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 Amendment
This Office Action is in response to the amendment filed on 01/14/2026. Claims 1, 67-69, and 72-74 are as currently amended. Claims 70-71 and 75-76 are as previously presented. Claims 2-66 are canceled. Claims 77-78 are withdrawn. Claim 79 is new. As such, claims 1 and 67-79 are pending in the instant application.
All objections presented in the Office Action mailed 10/20/2025 are withdrawn in light of the amendments.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 3: “the respiratory system” should read “the respiratory therapy system” for consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
Claims 1, 67-72, and 75-76 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of claims 1, 67-72, and 75-76 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of claims 1, 67-72, and 75-76 recite at least one step or instruction for observation, judgement, and evaluation, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. The claims involve receiving airflow data, analyzing said airflow data, determining a mouth leak status based on said analysis, and displaying a notification of said determined mouth leak status. Accordingly, each of claims 1, 67-72, and 75-76 recites an abstract idea.
Specifically, claim 1 recites,
A respiratory therapy system;
One or more processors;
A display device;
Receiving airflow data including pressure data and/or flow rate data (observation, judgement or evaluation, which is grouped as a mental process under the 2019 PEG);
analyzing the airflow data to identify one or more normalized features that distinguish mouth leak from (i) normal respiration during therapy and/or (ii) other types of unintentional leak, wherein the one or more normalized features includes one or both of a normalized ventilation with respect to a baseline ventilation and a normalized respiration rate with respect to a baseline respiration rate (observation, judgement or evaluation, which is grouped as a mental process under the 2019 PEG);
determining the mouth leak status (observation, judgement or evaluation, which is grouped as a mental process under the 2019 PEG);
providing a notification to the user, a physician, or a healthcare provider such that the user, physician, or healthcare provider is alerted of the mouth leak status (observation, judgement or evaluation, which is grouped as a mental process under the 2019 PEG).
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent claims 67-72 and 75-76 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 process steps are performed.
Step 2A, Prong 2
The above-identified abstract idea in each of independent claim 1 (and its respective dependent claims 67-72 and 75-76) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent claim 1), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: a respiratory therapy system, one or more processors, and a display device as recited in independent claim 1 and its dependent claims therein are generically recited computer elements in independent claim 1 (and its respective dependent claims 67-72 and 75-76) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation 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. 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. For at least these reasons, the abstract idea identified above in independent claim 1 (and its respective dependent claims 67-72 and 75-76) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g. one or more processors and a display device as claimed). 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. 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. 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 claim 1 (and its respective dependent claims 67-72 and 75-76) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent claim 1 (and its respective dependent claims 67-72 and 75-76) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of claims 1, 67-72, and 75-76 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of a respiratory therapy system, one or more processors, and a display device.
The above-identified additional elements are generically claimed computer 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, 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.
Per Applicant’s specification, “[t]he respiratory system 120 is generally used to treat individuals suffering from one or more sleep-related respiratory disorders” (see specification [0064]), “[t]he respiratory device 122 is generally used to generate pressurized air that is delivered to a user” (see specification [0065]), “[t]he processor 112 can be a general or special purpose processor or microprocessor” (see specification [0060]), “[t]he display device 128 is generally used to display image(s) including still images, video images, or both and/or information regarding the respiratory device 122” (see specification [0070]), and “[t]he display device 128 can be an LED display, an OLED display, an LCD display, or the like” (see specification [0071]).
Accordingly, in light of Applicant’s specification, the claimed terms a respiratory therapy system, one or more processors, and a display device are reasonably construed as a generic computing device. 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.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the processor. 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 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 Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in claims 1, 67-72, and 75-76 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 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. 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, 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 methods of claims 1, 67-72, and 75-76 are directed to applying an abstract idea (e.g., mental process or certain method of organizing human activity) on a general purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of claims 1, 67-72, and 75-76 provide 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.
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 claim 1 (and their dependent claims 67-72 and 75-76) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, 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. 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. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, 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. Thus, claims 1, 67-72, and 75-76 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the claims 1, 67-72, and 75-76 amount to significantly more than the abstract idea itself.
Accordingly, claims 1, 67-72, and 75-76 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 67-70, 73, and 79 are rejected under 35 U.S.C. 103 as being unpatentable over Aylsworth et al. (US 20100186741 A1; hereinafter “Aylsworth”) in view of Silver et al. (US 20190224434 A1; hereinafter “Silver”).
Regarding claim 1, Aylsworth discloses a method for determining a mouth leak status ([0032], lines 1-3) associated with a user of a respiratory therapy system ([0033], lines 2-3), the method comprising:
receiving, via one or more processors of the respiratory system during a therapy session (29; Fig. 3; [0010]-[0011]), airflow data associated with the user of the respiratory therapy system ([0036], lines 1-5; Fig. 4), the respiratory therapy system being configured to supply pressurized air to an airway of the user during the therapy session ([0036], lines 7-8), the airflow data associated with the user including pressure data and/or flow rate data ([0036], lines 1-3; Fig. 4);
analyzing, via the one or more processors ([0010]-[0011]), the airflow data associated with the user ([0038], lines 1-4, where the waveforms are airflow and pressure voltage waveforms);
based at least in part on the analysis of the airflow data associated with the user, determining, via the one or more processors ([0011]), the mouth leak status associated with the user ([0038], lines 1-4; [0038], lines 7-9), the mouth leak status being indicative of whether or not air is leaking from a mouth of the user ([0038], lines 9-11).
While Aylsworth further teaches analyzing the airflow data associated with the user ([0038], lines 1-4, where the waveforms are airflow and pressure voltage waveforms) such that a mouth leak can be distinguished from a nasal mask leak ([0038], lines 1-4; [0041], lines 6-9, where the mouth leak is distinguished from nasal mask leak by its comparably lower root mean squared voltage level of the waveforms, see Fig. 5), Aylsworth fails to explicitly disclose identifying one or more normalized features that distinguish mouth leak from (i) normal respiration during therapy and/or (ii) other types of unintentional leak, wherein the one or more normalized features includes one or both of a normalized ventilation with respect to a baseline ventilation and a normalized respiration rate with respect to a baseline respiration rate.
However, Silver teaches an analogous system for assisting patient airway management (Abstract) and detecting a leak ([0139], [0196]), where an alarm is generated and displayed on a display (596; Fig. 10A) in response to a detected leak ([0200]). Silver further teaches obtaining one or more baseline physiological values, such as a baseline airflow associated with the patient, where a deviation from the baseline includes a percentage difference between a current physiological value and the initial baseline ([0015]) to determine when a leak has occurred ([0102], [0139]-[0140], [0235], [0258]-[0261]).
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 method taught by Aylsworth such that a baseline for airflow data is obtained (Silver [0015]), such that the measured airflow data ([0038], lines 1-4) is can be normalized by comparison and determination of a difference between the measured airflow data and the baseline airflow (Silver [0015]) to improve accuracy of identifying when another type of unintentional leak has occurred (Silver [0102], [0139]-[0140], [0235], [0258]-[0261]; Aylsworth [0038], lines 1-4 and [0041], lines 6-9, where the mouth leak is distinguished from nasal mask leak by its comparably lower root mean squared voltage level of the waveforms, see Fig. 5). Additionally, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Aylsworth to include a display (Silver 596; Silver Fig. 10A) such that when an alarm is generated in response to a detected leak, the alarm is displayed on the display (Silver [0200]) to improve patient safety and care (Silver [0184] and [0195]-[0196]).
Regarding claim 67, Aylsworth as modified teaches the invention as set forth in claim 1, wherein the one or more normalized features (normalized airflow data, as taught by Silver, see claim 1 above) further include a covariance between leak and ventilation, a time the covariance holds above a threshold, an unintentional leak variability, a respiration rate variability (deviation between measured airflow data and baseline airflow is a percentage difference, see Silver [0015] and [0235]), or any combination thereof.
Regarding claim 68, Aylsworth as modified teaches the invention as set forth in claim 1, wherein the one or more normalized features (normalized airflow data, as taught by Silver, see claim 1 above) are computed on a user flow rate signal (Silver [0015]), a mask pressure signal, a blower flow rate signal, a blower pressure signal, or any combination thereof, wherein the one or more normalized features (normalized airflow data, as taught by Silver, see claim 1 above) include, for each signal, (i) a frame area (flow rate range of patient breathing depicted by range of line 52 in Fig. 5), (ii) a breath area, (iii) a complement to the breath area, (iv) a ratio of the breath area over the frame area, (v) a ratio of the breath area over the complement to the breath area, (vi) a skewness of the signal, (vii) a kurtosis of the signal, (viii) a first derivative of the skewness, (ix) a first derivative of the kurtosis, (x) a second derivative of the skewness, (xi) a second derivative of the kurtosis, or (xii) any combination thereof.
Regarding claim 69, Aylsworth as modified teaches the invention as set forth in claim 1, wherein the one or more normalized features (normalized airflow data, as taught by Silver, see claim 1 above) are associated with a first breath (sections 40 and 43 of Fig. 4, where the airflow voltage waveform depicts patient breathing, where patient breathing is normal and the patient’s mouth is closed for the duration of sections 40 and 43; [0036], lines 6-8 & lines 13-14), the method further comprising identifying, within the received airflow data associated with the user (patient breathing circuit pressure waveform and patient breathing waveform; [0036], lines 1-3; Fig. 4), the first breath of the user ([0036], lines 18-19, where the beginning of the first breath of section 43 is identified signifying the end a period of normal breathing with the mouth open, sections 41 and 42, and the beginning of a period of normal breathing with the mouth closed, section 43; Fig. 4), the first breath having an inhalation portion and an exhalation portion ([0036], lines 8-10; Fig. 4).
Regarding claim 70, Aylsworth as modified teaches the invention as set forth in claim 1, wherein the mouth leak status ([0032], lines 1-3) is (i) no mouth leak, (ii) valve-like mouth leak, or (iii) continuous mouth leak ([0040], lines 1-3, where a mouth in an opened position allows applied airflow and pressure to escape to atmosphere which is a mouth leak).
Regarding claim 73, Aylsworth as modified teaches the invention as set forth in claim 1, further comprising:
providing control signals (provide control signals via processor 29) to:
the respiratory therapy system (positive airway pressure machine 28 has a processor 29) and, in response to the mouth leak status, adjusting pressure settings of the respiratory therapy system ([0046], lines 11-14, where the processor 29 controls pressure settings, see [0010], lines 16-18), the pressure settings being associated with the pressurized air supplied to the airway of the user ([0010], lines 14-20).
Regarding claim 79, Aylsworth as modified teaches the invention as set forth in claim 1, further comprising in response to the mouth leak status being indicative that air is leaking from the mouth of the user, changing, via the one or more processors (control signals from processor 29), a configuration of the respiratory therapy system to mitigate the mouth leak ([0046], where the processor 29 controls pressure settings, see [0010], lines 16-18; Aylsworth claims 1-4).
Claims 71-72 are rejected under 35 U.S.C. 103 as being unpatentable over Aylsworth (US 20100186741 A1) in view of Silver (US 20190224434 A1) as applied to claim 1 above, and further in view of Ramanan & Armitstead (US 20120179061 A1).
Regarding claim 71, Aylsworth as modified teaches the invention as set forth in claim 1, but is silent to calculating a therapy score or AHI score based at least in part on the determined mouth leak status.
However, Ramanan & Armitstead teaches the calculation of a sleep quality score based in part on a number of apnea events during a treatment session ([0071], lines 17-21, where apnea event detection data is included within the data of the sleep stability detection module 116; [0394], last two sentences of paragraph) and a determined mouth leak status ([0071], lines 17-21, where leak detection data is included within the data of the sleep state detection module 118, and where a leak event is a mouth leak event, see [0345], line 9), where the sleep quality score is an indication of the quality of therapy being provided to the user ([0388], lines 3-9). Ramanan & Armitstead further teaches the option to exclude scoring events in the calculation of AHI based on the determination of a mouth leak status ([0078], lines 1-5) to improve accuracy of the sleep quality score by ensuring data used in the calculation of the sleep data score is recorded only when the mask is being worn by the patient ([0078], lines 5-10).
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 methods of Aylsworth, as modified in claim 1 above, with calculation of a sleep quality score, which is an indicator of the quality of therapy, as taught by Ramanan & Armitstead such that the method of Aylsworth as modified further comprises calculating a therapy score or AHI score based at least in part on the determined mouth leak status (Ramanan & Armitstead: [0071], lines 17-21, where leak detection data is included within the data of the sleep state detection module 118, and where a leak event is a mouth leak event, see [0345], line 9) to indicate the success of therapy currently being provided and propose how the therapy could be changed for more successful therapy (Ramanan & Armitstead: [0386], lines 1-7).
Regarding claim 72, Aylsworth as modified teaches the invention as set forth in claim 71, further comprising:
receiving, from a sensor coupled to the respiratory therapy system, sensor data associated with the user during the therapy session ([0011], lines 1-11), the sensor data being indicative of a number of sleep-disordered breathing events during the therapy session ([0036], lines 1-5; [0043], lines 8-16; regions 61 and 63 of Fig. 6);
correlating the mouth leak status with the sensor data (airflow of patient breathing 65, patient breathing circuit pressure 66, where the data of 65 and 66 is sensor data, [0011], lines 1-11; [0043], lines 7-13, where sensor data of 65 and 66 is correlated to a mouth leak status, where a mouth leak occurs when a user’s mouth is open and the user’s airway is not blocked or is partially blocked causing air to escape through the user’s mouth to atmosphere) to output one or more false positive sleep- disordered breathing events ([0044], lines 9-18, where mouth leak is identified in sensor data that indicates an apnea event; see region 74 of Fig. 7);
subtracting the one or more false positive sleep-disordered breathing events from the number of sleep-disordered breathing events to output a modified number of sleep-disordered breathing events (Ramanan & Armitstead: [0078], liens 1-10); and
calculating the therapy score based, at least in part, on the modified number of sleep-disordered breathing events (Ramanan & Armitstead: [0071], lines 17-21, where apnea event detection data is included within the data of the sleep stability detection module 116; [0394], last two sentences of paragraph; [0078], lines 1-10).
Claims 74-75 are rejected under 35 U.S.C. 103 as being unpatentable over Aylsworth (US 20100186741 A1) in view of Silver (US 20190224434 A1) as applied to claims 1 and 73 above, and further in view of Douglas et al. (US 20070215146 A1).
Regarding claim 74, Aylsworth as modified teaches the invention as set forth in claim 73, further comprising:
analyzing the airflow data associated with the user ([0038], lines 1-4, where the waveforms are airflow and pressure voltage waveforms) to determine that the user is exhaling (analyze patient breathing voltage waveform to determine when patient is exhaling, [0036], lines 8-10; Fig. 4)., but is silent to the method further comprising in response to the determination that the user is exhaling, reducing a pressure of the pressurized air supplied to the airway of the user during the exhaling of the user.
However, Douglas et al. teaches a CPAP apparatus analyzes airflow data associated with a user and identifies when the user is exhaling ([0051], lines 6-7 and line 14; [0063], lines 14-17). Douglas et al. further teaches decreasing the supplied pressure level in response to the user exhaling ([0051], lines 14-15).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Aylsworth, as modified in claim 73 above, with the reduction in supplied pressure to the user in response to a determination that the user is exhaling as taught by Douglas et al. such that, the method taught by Aylsworth as modified teaches in response to the determination that the user is exhaling ([0038], lines 1-4, where the waveforms are airflow and pressure voltage waveforms), reducing a pressure of the pressurized air to the airway of the user during the exhaling of the user (Douglas et al.: [0051], lines 14-15) to reduce mouth leak or any other detected mask leak (Douglas et al.: [0063], line 24), and increase patient comfort when receiving therapy (Douglas et al.: [0064], lines 10-14).
Regarding claim 75, Aylsworth as modified teaches the invention as set forth in claim 1, but fails to explicitly disclose the method further comprising in response to the mouth leak status, causing a notification to be provided to the user via an electronic device, such that the user is alerted of the mouth leak status.
However, Douglas et al. teaches a warning, such as an audible or visible alarm, is generated when a leak flow is detected ([0063], last sentence of paragraph, where it would be readily understood by one of ordinary skill in the art that the device generating the audible or visible alarm must be an electronic device).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the methods of Aylsworth, as modified in claim 1 above, with the generation of an audible or visual alarm in response to a detected mouth leak as taught by Douglas et al. such that the methods of Aylsworth as modified comprises in response to the mouth leak status, causing a notification to be provided to the user via an electronic device, such that the user is alerted of the mouth leak status (Douglas et al.: [0063], last sentence of paragraph, where it would be readily understood by one of ordinary skill in the art that the device generating the audible or visible alarm must be an electronic device) to increase the delivery of successful therapy to a user (Douglas et al.: [0063], lines 14-21).
Claim 76 is rejected under 35 U.S.C. 103 as being unpatentable over Aylsworth (US 20100186741 A1) in view of Silver (US 20190224434 A1) as applied to claim 1 above, and further in view of Shouldice (WO 2017032873 A2).
Regarding claim 76, Aylsworth as modified teaches the invention as set forth in claim 1. Aylsworth further teaches the collection of data over at least one sleep period during a therapy session ([0048], lines 1-9), the identification of a hypopnea event based on the data collected during the at least one sleep period (0045], lines 5-9), and the association of a mouth leak status with a hypopnea event ([0046], lines 8-14), But Aylsworth, as modified in claim 1 above, fails to explicitly teach the method as set forth in claim 1 further comprising:
receiving sleep stage data associated with the user during the therapy session;
determining a sleep stage based at least in part on the sleep stage data; and
associate the mouth leak status with the sleep stage.
However, Shouldice teaches a system and method for monitoring and managing a chronic disease, such as Obstructive Sleep Apnea, where sleep stage data is associated with a user during the therapy session ([324], lines 1-4; [324], lines 9-10). Shouldice further teaches the determination of if the user is awake based in part on the sleep stage data ([324], lines 1-7), and associates a mouth leak status with sleep stage data ([307], lines 2-4, where the leak flow rate Ql is an indicator of a mouth leak status, and the respiratory flow rate Qr is used in the identification of periods of awake breathing, see [324], lines 9-10).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Aylsworth, as modified in claim 1 above, with the receipt of sleep stage data, determination of a sleep stage, and association of a mouth leak with the sleep stage as taught by Shouldice such that the method of Aylsworth as modified teaches receiving sleep stage data associated with the user during the therapy session (Shouldice: [324], lines 1-4; [324], lines 9-10); determining a sleep stage based at least in part on the sleep stage data (Shouldice: [324], lines 1-7) ; and associate the mouth leak status with the sleep stage (Shouldice: [307], lines 2-4, where the leak flow rate Ql is an indicator of a mouth leak status, and the respiratory flow rate Qr is used in the identification of periods of awake breathing, see [324], lines 9-10) to teach the respiratory device the user’s behaviors, triggers, and symptoms for a more personalized and effective treatment (Shouldice: [105], lines 1-5).
Response to Arguments
Applicant’s arguments with respect to independent claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Specifically, Applicant argues Aylsworth fails to disclose or suggest a “normalized ventilation” or “normalized respiration rate” (see pgs. 9-10 of Remarks filed 01/14/2026). However, Applicant has amended claim 1 to read “identify one or more normalized features that distinguish mouth leak from (i) normal respiration during therapy and/or (ii) other types of unintentional leak, wherein the one or more normalized features includes one or both of a normalized ventilation with respect to a baseline ventilation and a normalized respiration rate with respect to a baseline respiration rate” (see amended claim 1, lines 9-13). As such, new grounds of rejection are necessitated by the amendment, and specifically by the amendment of “a normalized ventilation with respect to a baseline ventilation” and “a normalizes respiration rate with respect to a baseline respiration rate” (see amended claim 1, lines 11-13).
Silver (US 20190224434 A1) has been provided to teach a normalized respiration rate and a baseline respiration rate (see 103 rejection of amended claim 1 above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wysoski (WO 2020122739 A1): Regarding a method of assessing a baseline flow with a measured flow to identify leaks in a respiratory therapy system.
Truschel & Seymour (US 20180264214 A1): Regarding comparing a measured flow rate to a baseline flow rate to identify when a disconnection between a user and user interface has occurred.
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 ABIGAYLE DALE whose telephone number is (571)272-1080. The examiner can normally be reached Monday-Friday from 8:45am to 5:45pm ET.
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ABIGAYLE DALE/Examiner, Art Unit 3785 /BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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