DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim(s) 2 & 12 is/are objected to because of the following informalities: missing “an”. The claim limitation should read --an administration of a therapeutic agent--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims have been amended to cite: a manual stimulus. The Specification as originally filed fails to disclose a manual stimulus. Para 183 of the Specification as originally filed discloses: an external stimulus and the initial stimulus. The Examiner did a dictionary and Google search of the term “manual stimulus” and did not find a standard definition to the term. The Examiner assuming the claim should be interpreted as meaning the stimulus listed in Claim 2 & 12.
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) 1-2, 4-5, 11-12 & 14-15 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).
Claim 1: Zheng teaches –
A diagnostic method for monitoring changes in a fluid medium in a head of a patient [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), the method comprising:
positioning a transmitter at a first location on or near the head [transmitting electrodes propagates through brain tissue] (Col. 8, Line 56-57 and Figure 1, Element 102),
wherein the transmitter is configured to generate and transmit a time-varying magnetic field [broadband pulses having multiple frequencies] (Col. 8, Line 54-55) into the fluid medium in the head (Figure 1, Element 102) responsive to a first signal [Prescribed signals 100 are generated and applied to electrodes] (Col. 8, Line 52-53);
positioning a receiver at a second location on or near the head on an opposite side of the fluid medium from the transmitter [Electrodes or coils, or other sensors, 103 on other sides of the brain receive the propagated electromagnetic wave] (Col. 8, Line 58-60 and Figure 1, Element 103) and configured to generate a second signal responsive to a received magnetic field at the receiver [The received signal is conditioned, amplified, filtered, and converted to digital signal] (Col. 8, Line 60-62);
transmitting from the transmitter the time-varying magnetic field [broadband pulses having multiple frequencies] (Col. 8, Line 54-55) into the fluid medium in the head [transmitting electrodes propagates through brain tissue] (Col. 8, Line 56-57 and Figure 1, Element 102) in response to the first signal [baseline… wherein the baseline is either a phase shift previously measured] (Claim 8);
receiving at the receiver the time-varying magnetic field [The received signal is conditioned, amplified, filtered, and converted to digital signal] (Col. 8, Line 60-62);
generating with the receiver the second signal responsive to the received 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); and
determining, using a processing unit [control unit] (Figure 1, Element 109) coupled with [The entire system is controlled by 109] (Col. 9, Line 8-9) at least the receiver [Electrodes or coils, or other sensors, 103 on other sides of the brain receive the propagated electromagnetic wave] (Col. 8, Line 58-60 and Figure 1, Element 103), a plethysmogram of intracranial fluid changes [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)
Examiner’s Note: A plethysmogram is known to be a medical test that measures changes in the volume of an organ or the whole body.
Zheng teaches monitoring for the volume change in the brain tissue, which includes multiple transmitting and receiving steps to compare to the baseline in order to perform the disclosed monitoring (Col. 2, Line 60-65). Zheng fails to teach the stimulus. However, Stevens teaches –
introducing a stimulus into the patient [which would in turn activate a controller …which stimulates a physiologic response] (Para 0126),
wherein the stimulus is a manual stimulus [administration of drugs] (Para 0106) [provide diagnostic information, feedback, and/or control signals useful in treating patients with neurologic disease…Various medications such as steroids or mannitol could be used to reduce the swelling] (Para 0126)
Examiner’s Note: Stevens discloses ways to provide a stimulus such as in hyperventilation or in drug administration (Para 0126 and 0106).
determining a plethysmogram of intracranial fluid changes in response to the stimulus [An intracranial pressure probe or other continuous sensor…could sense an increase in intracranial pressure above a threshold level] (Para 0126) [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) 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 stimulus and monitoring the stimulus as taught by Stevens in order to reduce brain swelling (Para 00126).
Claim 2/1: Zheng fails to teach the stimulus. However, Stevens teaches wherein the manual stimulus is an administration of a therapeutic agent [administration of drugs] (Para 0106) [provide diagnostic information, feedback, and/or control signals useful in treating patients with neurologic disease…Various medications such as steroids or mannitol could be used to reduce the swelling] (Para 0126) in order to reduce brain swelling (Para 00126).
Claim 4/1: Zheng teaches further comprising determining, using the processing unit [control unit] (Figure 1, Element 109), a phase shift between the time-varying magnetic field and the received magnetic field for a plurality of frequencies of the time-varying magnetic field [where the receiving phase is directly compared with the transmitting phase to obtain the phase shift due to the brain tissue] (Col. 9, Line 37-39).
Claim 5/4/1: Zheng fails to teach a therapeutic agent. However, Stevens teaches further comprising administering a therapeutic agent, wherein the therapeutic agent comprises an agent selected from the group consisting of mannitol [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).
Claim 11: Zheng teaches –
A device for detecting a spatial difference in a fluid medium in a head of a patient [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), the device comprising:
a transmitter at a first location on or near the head [transmitting electrodes propagates through brain tissue] (Col. 8, Line 56-57 and Figure 1, Element 102),
wherein the transmitter is configured to generate and transmit a time-varying magnetic field [broadband pulses having multiple frequencies] (Col. 8, Line 54-55) into the fluid medium in the head (Figure 1, Element 102) responsive to a first signal [Prescribed signals 100 are generated and applied to electrodes] (Col. 8, Line 52-53);
a receiver at a second location on or near the head on an opposite side of the fluid medium from the transmitter [Electrodes or coils, or other sensors, 103 on other sides of the brain receive the propagated electromagnetic wave] (Col. 8, Line 58-60 and Figure 1, Element 103) and configured to generate a second signal responsive to a received magnetic field at the receiver [The received signal is conditioned, amplified, filtered, and converted to digital signal] (Col. 8, Line 60-62);
wherein the device is configured to:
transmit from the transmitter the time-varying magnetic field [broadband pulses having multiple frequencies] (Col. 8, Line 54-55) into the fluid medium in the head [transmitting electrodes propagates through brain tissue] (Col. 8, Line 56-57 and Figure 1, Element 102) in response to the first signal [baseline… wherein the baseline is either a phase shift previously measured] (Claim 8);
receive at the receiver the time-varying magnetic field [The received signal is conditioned, amplified, filtered, and converted to digital signal] (Col. 8, Line 60-62);
generate with the receiver the second signal responsive to the received 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); and
determine, using a processing unit [control unit] (Figure 1, Element 109) coupled with [The entire system is controlled by 109] (Col. 9, Line 8-9) at least the receiver [Electrodes or coils, or other sensors, 103 on other sides of the brain receive the propagated electromagnetic wave] (Col. 8, Line 58-60 and Figure 1, Element 103), a plethysmogram of intracranial fluid changes [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)
Examiner’s Note: A plethysmogram is known to be a medical test that measures changes in the volume of an organ or the whole body.
Zheng teaches monitoring for the volume change in the brain tissue, which includes multiple transmitting and receiving steps to compare to the baseline in order to perform the disclosed monitoring (Col. 2, Line 60-65). Zheng fails to teach the stimulus. However, Stevens teaches –
introducing a stimulus into the patient [which would in turn activate a controller…which stimulates a physiologic response] (Para 0126),
wherein the stimulus is a manual stimulus [administration of drugs] (Para 0106) [provide diagnostic information, feedback, and/or control signals useful in treating patients with neurologic disease…Various medications such as steroids or mannitol could be used to reduce the swelling] (Para 0126)
Examiner’s Note: Stevens discloses ways to provide a stimulus such as in hyperventilation or in drug administration (Para 0126 and 0106).
determining a plethysmogram of intracranial fluid changes in response to the stimulus [An intracranial pressure probe or other continuous sensor…could sense an increase in intracranial pressure above a threshold level] (Para 0126) [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) 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 stimulus and monitoring the stimulus as taught by Stevens in order to reduce brain swelling (Para 00126).
Claim 12/11: Zheng fails to teach the stimulus. However, Stevens teaches wherein the manual stimulus is an administration of a therapeutic agent [administration of drugs] (Para 0106) [provide diagnostic information, feedback, and/or control signals useful in treating patients with neurologic disease…Various medications such as steroids or mannitol could be used to reduce the swelling] (Para 0126) in order to reduce brain swelling (Para 00126).
Claim 14/11: Zheng teaches wherein the device (Figure 1) is further configured to determine a phase shift between the time-varying magnetic field and the received magnetic field for a plurality of frequencies of the time-varying magnetic field [where the receiving phase is directly compared with the transmitting phase to obtain the phase shift due to the brain tissue] (Col. 9, Line 37-39).
Claim 15/14/11: Zheng fails to teach a therapeutic agent. However, Stevens teaches to administer a therapeutic agent, wherein the therapeutic agent comprises an agent selected from the group consisting of mannitol [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).
Claim(s) 3 & 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (U.S. Patent 9,456,757 B1) and Stevens et al. (U.S. Patent Application 20100057046 A1) and further in view of Poupko et al. (U.S. Patent 8,211,031 B2).
Claim 3/1: Zheng teaches using a processing unit [control unit] (Figure 1, Element 109) and calculating based on the plethysmogram of the intracranial fluid changes [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)
Examiner’s Note: A plethysmogram is known to be a medical test that measures changes in the volume of an organ or the whole body.
Zheng and Stevens fail to teach further comprising calculating a patient-specific pressure-volume relationship for the fluid medium. However, Poupko teaches calculating a patient-specific [data is obtained] [The data may be generated in real time by measurements on a subject] (Col. 12, Line 59-63 and Figure 5, Element 702) pressure [Intracranial pressure (ICP)] (Figure 5, Element 726 and/or 734)-volume [cerebral blood volume (CBV)] (Figure 5, Element 734) relationship [calculate one or more indicators…Such an indicator may provide…a change in the value of an indicator may provide an estimate of the change in the level of an intracranial parameter, relative to a baseline level] (Col. 3, Line 34-40 and Figure 5, Element 738) for the fluid medium (Abstract) in order to have a non-invasive continuous monitoring of the cerebral fluid pressure-volume for patient diagnosing (Col. 1, Line 25 – Col. 3, Line 20)
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 processing unit of Zheng and Stevens to include the relationship as disclosed by Poupko in order to understand cranial fluids to aid in diagnosis conditions such as edema or cerebral bleeding (Para 149 & 152).
Claim 13/11: Zheng teaches wherein the device [control unit] (Figure 1, Element 109) is further to configured to calculate based on the plethysmogram of intracranial fluid changes [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)
Examiner’s Note: A plethysmogram is known to be a medical test that measures changes in the volume of an organ or the whole body.
Zheng and Stevens fail to teach to calculate a patient-specific volume relationship for the fluid medium. However, Poupko teaches to calculate a patient-specific [data is obtained] [The data may be generated in real time by measurements on a subject] (Col. 12, Line 59-63 and Figure 5, Element 702) pressure [Intracranial pressure (ICP)] (Figure 5, Element 726 and/or 734)-volume [cerebral blood volume (CBV)] (Figure 5, Element 734) relationship [calculate one or more indicators…Such an indicator may provide…a change in the value of an indicator may provide an estimate of the change in the level of an intracranial parameter, relative to a baseline level] (Col. 3, Line 34-40 and Figure 5, Element 738) for the fluid medium (Abstract) in order to have a non-invasive continuous monitoring of the cerebral fluid pressure-volume for patient diagnosing (Col. 1, Line 25 – Col. 3, Line 20)
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 processing unit of Zheng and Stevens to include the relationship as disclosed by Poupko in order to understand cranial fluids to aid in diagnosis conditions such as edema or cerebral bleeding (Para 149 & 152).
Claim(s) 6 & 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (U.S. Patent 9,456,757 B1) and Stevens et al. (U.S. Patent Application 2010/0057046 A1) and further in view of Kinrot et al. (U.S. Patent Application 2012/0203134 A1).
Claim 6/4/1: 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 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 and Stevens fail to teach an analog to digital converter mounted to a headset positioned on the head. However, Kinrot teaches the digital converter [digital signal processors] (Para 0034) mounted to a headset (Figure 1) positioned on the 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 and Stevens 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 16/14/11: Zheng teaches wherein the device is further configured to convert the first 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 device further comprises positioning the headset 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 and Stevens fail to teach an analog to digital converter mounted to a headset positioned on the head. However, Kinrot teaches the digital converter [digital signal processors] (Para 0034) mounted to a headset (Figure 1) positioned on the 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 and Stevens 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(s) 7 & 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (U.S. Patent 9,456,757 B1) and Stevens et al. (U.S. Patent Application 2010/0057046 A1) and further in view of Cook et al. (U.S. Patent Application U.S. Patent 6,049,706 A).
Claim 7/41: Zheng teaches the transmitted magnetic field and the received magnetic field (Figure 1, Element 101 & 103). Zheng and Stevens 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 further comprising 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 and Stevens to include the under-sampling of Cook in order to improve a receiver’s potential for interference (Col. 3, Line 21-23).
Claim 17/14/11: Zheng teaches the transmitted magnetic field and the received magnetic field (Figure 1, Element 101 & 103). Zheng and Stevens fail to teach the device is further configured to generate a sampling signal, using a sampling signal generator, the sampling signal having a frequency to under-sample. However, Cook teaches wherein the device is further configured to generate 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 and Stevens to include the under-sampling of Cook in order to improve a receiver’s potential for interference (Col. 3, Line 21-23).
Claim(s) 8-10 & 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 Stevens et al. (U.S. Patent Application 2010/0057046 A1) and further in view of Koh et al. (U.S. Patent Application 2012/0016253 A1).
Claim 8/4/1: 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 and Stevens 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 and Stevens 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 9/4/1: Zheng and Stevens 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 transmitter or the 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 exclusion of Koh with the data collection of Zheng and Stevens in order to remove signal artifacts (Para 0002 of Koh) to improve the accuracy of the signal and thus improve patient outcomes.
Claim 10/4/1: Zheng teaches the phase shift [where the receiving phase is directly compared with the transmitting phase to obtain the phase shift due to the brain tissue] (Col. 9, Line 37-39) between the time-varying magnetic [broadband pulses having multiple frequencies] (Col. 8, Line 54-55) field and the received magnetic field (Figure 1, Element 101 & 103).
Zheng and Stevens fail to teach excluding data further comprising using the processing unit to exclude data corresponding to periods of time [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) is such that it is unlikely a result of biological changes within the head [employs accelerometers…in order to acquire a signal that describes the motion of the 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.
Claim 18/14/11: Zheng teaches wherein the device is further configured 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 and Stevens 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 and Stevens 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 19/14/11: Zheng and Stevens fail to teach detecting motion and an accelerometer. However, Koh teaches further configured to detect motion [employs accelerometers…in order to acquire a signal that describes the motion of the patch electrodes] (Para 0060); and exclude 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 transmitter or the 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 and Stevens in order to remove signal artifacts (Para 0002 of Koh) to improve the accuracy of the signal and thus improve patient outcomes.
Claim 20/14/11: Zheng teaches the phase shift [where the receiving phase is directly compared with the transmitting phase to obtain the phase shift due to the brain tissue] (Col. 9, Line 37-39) between the time-varying magnetic [broadband pulses having multiple frequencies] (Col. 8, Line 54-55) field and the received magnetic field (Figure 1, Element 101 & 103). Zheng teaches intracranial fluid changes within the 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)
Zheng and Stevens fail to teach excluding data further comprising using the processing unit to exclude data corresponding to periods of time [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) is such that the data is unlikely to be a result of the biological changes [employs accelerometers…in order to acquire a signal that describes the motion of the 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 and Stevens in order to remove signal artifacts (Para 0002 of Koh) to improve the accuracy of the signal and thus improve patient outcomes.
Response to Arguments
Applicant’s arguments, see Page 6, filed 11/17/2025, with respect to the Rejection under 35 USC § 112(b) have been fully considered and are persuasive. The Rejection under 35 USC § 112(b) of the Claims has been withdrawn.
Applicant's arguments filed 11/17/2025 have been fully considered but they are not persuasive. The Applicant submitted arguments that Zheng and Stevens fail to teach or suggest a manual stimulus in Claim 1. Claim 2 & 12 have been amended to include “manual stimulus is…administration of a therapeutic agent”. The rejection above has been amended in response to the claim amendments. The rejection points to Stevens teaching administration of drugs (Para 0106) and provid[ing] diagnostic information, feedback, and/or control signals useful in treating patients with neurologic disease…Various medications such as steroids or mannitol could be used to reduce the swelling (Para 0126). Stevens uses therapeutic agents for feedback to administer medications to control swelling, which is further supported by Para 0106 of Stevens. The rejection above has been amended in response to the Applicant’s amendments to point to this disclosed embodiment of Stevens. The argument is unconvincing.
The Examiner notes that “manual stimulus” is not specifically defined by the Specification as originally filed (See pending 35 USC § 112 above). The Examiner is interpreting the claim limitation in view of Claim 2 & 12 but not that the “manual stimulus” is limited to the examples in Claim 2 & 12. As such, it is not clear what encompasses a manual stimulus. The user is applying a manual stimulus through the activation of a controller of a ventilator by manually pressing the button. The claim limitation is not a limiting as the Applicant may be intending.
The rejection is deemed proper and is hereby maintained.
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.
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/Helene Bor/Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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