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 .
Information Disclosure Statement
The Information Disclosure Statements (IDS) dated 02/12/2025, 09/03/2025, 12/03/2025, and 01/06/2026 have been considered by the Examiner.
Claim Objections
Claim 10 objected to because of the following informalities: Claim 10 is dependent upon ‘The method of claim 1,’ however, claim 1 is directed towards a medical device. Examiner is interpreting the claim as being dependent on the medical device of claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1 and 14 are directed to the abstract idea of determining if an apnea event has occurred based on measured signals, where the measured signals may be heart rate signals or impedance signals.
Step 1
Claim 1 recites a machine and claim 14 recites a method.
Step 2A, Prong 1
Claims 1 and 14 recite the limitations of determining heart rates of a patient based on the cardiac signal sensed during a first period;
detecting one or more sleep apnea episodes of the patient occurring during the first period based on the heart rates;
determining whether one or more verification conditions are satisfied; and
in a case where the verification conditions are satisfied, detecting one or more sleep apnea episodes of a patient occurring during a second period after the first period based on measured impedances.
These steps, under their broadest reasonable interpretation, could be practically performed in the human mind (and/or with the aid of pencil and paper) and are thereby considered to be directed to an abstract idea/mental process. A human could observe a heart rate signal at a first time and determine an apnea episode as a result of irregular heart rates, and determine whether the apnea episode met a verification threshold. In the case that the heart rate detected apnea episode met a verification threshold, a human could then observe an impedance signal measured at a second time after the first time, and detect the occurrence of an apnea episode based on the measured impedances. The claimed invention is directed to a mental process in the form of an observation and evaluation.
Step 2A, Prong 2
Claims 1 and 14 do not include any additional elements that integrate the abstract idea into a practical application.
Claims 1 and 14 include the additional elements of one or more electrodes, sensing circuitry configured to sense a cardiac signal and an impedance signal, and processing circuitry configured to detect one or more sleep apnea episodes in the measured signals.
The electrodes are used as a means to gather data and merely generically link the use of the judicial exception to a particular technological environment.
The sensing circuitry configured to sense a cardiac signal and an impedance signal is identified as extra-solution activity in the form of data gathering as performing clinical tests to obtain an input for an equation, wherein the data gathered is a cardiac signal and/or impedance signal which acts as input to detect an apnea episode. See MPEP 2106.05(g), In re Grams, 888 F.2d 835.
The processing circuitry configured to detected one or more sleep apnea episodes in the detected signals is merely generic computer implementation of the abstract idea.
Step 2B
Claims 1 and 14 do not include any additional elements which amount to significantly more than the abstract idea.
Claims 1 and 14 include the additional elements of one or more electrodes, sensing circuitry configured to sense a cardiac signal and an impedance signal, and processing circuitry configured to detect one or more sleep apnea episodes in the measured signals. As discussed above under Step 2A, Prong 2, these additional elements have been identified as extra-solution activity and generic computer implementation of the abstract idea. Additionally, the additional elements of one or more electrodes, sensing circuitry configured to sense a cardiac signal and an impedance signal, and processing circuitry configured to detect one or more sleep apnea episodes in the measured signals can be held to be well-understood, routine, and conventional in the art; and they are recited with a high level of generality which does not amount to significantly more than the abstract idea itself.
Claims 2-5, 9-13, 15, and 19-20 further define the abstract idea itself.
Claims 6-8 and 16-18 further limit the extra-solution activity of data gathering.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1, 2, 5-10, 11, 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cho et al (US 20050119711 A1).
Regarding claim 1, Cho teaches a medical device (10) comprising:
one or more electrodes (22, 24);
sensing circuitry (30) configured to:
sense a cardiac signal indicating activity of a heart of a patient (see [0034]; atrial electrode 22 detects atrial depolarizations and ventricular electrode 24 detects ventricular depolarization); and
measure impedances of the patient via the one or more electrodes (see [0042]; impedance sensing circuit 63 may be used for measuring thoracic impedance for the purposes of deriving a minute volume); and
processing circuitry (32) configured to:
determine heart rates of the patient based on the cardiac signal sensed during a first period (see [0034]; sensed P-P intervals or sensed R-R intervals, or the associated heart rate determined from the sensed intervals are monitored for the detection of apnea);
detect one or more sleep apnea episodes of the patient occurring during the first period based on the heart rates (see [0098]; Fig. 11 picturing method 700 for switching between heart rate monitoring and MV monitoring to detect a disordered breathing episode, initially sleep apnea detection is performed using heart rate monitoring at step 705 according to method 500 pictured in Fig. 4);
determine whether one or more verification conditions are satisfied, wherein the one or more verification conditions comprise detection of a threshold number or a threshold rate of sleep apnea episodes occurring during the first period (see Fig. 11, [0099]; apnea episode detected at step 710 based on heart rate monitoring and is verified as a valid apnea episode in accordance with the criteria defined for heart rate cycle period, cycle amplitude, number of cycles required, etc.); and
responsive to determining that the one or more verification conditions are satisfied (see Fig. 11; step 710 disordered breathing detection):
control the sensing circuitry to measure impedances of the patient during a second period subsequent to the first period; and detect one or more sleep apnea episodes of the patient occurring during the second period based on the measured impedances (see Fig. 11, [0099]; if an apnea episode is detected at decision step 710 based on heart rate monitoring then the sleep apnea detection is switched from heart rate monitoring to minute ventilation monitoring at step 715, [0042]; impedance sensing circuit 63 may be used for measuring thoracic impedance for the purposes of deriving a minute volume).
Regarding claim 2, Cho teaches the medical device of claim 1, wherein the processing circuitry is further configured to detect atrial fibrillation episodes based on the cardiac signal (see [0048]; alternating periods of bradycardia and tachycardia are observed to occur concurrently with apnea and hyperpnea periods, respectively, associated with sleep apnea, [0105]; Q-T interval variation during apnea-hyperpnea cycles has been found to follow a similar pattern as the bradycardia-tachycardia cycles associated with apnea-hypopnea cycles, therefore, monitoring of Q-T interval variations for detecting Q-T cycle changes associated with apnea may be performed according to the method 500 as generally described above in conjunction with FIG. 4), and
wherein the one or more verification conditions comprise detection of an atrial fibrillation episode during the first period (see [0060]; cyclic oscillations between longer intervals and shorter intervals may be detected as an indication of sleep disordered breathing, [0068]; disordered breathing cycle may be identified based on the periodicity, amplitude change, and morphology of heart rate oscillations). It can be appreciated that atrial fibrillation is a form of tachycardia and one of ordinary skill in the art would understand the disclosure of tachycardia in the prior art to encompass all forms of tachycardia including atrial fibrillation.
Regarding claim 5, Cho teaches the medical device of claim 1, wherein the one or more verification conditions comprise receipt, by the processing circuitry, of an input indicating that the patient has a prescription associated with a low heart rate variability (see [0068]; because special patient conditions may exist which affect these features of heart rate changes during a disordered breathing episode, such as prescribed drugs the patient may be taking or other pathological conditions, criteria for validating a detected cycle are preferably programmable such that they may be tailored to an individual patient).
Regarding claim 6, Cho teaches the medical device of claim 1, wherein the processing circuitry is configured to determine one or more heart rate parameters based on the determined heart rates of the patient (see Fig. 4, [0059]; a heart rate signal could be a sensed ECG or EGM signal from which P-P intervals or R-R intervals may be derived, or a pulse pressure signal, heart wall motion signal, or any other signal from which the heart rate may be derived), and
wherein the processing circuitry is configured to detect the one or more sleep apnea episodes of the patient occurring during the first period based on the determined heart rates by detecting the one or more sleep apnea episodes of the patient occurring during the first period based on the one or more heart rate parameters (see Fig. 4, [0059]; a method 500 for monitoring changes in heart rate as an indicator of disordered breathing, Fig. 11 step 705 for disordered breathing cycle detection using heart rate monitoring, [0068]; a disordered breathing episode may be identified based on the periodicity, amplitude change, and morphology of heart rate oscillations).
Regarding claim 7, Cho teaches the medical device of claim 1, wherein the processing circuitry is configured to detect respirations based on the measured impedances of the patient (see [0042]; impedance sensing circuit 63 may be used for measuring thoracic impedance for the purposes of deriving a minute volume), and
wherein the processing circuitry is configured to detect the one or more sleep apnea episodes of the patient occurring during the second period based on the measured impedances by detecting the one or more sleep apnea episodes of the patient occurring during the second period based on the respirations (see Fig. 11 step 715 for disordered breathing detection using MV monitoring performed according to the method described in Figs. 8 or 9).
Regarding claim 8, Cho teaches the medical device of claim 1, wherein the processing circuitry is further configured to determine a heart rate variability value based on the heart rates (see [0011]; cyclical variations in heart rate are detected and used for recognizing apnea-hypopnea cycles),
wherein the one or more verification conditions comprise the heart rate variability value being less than the heart rate variability threshold (see Fig. 4, [0064]; heart rate is monitored until it crosses a lower dynamic threshold boundary and a higher dynamic threshold boundary until each boundary has been crossed twice and the measured cycle length is within a disordered breathing cycle length range).
Regarding claim 9, Cho teaches the medical device of claim 1, wherein the processing circuitry is further configured to, responsive to
(1) detecting the one or more sleep apnea episodes of the patient occurring during the first period (Fig. 11; step 710 disordered breathing detected using heart rate monitoring) and
(2) not detecting the one or more sleep apnea episodes of the patient occurring during the second period (Fig. 11, [0099]; step 715 disordered breathing detection using MV monitoring preferably performed according to the method described in conjunction with Fig. 8 or 9),
discard from memory circuitry of the medical device indications of the one or more sleep apnea episodes of the patient occurring during the first period (see Figs. 8-9, [0090-0092]; at step 650 the duration counter is compared to a duration threshold, if the preliminary apnea event is greater than the duration threshold then the decline in MV is provisionally determined to be associated with a valid apnea episode and the cycle onset and duration are stored in the device memory at step 660, if the preliminary apnea event is less than the duration threshold then the apnea episode is not verified and the cycle onset, tolerance, and duration are reset at step 655).
Regarding claim 10, Cho teaches the medical device of claim 1, wherein the processing circuitry is further configured to, responsive to
(1) detecting the one or more sleep apnea episodes of the patient occurring during the first period (Fig. 11; step 710 disordered breathing detected using heart rate monitoring) and
(2) not detecting the one or more sleep apnea episodes of the patient occurring during the second period (Fig. 11, [0099]; step 715 disordered breathing detection using MV monitoring preferably performed according to the method described in conjunction with Fig. 8 or 9),
generate an indication that the patient has experienced limb movement during the first period (see [0095]; if an activity level is measures which exceeds the predetermined activity level threshold at step 652, the preliminary apnea detection is deemed unreliable and the method 600B resets the cycle onset).
Regarding claim 11, Cho teaches the medical device of claim 1, wherein the processing circuitry is further configured to stop detection of sleep apnea episodes based on the measured impedances in response to the second period lasting for a predetermined duration (see Fig. 11, [0100]; if no apnea detections are made during a predetermined period of time, the MV sensor is disabled and sleep apnea detection is switched back to heart rate monitoring).
Regarding claim 13, Cho teaches the medical device of claim 1, wherein the processing circuitry is further configured to,
responsive to not detecting an atrial fibrillation episode (see [0048]; alternating periods of bradycardia and tachycardia are observed to occur concurrently with apnea and hyperpnea periods, respectively, associated with sleep apnea, [0105]; Q-T interval variation during apnea-hyperpnea cycles has been found to follow a similar pattern as the bradycardia-tachycardia cycles associated with apnea-hypopnea cycles, therefore, monitoring of Q-T interval variations for detecting Q-T cycle changes associated with apnea may be performed according to the method 500 as generally described above in conjunction with FIG. 4; it can be appreciated that atrial fibrillation is a form of tachycardia and one of ordinary skill in the art would understand the disclosure of tachycardia in the prior art to encompass all forms of tachycardia including atrial fibrillation) based on the cardiac signal during the second period, (see [0050]; two or more physiological parameters may be monitored concurrently in order to detect cyclic patterns indicative of disordered breathing to avoid false positive or false negative detections of disordered breathing that might occur based on monitoring a single parameter),
stop detection of sleep apnea episodes based on the measured impedances (see Fig. 11, [0100]; if no apnea detections are made during a predetermined period of time, the MV sensor is disabled and sleep apnea detection is switched back to heart rate monitoring).
Regarding claim 14, Cho teaches a method (700) comprising:
sensing, by sensing circuitry (30) of a medical device (10), a cardiac signal indicating activity of a heart of a patient (see [0034]; atrial electrode 22 detects atrial depolarizations and ventricular electrode 24 detects ventricular depolarization);
determining, by processing circuitry of the medical device, heart rates of the patient based on the cardiac signal sensed during a first period (see [0034]; sensed P-P intervals or sensed R-R intervals, or the associated heart rate determined from the sensed intervals are monitored for the detection of apnea);
detecting, by the processing circuitry, one or more sleep apnea episodes of the patient occurring during the first period based on the heart rates (see [0098]; Fig. 11 picturing method 700 for switching between heart rate monitoring and MV monitoring to detect a disordered breathing episode, initially sleep apnea detection is performed using heart rate monitoring at step 705 according to method 500 pictured in Fig. 4);
determining, by the processing circuitry, whether one or more verification conditions are satisfied, wherein the one or more verification conditions comprise detection of a threshold number or a threshold rate of sleep apnea episodes occurring during the first period (see Fig. 11, [0099]; apnea episode detected at step 710 based on heart rate monitoring and is verified as a valid apnea episode in accordance with the criteria defined for heart rate cycle period, cycle amplitude, number of cycles required, etc.); and
responsive to determining that the one or more verification conditions are satisfied (see Fig. 11; step 710 disordered breathing detection):
controlling, by the processing circuitry (32),
the sensing circuitry to measure impedances of the patient during a second period subsequent to the first period (see [0042]; impedance sensing circuit 63 may be used for measuring thoracic impedance for the purposes of deriving a minute volume); and
determining whether one or more sleep apnea episodes of the patient occurred during the second period based on the measured impedances (see Fig. 11, [0099]; if an apnea episode is detected at decision step 710 based on heart rate monitoring then the sleep apnea detection is switched from heart rate monitoring to minute ventilation monitoring at step 715).
Regarding claim 15, Cho teaches the method of claim 14, further comprising detecting, by the processing circuitry, atrial fibrillation episodes based on the cardiac signal (see [0048]; alternating periods of bradycardia and tachycardia are observed to occur concurrently with apnea and hyperpnea periods, respectively, associated with sleep apnea, [0105]; Q-T interval variation during apnea-hyperpnea cycles has been found to follow a similar pattern as the bradycardia-tachycardia cycles associated with apnea-hypopnea cycles, therefore, monitoring of Q-T interval variations for detecting Q-T cycle changes associated with apnea may be performed according to the method 500 as generally described above in conjunction with FIG. 4), and
wherein the one or more verification conditions comprise detection of an atrial fibrillation episode during the first period (see [0060]; cyclic oscillations between longer intervals and shorter intervals may be detected as an indication of sleep disordered breathing, [0068]; disordered breathing cycle may be identified based on the periodicity, amplitude change, and morphology of heart rate oscillations). It can be appreciated that atrial fibrillation is a form of tachycardia and one of ordinary skill in the art would understand the disclosure of tachycardia in the prior art to encompass all forms of tachycardia including atrial fibrillation, as would further immediately envisage the limited species within the genus of tachycardias.
Regarding claim 16, Cho teaches the method of claim 14, further comprising determining one or more heart rate parameters based on the heart rates of the patient (see Fig. 4, [0059]; a heart rate signal could be a sensed ECG or EGM signal from which P-P intervals or R-R intervals may be derived, or a pulse pressure signal, heart wall motion signal, or any other signal from which the heart rate may be derived), and
wherein detecting the one or more sleep apnea episodes of the patient occurring during the first period based on the heart rates (Fig. 11, step 705 for disordered breathing cycle detection using heart rate monitoring) comprises detecting the one or more sleep apnea episodes of the patient occurring during the first period based on the one or more heart rate parameters (see Fig. 4, [0059]; a method 500 for monitoring changes in heart rate as an indicator of disordered breathing, Fig. 11 step 705 for disordered breathing cycle detection using heart rate monitoring, [0068]; a disordered breathing episode may be identified based on the periodicity, amplitude change, and morphology of heart rate oscillations).
Regarding claim 17, Cho teaches the method of claim 14, further comprising detecting respirations based on the measured impedances of the patient (see [0042]; impedance sensing circuit 63 may be used for measuring thoracic impedance for the purposes of deriving a minute volume), and
wherein detecting the one or more sleep apnea episodes of the patient occurring during the second period based on the measured impedances comprises detecting the one or more sleep apnea episodes of the patient occurring during the second period based on the respirations (see Fig. 11 step 715 for disordered breathing detection using MV monitoring performed according to the method described in Figs. 8 or 9).
Regarding claim 18, Cho teaches the method of claim 14, further comprising determining, by the processing circuitry, a heart rate variability value based on the heart rates (see [0011]; cyclical variations in heart rate are detected and used for recognizing apnea-hypopnea cycles),
comparing, by the processing circuitry, the heart rate variability value to a heart rate variability threshold (Fig. 4), wherein the one or more verification conditions comprise the heart rate variability value being less than the heart rate variability threshold (see Fig. 4, [0064]; heart rate is monitored until it crosses a lower dynamic threshold boundary and a higher dynamic threshold boundary until each boundary has been crossed twice and the measured cycle length is within a disordered breathing cycle length range, [0068]; alternative or additional criteria may be defined including the number of inflections within or outside of the threshold range, the maximum or minimum heart rates, or other criteria).
Regarding claim 19, Cho teaches the method of claim 14, further comprising, responsive to
(1) detecting the one or more sleep apnea episodes of the patient occurring during the first period (Fig. 11; step 710 disordered breathing detected using heart rate monitoring) and
(2) not detecting the one or more sleep apnea episodes of the patient occurring during the second period (Fig. 11, [0099]; step 715 disordered breathing detection using MV monitoring preferably performed according to the method described in conjunction with Fig. 8 or 9),
discarding, by the processing circuitry and from memory circuitry of the medical device indications of the one or more sleep apnea episodes of the patient occurring during the first period (see Figs. 8-9, [0090-0092]; at step 650 the duration counter is compared to a duration threshold, if the preliminary apnea event is greater than the duration threshold then the decline in MV is provisionally determined to be associated with a valid apnea episode and the cycle onset and duration are stored in the device memory at step 660, if the preliminary apnea event is less than the duration threshold then the apnea episode is not verified and the cycle onset, tolerance, and duration are reset at step 655).
Regarding claim 20, Cho teaches the method of claim 14, further comprising, responsive to
(1) detecting the one or more sleep apnea episodes of the patient occurring during the first period (Fig. 11; step 710 disordered breathing detected using heart rate monitoring) and
(2) not detecting the one or more sleep apnea episodes of the patient occurring during the second period (Fig. 11, [0099]; step 715 disordered breathing detection using MV monitoring preferably performed according to the method described in conjunction with Fig. 8 or 9),
generating, by the processing circuitry, an indication that the patient has experienced limb movement during the first period (see [0095]; if an activity level is measures which exceeds the predetermined activity level threshold at step 652, the preliminary apnea detection is deemed unreliable and the method 600B resets the cycle onset).
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3, 4, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al (US 20050119711 A1).
Regarding claims 3 and 4, Cho teaches the medical device of claim 1. Cho teaches wherein the one or more verification conditions may be a threshold number of a threshold rate of sleep apnea episodes occurring during the first period (Fig. 11).
It can be appreciated that in the case of a threshold number of apnea events, the threshold number is one. In Fig. 11 at step 710, Cho switches from using disordered breathing cycle detection using heart rate monitoring (705) to disordered breathing detecting using MV monitoring (715) when a disordered breathing event has been detected (710). This is because MV monitoring consumes greater battery energy but is expected to have a greater specificity for apnea detection than heart rate monitoring (Cho [0100]). The determination of the threshold number being 10 as recited in claim 3, is merely optimization of the claimed invention through routine experimentation.
It can also be appreciated that in the case of a threshold rate being 1 sleep apnea episode per 2 minutes, Cho teaches in method 500 for detecting apnea events based on heart rates, that in order to be classified as an apnea episode, the cycle length of interest must fall within a predefined cycle length range associated with the disordered breathing pattern of interest (Cho [0067]). Cho does not disclose the cycle length range used in method 500, however in method 300 Cho discloses that one apnea-hyperpnea cycle occurring during sleep apnea may have a typical duration of a minimum of about 25 to a maximum of about 120 seconds (Cho [0052]).
It can be appreciated that the method of Cho uses a verification condition which includes a rate of apnea episodes where the rate is one apnea episode in a predefined cycle length range. The determination of the cycle length range being 2 minutes as recited in claim 4, is merely optimization of the claimed invention through routine experimentation.
The prior art of Cho discloses the general conditions of the claim where detecting a sleep apnea event is switched from a heart rate based detection to an impedance/respiration based detection after a number of apnea events has been detected and/or after an apnea event has been detected within a defines time period. MPEP 2144.05(II)(A) states that: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One of ordinary skill in the art would have been motivated to optimize the verification conditions of the apnea monitoring device in order to prolong the battery operation of the device by only switching to the higher power demanding MV detection method when there is a high likelihood of an apnea episode in the second time period (Cho [0100]).
Regarding claim 12, Cho teaches the medical device of claim 11 wherein the processing circuitry is further configured to stop detection of sleep apnea episodes based on the measured impedances in response to the second period lasting for a predetermined duration (see Fig. 11, [0100]; if no apnea detections are made during a predetermined period of time, the MV sensor is disabled and sleep apnea detection is switched back to heart rate monitoring). Cho teaches wherein the pre-determined duration is a period on the order of 30 to 60 minutes (Cho [0100]).
However, it can be appreciated that the prior art of Cho does disclose the general conditions of the claim where the detection of sleep apnea episodes based on measured impedances is stopped if the second period lasts for a predetermined amount of time without any episodes detected. Determining the exact duration of the predetermined duration would merely involve routine experimentation by one having ordinary skill in the art. MPEP 2144.05(II)(A) states that: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One of ordinary skill in the art would have been motivated to optimize the predetermined duration after which the device stops detection of sleep apnea episodes using measured impedances/respirations in order to prolong the battery operation of the device by only switching to the higher power demanding MV detection method when there is a high likelihood of an apnea episode in the second time period (Cho [0100]).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Jensen et al (US 20060079802 A1) which teaches a method and apparatus to detect and monitor the frequency of obstructive sleep apnea.
Boute (US 20060241708 A1) which teaches a system comprising multiple sensors for sleep apnea with probability indication for sleep diagnosis and means for automatic activation of alert or therapy.
Koh (US 7404799 B1) which teaches a system and method for detection of respiration patterns via integration of intracardiac electrogram signals.
Cho et al (US 20180168502 A1) which teaches device-based detection and monitoring of sleep apnea conditions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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