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 Objections
Claims 1 and 12 are objected to because of the following informalities:
In claim 1, in line 3, the term --- (TEE) --- should be inserted after “echocardiography”.
In claim 1, in line 12, --- determining --- should be inserted before “whether”.
In claim 12, in line 3, the second occurrence of the “a processor” should be changed to --- the processor ---.
Appropriate correction is required.
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 1-13 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.
With regards to claim 1, in line 12, the limitation “determining a cardiac parameter trend..” is recited. It is unclear as to whether the “cardiac parameter trend” is a trend associated with the TEE cardiac parameter, the heart activity cardiac parameter, the determined cardiac parameter, or with another unclaimed cardiac parameter. For examination purposes, Examiner assumes that the trend is associated with either the TEE cardiac parameter, the heart activity cardiac parameter or the determined cardiac parameter.
Regarding claim 2, the phrase "preferably" in line 3 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, it is assumed that the limitations following the phrase are not part of the claimed invention.
Claim 8 recites the limitation "the electrocardiography electrode" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Eligibility
With regards to claim eligibility, Examiner notes that the claims further reflect the asserted improvement of providing an output reflective of checking the reliability of a cardiac parameter of a subject computed by a TEE probe and another sensor capable of detecting heart activity, as set forth in paragraphs [0002]-[0009] of Applicant’s PG-Pub specification, wherein it has been by Applicant that the use of both TEE and ECG measurements simultaneously can give a better idea of overall cardiac status or tracking of changes in cardiac status. However, TEE probes can get displaced due to patient’s movements or due to other procedural reasons and even small misalignments of the probe can lead to error in measurement, thus Applicant’s invention as set forth in claims 1, etc., as a whole, provides a technological solution to a technological problem. Examiner further notes that the steps of both determining a TEE cardiac parameter relative to the cardiac parameter estimated using data from the transesophageal echocardiography probe and determining a heart activity cardiac parameter relating to the cardiac parameter estimated using data from the heart activity sensor are directed to steps that may not be reasonably performed in the mind of a person, nor are conventionally performed together.
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) 1-4 and 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Semiz et al. (“Non-invasive Wearable Patch Utilizing Seismocardiography for Peri-Operative Use in Surgical Patients”, May 2021), as cited by Applicant in IDS filed on 12/6/24, in view of Simila et al. (US Pub No. 2023/0277074) and Sison et al. (US Pub No. 2014/0005496). Note that, with regards to Simila et al., the Provisional application No. 63/315,602, filed on March 2, 2022, supports the below teachings (see the drawings and specification of the Provisional application which matches the drawings and specification of the corresponding Simila et al. PG-Pub).
With regards to claims 1, 12 and 13, Semiz et al. disclose a non-transitory computer-readable medium, a system and a computer-implemented method for assessing reliability of a cardiac parameter of a subject (see pg. 1573, right column, last paragraph, referring to the computer; Figure 2), the method comprising:
receiving data from a transesophageal echocardiography probe (Abstract, referring to hemodynamic data being recorded using Transesophageal Doppler (TED); pg. 1573, left column, last paragraph-right column, 1st full paragraph, referring to the TED being inserted into the esophagus of the subject and used to obtain appropriate Doppler signals and waveforms),
receiving data from a heart activity sensor (i.e. ECG) (Abstract, referring to the wearable patch mounted on the mid-sternum which captured ECG signals continuously to predict stroke volume (SV) in patients; pg. 1573, right column, 2nd-3rd full paragraphs, referring to ECG waveforms measuring electrical activity of the heart; pg. 1574, left column, 1st paragraph, referring to the ECG signals; Figures 1, 2, wherein the ECG waveform depicts heart activity),
receiving data from a motion sensor (i.e. accelerometer) (pg. 1573, right column, 3rd full paragraph, referring to the SCG waveform assessing the mechanical motions and correspond to the local thoracic vibrations originating from the contraction of the heart and ejection of blood from the ventricles and wherein an accelerometer (i.e. motion sensor) is used to capture the SCG signals; pg. 1574, left column, last paragraph-pg. 1575, left column, 1st paragraph, referring to “where SCGx(t), SCGy(t) and SCGz(t) represent the acceleration measured in the X, Y, Z directions at time instant t”; Figure 1),
determining a TEE cardiac parameter (i.e. heart rate (HR) and/or stroke volume (SV)) relating to the cardiac parameter estimated using data (i.e. TED waveform) from the transesophageal echocardiography probe (pg. 1573, right column, 1st full paragraph, referring to stroke volume (SV) being calculated from the TED waveform; pg. 1574, right column, 1st paragraph, referring to the heart rate (HR) and SV values being obtained from the TED as the reference values; Figure 2),
determining a heart activity cardiac parameter (i.e. heart rate (HR)) relating to the cardiac parameter estimated using data from the heart activity sensor (pg. 1574, right column, last paragraph, referring to detecting R-peaks of the ECG and using the average R-R interval duration to obtain the heart rate; Table 1; Figures 2, 3),
determining the cardiac parameter based on at least one of the TEE cardiac parameter and or the heart activity cardiac parameter (pg. 1573, left column, 2nd paragraph, referring to TED being used as the reference standard against which the estimates from the wearable patch could be compared, and therefore the estimate from the wearable patch (i.e. HR values obtained from ECG, which corresponds to the “heart activity cardiac parameter”) are determined as the cardiac parameter which is assessed for reliability; pg. 1574, right column, 2nd paragraph, referring to the ECG signals being segmented in accordance with the interpolated SV and HR values which are obtained from TED, and therefore the heart activity cardiac parameter is determined based on at least the TEE cardiac parameter; Figures 2, 3), and
assessing the reliability of the cardiac parameter based on the TEE cardiac parameter (i.e. serving as a reference value) and the heart activity cardiac parameter (i.e. HR/SV based on ECG) and the data (i.e. SCG data) from the motion sensor (Abstract, referring to signal processing and regression techniques being used to derive SV from the SCG and ECG signals captured by the wearable patch and compare it to values obtained by TED, wherein the results show that the combination of SCG and ECG results in a correlation and median absolute error between the predicted and reference SV values of 0.81 and 7.56 mL, respectively, thus showing that the SCG/ECG method for obtaining SV values is an alternative to TED for continuous patient monitoring, and therefore the determination of the correlation and error between the predicted and reference SV values corresponds to assessing the reliability of the SV/cardiac parameter; pg. 1576, left column, last paragraph-right column, 1st paragraph, referring to determining the prediction error, which is the difference between the reference (i.e. SV from TED data) and predicted SV values (i.e. from SCG and ECG values); pg. 1577, right column, 3rd-4th paragraphs, referring to the combination of the SCG and ECG features containing salient information for enabling estimation of SV with sufficient high correlation with the TED reference standard across all subjects; Figures 5, 6; Table II.).
Additionally, with regards to claim 13, Semiz et al. disclose that the system further comprises a processor configured to carry out the method of claim 1 (see pg. 1573, right column, last paragraph, referring to the computer; Figure 2).
However, Semiz et al. do not specifically disclose that the method further comprises determining a cardiac parameter trend and whether the cardiac parameter trend exceeds a trend threshold and detecting motion of the subject during a first time period, based on the data of the motion sensor.
Further, Semiz et al. do not specifically disclose that assessing the reliability of the cardiac parameter is further based on whether the cardiac parameter trend exceeds the trend threshold and on whether motion of the subject has been detected.
Additionally, Semiz et al. do not specifically disclose that the method further comprises transmitting to an output device, a feedback signal based on the reliability of the cardiac parameter.
Simila et al. disclose methods and systems for heart rate detection, wherein heart rate data is collected over time (i.e. “heart rate trend”) and in cases where the collected heart rate data does not satisfy a first criteria or first threshold quality metric, instead of simply discarding the heart rate data (that would result in “gaps” in the user’s heart rate data trend), the system may compare the collected heart rate data to additional, less-stringent criteria/threshold quality metrics (Abstract; paragraphs [0175]-[0176], note that a heart rate/cardiac parameter trend over time is determined and it is determined whether the heart rate trend exceeds a threshold; Figure 9, referring to the “HR graph” which corresponds to a heart rate trend). If the heart rate data satisfies the additional, less-stringent/threshold quality metrics, the system may output the heart rate data for display to the user, thereby reducing (or preventing) gaps in the user’s heart rate data (paragraph [0176], note that the reliability of the HR data/cardiac parameter is assessed based on whether the HR trend exceeds the trend threshold or not). In the case that the output fails to satisfy any of the quality heartrate criteria, the device may refrain from outputting the data; otherwise, if at least one of the quality heartrate criteria is satisfied, the device may display the time series in an application, such as GUI (275), wherein the time-series of heart rate data may be displayed with or without quality labels indicative of the level of reliability of the data (paragraphs [0177]-[0182]; Figure 2, Figure 9, which depicts the GUI (i.e. output device) that supports the techniques for heart rate detection, including display of the heart rate graph/trend; note that the feedback signal (i.e. HR trend/graph data and/or quality labels indicative of the level of reliability of the HR data) is transmitted to an output device based on the quality/reliability of the HR data). Heart rate data provided to the user is thus improved and the heart rate data may be provided to the user with minimal gaps in the data (paragraphs [0024]-[0025]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the method of Semiz et al. further comprise determining a cardiac parameter trend and whether the cardiac parameter trend exceeds a trend threshold, have the assessing the reliability of the cardiac parameter be further based on whether the cardiac parameter trend exceeds the trend threshold and have the method further comprises transmitting to an output device, a feedback signal based on the reliability of the cardiac parameter, as taught by Simila et. al., in order to provide improved cardiac parameter data to the user and provide the cardiac parameter data to the user with minimal gaps in the data (paragraphs [0024]-[0025]).
However, the above combined references do not specifically disclose that the method of the above combined references further comprises detecting motion of the subject during a first time period, based on the data of the motion sensor, and that assessing the reliability of the cardiac parameter is further based on whether motion of the subject has been detected.
Sison et al. disclose a method for determining the source of an irregularity in physiologic data, wherein the method comprises monitoring a physiologic characteristic (such as heart rate) of a patient through physiologic data, such as ECG (Abstract; paragraph [0071]). Position data of the patient is also tracked and monitored through a position detector, such as a 3-axis accelerometer which detects the position and motion of a patient (paragraphs [0053], [0072]; Figure 8, step 102). If an irregularity in the physiologic data exists, a controller may determine whether the irregularity correlates with a change or aberration in position data (paragraph [0076]; Figure 8, step 108; note that a change in position data corresponds to motion of the data being detected). If the irregularity does not correlate with a change or aberration in the position data (i.e. position data remains steady), then the controller may determine that electromagnetic interference (EMI) is the source of the irregularity (Abstract; paragraphs [0004], [0078], [0106]; Figure 8). If, however, the irregularity does correlate with a change in position data (i.e. motion of the subject has been detected), the controller may determine the source of the irregularity to be due to a patient moving his/her arms, and/or laborious breathing, grunting or coughing or other such movements that tighten the diaphragm which causes muscles in the chest to move, thus providing the physician the opportunity to adapt sensing parameters if necessary (Abstract; paragraphs [0004], [0079], [0106]; Figure 8).
Before the effective filing date of the claimed inventio, it would have been obvious to one of ordinary skill in the art to modify the method of the above combined references to further comprise detecting motion of the subject during a first time period, based on the data of the motion sensor, and that assessing the reliability of the cardiac parameter is further based on whether motion of the subject has been detected, as taught by Sison et al., in order to quickly and easily determine the cause of the irregularity in the physiologic/received data, thus providing the physician the ability to adapt sensing parameters if necessary (Abstract; paragraphs [0004], [0078]-[0079], [0106]).
With regards to claim 2, Semiz et al. disclose that the method further comprises comparing the TEE cardiac parameter and the heart activity cardiac parameter to detect a correlated change between them, and preferably transmitting to the output device a first signal if a correlated change has not been detected (Abstract, referring to signal processing and regression techniques being used to derive SV from the SCG and ECG signals captured by the wearable patch and compare it to values obtained by TED, wherein the results show that the combination of SCG and ECG results in a correlation and median absolute error between the predicted and reference SV values of 0.81 and 7.56 mL, respectively, thus showing that the SCG/ECG method for obtaining SV values is an alternative to TED for continuous patient monitoring, and therefore the determination of the correlation and error between the predicted and reference SV values corresponds to assessing the reliability of the SV/cardiac parameter; pg. 1573, left column, 2nd paragraph, referring to TED being used as the reference standard against which the estimates from the wearable patch could be compared; note that, as indicated above in the 35 USC 112(b) rejection, the limitations following “preferably” are not considered to be further limitations of the claim).
With regards to claim 3, Semiz et al. disclose that assessing the reliability of the cardiac parameter comprises determining at least one of whether the transesophageal echocardiography probe has been misaligned, whether the heart activity sensor has been displaced, whether a cardiac parameter change has been induced by the motion of the subject, whether the cardiac parameter change is induced by a change in cardiac status, or that the cardiac parameter is considered reliable (Abstract, referring to signal processing and regression techniques being used to derive SV from the SCG and ECG signals captured by the wearable patch and compare it to values obtained by TED, wherein the results show that the combination of SCG and ECG results in a correlation and median absolute error between the predicted and reference SV values of 0.81 and 7.56 mL, respectively, thus showing that the SCG/ECG method for obtaining SV values is an alternative to TED for continuous patient monitoring and thus the cardiac parameter obtained using SCG/ECG is considered to be reliable; pg. 1577, right column, 3rd-4th paragraphs, referring to the combination of the SCG and ECG features containing salient information for enabling estimation of SV with sufficient high correlation with the TED reference standard across all subjects, and thus the cardiac parameter obtained using ECG/SCG is considered to be reliable; Figures 5, 6; Table II.). Sison et al. further disclose that assessing the reliability of the cardiac parameter comprises determining whether a cardiac parameter change has been induced by the motion of the subject (paragraphs [0073]-[0079], [0106]; referring to determining if the irregularity in the physiologic data exists or not, and if it exists, determining whether the irregularity correlates or not with changes in position (i.e. motion of the subject); Figure 8).
With regards to claim 4, as discussed above, the above combined references meet the limitations of claim 1. However, the above combined references do not specifically disclose that the method further comprises determining at least one of a type of the motion of the subject, wherein the type is physiological or pathological, and an impact of the motion of the subject on the cardiac parameter, and assessing the reliability of the cardiac parameter based on the type and/or impact of the motion of the subject. Sison et al. disclose that an irregularity in the physiologic data exists, a controller may determine whether the irregularity correlates with a change or aberration in position data (paragraph [0076]; Figure 8, step 108; note that a change in position data corresponds to motion of the data being detected). If the irregularity does not correlate with a change or aberration in the position data (i.e. position data remains steady), then the controller may determine that electromagnetic interference (EMI) is the source of the irregularity (Abstract; paragraphs [0004], [0078], [0106]; Figure 8). If, however, the irregularity does correlate with a change in position data (i.e. motion of the subject has been detected), the controller may determine the source of the irregularity to be due to a patient moving his/her arms, and/or laborious breathing, grunting or coughing or other such movements that tighten the diaphragm which causes muscles in the chest to move (i.e. type of motion of the subject is physiological or pathological), thus providing the physician the opportunity to adapt sensing parameters if necessary (Abstract; paragraphs [0004], [0079], [0106], note that if it is determined that sensing parameters need to be adapted, then it has been determined that the data is not reliable based on the type and/or impact of the motion of the subject; Figure 8). Before the effective filing date of the claimed inventio, it would have been obvious to one of ordinary skill in the art to modify the method of the above combined references to further comprise determining at least one of a type of the motion of the subject, wherein the type is physiological or pathological, and an impact of the motion of the subject on the cardiac parameter, and assessing the reliability of the cardiac parameter based on the type and/or impact of the motion of the subject, as taught by Sison et al., in order to quickly and easily determine the cause of the irregularity in the physiologic/received data, thus providing the physician the ability to adapt sensing parameters if necessary (Abstract; paragraphs [0004], [0078]-[0079], [0106]).
With regards to claim 10, Simila et al. disclose that the method further comprises at least one of determining a TEE cardiac parameter change during a third time period, determining a heart activity cardiac parameter change during the third time period, determining that the cardiac parameter change is induced by a change in cardiac status, when the motion of the subject does not exceed a motion threshold during the first time period, and the TEE cardiac parameter change correlates with the heart activity cardiac parameter change, or transmitting to the output device a third signal when the motion of the subject does not exceed the motion threshold during the first time period, and the TEE cardiac parameter change does not correlate with the heart activity cardiac parameter change (paragraphs [0145], [0175], referring to determining heart rate data (e.g., heart rate trend) over time and across time periods, which would thus include at least a “second” as well as “third” time period; Figure 9).
With regards to claim 11, Semiz et al. disclose that the motion sensor is at least one of an inertial sensor, a magnetometer, an optical sensor, a radar, an electromyography sensor, a pressure sensor, or a bed pad, an inertial sensor, or a magnetometer included in a device comprising the heart activity sensor, an inertial sensor, or a magnetometer included in the transesophageal echocardiography probe (10), or a balistocardiograpy, gyrocardiography, or seismocardiography sensor (Abstract; pg. 1573, right column, 2nd to last paragraph, referring to the tri-axial ultralow noise accelerometer (i.e. inertial sensor/SCG sensor) being used to capture seismocardiogrpahy (SCG) signals).
Claim(s) 5-6 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Semiz et al. in view of Simila et al. and Sison et al., as applied to claim 4 above, and further in view of Moller-Sorensen et al. (“Transesophageal Doppler reliably tracks changes in cardiac output in comparison with intermittent pulmonary artery thermodilution in cardiac surgery patients”, 2017).
With regards to claim 5, as discussed above, the above combined references meet the limitations of claim 4. Further, Simila et al. disclose that the method further comprises determining a heart activity cardiac parameter change during a second time period (paragraphs [0145], [0175], referring to determining heart rate data (e.g., heart rate trend) over time and across time periods, which would thus include at least a “second” time period; Figure 9), determining whether the heart activity cardiac parameter change corresponds to the type and/or impact of the motion of the subject (paragraph [0019], [0217]-[0218], referring to receiving physiological data which may include motion data, wherein a condition quality metric is associated with the time interval based on the received motion data and may be indicative of a relative quality of the physiological data collected throughout the time interval for determination of heart rate measurements; paragraphs [0143]-[0144], referring to selecting heart rate values for the user based on distinguishing the actual heart rate values of the user from motion artifacts impacting the data, wherein preprocessed motion data is used to select actual heart rate values and remove or ignore motion artifacts that may result in false heart rate measurements and the system may determine false or erroneous heart rate values that is due to motion rather than actual blood flow; paragraphs [0176]-[0181], referring to determining whether the heart rate data satisfies thresholds, wherein it would follow that if the heart rate data does not satisfy the threshold, then this would be indicative of an irregularity/change in the heart rate during the respective time period; Figures 8-9), and assessing the reliability of the cardiac parameter based on whether the TEE and heart activity cardiac parameter changes correspond to the type and/or impact of the motion of the subject (paragraphs [0143]-[0144], referring to selecting heart rate values for the user based on distinguishing the actual heart rate values of the user from motion artifacts impacting the data, wherein preprocessed motion data is used to select actual heart rate values and remove or ignore motion artifacts that may result in false heart rate measurements and the system may determine false or erroneous heart rate values that is due to motion rather than actual blood flow; paragraphs [0176]-[0181], referring to determining if the output fails to satisfy any of the criteria, which thus implies that there is a significant irregularity/change in heart rate data, then the device may refrain from outputting the data; Figure 9).
However, the above combined references do not specifically disclose that the method further comprises determining a TEE cardiac parameter change during a second time period, determining whether the TEE cardiac parameter change corresponds to the type and/or impact of the motion of the subject and wherein assessing the reliability of the cardiac parameter is further based on whether the TEE cardiac parameter changes correspond to the type and/or impact of the motion of the subject.
Moller-Sorensen et al. disclose acquiring cardiac output (CO) measurements with transesophageal Doppler (TED) during patient position changes (Abstract; pg. 136, Section 2.1; Figure 2, note that CO measurements are thus obtained at different time periods corresponding to changes in position). Changes in CO during the patient position changes were tracked with TED in order to assess the precision/reliability of TED (Abstract; pg. 141, right column, 1st -2nd paragraphs). In order to obtain an optimal Doppler signal, TED demands routine and frequent repositioning poses a problem wherein readjustment of the probe is necessary (pg. 136, right column, Section 2.1; pg. 141, right column, 1st-2nd paragraphs, note that it is thus clear that change in position (i.e. motion) of the subject results in cardiac output (i.e. TEE/TED cardiac parameter) changes, and thus cardiac output changes correspond to an impact of motion, thus requiring an adjustment of the probe).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the method of the above combined references further comprise determining a TEE cardiac parameter change during a second time period, determining whether the TEE cardiac parameter change corresponds to the type and/or impact of the motion of the subject and wherein assessing the reliability of the cardiac parameter is further based on whether the TEE cardiac parameter changes correspond to the type and/or impact of the motion of the subject, as taught by Moller-Sorensen et al., in order to obtain an optimal TEE signal (pg. 136, right column, Section 2.1; pg. 141, right column, 1st-2nd paragraphs).
With regards to claim 6, the above combined references disclose that the method further comprises determining that the cardiac parameter change is induced by the motion of the subject when the TEE and the heart activity cardiac parameter changes correspond to the type and/or impact of the motion of the subject (see Simila et al., paragraphs [0143]-[0144], referring to selecting heart rate values for the user based on distinguishing the actual heart rate values of the user from motion artifacts impacting the data, wherein preprocessed motion data is used to select actual heart rate values and remove or ignore motion artifacts that may result in false heart rate measurements and the system may determine false or erroneous heart rate values that is due to motion rather than actual blood flow; See Moller-Sorensen et al., pg. 136, right column, Section 2.1; pg. 141, right column, 1st-2nd paragraphs, note that it is thus clear that change in position (i.e. motion) of the subject results in cardiac output (i.e. TEE/TED cardiac parameter) changes, and thus cardiac output changes correspond to an impact of motion, thus requiring an adjustment of the probe).
With regards to claim 9, Simila et al. disclose that the method further comprises transmitting to the output device a second signal when the TEE and heart activity cardiac parameter changes do not correspond to the type and/or impact of the motion of the subject (paragraphs [0143]-[0144], referring to selecting heart rate values for the user based on distinguishing the actual heart rate values of the user from motion artifacts impacting the data, wherein preprocessed motion data is used to select actual heart rate values and remove or ignore motion artifacts that may result in false heart rate measurements and the system may determine false or erroneous heart rate values that is due to motion rather than actual blood flow, wherein there would be no erroneous/false data determined if the cardiac parameter changes do not correspond to the type/impact of motion, and thus a second signal (i.e error free heart rate values) would be transmitted; paragraphs [0176]-[0181], referring to comparing the heart rate output selection to the first criteria, and if the output satisfies the first set of criteria (as would be the case if the output does not correspond to the type and/or impact of the motion of the subject), then the device may output the heart rate data and further may be labeled with an appropriate reliable data label (i.e. second signal)).
Allowable Subject Matter
Claim 7-8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With regards to claim 7, the prior art does not teach or suggest determining that the transesophageal echocardiography probe has been misaligned, when the TEE cardiac parameter change does not correspond to the type and/or impact of the motion of the subject and the heart activity cardiac parameter change corresponds to the type and/or impact of the motion of the subject, in combination with the other claimed elements.
With regards to claim 8, the prior art does not teach or suggest determining that the electrocardiography electrode has been displaced, when the TEE cardiac parameter change corresponds to the type and/or impact of the motion of the subject and the heart activity cardiac parameter change does not correspond to the type and/or impact of the motion of the subject, in combination with the other claimed elements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dark et al. (“The validity of trans-esophageal Doppler ultrasonography as a measure of cardiac output in critically ill adults”, 2004) disclose studies performed to determine the validity of esophageal Doppler monitor (EDM) and echo-esophageal Doppler (Echo-ED) in measuring cardiac output (Abstract).
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798