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 argues on pg. 9 of the Remarks that “the at least one probe including a stimulation portion and a return portion that are concentric, extending along a longitudinal axis, and wherein a spacing between a distal end of the stimulation portion and a distal end of the return portion is adjustable,” now recited in claim 22 (previously recited in claim 10), are supported by the instant specification. The Examiner agrees that the claimed limitations are supported and withdraws the rejection under §112(a).
Applicant argues on page 9 and 10 of remarks that one of ordinary skill in the art would understand that it is “the entirety of ‘at least one probe’ that is interchangeable.” The examiner agrees, and the rejection of claim 5 under §112(b) is withdrawn.
Applicant argues on pg. 10 of Remarks that the amended claim 16 and the use of “one or more of” and “or” complies with the definiteness requirement. The Examiner agrees and withdraws the rejection of claim 16 under §112(b).
Applicant argues on pgs. 11 and 12 of Remarks that “the embedded electrodes 130 of Brunson cannot be said to be parallel to one another, nor can they be said to maintain a parallel orientation to each other at both a maximum and a minimum spacing therebetween. Thus, Brunson fails to disclose or suggest at least the feature of ‘wherein the stimulation portion and the return portion of at least one probe extend from the distal end of the handle parallel to one another, 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 and return portion’ as recited in independent claim 1.” The Examiner agrees, in light of the amendments to claim 1, that the embedded electrodes of Brunson cannot be parallel to one another, nor can they be said to maintain a parallel orientation to each other at both a maximum and a minimum spacing therebetween. The Examiner has taken the arguments in regards to 35 USC § 102, 103 and New Claims from pg. 10-15 of Remarks into account. Applicant's amendments necessitate new grounds for rejection, and the new rejections have been detailed below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 7, 12, 13, 15, and 16 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by McFarlin et al. (US 10039915 B2, “McFarlin”).
Regarding claim 1, McFarlin teaches an electrical stimulation device (Abstract: "A surgical tool…including first connecting elements… The contacting elements are configured to contact nerve tissue of a patient…The first connecting elements are configured to connect to and receive monophasic stimulation pulses from second connecting elements on a modular stimulation module.") comprising: a handle (Fig. 9; holding members 364) including: a proximal end (Fig. 9; the part of 364 moving towards 360); a distal end (Fig. 9; The part of 364 moving towards the tips 362); one or more actuators (Fig. 9; Adjustment buttons 369); and a display (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); and at least one probe attached to and extending from the distal end of the handle (Fig. 9; para. (73): "The instrument 350 functions as a tool and operates as a side-by-side bipolar stimulation probe."); para. (74): "Tips 362 of the tool 351 have exposed conductive portions. Examples of the exposed conductive portions are shown in FIGS. 11, 12, and 16A-19E."), the at least one probe including a stimulation portion (para. (7): "the stimulating electrode.") and a return portion (Fig. 9; para. (73): "The instrument 350 functions as a tool and operates as a side-by-side bipolar stimulation probe."; bipolar stimulation requires a stimulation and return probe (anode and cathode) to create a closed-loop. One jaw of probe tip 362 would be the stimulation probe and the other jaw would be the return.; para (7): "the anode may be used as a current returning electrode."), wherein a spacing and the return portion is adjustable (Fig. 16A shows the sides of the probe tip in an open position and Fig. 16B shows the tips in a closed position. Therefore, the spacing is adjustable), 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. 9; the tips 362 are shown to be parallel to one another and extending from the distal end of the handle; Additionally, the probes are shown to be parallel in Fig. 16A), and wherein a parallel orientation of the stimulation portion and return portion is maintainable at both a maximum spacing (Fig. 16A; The open position can be considered to be a maximum spacing) and a minimum spacing between the stimulation portion and the return portion (Fig. 16B; The closed position can be considered to be a minimum spacing).
Regarding claim 7, McFarlin teaches the electrical stimulation device of claim 1 (see above), wherein the at least one probe includes at least one forceps probe (Fig. 9; para. (73): "Although the tool 351 is shown as being forceps, another tool may be used.").
Regarding claim 12, McFarlin teaches the electrical stimulation device of claim 1 (see above), 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).
Regarding claim 13, McFarlin teaches the electrical stimulation device of claim 1 (see above), 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.")
Regarding claim 15, McFarlin teaches the electrical stimulation device of claim 1 (see above), wherein the one or more actuators include a button that, when depressed, causes generation of one or more stimulation pulses. (para. (75): "a multi-function button 368, current adjustment buttons 369, and light emitting diodes (LEDs) 370… In one embodiment, when any of the buttons 364, 368 are pushed the modular stimulation module 352 is activated… The current adjustment buttons 369 may be used to increase or decrease the current of the pulses supplied to the tool 351."; The current adjustment button would be considered to cause a generation of one or more pulses as it increases current).
Regarding claim 16, McFarlin teaches the electrical stimulation device of claim 1 (see above), 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.").
Claims 22, 23 and 25 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Bachinski et al. (US 20130085551 A1, “Bachinski”).
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").
Regarding claim 23, Bachinski teaches the electrical stimulation device of claim 22 (see above), 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 teaches the electrical stimulation device of claim 22 (see above), 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).).
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, 11, and 19-21 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; 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. 9; para. (73): "The instrument 350 functions as a tool and operates as a side-by-side bipolar stimulation probe."); para. (74): "Tips 362 of the tool 351 have exposed conductive portions. Examples of the exposed conductive portions are shown in FIGS. 11, 12, and 16A-19E."), 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."), 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), and 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 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.").
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over McFarlin et al. (US 10039915 B2, “McFarlin”) in view of Mo et al. (US 20010034544 A1, “Mo”).
Regarding claim 5, McFarlin teaches the electrical stimulation device of claim 1 (see 102 rejection above). However, McFarlin does 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 McFarlin to include an interchangeable probe, as disclosed by Mo. An interchangeable electrode module would be an improvement to in the art to include in a stimulation device (see Mo para. [0005]). Therefore, as it is already disclosed by Mo, it would have been obvious to further include the replaceable electrode feature in the device of Mcfarlin.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over 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, Mcfarlin, in combination with Mo, discloses the electrical stimulation device of claim 5 (see above). However, neither reference discloses 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 surgical 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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Martin et al. (US 20080009853 A1, “Martin”), Yates et al. (US 10265120 B2, “Yates”), and Cummings et al. (US 20110306973 A1, “Cummings”).
Regarding claim 8, Martin, in combination with Yates, discloses the electrical stimulation device of claim 1 (see 103 rejection above). However, neither reference expressly 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.
Cummings, 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. Cummings discloses wherein one or more actuators includes a slider (para. [0045]; “The handle 105… that is configured to carry actuator levers, triggers and/or sliders for actuating the first jaw 120A and second jaw 120B), and movement of the slider (para. [0045]; “actuator mechanisms configured to actuate the jaws”) causes the spacing (Fig. 1; The gap between 120A and 120B) between the stimulation portion (Fig. 1; para. [0046]; “electrodes within the jaws 120A) and the return portion (120B; (Fig. 5 (perspective view of end effector (110, including 120A and 120B) from Fig. 1); “the second jaw 322 can comprise a second frame 323b and at least one electrode, such as return electrode 363) of the at least one probe to change (para. [0046]; “First jaw 120A and second jaw 120B may close to thereby capture or engage tissue therebetween”; Fig. 4B (the closed jaw configuration)).
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 Martin and Yates, to further include the sliding actuation to change the spacing between the stimulation and return portion, as disclosed by Cummings. One of ordinary skill would recognize that the including the sliding actuator of Cummings would have been advantageous in that there would be a mechanism for effectively and precisely controlling the distance between the end effectors. This would allow the device to seal or "weld" many types of tissues, such as anatomic structures having walls with irregular or thick fibrous content, bundles of disparate anatomic structures, substantially thick anatomic structures, and/or tissues with thick fascia layers such as large diameter blood vessels (see para. [0005] of Cummings). Therefore, it would have been obvious to include the sliding actuator of Cummings in the device of claim 1, as disclosed by Martin in combination with Yates.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over McFarlin et al. (US 10039915 B2, “McFarlin”) in view of Willand et al. (US 20210283399 A1, “Willand”).
Regarding claim 9, McFarlin discloses the electrical stimulation device of claim 1 (see 102 rejection above). However, McFarlin does 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 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 McFarlin 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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over McFarlin et al. (US 10039915 B2, “McFarlin”) in view of Claude et al. (US 20220126096 A1, “Claude”).
Regarding claim 14, McFarlin discloses the electrical stimulation device of claim 13 (see 102 rejection above). However, McFarlin does not expressly disclose wherein the device is configured to provide tactile feedback as a vibration.
Claude, in the same field of endeavor of therapeutic, hand-held stimulation devices, discloses a device using electrodes to treat sinuses. Claude discloses wherein the device is configured to provide tactile feedback as a vibration. (para. [0044]: "According to an embodiment, the handheld sinus treatment device 102 can indicate that the handheld sinus treatment device 102 is in the treatment mode via haptic feedback (vibration).").
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 13, as disclosed by McFarlin, to further include tactile feedback as a vibration, as disclosed by Claude. One of ordinary skill would recognize the benefit of vibratory tactile feedback, as it can alert the user of the changes in device modes or parameters (see Claude para. [0044].) Therefore, it would have been an obvious improvement to include the vibratory feedback in the device of McFarlin to improve means of alerting the user of changes in the stimulation device.
Claims 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Bachinski et al. (US 20130085551 A1, “Bachinski”) in view of Brunson et al. (US 20170189227 A1, “Brunson”).
Regarding claim 24, Bachinski teaches the electrical stimulation device of claim 22 (see 102 rejection above). However, Brunson does not disclose 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 discloses the electrical stimulation device of claim 22 (see 102 rejection above). However, Bachineski does not expressly disclose 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/O.L.M./Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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