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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/28/2026 has been entered.
This Office Action is in response to the request for continued examination under 37 CFR 1.114 filed on 04/28/2026 and the amendment filed on 04/28/2026. Claims 1, 3, 11-12, and 30-31 are amended. Claims 2, 4-9, 13-14, 17-29, 32-41, and 58-60 are as previously presented. Claims 10, 15-16, and 42-57 are canceled. As such, claims 1-9, 11-14, 17-41, and 58-60 are pending in the instant application.
The rejection of claims 12-14, 17-29, and 58-60 under 35 U.S.C. 101 are withdrawn in light of the amendment.
Claim Objections
Claims 7, 12, 18, and 32 are objected to because of the following informalities:
Claim 7, line 4: “a patient interface” should read “the patient interface” for consistency and clarity.
Claim 12, line 10: “the supply of breathable gas” should read “a supply of breathable gas” to establish antecedent basis.
Claim 18, lines 2-3: “in patient interface” should read “in the patient interface” consistency and clarity.
Claim 32, line 2: “a patient” should read “the patient” for consistency and clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 32-35, and 59 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation “capture, using the camera, one or more images that include a patient” in line 3. It is unclear if the recited one or more images are in reference to the received one or more images taken by the camera disclosed in claim 1 (line 21), or if Applicant is attempting to disclose a new limitation. Furthermore, it is unclear if the recitation of “a patient” is an attempt to disclose a new limitation, or is in reference to the patient disclosed in claim 1 (line 2). For the purpose of examination, “one or more images that include a patient” will be interpreted as – one or more second images that include the patient – based on [0096]-[0097] of Applicant’s specification.
Claim 32 recites the limitation “the memory includes one or more images including a patient with the patient interface” in line 2. It is unclear if the recited one or more images are in reference to the one or more images of the patient with the patient interface disclosed in claim 31 (lines 23-24), or if Applicant is attempting to disclose a new limitation. Furthermore, it is unclear if the recitation of “a patient” is an attempt to disclose a new limitation, or is in reference to the patient disclosed in claim 31 (line 2). For the purpose of examination, the recited one or more images will be interpreted as a new disclosure of one or more images, and the recitation of “a patient” will be interpreted as – the patient.
Similarly, claim 33 recites the limitation “to capture one or more images of the patient with the patient interface” in lines 2-3. It is unclear if the recited one or more images are in reference to the one or more images of the patient with the patient interface disclosed in claim 31 (lines 23-24), or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the recited one or more images will be interpreted as a new disclosure of one or more images.
Claim 59 recites the limitation "subsequent to confirmation that the fit of the patient interface on the patient has been corrected or improved" in lines 3-4. There is insufficient antecedent basis for the confirmation of the fit of the patient interface on the patient in the limitation above. However, claim 58 provides antecedent basis for the limitation of claim 59 listed above. Hence, for the purpose of examination, claim 59 will be interpreted as depending from claim 58.
Claims 34-35 are rejected due to their dependency on a rejected claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6, 8, 11-14, 17-18, 21-22, 24, 26-41, 58, and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Lawrenson & Nolan (US 20170203071 A1; hereinafter "Lawrenson") in view of Hudson et al. (US 20200121873 A1; hereinafter “Hudson”).
Regarding claim 1, Lawrenson discloses a respiratory pressure therapy system (10, 14, 16, 18, 28; Fig. 1) for providing continuous positive air pressure (CPAP) (14, 16, 18; Fig. 1) to a patient via a patient interface (18; Fig. 1) configured to engage with at least one airway of the patient ([0090], lines 3-7), the system comprising:
a flow generator (16; Fig. 1) configured to generate a supply of breathable gas for delivery to the patient via the patient interface ([0091], lines 4-6), wherein the breathable gas is output from the flow generator ([0091], lines 4-5) at a pressure level that is above an atmospheric pressure (inherent to the definition of continuous positive air pressure);
at least one sensor (Camera 42, microphone 44, distance sensor 46, patient interface sensor 48; Figs. 2, 3) that is configured to measure a physical quantity while the breathable gas is supplied to the patient ([0097], lines 1-10; [0104], lines 9-19);
a display (52; Fig. 1); and
a computing device (10; Fig. 1) including memory (38, 40; Fig. 1; [0094], lines 3-17) and at least one hardware processor ([0099], lines 1-6), the computing device (10; Fig. 1) configured to:
receive, from the at least one sensor (Camera 42, microphone 44, distance sensor 46, patient interface sensor 48; Figs. 2, 3), sensor data that is based on a measured physical property of the supply of breathable gas (receiving unit 32 is a part of system 10, [0094], lines 2-3; receiving unit 32 receives data based on measured physical property of supply of breathable gas from sensors 42, 44, 46, and 48, [0097], lines 1-7);
control, based on the received sensor data (data received from sensors 42, 44, 46, 48), the flow generator (16) to adjust a property of the supply of breathable gas that is delivered to the patient ([0104], lines 5-8);
receive an input indicating assistance is needed with using the patient interface ([0101], lines 31-37);
receive one or more images that include the patient with the patient interface (system 10 receives one or more images of the patient 12 wearing the patient interface 18 via receiving unit 32, see [0101], lines 1-6).
While Lawrenson does disclose the use of technical data, where technical data includes information on the design and functionality of the patient interface and/or of the pressure support system, such as, how to attach the patient interface to a head of a patient ([0034]), Lawrenson fails to explicitly disclose displaying the technical data on a display; and capturing, via a camera and subsequent to the display of the technical data, one or more reference images that include the patient wearing the patient interface in a fitted position established based on the displayed technical data.
However, Hudson teaches providing and displaying a series of instructions for guiding a user through the setup of a CPAP therapy device ([0006]; [0009]; Figs. 2A-2B) and displaying instructions on how to put on a mask and check that the mask and headgear are properly fitted ([0006]; [0086]-[0090]; Fig. 2C). Additionally, Hudson teaches verifying the setup of the CPAP therapy device and mask has been completed ([0094]). Hudson further teaches a method and system for detecting a mask leak subsequent to the displaying of instruction for how to setup the CPAP therapy device and put on the mask (Figs. 3A-4; [0102], where test drive begins after the setup process for the CPAP therapy device and the mask), and the leak testing includes presenting the user with an image of their face with the mask on that is taken by a camera (first sentence of [0120]) as a reference image to diagnose the leak ([0120]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lawrenson to display the technical data on the display (52; [0034]) and subsequently take at least one image, with a camera, of the patient wearing the patient interface as instructed in the displayed instructions to be used as at least one reference image, as taught by Hudson (Hudson [0006], [0086]-[0088], [0094], [0102], and [0120]; Hudson Figs. 2A-4) to allow the patient to setup the pressure support system and patient interface without the assistance an on-site medical professional (Hudson first sentence of [0009]).
As such, it would be obvious to one of ordinary skill in the art that the pressure support system, taught by Lawrenson as modified by Hudson above, is further configured to analyse the received one or more images (one or more images of patient 12 wearing patient interface 18 received by receiving unit 32, see [0101], lines 1-6) based on a comparison between: 1) the one or more reference images that include the patient with the patient interface ([0038], lines 13-20, where the optimal setting of a virtual attachment of a 3D model of the patient and the patient interface is substituted out for the at least one reference image taught by Hudson above; Hudson [0086]-[0088], [0094], [0102], and [0120]), and 2) the received one or more images that include the patient with the patient interface (received images are analyzed by comparing the received images to the optimal setting, see [0101], lines 38-41, where the orientation and/or position of the patient interface is the received images, and where the optimal setting of a virtual attachment of a 3D model of the patient and the patient interface is substituted out for the at least one reference image taught by Hudson above); and
based on the analysis, display, on the display (52), instructions for positioning the patient interface towards the fitted position shown in the one or more reference images ([0099], lines 29-33) to improve the quality of therapy received by the patient by ensuring the patient interface is positioned correctly.
Regarding claim 2, Lawrenson as modified teaches the invention as set forth in claim 1, wherein the one or more reference images including the patient with the patient interface (the at least one reference image taught by Hudson, see claim 1 above) are stored in the memory (38, 40; [0094], lines 3-17, where databases 38 and 40 are one common database, and where the virtual 3D model of the patient’s head is substituted out for the at least one reference image taught by Hudson, see claim 1 above; Hudson [0094]).
Regarding claim 3, Lawrenson as modified teaches the invention as set forth in claim 1, wherein the computing device is further configured to:
capture, using the camera (42), one or more images that include a patient (first sentence of [0049]; [0101], lines 1-5); and
obtain, based on characteristics of facial features of the patient that are determined from the one or more images, data for adjusting one or more settings of the patient interface ([0101], lines 5-15; [0049], lines 25-28);
wherein the instructions for using the patient interface are displayed for adjusting the one or more settings of the patient interface based on the received data for the one or more settings of the patient interface ([0049], lines 31-34);
wherein the one or more reference images are captured with the camera subsequent to the display of instructions for adjusting the one or more settings (see claim 1 above, where the at least one reference image is taken subsequent to the display of the technical data, as taught by Hudson, where the technical data is the instructions for using the patient interface; hence, the instructions for using the patient interface for adjusting one or more settings of the patient interface are displayed prior to the camera capturing the at least one reference image of Hudson; [0034]; Hudson [0006], [0086]-[0088], [0094], [0102], and [0120]; Hudson Figs. 2A-4).
Regarding claim 4, Lawrenson as modified teaches the invention as set forth in claim 1, wherein the computing device (10) is configured to compare the one or more reference images and the received one or more images (see claim 1 above) to determine an improper fit position of the patient interface fitting position ([0099], lines 19-29, where the usage data is the received one or more images of the patient 12 wearing the patient interface 18, where the virtual 3D model of the patient’s head is substituted out for the at least one reference image taught by Hudson, see claim 1 above).
Regarding claim 5, Lawrenson as modified teaches the invention as set forth in claim 1, wherein the computing device (10) is configured to superimpose a correct position of the patient interface on the received one or more images ([0082], lines 1-9), wherein the displayed instructions include the one or more superimposed images (Fig. 1; [0099], lines 29-33).
Regarding claim 6, Lawrenson as modified teaches the invention as set forth in claim 1, further comprising a remote computing system (32, 34, 36, 38, 40; [0094], last sentence; [0070], lines 2-9; [0106], lines 13-23) and the remote computing system is configured to determine the instructions for positioning the patient interface, and transmit the instructions to the computing device ([0099], lines 27-33, where the system 10 includes advice unit 36 and display 52).
Regarding claim 8, Lawrenson as modified teaches the invention as set forth in claim 1, wherein the computing device (10) is further configured to receive a second input indicating a type of the patient interface (images of patient with patient interface are received by system 10, [0101], lines 1-8 and [0101], lines 24-27; images of patient with patient interface received by 10 indicate the type of patient interface, [0049], lines 25-28), and display, on the display (52), instructions for using the type of patient interface indicated by the second input ([0049], lines 31-34).
Regarding claim 11, Lawrenson discloses a non-transitory computer readable storage medium (solid-state medium; [0109], lines 1-4) storing instructions for use (computer program, see [0109], lines 1-4) with a computing device (10), the computing device configured to control a continuous positive air pressure (CPAP) (14, 16, 18; Fig. 1) device configured to generate the supply of breathable gas that is delivered to a patient via a patient interface configured to engage with at least one airway of the patient ([0090], lines 3-7), wherein the breathable gas is output from a flow generator (16; Fig. 1; [0091], lines 4-5) at a pressure level that is above atmospheric pressure (inherent to the definition of continuous positive pressure), the CPAP device associated with at least one sensor (camera 42, microphone 44, distance sensor 46, patient interface sensor 48; Figs. 2, 3) that is configured to measure a physical quantity while the breathable gas is supplied to the patient ([0097], lines 1-10; [0104], lines 9-19), the computing device (10) including at least one hardware processor ([0099], lines 1-6), the stored instructions (computer program, see [0109], lines 1-4) comprising instructions (computer program stored instructions for 32, 34, 36, 38, and 40; [0094], lines 1-12) that are configured to cause the computing device (10) to:
receive, from the at least one sensor (camera 42, microphone 44, distance sensor 46, patient interface sensor 48; Figs. 2, 3), sensor data that is based on measured physical property of the supply of breathable gas (receiving unit 32 is a part of system 10, [0094], lines 2-3; receiving unit 32 receives data based on measured physical property of supply of breathable gas from sensors 42, 44, 46, and 48, [0097], lines 1-7);
control, based on the received sensor data (data received from sensors 42, 44, 46, 48), the flow generator (16) to adjust a property of the supply of breathable gas that is delivered to the patient ([0104], lines 5-8);
receive, an input indicating assistance is needed with using the patient interface ([0101], lines 31-37); and
receive one or more images that include the patient with the patient interface (system 10 receives one or more images of the patient 12 wearing the patient interface 18 via receiving unit 32, see [0101], lines 1-6).
While Lawrenson does disclose the use of technical data, where technical data includes information on the design and functionality of the patient interface and/or of the pressure support system, such as, how to attach the patient interface to a head of a patient ([0034]), Lawrenson fails to explicitly disclose displaying the technical data on a display; and capturing, via a camera and subsequent to the display of the technical data, one or more reference images that include the patient wearing the patient interface in a fitted position established based on the displayed technical data.
However, Hudson teaches providing and displaying a series of instructions for guiding a user through the setup of a CPAP therapy device ([0006]; [0009]; Figs. 2A-2B) and displaying instructions on how to put on a mask and check that the mask and headgear are properly fitted ([0006]; [0086]-[0090]; Fig. 2C). Additionally, Hudson teaches verifying the setup of the CPAP therapy device and mask has been completed ([0094]). Hudson further teaches a method and system for detecting a mask leak subsequent to the displaying of instruction for how to setup the CPAP therapy device and put on the mask (Figs. 3A-4; [0102], where test drive begins after the setup process for the CPAP therapy device and the mask), and the leak testing includes presenting the user with an image of their face with the mask on that is taken by a camera (first sentence of [0120]) as a reference image to diagnose the leak ([0120]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lawrenson to display the technical data on the display (52; [0034]) and subsequently take at least one image, with a camera, of the patient wearing the patient interface as instructed in the displayed instructions to be used as at least one reference image, as taught by Hudson (Hudson [0006], [0086]-[0088], [0094], [0102], and [0120]; Hudson Figs. 2A-4) to allow the patient to setup the pressure support system and patient interface without the assistance an on-site medical professional (Hudson first sentence of [0009]).
As such, it would be obvious to one of ordinary skill in the art that the pressure support system, taught by Lawrenson as modified by Hudson above, is further configured to analyse the received one or more images (one or more images of patient 12 wearing patient interface 18 received by receiving unit 32, see [0101], lines 1-6) based on a comparison between: 1) the one or more reference images that include the patient with the patient interface ([0038], lines 13-20, where the optimal setting of a virtual attachment of a 3D model of the patient and the patient interface is substituted out for the at least one reference image taught by Hudson above; Hudson [0086]-[0088], [0094], [0102], and [0120]), and 2) the received one or more images that include the patient with the patient interface (received images are analyzed by comparing the received images to the optimal setting, see [0101], lines 38-41, where the orientation and/or position of the patient interface is the received images, and where the optimal setting of a virtual attachment of a 3D model of the patient and the patient interface is substituted out for the at least one reference image taught by Hudson above); and
based on the analysis, display, on the display (52), instructions for positioning the patient interface towards the fitted position shown in the one or more reference images ([0099], lines 29-33) to improve the quality of therapy received by the patient by ensuring the patient interface is positioned correctly.
Regarding claim 12, Lawrenson discloses a device (10; Fig. 1) for guiding a patient to position and/or adjust a fitting position of a patient interface of a continuous positive air pressure (CPAP) system ([0099], lines 19-39), the device (10; Fig. 1) comprising:
a display (52; Fig. 1);
a camera (42; Fig. 1);
a memory (38, 40; Fig. 1; [0094], lines 3-17); and
at least one hardware processor ([0099], lines 1-6) coupled to the display (52, see Fig. 2), the camera (42, see Fig. 2), and the memory (38, 40, see Fig. 2), the at least one hardware processor ([0099], lines 1-6) configured to:
control the continuous positive air pressure (CPAP) device that is configured to generate the supply of breathable gas delivered to the patient via the patient interface that is configured to engage with at least one airway of the patient ([0090], lines 3-7), wherein the breathable gas is output from a flow generator (16; Fig. 1; [0091], lines 4-5) at a pressure level that is above atmospheric pressure (inherent to the definition of continuous positive pressure);
receive, based on measurement by at least one sensor (camera 42, microphone 44, distance sensor 46, patient interface sensor 48; Figs. 2, 3), sensor data that is based on a measured physical property of the supply of breathable gas (receiving unit 32 is a part of system 10, [0094], lines 2-3; receiving unit 32 receives data based on measured physical property of supply of breathable gas from sensors 42, 44, 46, and 48, [0097], lines 1-7);
control, based on the received sensor data (data received from sensors 42, 44, 46, 48), the flow generator (16) to adjust a property of the supply of breathable gas that is delivered to the patient ([0104], lines 5-8);
receive an indication identifying a type of the patient interface ([0101], lines 31-35, where the image analysis unit 58 receives images of the patient with the patient interface that indicate the type of patient interface, see [0049], lines 25-28), wherein the patient interface (18; Fig. 1) is configured to engage with at least one airway of the patient ([0090], lines 3-7) and supply, to the patient, breathable gas that is received from a continuous positive air pressure (CPAP) device of the CPAP system ([0091], lines 4-6);
receive, from the camera (42), one or more images that include the patient with the patient interface (one or more images of the patient 12 wearing the patient interface 18 taken via camera 42, see [0101], lines 1-6).
While Lawrenson does disclose the use of technical data, where technical data includes information on the design and functionality of the patient interface and/or of the pressure support system, such as, how to attach the patient interface to a head of a patient ([0034]), Lawrenson fails to explicitly disclose displaying the technical data on a display; and capturing, via a camera and subsequent to the display of the technical data, one or more reference images that include the patient wearing the patient interface in a fitted position established based on the displayed technical data.
However, Hudson teaches providing and displaying a series of instructions for guiding a user through the setup of a CPAP therapy device ([0006]; [0009]; Figs. 2A-2B) and displaying instructions on how to put on a mask and check that the mask and headgear are properly fitted ([0006]; [0086]-[0090]; Fig. 2C). Additionally, Hudson teaches verifying the setup of the CPAP therapy device and mask has been completed ([0094]). Hudson further teaches a method and system for detecting a mask leak subsequent to the displaying of instruction for how to setup the CPAP therapy device and put on the mask (Figs. 3A-4; [0102], where test drive begins after the setup process for the CPAP therapy device and the mask), and the leak testing includes presenting the user with an image of their face with the mask on that is taken by a camera (first sentence of [0120]) as a reference image to diagnose the leak ([0120]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lawrenson to display the technical data on the display (52; [0034]) and subsequently take at least one image, with a camera, of the patient wearing the patient interface as instructed in the displayed instructions to be used as at least one reference image, as taught by Hudson (Hudson [0006], [0086]-[0088], [0094], [0102], and [0120]; Hudson Figs. 2A-4) to allow the patient to setup the pressure support system and patient interface without the assistance an on-site medical professional (Hudson first sentence of [0009]).
As such, it would be obvious to one of ordinary skill in the art that the pressure support system, taught by Lawrenson as modified by Hudson above, is further configured to analyse the received one or more images (one or more images of patient 12 wearing patient interface 18 received by receiving unit 32, see [0101], lines 1-6) based on a comparison between: 1) the one or more reference images that include the patient with the patient interface ([0038], lines 13-20, where the optimal setting of a virtual attachment of a 3D model of the patient and the patient interface is substituted out for the at least one reference image taught by Hudson above; Hudson [0086]-[0088], [0094], [0102], and [0120]), and 2) the received one or more images that include the patient with the patient interface (received images are analyzed by comparing the received images to the optimal setting, see [0101], lines 38-41, where the orientation and/or position of the patient interface is the received images, and where the optimal setting of a virtual attachment of a 3D model of the patient and the patient interface is substituted out for the at least one reference image taught by Hudson above); and
based on the analysis, display, on the display (52), instructions for positioning the patient interface towards the fitted position shown in the one or more reference images ([0099], lines 29-33) to improve the quality of therapy received by the patient by ensuring the patient interface is positioned correctly.
Regarding claim 13, Lawrenson as modified teaches the invention as set forth in claim 12, wherein the received indication identifying the type of the patient interface ([0101], lines 31-35, where the image analysis unit 58 receives images of the patient with the patient interface that indicate the type of patient interface, see [0049], lines 25-28) is a user input (users take image using camera 42, [0101], lines 1-3; images from camera 42 are received as input by receiving unit 32, [0101], lines 5-8).
Regarding claim 14, Lawrenson as modified teaches the invention as set forth in claim 12, wherein the received indication identifying the type of the patient interface ([0101], lines 31-35, where the image analysis unit 58 receives images of the patient with the patient interface that indicate the type of patient interface, see [0049], lines 25-28) is determined, by the processing system (advice unit 36), based on an image that includes the patient interface (received images taken by camera 42 include the patient 12 wearing the patient interface, see [0101], lines 1-6).
Regarding claim 17, Lawrenson as modified teaches the invention as set forth in claim 12, but fails to explicitly disclose wherein the one or more reference images (the at least one reference image taught by Hudson, see claim 12 above) include a plurality of reference points, and the analysis includes, detecting reference points in the received one or more images and comparing the detected reference points to the plurality of reference points in the one or more reference images.
However, Lawrenson does disclose one or more received images from the camera (42) have reference locations (first reference location, second reference location), where the image analysis unit (58) can identify the orientation and/or position of the patient interface (18) relative to the head of the patient via an image matching algorithm that utilizes the first and second reference locations for comparison and analysis ([0101], lines 10-15). Lawrenson further discloses that the image analysis unit (58) comprises one or more program modules that form part of a software application that also carries out the function of the advice unit (36; [0101], lines 24-27), which analyzes and compares received one or more images from the camera (42) to one or more reference images (virtual 3D model of patient’s head; [0095], lines 4-6).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Lawrenson, such that the one or more reference images (the at least one reference image taught by Hudson, see claim 12 above) include a plurality of reference points (first location, second location), and the analysis includes, detecting reference points in the received one or more images and comparing the detected reference points to the plurality of reference points in the one or more reference images ([0101], lines 10-15) to improve accuracy of determining the orientation and/or position of the patient interface relative to the head of the patient by being able to easily identify features on the patient interface and the head of the patient ([0101], lines 13-21).
Regarding claim 18, Lawrenson as modified teaches the invention as set forth in claim 12, wherein the analysis includes extracting, from the received one or more images (images from camera 42), one or more indicators (64; Fig. 1) included in patient interface (see Fig. 1).
Regarding claim 21, Lawrenson as modified teaches the invention as set forth in claim 12, wherein displaying the feedback includes displaying at least one of the received images ([0099], lines 29-33), and the processing system (advice unit 36) is configured to include, in the displayed received images, one or more visual indicators indicating locations on the patient interface where the fit of the patient interface can be improved (arrow and instructions 56 on display 52, see Fig. 1; [0099], lines 29-33).
Regarding claim 22, Lawrenson as modified teaches the invention as set forth in claim 12, wherein the processing system (advice unit 36) is configured to display instructions for using the identified type of patient interface ([0049], lines 31-34; [0049], lines 50-53).
Regarding claim 24, Lawrenson as modified teaches the invention as set forth in claim 12, wherein the analysis includes extracting features from the received one or more images (first reference location, second reference location; [0101], lines 10-15), and comparing positions and/or orientations of the features to a three-dimensional model of the patient interface ([0101], lines 31-37).
Regarding claim 26, Lawrenson as modified teaches the invention as set forth in claim 12, wherein the device (10) is a mobile phone, tablet or remote control (Fig. 1; [0093]).
Regarding claim 27, Lawrenson as modified teaches the invention as set forth in claim 12, wherein the processing system (advice unit 36) is further configured to receive sensor data from one or more sensors (receive data from sensors 48; Fig. 1) disposed on a surface of or in the patient interface (18, see Fig. 1; [0097], lines 12-14).
Regarding claim 28, Lawrenson as modified teaches the invention as set forth in claim 27, wherein the processing system (advice unit 36) is further configured to perform the analysis ([0098], lines 1-7) and display the feedback based on data received from the sensors ([0098], lines 7 to end of paragraph).
Regarding claim 29, Lawrenson as modified teaches the invention as set forth in claim 27, wherein the sensor data (data received from sensor 48) is compared to pre-set sensor values (threshold value, [0105], lines 25-27) stored in the memory (38; database 38 stores technical data relation to the pressure support system 14 and its components, hence a gas parameter’s threshold value detected by sensor 48 would be stored in database 38, Abstract).
Regarding claim 30, Lawrenson discloses a non-transitory computer readable storage medium (solid-state medium; [0109], lines 1-4) storing instructions for use (computer program, see [0109], lines 1-4) with a computing device (10), the stored instructions (computer program, see [0109], lines 1-4) comprising instructions (computer program stored instructions for 32, 34, 36, 38, and 40; [0094], lines 1-12) that are configured to cause the computing device (10) to:
receive an indication identifying a type of a patient interface ([0101], lines 31-35, where the image analysis unit 58 receives images of the patient with the patient interface that indicate the type of patient interface, see [0049], lines 25-28), configured to engage with at least one airway of a patient ([0090], lines 3-7) and supply breathable gas received from a continuous positive air pressure (CPAP) device to the patient ([0091], lines 4-6);
receive, from a camera (42), one or more images that include a patient with the patient interface (system 10 receives one or more images of the patient 12 wearing the patient interface 18 via receiving unit 32, where the one or more images are taken by camera 42, see [0101], lines 1-6).
While Lawrenson does disclose the use of technical data, where technical data includes information on the design and functionality of the patient interface and/or of the pressure support system, such as, how to attach the patient interface to a head of a patient ([0034]), Lawrenson fails to explicitly disclose displaying the technical data on a display; and capturing, via a camera and subsequent to the display of the technical data, one or more reference images that include the patient wearing the patient interface in a fitted position established based on the displayed technical data.
However, Hudson teaches providing and displaying a series of instructions for guiding a user through the setup of a CPAP therapy device ([0006]; [0009]; Figs. 2A-2B) and displaying instructions on how to put on a mask and check that the mask and headgear are properly fitted ([0006]; [0086]-[0090]; Fig. 2C). Additionally, Hudson teaches verifying the setup of the CPAP therapy device and mask has been completed ([0094]). Hudson further teaches a method and system for detecting a mask leak subsequent to the displaying of instruction for how to setup the CPAP therapy device and put on the mask (Figs. 3A-4; [0102], where test drive begins after the setup process for the CPAP therapy device and the mask), and the leak testing includes presenting the user with an image of their face with the mask on that is taken by a camera (first sentence of [0120]) as a reference image to diagnose the leak ([0120]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lawrenson to display the technical data on the display (52; [0034]) and subsequently take at least one image, with a camera, of the patient wearing the patient interface as instructed in the displayed instructions to be used as at least one reference image, as taught by Hudson (Hudson [0006], [0086]-[0088], [0094], [0102], and [0120]; Hudson Figs. 2A-4) to allow the patient to setup the pressure support system and patient interface without the assistance an on-site medical professional (Hudson first sentence of [0009]).
As such, it would be obvious to one of ordinary skill in the art that the pressure support system, taught by Lawrenson as modified by Hudson above, is further configured to analyse the received one or more images (one or more images of patient 12 wearing patient interface 18 received by receiving unit 32, see [0101], lines 1-6) based on a comparison between: 1) the one or more reference images that include the patient with the patient interface ([0038], lines 13-20, where the optimal setting of a virtual attachment of a 3D model of the patient and the patient interface is substituted out for the at least one reference image taught by Hudson above; Hudson [0086]-[0088], [0094], [0102], and [0120]), and 2) the received one or more images that include the patient with the patient interface (received images are analyzed by comparing the received images to the optimal setting, see [0101], lines 38-41, where the orientation and/or position of the patient interface is the received images, and where the optimal setting of a virtual attachment of a 3D model of the patient and the patient interface is substituted out for the at least one reference image taught by Hudson above); and
based on the analysis, display, on the display (52), instructions for positioning the patient interface towards the fitted position shown in the one or more reference images ([0099], lines 29-33) to improve the quality of therapy received by the patient by ensuring the patient interface is positioned correctly.
Regarding claim 31, Lawrenson discloses a respiratory pressure therapy system (10, 14, 16, 18, 28; Fig. 1) for providing continuous positive air pressure (CPAP) (14, 16, 18; Fig. 1) to a patient via a patient interface (18; Fig. 1) including one or more patient interface sensors (48; Figs. 1, 2) and configured to engage with at least one airway of the patient ([0090], lines 3-7), the system comprising:
a flow generator (16; Fig. 1) configured to generate a supply of breathable gas for delivery to the patient via the patient interface ([0091], lines 4-6), wherein the breathable gas is output from the flow generator ([0091], lines 4-5) at a pressure level that is above atmospheric pressure (inherent to the definition of continuous positive air pressure);
a display (52; Fig. 1); and
a computing device (10; Fig. 1) including memory (38, 40; Fig. 1; [0094], lines 3-17) and at least one hardware processor ([0099], lines 1-6), the computing device configured to:
control the flow generator (16) to adjust a property of the supply of breathable gas that is delivered to the patient (controlled via data received from sensors 42, 44, 46, and 48, [0104], lines 5-8);
receive sensor data (data from sensor 48) from the one or more patient interface sensors (48) comprising a connection sensor (extensometer, strain gauge; [0104], lines 9-14) configured to detect a connection between two components of the patient interface ([0104], lines 14-18, where the measure of a tensile stress or force occurring withing the headgear straps 30 can detect a connection between the headgear straps 30 and mask shell 22);
compare the received sensor data to pre-set values in the memory (advice unit 36 of system 10 compares the received data from sensor 48 to pre-set values of an optimal setting, where the information to determine the optimal setting is stored in databases 38 and 40, where data bases 38 and 40 are one database; [0070], [0092], [0094], lines 3-17, and [0099], lines 19-23);
based on the comparison, display, on the display (52; Fig. 1), instructions for positioning the patient interface ([0099], lines 24 to the end of the paragraph);
subsequent to display of the instructions for positioning the patient interface, receive further sensor data from one or more sensors disposed with the patient interface (the sensor 48 acquires current usage data and is disposed with the patient interface 18, see [0097], hence the sensor 48 is always acquiring usage data and transmitting the usage data to the receiving unit 32 of system 10; therefore, the system 10 is capable of receiving further sensor data from the sensor 48 subsequent to the display of instructions for positioning the patient interface 18; see also [0104], lines 1-7); and
automatically validating that the fit of the patient interface on the patient has been corrected based on the sensor data (the sensor 48 acquires current usage data and is disposed with the patient interface 18, see [0097], hence the sensor 48 is always acquiring usage data and transmitting the usage data to the receiving unit 32 of system 10. Additionally, the advice unit 36 compares the current data from the sensor 48 with the optimal setting to generate personalized advice, where if the current setting of the current data from sensor 48 deviates from the optimal setting, the advice unit 36 will automatically be triggered and will generate and output the personalized advice, see [0099], lines 24-30 and [0105], lines 9 to the end of the paragraph, hence the corrected position and orientation of the patient interface on the patient is automatically validated).
While Lawrenson does disclose the use of technical data, where technical data includes information on the design and functionality of the patient interface and/or of the pressure support system, such as, how to attach the patient interface to a head of a patient ([0034]), Lawrenson fails to explicitly disclose based on the validating, capturing one or more images of the patient with the patient interface and setting the captured one or more images as baseline image(s).
However, Hudson teaches providing and displaying a series of instructions for guiding a user through the setup of a CPAP therapy device ([0006]; [0009]; Figs. 2A-2B) and verifying the setup of the CPAP therapy device and mask has been completed and is proper ([0094]). Hudson further teaches a method and system for detecting a mask leak subsequent to the displaying of instruction for how to setup the CPAP therapy device and put on the mask (Figs. 3A-4; [0102], where test drive begins after the setup process for the CPAP therapy device and the mask), and the leak testing includes presenting the user with an image of their face with the mask on that is taken by a camera (first sentence of [0120]) as a reference image to diagnose the leak ([0120]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lawrenson to take at least one image, with a camera, of the patient wearing the patient interface subsequent to the validation of the corrected fit of the patient interface based on the sensor data (see claim 31 above) to be used as at least one reference image, as taught by Hudson (Hudson [0006], [0086]-[0088], [0094], [0102], and [0120]; Hudson Figs. 2A-4) to allow the patient to correct the fit of the patient interface without the assistance an on-site medical professional (Hudson first sentence of [0009]), and to improve the quality of therapy received by the patient by ensuring the patient interface is positioned correctly.
Regarding claim 32, Lawrenson as modified teaches the invention as set forth in claim 31, wherein the memory (38, 40; Fig. 1; [0094], lines 3-17) includes one or more images including a patient with the patient interface ([0101], lines 1-8; [0101], lines 24-27), wherein the displayed instructions include displaying the one or more images based on the comparison (Fig. 1; [0099], lines 29-33).
Regarding claim 33, Lawrenson as modified teaches the invention as set forth in claim 31, wherein the computing device (10) is coupled to a camera (42; Figs. 2, 3) configured to capture one or more images of the patient with the patient interface (one or more images of the patient 12 wearing the patient interface 18 are taken by camera 42, see [0101], lines 1-6).
Regarding claim 34, Lawrenson as modified teaches the invention as set forth in claim 33, wherein the computing device (10) is configured to compare one or more reference images (optimal setting, where the optimal setting includes a virtual attachment of the 3D model of the patient interface to the 3D model of the patient’s head, see [0038], lines 13-20) stored in memory (38 and 40, see [0094], lines 3-17; information to identify the optimal setting is stored in database 38 and 40, see [0099], lines 11-15, where database 38 and 40 are one singular database) and the captured one or more images (one or more images of patient 12 wearing patient interface 18 taken by camera 42, see [0101], lines 1-6) to determine improper patient interface fitting position (received images are analyzed by comparing the received images to the optimal setting, see [0101], lines 38-41, where the orientation and/or position of the patient interface is the received images; the comparison determines if the current position and/or orientation of the patient interface 18 on the patient 12 is proper or improper, see [0099], lines 11-29).
Regarding claim 35, Lawrenson as modified teaches the invention as set forth in claim 34, wherein the computing device (10) is configured to superimpose a correct position of the patient interface on the captured one or more images ([0082], lines 1-9), wherein the displayed instructions include the one or more superimposed images (Fig. 1; [0099], lines 29-33).
Regarding claim 36, Lawrenson as modified teaches the invention as set forth in claim 31, further comprising a remote computing system (32, 34, 36, 38, 40; [0094], last sentence; [0070], lines 2-9; [0106], lines 13-23) and the remote computing system is configured to determine the instructions for positioning the patient interface, and transmit the instructions to the computing device ([0099], lines 27-33, where the system 10 includes advice unit 36 and display 52).
Regarding claim 37, Lawrenson as modified teaches the invention as set forth in claim 31, wherein the computing device (10) is further configured to receive an input indicating a type of the patient interface (images of patient with patient interface are received by system 10, [0101], lines 1-8 and [0101], lines 24-27; images of patient with patient interface received by 10 indicate the type of patient interface, [0049], lines 25-28), and display, on the display (52), instructions for using the type of patient interface indicated by the input ([0049], lines 31-34).
Regarding claim 38, Lawrenson as modified teaches the invention as set forth in claim 31, wherein at least one of the one or more patient interface sensors (48) is disposed on a surface of the patient interface ([0097], lines 12-14).
Regarding claim 39, Lawrenson as modified teaches the invention as set forth in claim 31, wherein at least one of the one or more patient interface sensors (48) is a pressure sensor (48 includes a pressure sensor, [0104], lines 8-21) configured to a measure pressure inside of a mask of the patient interface ([0104], lines 18-21).
Regarding claim 40, Lawrenson as modified teaches the invention as set forth in claim 31, wherein at least one of the one or more patient interface sensors (48) is a sensor configured to measure a physical property of the supply of breathable gas ([0097], lines 1-7) in an oral or nasal cushion of the patient interface ([0090], lines 3-8; 48 is within nasal cushion element 20, [0104], lines 18-21).
Regarding claim 41, Lawrenson as modified teaches the invention as set forth in claim 31, wherein at least one of the one or more patient interface sensors (48) is disposed on a surface or inside of a strap of the patient interface ([0097], lines 12-14).
Regarding claim 58, Lawrenson as modified teaches the invention as set forth in claim 12, wherein the at least one hardware processor ([0099], lines 1-6) is further configured to:
subsequent to display of the instructions for positioning the patient interface (see claim 12 above), receive sensor data from one or more sensors disposed with the patient interface (the sensor 48 acquires current usage data and is disposed with the patient interface 18, see [0097], hence the sensor 48 is always acquiring usage data and transmitting the usage data to the receiving unit 32 of system 10; therefore, the system 10 is capable of receiving further sensor data from the sensor 48 subsequent to the display of instructions for positioning the patient interface 18; see also [0104], lines 1-7); and
automatically validating that the fit of the patient interface on the patient has been corrected based on the sensor data (the sensor 48 acquires current usage data and is disposed with the patient interface 18, see [0097], hence the sensor 48 is always acquiring usage data and transmitting the usage data to the receiving unit 32 of system 10. Additionally, the advice unit 36 compares the current data from the sensor 48 with the optimal setting to generate personalized advice, where if the current setting of the current data from sensor 48 deviates from the optimal setting, the advice unit 36 will automatically be triggered and will generate and output the personalized advice, see [0099], lines 24-30 and [0105], lines 9 to the end of the paragraph, hence the corrected position and orientation of the patient interface on the patient is automatically validated; Hudson [0094]).
Regarding claim 60, Lawrenson as modified teaches the invention as set forth in claim 12, wherein the at least one hardware processor ([0099], lines 1-6) is further configured to display, on the display (52; Fig. 1), an image that includes the patient wearing the patient inface, wherein the feedback for improving the fit of the patient interface is overlaid with the image ([0099], lines 29-34).
Claims 7, 9, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Lawrenson (US 20170203071 A1) in view of Hudson (US 20200121873 A1) as applied to claims 1, 6, and 12 above, and further in view of Lucey et al. (US 20170173289 A1; hereinafter “Lucey”).
Regarding claim 7, Lawrenson as modified teaches the invention as set forth in claim 6, wherein the remote computing system (32, 34, 36, 38, 40; [0094], last sentence; [0070], lines 2-9; [0106], lines 13-23) is configured to: receive, from the computing device, the one or more images ([0101], lines 1-8; [0101], lines 24-27), but fails to disclose wherein the remote computing system is configured to: train a machine learning model for instructing correct positioning of a patient interface, wherein the instructions for positioning the patient interface are determined based on the trained machine learning model.
However, Lucey teaches the making of a virtual 3D model of a user’s face, wherein the model is created via the identification of a plurality of points associated with landmark features on the user’s face from a plurality of video frames, or images, based on a machine learning algorithm ([0025], last sentence; [0040], lines 1-5). The machine learning algorithm can be trained to recognize movement of one or more points, or landmarks, on a user’s face based on a larger training dataset, containing a plurality of three-dimensional surfaces representative of a plurality of users’ faces, that is stored in the memory of the computing system ([0127], lines 3-9). The machine learning algorithm is used to generate a support vector or other supervised learning model to classify and recognize points or landmarks on the user’s face ([0129]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lawrenson with Lucey such that the remote computing system (32, 34, 36, 38, 40; [0094], last sentence; [0070], lines 2-9; [0106], lines 13-23) is configured to: train a machine learning model for instructing correct positioning of a patient interface (Lucey [0127], lines 3-9; [0129]), wherein the instructions for positioning the patient interface are determined based on the trained machine learning model ([0102], last two sentences, where the model is received by the advice unit 36 and the analysis of the model compared to the one or more images of the patient with the patient interface results in instructions for correcting the positioning of the patient interface, [0101], lines 31-36, where the model is the machine learning model of Lucey, [0127], lines 3-9; [0129]) to enhance the tracking and identification of the user’s face and the patient interface (Lucey [0127], lines 1-6).
Regarding claim 9, Lawrenson as modified teaches the invention as set forth in claim 1, wherein the computing device (10) is configured to transmit the received one or more images to a remote processing system (32, 34, 36, 38, 40; [0094], last sentence; [0070], lines 2-9; [0106], lines 13-23; [0099], lines 27-33; [0101], lines 1-8; [0101], lines 24-27), but fails to teach the remote processing system is configured to perform machine learning using the one or more images.
However, Lucey teaches the making of a virtual 3D model of a user’s face, wherein the model is created via the identification of a plurality of points associated with landmark features on the user’s face from a plurality of video frames, or images, based on a machine learning algorithm ([0025], last sentence; [0040], lines 1-5; [0127], lines 3-9).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lawrenson with Lucey such that the remote processing system is configured to perform machine learning using the one or more images (Lucey 0025], last sentence; Lucey [0040], lines 1-5; Lucey [0127], lines 3-9) to enhance the tracking and identification of the user’s face and the patient interface (Lucey [0127], lines 1-6).
Regarding claim 25, Lawrenson as modified teaches the invention as set forth in claim 12, but fails to teach wherein the analysis includes comparing the received one or more images (images from camera 42) to a machine trained model that is updated based on data received from other patients.
However, Lucey teaches the making of a virtual 3D model of a user’s face, wherein the model is created via the identification of a plurality of points associated with landmark features on the user’s face from a plurality of video frames, or images, based on a machine learning algorithm ([0025], last sentence; [0040], lines 1-5). The machine learning algorithm can be trained to recognize movement of one or more points, or landmarks, on a user’s face based on a larger training dataset, containing a plurality of three-dimensional surfaces representative of a plurality of users’ faces, that is stored in the memory of the computing system ([0127], lines 3-9). The machine learning algorithm is used to generate a support vector or other supervised learning model to classify and recognize points or landmarks on the user’s face ([0129]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lawrenson with Lucey such that the analysis includes comparing the received one or more images (images from camera 42) to a machine trained model (Lucey: support vector machine or other supervised learning model generated by machine learning algorithm; [0129]) that is updated based on data received from other patients (Lucey: [0127], lines 3-9) to enhance the tracking and identification of the user’s face and the patient interface (Lucey [0127], lines 1-6).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lawrenson (US 20170203071 A1) in view of Hudson (US 20200121873 A1) as applied to claims 1, 6, and 12 above, and further in view of Richard et al. (US 20060235877 A1; hereinafter “Richard”).
Regarding claim 19, Lawrenson as modified teaches the invention as set forth in claim 12, but fails to explicitly disclose wherein the received one or more images (images from camera 42) are captured from different positions and orientations of the camera.
However, Richard teaches a camera provided to take images of the patient from various angles for the measurement of various dimensions of the patient’s head ([0034], lines 1-5).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Lawrenson with Richard, such that the received one or more images (images from camera 42) are captured from different positions and orientations of the camera (Richard: [0034], lines 1-5) to measure and capture various dimensions of the patient’s head (Richard: [0034], lines 5-6).
Regarding claim 20, Lawrenson as modified teaches the invention as set forth in claim 12, but fails to explicitly disclose wherein a plurality of images are captured at different times, and the analysis includes comparing the plurality of images to determine changes in positioning of the patient interface between images captured at the different times.
However, Richard teaches a plurality of images (full facial scans including multiple images combined, or stitched, together) taken over a period of time which can be used to show how the patient’s face has changed. Richard further teaches Delta View Programs that can compare full facial scans from different times to show geometrically how the patient’s face has changed and the specific areas where the most change has occurred ([0145], lines 1-9).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Lawrenson with Richard, such that a plurality of images (full facial scans including multiple images combined, or stitched, together) are captured at different times, and the analysis includes comparing the plurality of images to determine changes in positioning of the patient interface between images captured at the different times (Richard: [0145], lines 1-9) as changes in patient weight can affect the fit of a respiratory mask (Richard: [0145], lines 4-6). With the information from the analysis above, a recommendation could be made as to whether the patient requires a new mask size or different type of mask (Richard: [0145], lines 9-11).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Lawrenson (US 20170203071 A1) in view of Hudson (US 20200121873 A1) as applied to claim 12 above, and further in view of Ho et al. (US 20150193650 A1; hereinafter “Ho”).
Regarding claim 23, Lawrenson as modified teaches the invention as set forth in claim 12, but fails to explicitly disclose wherein the analysis includes comparing the received one or more images (images from camera 42, see claim 12 above) to models generated based on information received from other patients.
However, Ho teaches a patient interface identification system for identifying a patient interface that is suited for a face of a user that includes a database (22) for storing reference pictures including the faces of other users ([0066], lines 1-3). Ho further teaches a processing unit (24) that analyses a received image of a user and compares said received image to the stored reference pictures ([0066], lines 8-14).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Lawrenson with Ho, such that the analysis includes comparing the received one or more images (images from camera 42, see claim 12 above) to models generated based on information received from other patients (Ho: [0066], lines 1-3; [0066], lines 8-14) to determine advice on how to improve the position and/or orientation of the patient interface based on the analysis above (Ho: [0066], lines 12-14).
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Lawrenson (US 20170203071 A1) in view of Hudson (US 20200121873 A1) as applied to claim 12 above, and further in view of Viner et al. (WO 2019043578 A1; hereinafter “Viner”).
Regarding claim 59, Lawrenson as modified teaches the invention as set forth in claim 12, but fails to explicitly disclose wherein the at least one hardware processor ([0099], lines 1-6) is further configured to: subsequent to confirmation that the fit of the patient interface on the patient has been corrected or improved, capture one or more additional images of the patient with the patient interface; and store the one or more additional images as replacement or additional of the one or more reference images.
However, Viner teaches an analogous system to guide a patient to adjust a fitting position of a respiratory mask (Abstract), where the respiratory sensor system (300) confirms the respiratory mask is positioned correctly when a measured aerosol leakage value drops below and accepted threshold, wherein a wireless sensor is subsequently automated to capture an image of the respiratory mask in the correct position on the user’s face, where the captured image is saved to be used as a reference image in the future (see pg. 20, lines 7-11).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lawrenson with above process taught by Viner, such that the at least one hardware processor ([0099], lines 1-6) is further configured to: subsequent to confirmation that the fit of the patient interface on the patient has been corrected or improved, capture one or more additional images of the patient with the patient interface (Viner pg. 20, lines 7-10); and store the one or more additional images as replacement (Viner pg. 20, line 11) to ensure a consistent fit and positioning of the patient interface on the patient every time the patient dons the patient interface (Viner pg. 20, line 12).
Response to Arguments
Applicant's arguments filed 04/28/2026, with regard to the rejection of claim 59 under 35 U.S.C. 112(b), have been fully considered but they are not persuasive.
On page 13 of the Remarks, Applicant argues the recited limitation “subsequent to confirmation that the fit of the patient interface on the patient has been corrected or improved” in claim 59 (lines 3-4) does not lack antecedent basis as the limitation is being introduced in claim 59 and does not recite “the confirmation of the fit of the patient interface…”. While the Examiner agrees that the limitation recited in claim 59 is introducing and requiring the limitation of “subsequent to confirmation that the fit of the patient interface on the patient has been corrected or improved” (lines 3-4), there is insufficient antecedent basis for the step or function of confirming the fit of the patient interface on the patient has been corrected or improved. Claim 12, from which claim 59 depends, simply discloses determining the fit of the patient interface on the patient and displaying feedback for improving the fit of the patient interface on the patient (claim 12, lines 27-33). Additionally, claim 59 does not disclose the step or function of confirming the fit of the patient interface on the patient has been corrected or improved, but simply utilizes this confirmation step to indicate when additional images will be captures (“subsequent to confirmation…”, line 3 of claim 59). As such, no step or function of confirming the fit of the patient interface on the patient has been corrected or improved is recited or disclosed in claim 12 or claim 59; hence, there is insufficient antecedent basis for a time or action that occurs subsequent to confirming the fit of the patient interface on the patient has been corrected or improved. To overcome the rejection of claim 59 under 35 U.S.C. 112(b), the Examiner suggests amending either claim 12 or claim 59 to include a limitation disclosing a confirmation that the fit of the patient interface on the patient has been corrected or improved (e.g., … wherein the at least one hardware processor is further configure to: … confirm the fit of the patient interface on the patient has been corrected or improved; capture, subsequent to the confirmation that the fit of the patient interface on the patient has been corrected or improved, one or more additional images of the patient with the patient interface; …”).
Applicant’s arguments with respect to independent claims 1,11, 12, and 30 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On pages 14-15 of the Remarks, Applicant argues Lawrenson fails to disclose “capture, via a camera and subsequent to the display of the instructions for using the patient interface, one or more reference images that include the patient wearing the patient interface in a fitted position established based on the displayed instructions”, as recited and introduced in amended claim 1, and as similarly recited in amended claims 11, 12, and 30 (see amendment of claims filed 04/28/2026). The amendment of the limitation “display, on the display, instructions for using the patient interface; capture, via a camera and subsequent to the display of the instructions for using the patient interface, one or more reference images that include the patient wearing the patient interface in a fitted position established based on the displayed instructions”, as recited in amended claim 1 (lines 16-19), and similarly recited in amended claims 11, 12, and 30, necessitate new ground(s) of rejection for claims 1, 11, 12, 30, and their dependents therein. As such, Hudson (US 20200121873 A1) has been introduced to teach displaying a series of instructions for guiding a user through the setup of a CPAP therapy device ([0006]; [0009]; Figs. 2A-2B) and instructing the user of how to put on a mask and check that the mask and headgear are properly fitted ([0006]; [0086]-[0090]; Fig. 2C). Hudson further teaches capturing images of the user wearing the mask subsequent to the display of said instructions ([0094]; [0102]; [0120]). Therefore, Lawrenson in combination with Hudson teaches displaying, on a display, instructions for using a patient interface; and subsequent to the display of the instructions, capturing at least one image, with a camera, of the patient wearing the patient interface (see rejection of amended claims 1, 11, 12, and 30 under 35 U.S.C. 103 above).
On page 15 of the Remarks, Applicant argues Lawrenson fails to disclose “a comparison between 1) the one or more reference images that include the patient with the patient interface, and 2) the received one or more images that include the patient with the patient interface", as Lawrenson does not disclose comparing two different images to one another, where those images both include the patient wearing the patient interface. However, the amendment of “capture, via a camera and subsequent to the display of the instructions for using the patient interface, one or more reference images that include the patient wearing the patient interface in a fitted position established based on the displayed instructions”, as recited in amended claim 1, and similarly recited in amended claims 11, 12, and 30, changes the scope of the one or more reference images. Hence, new ground(s) of rejection are necessitated by said amendment. As such, Hudson has been provided to teach at least one reference image of the patient wearing the patient interface being taken via a camera and subsequent to the display of instructions for using the patient interface ([0006], [0009], [0086]-[0090], [0094], [0102], and [0120]; Figs. 2A-2C; see rejection of amended claims 1, 11, 12, and 30 under 35 U.S.C. 103 above). Accordingly, Lawrenson in combination with Hudson teaches a comparison between 1) the at least one reference image of the patient wearing the patient interface being taken via a camera and subsequent to the display of instructions for using the patient interface, and 2) the received one or more that include the patient wearing the patient interface (see rejection of amended claims 1, 11, 12, and 30 under 35 U.S.C. 103 above).
On pages 15-16 of the Remarks, Applicant argues a temporal sequence of displaying instructions for using the patient interface, and then, subsequent to the display of said instructions, capturing reference images of the patient wearing the patient interface in a position based on the displayed instructions, is absent from Lawrenson. The amendment of the limitations disclosing said temporal sequence (i.e., claim 1, lines 16-19) necessitates new ground(s) of rejection. As such, Hudson has been provided to teach said temporal sequence as now required by, at least, independent claims 1, 11, 12, and 30 (see rejection of amended claims 1, 11, 12, and 30 under 35 U.S.C. 103 above).
Applicant's arguments filed on 04/28/2026, with regard to the rejection of independent claim 31 under 35 U.S.C. 102(a)(1), have been fully considered but they are not persuasive.
On pages 16-17 of the Remarks, Applicant argues there is no disclosure, express or inherent, in Lawrenson of acquiring sensor data subsequent to displaying instructions, and then, automatically validating the fit of the patient interface on the patient, as required by claim 31 (lines 17-21). However, Lawrenson does disclose displaying instructions on a display for positioning a patient interface (generation of personalized advice, see [0099], line 24 to end of paragraph). Furthermore, Lawrenson discloses a patient interface sensor (48; [0097]) that is observing and collecting patient data while the patient is wearing the patient interface ([0097], lines 5-7); hence, the patient interface sensor (48) is continuously collecting and transmitting, to the receiving unit (32) of the system (10), patient data while the patient is wearing the patient interface. As Lawrenson discloses the patient wearing the patient interface when the instructions for positioning the patient interface are displayed (instructions for positioning the patient interface are based on a comparison between received sensor data from the patient interface 48 and pre-set values stored in a memory; see [0070], [0092], [0094], lines 3-17, [0097], lines 5-7, and [0099], lines 19-23; see rejection of claim 31 under 35 U.S.C. 103 above), and the patient interface sensor (48) continuously collects patient data when the patient is wearing the patient interface, it would be readily understood by one of ordinary skill in the art that at least the patient interface sensor (48) continues to obtain and transmit, to the receiving unit (32) of the system (10), sensor data subsequent to the display of the instructions for positioning the patient interface.
Applicant’s arguments with respect to independent claims 1,11, 12, and 30 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On page 17 of the Remarks, Applicant further argues that Lawrenson fails to anticipate independent claim 31, and its dependents therein, as Lawrenson does not capture one or more images of the patient with the patient interface and setting the one or more captured images as baseline image(s), as required by amended claim 31 (lines 23-24). However, the amendment of “based on the validating, capturing one or more images of the patient with the patient interface and setting the captured one or more images as baseline image(s)”, as recited in amended claim 31 (lines 23-24), necessitates new ground(s) for rejection. Accordingly, Hudson has been provided to teach capturing at least one reference image of the patient wearing the patient interface, subsequent to verifying the fit of the mask has been adjusted and is proper ([0094]; [0102]; [0120]; see rejection of claim 31 under 35 U.S.C. 103 above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Smith (US 20120232403 A1): Regarding taking an image of a patient wearing a patient interface, and using said image as a baseline/reference image for analysis.
Drummond (FR 3021544 A1): Regarding capturing, with a camera, and reference image of a patient wearing a patient interface, and utilizing said image for analysis such that the position of the patient interface on the patient’s face can be corrected.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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