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 .
Status of Claims
The amendments and remarks filed on 16MAR2026 have been entered and considered.
Claims 1-8, 12-14, 24, & 26-28 are currently pending.
Claims 1, 7-8, 13-14, 24, & 28 have been amended.
Claims 26-27 have been canceled.
Claims 1-8, 12-14, 24, & 28 are under examination.
Response to Arguments
Applicant's amendments filed 16MAR2026 regarding the rejections under 35 USC 112(a) have been fully considered and have been found to obviate the rejection. Therefore, the rejection has been withdrawn.
Applicant's amendments filed 16MAR2026 regarding the rejections under 35 USC 112(b) have been fully considered and have been found to obviate the rejection. Therefore, the rejection has been withdrawn.
Applicant's arguments filed 16MAR2026 regarding the rejections under 35 USC 103 have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Pages 8-9 of the Remarks):
Vansickle fails to disclose supra-threshold stimulation with an amplitude limited to the claimed range defined as multiples of the "stimulus amplitude threshold." Vansickle at paragraph [0070] discloses that electrical pulse parameters can include pulse amplitude, but does not disclose any limitation on amplitude defined as multiples of the "stimulus amplitude threshold" as recited in amended claim 1. Vansickle further discloses in connection with FIGS. 6a-6f that the IPG can deliver pulse trains of "super-threshold therapy" with "a relatively high pulse amplitude," but again does not disclose any limitation on amplitude defined as multiples of the "stimulus amplitude threshold." See, e.g., id. 1 [0079]. Therefore, Applicant submits that Vansickle fails to disclose at least those features of amended claim 1. In response to Applicant's previous arguments, the Office Action at page 4 asserted "since the supra and sub threshold components of the instant application only indicate the threshold boundaries have a high and low value with no further indication of specific values, it is reasonable to assume any charge balanced configuration will contain a supra and sub threshold component." However, as indicated above, claim 1 has been amended to positively recite that the supra-threshold component with a stimulus amplitude that is set as a multiple within a particular range of a stimulus amplitude threshold. Applicant submits that Vansickle fails to disclose at least those features of amended claim 1.
However, the examiner is not persuaded. The limitation “wherein a stimulus amplitude of the supra- threshold component delivered by the first stimulus electrode is set as a multiple within the range of 1.05 to 1.8 of a stimulus amplitude threshold” can be found disclosed in Vansickle in: (Vansickle ¶0096 “…For example, the RC 16 may compute a new pulse amplitude value as function of the super-threshold pulse amplitude value. The computed function may be, e.g., a percentage (preferably in the range of 150% to 300%, and more preferably in the range of 175%-250%) of the sub-threshold pulse amplitude value, or a summation of the sub-threshold pulse amplitude value and a constant (e.g., 1 mA). “; ¶0094-¶0096 showing that the thresholds are set based on other thresholds at varying percentages of the original threshold.). Vansickle shows that there is a stimulus amplitude value which is based on a previous threshold value to create the supra threshold value. Vansickle ¶0096 also shows that these new threshold values as based on previously used values are ranging from 150% (1.5 times) to 300% (3 times). This range overlaps with claimed range of 1.05 times through 1.8 times. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists according to MPEP 2144.05(I).
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.
Claims 1-8, 12-14, 24, & 28 are rejected under 35 U.S.C. 103 as being unpatentable over Vansickle et al. (US Publication No. 2014027267; Previously Cited).
Regarding claim 1, Vansickle discloses a neurostimulation device (Vansickle Abstract “an implantable neuromodulator coupled to an electrode array implanted adjacent tissue of a patient having a medical condition.”; ¶0027 “In accordance with one aspect of the present inventions, an external control device for programming an implantable neuromodulator coupled to an electrode array is provided.” Wherein the term neuromodulator is encompassing of a neurostimulation device.) comprising: at least three stimulation electrodes configured to deliver an electrical stimulus pulse to neural tissue (Vansickle ¶0071 “Electrical modulation will occur between two (or more) activated electrodes, one of which may be the IPG case 44. Modulation energy may be transmitted to the tissue in a monopolar or multipolar (e.g., bipolar, tripolar, etc.) fashion…Tripolar modulation occurs when three of the lead electrodes 26 are activated” showing the possible electrode configuration using 3 stimulation electrodes) and a control unit (Vansickle ¶0027 “In accordance with one aspect of the present inventions, an external control device for programming an implantable neuromodulator coupled to an electrode array is provided.”; ¶0028; ¶0087) configured to deliver a first stimulus phase of the electrical stimulus pulse in which a first stimulus electrode of the stimulation electrodes delivers a supra-threshold stimulus component (Vansickle ¶0078 “More significant to some of the present inventions, the IPG 14 may be operated in either a super-threshold delivery mode, a sub-threshold delivery mode, and a hybrid delivery mode.”; ¶0079 “While in the super-threshold delivery mode, the IPG 14 is configured for delivering electrical modulation energy that provides super-threshold therapy to the patient (in this case, causes the patient to perceive paresthesia).”), the supra- threshold stimulus component being returned by at least two other return electrodes of the stimulation electrodes (Vansickle ¶0071 “Tripolar modulation occurs when three of the lead electrodes 26 are activated, two as anodes and the remaining one as a cathode, or two as cathodes and the remaining one as an anode.”; Showing the configuration of the claim limitation where two electrodes are cathodes (See ¶0072 describing cathode terminology being equivalent to a sinking current i.e a return electrode)), wherein a stimulus amplitude of the supra- threshold component delivered by the first stimulus electrode is set as a multiple within the range of 1.05 to 1.8 of a stimulus amplitude threshold (Vansickle ¶0096 “…For example, the RC 16 may compute a new pulse amplitude value as function of the super-threshold pulse amplitude value. The computed function may be, e.g., a percentage (preferably in the range of 150% to 300%, and more preferably in the range of 175%-250%) of the sub-threshold pulse amplitude value, or a summation of the sub-threshold pulse amplitude value and a constant (e.g., 1 mA). “; ¶0094-¶0096 showing that the thresholds are set based on other thresholds at varying percentages of the original threshold.) the control unit further configured to deliver at least a second stimulus phase of the electrical stimulus pulse, (Vansickle ¶0074 “For example, as illustrated in FIGS. 5a and 5b, multiphasic electrical energy may include a series of biphasic pulses, with each biphasic pulse including a cathodic (negative) modulation phase and an anodic (positive) charge recovery pulse phase that is generated after the modulation phase to prevent direct current charge transfer through the tissue, thereby avoiding electrode degradation and cell trauma. That is, charge is conveyed through the electrode-tissue interface via current at an electrode during a modulation period (the length of the modulation phase), and then pulled back off the electrode-tissue interface via an oppositely polarized current at the same electrode during a recharge period (the length of the charge recovery phase).”). For the limitation of “range of 1.05 to 1.8 of a stimulus amplitude threshold”, Vansickle’s teachings his range (175%-250%) as discussed above overlaps with claimed range of 1.05 times through 1.8 times. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists according to MPEP 2144.05(I). Before the effective filing date, it would have been obvious to a person of skill in the art to modify Vansickle by combining the embodiments of Vansickle to come to the claimed invention. Vansickle ¶0080-¶0082 describes the super- and sub-threshold stimuli, but not the first stimulus electrode delivering stimulus that is then returned by at least two return electrodes and the at least two of the stimuli return electrodes delivering stimulus and is then being returned by the first stimulus electrode. However, Vansickle ¶0071-¶0072 additionally discloses this electrode stimulus configuration and that the configuration can be as desired, and Vansickle ¶0148 describes how the embodiments encompass modifications and equivalents of the same invention. Thus, the combination of embodiments is intended by Vansickle. Therefore, claim 1 is obvious over the cited portions of Vansickle.
Regarding claim 2, Claim 1 is obvious over Vansickle. Vansickle additionally discloses wherein the electrical stimulus pulse comprises at least three phases, delivered by at least three electrodes of the stimulation electrodes, and configured so that the supra-threshold stimulus component is the only stimulus component that is a supra-threshold (Vansickle ¶0074 “Multiphasic electrical energy includes a series of pulses that alternate between positive and negative. For example, as illustrated in FIGS. 5a and 5b, multiphasic electrical energy may include a series of biphasic pulses, with each biphasic pulse including a cathodic (negative) modulation phase and an anodic (positive) charge recovery pulse phase that is generated after the modulation phase to prevent direct current charge transfer through the tissue, thereby avoiding electrode degradation and cell trauma.”; ¶0073 “The modulation energy may be delivered between a specified group of electrodes as monophasic electrical energy or multiphasic electrical energy.”). Before the effective filing date, it would have been obvious to a person of skill in the art to modify Vansickle by combining the aspects of Vansickle to come to the claimed invention. Vansickle ¶0080-¶0082 describes the super- and sub-threshold stimuli, but not the at least three electrodes of the stimulation electrodes configured so that the stimulus component is the only stimulus component that is a supra-threshold. However, Vansickle ¶0071-¶0072 additionally discloses this electrode stimulus configuration and that the configuration can be as desired. Therefore, claim 2 is obvious over the cited portions of Vansickle.
Regarding claim 3, Claims 1 & 2 are obvious over Vansickle. Vansickle additionally discloses wherein the first stimulus phase stimulus is delivered as a final phase of the electrical stimulus pulse. (Vansickle Figure 7 Block 200 & 206 showing that the supra threshold stimulus is delivered secondary to the sub-threshold stimulus).
Regarding claim 4, Claim 1 is obvious over Vansickle. Vansickle additionally discloses the device configured to utilise four of the stimulation electrodes to deliver quadrupolar stimulation. (Vansickle ¶0071 “Modulation energy may be transmitted to the tissue in a monopolar or multipolar (e.g., bipolar, tripolar, etc.) fashion”; ¶0072 “Any of the electrodes E1-E16 and case electrode may be assigned to up to k possible groups or timing "channels." In one embodiment, k may equal four.”). Before the effective filing date, it would have been obvious to a person of skill in the art to modify Vansickle by combining the aspects of Vansickle to come to the claimed invention. Vansickle ¶0071-¶0072 discloses this quadrapolar electrode stimulus configuration in the listing of multipolar configurations where k may equal four, and additionally states that the configuration can be as desired. Therefore, claim 1 is obvious over the cited portions of Vansickle.
Regarding claim 5, claims 1 & 4 are obvious over Vansickle. Vansickle additionally discloses the modulation device further configured to deliver offset quadrupolar stimulation whereby the supra-threshold stimulus component is delivered by one stimulus electrode of the stimulation electrodes and returned by three return electrodes of the stimulation electrodes (Vansickle ¶0071 additionally describes the general relationship of electrode configurations based on the multipolar configuration. The examiner is therefore interpreting that this relationship can carry on the higher multipolar electrode configurations per ¶0027 and ¶0072.). Before the effective filing date, it would have been obvious to a person of skill in the art to modify Vansickle by combining the aspects of Vansickle to come to the claimed invention. Vansickle ¶0080-¶0082 describes the super- and sub-threshold stimuli, but not the offset quadrupolar stimulation whereby the stimulus component is delivered by one stimulus electrode of the stimulation electrodes and returned by three return electrodes of the stimulation electrodes However, Vansickle ¶0071-¶0072 additionally discloses this electrode stimulus configuration and that the configuration can be as desired. Therefore, claim 1 is obvious over the cited portions of Vansickle.
Regarding claim 6, claim 1 is obvious over Vansickle. Vansickle additionally discloses the device further configured to adaptively select a number of the stimulation electrodes in order to best minimise second cathode stimulation by switching between multipolar stimulation modes. (Vansickle ¶0016 “The e-troll and navigation programming modes differ in part in the way in which the clinician changes electrode configurations from one configuration to another. The e-troll programming mode utilizes a technique known as "panning", which shifts a pre-defined electrode configuration down the sequence of electrodes without changing the basic form of the electrode configuration. The navigation programming mode utilizes a technique known as "weaving," which moves the anode or anodes around the cathode, while slowly progressing the cathode down the sequence of electrodes. The e-troll and navigation programming modes may have different clinical uses (e.g., finding the "sweet spot" in the case of panning, or shaping the electrical field around the cathode in the case of weaving).”).
Regarding claim 7, claim 1 is obvious over Vansickle. Vansickle additionally discloses wherein the supra-threshold stimulus component delivered by the first stimulus electrode is returned equally between the at least two return electrodes. (Vansickle ¶0128 “The parameters adjustment panel 106, when the manual programming mode is selected, also includes an equalization control 150 that can be actuated to automatically equalize current allocation to all electrodes of a polarity selected by respective "Anode +" and "Cathode -" icons.”; ¶0127).
Regarding claim 8, claim 1 is obvious over Vansickle. Vansickle additionally discloses wherein the supra-threshold stimulus component delivered by the first stimulus electrode is returned unequally between the two or more return electrodes. (Vansickle ¶0127 “In the illustrated embodiment, electrode E2 has been selected as a cathode to which 100% of the cathodic current has been allocated, and electrodes E1 and E3 have been respectively selected as anodes to which 25% and 75% of the anodic current has been respectively allocated. Electrode E15 is shown as being selected to allow the user to subsequently allocate the polarity and fractionalized electrical current to it via the graphical controls located in the amplitude/polarity area 144. Although the graphical controls located in the amplitude/polarity area 144 can be manipulated for any of the electrodes, a dedicated graphical control for selecting the polarity and fractionalized current value can be associated with each of the electrodes,” Showing how the electrodes may have various weights of utilization depending on the need of the patient).
Regarding claim 12, claim 1 is obvious over Vansickle. Vansickle additionally discloses the device configured to selectively connect one or more of the stimulation electrodes directly to a supply rail to serve as a passive return electrode. (Vansickle ¶0006 “The configuration of electrodes used to deliver electrical pulses to the targeted tissue constitutes an electrode configuration, with the electrodes capable of being selectively programmed to act as anodes (positive), cathodes (negative), or left off (zero).”; ¶0076).
Regarding claim 13, claim 1 is obvious over Vansickle. Vansickle additionally discloses wherein the first stimulus electrode is interposed between the at least two return electrodes. (Vansickle ¶0139 “In this case, the anode of the virtual anodic multipole can be placed at the location of the cathode of the virtual cathodic multipole, and the cathode(s) of the virtual anodic multipole can be placed at the location(s) of the anode(s) of the virtual cathodic multipole relative to the electrode array 26.”; ¶0068; ¶0017 “It can be appreciated that current steering can be implemented by moving the virtual poles about the leads, such that the appropriate fractionalized current values for the electrodes are computed for each of the various positions of the virtual pole. As a result, the current steering can be implemented using an arbitrary number and arrangement of electrodes, thereby solving the afore-described problems.”; ¶0021).
Regarding claim 14, claim 1 is obvious over Vansickle. Vansickle combined with Lane teach the limitations of claim 1. Vansickle additionally discloses wherein the first stimulus electrode is positioned to one side of all of the at least two return electrodes. (Vansickle ¶0139 “In this case, the anode of the virtual anodic multipole can be placed at the location of the cathode of the virtual cathodic multipole, and the cathode(s) of the virtual anodic multipole can be placed at the location(s) of the anode(s) of the virtual cathodic multipole relative to the electrode array 26.”; ¶0068; ¶0017 “It can be appreciated that current steering can be implemented by moving the virtual poles about the leads, such that the appropriate fractionalized current values for the electrodes are computed for each of the various positions of the virtual pole. As a result, the current steering can be implemented using an arbitrary number and arrangement of electrodes, thereby solving the afore-described problems.”; ¶0021).
Regarding claim 24, Vansickle discloses a method of neurostimulation, the method comprising (Vansickle Abstract “An external control device and method for programming an implantable neuromodulator coupled to an electrode array implanted adjacent tissue of a patient having a medical condition… an implantable neuromodulator coupled to an electrode array implanted adjacent tissue of a patient having a medical condition.”; Wherein the term neuromodulator is encompassing of a neurostimulation device.): delivering an electrical stimulus pulse to neural tissue using at least three stimulation electrodes (Vansickle ¶0071 “Electrical modulation will occur between two (or more) activated electrodes, one of which may be the IPG case 44. Modulation energy may be transmitted to the tissue in a monopolar or multipolar (e.g., bipolar, tripolar, etc.) fashion…Tripolar modulation occurs when three of the lead electrodes 26 are activated”), the electrical stimulus comprising a first stimulus phase of the electrical stimulus pulse in which a first stimulus electrode of the stimulation electrodes delivers a supra-threshold stimulus component (Vansickle ¶0078 “More significant to some of the present inventions, the IPG 14 may be operated in either a super-threshold delivery mode, a sub-threshold delivery mode, and a hybrid delivery mode.”; ¶0079 “While in the super-threshold delivery mode, the IPG 14 is configured for delivering electrical modulation energy that provides super-threshold therapy to the patient (in this case, causes the patient to perceive paresthesia).”), the supra- threshold stimulus component being returned by at least two other return electrodes of the stimulation electrodes (Vansickle ¶0071 “Tripolar modulation occurs when three of the lead electrodes 26 are activated, two as anodes and the remaining one as a cathode, or two as cathodes and the remaining one as an anode.”; Showing the configuration of the claim limitation where two electrodes are cathodes (See ¶0072 describing cathode terminology being equivalent to a sinking current i.e a return electrode)), wherein a stimulus amplitude of the supra-threshold component delivered by the first stimulus electrode is set as a multiple within the range of 1.05 to 1.8 of a stimulus amplitude threshold (Vansickle ¶0096 “…For example, the RC 16 may compute a new pulse amplitude value as function of the super-threshold pulse amplitude value. The computed function may be, e.g., a percentage (preferably in the range of 150% to 300%, and more preferably in the range of 175%-250%) of the sub-threshold pulse amplitude value, or a summation of the sub-threshold pulse amplitude value and a constant (e.g., 1 mA). “; ¶0094-¶0096 showing that the thresholds are set based on other thresholds at varying percentages of the original threshold.), at least a second stimulus phase of the electrical stimulus pulse, (Vansickle ¶0074 “For example, as illustrated in FIGS. 5a and 5b, multiphasic electrical energy may include a series of biphasic pulses, with each biphasic pulse including a cathodic (negative) modulation phase and an anodic (positive) charge recovery pulse phase that is generated after the modulation phase to prevent direct current charge transfer through the tissue, thereby avoiding electrode degradation and cell trauma. That is, charge is conveyed through the electrode-tissue interface via current at an electrode during a modulation period (the length of the modulation phase), and then pulled back off the electrode-tissue interface via an oppositely polarized current at the same electrode during a recharge period (the length of the charge recovery phase).”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify Vansickle by combining the embodiments of Vansickle to come to the claimed invention. Vansickle ¶0080-¶0082 describes the super- and sub-threshold stimuli, but not the first stimulus electrode delivering stimulus that is then returned by at least two return electrodes and the at least two of the stimuli return electrodes delivering stimulus and is then being returned by the first stimulus electrode. However, Vansickle ¶0071-¶0072 additionally discloses this electrode stimulus configuration and that the configuration can be as desired, and Vansickle ¶0148 describes how the embodiments encompass modifications and equivalents of the same invention. Thus, the combination of embodiments is intended by Vansickle. Therefore, claim 1 is obvious over the cited portions of Vansickle.
Regarding claim 28, claim 1 is obvious over Vansickle. Vansickle further discloses wherein the stimulus amplitude of the supra- threshold component delivered by the first stimulus electrode is set at a current below an anodic threshold of the neural tissue. (Vansickle ¶0079 “the IPG 14 is configured for delivering electrical modulation energy that provides super-threshold therapy to the patient (in this case, causes the patient to perceive paresthesia).”). Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lane et al. (US Patent No. 8543200).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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