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 .
Election/Restrictions
Newly submitted claims 36-40 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
Claims 1-21, claims 36-39, and claim 40 are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The groups lack unity of invention because even though the inventions of these groups require the technical feature of a resonant circuit sensor, the sensor including a variable inductance coil that changes resonant frequency in response to a change in a monitored physical parameter and produces a ring-back signal at a frequency correlated to the physical parameter when energized, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Sweeney (WO 2018102435 A1).
Regarding claims 1, 36, and 40, Sweeney discloses a resonant circuit sensor, the sensor including a variable inductance coil that changes resonant frequency in response to a change in a monitored physical parameter and produces a ring-back signal at a frequency correlated to the physical parameter when energized ([0005] “the resilient sensor construct has a variable inductance correlated to its dimensional expansion and contraction along at least one dimension; and the resilient sensor construct produces, when energized by an energy source directed at the construct, a signal readable wirelessly outside the patient's body indicative of the value of the at least one dimension, whereby a dimension of the vascular lumen may be determined; wherein the resilient sensor construct comprises a coil configured to engage at least two opposed points on the vascular lumen wall, the coil having an inductance that varies based on the distance between the two opposed points on the coil corresponding a distance between the points on the lumen wall;”[0056] “As reflected by the decreasing frequency ring-back signal from RC-WVM implant 12, the added fluid volume caused the IVC to expand, and with it the implant, which in turn causes a change in the inductance of the implant thus changing the frequency of its ring-back response to excitation”).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 36-40 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
In response to amendments, filed December 29, 2025, claims 1, 3-4, 11, 15, and 17 have been amended. Claims 5 and 22-35 have been cancelled. Claims 36-40 have been added but are not considered due to election by original presentation. Claims 1-4, 6-21, and 36-40 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed December 29, 2025, with respect to claim objections have been fully considered and are persuasive. The claim objections have been withdrawn.
Applicant’s arguments with respect to rejections under 35 USC 112(b) have been fully considered and are persuasive. While the previous rejections under 35 USC 112(b) have been withdrawn, there is a new rejection made.
Applicant’s arguments with respect to the prior art rejection have been considered but are moot because the new ground of rejection does not rely on the same reference combination applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new ground(s) of rejection is made in view of the combinations of Sweeney (WO 2018102435 A1), Wei (https://doi.org/10.1016/j.measurement.2018.11.033), Sundaram (US 20180247095 A1), Maile (US 20180140851 A1), McMahon (US 20180081030 A1), Cros (US 20110115497 A1), Allen (US 20070210786 A1), and Ritchey (US 20130063550 A1). Any arguments still relevant based on the new grounds of rejection are addressed below.
In response to applicant’s arguments regarding claim 8, Sweeney describes in [0041] adjusting the excitation frequency to match the natural frequency of the paired implant and continuing to excite at this frequency for a complete reading cycle. Sweeney, per [0058] and [0097] describes determining changes in IVC diameter via the implant over one or more respiratory cycles by translating the shift in natural frequency in signals received from the L-C circuit of the RC-WVM implant into changes in dimensions, which would logically require matching of the natural frequency to take place for each measurement so that a frequency shift can be determined.
In response to applicant’s arguments regarding claim 9, the motivation to combine the transmit power being a function of transmit frequency per Maile with the invention of Sweeney is for the reduction power consumption described in McMahon.
In response to applicant’s arguments regarding claim 17, the claim language does not specify a “manufacturing batch,” and the sensors used in the bench testing meet the requires for the batch specific parameter-frequency data.
In response to applicant’s arguments regarding claim 18, regardless of whether the purpose of minimizing physical parameter measurement error arising from sensor manufacturing variability is explicitly stated, the error is effectively minimized through the characterization curves described in [0055] of Sweeney.
Claims 10 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Claim 11 is 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.
The term “substantially constant” in claim 11 is a relative term which renders the claim indefinite. The term “substantially constant” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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) 1-3, 6, 8, 11, 16-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney (WO 2018102435 A1) in view of Wei (https://doi.org/10.1016/j.measurement.2018.11.033).
Regarding claim 1, Sweeney teaches a method for controlling a wireless, resonant circuit sensor ([0008] “a method for wirelessly monitoring changes in a dimension of a body lumen of a patient”), the sensor including a variable inductance coil that changes resonant frequency in response to a change in a monitored physical parameter and produces a ring-back signal at a frequency correlated to the physical parameter when energized ([0005] “the resilient sensor construct comprises a resonant circuit having a resonant frequency that varies with the variable inductance, the signal being correlated with the resonant frequency; wherein the coil comprises a resonant circuit having inductance and a capacitance defining a resonant frequency, wherein the resonant frequency varies based on the distance between the at least two points; and the coil is configured to be energized by a magnetic field directed at the coil from outside the patient's body.” [0018] “a ‘ring-back’ signal indicative of its inductance value at that moment. Because the inductance value is dependent on the geometry of the implant, which changes as mentioned above based on dimensional changes of the IVC in response to fluid state heart rate etc., the ring-back signal can be interpreted by control system 14 to provide information as to the IVC geometry and therefore fluid state.”), the method comprising:
outputting at least one excitation frequency sweep comprising a preestablished number of transmit pulses at pre-defined frequencies over a range of expected implant resonant frequencies ([0042] “each individual RF burst comprises a continuous frequency sweep over a predefined range of frequencies equal to the potential bandwidth of the implant (FIG 6A). This creates a broadband pulse that can energize the implant at all possible natural frequencies (FIG 6B). The excitation signal can continue in this ‘within burst frequency sweep mode’ or the control system can determine the natural frequency of the sensor and adjust to transmit solely at the natural frequency.” [0043] “In a further alternative implementation, the excitation comprises a transitory frequency sweep over a set of discrete frequency values covering the potential bandwidth of the paired RC- WVM implant 12. The frequency is sequentially incremented for each RF burst and the RMS value of the RC-WVM implant response is evaluated after each increment.”);
receiving the ring-back signals for each of the sequentially output transmit pulses; transmitting repeated excitation frequency sweeps during a predetermined initial period comprising a sufficiently long time to encompass at least one respiration cycle ([0055] “FIG. 10C thus shows variations in IVC area at the monitoring location in response to the respiration and cardiac cycles.” [0042] “The excitation signal can continue in this ‘within burst frequency sweep mode’;” [0058] “measurements of IVC diameter or area by implant 12 may be made continuously over one or more respiratory cycles to determine the variation in patient fluid volume over this cycle. Further, these measurement periods may be taken continuously, at preselected periods and/or in response to a remotely provided prompt from a health care provider/patient.”); receiving plural test ring-back signals in response to the repeated excitation frequency sweeps transmitted over the initial period ([0042] In another alternative implementation, each individual RF burst comprises a continuous frequency sweep over a predefined range of frequencies equal to the potential bandwidth of the implant (FIG 6A). This creates a broadband pulse that can energize the implant at all possible natural frequencies (FIG 6B). The excitation signal can continue in this "within burst frequency sweep mode").
However, Sweeney fails to disclose selecting a highest observed ring-back signal frequency across a plurality of excitation frequency sweeps. Wei teaches a method that uses a variable-step frequency search strategy to determine optimal excitation frequency for piezoelectric transducers by analyzing the receiving signals in time and frequency domains.
Wei discloses identifying an initial ring-back signal corresponding to a preferred excitation pulse frequency by selecting, during the predetermined initial period, a highest observed ring-back signal frequency generated by the repeated excitation frequency sweeps (pg 298, Col 2 [4] “the optimal excitation frequency judge basis is the maximum value of amplitude and FFT (Fast Fourier Transformation) amplitude for the receiving signal;” pg 298, Col 1 [3] “To get the optimal excitation frequency, the sweep frequency range is determined using a wide to narrow mechanism, which specifically includes two frequency ranges.” Pg 298, Col 2 [3] “Then the frequency tracking process is divided into two stages. Based on the wide sweep frequency range from Eq. (17), the first stage is mainly responsible for the search of the excitation frequency by a larger step as shown in Fig. 7. The second stage is used for finding the optimal excitation frequency by a smaller step on the basis of the narrow sweep frequency range from Eq. (18).”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sweeney to include selecting a highest observed ring-back signal frequency across a plurality of excitation frequency sweeps as disclosed in Wei for accurate automatic adjustment of the excitation frequency based on the varying resonance frequency of the object to maintain high power conversion efficiency in the detecting process (Wei pg 294, Col 2 [1]).
The combination of Sweeney/Wei discloses selecting said preferred excitation pulse frequency as a measurement transmit pulse frequency; and outputting measurement transmit pulses at the measurement transmit pulse frequency for a subsequent measurement period (Wei: pg 298, Col 2 [4] “the optimal excitation frequency judge basis is the maximum value of amplitude and FFT (Fast Fourier Transformation) amplitude for the receiving signal;” Sweeney: [0042] “determine the natural frequency of the sensor and adjust to transmit solely at the natural frequency.” [0097] “After such processing is complete, the frequency having the highest magnitude within the calibration frequency range of the implant (i.e. all possible frequencies that the implant can contain such as for instance 1.4 to 1.6Mhz) is determined and should correspond to the resonant frequency of the LC circuit in the RC-WVM implant. By continually monitoring the frequency having the highest magnitude in signals received from the LC circuit of the RC-WVM implant in response to discrete excitations of a transmit coil connected to the EFM circuit, the EFM circuit can be calibrated to translate a frequency shift in signals received from the L-C circuit of the RC-WVM implant into a dimension, area and/or collapsibility index of the vein or artery in which the RC-WVM implant is disposed.” Figs. 10A-C).
Regarding claim 2, the combination of Sweeney/Wei discloses the method of claim 1, further comprising: receiving measurement ring-back signals generated by the sensor in response to the measurement transmit pulses during the measurement period; and analyzing the measurement ring-back signals to determine a characteristic of the monitored physical parameter (Sweeney: [0018] “The magnetic field energizes the L-C circuit of RC-WVM implant 12 causing it to produce a ‘ring-back’ signal indicative of its inductance value at that moment. Because the inductance value is dependent on the geometry of the implant, which changes as mentioned above based on dimensional changes of the IVC in response to fluid state heart rate etc., the ring-back signal can be interpreted by control system 14 to provide information as to the IVC geometry and therefore fluid state”).
Regarding claim 3, the combination of Sweeney/Wei discloses the method of claim 1, wherein at least two excitation frequency sweeps are executed during the predetermined initial period (Wei: pg 298, Col 1 [3] “To get the optimal excitation frequency, the sweep frequency range is determined using a wide to narrow mechanism, which specifically includes two frequency ranges.” Pg 298, Col 2 [3] “Then the frequency tracking process is divided into two stages. Based on the wide sweep frequency range from Eq. (17), the first stage is mainly responsible for the search of the excitation frequency by a larger step as shown in Fig. 7. The second stage is used for finding the optimal excitation frequency by a smaller step on the basis of the narrow sweep frequency range from Eq. (18).”).
Regarding claim 6, the combination of Sweeney/Wei discloses the method of claim 1, further comprising dynamically adjusting the frequency of transmit pulses during acquisition of corresponding ring-back signals (Wei: pg 298, Col 1 [3] “To get the optimal excitation frequency, the sweep frequency range is determined using a wide to narrow mechanism, which specifically includes two frequency ranges.” Sweeney: [0043] “In a further alternative implementation, the excitation comprises a transitory frequency sweep over a set of discrete frequency values covering the potential bandwidth of the paired RC- WVM implant 12. The frequency is sequentially incremented for each RF burst and the RMS value of the RC-WVM implant response is evaluated after each increment.”).
Regarding claim 8, the combination of Sweeney/Wei discloses the method of claim 2, further comprising computing a new measurement pulse signal for each measurement transmit pulse after receiving a measurement ring-back signal during the measurement period (Sweeney: [0041] “control system 14 excites antenna module 16 at a predetermined frequency that is within an expected bandwidth of the paired RC-WVM implant 12. The system then detects the response from the paired RC-WVM implant and determines the implant natural frequency. Control system 14 then adjusts the excitation frequency to match the natural frequency of the paired implant and continues to excite at this frequency for a complete reading cycle.” [0058] “Using RC-WVM implant 12, measurements of IVC diameter or area by implant 12 may be made continuously over one or more respiratory cycles to determine the variation in patient fluid volume over this cycle.” 0097] “After such processing is complete, the frequency having the highest magnitude within the calibration frequency range of the implant (i.e. all possible frequencies that the implant can contain such as for instance 1.4 to 1.6Mhz) is determined and should correspond to the resonant frequency of the LC circuit in the RC-WVM implant. By continually monitoring the frequency having the highest magnitude in signals received from the LC circuit of the RC-WVM implant in response to discrete excitations of a transmit coil connected to the EFM circuit, the EFM circuit can be calibrated to translate a frequency shift in signals received from the L-C circuit of the RC-WVM implant into a dimension, area and/or collapsibility index of the vein or artery in which the RC-WVM implant is disposed.”).
Regarding claim 11, the combination of Sweeney/Wei discloses the method of claim 1 , further comprising: monitoring ring-back signals produced by the sensor; and dynamically adjusting transmit pulse output amplitude to achieve a substantially constant ring-back signal amplitude based on the monitored ring-back signals (Sweeney: [0046] In yet another implementation, signal generator module 20a can be configured to provide pulse shaping as illustrated in FIG. 8. Arbitrary waveform generation based on direct digital synthesis 98 is employed to create a pulse of a predefined shape, the spectrum of which is optimized in order to maximize the response of the paired RC-WVM implant 12. The magnitude of the frequency components that result in decreased ring back signal amplitude is maximized while the magnitude of the frequency components that result in increased ring back signal amplitude is reduced, in order to obtain an approximately constant output signal amplitude and thus improved response from RC-WVM implant 12.”).
Regarding claim 16, the combination of Sweeney/Wei discloses the method of claim 1, further comprising: determining physical parameter versus frequency data for at least one said sensor prior to placement in a patient; creating a characterization curve for the at least one sensor through curve fitting or interpolation; taking a measurement with the sensor; and translating the sensor measurement into a value for the physical parameter using said characterization curve (Sweeney: [0055] FIGS. 10A, 10B and 10C illustrate, respectively, the raw ring down signal, detection of the maximum frequency and conversion of this to an IVC area using a reference characterization curve … Conversion in this case was based on a characterization curve, which as determined through bench testing on a range of sample diameter lumens following standard lab/testing procedures.).
Regarding claim 17, the combination of Sweeney/Wei discloses the method of claim 16, wherein the at least one sensor comprises a batch of sensors and the frequency data comprises batch specific parameter-frequency data (Sweeney: [0055] FIGS. 10A, 10B and 10C illustrate, respectively, the raw ring down signal, detection of the maximum frequency and conversion of this to an IVC area using a reference characterization curve … Conversion in this case was based on a characterization curve, which as determined through bench testing on a range of sample diameter lumens following standard lab/testing procedures.).
Regarding claim 18, the combination of Sweeney/Wei discloses the method of claim 16, further comprising minimizing physical parameter measurement error arising from sensor manufacturing variability through use of sensor or sensor batch specific characterization curves (Sweeney: [0055] FIGS. 10A, 10B and 10C illustrate, respectively, the raw ring down signal, detection of the maximum frequency and conversion of this to an IVC area using a reference characterization curve … Conversion in this case was based on a characterization curve, which as determined through bench testing on a range of sample diameter lumens following standard lab/testing procedures.).
Regarding claim 19, the combination of Sweeney/Wei discloses the method of claim 1, wherein the resonant circuit sensor is configured for placement in a patient's vasculature and the physical parameter is a vascular dimension (Sweeney: [0005] “a wireless vascular monitoring implant adapted to be deployed and implanted in a patient vasculatures … indicative of the value of the at least one dimension, whereby a dimension of the vascular lumen may be determined … wherein the resilient sensor construct comprises a resonant circuit having a resonant frequency that varies with the variable inductance”).
Regarding claim 20, the combination of Sweeney/Wei discloses the method of claim 19, wherein said sensor is specifically configured for placement in a vena cava and the vascular dimension is the area or diameter of the vena cava (Sweeney: [0016] “The variable inductance is provided by the coil structure of the implant such that the inductance changes when the dimensions of the coil change with the IVC wall movement;” [0058] “measurements of IVC diameter or area by implant 12 may be made continuously over one or more respiratory cycles to determine the variation in patient fluid volume over this cycle”).
Regarding claim 21, the combination of Sweeney/Wei discloses the method of claim 20, further comprising correlating the measured area or diameter of the vena cava to patient fluid status (Sweeney: [0058] “measurements of IVC diameter or area by implant 12 may be made continuously over one or more respiratory cycles to determine the variation in patient fluid volume over this cycle”).
Claim(s) 4 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney (WO 2018102435 A1) in view of Wei (https://doi.org/10.1016/j.measurement.2018.11.033), and in further view of Sundaram (US 20180247095 A1).
Regarding claim 4, the combination of Sweeney/Wei discloses the method of claim 1, wherein selecting the preferred excitation pulse frequency (Wei: pg 298, Col 2 [4] “the optimal excitation frequency judge basis is the maximum value of amplitude and FFT (Fast Fourier Transformation) amplitude for the receiving signal;” Sweeney: [0042] “determine the natural frequency of the sensor and adjust to transmit solely at the natural frequency.”).
However, the combination of Sweeney/Wei fails to discloses enforcing a minimum signal quality threshold.
Sundaram teaches a reader device that receives a resonant signal from a wireless sensor and evaluate the signal against predetermined values. Sundaram discloses further comprises enforcing a predefined minimum signal quality threshold for ring-back signals during the predetermined initial period, the threshold comprising at least one of amplitude or signal-to-noise ratio (SNR), and in response to detection of signal quality below the threshold, executing an additional excitation frequency sweep within the initial period prior to selection ([0047] “the excitation pulse 14 may be a fixed or rapidly varying frequency burst or sweep of a very short duration at or near a frequency harmonically related to the sensor 12 resonant frequency” [0070] “Referring now to FIGS. 7B and 10, the reader device 10 may produce a plurality of stimulus signals 14 in search mode. Once the reader device 10 has identified at least one response signal 16 or a sufficient number of response signals 16 that includes an amplitude over a threshold value, the reader device 10 may then be considered locked and may enter the read mode to read and sample the responding response signals 16 from the sensor 12.” [0071] “the lock circuitry 22 may also identify whether a given reading from the sensor 12 is valid or not valid. Validity of a reading may be based on a predetermined parametric threshold, such as a response signal strength being above a certain amplitude. The reading device 10 may keep a running count of valid and invalid data points (a “data point” here is the result of one read cycle). If the number of invalid data points exceeds a predetermined amount, either cumulatively or continuously, the reading device 10 may issue an A/V/H signal indicating a “failed read session” designated “FAIL” in FIG. 7B. In this case the reading device 10 may re-enter search mode, allowing the user to attempt to initiate a new lock on sensor 12 and to try again.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Sweeney/Wei to include enforcing a minimum signal quality threshold and executing an additional frequency sweep if the threshold is not met as disclosed in Sundaram to ensure the signals are sufficient to extrapolate the measurement of the desired parameter (Sundaram [0071]).
Regarding claim 7, the combination of Sweeney/Wei discloses the method of claim 6, wherein said dynamically adjusting (Wei: pg 298, Col 1 [3] “To get the optimal excitation frequency, the sweep frequency range is determined using a wide to narrow mechanism, which specifically includes two frequency ranges.”).
However, the combination of Sweeney/Wei fails to discloses enforcing a minimum signal quality threshold.
Sundaram discloses comprises: monitoring at least one of the amplitude or signal-to-noise ratio of the corresponding ring-back signal; and in response to detection of a ring-back signal amplitude below a pre-defined threshold, outputting a new excitation frequency sweep to identify a new measurement transmit pulse frequency ([0047] “the excitation pulse 14 may be a fixed or rapidly varying frequency burst or sweep of a very short duration at or near a frequency harmonically related to the sensor 12 resonant frequency” [0070] “Referring now to FIGS. 7B and 10, the reader device 10 may produce a plurality of stimulus signals 14 in search mode. Once the reader device 10 has identified at least one response signal 16 or a sufficient number of response signals 16 that includes an amplitude over a threshold value, the reader device 10 may then be considered locked and may enter the read mode to read and sample the responding response signals 16 from the sensor 12.” [0071] “the lock circuitry 22 may also identify whether a given reading from the sensor 12 is valid or not valid. Validity of a reading may be based on a predetermined parametric threshold, such as a response signal strength being above a certain amplitude. The reading device 10 may keep a running count of valid and invalid data points (a “data point” here is the result of one read cycle). If the number of invalid data points exceeds a predetermined amount, either cumulatively or continuously, the reading device 10 may issue an A/V/H signal indicating a “failed read session” designated “FAIL” in FIG. 7B. In this case the reading device 10 may re-enter search mode, allowing the user to attempt to initiate a new lock on sensor 12 and to try again.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Sweeney/Wei to include enforcing a minimum signal quality threshold and executing an additional frequency sweep if the threshold is not met as disclosed in Sundaram to ensure the signals are sufficient to extrapolate the measurement of the desired parameter (Sundaram [0071]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney (WO 2018102435 A1) in view of Wei (https://doi.org/10.1016/j.measurement.2018.11.033), and in further view of Maile (US 20180140851 A1) and McMahon (US 20180081030 A1).
Regarding claim 9, the combination of Sweeney/Wei discloses the method of claim 1. However, Sweeney fails to disclose adjusting pulse output power as a function of pulse output frequency. Maile teaches near-field energy transmitters of an implantable medical device. Maile discloses, further comprising adjusting transmit pulse output power as a function of transmit pulse output frequency (Sweeney: [0118] “The controller 18 may be configured to cause the output driver 14 to adjust the transmit frequency of the near-field energy across two or more transmit frequencies, identify the transmit power of the near-field energy at each of the two or more transmit frequencies using the monitor 16”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sweeney to include adjusting pulse output power as a function of pulse output frequency as disclosed in Maile because reducing the output power, frequency, and/or duration of pulses reduces the overall power consumption (McMahon [0181]; McMahon teaches sensors for detection of characteristics of moving objects and living subjects using RF signals).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney (WO 2018102435 A1) in view of Wei (https://doi.org/10.1016/j.measurement.2018.11.033), and in further view of Cros (US 20110115497 A1).
Regarding claim 12, the combination of Sweeney/Wei discloses the method of claim 1. However, the combination of Sweeney/Wei fails to disclose validating the signal processing.
Cros teaches a wireless sensor having a primary passive electrical resonant circuit that has an intrinsic electrical property that is variable in response to a characteristic of a patient and a secondary passive electrical resonant circuit. Cros discloses further comprising: transmitting a known fixed frequency and fixed amplitude signal; capturing the said known signal as a portion of a captured ring-back signal; validating signal processing by comparing the captured known signal portion with the transmitted known signal ([0119] “the interrogation system energizes the switched "on" sensor with a low duty cycle, gated burst of RF energy of a predetermined frequency or set of frequencies and predetermined amplitude. This signal induces a current in the sensor that can be used to track the resonant frequency of the sensor. The interrogation system receives the ring down response of the sensor and determines the resonant frequency of the sensor, which is used to calculate the measured characteristic, such as, for example, pressure, acting thereon the sensor. As described above, interrogation the system can use a pair of PLL's to adjust the phase and the frequency of the energizing signal to track the resonant frequency of the sensor. In one exemplary aspect, the first measurement can be taken during introduction of the sensor for calibration and the second measurement can be taken after placement for functional verification of the sensor.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Sweeney/Wei to include validating the signal processing as disclosed in Cros for functional verification of the sensor (Cros [0119]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney (WO 2018102435 A1) in view of Wei (https://doi.org/10.1016/j.measurement.2018.11.033) and Cros (US 20110115497 A1), and in further view of Allen (US 20070210786 A1).
Regarding claim 13, the combination of Sweeney/Wei/Cros discloses the method of claim 12. However, the combination of Sweeney/Wei/Cros fails to disclose signal leakage.
Allen teaches determining the resonant frequency of a sensor by adjusting the phase and frequency of an energizing signal until the frequency of the energizing signal matches the resonant frequency of the sensor. Allen discloses wherein said transmitting and capturing a known signal comprises allowing signal leakage through a transmit/receive switch of a signal generating and receiving control system ([0048] “During the calibration cycle, the calibration signal which enters the receiver 310 is processed through the receive section 311 and the IF section 312, and is sampled. In one embodiment, the calibration signal is the portion of the energizing signal that leaks into the receiver (referred to herein as the energizing leakage signal). The signal is sampled during the on time of the energizing signal by a sample and hold circuit 314 to determine the phase difference between the signal and local oscillator 2. FIG. 3 illustrates two cascaded sample and holds in circuit 314 to provide both fast sampling and a long hold time. Alternatively, a single sample and hold can be used in circuit 314. In the embodiment where the calibration signal is the portion of the energizing signal that leaks into the receiver, the signal is sampled approximately 100 ns after the beginning of the energizing signal pulse.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Sweeney/Wei/Cros to include signal leakage through a transmit/receive switch as disclosed in Cros for functional verification of the sensor (Allen [0040]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney (WO 2018102435 A1) in view of Wei (https://doi.org/10.1016/j.measurement.2018.11.033), and in further view of Ritchey (US 20130063550 A1).
Regarding claim 14, the combination of Sweeney/Wei disclose the method of claim 1. However, the combination of Sweeney/Wei fails to disclose assessing electromagnetic background noise.
Ritchey teaches data logging of host internal physiological and external panoramic and positional sensors. The combination of Sweeney/Wei/Ritchey discloses further comprising assessing electromagnetic background noise prior to outputting the at least one excitation frequency sweep and adjusting signal processing based on a computed background noise signal level (Ritchey: [0184] “Accordingly, the first sensor array may be utilized for signal detection, and the second sensor array may be utilized to assess the level of noise present in the signals measured by the first sensor array. More particularly, the signals measured by the first sensor array may include both magnetic fields from a target area within the patient's body (e.g., the patient's brain) and noise. However, because the second sensor array may be shielded from magnetic field's emanating from the target area, the second sensor may measure substantially only the noise adjacent the first magnetometer. Accordingly, the magnetic fields from the target area may be determined by subtracting the noise (as measured by the second array) from the signals measured by the first sensor array.” Sweeney: [0042] “continuous frequency sweep over a predefined range of frequencies equal to the potential bandwidth of the implant (FIG 6A). This creates a broadband pulse that can energize the implant at all possible natural frequencies (FIG 6B).”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Sweeney/Wei to include assessing electromagnetic background noise and adjusting signal processing as disclosed in Ritchey to account for noise and screen signal from noise to prevent interference (Ritchey [0199]).
Allowable Subject Matter
Claims 10 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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:
Claim 10 would be allowable for disclosing wherein said adjusting comprises monotonically reducing transmit pulse output power as transmit pulse frequency decreases.
Maile (US 20180140851 A1) describes in [0118] that transmit power varies with the transmit frequencies and McMahon (US 20180081030 A1) describes reducing the output power, frequency, and/or duration of pulses as beneficial in reducing the overall power consumption. However, neither Maile nor McMahon disclose monotonically reducing transmit pulse output power as transmit pulse frequency decreases.
Claim 15 would be allowable for disclosing wherein said test frequency is selected to be sufficiently distant from an expected sensor excitation frequency so as to not energize the sensor; receiving a test signal with a sensor ring-back signal receiver, wherein the received test signal is made up of the test pulse and background electromagnetic noise.
Silvian (US 5562713 A) describes scanning to determine the frequency with the lowest ambient electromagnetic noise level, Ritchey describes assessing noise from magnetic fields using sensor arrays to then subtract the noise from the signal, and Allen describes an energizing signal that leaks into the receiver for comparison and calibration. However, none of the references disclose a test frequency sufficiently distant from an expected sensor excitation frequency that is used for receiving a test signal made up of the test pulse and noise.
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.
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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