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 .
Response to Amendment
This office action is responsive to the preliminary amendment filed on June 6, 2023. As directed by the amendment: claims 3-5, 7-12, and 14 have been amended, no claims have been cancelled, and claims 16-17 have been added. Thus, claims 1-17 are presently pending in this application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“photoplethysmography, PPG, sensing unit” in claim 1 line 3, claim 11 line 4, and claim 15 lines 2 and 5 are interpreted as a nasal alar PPG sensor, a nasal columella PPG sensor, an ear concha PPG sensor, and a forehead PPG sensor or the like according to page 2 lines 36-37 of the specification. The “PPG sensing unit” in claim 5 line 2, claim 6 line 1, and claim 7 line 1 are not being interpreted under 112f because sufficient structure is provided.
“motion sensing unit” in claim 1 lines 6 and 20, claim 2 line 1, claim 11 line 3, claim 15 lines 3, 7, and 20, claim 16 lines 2-3, and claim 17 lines 2-3 are interpreted as an accelerometer or the like according to page 6 lines 6-7 of the specification.
“mobile device” in claim 11 line 2 and claim 13 line 2 are interpreted as a smartphone or tablet according to page 9 lines 2-3 of the specification. The “mobile device” in claim 14 lines 1-2 is not being interpreted under 112f because sufficient structure is provided.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 8-9 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 8, the limitation “the processing unit is further configured to: acquire a core body temperature value of the subject” in lines 2-3 is indefinite because the term acquire suggests that the processing unit is measuring a body temperature, and it is unclear what structure allows the processing unit to measure a temperature. The claim limitation is being interpreted as –receive a body temperature measurement from a temperature sensor--.
Regarding claim 9, the limitation “the processing unit is further configured to acquire at least one of: an electrocardiography, ECG, signal associated with the subject and a signal indicating nasal flow of the subject” in lines 2-4 is indefinite because the term acquire suggests that the processing unit is measuring an ECG and/or a nasal flow, and it is unclear what structure allows the processing unit to measure. The claim limitation is being interpreted as –receive at least one of: receive an ECG signal from an ECG unit and s nasal flow signal from a nasal flow sensing unit--.
Claim limitation “core unit” in claim 1 lines 5, 20, and 21, claim 2 line 2, claim 11 line 3, claim 12 line 2, claim 13 line 1, claim 15 lines 3, 20, and 21, claim 16 line 2, and claim 17 line 3 has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the term “unit” is used as a generic placeholder without sufficient structure, but does not provide function besides its connection to other elements. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1, 3-5, 9-10, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giarracco et al. (US 2016/0206504) in view of Herken et al. (US 2013/0324894).
Regarding claim 1, Giarracco discloses a system for providing cardiopulmonary resuscitation, CPR, decision support (fig. 8, medical monitoring system 160 can identify a return to spontaneous circulation (ROSC) according to [0052]), comprising:
a photoplethysmography, PPG, sensing unit (fig. 8, sensor 162 performs regional oximetry [0058] which can be considered a photoplethysmography signal, see [0017]) configured to determine one or more PPG signals at a measurement site on a subject ([0058] states the sensor can be placed on various regions of the body);
a core unit (fig. 8, monitor 164 can be considered a core unit as it houses the processor 170 and display 174) comprising a user interface (fig. 8, display 174 and input 178);
a motion sensing unit (fig. 8, accelerometer 166) configured to detect motions correlated to chest compressions during compression therapy on the subject ([0052] states that accelerometer 166 enables monitoring chest compressions); and
a processing unit configured to (fig. 8, processor 170):
determine presence or absence of a spontaneous pulse ([0053] states that pulses can be attributed to chest compressions or ROSC) based on the detected motions correlated to chest compressions during compression therapy on the subject and the one or more PPG signals ([0053] states that the sensor 162 is used to determine if the pulses are due to ROSC);
determine a recommendation to be provided based on the determination of presence or absence of a spontaneous pulse (fig. 9, step 190 provides feedback based on if ROSC has occurred, see [0056]), wherein the recommendation is associated with CPR decision support ([0043] states that ROSC can help advise to person administering CPR to stop);
control the user interface to output the determined recommendation ([0054] states that feedback with respect to CPR can be provided using the monitor via display 174);
Giarracco further discloses the signal found from the sensor has an amplitude which can be compared to non-cardiac pulses and/or the cardiac pulses ([0018]), the amplitude can be used to evaluate CPR ([0019]), and the accelerometer can detect the chest compressions ([0054]), but does not expressly disclose that the processing unit is configured to determine whether amplitudes and/or signal quality corresponding to the detected motions correlated to chest compressions during compression therapy on the subject are within a predetermined target range; and control the user interface to output an instruction to adjust a position of the motion sensing unit or a position of the core unit if the motion sensing unit is integrated in the core unit, if it is determined that the amplitudes and/or the signal quality corresponding to the detected motions correlated to chest compressions during compression therapy on the subject are not within the predetermined target range.
However, Herken teaches of an automated chest compression device for performing CPR (fig. 1) that includes an accelerometer ([0013]) that can be used to confirm proper compression and proper position ([0013]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the processor of the system of Giarracco with proper compression and position steps programming as taught by Herken to ensure quality of compressions to improve patient outcomes (Herken [0003]).
The modified system of Giarracco reads on the processing unit is configured to determine whether amplitudes corresponding to the detected motions correlated to chest compressions during compression therapy on the subject (Herken [0013] states that the accelerometer can detect movement where the detected motions can be depth of compression or superior/inferior movement) are within a predetermined target range (Herken [0013] states that a proper compression and position exists and can be considered the target range); and control the user interface to output an instruction (Giarracco [0025] states that the monitor which includes a speaker can provide instructions to a user such as changing compression intensity or position) to adjust a position of the motion sensing unit or a position of the core unit if the motion sensing unit is integrated in the core unit (Herken [0013] states that the detected position can be used to detect improper placement or confirm proper placement), if it is determined that the amplitudes corresponding to the detected motions correlated to chest compressions during compression therapy on the subject are not within the predetermined target range (Herken [0013] if proper compression and position is not reached, Giarracco [0025] states CPR feedback can be provided).
Regarding claim 3, the modified system of Giarracco reads on the limitations of claim 1 and further reads on if it is determined that a spontaneous pulse is present (Giarracco [0043] states that ROSC can be determined by analyzing the received signal compared to signal metrics), the determined recommendation is to perform a further check for presence of a pulse (Giarracco [0043] states that additionally ROSC can be determined by comparing the detected pulse to see if it is due to CPR).
Regarding claim 4, the modified system of Giarracco reads on the limitations of claim 1 and further reads on if a spontaneous pulse if absent, the determined recommendation is to continue compression therapy on the subject (Giarracco [0043] states that CPR should no longer be administered once the patient experiences ROSC which inherently means until ROSC is experienced, CPR should continue).
Regarding claim 5, the modified system of Giarracco reads on the limitations of claim 1 and further reads on the PPG sensing unit comprises a forehead PPG sensor (Giarracco [0058] states that the regional oximeter is placed on a patient’s forehead).
Regarding claim 9, the modified system of Giarracco reads on the limitations of claim 1 and further reads on the processing unit is further configured to acquire an electrocardiography, ECG, signal associated with the subject (Giarracco [0052] states that an ECG sensor can monitor chest compressions), wherein determining the recommendation to be provided is further based on the acquired ECG signal (Giarracco [0052] states that the signal from the ECG sensor 168 can be also used to determine whether the patient has experience ROSC which advises future CPR decisions, see [0043]).
Regarding claim 10, the modified system of Giarracco reads on the limitations of claim 1 and further reads on the processing unit is further configured to control the user interface to further output an indication (Giarracco [0025] states that the monitor which includes a speaker can provide instructions to a user such as changing compression intensity or position which results from evaluating the measured values) of the result of the determination of whether the amplitudes (Herken [0013] states that the accelerometer can detect movement where the detected motions can be depth of compression or superior/inferior movement) are within a predetermined target range (Herken [0013] states that a proper compression and position exists and can be considered the target range).
Regarding claim 15, Giarracco discloses a method for operating a system for providing cardiopulmonary resuscitation, CPR, decision support (fig. 9) wherein the system comprises
a photoplethysmography, PPG, sensing unit (fig. 8, sensor 162 performs regional oximetry [0058] which can be considered a photoplethysmography signal, see [0017]),
a core unit (fig. 8, monitor 164 can be considered a core unit as it houses the processor 170 and display 174) comprising a user interface (fig. 8, display 174 and input 178),
a motion sensing unit (fig. 8, accelerometer 166), and
a processing unit (fig. 8, processor 170),
the method comprising:
determining, at the PPG sensing unit, one or more PPG signals at a measurement site on a subject (fig. 9, in step 182 monitor 170 receives a signal from sensor 162 which inherently requires determining a PPG signal at a measurement site by sensor 162, see [0055]);
detecting, at the motion sensing unit, motions correlated to chest compressions during compression therapy on the subject (fig. 9, in step 184 the monitor receives a signal indicative of chest compressions from accelerometer 166 which inherently requires detecting motions during compression therapy by accelerometer 166, see [0055]);
determining, at the processing unit ([0055] states that fig. 9, step 186 occurs using processor 170), presence or absence of a spontaneous pulse (fig. 9, step 188) based on the detected motions correlated to chest compressions during compression therapy on the subject (fig. 9, step 188 compares the pulses with chest compressions, see [0056]) and the one or more PPG signals ([0056] states that the pulses in the signal obtained by sensor 12, which is equivalent to sensor 162, are used to determine ROSC);
determining, at the processing unit ([0056] states step 190 occurs at the monitor which houses the processor), a recommendation to be provided based on the determination of presence or absence of a spontaneous pulse (fig. 9, in step 190 feedback is provided to the provider based on whether ROSC has occurred, see [0056]);
controlling, at the processing unit, the user interface to output the determined recommendation ([0056] states that the feedback is provided similar to fig. 7, step 148, and [0050] states that once ROSC is identified, the speaker and display can be used to adjust the administration of CPR such as stopping delivery of CPR);
Giarracco further discloses the signal found from the sensor has an amplitude which can be compared to non-cardiac pulses and/or the cardiac pulses ([0018]), the amplitude can be used to evaluate CPR ([0019]), and the accelerometer can detect the chest compressions ([0054]), but does not expressly disclose the steps of: determining, at the processing unit, whether amplitudes and/or a signal quality corresponding to the detected motions correlated to chest compressions during compression therapy on the subject are within a predetermined target range; and controlling, at the processing unit, the user interface to output an instruction to adjust a position of the motion sensing unit or a position of the core unit if the motion sensing unit is integrated in the core unit, if it is determined that the amplitudes and/or the signal quality corresponding to the detected motions correlated to chest compressions during compression therapy of the subject are not within the predetermined target range.
However, Herken teaches of an automated chest compression device for performing CPR (fig. 1) that includes an accelerometer ([0013]) that can be used to confirm proper compression and proper position ([0013]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the method of Giarracco with proper compression and position steps as taught by Herken to ensure quality of compressions to improve patient outcomes (Herken [0003]).
The modified method of Giarracco reads on the steps of determining, at the processing unit, whether amplitudes corresponding to the detected motions correlated to chest compressions during compression therapy on the subject (Herken [0013] states that the accelerometer can detect movement where the detected motions can be depth of compression or superior/inferior movement) are within a predetermined target range (Herken [0013] states that a proper compression and position exists and can be considered the target range); and controlling, at the processing unit, the user interface to output an instruction (Giarracco [0025] states that the monitor which includes a speaker can provide instructions to a user such as changing compression intensity or position) to adjust a position of the motion sensing unit or a position of the core unit if the motion sensing unit is integrated in the core unit (Herken [0013] states that the detected position can be used to detect improper placement or confirm proper placement), if it is determined that the amplitudes and/or the signal quality corresponding to the detected motions correlated to chest compressions during compression therapy of the subject are not within the predetermined target range (Herken [0013] if proper compression and position is not reached, Giarracco [0025] states CPR feedback can be provided, and Giarracco [0050] states that recommended adjustments of CPR can be provided).
Regarding claim 16, the modified method of Giarracco reads on the limitations of claim 15 and further reads on guiding a user in adjusting the position (Giarracco [0053] states that the accelerometer is place on or near the patient’s chest to monitor chest compression, where recommended adjustments require different positions/depths which affect the position of the accelerometer due to its proximity to the chest of the patient) of the motion sensing unit (Giarracco fig. 8, accelerometer 166) by using data which include the reading of the motion sensing unit (Herken [0013] if proper compression and position is not reached as detected by the accelerometer, Giarracco [0025] states CPR feedback can be provided, and Giarracco [0050] states that recommended adjustments of CPR can be provided).
Regarding claim 17, the modified system of Giarracco reads on the limitations of claim 1 and further reads on the processing unit is further configured to: guide a user in adjusting the position (Giarracco [0053] states that the accelerometer is place on or near the patient’s chest to monitor chest compression, where recommended adjustments require different positions/depths which affect the position of the accelerometer due to its proximity to the chest of the patient) of the motion sensing unit (Giarracco fig. 8, accelerometer 166) by using data which include the reading of the motion sensing unit (Herken [0013] if proper compression and position is not reached as detected by the accelerometer, Giarracco [0025] states CPR feedback can be provided, and Giarracco [0050] states that recommended adjustments of CPR can be provided).
Claim(s) 2 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giarracco in view of Herken as applied to claim 1 above, and further in view of Totman et al. (US 2012/0184882).
Regarding claim 2, the modified system of Giarracco reads on the limitations of claim 1, but does not expressly disclose the motion sensing unit (Giarracco fig. 8, accelerometer 166) is part of the core unit (fig. 8, monitor 164).
However, Totman teaches of a chest compression monitor (fig. 2, CPR chest compression monitor 5) that can measure and prompt chest compressions for effective CPR administration ([0006]) where the accelerometers are already fitted into smart phones ([0007]) which additionally have a display and speaker ([0006]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the monitor (fig. 8, 164) of Giarracco with the chest compression monitor as taught by Totman as a simply substitution of one known element for another to obtain a predictable result of providing feedback to the user during administration of CPR.
Regarding claim 11, the modified system of Giarracco presented in the rejection to claim 2 above reads on the limitations of claim 1 and further discloses the processing unit is implemented (Totman [0018] states that a smart phone houses a microprocessor) at a mobile device (Totman fig. 2, CPR chest compression monitor 5), and the processing unit is configured to connect wirelessly to the PPG sensing unit (Giarracco [0020] states that the sensor can communicate wirelessly with the monitor).
Regarding claim 12, the modified system of Giarracco presented in the rejection to claim 2 above reads on the limitations of claim 1 and further reads on the processing unit is part of the core unit (Totman [0018] states that a smart phone houses a microprocessor where the smart phone housing is defined as the core unit), and the core unit is configured such that it can be placed at or adjacent to an upper part of the chest area of the subject (Totman fig. 1, chest compression monitor 5 is shown being placed at or adjacent to an upper part of the chest area).
Regarding claim 13, the modified system of Giarracco reads on the limitations of claim 12 and further reads on the core unit (Totman [0018] states that a smart phone houses a microprocessor where the smart phone housing is defined as the core unit) is implemented at a mobile device (Totman fig. 2, CPR chest compression monitor 5 is attached using a strap or band 6 so that it can connect to a hand, see [0014], and is therefore inherently mobile).
Regarding claim 14, the modified system of Giarracco reads on the limitations of claim 11 and further reads on the mobile device is a smartphone (Totman fig. 2, monitor 5 is a smartphone, see [0016]).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giarracco in view of Herken as applied to claim 5 above, and further in view of Bui et al. (US 2020/0396532).
Regarding claim 6, the modified system of Giarracco reads on the limitations of claim 5 and further reads on the use of multiple detector elements (fig. 8, 18) of the sensor which allows detection of oxygen saturation in various tissue layers, but does not expressly disclose multiple sensors.
However, Bui teaches of the use of multiple PPG sensors ([0072]) to evaluate a relative signal quality or average the signals and factor out noise ([0072]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified system of Giarracco with multiple PPG sensors as taught by Bui ensure a quality signal (Bui [0072]).
Regarding claim 7, the modified system of Giarracco reads on the limitations of claim 5 and further reads on the use of multiple detector elements (fig. 8, 18) of the sensor which allows detection of oxygen saturation in various tissue layers, but does not expressly disclose multiple sensors or the processing unit is configured to receive one or more signal quality indicators corresponding to one or more of the PPG sensors; and determine at least one of the one or more PPG sensors to activate based on the received one or more signal quality indicators.
However, Bui teaches of the use of multiple PPG sensors ([0072]) to evaluate a relative signal quality or average the signals and factor out noise ([0072]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified system of Giarracco with multiple PPG sensors and the program for evaluating and selecting a sensor as taught by Bui ensure a quality signal (Bui [0072]).
The modified system of Giarracco reads on the PPG sensing unit comprises more than one of a forehead PPG sensor (Giarracco [0058] states that the regional oximeter is placed on a patient’s forehead, and Bui [0072] states that multiple PPG sensors can be used), and wherein the processing unit is configured to: receive one or more signal quality indicators corresponding to one or more of the PPG sensor (Bui [0072] states that each sensor has a relative signal quality); and determine at least one of the one or more PPG sensors to activate based on the received one or more signal quality indicators (Bui [0072] states that a sensor is selected based on a relative signal quality of each).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giarracco in view of Herken as applied to claim 1 above, and further in view of Lennox et al. (US 2004/0158303).
Regarding claim 8, the modified system of Giarracco reads on the limitations of claim 1, but is silent on the processing unit is further configured to: acquire a core body temperature value of the subject; and control the user interface to output at least one of: the detected core body temperature, an indication of whether the detected core body temperature is within a predetermined target range or at a predetermined target value, and an indication of whether the detected core body temperature is approaching a predetermined target range or a predetermined target value.
However, Lennox teaches of a method and device for rapidly inducing and maintaining hypothermia to reduce ischemic injury during cardiac arrest ([0002]) and also performing CPR on the patient ([0194] states CPR equipment can be provided to help restore blood circulation if a patient is undergoing cardiac arrest). This is accomplished by measuring the body temperature with a temperature sensor 10 ([0083]) and modulating the cooling device based on the measured temperature to induce hypothermia ([0163]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified system of Giarracco with the hypothermia inducing device as taught by Lennox to reduce ischemic injury by measuring and inducing hypothermia in patients that experience cardiac arrest (Lennox [0002]).
The modified system of Giarracco reads on the processing unit is further configured to: acquire a core body temperature value of the subject (Lennox] [0163] states a temperature signal is transmitted which inherently requires acquiring the temperature measurement); and control the user interface to output at least one of: the detected core body temperature (Lennox [0162] states the body temperature measurement can be displayed), an indication of whether the detected core body temperature is within a predetermined target range or at a predetermined target value (Lennox [0163] states that the patient’s body core temperature has a set-point range that is reached by measuring and adjusting the body core temperature by the controller, and [0187] states that the display can provide a user with information regarding the operation of the system such as the status of the patient’s body cooling).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Melker (US 2018/0256043) discloses a method of improving the effectiveness of chest compressions by monitoring PPG signals secured to a nose of an individual and detecting a ROSC. Wijshoff et al. (US 2016/0374623) discloses a device for determining a ROSC using sensors for physiological signals of the patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Friday 9:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS Z CHANG/ Examiner, Art Unit 3785
/TIMOTHY A STANIS/ Supervisory Patent Examiner, Art Unit 3785