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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/19/2025 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1, 9, 20, 34, 37, 39, 42-43, 45-47, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0150685 A1 (Toth) (previously cited) in view of US 2009/0234248 A1 (Zand) (previously cited) and US 2017/0224986 A1 (Imran) (previously cited)
With regards to claims 1 and 9, Toth teaches a monitoring system for detecting or predicting onset of an adverse physiological phenomenon in a patient relating to a tissue connection site and a patient site of interest monitoring system for detecting or predicting onset of an adverse physiological phenomenon relating to a tissue connection site in a patient (¶ [0003] discloses system for monitoring an anastomosis after surgery; also see Fig. 11 and ¶¶ [0051], [0054], [0196] with regards to the elongate probes and sensors), the system comprising: at least one monitoring electrode configured to be operably coupleable with a monitoring site of interest, the at least one monitoring electrode having electrical characteristics that are responsive to changes in physiological characteristics of the monitoring site interest (¶ [0051] discloses the sensor including an electrode based or bioelectrode based impedance sensor for detection of electrophysiological properties, bioelectric activity, biopotential, bioimpedance, etc.; Fig. 11 and ¶¶ [0196]-[0198] depict one or more elongate probes 824 a,b comprising one or more electrode sets 860a,b, wherein the electrode sets 860 a,b are coupleable with tissues external to a surgical site 12 (e.g., a gastrointestinal anastomosis)), determine at least one first output signal produced by the at least one monitoring electrode (¶ [0051] discloses the sensor is configured to measure or detect one or more physiological properties, which may include bioelectric activity, biopotentials, bioimpedance, bioimpedance tomography; wherein the at least one first output signal comprises at least one impedance and at least one signal relating to one the following: stomach function, small bowel function, or any combination of the aforesaid (¶ [0051] discloses the sensor is configured to measure or detect one or more physiological properties, which may include bioelectric activity, biopotentials, bioimpedance, bioimpedance tomography; ¶ [0071] discloses the surgical sight may be an anastomosis performed on a colon, small intestine, stomach, etc.).
The above embodiment of Toth is silent with regards to a memory, and processing circuitry or an analysis engine configured to execute instructions stored in the memory to perform sensing of the output signals and the detection of the adverse physiological phenomenon.
In an alternative embodiment for monitoring a surgical site, Toth teaches a memory, and processing circuitry or an analysis engine configured to execute instructions stored in the memory to perform sensing of output signals and the detection of the adverse physiological phenomenon (¶ [0040]-[0041] depict a microcircuit for monitoring states of a tissue, wherein the microcircuit includes a memory and processing circuitry adapted to (A) monitor, measure, or detect one or more physiological or electrophysiological properties associated with the surgical site and (B) monitor for one or more disease states associated with the surgical site including onset and/or development of a leak). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Fig. 11 of Toth to incorporate memory, and processing circuitry or an analysis engine configured to execute instructions stored in the memory to perform the sensing of the output signals and detection of the adverse physiological phenomenon as taught by the embodiment of ¶¶ [0040]-[0041] of Toth. The motivation(s) would have been to provide the structural elements that are required for monitoring the surgical site 12 and/or to consolidate all of the computing elements into the system, thereby improving the ease of use of the system.
Toth is silent regarding at least one reference electrode configured to be coupleable with a reference location for monitoring a reference site which is remote from the monitoring site and where no anastomotic leakage is expected to occur; sensing at least one second output signal produced by the at least one reference electrode; and detecting and/or determining the onset of the adverse physiological phenomenon by comparing at the least one first output signal against the at least one second output signal.
In the same field of endeavor of monitoring anastomotic failure, Zand teaches at least one reference sensor operably coupleable with a reference location for monitoring a reference site which is remote from the monitoring site and where no anastomotic leakage is expected to occur (Fig. 1 and ¶ [0065] depict a reference sensor device 135 placed outside the surgical area to capture baseline measurements; ¶ [0057] discloses that the reference sensor contains one or more sensor banks of the same or similar type, it may be placed on a healthy portion of bowel, and it may be used as an independent sensor for preoperative or postoperative monitoring); sensing at least one first output signal produced by the at least one reference electrode (¶ [0065] discloses a communication interface 125 for receiving baseline measurements); and detecting and/or determining the onset of the adverse physiological phenomenon by comparing at least one second output signal against the at least one second output signal (¶¶ [0016]-[0017], [0035], [0057], [0063], [0079], [0080] depict comparison between the signals of the reference sensor and the sensor to determine compromised tissue viability). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of the above combination of Toth to incorporate, based on the teachings of Zand, at least one reference electrode, sensing at least one second output signal, and detecting and/or determining onset of the adverse physiological phenomenon by comparing at least one first output signal against at least one second output signal. The motivation would have been to compare the physiological characteristics of the monitoring site with those of a baseline, thereby providing a more accurate determination of a disease state.
The above combination is silent regarding whether the at least one impedance and the at least one signal are sensed by a first same electrode of the at least one monitoring electrode and/or sensed by a second same electrode of the at least one reference electrode; and wherein the first same electrode and/or the second same electrode provide a stimulation output signal such that the at least one first and/or second output signals comprise the at least one impedance.
In a system relevant to the problem of monitoring gastric sites, Imran teaches at least one signal relating to one the following: stomach function, small bowel function, or any combination of the aforesaid (¶¶ [0036]-[0037] discloses electrodes placed in relation to the stomach wall to measure electrical activity (EMG or EGG)); at least one impedance and the at least one signal are sensed by a first same electrode of the at least one monitoring electrode and/or sensed by a second same electrode of the at least one reference electrode (Fig. 13 and ¶ [0152] depict circuitry for detecting impedance and EMG using the same electrodes 11, 12, wherein impedance is sensed using constant current source oscillator 154 and A/C converter 146f, and EMG is sensed using A/C converter 146e); and wherein the first same electrode and/or the second same electrode provide a stimulation output signal such that the at least one first and/or second output signals comprise the at least one impedance (¶ [0152] and Fig. 13 depict a constant current source oscillator 154 for providing a constant current through electrodes 11,12 resulting in a voltage across the electrodes 11, 12 that is representative of impedance). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate the at least one impedance and the at least one signal are sensed by a first same electrode of the at least one monitoring electrode and/or sensed by a second same electrode of the at least one reference electrode; and wherein the first same electrode and/or the second same electrode provide a stimulation output signal such that the at least one first and/or second output signals comprise the at least one impedance as taught by Imran. The motivation would have been to consolidate the sensing elements into a single pair of electrodes, thereby improving the ease of use of the device. Additionally or alternatively, the motivation would have been to improve disease diagnosis and evaluation of effectiveness of various treatment protocols (¶ [0037] of Imran).
With regards to claim 20, the above combination further teaches that the monitoring system is further configured to monitor a healing process (¶¶ [0040], [0143] of Toth discloses the microcircuit is configured to monitor, measure, or detect progression of wound healing).
With regards to claim 34, the above combination further teaches or suggest the analysis engine is configured to assess patient recover following anastomotic leakage (¶¶ [0040], [0143] of Toth discloses the microcircuit is configured to monitor, measure, or detect progression of wound healing, wherein wound healing encompasses recovery following anastomotic leakage).
With regards to claim 37, Toth teaches a method for monitoring a patient site of interest (¶¶ [0003], [0286] discloses systems and methods for monitoring an anastomosis after surgery; also see Fig. 11 and ¶¶ [0051], [0054], [0196] with regards to the elongate probes and sensors), comprising: operably engaging one or more electrodes with a monitoring site (¶ [0286] discloses placement of a sensory subsystem for monitoring the surgical site; ¶ [0051] discloses the sensor including an electrode based or bioelectrode based impedance sensor for detection of electrophysiological properties, bioelectric activity, biopotential, bioimpedance, etc.; Fig. 11 and ¶¶ [0196]-[0198] depict one or more elongate probes 824 a,b comprising one or more electrode sets 860a,b, wherein the electrode sets 860 a,b are coupled with tissues external to a surgical site 12 (e.g., a gastrointestinal anastomosis)), subjecting the monitoring site, via the one or more electrodes, with input signals (¶ [0051] discloses monitoring bioimpedance which necessarily requires subjecting the monitoring site with input signals; see analogous ¶ [0153] which discloses hardware for driving and for sensing signals at a frequency or over a frequency range suitable for monitoring biosignals or bioimpedance of the surrounding tissues); obtaining received response signals as a result of subjecting the monitoring site with the input signals (¶ [0051] discloses monitoring bioimpedance which is necessarily a result of subjecting the monitoring site with input signals; ¶ [0153] discloses monitoring biosignals or bioimpedance of the surrounding tissues based on the driving), wherein the received response signal comprises at least one impedance and at least one signal relating to one the following: stomach function, small bowel function, or any combination of the aforesaid (¶ [0051] discloses the sensor is configured to measure or detect one or more physiological properties, which may include bioelectric activity, biopotentials, bioimpedance, bioimpedance tomography; ¶ [0071] discloses the surgical sight may be an anastomosis performed on a colon, small intestine, stomach, etc.).
The above embodiment of Toth is silent with regards to determining, based on the response signals, an output pertaining to a physiological phenomenon with respect to the patient site of interest, wherein the physiological phenomenon pertains to anastomotic leak from a tissue connection site
In an alternative embodiment for monitoring a surgical site, Toth teaches determining, based on the response signals, an output pertaining to a physiological phenomenon with respect to the patient site of interest, wherein the physiological phenomenon pertains to anastomotic leak from a tissue connection site (¶ [0040]-[0041] depict a microcircuit for monitoring states of a tissue, wherein the microcircuit includes a memory and processing circuitry for monitoring for one or more disease states associated with the surgical site including onset and/or development of a leak; ¶ [0011] discloses determination of a leak in relation to an anastomosis). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of ¶ [0286] of Toth to incorporate determining, based on the response signals, an output pertaining to a physiological phenomenon with respect to the patient site of interest, wherein the physiological phenomenon pertains to anastomotic leak from a tissue connection site as taught by the embodiment of ¶¶ [0040]-[0041] of Toth. The motivation(s) would have been to provide a more accurate analysis and monitoring of the surgical site.
Toth is silent regarding operably engaging one or more electrodes to a reference site, subjecting the reference site via the one or more electrodes with input signals, receiving response signals as a result of the subjecting the reference site with the input signals, determining, based on the received response signals from the monitoring site and the reference site, an output pertaining to a physiological phenomenon with respect to the patient site of interest, wherein the monitoring site is remote from the reference site, where no anastomotic leakage is expected to occur at the reference site.
In the same field of endeavor of monitoring anastomotic failure, Zand teaches operably engaging one or more sensors with a reference site and with a monitoring site (Fig. 1 and ¶ [0065] depict an augmented surgical stapler 101 comprising sensing adjuncts 113, 115; ¶¶ [0066], [0081] discloses optical sensors that are responsive to changes in tissue characteristics; Fig. 1 and ¶ [0065] depict a reference sensor device 135 placed outside the surgical area to capture baseline measurements; ¶ [0057] discloses that the reference sensor contains one or more sensor banks of the same or similar type, it may be placed on a healthy portion of bowel, and it may be used as an independent sensor for preoperative or postoperative monitoring), receiving response signals (¶ [0065] discloses receiving signals from 113, 115, 135 at communication interface 125 and controller 131), determining, based on the received response signals, from the monitoring site and the reference site, an output pertaining to a physiological phenomenon with respect to the patient site of interest (¶¶ [0016]-[0017], [0035], [0057], [0063], [0079], [0080] depict comparison between the signals of the reference sensor and the sensor to determine compromised tissue viability), wherein the monitoring site is remote from the reference site, where no anastomotic leakage is expected to occur at the reference site (Fig. 1 and ¶ [0065] depict a reference sensor device 135 placed outside the surgical area to capture baseline measurements). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of the above combination of Toth to incorporate, based on the teachings of Zand, operably engaging one or more electrodes to a reference site, subjecting the reference site via the one or more electrodes with input signals, receiving response signals as a result of the subjecting the reference site with the input signals, determining, based on the received response signals from the monitoring site and the reference site, an output pertaining to a physiological phenomenon with respect to the patient site of interest, wherein the monitoring site is remote from the reference site where no anastomotic leakage is expected to occur. The motivation would have been to compare the physiological characteristics of the monitoring site with those of a baseline, thereby providing a more accurate determination of a disease state.
The above combination is silent regarding whether the at least one impedance and the at least one signal are sensed by using a first same electrode of the at least one monitoring electrode and/or sensed by a second same electrode of the at least one reference electrode; and wherein the first same electrode and/or the second same electrode provide a stimulation output signal such that the at least one first and/or second output signals comprise the at least one impedance.
In a system relevant to the problem of monitoring gastric sites, Imran teaches at least one signal relating to one the following: stomach function, small bowel function, or any combination of the aforesaid (¶¶ [0036]-[0037] discloses electrodes placed in relation to the stomach wall to measure electrical activity (EMG or EGG)); at least one impedance and the at least one signal are sensed by a first same electrode of the at least one monitoring electrode and/or sensed by a second same electrode of the at least one reference electrode (Fig. 13 and ¶ [0152] depict circuitry for detecting impedance and EMG using the same electrodes 11, 12, wherein impedance is sensed using constant current source oscillator 154 and A/C converter 146f, and EMG is sensed using A/C converter 146e); and wherein the first same electrode and/or the second same electrode provide a stimulation output signal such that the at least one first and/or second output signals comprise the at least one impedance (¶ [0152] and Fig. 13 depict a constant current source oscillator 154 for providing a constant current through electrodes 11,12 resulting in a voltage across the electrodes 11, 12 that is representative of impedance). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate the at least one impedance and the at least one signal are sensed by a first same electrode of the at least one monitoring electrode and/or sensed by a second same electrode of the at least one reference electrode; and wherein the first same electrode and/or the second same electrode provide a stimulation output signal such that the at least one first and/or second output signals comprise the at least one impedance as taught by Imran. The motivation would have been to consolidate the sensing elements into a single pair of electrodes, thereby improving the ease of use of the device. Additionally or alternatively, the motivation would have been to improve disease diagnosis and evaluation of effectiveness of various treatment protocols (¶ [0037] of Imran).
With regards to claim 39, the above combination teaches or suggests that the at least one first output signal, the at least one second output signal, or both relate to food intake by the patient (¶ [0040], [0182] of Toth discloses monitoring one or more of bioelectric activity, biopotentials, bioimpedance, bioimpedance tomography, and others. The Examiner asserts that the above biosignals at a gastrointestinal anastomosis site related to food intake).
With regards to claim 42, the above combination is silent with regards to whether the monitoring system is configured to perform, based on the at least one first output signal, the at least one second output signal, or both, temporal-spatial monitoring of the patient site of interest.
In an alternative embodiment for monitoring a surgical site, Toth discloses monitoring system is configured to perform, based on the at least one first output signal, the at least one second output signal, or both, temporal-spatial monitoring of the patient site of interest (¶ [0144] of Toth discloses electrodes 50c, d, f being used to provide measurements at the other side of the surgical site 12, thereby providing a spatial monitoring of the patient site of interest; ¶ [0147] of Toth indicates monitoring data over time). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrodes of Toth of the above combination to incorporate that there are a plurality of electrodes on both sides of the surgical site in order to provide temporal-spatial monitoring of the patient site of interest as taught by ¶¶ [0144], [0147] of Toth. The motivation would have been to provide a more complete diagnostic analysis of the patient.
.
With regards to claim 43, the above combination teaches or suggests the at least one first output signal is indicative of a change of an electrical characteristic of the monitoring electrode, wherein the analysis engine is configured for detecting and/or predicting, based on the at least one first output signal, the onset of anastomotic leakage based on the change of the electrical property of the at least one monitoring electrode (¶ [0040] of Toth discloses the microcircuit may be configured to monitor a tear, and/or onset and/or development of a leak; ¶ [0143] of Toth discloses that the biosignals may provide information regarding parameters that are indicators of the formation of a leak; ¶¶ [0145], [0147], [0148] of Toth disclose the microcircuit 45 analyzes the data from the sensors to determine clinically relevant metrics and predict changes in the state of the surgical site).
With regards to claim 45, the above combination teaches or suggests that the at least one monitoring electrode and the at least one reference electrode are implantable electrodes (Fig. 2 and ¶ [0131] of Toth depict the electrodes being implanted; also see Abstract of Toth which indicates implantation of the sensory subsystem).
With regards to claim 46, the above combination teaches or suggests the processing circuitry is operable to execute instructions stored in the memory to determine the onset of the adverse physiological phenomenon (¶ [0040]-[0041] of Toth depict a microcircuit for monitoring states of a tissue, wherein the microcircuit includes a memory and processing circuitry for monitoring for one or more disease states associated with the surgical site including onset and/or development of a leak; ¶ [0011] of Toth discloses determination of a leak in relation to an anastomosis).
With regards to claim 47, the above combination teaches or suggests that one or both of the at least one monitoring electrode and the at least one reference electrode is made of non-biodegradable, partially biodegradable or fully biodegradable material (the Examiner notes that the electrodes of Toth are necessarily non-biodegradable, partially biodegradable, or fully biodegradable).
With regards to claim 49, the above combination teaches or suggests the processing circuitry is operable to execute instructions stored in the memory to determine an adverse physiological phenomenon by comparing signals from the reference site and the monitoring site (see the above combination of Toth and Zand in relation to claim 1; see ¶¶ [0016]-[0017], [0035], [0057], [0063], [0079], [0080] of Zand depict comparison between the signals of the reference sensor and the sensor to determine compromised tissue viability; ¶ [0040] of Toth discloses the microcircuit may be configured to monitor a tear, and/or onset and/or development of a leak).
The above combination is silent with regards to whether the processing circuitry is operable to execute instructions stored in the memory to determine: anastomotic leakage in the patient, onset of the anastomotic leakage, or both based on data representing one of the following: the stomach function, the small bowel function, the large bowel function, or the combination of the aforesaid: phase, phase shifts over time, phase differences, or combination thereof.
In the same field of endeavor of monitoring anastomosis, Toth teaches determining a formation of a leak based on biosignals determined from an electrode (¶ [0143]) and that signal strength and phase will change due to integrity of walls of the organ and/or the surgical site (¶ [0210]), thereby indicating that a phase is indicative of an anastomotic leakage and/or onset of anastomotic leakage. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the instructions executed by the processing circuitry of the above combination to incorporate, based on the teachings of Toth, determining anastomotic leakage in the patient, onset of the anastomotic leakage, or both based on data representing one of the following: the stomach function, the small bowel function, the large bowel function, or the combination of the aforesaid: phase, phase shifts over time, phase differences, or combination thereof. The motivation would have been to provide a more complete diagnostic analysis of the anastomosis and/or to provide a more accurate determination of an anastomotic leakage.
Claims 8 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Toth in view of Zand and Imran, as applied to respective claims 1 and 9 above, and further in view of US 5,690,656 A (Cope) (previously cited).
With regards to claim 8 and 48, the above combination of Toth in view of Zand and Imran teaches the monitoring system of respective claims 1 and 9.
The above combination is silent regarding a fluid drainage catheter that is operably positionable to drain fluids from an internal body site of interest to outside the body of the patient, wherein the at least one monitoring electrode is operably integrated with the fluid drainage catheter or in fluid communication with a fluid path of the bodily fluid drainage catheter for measuring changes in the physiological characteristics of the patient.
In a related embodiment, Toth teaches a drain that is operably positionable to drain fluids from an internal body site of interest to outside the body of the patient, wherein the electronic sensor is operably integrated with the fluid drainage catheter or in fluid communication with a fluid path of the bodily fluid drain for measuring changes in the physiological characteristics of the patient (Fig. 9 and ¶¶ [0183], [0178] disclose a surgical drain or a portal 16 along which or through which the elongate probe 820a, b may be placed in order to monitor the surgical site). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate that the probes access the surgical site through a drain as taught by Fig. 9 and ¶¶ [0183], [0178] of Toth. Because both embodiments are capable of accessing the surgical site, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to provide an external connection, thereby allowing for better communication with the probe.
The above combination is silent with regards to whether the drain is a catheter.
In a system related to the problem of accessing anastomoses, Cope discloses that a drain may be a drainage catheter (Col. 5, lines 50-65 disclose a drainage catheter). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the drain of the above combination with a drainage catheter as taught by Cope. Because both elements are capable of providing drainage and access to anastomoses, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Toth in view of Zand and Imran, as applied to claim 1 above, and in view of US 2005/0197680 A1 (DelMain) (previously cited)
With regards to claim 44, the above combination teaches or suggests the monitoring system of claim 1.
The above combination is silent with regards to a first communication device comprising a first transmitter and receiver or a first transceiver operably coupled with the at least one monitoring electrode employed for monitoring the monitoring site of interest, and a second communication device comprising a second transmitter and receiver or a second transceiver operably coupled with the at least one reference electrode employed for monitoring the reference site of interest, wherein the first and the second communication devices are configured to perform in-body transmission of the at least one first output signal produced by the at least one monitoring electrode and the at least one second output signal produced by the at least one reference signal.
In system related to the problem of communication between implantable sensors, DelMain discloses sensors having corresponding communication devices, wherein the communication devices are configured to perform in-body transmission of signals between the different sensors (Fig. 2 and ¶ [0050] discloses implantable devices 100; ¶ [0057] discloses the implantable device 100 may operate as a microsensor for detecting impedance; ¶ [0059] discloses the implantable device 100 may act as microtransponders for communicating with other devices 100, wherein the communication is performed using magnetic, sonic, RF, or electric communication modes; ¶ [0053] discloses a signal transmitter and a signal receiver). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrode sensors of the above combination to have corresponding communication devices for performing in-body transmission of signals between the different sensors as taught by DelMain. The motivation would have been to improve the communication between the different sensing elements of the device.
Claims 50-51 are rejected under 35 U.S.C. 103 as being unpatentable over Toth in view of Zand and Imran, as applied to claim 1 above, and in view of US 2019/0099279 A1 (Shchukin) (previously cited).
With regards to claim 50, the above combination is silent with regards to whether the system is configured to perform concurrent sensing or measurement of the at least one impedance and of the at least one signal relating to the stomach function, the small bowel function, the large bowel function, or any combination of the aforesaid, while using the same electrode of the at least one monitoring electrode and/or the second same electrode of the at least one reference electrode.
In a system related to the problem of measuring impedance and electrophysiological signals, Shchukin teaches or suggests performing concurrent sensing or measurement of the at least one impedance and of at least one EMG signal using the same electrode (¶ [0035] discloses impedance being recorded concurrently with an electromyogram (i.e., electrophysiological signal; Figs. 2 and 4 and ¶¶ [0048]-[0050] depicts measuring EMG and Impedance using the same electrodes for each channel; ¶ [0050] of Shchukin teaches different frequency filters for the EMG and impedance signals). It would have been obvious for one of ordinary skill in the art before the effective filing date to have modified the determination of the at least one impedance signal and the at least one EMG/EGG signal of the above combination of Toth, Zand, and Imran to incorporate that they are performed concurrently as taught by Shchukin. The motivation would have been to reduce crosswise (interference distortions) when using different electrodes (¶ [0020] of Shchukin).
With regards to claim 51, the above combination teaches or suggests that a signal frequency related to the at least one impedance sensing or measurement is different from a signal frequency related to at least one signal relating to the stomach function, the small bowel function, the large bowel function, or any combination of the aforesaid (¶ [0050] of Shchukin teaches different frequency filters for the EMG and impedance signals, which indicates that the EMG signal frequency and the impedance signal frequency are different).
Response to Arguments
Claim Objections
In view of the claim amendments and arguments filed 11/25/2025, the claim objections were withdrawn
Rejections under 35 U.S.C. §112(b)
In view of the claim amendments filed 11/25/2025, the claim rejections under 35 U.S.C. §112(b) were withdrawn.
Rejections under 35 U.S.C. §103
Applicant's arguments filed 11/25/2025 have been fully considered but they are not persuasive.
On page 12-14 of the Remarks filed 11/25/2025, the Applicant asserts that Imran does not teach or suggest “wherein the at least one impedance and the at least one signal are sensed by a first same electrode of the at least one monitoring electrode and/or sensed by a second same electrode of the at least one reference electrode” of claim 1 and similar limitations of claim 9 because Imran does not disclose or teach employing an architecture configured to utilize the same single electrode. This argument is not persuasive.
First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., utilization of a same single electrode for measuring at least one impedance and the at least one signal) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In this case, the recitation of “sensed by a first same electrode” and “sensed by a second same electrode” does not preclude the use of additional electrodes for the sensing.
Second, the Applicant’s specification recites, “a monitoring electrode referred to herein can be a multi-electrode or comprise an arrangement of multiple electrodes” in ¶ [0022]. Such a recitation suggests that “a same first electrode of the at least one monitoring electrode” may comprise a multi-electrode or an arrangement of multiple electrodes. US 2017/0224986 A1 (Imran) (previously cited) teaches a multi-electrode or an arrangement of multiple electrodes for the measurement of both impedance and signals relating to one of stomach, small bowel, and large bowel function. See at least Fig. 13 and ¶ [0152] regarding the use of the arrangement of electrodes 11 and 12. Therefore, Imran teaches the above limitation.
Third, the specification does not provide sufficient written description for the sensing of both at least one impedance and the at least one signal by only a first same electrode and/or a second same electrode. One of ordinary skill in the art would understand that conventional impedance measurements require the use of a reference or ground electrode in order to measure the voltage drop generated by a known current. Therefore, the use of only one electrode for measuring impedance is not conventional or known in the art. However, the specification does not provide any description of the circuitry or electrode arrangement required for measurement of impedance and the at least one signal by only a single electrode. Applicant appears to find support from ¶ [0030] of the specification, which indicates “an input signal for stimulating the patient site of interest and, concurrently, measuring the voltage drop between at least two different locations of the same electrode(s).” However, the mere recitation of “same electrode(s)” does not amount to adequate written description for demonstrating that the inventor had possession of an invention capable of measuring both at least one impedance and the at least one signal by using only a single electrode.
Additionally or alternatively, the Examiner asserts that the use of the two-electrode measurement architecture of Imran amounts to at least “at least one impedance and the at least one signal are sensed by a first same electrode of the at least one monitoring electrode” even if the limitation is being interpreted to correspond to the measurement of both signals using a single electrode. As indicated by the Applicant’s arguments on Page 12 of the impedance circuit utilizes a constant current driven through an electrode pair, and the resulting voltage drop across the electrodes 11, 12 is representative of impedance. In this case, one of the electrodes 11, 12 amounts to “a reference electrode” or “a ground electrode”. Such a reference electrode or a ground electrode is merely used for providing a reference point for the voltage drop. The other electrode amounts to a “sensing electrode” for determining the potential between the two electrodes. Therefore, one of ordinary skill in the art would understand that the impedance is sensed by the sensing electrode, and the reference electrode is merely used for providing a reference point. Additionally, the claim language does not preclude such an interpretation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791