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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Therefore, the effective filing date of claims 2-7 & 9-20 is 01/19/2012.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-3, 9-11, 13-14 & 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (U.S. Patent 9,456,757 B1) and further in view of Stevens et al. (U.S. Patent Application 2010/0057046 A1) and Wariar et al. (U.S. Patent Application 2013/0178786 A1).
Claim 2: Zheng teaches –
A method for determining changes in a fluid in a patient’s head [monitoring status of hydrocephalus, cerebral edema, and intracranial bleeding comprises of detecting the complex wave number of electromagnetic waves that propagate through brain tissue and are altered by the changed volume of cerebrospinal fluid] (Col. 2, Line 52-56) and treating the patient [to provide critical information for patient care] (Col. 2, Line 13-14), the method comprising:
transmitting a time-varying magnetic field [broadband pulses having multiple frequencies] (Col. 8, Line 54-55) from at least one transmitter [electrodes] (Figure 1, Element 101) on or near the patient’s head through the fluid [electromagnetic wave transmitted from the transmitting electrodes propagates through brain tissue] (Col. 8, Line 55-57);
receiving the time-varying magnetic field [broadband pulses having multiple frequencies] (Col. 8, Line 54-55) with at least one receiver (Figure 1, Element 103) on or near the patient’s head [Electrodes or coils, or other sensors, 103 on other sides of the brain receive the propagated electromagnetic wave] (Col. 8, Line 58-60);
generating, with the at least one receiver, a signal responsive to a received magnetic field [The received signal is conditioned, amplified, filtered, and converted to digital signal 104] (Col. 8, Line 60-61 and Figure 1, Element 104);
determining, using a processor [a special-purpose processor operatively connected to the envelope and phase detector] (Claim 1) coupled with the at least one receiver (Figure 1, Element 103), a first phase shift [baseline… wherein the baseline is either a phase shift previously measured] (Claim 8) between a transmitted magnetic field and the received magnetic field for multiple frequencies [broadband pulses having multiple frequencies] (Col. 8, Line 54-55) of the transmitted magnetic field [the special-purpose processor is specially configured to estimate the relative phase shift (RPS) by comparing the phase shift of said wave propagating through said brain tissue to a baseline for assessing status of hydrocephalus, cerebral edema, and intracranial bleeding] (Claim 8);
repeating the transmitting, receiving, generating and determining steps, to determine a second phase shift [the special-purpose processor is specially configured to estimate the relative phase shift (RPS) by comparing the phase shift of said wave propagating through said brain tissue to a baseline for assessing status of hydrocephalus, cerebral edema, and intracranial bleeding] (Claim 8);
Examiner’s Note: The baseline is the first phase shift and as described in Claim 8 is compared to the RPS, which is the second phase shift.
determining a change in the fluid in the patient’s head over time, based on the first phase shift and the second phase shift [the baseline and measurement for the relative change are important for the monitoring processing] (Col. 6, Line 13-15) [the change of the RPS represents the change of the dielectric constant of the pathological condition of brain tissue] (Col. 7, Line 19-21) [monitoring status of hydrocephalus, cerebral edema, and intracranial bleeding comprises of detecting the relative phase shifts (RPS) of electromagnetic waves that propagate through brain tissue and are altered by the changed volume of cerebrospinal fluid or cerebral edema condition, or intracranial bleeding] (Col. 2, Line 60-65)
electromagnetic phase shift measurements [phase shift] (Claim 8)
Zheng teaches monitoring the change in fluid and treating a patient based on the monitoring. Zheng fails to teach an alert or what specific patient care or treatment to administer. However, Stevens teaches –
activating an alert by the processor when the intracranial pressure exceeds a predetermined threshold [the controller 406 could activate a visual, auditory, or other alarm to alert a health care provider if the physiologic parameter falls outside of a specified range] (Para 0133) [An intracranial pressure probe or other continuous sensor…could sense an increase in intracranial pressure above a threshold level] (Para 0126); and
administering a therapeutic agent to the patient in response to the alert, [to provide diagnostic information, feedback, and/or control signals useful in treating patients with neurologic disease (surgery, stroke, hydrocephalus, pseudotumor cerebri, blunt trauma, etc). For example, such patients have swelling of the brain tissue (cerebral edema)] (Para 0126)
wherein an amount of the therapeutic agent administered is based at least in part on the cerebral edema [to monitor cerebral edema to allow a treatment provider to optimize dosing, or to warn when a surgical procedure is required to reduce the swelling, such as at a threshold pressure that may indicate a higher risk of herniation] (Para 0126) in order to reduce brain swelling (Para 00126)
Zheng teaches that cerebral edema if left untreated can lead to permanent brain damage (Col. 2, Line 8-10). Further Zheng teaches the importance closely monitoring cerebral edema to provide critical information for patient care (Col. 2, Line 13-14). Based on these teachings, it would have been obvious for one of ordinary skill in the art to look at treatment options for cerebral edema before the effective filing date of the claimed invention and to look at monitoring options such as alerts and alarm for close monitoring. Stevens provides obvious solutions to both issues of treatment and monitoring in order to provide the benefit of treating the patient by reducing brain swelling which would help improve patient outcomes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Zheng to include the alert and administering of a therapeutic agent as taught by Stevens in order to reduce brain swelling (Para 00126).
Zheng teaches phase shift measurements and determining a patient’s brain water is changing. Zheng fails to teach comparing measurements after administering the therapeutic agent; and determining how the patient’s water is changing in response to the therapeutic agent. However, Stevens teaches –
comparing measurements [could sense an increase in intracranial pressure above a threshold level, which would in turn activate a controller to instruct] (Para 0126) after [continuous monitoring] (Para 0126) administering the therapeutic agent [to monitor cerebral edema to allow a treatment provider to optimize dosing] (Para 0126) [medications such as steroids or mannitol could be used to reduce the swelling] (Para 0126); and
Examiner’s Note: Monitoring reads on “comparing” since the measurements of Stevens are compared to a threshold continuously. In Stevens, the therapeutic agent of mannitol is administered and continuously monitored. The continuous monitoring means monitoring before, during and after the administration of the therapeutic agent. The Examiner contends that in a medical setting it would be very unusual to not monitor the patient during their stay and to stop monitoring after administering a therapeutic agent. The convention is to administer a therapeutic agent and observe the patient as patient do not response uniformly and may require higher doses for treatment.
determining how the patient’s water is changing [could sense an increase in intracranial pressure above a threshold level, which would in turn activate a controller to instruct] (Para 0126) in response to [continuous monitoring] (Para 0126) the therapeutic agent [to monitor cerebral edema to allow a treatment provider to optimize dosing] (Para 0126) [medications such as steroids or mannitol could be used to reduce the swelling] (Para 0126) in order to reduce brain swelling (Para 00126)
Zheng teaches that cerebral edema if left untreated can lead to permanent brain damage (Col. 2, Line 8-10). Further Zheng teaches the importance closely monitoring cerebral edema to provide critical information for patient care (Col. 2, Line 13-14). Based on these teachings, it would have been obvious for one of ordinary skill in the art to look at treatment options for cerebral edema before the effective filing date of the claimed invention and to look at continuous monitoring options. Stevens provides obvious solutions to both issues of treatment and monitoring in order to provide the benefit of treating the patient by reducing brain swelling which would help improve patient outcomes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Zheng to include the monitoring/comparing and administering of a therapeutic agent as taught by Stevens in order to reduce brain swelling (Para 00126).
Zheng teaches monitoring electromagnetic phase shift measurements [phase shift] (Claim 8) indicating that the change in the fluid in the patient’s head is occurring [the baseline and measurement for the relative change are important for the monitoring processing] (Col. 6, Line 13-15) [the change of the RPS represents the change of the dielectric constant of the pathological condition of brain tissue] (Col. 7, Line 19-21) [monitoring status of hydrocephalus, cerebral edema, and intracranial bleeding comprises of detecting the relative phase shifts (RPS) of electromagnetic waves that propagate through brain tissue and are altered by the changed volume of cerebrospinal fluid or cerebral edema condition, or intracranial bleeding] (Col. 2, Line 60-65)
Stevens teaches administration of the therapeutic agent based at least in part on the subsequent physiological measurement indicating fluid in the patient’s head [to monitor cerebral edema to allow a treatment provider to optimize dosing, or to warn when a surgical procedure is required to reduce the swelling, such as at a threshold pressure that may indicate a higher risk of herniation] (Para 0126) based on the physiological measurement within a predetermined range [the controller 406 could activate a visual, auditory, or other alarm to alert a health care provider if the physiologic parameter falls outside of a specified range] (Para 0133) [An intracranial pressure probe or other continuous sensor…could sense an increase in intracranial pressure above a threshold level] (Para 0126).
Zheng and Stevens fail to teach ceasing administration of the therapeutic agent based at least in part on the subsequent physiological measurements indicating that the change in measurements has returned to within a predetermined range of a baseline.
However, Wariar teaches ceasing administration of the therapeutic agent [stops the drug infusion] (Para 0088) based at least in part on the subsequent physiological measurements indicating that the change in measurements has returned [The control circuit 925 may adjust the drug infusion provided by the therapy circuit 920 using "ON/OFF control," where the closed-loop algorithm initiates drug infusion when a physiological parameter does not satisfy a physiological parameter threshold value and stops the drug infusion when the physiological parameter satisfies the physiological parameter threshold value] (Para 0088) to within a predetermined range of a baseline [to meet a target range of values for a physiological parameter] (Para 0088) in order to recurrently adjust delivery of therapeutic agents through the feedback of measured physiological parameters in comparison to physiological parameter targets for the benefit of improving patient outcomes (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Zheng and Stevens to include the ceasing of administration of therapeutic agents based on a predetermined range of a baseline as taught by Wariar in order to recurrently adjust delivery of therapeutic agents through the feedback of measured physiological parameters in comparison to physiological parameter targets for the benefit of improving patient outcomes (Abstract).
Claim 3/2: Zheng fails to teach mannitol. However, Stevens teaches wherein administering the therapeutic agent comprises administering an agent selected from the group consisting of mannitol (Para 0126) in order to reduce brain swelling (Para 00126)
Zheng teaches that cerebral edema if left untreated can lead to permanent brain damage (Col. 2, Line 8-10. Based on that teaching, it would have been obvious for one of ordinary skill in the art to look at treatment options for cerebral edema before the effective filing date of the claimed invention. Stevens provides an obvious solution to treatment in order to provide the benefit of treating the patient by reducing brain swelling which would help improve patient outcomes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Zheng to include administering of a therapeutic agent as taught by Stevens in order to reduce brain swelling (Para 00126).
Claim 9/2: Zheng teaches wherein each of the at least one transmitter is positioned in a fixed position relative to the at least one receiver (See Figure 3).
Claim 10/2: Zheng teaches further comprising multiple spacers [a pair of ear plug coils] (Col. 3, Line 42-45) positioned between the patient’s head and each of the at least one transmitter and the at least one receiver [an earplug, wherein said source electrode or coil comprises an electrode disposed inside the earplug] (Claim 4) [applying a pair of ear plug coils that are used as transmitter and receiver electrodes for transmitting electromagnetic signals and measuring changes] (Col. 3, Line 42-45).
Claim 11/2: Zheng teaches wherein the time-varying magnetic field comprises a plurality of frequencies [broadband pulses having multiple frequencies] (Col. 8, Line 54-55).
Claim 13/2: Zheng teaches the processor [the special-purpose processor is specially configured to estimate the relative phase shift (RPS) by comparing the phase shift of said wave propagating through said brain tissue to a baseline for assessing status of hydrocephalus, cerebral edema, and intracranial bleeding] (Claim 8).
Zheng fails to teach an alert signal. However, Stevens teaches further comprising generating an alert signal, via the processor [the controller 406 could activate a visual, auditory, or other alarm to alert a health care provider if the physiologic parameter falls outside of a specified range] (Para 0133), if it is determined that a clinically significant change has occurred [sense an increase in intracranial pressure above a threshold level] (Para 0126) in order to reduce brain swelling (Para 00126) in a timely manner
Zheng teaches the importance closely monitoring cerebral edema to provide critical information for patient care (Col. 2, Line 13-14). Based on that teaching, it would have been obvious for one of ordinary skill in the art to look at monitoring options such as alerts and alarm for close monitoring before the effective filing date of the claimed invention. Stevens provide an obvious solution to monitoring in order to provide the benefit of treating the patient by reducing brain swelling which would help improve patient outcomes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Zheng to include the alert as taught by Stevens in order to reduce brain swelling (Para 00126) in a timely manner.
Claim 14/2: Zheng teaches wherein the transmitted magnetic field and the received magnetic field are in a frequency range of 1 kHz to 10 GHz [wherein said signal generator is configured to generate electromagnetic waves from 0 Hz to 100 kHz] (Claim 11).
Claim 18/2: Zheng fails to teach mannitol. However, Stevens teaches wherein the therapeutic agent is selected from the group consisting of mannitol (Para 0126) in order to reduce brain swelling (Para 00126)
Zheng teaches that cerebral edema if left untreated can lead to permanent brain damage (Col. 2, Line 8-10. Based on that teaching, it would have been obvious for one of ordinary skill in the art to look at treatment options for cerebral edema before the effective filing date of the claimed invention. Stevens provides an obvious solution to treatment in order to provide the benefit of treating the patient by reducing brain swelling which would help improve patient outcomes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Zheng to include administering of a therapeutic agent as taught by Stevens in order to reduce brain swelling (Para 00126).
Claim 19/2: Zheng fails to teach the alert is an alarm sound. However, Stevens teaches wherein the alert is an alarm sound [auditory, or other alarm to alert a health care provider] (Para 0133) in order to reduce brain swelling (Para 00126) in a timely manner
Zheng teaches the importance closely monitoring cerebral edema to provide critical information for patient care (Col. 2, Line 13-14). Based on that teaching, it would have been obvious for one of ordinary skill in the art to look at monitoring options such as alerts and alarm for close monitoring before the effective filing date of the claimed invention. Stevens provide an obvious solution to monitoring in order to provide the benefit of treating the patient by reducing brain swelling which would help improve patient outcomes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Zheng to include the alert as taught by Stevens in order to reduce brain swelling (Para 00126) in a timely manner.
Claim 20/2: Zheng teaches further comprising:
repeating the steps of transmitting, receiving, generating and determining a phase shift, to determine a third phase shift [a method and a system of continuously monitoring hydrocephalus, cerebral edema, and cranial bleeding at a patient's bedside 24 hours a day in intensive care units] (Col. 2, Line 15-18 and see Rejection of Claim 2 and the repeating step above);
determining a new change in the fluid in the patient’s head [the baseline and measurement for the relative change are important for the monitoring processing] (Col. 6, Line 13-15) [the change of the RPS represents the change of the dielectric constant of the pathological condition of brain tissue] (Col. 7, Line 19-21) [monitoring status of hydrocephalus, cerebral edema, and intracranial bleeding comprises of detecting the relative phase shifts (RPS) of electromagnetic waves that propagate through brain tissue and are altered by the changed volume of cerebrospinal fluid or cerebral edema condition, or intracranial bleeding] (Col. 2, Line 60-65); and
Examiner’s Note: Zheng teaches the system monitoring for 24 hours. In order for a system to perform monitoring over 24 hours, the monitoring method must repeat. Otherwise, the system would be incapable of the disclosed 24 hour bedside monitoring.
As established earlier the monitoring method must repeat in order to perform 24 hour monitoring and the further treatment is a part of the monitoring method. The Examiner contends that it would have been obvious to one of ordinary skill in the art to determine whether to again administer the therapeutic agent to the patient, based at least in part on the new change [to monitor cerebral edema to allow a treatment provider to optimize dosing, or to warn when a surgical procedure is required to reduce the swelling, such as at a threshold pressure that may indicate a higher risk of herniation] (Para 0126 of Stevens) in order to reduce brain swelling (Para 00126 of Stevens). Cerebral edema needs to be closely monitored and if left untreated can lead to death (Col. 2, Line 8-14 of Zheng). One of ordinary skill in the art based on the disclosures of Zheng and Stevens would understand repeated treatment may be required.
Claim(s) 4 & 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (U.S. Patent 9,456,757 B1); Stevens et al. (U.S. Patent Application 2010/0057046 A1) and Wariar et al. (U.S. Patent Application 2013/0178786 A1) and further in view of Kinrot et al. (U.S. Patent Application 2012/0203134 A1).
Claim 4/2: Zheng teaches further comprising converting the signal from an analog signal to a digital signal using an analog to digital converter [The received signal is…converted to digital signal 104] (Col. 8, Line 60-61), wherein the method further comprises positioning the headset on the patient's head [applying a head band attached with transmitter electrodes or coils for transmitting electromagnetic signals and measuring the changes of RPS, RAC, WSC, TTD, and wave number of brain tissue] (Col. 3, Line 33-36).
Zheng, Stevens and Wariar fail to teach an analog to digital converter mounted to a headset positioned on the patient's head. However, Kinrot teaches the digital converter [digital signal processors] (Para 0034) mounted to a headset positioned on the patient's head [various circuitry] (Para 0044) in order to allow for wireless transmission (Para 0044), which would increase the operability of the headset by not having to worry about wire management.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the headband of Zheng, Stevens and Wariar to include the digital converter of Kinrot in order to allow for wireless transmission (Para 0044), which would increase the operability of the headset by not having to worry about wire management.
Claim 17/2: Zheng teaches further comprising positioning a headband on the head [applying a head band attached with transmitter electrodes or coils for transmitting electromagnetic signals and measuring the changes of RPS, RAC, WSC, TTD, and wave number of brain tissue] (Col. 3, Line 33-36). Zheng, Stevens and Wariar fail to teach an elastic headband. However, Kinrot teaches further comprising positioning an elastic headband on the head (Para 0045) in order to fix the electrodes of Zheng and Stevens into specific anatomical positions on the patient’s head (Para 0045), which would improve measurement accuracy and patient outcomes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the headband of Zheng, Stevens and Wariar to have an elastic band as taught by Kinrot in order to fix the electrodes of Zheng and Stevens into specific anatomical positions on the patient’s head (Para 0045), which would improve measurement accuracy and patient outcomes.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (U.S. Patent 9,456,757 B1), Stevens et al. (U.S. Patent Application 2010/0057046 A1) and Wariar et al. (U.S. Patent Application 2013/0178786 A1) and further in view of Cook et al. (U.S. Patent Application U.S. Patent 6,049,706 A).
Claim 5/2: Zheng teaches the transmitted magnetic field and the received magnetic field (Figure 1, Element 101 & 103. Zheng, Stevens and Wariar fail to teach further comprising generating a sampling signal, using a sampling signal generator, the sampling signal having a frequency to under-sample. However, Cook teaches generating a sampling signal [The control signal generator 1790 includes an oscillator 4204 and optionally a signal shaper 4205 that generate a series of pulses at a sampling frequency fs] (Col. 36, Line 49-51) using a sampling signal generator, the sampling signal having a frequency to under-sample [wherein said under-sampling means under-samples said input signal according to a control signal, wherein a frequency of said control signal is equal to a frequency of said input signal] (Claim 6) in order to improve a receiver’s potential for interference (Col. 3, Line 21-23)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the signal transmission and reception of Zheng, Stevens and Wariar to include the under-sampling of Cook in order to improve a receiver’s potential for interference (Col. 3, Line 21-23).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (U.S. Patent 9,456,757 B1), Stevens et al. (U.S. Patent Application 2010/0057046 A1) and Wariar et al. (U.S. Patent Application 2013/0178786 A1) and further in view of Koh et al. (U.S. Patent Application 2012/0016253 A1).
Claim 6/2: Zheng teaches further comprising using the processor to reduce errors [filtered] (Col.8, Line 61) in the first phase shift [baseline… wherein the baseline is either a phase shift previously measured] (Claim 8) of the patient (Figure 1, Element 102)
Examiner’s Note: Filtering a signal is understood to reduce errors.
Zheng, Stevens and Wariar fail to teach reducing errors resulting from movement of the patient. However, Koh teaches reducing errors resulting from movement of the patient [Patient respiration may introduce noise by moving] (Para 0005) [a localization signal that describes the position, and optionally the orientation, of a device within the localization field to account for signal artifacts attributable to patient respiration] (Para 0002) in order to remove signal artifacts (Para 0002) to improve the accuracy of the signal and thus improve patient outcomes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reduce the patent movement errors of Zheng, Stevens and Wariar with the error reducing strategy of Koh in order to remove signal artifacts (Para 0002) to improve the accuracy of the signal and thus improve patient outcomes.
Claim 7/2: Zheng, Stevens and Wariar fail to teach detecting motion and an accelerometer. However, Koh teaches further comprising detecting motion [employs accelerometers…in order to acquire a signal that describes the motion of the patch electrodes] (Para 0060); and excluding data, using the processor (Para 0048 and Figure 1, element 20), corresponding to periods of time wherein an accelerometer detects significant motion [the collection of localization data is gated to the patient's respiratory cycle, using the acquired acceleration signal, such that all data is collected at the same fiducial point in each respiration cycle (e.g., data is always collected at peak inspiration or always collected at peak expiration)] (Para 0072) of the at least one transmitter or the at least one receiver [accelerometers attached to one or more of the localization system patch electrodes] (Para 0060) in order to remove signal artifacts (Para 0002) to improve the accuracy of the signal and thus improve patient outcomes.
Examiner’s Note: “Gating” refers to timing controls in the collection of data. The prior art excludes the data based on the significant respiration motion detected by the accelerometer.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the data gating of Koh with the data collection of Zheng, Stevens and Wariar in order to remove signal artifacts (Para 0002 of Koh) to improve the accuracy of the signal and thus improve patient outcomes.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (U.S. Patent 9,456,757 B1), Stevens et al. (U.S. Patent Application 2010/0057046 A1) and Wariar et al. (U.S. Patent Application 2013/0178786 A1) and further in view of Gaw (U.S. Patent Application 2011/0060239 A1).
Claim 12/2: Zheng teaches wherein the time-varying magnetic field comprises a plurality of frequencies [broadband pulses having multiple frequencies] (Col. 8, Line 54-55) that are harmonics of a fundamental frequency [time-harmonic fields] (Col. 5, Line 23), and wherein the first phase shift and the second phase shift are determined and compared for at least one of the plurality of frequencies of the time-varying magnetic field [the baseline and measurement for the relative change are important for the monitoring processing] (Col. 6, Line 13-15) [the change of the RPS represents the change of the dielectric constant of the pathological condition of brain tissue] (Col. 7, Line 19-21) [monitoring status of hydrocephalus, cerebral edema, and intracranial bleeding comprises of detecting the relative phase shifts (RPS) of electromagnetic waves that propagate through brain tissue and are altered by the changed volume of cerebrospinal fluid or cerebral edema condition, or intracranial bleeding] (Col. 2, Line 60-65)
Zheng, Stevens and Wariar fail to teach wherein all of the plurality of frequencies are simultaneously transmitted. However, Gaw teaches wherein all of the plurality of frequencies are simultaneously transmitted [the measuring device 100 may either apply an alternating signal at a single frequency, at a plurality of frequencies simultaneously, or a number of alternating signals at different frequencies sequentially, depending on the preferred implementation] (Para 0199) in order to use different software analysis (Para 0233) to provide different perspective on the data analysis. Gaw discloses that there are different ways of driving the frequencies: sequentially and simultaneously (Para 0199). Each way requires different software analysis due to the inherent differences in the data sets. The different software analysis gives different perspectives on the same object being measured and a provides a better analysis in determining biological parameters (Para 0235).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the simultaneous frequency transmission as taught by Gaw in the transmission of Zheng, Stevens and Wariar in order to use different software analysis (Para 0233) to provide different perspective on the data analysis.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (U.S. Patent 9,456,757 B1); Stevens et al. (U.S. Patent Application 2010/0057046 A1) and Wariar et al. (U.S. Patent Application 2013/0178786 A1) and further in view of Ko (U.S. Patent 4,819,648 A).
Claim 15/2: Zheng teaches the time-varying magnetic field [broadband pulses having multiple frequencies] (Col. 8, Line 54-55). Zheng, Stevens and Wariar fail to teach a calibration magnetic field. However, Ko teaches further comprising, before transmitting the magnetic field, transmitting a calibration magnetic field from the at least one transmitter to the at least one receiver [the steps of periodically calibrating the electrical circuit used to generate said spatially concentrated magnetic field and correcting the magnitude of said secondary magnetic field to correct for drift or background noise based on calibration data] (Claim 9) in order to correct for drift or background noise (Claim 9)
Examiner’s Note: Since Ko teaches periodically calibrating during use, the calibration magnetic field will be before the transmitting of the magnetic field.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Zheng, Stevens and Wariar to include the calibration as taught by in order to correct for drift or background noise (Claim 9).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (U.S. Patent 9,456,757 B1), Stevens et al. (U.S. Patent Application 2010/0057046 A1) and Wariar et al. (U.S. Patent Application 2013/0178786 A1) and further in view of Causevic (U.S. Patent Application 2007/0032737 A1).
Claim 16/2: Zheng teaches further comprising calculating, with the processor [a special-purpose processor operatively connected to the envelope and phase detector] (Claim 1), samples of the transmitted and received magnetic fields (Claim 8 and Figure 1, Element 103 & 101); and determining the first phase shift and the second phase shift by comparing phase [the special-purpose processor is specially configured to estimate the relative phase shift (RPS) by comparing the phase shift of said wave propagating through said brain tissue to a baseline for assessing status of hydrocephalus, cerebral edema, and intracranial bleeding] (Claim 8).
Zheng, Stevens and Wariar fail to teach a Fourier transform. However, Causevic teaches a Fourier transform for each signal [processing the signals comprises removing noise from the acquired signals, or "de-noising." Internal memory 211 of processor 210 contains instructions for instructing processor 210 to perform an algorithm on acquired signals…Fourier transforms, is a process of decomposing a given signal into a set of orthonormal basis functions called wavelets] (Para 0039) in order to remove noise and denoise the signal (Para 0039)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add Fourier Transform of Causevic to the signal processing of Zheng, Stevens and Wariar in order in order to remove noise and denoise the signal (Para 0039 of Causevic)
Response to Arguments
Applicant's arguments filed 04/09/2026 have been fully considered but they are not persuasive. The Applicant submitted arguments that Zheng and Stevens fail to teach or suggest ceasing administration of the therapeutic agent based on a predetermined range of a baseline measurement. In response to the new amendment, the rejection above is now:
Claim(s) 2-3, 9-11, 13-15 & 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (U.S. Patent 9,456,757 B1) and further in view of Stevens et al. (U.S. Patent Application 2010/0057046 A1) and Wariar et al. (U.S. Patent Application 2013/0178786 A1).
Wariar is relied on for the teaching of ceasing the administration of the therapeutic agent. Stevens teaches feedback with respect to the administration of therapeutic agents but fails to specifically teach ceasing the administration of the therapeutic agent based on a predetermined range of a baseline measurement. The Examiner contends the teaching of Wariar is an obvious modification of the feedback control of Stevens.
The argument is unconvincing.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HELENE C BOR whose telephone number is (571)272-2947. The examiner can normally be reached Mon - Fri 10:30 - 6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Helene Bor/Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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