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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/2/2025 has been entered.
Response to Arguments
Applicant's arguments filed 10/2/2025 have been fully considered but they are not persuasive. The applicant argues that Chancellor is using a blocking threshold and the instant application is using at least 3 times an excitation threshold and argues an excitation threshold it determined by delivering stimulation at lower frequencies and by increasing the intensity to a degree that action potentials are induced. The examiner notes the claim does not require delivering excitation threshold to induce an action potential. The claim has the stimulation intensity which produces “a complete conduction block” using super-threshold intensity of at least 3 times the excitation threshold. The disclosure indicates in Paragraph [0117] of the instant published disclosure that nerve block can be initiated by super-threshold stimulation and the block will persist after ending the stimulation. Therefore the arguments that Chancellor is using a blocking threshold is not persuasive as the intensity emitted by the claimed device is multiple levels above an excitation threshold and produces a block of both pudendal nerves which persists after the stimulation has ended. Therefore, it is a question of what is an intensity that is a super-threshold that will block a nerve. The instant disclosure provides in Paragraph [0012] that the intensity is of 0.01mA to 100mA to produce at least five times the excitation threshold of the nerve. Paragraph [0024] discloses to produce an intensity greater than an excitation threshold of the nerve to produce a block of nerve condition the pulse generator delivers stimulation at an intensity of 0.01mA to 50mA. Numerous other paragraphs such as [0050], [0066], and [0145] disclose overlapping ranges. Therefore, while Chancellor does disclose a blocking stimulation, the instant disclosure also is using a blocking stimulation (e.g. Paragraph [0117]). Applicant argues that Chancellor had no consideration of post-stimulation block and thus no basis for the inventors there to investigate stimulation parameters that would induce such block. The examiner respectfully disagrees as MPEP 2112.02 states “[u]nder the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.” Since Chancellor utilizes in Paragraph [0060] applying stimulation to the left and right pudendal nerves to completely block contraction of the EUS or anal sphincter using a biphasic pulse with square (or other) shapes. Chancellor teaches in Paragraph [0073] using .5 to 15 Hz for inhibition of bladder contractions including anus (urethra) and in Paragraph [0157] of using a frequency of 1kHz to 10kHz; thereby overlapping with the claimed range of 1Hz to less than 4kHz. Paragraph [0157] discloses a duration of 10 seconds and Paragraph [0048] discloses applying blocking stimulation of 2mA for 10 seconds; thereby overlapping the claimed intensity and period. Applicant argues that using 4khZ, at 2mA as taught by Chancellor would not result in an action potential, but would immediately move to a blocked state (e.g. the stimulation was delivered at greater than the blocking threshold). This argument is not persuasive as the instant disclosure in paragraph [0121] teaches to produce generate nerve block is 1T, 2T, 3T, 4T, 5T, 10T, 20T, 30T, 40T, 50T, 60T, 70T, 80T, 90T, 100T, or higher. The claim does not have a capped value and could in include ∞T, which is greater than 3T. A stimulation value greater than the excitation threshold produces a nerve block. The applicant then argues that the stimulation of Chancellor is greater than the blocking threshold and would not induce an action potential. The claim nor the disclosure require the generation of an action potential in order to generate a nerve block. It is not clear based on this argument what the difference in the stimulation intensity generated by the instant invention and Chancellor is that would produce the alleged different outcomes. The examiner notes that Figure 1 of the instant disclosure and Paragraph [0117] states “[n]erve block can be initiated by super-threshold stimulation of a certain duration, and the block will persist after ending the stimulation (e.g., post-stimulation block). Therefore, it appears as if both the instant invention and Chancellor (as argued) use the stimulation to generate a nerve block signal. The Applicant argues that the claimed frequency of less than 4kHz cannot induce a block during stimulation, hence the high frequency stimulation disclosed by Chancellor was required and since block during stimulation was the focus of Chancellor, there was no impetus to administer stimulation at a lower frequency for the length of time required to induce post-stimulation block. The examiner respectfully disagrees as Paragraph [0157] discloses applying different frequency ranges from 1kHz to 10kHz for a 10 second duration. The instant disclosure in Paragraph [0123] teaches the super-threshold stimulation is applied for very short intervals (e.g. 5 seconds to 70 seconds). Therefore since 10 seconds is greater than 5 seconds the argument is not persuasive.
Claim Rejections - 35 USC § 102/103
Claim(s) 23, 24, 27, 28, 33-38, 55, 56, 59, 60, and 65-69 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chancellor et al (US Publication 2009/0036945) or, in the alternative, under 35 U.S.C. 103 as obvious over Gaunt et al (US Publication 2006/0184211).
Referring to Claim 23, Chancellor et al teaches a method of controlling micturition or defecation in a patient (e.g. Paragraph [0003]) comprising: applying a first electrical stimulation to the left pudendal nerve or branches thereof and a second electrical stimulation to the right pudendal nerve or branches thereof of a patient (e.g. Figure 2 A, electrode 2 and 3 and Paragraphs [0025] and [0060] discloses blocking both left and right pudendal nerve), wherein the first and second electrical stimulation is of an intensity that is equal to or greater than three times an excitation threshold (3T) of the pudendal nerve for a length of time sufficient to produce a complete conduction block of both pudendal nerves after ending the first and/or second electrical stimulation, thereby inhibiting contraction of the external urethral sphincter (EUS) and/or external anal sphincter (EAS) (e.g. Paragraph [0060] discloses applying a blocking electrical signal to the pudendal nerve to completely block reflexive contraction of the EUS and/or anal sphincter), wherein the electrical stimulation for pudendal nerve block is delivered at a frequency of 1Hz to less than 4kHz (e.g. Paragraph [0157]), and immediately after ending the first and/or second electrical stimulation when the EUS/EAS is relaxed, applying a third electrical stimulation to the left or right pudendal nerve at a location central to the blocked pudendal nerve site to induce bladder or colon/rectal contraction (e.g. Figure 2, Electrode 1 and Paragraph [0025] discloses while the blocking signal is applied activating an signal to induce bladder contraction), or immediately after ending the first and/or second electrical stimulation when the EUS/EAS is relaxed, applying a third electrical stimulation to a sacral spinal root (S1, S2, S3, or S4) to induce bladder or colon/rectal contraction, or immediately after ending the first and/or second electrical stimulation when the EUS/EAS is relaxed, applying a third electrical stimulation to the spinal cord by epidural electrodes, or skin surface electrodes or electromagnetic coils to induce bladder or colon/rectal contraction, or immediately after ending the first and/or second electrical stimulation when the EUS/EAS is relaxed, applying a third electrical stimulation to pelvic nerve to induce bladder or colon/rectal contraction, or immediately after ending the first and/or second electrical stimulation and when the EUS/EAS relaxation, manually applying pressure to the abdominal area to produce bladder or colon/rectal pressure (The examiner notes these are limitations are recited in the alternative and the examiner has found prior art teaching immediately after ending the first and/or second electrical stimulation when the EUS/EAS is relaxed, applying a third electrical stimulation to the left or right pudendal nerve at a location central to the blocked pudendal nerve site to induce bladder or colon/rectal contraction).
In order to advance prosecution and Chancellor does not disclose a frequency of 1Hz to less than 4kHz the examiner notes Gaunt et al teaches that it is known to use blocking of the pudendal nerve at frequencies of 1 kHz, 2 kHz and greater than 200Hz as set forth in Paragraphs [0037], [0038], [0069], [0071], [0099] to provide a range of values for optimized nerve blocking on an individual basis. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Chancellor et al, with blocking of the pudendal nerve at frequencies of 1 kHz, 2 kHz and greater than 200Hz as taught by Gaunt et al, since such a modification would provide the predictable results of a range of values for optimized nerve blocking on an individual basis.
Referring to Claims 24 and 56, Chancellor et al in view of Gaunt et al teaches the claimed invention, wherein the first and second electrical stimulation for pudendal nerve block is delivered at an intensity that is at least five times the excitation threshold of the pudendal nerve, (e.g. Paragraph [0048] discloses the biphasic stimulation pulses in 10 second blocks at 2mA intensity), at a frequency of 1 Hz to 1.5 kHz (e.g. Paragraph [0157] discloses using 1 kHz to 10 kHz in 1 kHz increments), and wherein the first and second electrical stimulation for pudendal nerve block is delivered for a period of from 5 seconds to 60 minutes (e.g. Paragraph [0157] discloses 10 second duration).
Referring to Claims 27 and 59, Chancellor et al in view of Gaunt et al teaches the claimed invention, wherein the first and second electrical stimulation results in the block of pudendal nerve conduction for at least 10 seconds following cessation of the electrical stimulation (e.g. Paragraphs [0048] and [0157] disclose blocking stimulation with the same intensity, frequency, and duration; therefore it would necessarily produce the same results).
Referring to Claims 28 and 60, Chancellor et al in view of Gaunt et al teaches the claimed invention, wherein the first and second electrical stimulation comprises symmetric biphasic electrical pulses (e.g. Figure 2, electrodes 2 and 3 and Paragraph [0060]).
Referring to Claims 33 and 65, Chancellor et al in view of Gaunt et al teaches the claimed invention, further comprising, once block of pudendal nerve conduction or excitation is achieved, maintaining the block by changing the intensity and/or frequency of the first and/or second electrical stimulation (e.g. Paragraph [0158] discloses the high-frequency blocking stimulation alone was gradually reduced as the stimulation frequency increased).
Referring to Claim 34, Chancellor et al teaches the method of claim 23, wherein the first and second stimulation comprises biphasic pulses at an intensity of 6-9 mA and a frequency of between 100Hz and 1kHz and applied for 10-60 seconds (e.g. Paragraphs [0050] discloses a stimulation of 6mA, [0157] discloses 1 kHz and [0157] and [0159] discloses applying a biphasic high frequency stimulation to block the pudendal nerve with a duration of 10 seconds).
In the alternative, Gaunt et al teaches that it is known to use blocking of the pudendal nerve at frequencies of 1 kHz, 2 kHz and greater than 200Hz as set forth in Paragraphs [0037], [0038], [0069], [0071], [0099] to provide a range of values for optimized nerve blocking on an individual basis. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Chancellor et al, with blocking of the pudendal nerve at frequencies of 1 kHz, 2 kHz and greater than 200Hz as taught by Gaunt et al, since such a modification would provide the predictable results of a range of values for optimized nerve blocking on an individual basis.
Referring to Claims 35 and 66, Chancellor et al in view of Gaunt et al teaches the claimed invention, wherein the third electrical stimulation for inducing bladder or colon/rectal contraction and applied to the pudendal nerve, the sacral (S1, S2, S3, or S4) spinal root, spinal cord, or the pelvic nerve has a frequency between 1 Hz to 100 Hz (e.g. Figure 1B electrode 1 and Paragraph [0025] discloses 20Hz induces bladder contraction and Paragraph [0064]).
Referring to Claims 36 and 67, Chancellor et al in view of Gaunt et al teaches the claimed invention, wherein the third electrical stimulation is delivered at an intensity above the excitation threshold, thereby causing bladder or colon/rectal contraction and causing bladder or colon/rectal pressure to increase more than 20 cm H2O (e.g. Figure 7 and Paragraph [0083] discloses the applied stimulation to electrode 1 elicited 40 cm H2O).
Referring to Claims 37 and 68, Chancellor et al in view of Gaunt et al teaches the claimed invention, wherein the third stimulation is delivered for a period longer than the period of bladder or colon/rectal contraction (e.g. Paragraph [0021] discloses to facilitate micturition the 15 to 50Hz signal is applied in intervals of 0.5 to 60 seconds).
Referring to Claims 38 and 69, Chancellor et al in view of Gaunt et al teaches the claimed invention, further comprising, once the bladder or colon/rectal contraction has ended, stopping application of the third electrical stimulation for a period of at least 10 seconds, after the period has concluded, resuming the third stimulation at the same or different intensity and/or at the same or different frequency to induce bladder or colon contraction again while the pudendal nerves are blocked and the EUS/EAS is relaxed (e.g. Paragraph [0021] discloses to facilitate micturition the 15 to 50Hz signal is applied in intervals with 0.5 seconds to 5 minutes between intervals).
Referring to Claim 55, Chancellor et al teaches a device controlling micturition or defecation in a patient comprising: a controller (e.g. Paragraph [0023] discloses the system comprises a controller for controlling parameters of the electrical pulses); one or two pulse generators in communication with the controller (e.g. Paragraphs [0023] and [0064]); one or more lead and/or cuff electrodes (e.g. Figure 1, leads 12 and 13 and Paragraph [0068] discloses cuff electrodes), configured to be placed near or in contact with the left and/or right pudendal nerves, the electrodes in electrical communication with the first pulse generator (e.g. Figure 2 electrodes 2 and 3 and Paragraphs [0025] and [0060] discloses blocking both left and right pudendal nerve), wherein the device is configured to apply an electrical stimulation to the pudendal nerve, wherein the electrical stimulation is of an intensity that is equal to or greater than three times an excitation threshold (3T) of the pudendal nerve for a length of time sufficient to produce a complete block of pudendal nerve conduction after ending the electrical stimulation, thereby inhibiting contraction of the external urethral sphincter (EUS) and/or the external anal sphincter (EAS) (e.g. Paragraph [0060] discloses applying a blocking electrical signal to the pudendal nerve to completely block reflexive contraction of the EUS and/or anal sphincter); wherein the electrical stimulation for pudendal nerve block is delivered at a frequency of 1Hz to less than 4kHz (e.g. Paragraph [0157]); and either another lead and/or cuff electrode, configured to be placed near or in contact with the blocked pudendal nerve at a site central to the blocked site, or be placed near or in contact with the sacral (S1, S2, S3, or S4) spinal root, spinal cord, or pelvic nerve, the another lead and/or cuff electrode in electrical communication with the first pulse generator, wherein the device is configured to apply electrical stimulation using the another lead and/or cuff electrode immediately after the ending of pudendal nerve blocking stimulation at an intensity that is greater than an excitation threshold of the pudendal nerve, sacral (S1, S2, S3, or S4) spinal root, spinal cord, or pelvic nerve to induce bladder or colon/rectal contraction (e.g. Figure 2, Electrode 1 (on the pudendal nerve) and Paragraph [0025] discloses while the blocking signal is applied activating an signal to induce bladder contraction); or skin surface electrodes or electromagnetic coils, configured to be placed on the skin surface along the patient's spine and in electrical communication with the second pulse generator, and wherein the device is configured to apply electrical stimulation using the skin surface electrodes or electromagnetic coils immediately after the ending of pudendal nerve blocking stimulation at an intensity that is greater than an excitation threshold of the spinal cord to induce bladder or colon/rectal contraction (The examiner notes these are limitations are recited in the alternative and the examiner has found prior art teaching another lead and/or cuff electrode, configured to be placed near or in contact with the blocked pudendal nerve at a site central to the blocked site and configured to apply electrical stimulation using the electrode immediately after the ending of pudendal nerve blocking stimulation at an intensity that is greater than an excitation threshold of the pudendal nerve to induce bladder or colon/rectal contraction).
In order to advance prosecution and Chancellor does not disclose a frequency of 1Hz to less than 4kHz a, the examiner notes Gaunt et al teaches that it is known to use blocking of the pudendal nerve at frequencies of 1 kHz, 2 kHz and greater than 200Hz as set forth in Paragraphs [0037], [0038], [0069], [0071], [0099] to provide a range of values for optimized nerve blocking on an individual basis. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Chancellor et al, with blocking of the pudendal nerve at frequencies of 1 kHz, 2 kHz and greater than 200Hz as taught by Gaunt et al, since such a modification would provide the predictable results of a range of values for optimized nerve blocking on an individual basis.
Claim(s) 32 and 64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chancellor et al (US Publication 2009/0036945) in view of Gaunt et al (US Publication 2006/0184211), as applied above and further in view of Yang et al (Yang et al., “Pudendal Nerve Stimulation and Block by a Wireless-Controlled Implantable Stimulator in Cats”, Neuromodulation, 2014, pp.490-496, Vol.17 (cited in IDS dated 4/22/2022).
Referring to Claims 32 and 64, Chancellor et al in view of Gaunt et al teaches the claimed invention, except further comprising, once block of pudendal nerve conduction is achieved, stopping application of the first and/or second electrical stimulation for a period of at least 10 seconds, wherein the block of pudendal nerve conduction is maintained during the period and, after the period has concluded, resuming the first and/or second electrical stimulation of the pudendal nerve or branch thereof at the same or different intensity and/or at the same or different frequency to continue or prolong the block of pudendal nerve conduction.
Yang et al teaches that it is known to use stopping application of the first and second stimulation for a period of about 50 seconds, where the block of pudendal nerve conduction is partially maintained during the period and, after the period is concluded, resuming the first and second electrical stimulation of the pudendal nerve at the same intensity and frequency as set forth in Figure 5A to provide EUS relaxation without continual stimulation that could lead to inadvertent charge build up or nerve damage. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Chancellor et al, with topping application of the first and second stimulation for a period of about 50 seconds, where the block of pudendal nerve conduction is partially maintained during the period and, after the period is concluded, resuming the first and second electrical stimulation of the pudendal nerve at the same intensity and frequency as taught by Yang et al, since such a modification would provide the predictable results of continual stimulation that could lead to inadvertent charge build up or nerve damage.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796