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
Claim 5 is objected to because of the following informalities:
Claim 5 recites “The respiratory assistance system according to any one of claim 1”, claim 5 should read “The respiratory assistance system according to claim 1” for proper format and clarity.
Appropriate correction is required.
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.
Claim(s) 1, 5, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wondka et al. (US20100252037), hereafter Wondka, in view of Truschel (WO2014162283), hereafter Truschel.
Regarding Claim 1, Wondka discloses a respiratory assistance system (Abstract, system shown in Fig. 2), comprising: a portable artificial respirator that noninvasively assists respiratory of a subject (Fig. 2, ventilator 201, par. 0196, “A ventilator 201 can be borne or worn by a patient 203”, the ventilator can be worn and is therefore portable); a respiratory circuit having one end to which the artificial respirator is connected (Fig. 2, gas delivery circuit 207 connects the respirator 201) and another end to which a mouthpiece is connected (Fig. 2, interface 205 is connected to the other end of the circuit 207, Fig. 104 shows an embodiment wherein the interface is a mouthpiece 10801); a neck holder configured such that the mouthpiece is placed in vicinity of the mouth of the subject when the neck holder is attached to the neck of the subject (Fig. 104, neck strap 10805, par. 0334, “A cannula 10803 may be secured to the patient with a neck strap 10805. The tip of the catheter can be proximal to the mouth entrance, coplanar with the mouth entrance, or recessed inside the mouth between the lips and the awe line”).
Wondka is silent on a contact sensor that is provided at a tip of the mouthpiece and that detects a contact state when the subject holds the mouthpiece in his or her mouth, wherein the artificial respirator controls a start or end of respiratory assistance to the subject based on a detection result of the contact sensor.
However, Truschel teaches a respiratory assistance system (Fig. 1, ventilation system 100), comprising of a respirator (Fig. 1, pressure generator 140), a respiratory circuit (Fig. 1, conduit 145) connecting the respirator to a mouthpiece (Fig. 1, interface 160, par. 0020, “Interface appliance 160 is configured to be at least partially and releasably received into an airway orifice (e.g. mouth) of subject 105”). Truschel further teaches a contact sensor that is provided at a tip of the mouthpiece and that detects a contact state when the subject holds the mouthpiece in his or her mouth (par. 0029, “For example, in an embodiment where interface appliance 160 is a mouthpiece, readiness of subject 105 is indicated when subject 105 receives interface appliance 160 in his/her mouth and/or makes an inspiratory effort… In various embodiments, engagement of subject 105 with interface appliance 160 may be detected using one or more sensors 150 including, for example, a push button or a touch sensor.”; sensor 150 is provided at the mouthpiece to detect contact). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known system of Wondka, with the contact sensor of Truschel, to detect readiness of the user for supplying ventilation as taught by Truschel (Truschel, par. 0029).
The modified Wondka further teaches wherein the artificial respirator controls a start or end of respiratory assistance to the subject based on a detection result of the contact sensor (Truschel, par. 0029, “readiness of subject 105 is indicated when subject 105 receives interface appliance 160 in his/her mouth and/or makes an inspiratory effort”; Wondka, par. 0193, “…the ventilator 109 may then synchronize and titrate the therapy to the needs of the patient and to match the gas delivery with the patient's breathing for maximal comfort and therapeutic titration”) (Examiner Notes: Wondka discloses detecting user respiration and match the gas delivery with the breathing cycle, Truschel further teaches using the contact sensor to detect when the user is inhaling. It would have been obvious that after the modification, the prior art would control the respiratory assistance based on the contact sensor detection).
Regarding Claim 5, the modified Wondka discloses the respiratory assistance system according any one of claim 1, wherein the artificial respirator has a wearable size and weight so that the artificial respirator can be attached to the body of the subject (See Wondka par. 0196, Fig. 2, the artificial respirator 201 is wearable and is attached to the user’s body, therefore it inherently has a wearable size and weight) and is held on the body of the subject via a holder (Wondka, par. 0196 discloses the respirator is worn by the user, Fig. 13A shows a belt holder holding the respirator on the body of the subject).
Regarding Claim 6, the modified Wondka discloses the respiratory assistance system according to claim 5, wherein the artificial respirator has a battery (Wondka, par. 0336, “The ventilator can be self contained with a battery”) and an operation interface arranged in parallel on an exposed surface of the subject to which the artificial respirator is attached (Wondka, Fig. 2, par. 0196, a user interface 209; interface 209 is parallel to the surface of the subject as shown in the figure), the operation interface including a display function (par. 0380, “The ventilator screen can include a mirror or camera and display to allow the user to adjust the mask”).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wondka, in view of Truschel, further in view of Hallback (WO2018143844), hereafter Hallback.
Regarding Claim 2, the modified Wondka discloses the respiratory assistance system according to claim 1, but is silent on further comprising: a signal detecting unit that is removably attached to a lower part of the chest of the subject and that detects a bioelectrical signal generated by shrinking and relaxing of the diaphragm with spontaneous respiration of the subject, wherein the artificial respirator controls either one or both of the ventilation amount and air pressure of the pressurized air to be supplied to the respiratory circuit so as to be synchronized with inhalation or exhalation timing of the subject based on a detection result from the signal detecting unit.
However, Hallback teaches a respiratory assistance system (Fig. 1), comprising of an artificial respirator (Fig. 1, pneumatic unit 17, computer 15), further comprising of a signal detecting unit (Fig. 1, bioelectric sensor arrangement 27) that is removably attached to a lower part of the chest of the subject (pg. 11, line 25-28, “For example, the bioelectric sensor arrangement 27 could comprise a number of surface electrodes placed on the ribcage, the abdomen or in the vicinity of the phrenic nerve of the patient 3 to sense and filter out diaphragmatic EMG signals”) and that detects a bioelectrical signal generated by shrinking and relaxing of the diaphragm with spontaneous respiration of the subject (pg. 9 line 9-16, “In some embodiments, the control computer may be configured to receive an Edi signal representing the electrical activity of the patient's diaphragm from a bioelectric sensor… The control computer of the breathing apparatus may, thus, be configured to use a bioelectric signal representing the electrical activity of a respiratory muscle of the patient both to control the ventilatory assist provided to the patient by the breathing apparatus”), wherein the artificial respirator controls either one or both of the ventilation amount and air pressure of the pressurized air to be supplied to the respiratory circuit so as to be synchronized with inhalation or exhalation timing of the subject based on a detection result from the signal detecting unit (pg. 1 line 6-16, “…a ventilator adapted for operation in a NAVA mode, configured to provide ventilatory assist to the patient in synchrony with and proportion to the electrical activity of a respiratory muscle, such as the diaphragm, of the patient… and to control the breathing apparatus to provide ventilatory assist to the patient in synchrony with and proportion to the received Edi signal…”). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known system of Wondka, with the signal detection unit of Hallback, to determine an accurate breathing efficiency dynamically with minimum influence of the patient as taught by Hallback (Hallback, pg. 3 line 6-19).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wondka, in view of Truschel, further in view of Glickman et al. (US20080281219, US6887208 incorporated by reference), hereafter Glickman.
Regarding Claim 3, Wondka discloses the respiratory assistance system according to claim 1, but is silent on further comprising: a vibration detecting unit that is removably attached to a part near the chest of the subject and that detects a lung activity with spontaneous respiration of the subject, wherein the artificial respirator controls either one or both of the ventilation amount and air pressure of the pressurized air to be supplied to the respiratory circuit so as to be synchronized with inhalation or exhalation timing of the subject based on a detection result from the vibration detecting unit.
However, Glickman teaches a respiratory assistance system (Fig. 1, Abstract), comprising of an artificial respirator (Fig. 1, ventilator 120), and a vibration detecting unit (par. 0056, “The system 100 is associated with a sensing unit 102 including one or more sensors, which may, for example, be acoustic sensor(s)”; par. 0058-0059 discloses detecting lung vibration) that is removably attached to a part near the chest of the subject (par. 0056, “The system 100 is associated with a sensing unit 102 including one or more sensors, which may, for example, be acoustic sensor(s), as described in U.S. Pat. No. 6,887,208”; US6887208 col. 4 line 36-39 discloses the sensor can be applied by fasten straps which is removable) and that detects a lung activity with spontaneous respiration of the subject (par. 0058, “the sum of the vibration energy function in the lungs is calculated by the processor unit 106 during each breath cycle (inspiration and expiration) and is matched with each tidal volume (V.sub.T)”), wherein the artificial respirator controls either one or both of the ventilation amount and air pressure of the pressurized air (par. 0078, “assist volume control (VC), assist pressure control (PC)”) to be supplied to the respiratory circuit so as to be synchronized with inhalation or exhalation timing of the subject based on a detection result from the vibration detecting unit (par. 0036, “the energy function recorded from an healthy subject, has two distinct peaks, one representing the inspiration and the other--the expiration of the lungs”; par. 0085, “synchronization with the ventilator waveforms (pressure, flow and/or volume) is important… The different waveforms for the pressure, air flow, volume and the energy function graph can be synchronized and displayed as shown in FIG. 8”; par. 0113, “a novel method for controlling mechanical ventilation using the combination of an acoustic image and an energy function as a feedback signal”) (Examiner Notes: The prior art disclose detecting lung vibration, and generate energy function representing inspiration and expiration of the lung based on the vibration; then the ventilation is controlled by synchronizing the energy function with the ventilator pressure/volume). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known system of Wondka, with the system of Glickman, for optimized ventilation parameters as taught by Glickman (Glickman, par. 0113).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wondka, in view of Truschel, in view of Hallback, further in view of Glickman.
Regarding Claim 4, the modified Wondka discloses the respiratory assistance system according to claim 1, but is silent on further comprising: a signal detecting unit that is removably attached to a lower part of the chest of the subject and that detects a bioelectrical signal generated by shrinking and relaxing of the diaphragm with spontaneous respiration of the subject; and a vibration detecting unit that is removably attached to a part near the chest of the subject and that detects a lung activity with spontaneous respiration of the subject, wherein the artificial respirator controls either one or both of the ventilation amount and air pressure of the pressurized air to be supplied to the respiratory circuit so as to be synchronized with inhalation or exhalation timing of the subject based on detection results from the signal detecting unit and the vibration detecting unit.
However, Hallback teaches a respiratory assistance system (Fig. 1), comprising of an artificial respirator (Fig. 1, pneumatic unit 17, computer 15), further comprising of a signal detecting unit (Fig. 1, bioelectric sensor arrangement 27) that is removably attached to a lower part of the chest of the subject (pg. 11, line 25-28, “For example, the bioelectric sensor arrangement 27 could comprise a number of surface electrodes placed on the ribcage, the abdomen or in the vicinity of the phrenic nerve of the patient 3 to sense and filter out diaphragmatic EMG signals”) and that detects a bioelectrical signal generated by shrinking and relaxing of the diaphragm with spontaneous respiration of the subject (pg. 9 line 9-16, “In some embodiments, the control computer may be configured to receive an Edi signal representing the electrical activity of the patient's diaphragm from a bioelectric sensor… The control computer of the breathing apparatus may, thus, be configured to use a bioelectric signal representing the electrical activity of a respiratory muscle of the patient both to control the ventilatory assist provided to the patient by the breathing apparatus”), wherein the artificial respirator controls either one or both of the ventilation amount and air pressure of the pressurized air to be supplied to the respiratory circuit so as to be synchronized with inhalation or exhalation timing of the subject based on a detection result from the signal detecting unit (pg. 1 line 6-16, “…a ventilator adapted for operation in a NAVA mode, configured to provide ventilatory assist to the patient in synchrony with and proportion to the electrical activity of a respiratory muscle, such as the diaphragm, of the patient… and to control the breathing apparatus to provide ventilatory assist to the patient in synchrony with and proportion to the received Edi signal…”). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known system of Wondka, with the signal detection unit of Hallback, to determine an accurate breathing efficiency dynamically with minimum influence of the patient as taught by Hallback (Hallback, pg. 3 line 6-19).
The modified Wondka is still silent on a vibration detecting unit that is removably attached to a part near the chest of the subject and that detects a lung activity with spontaneous respiration of the subject, wherein the artificial respirator controls either one or both of the ventilation amount and air pressure of the pressurized air to be supplied to the respiratory circuit so as to be synchronized with inhalation or exhalation timing of the subject based on a detection result from the vibration detecting unit.
However, Glickman teaches a respiratory assistance system (Fig. 1, Abstract), comprising of an artificial respirator (Fig. 1, ventilator 120), and a vibration detecting unit (par. 0056, “The system 100 is associated with a sensing unit 102 including one or more sensors, which may, for example, be acoustic sensor(s)”; par. 0058-0059 discloses detecting lung vibration) that is removably attached to a part near the chest of the subject (par. 0056, “The system 100 is associated with a sensing unit 102 including one or more sensors, which may, for example, be acoustic sensor(s), as described in U.S. Pat. No. 6,887,208”; US6887208 col. 4 line 36-39 discloses the sensor can be applied by fasten straps which is removable) and that detects a lung activity with spontaneous respiration of the subject (par. 0058, “the sum of the vibration energy function in the lungs is calculated by the processor unit 106 during each breath cycle (inspiration and expiration) and is matched with each tidal volume (V.sub.T)”), wherein the artificial respirator controls either one or both of the ventilation amount and air pressure of the pressurized air (par. 0078, “assist volume control (VC), assist pressure control (PC)”) to be supplied to the respiratory circuit so as to be synchronized with inhalation or exhalation timing of the subject based on a detection result from the vibration detecting unit (par. 0036, “the energy function recorded from an healthy subject, has two distinct peaks, one representing the inspiration and the other--the expiration of the lungs”; par. 0085, “synchronization with the ventilator waveforms (pressure, flow and/or volume) is important… The different waveforms for the pressure, air flow, volume and the energy function graph can be synchronized and displayed as shown in FIG. 8”; par. 0113, “a novel method for controlling mechanical ventilation using the combination of an acoustic image and an energy function as a feedback signal”) (Examiner Notes: The prior art disclose detecting lung vibration, and generate energy function representing inspiration and expiration of the lung based on the vibration; then the ventilation is controlled by synchronizing the energy function with the ventilator pressure/volume). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known system of Wondka, with the system of Glickman, for optimized ventilation parameters as taught by Glickman (Glickman, par. 0113).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20120298108 discloses a breathing assistance system comprising of a diaphragm electromyographic detection system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRIS HANYU GONG whose telephone number is (703)756-5898. The examiner can normally be reached M-F 8:30-4:30.
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/KRIS HANYU GONG/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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