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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 1, 7, 12, 15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0239057 A1 (Pu) (cited by Applicant) in view of US 2011/0224520 A1 (Skerl) (previously cited), US 2013/0197386 A1 (Cho), and US 2010/0152600 A1 (Droitcour) (cited by Applicant).
With regards to claims 1, 15, and 20, Pu discloses a medical device configured to be subcutaneously inserted into a patient, method, and a non-transitory computer-readable medium storing instructions for causing processing circuitry to perform a method (Abstract discloses systems and methods directed to evaluating breathing disorders; ¶ [0067] discloses that the system 800 is configured to include circuitry and functionality for periodic disordered breathing detection in accordance with embodiments of the invention; Fig. 9 and ¶¶ [0067]-[0068] disclose a cardiac rhythm management system 800 configured to be subcutaneously inserted into the patient) comprising: a plurality of electrodes (Fig. 9 and ¶¶ [0067]-[0068] disclose a cardiac rhythm management system 800, wherein intracardiac lead system 810 includes one or more electrodes); sensing circuitry configured to perform, using the plurality of electrodes, an impedance measurement to collect a set of impedance values over a period of time outside of a medical appointment, wherein the set of impedance values is indicative of a respiration pattern of a patient (Fig. 9 and ¶ [0075] disclose disordered breathing diagnostic circuitry 835 coupled to transthoracic impedance sensor 830; Fig. 4 and ¶¶ [0048]-[0049] disclose the method for detecting periodic disordered breathing which includes analyzing trans-thoracic impedance signals, wherein trans-thoracic impedance signals and the median value signal thereof are signals representative of patient respiration pattern; ¶ [0050] disclose an adjustable window of predetermined duration during which impedance measurements in the waveform are analyzed. Fig. 5 and ¶ [0011] discloses that the detection of periodic disordered breathing occurs during sleep, which indicates that the window will occur either during or outside of a medical appointment ); and processing circuitry (¶ [0067] discloses that the system 800 is configured to include circuitry and functionality for periodic disordered breathing detection in accordance with embodiments of the invention) configured to: identify a set of zero crossings based on the set of impedance values (¶ [0050] discloses zero-crossing points being determined at 408 and cycle length (k) of the waveform are determined at 410 as the duration between adjacent zero-crossing points with the same direction, thereby indicating that a set of zero-crossing points with the same direction are determined); determine, based on the set of zero crossings, a first set of respiration intervals, wherein each respiration interval of the first set of respiration intervals corresponds to a respective full respiratory cycle within the respiration pattern (¶ [0050] discloses that a series of k(i) cycles are determined based on the zero-crossing points with the same direction, wherein the cycle length corresponds to a full respiratory cycle); and determine, for the impedance measurement corresponding to the period of time, a value of a respiration metric based on the set of respiration intervals (¶ [0050] discloses the average cycle length being determined at 414 based on series of k(i) produced at 410).
Pu is silent with regards to a housing, at least one of the plurality of electrodes being disposed on a proximal portion of the housing and at least another one of the plurality of electrodes being disposed on a distal portion of the housing.
In the same field of endeavor of monitoring thoracic impedance (Abstract and ¶ [0015] of Skerl) and respiratory monitoring (¶ [0064] of Skerl), Skerl teaches a housing, at least one of the plurality of electrodes being disposed on a proximal portion of the housing and at least another one of the plurality of electrodes being disposed on a distal portion of the housing (Fig. 1 and ¶ [0065] disclose a housing 50 comprising electrodes 11.1, 11.2, 11.3 for measuring an impedance, wherein at least electrodes 11.1, 11.3 are located on proximal and distal portions of the housing). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrode system of Pu to incorporate a housing, at least one of the plurality of electrodes being disposed on a proximal portion of the housing and at least another one of the plurality of electrodes being disposed on a distal portion of the housing as taught by Skerl. Because both electrode measurement systems are capable of determining impedance (Abstract of Skerl, ¶ [0068] of Pu), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
The above combination is silent with regards to whether the processing circuitry is configured to evaluate at least one of a patient posture, a patient activity level, or data from an acoustic sensor to determine at least one of a change in the patient posture, a change in the patient activity level, or detection of sound in the data from the acoustic sensor; trigger the sensing circuitry to perform, based on the determination of the at least one of a change in the patient posture, a change in the patient activity level, or the detection of sound in the data from the acoustic sensor, the impedance measurement to collect the set of impedance values over the period of time.
In a system relevant to the problem of measuring impedance, Cho teaches processing circuitry (¶ [0097] discloses processors for implementing the method of Fig. 8 ) configured to evaluate at least one of a patient posture, a patient activity level, or data from an acoustic sensor to determine at least one of a change in the patient posture, a change in the patient activity level, or detection of sound in the data from the acoustic sensor (Fig. 8 and ¶ [0098] disclose turning on acoustic sensing circuits at 122 and collecting acoustic signals for a predetermined period of time after the circuits are turned on; ¶¶ [0099], [0101] discloses detecting changes in the acoustic waveforms at 124, wherein the change in acoustic characteristics may indicate presence of rales, ronchi, stridor or wheezing, and the acoustic signal may be compared to a specific template for rales, ronchi, stridor, or wheezing to determine what type of breathing abnormality, if any, is present; ¶ [0071] discloses initiating respiratory function detection when an activation event, such as activity/posture sensor 84 indicates that the patient is lying down, occurs); trigger the sensing circuitry to perform, based on the determination of the at least one of a change in the patient posture, a change in the patient activity level, or the detection of sound in the data from the acoustic sensor, the impedance measurement to collect the set of impedance values over the period of time (Fig. 8 and ¶ [0104] disclose that in response to the determination that a change in waveform has occurred (124), the IMD measures and stores impedance and acoustic signals for a predetermined period of time, for example 5 minutes; ¶ [0105] discloses the determination of a plurality of impedance parameter values, including respiratory rate, inspiration slope, and expiration slope; ¶ [0071] discloses initiating respiratory function detection when an activation event, such as activity/posture sensor 84 indicates that the patient is lying down, occurs). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processing circuitry of the above combination to incorporate that it is configured to evaluate at least one of a patient posture, a patient activity level, or data from an acoustic sensor to determine at least one of a change in the patient posture, a change in the patient activity level, or detection of sound in the data from the acoustic sensor; trigger the sensing circuitry to perform, based on the determination of the at least one of a change in the patient posture, a change in the patient activity level, or the detection of sound in the data from the acoustic sensor, the impedance measurement to collect the set of impedance values over the period of time, as taught by Cho. The motivation would have been to sense more physiological changes in order to improve the pace maker therapy (see ¶ [0072] of Pu).
The Examiner notes that “positive zero crossings” are being interpreted to be a group of zero crossings in which impedance values transition from a negative value to a positive value, as indicated in ¶ [0061] of the Applicant’s published application. “Negative zero crossings” are being interpreted to be a group of zero crossings in which impedance values transition from a positive value to a negative value, as indicated in ¶ [0061] of the Applicant’s published application.
The above combination is silent with regards to whether the set of zero crossings is a set of positive zero crossings, identifying a set of negative zero crossings based on the set of impedance values; determining, based on the set of negative zero crossings, a second set of respiration intervals, wherein each respiration interval of the second set of respiration intervals corresponds to a respective full respiratory cycle within the respiration pattern; and determining, for the impedance measurement corresponding to the period of time, a value of a respiration metric based on the first set of respiration intervals and a second set of respiration intervals.
In the same field of endeavor of determining respiration intervals, Droitcour discloses that the time between key points of a respiration cycle being the respiration period, with rate being the inverse of period. Droitcour further discloses that in some embodiments, only the negative-to-positive zero crossings are considered. In some embodiments, only the positive-to-negative zero crossings are considered. In some embodiments, the rate is calculated from negative-to-positive zero crossings and from positive-to-negative zero crossings, and the two rates are averaged (¶ [0356]). Such teachings indicate that a first set of respiration intervals can be determined from negative-to-positive zero crossings and a second set of respiration intervals can be determined from positive-to-negative zero crossings, and an averaged respiration interval can be determined from the two respiration intervals.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of the average cycle length of Pu of the above combination, based on the teachings of Droitcour, to incorporate using both negative-to-positive zero crossings and positive-to-negative zero crossings. The motivation would have been to improve the robustness of the rate estimate (¶ [0030] of Droitcour discloses averaging respiration rates based on different cycles improving the robustness of the rate estimate). Additionally or alternatively, because the use of only one type of zero crossing and the use of both types of zero crossings are viable in the estimation of cycle lengths, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 7, the above combination teaches or suggests that to determine the value of the respiration metric, the processing circuitry is configured to receive the set of positive zero crossings corresponding to the first set of respiration intervals and the set of negative zero crossings, corresponding to the second set of respiration intervals, wherein each respiration interval of the first set of respiration intervals comprises an amount of time separating each pair of consecutive positive zero crossings of the set of positive zero crossings, and, wherein each respiration interval of the second set of respiration intervals comprises an amount of time separating each pair of consecutive negative zero crossings of the set of negative zero crossings (see the above 103 analysis with regards to the determination of the respiration intervals k of Pu to incorporate the use of intervals determined from negative-to-positive zero crossings and from positive-to-negative zero crossings as taught by Droitcour; ¶ [0050] of Pu discloses that each interval k is an amount of time separating zero crossings of the same direction).
Although Pu discloses that the frequency of the periodicity (i.e., a respiration rate) is provided as measures for periodic disordered breathing severity (¶ [0041]), the above combination is silent with regards to determining a median respiration interval of a third set of respiration intervals including the first set of respiration intervals and the second set of respiration intervals; and calculating, based on the median respiration interval, a respiration rate corresponding to the impedance measurement.
In the same field of endeavor of determining respiration intervals, Droitcour discloses that embodiments for determining respiration intervals may either mean, median, weighted average (¶ [0378]); and calculating, based on the median respiration interval, a respiration rate corresponding to the impedance measurement (¶ [0356] discloses determination of respiratory rates, wherein the rate is the inverse of a respiration period).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calculation of the respiration metric of the above combination to incorporate that it utilizes the median respiration interval as taught by Droitcour. Because both an average and a median can be used for representing a respiration interval, it would have been the simple substitution of one known equivalent element to obtain predictable results. Additionally or alternatively, the motivation would have been to provide a more accurate representation of the respiration interval.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calculation of the respiration metric of the above combination to incorporate that a respiratory rate is determined according to Droitcour. The motivation would have been to provide measures for periodic disordered breathing severity (¶ [0041] of Pu) and/or to provide a more complete diagnostic analysis of the patient’s breathing.
With regards to claim 12, the above combination teaches or suggests that the processing circuitry is further configured to: determine a motion level of the patient corresponding to the impedance measurement (¶ [0054] of Pu discloses computing an apnea-hypopnea index (AHI) when the patient is asleep, wherein confirmation of sleep is determined using an activity sensor; ¶ [0070] of Pu discloses that activity sensor 820 is a motion sensor for determining when the patient is sleeping, awake, etc.; Fig. 5 and ¶¶ [0054]-[0056] of Pu disclose the process for determine the AHI); determine that the motion level satisfies a threshold motion level; and determine to use the impedance measurement based on the determination of whether the motion level satisfies the threshold motion level (¶ [0054] of Pu discloses confirming the activity sensor indicates a threshold level for sleeping, and then using the impedance measurements according to steps 512-520 of Fig. 5).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Pu in view of Skerl, Cho, and Droitcour, as applied to claim 1 above, and further in view of US 2011/0230779 A1 (Titchener) (cited by Applicant)
With regards to claim 2, the above combination teaches or suggests that the set of impedance values is a first set of impedance values (¶¶ [0048]-[0049] of Pu discloses the transthoracic impedance signal being rectified at 402, and a median value signal is determined at 404, wherein the median value signal is being interpreted to be a first set of impedance values), wherein the processing circuitry is configured to: calculate a mean impedance value of the first set of impedance values (¶ [0049] of Pu discloses that a mean of the median value signal is determined at 406); subtract, from each impedance value of the set of impedance values, the mean impedance value to obtain a second set of impedance values (¶ [0049] of Pu discloses the subtraction of the mean of the median value signal being subtracted at 406 to produce a waveform that fluctuates around zero or DC, wherein the waveform that fluctuates around zero or DC is being interpreted to be the second set of impedance values), wherein the processing circuitry is configured to identify the set of positive zero crossings and identify the set of negative zero crossings further based on the second set of impedance values (¶ [0050] of Pu discloses determination of the zero-crossing points of the waveform are detected at 408).
Although the above combination teaches the determination of zero-crossings (¶ [0050] of Pu) and distinguishing between negative zero crossings and positive zero crossings (¶ [0356] of Droitcour; see the above §103 analysis of claim 1 with regards to Pu in view of Droitcour), the above combination fails to teach how the negatively-sloped zero crossings and the positively-sloped zero crossings are computed. Therefore, the above combination is silent with regards to whether the processing circuitry is configured to calculate a derivative of the first set of impedance values to obtain a third set of impedance values, and wherein the processing circuitry is configured to identify the set of positive zero crossings and identify the set of negative zero crossings further based on the third set of impedance values.
In a related medical device for analyzing zero crossings (¶ [0026] of Titchener), Titchener discloses the determination of a higher order derivative of a signal in the determination of a negative-to-positive crossing (¶¶ [0128], [0132] disclose the determination of a third derivative with a positive value in order to confirm when a desired negative-to-positive zero crossing occurs in the second derivate). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calculations of the negative zero crossings and the positive zero crossings of the above combination to incorporate that a derivative is identified to obtain a third set of signal values as taught by Titchener such that the direction (i.e., negative-to-positive or positive-to-negative directions) of the zero crossings are determined. The motivation would have been to provide an algorithmic basis for the determination of the negative and positive zero crossings and/or to improve the accuracy of the determination of the negative and positive zero crossings.
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Pu in view of Skerl, Cho, Droitcour, and Titchener, as applied to claim 2 above, and further in view of US 6,128,584 A (Hemminger) (cited by Applicant).
With regards to claim 3, the above combination teaches or suggests a pair of consecutive impedance values of the set of pairs of consecutive impedance values corresponds to a respiration interval of the first set of respiration intervals (¶¶ [0048]-[0049] of Pu discloses the waveform that fluctuates around zero or DC, wherein the waveform represents pairs of consecutive impedance values at and around zero-crossings; ¶ [0050] of Pu discloses that a series of k(i) cycles are determined based on the zero-crossing points with the same direction, wherein the cycle length corresponds to a full respiratory cycle), and to identify the set of positive zero crossings, the processing circuitry is configured to: determine, for each pair of the set of pairs, whether an impedance value of the third set of impedance values corresponding to the second impedance value is greater than a positive threshold impedance value (see the above §103 analysis of claim 2; ¶¶ [0128], [0132] of Titchener discloses the determination of a negative-to-positive zero crossing if the derivative is positive (i.e., greater than zero)).
The above combination is silent with regards to whether the processing circuitry is configured to: identify, in the second set of impedance values, a set of pairs of consecutive impedance values, wherein a product of a first impedance value and a second impedance value of each respective pair is less than or equal to zero; determine, for each pair of the set of pairs, whether the second impedance value is greater than zero, wherein the medical device measures the first impedance value before the second impedance value.
In a system for determining zero-crossings, Hemminger discloses that zero crossings are determined by calculating the product of two successive samples. If the product is positive, then no zero crossing has occurred. If the product is negative and the first sample was positive, a negative zero crossing has occurred. If the product is negative and the first sample was negative, a positive zero crossing has occurred (Col. 5, line 65 to Col. 6, line 9). Because a positive zero crossing requires for the first sample to be negative and the second sample to be positive, Hemminger therefore suggests that, if the product is negative and the second sample was positive, a positive zero crossing has occurred. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for determining the zero crossings of the above combination to incorporate the method for determining determination of positive and negative zero crossings as taught by Hemminger. The motivation would have been to provide an algorithmic basis for the determination of the negative and positive zero crossings and/or to improve the accuracy of the determination of the negative and positive zero crossings.
With regards to claim 4, the above combination teaches or suggests that the processing circuitry is configured to: determine, for each pair of the set of pairs, if the second impedance value is greater than zero and if the impedance of the third set of impedance values corresponding to the second impedance value is greater than a positive threshold impedance value, that the respective pair represents a positive zero crossing of the set of positive zero crossings (See the above 103 analysis of claim 3; see ¶¶ [0128], [0132] of Titchener discloses the determination of a negative-to-positive zero crossing if the derivative is positive; see Col. 5, line 65 to Col. 6, line 9 of Hemminger with regards to the determination of a positive zero crossing if the second impedance value is greater than zero).
With regards to claim 5, the above combination teaches or suggests a pair of consecutive impedance values of the set of pairs of consecutive impedance values corresponds to a respiration interval of the first set of respiration intervals (¶¶ [0048]-[0049] of Pu discloses the waveform that fluctuates around zero or DC, wherein the waveform represents pairs of consecutive impedance values at and around zero-crossings; ¶ [0050] of Pu discloses that a series of k(i) cycles are determined based on the zero-crossing points with the same direction, wherein the cycle length corresponds to a full respiratory cycle) and to identify the set of negative zero crossings, the processing circuitry is configured to: whether an impedance value of the third set of impedance values corresponding to the second impedance value is less than a negative threshold impedance value (see the above §103 analysis of claim 2; ¶¶ [0128], [0132] of Titchener discloses the determination of a negative-to-positive zero crossing if the derivative is positive (i.e., greater than zero), thereby indicating that the inverse can be determined such that a positive-to-negative zero crossing is determined if the derivative is negative (i.e., less than zero)).
The above combination is silent with regards to whether the processing circuitry is configured to: identify, in the second set of impedance values, a set of pairs of consecutive impedance values, wherein a product of a first impedance value and a second impedance value of each respective pair is less than or equal to zero, determine, for each pair of the set of pairs, whether the second impedance value is less than zero, wherein the medical device measures the first impedance value before the second impedance value.
In a system for determining zero-crossings, Hemminger discloses that zero crossings are determined by calculating the product of two successive samples. If the product is positive, then no zero crossing has occurred. If the product is negative and the first sample was positive, a negative zero crossing has occurred. If the product is negative and the first sample was negative, a positive zero crossing has occurred (Col. 5, line 65 to Col. 6, line 9). Because a negative zero crossing requires for the first sample to be positive and the second sample to be negative, Hemminger therefore suggests that, if the product is negative and the second sample was negative, a negative zero crossing has occurred. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for determining the zero crossings of the above combination to incorporate the method for determining determination of zero crossings as taught by Hemminger. The motivation would have been to provide an algorithmic basis for the determination of the negative and positive zero crossings and/or to improve the accuracy of the determination of the negative and positive zero crossings.
With regards to claim 6, the above combination teaches or suggests that the processing circuitry is configured to: determine, for each pair of the set of pairs, if the second impedance value is less than zero and if the impedance of the third set of impedance values corresponding to the second impedance value is less than a negative threshold impedance value, that the respective pair represents a positive zero crossing of the set of positive zero crossings (See the above 103 analysis of claim 5; see ¶¶ [0128], [0132] of Titchener which suggests the determination of a positive-to-negative zero crossing if the derivative is negative; see Col. 5, line 65 to Col. 6, line 9 of Hemminger with regards to the determination of a negative zero crossing if the second impedance value is less than zero).
Claims 9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Pu in view of Skerl, Cho, and Droitcour, as applied to claim 1 above, and further in view of US 2010/0198097 A1 (Sowelam) (previously cited).
With regards to claim 9, the above combination teaches or suggests that processing circuitry is further configured to: determine, for each positive zero crossing of the set of positive zero crossings, a group of impedance values following the respective positive zero crossing; determine, for each negative zero crossing of the set of negative zero crossings, a group of impedance values following the respective negative zero crossing (¶ [0049] of Pu discloses a waveform that fluctuates around zero or DC as shown in Fig. 6B, which includes impedance values before and after each zero crossing).
Although Pu discloses that severity of a patient’s periodic disordered breathing may involve determining a depth of a change in peaks of the envelope (¶ [0012]), the above combination is silent with regards to whether the processing circuitry is configured to identify a maximum impedance value of the group of impedance values following each positive zero crossing; identify a minimum impedance value of the group of impedance values following each negative zero crossing; calculate a mean maximum impedance value; calculate a mean minimum impedance value; and calculate a peak-to-peak value by subtracting the mean minimum impedance value from the mean maximum impedance value.
In the same field of endeavor of determining respiratory parameters, Sowelam discloses identifying a maximum impedance value of the group of impedance values following each positive zero crossing (¶ [0077] discloses peak detector 152 for determining maxima and minima of the signal; ¶ [0083] discloses determining a maximum 166 and minimum 168 that are adjacent, which indicates that each max is after a positive zero crossing); identify a minimum impedance value of the group of impedance values following each negative zero crossing (¶ [0077] discloses peak detector 152 for determining maxima and minima of the signal; ¶ [0083] discloses determining a maximum 166 and minimum 168 that are adjacent, which indicates that each min is after a negative zero crossing); calculate a mean maximum impedance value; calculate a mean minimum impedance value; and calculate a peak-to-peak value by subtracting the mean minimum impedance value from the mean maximum impedance value (¶ [0078] discloses determining an average of a predetermined number of respiration depths, which indicates that an average max impedance value and an average min impedance value are determined in the determination of the average respiration depth).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of determining the severity of the disordered breathing as taught by the combination to incorporate the determination of peak-to-peak values of impedance as taught by Sowelam. The motivation would have been to provide a more accurate analysis of the severity of a patient’s periodic disordered breathing (¶ [0012] of Pu).
With regards to claim 13, the above combination is silent with regards to whether the processing circuitry is configured to: perform, at an impedance measurement rate, a set of impedance measurements including the impedance measurement, wherein the impedance measurement rate is within a range between one impedance measurement per month and ten impedance measurements per hour.
In the same field of endeavor of determining respiratory parameters, Sowelam discloses performing a set of impedance measurements at various rates, including hourly, daily, or weekly (¶ [0067]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of determining periodic disordered breathing as taught by the above combination to incorporate that impedance measurements occur at various rates, including hourly, daily, or weekly as taught by Sowelam. The motivation would have been to provide a more accurate diagnostic analysis of the patient.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Pu in view of Skerl, Cho, Droitcour, Sowelam, as applied to claim 9 above, and further in view of US 4,305,400 A (Logan).
With regards to claim 10, the above combination is silent with regards to whether the processing circuitry is further configured to: determine whether the peak-to-peak value satisfies a peak-to-peak value threshold; and determine to use the impedance measurement for the determination of the value of the respiration metric based on the determination that the peak-to-peak value satisfies the peak-to-peak value threshold.
In the same field of endeavor of determining respiratory parameters, Logan teaches determining whether an amplitude value satisfies an amplitude value threshold; and determining to use the impedance measurement for the determination of the value of the respiration metric based on the determination that the amplitude value satisfies the amplitude value threshold. (Col. 1, lines 30-39 discloses suppressing disturbances by feeding the electrical signals obtained by a variation of the thorax impedance to a trigger circuit, which will only deliver an output signal when the amplitude of the supplied input signal exceeds a predetermined threshold value. Col. 1, lines 16-29 discloses determination of respiration frequency. The Examiner notes that the comparison to the threshold and only delivering the output signal when the threshold is satisfied is a form of determining to use the measurements). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the above combination to incorporate, based on the teachings of Logan, determining whether the peak-to-peak value satisfies a peak-to-peak value threshold; and determining to use the impedance measurement for the determination of the value of the respiration metric based on the determination that the peak-to-peak value satisfies the peak-to-peak value threshold. The motivation would have been to suppress disturbances caused by heart activity (Col. 1, lines 16-39 of Logan).
With regards to claim 11, the above combination teaches or suggests that the peak-to-peak value represents a respiration effort of the patient corresponding to the impedance measurement (see the above §103 analysis of claim 10; ¶ [0078] of Sowelam discloses the differences between adjacent maximum values and minimum values is a respiration depth and is proportional to tidal volume. The Examiner asserts that respiration depth and tidal volume correspond to a respiration effort).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Pu in view of Skerl, Cho, and Droitcour, as applied to claim 15 above, and further in view of Titchener.
With regards to claim 16, the above combination teaches or suggests that the set of impedance values is a first set of impedance values (¶¶ [0048]-[0049] of Pu discloses the transthoracic impedance signal being rectified at 402, and a median value signal is determined at 404, wherein the median value signal is being interpreted to be a first set of impedance values), and calculating a mean impedance value of the first set of impedance values (¶ [0049] of Pu discloses that a mean of the median value signal is determined at 406); subtracting, from each impedance value of the set of impedance values, the mean impedance value to obtain a second set of impedance values (¶ [0049] of Pu discloses the subtraction of the mean of the median value signal being subtracted at 406 to produce a waveform that fluctuates around zero or DC, wherein the waveform that fluctuates around zero or DC is being interpreted to be the second set of impedance values), wherein identifying the set of positive zero crossings and identifying the set of negative zero crossings are further based on the second set of impedance values (¶ [0050] of Pu discloses determination of the zero-crossing points of the waveform are detected at 408).
Although the above combination teaches the determination of zero-crossings (¶ [0050] of Pu) and distinguishing between negative zero crossings and positive zero crossings (¶ [0356] of Droitcour), the above combination fails to teach how the negatively-sloped zero crossings and the positively-sloped zero crossings are computed. Therefore, the above combination is silent with regards to whether the processing circuitry is configured to calculate a derivative of the first set of impedance values to obtain a third set of impedance values, and wherein the processing circuitry is configured to identify the set of positive zero crossings and identify the set of negative zero crossings further based on the third set of impedance values.
In a related medical device for analyzing zero crossings (¶ [0026] of Titchener), Titchener discloses the determination of a higher order derivative of a signal in the determination of a negative-to-positive crossing (¶¶ [0128], [0132] disclose the determination of a third derivative with a positive value in order to confirm when a desired negative-to-positive zero crossing occurs in the second derivate). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calculations of the negative zero crossings and the positive zero crossings of the above combination to incorporate that a derivative is identified to obtain a third set of signal values as taught by Watson such that the direction (i.e., negative-to-positive or positive-to-negative directions) of the zero crossings are determined. The motivation would have been to provide an algorithmic basis for the determination of the negative and positive zero crossings and/or to improve the accuracy of the determination of the negative and positive zero crossings.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Pu in view of Skerl, Cho, Droitcour and Titchener, as applied to claim 16 above, and further in view of Hemminger.
With regards to claim 17, the above combination teaches or suggests a pair of consecutive impedance values of the set of pairs of consecutive impedance values corresponds to a respiration interval of the first set of respiration intervals (¶¶ [0048]-[0049] of Pu discloses the waveform that fluctuates around zero or DC, wherein the waveform represents pairs of consecutive impedance values at and around zero-crossings; ¶ [0050] of Pu discloses that a series of k(i) cycles are determined based on the zero-crossing points with the same direction, wherein the cycle length corresponds to a full respiratory cycle), and identifying the set of positive zero crossings comprises: determining whether an impedance value of the third set of impedance values corresponding to the second impedance value is greater than a positive threshold impedance value (¶¶ [0128], [0132] of Titchener discloses the determination of a negative-to-positive zero crossing if the derivative is positive (i.e., greater than zero)).
The above combination is silent with regards to identifying, in the second set of impedance values, a set of pairs of consecutive impedance values, wherein a product of a first impedance value and a second impedance value of each respective pair is less than or equal to zero; determining, for each pair of the set of pairs, whether the second impedance value is greater than zero, wherein the medical device measures the first impedance value before the second impedance value.
In a system for determining zero-crossings, Hemminger discloses that zero crossings are determined by calculating the product of two successive samples. If the product is positive, then no zero crossing has occurred. If the product is negative and the first sample was positive, a negative zero crossing has occurred. If the product is negative and the first sample was negative, a positive zero crossing has occurred (Col. 5, line 65 to Col. 6, line 9). Because a positive zero crossing requires for the first sample to be negative and the second sample to be positive, Hemminger therefore suggests that, if the product is negative and the second sample was positive, a positive zero crossing has occurred. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for determining the zero crossings of the of the above combination to incorporate the method for determining determination of zero crossings as taught by Hemminger. The motivation would have been to provide an algorithmic basis for the determination of the negative and positive zero crossings and/or to improve the accuracy of the determination of the negative and positive zero crossings.
With regards to claim 18, the above combination teaches or suggests that identifying the set of positive zero crossings further comprises: determining, for each pair of the set of pairs, if the second impedance value is greater than zero and if the impedance of the third set of impedance values corresponding to the second impedance value is greater than a positive threshold impedance value, that the respective pair represents a positive zero crossing of the set of positive zero crossings (See the above 103 analysis of claim 17 with regards to the combination; see ¶¶ [0128], [0132] of Titchener discloses the determination of a negative-to-positive zero crossing if the derivative is positive; see Col. 5, line 65 to Col. 6, line 9 of Hemminger with regards to the determination of a positive zero crossing if the second impedance value is greater than zero).
With regards to claim 19, the above combination teaches or suggests a pair of consecutive impedance values of the set of pairs of consecutive impedance values corresponds to a respiration interval of the first set of respiration intervals (¶¶ [0048]-[0049] of Pu discloses the waveform that fluctuates around zero or DC, wherein the waveform represents pairs of consecutive impedance values at and around zero-crossings; ¶ [0050] of discloses that a series of k(i) cycles are determined based on the zero-crossing points with the same direction, wherein the cycle length corresponds to a full respiratory cycle) and to identifying the set of negative zero crossings comprises: determining whether an impedance value of the third set of impedance values corresponding to the second impedance value is less than a negative threshold impedance value (See the above 103 analysis of claim 16 with regards to the combination of Pu in view of Droitcour and Titchener; ¶¶ [0128], [0132] of Titchener discloses the determination of a negative-to-positive zero crossing if the derivative is positive (i.e., greater than zero), thereby indicating that the inverse can be determined such that a positive-to-negative zero crossing is determined if the derivative is negative (i.e., less than zero)).
The above combination is silent with regards to identifying, in the second set of impedance values, a set of pairs of consecutive impedance values, wherein a product of a first impedance value and a second impedance value of each respective pair is less than or equal to zero, determining, for each pair of the set of pairs, whether the second impedance value is less than zero, wherein the medical device measures the first impedance value before the second impedance value.
In a system for determining zero-crossings, Hemminger discloses that zero crossings are determined by calculating the product of two successive samples. If the product is positive, then no zero crossing has occurred. If the product is negative and the first sample was positive, a negative zero crossing has occurred. If the product is negative and the first sample was negative, a positive zero crossing has occurred (Col. 5, line 65 to Col. 6, line 9). Because a negative zero crossing requires for the first sample to be positive and the second sample to be negative, Hemminger therefore suggests that, if the product is negative and the second sample was negative, a negative zero crossing has occurred. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for determining the zero crossings of the of the above combination to incorporate the method for determining determination of zero crossings as taught by Hemminger. The motivation would have been to provide an algorithmic basis for the determination of the negative and positive zero crossings and/or to improve the accuracy of the determination of the negative and positive zero crossings.
No Prior Art Rejection of Claim 8
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
With regards to claim 8, the prior art does not teach or suggest “determine a median duration of the third set of respiration intervals; determine a respiration interval duration window; determine a number of respiration intervals of the third set of respiration intervals which define a duration outside of the respiration interval duration window; determine that the number of respiration intervals satisfies a threshold number of respiration intervals; and determine to use the impedance measurement for the determination of the value of the respiration metric based on the determination that the number of respiration intervals satisfies the threshold number of respiration intervals”.
The closest art is US 2010/0317986 A1 (Colman) (Previously cited) which teaches calculating a breath cycle variance, wherein the variance may be calculated as the average squared deviation of each breath cycle parameter from its mean (¶ [0088]). Colman further teaches that if the breath cycle variance is below a given value, then the new respiratory rate is provided as the average over the predetermined time period (¶ [0091]). However, Colman does not teach or suggest determine a number of respiration intervals of the third set of respiration intervals which define a duration outside of the respiration interval duration window; determine that the number of respiration intervals satisfies a threshold number of respiration intervals; and determine to use the impedance measurement for the determination of the value of the respiration metric based on the determination that the number of respiration intervals satisfies the threshold number of respiration intervals.
Response to Arguments
Claim Rejections under 35 U.S.C. §103
Applicant' s amendment and arguments filed 11/25/2025 with respect to the 35 USC 103 rejections of independent claims 1, 15, and 20 set forth in the Non-Final Rejection mailed 08/26/2025 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 2013/0197386 A1 (Cho).
Applicant's arguments filed 11/25/2025 regarding claim 12 have been fully considered but they are not persuasive.
Applicant asserts that there is no determination to use the impedance measurement in Pu.
This argument is not persuasive. Paragraph ¶ [0054] of Pu discloses confirming the activity sensor indicates a threshold level for sleeping, and then using the impedance measurements according to steps 512-520 of Fig. 5. The confirmation of sleep in step 506 amounts to a determination to use the impedance measurements because the impedance measurements would not be used if the sleep is not detected. The broadest reasonable interpretation of “determine to use the impedance measurement for the determination of the value of the respiration metric based on the determination that the motion level satisfies the threshold motion level” does not preclude such an interpretation.
Double Patenting Rejections
In view of the Terminal Disclaimer filed 11/25/2025, the double patenting rejections were withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2008/0228094 A1 (Audet) teaches a method which includes activating a first-tier sensor/analyzer (Fig. 6 and ¶¶ [0082]-[0084], wherein the first-tier sensor/analyzer include a heart sound sensor, glucose sensor, oxygen level sensor, carbon dioxide level sensor, body temperature sensor, heart rate sensor, which amount to measuring patient activity level), and when a first-tier trigger condition has occurred, activating one or more second-tier sensors/analyzers (Fig. 6 and ¶¶ [0085]-[0086], wherein the second-tier sensors/analyzers include a respiration sensor and/or an impedance sensor).
US 2015/0283381 A1 (Denk) teaches a method in which a movement signal from a movement sensor initiates an active respiration mode which collects a respiratory sensor signal (Fig. 3 and ¶ [0025] depict blocks 306, 310, and 314 lead to active mode 301 when movement is detected).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791