CTNF 18/544,578 CTNF 101330 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 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 Farlow et al. (US 20220347415 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 controller (Fig.5, para 67; patient interface device = PAP Mask 112; controller 120; mask cleaning system = sanitizing chamber) , the method comprising: (a) operating the mask cleaning system during a cleaning period to clean the patient interface device (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 ”); (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) a sensor measurement for each of a number of sensors of the mask cleaning system 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 ) . However, Wilkins does not teach (c) determining an identity of or suspected change of the patient interface device in the controller 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 for each of the number of sensors to sensor data stored by the controller. In the same field of endeavor, Farlow et al. teach (c) determining an identity of or suspected change of the patient interface device in the controller 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 for each of the number of sensors to sensor data stored by the controller (Farlow et al., Para 537, “Over time (e.g. after many cleanings), the vent may have a detectably different resistance to flow than an unused vent of the same type/configuration. When the patient replaces the patient interface or a patient interface component comprising a well-used vent after a first therapy session, the new vent of the patient interface in use during the next therapy session may have a detectably different resistance to flow than the older vent. The method 6010 may detect this difference (via a comparing process) in resistance to flow to determine that the patient interface or at least the vent has been replaced during therapy sessions.” Therefore, it is detecting comparing two flow rate with new flow rate to identify change of patient interface. Also see para 538.) . Farlow et al. teach that there is a need for such identification when it is used through many cleanings operation (Farlow et al., para 537) and the detection is based on detectable flow rate change. Wilkins teaches that the cleaning system has the sensors to detect the flow rate (Wilkins, para 42). Therefore, it would have been obvious to a person ordinary skilled in art, before the effective filing date of the claim invention, to modify the teaching of Wilkins by adding the teaching of Farlow et al. in to the interface device. This would have been obvious because both Wilkins and Farlow et al. teach a patient interface device that uses mask cleaning system. The combination of Wilkins and Farlow et al.’s teaching will improve the overall patient interface device. 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, the combination of Wilkins and Farlow et al. teach 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”. Adjusting the voltage consumption requires to know the value of voltage, Farlow et al., para 608, uses power output is used to determine the difference in resistance to flow, para 537, difference in resistance to flow is used for identification of patience interface) . 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 Farlow et al. 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 (Farlow et al., para 537-538, the method 6010 uses a detection method to determine any change of resistance to flow, and determines if a different vent has been used during the therapy session) , and (ii) comparing the sensor measurement for each of the number of sensors to sensor data stored by the controller (Farlow et al., para 537, “Over time (e.g. after many cleanings), the vent may have a detectably different resistance to flow than an unused vent of the same type/configuration. When the patient replaces the patient interface or a patient interface component comprising a well-used vent after a first therapy session, the new vent of the patient interface in use during the next therapy session may have a detectably different resistance to flow than the older vent. The method 6010 may detect this difference in resistance to flow to determine that the patient interface or at least the vent has been replaced during therapy sessions.” Therefore, it is detecting comparing two flow rate with new flow rate to identify change of patient interface. Also see para 538) . As per claim 10, the combination of Wilkins and Farlow et al. teach 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 (Wilkins, para 64, sanitizing chamber 402) 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: 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, and (ii) a sensor measurement for each of a number of sensors of the mask cleaning system for the cleaning period device ( please refer to the analysis of claim 1 above) ; and determining an identity of or suspected change of the patient interface device 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 for each of the number of sensors to sensor data stored by the controller device ( please refer to the analysis of claim 1 above) . As per claim 11, claim 11 has the same limitations as claim 2. Please refer to the analysis above. As per claim 12, claim 12 has the same limitations as claim 3. Please refer to the analysis above. As per claim 13, claim 13 has the same limitations as claim 4. Please refer to the analysis above. As per claim 16, claim 16 has the same limitations as claim 7. Please refer to the analysis above. As per claim 17, claim 17 has the same limitations as claim 8. Please refer to the analysis above. As per claim 18, claim 18 has the same limitations as claim 9. Please refer to the analysis above . 07-21-aia AIA Claim s 5,6,14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over by Wilkins (US 20210338967 A1.), and in view of Farlow et al. (US 20220347415 A1.), and further in view of Parrish (US 20180028770 A1.) . As per claim 5, Wilkins in view of Farlow et al. teach The method of claim 1 (abstract, para 19) However, the combination of Wilkins and Farlow et al. 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 ordinary skilled in art, before the effective filing date of the claimed invention, to modify the combined teaching of Wilkins and Farlow et al. to include the mask cleaning system with temperature level taught by Parrish. This would have been obvious because the combination of Wilkins, Farlow et al. 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 ordinary skilled in art, before the effective filing date of the claimed invention, to modify the combined teaching of Wilkins and Farlow et al. and to include the ceramic heating unit taught by Parrish. This would have been obvious because the combination of Wilkins, Farlow et al. and Parrish teach a patient interface device that use 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, claim 14 has the same limitations as claim 5. Please refer to the analysis above. As per claim 15, claim 15 has the same limitations as claim 6. Please refer to the analysis above Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please refer to the form PTO-892 Notice of References Cited . 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 on 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. Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form. /ROKEYA SHAWALI ALAM/Examiner, Art Unit 2118 /SCOTT T BADERMAN/Supervisory Patent Examiner, Art Unit 2118 Application/Control Number: 18/544,578 Page 2 Art Unit: 2118 Application/Control Number: 18/544,578 Page 3 Art Unit: 2118 Application/Control Number: 18/544,578 Page 4 Art Unit: 2118 Application/Control Number: 18/544,578 Page 5 Art Unit: 2118 Application/Control Number: 18/544,578 Page 6 Art Unit: 2118 Application/Control Number: 18/544,578 Page 7 Art Unit: 2118 Application/Control Number: 18/544,578 Page 8 Art Unit: 2118 Application/Control Number: 18/544,578 Page 9 Art Unit: 2118 Application/Control Number: 18/544,578 Page 10 Art Unit: 2118 Application/Control Number: 18/544,578 Page 11 Art Unit: 2118