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 .
Election/Restrictions
Applicant’s election without traverse of Invention III (claims 14-20) in the reply filed on 05/27/2026 is acknowledged. Claims 1-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/27/2026.
Remarks
Claims 14-20, filed 05/27/2026, are currently pending and are under consideration.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14-17 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a method for treating pain. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 14 is directed towards a method and meets the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claim 14 is directed towards a method for treating a patient with a neuromodulation system, comprising delivering a first stimulation signal, and sensing an evoked response signal. The limitation of method for treating a patient with a neuromodulation system, as drafted in claims 14-20, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind or using pen and paper or generic computer components. For example, a user could provide stimulation and sense an evoked response signal.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
The step of delivering a stimulation signal is considered to be an extra-solution activity, as the stimulation is necessary to sense the evoked response signals. The step of sensing an evoked response signal is considered to be a mere data gathering step (i.e. an insignificant extra-solution activity, see MPEP 2106.05(g)).
The additional elements of a plurality of electrodes are recited at a high level of generality (i.e., as generic sensing components) such that they amount to no more than mere instructions to apply the exception using a generic computer component. The electrodes provide generic structure for the insignificant, extra-solution activity of data gathering and output.
Accordingly, these additional elements do no integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination is not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of electrodes amounts to no more than mere instructions to apply the exception using generic data analysis. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Furthermore, the additional elements do not amount to more than generically linking the use of a judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). Therefore, the claims are not patent eligible.
Claims 15-17 and 20 depend on claim 14 and recite the same abstract idea as claim 14 from which they depend. Further, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the additional limitations recited in claims 15 and 16 (i.e. providing details about the data gathered) are further data gathering steps. The additional limitations recited in claim 20 (additional sensing) are further data analysis steps. The additional elements individually do not amount to significantly more than the judicial exception explained above (the abstract idea). Looking at the limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves any technology or includes a particular solution to a computer-based problem or a particular way to achieve a computer-based outcome. Rather, the collective functions of the claimed invention merely provides a conventional computer implementation, i.e. the computer (processor) is simply a tool to perform the claimed invention.
Claims 18 and 19 contain the practical application steps of adjusting a stimulation signal in response to sensing the evoked response and thus are not rejected under 35 USC 101.
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.
Claims 14 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (US Patent Application Publication 2023/0173275), hereinafter Zhang.
Regarding claim 14, Zhang discloses a method of treating a patient with a neuromodulation system having at least one lead with a plurality of electrodes located in the spinal column of the patient (e.g. Abstract; Par. [0039]; Fig. 1A: electrodes 18), the method comprising: delivering a first stimulation signal using a first one or more of the electrodes to the patient's spinal cord at a stimulation site (e.g. Par. [0065]); sensing for an evoked response signal with a second one or more of the electrodes at a sensing site caudal to the stimulation site (e.g. Par. [0086]; Par. [0117]: ECAP data for stimulation on caudal electrodes).
Regarding claim 16, Zhang further discloses wherein the step of sensing for an evoked response signal comprises delaying at least 2 milliseconds from the issuance of the first stimulation signal, before sensing for the evoked response (e.g. Par. [0071]; Par. [0081]).
Regarding claim 17, Zhang further discloses wherein the stimulation system comprises first and second leads, and the first one or more electrodes are on the first lead, and the second one or more electrodes are on the second lead (e.g. Par. [0039]: multiple leads can be used).
Regarding claim 18, Zhang further discloses delivering a second stimulation signal after the first stimulation signal and in response to sensing the evoked response signal, wherein the second stimulation signal is delivered with at least one change to a frequency, a pulse width, an amplitude, a repetition rate, or a duty cycle of the first stimulation signal (e.g. Par. [0096]: amplitude can be changed).
Regarding claim 19, Zhang further discloses wherein the first stimulation signal is issued with a first central point of stimulation, and the method further comprises: determining a location of the evoked response signal; and in response to the location of the evoked response signal not matching a desired location, issuing a second stimulation signal at a second central point of stimulation different from the first central point of stimulation (e.g. Par. [0124]: detecting position of the leads; Pars. [0093], [0096]: adjusting parameters).
Regarding claim 20, Zhang further discloses determining whether the evoked response occurs at a first sensing site and, if not, to adjust a stimulation parameter used when delivering the first stimulation signal (e.g. Par. [0124]: detecting position of the leads; Pars. [0093], [0096]: adjusting parameters).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US Patent Application Publication 2023/0173275), hereinafter Zhang, as applied to claim 14 above, and further in view of Wah et al. (US Patent Application Publication 2023/0310843), hereinafter Wah.
Regarding claim 15, Zhang further discloses wherein the stimulation site is at a cervical spinal location (e.g. Par. [0046]). However, Zhang fails to specifically disclose the sensing site is at a thoracic or lumbar spinal location. Wah, in a similar field of endeavor, is directed towards a neurostimulation device. Wah discloses a sensing site at a thoracic spinal location (e.g. Par. [0218]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Zhang to include the sensing site being at a thoracic spinal location as taught by Wah because doing so would allow accurate sensing of evoked responses.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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