DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1, 3 and 4 are objected to because of the following informalities:
In claim 1 “being sensorially perceptible by the patient” should read ---configured to be sensorially perceptible by the patient---
In claim 3 “signal is transmitted to an airway of the patient” should read ---signal is configured to be transmitted to an airway of the patient---
In claim 4 “via her mechanoreceptors” should read ---via the patient’s mechanoreceptors---.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 6-9 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis (US 2013/0220325 A1).
Regarding claim 1, Davis discloses a device for respiratory therapy of a patient (abstract), wherein the device comprises a respiratory gas source (#12, 16 fig 1, par 0038) for specifying different respiratory gas parameters (par 0038), comprising at least one control unit (#26 fig 1, par 0040), and a signal unit (#20 fig 1, par 0044 “indicator”) for outputting at least one signal, the at least one signal being used for signaling changing respiratory gas parameters (par 0044 "indicator 20 when the treatment device 10 is about to switch from positive to negative pressure during a cough cycle") and being sensorially perceptible by the patient (par 0044 discloses visual or audible signals thus disclosing perceptible by the senses of sight and sound/hearing).
Regarding claim 2, Davis discloses the device of claim 1. Davis further discloses the signal unit emits the signal to the patient before a change of a respiratory gas parameter (par 0044 "about to switch" thus disclosing signal is before a change/switch).
Regarding claim 6, Davis discloses the device of claim 1. Davis further discloses the signal unit is controlled by the control unit (par 0044 "the controller 26 issues a signal to the indicator 20").
Regarding claim 7, Davis discloses the device of claim 1. Davis further discloses the changing respiratory gas parameter is a respiratory gas pressure provided by the device (par 0044 discloses changing between positive and negative pressure).
Regarding claim 8, Davis discloses the device of claim 1. Davis further discloses the respiratory gas parameter is changed upon switching from insufflation to coughing phase (par 0044 discloses positive to negative pressure during a cough cycle).
Regarding claim 9, Davis discloses the device of claim 1. Davis further discloses the changing respiratory gas parameter is a positive respiratory gas pressure, which is dissipated following an insufflation phase for a coughing phase or is switched to negative pressure (par 0044).
Regarding claim 20, Davis discloses a system for respiratory therapy of a patient (abstract), wherein the system comprises the device of claim 1 (see claim 1 above), and further comprises a patient interface (par 0041 “face mask”) and a respiratory gas hose (#14 fig 1, par 0041 disclosing a breathing tube and a flexible hose).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3-5, 11-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Davis as applied to claim 1 above, and further in view of Martin (US 2021/0046267 A1).
Regarding claim 3, Davis discloses the device of claim 1. Davis is silent to the at least one signal is transmitted to an airway of the patient pneumatically and includes a modulation of a specified respiratory gas with respect to pressure and/or flow and/or volume. Davis instead discloses the signal being a visual or audible signal (par 0044).
Martin teaches the use of a signal for communicating with a patient (par 0280) wherein the signal is transmitted to an airway of the patient pneumatically and includes a modulation of a specified respiratory gas with respect to pressure and/or flow and/or volume (par 0280 discloses both a soft pressure bump and a pressure oscillation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a pressure modulation as taught by Martin for the signal of Davis as doing so allows for the signal to be discernable to the patient but not be distracting or disturbing to those nearby (Martin: par 0280 discloses the signal not disturbing a bed partner).
Regarding claim 4, Davis discloses the device of claim 1. Davis is silent to the at least one signal is sensorially perceptible by the patient via her mechanoreceptors and/or cold receptors and/or smell receptors and/or taste receptors. Davis instead discloses the signal being a visually or audibly perceptible (par 0044).
Martin teaches the use of a signal for communicating with a patient (par 0280) wherein the signal is sensorially perceptible by the patient via her mechanoreceptors and/or cold receptors and/or smell receptors and/or taste receptors (par 0280 discloses a pressure oscillation perceptible by face mechanoreceptors).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a pressure modulation as taught by Martin for the signal of Davis as doing so allows for the signal to be discernable to the patient but not be distracting or disturbing to those nearby (Martin: par 0280 discloses the signal not disturbing a bed partner).
Regarding claim 5, Davis discloses the device of claim 1. Davis is silent to the signal unit is configured for generating pneumatic signals.
Martin teaches the use of a signal for communicating with a patient (par 0280) wherein the signal unit is configured for generating pneumatic signals (par 0280 discloses both a soft pressure bump and a pressure oscillation thus disclosing pneumatic signals).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a pressure modulation as taught by Martin for the signal of Davis as doing so allows for the signal to be discernable to the patient but not be distracting or disturbing to those nearby (Martin: par 0280 discloses the signal not disturbing a bed partner).
Regarding claim 11, Davis discloses the device of claim 1. Davis further discloses the device carries out an insufflation without oscillation (par 0020 discloses the positive pressure/insufflation comprising a gradual increase to a first positive pressure, thus disclosing insufflation is without oscillation).
Davis is silent to the at least one signal being a specific modulation of the respiratory gas with respect to pressure and/or flow and/or volume. Davis instead discloses the signal being a visual or audible signal (par 0044).
Martin teaches the use of a signal for communicating with a patient (par 0280) wherein the signal being a specific modulation of the respiratory gas with respect to pressure and/or flow and/or volume (par 0280 discloses both a soft pressure bump and a pressure oscillation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a pressure modulation as taught by Martin for the signal of Davis as doing so allows for the signal to be discernable to the patient but not be distracting or disturbing to those nearby (Martin: par 0280 discloses the signal not disturbing a bed partner).
Regarding claim 12, Davis discloses the device of claim 1. Davis is silent to the at least one signal includes a modulation of pressure and/or flow. Davis instead discloses the signal being a visual or audible signal (par 0044).
Martin teaches the use of a signal for communicating with a patient (par 0280) wherein the signal includes a modulation of pressure and/or flow (par 0280 discloses both a soft pressure bump and a pressure oscillation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a pressure modulation as taught by Martin for the signal of Davis as doing so allows for the signal to be discernable to the patient but not be distracting or disturbing to those nearby (Martin: par 0280 discloses the signal not disturbing a bed partner).
Regarding claim 13, Davis discloses the device of claim 1. Davis is silent to the at least one signal is a modulated-on oscillation having a fixed or changing frequency and/or amplitude. Davis instead discloses the signal being a visual or audible signal (par 0044).
Martin teaches the use of a signal for communicating with a patient (par 0280) wherein the signal is a modulated-on oscillation having a fixed or changing frequency and/or amplitude (par 0280 discloses a pressure oscillation with a fixed amplitude “delivered at an amplitude that is able to be perceived by face mechanoreceptors” thus disclosing a fixed amplitude).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a pressure modulation as taught by Martin for the signal of Davis as doing so allows for the signal to be discernable to the patient but not be distracting or disturbing to those nearby (Martin: par 0280 discloses the signal not disturbing a bed partner).
Regarding claim 15, Davis discloses the device of claim 1. Davis is silent to the at least one signal is a brief positive or negative pressure and/or flow pulse on an air column. Davis instead discloses the signal being a visual or audible signal (par 0044).
Martin teaches the use of a signal for communicating with a patient (par 0280) wherein the signal is a brief positive or negative pressure and/or flow pulse on an air column (par 0280 discloses a soft pressure bump thus disclosing a brief positive pressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a pressure modulation as taught by Martin for the signal of Davis as doing so allows for the signal to be discernable to the patient but not be distracting or disturbing to those nearby (Martin: par 0280 discloses the signal not disturbing a bed partner).
Regarding claim 16, Davis discloses the device of claim 1. Davis is silent to the at least one signal changes between a beginning of the at least one signal and a moment of switching. Davis instead discloses the signal being a visual or audible signal (par 0044).
Martin teaches the use of a signal for communicating with a patient (par 0280) wherein the signal changes between a beginning of the at least one signal and a moment of switching (par 0280 discloses a pressure oscillation thus disclosing the signal changing during its duration by oscillating pressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a pressure modulation as taught by Martin for the signal of Davis as doing so allows for the signal to be discernable to the patient but not be distracting or disturbing to those nearby (Martin: par 0280 discloses the signal not disturbing a bed partner).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Davis as applied to claim 1 above, and further in view of Goebel (US 2019/0151581 A1) and Martin.
Regarding claim 10, Davis discloses the device of claim 1. Davis is silent to an insufflation with overlaid oscillation, the at least one signal being an oscillation which is changed before switching to a coughing phase. However, Davis does disclose that the signal delivered/changed before switching to a coughing phase (par 0044 "about to switch" thus disclosing signal is before switching).
Goebel teaches a similar respiratory therapy device for assisting a cough (abstract), comprising an insufflation with overlaid oscillation (#303/304 fig 10, par 0173, par 0189 list of reference numerals discloses 303 as oscillation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to overlay oscillation as taught by Goebel on the insufflation of Davis as doing so can help to detach solidly fixed secretions (Davis: par 0051).
Modified Davis remains silent to the at least one signal being an oscillation which is changed before switching to a coughing phase.
Martin teaches the use of a signal for communicating with a patient (par 0280) wherein the signal being an oscillation (par 0280 a pressure oscillation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a differing pressure oscillation as taught by Martin for the signal of modified Davis as doing so allows for the signal to be discernable to the patient but not be distracting or disturbing to those nearby (Martin: par 0280 discloses the signal not disturbing a bed partner). Examiner notes: as the oscillation disclosed by Martin is designed to provide a signal to the patient it is seen that the oscillation signal would be different than the insufflation oscillation in order to still achieve the desired outcome of communicating with the patient.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over modified Davis as applied to claim 13 above, and further in view of Sterke (US 2022/0054772 A1).
Regarding claim 10, modified Davis discloses the device of claim 13. Modified Davis is silent to the oscillation has a frequency from 1 to 40 Hz, and an amplitude of the oscillation is from 0.2 to 50 hPa.
Sterke teaches a similar insufflation respiratory therapy device (abstract), comprising oscillation, wherein the oscillation has a frequency from 1 to 40 Hz (claim 10 “0.1-100 Hz”), and an amplitude of the oscillation is from 0.2 to 50 hPa (claim 10 “10 hPa”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize oscillation have a frequency and amplitude as taught by Sterke for the oscillation of modified Davis, as doing the amplitude and frequency are effective for insufflation (Sterke: abstract).
Claim 17-19 is rejected under 35 U.S.C. 103 as being unpatentable over modified Davis as applied to claim 1 above, and further in view of Balko (US 2013/0269698 A1).
Regarding claim 17, Davis discloses the device of claim 1. Davis is silent to the device further comprises a generator for generating a detector signal and a sensor for determining a change of the detector signal, the detector signal being suitable for detecting changes of a patency of airways and/or an at least advanced or complete filling of a lung and the sensor determining this change of the detector signal.
Balko teaches a similar insufflation-exsufflation cough assist device (par 0007) comprising a generator for generating a detector signal (par 0035 discloses a threshold detection) and a sensor for determining a change of the detector signal (par 0035 discloses the control module determining transition time based on the detection of reaching a threshold), the detector signal being suitable for detecting changes of a patency of airways and/or an at least advanced or complete filling of a lung (par 0035 discloses sensing a pressure or flow reaching a threshold indicative of “the point in time at which sufficient gas has been received into the lungs of subject” thus disclosing detecting advanced filling of the lung) and the sensor determining this change of the detector signal (par 0035 discloses reaching the threshold as a trigger for the transition time).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a detection of filling of the lungs to trigger the transition from insufflation to exsufflation as taught by Balko on the device of Davis as doing so ensures that the lungs have been filled enough such that exsufflation will be productive (Balko: par 0035 “the threshold may be determined to correspond to the point in time at which sufficient gas has been received into the lungs of subject 106 for a productive exsufflation to commence”).
Regarding claim 18, modified Davis discloses the device of claim 17. Balko further discloses automatic switching to a coughing phase takes place when, based on the detector signal, a change of the patency of the airways or an at least advanced or complete filling of the lung is determined (par 0035 discloses a transition threshold being indicative of advanced filling of the lungs, par 0034 discloses the transition time being when the device switches from positive pressure insufflation to negative pressure/exsufflation “at a transition time, control module 170 controls pressure generator 140 to reduce the pressure of the pressurized flow of breathable gas with sufficient abruptness that expiratory flow through the airway of subject 106 is sufficient to remove sputum and/or other debris from the airway and/or lungs of subject”).
Regarding claim 19, modified Davis discloses the device of claim 18. Balko further discloses the automatic switching is based on an oscillatory pressure, flow, and/or volume signal (par 0035 discloses the transition threshold being determined based on pressure or flow signals).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 6675797 B1 discloses detecting patency of airways
US 20070089740 A1 discloses an indicator unit utilizing sensory communication such as taste and smell
US 20060037615 A1 discloses detecting airway patency
US 8523758 B1 discloses scent and taste breathing cues
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIRA B DAHER whose telephone number is (571)270-0190. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIRA B DAHER/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799