DETAILED ACTION
This action is pursuant to the claims filed on 12/03/2024. Claims 1-14 are pending. A first action on the merits of claims 1-14 is as follows.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/17/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 5 and 11 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 5 and 11 respectively recite “generating electrocardiogram (ECG) data by applying a bandpass filter to the signal data, wherein the bandpass filter extends over a frequency range…” It is unclear if the bandpass filter of claims 5 and 11 are intending to recite a distinct second band pass filter that is different from the band pass filter recited in corresponding independent claims 1 and 8. For examination purposes, these limitations will be interpreted to read “generating electrocardiogram (ECG) data by applying a second bandpass filter to the signal data, wherein the second bandpass filter extends over a frequency range…”
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 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (U.S. PGPub No. 2015/0297104) in view of Pu (U.S. PGPub No. 2007/0173728) and Brewer (U.S. Patent No. 7,020,521).
Regarding claim 1, Chen teaches a system for diagnosing a disorder in a subject ([0065-0066] and Fig 2, system for diagnosing disorders, one of which being cardiac arrhythmias), the system comprising: a plurality of skin electrodes configured to sense electrical signals corresponding to a skin nerve activity in the subject ([0011] and Fig 15 disclosing electrodes to monitor skin nerve activity); a signal detector configured to sample the electrical signals sensed by the plurality of skin electrodes (Fig 1 signal amplifier and sampler 108 and Fig 2 block 204), and generate signal data using the electrical signals ([0050] signal amplifier and sampler 108 generates digitized samples of the electrical signals for further processing); a processor configured to: receive the signal data from the signal detector (Fig 1, signal processor 112 receives signal from signal amplifier and sampler 108); assemble a time-series of data indicating the skin nerve activity using the signal data (Fig 2 blocks 208, 212, and 216 and [0063]; processor records baseline activity over time including an average amplitude and expected variation); identify a disorder using the time-series of data (Fig 2 block 220 and [0063]; a disorder is identified based on a continued recording of a nerve activity value below a determined threshold); and generate a report indicative of the disorder (Fig 2 block 224 and [0064]; alarm is generated that includes a message, email, or page that is sent to a professional). Chen further teaches that many cardiac arrhythmias are preceded by rapid changes in the level of sympathetic nerve activity and that the level of sympathetic nerve activity often remains abnormally high or low during an episode of cardiac arrhythmia ([0065]). Chen further teaches wherein the processor, in assembling the time-series of data, is further configured to apply a filter to the signal data (Fig 1 high-pass filter 116 and Fig 2 block 208). Chen further teaches wherein the electrical activity corresponding to nerves occurs in a range of hundreds of hertz up to several kilohertz and that the high-pass filter provides signals of 150 Hz and higher to the nerve activity monitor module ([0055]).
Chen fails to explicitly teach wherein the diagnosed disorder is a sleep disorder; wherein the identified disorder is a sleep disorder; and wherein the generated report is indicative of the sleep disorder.
In related prior art, Pu teaches a similar system for diagnosing a sleep disorder wherein a sleep disorder is identified via nerve activity sensors ([0103]); Pu further teaches the presence of arrhythmia events being used as the diagnosis for sleep disorders ([0037]) and that monitored nerve activity dropping below a threshold value is a precursor to a sleep disorder (Fig 1 and [0045], drop in neural activity is a precursor for obstructive sleep apnea). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Chen in view of Pu to incorporate the step of identifying a sleep disorder and generating a report indicative of the sleep disorder. Doing so would be obvious to one of ordinary skill in the art as it is well-known in the art that a drop in nerve activity directly relates to the presence of arrhythmias and sleep disorders in a subject (Chen [0065] disclosing relationship between nerve activity and arrhythmias; Pu [0037, 0045] and Fig 1 discloses the known relationship between nerve activity, arrhythmias, and sleep disorders).
Chen fails to teach wherein the filter is a bandpass filter that extends over a range between 550 Hz and approximately 1000 Hz.
However, an alternative embodiment of Chen discloses the use of a band-pass filter extending over a range of 100 Hz to 500 Hz to acquire nerve activity (Fig 25 and [0116]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the high-pass filter of Chen in view of Pu and the second embodiment of Chen to incorporate a band-pass filter in place of the high-pass filter. Doing so would be obvious to one of ordinary skill in the art as a simple substitution of one well-known filter (Chen [0055] high-pass filter with cutoff of 150 Hz (i.e., filtered signals of 150 Hz or more)) for another well-known filter (Chen [0116] band-pass filter with range of 100 Hz to 500 Hz (i.e., filtered signals of 100 Hz to 500 Hz)) to yield the predictable result of filtered signals that are representative of nerve activity ([0055] disclosing nerve activity ranging from hundreds to thousands of Hz; [0055] and [0116] disclosing two successful acquisitions of nerve activity with high pass and band pass filters respectively).
Furthermore, in related prior art, Brewer teaches a similar device comprising a bandpass filter that extends over a range between 550 Hz and approximately 1000 Hz (Col 17 lines 42-59 discloses bandpass filter range of 500 Hz to 2500 Hz). Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen in view of Pu and Brewer to use a bandpass filter range between 550 Hz and approximately 1000 Hz as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, one would have done so to attenuate lower frequency signals that correspond to cardiac electrical activity to acquire filtered signals representing nerve activity as taught by Chen ([0055] disclosing nerve activity ranging from hundreds to thousands of Hz; [0055] disclosing nerve activity acquired via signals of 150 Hz or higher; Brewer Col 17 lines 42-59 bandpass filter between 500 and 2500 Hz for MSNA signals).
Regarding claim 2, in view of the combination of claim 1 above, Chen further teaches wherein the skin electrodes comprise patch electrodes configured to couple to a surface of the subject's skin (Fig 15 and [0052], electrodes 1504/1508/1512 used to monitor nerve activity and are cutaneous patch electrodes coupled to skin).
Regarding claim 3, in view of the combination of claim 1 above, Chen further teaches wherein the signal detector comprises signal amplifiers that are electrically connected to the plurality of skin electrodes and configured to generate amplified electrical signals (Fig 1 and [0050]; signal amplifier and sampler 108 amplifies the electrical signals and generates digitized samples of the amplified signals for further processing).
Regarding claim 4, in view of the combination of claim 3 above, Chen further teaches wherein the signal detector is configured to generate the signal data using the amplified electrical signals (Fig 1 and [0050]; signal amplifier and sampler 108 amplifies the electrical signals and generates digitized samples of the amplified signals for further processing).
Regarding claim 5, in view of the combination of claim 1 above, Chen further teaches wherein the processor is further configured to generate electrocardiogram (ECG) data by applying a bandpass filter to the signal data (Fig 1, Band-pass filter for ECG monitoring 144), wherein the bandpass filter extends over a frequency range between approximately 0.5 Hz and approximately 100 Hz (Fig 1 bandpass filter 140). Chen further discloses the use of a high-pass filter in the range of 100 to 150 Hz to attenuate lower frequency signals that correspond to cardiac activity when processing signals that correspond to nerve activity (Fig 1 filter 116 and [0060]).
Chen/Pu discloses the invention substantially as claimed above except for the upper frequency cutoff of the bandpass filter being approximately 150 Hz.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a bandpass filter with a higher frequency cutoff of approximately 150 Hz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. One would have done so to filter high frequency components of measured signals to be discarded as noise when processing an ECG signal ([0055]) since Chen discloses that cardiac activity can be represented by frequencies up to 150 Hz ([0060]).
Regarding claim 6, in view of the combination of claim 1 above, Chen further teaches wherein the processor is further configured to identify the disorder by comparing the skin nerve activity to a baseline (Fig 2 block 220 and [0063-0064]; nerve activity is monitored to acquire an average nerve activity and an expected variation (i.e., a baseline); a disorder is identified based on a nerve activity value relative to the baseline exceeding a determined threshold for a time).
Chen fails to teach wherein the disorder is a sleep disorder.
Pu teaches a similar system for diagnosing a sleep disorder wherein a sleep disorder is identified via nerve activity sensors ([0103]); Pu further teaches the presence of arrhythmia events being used as the diagnosis for sleep disorders ([0037]) and that monitored nerve activity dropping below a threshold value is a precursor to a sleep disorder (Fig 1 and [0045], drop in neural activity is a precursor for obstructive sleep apnea). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Chen in view of Pu to incorporate the step of identifying a sleep disorder based on comparing the skin nerve activity to a baseline to arrive at the system of claim 8. Doing so would be obvious to one of ordinary skill in the art as it is well-known in the art that a drop in nerve activity directly relates to the presence of arrhythmias and sleep disorders in a subject (Chen [0065] disclosing relationship between nerve activity and arrhythmias; Pu [0037, 0045] and Fig 1 discloses the known relationship between nerve activity, arrhythmias, and sleep disorders).
Regarding claim 7, in view of the combination of claim 1 above, Chen further teaches wherein the processor is further configured to identify the disorder ([0065-0066] cardiac events, such as arrhythmias, are identified based on nerve activity over a time period dropping below a threshold).
Chen fails to teach wherein the disorder is a sleep disturbed breathing (SDB) using the time-series of data.
Pu teaches a similar system for diagnosing a sleep disorder wherein a sleep disorder is identified via nerve activity sensors ([0103]); Pu further teaches the presence of arrhythmia events being used as the diagnosis for sleep disorders ([0037]) and that monitored nerve activity dropping below a threshold value is a precursor to sleep disturbed breathing (Fig 1 and [0045], drop in neural activity is a precursor for obstructive sleep apnea (i.e., sleep disturbed breathing)). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Chen in view of Pu to incorporate the step of identifying sleep disturbed breathing to arrive at the system of claim 9. Doing so would be obvious to one of ordinary skill in the art as it is well-known in the art that a drop in nerve activity directly relates to the presence of arrhythmias and sleep disorders in a subject (Chen [0065] disclosing relationship between nerve activity and arrhythmias; Pu [0037, 0045] and Fig 1 discloses the known relationship between nerve activity, arrhythmias, and sleep disturbed breathing (obstructive sleep apnea)).
Regarding claim 8, Chen teaches a method for diagnosing a disorder in a subject ([0065-0066] and Fig 2, method for diagnosing disorders, one of which being cardiac arrhythmias), the method comprising: sensing electrical signals corresponding to a skin nerve activity in the subject using a plurality of skin electrodes ([0011] and Fig 15 disclosing electrodes to monitor skin nerve activity); generating, using a signal detector (Fig 1 signal amplifier and sampler 108 and Fig 2 block 204), signal data using the electrical signals ([0050] signal amplifier and sampler 108 generates digitized samples of the electrical signals for further processing); assembling a time-series of data indicating the skin nerve activity using the signal data (Fig 2 block 208, 212, 216 and [0063]; processor records baseline activity over time including an average amplitude and expected variation); identifying a disorder using the time-series of data (Fig 2 block 220 and [0063]; a disorder is identified based on a continued recording of a nerve activity value below a determined threshold); and generating a report indicative of the disorder (Fig 2 block 224 and [0064]; alarm is generated that includes a message, email, or page that is sent to a professional). Chen further teaches that many cardiac arrhythmias are preceded by rapid changes in the level of sympathetic nerve activity and that the level of sympathetic nerve activity often remains abnormally high or low during an episode of cardiac arrhythmia ([0065]). Chen further teaches wherein the method further comprises applying a filter to the signal data in assembling the time-series of data (Fig 1 high-pass filter 116 and Fig 2 block 208). Chen further teaches wherein the electrical activity corresponding to nerves occurs in a range of hundreds of hertz up to several kilohertz and that the high-pass filter provides signals of 150 Hz and higher to the nerve activity monitor module ([0055]).
Chen fails to explicitly teach wherein the diagnosed disorder is a sleep disorder; wherein the identified disorder is a sleep disorder; and wherein the generated report is indicative of the sleep disorder.
In related prior art, Pu teaches a similar method for diagnosing a sleep disorder comprising identifying a sleep disorder using data ([0103]); Pu further teaches the presence of arrhythmia events being used for the diagnosis for sleep disorders ([0037]) and that monitored nerve activity dropping below a threshold value is a precursor to a sleep disorder (Fig 1 and [0045], drop in neural activity is a precursor for obstructive sleep apnea). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Chen in view of Pu to incorporate the step of diagnosing and identifying a sleep disorder and generating a report indicative of the sleep disorder. Doing so would be obvious to one of ordinary skill in the art as it is well-known in the art that a drop in nerve activity directly relates to the presence of arrhythmias and sleep disorders in a subject (Chen [0065] disclosing relationship between nerve activity and arrhythmias; Pu [0037, 0045] and Fig 1 discloses the known relationship between nerve activity, arrhythmias, and sleep disorders).
Chen fails to teach wherein the filter is a bandpass filter that extends over a range between 550 Hz and approximately 1000 Hz.
However, an alternative embodiment of Chen discloses the use of a band-pass filter extending over a range of 100 Hz to 500 Hz to acquire nerve activity (Fig 25 and [0116]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the high-pass filter of Chen in view of Pu and the second embodiment of Chen to incorporate a band-pass filter in place of the high-pass filter. Doing so would be obvious to one of ordinary skill in the art as a simple substitution of one well-known filter (Chen [0055] high-pass filter with cutoff of 150 Hz (i.e., filtered signals of 150 Hz or more)) for another well-known filter (Chen [0116] band-pass filter with range of 100 Hz to 500 Hz (i.e., filtered signals of 100 Hz to 500 Hz)) to yield the predictable result of filtered signals that are representative of nerve activity ([0055] disclosing nerve activity ranging from hundreds to thousands of Hz; [0055] and [0116] disclosing two successful acquisitions of nerve activity with high pass and band pass filters respectively).
Furthermore, in related prior art, Brewer teaches a similar device comprising a bandpass filter that extends over a range between 550 Hz and approximately 1000 Hz (Col 17 lines 42-59 discloses bandpass filter range of 500 Hz to 2500 Hz). Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen in view of Pu and Brewer to use a bandpass filter range between 550 Hz and approximately 1000 Hz as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, one would have done so to attenuate lower frequency signals that correspond to cardiac electrical activity to acquire filtered signals representing nerve activity as taught by Chen ([0055] disclosing nerve activity ranging from hundreds to thousands of Hz; [0055] disclosing nerve activity acquired via signals of 150 Hz or higher; Brewer Col 17 lines 42-59 bandpass filter between 500 and 2500 Hz for MSNA signals).
Regarding claim 9, in view of the combination of claim 8 above, Chen further teaches wherein the method further amplifying the electrical signals using signal amplifiers electrically connected to the plurality of skin electrodes (Fig 1 and [0050]; signal amplifier and sampler 108 amplifies the electrical signals and generates digitized samples of the amplified signals for further processing).
Regarding claim 10, in view of the combination of claim 8 above, Chen further teaches wherein the method further comprises generating the signal data using the amplified electrical signals (Fig 1 and [0050]; signal amplifier and sampler 108 amplifies the electrical signals and then generates digitized samples of the amplified signals for further processing).
Regarding claim 11, in view of the combination of claim 8 above, Chen further teaches wherein the method further comprises generating electrocardiogram (ECG) data by applying a bandpass filter to the signal data (Fig 1, Band-pass filter for ECG monitoring 144), wherein the bandpass filter extends over a frequency range between approximately 0.5 Hz and approximately 100 Hz (Fig 1 bandpass filter 140). Chen further discloses the use of a high-pass filter in the range of 100 to 150 Hz to attenuate lower frequency signals that correspond to cardiac activity when processing signals that correspond to nerve activity (Fig 1 filter 116 and [0060]).
Chen/Pu discloses the invention substantially as claimed above except for the upper frequency cutoff of the bandpass filter being approximately 150 Hz.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a bandpass filter with a higher frequency cutoff of approximately 150 Hz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. One would have done so to filter high frequency components of measured signals to be discarded as noise when processing an ECG signal ([0055]) since Chen discloses that cardiac activity can be represented by frequencies up to 150 Hz ([0060]).
Regarding claim 12, in view of the combination of claim 8 above, Chen further teaches wherein the method further comprises comparing the skin nerve activity to a baseline to identify the disorder. (Fig 2 block 220 and [0063-0064]; nerve activity is monitored to acquire an average nerve activity and an expected variation (i.e., a baseline); a disorder is identified based on a nerve activity value relative to the baseline exceeding a determined threshold for a time).
Chen fails to teach wherein the disorder is a sleep disorder.
Pu teaches a similar system for diagnosing a sleep disorder wherein a sleep disorder is identified via nerve activity sensors ([0103]); Pu further teaches the presence of arrhythmia events being used as the diagnosis for sleep disorders ([0037]) and that monitored nerve activity dropping below a threshold value is a precursor to a sleep disorder (Fig 1 and [0045], drop in neural activity is a precursor for obstructive sleep apnea). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Chen in view of Pu to incorporate the step of identifying a sleep disorder based on comparing the skin nerve activity to a baseline to arrive at the method of claim 12. Doing so would be obvious to one of ordinary skill in the art as it is well-known in the art that a drop in nerve activity directly relates to the presence of arrhythmias and sleep disorders in a subject (Chen [0065] disclosing relationship between nerve activity and arrhythmias; Pu [0037, 0045] and Fig 1 discloses the known relationship between nerve activity, arrhythmias, and sleep disorders).
Regarding claim 13, in view of the combination of claim 8 above, Chen further teaches wherein the method further comprises computing, using the time-series of data, an average skin nerve activity ([0063] and Fig 2 block 216; processor uses time-series data of nerve activity to compute a baseline defining an average value of nerve activity and expected variation of nerve activity) and comparing the average skin nerve activity to a predetermined threshold ([0063], “if the identified nerve activity remains within a predetermined threshold of the baseline” discloses an average skin nerve activity being compared to a predetermined threshold; further disclosed by Fig 2 block 220, a step of monitoring a change in nerve activity from an average baseline exceeding a threshold (i.e., the average skin nerve activity is at least indirectly compared to the threshold since the change in nerve activity is directly related to the average nerve activity)).
Regarding claim 14, in view of the combination of claim 8 above, Chen further teaches wherein the method further comprises identifying the disorder using the time-series of data ([0065-0066] cardiac events, such as arrhythmias, are identified based on nerve activity over a time period dropping below a threshold).
Chen fails to teach wherein the disorder is a sleep disturbed breathing (SDB) using the time-series of data.
Pu teaches a similar system for diagnosing a sleep disorder wherein a sleep disorder is identified via nerve activity sensors ([0103]); Pu further teaches the presence of arrhythmia events being used as the diagnosis for sleep disorders ([0037]) and that monitored nerve activity dropping below a threshold value is a precursor to sleep disturbed breathing (Fig 1 and [0045], drop in neural activity is a precursor for obstructive sleep apnea (i.e., sleep disturbed breathing)). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Chen in view of Pu to incorporate the step of identifying sleep disturbed breathing using the time-series of data to arrive at the method of claim 14. Doing so would be obvious to one of ordinary skill in the art as it is well-known in the art that a drop in nerve activity directly relates to the presence of arrhythmias and sleep disorders in a subject (Chen [0065] disclosing relationship between nerve activity and arrhythmias; Pu [0037, 0045] and Fig 1 discloses the known relationship between nerve activity, arrhythmias, and sleep disturbed breathing (obstructive sleep apnea)).
Conclusion
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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