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
Receipt is acknowledged of a request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) and a submission, filed on 08/27/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Examiner acknowledges the amendments made to claims 11, 19 and 20, with no new claims added. Claims 11-21 are currently pending in the present application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 11-17, 19-21 is/are rejected under 35 U.S.C. 103 as being anticipated by Rajagopalan (US Patent No 20130345670) in view of Kusumoto (US Patent No 20190262074).
Regarding claim 11, Rajagopalan teaches a surgical method, comprising: delivering energy to a target tissue from each of a plurality of electrodes of a surgical device (surgical device configured to treat a target tissue by delivering energy via electrode contact with the tissue, [0029]), the plurality of electrodes being located in the first anatomic space of the patient; (see fig 4, for electrode element 322b configured to delivery rf energy to the target body tissue, [0210]), and a second atomic space of the patient (sensor may be configured to be positioned outside the tissue body and contact the tissue wall, [0034], which is a different anatomic space); receiving, controlling, power of each of the plurality of electrodes (controller 360 is configured to allow the user to perform one of the many functions including… the type and quantity of energy delivered vie the electrodes to the tissue and the output is measured and provides feedback via the one or more sensors, [0211]).
Rajagopalan does not explicitly teach monitoring a first tissue parameter with a first sensor located in a first anatomical space of a patient; monitoring a second tissue parameter with a second sensor located in a second anatomical space of the patient; and a first signal from the first sensor indicative of the first monitored tissue parameter, and a second signal from the second sensor indicative of the second monitored tissue parameter; while the energy is being delivered to the target tissue determining, a tissue parameter gradient based on the first signal and the second signal and controlling power of each of the plurality of electrodes based on the tissue parameter gradient.
However, the analogous temperature sensing ablation device of Kusumoto does teach monitoring a first tissue parameter with a first sensor located in a first anatomical space of a patient (from Kusumoto, temperature sensor 35 found in the probe 20 that is found within the anatomical space, [0076]); monitoring a second tissue parameter with a second sensor located in a second anatomical space of the patient (from Kusumoto, the non-invasive tissue temperature measurement is also important for recording the temperature of the adjacent soft tissue, [0075], thereby indicating a second temperature sensor and measurement is taken for the adjacent tissue outside of the anatomical space); and a first signal from the first sensor indicative of the first monitored tissue parameter (from Kusumoto, temperature sensor 35 for measuring the interior affected tissue temperature found in the probe 20 that is found within the anatomical space, [0076]), and a second signal from the second sensor indicative of the second monitored tissue parameter (from Kusumoto, the non-invasive tissue temperature measurement is also important for recording the temperature of the adjacent soft tissue, [0075], thereby indicating a second temperature sensor and measurement is taken for the adjacent tissue outside of the anatomical space); while the energy is being delivered to the target tissue (see from Kusumoto, in which during the ablation of the target tissue exact temporal temperature measurements must occur precisely during energy delivery in order to measure the efficacy of the ablative energy on the tissue, [0070]-[0071]) determining a tissue parameter gradient based on the first signal and the second signal (from Kusumoto, the temperature relationships or temperature gradient is capable of being measured between the noninvasive soft tissue and the interior invasive probe 20, [0075]) and controlling power of each of the plurality of electrodes based on the tissue parameter gradient (see from Kusumoto, in which there is an adjustment feedback loop which is capable of controlling the power delivered to the ablation tool in which is responsive from the sensed threshold temperature gradient of the affected tissue, [0026]).
Therefore, it would be obvious for one skilled in the art prior to the effective filing date to combine the power delivery and control method taught by Rajagopalan with the temperature sensing and control technique of Kusumoto in order to effectively ablate and deliver energy to the target tissue without harming the non-target tissue as taught by Kusumoto, [0070].
Regarding claim 12, the combination teaches the method of claim 11, wherein the target tissue is duodenal mucosal tissue of a duodenum of the patient (from Rajagopalan, wherein the treatment region if the patients duodenal mucosa, [0008]); the first anatomic space is within the duodenum (from Rajagopalan, sometimes the treatment is the entire length of the mucosal layer of the duodenum and therefore the treatment device is inserted within the duodenum, [0018]); the second anatomic space is outside the duodenum (from Rajagopalan, sensor which occupies the second anatomic space may be configured to be positioned outside the tissue body and contact the tissue wall of the duodenum, [0034]); and the tissue parameter gradient is a temperature gradient from a non-target tissue to the target tissue (from Kusumoto, the temperature relationships or temperature gradient is capable of being measured between the noninvasive soft tissue and the interior invasive probe 20, [0075]); and wherein controlling the power of each of the plurality of electrodes includes activating a subset of the plurality of electrodes to deliver the energy, (from Rajagopalan, controller 360 may activate the electrode array and energy delivery unit 330 to start energy delivery, [0216]), so as to prevent the non-target tissue from exceeding a predetermined threshold (from Rajagopalan, the controller may be configured to initiate and terminate energy delivery once the tissue has reached a desired temperature, [0216]).
Regarding claim 13, the combination teaches the method of claim 11, wherein the tissue parameter gradient indicates a temperature gradient from the first anatomical space to the second anatomical space (from Kusumoto, the temperature relationships or temperature gradient is capable of being measured between the noninvasive soft tissue and the interior invasive probe 20, [0075]).
Regarding claim 14, Rajagopalan teaches the method of claim 11, wherein the target tissue is a tissue wall, the plurality of electrodes is located on a first side of the tissue wall (the treatment elements containing the electrode array may come in contact with the inner wall of the body lumen, [0036]), and the second anatomic space is located on an opposite side of the tissue wall (sensor which occupies the second anatomic space may be configured to be positioned outside the tissue body and contact the tissue wall of the duodenum, [0034]).
Regarding claim 15, the combination teaches the method of claim 11, wherein the first anatomic space is within a hollow organ (from Rajagopalan, the treatment elements containing the electrode array found in the first anatomic space may come in contact with the inner wall of the body lumen, [0036], in being a lumen it is within a hollow organ), and the second anatomic space is outside the hollow organ (from Rajagopalan, sensor which occupies the second anatomic space may be configured to be positioned outside the tissue body and contact the tissue wall of the duodenum, [0034], which is a hollow organ) and wherein the tissue parameter gradient is a tissue temperature gradient that indicates a temperature for each tissue layer of the hollow organ (from Kusumoto, the temperature relationships or temperature gradient is capable of being measured between the noninvasive soft tissue and the interior invasive probe 20 found inside the hollow organ, [0075], see also fig 1).
Regarding claim 16, the combination teaches the method of claim 11, wherein the first anatomic space is within a lumen (from Rajagopalan, the treatment elements containing the electrode array found in the first anatomic space may come in contact with the inner wall of the body lumen, [0036]), and the second anatomic space is outside the lumen (from Rajagopalan, sensor which occupies the second anatomic space may be configured to be positioned outside the tissue body and contact the tissue wall of the duodenum, [0034], which is a hollow organ and therefore outside the lumen) and wherein the tissue parameter gradient indicates a temperature gradient extending from an outer tissue wall of a serosal layer of the lumen to an inner tissue wall of a mucosal layer inside the lumen (from Kusumoto, the temperature relationships or temperature gradient is capable of being measured between the noninvasive soft tissue and the interior invasive probe 20 found inside the hollow organ, [0075], see also fig 1).
Regarding claim 17, the combination teaches the method of claim 11, wherein the first tissue parameter is associated with the target tissue (from Kusumoto, temperature sensor 35 for measuring the interior affected tissue temperature found in the probe 20 that is found within the anatomical space, [0076]), and wherein the second tissue parameter is associated with a non-target tissue (from Kusumoto, the non-invasive tissue temperature measurement is also important for recording the temperature of the adjacent soft tissue, [0075], thereby indicating a second temperature sensor and measurement is taken for the adjacent tissue outside of the anatomical space).
Regarding claim 19, Rajagopalan teaches a surgical method, comprising: delivering energy to a target tissue from each of a plurality of electrodes of a surgical device (surgical device configured to treat a target tissue by delivering energy via electrode contact with the tissue, [0029]), the plurality of electrodes being located on a first side of a tissue wall (the treatment elements containing the electrode array may come in contact with the inner wall of the body lumen, [0036], see also fig 4, for electrode element 322b configured to delivery rf energy to the target body tissue, [0210]); and during the energy delivery, adjusting, a power level of each of plurality of electrodes (controller 360 may activate the electrode array and energy delivery unit 330 to start energy delivery, [0216] and the controller may be configured to initiate and terminate energy delivery once the tissue has reached a desired temperature, [0216]).
Rajagopalan does not explicitly teach monitoring a first tissue parameter with a first sensor located in a first anatomical space of a patient; monitoring a second tissue parameter with a second sensor located in a second anatomical space of the patient; and a first signal from the first sensor indicative of the first monitored tissue parameter, and a second signal from the second sensor indicative of the second monitored tissue parameter; while the energy is being delivered to the target tissue determining, a tissue parameter gradient based on the first signal and the second signal and controlling power of each of the plurality of electrodes based on the tissue parameter gradient.
However, the analogous temperature sensing ablation device of Kusumoto does teach monitoring a first tissue parameter with a first sensor located in a first anatomical space of a patient (from Kusumoto, temperature sensor 35 found in the probe 20 that is found within the anatomical space, [0076]); monitoring a second tissue parameter with a second sensor located in a second anatomical space of the patient (from Kusumoto, the non-invasive tissue temperature measurement is also important for recording the temperature of the adjacent soft tissue, [0075], thereby indicating a second temperature sensor and measurement is taken for the adjacent tissue outside of the anatomical space); and a first signal from the first sensor indicative of the first monitored tissue parameter (from Kusumoto, temperature sensor 35 for measuring the interior affected tissue temperature found in the probe 20 that is found within the anatomical space, [0076]), and a second signal from the second sensor indicative of the second monitored tissue parameter (from Kusumoto, the non-invasive tissue temperature measurement is also important for recording the temperature of the adjacent soft tissue, [0075], thereby indicating a second temperature sensor and measurement is taken for the adjacent tissue outside of the anatomical space); while the energy is being delivered to the target tissue (see from Kusumoto, in which during the ablation of the target tissue exact temporal temperature measurements must occur precisely during energy delivery in order to measure the efficacy of the ablative energy on the tissue, [0070]-[0071]) determining a tissue parameter gradient based on the first signal and the second signal (from Kusumoto, the temperature relationships or temperature gradient is capable of being measured between the noninvasive soft tissue and the interior invasive probe 20, [0075]) and controlling power of each of the plurality of electrodes based on the tissue parameter gradient (see from Kusumoto, in which there is an adjustment feedback loop which is capable of controlling the power delivered to the ablation tool in which is responsive from the sensed threshold temperature gradient of the affected tissue, [0026]).
Therefore, it would be obvious for one skilled in the art prior to the effective filing date to combine the power delivery and control method taught by Rajagopalan with the temperature sensing and control technique of Kusumoto in order to effectively ablate and deliver energy to the target tissue without harming the non-target tissue as taught by Kusumoto, [0070].
Regarding claim 20, the combination teaches the method of claim 19, wherein the tissue wall is associated with a body lumen, wherein the tissue parameter gradient extends from outside the body lumen to inside the body lumen (from Kusumoto, the temperature relationships or temperature gradient is capable of being measured between the noninvasive soft tissue and the interior invasive probe 20 found inside the hollow organ, [0075], see also fig 1), and wherein the tissue parameter gradient is a temperature gradient that indicates a temperature of a serosal layer of the body lumen and indicates a temperature of a mucosal layer of the body lumen. (from Rajagopalan, wherein the treatment region if the patient’s duodenal mucosa, [0008], which is a hollow organ and Kusumoto teaches, the temperature relationships or temperature gradient is capable of being measured between the noninvasive soft tissue and the interior invasive probe 20 found inside the hollow organ, [0075], see also fig 1)).
Regarding claim 21, Rajagopalan teaches the method of claim 20, wherein the sensing and the adjusting repeatedly occurs until at least one of the indicated temperature of the serosal layer or the indicated temperature of the mucosal layer reaches a predetermined threshold. (the controller may be configured to initiate, terminate and adjust energy delivery once the tissue has reached a desired temperature, which equates to the predetermined goal parameter, [0216]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan (US Patent No 20130345670) in view of Kusumoto (US Patent No 20190262074) further in view of Denlinger (US Patent No 20200289223).
Regarding claim 18, the combination of Rajagopalan and Kusumoto teach the method of claim 11.
The previous combination does not teach the surgical device is releasably coupled to and controlled by the robotic surgical system.
However, having end effectors and surgical devices attached and coupled to robotic surgical systems is well known in the art and would have been obvious for one skilled in the art to use a robotic surgical system with this surgical device. See for example, Denlinger, which discloses a robotic surgical system (robotic system 110, [0085]) includes the controller (control unit 250 which contains the controller 254 in the robotic system 110, [0093]), and the surgical device is releasably coupled to and controlled by the robotic surgical system (and each tool or surgical device 126 is attachable and detachable from the respective surgical manipulators, [0090]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to use the method of treatment from a surgical device taught by Rajagopalan and Kusumoto and use it in conjunction with a robotic surgical system taught by Denlinger as it is a way to automate the treatment method controls and deliver the treatment in a more precise manner, as disclosed by Denlinger, [0090].
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/27/2025, with respect to the rejection(s) of claim(s) 11-21 under Rajagopalan in view of Kusumoto have been fully considered and have been found to be partially persuasive.
Regarding the amended claims of 11 and 19, examiner agrees with applicant that the former prior art of record rejection which was sent out in the previous office action did not fully explain and teach how the disclosure of the prior art was applied to each limitation of the independent claims. Specifically, it was unclear whether the prior art of Rajagopalan or Kusumoto was applied to teach the limitation of “controlling with the controller, power of each of the plurality of electrodes based on the tissue parameter gradient.” Therefore, the rejection has been rewritten as seen in the present non-final office action to specifically apply the prior art of Kusumoto to teach the limitation of “controlling with the controller, power of each of the plurality of electrodes based on the tissue parameter gradient.” Specifically, the prior art of Kusumoto teaches in which there is an adjustment feedback loop which is capable of controlling the power delivered to the ablation tool which is responsive from the sensed threshold temperature gradient of the affected tissue, [0026], thereby teaching the claimed limitation. Therefore, as the prior art of record of Rajagopalan in view of Kusumoto teaches the previously unclear limitations of the independent claims 11 and 19, they remain rejected under the present prior art of record rejection set forth in this office action.
Furthermore, in regards to the argument that neither Rajagopalan nor Kusumoto teach the amended limitation of claims 11 and 19 that determines the temperature gradient while the energy is being delivered to the tissue, this argument has been considered but ultimately falls unpersuasive. As the amended limitation necessitated further consideration of the prior art of record, it has been found that the previous prior art of Kusumoto does disclose the amended limitation of determining the temperature gradient while the energy is being delivered to the tissue. Specifically, Kusumoto teaches that during the ablation of the target tissue exact temporal temperature measurements must occur precisely during energy delivery in order to measure the efficacy of the ablative energy on the tissue, [0070]-[0071]. Therefore, Kusumoto discloses the exact temporal relationship of obtaining the temperature readings while ablation energy is being delivered to the target tissue as claimed by the amended limitation. Therefore, the amended limitations of the independent claims 11 and 19 remain rejected under the prior art of record rejection of Rajagopalan in view of Kusumoto set forth in the present office action.
As no further arguments or remarks have been made regarding any of the dependent claims, they too remain rejected under the prior art of record rejection set forth in the present office action.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794