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 Arguments
In view of the amendments, the 101 Rejection is withdrawn.
In view of the amendments, the 112(b) Rejection is withdrawn.
Applicant's arguments with respect to the 103 Rejection have been fully considered but they are not persuasive. Applicant argues “Halperin does not teach or suggest a filtering operation that is configured based on the one or more parameters associated with the location or motion of the at least one magnetic sensor” (Remarks, Page 5). The Vaidyanathan reference is used to address the motion of the magnetic sensor [0048, 0049] to measure motion combined maternal/fetal movement tracking [0108] and teach of isolating or filtering signals tied to fetal movement from the material vibration signals [0144]. The reference clearly teaches the use of magnetometers to sense translational movement of the sensor body where the oscillation noise due to impact vibration can be filtered from the MMG data using IMU data as a guide to where impacts occurred and therefore enabling isolation of fetal activity [0128]. Under broadest reasonable interpretation, the reference is teaching performing a de-noising operation on the combined maternal/fetal heart signal and filtering or isolating signals tied to fetal movement from the maternal vibration signals based on the data obtained from the motion of the magnetic sensor. Being a 103 Rejection, it is the combination of the references that are relied upon to address the rejection and the combination of the Halperin, Vaidyanathan, and Alford references provide teaching for the claimed elements and therefore it is not necessary for the Halperin reference to be relied upon for all the claim limitations. The claim language is directed to “parameters associated with location or motion of the at least one magnetic sensor”. Since claims 1 and 14, do not clarify the specific “parameters” that are distinct from the prior art, such as (filtering operation based on the motion of the magnetic sensor) from the Vaidyanathan reference, the Rejection is maintained and modified below to address the amendments.
Applicant argues that the Keenan reference does not teach filtering based on parameters associated with location or motion of the at least one magnetic sensor. Being a 103 Rejection, it is the combination of the references that are relied upon to address the rejection and the combination of the Halperin, Vaidyanathan, Alford, and Keenan references provide teaching for the claimed elements and therefore it is not necessary for the Keenan reference to be relied upon for all the claim limitations. The Vaidyanathan reference is used to address the motion of the magnetic sensor [0048, 0049] to measure motion combined maternal/fetal movement tracking [0108] and teach of isolating or filtering signals tied to fetal movement from the material vibration signals [0144]. The reference clearly teaches the use of magnetometers to sense translational movement of the sensor body where the oscillation noise due to impact vibration can be filtered from the MMG data using IMU data as a guide to where impacts occurred and therefore enabling isolation of fetal activity [0128]. The reference teaches of filtering based on parameters such as frequency of a heart signal corresponding to the sensor motion [0111, 0130, 0136], where increases in frequency in the motion data produces by steps taken when walking correspond with MMG data where an increase in activity can be se seen [0141]. Under broadest reasonable interpretation, the reference is teaching performing a de-noising operation on the combined maternal/fetal heart signal and filtering or isolating signals tied to fetal movement from the maternal vibration signals based on the data obtained from the motion of the magnetic sensor. The Keenan reference is used to provide support for the teaching of the Kalman filter [0057]. The Keenan reference also teaches of filtering information on maternal and fetal activities using a first filter and then a second loop of filtering at the appropriate frequency [0055, 0056].
In view of the amendments made to claims 6, 9, 19, and new claim 21, a modified rejection is set forth below with respect to these claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-7, 14, 15, 17, 18, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halperin et al. (8731646) in view of Vaidyanathan et al. (2019/0320944) and further in view of Alford et al. (2020/0072916).
With respect to claims 1, 2, 4, 14 and 15, Halperin et al. teach of a system and method for monitoring fetal heart signal in a subject by receiving a combined heart signal comprising a mixture of maternal heart signal and fetal heart signal (col. 50 lines 65-col. 51 line 18, fig. 11). Halperin et al. teach of generating a de-noised combined heart signal by performing de-noising operation on the combined heart signal such as a filtering operation and track the fetal heart signal (col. 51 lines 19-35). Halperin et al. teach of the filtering operation to comprise bandpass filtering operation and a notch filtering operation using a bandpass filter and a notched filter where the combined signal is filtered using a notch filter that removes the maternal pulse frequency and the resulting signal is then filtered using a bandpass filter appropriate for fetal pulse (col. 59, lines 55-65).
With respect to claims 1, 2, 4, 14, and 15, Halperin et al. teach of two or more motion sensors 30 to identify and discriminate between maternal pulse and fetal pulse (col. 59 lines 42-54) but do not teach of the motion of a magnetic sensor. In a similar field of endeavor Vaidyanathan et al. teach of the use of a magnetic sensor to estimation location or motion of the magnetic sensor [0048, 0049] to measure motion in combined maternal/fetal movement tracking [0108] and teach of isolating signals tied to fetal movement from the material vibration signals [0144]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Vaidyanathan et al. to modify Halperin et al. more effective fetal movement monitoring and excluding vibrations from maternal signals [Vaidyanathan, 0016]. With respect to claim 4, Vaidyanathan et al. teach of the sensor comprising a frequency response in various ranges that fall within 0.1 Hz to 200 Hz [0052]. Under broadest reasonable interpretation, the reference is teaching performing a de-noising operation on the combined maternal/fetal heart signal and filtering or isolating signals tied to fetal movement from the maternal vibration signals based on the data obtained from the motion of the magnetic sensor. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Vaidyanathan et al. to modify Halperin et al. more effective fetal movement monitoring and excluding vibrations from maternal signals [Vaidyanathan, 0016].
With respect to claims 1, 2, 4, 14, and 15, Vaidyanathan et al. teach of the use of a magnetometer but do not explicitly teach of the dynamic range and noise floor. In a related field of endeavor Alford et al. teach of a system and method that uses optically pumped magnetometers that operated within the dynamic range of less than 200 nT [0078] and with a noise floor within a range from 0.01pt/√Hz to 100pt/√Hz [0053]. Alford et al. teach of optically pumped magnetometers (OPM) that therefore do not require cryogenic cooling as the superconductive quantum interference device (SQUID) requires cryogenic cooling and the OPM does not require the cooling [0003]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Alford et al. to modify the previous teachings to more effectively suppress background signal and noise that do not contribute to the desired signal [Alford, 0052].
With respect to claims 3 and 21, the previous references do not explicitly teach of the magnetic sensor based on tunneling magnetoresistance or fluxgate magnetometry. Alford et al. teach of optically pumped magnetometers (OPM) that therefore do not require cryogenic cooling as the superconductive quantum interference device (SQUID) requires cryogenic cooling and the OPM does not require the cooling [0003]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Alford et al. to modify the previous teachings to more effectively suppress background signal and noise that do not contribute to the desired signal [Alford, 0052].
With respect to claims 5 and 7, Halperin et al. do not explicitly teach of a magnetometer. Vaidyanathan et al. in view of Alford et al. teach of the magnetic sensor to comprise a tri-axis magnetometer [Vaidyanathan, 0049]. Vaidyanathan et al. teach of positioning the magnetic sensor at an initial location on the subject such as any suitable part of the body such as arms, legs, hands, etc. from which limb or body motion can be detected [0048]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Vaidyanathan et al. to modify Halperin et al. to provide a magnetic sensors to measure motion due to its low cost, small size, light weight and accuracy [Vaidyanathan, 0049].
With respect to claims 17 and 18, Halperin et al. do not explicitly teach of the simultaneous tracking or monitoring or parallel tracking loops for tracking the fetal heart signal. Vaidyanathan et al. in view of Alford et al. teach of simultaneous monitoring of the maternal and fetal movement and therefore tracking the maternal and fetal signal simultaneously or in parallel tracking loop [Vaidyanathan, 0016, 0018]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Vaidyanathan et al. to modify Halperin et al. to more effectively distinguish between maternal and fetal signals [Vaidyanathan, 0144].
Claim(s) 6 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halperin et al. in view of Vaidyanathan et al. in view of Alford et al. and further in view of Vajinepalli et al. (2024/0206842). Halperin et al. do not teach of an inertial measurement unit. Vaidyanathan et al. in view of Alford et al. teach of the use of inertial measurement units for muscle activity sensing or fetal movement monitoring and wherein the processor [Vaidyanathan, 0053] is configured to estimate the one or more parameters based on an output of the IMU [Vaidyanathan, 0047, 0049, 0111]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Vaidyanathan et al. to modify Halperin et al. to more effectively sense translational motion and sense rotation of the sensor body [Vaidyanathan, 0005]. The previous references do not teach of one of the claimed manners of representing the parameters. In a related field of endeavor Vajinepalli et al. teach of an apparatus and method or monitoring heartbeat of a fetus and filtering maternal heart beat and other motions [0028] by filtering certain signals [0056] and use of a Cartesian coordinate system [0062] and use of Euler angles [0096]. Vajinepalli et al. teach of determining the location of the fetal heart using data from IMU sensor [0096]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Vajinepalli et al. to modify the previous teaching to more efficiently and reliably monitor a fetal heart without the need for input from a clinician [Vajinepalli, 0096].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halperin et al. in view of Vaidyanathan et al. in view of Alford et al. in view of Montgomery et al. (2005/0165323) and further in view of Keenan (2023/0218219). The previous references do not teach of the handheld device. In a similar field of endeavor Montgomery et al. teach of the use of a handheld display unit 102 [0079]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Montgomery et al. to modify the combined teaching to provide easier control for tracking the location of the sensor. Halperin et al. in view of Vaidyanathan et al. in view of Alford et al. teach of enhancing the signal quality with the use of the sensors and making adjustments by adding more sensors to maximize signal quality (Halperin, col. 59 lines 39-54). Halpern et al. do not explicitly teach of the applying the adjustment to the initial location of the sensor to generate the location of the magnetic sensor. In a related field of endeavor Keenan teaches of a system and method for monitoring maternal/fetal activities where the maternal ECG signal is subtracted for each channel and the remaining fetal signal is passed through filtering stages including Kalman filtering [0057]. Keenan teaches of undertaking sensor placement to ensure optimal signal quality for monitoring maternal and fetal activities where the optimal initial sensor placement is adjusted based on the signal quality assessment [0051]. The previous reference that would, under broadest reasonable interpretation, would be capable of display the initial location of the sensor (as set forth by Halperin et al., Vaidyanathan et al. , and Alford et al.) and measure signal quality, make adjustments to the location to improve signal quality (as set forth by the Keenan reference) and where the adjusted location is displayed on the handheld device (as set forth by Montgomery reference). It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Keenan to modify the previous teachings to improve signal quality for monitoring maternal and fetal activities [Keenan, 0011].
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halperin et al. in view of Vaidyanathan et al. in view of Alford et al. in view of Vajinepalli et al. and further in view of Anderson et al. (2021/0386315). Halperin et al. teach of using the maternal heart signal and the fetal heart signal (fig. 11) but do not explicitly teach of the reference frame determined based on the signals received from a plurality of beacons. In a related field of endeavor Anderson et al. teach of a system and method for estimating the position and orientation of surgical devices that includes field generator beacons in a fixed reference frame combined with the medical device mounted magnetometer sensors and send out time-varying magnetic signals which are typically continuous alternating current signals [0045]. Anderson et al. further teach of the system using drive coils to produce magnetic gradient fields [0053] where the drive coils are mounted within the invasive device [0055]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Anderson et al. to modify the previous teachings to effectively estimate the position and orientation of the sensor from the signals transmitted between the antennas and provide accurate position and orientation information at a consistently high data rate [Anderson, 0004].
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halperin et al. in view of Vaidyanathan et al. in view of Alford et al. in view of Vajinepalli et al. in view of Anderson et al. and further in view of Montgomery et al. The previous references also do not explicitly teach of a spread-spectrum signal. In a similar field of endeavor Montgomery et al. teach of system and method for physiological signal monitoring that includes maternal/fetal monitoring [0030]and includes spread spectrum signal transmission [0063]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Montgomery et al. to modify the combined teaching for more effective monitoring and control of maternal/fetal signals and increase resistance to noise.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halperin et al. in view of Vaidyanathan et al. in view of Alford et al. and further in view of Petrikovsky et al. (2018/0317783). The previous teachings do not explicitly teach of one of the claimed source separation operations. In a similar field of endeavor Petrikovsky et al. teach of a fetal heart monitor system and method that includes filter to determine the maternal heart rate by using the signal ECG to construct an estimate of a mixing matrix which is then converged to final form through successive iterations of a process such a as Independent Component Analysis [0046]. It would have therefore been obvious ton one of ordinary skill in the art to use the teaching by Petrikovsky et al. to modify the previous teachings for effective detecting and monitoring of the fetal heartbeat [Petrikovsky et al., 0002].
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halperin et al. in view of Vaidyanathan et al. in view of Alford et al. and further in view of Keenan. The previous teachings do not explicitly teach of a Kalman filter. In a related field of endeavor Keenan teaches of a system and method for monitoring maternal/feal activities where the maternal ECG signal is subtracted for each channel and the remaining fetal signal is passed through filtering stages including Kalman filtering [0057]. The Vaidyanathan reference teaches of filtering based on parameters such as frequency of a heart signal corresponding to the sensor motion [0111, 0130, 0136], where increases in frequency in the motion data produces by steps taken when walking correspond with MMG data where an increase in activity can be se seen [0141]. Under broadest reasonable interpretation, the Vaidyanathan reference is teaching performing a de-noising operation on the combined maternal/fetal heart signal and filtering or isolating signals tied to fetal movement from the maternal vibration signals based on the data obtained from the motion of the magnetic sensor. The Keenan reference is used to provide support for the teaching of the Kalman filter [0057]. The Keenan reference also teaches of filtering information on maternal and fetal activities using a first filter and then a second loop of filtering at the appropriate frequency [0055, 0056]. With respect to claim 20, Halperin et al. in view of Vaidyanathan et al. in view of Alford et al. teach of enhancing the signal quality with the use of the sensors and making adjustments by adding more sensors to maximize signal quality (Halperin, col. 59 lines 39-54). Halpern et al. do not explicitly teach of the applying the adjustment to the initial location of the sensor to generate the location of the magnetic sensor. Keenan teaches of undertaking sensor placement to ensure optimal signal quality for monitoring maternal and fetal activities where the optimal initial sensor placement is adjusted based on the signal quality assessment [0051]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Keenan to modify the previous teachings to improve signal quality for monitoring maternal and fetal activities [Keenan, 0011].
Conclusion
THIS ACTION IS MADE FINAL. 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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BR
/BAISAKHI ROY/Primary Examiner, Art Unit 3797