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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/24/2026 has been entered.
Claim Objections
Claim 26 is objected to because of the following informalities:
Claim 26, line 3: “detecting” should be replaced with –detect–.
Appropriate correction is required.
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 11-15, 23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0100387 A1 (Gerber)(cited by applicant) in view of US 2016/0242667 A1 (Fay) (previously cited), US 2017/0120048 A1 (He) (previously cited), and US 2018/0344244 A1 (Botzer).
With regards to claims 11, Gerber teaches an intraoperative neuromonitoring apparatus for localization of nerves in the pelvic region of a patient and/or for checking the nerves for integrity and/or functionality during an operation (¶ [0028] and FIG. 1 depicts a system 10 that senses parameters of a bladder 14 of a patient 12 based on a detected impedance through the bladder; ¶ [0032] depicts delivering an electrical stimulation to sacral or pudendal nerves; ¶ [0077] discloses controlling stimulation based on detected impedance; The system 10 is capable of being used for localization of nerves and/or checking a nerve for integrity and/or functionality during an operation because the impedance provides feedback based on successful nerve stimulation), the apparatus comprising:
at least one nerve stimulator insertable into the surgical area during the operation, the nerve stimulator comprising a stimulation appliable to the at least one pelvic region and adapted to introduce a stimulating current into a nerve to be monitored (¶¶ [0037], [0039] and Fig. 1 depict the IMD 18 connected to one or more electrical stimulation leads 20, wherein the leads 20 are at a pelvic nerve or muscle site, such as a sacral or pudendal nerve site, wherein the leads 20 provide stimulation pulses with a range of electrical parameter values),
a sensor device connectable to at least one pelvic organ of the patient, wherein the sensor device has at least two measurement electrodes, which are appliable to the at least one pelvic organ, and an impedance measurement device, which is connected or connectable to the at least two measurement electrodes (Fig. 1 and ¶ [0029] depict first electrode 26A and second electrode 26B appliable to the bladder 14; ¶ [0030] depicts the IMD 18 detecting an impedance through bladder 14 based on a signal between the electrodes 26; Figs. 1, 9 and ¶¶ [0077], [0082] depict the impedance measurement circuit 76 connected to leads 16 and electrodes 26),
a display indicating impedance changes at the at least one pelvic organ between the at least two measurement electrodes (Figs. 1, 10 and ¶ [0091] depict a user interface 85 of an external programmer 22 for presenting information relating to detected impedance, bladder parameters such as volume, or bladder filling and emptying),
wherein the apparatus is configured to measure the impedance changes versus time, as a physiological response (Fig. 12 and ¶¶ [0108]-[0112] depict detecting impedance 92 after an initiation/adjustment of stimulation 96, wherein the impedance measurement is necessarily time correlated with and in response to the stimulation; ¶ [0032] discloses stimulation of the sacral or pudendal nerve results in an increase in pelvic floor muscle tone or the contraction of the urinary sphincter, which keeps urine inside bladder 14)
Gerber is silent with regards to whether identifying the impedance comprises using a test current supply device with at least two test current electrodes which are appliable to the pelvic organ.
In the same field of endeavor of monitoring impedance, Fay teaches a test current supply device with at least two test current electrodes which are appliable to the pelvic organ (¶¶ [0115]-[0116] disclose a four-terminal sensing configuration among any mapping electrodes 24 comprising a pair of “current-carrying” electrodes and a pair of “sensing” electrodes”; ¶ [0112] discloses sensing an impedance using the processing system 32, indicating that the current-carrying electrodes are driven by a test current supplying device). 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 apparatus for performing the impedance measurement of Gerber to incorporate, based on the teachings of Fay, to incorporate two test current electrodes driven by a test current supply device. Because both the two-terminal configuration of Gerber and the four-terminal configuration of Fay are capable of being used for sensing impedance, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
The above combination is silent regarding whether the apparatus is configured to cause presentation at the display of the physiological response waveform including at least a post-stimulation impedance deflection, wherein the post-stimulation impedance deflection is temporally synchronized with an energization of the stimulation electrode
In the same field of endeavor of monitoring impedance, He teaches an apparatus configured to cause presentation at the display of the physiological response waveform including at least a post-stimulation impedance deflection, wherein the post-stimulation impedance deflection is temporally synchronized with an energization of the stimulation electrode (¶ [0054] depicts electrode pair 1-2 may be paced first and the resulting activity at the other electrode pairs may be measured and stored, wherein the graphical representation of electrical activity may be similar to Fig. 3A; ¶ [0045] and Fig. 3A depict the electrode array sensing mechanical contractions of the bladder through the use 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 apparatus of Gerber in view of Fay to incorporate that it is configured to cause presentation at the display of the physiological response waveform including at least a post-stimulation impedance deflection, wherein the post-stimulation impedance deflection is temporally synchronized with an energization of the stimulation electrode, as taught by He. The motivation would have been to provide a graphical representation of the physiological response to the user, thereby providing a more complete diagnostic picture of the patient.
The above combination is silent regarding whether the physiological response waveform includes a pre-stimulation impedance characteristic representing the pelvic organ in a resting, unstimulated state which is presented in visual reference to a post-stimulation impedance deflection, whereby a deviation of the post-stimulation impedance deflection from the pre-stimulation impedance characteristic is visually indicative of nerve conduction status.
In a system relevant to the problem of monitoring organ stimulation using impedance, Botzer teaches a physiological response waveform includes a pre-stimulation impedance characteristic representing an organ in a resting, unstimulated state which is presented in visual reference to a post-stimulation impedance deflection (¶ [0055] and the top graph of Fig. 2 depict an impedance signal including a first portion 42a prior to application of current-pulses (which is representative of normal respiration) presented in visual reference to a portion 44 obtained during the application of current-pulses), whereby a deviation of the post-stimulation impedance deflection from the pre-stimulation impedance characteristic is visually indicative of nerve conduction status (¶ [0059] depicts the current-pulses 38 being used for identifying stimulation of phrenic nerve; the top graph of Fig. 2 depicts a deviation of the portion 44 being indicative of the nerve conduction of the phrenic nerve). 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 physiological response waveform of the above combination to incorporate a pre-stimulation impedance characteristic representing an organ in a resting, unstimulated state which is presented in visual reference to a post-stimulation impedance deflection, whereby a deviation of the post-stimulation impedance deflection from the pre-stimulation impedance characteristic is visually indicative of nerve conduction status, as taught by Botzer. The motivation would have been to identify when the nerve is being stimulated using the baseline measurements, thereby providing a more complete diagnostic picture of the patient.
With regards to claim 12, the above combination teaches or suggests wherein the sensor device comprises the test current supply device with at least two test current electrodes which are appliable to the at least one pelvic organ (see the above combination of Gerber in view of Fay; The Examiner notes that the test current drive of Fay would necessarily be a part of the IMD of Gerber).
With regards to claim 13, the above combination teaches or suggests one of the at least two test current electrodes and one of the at least two measurement electrodes are each combined in an electrode unit (¶ [0115] of Fay depict a four-terminal sensing configuration which amounts to an electrode unit)
With regards to claim 14, the above combination teaches or suggests the test current supply device provides an alternating test current applied to the at least two test current electrodes with a fixed or adjustable test current frequency (¶ [0082] of Gerber teaches the impedance measurement circuitry 76 may include a voltage or current source, and may include an oscillator or the like for producing an alternating signal, wherein the frequency is necessarily one of fixed or adjustable).
With regards to claim 15, the above combination teaches or suggests the test current supply device provides an alternating test current applied to the at least two test current electrodes with a fixed or adjustable test current frequency (¶ [0082] of Gerber teaches the impedance measurement circuitry 76 may include a voltage or current source, and may include an oscillator or the like for producing an alternating signal, wherein the frequency is necessarily one of fixed or adjustable).
With regards to claim 23, the above combination is silent regarding whether the electrode unit is designed in the form of an electrode catheter or a rectal probe.
In the same field of endeavor of monitoring impedance, Fay teaches an electrode catheter comprising an electrode unit for measuring impedance (Fig. 1 and ¶¶ [0074]-[0075] depict a mapping catheter or probe 14 comprising a three-dimensional multiple electrode structure 20). 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 unit of the above combination to incorporate that it is designed in the form of an electrode catheter or a rectal probe as taught by Fay. Because both the electrodes of Gerber and the electrode catheter of Fay are formed to interact with an organ to sense impedance, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 25, the above combination teaches or suggests each of the at least two measurement electrodes and the two test electrodes are configured to be applied to the bladder and rectum of the patient (Fig. 1 and of Gerber depicts the electrodes being capable of implanted and applied to the bladder. The examiner asserts that the electrodes are also capable of being applied to a rectum).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gerber in view of Fay, He, and Botzer, as applied to claim 14 above, and in view of US 2015/0196220 A1 (Rutkove)(cited by Applicant).
With regards to claim 16, the above combination is silent with regards to whether the test current supply device comprises a plurality of test current electrode pairs, each with two test current electrodes, and means for generating test alternating currents with different test current frequencies at the different test current electrode pairs.
In a system related to the problem of monitoring impedance across tissue, Rutkove teaches a plurality of test current electrode pairs, each with two test current electrodes (¶¶ [0047]-[0048] and Fig. 5 depict a plurality of current-injecting electrodes 502 and measuring impedances using different pairs of current-injecting electrodes), and means for generating test alternating currents with different test current frequencies at the different test current electrode pairs (¶ [0036] discloses performing multi-frequency electrical impedance myography, using a plurality of frequencies; ¶ [0047] discloses a signal generation circuit that is couplable to the different pairs of current-injecting electrodes). 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, based on the teachings of Rutkove, that the test current supply device comprises a plurality of, in particular two, test current electrode pairs, each with two test current electrodes, and means for generating test alternating currents with different test current frequencies at the different test current electrode pairs. The motivation would have been to provide more information useful in assessment or diagnosis of the tissue region (¶ [0045] of Rutkove) in order to provide a more complete diagnostic analysis.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Gerber in view of Fay, He, and Botzer, as applied to claim 12 above, and in view of Rutkove.
With regards to claim 17, the above combination is silent with regards to whether the test current supply device comprises a plurality of test current electrode pairs, each with two test current electrodes, and means for generating test alternating currents with different test current frequencies at the different test current electrode pairs.
In a system related to the problem of monitoring impedance across tissue, Rutkove teaches a plurality of test current electrode pairs, each with two test current electrodes (¶¶ [0047]-[0048] and Fig. 5 depict a plurality of current-injecting electrodes 502 and measuring impedances using different pairs of current-injecting electrodes), and means for generating test alternating currents with different test current frequencies at the different test current electrode pairs (¶ [0036] discloses performing multi-frequency electrical impedance myography, using a plurality of frequencies; ¶ [0047] discloses a signal generation circuit that is couplable to the different pairs of current-injecting electrodes). 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, based on the teachings of Rutkove that the test current supply device comprises a plurality of, in particular two, test current electrode pairs, each with two test current electrodes, and means for generating test alternating currents with different test current frequencies at the different test current electrode pairs. The motivation would have been to provide more information useful in assessment or diagnosis of the tissue region (¶ [0045] of Rutkove) in order to provide a more complete diagnostic analysis.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber in view of Fay, He, and Botzer, as applied to claim 11 above, and in view of US 2015/0160185 A1 (Just) (previously cited).
With regards to claim 18, the above combination is silent with regards to whether the sensor device has a measurement signal amplifier configured for processing a measurement signal tappable at the at least two measurement electrodes.
In a system related to the problem of measuring bioimpedance, Just teaches a measurement signal amplifier configured for processing a measurement signal tappable at the at least two measurement electrodes (¶ [0038] discloses analyzing signals tapped from electrodes using a two-phase lock-in amplifier). 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 impedance analysis system of the above combination to incorporate a two-phase lock-in amplifier as taught by Just. The motivation would have been to provide an output meaningful to an end user from the measured potential and current from the control circuit (¶ [0038] of Just) and/or to provide an improved impedance measurement.
With regards to claim 19, the above combination is silent with regards to whether the sensor device has a lock-in amplifier configured for processing a measurement signal tappable at the at least two measurement electrodes.
In a system related to the problem of measuring bioimpedance, Just teaches a dual-phase lock-in amplifier processing the measurement signal tappable at the measurement electrodes (¶ [0038] discloses analyzing signals tapped from electrodes using a two-phase lock-in amplifier). 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 impedance analysis system of the above combination to incorporate a two-phase lock-in amplifier as taught by Just. The motivation would have been to provide an output meaningful to an end user from the measured potential and current from the control circuit (¶ [0038] of Just) and/or to provide an improved impedance measurement.
With regards to claim 20, the above combination teaches or suggests the lock-in amplifier is a dual-phase lock-in amplifier (¶ [0038] of Just).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber in view of Fay, He, and Botzer, as applied to claim 11 above, and in view of US 2015/0289929 A1 (Toth ‘929) (Previously cited)
With regards to claim 21, the above combination is silent regarding whether the impedance measurement device comprises an impedance spectroscope.
In the same field of endeavor of monitoring tissue and nerve monitoring (¶ [0003] of Toth), Toth teaches an impedance measurement device comprising an impedance spectroscope (¶ [0130] discloses performing electrochemical impedance spectroscopy using one or more probes). 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 impedance measurement device of the above combination to incorporate an impedance spectroscope as taught by Toth. The motivation would have been to provide a more complete diagnostic analysis of the patient by using additional impedance measurement modalities.
With regards to claim 22, the above combination teaches or suggests one test current electrode of the at least two test current electrodes and one measurement electrode of the at least two measurement electrodes are each combined in an electrode unit (¶ [0115] of Fay depict a four-terminal sensing configuration which amounts to an electrode unit).
The above combination is silent regarding whether the at least one electrode unit is in the form of an electrode catheter and/or a rectal probe.
In the same field of endeavor of monitoring impedance, Fay teaches an electrode catheter comprising an electrode unit for measuring impedance (Fig. 1 and ¶¶ [0074]-[0075] depict a mapping catheter or probe 14 comprising a three-dimensional multiple electrode structure 20). 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 unit of the above combination to incorporate that it is designed in the form of an electrode catheter or a rectal probe as taught by Fay. Because both the electrodes of Gerber and the electrode catheter of Fay are formed to interact with an organ to sense impedance, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Gerber in view of Fay, He, and Botzer, as applied to claim 11 above, and in view of US 2008/0058872 A1 (Brockway) (previously cited)
With regards to claim 24, the above combination is silent regarding whether the
stimulation electrode of the at least one nerve stimulator is a bipolar stimulation electrode.
In a system relevant to the problem of stimulating a nerve, Brockway teaches the stimulation electrode of at least one nerve stimulator is a bipolar stimulation electrode (¶ [0016] discloses a bipolar or unipolar electrode at a distal end of a lead 110 for stimulating nervous tissue). 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 stimulation electrode of the above combination with the bipolar stimulation electrode of Brockway. Because both elements are capable of stimulating nervous tissue (¶ [0016] of Brockway; ¶ [0032] of Gerber), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Gerber in view of Fay, He, and Botzer, as applied to claim 11 above, and in view of US 2016/0166310 A1 (Stewart)
With regards to claim 26, the above combination is silent regarding whether the apparatus is further configured to, based on the deviation of the post-stimulation impedance deflection from the pre-stimulation impedance characteristic, detecting a location of a second nerve.
In the same field of endeavor of monitoring pelvic nerve function, Stewart teaches, based on the deviation of the post-stimulation response deflection from the pre-stimulation response characteristic, detecting a location of a second nerve (¶ [0039] discloses evaluating a proximity to nerves (i.e., at least two nerves) or muscles that may be stimulated by energy delivery, as determined by monitoring responses to stimuli delivered from the delivery electrodes). 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, based on the teachings of Stewart, detecting a location of a second nerve based on the deviation of the post-stimulation impedance deflection from the pre-stimulation impedance characteristic. The motivation would have been to provide a more complete diagnostic analysis of the nerves of the patient.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Gerber in view of He and Botzer
With regards to claim 27, Gerber teaches an intraoperative neuromonitoring apparatus for evaluating nerves in the pelvic region of a patient (¶ [0028] and FIG. 1 depicts a system 10 that senses parameters of a bladder 14 of a patient 12 based on a detected impedance through the bladder; ¶ [0032] depicts delivering an electrical stimulation to sacral or pudendal nerves; ¶ [0077] discloses controlling stimulation based on detected impedance; The Examiner asserts that the system 10 is capable of being used for evaluating nerve conduction because the impedance is capable of provide feedback based on successful nerve stimulation), the apparatus comprising:
a nerve stimulator configured to deliver a stimulation pulse into a pelvic nerve (¶¶ [0037], [0039] and Fig. 1 depict the IMD 18 connected to one or more electrical stimulation leads 20, wherein the leads 20 are at a pelvic nerve or muscle site, such as a sacral or pudendal nerve site, wherein the leads 20 provide stimulation pulses with a range of electrical parameter values),
an impedance measurement device configured to measure impedance changes in a pelvic organ (Fig. 1 and ¶ [0029] depict first electrode 26A and second electrode 26B appliable to the bladder 14; ¶ [0030] depicts the IMD 18 detecting an impedance through bladder 14 based on a signal between the electrodes 26; Figs. 1, 9 and ¶¶ [0077], [0082] depict the impedance measurement circuit 76 connected to leads 16 and electrodes 26),
a display; (Figs. 1, 10 and ¶ [0091] depict a user interface 85 of an external programmer 22 for presenting information relating to detected impedance, bladder parameters such as volume, or bladder filling and emptying),
wherein the apparatus is configured to measure the impedance changes versus time (Fig. 12 and ¶¶ [0108]-[0112] depict repeatedly detecting impedance 92)
Gerber is silent regarding whether the apparatus is configured to capture a post-stimulation response representing a muscle contraction temporally synchronized with the stimulation pulse; and present on the display a visual indicator of the post-stimulation response.
In the same field of endeavor of monitoring impedance, He teaches an apparatus configured to capture a post-stimulation response representing a muscle contraction temporally synchronized with the stimulation pulse; and present on the display a visual indicator of the post-stimulation response in real time (¶ [0054] depicts electrode pair 1-2 may be paced first and the resulting activity at the other electrode pairs may be measured and stored, wherein the graphical representation of electrical activity may be similar to Fig. 3A; ¶ [0045] and Fig. 3A depict the electrode array sensing mechanical contractions of the bladder through the use of impedance; ¶ [0036] discloses displaying the graphical representation of electrical signals (e.g., Figs. 3A-3B) on a display screen). 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 apparatus of Gerber to incorporate that it is configured to capture a post-stimulation response representing a muscle contraction temporally synchronized with the stimulation pulse; and present on the display a visual indicator of the post-stimulation response in real-time, as taught by He. The motivation would have been to provide a graphical representation of the physiological response to the user, thereby providing a more complete diagnostic picture of the patient.
The above combination is silent regarding whether the apparatus is configured to capture a pre-stimulation baseline representing the pelvic organ in a resting state; and present on the display a comparative visual indicator derived from a deviation of the post-stimulation response from the pre-stimulation baseline, whereby the comparative visual indicator provides a real-time signal of nerve integrity.
In a system relevant to the problem of monitoring organ stimulation using impedance, Botzer teaches capturing a pre-stimulation baseline representing the organ in a resting state; and presenting a comparative visual indicator derived from a deviation of the post-stimulation response from the pre-stimulation baseline, (¶ [0055] and the top graph of Fig. 2 depict a captured impedance signal including a first portion 42a prior to application of current-pulses (which is representative of normal respiration) presented in visual reference to a portion 44 obtained during the application of current-pulses), whereby the comparative visual indicator provides a signal of nerve integrity (¶ [0059] depicts the current-pulses 38 being used for identifying stimulation of phrenic nerve; the top graph of Fig. 2 depicts a deviation of the portion 44 being indicative of the integrity of the phrenic nerve). 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 capturing a pre-stimulation baseline representing the organ in a resting state; and presenting a comparative visual indicator derived from a deviation of the post-stimulation response from the pre-stimulation baseline, whereby the comparative visual indicator provides a signal of nerve integrity, as taught by Botzer. The motivation would have been to identify when the nerve is being stimulated using the baseline measurements, thereby providing a more complete diagnostic picture of the patient. The Examiner notes that the combination of the real-time displaying of the visual indicator of He and the comparative visual indicator of Botzer teaches or suggests the comparative visual indicator being a real-time signal of nerve integrity.
Response to Arguments
Rejection under 35 U.S.C. §103
There are new grounds of rejections necessitated by the claim amendments filed 10/07/2025.
Applicant’s arguments and amendments with respect to the rejections under 35 U.S.C. §103 have been considered and are persuasive. However, upon further consideration, a new ground(s) of rejection is made in view of US 2018/0344244 A1 (Botzer). Specifically, the previously applied prior combination does not disclose capturing a pre-stimulation baseline representing the pelvic organ in a resting state; and present on the display a comparative visual indicator derived from a deviation of the post-stimulation response from the pre-stimulation baseline but Botzer discloses this feature in ¶ [0055] and the top graph of Fig. 2. Therefore, the previously applied 103 rejection has been modified to incorporate the teachings of Botzer.
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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/S.C.K./Examiner, Art Unit 3791 /JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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