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 .
Response to Amendment
The amendment filed 07/16/2026 has been entered. Claims 1-2, 4, 6-8, 10, 17, 19, 21, 31, 33, 35-36 remain pending in the application. Claims 14-15, 22, 27-29 have been cancelled. Applicants’ amendments to the claims have overcome the 112(b) and 112(d) rejections previously set forth in the Non-final Office Action mailed 4/17/2026.
Response to Arguments
Applicant's arguments filed 17/16/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) 1:
Applicant’s arguments, page 13 liens 13-23 and page 15 lines 1-22, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s argument, page 15 lines 11-23 page 16 lines 1-8, that Seung-June does not disclose an integrated neuroelectrophysiological monitoring device has been considered; however, this is not seen as persuasive. Integrated is seen as taking separate entities and connecting them in one system which is disclosed by Seung-June.
Applicant’s arguments with respect to claims 4, 6, 7-8, 10, 17-18, 21-22, 28-29, 31, 33, 35 and 36:
Applicant’s argument, page 16 lines 22-23 and page 17 lines 1-5, regarding feature B have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Further are rejected in view of Chancellor as disclosed below.
Applicant’s argument, page 17 6-9, that Hvid does not disclose the communication tube of feature A merely because it inflates the ballon has been considered, however is not persuasive. Feature A of claim 1 does not exclude the communication tube from inflating a ballon.
Applicant’s argument, page 17 lines 17-22 and page 18 lines 1-2, that Hvid does not disclose pressure sensing of physiological signals has been considered, however is not persuasive. Hvid disclosed sensing pressure of the bowels [((29)]), which is seen as pressure of a physiological signal.
Applicant’s argument, page 16-18, regarding feature C has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Further is rejected in view of Imran 196 as disclosed below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The amended claim 1 introduces the limitation of “non-penetratingly contact” of the electrode. The cited support as stated by applicant in page 12 lines 16-21 and page 13 lines 1-6 of the remarks filed 07/16/2026 located in paragraph [0053] of the specification is not sufficient in describing “non-penetratingly contact”. Paragraph {0053] of the specification states that invasive monitoring can cause trauma however there is no mention of the claimed invention electrodes specifically prohibiting and not penetrating.
Claim 2 depends on claim 1 and there for inherits claim 1’s 35 U.S.C. 112(b) rejection.
Claims 4, 6 and 7 depend on claim 2 and there for inherits claim 2’s 35 U.S.C. 112(b) rejection.
Claim 8 depends on claim 7 and there for inherits claim 7’s 35 U.S.C. 112(b) rejection.
Claim 10 depends on claim 8 and there for inherits claim 8’s 35 U.S.C. 112(b) rejection.
Claim Rejections - 35 USC § 103
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seung-June (previously cited) in view of Imran (previously cited) further in view of Hvid (previously cited) further in view of Chancellor et al. (US 20140249595 A1) herein referred to as “Chancellor” further in view of Imran et al. (CN 107847196 A) herein referred to as “Imran 196”.
Regarding claim 1, Seung-June discloses: An integrated neuroelectrophysiological monitoring apparatus, comprising: a urethra testing device, comprising ([Abstract]; Seung-June discloses components that are connected to obtain and receive data in a system used to tract urinary urodynamic parameters which is seen as being part of an integrated system, [Figure 1C]; Seung-June discloses a device inserted into the urethra): a first communication tube ([Figure 1C]; Seung-June discloses a communication tube as disclosed below) being adapted to deliver a medium and having an open end configured to be set in a patient's bladder ([Figure 1C]; the communication tube is attached to a container described fluid to fill bladder) and an opposite end extending outside the patient's body ([Figure 1C]; The opposite end is outside of the patient’s body), a first pressure transducing device ([Figure 1C]; Pressure transducer (140)) in fluid communication with the first communication tube ([0062]; Seung-June discloses the pressure transducer connected to the communication tube, which is seen as in communication with the communication tube) and configured to measure an intravesical pressure of the patient ([0062]; Seung-June discloses the bladder pressure being measured by pressure transducer (140)). a first myoelectricity measuring member ([Figure 1B]; EMG electrode (120a), which is seen as a myoelectricity measuring member) and a second myoelectricity measuring member ([0044]; Seung-June discloses a electrode 120b) and a monitoring module ([Figure 1B]; Computer (132)), the monitoring module being electrically connected to the bladder pressure measuring member, the first myoelectricity measuring member, the rectal pressure measuring member, and the second myoelectricity measuring member, respectively ([Figure 1B]; Seung-June discloses computer (132) attached to urethral catheter (124), which contains the pressure measurement member, electrode (120a) which is seen as the first myoelectricity measuring member, rectal catheter (122), which is seen as the rectal pressure measuring member, and electrode (120b), which is seen as the second myoelectricity measuring member.)
Seung-June does not explicitly disclose: and the first myoelectricity measuring member comprising a plurality of first electromyography electrodes disposed on an outer periphery of the first communication tube and configured to non-penetratingly contact an external urethra sphincter to measure an external urethra sphincter electromyographic activity; a rectum testing device, comprising: a second communication tube being adapted to deliver the medium and having one end configured to be set in the patient's rectum and an opposite end extending outside the patient's body, an intrarectal expandable balloon disposed at said one end of the second communication tube and in fluid communication therewith, with an outer peripheral wall of the intrarectal expandable balloon abutting against an inside lining of the patient's rectum a second pressure transducing device, a second pressure transducing device in fluid communication with the second communication tube and configured to measure an intrarectal pressure of the patient, and the second myoelectricity measuring member comprising a plurality of second electromyography electrodes disposed on an outer periphery of the second communication tube and configured to non-penetratingly contact an external anal sphincter to measure an external anal sphincter electromyographic activity; wherein the integrated neuroelectrophysiological monitoring apparatus simultaneously monitors the intravesical pressure, the intrarectal pressure, the external urethra sphincter electromyographic activity, and the external anal sphincter electromyographic activity.
However, Imran disclose: and the first myoelectricity measuring member comprising a plurality of first electromyography electrodes ([Figure 2]; Electrodes 228 and 230) disposed on an outer periphery of the first communication tube ([Figure 2]; Imran discloses electrodes (228) and (230) on the periphery of communication tube (202)) and configured to non-penetratingly contact an external urethra sphincter to measure an external urethra sphincter electromyographic activity; ([0035]; Electrodes (228) and (230) are disclosed as being in contact with the urethra sphincter and do not penetrate)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June with the electrodes as discloses by Imran. The motivation being to provide stimulation to the pudendal nerve ([0015]).
However, Hvid discloses: a rectum testing device, comprising: a second communication tube ([Figure 1C]; Hvid discloses communication tube (115)) being adapted to deliver the medium ([(61)]; “The inflation channel 115 is in fluid communication with a container holding the liquid used for inflating the balloon 111” which is seen as being adapted to deliver medium) and having one end configured to be set in the patient's rectum ([Figure 1C]; Hvid discloses one end of tube (115) within the patients rectum (3)) and an opposite end extending outside the patient's body ([Figure 1C]; Hvid discloses an opposite end outside of the patients rectum (3)), an intrarectal expandable balloon disposed at said one end of the second communication tube and in fluid communication therewith ([61)]; “The inflation channel 115 is in fluid communication with a container holding the liquid used for inflating the balloon 111” which is seen as balloon (111) being in communication with a communication tube (115)), with an outer peripheral wall of the intrarectal expandable balloon abutting against an inside lining of the patient's rectum [Figure 1C]; Hvid discloses balloon (111) against rectum walls (4)) a second pressure transducing device ([Figure 4]; Pressure sensor (414)), a second pressure transducing device in fluid communication with the second communication tube and configured to measure an intrarectal pressure of the patient ([(68)]; Hvid discloses pressure sensor (414) in fluid connection with the ballon (411) and therefore must read pressure from tube (402)),
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June with the fluid medium tubbing and pressure sensor as disclosed by Hvid. The motivation being to inflate the rectal balloon ([(62)]) and monitor pressure within the balloon ([(68)]) respectively.
However, Chancellor discloses: and the second myoelectricity measuring member comprising a plurality of second electromyography electrodes disposed on an outer periphery of the second communication tube ([Figure 1]; electrodes 14 and 15 located at the end of 20, which is seen as the second communication tube) and configured to non-penetratingly contact an external anal sphincter to measure an external anal sphincter electromyographic activity; ([0070]; Electrodes 14 and 15 disclosed external sphincter activity)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June with the multiple electrodes at the end of the communication tube as disclosed by Chancellor. The motivation being to stimulate or inhibit the anal sphincter ([0070]).
However, Imran 196 discloses: wherein the integrated neuroelectrophysiological monitoring apparatus simultaneously monitors the intravesical pressure, the intrarectal pressure, the external urethra sphincter electromyographic activity, and the external anal sphincter electromyographic activity.([Invention Content pp 1 – pp 7]; External and internal pressures of urethra and rectum and further electrode recording information, which is seen as electromyographic activity, recorded at the disclosed locations simultaneously)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the integrated neuroelectrophysiological monitoring apparatus as disclosed by Seung-June with the simultaneous monitoring as disclosed by Imran 196. The motivation being to determine the effectiveness of the treatment ([Invention Content pp8]).
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Regarding claim 2, Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 disclose: The integrated neuroelectrophysiological monitoring apparatus according to claim 1. Seung-June further discloses: wherein the first pressure transducing device has a first testing end ([Figure 1C]; Pressure transducer (140) has a testing end which is attached to the tubing) and a first signal output end ([Figure 1C]; Pressure transducer (140) has a output end which leads to the computer (132)), the first testing end communicating with the first communication tube ([0062]; Seung-June discloses the pressure transducer connected to the communication tube, which is seen as in communication with the communication tube) and being adapted to measure a pressure of the medium in the first communication tube ([0062]; Seung-June discloses the bladder pressure being measured by pressure transducer (140)), the first signal output end being in communicative connection to the monitoring module ([Figure 1C]; The signal output end of pressure transducer (140) attached to computer (132)), the first pressure transducing device being adapted to convert the pressure of the medium in the first communication tube to an intravesical pressure signal ([0046]; Seung-June discloses measuring intravesical pressure while attaches to catheter (122), which is seen as communication tube) and to transmit the intravesical pressure signal to the monitoring module via the first signal output end. ([0046]; Seung-June discloses inputting the measured pressure to computer 132, which is seen as converting and transmitting the pressure measurement to a output signal, received by a monitoring module)
Regarding claim 4, Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 disclose: The integrated neuroelectrophysiological monitoring apparatus according to claim 2, Seung-June does not explicitly discloses: wherein the plurality of first electromyography electrodes are arranged at intervals in an extending direction of the first communication tube or in a circumferential direction of the first communication tube.
However, Imran discloses: wherein the plurality of first electromyography electrodes being arranged at intervals in an extending direction of the first communication tube ([Figure 2]; Electrodes (228) and (230) are arranged at intervals from each other extending in the direction of the communication tube (202)) or in a circumferential direction of the first communication tube.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the electrodes as further disclosed by Imran. The motivation being to provide stimulation to the pudendal nerve ([0015]).
Regarding claim 6, Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 disclose: The neuroelectrophysiological monitoring apparatus according to claim 2. Seung-June does not explicitly disclose: further comprising: a first communication tube anchoring device, the first communication tube anchoring device being disposed at one end of the first communication tube, the first communication tube anchoring device being selectively deformed to be tensioned in the patient's bladder, an expandable cavity being formed inside the first communication tube anchoring device, the expandable cavity communicating with a syringe connection tube so that the medium is injected into the expandable cavity to control deformation of the communication tube anchoring device.
However, Imran discloses: further comprising: a first communication tube anchoring device ([Figure 2]; Ballon (220)), the first communication tube anchoring device being disposed at one end of the first communication tube ([Figure 2]; Ballon (220) is located at the end of tube (202), the first communication tube anchoring device being selectively deformed to be tensioned in the patient's bladder ([0016]; Imran discloses the balloon being pulled against the bladder neck which is seen as tensioning), an expandable cavity being formed inside the first communication tube anchoring device ([Figure 2]; Imran discloses a deflated anchoring device (220), [Figure 3]; Imran discloses anchoring device (220) expanded and therefore, having an expandable cavity), the expandable cavity communicating with a syringe connection tube so that the medium is injected into the expandable cavity to control deformation of the communication tube anchoring device ([0035]; “The balloon 220 will be inflated by a conventional inflation source 222 of the type normally used with Foley catheters”, [Figure 2]; Imran discloses (222) as an inlet tube that provides medium to the balloon).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the anchoring device as further disclosed by Imran. The motivation being to stabilize the catheter ([0035]).
Regarding claim 7, Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 disclose: The integrated neuroelectrophysiological monitoring apparatus according to claim 2. Hvid further discloses: wherein the second pressure transducing device ([Figure 4]; Pressure sensor (414)) having has a second testing end ([Figure 4]; Hvid discloses a testing end attached to the tube) and a second signal output end ([Figure 4]; Hvid discloses a signal output end (404’)), the second testing end communicating with the second communication tube ([Figure 4, which is an illustration of a bowel irrigation system that includes the catheter as disclosed in Figure 1C.]; Hvid discloses pressure sensor in communication with 402, [(68)]; Hvid discloses “The tubing 402 can comprise a first and a second lumen, such that a separate fluid communication can be established between the container 401 and the balloon 411 through the first lumen”) and being adapted to measure a pressure of the medium in the second communication tube ([(68)]; Hvid discloses pressure sensor (414) in fluid connection with the ballon (411) and therefore must read pressure from tube (402)), the second signal output end being in communicative connection to the monitoring module ([Figure 4]; output end (404’) in communication with control unit (404), which is seen a monitoring module), the second pressure transducing device being adapted to convert the pressure of the medium to an intrarectal pressure signal and transmit the intrarectal pressure signal to the monitoring module via the second signal output end. ([(68)]; Hvid discloses pressure sensor (414) in connection with control unit (404) and relaying pressure information via coupling (404’))
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the fluid medium tubbing and pressure sensor as further disclosed by Hvid. The motivation being to inflate the rectal balloon ([(62)]) and monitor pressure within the balloon ([(68)]) respectively.
Regarding claim 8, Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 disclose: The integrated neuroelectrophysiological monitoring apparatus according to claim 7. Hvid further discloses: wherein the opposite end of the second communication tube is adaptable to be connected to the medium injecting device ([(68)]; Hvid discloses lumens in tube (402) which is connected to catheter (410), which contains channel (115), which is seen as the second communication tube. Further Hvid discloses lumens in fluid communication with fluid pump (403), which is seen as a medium injecting device), the medium injecting device selectively injecting the medium into the second communication tube ([(68)]; “Thereby, liquid held in the container 401 can be pumped selectably into the balloon 410, and through eyelets provided in the proximal end 413 of the catheter 410”). wherein the integrated neuroelectrophysiological monitoring apparatus further comprising: a three- way tube ([Figure 4]; Hvid discloses a three-way tube as shown by the black square below), the three-way tube having a first interface, a second interface, and a third interface which selectively communicate with each other ([Figure 4]; Hvid discloses three interfaces as disclosed below with arrows , ([(68)]; Hvid discloses the interfaces in fluid communication with each other which is seen as selectively communicating with each other), the first interface being connected to the opposite end of the second communication tube ([Figure 4]; Hvid discloses a firest interface in communication with tube (402)), the second interface being connected to the second testing end of the second pressure transducing device ([Figure 4]; Hvid discloses a second interface in communication with testing end of pressure sensor (414)), the third interface being connected to the medium iniecting device. ([Figure 4]; Hvid discloses the third interface in communication with container (403), [(68)]; “a pump 403 (not shown, but is preferably incorporated in the container, e.g. in the bottom)” wherein the pump (403) is seen as medium injecting device)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the three way tube as further disclosed by Hvid. The motivation being to have pressure sensor, pump and communication tube in fluid communication ([(68)].
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Regarding claim 10 Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 disclose: The integrated neuroelectrophysiological monitoring apparatus according to claim 8. Imran further discloses: the plurality of second electromyography electrodes are arranged at intervals in an extending direction of the first communication tube ([Figure 2]; Electrodes (228) and (230) are arranged at intervals from each other extending in the direction of the communication tube (202)) or in a circumferential direction of the first communication tube.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the electrodes as further disclosed by Imran the motivation being to provide stimulation to the pudendal nerve ([0015]).
Regarding claim 17, Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 disclose: The integrated neuroelectrophysiological monitoring apparatus according to claim 1. Seung-June discloses: the first myoelectromyography electrode. ([Figure 1B]; EMG electrode (120a)) and first communication tube ([Figure 1C]; Seung-June discloses a communication tube as disclosed above). Seung-June does not explicitly disclose: wherein the plurality of first electromyography electrodes are arranged at intervals in an extending direction of the communication tube.
However, Imran further discloses: wherein the plurality of first electromyography electrodes are arranged at intervals in an extending direction of the communication tube ([Figure 2]; Electrodes (228) and (230) are arranged at intervals from each other extending in the direction of the communication tube (202))
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the electrodes as further disclosed by Imran. The motivation being to provide stimulation to the pudendal nerve ([0015]).
Regarding claim 19, Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 disclose: The integrated neuroelectrophysiological monitoring apparatus according to claim 17. Seung-June discloses: The first electromyography electrode ([Figure 1B]; EMG electrode (120a)) and first communication tube ([Figure 1C]; Seung-June discloses a communication tube as disclosed above). Seung-June does not explicitly disclose: wherein each of the plurality of first electromyography electrodes is configured to have a strip shape an extending direction of the plurality of first electromyography electrodes being consistent with an extending direction of the first communication tube the plurality of first electromyography electrodes being arranged at intervals at the outer periphery of the first communication tube
However, Imran discloses: wherein each of the plurality of first electromyography electrodes is configured to have a strip shape ([Figure 2]; Imran discloses electrodes (228) and (230) having a stripped shape), an extending direction of the plurality first electromyography electrodes being consistent with an extending direction of the first communication tube ([Figure 2]; Electrodes (228) and (230) are extending in the direction of rube (202)), the plurality of first electromyography electrodes being arranged at intervals at the outer periphery of the first communication tube ([Figure 2]; Imran discloses electrodes (228) and (230) arranged in interval at the outer periphery of tube (202).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the electrodes as further disclosed by Imran. The motivation being to provide stimulation to the pudendal nerve ([0015]).
Regarding claim 21, Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 disclose: The integrated neuroelectrophysiological monitoring apparatus according to claim 1. Seung-June discloses: The first electromyography electrode ([Figure 1B]; EMG electrode (120a)) and first communication tube ([Figure 1C]; Seung-June discloses a communication tube as disclosed above). Seung-June does not explicitly disclose: further comprising: an first electromyography electrode connecting harness, the first electromyography electrode connecting harness being at least partially set in the first communication tube one end of the first electromyography electrode connecting harness being connected to the plurality of first electromyography electrodes opposite end of the first electromyography electrode connecting harness being connected to the monitoring module.
Imran further discloses: further comprising: an first electromyography electrode connecting harness ([0035]; Imran discloses electrodes (228) and (230) being connected to wires (238), which is seen as an electromyography electrode connecting harness), the first electromyography electrode connecting harness being at least partially set in the first communication tube ([0035]; Imran discloses wires (238) passing through the catheter body, which is seen as being at least partially set in a communication tube), one end of the first electromyography electrode connecting harness being connected to the plurality of first electromyography electrodes ([0035]), opposite end of the first electromyography electrode connecting harness being connected to the monitoring module. ([0035]; Imran discloses wires (238) connecting to controller (216), which is seen as a monitoring module)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the electrode harness as further disclosed by Imran the motivation being to connect the electrodes to a control module ([0035]).
Regarding claim 31, Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 disclose: The integrated neuroelectrophysiological monitoring apparatus according to claim 1. Seung-June further discloses: The second myoelectricity electrode ([0044]; Seung-June discloses an electrode 120b). Seung-June does not explicitly disclose: wherein the plurality of second electromyographic electrodes being arranged at intervals at the outer periphery of the second communication tube.
However, Hvid discloses: The second communication tube ([Figure 1C]; Hvid discloses communication tube (115)).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the fluid medium tubbing as further disclosed by Hvid. The motivation being to inflate the rectal balloon ([(62)]).
However, Imran discloses: wherein the plurality of second electromyographic electrodes being arranged at intervals at the outer periphery of the second communication tube. ([Figure 2]; Electrodes (228) and (230) are arranged at intervals from each other extending in the direction of the communication tube (202))
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the electrodes as further disclosed by Imran the motivation being to provide stimulation to the pudendal nerve ([0015])
Regarding claim 33, Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 disclose: The integrated neuroelectrophysiological monitoring apparatus according to claim 1. Seung-June further discloses: The second myoelectricity electrode ([0044]; Seung-June discloses an electrode 120b). Seung-June does not explicitly disclose: wherein each of the plurality of second electromyographic electrodes is configured to have a strip shape, an extending direction of the plurality of second electromyographic electrodes being consistent with an extending direction of the second communication tube, the plurality of electromyographic electrodes being arranged at intervals at the outer periphery of the second communication tube.
However, Hvid discloses: The second communication tube ([Figure 1C]; Hvid discloses communication tube (115)).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the fluid medium tubbing as further disclosed by Hvid. The motivation being to inflate the rectal balloon ([(62)]).
However, Iman discloses: wherein each of the plurality of second electromyography electrodes is configured to have a strip shape ([Figure 2]; Imran discloses electrodes (228) and (230) having a stripped shape), an extending direction of the plurality of second electromyography electrodes being consistent with an extending direction of the second communication tube ([Figure 2]; Electrodes (228) and (230) are extending in the direction of rube (202)), the plurality of second electromyography electrodes being arranged at intervals at the outer periphery of the second communication tube([Figure 2]; Imran discloses electrodes (228) and (230) arranged in interval at the outer periphery of tube (202)).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the electrodes as further disclosed by Imran the motivation being to provide stimulation to the pudendal nerve ([0015]).
Regarding claim 35, Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 disclose: The integrated neuroelectrophysiological monitoring apparatus according to claim 1. Seung-June further discloses: The second myoelectricity electrode ([0044]; Seung-June discloses an electrode 120b). Seung-June does not explicitly disclose: further comprising: an second electromyography electrode connecting harness, the second electromyography electrode connecting harness being at least partially set in the second communication tube, one end of the second electromyography electrode connecting harness, being connected to the plurality of second electromyography electrodes, opposite end of the second electromyography electrode connecting harness being connected to the monitoring module.
However, Hvid discloses: The second communication tube ([Figure 1C]; Hvid discloses communication tube (115)).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the fluid medium tubbing as further disclosed by Hvid. The motivation being to inflate the rectal balloon ([(62)]).
However, Imran discloses: further comprising: an second electromyography electrode connecting harness ([0035]; Imran discloses electrodes (228) and (230) being connected to wires (238), which is seen as an electromyography electrode connecting harness), the second electromyography electrode connecting harness being at least partially set in the second communication tube ([0035]; Imran discloses wires (238) passing through the catheter body, which is seen as being at least partially set in a communication tube), one end of the second electromyography electrode connecting harness being connected to the plurality of second electromyography electrodes ([0035]), opposite end of the second electromyography electrode connecting harness being connected to the monitoring module. ([0035]; Imran discloses wires (238) connecting to controller (216), which is seen as a monitoting module)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the electrode harness as further disclosed by Imran the motivation being to connect the electrodes to a control module ([0035]).
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seung-June in view of Hvid further in view of Pinchuk et al. (US 20140012235 A1) herein referred to as “Pinchuk”.
Regarding claim 36, Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 disclose: The integrated neuroelectrophysiological monitoring apparatus according to claim 1. Seung-June does not explicitly disclose: wherein a plurality of scale markers arranged at intervals in the extending direction of the communication tube are provided on an outer peripheral wall of the communication tube.
However, Hvid discloses: The second communication tube ([Figure 1C]; Hvid discloses communication tube (115)).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the fluid medium tubbing as further disclosed by Hvid. The motivation being to inflate the rectal balloon ([(62)]).
However, Pinchuk discloses: wherein a plurality of scale markers ([0155]; Markers (1030) and (1032) arranged at intervals in the extending direction of the second communication tube are provided on an outer peripheral wall of the second communication tube. ([Figure 9]; Pinchunk discloses markers (1030) and (1032) arranged at intervals and provided on an outer peripheral wall of catheter shaft (1020))
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran further in view of Hvid further in view of Chancellor further in view of Imran 196 with the scale markers as disclosed by Pinchunk the motivation being to indicate average length of female and male urethras ([0155]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CASEY GEORGE CHA/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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