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 Arguments
Applicant’s arguments, see pgs. 9-12 in Remarks, filed 08/17/2026, with respect to the rejections of claim(s) 1, 7, 12, 13, 15, 16, 22, 23, and 25 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejections of independent claims 1 and 22, considering their respective amendments, have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made (see detailed rejections below in Response to Amendment).
Applicant's arguments with respect to the rejections under 35 USC 103 of claims 1, 11, and 19-21 over Martin et al. (US 20080009853 A1, “Martin”) in view of Yates et al. (US 10265120 B2, “Yates”), see pgs. 13-15 of Remarks filed 08/17/2026, have been fully considered but they are not persuasive. On pg. 14, asserts that “[t]he electrodes 634 and 624 of Martin, having irregular, step-shaped surfaces, cannot be said to be spaced apart from each other. Such that ‘the spacing between the stimulation portion and the return portion is adjusted consistently along a length of each of the stimulation and return portion.’” The Examiner respectfully disagrees. The Examiner contends that the shape of Martin’s electrodes does not inhibit consistent adjustment between the stimulation and return portion along a length. There is nothing in Martin that would suggest that the shape of the stimulation and return portions has an effect on the adjustment mechanism. Although the shape of the electrode may be step-shaped, this does not change the fact that the distance along the length of the electrode can be adjusted along the length of the electrodes using the vertical force of springs 645. Therefore, the examiner maintains that claim 1 is made obvious over Martin in view of Yates (see detailed rejection below in Response to Amendment).
Claim Rejections - 35 USC § 112(a)
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.
Claims 1, 5-9, 11-13, 15, 16, 19-21 and 27 are 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.
Claims 1 and 27 recite, “wherein the stimulation portion and the return portion of the at least one probe extends from the distal end of the handle parallel to one another, with the spacing between the stimulation portion and the return portion is adjusted consistently along a length of each of the stimulation portion and the return portion…”. Specifically, the limitation “with the spacing between the stimulation portion and the return portion is adjusted consistently along a length of each of the stimulation portion and the return portion” is not supported adequately by the instant specification. The instant specification discloses that the distance between the stimulation and return portion is adjustable (best described in para. [0045] of the instant specification); However, it is not disclosed that the adjustment is consistent along the length of the stimulation and return portion. One of ordinary skill would not know what mechanisms are in place to cause the adjustments between portions to be consistent along the length. Therefore, there is inadequate support by the instant specification to convey that the inventors had possession of the claimed invention at the time the application was filed.
Claims 5-9, 11-13, 15, 16, and 19-21 are rejected for their dependency on claim 1.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 5-9, 11-13, 15, 16, 19-21 and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 27, the claim recites, “wherein the stimulation portion and the return portion of the at least one probe extends from the distal end of the handle parallel to one another, with the spacing between the stimulation portion and the return portion is adjusted consistently along a length of each of the stimulation portion and the return portion…”. The claimed limitation, “with the spacing between the stimulation portion and the return portion is adjusted consistently along a length” limits a method of adjusting the stimulation and return portions and does not limit a structure of the device. MPEP 2173.05(p) states: “A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011).” The claim is therefore indefinite for reciting a product and process in the same claim.
Claims 5-9, 11-13, 15, 16, and 19-21 are rejected for their dependency on claim 1.
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.
Claims 1, 12, 13, 15, 16, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Chu (US 20080027508 A1) in view of McFarlin et al. (US 10039915 B2, “McFarlin”).
Regarding claim 1, Chu teaches an electrical stimulation device (Fig. 1-6; Abstract: “A bipolar stimulator probe”) comprising: a handle (para. [0018], handle 2; Fig. 1-4) including: a proximal end (Fig. 1-4; the end away from 5 and 7); a distal end (Fig. 1-4; the end towards 5 and 7); one or more actuators (para. [0019]: "The switch is preferably touch-sensitive, activated by a pressure on the patient contact surface of the stimulating electrode or activated by a push-button on the handle, on its side or end, for on/off control triggered by the clinician."; push button 23 of para. [0030]; The control wheel or button of para. [0020]); and at least one probe attached to and extending from the distal end of the handle (bipolar stimulation probe 1), the at least one probe including a stimulation portion (stimulating electrode 5) and a return portion (return electrode 7), wherein the spacing between the stimulation portion (Fig. 1; electrode 5 and prong 9; para. [0018]: “As illustrated, electrode 5 may be the stimulating electrode…”) and the return portion (Fig. 1; electrode 7 and prong 11; para. [0018]: “As illustrated, electrode 5 may be the stimulating electrode, and electrode 7 may be the reference electrode. “), wherein a spacing between the stimulation portion and the return portion is adjustable using an actuator (control of para. [0020]: “The handle should be of a girth comfortable for gripping for long periods of time. The control for changing the inter-electrode distance can be suitably placed on the handle for thumb manipulation. The control may be a wheel or button that can also lock-in the chosen inter-electrode distance.”), of the one or more actuators (control wheel or button of para. [0020]), wherein the stimulation portion (electrode 5 and prong 9) and the return portion (electrode 7 and prong 11) of the at least one probe extends from the distal end of the handle parallel to one another (Fig. 5 shows electrode 5 and prong 9 parallel to electrode 7 and prong 11), with the spacing between the stimulation portion and the return portion is adjusted consistently along a length of each of the stimulation portion and the return portion (Fig. 5; para. [0030]: “A slidable movement of the electrodes along the cross-arm 20, to adjust the electrode spacing, is diagrammatically depicted by arrows B.sub.1 and B.sub.2 in FIG. 5.”; the stimulation portion, including 5 and 9, would maintain parallel orientation to the return portion, 7 and 11, after sliding across cross-arm 20), wherein a parallel orientation of the stimulation portion and return portion is maintainable at both a maximum spacing (when the 5 and 9 are spaced furthest from 7 and 11) and a minimum spacing between the stimulation portion and the return portion (when the 5 and 9 are spaced closest from 7 and 11 on crossarm 20). However, Chu does not teach a display on the handle.
McFarlin, in the same field of endeavor of bipolar stimulation tools, discloses a surgical tool and probe for nervous tissue stimulation. McFarlin discloses a display on the handle of the device (Fig. 9; LEDs 370; para. (75): "The LEDs 370 may indicate: whether the modular stimulation module 352 is ON; the modular stimulation module 352 is supplying current to the tool 351; status or activity of the wireless stimulation module 352; and/or whether the tips 362 of the tool 351 are in contact with tissue." The LEDs display information about the device).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chu to include a display on the handle, as McFarlin demonstrates. One of ordinary skill in the art would have recognized the benefit of including an LED on the handle of the device to indicate stimulation parameters, such as current, frequency, and power parameters. One would recognize that the LED display would improve the device of Chu by allowing it to display stimulation parameters in the same fashion. Therefore, it would have been an obvious improvement to the device of Chu to include a display on the handle.
Regarding claim 12, Chu, in combination with McFarlin, discloses the electrical stimulation device of claim 1 (see above). However, Chu does not explicitly disclose wherein the device is capable of providing both: monophasic stimulation in which the stimulation portion acts only as a stimulation probe and the return portion acts only as a return probe; and biphasic stimulation in which the stimulation portion and the return portion each act as a stimulation probe and a return probe in an alternating manner.
McFarlin further discloses wherein the device (Abstract; “surgical tool including first connecting elements, contacting elements, and conductive elements”) is capable of providing both: monophasic stimulation (para. [0080]; “The first pulse and the second pulse output at 314, 328 are monophasic.) in which the stimulation portion acts only stimulation probe and the return portion acts only as a return probe (in a monophasic stimulation configuration, there can only be distinct stimulation portions and return portions since the current is not alternating; Therefore, although McFarlin doesn’t specify each probe as stimulation or return, that is the case for monophasic stimulation); and biphasic stimulation (para. [0097]; “Another contemporary solution to solving the traditional electrode orientation problem includes generating biphasic stimulation waveforms”) in which the stimulation portion and return portion each act as stimulation and return probes in an alternating manner (in a biphasic stimulation configuration, the electrodes or probes must alternate roles as a stimulation probe and return probe since the current is alternating; Therefore, although McFarlin doesn’t specify the probes are alternating roles, that is the case for biphasic stimulation).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Chu to include both monophasic and biphasic capabilities, as disclosed by McFarlin. One of ordinary skill would recognize the improvements in configuring the stimulation to be both monophasic or biphasic since the user could tailor stimulation to optimize therapeutic benefits and optimal power consumption. McFarlin discloses tradeoffs and benefits to monophasic and biphasic stimulation (para. (85)). It would have been obvious to include both monophasic and biphasic capabilities in the device of Chu to improve the versatility in treatment and improve efficiency of the stimulation delivery in the device of Chu.
Regarding claim 13, Chu, in combination with McFarlin, discloses the electrical stimulation device of claim 1 (see above). However, Chu does not disclose wherein the device is configured to provide one or more of tactile feedback, auditory feedback, or visual feedback to a user.
McFarlin further discloses wherein the device is configured to provide one or more of tactile feedback, auditory feedback, or visual feedback to a user (para. (32): "The stimulation probe 46 may also include visual and/or audible alerts (e.g., via the light 50) to indicate when the electrodes are contacting and/or supplying current to tissue.").
It would have been obvious for one of ordinary skill in the art to improve the device of Chu by including the feedback mechanisms as disclosed by McFarlin. One of ordinary skill in the art would have recognized the benefit of including feedback to a user on the status of the device, such as parameters, as demonstrated by McFarlin. One would recognize that the visual feedback (LED display) would improve the device of Chu by allowing it to display stimulation parameters in the same fashion. Therefore, it would have been an obvious improvement to the device of Chu to include a feedback mechanism based on the teachings of McFarlin.
Regarding claim 15, Chu, in combination with McFarlin, discloses the electrical stimulation device of claim 1 (see above). Chu further discloses wherein the one or more actuators include a button that, when depressed, causes generation of one or more stimulation pulses. (para. [0019]: “[0019] A trigger button may be mounted on probe tool 1, to permit a clinician to conveniently activate the probe for stimulation applications. The switch is preferably touch-sensitive, activated by a pressure on the patient contact surface of the stimulating electrode or activated by a push-button on the handle, on its side or end, for on/off control triggered by the clinician. The probe may also be activated via a separate hand button that can be triggered by the patient or another person.”).
Regarding claim 16, Chu, in combination with McFarlin, discloses the electrical stimulation device of claim 1 (see above). However, Chu does not disclose a set of control buttons configured to increase or decrease a value by a predetermined amount, the value being one or more of: a pulse width; a current amplitude or a frequency of the electricity supplied to the stimulation portion.
McFarlin further discloses wherein the one or more actuators includes a set of control buttons (Fig. 9; current adjustment buttons 369) configured to increase or decrease a value by a predetermined amount, the value being one or more of: a pulse width; a current amplitude (Fig. 9; Current adjustment button 369; para. (75): "The current adjustment buttons 369 may be used to increase or decrease the current of the pulses supplied to the tool 351."); or a frequency of the electricity supplied to the stimulation portion (para. (26): "sed on the signals/parameters received from the stimulation probe 14. The WIA 16 and/or the NIM device 18 may control the number of pulses, pulse durations, direction of pulses (applied via cathodal electrode or anodal electrode), amplitudes of pulses, and/or frequency of pulses generated by the stimulation probe 14.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Chu to include the actuation mechanism for controlling stimulation parameters, as disclosed by McFarlin. One of the ordinary skill in the art would recognize that including a control button to adjust stimulation parameters would have been an obvious improvement in that the button would allow the user to easily modify stimulation parameters. This would give the device of Chu capabilities for adjusting stimulation more easily throughout the course of a procedure rather than having to stop therapy during the course of parameter changes. It would have been an obvious improvement to the device of Chu to include the control buttons of McFarlin.
Regarding claim 27, Chu teaches an electrical stimulation device (Fig. 1-6; Abstract: “A bipolar stimulator probe”) comprising: a handle (para. [0018], handle 2; Fig. 1-4) including: a proximal end (Fig. 1-4; the end away from 5 and 7); a distal end (Fig. 1-4; the end towards 5 and 7); one or more actuators (para. [0019]: "The switch is preferably touch-sensitive, activated by a pressure on the patient contact surface of the stimulating electrode or activated by a push-button on the handle, on its side or end, for on/off control triggered by the clinician."; push button 23 of para. [0030]; The control wheel or button of para. [0020])); and at least one probe attached to and extending from the distal end of the handle (bipolar stimulation probe 1), the at least one probe including a stimulation portion (stimulating electrode 5) and a return portion (return electrode 7), wherein the spacing between the stimulation portion (Fig. 1; electrode 5 and prong 9; para. [0018]: “As illustrated, electrode 5 may be the stimulating electrode…”) and the return portion (Fig. 1; electrode 7 and prong 11; para. [0018]: “As illustrated, electrode 5 may be the stimulating electrode, and electrode 7 may be the reference electrode. “), wherein a spacing between the stimulation portion and the return portion is adjustable using an actuator (control of para. [0020]: “The handle should be of a girth comfortable for gripping for long periods of time. The control for changing the inter-electrode distance can be suitably placed on the handle for thumb manipulation. The control may be a wheel or button that can also lock-in the chosen inter-electrode distance.”), of the one or more actuators (control wheel or button of para. [0020]), the actuator being selected from the group consisting of: a slider, a wheel, a knob, a lever, a switch, a trigger, and a touch-screen (para. [0020]: “The handle should be of a girth comfortable for gripping for long periods of time. The control for changing the inter-electrode distance can be suitably placed on the handle for thumb manipulation. The control may be a wheel or button that can also lock-in the chosen inter-electrode distance.”), wherein the stimulation portion (electrode 5 and prong 9) and the return portion (electrode 7 and prong 11) of the at least one probe extends from the distal end of the handle parallel to one another (Fig. 5 shows electrode 5 and prong 9 parallel to electrode 7 and prong 11), wherein a parallel orientation of the stimulation portion and return portion is maintainable at both a maximum spacing (when the 5 and 9 are spaced furthest from 7 and 11) and a minimum spacing between the stimulation portion and the return portion (when the 5 and 9 are spaced closest from 7 and 11 on crossarm 20). However, Chu does not teach a display on the handle.
Claims 1, 8, 11, 19-21, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Martin et al. (US 20080009853 A1, “Martin”) in view of Yates et al. (US 10265120 B2, “Yates”).
Regarding claim 1, Martin teaches an electrical stimulation device (Abstract: "An electrosurgical device having a distal tip for creating a lesion on tissue includes a first electrode and a second electrode…"; para. [0043]: " In a high frequency stimulation mode, the device 10 may be used to identify specific anatomical structures.") comprising: a handle (Fig. 14; handle 16) including: a proximal end (Fig. 1; The part of handle 16 moving towards 18); a distal end (The part of Fig. 14 moving towards 14); one or more actuators (Fig. 15; electrode gap adjustment mechanism 650, slidable gap adjustor 670, and actuator 655 are all involved in the actuation of the gap and can be considered actuators; para. [0060]: " An actuator 655 extends through sheath 640 for the operator to adjust the gap 660); and at least one probe attached to and extending from the distal end of the handle (Fig. 14; tip 19), the at least one probe including a stimulation portion (Fig. 15; first pole electrode 623) and a return portion (Fig. 15; second pole electrode 624), wherein a spacing and the return portion is adjustable (para. [0060]: "An actuator 655 extends through sheath 640 for the operator to adjust the gap 660 between electrodes 623, 624. Movement of the gap adjustor 650 in the direction of the arrow shown results in sliding contact between ramps 651 and mating ramps 652 and move electrode 624 towards electrode 623, compress springs 645, and narrow the gap 660."), using an actuator, of the one or more actuators (Fig. 15; electrode gap adjustment mechanism 650, slidable gap adjustor 670, and actuator 655 are all involved in the actuation of the gap and can be considered actuators; para. [0060]: "An actuator 655 extends through sheath 640 for the operator to adjust the gap 660 between electrodes 623, 624. Movement of the gap adjustor 650 in the direction of the arrow shown results in sliding contact between ramps 651 and mating ramps 652 and move electrode 624 towards electrode 623, compress springs 645, and narrow the gap 660… Widening of gap 660 when electrodes 623, 624 are in a narrowed position involves moving slidable gap adjustor 670 in the direction opposite to the arrow."), wherein the stimulation portion and the return portion of the at least one probe extends from the distal end of the handle parallel to one another (Fig. 15; 623 and 624 are shown to be parallel to one another in Fig. 15), with the spacing between the stimulation portion and the return portion is adjusted consistently along a length of each of the stimulation portion and the return portion (Fig. 15, the gap 660 could be adjusted consistently with the slidable gap adjustor 670 and gap adjustment mechanism 650; The Examiner reiterates that, as reflected in the claim language, the stimulation portion and return portion are adjusted consistently, and the fact that the shape of the probe is irregular does not mean that the spacing between portions cannot be adjusted consistently across the entire length), wherein a parallel orientation of the stimulation portion and return portion is maintainable at both a maximum spacing (Fig. 15; There would be a maximum spacing for when 623 and 624 are furthest apart) and a minimum spacing between the stimulation portion and the return portion (Fig. 15; There would be a minimum spacing when 623 and 624 are in closest configuration; Further, the spring mechanism 645 only adjusts the electrodes vertically. Therefore, the parallel orientation would be maintained.) However, Martin does not teach a display on the handle.
Yates, in the same field of endeavor of electrostimulation tools for ablating and cutting, discloses a surgical tool with electrodes and end effectors for sealing and cutting tissue. Yates discloses a display (para. (73): "As shown in FIG. 1, the handle assembly 500 may also include a display screen 430") on the handle.
It would have been obvious for one of ordinary skill in the before the effective filing date of the claimed invention to modify the device of Martin to include a display on the handle. One of ordinary skill would recognize that including the display would provide the device of Martin a way to display parameters for ablating tissue. This would optimize the user’s ability to control parameters for optimal delivery of energy to the end effectors for ablating tissue, as disclosed by Yates, which would be desirable for the device of Martin.
Regarding claim 8, Martin, in combination with Yates, discloses the electrical stimulation device of claim 1 (see 103 rejection above). Martin further discloses wherein the actuator (Fig. 15; electrode gap adjustment mechanism 650, slidable gap adjustor 670, and actuator 655 are all involved in the actuation of the gap and can be considered actuators; para. [0060]: " An actuator 655 extends through sheath 640 for the operator to adjust the gap 660) usable to adjust the spacing between the stimulation portion and the return portion is a slider (Fig. 15; electrode gap adjustment mechanism 650, slidable gap adjustor 670, and actuator 655 are all involved in the actuation of the gap and can be considered actuators; para. [0060]: "An actuator 655 extends through sheath 640 for the operator to adjust the gap 660 between electrodes 623, 624. Movement of the gap adjustor 650 in the direction of the arrow shown results in sliding contact between ramps 651 and mating ramps 652 and move electrode 624 towards electrode 623, compress springs 645, and narrow the gap 660… Widening of gap 660 when electrodes 623, 624 are in a narrowed position involves moving slidable gap adjustor 670 in the direction opposite to the arrow."); slidable gap adjustor 670 is a slider), such that movement of the slider causes the spacing between the stimulation portion (Fig. 15, positive electrode of either 623 and 624) and the return portion (Fig. 15, negative electrode of either 623 and 624) of the at least one probe to change (para. [0060]: “Movement of the gap adjustor 650 in the direction of the arrow shown results in sliding contact between ramps 651 and mating ramps 652 and move electrode 624 towards electrode 623, compress springs 645, and narrow the gap 660. Detents 652, 653 hold the moveable electrode 624 at whatever gap setting 660 is selected. Widening of gap 660 when electrodes 623, 624 are in a narrowed position involves moving slidable gap adjustor 670 in the direction opposite to the arrow.”).
Regarding claim 11, Martin, in combination with Yates, discloses the electrical stimulation device of claim 1 (see 103 rejection above). Martin further discloses wherein the at least one probe further includes an insulator portion located between at least a portion of the stimulation portion and at least a portion of the return portion. (para. [0031]: "The electrodes 22 in this example are substantially parallel to one another, and as shown here the electrodes 22 are spaced between about 2 to 4 mm from one another. It will be appreciated, however, that these dimensions are merely exemplary. An electrically insulative surface 32 is interposed between the electrodes 22.").
Regarding claim 19, Martin, in combination with Yates, discloses the electrical stimulation device of claim 1 (see 103 rejection above). Martin further discloses wherein the spacing between the stimulation portion and the return portion of the at least one probe is adjustable along an axis that is perpendicular to a longitudinal axis of the at least one probe. (Fig. 15; As indicated by the arrows pointing up and down to show a change in space between first pole electrode 623 and second pole electrode 624, gap 660 is perpendicular to the direction of the head 612 of the electrosurgical device 610.).
Regarding claim 20, Martin, in combination with Yates, discloses the electrical stimulation device of claim 1 (see 103 rejection above). Martin further discloses wherein the spacing between the stimulation portion and the return portion of the at least one probe is continuously adjustable. (para. [0060]: "slidable gap adjustor"; Additionally, para. [0060] shows a spring mechanism is used for controlling the gap distance, which is a form of continuous adjustment.)
Regarding claim 21, Martin, in combination with Yates, discloses the electrical stimulation device of claim 1 (see 103 rejection above). Martin further discloses wherein the spacing between the stimulation portion and the return portion of the at least one probe is adjustable between discrete spacing settings. (para. [0067]: "The electrodes 623, 624 are adjusted to a pacing gap with a gap adjusting mechanism 650 and are placed into contact with tissue at a number of the mapped positions.").
Regarding claim 27, Martin teaches an electrical stimulation device (Abstract: "An electrosurgical device having a distal tip for creating a lesion on tissue includes a first electrode and a second electrode…"; para. [0043]: " In a high frequency stimulation mode, the device 10 may be used to identify specific anatomical structures.") comprising: a handle (Fig. 14; handle 16) including: a proximal end (Fig. 1; The part of handle 16 moving towards 18); a distal end (The part of Fig. 14 moving towards 14); one or more actuators (Fig. 15; electrode gap adjustment mechanism 650, slidable gap adjustor 670, and actuator 655 are all involved in the actuation of the gap and can be considered actuators; para. [0060]: " An actuator 655 extends through sheath 640 for the operator to adjust the gap 660); and at least one probe attached to and extending from the distal end of the handle (Fig. 14; tip 19), the at least one probe including a stimulation portion (Fig. 15; first pole electrode 623) and a return portion (Fig. 15; second pole electrode 624), wherein a spacing and the return portion is adjustable (para. [0060]: "An actuator 655 extends through sheath 640 for the operator to adjust the gap 660 between electrodes 623, 624. Movement of the gap adjustor 650 in the direction of the arrow shown results in sliding contact between ramps 651 and mating ramps 652 and move electrode 624 towards electrode 623, compress springs 645, and narrow the gap 660."), using an actuator, of the one or more actuators (Fig. 15; electrode gap adjustment mechanism 650, slidable gap adjustor 670, and actuator 655 are all involved in the actuation of the gap and can be considered actuators; para. [0060]: "An actuator 655 extends through sheath 640 for the operator to adjust the gap 660 between electrodes 623, 624. Movement of the gap adjustor 650 in the direction of the arrow shown results in sliding contact between ramps 651 and mating ramps 652 and move electrode 624 towards electrode 623, compress springs 645, and narrow the gap 660… Widening of gap 660 when electrodes 623, 624 are in a narrowed position involves moving slidable gap adjustor 670 in the direction opposite to the arrow."), the actuator (Fig. 15; electrode gap adjustment mechanism 650, slidable gap adjustor 670, and actuator 655 are all involved in the actuation of the gap and can be considered actuators) being selected from the group consisting of: a slider (Fig. 15; para. [0060]: "A slidable gap adjustor 670 has a pair of ramps 651 that engage with mating ramps 625 in second pole electrode 624. A plurality of detents 652 are located on slidable gap adjustor 670 and engage with detent features 653 in sheath 640. An actuator 655 extends through sheath 640 for the operator to adjust the gap 660 between electrodes 623, 624. Movement of the gap adjustor 650 in the direction of the arrow shown results in sliding contact between ramps 651 and mating ramps 652 and move electrode 624 towards electrode 623, compress springs 645, and narrow the gap 660."), a wheel, a knob, a lever, a switch, a trigger, and a touch-screen, wherein the stimulation portion and the return portion of the at least one probe extends from the distal end of the handle parallel to one another (Fig. 15; 623 and 624 are shown to be parallel to one another in Fig. 15), with the spacing between the stimulation portion and the return portion is adjusted consistently along a length of each of the stimulation portion and the return portion Fig. 15, the gap 660 could be adjusted consistently with the slidable gap adjustor 670 and gap adjustment mechanism 650; The Examiner reiterates that, as reflected in the claim language, the stimulation portion and return portion are adjusted consistently, and the fact that the shape of the probe is irregular does not mean that the spacing between portions cannot be adjusted consistently across the entire length), wherein a parallel orientation of the stimulation portion and return portion is maintainable at both a maximum spacing (Fig. 15; There would be a maximum spacing for when 623 and 624 are furthest apart) and a minimum spacing between the stimulation portion and the return portion (Fig. 15; There would be a minimum spacing when 623 and 624 are in closest configuration; Further, the spring mechanism 645 only adjusts the electrodes vertically. Therefore, the parallel orientation would be maintained.). However, Martin does not teach a display on the handle.
Yates, in the same field of endeavor of electrostimulation tools for ablating and cutting, discloses a surgical tool with electrodes and end effectors for sealing and cutting tissue. Yates discloses a display (para. (73): "As shown in FIG. 1, the handle assembly 500 may also include a display screen 430") on the handle.
It would have been obvious for one of ordinary skill in the before the effective filing date of the claimed invention to modify the device of Martin to include a display on the handle. One of ordinary skill would recognize that including the display would provide the device of Martin a way to display parameters for ablating tissue. This would optimize the user’s ability to control parameters for optimal delivery of energy to the end effectors for ablating tissue, as disclosed by Yates, which would be desirable for the device of Martin.
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Yates et al. (US 10265120 B2, “Yates”) in view of Martin et al. (US 20080009853 A1, “Martin”).
Regarding claim 1, Yates teaches an electrical stimulation device (abstract: “The surgical instrument comprises an end effector comprising a first jaw and a second jaw, a first set of electrodes and a second set of electrodes and a slot defined between the first set of electrodes and the second set of electrodes”; Fig. 1-5) comprising: a handle (Fig. 1-2; handle assembly 500) including: a proximal end (Fig. 1-2; away from the 1600); a distal end (Fig. 1-2; towards 1600); one or more actuators (Fig. 1-2; closure release button 518); and a display (Fig. 1-2; display screen 430); and at least one probe (Fig. 1-2; surgical end effector 1500) attached to and extending from the distal end of the handle (1500 extends from the distal end of handle assembly 500), the at least one probe including a stimulation portion (first jaws 1600; para. (41): “Electrosurgical devices can be configured for monopolar or bipolar operation. During monopolar operation, current may be introduced into the tissue by an active (or source) electrode on the end effector and returned through a return electrode.”) and a return portion (second jaw 1800; para. (41): “Electrosurgical devices can be configured for monopolar or bipolar operation. During monopolar operation, current may be introduced into the tissue by an active (or source) electrode on the end effector and returned through a return electrode.”; Additionally, para. (104) discloses where each jaw can have an electrode, where one is stimulation and one is return, and energy flows between the electrodes and opposing jaws; where the electricity flows to is a return and where the electricity is sourced from is a stimulation) wherein a spacing between the stimulation portion and the return portion is adjustable using an actuator (Fig. 1-4; closure trigger 512), of the one or more actuators (para. (47) describes the closure drive system 510 that actuates the jaws 1600 and 1700; para. (3): “wherein the first jaw includes a proximate portion and a distal portion and the second jaw is movable relative to the first jaw…”; para. (42): “The end effector may include two or more jaw members. At least one of the jaw members may have at least one electrode. At least one jaw may be moveable from a position spaced apart from the opposing jaw for receiving tissues to a position in which the space between the jaw members is less than that of the first position. This movement of the moveable jaw may compress the tissue held between.”). However, Yates does not disclose wherein the stimulation portion and the return portion of the at least one probe extend from the distal end of the handle parallel to one another, with the spacing between the stimulation portion and the return portion is adjusted consistently along a length of each of the stimulation portion and the return portion, and wherein a parallel orientation of the stimulation portion and the return portion is maintainable at both a maximum spacing and a minimum spacing between the stimulation portion and the return portion.
Martin, in the same field of endeavor of electrosurgical devices, discloses a surgical device with electrodes. Martin discloses a stimulation portion (active electrode 623 where current is being supplied from) and return portion (active electrode 624 with electric current running to it), wherein the stimulation portion and the return portion (electrodes 623 and 624) of the at least one probe (tip 19) extends from the distal end of the handle (Tip 19 extends from the end of handle 16 in Fig. 1) parallel to one another (Fig. 15; 623 and 624 are shown to be parallel to one another in Fig. 15), with the spacing between the stimulation portion and the return portion is adjusted consistently along a length of each of the stimulation portion and the return portion (Fig. 15, the gap 660 could be adjusted consistently with the slidable gap adjustor 670 and gap adjustment mechanism 650; The Examiner reiterates that, as reflected in the claim language, the stimulation portion and return portion are adjusted consistently, and the fact that the shape of the probe is irregular does not mean that the spacing between portions cannot be adjusted consistently across the entire length), wherein a parallel orientation of the stimulation portion and return portion is maintainable at both a maximum spacing (Fig. 15; There would be a maximum spacing for when 623 and 624 are furthest apart) and a minimum spacing between the stimulation portion and the return portion (Fig. 15; There would be a minimum spacing when 623 and 624 are in closest configuration; Further, the spring mechanism 645 only adjusts the electrodes vertically. Therefore, the parallel orientation would be maintained.).
It would have been obvious for one of ordinary skill in the art to modify the device of Yates to include the parallel stimulation and return portions with adjustable spacing at a consistent, maximum and minimum distance using a gap adjustment mechanism, as disclosed by Martin. One of ordinary skill would recognize that including the parallel configuration and gap adjustment mechanism of Martin would have been an obvious improvement to enhance Yates’s device to include ablative capabilities. Doing so with a parallel configuration would optimize lesion width, lesion depth, voltage sensing across a lesion, electrical conduction across a lesion, electrical conduction velocity across a lesion, and phase angle of a signal measured across a lesion. One would expect with a reasonable expectation of success that including the parallel configuration would optimize lesion parameters while enhancing the device of Yates to include ablative capabilities. Further, one of ordinary skill would recognize that the parallel jaw configuration and actuation mechanism would be capable of being implemented in the interchangeable tool of Yates to improve the versatility of Yate’s device.
Regarding claim 7, Yates, in combination with Martin, discloses the electrical stimulation device of claim 1 (see rejection above). Yates further discloses wherein the at least one probe (surgical end effector 1500) includes at least one forceps probe (the end effector 1500 of claim 1 and Fig. 1 is shaped like a forceps, and is used for grasping tissue the same way a forceps would; Claim 1: “an end effector for grasping tissue, wherein the end effector comprises: a first jaw; a second jaw”; therefore, although it isn’t explicitly called a forceps probe, the end effector 1500 of Yates is considered to be a forceps probe).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Chu (US 20080027508 A1), McFarlin et al. (US 10039915 B2, “McFarlin”), and Mo et al. (US 20010034544 A1, “Mo”).
Regarding claim 5, Chu, in combination with McFarlin, discloses the electrical stimulation device of claim 1 (see rejection above). However, the references do not disclose wherein at least one probe is interchangeable.
Mo, in the same field of endeavor of electrical stimulation devices, discloses an apparatus for providing electrical stimulation with an interchangeable electrode module. Mo discloses wherein at least one probe (Fig. 1; electrodes 28 and 29; para. [0028]; “First electrode 28 and second electrode 29” are included in the electrode module 20.) is interchangeable (para. [0002]; “having an interchangeable electrode module”).
It would have been obvious for one of ordinary skill in the before the effective filing date of the claimed invention to modify the device of Chu to include an interchangeable probe, as disclosed by Mo. One of ordinary skill would recognize the benefit in making the probe replaceable, such as being able to swap out probes for different patients, which would improve sterilization and sanitization. Therefore, it would have been an obvious improvement to make the probe of Chu interchangeable.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Chu (US 20080027508 A1), McFarlin et al. (US 10039915 B2, “McFarlin”), Mo et al. (US 20010034544 A1, “Mo”), and Ignagni et al. (US 20070150023 A1, “Ignagni”).
Regarding claim 6, Chu, in combination with McFarlin and Mo, discloses the electrical stimulation device of claim 5 (see above). However, the references do not disclose wherein the handle includes a release button configured to detach the at least one interchangeable probe.
Ignangni, concerned with the common problem as Mo of mechanisms for releasing electrodes on a tip of a stimulation device, discloses a device for providing electrical stimulation to a patient’s diaphragm. Ignagni discloses wherein a handle (Fig. 11; para. [0048]; “Handle 500”) includes a release button (Fig. 11; 506; para. [0048]:“Handle 500 may also have a suction release actuator, such as release button 506”) configured to detach the at least one interchangeable probe. (para. [0044]; “Suction is then released, and the electrode is moved to another stimulation site”; para, [0048] describes Ignagni’s method of removing the electrodes by actuating suction to attach and remove the electrodes).
It would have been obvious for one of ordinary skill in the before the effective filing date of the claimed invention to modify the device of Mo to include a release mechanism on the handle, as disclosed by Ignagni. This would solve the common problem of mechanisms for detaching electrodes for stimulation, as both Mo and Ignagni are concerned with methods for electrode detachment. Therefore, it would have been obvious to one of ordinary skill to include the release button of Ignagni with the device of Mo. Further, one of ordinary skill would have a reasonable expectation that the release button could have been implemented on the modified handle of Chu and Mo to implement Ignangni’s mechanism for releasing an interchangeable prove.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Chu (US 20080027508 A1), McFarlin et al. (US 10039915 B2, “McFarlin”), and Willand et al. (US 20210283399 A1, “Willand”).
Regarding claim 9, Chu, in combination with McFarlin, discloses the electrical stimulation device of claim 1 (see rejection above). However, the references do not disclose wherein the one or more actuators includes a slider, and movement of the slider causes a change in one or more of: a pulse width; a current amplitude; or a frequency, of the electricity supplied to the stimulation portion.
Willand, in the same field of endeavor of therapeutic electrical stimulation, discloses a device for delivering therapeutic energy for managing pain. Willand discloses wherein the one or more actuators includes a slider, and movement of the slider causes a change in one or more of: a pulse width; a current amplitude; or a frequency, of the electricity supplied to the stimulation portion. (para. [0201]: "In one embodiment, the controls may include two buttons. In another arrangement, the first set of controls may include a slider or similar feature or device. In yet another arrangement, the first set of controls may include a wheel control (e.g., a roller, a wheel, etc.). However, any other type of control (e.g., button, dial, etc.) can be incorporated into the device, either in lieu of or in addition a slider and/or a wheel control. In some arrangements, when using the wheel control, a discrete set of steps may allow for adjusting the stimulus amplitude.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 1, as disclosed by Chu and McFarlin, to include the slider for actuating stimulation parameters, as disclosed by Willand. One of ordinary skill would have recognized that including a slider for modulating stimulation parameters would improve the device of Chu by allowing the effective regeneration of nerves (see Willand para. [0004]). Therefore, it would have been obvious to combine the features of Willand with the device of McFarlin.
Claims 22, 23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Bachinski et al. (US 20130085551 A1, “Bachinski”) in view Netherton et al. (US 20210077809 A1, “Netherton”).
Regarding claim 22, Bachinski teaches an electrical stimulation device comprising: a handle (Fig. 3; conductive surface 160; para. [0073]: "The conductive surfaces 160 provide simplicity and convenience in use because the user can simply hold the device 100 to use it") including: a proximal end (Fig. 3; moving away from 130); a distal end (Fig. 3; moving towards 130); one or more actuators (Fig. 3; buttons 108a and 108b."); and a display (para. [0091]: "The status indicator 170 informs a user of the operational status of the device 100 and can come in the form of a visual, an audible, and/or a tactile indicators. Examples of suitable status indicators include a light, an LED, a liquid crystal or other type of display"); and at least one probe attached to and extending from the distal end of the handle, the at least one probe including a stimulation portion and a return portion that are concentric (Fig. 3; Electrode 130 extending from the distal end of the device), extending along a longitudinal axis (Fig. 3; The axis in which electrode 130 is extending), and wherein a spacing between a distal end of the stimulation portion and a distal end of the return portion is adjustable (Fig. 20A and 20B; Additionally, Fig. 20A and 20B mention where the inner electrode (374) and outer electrode (372) are adjustable in para. [0116]: "The inner electrode 374 functions similarly to the depressible electrode 230 described in FIGS. 9A and 9B. Before pressure is applied to the electrode system 370, the tip 380 of the inner electrode 374 extends beyond the opening 376 of the outer electrode 372 and is in a neutral state, disconnected from a signal generator (e.g., the signal generator 660 of FIG. 8). The inner electrode 374 is depressible to control the delivery of current to the patient. As shown in FIG. 20B, when the electrode system 370 is pressed against the skin 84 with sufficient pressure, the skin is depressed at region 86 and the inner electrode 374 is repositioned within the outer electrode 372."; Additionally, see para. [0021] which mentions the "axially repositionable" first electrode") by movement of one or both of the stimulation portion and the return portion along axes that are parallel to the longitudinal axis (para. Fig. 20A and 20B; para. [0116]: "The shaft 378 of the inner electrode 374 extends through an opening 376 of the outer electrode 372. The inner electrode 374 functions similarly to the depressible electrode 230 described in FIGS. 9A and 9B. Before pressure is applied to the electrode system 370, the tip 380 of the inner electrode 374 extends beyond the opening 376 of the outer electrode 372 and is in a neutral state, disconnected from a signal generator (e.g., the signal generator 660 of FIG. 8). The inner electrode 374 is depressible to control the delivery of current to the patient. As shown in FIG. 20B, when the electrode system 370 is pressed against the skin 84 with sufficient pressure, the skin is depressed at region 86 and the inner electrode 374 is repositioned within the outer electrode 372."; the concentric electrodes are on the same longitudinal axes). However, Bachinski does not explicitly disclose the spacing being adjustable using an actuator, of the one or more actuators since the spring actuation mechanism of disclosed in para. [0106] and Fig. 11A and 11B are not disclosed as being on the handle of the stimulation device, as recited in claim 22 (buttons 108a and 108b include the actuation of stimulation, but not actuation of the distance between electrodes).
Netherton, in the same field of endeavor of electrical stimulation devices, discloses an adjustable nerve probe assembly. Netherton discloses where one or more actuators (para. [0051]: “spatial adjustment mechanism” and “adjustment structure”) are on the handle of the device (para. [0051]: “A spatial distance between the electrodes of each of the electrical probes may be adjusted by a spatial positioning mechanism, which may be coupled to the handle or one or more of the number of arms.”), and the one or more actuators are used to actuate the spacing between electrodes (para. [0051]: “A spatial distance between the electrodes of each of the electrical probes may be adjusted by a spatial positioning mechanism, which may be coupled to the handle or one or more of the number of arms.”). Netherton also discloses concentric electrodes (para. [0065]: “In FIG. 4D, two electrodes 400D are shaped to be flush with an end of an electrical probe and are arranged in concentric circles (i.e., a concentric bipolar tip electrode).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bachinski to include an actuation mechanism for adjusting the spacing between electrodes on a handle, as disclosed by Netherton. One of ordinary skill would recognize that it is desirable to have adjustable stimulation and return portions on a probe based on the teachings of Netherton. One would further recognize that there would need to be an actuation mechanism for the surgeon to easily adjust the location of stimulation and return portions, and that including this on the handle, as disclosed in Netherton, would’ve yielded predictable results as an effective way to allow the user to adjust the distance. Therefore, it would have been obvious to include an actuator mechanism on the handle of Bachinski, as disclosed by Netherton. Lastly, the disclosure of a concentric probe configuration would have suggested to one of ordinary skill that adjustment between stimulation and return portions could be done in a concentric configuration.
Regarding claim 23, Bachinski, in combination with Netherton, discloses the electrical stimulation device of claim 22 (see above). Bachinski further discloses wherein the at least one probe is interchangeable. (Fig. 2; para. [0022]: "In certain embodiments, the first electrode is removably coupled to housing. In certain embodiments, the second electrode is removably coupled to housing.").
Regarding claim 25 Bachinski, in combination with Netherton, discloses the electrical stimulation device of claim 22 (see above). Bachinski further discloses wherein the spacing between the stimulation portion and the return portion of the at least one probe is continuously adjustable. (Para. [0021]: "The system may include a first compression spring coupled to the first electrode, such that the first spring is compressed when the first electrode is in the second position. For example, the first electrode may actuate the first contact pad when the first electrode is repositioned to the second position."; The movement of the electrode by a spring mechanism is a form of continuous repositioning (actuation).).
Claims 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Bachinski et al. (US 20130085551 A1, “Bachinski”), Netherton et al. (US 20210077809 A1, “Netherton”), Brunson et al. (US 20170189227 A1, “Brunson”).
Regarding claim 24, Bachinski, in combination with Netherton, discloses the electrical stimulation device of claim 22 (see rejection above). However, neither Brunson nor Netherton discloses wherein the at least one probe further includes an insulator portion located between at least a portion of the stimulation portion and at least a portion of the return portion.
Brunson, in the same field of endeavor of therapeutic stimulation devices, discloses a electrodes for electrically stimulating. Brunson discloses wherein the at least one probe further includes an insulator portion located between at least a portion of the stimulation portion and at least a portion of the return portion. (Fig. 4D; Abstract: " wherein the at least one embedded electrode is configured to serve as a source electrode and another of the at least two electrodes is configured to serve as a return electrode"; The embedded electrode can either be stimulation or return; para. [0186]: "FIG. 4D shows an embodiment of the embedded electrode 130 divided into multiple concentric electrodes forming a concentric electrode system 450. Each concentric electrode can be separated from the other concentric electrodes by an insulator." Each electrode 130 is separated by an insulator, and therefore, the stimulation and return portion is separated by an insulator.)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 22, as disclosed by Bachinski, to further include an insulator portion between the stimulation and return portion of the concentric electrodes, as disclosed by Brunson. One of ordinary skill would recognize the benefit of insulating between stimulation and return in that there would be reduced electrical interference between electrode portions. This would allow the concentric electrodes to be independently managed and better controlled (see Brunson [0112]). Therefore, it would have been obvious to combine the insulative portion between stimulation and return electrodes, as disclosed by Brunson, with the device of Bachinski.
Regarding claim 26, Bachinski, in combination with Netherton, discloses the electrical stimulation device of claim 22 (see rejection above). However, neither Brunson nor Netherton expressly discloses wherein the spacing between the stimulation portion and the return portion of the at least one probe is adjustable between discrete spacing settings.
Brunson discloses wherein the spacing between a stimulation portion and a return portion of the at least one probe is adjustable between discrete spacing settings. (Fig. 6C/6D; para. [0200]: " In the embodiment shown in FIG. 6C, the system 10 is shown with at least one arm 122 on the end effector 120 not being in contact with the portion of the skin 80 or the treatment area 81. Here the end effector 120 is shown with three embedded electrodes 131, 132, and 133. As compared to FIG. 6B, the skin 80 is shown having a contour such that there is a large separation with the embedded electrode 133. The embedded electrodes 131 and 132 are in contact with the skin 80 while the embedded electrode 133 is shown away from the skin 80 and no longer in electrical communication with the skin 80."; para. [0140]: "Each embedded electrode 130 can operate as a source electrode or as a return electrode."; "In one example any of the embedded electrodes 130 on the end effector 120 can be configured to act as a return electrode that is in electrical communication with a separate location of the subject's skin simultaneously during operation from that of the remaining embedded electrodes 130."; The distance between the electrodes can be adjusted to be either on the skin or off this skin, and the electrodes can be either source (stimulation) or return electrodes (para. [0140].) This is a form of discrete spacing as the electrodes are either on the skin or off the skin.).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 22, as disclosed by Bachinski, to further include discrete adjustment between stimulation and return portions, as disclosed by Brunson. One of ordinary skill would have recognized that discrete spacing would allow better control over contact with the skin, providing improved electrotherapy using microcurrents (see Brunson para. [0043]). Therefore, it would have been obvious to include the discrete adjustment feature of Brunson in the device of Bachinski.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OWEN LEWIS MARSH whose telephone number is (571)272-8584. The examiner can normally be reached 7:30am – 5pm (M-Th), 8am – noon (F).
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/O.L.M./Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
