DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Remarks/Arguments
Applicant’s arguments with respect to claim rejection have been fully considered but are moot in
view of new ground of rejection.
Claim objection
Claim 1 is objected to because of the following informalities: In line 9, the order of the limitations is marked as (b). (b) is repeated twice. It appears that in line 9, (b) should be marked as (c), and in line 13, (c) should be marked as (d). Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 & 10 recites “without using the patient interface device in a therapy session to treat a patient”, which is not supported by applicant’s specification. Examiner finds no support in the specification where it is explicitly excluding a therapy session. If anything, from applicant’s published paragraphs 3-7, it is trying to resolve cleaning issues related to a therapy session. Dependent claims inherit these issues through their dependence without providing any remedy.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4,7-13, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over by Wilkins (US 20210338967 A1.), and in view of Smith (US 20110232645 A1.).
As per claim 1, Wilkins teaches
A method (abstract, para 19) of identifying a patient interface device to be used in a pressure support system using a mask cleaning system structured and configured to clean the patient interface device, the mask cleaning system having a holding chamber (para 64, Fig. 4, #402 sanitizing chamber teaches a holding chamber), a sensor adapted to provide a sensor measurement indicative of a physical condition in the holding chambers (para 42, one or more sensors 124 configured to monitor the characteristics of the self-sanitizing pap system 100 and chamber 402) and a controller ( para 67,Fig. 5, #120, a controller), the method comprising:
(a) placing the patient interface device into the holding chamber (para 67, Fig. 5, the patient interface device PAP 112 is placed inside the holding chamber 402);
(b) operating the mask cleaning system during a cleaning period to clean the patient interface device while the patient interface device remains in the holding chamber (para 41, “controller 120 and/or user interface 122 may include a timer that monitors the length of performance of a PAP and/or sanitization operation” , also see Fig. 4 and Fig 5, the holding chamber 402 holds the patient interface device PAP 112)
(b) obtaining in the controller one or both of the following: (i) a value for each of a number of operational parameters of the mask cleaning system for the cleaning period (para 44, “regulate the flow rate and/or pressure of the airflow 202” “adjusting the voltage to the fluid transfer device”), and (ii) the sensor measurement for the cleaning period (para 42, “a sensor configured to detect the pressure of the air delivered to the user, the flow rate of the air delivered to the user, the humidity of the air delivered to the user, the amount of oxygen in the air delivered to the user, that status of an air filter, the level of water in a water reservoir, the status of the sanitizing system 106, the status of a sanitizing gas filter/converter, user's contact sensors,”; also see para 62-64 ); and
However, Wilkins does not teach
(c) determining an identity of or a change of the patient interface device in the controller, without using the patient interface device in a therapy session to treat a patient, by one or both of the following: (i) comparing the value for each of the number of operational parameters to operational parameter data stored by the controller, and (ii) comparing the sensor measurement to sensor data stored by the controller.
In the same field of endeavor, Smith teaches
(c) determining an identity of or a change of the patient interface device in the controller, without using the patient interface device in a therapy session to treat a patient, by one or both of the following: (i) comparing the value for each of the number of operational parameters to operational parameter data stored by the controller and (ii) comparing the sensor measurement to sensor data stored by the controller (Smith, para 40, Fig. 5, teaches identifying a patient interface apparatus 112 within a predefined category. At the step 162, the patient interface device 112 is coupled with a respiratory machine 110, and at step 164, the detection element detects whether a differentiating feature 106 of patient interface 104 is present. At step 166, the patient interface is synchronized to determine whether to deliver for the desired therapy. The detection element could be a sensor to measure the data for comparison. The patient interface apparatus is determined within a predefined category. Therefore, the value is determined based on comparison with the predefined category. Also see para 30 for controller 150).
Smith teaches a detection process for patient interface device 112 by coupling a mask to a respiration machine and detecting differentiation by a machine sensor. If the mask is not recognized, manual override is performed. If the mask is recognized, then it is being synchronized and operates the machine.
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 the teaching of Wilkins by adding the teaching of Smith into the system. This would have been obvious because both Wilkins and Smith teach a patient interface device. The combination of Wilkins and Smith will be able to detect the patient interface device and apply the appropriate mask to use (Smith, para 40, Fig.5).
As per claim 2, Wilkins teaches
The method according to claim 1, wherein the number of operational
parameters includes a run time of the mask cleaning system for the cleaning period (Wilkins, para 41, “a timer that monitors the length of performance of a PAP and/or sanitization operation”).
As per claim 3, Wilkins teaches
The method according to claim 1, wherein the number of operational
parameters includes a level of power consumption of the mask cleaning system for the cleaning period (Wilkins, para 44, “e.g., by adjusting the voltage to the fluid transfer device 107 to change the speed of the fluid transfer device 107”.).
As per claim 4, Wilkins teaches
The method according to claim 1, wherein the number of operational
parameters includes a fluid pressure level or a fluid flow level of the mask cleaning system for the cleaning period (para 39, “e.g., but not limited to, air flow rates, pressures, delivery of supplemental oxygen, filtering, humidification, combinations thereof, and the like.”; para 44, “the controller 120 may regulate the flow rate and/or pressure of the airflow 202 by regulating the fluid transfer device 107”, para 50, “the sanitizing system 106 may be configured to selectively distribute the flow of sanitizing gas 302 based on one or parameters (e.g., but not limited to, user input, predefined or calculated schedules, selected events, input from sensor(s) 124, combinations thereof, and the like)”).
As per claim 7, Wilkins teaches
The method according to claim 1, wherein the number of operational
parameters includes a number of operational settings of the mask cleaning system for the
cleaning period (para 50, “In some examples, the sanitizing system 106 may be configured to selectively distribute the flow of sanitizing gas 302 based on one or parameters (e.g., but not limited to, user input, predefined or calculated schedules, selected events, input from sensor(s) 124, combinations thereof, and the like).”).
As per claim 8, Wilkins teaches
The method according to claim 1, wherein the number of sensors
includes one or more of a pressure sensor, a flow sensor, a temperature sensor, a force
sensor, a liquid level sensor, a capacitive sensor and a magnetic sensor (para 42, “a sensor configured to detect the pressure of the air delivered to the user, the flow rate of the air delivered to the user, the humidity of the air delivered to the user, the amount of oxygen in the air delivered to the user, that status of an air filter, the level of water in a water reservoir, the status of the sanitizing system 106, the status of a sanitizing gas filter/converter, user's contact sensors,”).
As per claim 9, the combination of Wilkins and Smith teach
The method according to claim 1, wherein (b) comprises obtaining both
of: (i) the value for each of the number of operational parameters of the mask cleaning
system for the cleaning period (Wilkins, para 44, “regulate the flow rate and/or pressure of the airflow 202” “adjusting the voltage to the fluid transfer device”), and (ii) the sensor measurement for each of the number of sensors of the mask cleaning system for the cleaning period (Wilkins, para 42, “a sensor configured to detect the pressure of the air delivered to the user, the flow rate of the air delivered to the user, the humidity of the air delivered to the user, the amount of oxygen in the air delivered to the user, that status of an air filter, the level of water in a water reservoir, the status of the sanitizing system 106, the status of a sanitizing gas filter/converter, user's contact sensors,”; also see para 62-64 ), and wherein (c) comprises determining the identity of or the suspected change of the patient interface device by both of: (i) comparing the value for each of the number of operational parameters to operational parameter data stored by the controller (Smith, para 30 , the detection element or sensor 112 of the of the ventilator 110 communicate with the controller 150 and evaluate the compatibility of the patient interface apparatus 112 with a predetermined category, the predetermined category teaches stored data) , and (ii) comparing the sensor measurement for each of the number of sensors to sensor data stored by the controller (Smith, para 40, Fig. 5, teaches identifying a patient interface apparatus 112 within a predefined category. At the step 162, the patient interface device 112 is coupled with a respiratory machine 110, and at step 164, the detection element detects whether a differentiating feature 106 of patient interface 104 is present. At step 166, the patient interface is synchronized to determine whether to deliver for the desired therapy. The detection element could be a sensor to measure the data for comparison. The patient interface apparatus is determined within a predefined category. Therefore, the value is determined based on comparison with the predefined category. Also see para 30 for controller 150).
As per claim 10, Wilkins teaches
A mask cleaning system structured and configured to clean a patient interface device to be used in a pressure support system, comprising:
a main chamber for holding the patient interface device while operating the mask cleaning system during a cleaning period to clean the patient interface device (Please refer to the analysis of claim 1 above); and
a controller structured and configured for:
(a) obtaining one or both of the following: (i) a value for each of a number of operational parameters of the mask cleaning system for the cleaning period ((Please refer to the analysis of claim 1)), and (ii) a sensor measurement for each of a number of sensors of the mask cleaning system for the cleaning period ((Please refer to the analysis of claim 1 above); and
(b) determining an identity of or a change of the patient interface device, without using the patient interface device in a therapy session to treat a patient, by one or both of the following: (i) comparing the value for each of the number of operational parameters to operational parameter data stored by the controller (Please refer to the analysis of claim 1 above), and (ii) comparing the sensor measurement for each of the number of sensors to sensor data stored by the controller.
As per claim 11, please refer to the analysis of claim 2 above, as they recite the same limitations.
As per claim 12, please refer to the analysis of claim 3 above, as they recite the same limitations.
As per claim 13, please refer to the analysis of claim 4 above, as they recite the same limitations.
As per claim 16, please refer to the analysis of claim 7 above, as they recite the same limitations.
As per claim 17, please refer to the analysis of claim 8 above, as they recite the same limitations.
As per claim 18, please refer to the analysis of claim 9 above, as they recite the same limitations.
Claims 5,6,14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over by Wilkins (US 20210338967 A1.), in view of Smith (US 20110232645 A1.), and further in view of Parrish (US 20180028770 A1.).
As per claim 5, The combination of Wilkins and Smith. teach
The method of claim 1(abstract, para 19)
However, the combination of Wilkins and Smith do not teach
wherein the number of operational parameters includes a temperature level of the mask cleaning system for the cleaning period.
In the same field of endeavor Parrish teaches
wherein the number of operational parameters includes a temperature level of the mask cleaning system for the cleaning period (a self-cleaning pap mask machine {Abstract} temperature is adjusted {in para 250 & 63}, Parrish).
Parrish teaches a self-cleaning pap mask machine that uses a water heater to heat up and steam the hose and mask for better cleaning. The heater also includes the feature for humidity and temperature adjustment, (Parrish, para 63, para 250).
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 the combined teaching of Wilkins and Smith to include the mask cleaning system with temperature level taught by Parrish. This would have been obvious because the combination of Wilkins, Smith and Parrish teach a patient interface device that use mask cleaning system. The temperature adjustment feature of the heating system will enhance overall mask cleaning system of the patient interface device (Parrish, abstract, para 63, para 250).
As per claim 6, Wilkins Teaches
The method according to claim 1(Wilkins, abstract, para 19)
However, Wilkins does not teach
wherein the number of operational parameters includes an amount of heat used by the mask cleaning system for the cleaning period
In the same field of endeavor Parrish teaches,
wherein the number of operational parameters includes an amount of heat used by the mask cleaning system for the cleaning period (Parrish, a self-cleaning pap mask machine {Abstract} heat is used to adjust temperature {in para 250 & 63}).
Parrish teaches a ceramic heating unit 21 to heat water to steam, and the unit also provides adjustment for humidity and temperature during the mask cleaning, so it knows the amount of heat being used (Parrish, para 250).
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 the combined teaching of Wilkins and Smith and to include the ceramic heating unit taught by Parrish. This would have been obvious because the combination of Wilkins, Smith and Parrish teach a patient interface device that uses mask cleaning system. The temperature and humidity adjustment feature of the heating system will control the amount of heat being used and will enhance overall mask cleaning system of the patient interface device (Parrish, abstract, para 63, para 250).
As per claim 14, please refer to the analysis of claim 5 above, as they recite the same limitations.
As per claim 15, please refer to the analysis of claim 6 above, as they recite the same limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please refer to the form 892.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rokeya Alam whose telephone number is (571) 272-0083. The examiner can normally be reached between 7:30am - 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Scott Baderman can be reached at telephone number (571-272-3644). The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ROKEYA SHAWALI ALAM/Examiner, Art Unit 2118
/SCOTT T BADERMAN/Supervisory Patent Examiner, Art Unit 2118
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