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 .
Status of Claims
Claims 152-154 and 169-191 are currently pending and under examination. Claims 1-151 and 155-168 are canceled. As per the amendments filed on 06/23/2026, claims 152, 154, 189, and 191 are amended.
Priority
The instant application (filed on 08/24/2022) is a national stage of PCT/IB2021/051652 (filed on 02/27/2021) filed under 35 USC 371. Acknowledgment is made of Applicant's claim for domestic priority based on provisional applications 62/982,608 (filed on 02/27/2020) and 63/018,206 (filed on 04/30/2020). Amended claims 152-154 and 169-191 are adequately supported in 62/982,608 to receive the earliest effective filing date of 02/27/2020 for the instant application.
Response to Arguments
Applicant’s arguments, see Remarks page 9 (Claim Rejections - 35 USC § 101), filed 06/23/2026, with respect to the rejections of claims 152-154, 160, and 169-191 under 35 U.S.C. § 101 have been fully considered and are found persuasive. The mental process was integrated into a practical application in canceled claim 160 by using the mental process to change settings on the respiratory therapy device. The relevant limitation from claim 160 has been added to independent claim 152, which therefore integrates the mental process in claim 152 into a practical application. Therefore, the rejections of claims 152-154, 160, and 169-191 are withdrawn.
Applicant’s arguments, see Remarks page 9 (Claim Rejections - 35 USC§ 112), filed 06/23/2026, with respect to the rejections of claims 154 and 189-191 under 35 U.S.C. § 112(b) have been fully considered and are found persuasive. Therefore, the rejections of claims 154 and 189-191 are withdrawn.
Applicant’s arguments, see Remarks pages 9-10 (Claim Rejections - 35 USC§ 102), filed 06/23/2026, with respect to the rejections of claims 152-154 and 174-178 under 35 U.S.C. § 102 have been fully considered. Regarding independent claim 152, Applicant argues:
Heneghan discloses a psychomotor vigilance test (PVT) based fatigue monitoring system used in conjunction with CPAP therapy. Amended claim 152 now recites two additional limitations that are not disclosed in Heneghan.
First, amended claim 152 requires that the control system, "based at least in part on a change between the first score and the second score, for a next therapy session, cause an adjustment to (i) a pressure setting of the supplied pressurized air, (ii) a humidity setting of the supplied pressurized air, or (iii) both." The Office Action itself, in analyzing now canceled dependent claim 160, expressly found that Heneghan does not disclose an adjustment to "(i) a pressure setting of the supplied pressurized air, (ii) humidity setting of the supplied pressurized air, or (iii) both." Office Action p. 15. Because the Office Action has already found that this limitation is absent from Heneghan, the§ 102 anticipation rejection cannot be maintained against amended claim 152.
This argument is persuasive. Heneghan discloses an assessment of the effectiveness of CPAP therapy where more fatigue during the testing period suggests ineffective CPAP usage ([0181]) and a recommendation of changes to improve CPAP therapy are provided ([0056]). However, Heneghan does not disclose "based at least in part on a change between the first score and the second score, for a next therapy session, cause an adjustment to (i) a pressure setting of the supplied pressurized air, (ii) a humidity setting of the supplied pressurized air, or (iii) both." Therefore, the rejection of claim 152 is withdrawn. However, upon further consideration, a new grounds of rejection is made newly in view of Asanoi (US 2019/0083723 A1).
Applicant additionally argues:
Second, amended claim 152 now specifies that the first stimulus and the second stimulus are each generated "by the respiratory therapy system," that is, by the respiratory therapy device, the conduit, and the user interface that together constitute the claimed respiratory therapy system. In contrast, Heneghan discloses that the PVT stimulus is "a light ... presented to a user via a handheld device" and the user's response is "pressing a button" on that handheld device. Heneghan at [0107]. The handheld PVT device described by Heneghan is separate from the CPAP apparatus itself By requiring that the stimulus be generated by the respiratory therapy system, amended claim 152 further distinguishes over Heneghan. (06/23/2026, pages 9-10)
This argument is persuasive. Heneghan discloses a PVT test involving a stimulus such as a light blinking randomly during the assessment period ([0107]). Heneghan also discloses a respiratory system with a CPAP device ([0017]), flexible conduit ([0019]), and user interface such as a nasal or face mask ([0018]). However, Heneghan does not disclose the stimulus as originating from the CPAP system based on the amended limitations “the first test including causing a first stimulus to be generated by the respiratory therapy system at a first point in time when the user is awake” and “the second test including causing a second stimulus to be generated by the respiratory therapy system at a third point in time when the user is awake.” Therefore, the rejection of claim 152 is additionally withdrawn for this reason. However, upon further consideration, a new grounds of rejection is made newly in view of Remmers (US 5,645,053 A1).
Applicant additionally argues:
Heneghan therefore fails to teach every element of amended claim 152, and cannot
anticipate claim 152. Therefore, claim 152, and claims 153, 154, and 169-191 dependent on claim 152 are in condition for allowance over Heneghan. Applicant respectfully requests that the § 102 rejection of claims 152-154 and 174-178 be withdrawn. (06/23/2026, page 10)
This argument is overall persuasive. The rejection of independent claim 152 is withdrawn and the rejections of dependent claims 153-154 and 169-191 are therefore similarly withdrawn. However, upon further consideration, new grounds of rejection are made newly in view of Remmers (US 5,645,053 A1) and Asanoi (US 2019/0083723 A1).
Applicant’s arguments, see Remarks pages 10-12 (Claim Rejections - 35 USC§ 103), filed 06/23/2026, with respect to the rejections of claims 160, 169-173, and 179-191 under 35 U.S.C. § 103 have been fully considered. Regarding canceled claim 160, Applicant argues:
Claim 160 is rejected under U.S.C 103 as allegedly being unpatentable over Heneghan in view of Asanoi, US2019/0083723 (hereinafter "Asanoi"). Applicant disagrees with this rejection. The limitations of claim 160 are now incorporated into claim 152. In rejecting prior claim 160, the Office Action relied on Asanoi for teaching that a "respiratory therapy device uses a physiologic index to change the feeding-out pressure of the device." Office Action p. 15. However, Asanoi's physiologic index and pressure adjustment are directed to evaluating sleep quality based on respiratory waveforms analyzed during sleep. Asanoi does not teach or suggest using a change between alertness scores derived from voluntary waking responses to stimuli, as recited in the amended claims, as the basis for adjusting pressure or humidity settings for a next therapy session.
The indices computed by Asanoi are fundamentally different in nature from the alertness test scores recited in claim 152, which are based on timestamps associated with a stimulus and a voluntary waking response from the user. Thus, even if Heneghan's fatigue monitoring system were combined with Asanoi's pressure adjustment, the combination would not arrive at the claimed system, which requires that the adjustment to pressure or humidity settings be based on a change between scores derived from voluntary alertness testing of a waking user conducted before and after a therapy session. Applicant respectfully submits that a person of ordinary skill in the art would not have been motivated to apply Asanoi's sleep-state-derived pressure adjustment to the waking-user alertness test scores of Heneghan because the two systems measure fundamentally different physiological phenomena under fundamentally different conditions. Applicant respectfully submits that claim 152 is therefore in condition for allowance over Heneghan in view of Asanoi. (06/23/2026, pages 10-11)
This argument is not persuasive. While claim 60 is canceled, the relevant limitation is imported into independent claim 152. Heneghan discloses a respiratory system with a CPAP device ([0017-0019]) which uses the alertness tests as an assessment of the effectiveness of CPAP therapy where more fatigue during the testing period suggests ineffective CPAP usage ([0181]) and a recommendation of changes to improve CPAP therapy are provided ([0056]). Asanoi teaches a respiratory therapy device uses a physiologic index to direct changing a feeding out pressure of the device to improve respiratory therapy ([0081-0082]), where the respiratory therapy device is identified as a CPAP ([0352-0356]).
The Examiner agrees that Heneghan and Asanoi assess fatigue using different tests in relation to the use of a CPAP device. However, Heneghan already teaches fatigue/alertness tests when the user is awake as a means to assess and enhance the effectiveness of CPAP therapy (although the specific modifications are not elaborated on). The teachings of Asanoi are presented as the rationale for using device pressure changes as a type of modification to improve CPAP therapy.
Summary: The prior art rejections for claims 152-154 and 169-191 are withdrawn. New 35 U.S.C. § 103 rejections for claims 152-154 and 169-191, newly in view of Remmers (US 5,645,053 A1) and Asanoi (US 2019/0083723 A1), are added.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C.
103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 152-154, 174-178, and 189-191 are rejected under U.S.C 103 as being unpatentable over Heneghan (US 2016/0270718 A1) in view of Remmers (US 5,645,053 A1) and Asanoi (US 2019/0083723 A1).
Regarding Claim 152, Heneghan discloses a system comprising:
• a respiratory therapy system ([0017], [0056], [0181-0182], [0217]) including a respiratory therapy device ([0017]– a CPAP system providing positive airway pressure), a conduit ([0019] – flexible conduit), and a user interface ([0018] – user interface such as nasal or face masks), the respiratory therapy device being configured to supply pressurized air to an airway of a user by way of the user interface that is coupled to the respiratory therapy device via the conduit ([0017-0019]);
• a memory storing machine-readable instructions ([0074] – memory and processor implementing instructions in memory); and
• a control system including one or more processors configured to execute the machine- readable instructions ([0049], [0056], [0074] – processors implementing instructions) to:
- cause a first test for measuring an alertness level of the user to begin prior to a first therapy session ([0108] – a psychomotor vigilance test (PVT) is performed before the sleep therapy session), the first test including causing a first stimulus to be generated at a first point in time when the user is awake ([0107] – PVT test involves a stimulus such as light being blinked randomly during the assessment period);
- receive a first voluntary response to the first stimulus from the user at a second point in time, the first voluntary response being detected using the respiratory therapy system ([0107] – the user presses a button on a user interface upon seeing the light to assess reaction time);
- determine a first score based at least in part on timestamps associated with (i) the first point in time and (ii) the second point in time ([0107] – average or median reaction time would be the time between the stimulus and user response) ;
- cause the respiratory therapy device to deliver the supplied pressurized air to the user during the first therapy session ([0017], [0056], [0181-0182], [0217] – a CPAP system is used where the fatigue monitoring system is used to inform the use of the CPAP system) ;
- cause a second test for measuring an alertness level of the user to begin after the first therapy session ([0108] – a psychomotor vigilance test (PVT) is performed after the sleep therapy session), the second test including causing a second stimulus to be generated at a third point in time when the user is awake ([0107] – PVT test involves a stimulus such as light being blinked randomly during the assessment period);
- receive a second voluntary response to the second stimulus from the user at a fourth point in time, the second voluntary response being detected using the respiratory therapy system ([0107] – the user presses a button on a user interface upon seeing the light to assess reaction time);
- determine a second score based at least in part on timestamps associated with (i) the third point in time and (ii) the fourth point in time ([0107] – average or median reaction time would be the time between the stimulus and user response); and
- communicate a result associated with the first score and the second score to the user ([0068], [0169-0171] - user information module 185 provides information about the fatigue metrics to the user).
However, Heneghan does not disclose the first or second test causing a stimulus to be generated by the respiratory therapy system.
The CPAP regulation device in Remmers would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the alertness testing system using a respiratory device in the instant application because Remmers teaches a respiratory therapy system which titrates pressures to discover a critical pressure, where respiration after each change is monitored (col 8, lines 10-25). The critical pressure of the CPAP is the lowest effective pressure for treating the obstructive apnea (col 5, lines 8-23). After the settings change is applied (which acts to modify the CPAP air pressure stimulus), the response is measured via variables in the table at col 7, lines 52-66 (which include changes to inspiration, expiration, and total breath time).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Heneghan’s fatigue monitoring system (using a reaction time test to inform CPAP usage) by incorporating the modification of respiratory therapy via the assessment of a user’s response to a pressure change in the device. This would have been obvious because both Heneghan and Remmers incorporate a feedback analysis to determine enhancements of CPAP respiratory therapy. Remmers provides a solution/improvement where a pressure change in the actual CPAP system, rather than a component external to the therapy device, is used as a stimulus to measure the user’s reaction to the therapy to determine a critical pressure. Therefore, a person of ordinary skill in the art would be motivated to modify the reaction time test of Heneghan by incorporating the change in pressure of the CPAP system in Remmers as a possible stimulus for assessing a CPAP user’s reaction.
Heneghan discloses an assessment of the effectiveness of CPAP therapy where more fatigue during the testing period suggests ineffective CPAP treatment ([0181]) and a recommendation of changes to improve CPAP therapy ([0056]). However, Heneghan does not disclose based at least in part on a change between the first score and the second score, for a next therapy session, cause an adjustment to (i) a pressure setting of the supplied pressurized air, (ii) a humidity setting of the supplied pressurized air, or (iii) both.
Asanoi, in the same field of endeavor of characterizing sleep quality to inform changes to respiratory therapy ([0084]), teaches the respiratory therapy device uses a change in the physiologic index to alter the feeding out pressure of the device to improve the respiratory therapy device treatment ([0081-0082]). The respiratory therapy device is identified as a CPAP ([0352-0356]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Heneghan’s fatigue monitoring system (using a reaction time test to inform CPAP usage) by incorporating a pressure setting control for the respiratory device based on a calculated index in Asanoi. This would have been obvious because both Heneghan and Asanoi compute indices to modify respiratory therapy and Asanoi provides a solution/improvement by specifically modifying respiratory device pressure as a control parameter to improve therapy. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Heneghan by incorporating a pressure setting control for the respiratory device based on a calculated index, such as seen in Asanoi.
Regarding Claim 153, the system according to Claim 152 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan further discloses wherein the control system is further configured to execute the machine-readable instructions ([0049], [0056], [0074] – processors implementing instructions) to:
• determine the first score based at least in part on an elapsed time between the first point in time and the second point in time ([0107] – average or median reaction time would be the time between the stimulus and user response, functioning as a score from the PVT test, in the test occurring before sleep in [0108]); and
• determine the second score based at least in part on an elapsed time between the third point in time and the fourth point in time ([0107] – average or median reaction time would be the time between the stimulus and user response, functioning as a score from the PVT test, in the test occurring after sleep in [0108]).
Regarding Claim 154, the system according to Claim 152 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan further discloses wherein the control system is further configured to execute the machine-readable instructions ([0049], [0056], [0074] – processors implementing instructions) to:
• determine the first point in time for causing the first stimulus to be generated or the third point in time for causing the second stimulus to be generated based at least in part on (i) detecting that the user has donned the user interface, (ii) detecting that a sleep state of the user has transitioned to a wakefulness sleep state, (iii) a current time of day, or (iv) an input from the user ([0108] – testing done at certain times throughout a day, such as an hour before bed).
Regarding Claim 174, the system according to Claim 152 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan further discloses wherein the control system is further configured to execute the machine-readable instructions to: receive a first subjective input and a second subjective input from the user via an electronic device associated with the user ([0118-0127] – subjective user data 145 acquired both before and after a sleep session captured via a user device), wherein the first test is further determined based at least in part on the first subjective input and the second test is further determined based at least in part on the second subjective input (Fig. 1, [0068] – subjective user data 145 used to compute an assessment of fatigue state in concert with objective fatigue measures 130, such as PVT). Note Heneghan also states a combination of objective and subjective data is used to assess fatigue ([0048] – “A method of combining objective sleep measures, and optionally activity and other lifestyle parameters, with subjective user data gathered via questionnaire and/or via games to estimate reaction time/vigilance as a proxy for fatigue”).
Regarding Claim 175, the system according to Claim 152 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan further discloses wherein the first test includes a plurality of stimuli ([0107] – multiple stimuli used during PVT test to arrive at average or median reaction time).
Regarding Claim 176, the system according to Claim 175 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan further discloses wherein the first voluntary response includes at least one voluntary response to the plurality of stimuli in the first test, wherein each of the plurality of stimuli in the first test can be responded to by the user ([0107] – the user responds to each stimulus with a button push).
Regarding Claim 177, the system according to Claim 152 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan further discloses wherein the second test includes a plurality of stimuli ([0107] – multiple stimuli used during PVT test to arrive at average or median reaction time).
Regarding Claim 178, the system according to Claim 177 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan further discloses wherein the second voluntary response includes at least one voluntary response to the plurality of stimuli in the second test, wherein each of the plurality of stimuli in the second test can be responded to by the user ([0107] – the user responds to each stimulus with a button push).
Regarding Claim 189, the system according to Claim 152 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan discloses a light is used as the stimulus ([0107]). Heneghan also discloses the use of a CPAP system for therapy where the therapy is modified based on the assessment of the user’s reaction ([0181-0182]). However, Heneghan does not disclose wherein the first stimulus, the second stimulus, or both includes varying a pressure of the pressurized air supplied by the respiratory therapy device, from a first pressure to a second pressure.
As stated in claim 152, the proposed combination with Remmers yields a respiratory therapy system which titrates pressures to discover a critical pressure, where respiration after each change is monitored (col 8, lines 10-25). The critical pressure of the CPAP is the lowest effective pressure for treating the obstructive apnea (col 5, lines 8-23). After the settings change is applied (which acts to modify the CPAP air pressure stimulus), the patient response is measured via variables in the table at col 7, lines 52-66 (which include changes to inspiration, expiration, and total breath time). A person of ordinary skill in the art would be motivated to modify the reaction time test of Heneghan by incorporating the change in pressure of the CPAP system in Remmers as a possible stimulus for assessing a CPAP user’s reaction to therapy.
Regarding Claim 190, the system according to Claim 189 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan discloses a light is used as the stimulus ([0107]). Heneghan also discloses the use of a CPAP system for therapy where the therapy is modified based on a fatigue index ([0181-0182]). However, Heneghan does not disclose wherein the stimulus further includes varying the pressure of the pressurized air back to the first pressure.
As stated in claim 152, the proposed combination with Remmers yields a respiratory therapy system which titrates pressures to discover a critical and optimal pressure, where respiration after each change is monitored (col 8, lines 10-25). The critical and optimal pressures of the CPAP are the lowest effective pressure for treating the obstructive apnea (col 5, lines 8-23). After the settings change is applied (which acts to modify the CPAP air pressure stimulus), the response is measured via variables in the table at col 7, lines 52-66 (which include changes to inspiration, expiration, and total breath time). The titration consists of either step increases or step decreases (col 11, lines 55-60). A person of ordinary skill in the art would be motivated to modify the reaction time test of Heneghan by incorporating the change in pressure of the CPAP system in Remmers as a possible stimulus for assessing a CPAP user’s reaction to therapy.
Regarding Claim 191, the system according to Claim 152 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan discloses a light is used as the stimulus ([0107]). Heneghan also discloses the use of a CPAP system for therapy where the therapy is modified based on a fatigue index ([0181-0182]). However, Heneghan does not disclose wherein the first stimulus, the second stimulus, or both includes the respiratory therapy device (a) stopping supply of the pressurized air to the user or (b) starting the supply of the pressurized air to the user.
As stated in claim 152, the proposed combination with Remmers yields a respiratory therapy system which titrates pressures to discover a critical and optimal pressure, where respiration after each change is monitored (col 8, lines 10-25). The critical and optimal pressures of the CPAP are the lowest effective pressure for treating the obstructive apnea (col 5, lines 8-23). After the settings change is applied (which acts to modify the CPAP air pressure stimulus), the response is measured via variables in the table at col 7, lines 52-66 (which include changes to inspiration, expiration, and total breath time). CPAP application itself (i.e. being on or off the user) is known to affect respiration with a measurable response (col 1, lines 21-50), this being a more pronounced form of the pressure change protocol in Remmers. A person of ordinary skill in the art would be motivated to modify the reaction time test of Heneghan by incorporating the change in pressure via an on/off mechanism of the CPAP system in Remmers as a possible stimulus for assessing a CPAP user’s reaction to therapy.
Claims 169-173, 180, 182-186, and 188 are rejected under U.S.C 103 as being unpatentable over Heneghan (US 2016/0270718 A1) in view of Remmers (US 5,645,053 A1), Asanoi (US 2019/0083723 A1), and Curtiss (US 2015/0094622 A1).
Regarding Claim 169, the system according to Claim 152 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan discloses reaction time tests noting the time between stimuli and a user’s responses ([0107]) both before and after a sleep period ([0108]). Heneghan does not disclose wherein the control system is further configured to execute the machine-readable instructions to:
• provide a first alert to the user prior to causing the first stimulus to be generated, the first alert informing the user of when the first test is to begin; and
• provide a second alert to the user prior to causing the second stimulus to be generated, the second alert informing the user of when the second test is to begin.
Curtiss, in the same field of endeavor of measuring a reaction time of a patient ([0024]), teaches a display device warns the user the response time test is about to begin ([0028] – “Note that one potential use for the display device 230 would be to initiate a response time test (e.g., by changing color, flashing, printing a "START' or other text message, etc.). That being said those of ordinary skill in the art will recognize that a test could be initiated in any number of other ways including, for example, sounding an audible tone, vibrating the device (e.g., using the vibration mode of a phone), etc.”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Heneghan’s fatigue monitoring system (using a reaction time test) by incorporating the warning that a reaction time test is about to begin in Curtiss. This would have been obvious because both Heneghan and Curtiss perform reaction time testing and Curtiss provides a solution/improvement by making sure the user is ready to submit the fastest response to the reaction time test. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Heneghan by incorporating the warning that a reaction time test is about to begin in Curtiss.
Regarding Claim 170, the system according to Claim 169 is obvious over Heneghan in view of Remmers, Asanoi, and Curtiss, as indicated hereinabove. Heneghan discloses reaction time tests noting the time between stimuli and a user’s responses ([0107]) both before and after a sleep period ([0108]). Heneghan does not disclose wherein any of the first alert or the second alert includes:
a prompt on a screen of the respiratory therapy device or on a screen of an electronic device associated with the user,
sound emitted by the electronic device, a speaker partially positioned within a housing of the respiratory therapy device, or a speaker coupled to a housing of the electronic device,
noise generated by a motor of the respiratory therapy device or a motor of the electronic device,
light generated by a light source coupled to the respiratory therapy device or a light source coupled to the electronic device,
vibration of the motor of the respiratory therapy device or the motor of the electronic device, or
any combination thereof.
As stated in claim 169, the proposed combination with Curtiss yields a display device warning the user the response time test is about to begin with a message on a screen, light, audible tone, or vibration of a device ([0028]).
Regarding Claim 171, the system according to Claim 169 is obvious over Heneghan in view of Remmers, Asanoi, and Curtiss, as indicated hereinabove. Heneghan discloses reaction time tests noting the time between stimuli and a user’s responses ([0107]) both before and after a sleep period ([0108]). Heneghan does not disclose wherein the control system is further configured to execute the machine-readable instructions to:
• receive a first acknowledgment to the first alert prior to causing the first stimulus to be generated, the first acknowledgment indicating that the user is ready for the first test to begin;
• receive a second acknowledgment to the second alert prior to causing the second stimulus to be generated, the acknowledgment indicating that the user is ready for the second test to begin.
As stated in claim 169, the proposed combination with Curtiss yields a display device warning the user the response time test is about to begin with a message on a screen, light, audible tone, or vibration of a device ([0028]). Curtiss further teaches the display device requires acknowledgement that the user is ready for the test to begin ([0034] – “The user will then be asked to presses "Begin Test" (step 315) or provide some similar indicium to the recording device to indicate that s/he is ready to begin testing”; [0051] – (1-2)).
Regarding Claim 172, the system according to Claim 171 is obvious over Heneghan in view of Remmers, Asanoi, and Curtiss, as indicated hereinabove. Heneghan discloses reaction time tests noting the time between stimuli and a user’s responses ([0107]) both before and after a sleep period ([0108]). Heneghan does not disclose wherein any of the first acknowledgment or the second acknowledgment includes (i) a touch signal generated by a screen of the respiratory therapy device or a screen of an electronic device associated with the user, (ii) a press signal from a button coupled to a housing of the respiratory therapy device or from a button coupled to a housing of the electronic device, or (iii) voice data that is received via a microphone.
As stated in claim 169, the proposed combination with Curtiss yields a display device warning
the user the response time test is about to begin ([0028]). Curtiss also teaches the display device requires acknowledgement that the user is ready for the test to begin by pressing a button on a screen ([0034]; [0051] – “After the user indicates a readiness to participate by pressing a "Begin Test" or similar on-screen button, a one to four second fore-period or delay (which might be randomly selected) before the stimulus is presented will be used to reduce the likelihood the user will be able to anticipate the stimulus”).
Regarding Claim 173, the system according to Claim 152 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan discloses a button push is used as a mechanism to respond as part of a user input screen ([0107]). However, Heneghan does not disclose wherein the control system is further configured to execute the machine-readable instructions to: receive secondary data including (i) motion data from a motion sensor, (ii) sound data from a microphone, or (iii) both.
Curtiss, in the same field of endeavor of measuring a reaction time of patient ([0024]), teaches user reaction time has traditionally been measured using a tapping response ([0008]). Curtiss teaches a mechanism to record user motion where a detected acceleration is the response to a stimulus during a reaction time test ([0050] – “A reaction time test includes the movement of the device in any axis that breaks a threshold of movement with an analysis of acceleration immediately prior to breaking the threshold to determine when intentional motion had been initiated. One embodiment stores the acceleration values as an array to allow for a reverse analysis of acceleration data points to determine when acceleration started in the direction of intentional movement, determined by breaking the threshold”). Additionally, Curtiss teaches the components of the handheld stimulation device can be integrated into a worn structure on the body ([0028] - “Although some embodiments will be based on an Apple iPhone® that is not a requirement and any device that that can be hand held or worn on the body (such as a wrist watch or glasses) and that contains an accelerometer or gyroscope could potentially be utilized”). The detection of a motion-based response is suggested as a solution to improve the accuracy of reaction time testing due to the deficiencies inherent to detecting a button push ([0008-0012]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Heneghan’s fatigue monitoring system (using a reaction time test) by incorporating the detected movement-based response to stimulation in Curtiss. This would have been obvious because both Heneghan and Curtiss perform reaction time testing and Curtiss provides a solution/improvement by detecting movement via an accelerometer rather than the detection and lag issues which accompany a button push. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Heneghan by incorporating the detected movement-based response to stimulation in Curtiss into the wearable interface in Heneghan.
Regarding Claim 180, the system according to Claim 152 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan discloses a button push is used as a mechanism to respond as part of a user input screen ([0107]). However, Heneghan does not disclose wherein any of the first voluntary response or the second voluntary response includes a purposeful physical contact with or movement of the respiratory therapy device, the user interface, and/or the conduit.
Curtiss, in the same field of endeavor of measuring a reaction time of patient ([0024]), teaches user reaction time has traditionally been measured using a tapping response ([0008]). Curtiss teaches a mechanism to record user motion where a detected acceleration is the response to a stimulus during a reaction time test ([0050]). Additionally, Curtiss teaches the components of the handheld stimulation device can be integrated into a worn structure on the body ([0028]). The detection of a motion-based response is suggested as a solution to improve the accuracy of reaction time testing due to the deficiencies inherent to detecting a button push ([0008-0012]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Heneghan’s fatigue monitoring system (using a reaction time test) by incorporating the detected movement-based response to stimulation in Curtiss. This would have been obvious because both Heneghan and Curtiss perform reaction time testing and Curtiss provides a solution/improvement by detecting movement via an accelerometer rather than the detection and lag issues which accompany a button push. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Heneghan by incorporating the detected movement-based response to stimulation in Curtiss into the wearable interface in Heneghan.
Regarding Claim 182, the system according to Claim 180 is obvious over Heneghan in view of Remmers, Asanoi, and Curtiss, as indicated hereinabove. Heneghan discloses a button push is used as a mechanism to respond as part of a user input screen ([0107]). However, Heneghan does not disclose wherein the purposeful physical contact with or movement of the respiratory therapy device, the user interface, and/or the conduit includes a tap that is detected using the user interface or the conduit.
As stated in claim 180, the proposed combination with Curtiss yields a mechanism to record user motion where a detected acceleration is the response to a stimulus during a reaction time test ([0050]). The Examiner is interpreting tapping as a motion which would cause movement/acceleration in the accelerometer. Additionally, Curtiss teaches the components of the handheld stimulation device can be integrated into a worn structure on the body ([0028]), which could include the worn interface in Heneghan. The detection of a motion-based response is suggested as a solution to improve the accuracy of reaction time testing due to the deficiencies inherent to detecting a button push ([0008-0012]).
Regarding Claim 183, the system according to Claim 180 is obvious over Heneghan in view of Remmers, Asanoi, and Curtiss, as indicated hereinabove. Heneghan discloses a button push is used as a mechanism to respond as part of a user input screen ([0107]). However, Heneghan does not disclose wherein the purposeful physical contact with or movement of the respiratory therapy device, the user interface, and/or the conduit includes a movement of the head of the user that is detected using the user interface or the conduit.
As stated in claim 180, the proposed combination with Curtiss yields a mechanism to record user motion where a detected acceleration is the response to a stimulus during a reaction time test ([0050]). Additionally, Curtiss teaches the components of the handheld stimulation device can be integrated into a worn structure on the body ([0028]), which could include the worn interface in Heneghan. The detection of a motion-based response is suggested as a solution to improve the accuracy of reaction time testing due to the deficiencies inherent to detecting a button push ([0008-0012]).
Regarding Claim 184, the system according to Claim 180 is obvious over Heneghan in view of Remmers, Asanoi, and Curtiss, as indicated hereinabove. Heneghan discloses a button push is used as a mechanism to respond as part of a user input screen ([0107]). However, Heneghan does not disclose a button coupled to the user interface in wherein the purposeful physical contact with or movement of the respiratory therapy device, the user interface, and/or the conduit includes pressing a button coupled to the user interface.
Curtiss, in the same field of endeavor of measuring a reaction time of patient ([0024]), teaches user reaction time has traditionally been measured using a button tapping response ([0004]). Curtiss teaches a mechanism to record user motion where a detected acceleration is the response to a stimulus during a reaction time test ([0050]). Curtiss teaches the components of the handheld stimulation device can be integrated into a worn structure on the body ([0028]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Heneghan’s fatigue monitoring system (using a reaction time test with a button pressing mechanism) by incorporating the integration of components used for detecting reaction responses into a wearable device in Curtiss. This would have been obvious because both Heneghan and Curtiss perform reaction time testing and Curtiss provides a solution/improvement by teaching the integration of rection time elements into a wearable device so the technology is not restricted to a handheld computing/mobile device. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Heneghan by incorporating a button push mechanism into the wearable interface in Heneghan.
Regarding Claim 185, the system according to Claim 152 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan discloses a button push is used as a mechanism to respond as part of a user input screen ([0107]). However, Heneghan does not disclose wherein any of the first voluntary response or the second voluntary response includes a gesture of the user that is detected using a sensor in the respiratory therapy system.
Curtiss, in the same field of endeavor of measuring a reaction time of patient ([0024]), teaches user reaction time has traditionally been measured using a tapping response ([0008]). Curtiss teaches a
mechanism to record user motion where a detected acceleration is the response to a stimulus during a reaction time test ([0050]). The Examiner is interpreting the gesture as a motion which would cause movement/acceleration in the accelerometer. Additionally, Curtiss teaches the components of the handheld stimulation device can be integrated into a worn structure on the body ([0028]). The detection of a motion-based response is suggested as a solution to improve the accuracy of reaction time testing due to the deficiencies inherent to detecting a button push ([0008-0012]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Heneghan’s fatigue monitoring system (using a reaction time test) by incorporating the detected movement-based response to stimulation in Curtiss. This would have been obvious because both Heneghan and Curtiss perform reaction time testing and Curtiss provides a solution/improvement by detecting movement via an accelerometer rather than the detection and lag issues which accompany a button push. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Heneghan by incorporating the detected movement-based response to stimulation in Curtiss into the wearable interface in Heneghan.
Regarding Claim 186, the system according to Claim 185 is obvious over Heneghan in view of Remmers, Asanoi, and Curtiss, as indicated hereinabove. Heneghan discloses a button push is used as a mechanism to respond as part of a user input screen ([0107]). However, Heneghan does not disclose wherein the gesture includes a hand movement, a head movement, or a facial movement of the user that is detected using a sensor in the respiratory therapy system.
As stated in claim 185, the proposed combination with Curtiss yields a mechanism to record user motion where a detected acceleration is the response to a stimulus during a reaction time test ([0050]). Additionally, Curtiss teaches the components of the handheld stimulation device can be integrated into a worn structure on the body ([0028]), which could include the worn interface in Heneghan. The detection of a motion-based response is suggested as a solution to improve the accuracy of reaction time testing due to the deficiencies inherent to detecting a button push ([0008-0012]).
Regarding Claim 188, the system according to Claim 152 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan discloses a light is used as the stimulus ([0107]). Heneghan does not disclose: wherein any of the first stimulus or the second stimulus includes
light generated by a light source coupled to the respiratory therapy device, the conduit, the user interface, or any combination thereof,
sound generated by a speaker coupled to a housing of the respiratory therapy device, the conduit, or the user interface,
vibration generated by a motor of the respiratory therapy device, or
(iv) any combination of (i), (ii), and (iii).
Curtiss, in the same field of endeavor of measuring a reaction time of patient ([0024]), teaches the stimulus can either be a visual, auditory, or vibratory signal ([0039]). Curtiss also teaches the components of the handheld stimulation device can be integrated into a worn structure on the body ([0028]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Heneghan’s fatigue monitoring system (using a reaction time test) by incorporating stimulus types for reaction time testing in Curtiss. This would have been obvious because both Heneghan and Curtiss perform reaction time testing and Curtiss provides a solution/improvement by using a variety of different stimuli which use different perception pathways with unique minimum reaction times. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Heneghan by incorporating the stimulus types for reaction time testing in Curtiss into the wearable interface in Heneghan.
Claim 179 is rejected under U.S.C 103 as being unpatentable over Heneghan (US 2016/0270718 A1) in view of Remmers (US 5,645,053 A1), Asanoi (US 2019/0083723 A1), and Kremer (US 2019/0030278 A1).
Regarding Claim 179, the system according to Claim 152 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan discloses a guided respiration routine for use during CPAP therapy ([0182]). However, Heneghan does not disclose wherein any of the first voluntary response or the second voluntary response includes an expelled air current from the user that is detected using the user interface, the conduit, the respiratory therapy device, or any combination thereof.
The respiratory therapy device in Kremer ([0003]) would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the alertness testing system using a respiratory device in the instant application because Kremer teaches entrainment of respiration where a stimulus ([0053] – “Various examples may provide entrainment cues by visible means (e.g., light components, displays, etc.), haptic (e.g., vibration, tactile) means, audible means, or any combination of these”) emitted by a handheld or worn device ([0053]) provides a stimulus which the user attempts to match with a respiration response ([0054]). A biometric sensor measures real-time respiration and assesses how well the user creates respirations in response to the entrainment stimuli, where the ability of the user to manually follow entrainment is impaired as the user transitions into an autonomic pattern during drowsiness ([0078]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Heneghan’s fatigue monitoring system (using a reaction time test) by incorporating the measured manual respiratory response to a stimulus in Kremer. This would have been obvious because both Heneghan and Kremer perform sensory stimulus and response testing and Kremer provides a solution/improvement by measuring a manual respiratory response to a recurring stimulus over a time period to assess user relaxation and alertness (which uses different nervous pathways than the button pushing alertness testing in Heneghan) to give a more comprehensive measure of alertness. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Heneghan by incorporating the measured manual respiratory response to a stimulus in Kremer.
Claim 181 is rejected under U.S.C 103 as being unpatentable over Heneghan (US 2016/0270718 A1) in view of Remmers (US 5,645,053 A1), Asanoi (US 2019/0083723 A1), and Mott (US 2012/0191425 A1).
Regarding Claim 181, the system according to Claim 152 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan further discloses wherein the control system is further configured to execute the machine-readable instructions to: determine a predicted first score associated with the first score or a predicted second score associated with the second score, the predicted first score based on a mode of obtaining responses associated with the first voluntary response, and the predicted second score based on a mode of obtaining responses associated with the second voluntary response (Fig. 7, [0214] – predicted reaction time tests compared to measured reaction time tests). However, Heneghan does not disclose (i) the first score is accurate based on the first score being within a percentage threshold of the predicted first score, (ii) the second score is accurate based on the second score being within a percentage threshold of the predicted second score.
Mott, in same field of endeavor of characterizing a patient’s alertness as a feedback mechanism ([0002]), teaches:
• determining that the score is accurate based on the score being within a percentage threshold of the predicted score ([0025] – reaction time testing, [0123] – a statistical test using confidence interval thresholds is used to compare the predicted and actual scores to assess accuracy where the predicted scores are meant to match the actual as closely as possible: “It can be seen from comparing the future alertness predictions 312A-312D, to the actual future alertness 310A-310D, that the future alertness predictions 312A-312D improve in accuracy with an increasing number of alertness measurements 306A-306D, and even a few measurements make a difference. It can also be seen from FIGS. SA-SD, that the 95% confidence intervals 314A-314D of the future alertness predictions tends to decrease with an increasing number of alertness measurements 306A-306D”).
Mott teaches “The mathematical model and/or prediction techniques may incorporate effects of the subject's sleep timing, the subject's intake of biologically active agents (e.g. caffeine) and/or the subject's circadian rhythms. The mathematical model and/or prediction techniques may incorporate feedback from the subject's measured alertness and/or performance” ([0005]), “Over time, probability distributions of the model variables may be updated using recursive statistical estimation to combine new alertness or performance measurements and the previous estimates about the probability distributions of the model variables” ([0006]), and “The width of the probability distribution that is assumed for the noise (e.g. variance of Ek) associated with alertness measurements Yk may determine the degree of accuracy, and thus the amount of new information that is gained from the alertness measurement yk” ([0098]). This predictive model of alertness would enhance accuracy by allowing data -driven estimates of alertness to provide information about the noise content of actual measurements.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Heneghan’s fatigue monitoring system using a reaction time test by incorporating the alertness prediction statistical model in Mott. This would have been obvious because both Heneghan and Mott perform reaction time testing and Mott provides a solution/improvement by providing a statistical method for determining whether the predicted values are significantly different from actual values to validate the predictive utility of the model in Heneghan. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Heneghan by incorporating the alertness prediction statistical model in Mott.
Claim 187 is rejected under U.S.C 103 as being unpatentable over Heneghan (US 2016/0270718 A1) in view of Remmers (US 5,645,053 A1), Asanoi (US 2019/0083723 A1), and
Singhal (US 2007/0024454 A1).
Regarding Claim 187, the system according to Claim 152 is obvious over Heneghan in view of Remmers and Asanoi, as indicated hereinabove. Heneghan discloses a button push is used as a mechanism to respond as part of a user input screen ([0107]). However, Heneghan does not disclose wherein any of the first voluntary response or the second voluntary response includes a voice of the user that is detected using a microphone in the respiratory therapy system.
Singhal, in the same field of endeavor of measuring a reaction time of the user ([0049]), teaches
a reaction time is calculated between a prompt question (stimulus) and a user’s voice response to the prompt question ([0073], [0096-0097]). The reaction time test is used to assess the level of mental impairment due to alcohol consumption ([0095]), where this impairment could be likened to impairment from fatigue as measured in Heneghan.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Heneghan’s fatigue monitoring system using a reaction time test by incorporating the voice response to a stimulus in a reaction time test in Singhal. This would have been obvious because both Heneghan and Singhal perform reaction time testing and Singhal provides a solution/improvement by using a voice response reaction test to test auditory sensory pathways for responding to and assessing the level of impairment. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Heneghan by incorporating the voice response to a stimulus in a reaction time test in Singhal.
Conclusions
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 9:00 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
Prosecution Insights