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
Claims 9, 37, 42, 43, 48, 49, and 52 are objected to because of the following informalities:
Claim 9, line 13: “an adverse” should be replaced with –the adverse–;
Claim 9, line 44: “a” should be deleted;
Claim 37, line 28: the semicolon should be replaced with a comma;
Claim 37, lines 29, 31, and 33: the paragraph breaks should be deleted;
Claim 42, line 6: “an” should be replaced with –the–;
Claim 43, line 2: “first” should be replaced with –monitoring–;
Claim 48, line 4: –at least one– should be inserted before “monitoring”;
Claim 48, line 5: “bodily” should be deleted;
Claim 49, line 7: “aforesaid:” should be replaced with –aforesaid; and/or”
Claim 52, line 4: “the first output signals and the second output signals” should be replaced with –the at least one first output signal and the at least one second output signal–.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 20, 34, 37, 43, 48, 49, 51, and 52 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 9, 37, and 52 recite “a recent time interval”, which is a relative term which renders the claim indefinite. The term “recent” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this case it is unclear when something is considered recent or old, so it is unclear what constitutes a recent time interval.
Claim 9 recites “wherein one or both of the at least one monitoring output signal and the at least one reference output signal comprises, respectively, reference impedance signals, monitoring impedance signals, electrophysiological reference signals, and electrophysiological monitoring signals” in lines 17-21. It is unclear how the different signals are related to each other because one of ordinary skill would not be able to understand how the term “respectively” should be applied to the different signals. For the purposes of examination, the recitation will be interpreted to be “wherein the at least one monitoring output signal comprises monitoring impedance signals and monitoring electrophysiological signals, and/or the at least one reference output signal comprises reference impedance signals and reference electrophysiological signals”.
Claim 9 recites “the electrophysiological reference signals recorded from the reference site by a same electrode of the at least one reference electrode” in lines 27-29 and “the electrophysiological monitoring signals recorded by the monitoring site and sensed by a same electrode of the at least one monitoring electrode” in lines 30-32. There are insufficient antecedent bases for these limitations in the claim. Although claim 9 recites “electrophysiological reference signals” in line 20 and “electrophysiological monitoring signals” in line 21”, there is no indication that they are recorded by a same electrode. The Examiner suggests amending the recitations in lines 27-29 and 30-32 to be, for example “the electrophysiological reference signals, wherein the electrophysiological reference signals are recorded from the reference site by a single electrode of the at least one reference electrode” and “the electrophysiological monitoring signals, wherein the electrophysiological monitoring signals are recorded by the monitoring site and sensed by a single electrode of the at least one monitoring electrode”.
Claim 9 recites “the single monitoring electrode” in line 53. There is insufficient antecedent basis for this limitation in the claim.
Claims 20, 34, 43, 48, and 51 are rejected by virtue of their dependence from claim 9.
Claim 37 recites “the at least one monitoring electrode” in lines 5-6, “the at least one reference electrode” in lines 7-8, “the adverse physiological phenomenon” in line 9 and “the tissue connection site” in line 10. There are insufficient antecedent bases for these limitations in the claim. For the purposes of examination, the recitations will be interpreted to be “an adverse physiological phenomenon” in line 9 and “a tissue connection site” in line 10.
Claim 49 recites “the anastomotic leakage” in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the recitation will be interpreted to be “
Claim 51 recites “the at least one impedance signal” in line 2 and “the at least one signal relating to…” in line 3. There are insufficient antecedent bases for these limitations in the claim. Additionally, it is unclear how these recitations and the frequencies thereof are related to the “reference impedance signals”, “monitoring impedance signals”, “electrophysiological reference signals”, “and “electrophysiological monitoring signals” in lines 19-21 of claim 9 and the frequencies of lines 53-56 of claim 9.
Claim 51 recites “the stomach function”, “the small bowel function”, and “the large bowel function” in lines 4-5. There are insufficient antecedent bases for these limitations in the claim. For the purposes of examination, the recitations will be interpreted as “
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, 39, 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 claim 1, Toth teaches a monitoring system for detecting or predicting onset of an adverse physiological phenomenon associated with 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 associated with the tissue connection 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), 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 processing circuitry operably coupled to the at least one monitoring electrode; and a memory storing instructions which, when executed by the processing circuitry, cause the processing circuitry to sense at least one first output signal produced by the at least one monitoring electrode and determine the onset of the adverse physiological phenomenon associated with the tissue connection site.
In an alternative embodiment for monitoring a surgical site, Toth teaches processing circuitry operably coupled to the at least one monitoring electrode; and a memory storing instructions which, when executed by the processing circuitry, cause the processing circuitry to sense at least one first output signal produced by the at least one monitoring electrode and determine the onset of the adverse physiological phenomenon associated with the tissue connection site (¶ [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 processing circuitry operably coupled to the at least one monitoring electrode; and a memory storing instructions which, when executed by the processing circuitry, cause the processing circuitry to sense at least one first output signal produced by the at least one monitoring electrode and determine the onset of the adverse physiological phenomenon associated with the tissue connection site 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 physiologically unaffected by the tissue connection site; sense at least one second output signal produced by the at least one reference electrode; and determine 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 electrode configured to be coupleable with a reference location for monitoring a reference site which is remote from the monitoring site and physiologically unaffected by the tissue connection site (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); sense at least one second output signal produced by the at least one reference electrode (¶ [0065] discloses a communication interface 125 for receiving baseline measurements); and determine the onset of the adverse physiological phenomenon by comparing at the least one first 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 configured to be coupleable with a reference location for monitoring a reference site which is remote from the monitoring site and physiologically unaffected by the tissue connection site; sense at least one second output signal produced by the at least one reference electrode; and determine the onset of the adverse physiological phenomenon by comparing at the least one first output signal against the 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 first output signal comprises first impedance signals obtained responsive to providing first stimulation signals, and first additional signals; wherein the at least one second output signal comprises second impedance signals obtained responsive to providing second stimulation signals, and second additional signals, wherein the first and second additional signals relate to one of the following: stomach function, small bowel function, large bowel function, or any combination of the aforesaid, wherein the first impedance signals and first additional signals are both sensed by a single monitoring electrode of the at least one monitoring electrode; wherein the second impedance signals and the second additional signals are both sensed by a single reference electrode of the at least one reference electrode; and wherein, for sensing the first impedance signals and the first additional signals by the single monitoring electrode, and for sensing the second impedance signals and the second additional signals by the single reference electrode, a frequency of the first impedance signals is different from a frequency of the first additional signals, and a frequency of the second impedance signals is different from a frequency of the second additional signals.
In a system relevant to the problem of monitoring gastric sites, Imran teaches at least one output signal comprises impedance signals obtained responsive to providing stimulation signals, and additional signals (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 (which provides a constant current source through electrodes 11, 12) and A/C converter 146f, and EMG is sensed using A/C converter 146e), the additional signals 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)); wherein the impedance signals and the additional signals are sensed by a single electrode (¶ [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. First, the Examiner notes that 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 indicates that the claimed “single monitoring electrode” and “single reference electrode” may comprise a multi-electrode or an arrangement of multiple electrodes which corresponds to the electrodes 11, 12 of Imran. Alternatively, 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 of the electrodes 11, 12 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 and EMG or EGG are sensed by the sensing electrode, and the reference electrode is merely used for providing a reference point), wherein, for sensing the impedance signals and the additional signals by the single electrode, a frequency of the impedance signals is different from a frequency of the additional signals (¶ [0152] discloses that the A/C convertor 146f has a bandwidth that includes the 50kHz signal representative of the impedance while filtering out the EMG signal that is sensed by the electrodes, which indicates that the EMG and impedance have different frequencies). 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 at least one monitoring electrode and the at least one second electrode of the above combination to incorporate, based on the teachings of Imran, the at least one first output signal comprises first impedance signals obtained responsive to providing first stimulation signals, and first additional signals; wherein the at least one second output signal comprises second impedance signals obtained responsive to providing second stimulation signals, and second additional signals, wherein the first and second additional signals relate to one of the following: stomach function, small bowel function, large bowel function, or any combination of the aforesaid, wherein the first impedance signals and first additional signals are both sensed by a single monitoring electrode of the at least one monitoring electrode; wherein the second impedance signals and the second additional signals are both sensed by a single reference electrode of the at least one reference electrode; and wherein, for sensing the first impedance signals and the first additional signals by the single monitoring electrode, and for sensing the second impedance signals and the second additional signals by the single reference electrode, a frequency of the first impedance signals is different from a frequency of the first additional signals, and a frequency of the second impedance signals is different from a frequency of the second additional signals. 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 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 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.
Claim 8 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 further in view of US 5,690,656 A (Cope) (previously cited).
With regards to claim 8, the above combination of Toth in view of Zand and Imran teaches the monitoring system of claim 1, wherein the at least one monitoring electrode has electrical characteristics that are responsive to changes in physiological characteristics of the monitoring site (¶ [0051] of Toth discloses the sensor including an electrode based or bioelectrode based impedance sensor for detection of electrophysiological properties, bioelectric activity, biopotential, bioimpedance, etc., wherein the electrodes necessarily have electrical characteristics that are responsive to changes in physiological characteristics).
The above combination is silent regarding whether the monitoring system further comprises a fluid drainage catheter that is operably positionable to drain fluids from an internal body site 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 monitoring site.
In a related embodiment, Toth teaches a drain that is operably positionable to drain fluids from an internal body site of to outside the body of the patient, wherein the electronic sensor is operably integrated with the fluid drain 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.
Claims 9, 20, 34, 37, 43, and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Toth in view of Zand, Imran, and US 2012/0316611 A1 (Armoundas).
With regards to claims 9 and 37, Toth teaches a patient site 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) 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), the system comprising: at least one monitoring electrode configured to be operably coupleable with a monitoring site associated with the tissue connection site, the at least one monitoring electrode having electrical characteristics that are responsive to changes in physiological characteristics of the monitoring 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), 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 electrophysiological monitoring 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 an analysis engine configured for determining the onset of an adverse physiological phenomenon.
In an alternative embodiment for monitoring a surgical site, Toth teaches an analysis engine configured to determine the onset of the adverse physiological phenomenon associated with the tissue connection site (¶ [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 an analysis engine configured for determining the onset of an 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; and determining the onset of the adverse physiological phenomenon by comparing at least one monitoring output signal against at least one reference output signal.
In the same field of endeavor of monitoring anastomotic failure, Zand teaches 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 (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); and determine the onset of the adverse physiological phenomenon by comparing at least one monitoring output signal against at least one reference 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), wherein one or both of the at least one monitoring output signal and the at least one reference output signal comprises, respectively, reference impedance signals, monitoring impedance signals, electrophysiological reference signals, and electrophysiological monitoring signals (¶ [0082] discloses sensing tissue electrical impedance and tissue electrical activity; also see claim 5). 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 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; and determine the onset of the adverse physiological phenomenon by comparing at least one monitoring output signal against at least one reference output signal, wherein one or both of the at least one monitoring output signal and the at least one reference output signal comprises, respectively, reference impedance signals, monitoring impedance signals, electrophysiological reference signals, and electrophysiological monitoring signals. 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 electrophysiological reference signals are recorded from the reference site by a same electrode of the at least one reference electrode and the electrophysiological monitoring signals are recorded at the monitoring site and sensed by a same electrode of the at least one monitoring electrode, the same electrode of the at least one monitoring electrode is configured to provide monitoring simulation output signals for responsively sensing the monitoring impedance signals, in addition to sensing the monitoring electrophysiological signals; and wherein the same electrode of the at least one reference electrode is configured to provide reference stimulation output signals for responsively sensing the reference impedance signals, in addition to sensing the reference electrophysiological signals; wherein for sensing the monitoring impedance signals and the monitoring electrophysiological signals by the single monitoring electrode, a frequency of the monitoring impedance signals is different from a frequency of the monitoring electrophysiological signals, and wherein a frequency of the reference impedance signals is different from a frequency of the reference electrophysiological signals.
In a system relevant to the problem of monitoring gastric sites, Imran teaches electrophysiological signals are recorded from the site by a same electrode of at least one electrode (Fig. 13 and ¶ [0152] depict circuitry for detecting multiple EMG signals using the same electrodes 11, 12. First, the Examiner notes that 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 indicates that the claimed “same electrode” or single electrode may comprise a multi-electrode or an arrangement of multiple electrodes which corresponds to the electrodes 11, 12 of Imran. Alternatively, 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 of the electrodes 11, 12 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 and EMG or EGG are sensed by the sensing electrode, and the reference electrode is merely used for providing a reference point), the same electrode of the at least one electrode is configured to provide simulation output signals for responsively sensing the monitoring impedance signals, in addition to sensing the monitoring electrophysiological signals (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 (which provides a constant current source through electrodes 11, 12) and A/C converter 146f, and EMG is sensed using A/C converter 146e), wherein, for sensing the impedance signals and the electrophysiological signals by the single electrode, a frequency of the impedance signals is different from a frequency of the electrophysiological signals (¶ [0152] discloses that the A/C convertor 146f has a bandwidth that includes the 50kHz signal representative of the impedance while filtering out the EMG signal that is sensed by the electrodes, which indicates that the EMG and impedance have different frequencies). 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 at least one monitoring electrode and the at least one second electrode of the above combination to incorporate, based on the teachings of Imran, the electrophysiological reference signals are recorded from the reference site by a same electrode of the at least one reference electrode and the electrophysiological monitoring signals are recorded at the monitoring site and sensed by a same electrode of the at least one monitoring electrode, the same electrode of the at least one monitoring electrode is configured to provide monitoring simulation output signals for responsively sensing the monitoring impedance signals, in addition to sensing the monitoring electrophysiological signals; and wherein the same electrode of the at least one reference electrode is configured to provide reference stimulation output signals for responsively sensing the reference impedance signals, in addition to sensing the reference electrophysiological signals; wherein for sensing the monitoring impedance signals and the monitoring electrophysiological signals by the single monitoring electrode, a frequency of the monitoring impedance signals is different from a frequency of the monitoring electrophysiological signals, and wherein a frequency of the reference impedance signals is different from a frequency of the reference electrophysiological signals. 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).
Although Toth teaches preemptive prediction of the onset of a leak in an upcoming time interval consecutive to a recent monitoring time interval (¶¶ [0011], [0021], [0147]) and providing an output relating to the onset (¶ [0066] discloses an alerting component adapted to raise an alarm conditional on the physiological data), the above combination is silent regarding whether the analysis engine is further configured to: determine, for a recent time interval, cross-correlation values between: a) the electrophysiological reference signals recorded from the reference site by a same electrode of the at least one reference electrode; and b) the electrophysiological monitoring signals recorded at the monitoring site and sensed by a same electrode of the at least one monitoring electrode; determine based on the cross-correlation values, a probability of impending onset of leak through the tissue connection site; and providing an output relating to the probability.
In a system relevant to the problem of detecting an adverse physiological phenomenon in relation to a baseline, Armoundas teaches determining, for a recent time interval, cross-correlation values between: a) reference signals; and b) monitoring signals (¶ [0048] discloses cross-correlating a “normal” median QRS template with current beat and repeating the cross-correlation twice); determine based on the cross-correlation values, a probability of an adverse phenomenon (¶ [0048] discloses determining a correlation coefficient, which is indicative of a probability of an abnormal beat); and providing an output relating to the probability (¶ [0049] discloses labeling the beat as abnormal). 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 determination of the adverse physiological phenomenon to incorporate, based on the teachings of Armoundas, the analysis engine is further configured to: determine, for a recent time interval, cross-correlation values between: a) the electrophysiological reference signals recorded from the reference site by a same electrode of the at least one reference electrode; and b) the electrophysiological monitoring signals recorded at the monitoring site and sensed by a same electrode of the at least one monitoring electrode; determine based on the cross-correlation values, a probability of impending onset of leak through the tissue connection site; and providing an output relating to the probability. The motivation would have been to improve the accuracy of the diagnosis of the prediction of the onset of the leak.
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 43, the above combination teaches or suggests the at least one monitoring output signal is indicative of a change of an electrical characteristic of the monitoring electrode, wherein the analysis engine is configured to detect and/or predict, based on the at least one first output signal, the onset of anastomotic leakage based on the change of the electrical characteristics 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 51, the above combination teaches or suggests a frequency of the at least one impedance signal is different from frequency of the at least one signal relating to at least one of the following: the stomach function, the small bowel function, the large bowel function, or any combination of the aforesaid (¶ [0152] of Imran discloses that the A/C convertor 146f has a bandwidth that includes the 50kHz signal representative of the impedance while filtering out the EMG signal that is sensed by the electrodes, which indicates that the EMG and impedance have different frequencies)
Claim 42 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 2011/0306845 A1 (Osorio)
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 monitoring site.
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.
The above combination is silent regarding whether the system is configured to provide, based on the temporal-spatial monitoring, a propagation velocity of the onset of an adverse physiological phenomenon.
In a system relevant to the problem of detecting a progression of a patient state, Osorio teaches providing, based on the temporal-spatial monitoring, a propagation velocity of the onset of an adverse physiological phenomenon (¶ [0043] discloses comparisons based on a function of time or state space to determine disease progression (deterioration in the index expressed as one of a numerical difference in relation to past values, a rate of change of the index as a function of time from the previous measurements, or a qualitative change (e.g., minimal and slow or marked and rapid); disease stabilization (no change in the index); disease regression (improvement in the index)). 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 providing, based on the temporal-spatial monitoring, a propagation velocity of the onset of an adverse physiological phenomenon as taught by Osorio. The motivation would have been to provide a more complete diagnostic analysis of the patient.
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 further 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, 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.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Toth in view of Zand, Imran, and Armoundas, as applied to claim 9 above, and further in view of Cope.
With regards to claim 48, the above combination teaches the monitoring system of claim 9, wherein the at least one monitoring electrode has electrical characteristics that are responsive to changes in physiological characteristics of the monitoring site (¶ [0051] of Toth discloses the sensor including an electrode based or bioelectrode based impedance sensor for detection of electrophysiological properties, bioelectric activity, biopotential, bioimpedance, etc., which necessarily have electrical characteristics that are responsive to changes in physiological characteristics).
The above combination is silent regarding whether the monitoring system further comprises a fluid drainage catheter that is operably positionable to drain fluids from an internal body site 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 monitoring site.
In a related embodiment, Toth teaches a drain that is operably positionable to drain fluids from an internal body site of to outside the body of the patient, wherein the electronic sensor is operably integrated with the fluid drain 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 52 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 further in view of Armoundas
With regards to claim 52, Toth teaches preemptive prediction of the onset of a leak in an upcoming time interval consecutive to a recent monitoring time interval (¶¶ [0011], [0021], [0147]) and providing an output relating to the onset (¶ [0066] discloses an alerting component adapted to raise an alarm conditional on the physiological data). However, the above combination is silent regarding whether the system is further configured to determine, for a recent time interval, cross-correlation values between: the first output signals and the second output signals; determine based on the cross-correlation values, a probability of impending onset of leak through the tissue connection site; and providing an output relating to the probability.
In a system relevant to the problem of detecting an adverse physiological phenomenon in relation to a baseline, Armoundas teaches determining, for a recent time interval, cross-correlation values between: a) reference signals; and b) monitoring signals (¶ [0048] discloses cross-correlating a “normal” median QRS template with current beat and repeating the cross-correlation twice); determine based on the cross-correlation values, a probability of an adverse phenomenon (¶ [0048] discloses determining a correlation coefficient, which is indicative of a probability of an abnormal beat); and providing an output relating to the probability (¶ [0049] discloses labeling the beat as abnormal). 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 determination of the adverse physiological phenomenon to incorporate, based on the teachings of Armoundas, the system is further configured to: determine, for a recent time interval, cross-correlation values between: the first output signals and the second output signals; determine based on the cross-correlation values, a probability of impending onset of leak through the tissue connection site; and providing an output relating to the probability. The motivation would have been to improve the accuracy of the diagnosis of the prediction of the onset of the leak.
Response to Arguments
Rejections under 35 U.S.C. §103
There are new grounds of rejections necessitated by the claim amendments filed 05/26/2026. To the extent that the Applicant’s arguments are applicable to the current rejections, the Examiner makes the following comments.
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive.
The Applicant asserts that Imran does not teach or suggest “the first impedance signals and first additional signals are both sensed by a single monitoring electrode” and “the second impedance signals and the second additional signals are both sensed by a single reference electrode” of claim 1 and similar limitations of claim 9 because “the single monitoring electrode forms the sole tissue-engaging conductive element for sensing first impedance and first additional signals, without requiring a second tissue-engaging element at all”. Page 20 of the Remarks filed 05/26/2026. Applicant further asserts that Imran requires a closed current path through two spatially distinct tissue-engaging elements to establish a measurable voltage drop across tissue. Page 20 of Id. These 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., the single monitoring electrode forming the sole tissue-engaging conductive element for sensing first impedance and first additional signals, without requiring a second tissue-engaging element at all) 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 there is no indication within the specification that prevents the use of a reference or ground electrode that engages the tissue.
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 single monitoring electrode” or “a single reference 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 sensing impedance signals and additional signals by a single electrode. The impedance circuit of Imran 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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