DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10 is rejected under 35 U.S.C. 112(a) or 3555 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.
Regarding claim 10, the applicant claims “the probe including a stimulation and a return portion, wherein a spacing between the stimulation portion and return portion is adjustable” and “wherein the stimulation portion and return portion of the probe are concentric.” However, the applicant has not pointed out where the claim is supported, nor does there appear to be a written description of the claim limitation regarding the adjustability of the concentric probe in the application filed.
Per MPEP 2163, issues of adequate written description may arise for original claims when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing (MPEP 2163(I)(A)). In the instant case, the disclosure is silent with regard to how the concentric leads may be adjusted to alter the space between the leads. Figure 4 and paragraph [0044] depict a probe comprising concentric leads, but this disclosure does not provide a description of how the spacing between the stimulation lead and the return lead may be adjusted. Therefore, claim 10 lacks written description.
Claim Rejections - 35 USC § 112
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.
Claim 2, 5, 6, 16, and 18 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 claim 2, applicant claims “The electrical stimulation device from claim 1” which comprises a “probe including a stimulation portion and a return portion,” and “wherein each of the stimulation portion and the return portion of the probe is a lead, and together, the leads form a single probe”. Applicant has effectively claimed the same probe from claim 1 in claim 2. Both claim 1 and claim 2 recite “a probe,” and it is unclear if it is the same probe. In short, it is interpreted that claim 2 recites that the probe recited in claim 1 is a stimulation lead and a return lead, and together, the two leads are the same probe from claim 1.
Regarding claim 5, the applicant recites, “wherein the probe is interchangeable.” However, claim 1 only mentions one a single probe, and it is unclear what the aspect of the single probe is interchangeable.
Claim 6 is also rejected due to its dependency from 5.
Regarding claim 16, the applicant recites, in line 4-6, “a pulse width; a current amplitude; or a frequency;” The use of “or” is improper Markush language and should be corrected to “and” since it is unclear which input value is being claimed.
Regarding claim 18, applicant claims “wherein the device is configured for use in one or more of the following: locating one or more nerves; identifying one or more nerves, including identifying one or more of motor nerves and sensory nerves; stimulating regeneration of one or more nerves; providing a nerve block to one or more nerves; and managing and relieving nerve pain.” The claim does not provide the structure for each configuration such that the meats and bounds of the claim are clear. Therefore, the claim will be interpreted as a device comprising of the limiting structures of claim 1 that is capable of performing the intended functions.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1, 2, 3, 10, 11, 13, and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Brunson et al. (US 2017/0189227 A1, “Brunson”), herein after referred to as Brunson.
Regarding claim 1, Brunson discloses an electrical stimulation device (abstract; “A system is provided for stimulating”; Fig. 1C) comprising: a handle (Fig. 1C; 112; para. [0088]); a proximal end (Fig. 1C; The bottom end of the handle 112 moving away from 110); a distal end (Fig. 1C; The top end of the handle 112 moving towards 110); one or more actuators (Fig. 1C; para. [0088]; “the one or more user input mechanisms or buttons; 111) and a display (Fig. 1C; para. [0086]; The device head 110 can further include other user interfacing features not shown such as a screen or an indicator for displaying an operating or function mode” and a probe (Fig. 1C; “embedded electrode”; 130) attached to and extending from the distal end of the handle (See Fig. 1C; embedded electrode attached at the distal end of the handle), the probe (Fig. 1C; “embedded electrode”; 130) including a stimulation portion (Fig. 1C; 130; para. [0087]; “an embedded electrode 130 can be also used as a source electrode”) and a return portion (Fig. 1C; 130; para. [0087]; “an embedded electrode 130 can be also used as a source electrode, a return electrode…”; 130 functions as both the stimulating source electrode or as the return electrode) wherein a spacing (Fig. 1C; the distance between the embedded electrodes 130; see Fig. 1C below) between the stimulation portion and the return portion is adjustable (Fig. 9A; para [0217] “FIG. 9A shows an embodiment of the end effector 120 that can be adjusted to change the spatial distribution of the electrode assembly 140; 140 is shown on Fig. 1E as an embodiment of the electrode assembly of Fig. 1C).
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Regarding claim 2, Brunson discloses the electrical stimulation device of claim 1 (see above), wherein the stimulation portion (Fig. 1C; 130; para. [0087]; “an embedded electrode 130 can be also used as a source electrode”) and the return portion (Fig. 1C; 130; para. [0087]; “an embedded electrode 130 can be also used as a source electrode, a return electrode…”; 130 functions as both the stimulating source electrode or as the return electrode) of the probe (Fig. 1C; “embedded electrode”; 130) is a lead (Fig. 1C; “embedded electrode”) and together, and together, the leads form a single probe (Fig. 1C; “embedded electrode”).
Regarding claim 3, Brunson discloses electrical stimulation device of claim 1 (see above), wherein the probe is formed by the stimulation portion as a stimulation probe (Fig. 1C; 130; para. [0087]; “an embedded electrode 130 can be also used as a source electrode”) and the return portion as a return probe (Fig. 1C; 130; para. [0087]; “an embedded electrode 130 can be also used as a source electrode, a return electrode…”; 130 functions as both the stimulating source electrode or as the return electrode) and together, the probes form a double probe (Both the stimulation probe 130 and the return probe 130 come together to form the double probe in Fig. 1C).
Regarding claim 10, Brunson discloses the electrical stimulation device of claim 1 (see rejection above) wherein the stimulation portion (Fig. 4D (the bedded electrode 130 from Fig. 1A-F); one of the concentric electrodes 451-454) and the return portion (Fig. 4D (an embodiment of the embedded electrode 130 from Fig. 1A-F); one of the concentric electrodes 451-454) of the probe (Fig. 1C; “embedded electrode”130) are concentric (Fig. 4D; para. [0186]; “an embodiment of the embedded electrode 130 divided into multiple concentric electrodes”).
Regarding claim 11, Brunson discloses the electrical stimulation device of claim 1 (see rejection above), wherein the probe (Fig. 1C; “embedded electrode”130) further discloses an insulator portion (Fig. 4D (an embodiment of the embedded electrode from 130 from Fig. 1A-F); para. [0186]; “Each concentric electrode can be separated from the other concentric electrodes by an insulator.”) provided between at least a portion of the stimulation portion and at least a portion of the return portion (See Fig. 4D of the embedded electrode 130 where the white gaps between each concentric electrode represent an insulator).
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Regarding claim 13, Brunson discloses the electrical stimulation device of claim 1 (see rejection above), wherein the device is configured to provide one or more of tactile feedback, auditory feedback, or visual feedback (para. [0199]; The microcontroller 240 can also be configured to cause the display of information on a screen or an indicator so that the subject can see the operating mode of the appliance 100) to a user.
Regarding claim 18, the applicant does not recite language that limits the structure of the electrical stimulation device. Absent evidence on the contrary, it is interpreted that a device comprising of the elements of claim 1 would be capable of performing the intended functions in claim 18. Brunson discloses the electrical stimulation device of claim 1 (see rejection above), wherein the device (abstract; “A system is provided for stimulating”; Fig. 1C) is configured for use in one or more of the following: locating one or more nerves; identifying one or more nerves, including identifying one or more of motor nerves and sensory nerves; stimulating regeneration of one or more nerves; providing a nerve block to one or more nerves; and managing and relieving nerve pain (para. [0078]; For instance, for pain management or to induce muscle contractions as part of electrical muscle stimulation (EMS))
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Cummings et al. (US 2011/0306973 A1, “Cummings”), herein after referred to as Cummings, in view of Brunson et al. (US 2017/0189227 A1, “Brunson”).
Regarding claim 1, Cummings discloses a handheld electrosurgical instrument using electrically stimulated electrodes attached to jaws to cut and seal tissue. Further, Cummings discloses an electrical stimulation device (Fig. 1; abstract) comprising: a handle (para. [0045]; “Handle 105”; Fig. 1) including: a proximal end (Fig. 1; 105; the end of the handle 105 moving towards the cable 152); a distal end (Fig. 1; 105; the end of the handle 105 moving away from the cable 152); one or more actuators (Fig. 1; 128; para. [0045]; “Lever arm 128 may be coupled to a movable cutting member disposed within elongate shaft 108”); and a probe (Fig. 1; para. [0045]; “First jaw 120A and second jaw 120B may be coupled to an electrical source or RF source 145”) attached to and extending from the distal end of the handle (See Fig. 1 below where 120A and 120B extend from the distal end of the handle 105), the probe (Fig. 1; para. [0045]; “First jaw 120A and second jaw 120B may be coupled to an electrical source or RF source 145”) including a stimulation portion (Fig. 1; para. [0046]; “electrodes within the jaws 120A) and a return portion (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), wherein a 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), is adjustable (para. [0046]; “First jaw 120A and second jaw 120B may close to thereby capture or engage tissue therebetween.”). However, Cummings does not disclose a display on the handle.
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Brunson discloses an electrical system for stimulating a portion of the skin. Brunson, in the same field of endeavor of displaying stimulation device parameters, discloses a display ([0086]; “The device head 110 can further include other user interfacing features not shown such as a screen or an indicator for displaying an operating or function mode).
It would have been obvious for one of ordinary skill in the art before the effective filling date to include the display on the stimulation device of Brunson on the handle of the electrosurgical device of Cummings since doing so would enable Cumming’s invention to provide an improved means of feedback to the user regarding the device parameters.
Regarding claim 2, the limitations of claim 1 are obvious over Cummings in view of Brunson as indicated above. Claim 2 is also obvious over Cummings in view of Brunson. Cummings further discloses wherein each of 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 probe (Fig. 1; para. [0045]; “First jaw 120A and second jaw 120B may be coupled to an electrical source or RF source 145”) is a lead (Fig. 4A, which is illustrates the end effector 110 (comprising of jaws 120A and 120B) in further detail; para. [0050]; “250 by electrical leads in cable 252 in order for the electrodes 265A and 265B), and together, the leads form a single probe (Fig. 4B, which illustrates the jaws 120A and 120B from 4A in a closed configuration (the jaws being 262a and 262b in this configuration)). However, Cummings does not disclose a display.
Brunson, in the same field of endeavor of displaying stimulation device parameters, includes a display ([0086]; “The device head 110 can further include other user interfacing features not shown such as a screen or an indicator for displaying an operating or function mode).
It would have been obvious for one of ordinary skill in the art before the effective filling date to include the display on the stimulation device of Brunson on the handle of the electrosurgical device of Cummings since doing so would enable Cumming’s invention to provide an improved means of feedback to the user regarding the device parameters.
Regarding claim 3, the limitations of claim 1 are obvious over Cummings in view of Brunson as indicated above. Claim 3 is also obvious over Cummings in view of Brunson. Further, Brunson discloses wherein the probe (Fig. 1; para. [0045]; “First jaw 120A and second jaw 120B may be coupled to an electrical source or RF source 145”) is formed by the stimulation portion (Fig. 1; para. [0046]; “electrodes within the jaws 120A) as a stimulation probe (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) as a return probe (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), and together (Fig. 4B, which illustrates the jaws 120A and 120B from 4A in a closed configuration (the jaws being 262a and 262b in this configuration), the probes (Fig. 4B; 262a and 262b) form a double probe (Fig. 4B). )). However, Cummings does not disclose a display.
Brunson, in the same field of endeavor of displaying stimulation device parameters, includes a display ([0086]; “The device head 110 can further include other user interfacing features not shown such as a screen or an indicator for displaying an operating or function mode).
It would have been obvious for one of ordinary skill in the art before the effective filling date to include the display on the stimulation device of Brunson on the handle of the electrosurgical device of Cummings since doing so would enable Cumming’s invention to provide an improved means of feedback to the user regarding the parameters of the device.
Regarding claim 4, the limitations of claim 1 are obvious over Cummings in view of Brunson as indicated above. Claim 4 is also obvious over Cummings in view of Brunson. Brunson further discloses wherein 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 probe (Fig. 1; para. [0045]; “First jaw 120A and second jaw 120B may be coupled to an electrical source or RF source 145”) extend from the distal end of the handle (See Fig. 1 above where 120A and 120B extend from the distal end of the handle 105) parallel to one another (Fig. 4B, which illustrates the jaws 120A and 120B from 4A in a closed configuration (the jaws being 262a and 262b in this configuration), the probes (Fig. 4B; 262a and 262b) being parallel to one another in this configuration). However, Cummings does not disclose a display.
Brunson, in the same field of endeavor of displaying stimulation device parameters, includes a display ([0086]; “The device head 110 can further include other user interfacing features not shown such as a screen or an indicator for displaying an operating or function mode).
It would have been obvious for one of ordinary skill in the art before the effective filling date to include the display on the stimulation device of Brunson on the handle of the electrosurgical device of Cummings since doing so would enable Cumming’s invention to provide an improved means of feedback to the user regarding the device parameters.
Regarding claim 7, the limitations of claim 1 are obvious over Cummings in view of Brunson as indicated above. Claim 7 is also obvious over Cummings in view of Brunson. Brunson further discloses wherein the probe (Fig. 1; para. [0045]; “First jaw 120A and second jaw 120B may be coupled to an electrical source or RF source 145”) is a forceps probe (Fig. 1; para. [0044]; “captured tissue between the jaws”; “a set of openable-closeable jaws with straight or curved jaws--an upper first jaw 120A and a lower second jaw 120B”) attached to and extending from the distal end of the handle (See Fig. 1 above where 120A and 120B extend from the distal end of the handle 105), the forceps probe (Fig. 1; para. [0044]; “captured tissue between the jaws”; “a set of openable-closeable jaws with straight or curved jaws--an upper first jaw 120A and a lower second jaw 120B”) functioning as a forceps (Fig. 1; para. [0044]; “captured tissue between the jaws”; “a set of openable-closeable jaws with straight or curved jaws--an upper first jaw 120A and a lower second jaw 120B”). However, Cummings does not disclose a display.
Brunson, in the same field of endeavor of displaying stimulation device parameters, includes a display ([0086]; “The device head 110 can further include other user interfacing features not shown such as a screen or an indicator for displaying an operating or function mode).
It would have been obvious for one of ordinary skill in the art before the effective filling date to include the display on the stimulation device of Brunson on the handle of the electrosurgical device of Cummings since doing so would enable Cumming’s invention to provide an improved means of feedback to the user regarding the device parameters.
Regarding claim 8, the limitations of claim 1 are obvious over Cummings in view of Brunson as indicated above. Claim 8 is also obvious over Cummings in view of Brunson. Brunson further discloses wherein the 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 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)). However, Cummings does not disclose a display.
Brunson, in the same field of endeavor of displaying stimulation device parameters, includes a display ([0086]; “The device head 110 can further include other user interfacing features not shown such as a screen or an indicator for displaying an operating or function mode).
It would have been obvious for one of ordinary skill in the art before the effective filling date to include the display on the stimulation device of Brunson on the handle of the electrosurgical device of Cummings since doing so would enable Cumming’s invention to provide an improved means of feedback to the user regarding the device parameters.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mo et al. (US 2001/0034544 A1, “Mo”) in view of Cummings US 2011/0306973 A1, “Cummings”).
Regarding claim 5, Mo discloses a programmable electric stimulation apparatus with interchangeable electrodes. Mo, in the same field of endeavor of electrical stimulation devices used as treatment for tissue, discloses an electrical stimulation device (abstract; “an electrical stimulation apparatus”) comprising: a handle (para. [0027]; “Housing 12 is configured to be hand portable”; Fig. 1) including: a proximal end (the end of the stimulation apparatus 10 moving towards the buttons 42, 44, and 46; Fig. 1); a distal end (the end of the stimulation apparatus 10 moving towards the electrode module 20) ; one or more actuators (para. [0027]; “ON/OFF switch 42, an ACT switch 44, and a set switch 46”; Fig. 1 ; and a display (para. [0027]; “an LCD screen 40”; Fig. 1); and a probe attached to and extending from the distal end of the handle (Fig. 1; electrode module 20 comprising of first electrode 28 and second electrode 29). Mo also discloses wherein the 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”). However, Mo does not disclose the probe including a stimulation portion and a return portion, wherein a spacing between the stimulation portion and the return portion is adjustable.
Cummings, in the same field of endeavor of handheld devices to apply electrical stimulation, discloses an electrical stimulation device (Fig. 1; abstract); the probe (Fig. 1; para. [0045]; “First jaw 120A and second jaw 120B may be coupled to an electrical source or RF source 145”) including a stimulation portion (Fig. 1; para. [0046]; “electrodes within the jaws 120A) and a return portion (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), wherein a 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), is adjustable (para. [0046]; “First jaw 120A and second jaw 120B may close to thereby capture or engage tissue therebetween.”).
It would have been obvious for one of ordinary skill in the art to combine the electrical stimulation device of Mo, which includes the handle with a proximal and distal end, one or more actuators, a display, and a probe, with the adjustable stimulation and return portions of Cummings. Doing so would allow the user of Mo’s stimulation device to apply and return stimulation to specific tissue. Including a return portion could also enable the device to detect tissue as well as apply stimulation. Further, the adjustability of the gap between electrodes would enable more versatility in locations where the stimulation device is applied.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Cummings et al. (US 2011/0306973 A1, “Cummings”), Brunson et al. (US 2017/0189227 A1, “Brunson”), Mo (US 2001/0034544 A1, “Mo”), and Ignagni et al. (US 2007/0150023 A1, “Ignagni”), hereinafter referred to as Ignagni.
Regarding claim 6, the Cummings and Brunson combination discloses the limitations of claim 1 (see above). However, neither Brunson nor Cummings disclose wherein the probe is interchangeable, or wherein the handle includes a release button configured to detach the interchangeable probe.
Further, as mentioned in the previous rejection of claim 5, Mo, in combination with the electrosurgical tool of Cummings and the display of Brunson, discloses an interchangeable probe (para. [0002]; “having an interchangeable electrode module”). However, Mo does not disclose wherein the handle includes a release button configured to detach the interchangeable probe.
Ignagni discloses a transvisceral neurostimulation mapping device that delivers an electrode into the patient’s body via an endoscope. Ignagni, concerned with the same problem of a method of detaching electrodes from the stimulation device, discloses wherein the 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 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 art before the effective filling date to combine the interchangeable probe of Mo with the surgical tool of Cummings and display of Brunson since doing so would allow for easy replacement of probes and electrodes following their use during a procedure. Additionally, it would have been obvious to combine the release button of Ignagni with the interchangeable probe of Mo since doing so would provide a method of actuating the detachment of the electrodes. This would improve the device by adding a simple mechanism to perform the detachment when interchanging electrodes.
Claim(s) 9, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Cummings et al. (US 2011/0306973 A1, “Cummings”), Brunson et al. (US 2017/0189227 A1, “Brunson”), and Yates et al. (US 2020/0078085 A1, “Yates”), herein after referred to as Yates.
Regarding claim 9, Cummings and discloses all the limitations of the electrical stimulation Brunson, in combination, disclose the stimulation device of claim 1 (see above). However, Cummings does not disclose the display of claim 1 or 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.
Brunson, in the same field of endeavor of displaying stimulation device parameters, includes a display ([0086]; “The device head 110 can further include other user interfacing features not shown such as a screen or an indicator for displaying an operating or function mode). However, Brunson 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.
Yates discloses a bilateral jaw configuration nerve stimulation device. Yates, concerned with the same problem as Cummings of a mechanism that allows the user to control device output parameters, discloses wherein the one or more actuators includes a slider (Fig. 5; 504; para. [0062]; “may include a current amplitude control switch 504 to control the level of current applied to the probes at the end effector”), 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. [0062]; “may include a current amplitude control switch 504 to control the level of current applied to the probes at the end effector”).
It would have been obvious for one of ordinary skill in the art before the effective filling date to combine the display on the stimulation device of Brunson on the handle of the electrosurgical device of Cummings since doing so would enable Cumming’s invention to provide an improved means of feedback to the user regarding the parameters of the device. Further, it would have been obvious for one of ordinary skill in the art before the effective filling date to combine the control switch on the handle of Yates with Cumming’s electrical stimulation device since doing so would provide the user a means of controlling the stimulation output parameters.
Regarding claim 15, Cummings discloses all the limitations of the electrical stimulation device (Fig. 1; abstract) of claim 1 mentioned above. However, Cummings does not disclose the display of claim 1 or wherein the one or more actuators include a button that, when depressed, causes the generation of one or more stimulation pulses.
Brunson, in the same field of endeavor of displaying stimulation device parameters, includes a display ([0086]; “The device head 110 can further include other user interfacing features not shown such as a screen or an indicator for displaying an operating or function mode). However, Brunson does not disclose wherein the one or more actuators include a button that, when depressed, causes the generation of one or more stimulation pulses.
Yates, concerned with the same problem as Cummings of a mechanism that allows the user to control device output parameters, discloses wherein the one or more actuators (fig. 2; 122; para. [0053]; “an energy button 122”) include a button (fig. 2; 122; para. [0053]; “an energy button 122”) that, when depressed, causes the generation of one or more stimulation pulses (para. (0054); “The energy button 122 controls the delivery of energy to the electrodes; additionally, para. [0068] specifies that the stimulation is a pulse).
It would have been obvious for one of ordinary skill in the art before the effective filling date to combine the display on the stimulation device of Brunson on the handle of the electrosurgical device of Cummings since doing so would enable Cumming’s invention to provide an improved means of feedback to the user regarding the parameters of the device. Further, it would have been obvious for one of ordinary skill in the art before the effective filling date to combine the actuator button of Yates that, when depressed, generates stimulation, with the stimulation device of Cummings. Combining button is obvious since it would allow the user to easily control when the stimulation is turned on and generated for the device.
Regarding claim 18, Cummings discloses all the limitations of the electrical stimulation device (Fig. 1; abstract) of claim 1 mentioned above. However, Cummings does not disclose the display of claim 1 or wherein the device is configured for use in one or more of the following: locating one or more nerves; identifying one or more nerves, including identifying one or more of motor nerves and sensory nerves; stimulating regeneration of one or more nerves; providing a nerve block to one or more nerves; and managing and relieving nerve pain.
63. Brunson, in the same field of endeavor of displaying stimulation device parameters, includes a display ([0086]; “The device head 110 can further include other user interfacing features not shown such as a screen or an indicator for displaying an operating or function mode). However, Brunson does not disclose wherein the device is configured for use in one or more of the following: locating one or more nerves; identifying one or more nerves, including identifying one or more of motor nerves and sensory nerves; stimulating regeneration of one or more nerves; providing a nerve block to one or more nerves; and managing and relieving nerve pain.
64. Yates discloses a bilateral jaw configuration nerve stimulation device. Yates, in the same field of endeavor of nerve stimulation, discloses wherein the device (Fig. 1) is configured for use in one or more of the following: locating one or more nerves (para. [0051]; “locating the nerves by this type of stimulation may be achieved through any of three desired usage modes”) identifying one or more nerves), including identifying one or more of motor nerves and sensory nerves; stimulating regeneration of one or more nerves; providing a nerve block to one or more nerves; and managing and relieving nerve pain.
65. It would have been obvious for one of ordinary skill in the art before the effective filing date to configure the combined stimulation device of Cummings and display of Brunson with the intended uses of Yates. A device with all the particular elements of claim 1 would be able to perform the functions mentioned in claim 18. Further, both Cummings and Yates are both in the field of electrosurgery tools, and the uses mentioned in claim 18 are common uses of these instruments.
66. Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Cummings et al. (US 2011/0306973 A1, “Cummings”), Brunson et al. (US 2017/0189227 A1, “Brunson”), and McFarlin et al. (US 20160287861 A1, McFarlin), herein after referred to as McFarlin.
Regarding claim 12, Cummings discloses all the limitations of the electrical stimulation device (Fig. 1; abstract) of claim 1 mentioned above. However, Cummings does not disclose the display of claim 1 or wherein the device is capable of providing both: monophasic stimulation in which the stimulation portion acts only stimulation probe and the return portion acts only as a return probe; and biphasic stimulation in which the stimulation portion and return portion each act as stimulation and return probes in an alternating manner.
Brunson, in the same field of endeavor of displaying stimulation device parameters, includes a display ([0086]; “The device head 110 can further include other user interfacing features not shown such as a screen or an indicator for displaying an operating or function mode). However, Brunson does not disclose wherein the device is capable of providing both: monophasic stimulation in which the stimulation portion acts only stimulation probe and the return portion acts only as a return probe; and biphasic stimulation in which the stimulation portion and return portion each act as stimulation and return probes in an alternating manner.
McFarlin discloses a tool for stimulating nerve tissue using both monophasic and biphasic stimulation. McFarlin 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 filling date to combine the display on the stimulation device of Brunson on the handle of the electrosurgical device of Cummings since doing so would enable Cumming’s invention to provide an improved means of feedback to the user regarding the parameters of the device. Further, it would have been obvious for one of ordinary skill in the art before the effective filling date to combine the monophasic and biphasic capabilities of McFarlin with the surgical tool of Cummings since doing so would give the device versatility in the type of power supply (either direct current or alternating current). Further, combining the monophasic and biphasic capabilities would reduce the buildup of harmful electrical charge that can occur with devices only capable of monophasic stimulation.
Claim(s) 13 and 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cummings et al. (US 2011/0306973 A1, “Cummings”), Brunson et al. (US 2017/0189227 A1, “Brunson”), and Kermani et al. (US 20140276352 A1, “Kermani”), herein after referred to as Kermani.
Regarding claim 13, Cummings discloses all the limitations of the electrical stimulation device (Fig. 1; abstract) of claim 1 mentioned above. However, Cummings does not disclose the display of claim 1 or wherein the device is configured to provide one or more of tactile feedback, auditory feedback, or visual feedback to a user.
Brunson, in the same field of endeavor of displaying stimulation device parameters, includes a display ([0086]; “The device head 110 can further include other user interfacing features not shown such as a screen or an indicator for displaying an operating or function mode). However, Brunson does not disclose wherein the device is configured to provide one or more of tactile feedback, auditory feedback, or visual feedback to a user.
Kermani discloses an electrical stimulation system and method of providing iontophoresis. Kermani, concerned with the common problem as Brunson of providing a means to provide feedback to the user, discloses wherein the device (abstract; Fig. 1) is configured to provide one or more of tactile feedback, auditory feedback, or visual feedback to a user (para. [0080]; “operable to drive an operator feedback feature”; “Such feedback may be audible (e.g., a tone, buzzer, etc.), visual (e.g., a light illuminating, a display providing a textual/graphic indication, etc.), and/or haptic (e.g., a handheld version of control unit (170) vibrating, etc.)”).
It would have been obvious for one of ordinary skill in the art before the effective filling date to combine the display on the stimulation device of Brunson on the handle of the electrosurgical device of Cummings since doing so would enable Cumming’s invention to provide an improved means of feedback to the user regarding the parameters of the device. Further, it would have been obvious for one of ordinary skill in the art before the effective filling date to combine the feedback mechanisms of Kermani with the surgical device of Cummings since doing so would provide the user with information regarding the current status and function of the surgical tool. Lastly, the feedback system would alert the user to make when necessary that would ensure a successful surgical procedure.
Regarding claim 14, Cummings discloses all the limitations of the electrical stimulation device (Fig. 1; abstract) of claim 1 mentioned above. However, Cummings does not disclose the display of claim 1 or wherein the device is configured to provide one or more of tactile feedback, auditory feedback, or visual feedback to a user. Additionally, Cummings does not disclose wherein the device is configured to provide tactile feedback as a vibration.
Brunson, in the same field of endeavor of displaying stimulation device parameters, includes a display ([0086]; “The device head 110 can further include other user interfacing features not shown such as a screen or an indicator for displaying an operating or function mode). However, Brunson does not disclose wherein the device is configured to provide one or more of tactile feedback, auditory feedback, or visual feedback to a user or wherein the device is configured to provide tactile feedback as a vibration.
Kermani, concerned with the common problem as Brunson of providing a means to provide feedback to the user, discloses wherein the device (abstract; Fig. 1) is configured to provide one or more of tactile feedback, auditory feedback, or visual feedback to a user (para. [0080]; “operable to drive an operator feedback feature”; “Such feedback may be audible (e.g., a tone, buzzer, etc.), visual (e.g., a light illuminating, a display providing a textual/graphic indication, etc.), and/or haptic (e.g., a handheld version of control unit (170) vibrating, etc.)”). Additionally, Kermani discloses wherein the device (abstract; Fig. 1) is configured to provide tactile feedback as a vibration (para. [0080]; “and/or haptic (e.g., a handheld version of control unit (170) vibrating, etc.”)
It would have been obvious for one of ordinary skill in the art before the effective filling date to combine the display on the stimulation device of Brunson on the handle of the electrosurgical device of Cummings since doing so would enable Cumming’s invention to provide an improved means of feedback to the user regarding the parameters of the device. Further, it would have been obvious for one of ordinary skill in the art before the effective filling date to combine the feedback mechanisms of Kermani with the surgical device of Cummings since doing so would provide the user with information regarding the current status and function of the surgical tool. Moreso, the means of feedback would prompt the user to make necessary changes to ensure a successful surgical procedure. Lastly, combining vibration feature of Kermani as the specific type of feedback with the surgical tool of Cummings would have been obvious since vibrations are a feedback mechanism that better ensures the users attention is caught. Additionally, vibration feedback is a better mechanism for alerting the user when the user’s auditory and visual senses are already occupied, as in the case of a surgical procedure.
Claim(s) 16 is are rejected under 35 U.S.C. 103 as being unpatentable over Cummings et al. (US 2011/0306973 A1, “Cummings”), Brunson et al. (US 2017/0189227 A1, “Brunson”), and Bhagat et al. (US 11052249 B2, “Bhagat”), hereinafter referred to as Bhagat.
Regarding claim 16, Cummings discloses all the limitations of the electrical stimulation device (Fig. 1; abstract) of claim 1 mentioned above. However, Cummings does not disclose the display of claim 1 or wherein the one or more actuators includes a set of control buttons configured to receive an input value to increase or decrease value by a predetermined amount, the input value being one of: a pulse width; a current amplitude; or a frequency; of the electricity supplied to the stimulation portion.
Brunson, in the same field of endeavor of displaying stimulation device parameters, includes a display ([0086]; “The device head 110 can further include other user interfacing features not shown such as a screen or an indicator for displaying an operating or function mode). However, Brunson does not disclose wherein the one or more actuators includes a set of control buttons configured to receive an input value to increase or decrease value by a predetermined amount, the input value being one of: a pulse width; a current amplitude; or a frequency; of the electricity supplied to the stimulation portion.
Bhagat discloses a neuromuscular stimulation device used for therapeutic treatment. Bhagats, concerned with the same problem of controlling stimulation parameters, discloses wherein the one or more actuators includes a set of control buttons (Fig. 4A and 4B; para. 25; “user uses a graphical user interface”) configured to receive an input value (Fig. 4A and 4B; user specifies the pulse parameters) to increase or decrease value by a predetermined amount (para. (9); “using a network of switches and resistors, we can selectively divert or attenuate the current in the subsequent output drivers and thus, proportionally control the current intensities”; the disclosed control method describes the attenuation of current as a means of increasing and decreasing), the input value being one of: a pulse width; a current amplitude; or a frequency; of the electricity supplied to the stimulation portion (Fig. 1; para. (22); “the user uses a graphical user interface (GUI) to specify the stimulation parameters such as pulse-duration, amplitude, inter-phase delay, etc”).
It would have been obvious for one of ordinary skill in the art before the effective filling date to combine the display on the stimulation device of Brunson on the handle of the electrosurgical device of Cummings since doing so would enable Cumming’s invention to provide an improved means of feedback to the user regarding the parameters of the device. Further, it would have been obvious to combine the control buttons of the graphical interface of Bhagat with the surgical device of Cummings since doing so would allow the user to specify specific output parameters to the leads of the stimulation device. Lastly, doing so would provide more control and modulation of output parameters during stimulation, giving the device more versatility.
Claim(s) 17 is are rejected under 35 U.S.C. 103 as being unpatentable over Cummings et al. (US 2011/0306973 A1, “Cummings”) Brunson et al. (US 2017/0189227 A1, “Brunson”), and Goetz et. al. (US 20070203540 A1, “Goetz”), herein after referred to as Goetz.
Regarding claim 17, Cummings discloses all the limitations of the electrical stimulation device (Fig. 1; abstract) of claim 1 mentioned above. However, Cummings does not disclose the display of claim 1 or wherein the display is a liquid crystal display (LCD).
Brunson, in the same field of endeavor of displaying stimulation device parameters, includes a display ([0086]; “The device head 110 can further include other user interfacing features not shown such as a screen or an indicator for displaying an operating or function mode). However, Brunson does not disclose wherein the display is a liquid crystal display (LCD).
Goetz discloses a stimulation lead with complex electrode array geometry with a user interface display. Goetz, concerned with the similar problem as Brunson as displaying information on a user interface, discloses wherein the display is a liquid crystal display (para. [0069]; “The user interface of programmer 19 displays, e.g., with a liquid crystal display (LCD).
It would have been obvious for one of ordinary skill in the art before the effective filling date to combine the display on the stimulation device of Brunson on the handle of the electrosurgical device of Cummings since doing so would enable Cumming’s invention to provide an improved means of feedback to the user regarding the parameters of the device. Further, it would have been obvious for one of ordinary skill in the art before the effective filling date to combine the liquid crystal display of Goetz user interface with the display of Brunson since doing so would optimize visual appearance of the transmitted device information to the user.
Conclusion
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/O.L.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796