regarding the structure of Rapport’s device not being “fully capable” of performing a recited limitation, the Examiner again notes that claims 1-4, 7-9 are apparatus claims reciting various method steps (such as the detection of various maximum/minimum respiratory cycle points) – and therefore are considered met by the prior art as long as the prior art possesses the structure fully capable of performing said functions, such as in this case, sensors configured to detect various respiratory cycle parameters (as supported in Paragraph 0036 of Rapport), see MPEP 2114 I. involving the use of functional language limitations in apparatus claims. Regardless, a new secondary reference is now being applied to better reflect the newly added limitations.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 7-9, 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Rapport et al. (US 2019/0255272 A1) in view of Tams et al. (US 2016/0325061 A1).
Regarding claim 1, Rapport discloses a high flow respiratory therapy device (respiratory therapy device comprising a blower unit 6, humidifier 4, conduit 2, patient interface 5, configured to deliver nasal high flow therapy to a user, Paragraph 0127 and Figure 1; the supply flow of a breathable gas to a user is supplied to the user synchronously with the breathing of the user, Paragraph 0087) comprising: a breathing pattern monitoring part, configured to monitor changes in a flow rate and a pressure of a mixed gas supplied to a patient (various sensors may be placed throughout the respiratory therapy device, including flow, pressure, temperature, and/or humidity sensors; one or more controllers 7 can control the blower unit 6 to generate a gas flow of desired flow rate and pressure supplied to the user) and collect the breathing pattern information of the patient (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of inspiration, and the onset, duration and/or end of expiration of the user, Paragraph 0036, Figure 2A; see also Paragraph 0026 specifically stating one or more sensors configured to measure data relating to the patient’s breathing pattern); an inspiratory effort point detection part configured to detect an inspiratory effort point, at which the patient initiates inhalation, from the breathing pattern information; (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of inspiration Paragraph 0036), an expiratory effort point detection part, configured to detect an expiratory effort point, at which the patient initiates exhalation, from the breathing pattern information (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of expiration, Paragraph 0036, Figure 2A); and a supply flow control part (controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127), configured to increase the flow rate of the mixed gas when respiration becomes the inspiratory effort point (the controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller 9 is further configured to increase the pressure/flow of the gases supplied to the user upon detection of a rise of CO2 during inhalation, therefore during the initiation of inhalation, Paragraph 0025 and Figure 6) and decreases the flow rate of the mixed gas when the respiration becomes the expiratory effort point (controller 9 further configured to decrease the pressure/flow of gases supplied to the user upon exhalation, Paragraph 0025 and Figure 6), wherein the inspiratory effort point detection part is configured to: extract, from the breathing pattern information, a maximum inspiratory effort point at which a change in inhalation flow rate is maximized, (one or more sensors configured to measure data relating to the patient’s breathing pattern, Paragraph 0026; see Figure 2B and Paragraph 0139 showing the patient’s respiratory cycle including the inspiration phase I comprising a peak and/or maximum wherein the flow rate is maximized), and an expiratory effort end point, at which the respiration temporarily stops before inhaling again and exhaling (see Figure 2B and Paragraph 0139 describing the point “P” indicating when the user transits from inspiration to expiration, therefore temporarily stops before inhaling again), and detect, as the inspiratory effort point, a point between the expiratory effort end point and the maximum inspiratory effort point (one or more sensors configured to measure data relating to the patient’s breathing pattern, Paragraph 0026; see also Figure 2B showing various points/data between the expiratory effort end point and the maximum inspiratory effort point), wherein the expiratory effort point detection part is configured to: extract a maximum expiratory effort point, at which a change in the exhalation flow rate is maximized (see Figure 2B and Paragraph 0139 showing a maximum expiratory effort point in which the change in exhalation flow rate is maximized), and the expiratory end point, and detect, as the expiratory effort point, a point between the maximum expiratory effort point and the expiratory effort end point (one or more sensors configured to measure data relating to the patient’s breathing pattern, Paragraph 0026; see also Figure 2B showing various points/data between the maximum respiratory effort point and the expiratory effort end point).
Although Rapport teaches one or more sensors configured to detect various breathing pattern information (Paragraph 0026), and a controller configured to analyze said detected information (Paragraph 0022), Rapport doesn’t explicitly state the expiratory effort end point corresponding to an average value of respiratory flow rate of the patient over one respiratory cycle.
However, Tams teaches a system for detecting asynchrony between a patient and a ventilator based on analyzing respiratory parameters across respiratory cycles (Abstract, Figure 1) wherein the average value of respiratory flow rate over one respiratory cycle is measured (the calculated flow rate of an individual respiratory cycle may comprise the average flow rate value, Paragraphs 0041-0042).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Rapport’s system such that the system may measure an average value of respiratory flow rate, as taught by Tams, as measuring/calculating the average flow rate value over a respiratory cycle may provide the user with useful breathing pattern information such as calculating accurate breathing volumes, detecting ventilator leaks, and adjusting gas delivery smoothly.
Regarding claim 2, Rapport further discloses a breathing synchronization unit (the supply flow of a breathable gas to a user is supplied to the user synchronously with the breathing of the user, Paragraph 0087), including a breathing pattern monitoring part (various sensors may be placed throughout the respiratory therapy device, including flow, pressure, temperature, and/or humidity sensors; one or more controllers 7 can control the blower unit 6 to generate a gas flow of desired flow rate and pressure supplied to the user), an inspiratory effort point detection part (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of inspiration Paragraph 0036), and the expiratory effort point detection part (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of expiration Paragraph 0036), the breathing synchronization unit being configured to synchronize inspiratory effort point and the expiratory effort point with the breathing pattern information (the supply flow of a breathable gas to a user is supplied to the user synchronously with the breathing of the user, Paragraph 0087 and Figure 2A), wherein the supply flow control part is configured to synchronize the flow control of the mixed gas with respect to the inspiratory effort point and expiratory effort point synchronized in the breathing synchronization unit (controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller configured to adjust flow rate/pressure supplied to the user synchronously with the user’s breathing, Paragraph 0087).
Regarding claim 3, Rapport further discloses wherein the supply flow control part is configured to set a basic flow (the controller 9 configured to adjust flow rate/pressure supplied to the user as desired, therefore fully capable of setting a basic flow to the user, Paragraph 0127), which includes a flow rate capable of ventilating a nasal cavity of the patient with fresh air and a maximum inhalation flow rate of the patient (nasal high flow therapy provided to the user, Paragraph 0127 and Figure 1), and supply the mixed gas of the bias flow rate when the respiration starts (the controller configured to ramp the therapy pressure and flow being supplied to the user such that the ramp cycle begins in synchrony with the start of inspiration portion of a breath, Paragraph 0160), increase the flow rate of the mixed gas by adding an auxiliary flow to the bias flow at the inspiratory effort point (ramp cycle then continues to increase, Paragraph 0159-0160), and reduces the flow rate to the basic flow at the expiratory effort point (ramp cycle ends during the expiration portion of a breath, Paragraph 0160).
Regarding claim 4, Rapport further discloses wherein the supply flow control part is configured to calculate the maximum inhalation flow is to be three to four times the patient's respiration rate per minute (Rapport’s device is fully capable of calculating various inhalation flow rate values, therefore meets the claim, see MPEP 2114 I.).
Regarding claim 7, Rapport discloses a high flow respiratory therapy device (respiratory therapy device comprising a blower unit 6, humidifier 4, conduit 2, patient interface 5, configured to deliver nasal high flow therapy to a user, Paragraph 0127 and Figure 1) comprising: a breathing pattern monitoring part, configured to monitor at least one of flow rate change and a pressure change, or combination thereof, of a mixed gas supplied to a patient (various sensors may be placed throughout the respiratory therapy device, including flow, pressure, temperature, and/or humidity sensors; one or more controllers 7 can control the blower unit 6 to generate a gas flow of desired flow rate and pressure supplied to the user) and collect breathing pattern information of the patient (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of inspiration, and the onset, duration and/or end of expiration of the user, Paragraph 0036, Figure 2A); an expiratory effort point detection part, configured to detect an expiratory effort point at which the patient initiates exhalation from the breathing pattern information (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of expiration, Paragraph 0036, Figure 2A); and a supply flow control part (controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127), configured to supply the mixed gas of a predetermined basic flow when the patient's respiration starts (the controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller 9 is further configured to increase the pressure/flow of the gases supplied to the user upon detection of a rise of CO2 during inhalation, Paragraph 0025 and Figure 6), and reduce the predetermined basic flow rate of the mixed gas by an minus auxiliary exhalation flow rate at the expiratory effort point to reduce expiratory effort of the patient (controller 9 further configured to decrease the pressure/flow of gases supplied to the user during exhalation, fully capable of reducing the flow rate of the supplied gas by any degree desired, Paragraph 0025 and Figure 6), wherein the expiratory effort point detection part is configured to: extract, from the breathing pattern information, a maximum expiratory effort point at which a change in exhalation flow rate is maximized (one or more sensors configured to measure data relating to the patient’s breathing pattern, Paragraph 0026; see Figure 2B and Paragraph 0139 showing the patient’s respiratory cycle including the expiration phase comprising a peak and/or maximum wherein the exhalation flow rate is maximized), and an expiratory effort end point, at which the respiration temporarily stops before inhaling again and exhaling (see Figure 2B and Paragraph 0139 describing the point “P” indicating when the user transits from inspiration to expiration, therefore temporarily stops before inhaling again), and detect, as the expiratory effort point, a point between the expiratory effort end point and the maximum expiratory effort point (one or more sensors configured to measure data relating to the patient’s breathing pattern, Paragraph 0026; see also Figure 2B showing various points/data between the expiratory effort end point and the maximum inspiratory effort point).
Although Rapport teaches one or more sensors configured to detect various breathing pattern information (Paragraph 0026), and a controller configured to analyze said detected information (Paragraph 0022), Rapport doesn’t explicitly state the expiratory effort end point corresponding to an average value of respiratory flow rate of the patient over one respiratory cycle.
However, Tams teaches a system for detecting asynchrony between a patient and a ventilator based on analyzing respiratory parameters across respiratory cycles (Abstract, Figure 1) wherein the average value of respiratory flow rate over one respiratory cycle is measured (the calculated flow rate of an individual respiratory cycle may comprise the average flow rate value, Paragraphs 0041-0042).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Rapport’s system such that the system may measure an average value of respiratory flow rate, as taught by Tams, as measuring/calculating the average flow rate value over a respiratory cycle may provide the user with useful breathing pattern information such as calculating accurate breathing volumes, detecting ventilator leaks, and adjusting gas delivery smoothly.
Regarding claim 8, Rapport further discloses a breathing synchronization unit (the supply flow of a breathable gas to a user is supplied to the user synchronously with the breathing of the user, Paragraph 0087), including the breathing pattern monitoring part (various sensors may be placed throughout the respiratory therapy device, including flow, pressure, temperature, and/or humidity sensors; one or more controllers 7 can control the blower unit 6 to generate a gas flow of desired flow rate and pressure supplied to the user), the expiratory effort point detection part (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of expiration Paragraph 0036), and an expiratory effort point detection part (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of expiration Paragraph 0036), and synchronizes the expiratory effort point with the patient's breathing pattern information and synchronizes the extracted inspiratory effort point and the expiratory effort point with the patient's breathing pattern information (the supply flow of a breathable gas to a user is supplied to the user synchronously with the breathing of the user, Paragraph 0087 and Figure 2A), wherein the supply flow control part is configured to synchronize the flow control of the mixed gas with respect to the inspiratory effort point and expiratory effort point synchronized in the breathing synchronization unit (controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller configured to adjust flow rate/pressure supplied to the user synchronously with the user’s breathing, Paragraph 0087).
Regarding claim 9, Rapport further discloses wherein the supply flow control part is configured to set the predetermined basic flow rate capable of ventilating the patient's nasal cavity with fresh air and the patient's maximum inhalation flow (the controller 9 configured to adjust flow rate/pressure supplied to the user as desired, therefore fully capable of setting a basic flow to the user, Paragraph 0127; nasal high flow therapy provided to the user, Paragraph 0127 and Figure 1), and wherein the supply flow control part is configured to calculate the patient's maximum inhalation flow is calculated to be three to four times the patient's respiration rate per minute (Rapport’s device is fully capable of calculating various inhalation flow rate values, therefore meets the claim, see MPEP 2114 I.).).
Regarding claim 11, Rapport discloses a therapy method in a high flow respiratory therapy device (respiratory therapy device comprising a blower unit 6, humidifier 4, conduit 2, patient interface 5, configured to deliver nasal high flow therapy to a user, Paragraph 0127 and Figure 1; the supply flow of a breathable gas to a user is supplied to the user synchronously with the breathing of the user, Paragraph 0087), comprising: monitoring, by a breathing pattern monitoring part monitors flow rate and pressure changes of a mixed gas supplied to a patient (various sensors may be placed throughout the respiratory therapy device, including flow, pressure, temperature, and/or humidity sensors; one or more controllers 7 can control the blower unit 6 to generate a gas flow of desired flow rate and pressure supplied to the user) and collecting the patient's breathing pattern information (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of inspiration, and the onset, duration and/or end of expiration of the user, Paragraph 0036, Figure 2A); detecting, by a detection part of a control part detects an inspiratory effort point, at which the patient tries to start inhalation (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of inspiration Paragraph 0036), and an expiratory effort point, at which the patient tries to start exhalation, from the patient's breathing pattern information, or detects only the expiratory effort point (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of expiration, Paragraph 0036, Figure 2A); and a step in which a supply flow control part of the control part flow rate of the mixed gas in response to the inspiratory effort point or the expiratory effort point (the controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller 9 is further configured to increase the pressure/flow of the gases supplied to the user upon detection of a rise of CO2 during inhalation, and decrease the pressure/flow of gases supplied to the user during exhalation, Paragraph 0025 and Figure 6), wherein the detecting comprises: extracting, from the breathing pattern information, a maximum effort point at which a change in flow rate is maximized (one or more sensors configured to measure data relating to the patient’s breathing pattern, Paragraph 0026; see Figure 2B and Paragraph 0139 showing the patient’s respiratory cycle including the expiration phase comprising a peak and/or maximum wherein the exhalation flow rate is maximized), and an expiratory effort end point, at which the respiration temporarily stops before inhaling again and exhaling (see Figure 2B and Paragraph 0139 describing the point “P” indicating when the user transits from inspiration to expiration, therefore temporarily stops before inhaling again), and detecting, as the inspiratory or expiratory effort point, a point between the expiratory effort end point and the maximum effort point (one or more sensors configured to measure data relating to the patient’s breathing pattern, Paragraph 0026; see also Figure 2B showing various points/data between the expiratory effort end point and the maximum inspiratory effort point).
Although Rapport teaches one or more sensors configured to detect various breathing pattern information (Paragraph 0026), and a controller configured to analyze said detected information (Paragraph 0022), Rapport doesn’t explicitly state the expiratory effort end point corresponding to an average value of respiratory flow rate of the patient over one respiratory cycle.
However, Tams teaches a system for detecting asynchrony between a patient and a ventilator based on analyzing respiratory parameters across respiratory cycles (Abstract, Figure 1) wherein the average value of respiratory flow rate over one respiratory cycle is measured (the calculated flow rate of an individual respiratory cycle may comprise the average flow rate value, Paragraphs 0041-0042).
Regarding claim 12, Rapport further discloses after detecting, synchronizing, by the breathing synchronization part of the control part synchronizes the detected inspiratory effort point or the expiratory effort point with the patient's breathing pattern information (the controller is configured to supply the flow of mixed gases synchronously with the breathing of the user, Paragraph 0087), and wherein in the step of controlling the flow of the mixed gas, the supply flow control part of the control part synchronizes the flow control of the mixed gas in response to the inspiratory effort point and expiratory effort point synchronized in the breathing synchronization part (the controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller 9 is further configured to increase the pressure/flow of the gases supplied to the user upon detection of a rise of CO2 during inhalation, and decrease the pressure/flow of gases supplied to the user during exhalation, Paragraph 0025 and Figure 6).
Regarding claim 13, Rapport further discloses wherein in the step of detecting, in a case in which the inspiratory effort point and the expiratory effort point are detected, in the step of controlling the flow of the mixed gas, the supply flow control part supplies the mixed gas of the bias flow when the patient's respiration starts (the controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller 9 is further configured to increase the pressure/flow of the gases supplied to the user upon detection of a rise of CO2 during inhalation, Paragraph 0025 and Figure 6), increases and supplies the flow rate by adding an plus auxiliary flow to the bias flow at the inspiratory effort point (ramp cycle then continues to increase, Paragraph 0159-0160), and reduces and supplies the flow rate to the bias flow rate and supplies the bias flow rate at the expiratory effort point (controller 9 further configured to decrease the pressure/flow of gases supplied to the user during exhalation, fully capable of reducing the flow rate of the supplied gas by any degree desired, Paragraph 0025 and Figure 6).
Regarding claim 14, Rapport further discloses wherein in a case in which only the expiratory effort point is detected in the step of detecting (the one or more sensors may be configured to measure a respiration signal indicative of the onset, duration and/or end of expiration Paragraph 0036), in the step of controlling the flow rate of the mixed gas, the supply flow control part supplies the mixed gas of a set basic flow when the patient's respiration starts (the controller 9 configured to adjust flow rate/pressure supplied to the user, Paragraph 0127; controller 9 is further configured to increase the pressure/flow of the gases supplied to the user upon detection of a rise of CO2 during inhalation, Paragraph 0025 and Figure 6), and reduces the flow rate of the mixed gas by an minus auxiliary exhalation flow rate (relief flow) at the expiratory effort point (controller 9 further configured to decrease the pressure/flow of gases supplied to the user during exhalation, fully capable of reducing the flow rate of the supplied gas by any degree desired, Paragraph 0025 and Figure 6), and then, increases the flow rate to the basic flow in proportion to the decrease in expiratory effort, thereby reducing the expiratory effort (process may be repeated overall a number of breaths, therefore repeated, Paragraph 0023).
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 SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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