The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse in the reply filed on January 23, 2026 is acknowledged. Claims 15 and new claim 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Interpretation
The term “level” is used within the claims (e.g., “wherein the electrical stimulation signal is modulated between a first level and a second level over time”), as is “therapeutic threshold” (e.g., see claim 4). Paragraph 26 of the application’s PGPUB 2024/0278018 states the following:
In one or more examples, the modulation of the electrical stimulation signals may be suprathreshold therapeutic modulation. That is, processing circuitry may modulate an electrical stimulation signal between a first level and a second level over time. The term “level” generally refers to characteristic of the electrical stimulation signal indicative of the energy of the electrical stimulation signal. The term “level” may refer to the energy, amplitude, pulse width, or frequency. As described in more detail, the first level and the second level may also refer to electrode selection. The threshold may correspond to a therapeutic threshold, perception threshold, or any other threshold related to nerve activity.
Therefore, “level” in the claims refers to the energy, amplitude, pulse width, or frequency, or to electrode selection. And the threshold may refer to “a therapeutic threshold, perception threshold, or any other threshold related to nerve activity”.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7 is objected to because it states “The system of any of claim 1”. The “any of” language should be removed.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Second Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 is rejected because it is unclear whether the frequency being “greater than or equal to 0.01 Hz” relates to “a frequency of the period wave” or whether it relates to “a frequency… at which the plurality of pulses of the stimulation signal increase or decrease”.
Claim 12 is rejected because “the second level or adjusted second level” in lines 6 and 8-9 lacks antecedent basis. Specifically, “the … adjusted second level” lacks antecedent basis.
Claim Rejections - 35 USC § 102
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 1-5, 7, 14, 16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steinke et al. (US Patent Pub. No. 2018/0345022).
Regarding claims 1 and 18, Steinke discloses an implantable device, such as that shown in Figures 1-3, which are taught by Steinke for being used to treat either one of hyper-synchronicity or hypo-synchronicity (see paragraphs 13-15). The teaches discussed herein are taught by Steinke as a way to program these implantable devices. Steinke teaches a system with memory (see paragraph 52) and a processor within the implantable devices configured to:
cause stimulation circuitry to deliver an electrical stimulation signal to a target neural population (see waveform E2 at tope of Figure 6, for example), wherein the electrical stimulation signal is modulated between a first level (see waveforms 90(1) in times t1 and t3) and a second level (see waveforms 90(2) in times t2 and t4) over time (see times t1-t4), wherein the delivery of the electrical stimulation signal at the first level recruits a first collateral neural population (see paragraph 39, “As shown to the left, the issuance of smaller pulse width pulses (PW1, 90(1)) will recruit within subpopulation 82 larger-diameter neural elements 85 within subpopulation 82(2) proximate to the stimulated electrode E2”; also see bottom portion of Figure 6 labeled as “90(1)”), and the delivery of the electrical stimulation signal at the second level recruits a second collateral neural population (see paragraph 39, “By contrast, the issuance of longer pulse widths (PW2, 90(2)) will recruit within subpopulation 82′ both larger-diameter neural elements 85 and smaller-diameter neural elements 86”; also see bottom portion of Figure 6 labeled as “90(2)”).
Regarding claim 2, in a first interpretation of Steinke, it can be seen in the bottom of Figure 6 that pulse 90(1) recruits the large neural elements 85, whereas pulse 90(2) additionally recruits small neural elements 86, which are different from those recruited during pulse 90(1). In a second interpretation of Steinke, Figure 14 of Steinke illustrates another embodiment in which not only are the pulse widths varied, but also the specific electrodes used for delivery of the stimulation. As seen in Figure 14, electrode E4 is activated during wider pulses 93(2), which as illustrated in the bottom portion of the figure elicits recruitment of larger neural elements 85 in an area proximate to electrode E4. Utilizing the protocols illustrated in Figure 14, this can allow for recruitment of different nerves as compared to those recruited in the bottom-left side (i.e., “93(1)”) of Figure 14.
Regarding claim 3, it can be seen in the bottom of Figure 6 that pulse 90(1) recruits large neural elements 85, whereas pulse 90(2) also recruits large neural elements 85, which are the same.
Regarding claim 4, paragraph 39 teaches that pulse 90(1) recruits neural elements 85 and that pulse 90(2) recruits both neural elements 85 and 86. Additionally, the whole purpose and teachings of Steinke are for effecting these neural elements to correct neural coupling. As such, recruitment by these pulses is at or above a therapeutic threshold of the neural elements. Additionally, the waveform at the top of Figure 6 illustrates that pulses 90(1) has a smaller pulse width than that of pulses 90(2) (i.e., the second level is greater than the first level).
Regarding claim 5, the bottom portions of Figure 6 illustrate that the neural population recruited by pulse 90(2) comprises a greater number of neurons than that of pulse 90(1) (i.e., simply by counting circles of elements 85 and 86 in top and bottom portions of the bottom of Figure 6, it is easily seen that 90(2) has more than 90(1)).
Regarding claim 7, the bottom-most waveform in Figure 8 illustrates an example where amplitudes are modulated, rather than pulse widths, and it can be readily seen that this periodic wave 96 sequentially increases and decreases from a higher level to a lower level (also see paragraph 42 for a description).
Regarding claim 14, it is noted that Steinke teaches that “While benefits of the disclosed techniques focus on use in Deep Brain Stimulation (DBS) therapy, the techniques are not so limited. For example, the techniques can be used in Spinal Cord Stimulation (SCS) therapy, in which one or more leads are implanted in the epidural space within the spinal column. Other neurostimulation therapies involving neural recruitment will also benefit from the disclosed techniques” (see paragraph 53, emphasis added).
Regarding claim 16, Steinke teaches that “As shown in FIG. 1, a DBS system typically includes an Implantable Pulse Generator (IPG) 10, which includes a biocompatible device case 12 formed of titanium for example. The case 12 typically holds the circuitry and battery 14 necessary for the IPG to function.”
Regarding claim 18, it is noted that the description of Steinke in the rejection of claim 1 includes the teaching of programmed stimulation circuitry (see numeral 31 and see paragraph 7), which delivers stimulation as illustrated in the waveforms of the various figures, including Figure 6, which shows modulation of pulse waves from 90(1) to 90(2) repetitively over time. Additionally, paragraph 39 as quoted in the rejection of claim 1 teaches the recruitment of different neural populations.
Regarding claims 19 and 20, in a first interpretation of Steinke, it can be seen in the bottom of Figure 6 that pulse 90(1) recruits the large neural elements 85, whereas pulse 90(2) additionally recruits small neural elements 86, which are different from those recruited during pulse 90(1). In a second interpretation of Steinke, Figure 14 of Steinke illustrates another embodiment in which not only are the pulse widths varied, but also the specific electrodes used for delivery of the stimulation. As seen in Figure 14, electrode E4 is activated during wider pulses 93(2), which as illustrated in the bottom portion of the figure elicits recruitment of larger neural elements 85 in an area proximate to electrode E4. Utilizing the protocols illustrated in Figure 14, this can allow for recruitment of different nerves as compared to those recruited in the bottom-left side (i.e., “93(1)”) of Figure 14.
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 6, 8-9 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Steinke alone.
Regarding claim 6, it is noted that in paragraph 36, Steinke teaches “To give some non-limiting examples, pulse widths PW1 and PW2 may range from 10 microseconds to 1 milliseconds”. As such, if the pulses 90(1) are at the lower end of this range (i.e., 10 microseconds) and the pulses 90(2) are at the upper end of this range (i.e., 1 milllisecond), then this would represent a 10,000% increase. As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that the changing pulse widths between 90(1) and 90(2) would be at least 5% greater (i.e., for pulse 90(2)), since it has been held that "[W]here 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) (see MPEP 2144.05(II)(A)).
Regarding claims 8-9, it is initially noted that paragraph 34 of the application’s PGPUB 2024/0278018 states the following (emphasis added):
In this way, the electrical stimulation signal includes a repeating periodic wave of pulses, with each of the periodic wave of pulses includes a first set of plurality of pulses having levels that sequentially increase from the first level to the second level, followed by a second set of plurality of pulses having levels that sequentially decrease from the second level to the first level. The frequency of the periodic wave may be greater than 0.01 Hz, greater than 0.1 Hz, greater than 1 Hz, such as greater than 0.01 Hz, 0.1 Hz, or 1 Hz and less than or equal to 5 Hz. This periodic wave that defines the rate at which the levels of the electrical pulses of the electrical stimulation signal increase or decrease may be an envelope over the stimulation signal, and the rate at which the levels of the electrical pulses increase or decrease may be set by a frequency of the periodic wave, which may be greater than 0.01 Hz, and in some examples, between 1 Hz and 5 Hz. In general, the frequency of the periodic wave may be greater than 0.01 Hz, greater than 0.2 Hz, and so on, including greater than 1 Hz. In some examples, the frequency of the periodic wave may be less than 5 Hz, but it is possible for the frequency of the periodic wave to be greater than 5 Hz as well, including 10 Hz and 100 Hz.
The underlined portions all teach possible frequencies for the periodic wave discussed in claims 7-9. The bold portion illustrates that the range that is positively claimed lacks criticality to the claimed invention, since the claimed limit at 5 Hz is explicitly stated in the specification (see above) as not being limiting, as the range could be 0.01 Hz to 100 Hz. In Steinke, paragraph 14 teaches that “the pulse packets 80 delivered to electrodes E1-E4 occur during a time period Ts, which preferably matches the frequency fs at which the sub-populations 82(x) are noticed to oscillate, such as between 12 to 25 Hz for example.” This discussion is with regard to the pulse sequence illustrated in Figure 4A, and this reads explicitly on the language of claim 8, which does not provide an upper limit (i.e., only a lower limit of 0.01 Hz). With regard to claim 9, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a frequency of the periodic waves taught by Steinke between 12-25 Hz, or a lower frequency if the desired effect required a lower frequency (e.g., a lower frequency at or below 5 Hz), since it has been held that "[W]here 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) (see MPEP 2144.05(II)(A)). Additionally, it is re-iterated that the specific range of 0.01 – 5 Hz in claim 9 lacks criticality (see above).
Regarding claim 12, Steinke teaches an embodiment in Figure 10, in which “the pulse packets 102 issued from a selected stimulation electrode (e.g., E2) can be varied using combinations of the pulse packets described earlier in FIGS. 6 through 9. For example and as shown, a first pulse packet 90(2) with large pulse width pulses (FIG. 6) is issued; followed by a second pulse packet 98(1) with pulses of a first shape (FIG. 9); followed by a third pulse packet 100 (FIG. 9) having a mixture of different pulses shapes; followed by a fourth pulse packet 94(2) having pulses with a small amplitude (FIG. 7); etc.” (see paragraph 45). Additionally, each of these pulse packets in Figure 10 are separated by a gap tg. During this gap, no stimulation pulse is delivered, which could be interpreted to be “a third level” that does not recruit any collateral neural population. Additionally, it is noted that by the teachings of Steinke such as the ability to vary and modify pulse parameters to nearly any extent (see last sentences of paragraph 40 and 41, for example), would make it obvious to one of ordinary skill in the art that a pulse width or amplitude or other parameter may be programmed into the pulse sequence such that a time period of no recruitment occur (i.e., the claimed “third level”).
Regarding claim 13, Steinke illustrates in Figure 14 that stimulation may be toggled between electrode E2 versus the combined electrode pairing E2+E4. Additionally, Steinke teaches using different pulse packets via different electrodes in Figures 11, 12 and 13A-B, and finally in paragraph 14 states “Coordinated reset involves using stimulation pulses at two or more electrodes Ex to stimulate different sub-populations 82(x) of neurons within the target neural population 36 at different times” (emphasis added). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that the teachings of Steinke includes alternating pulses between two electrodes based on the evidence above.
Claims 10-11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Steinke in view of Moffitt et al. (US Patent Pub. No. 2016/0082253).
Steinke is discussed above with regard to claim 1. However, there is no mention of receiving information related to the neural populations, or adjustments for such information.
Regarding claims 10-11, Moffitt teaches system and methods for providing therapy using electrical stimulation to disrupt neuronal activity (see Title). Paragraph 92 teaches that “the programming unit 508 may be utilized to control and adjust stimulation (e.g., the time-delay between stimulation signals from the two or more electrodes (or sets of electrodes), select between different electrodes (or sets of electrodes) for providing stimulation.” This teaches that an adjustment may include which electrodes are used to deliver the stimulation. Additionally, at least paragraph 77 also teaches that adjustments may be made to stimulation parameters, such as “amplitude, frequency, impedance, voltage, pulse width, or the like”. Paragraph 103 teaches that “A computer model may be used to adjust the stimulation parameters of first and second effective electric fields generated by the first and second electrode sets, respectively. The computer model(s) can be used to adjust the location, the size, the shape (or any combination of the above) so that the generated effective electric fields are non-overlapping, or partially overlapping. Stimulation, via the first and second electrode sets, may be initiated in response to the pain indicator, such as the detected frequency shift in the patient's theta band activity. The frequencies of the first and second effective electric fields can be based, at least in part, on the pain indicator, such as the frequency of the detected shift in theta band activity. The stimulation parameters of the first and/or second effective electric fields may be adjusted in response to a feedback loop, such as an observed frequency shift towards or away from a particular frequency or frequency range.” Therefore, if and when the stimulation causes discomfort to the patient and this discomfort elicits a change in the theta band (or other pain indicator), then the feedback taught by Moffitt would alter the stimulation parameters and/or electrode configurations.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to include parameter and electrode selection modifications based on a feedback loop, as taught by Moffitt, within the system and methods of Steinke, in order to increase patient comfort when undergoing electrical stimulation, thereby ensuring that the patient can tolerate the therapy and get the treatment they need.
Regarding claim 17, it is noted that Moffitt teaches that “Patient pain may be identified by any suitable technique including, for example, … patient feedback” (see paragraph 80). Also, paragraph 85 teaches that “the system employs feedback to adjust one or more stimulation parameters (e.g., amplitude, frequency, impedance, voltage, pulse width, or the like) after a period of stimulation.”
Conclusion
The following prior art is herein made of record is considered pertinent to applicant's disclosure, but not relied upon in the rejections above:
Scheiner (US Patent Pub. No. 2020/0281763)
“Time varying electrical fields produced by sequentially selecting different electrode pairs may allow different branches of the medial HGN to be stimulated, thereby recruiting different portions of the protrusor muscles during a sequential stimulation protocol, promoting sustained protrusion of the tongue 40 while avoiding or reducing fatigue” (see paragraph 54). “Distal electrodes 30 may be switchably coupled to output circuitry of pulse generator 12 to enable delivery of electrical stimulation pulses in a manner that selectively activates the right and left protrusor muscles in a cyclical or alternating pattern to avoid muscle fatigue while maintaining upper airway patency” (see paragraph 28).
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/JAMES KISH/ Primary Examiner, Art Unit 3792