DETAILED ACTION
Response to Amendment
This Office Action is responsive to the Amendment filed 12 May 2026. Claims 1-3, 7-10, 14, 16, 18-20, 22, 27-28, 32-33, 36, 39-41, 44, 52-53 are now pending. The Examiner acknowledges the amendments to claims 1, 3, 8, 9, 19, 20, 22, 28, 32, 39, 40, 41, 44, 52, 53.
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 .
Drawings
The drawings were received on 12 May 2026. These drawings are acceptable.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
-Claim 44 recites “user interface” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to engage a portion of the user. According to the specification the user interface includes full face mask, nasal pillows mask, nasal mask [0172] and equivalents thereof.
-Claim 52 recites “electronic interface” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to receive physiological data associated with a user. According to the specification the electronic interface includes an antenna, receiver (RF receiver), transmitter (RF transmitter), transceiver [0042] and equivalents thereof.
-Claim 52 recites “control system” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to execute the machine-readable instructions. According to the specification the control system includes a processor located in a cloud, server, IoT device, [0097] and equivalents thereof.
-Claim 53 recites “one or more sensors/first sensor” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to generate physiological data associated with the user when the user is wearing the user interface and when the user is not wearing the user interface. According to the specification the sensors include EEG, ECG, EMG, EOG, acoustic, SpO2, GSR, CO2, O2, pressure, temperature, motion, microphone, flow, tension [0116-0117] and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 20, 53 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 20 recites “the predetermined pressure that is different than the predetermined pressure” in lines 3-4. It is unclear which pressures are being referred to in this limitation and whether these pressures are actually different from one another. Further clarification should be provided.
-Claim 53 recites “a respiratory therapy device” in line 2. It is unclear whether this is the same or different from the respiratory therapy device originally recited in claim 52, lines 14-15.
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.
Claim(s) 1, 2, 3, 14, 16, 17, 18, 19, 20, 22, 27, 28, 32, 33, 36, 39, 40, 41, 44, 52 and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeman (WO 2018085563) in view of Wren (U.S. 20220339380).
Regarding Claim 1, Freeman teaches a method comprising: receiving first physiological data associated with a user [Pg. 15, lines 9-11]—reference to sensors acquiring physiological data; determining a first emotion score associated with the user [Pg. 15, line 14]—reference to calculating early warning score and [Pg. 62, lines 3-15]—reference to an early warning score being calculated by prediction/prevention of disease state and distress, the early warning score is interpreted to be the first emotion score, the first emotion score being indicative of a quantitative measure of anxiety or stress of the user based on one or more physiological parameters derived from the first physiological data [Pg. 60 lines 21-31]—describing MV, TV, and/or RR quantitative components of a predictive algorithm indicating distress, and being determined relative to a prior emotion score at which the user was able to fall asleep [Pg. 70, lines 16-19]—reference to comparison to baseline values measure before surgery, [Abstract; “calculates the early warning score, and compares to the early waring score to predetermined limits”] and [Pg. 71, lines 10-11]—reference to patient under the effects of anesthesia, interpreted to be user was able to fall asleep; and responsive to determining that the first emotion score satisfies a predetermined condition [Pgs. 53-54, lines 29-5; “In one embodiment, the RHI 30 is coupled with alarms that sound either when respiration falls below what is deemed as adequate, or within the range that is deemed adequate, if the patient experiences a very sudden change. In one embodiment, the device provides information to calculate an RHI. Preferably the device calculates and displays the RHI. In one embodiment, the Respiratory Health Index is compared against a universal calibration based on patient characteristics. In one embodiment, the RHI provides quantitative data with the system calibrated to a specific patient.”], determining a modification of one or more settings of a respiratory therapy system [Abstract; “if the score is outside the limits, triggers an alarm or actuates or modifies a treatment or medical intervention.”], and [Pg. 14, lines 16-26]—with reference to numerous respiratory therapies and systems such as CPAP, BiPAP and mechanical ventilation.
Freeman is silent on wherein the modification of the one or more settings of the respiratory therapy system causes a respiratory therapy device of the respiratory therapy system to supply pressurized air at a predetermined pressure. Wren teaches wherein the modification of the one or more settings of the respiratory therapy system causes a respiratory therapy device of the respiratory therapy system to supply pressurized air at a predetermined pressure [0005] and [0078].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine a predetermined pressure and related settings for a respiratory therapy device as taught by Wren to apply the use of physiological data in order to calculate and determine modifications for as suggested by Freeman, as Freeman the use of open and closed loop control systems to adjust ventilatory settings [Pgs. 57-58, lines 30-4] with Wren because Wren teaches standard characterization and adjustment involving reading physiological data and modifying various settings accordingly [0078].
Regarding Claim 2, Freeman teaches further comprising causing one or more prompts to be communicated to the user to aid in modifying the first emotion score [Pg. 63, lines 1-7]—reference to external entry of data regarding the early warning scoring system and patient data, [Pg. 41, line 15; “The user is prompted to enter patient data.”]
Regarding Claim 3, Freeman teaches wherein the one or more prompts include a visual prompt, an audio prompt, or both [Pg. 60, lines 13-14; “If the score exceeds a predetermined level, one or more alarms (audible and/or visual) may be activated.”], the visual prompt including light emitted from a light source, this limitation is interpreted as not being required due to the limitation being listed in the alternative.
Regarding Claim 14, Freeman teaches wherein the audio prompt is communicated to the user via a transducer [Pg. 19, lines 19-22]—reference to a microphone/speaker providing an assessment of the subject.
Regarding Claim 16, Freeman teaches wherein the determining the first emotion score associated with the user includes determining a movement, a respiration rate, a respiration rate variability, a respiration depth, a tidal volume, an inspiration amplitude, an inspiration duration, an expiration amplitude, an expiration duration, an inspiration-expiration ratio, a heart rate, a heart rate variability, a cardiac waveform, perspiration, blood oxygenation, blood pressure, peripheral arterial tone, cardiogenic oscillations, a galvanic skin response, a sympathetic nervous system response, a skin temperature, an ambient temperature, photoplethysmography, pulse transit time, a core body temperature, a trend associated with the respiration rate, a trend associated with the heart rate, a trend associated with the galvanic skin response, or any combination thereof [Pg. 60, lines 8-20]—with reference to respiration rate, tidal volume, oxygen saturation, blood pressure, heart rate, unresponsiveness/movement.
Regarding Claim 18, Freeman is silent on wherein the first physiological data is received when the user is wearing a user interface of the respiratory therapy system. Wren teaches wherein the first physiological data is received when the user is wearing a user interface of the respiratory therapy system [0005]—reference to the user engaged with the user interface of the respiratory device to supply pressurized air and generate first physiological data during a sleep session.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a user interface as taught by Wren for the user to wear when collecting data as suggested by Freeman, as Freeman discusses the patient wearing a High-Frequency Chest Wall Oscillation vest with a CPAP [Pg. 14, lines 16-23] with Wren because Wren teaches the use of the data collected during sleep to determine sleep-related parameters and generate reports indicative of sleep quality [0003].
Regarding Claim 19, Freeman is silent on wherein the respiratory therapy system supplies pressurized air at a prior predetermined pressure prior to determining that the first emotion score satisfies the predetermined condition. Wren teaches wherein the respiratory therapy system supplies pressurized air at a prior predetermined pressure prior to determining that the first emotion score satisfies the predetermined condition [0040]—discusses delivering pressurized air after the system has obtained respiration data from the user but prior to delivering a second predetermined pressure where the predetermined condition is interpreted to be regulating the second predetermined pressure to be lower than of the first predetermined pressure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a first predetermined pressure as taught by Wren based on data collected from the user as suggested by Freeman, as Freeman discusses the use of CHFO, CPAP, BiPAP and CPEP that communicates with a sensor that acquires physiological bioelectrical impedance signal [Pg. 76, lines 22-28] with Wren because Wren teaches configuring the respiratory device to deliver two or more predetermines pressures within a predetermined range [0033].
Regarding Claim 20, Freeman is silent on wherein the modification of the one or more settings of the respiratory therapy system causes the respiratory therapy system to supply pressurized air the predetermined pressure that is different than the predetermined pressure. Wren teaches wherein the modification of the one or more settings of the respiratory therapy system causes the respiratory therapy system to supply pressurized air the predetermined pressure that is different than the predetermined pressure [0040]—discusses delivering pressurized air after the system has obtained respiration data from the user but prior to delivering a second predetermined pressure where the predetermined condition is interpreted to be regulating the second predetermined pressure to be lower than that of the first predetermined pressure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a second predetermined pressure different than the first predetermined pressure as taught by Wren based on data collected from the user as suggested by Freeman, as Freeman discusses the use of CHFO, CPAP, BiPAP and CPEP that communicates with a sensor that acquires physiological bioelectrical impedance signal [Pg. 76, lines 22-28] with Wren because Wren teaches configuring the respiratory device to deliver two or more predetermines pressures within a predetermined range [0033].
Regarding Claim 22, Freeman teaches wherein the determining that the first emotion score satisfies the predetermined condition includes determining that the first emotion score is less than a predetermined threshold [Pg. 45-46, lines 29-3]—reference to the impedance, tidal volume or minute volume (interpreted to be the first emotion score) varying from the baseline by a certain percentage.
Regarding Claim 27, Freeman is silent on wherein at least a portion of the first physiological data is associated with at least a portion of a first sleep session of the user. Wren teaches wherein at least a portion of the first physiological data is associated with at least a portion of a first sleep session of the user [Abstract; “A method includes receiving, from a first sensor, first physiological data associated with a first sleep session of a user.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to collect physiological data during a first sleep session as taught by Wren to associate this data with user sleep as suggested by Freeman, as Freeman discusses the patient’s disease states which include sleep disorders that the early warning signs are based on [Pg. 62, lines 23-28] with Wren because Wren teaches the user interface engaging the user during sleep sessions and generating respirator data associated with the user during these sessions [0008].
Regarding Claim 28, Freeman is silent on further comprising: receiving second physiological data associated with the user subsequent to the modification of the one or more settings of the respiratory therapy system, the second physiological data being associated with a first sleep session of the user; determining a second emotion score associated with the user, the second emotion score being indicative of a quantitative measure of anxiety or stress of the user based on one or more physiological parameters derived from the first physiological data and being determined relative to the prior emotion score; and further modifying the one or more settings of the respiratory therapy system responsive to determining that the second emotion score does not satisfy the predetermined condition. Wren teaches further comprising: receiving second physiological data associated with the user subsequent to the modification of the one or more settings of the respiratory therapy system [Fig. 4, elements 406 (the implementation of the determined modification of one or more settings) and 407 (receiving second physiological data)]—in this interpretation, Wren also teaches that the physiological data can include subjective stress reporting according to [0030] and [0076] therefore, the second physiological data is interpreted to be this self-report and/or second data collected and physiological data collected from the second sensors, the second physiological data being associated with a first sleep session of the user [Fig. 3, element 302 (second physiological data associated with the sleep session)]; determining a second emotion score associated with the user, the second emotion score being indicative of a quantitative measure of anxiety or stress of the user based on one or more physiological parameters derived from the first physiological data [0030]—as described above with specific reference to “stress level of the user” and [Fig. 3, element 304 (analysis of second physiological data to determine second set of sleep parameters)], the second emotion score being determined relative to the prior emotion score [0077]—references include data related to first pattern of events, average events per hour, etc. which is interpreted to be prior emotion score and further reference to this data collected prior to calibrating the second sensor collecting the second physiological data; and further modifying the one or more settings of the respiratory therapy system responsive to determining that the second emotion score does not satisfy the predetermined condition [0077]—reference to analyzing second physiological data and basing this analysis on the first physiological data to determine what events the user is experiencing and [0078]—disclosing modifying one or more parameters of the sensors based on first and second data collected followed by recharacterization and further adjustment of the parameters.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use secondary physiological data as taught by Wren to adjust non-invasive respiratory therapy as suggested by Freeman, as Freeman discusses taking a second set of RVM data and comparing this data to previous data collected [Pg. 69, lines 17-18] with Wren because Wren teaches the use of first and second physiological data to determine sleep-related parameters and/or generate reports indicating sleep quality [0003].
Regarding Claim 32, Freeman teaches further comprising determining a therapy recommendation for the user based on the first emotion score and causing an indication of the therapy recommendation to be communicated to the user, a third party, or both [Pg. 69, lines 10-23]—references the system making recommendations to the user involving further therapeutic steps (i.e. use of inhaler, repeating dosage, call physician or go to the hospital).
Regarding Claim 33, Freeman teaches wherein the therapy recommendation includes (a) a recommendation to modify a type of user interface for the respiratory therapy system and/or (b) a medication recommendation [Pg. 69, lines 16-21]—recommendation to use inhaler or repeat dosage (medication recommendation).
Regarding Claim 36, Freeman teaches wherein the therapy recommendation includes (a) a recommendation to cease using the respiratory therapy system and/or (b) a recommendation to use an alternative medical device [Pg. 69, lines 19-20]—reference to needs no further therapy (recommendation to cease using therapy device) and [Pg. 69, lines 16-17]—discusses use of an inhaler (alternative medical device).
Regarding Claim 39, Freeman is silent on wherein the first physiological data is generated during at least a portion of a first sleep session and the user uses the respiratory therapy system with the modified one or more settings during the at least a portion of the first sleep session. Wren teaches wherein the first physiological data is generated during at least a portion of a first sleep session [Fig. 4, elements 402 and 403]—with particular reference to first and second data analyzed to determine parameters during first portion of the sleep session, and the user uses the respiratory therapy system with the modified one or more settings during the at least a portion of the first sleep session [0098]—reference to modifying parameters during the sleep session shown in [Fig. 4.] process, interpreted to be the first sleep session.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use secondary physiological data as taught by Wren to deliver and control treatments as suggested by Freeman, as Freeman discusses using scoring systems to deliver or control treatment or medical intervention when patient condition changes are detected [Pgs. 63-64, lines 30-5] with Wren because Wren teaches modification of the parameters including characterizing and adjustment followed by further recharacterization [0078].
Regarding Claim 40, Freeman is silent on further comprising: causing one or more prompts to be communicated to the user to aid in modifying the first emotion score; receiving second physiological data associated with the user during at least a portion of a second sleep session that is subsequent to the first sleep session; determining a second emotion score associated with the user, the second emotion score being indicative of a quantitative measure of anxiety or stress of the user based on one or more physiological parameters derived from the first physiological data and being determined relative to the prior emotion score; and causing one or more prompts to be communicated to the user to aid in modifying the determined second emotion score. Wren teaches further comprising: causing one or more prompts to be communicated to the user to aid in modifying the first emotion score [0078]; receiving second physiological data associated with the user during at least a portion of a second sleep session that is subsequent to the first sleep session [0080]—references the method 300 repeated a plurality of times which includes steps 301-305, the second sleep session is interpreted to be the second repetition of the method with reference to “a sleep session”; determining a second emotion score associated with the user [Fig. 4, elements 406 (the implementation of the determined modification of one or more settings) and 407 (receiving second physiological data)]—in this interpretation, the second emotion score being indicative of a quantitative measure of anxiety or stress of the user based on one or more physiological parameters derived from the first physiological data, Wren also teaches that the physiological data can include subjective stress reporting according to [0030]—as described above with specific reference to “stress level of the user” and [0076] therefore, the second physiological data is interpreted to be this self-report and/or second data collected and physiological data collected from the second sensors, the second emotion score being determined relative to the prior emotion score; and causing one or more prompts to be communicated to the user to aid in modifying the determined second emotion score [0077]—references include data related to first pattern of events, average events per hour, etc. which is interpreted to be prior emotion score and further reference to this data collected prior to calibrating the second sensor collecting the second physiological data and [Fig. 5, element 508 (display a prompt requesting feedback from the user] and [0112]-further describing the feedback collected by the prompt.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to repeat the method described including secondary data as taught by Wren to communicate a recommendation or prompt to the user as suggested by Freeman, as Freeman discusses using data to prompt a patent to perform an action [Pg. 69, lines 1-4] with Wren because Wren teaches using the patient
Regarding Claim 41, Freeman further teaches wherein the one or more prompts for aiding in modifying the second emotion score are different than the one or more prompts for aiding in modifying the first emotion score. Wren teaches wherein the one or more prompts for aiding in modifying the second emotion score are different than the one or more prompts for aiding in modifying the first emotion score [0078]—discusses prompting the user to follow instructions and modify parameters of the device in comparison to [0112]—which discusses prompting to user to provide feedback.
Regarding Claim 44, Freeman teaches wherein the respiratory therapy system includes a user interface configured to engage a portion the user [Fig. 41, element “face mask”], Freeman is silent on the user interface including a vent, and wherein the modification of the one or more settings of the respiratory therapy system includes modifying a position of the vent. Wren teaches the user interface including a vent [0035], and wherein the modification of the one or more settings of the respiratory therapy system includes modifying a position of the vent [0035]—reference to repositioning device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include vents in the user interface as taught by Wren to regulate optimize O2 and CO2 levels in the patient as suggested by Freeman, as Freeman discusses using a HFCWO to increase turbulence in the lungs during inhalation and exhalation to achieve better O2 and CO2 transfer [Pg. 75, lines 10-15] with Wren because Wren teaches creating an air tight seal between the user interface and the user [0035].
Regarding Claim 52, Freeman teaches a system comprising: an electronic interface configured to receive physiological data associated with a user [Pg. 34, lines 22-23]—reference to transmitter receiver and remote probes including an array of electrodes to collect physiological data [Pg. 34, lines 3-6]; a memory storing machine-readable instructions [Pg. 23, lines 1-3]—reference to memory and [Pg. 23, lines 13-15]—reference to storage computer readable instructions; and a control system including one or more processors [Pg. 23, lines 20-24]—reference to CPUs and MPs, configured to execute the machine- readable instructions [Pg. 24, lines 13-14] to: determine an emotion score associated with the user [Pg. 15, line 14]—reference to calculating early warning score and [Pg. 62, lines 3-15]—reference to an early warning score being calculated by prediction/prevention of disease state and distress, the early warning score is interpreted to be the first emotion score, the emotion score being indicative of a quantitative measure of anxiety or stress of the user based on one or more physiological parameters derived from the physiological data [Pg. 60 lines 21-31]—describing MV, TV, and/or RR quantitative components of a predictive algorithm indicating distress and being determined relative to a prior emotion score at which the user was able to fall asleep [Pg. 70, lines 16-19]—reference to comparison to baseline values measure before surgery, [Abstract; “calculates the early warning score, and compares to the early waring score to predetermined limits”] and [Pg. 71, lines 10-11]—reference to patient under the effects of anesthesia, interpreted to be user was able to fall asleep; and responsive to the emotion score satisfying a predetermined condition [Abstract; “if the score is outside the limits, triggers an alarm or actuates or modifies a treatment or medical intervention.”] modify one or more settings of a respiratory therapy system[Pg. 42, lines 16-22] and [Pg. 14, lines 16-26]—with reference to numerous respiratory therapies and systems such as CPAP, BiPAP and mechanical ventilation and [Pgs. 53-54, lines 29-5; “In one embodiment, the RHI 30 is coupled with alarms …specific patient.”] Freeman is silent on to cause a respiratory therapy device of the respiratory therapy system to supply pressurized air at a predetermined pressure. Wren teaches to cause a respiratory therapy device of the respiratory therapy system to supply pressurized air at a predetermined pressure [0005] and [0078].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine a predetermined pressure and related settings for a respiratory therapy device as taught by Wren to apply the use of physiological data in order to calculate and determine modifications for as suggested by Freeman, as Freeman the use of open and closed loop control systems to adjust ventilatory settings [Pgs. 57-58, lines 30-4] with Wren because Wren teaches standard characterization and adjustment involving reading physiological data and modifying various settings accordingly [0078].
Regarding Claim 53, Freeman teaches further comprising: the respiratory therapy system including a respiratory therapy device, a conduit, a user interface, or any combination thereof [Fig. 41, element “face mask”], [Pg. 76, lines 20-24] and [Pg. 71, lines 3-9] and one or more sensors configured to generate the physiological data [Pg. 15, lines 9-10]; wherein a first one of the one or more sensors is physically coupled to or integrated in the respiratory therapy system [Fig. 41, element “RVM electrode”]—depicting wired connection with the ventilator, the first one of the one or more sensors being configured to generate physiological data associated with the user when the user is using the respiratory therapy system [Fig. 41, element “RVM electrode”]—depicting user wearing the RVM and [Pg. 72, lines 15-17]—describing the electrodes collecting continuous or intermittent measurements where physiological data is interpreted to be the respiratory volume monitoring data;
Freeman is silent on and wherein a second one of the one or more sensors is configured to generate physiological data associated with the user when the user is not wearing the user interface. Wren teaches and wherein a second one of the one or more sensors is configured to generate physiological data associated with the user when the user is not wearing the user interface [0069].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow for physiological measurement during and periods of time where the user is wearing and not wearing the mask interface of the device as taught by Wren to continuously or intermittently collect data as suggested by Freeman, as Freeman discusses providing trending data [Pg. 72, lines 15-17] with Wren because Wren teaches determining and quantifying differences between wearing the respirator and not wearing the system to show difference in sleep quality and to encourage and incentivize users to use the system and adhere to prescribed usage [0069].
Claim(s) 7, 8, 9, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeman (WO 2018085563) in view of Wren (U.S. 20220339380) and in further view of Yun (U.S. 20190240468).
Regarding Claim 7, Freeman and Wren are silent on wherein the one or more prompts include a breathing exercise to aid in modifying a respiration rate of the user. Yun teaches wherein the one or more prompts include a breathing exercise to aid in modifying a respiration rate of the user [0088]—reference to breathing exercise that includes metered breathing.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate breathing exercises as taught by Yun to modify a respiration rate as suggested by Freeman and Wren, as Freeman discusses using respiration rate to derive the patients state and output early warning scores [Pg. 61, lines 5-7] and Wren which discloses the use of respiration signal indicative of respiration or breathing of the user during sleep [0045] with Yun because Yun teaches the breaths being metered at a rate above or below a respiratory rate [0088].
Regarding Claim 8, Freeman further teaches wherein the determining the first emotion score associated with the user includes determining the respiration rate associated with the user based on the one or more physiological parameters derived from the first physiological data [Pg. 61, lines 5-7]—reference to determining a respiration rate in combination with other sensor data to determine early warning score—interpreted to be the first emotion score.
Regarding Claim 9, Freeman and Wren are silent on wherein one or more light pulses are emitted from a light source at a predetermined frequency to aid in modifying the respiration rate associated with the user. Yun teaches wherein one or more light pulses are emitted from a light source at a predetermined frequency to aid in modifying the respiration rate associated with the user [0074]—reference to light applied to a subject at pulsed frequencies and [0103]—includes combinatorial modulation with light and breathing exercises.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use light pulses as taught by Yun to modify a respiration rate as suggested by Freeman and Wren, as Freeman discusses using respiration rate to derive the patients state and output early warning scores [Pg. 61, lines 5-7] and Wren which discloses using an LED display as part of the input interface [0038, with Yun because Yun teaches the breaths being metered at a rate above or below a respiratory rate and controlled by a combination of light and breathing exercises [0103].
Regarding Claim 10, Freeman and Wren are silent on wherein the light source is physically coupled to or integrated in (a) a user device or (b) a portion of the respiratory therapy system. Yun teaches wherein the light source is physically coupled to or integrated in (a) a user device or (b) a portion of the respiratory therapy system [0082]—reference to user devices including wristbands, etc. to which a user device is interpreted to be a wearable device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the light source into a user device as taught by Yun to emit a visual stimulus to the user as suggested by Freeman and Wren, as Freeman discusses activating a visual alarm [Pg. 60, line 14] and Wren which discloses feedback communicated visually with the user [0112], with Yun because Yun teaches the use of optical light to modulate the autonomic nervous system [0038].
Response to Arguments
Applicant's arguments filed 12 May 2026 with respect to the drawing and claim objections have been fully considered and are persuasive in light of the amendments.
Applicant's arguments filed 12 May 2026 with respect to 35 U.S.C. 112(b)
rejections have been fully considered and are persuasive however, new rejections are
presented in light of the amendments. Claim 20 were amended previously in response to previous objections and 112b rejections, however the limitations related to the predetermined pressures recited still remain unclear.
Applicant’s arguments filed 12 May 2026 with respect to the rejection of
claims 1, 2, 3, 7, 8, 9, 10, 14, 16, 17, 18, 19, 20, 22, 27, 28, 32, 33, 36, 39, 40, 41, 44, 52 and 53 under 35 U.S.C.101 have been fully considered and are persuasive,
therefore the amendments appear to overcome the previous rejection and the rejection is withdrawn.
Applicant’s arguments filed 12 May 2026 with respect to the rejection of
claims 1-3, 14, 16, 22, 32, 33, 36, 52 under 35 U.S.C.102 have been fully considered and are persuasive in light of the amendments. Regarding claims 1, 28, and 52, the applicant contends that Freeman does not teach “indicative of a quantitative measure of anxiety or stress of the user based on one or more physiological parameters derived from the first physiological data.” The examiner presents reference to [Pg. 60 lines 21-31]—describing MV, TV, and/or RR respiration quantitative components of a predictive algorithm indicating distress, which would therefore fulfill the limitation of quantitative physiological data (MV, TV and RR) indicating stress (“distress”). However, the applicant also contends that Freeman does not teach the amended limitation of “and further requires that the modification of the one or more settings of the respiratory therapy system causes a respiratory therapy device of the respiratory therapy system to supply pressurized air at a predetermined pressure.” The examiner agrees with this assertion. In view of the foregoing, claims 1, 2, 3, 14, 16, 17, 18, 19, 20, 22, 27, 28, 32, 33, 36, 39, 40, 41, 44, 52 and 53 are rejected under 35 U.S.C. 103 citing Freeman in view of Wren.
Applicant’s arguments filed 12 May 2026 with respect to the rejection of
claims 7, 8, 9, and 10 under 35 U.S.C.103 have been fully considered and are persuasive in light of the amendments. Regarding claims 1, 28, and 52, the applicant contends that Freeman does not teach “indicative of a quantitative measure of anxiety or stress of the user based on one or more physiological parameters derived from the first physiological data.” As discussed in the previous response to arguments paragraph, claims 1, 2, 3, 14, 16, 17, 18, 19, 20, 22, 27, 28, 32, 33, 36, 39, 40, 41, 44, 52 and 53 are rejected under 35 U.S.C. 103 citing Freeman in view of Wren. Regarding claims 7, 8, 9, and 10, the applicant contends that:
there is no articulated reasoned motivation in the Office Action as supported by the cited references, to repurpose Freeman's clinical deterioration scoring, Wren's sleep-quality scoring, or Yun's autonomic-modulation protocols into an anxiety/stress-based control scheme, for respiratory pressure delivery during sleep therapy, nor is there any showing that such a combination would have been routine or predictable to a person of ordinary skill at the relevant time. Accordingly, a prima facie case for obviousness cannot be made for claims 1 or 52 over a combination of Freeman, Yun, and Wren, and
None of the cited references teaches or suggests using an emotion-derived anxiety/stress score, relative to a prior emotion score at which the user was able to fall asleep, as the decision criterion for when and how a respiratory device will supply pressurized air at a predetermined pressure.
In response to argument 1—all three references include physiological monitoring during various aspects of sleep cycles and include different methods and characterizations related to scoring and computing the data collected from these methods. Therefore the prima facie case of obviousness to combine Freeman, Yun and Wren is maintained for the rejections under 35 U.S.C. 103 citing Freeman in view of Wren and in further view of Yun for claims 7-10.
In respond to argument 2—Wren teaches the aspect of controlling the delivery of pressurized air at a predetermined pressure based on physiological and other collected sensor data. Since the limitation reciting the anxiety and/or stress scoring involving physiological measurement and data as taught by Freeman, it would have been obvious to combine Freeman in light of Wren to receive physiological data, score and calculate that data based on stress, and then make determinations on that data to select and adjust settings and parameters of pressurized air delivery. In view of the foregoing, claims 7-10 are rejected under 35 U.S.C. 103 citing Freeman in view of Wren.
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.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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