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 2-13, 15-17, 19-20, 22, and 24 are objected to because of the following informalities:
Claims 2-13, line 1, replace “An apparatus” with “The apparatus”.
Claim 10, line 3, insert “,” after “location”.
Claim 15-17, line 1, replace “A patient interface” with “The patient interface”.
Claim 19-20, line 1, replace “A system” with “The system”.
Claim 22, line 1, replace “A method” with “The method”.
Claim 24, line 1, replace “A flow regulator valve” with “The flow regulator valve”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-11, and 21-22 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Grashow et al. (US 20150083136 A1).
Regarding claim 1, Grashow discloses an apparatus for delivery of pressurised air or breathable gas to a patient ([0030] and figure 1), the apparatus comprising:
a flow generator configured to generate a flow of air ([0030] pressure generating system 16 is any device capable of generating a flow of breathing gas or providing gas at an elevated pressure; figure 1);
a patient interface constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways ([0030] a respiratory interface device 8 includes a respiratory mask 10 (shown schematically) and a support assembly 40; figure 1), the patient interface being configured to deliver the pressurised air or breathable gas to the patient's airways for respiratory therapy (see [0030-0031]); and
an air delivery tube coupled between the flow generator and the patient interface ([0030] hose 18; figure 1) to deliver a first portion of the flow of air from the flow generator to the patient interface as the pressurised air or breathable gas ([0030] That is, pressure generating system 16 is coupled to, and in fluid communication with, respiratory interface device 8 via a hose 18 or similar construct; figure 1. [0051] communicating 204 the pressurized gas via support assembly 40 to mask 10; figure 12); and
a complementary flow device configured to deliver a second portion of the flow of air to the patient as a complementary activity to the respiratory therapy ([0036] Support member at least one porous portion 46 is further structured to allow for at least one radial exhaust rate. That is, support member at least one porous portion 46 allows for gas to escape radially. As used herein, "radially" is to be interpreted broadly and in reference to the local longitudinal axis of at least one elongated support member 42. It is noted that the gas may leave the outer surface of support member at least one porous portion 46 at a random direction. [0051] exhausting 206 a portion of the pressurized gas radially through support member at least one porous portion 46; figure 1, 6a-6c, and 12).
Regarding claim 2, Grashow discloses an apparatus according to claim 1, wherein the second portion of the flow of air is delivered away from the patient’s airways ([0036] Support member at least one porous portion 46 is further structured to allow for at least one radial exhaust rate. That is, support member at least one porous portion 46 allows for gas to escape radially. Also see [0041] and figure 6B).
Regarding claim 3, Grashow discloses an apparatus according to claim 2, wherein the complementary flow device is configured to deliver the second portion of the flow of air outside the patient interface (figure 6B, radially).
Regarding claim 4, Grashow discloses an apparatus according to claims 2, wherein the complementary flow device is configured to deliver the second portion of the flow of air onto the patient’s skin ([0038] Support member at least one porous portion second section 82 may be disposed over the user's cheek and allow for a greater radial flow rate so as to help cool the user's face; figure 1 and 6A-6B).
Regarding claim 5, Grashow discloses an apparatus according to claim 4, wherein the complementary flow device is configured to target a discrete location of the patient’s skin with the second portion of the flow of air to stimulate a response in the patient that forms at least part of an active complementary therapy ([0038] Support member at least one porous portion second section 82 may be disposed over the user's cheek and allow for a greater radial flow rate so as to help cool the user's face; figure 1 and 6A-6B).
Regarding claim 6, Grashow discloses an apparatus according to claim 4, wherein the complementary flow device is configured to diffuse the second portion of the flow of air across the patient’s skin to alter the environment around the patient ([0038] Support member at least one porous portion second section 82 may be disposed over the user's cheek and allow for a greater radial flow rate so as to help cool the user's face; figure 1 and 6A-6B).
Regarding claim 8, Grashow discloses an apparatus according to claim 1, wherein the patient interface comprises a frame ([0030] a respiratory interface device 8 includes a respiratory mask 10 (shown schematically) and a support assembly 40) configured to conform to the shape of the patient’s face ([0031] That is, as shown, support assembly 40 is disposed about the user's head; figure 1), the complementary flow device forming part of the patient interface and being arranged in the frame to direct the second portion of the flow of air as part of the complementary therapy ([0036] Support member at least one porous portion 46 is further structured to allow for at least one radial exhaust rate. That is, support member at least one porous portion 46 allows for gas to escape radially; figure 1 and 6A-6C).
Regarding claim 9, Grashow discloses an apparatus according to claim 8, wherein the complementary flow device comprises routing to direct the second portion of the flow of air ([0041] at least one porous portion first section 80 may be substantially enclosed within support member at least one porous portion second section 82. At least one porous portion first section 80 is a tubular conduit 87, such as, but not limited to a silicone tube, having a plurality of radial openings 88; figure 6A-6C), the routing provided at least in part on the frame of the patient interface (see figure 6A-6C and [0041]).
Regarding claim 10, Grashow discloses an apparatus according to claim 1, comprising more than one complementary flow device for directing the second portion of the flow of air towards more than one location ([0036] Support member at least one porous portion 46 is further structured to allow for at least one radial exhaust rate. That is, support member at least one porous portion 46 allows for gas to escape radially. As used herein, "radially" is to be interpreted broadly and in reference to the local longitudinal axis of at least one elongated support member 42. It is noted that the gas may leave the outer surface of support member at least one porous portion 46 at a random direction. [0051] exhausting 206 a portion of the pressurized gas radially through support member at least one porous portion 46; figure 1, 6a-6c, and 12. Examiner notes the at least one porous portion 46 is located both on the left and the right side of a user’s face based on figure 6B; therefore are two “porous portions 46”), the more than one complementary flow device are for delivering more than one of active complementary therapy to the patient where the diverted airflow is configured to stimulate a response in the patient and/or passive complementary therapy where the diverted airflow alters the environment around the patient ([0038] Support member at least one porous portion second section 82 may be disposed over the user's cheek and allow for a greater radial flow rate so as to help cool the user's face; see figure 1 and 6B).
Regarding claim 11, Grashow discloses an apparatus according to claim 1, wherein the complementary flow device comprises an array of apertures configured to direct the flow of air ([0041] radial openings 88; figure 6A-6C).
Regarding claim 21, Grashow discloses a method for delivering pressurised air or breathable gas to a patient ([0030] and figure 1 and 12) comprising:
arranging a patient interface to form a seal with a region of the patient's face surrounding an entrance to the patient's airways ([0030] a respiratory interface device 8 includes a respiratory mask 10 (shown schematically) and a support assembly 40; figure 1. [0051] respiratory interface device 8 may be used by performing the following steps: positioning 200 mask 10 over at least one of the user's nose or mouth; figure 12);
generating a flow of air to be delivered to the patient interface as the pressurised air or breathable gas ([0030] pressure generating system 16 is any device capable of generating a flow of breathing gas or providing gas at an elevated pressure; figure 1. [0051] generating 202 a flow of pressurized gas; figure 12);
delivering a first portion of the flow of air as the pressurised air or breathable gas to the patient's airways via the patient interface for respiratory therapy ([0051] communicating 204 the pressurized gas via support assembly 40 to mask 10); and
delivering a second portion of the flow of air to the patient as a complementary activity to the respiratory therapy ([0036] Support member at least one porous portion 46 is further structured to allow for at least one radial exhaust rate. That is, support member at least one porous portion 46 allows for gas to escape radially. As used herein, "radially" is to be interpreted broadly and in reference to the local longitudinal axis of at least one elongated support member 42. It is noted that the gas may leave the outer surface of support member at least one porous portion 46 at a random direction. [0051] exhausting 206 a portion of the pressurized gas radially through support member at least one porous portion 46; figure 1, 6a-6c, and 12).
Regarding claim 22, Grashow discloses a method according to claim 21, wherein at least part of the second portion of the flow of air is directed away from the patient's airways ([0036] Support member at least one porous portion 46 is further structured to allow for at least one radial exhaust rate. That is, support member at least one porous portion 46 allows for gas to escape radially. Also see [0041] and figure 6B).
Claim(s) 1, 7, and 14-16 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Sher et al. (US 20140026889 A1).
Regarding claim 1, Sher discloses an apparatus for delivery of pressurised air or breathable gas to a patient (System, Method and Ventilation Interface for Providing Pressurized Breathable Gas to the Mouth and Nose Separately; figure 1A-2B), the apparatus comprising:
a flow generator configured to generate a flow of air ([0027] a flow generator (not shown) can be connected to gas supply tube 106 for delivering breathable gas to mask 100; figure 1A-2B);
a patient interface constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways ([0021-0022] mask 100; figure 1A-1D), the patient interface being configured to deliver the pressurised air or breathable gas to the patient's airways for respiratory therapy ([0027; figure 1A-1D); and
an air delivery tube coupled between the flow generator and the patient interface ([0028] gas supply tube 106; figure 1A-1D) to deliver a first portion of the flow of air from the flow generator to the patient interface as the pressurised air or breathable gas ([0028] Gas supply tube 106 can be fluidly coupled to mask 100. Gas supply divider 130 can split the gas supply tube 106 into nasal channel 132 and oral channel 134 for delivering breathable gas to nasal breathing chamber 124 and oral breathing chamber 126, respectively; figure 1A-1D); and
a complementary flow device configured to deliver a second portion of the flow of air to the patient as a complementary activity to the respiratory therapy ([0028] Gas supply tube 106 can be fluidly coupled to mask 100. Gas supply divider 130 can split the gas supply tube 106 into nasal channel 132 and oral channel 134 for delivering breathable gas to nasal breathing chamber 124 and oral breathing chamber 126, respectively; figure 1A-1D).
Regarding claim 7, Sher discloses an apparatus according to claim 1, wherein the second portion of the flow of air is directed to one or more specific areas of the patient airways as the complementary activity ([0028] Gas supply tube 106 can be fluidly coupled to mask 100. Gas supply divider 130 can split the gas supply tube 106 into nasal channel 132 and oral channel 134 for delivering breathable gas to nasal breathing chamber 124 and oral breathing chamber 126, respectively; figure 1A-1D).
Regarding claim 14, Sher discloses a patient interface for delivery of pressurised air or breathable gas to a patient ([0021-0022] mask 100; figure 1A-1D), the patient interface constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways ([0022] Mask shell 102 can be coupled to cushion 108 for forming a seal around the mouth of a wearer when in use; figure 1A-1D) to deliver the pressurised air or breathable gas to the patient's airways for respiratory therapy (see [0021] and [0027]), the patient interface further comprising a complementary flow device configured to divert at least part of the pressurised air or breathable gas as a complementary activity to the respiratory therapy ([0028] Gas supply tube 106 can be fluidly coupled to mask 100. Gas supply divider 130 can split the gas supply tube 106 into nasal channel 132 and oral channel 134 for delivering breathable gas to nasal breathing chamber 124 and oral breathing chamber 126, respectively; figure 1A-1D).
Regarding claim 15, Sher discloses a patient interface according to claim 14, wherein the patient interface comprises a frame configured to conform to the shape of the patient’s face ([0021] mask shell 102; figure 1A-1D), the complementary flow device forming part of the patient interface and being arranged in the frame ([0021] Mask 100 can have mask shell 102 with port 104 defined therein. Gas supply tube 106 can extend from mask shell 102 in fluid communication with port 104; figure 1A-1D. Examiner notes gas supply divider 130 and nasal channel are configured as art of the gas supply tube 106) to direct the diverted flow of air as part of the complementary activity ([0028] Gas supply tube 106 can be fluidly coupled to mask 100. Gas supply divider 130 can split the gas supply tube 106 into nasal channel 132 and oral channel 134 for delivering breathable gas to nasal breathing chamber 124 and oral breathing chamber 126, respectively; figure 1A-1D).
Regarding claim 16, Sher discloses a patient interface according to claim 15, wherein the complementary flow device comprises routing to direct the diverted flow of air ([0028] Gas supply tube 106 can be fluidly coupled to mask 100. Gas supply divider 130 can split the gas supply tube 106 into nasal channel 132 and oral channel 134 for delivering breathable gas to nasal breathing chamber 124 and oral breathing chamber 126, respectively; figure 1A-1D), the routing provided at least in part on the frame of the patient interface ([0021] Mask 100 can have mask shell 102 with port 104 defined therein. Gas supply tube 106 can extend from mask shell 102 in fluid communication with port 104. Examiner notes that during use, as depicted in figure 1, the routing of the nasal chamber 132 extends into the mask shell 102 via the port 104).
Claim(s) 18 and 20 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Nelson et al. (US 20200101250 A1).
Regarding claim 18, Nelson discloses a system for delivery of pressurised air or breathable gas to a patient (Respiratory User Interface; title; figure 1), the system comprising: an apparatus for delivery of pressurised air or breathable gas to a patient ([0093] respiratory therapy system 1; figure 1), the apparatus comprising:
a flow generator configured to generate a flow of air ([0094-0098] gas source 3; figure 1);
a patient interface constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways ([0104] user interface 7; figure 1-20), the patient interface being configured to deliver the pressurised air or breathable gas to the patient's airways for respiratory therapy (see [0104]); and
an air delivery tube coupled between the flow generator and the patient interface ([0123] elbow connector 111; figure 2 and 5a-10b) to deliver a first portion of the flow of air from the flow generator to the patient interface as the pressurised air or breathable gas ([0128] The first flow path F1, with reference to FIG. 5, is from the inlet end 117 to the nasal prongs 123 to deliver breathing gas directly to the nares of the user; figure 4a-5b. Inlet end 117 of assembly 113 is connected to connector 111);
a complementary flow device configured to deliver a second portion of the flow of air to the patient as a complementary activity to the respiratory therapy ([0128] The second gas flow path F2 is from the inlet end 117 to the vent apertures 125 to deliver breathing gas to the interior space or chamber defined by the mask body 103 and mask cushion 105. The first flow path F1 therefore delivers breathing gases directly to the user's nares, whilst the second flow path F2 pressurises the interior of the user interface 7. The first flow path F1 assists in flushing dead space of the user, whilst the second flow path F2 delivers pressurised therapy. The second flow path F2 can also assist in forming a good seal between the cushion 105 and the user's face; figure 5b); and
a sensory monitoring and stimulation unit and a controller configured with respect to the flow generator to set an operation of the complementary flow device ([0096] The pressure and/or flow rate of breathing gas exiting the gas source 3 is regulated by a controller 15. The controller 15 manipulates the rotational speed of the impeller 11 according to one or more predetermined algorithms and in accordance with one or more user inputs provided via a user input 17. [0103] The controller 15 may receive feedback from one or more sensors incorporated in a control network throughout the respiratory therapy system to monitor properties of the breathing gas, such as pressure, flow, temperature and/or humidity. [0107] Preferably, breathing gases are delivered at a flow rate exceeding the user's peak inspiratory flow requirements to ensure that expired gases are purged throughout the entire respiratory cycle. [0108] The delivery and exhaust of gases to and from the mask respectively may be controlled to regulate the pressure within the mask; figure 1).
Regarding claim 20, Nelson discloses a system according to claim 18, wherein the sensory monitoring and stimulation unit is coupled with one or more sensors configured to detect data of the patient’s sleep environment ([0103] The controller 15 may receive feedback from one or more sensors incorporated in a control network throughout the respiratory therapy system to monitor properties of the breathing gas, such as pressure, flow, temperature and/or humidity. Examiner notes the gas a patient breathes is part of a user’s sleep environment), the controller configured to set the operation of the complementary flow device ([0128] The second gas flow path F2 is from the inlet end 117 to the vent apertures 125 to deliver breathing gas to the interior space or chamber defined by the mask body 103 and mask cushion 105; figure 5b) based on a signal from the one or more sensors ([0096] The pressure and/or flow rate of breathing gas exiting the gas source 3 is regulated by a controller 15. The controller 15 manipulates the rotational speed of the impeller 11 according to one or more predetermined algorithms and in accordance with one or more user inputs provided via a user input 17. [0107] Preferably, breathing gases are delivered at a flow rate exceeding the user's peak inspiratory flow requirements to ensure that expired gases are purged throughout the entire respiratory cycle. [0108] The delivery and exhaust of gases to and from the mask respectively may be controlled to regulate the pressure within the mask; figure 1).
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.
Claim(s) 12 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sher et al. (US 20140026889 A1) as applied to claim 1 and 14 above, and further in view of Jhetam (US 20210236763 A1).
Regarding claim 12, Sher discloses an apparatus according to claim 1, the apparatus further comprising a flow regulator valve for regulating the second portion of the flow of air to the patient ([0036] first valve 336 can be disposed within any portion of nasal channel 132; figure 1C), the flow regulator configured to move between an open state for allowing airflow therethrough (see figure 1C), and a closed state for blocking airflow therethrough ([0032] Valves can have positions ranging from fully opened to fully closed and any selectable position there between), but is silent as to wherein the state of the flow regulator valve between the open and closed states is dependent on an orientation of the apparatus.
However, Jhetam teaches a sleeping aid mask (99; figure 1-2) comprising a flow regulator valve ([0063] At least one of the one-way inlet valves 22, 32 may be partially closed to a first position to restrict the amount of oxygen allowed into the breathing space to that of the ambient air around user. At least one of the one-way inlet valves 22, 32 may be partially closed even further than the first position to a second position to restrict the amount of oxygen in the breathing level to make user's blood oxygen level to where they are drowsy, restful, and easily fall asleep; figure 3-4) the state of the flow regulator valve between the open and closed states is dependent on an orientation of the apparatus ([0063] The trigger event identification apparatus operates the inlet valves according to identified trigger events to help the person sleep or wake up. The trigger event identification apparatus comprises a timer to schedule the person's sleep and wake cycle. The trigger event identification apparatus also uses the timer to identify trigger events that depend on timing and/or patterns of change in blood oxygen level and head orientation and movement. [0068] The orientation sensor 26 is monitored by the trigger event identification apparatus 26 so that various sleep states are identified as trigger events and the inlet valves 22, 32 and outlet valve 3 amount of opening is adjusted accordingly; figure 3-4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mask of Sher to implement an orientation sensor and trigger event identification apparatus in order to adjust the amount of opening of the flow regulator valves based on the detected sleep state of the user, so that the delivered therapy is adjusted based on a user’s sleep state as taught by Jhetam [0068].
Regarding claim 17, Sher discloses a patient interface according to claim 14, further comprising a flow regulator valve for regulating the second portion of the flow of air to the patient ([0036] first valve 336 can be disposed within any portion of nasal channel 132; figure 1C), the flow regulator configured to move between an open state for allowing airflow therethrough (see figure 1C), and a closed state for blocking airflow therethrough (Valves can have positions ranging from fully opened to fully closed and any selectable position there between), but is silent as to wherein the state of the flow regulator valve between the open and closed states is dependent on an orientation of the patient interface.
However, Jhetam teaches a sleeping aid mask (99; figure 1-2) comprising a flow regulator valve ([0063] At least one of the one-way inlet valves 22, 32 may be partially closed to a first position to restrict the amount of oxygen allowed into the breathing space to that of the ambient air around user. At least one of the one-way inlet valves 22, 32 may be partially closed even further than the first position to a second position to restrict the amount of oxygen in the breathing level to make user's blood oxygen level to where they are drowsy, restful, and easily fall asleep; figure 3-4) the state of the flow regulator valve between the open and closed states is dependent on an orientation of the apparatus ([0063] The trigger event identification apparatus operates the inlet valves according to identified trigger events to help the person sleep or wake up. The trigger event identification apparatus comprises a timer to schedule the person's sleep and wake cycle. The trigger event identification apparatus also uses the timer to identify trigger events that depend on timing and/or patterns of change in blood oxygen level and head orientation and movement. [0068] The orientation sensor 26 is monitored by the trigger event identification apparatus 26 so that various sleep states are identified as trigger events and the inlet valves 22, 32 and outlet valve 3 amount of opening is adjusted accordingly; figure 3-4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mask of Sher to implement an orientation sensor and trigger event identification apparatus in order to adjust the amount of opening of the flow regulator valves based on the detected sleep state of the user, so that the delivered therapy is adjusted based on a user’s sleep state as taught by Jhetam [0068].
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sher et al. (US 20140026889 A1) and Jhetam (US 20210236763 A1) as applied to claim 12 above, and further in view of Lalonde (US 20120304985 A1).
Regarding claim 13, modified Sher teaches an apparatus according to claim 12, but is silent as to wherein the flow regulator valve is arranged to move between the closed and open states under gravity.
However, Lalonde teaches a CPAP system (title; figure 1-2) wherein a flow regulator valve ([0088] The valve 236, a ball valve, has a ball 264 that is captured in a chamber 266 having an enlarged square-shaped containment area 268 at one end that is open to the exterior 132 (environment) The valve 236 has a retainer 270 which consists of three arms 272, as best seen in FIG. 8, to prevent the ball 264 from falling out of the chamber 266. The other end of the chamber 266 is defined by a round-shaped containment 274 with a plurality of holes 276 that open onto the interior 122. When the ball 264 is blocking the holes 276, no air can escape from the interior 122 of the mask 234 to the exterior 132. When the ball 264 is in the open position, as seen in phantom, the gases from the interior 122 of the mask 234 can flow freely by way of air flow path 278. The retainer 270 obstructs the ball 264 from escaping but also permits air to pass; figure 10) is arranged to move between the closed and open states under gravity ([0087] Referring to FIG. 9, a graphical representation of the orientation of the mask 234 is shown. The mask 234 is represented by a point 240 at the origin of the plot. When the mask 234 is orientated upward, such as on a face 14 of a user 10 lying on their back, it is represented by a point 242 and arrow 254. When a user 10 is lying on their side, the orientation is represented by points 244 and 246. When a user 10 is lying on their chest such that her/his face is facing downward is represented by a point 248 and arrow 256. In addition, FIG. 9 shows a range represented by arrow 258 from a point 250 to a point 252 which are a certain angle of a user 10 having their face 14 facing downward. [0089] When the mask 234 is orientated between points 250 and 252 of FIG. 9, that is with the mask 234 facing downward, the ball 264 rolls to the position shown in phantom in FIG. 10 and air can flow between the exterior 132 and the interior 122 of the mask 234 along flow path 278. When the user 10 is in the position between 250 and 252 including position 242, the ball 264 is in the closed position shown in FIG. 10. Examiner notes that the ball’s position is moved via the gravity caused by the user’s orientation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first valve of the nasal channel of Sher to be a ball valve that is movable between a closed state, where airflow is blocked, and an open state where airflow is permitted to pass, based on the gravity caused by the user’s orientation, in order to allow or prevent air flow into the mask in certain mask/sleeping positions as taught by Lalonde [0088-0089].
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 20200101250 A1) as applied to claim 18 above, and further in view of Belson et al. (US 20120167878 A1).
Regarding claim 19, Nelson discloses a system according to claim 18, but is silent as to wherein the sensory monitoring and stimulation unit is coupled with one or more sensors configured to detect physiological data of the patient, the controller configured to set the operation of the complementary flow device based on a signal from the one or more sensors.
However, Belson teaches a gas delivery system (100; figure 1A) comprising a sensory monitoring and stimulation unit configured to control operation of a delivered breathing gas based on detected physiological data of the patient ([0045] The control system and sensors 112 can also record and monitor the patient's temperature using any known way of measuring a patient's temperature, such as an oral, urethral, skin, IR, or rectal probe. The control system can use the measured temperatures and pressure/flow sensors as feedback to adjust the temperature of the breathing gas mixture, the temperature of the fluid, the rate and volume of breathing gas mixture delivered to the patient, and the volume of fluid injected into the breathing gas mixture by the injection device according to the desired patient temperature; figure 1A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Nelson to implement a patient temperature sensor coupled to the control system to use the measured temperatures and pressure/flow sensors as feedback to adjust the temperature of the breathing gas, and the rate and volume of breathing gas delivered to the patient in order to achieve a desired patient temperature, as taught by Belson [0045].
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sher et al. (US 20140026889 A1) and Jhetam (US 20210236763 A1).
Regarding claim 23, Sher discloses a flow regulator valve ([0036] first valve 336 can be disposed within any portion of nasal channel 132; figure 1C) for use with an apparatus for delivery of pressurised air or breathable gas to a patient for respiratory therapy (System, Method and Ventilation Interface for Providing Pressurized Breathable Gas to the Mouth and Nose Separately; figure 1A-1D), the flow regulator valve configured for regulating a flow of air to the patient as a complementary activity to the respiratory therapy ([0028] Gas supply tube 106 can be fluidly coupled to mask 100. Gas supply divider 130 can split the gas supply tube 106 into nasal channel 132 and oral channel 134 for delivering breathable gas to nasal breathing chamber 124 and oral breathing chamber 126, respectively. [0036] first valve 336 can be disposed within any portion of nasal channel 132 and second valve 338 can be disposed within any portion of oral channel 134. As shown, first valve 336 can be set to provide less obstruction to nasal channel 132 than second valve 338 is set to provide to oral channel 134. The less obstructed channels 132, 134 are by valves 336, 338, respectively, the greater the pressure of the breathable gas that passes through the passageways of valves 336, 338; figure 1C), the flow regulator configured to move between an open state for allowing airflow therethrough (see figure 1C), and a closed state for blocking airflow therethrough ([0032] Valves can have positions ranging from fully opened to fully closed and any selectable position there between), but is silent as to wherein the state of the flow regulator valve between the open and closed states is dependent on an orientation of the apparatus.
However, Jhetam teaches a sleeping aid mask (99; figure 1-2) comprising a flow regulator valve ([0063] At least one of the one-way inlet valves 22, 32 may be partially closed to a first position to restrict the amount of oxygen allowed into the breathing space to that of the ambient air around user. At least one of the one-way inlet valves 22, 32 may be partially closed even further than the first position to a second position to restrict the amount of oxygen in the breathing level to make user's blood oxygen level to where they are drowsy, restful, and easily fall asleep; figure 3-4) the state of the flow regulator valve between the open and closed states is dependent on an orientation of the apparatus ([0063] The trigger event identification apparatus operates the inlet valves according to identified trigger events to help the person sleep or wake up. The trigger event identification apparatus comprises a timer to schedule the person's sleep and wake cycle. The trigger event identification apparatus also uses the timer to identify trigger events that depend on timing and/or patterns of change in blood oxygen level and head orientation and movement. [0068] The orientation sensor 26 is monitored by the trigger event identification apparatus 26 so that various sleep states are identified as trigger events and the inlet valves 22, 32 and outlet valve 3 amount of opening is adjusted accordingly; figure 3-4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mask of Sher to implement an orientation sensor and trigger event identification apparatus in order to adjust the amount of opening of the flow regulator valves based on the detected sleep state of the user, so that the delivered therapy is adjusted based on a user’s sleep state as taught by Jhetam [0068].
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sher et al. (US 20140026889 A1) and Jhetam (US 20210236763 A1) as applied to claim 23 above, and further in view of Lalonde (US 20120304985 A1).
Regarding claim 24, modified Sher teaches a flow regulator valve according to claim 23, but is silent as to wherein the flow regulator valve is arranged to move between the closed and open states under gravity.
However, Lalonde teaches a CPAP system (title; figure 1-2) wherein a flow regulator valve ([0088] The valve 236, a ball valve, has a ball 264 that is captured in a chamber 266 having an enlarged square-shaped containment area 268 at one end that is open to the exterior 132 (environment) The valve 236 has a retainer 270 which consists of three arms 272, as best seen in FIG. 8, to prevent the ball 264 from falling out of the chamber 266. The other end of the chamber 266 is defined by a round-shaped containment 274 with a plurality of holes 276 that open onto the interior 122. When the ball 264 is blocking the holes 276, no air can escape from the interior 122 of the mask 234 to the exterior 132. When the ball 264 is in the open position, as seen in phantom, the gases from the interior 122 of the mask 234 can flow freely by way of air flow path 278. The retainer 270 obstructs the ball 264 from escaping but also permits air to pass; figure 10) is arranged to move between the closed and open states under gravity ([0087] Referring to FIG. 9, a graphical representation of the orientation of the mask 234 is shown. The mask 234 is represented by a point 240 at the origin of the plot. When the mask 234 is orientated upward, such as on a face 14 of a user 10 lying on their back, it is represented by a point 242 and arrow 254. When a user 10 is lying on their side, the orientation is represented by points 244 and 246. When a user 10 is lying on their chest such that her/his face is facing downward is represented by a point 248 and arrow 256. In addition, FIG. 9 shows a range represented by arrow 258 from a point 250 to a point 252 which are a certain angle of a user 10 having their face 14 facing downward. [0089] When the mask 234 is orientated between points 250 and 252 of FIG. 9, that is with the mask 234 facing downward, the ball 264 rolls to the position shown in phantom in FIG. 10 and air can flow between the exterior 132 and the interior 122 of the mask 234 along flow path 278. When the user 10 is in the position between 250 and 252 including position 242, the ball 264 is in the closed position shown in FIG. 10. Examiner notes that the ball’s position is moved via the gravity caused by the user’s orientation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first valve of the nasal channel of Sher to be a ball valve that is movable between a closed state, where airflow is blocked, and an open state where airflow is permitted to pass, based on the gravity caused by the user’s orientation, in order to allow or prevent air flow into the mask in certain mask/sleeping positions as taught by Lalonde [0088-0089].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ho et al. (US 8251066 B1) teaches a respiratory mask comprising an exhalation port with an entrainment valve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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