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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/08/2025 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/08/2025 and 02/09/2026 are being considered by the examiner.
Status of Claims
Claims 115, 117, 119, 122, 124-125, 129, 137-139, 141-143, 152-154, 160, and 169-191 are currently pending. Claims 1-2, 5-7, 9, 12-13, 15, 18, 23, 25-26, 126-128, 130-136, 140, 144-151, 155-159, and 161-168 are cancelled. Claims 115, 117, 119, 122, 124-125, 129, 137-139, and 141-143 are withdrawn. As per the amendments filed on 12/08/2025, claims 152, 173, 176, and 178-181 are amended and claims 182-191 are newly added. Claims 152-154, 160, and 169-191 are under examination.
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). Claims 152-154, 160, and 169-191 are sufficiently described in 62/982,608 to receive an effective filing date of 02/27/2020 for the instant application. Therefore, all prior art will be evaluated with respect to this date
Response to Arguments
Applicant’s arguments, see Remarks pages 9-11 (Claim Rejections - 35 USC§ 103), filed 12/08/2025, with respect to the 35 U.S.C. § 103 rejections of claim 152 over Asanoi (US PG Pub 2019/0083723 A1) in view of Heneghan (US PG Pub 2016/0270718 A1) have been fully considered. Applicant argues:
Claim 152 is amended to recite, " ... the first test including causing a first stimulus to be generated at a first point in time when the user is awake; receive a first voluntary response to the first stimulus from the user at a second point in time ... " and "the second test including causing a second stimulus to be generated at a third point in time when the user is awake; receive a second voluntary response to the second stimulus from the user at a fourth point in time ... " As noted in the prior response, Asanoi describes "a sleep evaluation system on the basis of respiratory waveform." Asanoi [0126], see also FIG. 1. Asanoi describes a "CPAP device 21a" having a "respiratory waveform detection amplification unit" and a "sleep-state analysis unit." See, e.g., Id at [0368]-[0373] and FIG. 34. Asanoi also describes a "sleep inducing device 22a" having a "respiratory waveform detection amplification unit" and "a sleep-state analysis unit." See, e.g., Id at [0414]-[0420] and FIG. 35.
Asanoi is directed "to evaluate the comfort level including the quality of sleep," whereas the current application is directed to the alertness of a waking user based on the sleep that the user previously experienced. The voluntary response is an action consciously taken by the user in response to the stimulus, which the user can do because he is awake. (See, e.g., paragraphs [0085][0094]). The voluntary response includes an expelled air current ([0085]-[0089]), or a purposeful physical contact with or movement of the respiratory therapy device, the user interface, and/or the conduit ([0090] and [0091 ]). The voluntary response further includes gestures ([0092] and [0093 ]), and/or the voice of the user ([0094]). In contrast, any "response" from the user in Asanoi can only be involuntary because the user in Asanoi is sleeping. Thus, it makes sense that Asanoi does not disclose, suggest, or even contemplate claim 152 as a whole or in particular the limitations "cause a first test for measuring an alertness level of the user to begin prior to a first therapy session, the first test including causing a first stimulus to be generated at a first point in time when the user is awake; receive a first voluntary response to the first stimulus from the user at a second point in time, the first response being detected using the respiratory therapy system;" and "cause a second test for measuring an alertness level of the user to begin after the first therapy session, the second test including causing a second stimulus to be generated at a third point in time when the user is awake; receive a second voluntary response to the second stimulus from the user at a fourth point in time, the second response being detected using the respiratory therapy system." (12/08/2025 Remarks, pages 9-10)
This argument is persuasive. Applicant has amended to require a voluntary response and that the test occurs before and after a treatment session when the user is awake, which is not taught in Asanoi. Therefore, the rejection of claim 152 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Heneghan, see “Claim Rejections - 35 USC § 102” section.
Applicant also argues:
Heneghan does not cure the deficiency of Asanoi in regard to claim 152. No combination of Asanoi and Heneghan discloses, suggests, or contemplates claim 152 as a whole or the particular limitations noted above. Thus, a prima facie case for obviousness cannot be made for claim 152 over Asanoi and Heneghan. Claims 153, 154, 160, 173-179 are also in condition for allowance over Asanoi and Heneghan as being dependent on an allowable base claim. Applicant respectfully requests that the section 103 rejections of claims 152-154, 160, and 173-179 be withdrawn. No combination of Yoo, Shouldice, and Mott cures the deficiencies of Asanoi and Heneghan in regard to claim 152. Therefore, claims 169-172, 180, and 181, dependent on claim 152, are in condition for allowance as being dependent on an allowable base claim. Applicant respectfully requests that the section 103 rejections of claims 169-172, 180, and 181 be withdrawn. (12/08/2025 Remarks, page 10)
The argument is overall persuasive in that the rejections of claims 153-154, 160, and 169-181 are withdrawn due to claim 152’s 103 rejection being withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Heneghan (which the Examiner interprets as disclosing the limitations of claim 152), see new prior art rejections.
Applicant also argues:
Withdrawn claim 115 has been amended to include the test being generated "when the user is awake," and a "voluntary response to the stimulus from the user...the voluntary response including an expelled air current from the user that is detected using the respiratory therapy device." As noted above, no combination of the cited prior art discloses, suggests, or contemplates the limitations of generation of a stimulus for a user while awake, and receipt of a voluntary response to the stimulus from the user. Thus, no combination of the cited prior art discloses, suggests or contemplates claim 115 as a whole, or the particular limitations noted above. Applicant respectfully requests rejoinder of claims 115, 142, and 143. (12/08/2025 Remarks, page 11)
The argument is not persuasive. Claim 152 has been newly rejected as anticipated by Heneghan and would prevent the request for rejoinder regarding claim 115 and claim 115’s dependent claims.
Newly added claims 182-191 are evaluated in light of the above arguments and rejected under 35 U.S.C. § 103, see “Claim Rejections - 35 USC § 103” section.
Summary: The 35 U.S.C. § 103 rejections of claims 152-154, 160, and 169-181 are withdrawn. New 35 U.S.C. § 102 rejections of claims 152-154 and 174-178 over Heneghan are added. New 35 U.S.C. § 103 rejections of claims 160, 169-173, and 179-191 are added.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 152-154, and 169-191 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (a mental process) without significantly more.
Step 1
The invention in 152-154, 160, and 169-191 is to a statutory subject matter as the claims recite a respiratory therapy device.
Step 2A, Prong One
Claim 152 recites abstract ideas in the form of mental processes that "can be performed in the human mind, or by a human using a pen and paper" (see MPEP 2106.04(a)(2) subsection (III)).
Regarding Claim 152, the limitations “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” and “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” could be performed by the human mind.
Step 2A, Prong Two
For the claim 152 limitations from Step 2A Prong One, the claims do not recite additional elements that integrate the judicial exceptions into a practical application. Additional elements from claim 152 include: “a respiratory therapy device,” “a conduit,” and “a user interface” which link the exception to a particular technological environment or field of use and “control system including one or more processors” describes a generic computer structure for performing generic computer functions.
The processors additionally “cause a first test for measuring an alertness level of the user to begin prior to a first therapy session, the first test including causing a first stimulus to be generated at a first point in time when the user is awake; 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” and “cause a second test for measuring an alertness level of the user to begin after the first therapy session, the second test including causing a second stimulus to be generated at a third point in time when the user is awake; 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,” which are insignificant extra-solution activities of data gathering. The limitation “cause the respiratory therapy device to deliver the supplied pressurized air to the user during the first therapy session” only links the exception to a particular technological environment or field of use because the exception is not integrated into how the supplied pressurized air is applied.
Dependent claims 153-154, 174, and 181 further describe the mental process of score determination.
Dependent claims 154, 169-180, and 182-191 recite further insignificant extra-solution activities of data gathering.
Dependent claim 160 integrates the mental process into a determination of respiratory therapy settings applied to the therapy device (practical application).
Step 2B
For the claim 152 limitations from Step 2A Prong One, the claims do not recite additional elements that are sufficient to amount to significantly more than the judicial exception. Additional elements from claim 152 include: “a respiratory therapy device,” “a conduit,” and “a user interface” which link the exception to a particular technological environment or field of use and “control system including one or more processors” describes a generic computer structure for performing generic computer functions.
The processors additionally cause “cause a first test for measuring an alertness level of the user to begin prior to a first therapy session, the first test including causing a first stimulus to be generated at a first point in time when the user is awake; 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” and “ cause a second test for measuring an alertness level of the user to begin after the first therapy session, the second test including causing a second stimulus to be generated at a third point in time when the user is awake; 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,” which are insignificant extra-solution activities of data gathering. The limitation “cause the respiratory therapy device to deliver the supplied pressurized air to the user during the first therapy session” only links the exception to a particular technological environment or field of use because the exception is not integrated into how the supplied pressurized air is applied. CPAP machines (see Heneghan [0017-0021]) and indices such as reaction time tests (see Heneghan [0107]) are established in the art.
Dependent claims 153-154, 174 and 181 further describes the mental process of score determination.
Dependent claims 153-154, 169-180, and 182-191 recite further insignificant extra-solution activities of data gathering.
Dependent claim 160 integrates the mental process into a determination of respiratory therapy settings.
Therefore, Claims 152-154 and 169-191 are directed to a judicial exception, as abstract ideas (mental processes), without significantly more. Claim 160 integrates the judicial exception into a practical application.
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 154 and 189-191 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.
Claims 154: The limitation “determine the first point in time for causing the first stimulus to be generated or the second point in time for causing the second stimulus to be generated based at least in part on” is unclear if the “second point in time” is the reaction to the first stimulus (as established in the parent claim) or the second stimulus time (which is previously established as the “third point in time” in the parent claim).
Claims 189 and 191: The term “the stimulus” lacks an antecedent basis as only “first stimulus”
and “second stimulus” are used throughout the rest of the examined claims.
Dependent claim 190 is rejected for being dependent on a rejected claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 152-154 and 174-178 are rejected under U.S.C 102(a)(1) and U.S.C 102(a)(2) as being anticipated by Heneghan (US PG Pub 2016/0270718 A1, see previously cited).
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).
Therefore, Claim 152 is anticipated by Heneghan.
Regarding Claim 153, Heneghan anticipates the system according to Claim 152, 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]).
Therefore, Claim 153 is anticipated by Heneghan.
Regarding Claim 154, Heneghan anticipates the system according to Claim 152, 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 second 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).
Therefore, Claim 154 is anticipated by Heneghan.
Regarding Claim 174, Heneghan anticipates the system according to Claim 152, 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”).
Therefore, Claim 174 is anticipated by Heneghan.
Regarding Claim 175, Heneghan anticipates the system according to Claim 152, 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).
Therefore, Claim 175 is anticipated by Heneghan.
Regarding Claim 176, Heneghan anticipates the system according to Claim 175, 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).
Therefore, Claim 176 is anticipated by Heneghan.
Regarding Claim 177, Heneghan anticipates the system according to Claim 152, 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).
Therefore, Claim 177 is anticipated by Heneghan.
Regarding Claim 178, Heneghan anticipates the system according to Claim 177, 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).
Therefore, Claim 178 is anticipated by Heneghan.
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.
Claim 160 is rejected under U.S.C 103 as being unpatentable over Heneghan (US PG Pub 2016/0270718 A1, see previously cited) in view of Asanoi (US PG Pub 2019/0083723 A1, see previously cited).
Regarding Claim 160, Heneghan anticipates the system according to Claim 152, as indicated hereinabove. Heneghan further discloses wherein the control system is further configured to execute the machine-readable instructions to: based at least in part on the change between the first score and the second score, for a next therapy session, cause an adjustment ([0181] - assess the effectiveness of CPAP therapy where more fatigue during the testing period suggests ineffective CPAP usage; [0056] - recommends changes to improve CPAP therapy). However, 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.
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 physiologic index to change 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 in Asanoi.
Therefore, Claim 160 is obvious over Heneghan in view of Asanoi.
Claims 169-173, 180, 182-186, and 188 are rejected under U.S.C 103 as being unpatentable over Heneghan (US PG Pub 2016/0270718 A1, see previously cited) in view of Curtiss (US PG Pub 2015/0094622 A1, see “Notice of References Cited”).
Regarding Claim 169, Heneghan anticipates the system according to Claim 152, as indicated hereinabove. Heneghan discloses reaction time tests noting the time between stimuli and a user response ([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.”).
49. 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.
Therefore, Claim 169 is obvious over Heneghan in view of Curtiss.
Regarding Claim 170, the system according to Claim 169 is obvious over Heneghan in view of Curtiss, as indicated hereinabove. Heneghan discloses reaction time tests noting the time between stimuli and a user response ([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.
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 with a message on a screen, light, audible tone, or vibration of a device ([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.”).
49. 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.
Therefore, Claim 170 is obvious over Heneghan in view of Curtiss.
Regarding Claim 171, the system according to Claim 169 is obvious over Heneghan in view of Curtiss, as indicated hereinabove. Heneghan discloses reaction time tests noting the time between stimuli and a user response ([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.
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]). Curtiss also 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)).
49. 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.
Therefore, Claim 171 is obvious over Heneghan in view of Curtiss.
Regarding Claim 172, the system according to Claim 171 is obvious over Heneghan in view of Curtiss, as indicated hereinabove. Heneghan discloses reaction time tests noting the time between stimuli and a user response ([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.
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]). 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] – “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] – (2) – “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”).
49. 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.
Therefore, Claim 172 is obvious over Heneghan in view of Curtiss.
Regarding Claim 173, Heneghan anticipates the system according to Claim 152, 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]).
49. 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.
Therefore, Claim 173 is obvious over Heneghan in view of Curtiss.
Regarding Claim 180, Heneghan anticipates the system according to Claim 152, 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] – “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]).
49. 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.
Therefore, Claim 180 is obvious over Heneghan in view of Curtiss.
Regarding Claim 182, the system according to Claim 180 is obvious over Heneghan in view of 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.
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 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]). 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]).
49. 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.
Therefore, Claim 182 is obvious over Heneghan in view of Curtiss.
Regarding Claim 183, the system according to Claim 180 is obvious over Heneghan in view of 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.
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]).
49. 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.
Therefore, Claim 183 is obvious over Heneghan in view of Curtiss.
Regarding Claim 184, the system according to Claim 180 is obvious over Heneghan in view of 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]).
49. 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.
Therefore, Claim 184 is obvious over Heneghan in view of Curtiss.
Regarding Claim 185, Heneghan anticipates the system according to Claim 152, 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] - “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]).
49. 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.
Therefore, Claim 185 is obvious over Heneghan in view of Curtiss.
Regarding Claim 186, the system according to Claim 185 is obvious over Heneghan in view of 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.
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]).
49. 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.
Therefore, Claim 186 is obvious over Heneghan in view of Curtiss.
Regarding Claim 188, Heneghan anticipates the system according to Claim 152, as indicated hereinabove. Heneghan discloses a light is used as the stimulus ([0107] – “In one example of a PVT, a light is presented to a user via a handheld device at random times, to which the user must respond by pressing a button”). 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] – “Next in some embodiments a stimulus will be presented to the user (step 325). The stimulus might take many forms. In some embodiments the stimulus will be presented by printing a text message on the screen, changing the color of the screen, flashing the handheld devices camera flash, etc. In other instances, an audible tone or vibration of the device might be utilized as the stimulus”). Curtiss also teaches the components of the handheld stimulation device can be integrated into a worn structure on the body ([0028]).
49. 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 stimuli 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 stimuli types for reaction time testing in Curtiss.
Therefore, Claim 188 is obvious over Heneghan in view of Curtiss.
Claim 179 is rejected under U.S.C 103 as being unpatentable over Heneghan (US PG Pub 2016/0270718 A1, see previously cited) in view of Kremer (US PG Pub 2019/0030278 A1, see “Notice of References Cited”).
Regarding Claim 179, Heneghan anticipates the system according to Claim 152, 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.
Kremer, in the same field of endeavor of respiratory therapy ([0003]), 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]).
49. 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.
Therefore, Claim 179 is obvious over Heneghan in view of Kremer.
Claim 181 is rejected under U.S.C 103 as being unpatentable over Heneghan (US PG Pub 2016/0270718 A1, see previously cited) in view of Mott (US PG Pub 2012/0191425 A1, see previously cited).
Regarding Claim 181, Heneghan anticipates the system according to Claim 152, 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.
Therefore, Claim 181 is obvious over Heneghan in view of Mott.
Claim 187 is rejected under U.S.C 103 as being unpatentable over Heneghan (US PG Pub 2016/0270718 A1, see previously cited) in view of Singhal (US PG Pub 2007/0024454 A1, see “Notice of References Cited”).
Regarding Claim 187, Heneghan anticipates the system according to Claim 152, 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.
49. 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.
Therefore, Claim 186 is obvious over Heneghan in view of Singhal.
Claims 189-191 are rejected under U.S.C 103 as being unpatentable over Heneghan (US PG Pub 2016/0270718 A1, see previously cited) in view of Remmers (US 5,645,053 A1, see “Notice of References Cited”).
Regarding Claim 189, Heneghan anticipates the system according to Claim 152, as indicated hereinabove. Heneghan discloses a light is used as the stimulus ([0107] – “In one example of a PVT, a light is presented to a user via a handheld device at random times, to which the user must respond by pressing a button”). 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 includes varying a pressure of the pressurized air supplied by the respiratory therapy device, from a first pressure to a second pressure.
Remmers, in the same field of endeavor of characterizing sleep quality to inform changes to respiratory therapy (col 2, lines 30-42), teaches a respiratory therapy device titrating pressure changes in order to discover a critical pressure where respiration after the pressure change is monitored (col 8, lines 10-25). After the settings change is applied (which acts to modify the CPAP air pressure stimulus), the response via variables in the table at col 7, lines 52-66 (which include changes to inspiration, expiration, and total breath time) is measured. The critical pressure of the CPAP is the lowest effective pressure for treating the obstructive apnea (col 5, lines 8-23).
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 titration process in a respiratory therapy device to identify timing responses to respiration in Remmers. This would have been obvious because both Heneghan and Remmers assess modifications to enhance CPAP respiratory therapy and Remmers provides a solution/improvement by increasing or decreasing CPAP pressure to find the minimum effective pressure able to create the desired respiratory timing response. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Heneghan by incorporating a pressure titration process in a respiratory therapy device to identify timing responses to respiration in Remmers.
Therefore, Claim 189 is obvious over Heneghan in view of Remmers.
Regarding Claim 190, the system according to Claim 189 is obvious over Heneghan in view of Remmers, as indicated hereinabove. Heneghan discloses a light is used as the stimulus ([0107] – “In one example of a PVT, a light is presented to a user via a handheld device at random times, to which the user must respond by pressing a button”). 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.
Remmers, in the same field of endeavor of characterizing sleep quality to inform changes to respiratory therapy (col 2, lines 30-42), teaches a respiratory therapy device titrating pressure changes in order to discover a critical pressure where respiration after the pressure change is monitored (col 8, lines 10-25). After the settings change is applied (which acts to modify the CPAP air pressure stimulus), the response via variables in the table at col 7, lines 52-66 (which include changes to inspiration, expiration, and total breath time) is measured. The critical pressure of the CPAP is the lowest effective pressure for treating the obstructive apnea (col 5, lines 8-23).
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 titration process in a respiratory therapy device to identify timing responses to respiration in Remmers. This would have been obvious because both Heneghan and Remmers assess modifications to enhance CPAP respiratory therapy and Remmers provides a solution/improvement by increasing or decreasing CPAP pressure to find the minimum effective pressure able to create the desired respiratory timing response. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Heneghan by incorporating a pressure titration process in a respiratory therapy device to identify timing responses to respiration in Remmers.
Therefore, Claim 190 is obvious over Heneghan in view of Remmers.
Regarding Claim 191, Heneghan anticipates the system according to Claim 152, as indicated hereinabove. Heneghan discloses a light is used as the stimulus ([0107] – “In one example of a PVT, a light is presented to a user via a handheld device at random times, to which the user must respond by pressing a button”). 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 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.
Remmers, in the same field of endeavor of characterizing sleep quality to inform changes to respiratory therapy (col 2, lines 30-42), teaches a respiratory therapy device titrating pressure changes in order to discover a critical pressure where respiration after the pressure change is monitored (col 8, lines 10-25). After the settings change is applied (which acts to modify the CPAP air pressure stimulus), the response via variables in the table at col 7, lines 52-66 (which include changes to inspiration, expiration, and total breath time) is measured. The critical pressure of the CPAP is the lowest effective pressure for treating the obstructive apnea (col 5, lines 8-23). CPAP application itself (i.e. being on/off the user) is known to have an effect on respiration with a measurable response (col 1, lines 21-50).
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 an on/off feature of CPAP to identify timing responses in respiration during CPAP in Remmers. This would have been obvious because both Heneghan and Remmers assess modifications to enhance CPAP respiratory therapy and Remmers provides a solution/improvement by characterizing respiration with and without CPAP support (which would be considered a more general setting than the pressure titration in instant claims 189-190). Therefore, a person of ordinary skill in the art would be motivated to improve the system of Heneghan by incorporating an on/off feature of CPAP to identify timing responses in respiration during CPAP in Remmers.
Therefore, Claim 191 is obvious over Heneghan in view of Remmers.
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 8:30 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796