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 responsive to the amendment filed on 12/03/2025. As directed by the amendment: claims 1, 32-33, and 40 have been amended, claims 11, 17-24, 35, and 46-51 have been canceled, and no new claims have been added. Thus, claims 1-4, 27, 32-34, and 40 are presently pending in the application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The terms “reduced-pressure testing mode” and “automatically configuring” (From claims 1 and 40), and what they each comprise, should be recited in the specification. Additionally, In lines 7 and 14-22, claim 1 recites, “operating the respiratory therapy system in a reduced-pressure testing mode that:
(iii) actuates a vent of the mask by opening the vent when at least one of
(a) the air pressure is below a predetermined minimum threshold within the range of approximately 0.5-4 centimeters H20,
(b) the air flow rate is approximately 5 liters/minute or less,
(c) a measured carbon dioxide level in the mask reaches at least about 20 percent, or
(d) the user exhales, and
by closing the vent when the user inhales, to avoid accumulation of carbon dioxide during the reduced-pressure testing mode;”
and also in lines 39-41, which recite that “the actuation of the vent… is performed by the control system without user intervention during the second sleep session.”
The specification vaguely suggests a “reduced-pressure testing mode” in [0135] of the specification and in FIG. 6, and paragraph [0138] discusses the 0.5-4cm H2O range with respect to the vent. However, nothing recited in the specification suggests operating the vent, according to the limitations set forth above, at any point during the “reduced-pressure testing mode”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "the recommended therapy settings" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claims 3-4 are rejected based on their dependency to claim 2.
Examiner is taking the limitation “indications associated with the recommended therapy settings to be…” to be “indications associated with recommended therapy settings to be…” from claim 2.
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, 27, 32-34, and 40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an Abstract Idea without significantly more.
[STEP 1]
Regarding claims 1 and 32, the claims are a process/method and are one of the four statutory categories.
[STEP 2A, Prong One]
The claims recite the following limitations that recite an abstract idea: Receiving first physiological data generated during the first sleep session; receiving second physiological data generated during the second sleep session; determining a set of sleep-related parameters based on changes between the first physiological data and the second physiological data; configuring a therapy parameter, configuring the therapy parameter based on a positional sleep apnea and according to a position of the user (judgement or evaluation, which is grouped as mental process under the 2019 PEG). The above limitations are directed to mental processes that can be done by a person simply observing the output of one of the various sleep parameter sensors, evaluating or comparing the readings using a percentage comparing equation or similar equation that can be expressed in decimals, and verifying its values with predefined value or user-defined threshold to alert others when the evaluated values are higher than the user-defined threshold values.
[STEP 2A, Prong Two]
Claim 1 recites the additional elements of: a respiratory therapy system, one or more sensors, and a vent.
The respiratory therapy system is described as having “a respiratory device configured to supply pressurized air. The respiratory therapy system further has a user interface coupled to the respiratory device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user. The system further includes a memory storing machine-readable instructions, and a control system including one or more processors configured to execute the machine-readable instructions” (Specification [0005]). It is essentially acting as a computer element just to execute the program that carries out the abstract method and amounts to merely being the field of use. Paragraphs [0138]-[0141] in the specification describe the vent as being movable between a closed position and an open position based on predetermined thresholds and conditions. This vent also essentially acting as a computer element just to execute the program that carries out the abstract method and amounts to merely being the field of use. The recited abstract process does not improve the functioning of the ventilator, or any other technology or technical field. Nor does the above-identified additional element 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.
The one or more sensors merely measures physiological data during a first sleep session and physiological data during a second sleep session. The sensors collect the data to feed the abstract determination process and thus is merely extra-solution activity. Furthermore, the above identified additional element, the respiratory therapy system, does not add a meaningful limitation to the abstract idea because it amounts to simply performing basic calculations and outputting said results is considered well-understood, routine, conventional computer functions. See MPEP 2106.05(d). 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) is not integrated into a practical application under the 2019 PEG.
[STEP 2B]
The claims do not cite any additional structures that would make it significantly more than the judicial exception. The respiratory therapy system consists of various components such as sensors, a user interface, a conduit, a memory storing machine-readable instructions, a control system, one or more processors configured to execute the machine-readable instructions (Specification [0005]). These elements are conventional and well-known in the art as shown by Farrugia (US 20140318543 A1). The operation of the vent according to a thresholds and conditions set by a control system is conventional and well-known in the art as shown by Foote (US 10029058 B2). The use of a generic processor, memory and/or any other general computer components to store information and perform basic calculations and outputting said results is considered well-understood, routine, conventional computer functions. See MPEP 2106.05(d). The automatically configured therapy parameter based on the set of sleep-related parameters is merely extra solution activity in that it provides an indication of the result of the abstract determination process. It is well-known analysis technique involving an act of evaluating information to a predefined threshold can be practically performed in the human mind. Therefore, in addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is-well-understood or conventional. See MPEP 2106.05((g). With respect to the sensor, Farrugia (US 20140318543 A1) mentions utilizing sensors for pressure and flow rate are well known in the art as well as method of comparing the measured/sensed values. The components found in the claim is-well-known to be conventional in the art.
Further, dependent claims 2-4, 11, 27, and 33-34 include limitations that either further define the abstract idea by providing an indication associated with the determined therapy parameter in claims 2-4, further defining the physiological data sets to include the position of the user in claim 27, or indicating specific therapy parameters in claims 33 and 34 (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 1]
Regarding claim 40, the claim is a machine/system and is one of the four statutory categories.
[STEP 2A, Prong One]
The claims recite the following limitations that recite an abstract idea: Receiving first physiological data generated during the first sleep session; receiving second physiological data generated during the second sleep session; determining a set of sleep-related parameters based on changes between the first physiological data and the second physiological data; configuring a therapy parameter (judgement or evaluation, which is grouped as mental process under the 2019 PEG). The above limitations are directed to mental processes that can be done by a person simply observing the output of one of the various sleep parameter sensors, evaluating or comparing the readings using a percentage comparing equation or similar equation that can be expressed in decimals, and verifying its values with predefined value or user defined threshold to alert others when the evaluated values are higher than the user-defined threshold values.
[STEP 2A, Prong Two]
Claim 40 recites the additional elements of: a respiratory device, a mask/user interface, a conduit, a memory storing machine, and a control system, and a vent.
The respiratory therapy system is described as having “a respiratory device configured to supply pressurized air. The respiratory therapy system further has a user interface coupled to the respiratory device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user. The system further includes a memory storing machine-readable instructions, and a control system including one or more processors configured to execute the machine-readable instructions” (Specification [0005]). It is essentially acting as a computer element just to execute the program that carries out the abstract method and amounts to merely being the field of use. Paragraphs [0138]-[0141] in the specification describe the vent as being movable between a closed position and an open position based on predetermined thresholds and conditions. This vent also essentially acting as a computer element just to execute the program that carries out the abstract method and amounts to merely being the field of use. The recited abstract process does not improve the functioning of the ventilator, or any other technology or technical field. Nor does the above-identified additional element 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. 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 40 (and its respective dependent claims) is not integrated into a practical application under the 2019 PEG.
[STEP 2B]
The claims do not cite any additional structures that would make it significantly more than the judicial exception. The respiratory therapy system consists of various components such as, a user interface, a conduit, a memory storing machine-readable instructions, a control system, one or more processors configured to execute the machine-readable instructions (Specification [0005]). These elements are conventional and well-known in the art as shown by Farrugia (US 20140318543 A1). The operation of the vent according to a thresholds and conditions set by a control system is conventional and well-known in the art as shown by Foote (US 10029058 B2). The use of a generic processor, memory and/or any other general computer components to store information and perform basic calculations and outputting said results is considered well-understood, routine, conventional computer functions. See MPEP 2106.05(d). The configured therapy parameter based on the set of sleep-related parameters is merely extra solution activity in that it provides an indication of the result of the abstract determination process. It is well-known analysis technique involving an act of evaluating information to a predefined threshold can be practically performed in the human mind. Therefore, in addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is-well-understood or conventional. See MPEP 2106.05(g). The components found in the claim is-well-known to be conventional in the art.
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.
Claims 1 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Farrugia (US 20140318543 A1) in view of Foote (US 10029058 B2).
Regarding claim 1, Farrugia discloses a method (FIG. 2 and Abstract) comprising: applying, via a respiratory therapy system (FIG. 1 Pressure treatment apparatus set forth in [0023]), initial therapy settings for a user during a first sleep session in which the user uses the respiratory therapy system (A first therapeutic pressure treatment level during a first treatment session as set forth in claim 1; FIG. 2 As shown in step 20, airway pressure treatment is provided to the patient during a first treatment session. In such a session, in the absence of historic AHI, the pressure treatment level will be set to a default low or minimum level, or a level prescribed by a physician or clinician as set forth in [0032]);
receiving, from one or more sensors, first physiological data generated during the first sleep session (FIG. 2 During the treatment session, in step 22, sleep disordered breathing events are detected and an index of these events is determined as set forth in [0032]; FIG. 1 The parameters measure by pressure sensor 4p and flow sensor 4f as set forth in [0013], [0027]);
during a second sleep session of the user that is subsequent to the first sleep session (FIG. 2 In step 24, a new or subsequent treatment session is initiated with the apparatus. In this subsequent session, a therapeutic level of the treatment is set automatically as a function of the SOB event related index that was determined in the prior treatment session set forth in [0032]), operating the respiratory therapy system in a reduced-pressure testing mode (FIG. 4 In step 44, the new pressure for the current setting will be the pressure from the prior session less the fixed decrement amount as set forth in [0047],[0049], for an AHI of 0 or an AHI of less than 8 from the prior session, the device may lower the pressure in the new session. In lowering the pressure, the device may decrement the pressure by a fixed amount as set forth in [0047]) that:
(i) applies, via the respiratory therapy system, modified therapy settings that are modified relative to the initial therapy settings, the modified therapy settings comprising a reduced air pressure of supplied pressurized air (FIG. 4 In step 44, the new pressure for the current setting will be the pressure from the prior session less the fixed decrement amount as set forth in [0047],[0049], for an AHI of 0 or an AHI of less than 8 from the prior session, the device may lower the pressure in the new session. In lowering the pressure, the device may decrement the pressure by a fixed amount as set forth in [0047]);
(ii) monitors, via at least one sensor, an air flow rate (FIG. 4 At step 48, the system cycles back to step 30 (FIG. 3) and again begins the process of determining a new AHI as set forth in [0049], the Apnea Hypopnea Index ("AHI") is an indicator of severity of a patient's sleep disordered breathing, which is determined based on parameters the air flow which is continuously measured or determined in step 32, with flow information or the flow signal from a differential pressure transducer or derived from blower speed or power to the blower motor as set forth in [0036]); and
receiving, from the sensor, second physiological data generated by the sensor during the second sleep session while the respiratory therapy system operates in the reduced-pressure testing mode, the second physiological data being indicative of the user's breathing during the modified therapy settings (FIG. 4 At step 48, the system cycles back to step 30 (FIG. 3) and again begins the process of determining a new AHI as set forth in [0049], the Apnea Hypopnea Index ("AHI") is an indicator of severity of a patient's sleep disordered breathing, which is determined based on parameters the air flow which is continuously measured or determined in step 32, with flow information or the flow signal from a differential pressure transducer or derived from blower speed or power to the blower motor as set forth in [0036]);
determining, by a processor (FIG. 1 The controller/microprocessor 6 is configured and adapted to implement the methodology as set forth in [0028]), a set of sleep-related parameters based on changes between the first physiological data and the second physiological data ([0013]-[0015] Set forth that a measurement of parameters provide information to established an apneic event has occurred, the Apnea Hypopnea Index determined from the parameters, an indicator or a patients sleep disordered breathing, is determined over a particular time period. adjustment of the pressure may be based on patterns of the AHI over more than a single night, such as two or more nights. For example, the pressure may be lowered if the AHI has been 0 for two or more consecutive sessions. Similarly, pressure may be increased only if the AHI in more than one consecutive night, for example, 2 or 3 nights, suggests a need for an increase as set forth in [0050]);
automatically configuring, by the respiratory therapy system based on the set of sleep- related parameters, at least one therapy parameter of the respiratory therapy system for a subsequent sleep session, the automatically configuring comprising setting at least one of: a minimum pressure setting, a maximum pressure setting, or a pressure range (As set forth in [0050], adjustment of the pressure may be based on patterns of the AHI over more than a single night, such as two or more nights. For example, the pressure may be lowered if the AHI has been 0 for two or more consecutive sessions. Similarly, pressure may be increased only if the AHI in more than one consecutive night, for example, 2 or 3 nights, suggests a need for an increase; a lowered value being a minimum setting, an increased value being a maximum setting, and those two values to be a range);
wherein the reduced-pressure testing mode and the automatic configuration of the at least one therapy parameter are performed by the control system without user intervention during the second sleep session (FIG. 4 The treatment pressure is automatically set as set forth in [0048]-[0051]; It is an objective of the invention to provide a device that can detect SOB events and automatically and effectively determine an appropriate pressure response as set forth in [0017] and [0020]).
Farrugia discloses a vent (FIG. 1 Mask 18 with an integrated exhaust vent 20 as set forth in [0029]), but fails to explicitly disclose that during the reduced-pressure testing mode, the system actuates a vent of the mask, performed by the control system without user intervention during the second sleep session, by opening the vent when at least one of
(a) the air pressure is below a predetermined minimum threshold within the range of approximately 0.5-4 centimeters H20,
(b) the air flow rate is approximately 5 liters/minute or less,
(c) a measured carbon dioxide level in the mask reaches at least about 20 percent, or
(d) the user exhales, and
by closing the vent when the user inhales, to avoid accumulation of carbon dioxide during the reduced-pressure testing mode.
However, Foote teaches a control system which actuates a vent of the mask (Foote: FIG. 7 Control system 706 provides automated control of gas washout of a patient interface as set forth in the abstract) by opening the vent when the user exhales, and by closing the vent when the user inhales, to avoid accumulation of carbon dioxide (Foote: The vent area is reduced or closed at a time corresponding to inhalation when gas washout is not required, and is opened coinciding with patient exhalation as set forth in column 32 lines 1-3).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system of Farrugia to incorporate the teaching of Foote during the second sleep session and include wherein the control system which actuates a vent of the mask (Foote: FIG. 7 Control system 706 provides automated control of gas washout of a patient interface as set forth in the abstract) by opening the vent when the user exhales, and by closing the vent when the user inhales, to avoid accumulation of carbon dioxide (Foote: The vent area is reduced or closed at a time corresponding to inhalation when gas washout is not required, and is opened coinciding with patient exhalation as set forth in column 32 lines 1-3). Doing so would make it so that the mean and peak flow rate required to be generated by the flow generator may be reduced, with resultant decreases in flow generator capability and size, and air delivery conduit diameter being possible. Furthermore, the power consumption of the apparatus may be able to be reduced (Foote: As set forth in Column 32 Lines 4-10), and will prevent the accumulation of carbon dioxide in the mask (Foote: As set forth in column 35 lines 27-41).
Regarding claim 40, Farrugia discloses a system comprising: a respiratory therapy system including:
a respiratory device (FIG. 1 Pressure treatment apparatus set forth in [0023]) configured to supply pressurized air (FIG. 1 The impellor 8 is controlled by a servo 10, receives ambient air through an inlet 12 and delivers pressurized air through an outlet 14 set forth in [0029]); and
a user interface in the form of a mask (FIG. 1 Mask 18 set forth in [0029]) coupled to the respiratory device via a conduit (FIG. 1 Delivery conduit 16 set forth in [0029]), the user interface mask including a vent (FIG. 1 Mask 18 with an integrated exhaust vent 20 as set forth in [0029]) and being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user (Well-known function of a mask known by one of ordinary skill in the art; and as set forth in [0004] of Farrugia);
a sensor configured to provide signals indicative of at least one of air pressure or air flow rate (FIG. 2 During the treatment session, in step 22, sleep disordered breathing events are detected and an index of these events is determined as set forth in [0032]; FIG. 1 The parameters measure by pressure sensor 4p and flow sensor 4f as set forth in [0013], [0027]);
a memory storing machine-readable instructions; and a control system including one or more processors configured to execute the machine- readable instructions (The controller 6 is configured and adapted to implement the methodology described in more detail herein and may include integrated chips, a memory and/or other instruction or data storage medium. For example, programmed instructions with the control methodology may be coded on integrated chips in the memory of the device or loaded as software as set forth in [0028]) to:
apply initial therapy settings for the user during a first sleep session in which the user uses the respiratory therapy system (A first therapeutic pressure treatment level during a first treatment session as set forth in claim 1; FIG. 2 As shown in step 20, airway pressure treatment is provided to the patient during a first treatment session. In such a session, in the absence of historic AHI, the pressure treatment level will be set to a default low or minimum level, or a level prescribed by a physician or clinician as set forth in [0032]);
receive first physiological data generated by the one or more sensors during the first sleep session (FIG. 2 During the treatment session, in step 22, sleep disordered breathing events are detected and an index of these events is determined as set forth in [0032]; FIG. 1 The parameters measure by pressure sensor 4p and flow sensor 4f as set forth in [0013], [0027]);
operate, during a second sleep session subsequent to the first sleep session (FIG. 2 In step 24, a new or subsequent treatment session is initiated with the apparatus. In this subsequent session, a therapeutic level of the treatment is set automatically as a function of the SOB event related index that was determined in the prior treatment session set forth in [0032]), the respiratory therapy system in a reduced-pressure testing mode (FIG. 4 In step 44, the new pressure for the current setting will be the pressure from the prior session less the fixed decrement amount as set forth in [0047],[0049], for an AHI of 0 or an AHI of less than 8 from the prior session, the device may lower the pressure in the new session. In lowering the pressure, the device may decrement the pressure by a fixed amount as set forth in [0047]) that:
(i) applies modified therapy settings that are modified relative to the initial therapy settings, the modified therapy settings comprising at least one of a reduced air flow rate and a reduced air pressure of supplied pressurized air (FIG. 4 In step 44, the new pressure for the current setting will be the pressure from the prior session less the fixed decrement amount as set forth in [0047],[0049], for an AHI of 0 or an AHI of less than 8 from the prior session, the device may lower the pressure in the new session. In lowering the pressure, the device may decrement the pressure by a fixed amount as set forth in [0047]), and
receive second physiological data generated by the one or more sensors during the second sleep session while the reduced-pressure testing mode is active (FIG. 4 At step 48, the system cycles back to step 30 (FIG. 3) and again begins the process of determining a new AHI as set forth in [0049], the Apnea Hypopnea Index ("AHI") is an indicator of severity of a patient's sleep disordered breathing, which is determined based on parameters the air flow which is continuously measured or determined in step 32, with flow information or the flow signal from a differential pressure transducer or derived from blower speed or power to the blower motor as set forth in [0036]);
determine a set of sleep-related parameters based on changes between the first physiological data and the second physiological data ([0013]-[0015] Set forth that a measurement of parameters provide information to established an apneic event has occurred, the Apnea Hypopnea Index determined from the parameters, an indicator or a patients sleep disordered breathing, is determined over a particular time period. adjustment of the pressure may be based on patterns of the AHI over more than a single night, such as two or more nights. For example, the pressure may be lowered if the AHI has been 0 for two or more consecutive sessions. Similarly, pressure may be increased only if the AHI in more than one consecutive night, for example, 2 or 3 nights, suggests a need for an increase as set forth in [0050]); and
automatically configure at least one therapy parameter of the respiratory therapy system for a subsequent sleep session based on the set of sleep-related parameters, the at least one therapy parameter comprising at least one of: a minimum pressure setting, a maximum pressure setting, or a pressure range (As set forth in [0050], adjustment of the pressure may be based on patterns of the AHI over more than a single night, such as two or more nights. For example, the pressure may be lowered if the AHI has been 0 for two or more consecutive sessions. Similarly, pressure may be increased only if the AHI in more than one consecutive night, for example, 2 or 3 nights, suggests a need for an increase);
wherein the reduced-pressure testing mode and the automatic configuration of the at least one therapy parameter are performed by the control system without user intervention during the second sleep session (FIG. 4 The treatment pressure is automatically set as set forth in [0048]-[0051]; It is an objective of the invention to provide a device that can detect SOB events and automatically and effectively determine an appropriate pressure response as set forth in [0017] and [0020]).
Farrugia discloses a vent (FIG. 1 Mask 18 with an integrated exhaust vent 20 as set forth in [0029]), but fails to explicitly disclose that during the reduced-pressure testing mode, the system actuates a vent of the mask, performed by the control system without user intervention during the second sleep session, by opening the vent when at least one of
(a) the air pressure is below a predetermined minimum threshold within the range of approximately 0.5-4 centimeters H20,
(b) the air flow rate is approximately 5 liters/minute or less,
(c) a measured carbon dioxide level in the mask reaches at least about 20 percent, or
(d) the user exhales, and
by closing the vent when the user inhales, to avoid accumulation of carbon dioxide during the reduced-pressure testing mode.
However, Foote teaches a control system which actuates a vent of the mask (Foote: FIG. 7 Control system 706 provides automated control of gas washout of a patient interface as set forth in the abstract) by opening the vent when the user exhales, and by closing the vent when the user inhales, to avoid accumulation of carbon dioxide (Foote: The vent area is reduced or closed at a time corresponding to inhalation when gas washout is not required, and is opened coinciding with patient exhalation as set forth in column 32 lines 1-3).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system of Farrugia to incorporate the teaching of Foote during the second sleep session and include wherein the control system which actuates a vent of the mask (Foote: FIG. 7 Control system 706 provides automated control of gas washout of a patient interface as set forth in the abstract) by opening the vent when the user exhales, and by closing the vent when the user inhales, to avoid accumulation of carbon dioxide (Foote: The vent area is reduced or closed at a time corresponding to inhalation when gas washout is not required, and is opened coinciding with patient exhalation as set forth in column 32 lines 1-3). Doing so would make it so that the mean and peak flow rate required to be generated by the flow generator may be reduced, with resultant decreases in flow generator capability and size, and air delivery conduit diameter being possible. Furthermore, the power consumption of the apparatus may be able to be reduced (Foote: As set forth in Column 32 Lines 4-10), and will prevent the accumulation of carbon dioxide in the mask (Foote: As set forth in column 35 lines 27-41).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Farrugia (US 20140318543 A1) in view of Foote (US 10029058 B2) as applied to claim 1, in further view of Chazal (US 20200107775 A1).
Regarding claim 2, Farrugia as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Farrugia as modified fails to explicitly disclose the method further comprising causing one or more indications associated with recommended therapy to be communicated to the user, via a user device, subsequent to the second sleep session.
However, Chazel teaches causing an indication associated with recommended therapy settings to be communicated to the user, via a user device, subsequent to the second sleep session (Chazel: Based on an output AHI value, transmitting the data to a display device, such as a monitor, a mobile phone, a laptop, or tablet computer which may have one or more of the following visual representations: a) an indication of the AHI or any values related thereto, b) an explanation of the medical meaning of the AHI or any values related thereto, including a likelihood, extent, degree, or severity of the monitored patient's sleep apnea, c) graphs of any of the aforementioned values over time and/or sensitivity vs. specificity as described above, and/or d) recommendations for further testing or other action items as set forth in [0090]; The data being transmitted based on an AHI output over a specific time frame indicates that the recommended therapy is subsequent to a second sleep session).
Farrugia and Chazel are both considered to be analogous to the claimed invention because they are in the same field of methods and systems for detecting sleep apnea. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Farrugia to incorporate the teaching of Chazel and include causing an indication associated with recommended therapy to be communicated to the user, via a user device, subsequent to the second sleep session (Chazel: Based on an output AHI value, transmitting the data to a display device, such as a monitor, a mobile phone, a laptop, or tablet computer which may have one or more of the following visual representations: a) an indication of the AHI or any values related thereto, b) an explanation of the medical meaning of the AHI or any values related thereto, including a likelihood, extent, degree, or severity of the monitored patient's sleep apnea, c) graphs of any of the aforementioned values over time and/or sensitivity vs. specificity as described above, and/or d) recommendations for further testing or other action items as set forth in [0090]; The data being transmitted based on an AHI output over a specific time frame indicates that the recommended therapy is subsequent to a second sleep session). Doing so would allow the user/medical professional to make informed decisions as to their care based on the recommendations being provided to them (Chazel: Set forth in [0090]).
Farrugia as modified by Chazel fails to explicitly disclose that the recommended therapy is in the context of settings.
However, Farrugia teaches that an adjustment of the pressure may be based on patterns of the AHI over more than a single night, such as two or more nights. For example, the pressure may be lowered if the AHI has been 0 for two or more consecutive sessions. Similarly, pressure may be increased only if the AHI in more than one consecutive night, for example, 2 or 3 nights, suggests a need for an increase (set forth in [0050]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention that one of the “recommendations for other action items”, of Chazel, communicated to the user via a user device could include recommended settings based on the AHI such as a recommended increase or decrease in pressure supplied to the user. This would allow the user to know whether or not they have to increase the pressure if the AHI remains higher, or lower the pressure if the AHI is lowered ([0050]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Farrugia (US 20140318543 A1) in view of Foote (US 10029058 B2), in further view of Chazal (US 20200107775 A1) as applied to claim 2, in further view of EdenSleep (“What Should My CPAP Pressure Be?” Edensleep.co.nz, ResMed, 25 Apr. 2019, www.edensleep.co.nz/blog/what-should-my-cpap-pressure-be. Accessed 14 July 2025).
Regarding claim 3, Farrugia as modified discloses the claimed invention substantially as claimed as set forth for claim 2 above.
Farrugia as modified discloses determining one or more of a recommended therapy or recommended therapy settings based on the set of sleep-related parameters.
Farrugia as modified does not explicitly disclose, wherein the one or more indications include a recommendation that encourages the user to continue use of the respiratory therapy system.
However, EdenSleep teaches if a user is experiencing an AHI level of five or more each hour, the CPAP device settings should be increased and the use of the respiratory therapy system should be continued (EdenSleep: Page 4 paragraph 3).
Farrugia and EdenSleep are both considered to be analogous to the claimed invention because they are in the same field of methods and systems for detecting sleep apnea. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Farrugia to incorporate the teaching of EdenSleep and include that one or more of a recommended therapy or recommended therapy settings based on the set of sleep-related parameters could include a recommendation that encourages the user to continue use of the respiratory therapy system as a result of an AHI level of five or more each hour (EdenSleep: Page 4 paragraph 3). Doing so would ensure that the user can determine if the proper pressure is being delivered, and whether or not the user needs to continue usage.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Farrugia (US 20140318543 A1) in view of Foote (US 10029058 B2), in further view of Chazal (US 20200107775 A1) as applied to claim 2, in further view of in further view of Boyd (Boyd, Scott B., and Arthur S. Walters. “Effectiveness of Treatment Apnea-Hypopnea Index: A Mathematical Estimate of the True Apnea-Hypopnea Index in the Home Setting.” https://doi.org/10.1016/j.joms.2012.05.009 Accessed 15 July 2025).
Regarding claim 4, Farrugia as modified discloses the claimed invention substantially as claimed as set forth for claim 2 above.
Farrugia as modified discloses determining one or more of a recommended therapy or recommended therapy settings based on the set of sleep-related parameters.
Farrugia as modified does not explicitly disclose, wherein the one or more indications include a recommendation to discontinue use of the respiratory therapy system.
However, Boyd teaches if a user is experiencing an AHI level of five or less, their condition is mild and does not require treatment, so the use of the respiratory therapy system should be discontinued (Boyd: Page 5 paragraph 1).
Farrugia and Boyd are both considered to be analogous to the claimed invention because they are in the same field of methods and systems for detecting sleep apnea. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Farrugia to incorporate the teaching of Boyd and include that one or more of a recommended therapy or recommended therapy settings based on the set of sleep-related parameters could include a recommendation that encourages the user to discontinue the use of the respiratory therapy system as a result of an AHI level of five or less (Boyd: Page 5 paragraph 1). Doing so would ensure that the user can determine if the proper pressure is being delivered, and whether or not the user needs to discontinue usage.
Claims 27 and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Farrugia (US 20140318543 A1) in view of Foote (US 10029058 B2) as applied to claim 1, in further view of Shelly (US 20190099571 A1).
Regarding claim 27, Farrugia as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Farrugia as modified fails to explicitly disclose the method, wherein the first physiological data and the second physiological data include a body position of the user.
However, Shelly teaches wherein the first physiological data and the second physiological data include a body position of the user. (Shelly: FIG. 1 Processing unit 24 may determine a body or head position of patient 10 based on the outputs of the one or more sensors, such as body position sensor 36 (shown in FIG. 2). Processing unit 24 may further determine whether patient 10 is in a supine position based on the output of body position sensor 36. In some example embodiments, processing unit 24 only output the alert if patient 10 is in the supine position. In this case, the alert may not be beneficial to patient 10 if patient 10 is already in a non-supine position. In some example embodiments, information from body position sensor 36 can be used to determine that patient 10 is a good candidate for positional therapy only (e.g., no longer needs pressure support therapy if he/she will sleep in a non-supine position) or that pressure (or pressure range) could be significantly decreased if positional therapy was used as set forth in [0036]).
Farrugia and Shelly are both considered to be analogous to the claimed invention because they are in the same field of CPAP treatment devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Farrugia to incorporate the teaching of Shelly and include wherein the first physiological data and the second physiological data include a body position of the user. (Shelly: FIG. 1 Processing unit 24 may determine a body or head position of patient 10 based on the outputs of the one or more sensors, such as body position sensor 36 (shown in FIG. 2). Processing unit 24 may further determine whether patient 10 is in a supine position based on the output of body position sensor 36. In some example embodiments, processing unit 24 only output the alert if patient 10 is in the supine position. In this case, the alert may not be beneficial to patient 10 if patient 10 is already in a non-supine position. In some example embodiments, information from body position sensor 36 can be used to determine that patient 10 is a good candidate for positional therapy only (e.g., no longer needs pressure support therapy if he/she will sleep in a non-supine position) or that pressure (or pressure range) could be significantly decreased if positional therapy was used as set forth in [0036]). Doing so would enable the device to determine that patient is a good candidate for positional therapy (Shelly: As set forth in [0036]).
Regarding claim 32, Farrugia as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Farrugia as modified fails to explicitly disclose the method, further comprising: automatically configuring the at least one therapy parameter based on a positional sleep apnea, and according to a position of the user.
However, Shelly teaches automatically configuring the at least one therapy parameter based on a positional sleep apnea according to a position of the user (Shelly: Processing unit 24 may further determine whether patient 10 is in a supine position based on the output of body position sensor 36. In some example embodiments, processing unit 24 only output the alert if patient 10 is in the supine position. In this case, the alert may not be beneficial to patient 10 if patient 10 is already in a non-supine position. In some example embodiments, information from body position sensor 36 can be used to determine that patient 10 is a good candidate for positional therapy only (e.g., no longer needs pressure support therapy if he/she will sleep in a non-supine position) or that pressure (or pressure range) could be significantly decreased if positional therapy was used as set forth in [0036]. An indicator 40 provides a tactile indication to alert patient to change position as set forth in [0033]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Farrugia to incorporate the teaching of Shelly and include automatically configuring the at least one therapy parameter based on a positional sleep apnea according to a position of the user (Shelly: Processing unit 24 may further determine whether patient 10 is in a supine position based on the output of body position sensor 36. In some example embodiments, processing unit 24 only output the alert if patient 10 is in the supine position. In this case, the alert may not be beneficial to patient 10 if patient 10 is already in a non-supine position. In some example embodiments, information from body position sensor 36 can be used to determine that patient 10 is a good candidate for positional therapy only (e.g., no longer needs pressure support therapy if he/she will sleep in a non-supine position) or that pressure (or pressure range) could be significantly decreased if positional therapy was used as set forth in [0036]. An indicator 40 provides a tactile indication to alert patient to change position as set forth in [0033]). Doing so would enable the device to determine whether the correct pressure is being supplied to the user and allow it to adjust according to, in this case, the user’s body position (Shelly: As set forth in [0036]).
Regarding claim 33, Farrugia as modified discloses the claimed invention substantially as claimed as set forth for claim 32 above.
Farrugia as modified by Shelly further teaches the method, wherein automatically configuring the at least one therapy parameter includes increasing a magnitude of a response to a health event, when the user changes between a first position and a second position (Shelly: An indicator 40 provides a tactile indication to alert patient to change position as set forth in [0033]).
Regarding claim 34, Farrugia as modified discloses the claimed invention substantially as claimed as set forth for claim 33 above.
Farrugia as modified by Shelly further teaches the method, wherein first position is a back position (The first position is any non-supine position, by the fact the sensors haven’t indicated the body is in a supine position, leading to an indication as set forth in [0033], this could include a back position) and the second position is a supine position (Device determines when the patient is in a supine position and alerts them if so as set forth in [0033] and [0036]).
Response to Arguments
Given claim 17 has been canceled, the rejection under 35 U.S.C. 112 is moot.
New grounds of rejection have been made above to address the amendments to claims 1, 32, 33, and 40.
Applicant's arguments filed 12/01/2025 have been fully considered but they are not persuasive.
Applicant argues that the addition of a reduced-pressure testing mode and venting actions provide a practical application and therefore, the 35 U.S.C. 101 rejection should be withdrawn.
New grounds of rejection have been made above to address the amendments to claims 1 and 40, and as stated in the 35 U.S.C. 101 rejection above, the limitations in claims 1 and 40 are directed to mental processes that can be done by a person simply observing the output of one of the various sleep parameter sensors, evaluating or comparing the readings using a percentage comparing equation or similar equation that can be expressed in decimals, and verifying its values with predefined value or user-defined threshold. While the modified therapy settings are based on the initial therapy settings, amended claim 1 is still determining (or automatically configuring), based on the differences between the first and second data, "a set of sleep-related parameters", and using that set of parameters to determine a "therapy parameter" that amounts to no more than an abstract idea. The "therapy parameter" based on the first and second data is not involved in a practical application.
Applicant’s remaining arguments with respect to claims 1-40 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.
Conclusion
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 KEIRA EILEEN CALLISON whose telephone number is (571)272-0745. The examiner can normally be reached Monday-Friday 7:30-4:30.
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/KEIRA EILEEN CALLISON/ Examiner, Art Unit 3785
/PAIGE KATHLEEN BUGG/ Primary Examiner, Art Unit 3785