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
Applicant’s amendments, filed 07/16/2026, have been entered, claims 1, 7, 8, 10-18, 21-29 remain pending.
Claim Objections
Claim 1 objected to because of the following informalities:
Claim 1 recites “… and having an electrically conductive material provided on at least one side of the conductive membrane such that the conductive has an electrically conductive side”, claim 1 should read “… and having an electrically conductive material provided on at least one side of the conductive membrane such that the conductive membrane has an electrically conductive side” for 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, 10-12, 15, 18, 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abusleme (WO 2016106460), in view of Caldwell (US20050065449), hereafter Caldwell.
Regarding Claim 1, Abusleme teaches a tracheotomy tube monitoring device (par. 0036“The present invention relates to a device (1) that monitors in real time the breathing of patients with tracheostomy or endotracheal tubes, alerting quickly and early to any abnormality in the patient's breathing.”) comprising:
an airflow tube configured to connect to a tracheotomy tube (see fig. 7b, inner tube portion of 2a; see fig. 8 showing how the tube receives the end of the tracheotomy tube), the airflow tube including an inlet opening and an outlet opening (Fig. 8 and 9 shows an outlet opening connected to a tracheostomy tube 3, and an inlet opening opposite to the tracheostomy tube 3), wherein an end member is located at the inlet opening (Fig. 7a-9, an narrower end member is defined at the inlet opening) and the outlet opening is configured to receive the tracheotomy tube (Fig. 8 and 9);
Sensing means associated with the airflow tube for monitoring respiration of a patient in which the tracheotomy tube is inserted (Fig. 1, sensor 4; par. 0038, “The device comprises at least one sensor (4) which is preferably arranged on the periphery of the first portion (2a) of the device (1)”); and
Alert means for alerting relevant persons when data collected by the sensing means indicate that there is a problem (par. 0039, “the device (1) comprises a second alarm system redundant to the alert system (7), which wirelessly transmits signals to the outside to alert of any problems with the device (1)”).
Abulseme is silent on the sensing means including an electrically conductive membrane having a center and an outer edge, the center being secured to the end member of the airflow tube and the outer edge being free, the conductive membrane being made of a flexible material and having an electrically conductive material provided on at least one side of the conductive membrane such that the conductive has an electrically conductive side, and a sensing element positioned in proximity to the conductive membrane and including electrical contacts, wherein the electrically conductive side of the conductive membrane naturally seats against the end member in is urged into contact with the electrical contacts of the sensing element without any pressure being applied to the conductive membrane, and wherein and the electrically conductive side of the conductive membrane is only drawn out of contact with the electrical contacts of the sensing element when the patient inhales through the tracheotomy tube.
However, Caldwell teaches a respiration monitoring device (Abstract), comprising of an inlet and an outlet (Fig. 1, par. 0031, airflow inlet 12 and outlet 13), an end member located in the inlet opening (See Fig. A below) a sensing mean (Fig. 1, non-contact respiration monitor 1), wherein the sensing means including an electrically conductive membrane (Fig. 1, par. 0031, flexible electrically conducting flap-valve switch 14) having a center and an outer edge (See Fig. A below), the center being secured to the end member of the airflow tube and the outer edge being free (See Fig. 1 and 2, the center is secured to the end member and the outer edge is free), the conductive membrane being made of a flexible material (par. 0031, flexible electrically conducting flap-valve switch 14) and having an electrically conductive material provided on at least one side of the conductive membrane such that the conductive has an electrically conductive side (par. 0011, “the flap-valve switch is a flexible electrically-conducting switch”; the membrane is conductive and therefore it inherently have an conductive material provided to have an electrically conductive side), and a sensing element positioned in proximity to the conductive membrane and including electrical contacts (See annotated Fig. A, the sensing elements are part of the battery-powered logic circuit 16, par. 0031), wherein the electrically conductive side of the conductive membrane naturally seats against the end member in is urged into contact with the electrical contacts of the sensing element without any pressure being applied to the conductive membrane (Fig. 1 shows the sensing mean in a closed position, wherein the membrane is naturally in contact with the sensing element), and wherein and the electrically conductive side of the conductive membrane is only drawn out of contact with the electrical contacts of the sensing element when the patient inhales through the tracheotomy tube (Fig. 2, when inspiration occurs, the membrane is drawn out of contact with the sensing element, par. 0013, “it is preferable that movement of inhalation air operates to not only move the flap to cause the circuit to sense respiration…”; arrows in Fig. 2 shows the inhalation airflow). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known monitoring device of Abusleme, with the device of Caldwell, for non-contact respiration monitoring and to monitor the presence or absence of respiration (Caldwell, par. 0008-0010).
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Fig. A, Adapted from Caldwell Fig. 1
Regarding Claim 10, the modified Abusleme discloses the monitoring device of claim 1, further comprising a microcontroller configured to receive data sensed by the sensing means, to analyze the data to evaluate the patient's breathing, and to generate an alert when the patient's breathing is determined to be abnormal (see Abusleme par. 0039, “at least one electronic processing device (6) that allows automatic calibration of flow thresholds, processes circulating flow signals, detects anomalies in the operation of the cannula according to the defined thresholds, and in case of anomalies, activates the audible alarm and transmits wirelessly to the outside of the device (1), and is adaptable to the respiratory characteristics of each patient.”).
Regarding Claim 11, the modified Abusleme discloses the monitoring device of claim 10, further comprising a speaker controlled by the microcontroller and configured to emit an audible alarm (Abusleme, Fig 3. 3, speaker 7; par. 0039, “The device (1) further comprises at least one alert system (7) on the outer periphery of the first portion (2a), which emits a noise signal when the parameters measured by the sensors (4) exceed the pre-established flow threshold conditions”).
Regarding Claim 12, the modified Abusleme discloses the monitoring device of claim 10, further comprising a wireless transceiver controlled by the microcontroller and configured to wirelessly transmit an alert signal to another device (see Abusleme, par. 0039, “the device (1) comprises a second alarm system redundant to the alert system (7), which wirelessly transmits signals to the outside to alert of any problems with the device (1)”).
Regarding Claim 15, the modified Abusleme discloses the monitoring device of claim 1, further comprising a temperature sensor and a humidity sensor proved within the airflow tube configured to sense a temperature and a humidity, respectively, of air exhaled by the patient (Abusleme, par. 0038, “The at least one sensor may include a pressure sensor, temperature sensor, accelerometer, audio sensor and/or humidity sensor.” ).
Regarding claim 18, Abusleme teaches a system for monitoring a tracheotomy patient, the system comprising: a tracheotomy tube monitoring device (par. 0036“The present invention relates to a device (1) that monitors in real time the breathing of patients with tracheostomy or endotracheal tubes, alerting quickly and early to any abnormality in the patient's breathing.”) including an airflow tube configured to connect to a tracheotomy tube (see fig. 7b, inner tube portion of 2a; see fig. 8 showing how the tube receives the end of the tracheotomy tube), ), the airflow tube including an inlet opening and an outlet opening (Fig. 8 and 9 shows an outlet opening connected to a tracheostomy tube 3, and an inlet opening opposite to the tracheostomy tube 3), wherein an end member is located at the inlet opening (Fig. 7a-9, an narrower end member is defined at the inlet opening) and the outlet opening is configured to receive the tracheotomy tube (Fig. 8 and 9);
Sensing means for monitoring respiration of a patient in which the tracheotomy tube is inserted (Fig. 1, sensor 4; see pg. 4, first paragraph);
And a wireless transceiver configured to wirelessly transmit an alert signal when data collected by the sensing means indicates that there is a problem; (par. 0039, “the device (1) comprises a second alarm system redundant to the alert system (7), which wirelessly transmits signals to the outside to alert of any problems with the device (1)”), and a computing device configured to receive the alert wireless transmitted by the wireless transceiver (par. 0039, “at least one electronic processing device (6) that allows automatic calibration of flow thresholds, processes circulating flow signals, detects anomalies in the operation of the cannula according to the defined thresholds… a second alarm system redundant to the alert system (7), which wirelessly transmits signals to the outside to alert of any problems with the device (1).”)
Abulseme is silent on the sensing means including an electrically conductive membrane having a center and an outer edge, the center being secured to the end member of the airflow tube and the outer edge being free, the conductive membrane being made of a flexible material and having an electrically conductive material provided on at least one side of the conductive membrane such that the conductive has an electrically conductive side, and a sensing element positioned in proximity to the conductive membrane and including electrical contacts, wherein the electrically conductive side of the conductive membrane naturally seats against the end member in is urged into contact with the electrical contacts of the sensing element without any pressure being applied to the conductive membrane, and wherein and the electrically conductive side of the conductive membrane is only drawn out of contact with the electrical contacts of the sensing element when the patient inhales through the tracheotomy tube.
However, Caldwell teaches a respiration monitoring device (Abstract), comprising of an inlet and an outlet (Fig. 1, par. 0031, airflow inlet 12 and outlet 13), an end member located in the inlet opening (See Fig. A below) a sensing mean (Fig. 1, non-contact respiration monitor 1), wherein the sensing means including an electrically conductive membrane (Fig. 1, par. 0031, flexible electrically conducting flap-valve switch 14) having a center and an outer edge (See Fig. A below), the center being secured to the end member of the airflow tube and the outer edge being free (See Fig. 1 and 2, the center is secured to the end member and the outer edge is free), the conductive membrane being made of a flexible material (par. 0031, flexible electrically conducting flap-valve switch 14) and having an electrically conductive material provided on at least one side of the conductive membrane such that the conductive has an electrically conductive side (par. 0011, “the flap-valve switch is a flexible electrically-conducting switch”; the membrane is conductive and therefore it inherently have an conductive material provided to have an electrically conductive side), and a sensing element positioned in proximity to the conductive membrane and including electrical contacts (See annotated Fig. A, the sensing elements are part of the battery-powered logic circuit 16, par. 0031), wherein the electrically conductive side of the conductive membrane naturally seats against the end member in is urged into contact with the electrical contacts of the sensing element without any pressure being applied to the conductive membrane (Fig. 1 shows the sensing mean in a closed position, wherein the membrane is naturally in contact with the sensing element), and wherein and the electrically conductive side of the conductive membrane is only drawn out of contact with the electrical contacts of the sensing element when the patient inhales through the tracheotomy tube (Fig. 2, when inspiration occurs, the membrane is drawn out of contact with the sensing element, par. 0013, “it is preferable that movement of inhalation air operates to not only move the flap to cause the circuit to sense respiration…”; arrows in Fig. 2 shows the inhalation airflow). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known monitoring device of Abusleme, with the device of Caldwell, for non-contact respiration monitoring and to monitor the presence or absence of respiration.
Regarding Claim 24, the modified Abusleme discloses the system of claim 18, wherein the tracheotomy tube monitoring device further includes a microcontroller configured to receive data sensed by the sensing means, to analyze the data to evaluate the patient's breathing, and to generate an alert when the patient's breathing is determined to be abnormal (see Abusleme par. 0039, “at least one electronic processing device (6) that allows automatic calibration of flow thresholds, processes circulating flow signals, detects anomalies in the operation of the cannula according to the defined thresholds, and in case of anomalies, activates the audible alarm and transmits wirelessly to the outside of the device (1), and is adaptable to the respiratory characteristics of each patient.”).
Regarding Claim 25, the modified Abusleme discloses the system of claim 24, further comprising a speaker controlled by the microcontroller configured to emit an audible alarm (Abusleme, Fig 3. 3, speaker 7; par. 0039, “The device (1) further comprises at least one alert system (7) on the outer periphery of the first portion (2a), which emits a noise signal when the parameters measured by the sensors (4) exceed the pre-established flow threshold conditions”).
Claim(s) 7, 8, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abusleme, in view of Caldwell, further in view of Biegelsen et al. (US6044717), hereafter Biegelsen.
Regarding Claim 7, the modified Abusleme discloses the monitoring device of claim 1, wherein the conductive material comprises a thin conductive substrate that has been applied to the conductive membrane.
However, Biegelsen teaches a pressure sensor (Abstract, Fig. 2) for detecting flow (col. 3 line 53 – col. 4 line 5), comprising of a sensing mean (Fig. 2, pressure sensor 100), wherein the sensing means including an electrically conductive membrane (Fig. 2, sensor membrane 112) made of a flexible material (col. 2, line 12-14, “the sensor membrane may be formed of a flexible film such as silicone and a conductive film such as aluminized mylar”) and having an electrically conductive material provided on at least one side of the membrane such that the membrane has an electrically conductive side (col. 2, line 12-15, “the sensor membrane may be formed of a flexible film such as silicone and a conductive film such as aluminized mylar. The flexible film is attached to the conductive film, for example, by a lamination process”; col. 2 line 55-59, “the sensor membrane will deform and contact both the conductive strip and the resistive strip. The conductive sensor membrane thus electrically connects the conductive strip to the resistive strip”; the term ‘conductive’ in this case means electrically conductive). Biegelsen further teaches the conductive material comprises a thin conductive substrate that is has been applied to the membrane (Biegelsen, col. 2 line 13-15, “a conductive film such as aluminized mylar. The flexible film is attached to the conductive film, for example, by a lamination process”, see Fig. 2). Caldwell already teaches the membrane comprises of conductive material (Caldwell, par. 0011). It would have been obvious for one of ordinary skilled in the art to further modify the known device of Abusleme, with the device of Biegelsen, and apply a thin conductive substrate to the membrane for a flexible film, as such modification would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to apply a thin conductive substrate to the membrane through lamination (Biegelsen, col. 2 line 7-21).
Regarding Claim 8, the modified Abusleme discloses the monitoring device of claim 1, but is silent on wherein the conductive material comprises material that has been deposited on a surface of the membrane.
However, Biegelsen teaches a pressure sensor (Abstract, Fig. 2) for detecting flow (col. 3 line 53 – col. 4 line 5), comprising of a sensing mean (Fig. 2, pressure sensor 100), wherein the sensing means including an electrically conductive membrane (Fig. 2, sensor membrane 112) made of a flexible material (col. 2, line 12-14, “the sensor membrane may be formed of a flexible film such as silicone and a conductive film such as aluminized mylar”) and having an electrically conductive material provided on at least one side of the membrane such that the membrane has an electrically conductive side (col. 2, line 12-15, “the sensor membrane may be formed of a flexible film such as silicone and a conductive film such as aluminized mylar. The flexible film is attached to the conductive film, for example, by a lamination process”; col. 2 line 55-59, “the sensor membrane will deform and contact both the conductive strip and the resistive strip. The conductive sensor membrane thus electrically connects the conductive strip to the resistive strip”; the term ‘conductive’ in this case means electrically conductive). Biegelsen further teaches wherein the conductive material comprises material that has been deposited on a surface of the membrane (Biegelsen, col. 2 line 13-15, “a conductive film such as aluminized mylar. The flexible film is attached to the conductive film, for example, by a lamination process”, see Fig. 2). Caldwell already teaches the membrane comprises of conductive material (Caldwell, par. 0011). It would have been obvious for one of ordinary skilled in the art to further modify the known device of Abusleme, with the device of Biegelsen, and deposit the conductive material on a surface of the membrane for a flexible film, as such modification would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to deposit the conductive material on a surface of the membrane through lamination (Biegelsen, col. 2 line 7-21).
Regarding Claim 23, the modified Abusleme discloses the system of claim 18, but is silent on wherein the conductive material comprises a thin conductive substrate that has been applied to the membrane or conductive material that has been deposited on a surface of the membrane.
However, Biegelsen teaches a pressure sensor (Abstract, Fig. 2) for detecting flow (col. 3 line 53 – col. 4 line 5), comprising of a sensing mean (Fig. 2, pressure sensor 100), wherein the sensing means including an electrically conductive membrane (Fig. 2, sensor membrane 112) made of a flexible material (col. 2, line 12-14, “the sensor membrane may be formed of a flexible film such as silicone and a conductive film such as aluminized mylar”) and having an electrically conductive material provided on at least one side of the membrane such that the membrane has an electrically conductive side (col. 2, line 12-15, “the sensor membrane may be formed of a flexible film such as silicone and a conductive film such as aluminized mylar. The flexible film is attached to the conductive film, for example, by a lamination process”; col. 2 line 55-59, “the sensor membrane will deform and contact both the conductive strip and the resistive strip. The conductive sensor membrane thus electrically connects the conductive strip to the resistive strip”; the term ‘conductive’ in this case means electrically conductive). Biegelsen further teaches the conductive material comprises a thin conductive substrate that has been applied to the membrane or conductive material that has been deposited on a surface of the membrane (Biegelsen, col. 2 line 13-15, “a conductive film such as aluminized mylar. The flexible film is attached to the conductive film, for example, by a lamination process”, see Fig. 2). Caldwell already teaches the membrane comprises of conductive material (Caldwell, par. 0011). It would have been obvious for one of ordinary skilled in the art to further modify the known device of Abusleme, with the device of Biegelsen, and apply a thin conductive material on a surface of the membrane for a flexible film, as such modification would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to apply a thin conductive material on a surface of the membrane through lamination (Biegelsen, col. 2 line 7-21).
Claims 13, 21-22, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Abusleme in view of Caldwell, further in view of Conrad (WO2018064471).
Regarding Claim 13, the modified Abusleme discloses the monitoring device of claim 1, but is silent on further comprising a device configured to sense vibrations transmitted through the tracheotomy tube to the monitoring device.
However, Conrad teaches an analogous tracheotomy monitoring device (abstract and fig. 1) wherein a device is configured to sense vibrations transmitted through the tracheotomy tube to the monitoring device (see page 5, lines 5-9). Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify Abusleme to be use a device to sense vibrations transmitted through the tracheotomy tube to the monitoring device, as taught by Conrad, in order to detect problems associated with patient breathing and obstruction of the tube (Conrad page 5, lines 5-9).
Regarding Claim 21, the modified Abusleme discloses the monitoring device of claim 13, wherein the device configured to sense vibrations includes an accelerometer (see Conrad page 5, lines 5-9).
Regarding Claim 22, the modified Abusleme discloses the monitoring device of claim 13, wherein the device configured to sense vibrations includes a microphone (see Conrad page 5, lines 5-9).
Regarding Claim 26, the modified Abusleme discloses the system of claim 18, but is silent on wherein the tracheotomy tube monitoring device further includes a device configured to sense vibrations transmitted through the tracheotomy tube to the monitoring device.
However, Conrad teaches an analogous tracheotomy monitoring device (abstract and fig. 1) wherein a device is configured to sense vibrations transmitted through the tracheotomy tube to the monitoring device (see page 5, lines 5-9). Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify Abusleme to be use a device to sense vibrations transmitted through the tracheotomy tube to the monitoring device, as taught by Conrad, in order to detect problems associated with patient breathing and obstruction of the tube (Conrad page 5, lines 5-9).
Claims 14 and 27 rejected under 35 U.S.C. 103 as being unpatentable over Abusleme in view of Caldwell, further in view of Sethiya et al. (US20150013684), hereafter Sethiya.
Regarding Claim 14, the modified Abusleme discloses the monitoring device of claim 1, but is silent on further comprising a connection sensor configured to sense positive connection between the monitoring device and the tracheotomy tube.
However, Sethiya teaches an analogous tracheal system valve (abstract and fig. 1) comprising a connection sensor (fig. 1, sensor 68) configured to sense positive connection between the monitoring device (Fig. 1, device 8) and the tracheotomy tube (Fig. 1, tube 20. See paragraph 30, sensor 68 may sense the coupling of the valve to the end connector). Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify monitoring device of Abusleme to have a connection sensor configured to sense positive connection between the monitoring device and the tracheotomy tube, as taught by Sethiya, for the purpose of making sure the two components are properly connected and the monitoring device is in the right position to monitor.
Regarding Claim 27, the modified Abusleme discloses the system of claim 18, but is silent on wherein the tracheotomy tube monitoring device further includes a connection sensor configured to sense positive connection between the monitoring device and the tracheotomy tube.
However, Sethiya teaches an analogous tracheal system valve (abstract and fig. 1) comprising a connection sensor (fig. 1, sensor 68) configured to sense positive connection between the monitoring device (Fig. 1, device 8) and the tracheotomy tube (Fig. 1, tube 20. See paragraph 30, sensor 68 may sense the coupling of the valve to the end connector). Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify monitoring device of Abusleme to have a connection sensor configured to sense positive connection between the monitoring device and the tracheotomy tube, as taught by Sethiya, for the purpose of making sure the two components are properly connected and the monitoring device is in the right position to monitor.
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Abusleme in view of Caldwell, further in view of Murray-Harris (US20070062540).
Regarding Claim 16, the modified Abusleme discloses the monitoring device of claim 1, but is silent on further comprising a carbon dioxide sensor configured to sense a concentration of carbon dioxide of air exhaled by the patient.
However, Murray-Harris teaches an analogous tracheal system monitoring device (abstract and fig. 1) comprising a carbon dioxide sensor (Fig. 1, 50; see paragraph 27) configured to sense a concentration of carbon dioxide of air exhaled by the patient (se paragraph 30). Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify monitoring device of Abusleme to have a carbon dioxide sensor configured to sense a concentration of carbon dioxide of air exhaled by the patient, as taught by Murray-Harris, for the purpose of monitoring the adequacy of respiration by the subject using capnographic data (see paragraph 13 of Murray-Harris).
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Abusleme in view of Caldwell, further in view of Persson (US20040089291).
Regarding Claim 17, the modified Abusleme discloses the monitoring device of claim 1, but is silent on further comprising a heat and moisture exchanger provided within the airflow tube configured to trap moisture in air exhaled by the patient and to humidify air to be inhaled by the patient.
However, Persson teaches an analogous valve used on a tracheotomy patient (abstract and fig. 1) wherein the valve comprises a heat and moisture exchanger (fig. 1, HME components 14 and 15; see paragraph 16) provided within the airflow tube configured to trap moisture in air exhaled by the patient and humidify air to be inhaled by the patient (see paragraph 16). Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the device of Abusleme to have a heat and moisture exchanger provided within the airflow tube, as taught by Persson, for the purpose of humidifying the air the patient is breathing in so it is more comfortable for the user.
Claims 28, 29 are rejected under 35 U.S.C. 103 as being unpatentable over Abusleme in view of Caldwell, further in view of Rutter (US20040123868), hereafter Rutter.
Regarding Claim 28, the modified Abusleme discloses the monitoring device of claim 1, but is silent on wherein the end member includes a series of passages defined by ribs that extend outward from a center of the end member to an outer periphery of the end member.
However, Rutter teaches a tracheotomy valve unit (Abstract), comprising of an airflow tube configured to connect to a tracheotomy tube (Fig. 1, valve unit 10 defines an air flow tube, see Fig. 3, tracheostomy tube 22 is inserted to the airflow tube), the airflow tube including an inlet opening (Fig. 2, a valve unit inlet comprising air ports 30) and an outlet opening (Fig. 3, outlet comprising of a coupling section 38), wherein an end member is located at the inlet opening (Fig. 2, support 16) and the outlet opening is configured to receive the tracheotomy tube (Fig. 1, 3), wherein the end member includes a series of passages (Fig. 2, air ports 30) defined by ribs that extend outward from a center of the end member to an outer periphery of the end member (Fig. 2, crosspiece 28). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Abusleme, with the end member of Rutter, to provide support to the airflow tube as taught by Rutter (Rutter, par. 0036).
Regarding Claim 29, the modified Abusleme discloses the monitoring device of claim 1, but is silent on further comprising an inner element that includes a series of passages defined by ribs that extend outward from a center of the inner element to a wall of the airflow tube, the inner element functioning to limit insertion of the tracheotomy tube.
However, Rutter teaches a tracheotomy valve unit (Abstract), comprising of an airflow tube configured to connect to a tracheotomy tube (Fig. 1, valve unit 10 defines an air flow tube, see Fig. 3, tracheostomy tube 22 is inserted to the airflow tube), the airflow tube including an inlet opening (Fig. 2, a valve unit inlet comprising air ports 30) and an outlet opening (Fig. 3, outlet comprising of a coupling section 38), an inner element (support 16) that includes a series of passages (Fig. 2, air ports 30) defined by ribs that extend outward from a center of the inner element (Fig. 2, crosspiece 28) to a wall of the airflow tube (Fig. 2 and 3, the ribs 28 extends to a wall of the tube 14), the inner element functioning to limit insertion of the tracheotomy tube (par. 0036, the inner element is for providing support, see Fig. 3, the prior art has the claimed structure, The claimed limitations are functional languages and do not structurally distinguish the claimed invention the from prior art. See MPEP 2114, "[A]pparatus claims cover what a device is, not what a device does. Hewlett-PackardCo. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Abusleme, with the end member of Rutter, to provide support to the airflow tube as taught by Rutter (Rutter, par. 0036).
Response to Arguments
Applicant’s arguments, see applicant’s remarks, filed 07/16/2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Caldwell. Specifically, Caldwell teaches an airflow sensor comprising of a flexible conductive membrane, wherein the membrane is secured at the center and naturally seats against an end member in contact with electrical contacts without any pressure being applied to the conductive membrane (Fig. 1 and 2).
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.
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/KRIS HANYU GONG/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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