Prosecution Insights
Last updated: April 19, 2026
Application No. 18/028,337

SYSTEMS AND METHODS FOR DIAGNOSING OPERATIONAL ISSUES IN A RESPIRATORY SYSTEM

Non-Final OA §101§103
Filed
Mar 24, 2023
Examiner
PATEL, ROHAN DEEP
Art Unit
3785
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
ResMed
OA Round
1 (Non-Final)
57%
Grant Probability
Moderate
1-2
OA Rounds
3y 7m
To Grant
99%
With Interview

Examiner Intelligence

Grants 57% of resolved cases
57%
Career Allow Rate
12 granted / 21 resolved
-12.9% vs TC avg
Strong +45% interview lift
Without
With
+45.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
49 currently pending
Career history
70
Total Applications
across all art units

Statute-Specific Performance

§101
4.8%
-35.2% vs TC avg
§103
55.4%
+15.4% vs TC avg
§102
22.3%
-17.7% vs TC avg
§112
16.4%
-23.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 21 resolved cases

Office Action

§101 §103
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. Information Disclosure Statement The information disclosure statement (IDS) submitted on 04/05/2023 has been considered by the examiner. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1, 4, 7, 10, 12, 15, 21, 23, 25-27, 30-31, 37, 40-42, 44, 46, and 48 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. With respect to step 1 , claims 1, 4, 7, 10, 12, 15, 21, 23, 25-27, 30-31, 37, 40-42, 44, 46, and 48 are all within at least one of the four categories of invention. More specifically, claims 1, 4, 7, 10, 12, 15, 21, 23, 25-27, 30-31, 37, 40-42, and 44 are directed to a method, claim 4 6 is directed to a system, and claim 4 8 is directed towards a non-transitory computer readable storage medium . In accordance with MPEP 2106.04, each of claims 1, 4, 7, 10, 12, 15, 21, 23, 25-27, 30-31, 37, 40-42, 44, 46, and 48 has been analyzed to determine whether it is directed to any judicial exceptions. Step 2A, Prong 1 per MPEP 2106.04(a) Each of claims 1, 4, 7, 10, 12, 15, 21, 23, 25-27, 30-31, 37, 40-42, 44, 46, and 4 8 recites at least one step or instruction for identifying the location and/or cause of an operational issue within the device , which is grouped as a mental process in MPEP 2106.04(a)(2)(III). The claimed limitations involve concepts performed in the human mind, namely observation, evaluation, and judgement, which are mental processes in MPEP 2106.04(a)(2)(III). Accordingly, each of claims 1, 4, 7, 10, 12, 15, 21, 23, 25-27, 30-31, 37, 40-42, 44, 46, and 48 recites an abstract idea. Specifically, independent claim 1 recites: A method for diagnosing an operational issue in a respiratory therapy system, comprising: receiving, via an external device, a command to begin diagnosing the operational issue in the respiratory therapy system ( observation , which is grouped as a mental process in MPEP 2106.04(a)(2)(III)) ; causing one or more sensors of the external device to generate acoustic data and image data, the acoustic data being indicative of one or more sounds emanating from the respiratory therapy system, and the image data being reproducible as one or more images; and analyzing at least a portion of the generated acoustic data and the image data to identify (i) a location of the operational issue in the respiratory therapy system, (ii) one or more causes of the operational issue in the respiratory therapy system, or (iii) both (i) and (ii) (judgement or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)) . Independent claim 46 recites: A system comprising: a control system including one or more processors; and a memory having stored thereon machine readable instructions; wherein the control system is coupled to the memory, and the one or more processors are configured to execute the machine readable instructions to: receive, via an external device, a command to begin diagnosing an operational issue in a respiratory therapy system ( observation , which is grouped as a mental process in MPEP 2106.04(a)(2)(III)) ; cause one or more sensors of the external device to generate acoustic data and image data, the acoustic data being indicative of one or more sounds emanating from the respiratory therapy system, and the image data being reproducible as one or more images; and analyze at least a portion of the generated acoustic data and the image data to identify (i) a location of the operational issue in the respiratory therapy system, (ii) one or more causes of the operational issue in the respiratory therapy system, or (iii) both (i) and (ii) (judgement or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)) . Independent claim 4 8 recites: A non-transitory computer readable storage medium storing machine readable instructions that, when executed by one or more processors of a control system, cause the one or more processors to: receive, via an external device, a command to begin diagnosing an operational issue in a respiratory therapy system ( observation , which is grouped as a mental process in MPEP 2106.04(a)(2)(III)) ; cause one or more sensors of the external device to generate acoustic data and image data, the acoustic data being indicative of one or more sounds emanating from the respiratory therapy system, and the image data being reproducible as one or more images; and analyze at least a portion of the generated acoustic data and the image data to identify (i) a location of the operational issue in the respiratory therapy system, (ii) one or more causes of the operational issue in the respiratory therapy system, or (iii) both (i) and (ii) (judgement or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)) . Further, dependent claims 4, 7, 10, 12, 15, 21, 23, 25-27, 30-31, 37, 40-42, and 44 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed. Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a). Step 2A, Prong 2 per MPEP 2106.04(d) The above-identified abstract idea in each of independent claims 1, 46, and 48 (and their respective dependent claims 4 , 7, 10, 12, 15, 21, 23, 25-27, 30-31, 37, 40-42, and 44 ) are not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in bold in independent claims 1, 46, and 48) either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h). Further, the additional elements of: a respiratory therapy system , an external device, and at least one or more sensors as recited in claim 26 and their respective dependent claims , a control system, one or more processors, a memory, a respiratory therapy system , an external device, and at least one or more sensors as recited in claim 4 6 , and a non-transitory computer readable storage medium storing machine , a control system, one or more processors, a respiratory therapy system , an external device, and at least one or more sensors as recited in claim 48 are generically recited elements which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea s identified above in independent claims 1, 46, and 48 (and their respective dependent claims) are not integrated into a practical application in accordance with MPEP 2106.04(d). Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., at least one processor as recited in claims 46 and 48 ). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. V. DirecTV, LLC , the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claims 1, 46, and 48 (and their respective dependent claims) are not integrated into a practical application under MPEP 2106.04(d)(I). Accordingly, independent claims 1, 46, and 48 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d). Step 2B per MPEP 2106.05 None of claims 1, 46, and 48 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons. These claims require the additional elements of: a respiratory therapy system , an external device, and at least one or more sensors as recited in claim 26 and its respective dependent claims , a control system, one or more processors, a memory, a respiratory therapy system , an external device, and at least one or more sensors as recited in claim 46 , and a non-transitory computer readable storage medium storing machine , a control system, one or more processors, a respiratory therapy system , an external device, and at least one or more sensors as recited in claim 48. The above-identified additional elements are generically claimed components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am. , Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs. , 788 F.3d at 1363, 115 USPQ2d at 1092-93. Further, the above-identified additional element of a r espiratory therapy system does no more than generally link the use of the above-identified abstract idea(s) to a particular technological environment or field of use as described in MPEP 2106.05(h). Per Applicant’s specification, the control system, one or more processors, a memory, a respiratory therapy system, an external device, and at least one or more sensors are generic devices that are “ apparent to those of skill in the art how the several forms of the present invention may be embodied in practice ”, as the respiratory therapy system is described simply as a generic respiratory therapy device (0034) , the control system is depicted as a general control system containing processors (0029), the external device is depicted as a general device with wired or wireless communication (0033) , and the at least one or more sensors is depicted as generic sensor devices (0039) . Additionally, Applicant’s specification does not provide structure or detailed drawing of the control system, one or more processors, a memory, a respiratory therapy system, an external device, and at least one or more sensors . These units are only depicted schematically in Fig. 1. Per Applicant’s disclosure, it is demonstrated that such components are routine and conventional devices. Accordingly, in light of Applicant’s specification, the claimed terms the ventilator, control unit , and usage clock are reasonably construed as generic devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f). Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the control system, one or more processors, a memory, a respiratory therapy system, an external device, and at least one or more sensors . This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer and ventilation arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activities’ previously known to the industry” will not make claims patent-eligible ( TLI Communications along with MPEP 2106.05(d)(I)). The recitation of the above-identified additional limitations in claims 1, 4, 7, 10, 12, 15, 21, 23, 25-27, 30-31, 37, 40-42, 44, 46, and 48 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV , 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC , 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer. A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc. , 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp. , 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. For at least the above reasons, the devices and process of claims 1, 4, 7, 10, 12, 15, 21, 23, 25-27, 30-31, 37, 40-42, 44, 46, and 48 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent claims 1, 46, and 48 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05. Therefore, for at least the above reasons, none of the claims 1, 4, 7, 10, 12, 15, 21, 23, 25-27, 30-31, 37, 40-42, 44, 46, and 48 amounts to significantly more than the abstract idea itself. Accordingly, claims 1, 4, 7, 10, 12, 15, 21, 23, 25-27, 30-31, 37, 40-42, 44, 46, and 48 are not patent eligible and rejected under 35 U.S.C. 101. 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. 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. Claim s 1, 4, 7, 10, 12, 15, 21, 23, 25-27, 37, 40-42, 44, 46, and 48 rejected under 35 U.S.C. 103 as being unpatentable over Holley et al. EP 2,396,062, in view of Truschel et al. 2020/0046924 Regarding claim 1, Holley teaches a method for diagnosing an operational issue in a respiratory therapy system (abstract states “detection of obstruction”) , comprising: receiving, via an external device (0064 states “the obstruction detection apparatus 102 may serve as a detector that is used with, but structurally independent of, a respiratory treatment apparatus”) , a command to begin diagnosing the operational issue in the respiratory therapy system (0061 states “ o f the detector such as to initiate a pre-measuring process, select premeasured tube data, initiate an obstruction measuring process, etc. may be performed in conjunction with a user interface such as input switches that operate the controller or processor of the detection apparatus.”) ; causing one or more sensors of the external device to generate acoustic data (0066 states “The device may also include a sensor or data interface 1214, such as a bus, for receiving/transmitting data such as programming instructions, settings data, sound data, microphone sound samples, acoustic measurement data, obstruction information, etc.”) , the acoustic data being indicative of one or more sounds emanating from the respiratory therapy system (0014 states “a respiratory treatment conduit obstruction by determining with a sound sensor a measure of sound of a flow generator within a respiratory treatment conduit, such as an endotracheal tube. The measure of sound is then be analyzed with a processor. The processor then indicates a presence or absence of obstruction in the respiratory treatment conduit based on the analyzing.”) ; and analyzing at least a portion of the generated acoustic data to identify (i) a location of the operational issue in the respiratory therapy system (0016 states “a location and extent of the presence of obstruction based on data of the difference calculating may be determined”) , ( ii) one or more causes of the operational issue in the respiratory therapy system (0014 states “The processor then indicates a presence or absence of obstruction in the respiratory treatment conduit based on the analyzing.”) , or (iii) both (i) and (ii). Holley fails to teach a generation of image data with the image data being reproducible as one or more images, and analyzing at least a portion of the image data to identify (i) a location of the operational issue in the respiratory therapy system, (ii) one or more causes of the operational issue in the respiratory therapy system, or (iii) both (i) and (ii). Truschel teaches an analogous ventilation imaging and diagnostic system that does teach a generation of image data and the image data being reproducible as one or more images (0033 states “The camera 14 can comprise any suitable camera configured to capture images of at least two or more of (i) the ventilator source 12, (ii) one or more component of the first plurality of ventilation components in the ventilation circuit 34, and (iii) the patient 40”), and analyzing at least a portion of the image data (0012 states “the method further comprises analyzing, via the component recognition and identification module, at least one captured image to recognize or identify at least two or more of (i) the ventilator source, (ii) one or more component of the first plurality of ventilator components, and (iii) one or more characteristic of the patient”) to identify (i) a location of the operational issue in the respiratory therapy system, (ii) one or more causes of the operational issue in the respiratory therapy system (0005 states “the controller includes at least (i) a control module, (ii) a component recognition and identification module, (iii) a component tracking module configured to track targets within a plurality of real-time images captured via the camera and to detect at least one change in tracked targets, and (iv) a ventilation compensation module. The control module is configured to control an operation of the ventilator source with operating parameters determined as a function of at least (i) a gas composition algorithm, (ii) an output of the component recognition and identification module, and (iii) an output of the ventilation compensation module determined as a function of an output of the component tracking module, wherein responsive to the operating parameters, the ventilator source outputs the ventilation gas with one or more ventilation properties.”), or (iii) both (i) and (ii). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the external device of Holley with the teachings of Truschel and include a generation and analyzing of image data to diagnose issues with the respiratory therapy system as this allows for the use of image recognition software to adjust the operating status of the ventilator based on component identification tags (0016 and 0032). Further motivation is found in Chamtie WO 2019/006496, which discloses a similar acoustic measurement system, however the external device conducting acoustic receiving is mentioned as being a smartphone (0151) . Since smartphones contain cameras, a modification of the concept of image tracking as taught by Truschel can be implemented into an external acoustic receiving system, such as the one taught by Holley, to allow for further diagnostic capabilities. Regarding claim 4, Holley teaches the method of claim 1, wherein the analyzing the at least the portion of the generated acoustic data includes identifying one or more components of the respiratory therapy system that are associated with the operational issue (0078 states “The present technology may provide improvements to known apparatus to facilitate the coordination between the flow generator and the peripheral components based on acoustic detection to distinguish or identify particular components.”). Regarding claim 7, Holley teaches t he method claim1, wherein the one or more sensors of the external device further include (i) a microphone configured to generate or detect at least a portion of the acoustic data (0016 states “According to the invention the sound source that generates the sound within the respiratory treatment conduit is a flow generator. Still further, the sound sensor may be a single microphone.”) , (ii) a speaker configured to generate or emit sound waves, where the microphone is further configured to detect reflections of the generated or emitted sound waves from the speaker (0142 states “, in some examples, a speaker or horn driver may be implemented in the conduit to generate the sound impulse that is recorded by the sound sensor.”) , or (iii) a combination thereof. Regarding claim 10, modified Holley teaches the method of claim 1, further comprising: analyzing at least a portion of the generated image data to confirm (i) the identified location of the operational issue in the respiratory therapy system, (ii) the identified one or more causes of the operational issue in the respiratory therapy system (0007 of Truschel states “ In addition, the component tracking module is further configured to detect at least one change in the one or more interrelationship, connection, or physical condition of the tracked targets. Furthermore, the output of the component tracking module includes data indicative of the at least one detected change in the one or more interrelationship, connection, or physical condition of the tracked targets. ”) , or (iii) both (i) and (ii). Regarding claim 12, modified Holley teaches the method of claim 1, further comprising: scanning, via a camera of the external device, one or more identifiers of the respiratory therapy system (0017 of Truschel states “ Packaged ventilation circuit items may also be held near the camera for scanning of the ventilation components and/or patient interface manufacturers' bar codes before placing a respective component into the ventilation circuit to pre-load the image recognition/processing algorithm with the scanned components. ”) . Regarding claim 15, modified Holley teaches the method of claim 12, wherein the one or more identifiers are associated with one or more components of the respiratory therapy system, and wherein the one or more components of the respiratory therapy system includes a respiratory therapy device (apparatus 10 of Truschel ) , a user interface (user interface 18) , a conduit (36) , a display device (interface 18) , a humidifier, one or more sensors of the respiratory therapy system (sensors 46) , or any combination thereof. Regarding claim 21, Holley teaches the method of claim 1, wherein the analyzing the at least the portion of the generated acoustic data is based, at least in part, on a fast Fourier transform (FFT) analysis, a short time Fourier transform (STFT) analysis, a spectral analysis, a Cepstrum analysis, an autocepstrum analysis, an auto-correlation analysis, or any combination thereof (0015 and 0018 discuss the use of a Fourier transform and cepstrum as methods of analyzing the acoustic data.). Regarding claim 23, Holley teaches the method of claim 1, wherein the analyzing the at least the portion of the generated acoustic data includes identifying a plurality of features for the at least the portion of the generated acoustic data (0015 states “he analyzing may also involve calculating a difference between (a) the inverse transform of the logarithm of the transformed data samples representing the measure of sound and (b) an inverse transform of a logarithm of Fourier transformed data samples representing a sound measured from an unobstructed version of the respiratory treatment conduit.”) . Regarding claim 25, Holley teaches the method of claim 1, further comprising: responsive to the identified one or more causes of the operational issue in the respiratory therapy system, adjusting one or more settings of the respiratory therapy system (0067 states “At 1224, these may also include stored processor control instructions for flow generator control, such as respiratory treatment control based on feedback processing and measuring process settings adjustment, etc.”). Regarding claim 26, Holley teaches the method of claim 25, wherein the adjusting one or more settings of the respiratory therapy system includes (i) preventing the respiratory therapy system from turning on, (ii) preventing one or more components of the respiratory therapy system from turning on (Paragraph 0116 states “ operations may be permitted or prevented by sending an enable or disable signal(s) from the authorization controller 19-106 to another controller of the device. ”) or (iii) both (i) and (ii). Regarding claim 27, Holley teaches the method of claim 1, further comprising: responsive to the analyzing the at least the portion of the generated acoustic data, causing a notification to be provided, via the external device, to a user of the respiratory therapy system (0061 states “The detector may even trigger a warning message and/or alarm in the event of the detection of a substantial obstruction, such that it may recommend or warn of the need of replacement or cleaning of a current endotracheal tube in use”). Regarding claim 37, Holley teaches the method of claim 1, further comprising: receiving, from an internal microphone of the respiratory therapy system, acoustic data associated with a user of the respiratory therapy system during a respiratory therapy session; and differentiating the acoustic data generated by the one or more sensors of the external device from the acoustic data received from the internal microphone of the respiratory therapy system to exclude sounds of a user undergoing the respiratory therapy session (0076 states “ In some embodiments, the frequency domain may be processed to isolate or emphasize data of interest in detecting a particular condition or system accessory. For example, the process may involve filtering with respect to particular frequencies (e.g., low pass, high pass, band pass, etc.). In this regard, it may be useful to include or exclude certain spectral components such as filtering out spectral components to exclude frequencies not particularly related to a detection of interest. For example, frequencies associated with snoring sounds or leak sounds may be filtered out to assist in mask detection or other patient condition detection. ”) . Regarding claim 40, Holley teaches the method of claim 1, further comprising: receiving, from an internal microphone of the respiratory therapy system, internal acoustic data associated with a user of the respiratory therapy system (0106 states “ some embodiments may also detect and measure the reflections or echoes returned from the patient's own respiratory system that is connected to the patient interface. For example, the embodied systems, methods, and devices may detect and identify the state, and conditioning of the patient's respiratory system or even an identity thereof for authentication purpose ”) . Regarding claim 41, Holley teaches the method of claim 40, further comprising: analyzing at least a portion of the received internal acoustic data to confirm (i) the identified location of the operational issue in the respiratory therapy system (0107 states “ the present technology may permit an apparatus to discern the location of a leak in addition to whether a leak has occurred. ”) , (ii) the identified one or more causes of the operational issue in the respiratory therapy system (0106 states “ the apparatus may be implemented to detect the diameter of airways of a patient at any given point or points. Using the same or similar technique as previously discussed, closed airways or increased resistance in the patient's airways may be detected. Furthermore, the embodiments may also be able to detect whether the patient's mouth is open during CPAP treatment. ”) , or (iii) both (i) and (ii). Regarding claim 42, Holley teaches the method of claim 40, wherein the internal acoustic data associated with the user of the respiratory therapy system is received from the internal microphone in response to analyzing the acoustic data generated by the one or more sensors of the external device (0106 states “ some embodiments may also detect and measure the reflections or echoes returned from the patient's own respiratory system that is connected to the patient interface. For example, the embodied systems, methods, and devices may detect and identify the state, and conditioning of the patient's respiratory system or even an identity thereof for authentication purpose ”) , and the command to begin diagnosing the operational issue in the respiratory therapy system is generated in response to analyzing at least a portion of the received internal acoustic data (0107 states “ the leak may be identified and/or quantified by examination of cepstrum data such as comparing known stored cepstrum data representative of a leak to a current test cepstrum data. Once the leak is identified from the cepstrum data, the location (e.g., based on the timing of the leak related data in the cepstrum data) may be detected and a suitable response by the device may be made. ”). Regarding claim 44, Holley teaches the method of claim 1, further comprising receiving, via the external device, user input associated with the respiratory therapy system, wherein (i) the location of the operational issue in the respiratory therapy system, (ii) the one or more causes of the operational issue in the respiratory therapy system, or (iii) both (i) and (ii) are identified based at least in part on the received user input (0066 states “ A user control/input interface 1212, for example, for a keyboard, touch panel, control buttons, mouse etc. may also be included as previously discussed and for inputting data, or otherwise activating or operating the methodologies described herein ”. This is stating the use of user input to operate the device and activate the methods that have already been described (0014, 0016, 0106, 0107) of locating and identifying the operational issues.) . Regarding claim 46, Holley teaches a system comprising: a control system including one or more processors (0019 states “ The apparatus may also include a controller or processor configured to analyze data samples of the measure of sound from the microphone by calculation of a cepstrum with the data samples of the measure of sound. ”) ; and a memory having stored thereon machine readable instructions; wherein the control system is coupled to the memory, and the one or more processors are configured to execute the machine readable instructions (0046 states “ Thus, the controller may include integrated chips, a memory and/or other control instruction, data or information storage medium. For example, programmed instructions encompassing such a detection methodology may be coded on integrated chips in the memory of the device. Such instructions may also or alternatively be loaded as software or firmware using an appropriate data storage medium. With such a controller or processor, the device can be used for determining and analyzing sound data from the sound sensor. Thus, the processor may control the assessment of obstruction as described in the embodiments discussed in more detail herein. ”) ; to: receive, via an external device (0064 states “the obstruction detection apparatus 102 may serve as a detector that is used with, but structurally independent of, a respiratory treatment apparatus”) , a command to begin diagnosing an operational issue in a respiratory therapy system (0061 states “ o f the detector such as to initiate a pre-measuring process, select premeasured tube data, initiate an obstruction measuring process, etc. may be performed in conjunction with a user interface such as input switches that operate the controller or processor of the detection apparatus.”) ; cause one or more sensors of the external device to generate acoustic data (0066 states “The device may also include a sensor or data interface 1214, such as a bus, for receiving/transmitting data such as programming instructions, settings data, sound data, microphone sound samples, acoustic measurement data, obstruction information, etc.”) , the acoustic data being indicative of one or more sounds emanating from the respiratory therapy system ( 0014 states “a respiratory treatment conduit obstruction by determining with a sound sensor a measure of sound of a flow generator within a respiratory treatment conduit, such as an endotracheal tube. The measure of sound is then be analyzed with a processor. The processor then indicates a presence or absence of obstruction in the respiratory treatment conduit based on the analyzing.”) ; and analyzing at least a portion of the generated acoustic data to identify (i) a location of the operational issue in the respiratory therapy system (0016 states “a location and extent of the presence of obstruction based on data of the difference calculating may be determined”), ( ii) one or more causes of the operational issue in the respiratory therapy system (0014 states “The processor then indicates a presence or absence of obstruction in the respiratory treatment conduit based on the analyzing.”), or (iii) both (i) and (ii). Holley fails to teach one or more sensors generating image data with the image data being reproducible as one or more images, and analyzing at least a portion of the image data to identify (i) a location of the operational issue in the respiratory therapy system, (ii) one or more causes of the operational issue in the respiratory therapy system, or (iii) both (i) and (ii). Truschel does teach causing one or more sensors of the external device to generate acoustic data and image data and the image data being reproducible as one or more images (0033 states “The camera 14 can comprise any suitable camera configured to capture images of at least two or more of (i) the ventilator source 12, (ii) one or more component of the first plurality of ventilation components in the ventilation circuit 34, and (iii) the patient 40”) ; and analyzing at least a portion of the image data (0012 states “the method further comprises analyzing, via the component recognition and identification module, at least one captured image to recognize or identify at least two or more of (i) the ventilator source, (ii) one or more component of the first plurality of ventilator components, and (iii) one or more characteristic of the patient”) to identify (i) a location of the operational issue in the respiratory therapy system, (ii) one or more causes of the operational issue in the respiratory therapy system ( 0005 states “the controller includes at least (i) a control module, (ii) a component recognition and identification module, (iii) a component tracking module configured to track targets within a plurality of real-time images captured via the camera and to detect at least one change in tracked targets, and (iv) a ventilation compensation module. The control module is configured to control an operation of the ventilator source with operating parameters determined as a function of at least (i) a gas composition algorithm, (ii) an output of the component recognition and identification module, and (iii) an output of the ventilation compensation module determined as a function of an output of the component tracking module, wherein responsive to the operating parameters, the ventilator source outputs the ventilation gas with one or more ventilation properties.”), or (iii) both (i) and (ii). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the external device of Holley with the teachings of Truschel and include a generation and analyzing of image data to diagnose issues with the respiratory therapy system as this allows for the use of image recognition software to adjust the operating status of the ventilator based on component identification tags (0016 and 0032). Further motivation is found in Chamtie WO 2019/006496, which discloses a similar acoustic measurement system, however the external device conducting acoustic receiving is mentioned as being a smartphone (0151). Since smartphones contain cameras, a modification of the concept of image tracking as taught by Truschel can be implemented into an external acoustic receiving system, such as the one taught by Holley, to allow for further diagnostic capabilities. Regarding claim 48, Holley teaches a non-transitory computer readable storage medium storing machine readable instructions that, when executed by one or more processors of a control system (0019 states “ The apparatus may also include a controller or processor configured to analyze data samples of the measure of sound from the microphone by calculation of a cepstrum with the data samples of the measure of sound. ”) , cause the one or more processors to: receive, via an external device (0064 states “the obstruction detection apparatus 102 may serve as a detector that is used with, but structurally independent of, a respiratory treatment apparatus”) , a command to begin diagnosing an operational issue in a respiratory therapy system (0061 states “ o f the detector such as to initiate a pre-measuring process, select premeasured tube data, initiate an obstruction measuring process, etc. may be performed in conjunction with a user interface such as input switches that operate the controller or processor of the detection apparatus.”) ; cause one or more sensors of the external device to generate acoustic data ( 0066 states “The device may also include a sensor or data interface 1214, such as a bus, for receiving/transmitting data such as programming instructions, settings data, sound data, microphone sound samples, acoustic measurement data, obstruction information, etc.”) , the acoustic data being indicative of one or more sounds emanating from the respiratory therapy system ( 0014 states “a respiratory treatment conduit obstruction by determining with a sound sensor a measure of sound of a flow generator within a respiratory treatment conduit, such as an endotracheal tube. The measure of sound is then be analyzed with a processor. The processor then indicates a presence or absence of obstruction in the respiratory treatment conduit based on the analyzing.”) ; and analyzing at least a portion of the generated acoustic data to identify (i) a location of the operational issue in the respiratory therapy system (0016 states “a location and extent of the presence of obstruction based on data of the difference calculating may be determined”), ( ii) one or more causes of the operational issue in the respiratory therapy system (0014 states “The processor then indicates a presence or absence of obstruction in the respiratory treatment conduit based on the analyzing.”), or (iii) both (i) and (ii). Holley fails to teach one or more sensors generating image data with the image data being reproducible as one or more images, and analyzing at least a portion of the image data to identify (i) a location of the operational issue in the respiratory therapy system, (ii) one or more causes of the operational issue in the respiratory therapy system, or (iii) both (i) and (ii). Truschel does teach causing one or more sensors of the external device to generate acoustic data and image data and the image data being reproducible as one or more images (0033 states “The camera 14 can comprise any suitable camera configured to capture images of at least two or more of (i) the ventilator source 12, (ii) one or more component of the first plurality of ventilation components in the ventilation circuit 34, and (iii) the patient 40”) ; and analyzing at least a portion of the image data (0012 states “the method further comprises analyzing, via the component recognition and identification module, at least one captured image to recognize or identify at least two or more of (i) the ventilator source, (ii) one or more component of the first plurality of ventilator components, and (iii) one or more characteristic of the patient”) to identify (i) a location of the operational issue in the respiratory therapy system, (ii) one or more causes of the operational issue in the respiratory therapy system ( 0005 states “the controller includes at least (i) a control module, (ii) a component recognition and identification module, (iii) a component tracking module configured to track targets within a plurality of real-time images captured via the camera and to detect at least one change in tracked targets, and (iv) a ventilation compensation module. The control module is configured to control an operation of the ventilator source with operating parameters determined as a function of at least (i) a gas composition algorithm, (ii) an output of the component recognition and identification module, and (iii) an output of the ventilation compensation module determined as a function of an output of the component tracking module, wherein responsive to the operating parameters, the ventilator source outputs the ventilation gas with one or more ventilation properties.”), or (iii) both (i) and (ii). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the external device of Holley with the teachings of Truschel and include a generation and analyzing of image data to diagnose issues with the respiratory therapy system as this allows for the use of image recognition software to adjust the operating status of the ventilator based on component identification tags (0016 and 0032). Further motivation is found in Chamtie WO 2019/006496, which discloses a similar acoustic measurement system, however the external device conducting acoustic receiving is mentioned as being a smartphone (0151). Since smartphones contain cameras, a modification of the concept of image tracking as taught by Truschel can be implemented into an external acoustic receiving system, such as the one taught by Holley, to allow for further diagnostic capabilities. Claim s 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over modified Holley, in view of Anderson et al. 10,171,944 Regarding claim 30, modified Holley teaches the method of claim 27 , but fails to teach wherein the providing the notification is indicat
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Prosecution Timeline

Mar 24, 2023
Application Filed
Dec 18, 2025
Non-Final Rejection — §101, §103
Mar 25, 2026
Interview Requested
Mar 31, 2026
Examiner Interview Summary
Apr 06, 2026
Response Filed

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Prosecution Projections

1-2
Expected OA Rounds
57%
Grant Probability
99%
With Interview (+45.0%)
3y 7m
Median Time to Grant
Low
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