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 filed 1/26/2026 have been fully considered but they are not persuasive.
Applicant argues on pp. 9 and 10 of the Remarks that “the limitations of the independent claims do not constitute a mental process because the limitations are not practically performed in the human mind…a person cannot mentally use circuitry configured to control generation and delivery of electrical pulses using at least one electrode of a stimulation lead.” The Examiner notes that the limitation in question (the circuitry and delivery of electrical pulses) was not indicated as being the recited abstract idea and instead was an additional; element addressed in step 2A, Prong 2. The identified mental process abstract idea was “monitor a signal indicative of a present level of the amplitude of the at least one pulse” and “based on the signal, declare a valid pulse based on the present level satisfying an initial criteria for a sub-duration of the pulse duration that is less than an entire pulse duration.” As noted in the Non-Final Rejection dated 11/17/2025, these steps, given their broadest, reasonable interpretation can be performed in the human mind. Specifically, a clinician can look at a signal; observe it and determine whether the amplitude of the signal is above or below a threshold value.
Applicant argues on pp 11-12 that “the decision to declare a pulse valid has to be made very quickly, such as within 30 microseconds of a 100 microsecond pulse.” However, the Examiner notes such details are absent from the claim and the claim does not place any time constraints on the decision making process as argued. Applicant is arguing a scope of claim different than what is currently pending. Even if Applicant were to claim a particular speed of decision making, the Examiner notes “Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).” (MPEP §2106.05(f)).
On pp. 13 and 14 of the Remarks, Applicant argues “Applicant is solving problems associated with determining whether an IPG is delivering pulses that result in the desired effect for the patient. For example, the one or more processors declare a valid pulse when the amplitude level meets or exceeds an initial criteria, such as an amplitude level, for a sub-duration of an entire pulse duration. (Applicant's application, para. 49.) Accordingly, the claims provide a specific improvement to the technical field of implantable pulse generators.” The Examiner notes Applicant is relying on the identified abstract idea as the improvement and not an additional element or combination of an additional element with the abstract idea as required by Step 2A, Prong 2.
Applicant argues on pp. 14-15 that the electrodes as shown in Fig., 8A, B and 9 are “neither generic nor are they use din an insignificant, extra-solution activity, as the data gathered as a result of delivering the electrical pulses cannot be performed mentally. First, the Examiner notes any particular details of electrode configurations on a lead as illustrated in the cited figures is not present in the independent claim. Applicant is relying on features not in the claim. Secondly, Applicant is improperly conflating Step 2A, Prong 1 and Step 2A, Prong 2. The Step 2A, Prong 1 analysis involves identifying any limitations that can be performed mentally, which again, the Examiner identified as the steps of “monitor a signal indicative of a present level of the amplitude of the at least one pulse” and “based on the signal, declare a valid pulse based on the present level satisfying an initial criteria for a sub-duration of the pulse duration that is less than an entire pulse duration.” The step 2A, Prong 2 analysis involves identifying the additional element so the claim outside of the abstract idea and determining whether they alone or in combination with the abstract idea amount to integration of the abstract idea into a practical application. Whether or not these additional limitations can be performed mentally is not a consideration for Prong 2. If the additional limitations fall into one of the following categories, it is determined that the additional elements alone or in combination do not amount to integration of the abstract idea into a practical application (MPEP §2106.04(d), I):
• Merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
• Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g); and
• Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
As noted in the Non-Final Rejection, Claim 1 includes the additional elements of circuity configured to control generation and delivery of electrical pulses; memory; one or more processors; and the delivery of pulses to at least one electrode. The control circuitry, memory and processors are generically claimed so that they amount to generic computer implementation of the abstract idea with generic computer structure. The initial delivery of electrical pulses to at least one electrode is insignificant, extra-solution activity in that this step is performed in order to gather data for the mental analysis steps (see example (c) in MPEP §2106.04(d)(2)). Claim 12 likewise includes the processors (generic computer structure) and the delivery of electrical pulses with a pulse generator (insignificant extra-solution activity). Insignificant extra-solution activity and generic computer implementation do not amount to integration of the abstract idea into a practical application.
Applicant argues on p. 15 that “The IPG delivers the particular treatment which transforms the nervous system of a patient to a normal activity state, wherein the nervous system can cause abnormal or undesirable movements/activity in the patient prior to treatment. The one or more processors can then determine whether the therapeutic pulse meets the initial criteria. (Applicant's application, para. 127.)”. The Examiner respectfully disagrees and contends that Applicant is looking at that additional element in isolation and not in combination with the abstract idea. The result of the abstract idea does not control the therapy; rather the therapy is a pre-cursor to setting up the environment in which the data is gathered and the decision making process is made. As noted in the Non-Final rejection, the MPEP provides an example in which a therapy is applied before the gathered data and decision making and notes that such a limitation has only a nominal or insignificant relationship to the exception (see example (c) in MPEP §2106.04(d)(2)), therefore failing to integrate the abstract idea into a practical application.
The response above likewise addresses Applicant’s arguments with respect to step 2B.
Regarding the 35 USC 102 rejection of Claim 1 with respect to Shi, Applicant argues on pp. 19-20, “Applicant respectfully asserts that Shi only discloses taking a single measurement, which is not the same as Applicant's satisfying an initial criteria for a sub- duration 676 of the pulse duration that is less than an entire pulse duration 674.” The Examiner respectfully disagrees. The claim requires monitoring “a signal indicative of a present level of the amplitude of the at least one pulse”. Shi discloses a sampling phase (sample phase during active) that occurs for a sub-duration of the entire stimulation pulse (stimulation active), see Fig. 19. Shi further discloses if the sampled voltage satisfies initial criteria for the NDACs and PDAC, the compliance voltage is maintained (not altered) and therefore would be considered a “valid pulse”, i.e. a pulse that is operating according to the operational tolerances of the device (see Fig. 21, the decision tree following, on the NDAC side, each “N” path in the flow chart to the box labeled Min (VNX) > 1.2 V, taking the “Y” path from that box and repeating for the PDAC side, concluding with the “End” box after the “Y” path at the box labeled Min(VPY) > 1.5V). Since the sampled value occurs during the sub-duration, any decision using that value is based on the level of that value satisfying a criteria for that sub-duration, which is all that the broadest reasonable interpretation of the claim requires. The entire duration of the pulse is from 0-260 microseconds; the sampling occurs at 240-259 microseconds, which is a sub-duration less than the entire duration of 0-260 microseconds (see Fig. 19).
Regarding Claim 2, Applicant argues Shi does not use a current regulator circuit to output the claimed signal. The Examiner respectfully disagrees. Shi discloses that the sampled voltage is fed to the ADC of the processor (see Fig. 10) and that the processor has regulators for supplying operational voltages to the processor (col. 11, lines 25-67). This is a common practice in maintaining compliance voltages and voltages within the system that will not overload the system.
Regarding Claims 4 and 15, Applicant argues Shi does not teach or suggest declaring a pulse valid or invalid. The Examiner respectfully disagrees. Applicant has not claimed any particular criteria for validity. Therefore, identifying if a pulse satisfies a criteria would fall within the BRI of the terms “valid” and “invalid”. If the criteria is satisfied, the pulse is considered “valid”. If it is not satisfied, the pulse is considered invalid”. Regarding the “voltage multiplier”, the Examiner notes the system operates with a source voltage form a power source. In order to adjust the voltage, the voltage is scaled down or up by a set value. This scaling is listed as subtraction or addition in Shi but is commonly practiced by adjusting a gain on an amplifier (a multiplication function).
In regards to Applicant’s argument with respect to Claim 8, The Examiner notes Shi clearly sets forth a sampling phase of a duration of 19 microseconds. Even if a sample is taken at the end, it is during the phase which is a monitoring period less than the entire duration of the stimulation pulse wherein the length of that monitoring period is predetermined.
Applicant’s arguments regarding the 35 USC 103 rejection have been considered and are not persuasive. The Examiner notes the sample taken during the sampling phase is representative of the sampling duration and therefore any decision regarding the sampled value can be considered representative of the entire duration. While Shi does not discloses a specific embodiment in which multiple samples are taken, Shi is not a single sue system (e.g. only takes one sample and never operates again) and instead can be used iteratively over long stretches of time. Applicant has not placed any time constraints on when the pulses are delivered and has not provided any time constraints on when they are delivered with respect to one another. The process illustrated in Fig. 20 of Shi can be performed three times, thus corresponding to three pulses; three sampling phases and three decisions based on each individual sampling phase.
The rejections are maintained.
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 1-3, 5-14 and 16-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Step 1
The claims are drawn to an implantable pulse generator (a product) and method of use (a process)
Step 2A, Prong 1
Claims 1 and 12 recite the steps of monitoring a signal and, based on the monitored signal, declaring a valid pulse if the signal level satisfies an initial criteria for a sub-duration. These steps, given their broadest, reasonable interpretation can be performed in the human mind. Specifically, a clinician can look at a signal; observe it and determine whether the amplitude of the signal is above or below a threshold value.
Step 2A, Prong 2
Claims 1 and 12 do not include any additional elements that amount to integration of the abstract idea into a practical application. Claim 1 includes the additional elements of circuity configured to control generation and delivery of electrical pulses; memory; one or more processors; and the delivery of pulses to at least one electrode. The control circuitry, memory and processors are generically claimed so that they amount to generic computer implementation of the abstract idea with generic computer structure. The initial delivery of electrical pulses to at least one electrode is insignificant, extra-solution activity in that this step is performed in order to gather data for the mental analysis steps (see example (c) in MPEP §2106.04(d)(2)). Claim 12 likewise includes the processors (generic computer structure) and the delivery of electrical pulses with a pulse generator (insignificant extra-solution activity). Insignificant extra-solution activity and generic computer implementation do not amount to integration of the abstract idea into a practical application.
Step 2B
Claims 1 and 12 do not include any additional elements that amount, alone or in combination, to significantly more than the abstract idea itself. Claim 1 includes the additional elements of circuity configured to control generation and delivery of electrical pulses; memory; one or more processors; and the delivery of pulses to at least one electrode. The control circuitry, memory and processors are generically claimed so that they amount to generic computer implementation of the abstract idea with generic computer structure. The initial delivery of electrical pulses to at least one electrode is insignificant, extra-solution activity in that this step is performed in order to gather data for the mental analysis steps (see example (c) in MPEP §2106.04(d)(2)). Claim 12 likewise includes the processors (generic computer structure) and the delivery of electrical pulses with a pulse generator (insignificant extra-solution activity). Insignificant extra-solution activity and generic computer implementation do not amount, alone or in combination) to significantly more than the abstract idea itself.
Claims 2, 3, 7, 9 and 18 only further define the insignificant extra-solution activity of the initial pulse delivery.
Claims 5-6, 8, 10, 11, 13, 14, 16, 17, 19 and 20 only further define the mental process abstract idea.
Claims 4 and 15 includes adjusting an electrical pulse amplitude based on the criteria decision, which amounts to integration of the abstract idea into a practical application. Amending Claims 1 and 12 to include the features of claims 4 and 15, respectively, would overcome the currently applied rejection.
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.
Claims 1-5, 8-16, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Shi et al. (7,444,181).
Regarding Claims 1, 3, 9, 12-14, Shi discloses an implantable pulse generator (for example IPG 100 in Fig. 5, 7B that is used in spinal cord stimulation; a type of neurostimulation) and method of operating said generator (Abstract; col. 4, lines 43-45) comprising circuitry 186 configured to deliver stimulation pulses via at least one electrode E1-EN (Fig. 8); memory 162 for storing program instructions (Fig. 8); and one or more processors 160, 166 (Fig. 8). Shi discloses the device is configured to deliver pulses to the at least one electrode, wherein the amplitude of the pulses can vary over time (due to factors such as settling and stabilization of the circuitry as well as the build-up of polarization voltage, see col. 16, lines 7-25). Hence, Shi discloses monitoring a signal indicative of a present level of the amplitude (the voltage level which is also indicative, to some degree, of a current output due to Ohm’s law and the relationship of voltage to resistance) during a sampling period at the end of a pulse duration that is a sub-duration of the entire active stimulation duration (see Fig. 19; col. 16, lines 7-25). If the sampled voltage satisfies initial criteria for the NDACs and PDAC, the compliance voltage is maintained (not altered) and therefore would be considered a “valid pulse”, i.e. a pulse that is operating according to the operational tolerances of the device (see Fig. 21, the decision tree following, on the NDAC side, each “N” path in the flow chart to the box labeled Min (VNX) > 1.2 V, taking the “Y” path from that box and repeating for the PDAC side, concluding with the “End” box after the “Y” path at the box labeled Min(VPY) > 1.5V).
In regard to Claim 2, Shi discloses a current regulator circuit 186’ (Fig. 9; col. 11, lines 55-61).
With regard to Claims 4 and 15, Shi discloses directing the voltage to be increased when the voltage does not satisfy a criteria, e.g. the pulse is invalid (see block labeled Increase V+ by 0.6V in Fig. 21)
In regard to Claims 5, 10, 16 and 19, Shi discloses an invalid pulse (one that needs to be adjusted) if the value is not above 1.2V in the last block of the NDAC side of Fig. 21 and therefore, if the value is above the value of 1.2V in that block, the pulse is not adjusted and is valid (one that does not need to be adjusted).
Regarding Claim 8, Shi discloses setting up a monitoring period of a predetermined time duration, such as 19 microseconds, see Fig. 19; col. 16, line 10.
Regarding Claims 11 and 20, Shi discloses an embodiment in which only one of the NDAC or PDAC is adjusted and not both as disclosed in Fig. 21. In this embodiment, one of either the NDAC or PDAC is then disabled form being adjusted (see col. 19, lines 45-50).
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.
Claims 6, 7, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Shi et al. (7,444,181).
Regarding Claims 6 and 17, Shi discloses an iterative process that can be performed on multiple pulses, wherein if the pulses do not satisfy a threshold criteria for a sampling phase, the pulses would be “invalid” and thus in need of adjustment (Fig. 21; col. 18, line 17-col. 19, line 26). Regarding the timing and duration of the sampling period, Shi discloses that the selection of a particular timing period is adjustable and use-specific based on the design considerations of the system (see col. 16, lines 25-37; col. 17, line 60- col. 18, line 3). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the sampling phase of whatever time duration of the stimulation pulse width as would be desired or expedient, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In regard to Claims 7 and 18, Shi discloses power supply 180 coupled to control circuitry 160, 166 (Fig. 8).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796