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 .
Status of Claims
This present office action is responsive to the Application filed on July 16, 2024. As directed, claims 1-20 are presently pending in this application.
Drawings
The drawings are objected to because of the following informalities:
Regarding figures 1B, 3E, 4A-4B, 5C-5D, 11C, 12A-F, 13B, and 14B, photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention. See 37 CFR 1.84 (b)(1).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because of the following informality:
Ln 6 recites, “less than 180 cm2” which Examiner suggest amending to read --less than 180 cm3--
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
The same incorrect units of volume are also used in the specification itself. For example, see ¶0024 of Page 8, and ¶0029 of Page 9 and etc. in the specification. Examiner suggest amending to read --180 cm3--
Appropriate correction is required.
Claim Objections
Claims 1-20 are objected to because of the following informalities:
Claims 1 and 19-20 each recite, “a volume of less than 180 cm2” which Examiner suggest amending to read -- a volume of less than less than 180 cm3-- for a unit used in the measurement of volume.
Claims 2-18 are objected by dependency to claim 1.
Claim 2 recites, “a an” in ln 1 which Examiner suggest amending to read --an--
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 8-10 are 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 8 recites a limitation, “the breath-analysis sensor” in ln 1 while the claim is depended on claim 15 which renders claim indefinite. It is unclear whether claim 8 is intended to be dependent on claim 7 as the limitation is introduced or newly introduce the limitation while depended on claim 15.
For examination purposes, it is interpreted as to --dependent to claim 7--.
Claims 9-10 are rejected by virtue of dependency to claim 8.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 7-10, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mumford et al. (US 20070208269 A1) in view of Valiyambath et al. (US 20230390513 A1) and Vuorinen et al. (“Unobtrusive, Low-Cost Out-of-Hospital, and In-Hospital Measurement and Monitoring System”, https://doi.org/10.1002/aisy.202000030, 05/2020) as evidenced by “Hair of Istanbul” (https://www.hairofistanbul.com/average-forehead-size/, June 2023).
Regarding claim 1, Mumford et al. discloses, a system for monitoring a patient (a system of Fig 5; ¶0086, a monitoring system via a remote processing unit and integrated sensors), comprising:
a wearable mask (a nasal interface or mask 20, Fig 5) coupled to a positive airway pressure (PAP) machine (a connection between the mask and a CPC device 14 via a shoes 30 as shown in Fig 5),
the wearable mask configured to deliver a flow of gas at positive pressures generated by the PAP machine to an airway of the patient (¶0019, “An air supply interface may be provided for supplying positive airway pressure to an airway of the person”; ¶0024, “supplying positive airway pressure to an airway of the person”; ¶0059);
an electronics control unit (a remote processing unit 414 is attached to the mask as shown in Fig 5; 514 of Fig 7 which is an alternate embodiment of a remote processing unit), attached to the wearable mask and comprising a microprocessor (a control unit 426, Fig 7; ¶0088), a wireless transmitter (a wireless communication unit 516, and an antenna 518, Fig 7), and a battery (a battery 520, Fig 7) and at least one sensor electrically connected to the electronics control unit (¶0086-0087, “…connected to the remote processing unit 414 which processes the signals provided by these sensors prior to transmitting the signals to the monitoring unit… there can be various combinations of the sensors”).
While Mumford et al. appears to disclose a size of the remote processing unit as less than 1/3 of the a contoured forehead support member 214 which extends over the eyebrows of the wearer (¶0078; 414, Fig 5), Mumford et al. is silent on the arrangement of the remote processing unit and the forehead support member and does not specifically discloses the remote processing unit comprising a printed circuit board and the electronics control unit comprised by an enclosure having a volume of less than 180 cm3.
However, Valiyambath et al. which is analogous art to the claimed invention for OSA therapy (¶0018), teaches a patient interface comprising a connection port to a tubing and a headband with a processor (Fig 7B; ¶0253, “an integrated transceiver for transmitting data to, and receiving data from, external computing device”) to measure the patient’s physiological and sleep data (¶0249) and teaches, a processor module (6350, Fig 7B which is shown as a printed circuit board capable of transmitting data as described in ¶0253) and a battery module (6352, Fig 7B) configured for transmitting data from the one or more sensors to one or more external computing devices, and/or for receiving data at the one or more actuators from the one or more external computing device (¶0097,0253) and further teaches an arrangement of the said components enclosed within the headband as shown in Fig 7C in purposes of improving data collection and replace modules or components at ease (¶0250-0260).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mumford et al. to include a printed circuit board and the arrangement of the components comprised by an enclosure as taught by Valiyambath et al. in purposes of improving data collection and replace modules or components at ease (¶0250-0260).
And further, it would have been obvious to one of the ordinary skills in the art that the volume of the electronic control unit of Mumford et al. would have a volume of less than 180 cm3 based on the remote processing unit arranged on a portion of the forehead strap as illustrated on Fig 5 and the measures of average forehead (6 cm in height and 14 cm in length) as evidenced by NPL, “Hair of Istanbul”. Even if the processing unit was provided with a footprint extending ½ of the forehead region of 6 cm x 14 cm forehead region, a thickness of approximately 4.28 cm would correspond to a volume of 180 cm3. Thus, said volume would have been recognized by the ordinary skill in the art as obviously expected from the arrangement of the electronic control unit of Mumford et al.
Modified Mumford et al. is silent on the electronics control unit having a weight less than 30 grams.
However, Vuorinen et al., which is analogous art to the claimed invention for body-worn monitoring system (abstract), teaches a microcontroller unit (nRF52832) which has a powerful BLE capable radio module and integrated BLE protocol stack configured to connected to the electrodes via a micro USB connector and its PCB (Fig 2c; PG 4, section, “2.4. Measurement Unit”). The unit has a circular shape with a diameter of 33 mm and the PCB consists of 4 layers and about 200 components and the PCB weights 3.7 g including an SD card while the total weight including a prismatic 300 mAh battery and the enclosure is 13.4 g in purpose of improving the processing unit in order to achieve desired quality of service and optimize power consumption and communication cost while using available miniaturized electronics (PG 6, Col 1, ln 2-4).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mumford et al. to have specified with the electronics control unit having a weight less than 30 grams as taught by Vuorinen et al. in purpose of improving the processing unit in order to achieve desired quality of service and optimize power consumption and communication cost while using available miniaturized electronics (PG 6, Col 1, ln 2-4).
Regarding claim 2, Mumford et al. in view of Valiyambath et al. and Vuorinen et al. and as evidenced by Hair of Istanbul discloses the system of claim 1 as discussed above.
Mumford et al. discloses, wherein the at least one sensor comprises an optical sensor (¶0125, “one or more body movement sensors for providing signal data over the body movement channel…. optical imaging”).
Regarding claim 3, Mumford et al. in view of Valiyambath et al. and Vuorinen et al. and as evidenced by Hair of Istanbul discloses the system of claim 1 as discussed above.
Mumford et al. does not specifically discloses, wherein the at least one sensor comprises a microphone.
However, Valiyambath et al. teaches wherein the at least one sensor comprises a microphone (¶0279, “an acoustic sensor, for example a microphone”) in purpose of detecting snoring or other sounds indicative of disturbed sleep (¶0522,0525).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mumford et al. to include a microphone as taught by Valiyambath et al. in purpose of detecting snoring or other sounds indicative of disturbed sleep (¶0522, ¶0525).
Regarding claim 4, Mumford et al. in view of Valiyambath et al. and Vuorinen et al. and as evidenced by Hair of Istanbul discloses the system of claim 3 as discussed above.
Modified Mumford et al. further discloses, wherein the microphone comprises an acoustic detector (Valiyambath et al.: ¶0279).
Regarding claim 7, Mumford et al. in view of Valiyambath et al. and Vuorinen et al. and as evidenced by Hair of Istanbul discloses the system of claim 1 as discussed above.
Mumford et al. further discloses, a breath-analysis sensor (a pressure transducer 316, Fig 5; a pressure transducer interface 422, Fig 7; ¶0084, “The pressure transducer 316 can be used to detect the pressure within the cavity of the nasal mask 20 from which the breathing rate (respiration) of the wearer 18 can be derived”; Examiner interprets that the pressure transducer 422 of Fig 7 has same capability of the pressure transducer 316 of Fig 5 as the Fig 7 represents a block diagram of the remote processing unit of FIG. 5, employing wireless communication as described in ¶0037).
Regarding claim 8, Mumford et al. in view of Valiyambath et al. and Vuorinen et al. and as evidenced by Hair of Istanbul discloses the system of claim 7 as discussed above (Examiner interprets that claim 8 is dependent to claim 7 instead of claim 15 as discussed in 112b rejection above).
Mumford et al. further discloses, wherein the breath-analysis sensor comprises a pressure sensor (316, Fig 5; 422, Fig 7; ¶0084).
Regarding claim 9, Mumford et al. in view of Valiyambath et al. and Vuorinen et al. and as evidenced by Hair of Istanbul discloses the system of claim 8 as discussed above
Mumford et al. further discloses, wherein the breath-analysis sensor comprises an analog-to-digital converter (ADC 430, Fig 7) in electrical contact with at least one of the sensors within the breath-analysis sensor (¶0093, “The electrode interface 420 receives analog electrode signals 444 from the electrodes E1, E3 and E4 and the pressure transducer interface 450 receives an analog pressure signal 446. Both of these analog signals are sent to the pre-processing unit 428 which generates pre-processed signals 448. The pre-processed signals 448 are then digitized by the ADC 430 resulting in digital pre-processed signals 450”).
Regarding claim 10, Mumford et al. in view of Valiyambath et al. and Vuorinen et al. and as evidenced by Hair of Istanbul discloses the system of claim 9 as discussed above
Mumford et al. further discloses, wherein the breath-analysis sensor is positioned on the wearable mask to detect breath generated by the patient and, in response, generate a signal (¶0084).
Regarding claim 16, Mumford et al. in view of Valiyambath et al. and Vuorinen et al. and as evidenced by Hair of Istanbul discloses the system of claim 1 as discussed above
Mumford et al. further discloses, wherein the at least one sensor comprises an electromyography (EMG) sensor (electrodes E1, E3 and E4, Fig 5; Electrode Interface 420, Fig 7; ¶0076, “The combination of electrodes E1, E3 and E4 provides three channels of physiological data which have a sufficient content of EEG, EMG and EOG information to perform frontal sleep staging”).
Regarding claim 17, Mumford et al. in view of Valiyambath et al. and Vuorinen et al. and as evidenced by Hair of Istanbul discloses the system of claim 16 as discussed above
Mumford et al. further discloses, wherein the EMG sensor comprises a sense electrode configured to sense a bioelectric signal (¶0070, “Conductive wires are coupled to electrodes E1, E2, E3, E4 and E5 for providing sensed biological signals”).
Regarding claim 18, Mumford et al. in view of Valiyambath et al. and Vuorinen et al. and as evidenced by Hair of Istanbul discloses the system of claim 16 as discussed above
Mumford et al. further discloses, wherein the EMG sensor comprises an analog-to-digital converter (ADC 430, Fig 7) in electrical contact with the analog electrical circuit (¶0089, 0093, “…the electrode interface 420 and an analog-to-digital converter (ADC) … receives an analog pressure signal 446… The pre-processed signals 448 are then digitized by the ADC 430 resulting in digital pre-processed signals 450”), and wherein the EMG sensor is positioned on the wearable mask (the electrodes are positioned on the mask as shown in Fig 5) to detect muscle activity within the patient and, in response, generate a signal (¶0066-0067, “…to obtain good physiological data from as little as two electrodes which can provide EEG, EOG or EMG data…the physiological signals obtained from the forehead at these locations provide data related to the CPAP wearer's brainwaves, facial muscle tone and eye movements).
Regarding claim 19, Mumford et al. discloses, a system for monitoring a patient (a system of Fig 5; ¶0086, a monitoring system via a remote processing unit and integrated sensors), comprising:
a wearable mask (a nasal interface or mask 20, Fig 5) coupled to a positive airway pressure (PAP) machine (a connection between the mask and a CPC device 14 via a shoes 30 as shown in Fig 5),
the wearable mask configured to deliver a flow of gas at positive pressures generated by the PAP machine to an airway of the patient (¶0019, “An air supply interface may be provided for supplying positive airway pressure to an airway of the person”; ¶0024, “supplying positive airway pressure to an airway of the person”; ¶0059);
an electronics control unit (a remote processing unit 414 is attached to the mask as shown in Fig 5; 514 of Fig 7 which is an alternate embodiment of a remote processing unit), attached to the wearable mask and comprising a microprocessor (a control unit 426, Fig 7; ¶0088), a wireless transmitter (a wireless communication unit 516, and an antenna 518, Fig 7), and a battery (a battery 520, Fig 7) and at least one sensor electrically connected to the electronics control unit (¶0086-0087, “…connected to the remote processing unit 414 which processes the signals provided by these sensors prior to transmitting the signals to the monitoring unit… there can be various combinations of the sensors”), and a plurality of sensors (electrodes E1, E2, E3, E4, a oximeter sensor 314, a pressure transducer 316, a position sensor 318 as shown in Fig 5), electrically connected to the electronics control unit (sensors are connected via the interfaces, 416, 418, 420, 422 as shown in Fig 7), the plurality of sensors comprising at least one of: a breath-analysis sensor (316, Fig 5; 422, Fig 7; ¶0084), and an electromyography sensor (E1, E3 and E4, Fig 5; 420, Fig 7; ¶0076).
While Mumford et al. disclose a size of the remote processing unit deems to be less than 1/3 of the a contoured forehead support member 214 which extends over the eyebrows of the wearer (¶0078; 414, Fig 5), Mumford et al. is silent on the arrangement of the remote processing unit and the forehead support member and does not specifically discloses the remote processing unit comprising a printed circuit board and the electronics control unit comprised by an enclosure of having a volume of less than 180 cm3.
However, Valiyambath et al. which is analogous art to the claimed invention for OSA therapy (¶0018), teaches a patient interface comprising a connection port to a tubing and a headband with a processor (Fig 7B; ¶0253, “an integrated transceiver for transmitting data to, and receiving data from, external computing device”) to measure the patient’s physiological and sleep data (¶0249) and teaches, a processor module (6350, Fig 7B which is shown as a printed circuit board capable of transmitting data as described in ¶0253) and a battery module (6352, Fig 7B) configured for transmitting data from the one or more sensors to one or more external computing devices, and/or for receiving data at the one or more actuators from the one or more external computing device (¶0097,0253) and further teaches an arrangement of the said components enclosed within the headband as shown in Fig 7C in purposes of improving data collection and replace modules or components at ease (¶0250-0260).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mumford et al. to include a printed circuit board and the arrangement of the components comprised by an enclosure as taught by Valiyambath et al. in purposes of improving data collection and replace modules or components at ease (¶0250-0260).
And further, it would have been obvious to one of the ordinary skills in the art that the volume of the electronic control unit of Mumford et al. would have a volume of less than 180 cm3 based on the remote processing unit arranged on a portion of the forehead strap as illustrated on Fig 5 and the measures of average forehead (6 cm in height and 14 cm in length) as evidenced by NPL, “Hair of Istanbul”. Even if the processing unit was provided with a footprint extending ½ of the forehead region of 6 cm x 14 cm forehead region, a thickness of approximately 4.28 cm would correspond to a volume of 180 cm3. Thus, said volume would have been recognized by the ordinary skill in the art as obviously expected from the arrangement of the electronic control unit of Mumford et al.
Modified Mumford et al. is silent on the electronics control unit having a weight less than 30 grams.
However, Vuorinen et al., which is analogous art to the claimed invention for body-worn monitoring system (abstract), teaches a microcontroller unit (nRF52832) which has a powerful BLE capable radio module and integrated BLE protocol stack configured to connected to the electrodes via a micro USB connector and its PCB (Fig 2c; PG 4, section, “2.4. Measurement Unit”). The unit has a circular shape with a diameter of 33 mm and the PCB consists of 4 layers and about 200 components and the PCB weights 3.7 g including an SD card while the total weight including a prismatic 300 mAh battery and the enclosure is 13.4 g in purpose of improving the processing unit in order to achieve desired quality of service and optimize power consumption and communication cost while using available miniaturized electronics (PG 6, Col 1, ln 2-4).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mumford et al. to have specified with the electronics control unit having a weight less than 30 grams as taught by Vuorinen et al. in purpose of improving the processing unit in order to achieve desired quality of service and optimize power consumption and communication cost while using available miniaturized electronics (PG 6, Col 1, ln 2-4).
Regarding claim 20, Mumford et al. discloses, a system for monitoring a patient (a system of Fig 5; ¶0086, a monitoring system via a remote processing unit and integrated sensors), comprising:
a wearable mask (a nasal interface or mask 20, Fig 5) coupled to a positive airway pressure (PAP) machine (a connection between the mask and a CPC device 14 via a shoes 30 as shown in Fig 5),
the wearable mask configured to deliver a flow of gas at positive pressures generated by the PAP machine to an airway of the patient (¶0019, “An air supply interface may be provided for supplying positive airway pressure to an airway of the person”; ¶0024, “supplying positive airway pressure to an airway of the person”; ¶0059) and
comprising an electronics control unit (a remote processing unit 414 is attached to the mask as shown in Fig 5; 514 of Fig 7 which is an alternate embodiment of a remote processing unit) and the electronics control unit in electrical communication (¶0086-0087, “…connected to the remote processing unit 414 which processes the signals provided by these sensors prior to transmitting the signals to the monitoring unit… there can be various combinations of the sensors”) with at least one of the following sensors: a breath-analysis sensor (316, Fig 5; 422, Fig 7; ¶0084), and an electromyography sensor (E1, E3 and E4, Fig 5; 420, Fig 7; ¶0076).
While Mumford et al. disclose a size of the remote processing unit deems to be less than 1/3 of the a contoured forehead support member 214 which extends over the eyebrows of the wearer (¶0078; 414, Fig 5), Mumford et al. is silent on the arrangement of the remote processing unit and the forehead support member and does not specifically discloses the electronics control unit comprised by an enclosure of having a volume of less than 180 cm3.
However, Valiyambath et al. which is analogous art to the claimed invention for OSA therapy (¶0018), teaches a patient interface comprising a connection port to a tubing and a headband with a processor (Fig 7B; ¶0253, “an integrated transceiver for transmitting data to, and receiving data from, external computing device”) to measure the patient’s physiological and sleep data (¶0249) and teaches, a processor module (6350, Fig 7B which is shown as a printed circuit board capable of transmitting data as described in ¶0253) and a battery module (6352, Fig 7B) configured for transmitting data from the one or more sensors to one or more external computing devices, and/or for receiving data at the one or more actuators from the one or more external computing device (¶0097,0253) and further teaches an arrangement of the said components enclosed within the headband as shown in Fig 7C in purposes of improving data collection and replace modules or components at ease (¶0250-0260).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mumford et al. to include a printed circuit board and the arrangement of the components comprised by an enclosure as taught by Valiyambath et al. in purposes of improving data collection and replace modules or components at ease (¶0250-0260).
And further, it would have been obvious to one of the ordinary skills in the art that the volume of the electronic control unit of Mumford et al. would have a volume of less than 180 cm3 based on the remote processing unit arranged on a portion of the forehead strap as illustrated on Fig 5 and the measures of average forehead (6 cm in height and 14 cm in length) as evidenced by NPL, “Hair of Istanbul”. Even if the processing unit was provided with a footprint extending ½ of the forehead region of 6 cm x 14 cm forehead region, a thickness of approximately 4.28 cm would correspond to a volume of 180 cm3. Thus, said volume would have been recognized by the ordinary skill in the art as obviously expected from the arrangement of the electronic control unit of Mumford et al.
Modified Mumford et al. is silent on the electronics control unit having a weight less than 30 grams.
However, Vuorinen et al., which is analogous art to the claimed invention for body-worn monitoring system (abstract), teaches a microcontroller unit (nRF52832) which has a powerful BLE capable radio module and integrated BLE protocol stack configured to connected to the electrodes via a micro USB connector and its PCB (Fig 2c; PG 4, section, “2.4. Measurement Unit”). The unit has a circular shape with a diameter of 33 mm and the PCB consists of 4 layers and about 200 components and the PCB weights 3.7 g including an SD card while the total weight including a prismatic 300 mAh battery and the enclosure is 13.4 g in purpose of improving the processing unit in order to achieve desired quality of service and optimize power consumption and communication cost while using available miniaturized electronics (PG 6, Col 1, ln 2-4).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mumford et al. to have specified with the electronics control unit having a weight less than 30 grams as taught by Vuorinen et al. in purpose of improving the processing unit in order to achieve desired quality of service and optimize power consumption and communication cost while using available miniaturized electronics (PG 6, Col 1, ln 2-4).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Mumford et al. (US 20070208269 A1) in view of Valiyambath et al. (US 20230390513 A1) and Vuorinen et al. (“Unobtrusive, Low-Cost Out-of-Hospital, and In-Hospital Measurement and Monitoring System”, https://doi.org/10.1002/aisy.202000030, 05/2020) as evidenced by “Hair of Istanbul” (https://www.hairofistanbul.com/average-forehead-size/, June 2023) as applied to claim 4 above, and further in view of Truschel et al. (US 20030066529 A1).
Regarding claim 5, Mumford et al. in view of Valiyambath et al. and Vuorinen et al. and as evidenced by Hair of Istanbul and as evidenced by Hair of Istanbul discloses the system of claim 4.
While Mumford et al. discloses an analog-to-digital converter (430, Fig 7), modified Mumford et al. does not specifically disclose, wherein the microphone comprises an analog-to-digital converter in electrical contact with the acoustic detector.
However, Truschel et al. which is analogous art to the claimed invention for a method for detecting patient snoring (abstract) teaches a microphone (48, Fig 2) and an analog-to-digital converter (56, Fig 2) in electrical contact with the acoustic detector (64, Fig 2) in purpose of detecting audible snore frequencies (¶0049).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mumford et al. to include wherein the microphone comprises an analog-to-digital converter in electrical contact with the acoustic detector as taught by Truschel et al. in purpose of detecting audible snore frequencies (¶0049).
Regarding claim 6, Mumford et al. in view of Valiyambath et al., Vuorinen et al., and Truschel et al. and as evidenced by Hair of Istanbul discloses the system of claim 5.
Modified Mumford et al. further discloses, wherein the microphone is positioned on the wearable mask to detect acoustic sounds generated by the patient and, in response, generate a signal (Valiyambath et al.: ¶0522, ¶0525).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mumford et al. (US 20070208269 A1) in view of Valiyambath et al. (US 20230390513 A1) and Vuorinen et al. (“Unobtrusive, Low-Cost Out-of-Hospital, and In-Hospital Measurement and Monitoring System”, https://doi.org/10.1002/aisy.202000030, 05/2020) as evidenced by “Hair of Istanbul” (https://www.hairofistanbul.com/average-forehead-size/, June 2023) as applied to claim 4 above, and further in view of Narkiss et al. (US 20190076100 A1).
Regarding claim 11, Mumford et al. in view of Valiyambath et al., Vuorinen et al., and Truschel et al. and as evidenced by Hair of Istanbul and as evidenced by Hair of Istanbul discloses the system of claim 1.
While Mumford et al. discloses a position sensor positioned in the mask connected to the remove processing unit and the position sensor configured to detect the position of the head (¶0085-0086), Mumford et al. does not specifically disclose wherein the at least one sensor comprises an impedance sensor.
However, Narkiss et al. which is analogous art to the claimed invention for a medical device such as cannula, mask, nasal tubing and sensors that are attached to a patient teaches a position sensor is an impedance sensor (¶0033) in purpose of detecting whether the position of the mask on the face of the subject (¶0069).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Mumford et al. to include an impedance sensor as taught by Narkiss et al. in purpose of detecting whether the position of the mask on the face of the subject (¶0069).
Allowable Subject Matter
Claims 12-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons For Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: regarding claim 12, the closest identified prior art of record are Jaffe et al. (US 20080190436 A1), and Shouldice (US 20200297955 A1).
Jaffe et al. discloses a nasal mask comprising an emitter and a detector configured to detect the light that is reflect from this tissue to which the emitter emits the light (Fig 48; ¶0253), but the skin reflectance is different from the skin impedance.
Shouldice discloses, a device, Up3™ produced by Jawbone, may use bio-impedance measures to derive heart rate, respiration rate and galvanic skin response, by sending a small electrical current through the body and measuring tissue resistance to the electrical signal (¶0096), but the prior art does not suggest or teach the said device electrically connected to the electronic control unit which is attached to the wearable mask while the mask is coupled to a PAP machine.
It is thus found that one of ordinary skills in the art at the time of the invention would only have arrived at the instantly claimed inventions by way of improper hindsight reasoning. No other prior arts have been found that teaches or suggest “wherein the impedance sensor comprises a sense electrode configured to sense a bioelectric signal, and a drive electrode configured to inject electrical current into the patient” while the impedance sensor is electronically connected to the electronics control unit attached to the wearable mask which is connected to the PAP machine.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dhruba et al. (“Development of an IoT-Based Sleep Apnea Monitoring System for Healthcare Applications”, https://pmc.ncbi.nlm.nih.gov/articles/PMC8580633/, Nov 2021) is cited for a printed circuit board, Arduino Uno having a DC power jack 7-20V and means to monitor sleep apnea.
Ehrmann et al. (“Measuring Biosignals with Single Circuit Boards”, https://pmc.ncbi.nlm.nih.gov/articles/PMC8869486/, Feb 2022) is cited for pursuit of smaller boards in purpose of reducing cost while measuring various bio-signals (see “Conclusion” of PG 14).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAEICK JANG whose telephone number is (703)756-4569. The examiner can normally be reached M-F 8:30 - 4:30.
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/J.J./Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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