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 .
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/06/2026, with respect to the rejection(s) of claim(s) under 35 USC 102/103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the following.
Claim(s) 1, 5-7, 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat Pub 20160339251 to Kent et al. (hereinafter “Kent” – on IDS).
Claim(s) 3-4, 8-11, 14-15, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub 20160339251 to Kent et al. (hereinafter “Kent” – on IDS).
Claim(s) 2, 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kent (US 20160339251) in view of US Pat Pub No 20210128928 to Serrano et al. (hereinafter “Serrano”).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kent as applied to claims 3-4, 8-11, 14-15, 20 above, and further in view of WO2020223165A1 to Zhang et al. (hereinafter “Zhang” – previously presented).
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.
Claim(s) 1, 5-7, 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat Pub 20160339251 to Kent et al. (hereinafter “Kent” – on IDS).
Regarding claim 1. (original) Kent discloses a method of providing electrical stimulation to a patient's spinal cord using a pulse generator (PG) connected to one or more electrode leads implanted in the patient's spinal column (para 0005, 0024, 0042, fig. 2), each electrode lead comprising a plurality of electrodes (para 0030 “electrodes 111a-d [] of the lead 110”), the method comprising: using a first one or more of the plurality of electrodes as stimulating electrodes to apply evoking stimulation to the patient's spinal cord (para 0005, “deliver excitation pulses to the first electrode based on a stimulation level”, para 0052, steps 202-204), using a second two or more of the plurality of electrodes as recording electrodes to record neural responses evoked in the patient's spinal cord by the evoking stimulation (para 0005 “positioning a second electrode proximate to a dorsal root”, para 0058-0061, steps 206-208 of fig. 2, para 0059 “second series of electrodes 303 of the lead 412 enable one or more of the electrodes 303 (e.g., the electrode 303a) to detect and/or measure the evoked []”), comparing the recorded evoked neural responses at each of the recording electrodes (para 0066), using the comparison to assess the electrode lead's placement with respect to the spinal cord (para 0063 “if the evoked potential waveform 706 is not detected by the sensing circuitry 158, the clinician may adjust a position of the lead (e.g., the lead 310, the leads 410, 412) during the intraoperative placement procedure.”).
Regarding claim 5. (original) Kent discloses the method of claim 1, wherein comparing the recorded evoked neural responses comprises extracting one or more features of the recorded neural responses (para 0120-0121, fig. 7).
Regarding claim 6. (original) Kent discloses the method of claim 5, wherein the extracted one or more features comprises one or more of a peak amplitude, an area under the curve, and a curve length (para 0120-0121, fig. 7).
Regarding claim 7. (original) The method of claim 1, wherein comparing the recorded evoked neural responses comprises determining an inversion location on the lead where a polarity of the evoked neural responses switch between positive polarity and negative polarity (para 0055-0057, fig. 5).
Regarding claim 16. (original) The method of claim 1, wherein the PG is an implantable pulse generator ([PG) (para 0005).
Regarding claim 18. (original) Kent discloses a system (para -0005-0006) for providing electrical stimulation to a patient's spinal cord using a pulse generator (PG) connected to one or more electrode leads implanted in the patient's spinal column (para 0005, 0024, 0042, figs. 1-2), each electrode lead comprising a plurality of electrodes (fig. 1, para 0049, “lead 310 includes a plurality of electrodes that form a first and second series of electrodes 302 and 303”), the system comprising: control circuitry configured to (para 0063 “controller”):use a first one or more of the plurality of electrodes as stimulating electrodes to apply evoking stimulation to the patient's spinal cord (para 0005, “deliver excitation pulses to the first electrode based on a stimulation level”, para 0052, steps 202-204), use a second two or more of the plurality of electrodes as recording electrodes to record neural responses evoked in the patient's spinal cord by the evoking stimulation (para 0005 “positioning a second electrode proximate to a dorsal root”, para 0058-0061, steps 206-208 of fig. 2, para 0059 “second series of electrodes 303 of the lead 412 enable one or more of the electrodes 303 (e.g., the electrode 303a) to detect and/or measure the evoked []”),compare the recorded evoked neural responses at each of the recording electrodes (para 0066), and use the comparison to assess the electrode lead's placement with respect to the spinal cord (e.g., the lead 310, the leads 410, 412) during the intraoperative placement procedure.”).
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 3-4, 8-11, 14-15, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub 20160339251 to Kent et al. (hereinafter “Kent” – on IDS).
Regarding claim 3. (original) Kent discloses the method of claim 1, wherein the evoked neural response occurs at least 2 milliseconds following the evoking stimulations (para 0105 “the controller 151 may determine that a negative peak occurring within a predetermined time 1224, such as 1 ms, after the delivery of the test excitation pulses”). It is noted that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It would be obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify the response to be more than 1ms as an exemplary disclosure by Kent.
Regarding claim 4. (original) The method of claim 1, wherein the evoked neural responses is indicative of synaptic activity within the patient's spinal cord (it is noted that the claim as recited does not provide any details regarding how the evoked neural responses is indicative of synaptic activity. Under its BRI, any evoked neural response captured could be indicative of synaptic activity as determined by a physician or automatically).
Regarding claim 8. (original) The method of claim 1, further comprising: using one or more patient metrics to determine a first stimulation configuration configured to provide optimized stimulation for the patient, using the first one or more of the plurality of electrodes to apply the optimized stimulation as the evoking stimulation, and determining a first value of one or more features of the recorded evoked neural response that correlates to the first stimulation configuration (para 0040, 0068, 0071, 0097, etc., the memory could store various parameter sets as well as the measurements).
Regarding claim 9. (original) The method of claim 8, wherein the one or more patient metrics comprise a pain level and/or pain-paresthesia overlap (para 0111).
Regarding claim 10. (original) The method of claim 8, wherein the one or more patient metrics comprise a patient posture (para 0083-0086).
Regarding claim 11. (original) The method of claim 8, wherein the one or more patient metrics are determined using one or more sensors and/or input received from the patient via an external device (para 0085).
Regarding claim 14. (original) The method of claim 8, wherein one or more features of the recorded evoked neural response comprises one or more of a peak amplitude, an area under the curve, a curve length and an inversion location on the lead where a polarity of the evoked neural responses switch between positive polarity to negative polarity (para 0094, 0120 “maximum amplitude”).
Regarding claim 15. (original) The method of claim 8, further comprising: determining a change in the first value of one or more features of the recorded evoked neural response and adjusting the first stimulation configuration based on the change (abstract, para 0005,etc., “closed loop spinal cord stimulation”).
Regarding claim 20. (original) The system of claim 18, wherein the evoked neural responses are indicative of synaptic activity within the patient's spinal cord (it is noted that the claim as recited does not provide any details regarding how the evoked neural responses is indicative of synaptic activity. Under its BRI, any evoked neural response captured could be indicative of synaptic activity as determined by a physician or automatically).
Claim(s) 2, 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kent (US 20160339251) in view of US Pat Pub No 20210128928 to Serrano et al. (hereinafter “Serrano”).
Regarding claim 2. (original) Kent discloses the method of claim 1, but fails to disclose wherein the evoking stimulation has a frequency of 10 Hz or less.
Serrano, from a similar field of endeavor, teaches the selected electrode and the complementary electrode are stimulated having a low frequency of approximately 2-10 Hz (para 0050, 0056, 0074, etc.). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the disclosure of Kent with the teachings of Serrano to provide the predictable result of providing stimulation at known frequencies. It is noted that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 17. (original) Kent discloses the method of claim 1, but fails to disclose wherein the PG is an external trial stimulator (ITS).
Serrano, from a similar field of endeavor, teaches the electrode terminals, are ultimately coupled to an external trial stimulator (ETS) that is external to (i.e., not implanted in) the patient and mimics operation of the IPG 10 to provide stimulation to the implanted electrodes (para 0011, 0012, etc.). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the disclosure of Kent with the teachings of Serrano to provide the predictable result of using ETS which mimics operation of the IPG 10 and provide stimulation to the implanted electrodes.
Regarding claim 19. (original) Kent discloses the system of claim 18, the evoked neural response occurs at least 2 milliseconds following the evoking stimulations (para 0105 “the controller 151 may determine that a negative peak occurring within a predetermined time 1224, such as 1 ms, after the delivery of the test excitation pulses”). It is noted that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It would be obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify the response to be more than 1ms as an exemplary disclosure by Kent.
Kent fails to disclose wherein the evoking stimulation has a frequency of 10 Hz or less.
Serrano, from a similar field of endeavor, teaches the selected electrode and the complementary electrode are stimulated having a low frequency of approximately 2-10 Hz (para 0050, 0056, 0074, etc.). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the disclosure of Kent with the teachings of Serrano to provide the predictable result of providing stimulation at known frequencies. It is noted that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kent as applied to claims 3-4, 8-11, 14-15, 20 above, and further in view of WO2020223165A1 to Zhang et al. (hereinafter “Zhang” – previously presented).
Regarding claim 12. Kent discloses the method of claim 11, but fails to disclose wherein the one or more sensors comprise an accelerometer.
Zhang, from similar field of endeavor, using an accelerometer 31 able to detect the orientation of the IPG 10 in the patient (para 0005). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Kent with the teaching of Zhang to provide the predictable result of detecting the orientation of the IPG 10 in the patient.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kent as applied to claims 3-4, 8-11, 14-15, 20 above, and further in view of US Pat Pub 20220296892 to Esteller et al. (hereinafter “Esteller” – on IDS).
Regarding claim 13. (original) The method of claim 11, but fails to disclose wherein the one or more sensors comprise a wearable sensor.
Esteller, from similar field of endeavor teaches having wand [] to establish near-field magnetic-induction communications at small distances, wherein, the wand may be affixed in close proximity to the patient, such as by placing the wand in a belt or holster wearable by the patient and proximate to the patient's IPG or ETS (para 0068). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Kent with the teaching of Esteller to provide the predictable result of communicating data between devices.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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/SANA SAHAND/Examiner, Art Unit 3796
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