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 .
This action is in response to the filing on 12/9/2025. Since the previous filing, claims 1 and 11 have been amended and no claims have been added or cancelled. Thus, claims 1-7, 9-17 and 19-20 are pending in the application.
In regards to the previous 103 rejections, Applicant’s arguments and amendments do not overcome the current prior art and the rejections have been maintained, modified for the amendments, below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7 and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Plattner (US Patent Publication No. 2009/0107498) in view of Mazar (US Patent Publication No. 2009/0264792), Ni (US Patent No. 7,329,226), Lee (US 2005/0074741) and Teschner (US 2010/0228143).
In regards to claim 1, Plattner teaches a non-invasive ventilation therapy system (paragraph 10), the system comprising: a ventilation device (paragraph 10, Fig 8, paragraph 320) adapted to generate and output a volume of air (paragraph 135) and record the output volume data of the output volume of air (recording of therapy monitoring, paragraph 141, monitoring including volume measurements over period of time, paragraph 144 and 146, 160 and 162, 173); a computing device coupled to the ventilation device (analyzer, paragraph 38 line 6-15); a plurality of sensors external to the patient (paragraph 248), wherein the sensors are functionally connected to the computing device; wherein the computing device: obtains the output volume data recorded by the ventilation device (record of signals from device kept and used for therapy control, paragraph 54); receives data from sensors (paragraph 38 line 1-6), based on the sensor data, transmits a signal to the ventilation device to adjust therapy levels (paragraph 38 line 6-15, paragraph 45).
Plattner does not teach that the sensors are adapted for acquiring a physiological bioelectrical impedance signal externally and transthoracically around a torso of a patient to measure the change in impedance due to the torso’s expansion during respiration, wherein the computing device: receives the physiological bioelectrical impedance signal from the sensors, analyzes the physiological bioelectrical impedance signal and wherein the physiological bioelectrical impedance signal comprises a measurement of respiratory volume; compares the output volume data generated by the ventilation device with the measurement of respiratory volume from the physiological bioelectric impedance signal; and based on the comparison, transmits a signal to the ventilation device to adjust therapy levels.
While Plattner does teach impedance measurements acquired through electrodes (paragraph 254), it does not teach that these are measurements of physiological bioelectrical impedance. However, Mazar teaches a non-invasive device for measuring physiological bioelectrical impedance from an exterior of a torso of a patient utilizing electrodes (device 100 may be adhered onto thorax, paragraph 45 line 4-6, device 100 contains electrodes 112A-112D, paragraph 53 line 9-10). Further, Ni teaches a computing device which receives the physiological bioelectrical impedance signal from the sensors (server 136 contains analysis module 144 and telemetry module 142 which receives physiological measures, column 8 line 25-40), analyzes the physiological bioelectrical impedance signal (column 8 line 61 – column 9 line 2); and wherein a physiological bioelectrical impedance signal comprises a measurement of respiratory volume (column 3 line 14-16, column 6 line 22-33).
Therefore, it would have been obvious and one of ordinary skill in the art would have been motivated before the effective filing date of the claimed invention to modify Plattner to measure physiological bioelectrical impedance from the patient utilizing electrodes, wherein the computing device: receives the physiological bioelectrical impedance signal from the sensors, analyzes the physiological bioelectrical impedance signal and wherein the physiological bioelectrical impedance signal comprises a measurement of respiratory volume as taught by Mazar and Ni as this is a known method of non-invasive monitoring and an effective method of acquiring respiratory data in a non-clinical setting with an added benefit that the sensors, signal and analysis of Ni are able to test pulmonary performance as well (Ni: column 1 line 60 – column 2 line 5).
Further, Lee teaches impedance measured transthoracically and wherein the thransthoracic impedance is acquired from around the torso (paragraph 43 line 12-14) measuring the change in impedance due to the torso’s expansion during respiration (transthoracic impedance modulated as chest wall moves during inspiratory efforts, paragraph 43 line 6-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Plattner such that the physiological bioelectrical impedance signal is measured transthoracically around a torso of a patient to measure the change in impedance due to the torso’s expansion during respiration as taught by Ni and Lee as this is a known means by which to measure physiological bioelectrical impedance.
Additionally, Teschner teaches a respiratory monitoring device which uses impedance to determine respiratory volume (paragraph 40) which compares the ventilator settings with the measurement of respiratory volume from the physiological bioelectric impedance signal in order to adjust therapy (paragraph 54).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Plattner such that the device compares the ventilator settings with the measurement of respiratory volume from the physiological bioelectric impedance signal in order to adjust therapy as taught by Teschner as this is a known means of acquiring this parameter of respiratory data to compare with and adjust ventilator parameters to ensure the applied therapy is based on the needs of the user.
In regards to claim 2, Plattner in view of Mazar, Ni, Lee and Teschner teaches the system of claim 1.
Plattner does not teach wherein the computing device provides an assessment of minute ventilation, tidal volume, and respiratory rate of the patient based on the analyzed bioelectrical impedance signal.
However, Ni teaches wherein the computing device further provides an assessment of minute ventilation, tidal volume, and respiratory rate of the patient based on the analyzed bioelectrical impedance signal (column 5 line 3-7 and 39-41).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Plattner such that the computing device further provides an assessment of minute ventilation, tidal volume, and respiratory rate of the patient based on the analyzed bioelectrical impedance signal as taught by Ni as these parameters would reasonably aid the device in properly calibrating therapy levels.
In regards to claim 3, Plattner in view of Mazar, Ni, Lee and Teschner teaches the system of claim 1 and Plattner further teaches wherein the therapy levels are at least one of pressure (paragraph 3 and 6), and length of therapy (paragraph 77).
In regards to claim 4, Plattner in view of Mazar, Ni, Lee and Teschner teaches the system of claim 1 and Plattner further teaches further comprising an aerosol delivery system (paragraph 41, 43, 232 and 245).
In regards to claim 5, Plattner in view of Mazar, Ni, Lee and Teschner teaches the system of claim 1 and Plattner further teaches wherein the computing device further monitors session-to-session lung performance to determine effectiveness of therapy (analyzer draws information from patient history in order to decide mode assignment, paragraph 38 line 6-10 and 12-15).
In regards to claim 6, Plattner in view of Mazar, Ni, Lee and Teschner teaches the system of claim 1 and Plattner further teaches wherein the non- invasive ventilation device is one of a Continuous High Frequency Oscillation ("CHFO") system (paragraph 108), a ventilator (paragraph 40), a Continuous Positive Airway Pressure ("CPAP") device (paragraph 40), a Bilevel Positive Airway Pressure ("BiPAP") device (paragraph 40), a Continuous Positive Expiratory Pressure ("CPEP") device (paragraph 101), another mechanical ventilation device (paragraph 320), or an oxygenation therapy device (paragraph 303).
In regards to claim 7, Plattner in view of Mazar, Ni, Lee and Teschner teaches the system of claim 1.
Plattner does not teach wherein the computing device further outputs a bioimpedance exhalation/inhalation curve and determines effectiveness of therapy based on the bioimpedance exhalation/inhalation curve.
However, Ni teaches wherein the computing device further outputs a bioimpedance exhalation/inhalation data so they might be evaluated so as to determine respiratory patterns based on the bioimpedance exhalation/inhalation data (column 3 line 32-38).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Plattner such that the computing device further outputs a bioimpedance exhalation/inhalation data so they might be evaluated so as to determine respiratory patterns based on the bioimpedance exhalation/inhalation data as taught by Ni and it would be well within the skill of the art to plot the measurement sets for inspiratory and expiratory data as this would provide an easily interpreted means for the patient or a medical professional to assess the effectiveness of the applied therapy.
In regards to claim 11, Plattner teaches a method of providing non-invasive ventilation therapy system (paragraph 10), the method comprising the steps of: providing a ventilation device to a patient (paragraph 10, Fig 8, paragraph 320), wherein the ventilation device is adapted to generate and output a volume of air (paragraph 135) and record the output volume data of the output volume of air (recording of therapy monitoring, paragraph 141, monitoring including volume measurements over period of time, paragraph 144 and 146, 160 and 162, 173); coupling a plurality of sensors to a patient (paragraph 38 line 1-6) to acquire a signal externally (paragraph 248); and coupling the ventilation device and the plurality of sensors to a computing device (paragraph 38), the computing device: obtaining output volume data recorded by the ventilation device (record of signals from device kept and used for therapy control, paragraph 54); receiving the signal from the sensors (paragraph 38 line 1-6), and based on the analyzed sensor signal, adjusting the therapy levels of the ventilation device (paragraph 38 line 6-15, paragraph 45).
Plattner does not teach that the plurality of sensors are for acquiring a physiological bioelectrical impedance signal externally and transthoracically around a torso of a patient to measure the change in impedance due to the torso’s expansion during respiration, the computing device: receiving the physiological bioelectrical impedance signal from the sensors, analyzing the physiological bioelectrical impedance signal, wherein the analyzed physiological bioelectrical impedance signal comprises a measurement of a respiratory volume; compares the output volume data generated by the ventilation device with the measurement of respiratory volume from the physiological bioelectric impedance signal; and based on the comparison, transmits a signal to the ventilation device to adjust therapy levels.
While Plattner does teach impedance measurements acquired through electrodes (paragraph 254), it does not teach that these are measurements of physiological bioelectrical impedance. However, Mazar teaches a non-invasive device for measuring physiological bioelectrical impedance from an exterior of a torso of a patient utilizing electrodes (device 100 may be adhered onto thorax, paragraph 45 line 4-6, device 100 contains electrodes 112A-112D, paragraph 53 line 9-10). Further, Ni teaches a computing device for receiving the physiological bioelectrical impedance signal from the sensors (server 136 contains analysis module 144 and telemetry module 142 which receives physiological measures, column 8 line 25-40), analyzing the physiological bioelectrical impedance signal (column 8 line 61 – column 9 line 2); wherein the analyzed physiological bioelectrical impedance signal comprises a measurement of a respiratory volume (column 3 line 14-16, column 6 22-33).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Plattner to measure physiological bioelectrical impedance from the patient utilizing electrodes in a tetrapolar configuration, the computing device: receiving the physiological bioelectrical impedance signal from the sensors, analyzing the physiological bioelectrical impedance signal, wherein the analyzed physiological bioelectrical impedance signal comprises a measurement of a respiratory volume as taught by Mazar and Ni as this is a known method of non-invasive monitoring and an effective method of monitoring and testing pulmonary performance in a non-clinical setting (Ni: column 1 line 60 – column 2 line 5).
Further, Lee teaches impedance measured transthoracically and wherein the thransthoracic impedance is acquired from around the torso (paragraph 43 line 12-14) measuring the change in impedance due to the torso’s expansion during respiration (transthoracic impedance modulated as chest wall moves during inspiratory efforts, paragraph 43 line 6-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Plattner such that the physiological bioelectrical impedance signal is measured transthoracically around a torso of a patient to measure the change in impedance due to the torso’s expansion during respiration as taught by Lee as this is a known means by which to measure physiological bioelectrical impedance.
Additionally, Teschner teaches a respiratory monitoring device which uses impedance to determine respiratory volume (paragraph 40) which compares the ventilator settings with the measurement of respiratory volume from the physiological bioelectric impedance signal in order to adjust therapy (paragraph 54).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Plattner such that the device compares the ventilator settings with the measurement of respiratory volume from the physiological bioelectric impedance signal in order to adjust therapy as taught by Teschner as this is a known means of acquiring this parameter of respiratory data to compare with and adjust ventilator parameters to ensure the applied therapy is based on the needs of the user.
In regards to claim 12, Plattner in view of Mazar, Ni, Lee and Teschner teaches the method of claim 11.
Plattner does not teach wherein the computing device further provides an assessment of minute ventilation, tidal volume, and respiratory rate of the patient based on the analyzed bioelectrical impedance signal.
However, Ni teaches wherein the computing device further provides an assessment of minute ventilation, tidal volume, and respiratory rate of the patient based on the analyzed bioelectrical impedance signal (column 5 line 39-41).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Plattner such that the computing device further provides an assessment of minute ventilation, tidal volume, and respiratory rate of the patient based on the analyzed bioelectrical impedance signal as taught by Ni as these parameters would aid the device in properly calibrating therapy levels.
In regards to claim 13, Plattner in view of Mazar, Ni, Lee and Teschner teaches the method of claim 11 and Plattner further teaches wherein the therapy levels are at least one of pressure (paragraph 3), and length of therapy (paragraph 77).
In regards to claim 14, Plattner in view of Mazar, Ni, Lee and Teschner teaches the method of claim 11 and Plattner further teaches further comprising coupling an aerosol delivery system to the patient and the computing device (paragraph 41, 43, 232 and 245).
In regards to claim 15, Plattner in view of Mazar, Ni, Lee and Teschner teaches the method of claim 11 and Plattner further teaches wherein the computing device further monitors session-to-session lung performance to determine effectiveness of therapy (analyzer draws information from patient history in order to decide mode assignment, paragraph 38 line 6-10 and 12-15).
In regards to claim 16, Plattner in view of Mazar, Ni, Lee and Teschner teaches the method of claim 11 and Plattner further teaches wherein the non-invasive ventilation device is one of a Continuous High Frequency Oscillation ("CHFO") system (paragraph 108), a ventilator (paragraph 40), a Continuous Positive Airway Pressure ("CPAP") device, a Bilevel Positive Airway Pressure ("BiPAP") device (paragraph 40), a Continuous Positive Expiratory Pressure ("CPEP") device (paragraph 101), another mechanical ventilation device (paragraph 320), or an oxygenation therapy device (paragraph 303).
In regards to claim 17, Plattner in view of Mazar, Ni, Lee and Teschner teaches the method of claim 11.
Plattner does not teach wherein the computing device further outputs a bioimpedance exhalation/inhalation curve and determines effectiveness of therapy based on the bioimpedance exhalation/inhalation curve.
However, Ni teaches wherein the computing device further outputs bioimpedance exhalation/inhalation data so they might be evaluated so as to determine respiratory patterns based on the bioimpedance exhalation/inhalation data (column 3 line 32-38).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Plattner such that the computing device further outputs a bioimpedance exhalation/inhalation data so they might be evaluated so as to determine respiratory patterns based on the bioimpedance exhalation/inhalation data as taught by Ni and it would be well within the skill of the art to plat the measurement sets for inspiratory and expiratory data as this would provide an easily interpreted means for the patient or a medical professional to assess the effectiveness of the applied therapy.
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Plattner (US Patent Publication No. 2009/0107498) in view of Mazar (US Patent Publication No. 2009/0264792), Ni (US Patent No. 7,329,226), Lee (US 2005/0074741) and Teschner (US 2010/0228143) as applied to claims 1 and 11 above and in further view of Tran (US Patent Publication No. 2019/0038133).
In regards to claim 9, Plattner in view of Mazar, Ni, Lee and Teschner teaches the system of claim 1 and Plattner further teaches the device further comprising a means to measure the oxygenation of the patient (oxygen saturation is monitored though method of monitoring is not disclosed, paragraph 18, paragraph 237).
Plattner does not teach that the means to measure the oxygenation of the patient is a pulse oximeter.
However, Tran teaches a pulse oximeter that measures oxygenation of the patient (paragraph 34 line 12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Plattner to use a pulse oximeter as they are easy, unobtrusive and effective means to measure the oxygenation of the patient (oximeter can be placed on the finger, wrist or ear of patient, paragraph 237 line 1-4).
In regards to claim 19, Plattner in view of Mazar, Ni, Lee and Teschner teaches the method of claim 11 and Plattner further teaches coupling a means to measure the oxygenation of the patient to the patient and the computing device (oxygen saturation is monitored though method of monitoring is not disclosed, paragraph 18, paragraph 237).
Plattner does not teach that the means to measure the oxygenation of the patient is a pulse oximeter.
However, Tran teaches a pulse oximeter that measures oxygenation of a patient (paragraph 34 line 12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Plattner to use a pulse oximeter as they are easy, unobtrusive and effective means to measure the oxygenation of the patient (oximeter can be placed on the finger, wrist or ear of patient, paragraph 237 line 1-4).
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Plattner (US Patent Publication No. 2009/0107498) in view of Mazar (US Patent Publication No. 2009/0264792), Ni (US Patent No. 7,329,226), Lee (US 2005/0074741) and Teschner (US 2010/0228143) as applied to claims 1 and 11 above and in further view of Cabal (US Patent No. 4,291,691).
In regards to claim 10, Plattner in view of Mazar, Ni, Lee and Teschner teaches the system of claim 1.
Plattner does not teach wherein the ventilation device causes the mobilization of fluid in the lungs.
However, Cabal teaches wherein the ventilation device causes the mobilization of fluid in the lungs (respiratory suction adaptor allows for suction of fluid in lungs, column 2 line 50-63).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Plattner such that the ventilation device causes the mobilization of fluid in the lungs as taught by Cabal as provision of an adapter for suction would enable the ventilation device to help ensure that the lungs are cleared of obstructions.
In regards to claim 20, Plattner in view of Mazar, Ni, Lee and Teschner teaches the method of claim 11.
Plattner does not teach wherein the ventilation device causes the mobilization of fluid in the lungs.
However, Cabal teaches wherein the ventilation device causes the mobilization of fluid in the lungs (respiratory suction adaptor allows for suction of fluid in lungs, column 2 line 50-63).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Plattner such that the ventilation device causes the mobilization of fluid in the lungs as taught by Cabal as provision of an adapter for suction would enable the ventilation device to help ensure that the lungs are cleared of obstructions.
Response to Arguments
In regards to the arguments concerning independent claims 1 and 11, these arguments are not persuasive. Applicant argues against the combination by alleging that individual references used to build to claimed invention do not provide the full teachings of the limitations. The Examiner respectfully disagrees, and notes that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 2145(IV). Plattner does not teach all of the analysis and volumetric comparison details of the limitations, as Applicant points out, but Examiner would note that Plattner is not being called upon for those details. Teschner is also noted as not teaching the exact wordage of the claims. However, Teschner is only called upon for the teaching of bioelectric impedance monitoring of respiratory volume being compared to ventilator treatment settings in order to adjust the therapy to maintain the appropriate treatment. While neither teaches the full scope of the limitations individually, the combination therein does.
Arguments in regards to the dependent claims are in regards to their dependency on independent claims 1 and 11 and are addressed in the rejections entered above.
Conclusion
THIS ACTION IS MADE FINAL. 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 Arielle Wolff whose telephone number is (571)272-8727. The examiner can normally be reached on Mon-Fri 8:00-4:00.
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/ARIELLE WOLFF/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785