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 .
Terminal Disclaimer
The terminal disclaimer filed on 3/13/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patents 11660005 and 12076117 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendment
This office action is responsive to the amendment filed on 3/13/2026. As directed by the amendment, the status of the claim(s) are:
Claim(s) 1, 12, 20 has/have been amended;
Claim(s) 1-20 is/are presently pending.
The amendment(s) to the claim(s) is sufficient to overcome the 35 U.S.C. 112 rejection(s) from the previous office action. However, the amendments to fix the 112’s now make the instant claims identical to US Patent 12076117; as was discussed on p. 24 top of previous non-final action.
Response to Arguments
Applicant amendments and filing of TD’s overcome the outstanding rejections but the amendments now present a statutory double patenting issue, which a TD cannot overcome; see below. Also see 112 antecedent basis below.
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 12-19 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.
Regarding claim 12 and its dependents, claim 12 recites the limitation "derived from the 3-axis accelerometer" in line 4. There is insufficient antecedent basis for this limitation in the claim. Note that US Patent 12076117 claim 12 recited “derived from a 3 axis accelerometer” for this limitation.
Regarding claim 12 and its dependents, claim 12 recites the limitation "derived from the PPG sensor" in line 16. There is insufficient antecedent basis for this limitation in the claim. Note that US Patent 12076117 claim 12 recited “derived from the received PPG data” for this limitation.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-20 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim(s) 1-20 of prior U.S. Patent No. 12076117. This is a statutory double patenting rejection.
Instant application claims
U.S. Patent No. 12076117 claims
1. A cardiorespiratory analysis system comprising:
a conformal patch comprising:
an array of sensors comprising:
a photoplethysmography (PPG) sensor;
a 3-axis accelerometer; and
an electrocardiogram (ECG) sensor; and
a microcontroller wired to the PPG sensor, the 3-axis accelerometer, and the ECG sensor;
a compressible viscoelastic interface for attaching the microcontroller to at least one of the sensors of the array of sensors to a patient; and
a computing system comprising at least one processor and configured for:
computing:
a respiratory effort contraction during a first time window by:
transforming x axis data, y axis data, and/or z axis data derived from the 3-axis accelerometer into one or more amplitude envelopes; and
identifying at least one trough of a particular decrement from a nearby baseline with a minimum width and distance of at least 10 seconds from any neighboring trough;
a bradycardia event during a second time window by:
calculating a heart rate based on ECG or PPG data; and
determining that the heart rate slowed by at least 6 beats per minute over a 6 second time period and at least 10 seconds distance from another nearby peak or trough;
a desaturation event during a third time window by:
deriving a plurality of oxygen saturation (SpO2) data points over time based on red data and IR data derived from the PPG sensor; and
identifying at least one relative minimum in the plurality of SpO2 data points of a particular depth, a particular width, and a particular distance from other nearby SpO2 minima;
a tachycardia event during a fourth time window by:
calculating the heart rate based on the ECG or PPG data; and
determining that the heart rate increased by at least 6 beats per minute over a 6 second time period and at least 10 seconds distance from another nearby peak or trough; and
an increase in respiratory effort during a fifth time window by:
transforming the x axis data, y axis data, and/or z axis data into one or more amplitude envelopes; and
identifying at least one peak of a particular height relatively to a nearby baseline with a minimum width and distance of at least 10 seconds from any neighboring peak; and
determining that a respiratory disturbance occurred for the patient based upon the first time window, the second time window, the third time window, the fourth time window, and/or the fifth time window occurring in a particular order.
1. A cardiorespiratory analysis system comprising:
a conformal patch comprising: an array of sensors comprising: a photoplethysmography (PPG) sensor; a 3-axis accelerometer; and an electrocardiogram (ECG) sensor; and a microcontroller wired to the PPG sensor, the 3-axis accelerometer, and the ECG sensor; a compressible viscoelastic interface for attaching the microcontroller to at least one of the sensors of the array of sensors to a patient; and a computing system comprising at least one processor and configured for: computing: a respiratory effort contraction during a first time window by: transforming x axis data, y axis data, and/or z axis data derived from the 3-axis accelerometer into one or more amplitude envelopes; and identifying at least one trough of a particular decrement from a nearby baseline with a minimum width and distance of at least 10 seconds from any neighboring trough; a bradycardia event during a second time window by: calculating a heart rate based on ECG or PPG data; and determining that the heart rate slowed by at least 6 beats per minute over a 6 second time period and at least 10 seconds distance from another nearby peak or trough; a desaturation event during a third time window by: deriving a plurality of oxygen saturation (SpO2) data points over time based on red data and IR data derived from the PPG sensor; and identifying at least one relative minimum in the plurality of SpO2 data points of a particular depth, a particular width, and a particular distance from other nearby SpO2 minima; a tachycardia event during a fourth time window by: calculating the heart rate based on the ECG or PPG data; and determining that the heart rate increased by at least 6 beats per minute over a 6 second time period and at least 10 seconds distance from another nearby peak or trough; and an increase in respiratory effort during a fifth time window by: transforming the x axis data, y axis data, and/or z axis data into one or more amplitude envelopes; and identifying at least one peak of a particular height relatively to a nearby baseline with a minimum width and distance of at least 10 seconds from any neighboring peak; and determining that a respiratory disturbance occurred for the patient based upon the first time window, the second time window, the third time window, the fourth time window, and/or the fifth time window occurring in a particular order.
2. The cardiorespiratory analysis system of claim 1, wherein determining that the respiratory disturbance occurred for the patient is further based on determining that the first time window, the second time window, the third time window, the fourth time window, and/or the fifth time window occurred within less than 45 seconds.
2. The cardiorespiratory analysis system of claim 1, wherein determining that the respiratory disturbance occurred for the patient is further based on determining that the first time window, the second time window, the third time window, the fourth time window, and/or the fifth time window occurred within less than 45 seconds.
3. The cardiorespiratory analysis system of claim 1, wherein:
the particular depth is 3%-4%;
the particular width is 3 seconds; and
the particular distance from the other nearby SpO2 minima is 10 seconds.
3. The cardiorespiratory analysis system of claim 1, wherein: the particular depth is 3%-4%; the particular width is 3 seconds; and the particular distance from the other nearby SpO2 minima is 10 seconds.
4. The cardiorespiratory analysis system of claim 1, wherein the computing system is further configured for determining a first dyad by determining that the desaturation event occurred within a second predetermined time after the respiratory effort contraction.
4. The cardiorespiratory analysis system of claim 1, wherein the computing system is further configured for determining a first dyad by determining that the desaturation event occurred within a second predetermined time after the respiratory effort contraction.
5. The cardiorespiratory analysis system of claim 4, wherein the computing system is further configured for determining a second dyad by determining that the tachycardia event occurred within a third predetermined time after the respiratory effort contraction.
5. The cardiorespiratory analysis system of claim 4, wherein the computing system is further configured for determining a second dyad by determining that the tachycardia event occurred within a third predetermined time after the respiratory effort contraction.
6. The cardiorespiratory analysis system of claim 5, wherein the computing system is further configured for determining that the first dyad and the second dyad occurred in temporal order.
6. The cardiorespiratory analysis system of claim 5, wherein the computing system is further configured for determining that the first dyad and the second dyad occurred in temporal order.
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8. The cardiorespiratory analysis system of claim 7, wherein the computing system is further configured for removing baseline wander from the red DC signal and the IR DC signal by removing a particular range of values from the red DC signal and the IR DC signal based on a number of baseline data shifts included in the ECG data.
8. The cardiorespiratory analysis system of claim 7, wherein the computing system is further configured for removing baseline wander from the red DC signal and the IR DC signal by removing a particular range of values from the red DC signal and the IR DC signal based on a number of baseline data shifts included in the ECG data.
9. The cardiorespiratory analysis system of claim 8, wherein the computing system is configured for: determining a plurality of PPG beats based on the red AC signal and the IR AC signal; computing a template comprising averaging a portion of the plurality of PPG beats over time; comparing the template to each PPG beat; and discarding one or more PPG beats of the plurality of PPG beats that do not match the template.
9. The cardiorespiratory analysis system of claim 8, wherein the computing system is configured for: determining a plurality of PPG beats based on the red AC signal and the IR AC signal; computing a template comprising averaging a portion of the plurality of PPG beats over time; comparing the template to each PPG beat; and discarding one or more PPG beats of the plurality of PPG beats that do not match the template.
10. The cardiorespiratory analysis system of claim 1, wherein one or more of the first time window, the second time window, the third time window, the fourth time window, and the fifth time window occur simultaneously.
10. The cardiorespiratory analysis system of claim 1, wherein one or more of the first time window, the second time window, the third time window, the fourth time window, and the fifth time window occur simultaneously.
11. The cardiorespiratory analysis system of claim 1, wherein the particular order is temporal order.
11. The cardiorespiratory analysis system of claim 1, wherein the particular order is temporal order.
12. A process for computing respiratory disturbances comprising: computing, via at least one processor: a respiratory effort contraction during a first time window by: transforming x axis data, y axis data, and/or z axis data derived from the 3-axis accelerometer into one or more amplitude envelopes; and identifying at least one trough of a particular decrement from a nearby baseline with a minimum width and distance of at least 10 seconds from any neighboring trough; a bradycardia event during a second time window by: calculating a heart rate based on received ECG or PPG data; and determining that the heart rate slowed by at least 6 beats per minute over a 6 second time period and at least 10 seconds distance from another nearby peak or trough; a desaturation event during a third time window by: deriving a plurality of oxygen saturation (SpO2) data points over time based on red data and IR data derived from the PPG sensor; and identifying at least one relative minimum in the plurality of SpO2 data points of a particular depth, a particular width, and a particular distance from other nearby SpO2 minima; a tachycardia event during a fourth time window by: calculating the heart rate based on the ECG or PPG data; and determining that the heart rate increased by at least 6 beats per minute over a 6 second time period and at least 10 seconds distance from another nearby peak or trough; and an increase in respiratory effort during a fifth time window by: transforming the x axis data, y axis data, and/or z axis data into one or more amplitude envelopes; and identifying at least one peak of a particular height relatively to a nearby baseline with a minimum width and distance of at least 10 seconds from any neighboring peak; and determining that a respiratory disturbance occurred for a patient based upon the first time window, the second time window, the third time window, the fourth time window, and/or the fifth time window occurring in a particular order.
12. A process for computing respiratory disturbances comprising: computing, via at least one processor: a respiratory effort contraction during a first time window by: transforming x axis data, y axis data, and/or z axis data derived from a 3 axis accelerometer into one or more amplitude envelopes; and identifying at least one trough of a particular decrement from a nearby baseline with a minimum width and distance of at least 10 seconds from any neighboring trough; a bradycardia event during a second time window by: calculating a heart rate based on received ECG or PPG data; and determining that the heart rate slowed by at least 6 beats per minute over a 6 second time period and at least 10 seconds distance from another nearby peak or trough; a desaturation event during a third time window by: deriving a plurality of oxygen saturation (SpO2) data points over time based on red data and IR data derived from the received PPG data; and identifying at least one relative minimum in the plurality of SpO2 data points of a particular depth, a particular width, and a particular distance from other nearby SpO2 minima; a tachycardia event during a fourth time window by: calculating the heart rate based on the ECG or PPG data; and determining that the heart rate increased by at least 6 beats per minute over a 6 second time period and at least 10 seconds distance from another nearby peak or trough; and an increase in respiratory effort during a fifth time window by: transforming the x axis data, y axis data, and/or z axis data into one or more amplitude envelopes; and identifying at least one peak of a particular height relatively to a nearby baseline with a minimum width and distance of at least 10 seconds from any neighboring peak; and determining that a respiratory disturbance occurred for a patient based upon the first time window, the second time window, the third time window, the fourth time window, and/or the fifth time window occurring in a particular order.
13. The process of claim 12, wherein determining that the respiratory disturbance occurred for the patient is further based on determining that the first time window, the second time window, the third time window, the fourth time window, and/or the fifth time window occurred within less than 45 seconds.
13. The process of claim 12, wherein determining that the respiratory disturbance occurred for the patient is further based on determining that the first time window, the second time window, the third time window, the fourth time window, and/or the fifth time window occurred within less than 45 seconds.
14. The process of claim 12, wherein: the particular depth is 3%-4%; the particular width is 3 seconds; and the particular distance from the other nearby SpO2 minima is 10 seconds.
14. The process of claim 12, wherein: the particular depth is 3%-4%; the particular width is 3 seconds; and the particular distance from the other nearby SpO2 minima is 10 seconds.
15. The process of claim 12, further comprising determining a first dyad by determining that the desaturation event occurred within a second predetermined time after the respiratory effort contraction.
15. The process of claim 12, further comprising determining a first dyad by determining that the desaturation event occurred within a second predetermined time after the respiratory effort contraction.
16. The process of claim 15, further comprising determining a second dyad by determining that the tachycardia event occurred within a third predetermined time after the respiratory effort contraction.
16. The process of claim 15, further comprising determining a second dyad by determining that the tachycardia event occurred within a third predetermined time after the respiratory effort contraction.
17. The process of claim 16, further comprising determining that the first dyad and the second dyad occurred in temporal order.
17. The process of claim 16, further comprising determining that the first dyad and the second dyad occurred in temporal order.
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19. The process of claim 18, further comprising removing baseline wander from the red DC signal and the IR DC signal by removing a particular range of values from the red DC signal and the IR DC signal based on a number of baseline data shifts included in the ECG data.
19. The process of claim 18, further comprising removing baseline wander from the red DC signal and the IR DC signal by removing a particular range of values from the red DC signal and the IR DC signal based on a number of baseline data shifts included in the ECG data.
20. A cardiorespiratory analysis system comprising: a device comprising:
an array of sensors comprising: a photoplethysmography (PPG) sensor; a 3-axis accelerometer; and an electrocardiogram (ECG) sensor; and a microcontroller operatively connected to the PPG sensor, the 3-axis accelerometer, and the ECG sensor; and a computing system communicably coupled to the microcontroller, comprising at least one processor, and configured for: computing: one or more amplitude envelopes based on x axis data, y axis data, and/or z axis data derived from the 3-axis accelerometer; a respiratory effort contraction during a first time window by identifying at least one trough of a particular decrement from a nearby baseline with a minimum width and distance of at least 10 seconds from any neighboring trough; a bradycardia event during a second time window based on ECG or PPG data; a desaturation event during a third time window by: deriving a plurality of oxygen saturation (SpO2) data points over time based on red data and IR data derived from the PPG sensor; and identifying at least one relative minimum in the plurality of SpO2 data points of a particular depth, a particular width, and a particular distance from other nearby SpO2 minima; a tachycardia event during a fourth time window based on the ECG or PPG data; and an increase in respiratory effort during a fifth time window by identifying at least one peak of a particular height relatively to a nearby baseline with a minimum width and distance of at least 10 seconds from any neighboring peak; and determining that a respiratory disturbance occurred for a patient based upon the first time window, the second time window, the third time window, the fourth time window, and/or the fifth time window occurring in a particular order.
20. A cardiorespiratory analysis system comprising: a device comprising: an array of sensors comprising: a photoplethysmography (PPG) sensor; a 3-axis accelerometer; and an electrocardiogram (ECG) sensor; and a microcontroller operatively connected to the PPG sensor, the 3-axis accelerometer, and the ECG sensor; and a computing system communicably coupled to the microcontroller, comprising at least one processor, and configured for: computing: one or more amplitude envelopes based on x axis data, y axis data, and/or z axis data derived from the 3-axis accelerometer; a respiratory effort contraction during a first time window by identifying at least one trough of a particular decrement from a nearby baseline with a minimum width and distance of at least 10 seconds from any neighboring trough; a bradycardia event during a second time window based on ECG or PPG data; a desaturation event during a third time window by: deriving a plurality of oxygen saturation (SpO2) data points over time based on red data and IR data derived from the PPG sensor; and identifying at least one relative minimum in the plurality of SpO2 data points of a particular depth, a particular width, and a particular distance from other nearby SpO2 minima; a tachycardia event during a fourth time window based on the ECG or PPG data; and an increase in respiratory effort during a fifth time window by identifying at least one peak of a particular height relatively to a nearby baseline with a minimum width and distance of at least 10 seconds from any neighboring peak; and determining that a respiratory disturbance occurred for a patient based upon the first time window, the second time window, the third time window, the fourth time window, and/or the fifth time window occurring in a particular order.
Allowable Subject Matter with respect to 102/103
The instant claims are identical to the issued parent 12076117 claims, application 18/299539. See notice of allowance for 18/299539 of 4/16/2024 p. 8 for reasons for allowance and 17/833894 (issued as US 11660005) notice of allowance of 9/6/2022 p. 3 for discussion of close prior art of record.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/ Primary Examiner, Art Unit 3792