Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. This action is responsive to the amendments filed 12/19/2025. Claim 1 has been amended. No claims were canceled or newly added.
Response to Arguments
3. Applicant’s arguments filed on 12/19/2025 with respect to the art rejections have been fully considered but they are not persuasive. In substance, applicant argues that A) The combination of McClure, Baru, and Wu does not teach first, second, and third metal contacts.
4. In response to A), the examiner respectfully disagrees.
At the onset, the Applicant is reminded to view the rejection as a whole. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). McClure teaches projections with a metal contact on each prong (see paragraph 0035). Additionally, Wu teaches three projections (see T97 heading). Therefore, the combination of McClure, Baru, and Wu still meet the scope of the limitations as currently claimed.
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 1-4, 6-13, and 17-19 are rejected under 35 U.S.C 103 as being unpatentable over McClure et al. (US Pub.: 2006/0195143 A1, – Previously Cited) and further in view of Baru et al. (US Pub.: 2019/0030339 A1, – Previously Cited) and further in view of Wu et al. (NPL reference, “A revisit of the clinically used methods for intraoperative nerve action potential recordings”, published May 2018, – Previously Cited).
Regarding claim 1, McClure teaches a system for stimulation or recording of a compound nerve action potential comprising:
a base (e.g. Fig. 2 – base 101),
having at least two projections (e.g. Fig. 2 – prongs 102; paragraph 0035),
wherein each of the at least two projections extends distally from the base (e.g. Fig. 2), wherein each of the at least two projections is positioned in parallel to each of the other projections (e.g. Fig. 2; paragraph 0034),
wherein at least one of the projections is configured to be positioned on a top side of a nerve fiber and at least one of the projections are configured to be positioned on a bottom side of the nerve fiber, such that the nerve fiber lies at least partially over and under the at least two projections, such that the nerve is woven through the projections, and such that the nerve is sandwiched by the projections (e.g. Fig. 2 – channel 104; paragraph 0042);
and such that the nerve fiber is in contact with underneath tissue to provide a non-lifting stimulation or recording (e.g. paragraphs 0034, 0032);
an electrode for stimulation or recording of a nerve action potential comprising a first metal contact positioned on a first projection of the two projections (e.g. Fig. 2 – electrode 103-1; paragraph 0035, – electrode is made of titanium),
wherein the electrode for stimulation or recording of a nerve action potential comprises a second metal contact positioned on a second of the two projections (e.g. Fig. 2 – electrode 103-2; paragraph 0035, – electrode is made of titanium);
wherein the base and the electrode are self-insulating and self-holding, such that a non-lifting nerve action potential can be stimulated and/or recorded (e.g. Fig. 2; paragraph 0036). However, McClure does not explicitly teach an elastic base and that there are at least three projections (i.e. the presence of at least a third projection). As a result, McClure also does not teach at least two of the at least three projections are configured to be positioned on a bottom side of the nerve fiber, such that the nerve fiber lies at least partially over and under the at least three projections, such that the nerve is woven through the at least three projections and such that the nerve fiber is sandwiched by the at least three projections and wherein the electrode for stimulation or recording comprises a third metal contact positioned on a third projection of the three projections, such that the first metal contact and the third metal contact are positioned conductively on a bottom side of the nerve fiber, and such that the second metal contact is conductively positioned on a top side of the nerve fiber.
Baru, in a same field of endeavor of neural stimulation systems, discloses an elastic base (e.g. paragraph 0064 – silicone rubber).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of McClure to include an elastic base, as taught and suggested by Baru, in order to increase the flexibility of the system.
However, McClure in view of Baru does not explicitly teach that there are at least three projections (i.e. the presence of at least a third projection). As a result, McClure in view of Baru also does not teach at least two of the at least three projections are configured to be positioned on a bottom side of the nerve fiber, such that the nerve fiber lies at least partially over and under the at least three projections, such that the nerve is woven through the at least three projections and such that the nerve fiber is sandwiched by the at least three projections and wherein the electrode for stimulation or recording comprises a third metal contact positioned on a third projection of the three projections, such that the first metal contact and the third metal contact are positioned conductively on a bottom side of the nerve fiber, and such that the second metal contact is conductively positioned on a top side of the nerve fiber.
Wu, in a same field of endeavor of neural stimulation/recording systems, discloses a third projection (i.e. three projections) and thus further teaches wherein at least one of the at least three projections is configured to be positioned on a top side of a nerve fiber and at least two of the at least three projections are configured to be positioned on a bottom side of the nerve fiber, such that the nerve fiber lies at least partially over and under the at least three projections such that the nerve is woven through the at least three projections and such that the nerve is sandwiched by the at least three projections and wherein the electrode for stimulation or recording comprises a third metal contact positioned on a third projection of the three projections, such that the first metal contact and the third metal contact are positioned conductively on a bottom side of the nerve fiber, and such that the second metal contact is conductively positioned on a top side of the nerve fiber (e.g. T97 heading, – “when the nerve was placed between the middle prong and the outer 2 prongs (i.e. ‘sandwich stimulation’)”, – the nerve is interweaved between the 3 prongs and the position of the top/bottom is relative to how the nerve is positioned).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of McClure and Baru to include a third projection, as taught and suggested by Wu, in order to make the system more effective by having the potentials increased markedly in size and to have a better grip on the nerve (Wu, T97 heading).
Regarding claim 2, McClure in view of Baru in view of Wu teaches the system of claim 1 as discussed above, and McClure further teaches wherein a middle projection and two outer projections comprise insulation that covers all of the middle projection and the two outer projections except for an area of the metal contact for nerve stimulation or recording (e.g. paragraphs 0036).
Regarding claim 3, McClure in view of Baru in view of Wu teaches the system of claim 1 as discussed above, and Baru further teaches further comprising the elastic base being formed from one selected from a group consisting of a plastic or silicone (e.g. paragraph 0064 – silicone rubber).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of McClure, Baru, and Wu to include the elastic base being formed from one selected from a group consisting of a plastic or silicone, as taught and suggested by Baru, for the purpose of increasing the biocompatibility of the system.
Regarding claim 4, McClure in view of Baru in view of Wu teaches the system of claim 1 as discussed above, and McClure further teaches wherein a pressure is applied to the nerve fiber because it is sandwiched by the at least three projections and wherein the pressure is less than what would be damaging to the nerve fiber for a duration of a test of the compound nerve action potential (e.g. Fig. 5; paragraphs 0042, 0045).
Regarding claim 6, McClure in view of Baru in view of Wu teaches the system of claim 1 as discussed above, and McClure further teaches wherein the projections can be opened by applying pressure to the elastic base using fingers or a surgical tool (e.g. paragraph 0040).
Regarding claim 7, McClure in view of Baru in view of Wu teaches the system of claim 1 as discussed above, and Baru further teaches wherein the elastic base returns to its original shape after a deformation (e.g. paragraph 0064, – silicone rubber is an elastomer and an elastomer returning to its original shape after a deformation is an inherent property of an elastomer. See page 5 of McKeen NPL attached).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of McClure, Baru, and Wu to include wherein the elastic base returns to its original shape after a deformation, as taught and suggested by Baru, for the purpose of helping the base maintain its shape as well as increasing the biocompatibility of the system.
Regarding claim 8, McClure in view of Baru in view of Wu teaches the system of claim 1 as discussed above, and McClure further teaches further comprising a device for applying deformation force to the elastic base (e.g. paragraph 0040).
Regarding claim 9, McClure in view of Baru in view of Wu teaches the system of claim 1 as discussed above, and McClure further teaches the elastic base is configured such that an application of deformation force to the elastic base releases pressure on the nerve fiber (e.g. Fig. 2; paragraph 0040).
Regarding claim 10, McClure in view of Baru in view of Wu teaches the system of claim 1 as discussed above, and McClure further teaches wherein the elastic base is configured such that an application of deformation force allows the elastic base to be repositioned (e.g. paragraphs 0040, 0042).
Regarding claim 11, McClure in view of Baru in view of Wu teaches the system of claim 1 as discussed above, and Baru further teaches further comprising an impedance monitor (e.g. Fig. 2 – element 218 impedance measuring unit and element 221 impedance measurement unit; paragraph 0069, – the implantable pulse generator (IPG) has a built in impedance monitor).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of McClure, Baru, and Wu to include an impedance monitor, as taught and suggested by Baru, for the purpose of determining whether current is remaining constant during stimulation and assessing the status of the electrodes (Baru, paragraph 0069).
Regarding claim 12, McClure in view of Baru in view of Wu teaches the system of claim 11 as discussed above, and Baru further teaches wherein the impedance monitor measures impedance in real time (e.g. paragraph 0069, – the impedance measurement unit 218 measuring voltage difference whenever there is a delivery of current pulses by the current source is construed as real time measurement).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of McClure, Baru, and Wu to include wherein the impedance monitor measures impedance in real time, as taught and suggested by Baru, for the purpose of determining whether current is remaining constant during stimulation and assessing the status of the electrodes more accurately as well as improving safety.
Regarding claim 13, McClure in view of Baru in view of Wu teaches the system of claim 11 as discussed above, and Baru further teaches wherein the impedance monitor couples the electrode to a neural stimulator device (e.g. Fig. 1 – element 100 nerve cuff electrode, element 102 IPG, elements 104.1, 104.2, 104.3 electrode contacts; Fig. 2 – element 218 impedance measuring unit, element 219 current source; paragraph 0069).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of McClure, Baru, and Wu to include wherein the impedance monitor couples the electrode to a neural stimulator device, as taught and suggested by Baru, for the purpose of determining whether current is remaining constant during stimulation and assessing the status of the electrodes more accurately as well as improving safety.
Regarding claim 17, McClure in view of Baru in view of Wu teaches the system of claim 11 as discussed above, and Baru further teaches wherein the impedance monitor is configured to deliver short voltage pulses through the electrode (e.g. paragraph 0069).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of McClure, Baru, and Wu to include wherein the impedance monitor is configured to deliver short voltage pulses through the electrode, as taught and suggested by Baru, for the purpose of measuring the impedance more effectively as well as efficiently.
Regarding claim 18, McClure in view of Baru in view of Wu teaches the system of claim 11 as discussed above, and Baru further teaches wherein the impedance monitor further comprises an op-amp (e.g. Fig. 4 – element 401; paragraph 0078).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of McClure, Baru, and Wu to include wherein the impedance monitor further comprises an op-amp, as taught and suggested by Baru, for the purpose of increasing the effectiveness and efficiency of the circuit.
Regarding claim 19, McClure in view of Baru in view of Wu teaches the system of claim 18 as discussed above, and Baru further teaches wherein the op-amp measures output from a voltage divider (e.g. Fig. 4).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of McClure, Baru, and Wu to include wherein the op-amp measures output from a voltage divider, as taught and suggested by Baru, for the purpose of further increasing the effectiveness and efficiency of the circuit as well as being able to the voltage divider rule for calculations.
Claim 5 is rejected under 35 U.S.C 103 as being unpatentable over McClure and further in view of Baru and further in view of Wu and further in view of Hoffer et al. (NPL reference, “How to Use Nerve Cuffs to Stimulate, Record or Modulate Neural Activity”, published September 2000, – Previously Cited).
Regarding claim 5, McClure in view of Baru in view of Wu teaches the system of claim 1 as discussed above. However, McClure in view of Baru in view of Wu does not explicitly teach wherein the at least three projections comprise grooves at a location of the electrode contact with the nerve fiber, such that the nerve fiber is self-positioned on the grooves.
Hoffer, in a same field of endeavor of cuff electrodes, discloses wherein the at least three projections comprise grooves at a location of the electrode contact with the nerve fiber, such that the nerve fiber is self-positioned on the grooves (e.g. Fig. 8B; pages 19-20).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of McClure, Baru, and Wu to include grooves, as taught and suggested by Hoffer, for the purpose of enhancing the recording selectivity achieved from the electrodes (Hoffer, page 5).
Claims 14-16 and 20 are rejected under 35 U.S.C 103 as being unpatentable over McClure and further in view of Baru and further in view of Wu and further in view of Gozani et al. (US Pub.: 2014/0296934 A1, – Previously Cited).
Regarding claim 14, McClure in view of Baru in view of Wu teaches the system of claim 11 as discussed above. However, McClure in view of Baru in view of Wu does not explicitly teach wherein the impedance monitor comprises a light emitting diode (LED).
Gozani, in a same field of endeavor of nerve stimulation, discloses wherein the impedance monitor comprises a light emitting diode (LED) (e.g. Fig. 1 – element 108; paragraph 0067).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of McClure, Baru, and Wu to include an LED, as taught and suggested by Gozani, in order to provide the predictable results of providing a visual indication that an impedance threshold has been exceeded (Gozani, paragraph 0067).
Regarding claim 15, McClure in view of Baru in view of Wu in view of Gozani teaches the system of claim 14 as discussed above, and Gozani further teaches wherein the LED is configured to indicate whether the electrode has a good connection to the nerve fiber (e.g. paragraph 0067).
Regarding claim 16, McClure in view of Baru in view of Wu teaches the system of claim 11 as discussed above. However, McClure in view of Baru in view of Wu does not explicitly teach wherein the impedance monitor further comprises a switch, wherein the switch can be engaged to convert the electrode from stimulation and recording mode to impedance monitoring mode.
Gozani, in a same field of endeavor of nerve stimulation, discloses wherein the impedance monitor further comprises a switch, wherein the switch can be engaged to convert the electrode from stimulation and recording mode to impedance monitoring mode (e.g. paragraph 0066, – a switch).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of McClure, Baru, and Wu to include a switch, as taught and suggested by Gozani, for the purpose of being able to change between different functionalities of the device more effectively (Gozani, paragraph 0066).
Regarding claim 20, McClure in view of Baru in view of Wu teaches the system of claim 11 as discussed above. However, McClure in view of Baru in view of Wu does not explicitly teach wherein a low impedance measurement indicates the electrode is shorted through saline in the body and a high impedance measurement indicates that the electrode is not connected.
Gozani, in a same field of endeavor of nerve stimulation, discloses wherein a low impedance measurement indicates the electrode is shorted through saline in the body and a high impedance measurement indicates that the electrode is not connected (e.g. paragraphs 0065, 0070).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of McClure, Baru, and Wu to include impedance measurement thresholds, as taught and suggested by Gozani, for the purpose of being able to determine electrode contact more effectively and improve patient safety (Gozani, paragraph 0065).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792