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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/05/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 05/05/2026 have been fully considered but are unpersuasive or are moot in view of a new grounds of rejection.
Applicant argues that the cited references fail to disclose
“determine a lateralization decision for each of the subsets of contact points from the plurality of contact points based on processing the electrophysiological signals,
wherein processing the electrophysiological signals comprises:
comparing the electrophysiologic signals to a reference electrophysiologic signal;
determining a deviation as a function of comparing the electrophysiologic signals to the reference electrophysiologic signal; and
adjusting the predefined electrical stimulation protocol as a function of the deviation,
wherein adjusting the predefined electrical stimulation protocol determines a spatial position of the stimulation electrode relative to a patient’s spine;
implement a neuromodulation algorithm to adjust the predefined electrical stimulation protocol, wherein the implementation further comprises determining a suboptimal activity,
wherein the neuromodulation algorithm adjusts the predefined electrical stimulation protocol as a function of therapeutic neural activity independent of the deviation used to determine the lateralization decision,”
as recited in amended claim 1
Examiner respectfully disagrees.
Regarding the limitations,
“determine a lateralization decision for each of the subsets of contact points from the plurality of contact points based on processing the electrophysiological signals,
wherein processing the electrophysiological signals comprises:
comparing the electrophysiologic signals to a reference electrophysiologic signal;
determining a deviation as a function of comparing the electrophysiologic signals to the reference electrophysiologic signal; and
adjusting the predefined electrical stimulation protocol as a function of the deviation;
implement a neuromodulation algorithm to adjust the predefined electrical stimulation protocol, wherein the implementation further comprises determining a suboptimal activity,”
Serrano Carmona discloses
determine a lateralization decision for each of the subsets of contact points from the plurality of contact points based on processing the electrophysiological signals (fig. 9: step 852: data from monitor i.e. peripheral electrodes is measured and recorded which is evaluated at step 864 and used to determine a lateral position at step 866 for each of the subsets of contact points; [0050-0054]);
wherein processing the electrophysiological signals [0057] comprises:
comparing the electrophysiologic signals to a reference electrophysiologic signal ([0057]: measured electrophysiologic signals from the peripheral electrodes are compared to a threshold value i.e. a reference electrophysiologic signal);
determining a deviation as a function of comparing the electrophysiologic signals to the reference electrophysiologic signal
([0051]: deviation occurs when there is not enough information to make a determination regarding the location of the midline with respect to the selected spinal electrode and results in the classification criteria not being evoked; [0057]: determining a deviation occurs when it is determined whether or not the measured response exceeds the threshold, i.e. whether the classification criterion is evoked and the next spinal electrode is selected [0051-0053]); and
adjusting the predefined electrical stimulation protocol as a function of the deviation ([0051-0052]: if it’s determined that the deviation exists i.e. the class criteria is not met, then the amplitude is increased as long as the current amplitude is not already equal to the maximum amplitude; see also fig. 9);
implement a neuromodulation algorithm (802) to adjust the predefined electrical stimulation protocol ([0006]: controller 40 may adjust a stimulation program; [0052]: if no classification criterion is met, then stimulation amplitude may be increased if the stimulation amplitude is not equal to the maximum stimulation amplitude).
Regarding the limitation, “wherein adjusting the predefined electrical stimulation protocol determines a spatial position of the stimulation electrode relative to a patient’s spine”, Agnesi teaches a spinal cord stimulation (SCS) therapy [0001] and teaches a processor (fig. 1: 151; [0024]) configured to:
adjust a predefined electrical stimulation protocol [0040, 0067],
wherein adjusting the predefined electrical stimulation protocol determines a spatial position of the stimulation electrode relative to a patient’s spine (fig. 5: at step 515, adjustment in position of lead and adjustment to test stimulation are determined based on relation between physiological signals; [0018]: implanted in spinal cord; [0018]: optimal programming requires detecting proper orientation of electrodes; [0068]);
Agnesi further teaches that improper positioning of the electrodes ([0018]: array of electrodes positioned diagonally relative to the physiological midline) makes it more difficult to achieve proper coverage of spinal cord stimulation [0018], therefore, the spatial position of the stimulation electrode relative to a patient’s spine should be determined while adjusting stimulation [0018].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the processor of the electrode positioning system yielded by the proposed combination, to be configured to provide wherein adjusting the predefined electrical stimulation protocol determines a spatial position of the stimulation electrode relative to a patient’s spine, as taught by the electrodes in Agnesi, because improper positioning of the electrodes makes it more difficult to achieve proper coverage of spinal cord stimulation, therefore, the spatial position of the stimulation electrode relative to a patient’s spine should be determined while adjusting the predefined electrical stimulation protocol.
Regarding the limitation, “wherein the neuromodulation algorithm adjusts the predefined electrical stimulation protocol as a function of therapeutic neural activity independent of the deviation used to determine the lateralization decision,” there is a new grounds of rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15,18-19 and 21-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In re claim 1, the limitation, “function of therapeutic neural activity” introduces new matter that is not supported by the specification.
Although Applicant’s specification disclose “suboptimal activity may also be defined based on the most desirable EMG signal received with a number of successive readings with different input parameters”, there is no mention of a “therapeutic neural activity” in the specification.
In re claim 13, see in re claim 1 above.
In re claim 14, see in re claim 1 above.
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.
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 1-5, 7-11, 13-14, 18-19, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Serrano Carmona et al. (US 2017/0281959) in view of Jiang et al. (US 2016/0045747) in view of Agnesi et al. (US 2019/0134382) in view of Mandwal et al. (US 2020/0005481) in view of Ghosh (US 2019/0269926).
In re claim 1, Serrano Carmona discloses an electrode positioning system [0003, 0054], comprising:
a stimulation device (fig. 6: 70’; [0044]) configured to generate electrical pulse currents based on a parameter ([0010-0012]: ETS 70 mimics IPG 10 in providing stimulation to implanted electrodes 16 using stimulation parameters; [0044]: ETS 70’ is a modified ETS 70),
the stimulation device configured to be coupled to a stimulation electrode ([0041]: stimulation electrode is combination of both leads 18; [0004]: two leads 18 are used, one on each side of the spinal cord) that is configured to apply the electrical pulse currents at a plurality of contact points along or adjacent to a spine of a subject ([0041]: plurality of contact points are all spinal electrodes 16; [0053]);
a set of recording electrodes (fig. 6: peripheral electrodes L1, L2, R1, and R2; [0041]) configured to measure electrophysiologic signals triggered by an application of the electrical pulse currents by the stimulation electrode [0041];
an output device (fig. 12: CP GUI 94’; [0019; 0066]); and
a processor [0018, 0084] operatively coupled to
the stimulation device [0018],
the set of recording electrodes [0018], and
the output device [0018],
the processor configured to:
control the stimulation device to generate the electrical pulse currents according to a predefined electrical stimulation protocol ([0012-0013]: stimulation program is used to provide stimulation therapy; [0006, 0049]), such that the electrical pulse currents are applied to subsets of contact points from the plurality of contact points ([0053]: each lead, i.e. a subset of contact points, has 8 electrodes, and each electrode from the leads are selected; fig. 9);
receive the electrophysiologic signals from the set of recording electrodes [0041];
determine a lateralization decision for each of the subsets of contact points from the plurality of contact points based on processing the electrophysiological signals (fig. 9: step 852: data from monitor i.e. peripheral electrodes is measured and recorded which is evaluated at step 864 and used to determine a lateral position at step 866 for each of the subsets of contact points; [0050-0054]);
wherein processing the electrophysiological signals [0057] comprises:
comparing the electrophysiologic signals to a reference electrophysiologic signal ([0057]: measured electrophysiologic signals from the peripheral electrodes are compared to a threshold value i.e. a reference electrophysiologic signal);
determining a deviation as a function of comparing the electrophysiologic signals to the reference electrophysiologic signal
([0051]: deviation occurs when there is not enough information to make a determination regarding the location of the midline with respect to the selected spinal electrode and results in the classification criteria not being evoked; [0057]: determining a deviation occurs when it is determined whether or not the measured response exceeds the threshold, i.e. whether the classification criterion is evoked and the next spinal electrode is selected [0051-0053]); and
adjusting the predefined electrical stimulation protocol as a function of the deviation ([0051-0052]: if it’s determined that the deviation exists i.e. the class criteria is not met, then the amplitude is increased as long as the current amplitude is not already equal to the maximum amplitude; see also fig. 9),
implement a neuromodulation algorithm (802) to adjust the predefined electrical stimulation protocol ([0006]: controller 40 may adjust a stimulation program; [0052]: if no classification criterion is met, then stimulation amplitude may be increased if the stimulation amplitude is not equal to the maximum stimulation amplitude),
wherein the implementation further comprises determining a suboptimal activity (854; [0051]: determining a suboptimal activity is determining if a classification criteria has not been met, which occurs when not enough information has been gathered to determine the location of the physiological midline with respect to the electrode);
display (fig. 12), using a user interface (94’; [0066]), an interpretation of the lateralization decision (fig. 12; combination of computed physiological midline 1114 and representations 506A1 and 506A2 are considered as an interpretation of the lateralization decision since they show the lateral position and relative distance from the midline for each electrode; [0054]),
wherein the interpretation of the lateralization decision comprises a visual representation of the set of recording electrodes (fig. 12; [0066, 0083]);
modify, using the stimulation device, placement of at least a recording electrode of the set of recording electrodes as a function of a response ratio ([0069-0070]: depending on a response ratio, a lateral change of the stimulation location may be made and is done using the stimulation device which stimulates the new electrodes; [0060]: response ratio is a measure of electrode’s position with respect to the physiological midline);
update the lateralization decision as a function of the response ratio of the at least recording electrode of the set of recording electrodes ([0064]: correlation value adjusted until the physiological midline best fits points 1116; [0063-0064]: physiological midline calculated by multiplying ratio with correlation value; [0069-0070]);
determine a functional midline ([0066]: computed physiological midline provides additional information that can be used in determining an appropriate stimulation program or evaluating suitability of the location of the implanted electrode leads) of the spine [0049] based on
the predefined electrical stimulation protocol [0049, 0051-0054] and
the updated lateralization decision determined for each of the subsets of contact points from the plurality of contact points [0063-0064, 0069-0070];
identify a location of the stimulation electrode relative to the functional midline based on an aggregation of the electrophysiologic signals [0054, 0069-0070]; and
output, via the output device,
information indicative of the functional midline of the spine ([0066]; fig. 12: 1114) and
the location of the stimulation (fig. 12: 506A1 and 506A2; [0019]: representations 506A1 and 506A2 provide a representation of the implanted electrode leads; [0066]; fig. 12: 506A1 and 506A2).
Serrano Carmona fails to disclose
the processor configured to:
…wherein adjusting the predefined electrical stimulation protocol determines a spatial position of the stimulation electrode relative to a patient’s spine;
…wherein the neuromodulation algorithm adjusts the predefined electrical stimulation protocol as a function of therapeutic neural activity independent of the deviation used to determine the lateralization decision;
…modify placement of at least a recording electrode of the set of recording electrodes as a function of the displayed interpretation of the lateralization decision;
update the lateralization decision as a function of the modified placement of the at least recording electrode of the set of recording electrodes;
adapt video information to a fluoroscopy screen such that an animated image of the location of the stimulation electrode identified by an algorithm module is superimposed over the fluoroscopy screen in real time,
wherein the animated image of the location of the stimulation electrode and the fluoroscopy screen are aligned by at least a reference point.
Jiang teaches a nerve stimulation system setup (fig. 1: combination of 100 and 200; [0071]) and teaches
a processor ([0087]: pulse generators include processor to deliver stimulation) configured to implement a neuromodulation algorithm ([0027]: user adjusting stimulation amplitude threshold in increments would require an algorithm) to adjust a predefined electrical stimulation protocol ([0027]: stimulation protocol includes stimulation amplitude threshold for a test stimulation),
wherein an implementation further comprises determining a suboptimal activity ([0027]: suboptimal activity is a user not achieving a desired stimulation induced EMG motor and choosing to adjust stimulation amplitude threshold);
wherein the neuromodulation algorithm adjusts the predefined electrical stimulation protocol as a function of therapeutic neural activity ([0027]: therapeutic neural activity is a patient’s desired stimulation-induced response) independent of a deviation ([0014]: visual feedback provided to user on how to laterally or axially position implantable lead via a graphical user interface) used to determine the lateralization decision ([0027]: after initial lead placement i.e. after a lateralization decision, the user may further adjust stimulation amplitude threshold in proportional increments).
Jiang further teaches that after initial lead placement [0027], a user can provide input related to each test stimulation or sensor response [0027], and can also modify stimulation to achieve a desired response [0027] at a minimum stimulation amplitude threshold [0027].
The proposed combination would yield wherein the electrode positioning system of Serrano Carmona would be modified to include a neuromodulation algorithm that allows a user to adjust a predefined electrical stimulation protocol based on a desired stimulation-induced response, after a deviation is used to determine the lateralization decision (i.e. independent of the deviation used to determine the lateralization decision).
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the processor of the electrode positioning system taught by Serrano Carmona, to be configured to provide wherein the neuromodulation algorithm adjusts the predefined electrical stimulation protocol as a function of therapeutic neural activity independent of the deviation used to determine the lateralization decision, as taught by the neuromodulation algorithm of Jiang, because after initial lead placement, a user can provide input related to each test stimulation or sensor response, and can also modify stimulation to achieve a desired response at a minimum stimulation amplitude threshold.
Agnesi teaches a spinal cord stimulation (SCS) therapy [0001] and teaches a processor (fig. 1: 151; [0024]) configured to:
adjust a predefined electrical stimulation protocol [0040, 0067],
wherein adjusting the predefined electrical stimulation protocol determines a spatial position of the stimulation electrode relative to a patient’s spine (fig. 5: at step 515, adjustment in position of lead and adjustment to test stimulation are determined based on relation between physiological signals; [0018]: implanted in spinal cord; [0018]: optimal programming requires detecting proper orientation of electrodes; [0068]);
modify placement of at least an electrode (fig. 1: any one of electrodes 112; [0021]: electrodes adjusted) of a set of recording electrodes (fig. 1: combination of electrodes 112) as a function of a displayed interpretation of a lateralization decision
([0090]: bars 1004a-f correspond to a bilateral side of the patient and can indicate symmetry (i.e. a lateralization decision since it determines if physiological signals acquired by sensors are asymmetrical or not) when they’re the same size (see also fig. 10C which indicate asymmetry); [0083-0084]: lack of symmetry indicates the lead 110 needs to be rotated and is displayed on action window 812; fig. 10B: 1004; [0091-0092]: difference in phases which determine symmetry [0021] may also indicate electrode array needs to be adjusted laterally);
update the lateralization decision as a function of the modified placement of the at least electrode of the set of electrodes ([0092-0093]: when physiological signals are determined to be symmetric i.e. once the electrodes are adjusted, confirmation of the symmetry is displayed).
Agnesi further teaches that visualizations helps indicate information relative to the position of the electrode to a clinician [002] so that the clinician can take the appropriate action needed to reposition the electrode [0021]. Agnesi further teaches that asymmetry may indicate that the stimulation lead is not located in an intended position relative to the physiological midline [0051] and therefore will need to be adjusted [0071].
Agnesi additionally teaches that improper positioning of the electrodes ([0018]: array of electrodes positioned diagonally relative to the physiological midline) makes it more difficult to achieve proper coverage of spinal cord stimulation [0018], therefore, the spatial position of the stimulation electrode relative to a patient’s spine should be determined while adjusting stimulation [0018].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the processor of the electrode positioning system yielded by the proposed combination, to be configured to provide wherein adjusting the predefined electrical stimulation protocol determines a spatial position of the stimulation electrode relative to a patient’s spine; modify placement of at least a recording electrode of the set of recording electrodes as a function of the displayed interpretation of the lateralization decision; update the lateralization decision as a function of the modified placement of the at least a recording electrode of the set of recording electrodes, as taught by the electrodes in Agnesi, because modifying the placement of the electrode using a visualization helps a clinician receive appropriate action needed to reposition the electrode so that symmetry can be confirmed as an indicator that the electrodes are positioned in an intended position relative to the physiological midline, and also Agnesi because improper positioning of the electrodes makes it more difficult to achieve proper coverage of spinal cord stimulation, therefore, the spatial position of the stimulation electrode relative to a patient’s spine should be determined while adjusting the predefined electrical stimulation protocol.
Regarding the limitations,
“adapt video information to a fluoroscopy screen such that an animated image of the location of the stimulation electrode identified by an algorithm module is superimposed over the fluoroscopy screen in real time,
wherein the animated image of the location of the stimulation electrode and the fluoroscopy screen are aligned by at least a reference point”,
Mandwal teaches a system to detect and confirm proper electrode position [0011] and teaches
adapting video information [0006, 0044] to a screen ([0028]: superimposed image is obtained and displayed; fig. 8; [0046]) such that an animated image of a location of an electrode identified by an algorithm module is superimposed over a fluoroscopy screen in real time ([0046]: algorithm detects if electrodes are placed correctly and if not then an animated image i.e. visual instruction indicator 70 is superimposed over the screen in real-time to provide feedback; [0028, 0046]),
wherein the animated image of the location of the electrode and the screen are aligned by at least a reference point (fig. 8: 70 is aligned with the screen by a reference point of lead wires 62 that are displayed on the image; [0046]).
Mandwal further teaches that the visual instruction indicator can be used to provide specific feedback and instructions in in real-time to a clinician [0046] while the clinician is viewing the patient [0046], and is also useful for assisting less experienced clinicians in electrode placement [0046].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the electrode positioning system and the stimulation electrode yielded by the proposed combination, to provide adapting video information to a screen such that an animated image of the location of the electrode identified by an algorithm module is superimposed over the fluoroscopy screen in real time, wherein the animated image of the location of the electrode and the screen are aligned by at least a reference point, as taught by Mandwal, because the visual instruction indicator can provide specific feedback and instructions in real-time to a clinician, and is also useful for assisting less experienced clinicians with electrode placement.
Regarding the limitations,
“…to a fluoroscopy screen…” and
“wherein the animated image of the location of the electrode and the fluoroscopy screen are aligned…”
Ghosh teaches a pacing therapy device [0002] and teaches providing imaging using fluoroscopy [0029] combined with video frame data [0029], where functional image data is superimposed onto anatomical data [0029] to assist placing electrodes within specific areas of interest in a heart of a patient [0029].
Ghosh further teaches that a combination of various imaging apparatuses may be used [0029], such as fluoroscopy (see above), to assist in electrode placement [0029].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the screen of the electrode positioning system yielded by the proposed combination, to instead be a fluoroscopy screen, as taught by Ghosh, because a combination of various imaging apparatuses may be used, such as fluoroscopy, to assist in electrode placement.
In re claim 2, the proposed combination yields (all mapping directed to Serrano Carmona unless otherwise stated)
wherein the output device comprises a display [0066], and
wherein the processor is further configured to output a representation of a location of the functional midline of the spine on the display [0066].
In re claim 3, the proposed combination yields (all mapping directed to Serrano Carmona unless otherwise stated) wherein the processor is further configured to display the location of the stimulation electrode relative to the functional midline of the spine based on the measured electrophysiologic signal ([0054]: data recorded at the peripheral electrodes, i.e. the measured electrophysiologic signal, is used to determine location of the stimulation electrode relative to the functional midline of the spine; fig. 12: 506A1 and 506A2 represent the location of the stimulation electrode; [0019, 0065-0066]).
In re claim 4, the proposed combination yields (all mapping directed to Serrano Carmona unless otherwise stated) wherein the processor is further configured to display
an overlay of the location of the stimulation electrode ([0066]; fig. 12: combination of 506A1 and 506A2 is shown overlaying image 506) and
the representation of the location of the functional midline of the spine over an image (502) captured by another modality of an area surrounding the stimulation electrode ([0066]: functional midline 1114 of the spine overlays image 502 and captures information about the area surrounding the stimulation electrode; fig. 12).
In re claim 5, the proposed combination yields (all mapping directed to Serrano Carmona unless otherwise stated) wherein the measured electrophysiologic signal is
an electromyography (EMG) signal [0041, 0049] or
a Compound Muscle Action Potential (CMAP).
In re claim 7, the proposed combination yields (all mapping directed to Serrano Carmona unless otherwise stated) wherein the electrode positioning system further includes an amplifier configured to amplify the measured electrophysiologic signal ([0048]: peripheral electrodes 616 pass the electrophysiologic signal to sense amp 818 for amplification).
In re claim 8, the proposed combination yields (all mapping directed to Serrano Carmona unless otherwise stated) wherein the predefined electrical stimulation protocol includes:
generating electrical pulse currents based on the parameter ([0006]: stimulation program specifies stimulation parameters used to provide stimulation);
applying the generated electrical pulse currents each of the subsets of contact points from the plurality of contact points ([0053]: generated electrical pulse currents is applied to each of the subsets of contact points);
measuring electrophysiologic signals triggered by the application of the generated electrical pulse currents (fig. 9: 852; [0051]);
comparing the measured electrophysiologic signals to a reference electrophysiologic signal ([0057]: measured electrophysiologic signals from the peripheral electrodes are compared to a threshold value i.e. a reference electrophysiologic signal);
determining a deviation based on the comparison
([0051]: deviation occurs when there is not enough information to make a determination regarding the location of the midline with respect to the selected spinal electrode and results in the classification criteria not being evoked; [0057]: determining a deviation occurs when it is determined whether or not the measured response exceeds the threshold, i.e. whether the classification criterion is evoked and the next spinal electrode is selected [0051-0053]);
adjusting the parameter based on the deviation ([0051-0052]: if it’s determined that the deviation exists i.e. the class criteria is not met, then the amplitude is increased as long as the current amplitude is not already equal to the maximum amplitude; see also fig. 9);
repeating
the generation of the electrical pulse currents (850; [0054]),
the application of the generated electrical pulse currents (850; [0054]),
the measurement of the electrophysiologic signals (852),
the comparison of the measured electrophysiologic signals (854; [0052-0053, 0057]),
the determination of the deviation (854, [0051-0053, 0057]), and
the adjusting of the parameter until the deviation is minimized (fig. 9: the amplitude is increased at step 858 until the class criteria is met at step 854, [0051-0054]: class criteria being met at 854 is the deviation being minimized because there is enough information gathered to determine the location of the midline with respect to the selected spinal electrode, therefore the stimulation for the selected spinal electrode is stopped and the next spinal electrode is selected);
storing a subset of contact points of the stimulation electrode in which the deviation is minimized in a memory as stored data [0051-0054]; and
moving from the subset of contact points to a subsequent subset of contact points ([0053]: after electrodes from the first lead are selected, then the electrodes from the second lead are selected; fig. 11).
In re claim 9, the proposed combination yields (all mapping directed to Serrano Carmona unless otherwise stated) wherein the adjusting the parameter includes
incrementally increasing an intensity of the generated electrical pulse currents (858; [0052]),
changing a pulse width of the generated electrical pulse currents, or
changing a pattern of the generated electrical pulse currents.
In re claim 10, the proposed combination yields (all mapping directed to Serrano Carmona unless otherwise stated) wherein the moving to the subsequent subset of contact points includes activating in a rostral-to-caudal or a left-to-right direction along the stimulation electrode (fig. 11: contact points move from E1 to E8 (i.e. the first subset of contact points) before moving to the subsequent subset of contact points (i.e. E9 to E18), in a rostral-to-caudal direction, which is interpreted as from top to bottom, and then also in a left-to-right direction from the first subset on the left to the second subset on the right; [0053, 0059]).
In re claim 11, the proposed combination yields (all mapping directed to Serrano Carmona unless otherwise stated) wherein the predefined electrical stimulation protocol further includes determining whether the parameter is within a predetermined threshold after being adjusted (fig. 9: after amplitude ‘A’ is increased at step 858, the algorithm goes back to step 856, where the current amplitude ‘A’ is checked to determine if it’s within a predetermined threshold ‘Amax’; [0052-0054]).
In re claim 13, regarding the limitations, “an electrode positioning method, the electrode positioning method comprising:
receiving, from a set of recording electrodes and by at least a processor,
an electrophysiologic signal from muscles of a patient that is triggered by electrical pulse currents applied by a stimulation electrode at a plurality of contact points along or adjacent to a spine of a subject controlling,
using the at least a processor, a stimulation device to generate electrical pulse currents according to a predefined electrical stimulation protocol such that the electrical pulse currents are applied to subsets of contact points from the plurality of contact points,
determining, using the at least a processor, a lateralization decision for each of the subsets of contact points from the plurality of contact points based on processing the electrophysiologic signals,
wherein processing the electrophysiological signals comprises:
comparing the electrophysiologic signals to a reference electrophysiologic signal;
determining a deviation as a function of comparing the electrophysiologic signals to the reference electrophysiologic signal; and
adjusting the predefined electrical stimulation protocol as a function of the deviation,
wherein adjusting the predefined electrical stimulation protocol determines a spatial position of the stimulation electrode relative to a patient’s spine;
implementing, using the at least a processor, a neuromodulation algorithm to adjust the predefined electrical stimulation protocol,
wherein the implementation further comprises determining a suboptimal activity,
wherein the neuromodulation algorithm adjusts the predefined electrical stimulation protocol as a function of therapeutic neural activity independent of the deviation used to determine the lateralization decision;
displaying, using a user interface and the at least a processor, an interpretation of the lateralization decision,
wherein the interpretation of the lateralization decision comprises a visual representation of the set of recording electrodes;
modifying, using the stimulation device and the at least a processor, placement of at least a recording electrode of the set of recording electrodes as a function of the displayed interpretation of the lateralization decision;
updating, using the at least a processor, the lateralization decision as a function of the modified placement of the at least a recording electrode of the set of recording electrodes;
determining, using the at least a processor, a functional midline of the spine based on the predefined electrical stimulation protocol and the updated lateralization decision determined for each of the subsets of contact points from the plurality of contact points;
identifying, using the at least a processor, a location of the stimulation electrode relative to the location of the functional midline of the spine based on an aggregation of the received electrophysiologic signals;
adapting, using the at least a processor, video information to a fluoroscopy screen such that an animated image of the location of the stimulation electrode identified by an algorithm module is superimposed over the fluoroscopy screen in real time,
wherein the animated image of the location of the stimulation electrode and the fluoroscopy screen are aligned by at least a reference point; and
outputting, via an output device and the at least a processor, information indicative of the functional midline of the spine and the location of the stimulation electrode”,
see in re claim 1 above.
In re claim 14, regarding the limitations, “a non-transitory computer readable medium having computer readable program code stored thereon, the computer readable program code comprising instructions executable by a processing circuitry to…,” Serrano Carmona discloses a non-transitory computer readable medium [0014-0018] having computer readable program code stored thereon [0014-0018], the computer readable program code comprising instructions [0072] executable by a processing circuitry [0018, 0084].
Regarding the following limitations:
“…control a stimulation device to generate electrical pulse currents according to a predefined electrical stimulation protocol such that the electrical pulse currents are applied to subsets of contact points of a stimulation electrode;
determine a lateralization decision for each of the subsets of contact points based on processing measured electrophysiologic signals;
wherein processing the electrophysiological signals comprises: comparing the electrophysiologic signals to a reference electrophysiologic signal; determining a deviation as a function of comparing the electrophysiologic signals to the reference electrophysiologic signal; and adjusting the predefined electrical stimulation protocol as a function of the deviation, wherein adjusting the predefined electrical stimulation determines a spatial position of the stimulation electrode relative to a patient’s spine;
implement a neuromodulation algorithm to adjust the predefined electrical stimulation protocol,
wherein the implementation further comprises determining a suboptimal activity;
wherein the neuromodulation algorithm adjusts the predefined electrical stimulation protocol as a function of therapeutic neural activity independent of the deviation used to determine the lateralization decision;
display, using a user interface, an interpretation of the lateralization decision,
wherein the interpretation of the lateralization decision comprises a visual representation of a set of recording electrodes;
modify, using the stimulation device, placement of at least a recording electrode of the set of recording electrodes as a function of the displayed interpretation of the lateralization decision;
update the lateralization decision as a function of the modified placement of the at least a recording electrode of the set of recording electrodes;
determine a functional midline of a spine based on the predefined electrical stimulation protocol and the updated lateralization decision determined for each of the subsets of contact points;
identify a location of the stimulation electrode relative to the functional midline based on an aggregation of received physiologic signals;
adapt video information to a fluoroscopy screen such that an animated image of the location of the stimulation electrode identified by an algorithm module is superimposed over the fluoroscopy screen in real time, wherein the animated image of the location of the stimulation electrode and the fluoroscopy screen are aligned by at least a reference point; and
output information indicative of the functional midline and the location of the stimulation electrode,”
see in re claim 1 above.
In re claim 18, regarding the limitations, “wherein controlling the stimulation device to generate electrical pulse currents according to the predefined electrical stimulation protocol includes: generating electrical pulse currents based on a parameter; applying the generated electrical pulse currents each of the subsets of contact points from the plurality of contact points; measuring electrophysiologic signals triggered by the application of the generated electrical pulse currents; comparing the measured electrophysiologic signals to a reference electrophysiologic signal; determining a deviation based on the comparison; adjusting the parameter based on the deviation; repeating the generation of the electrical pulse currents, the application of the generated electrical pulse currents, the measurement of the electrophysiologic signals, the comparison of the measured electrophysiologic signals, the determination of the deviation, and the adjusting of the parameter until the deviation is minimized; and moving from the subset of contact points to a subsequent subset of contact points,” see in re claim 8 above.
In re claim 19, regarding the limitations, “wherein the instructions executable by the processing circuitry to control the stimulation device to generate electrical pulse currents according to the predefined electrical stimulation protocol includes instructions executable by the processing circuitry to: generate electrical pulse currents based on a parameter; apply the generated electrical pulse currents each of the subsets of contact points from a plurality of contact points; measure electrophysiologic signals triggered by the application of the generated electrical pulse currents; compare the measured electrophysiologic signals to a reference electrophysiologic signal; determine a deviation based on the comparison; adjust the parameter based on the deviation; repeat the generation of the electrical pulse currents, the application of the generated electrical pulse currents, the measurement of the electrophysiologic signals, the comparison of the measured electrophysiologic signals, the determination of the deviation, and the adjusting of the parameter until the deviation is minimized; and move from the subset of contact points to a subsequent subset of contact points,” see in re claim 8 above.
In re claim 21, the proposed combination yields wherein
the information indicative of the functional midline of the spine (see above, where Serrano Carmona teaches that the functional midline can be used in the evaluation of the suitability of the location of the electrodes which would be in real time i.e. the time that the evaluation was completed) and
the location of the stimulation electrode (see in re claim 1 above, where Mandwal teaches the visual instruction indicator being superimposed over the screen in real-time to provide feedback for positioning the electrode in real time)
comprises feedback for positioning the electrode in real time (see above).
In re claim 22, regarding the limitations, “wherein the information indicative of the functional midline of the spine and the location of the stimulation electrode comprises feedback for positioning the electrode in real time”, see in re claim 21 above.
In re claim 22, regarding the limitations, “wherein the information indicative of the functional midline of the spine and the location of the stimulation electrode comprises feedback for positioning the electrode in real time”, see in re claim 21 above.
Claims 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Serrano Carmona et al. (US 2017/0281959) Jiang et al. (US 2016/0045747) in view of Agnesi et al. (US 2019/0134382) in view of Mandwal et al. (US 2020/0005481) in view of Ghosh (US 2019/0269926) in view of Raschella et al. (US 2020/0384272).
In re claim 6, the proposed combination fails to yield wherein the measured electrophysiologic signal indicates a level of myotomal activation.
Raschella teaches an analogous system for planning and/or providing neurostimulation [0001], wherein
measured electrophysiologic signal ([0031]: recordings of muscle activity i.e. EMG) indicates a level of myotomal activation ([0031]: EMG used to construct spinal maps of spinal α-motoneurons activity which indicate a level of myotomal activation; [0059]), and
a processor (fig. 1: 14; [0087, 0096-0101]) is further configured to: automate functional myotomal mapping based on the level of myotomal activation (myotomal maps determine the approximate rostro-caudal location of α-motoneurons pools and map the recorded patterns of muscle activity).
Raschella further teaches that myotomal maps can be used to “provide information regarding location, duration and intensity of α-motoneurons activation during any kind of movement” [0031]. Raschella additionally teaches that an injury spinal map can be compared with a reference spinal map to provide a differentia map that shows missing activation which can be used to determine a stimulation strategy to apply [0264].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the electrode positioning system yielded by the proposed combination, to provide wherein the measured electrophysiologic signal indicates a level of myotomal activation, and wherein a processor is further configured to: automate functional myotomal mapping based on the level of myotomal activation, as taught by Raschella, because doing so provides information on the location, duration, and intensity of α-motoneurons activation during movement, and allows the level of myotomal activation observed to be compared with a reference myotomal activation so that missing activation can be determined for appropriate stimulation strategy.
In re claim 15, regarding the limitation “wherein the processor is further configured to: automate functional myotomal mapping based on the level of myotomal activation,” see the proposed combination yielded in re claim 6 above.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Serrano Carmona et al. (US 2017/0281959) Jiang et al. (US 2016/0045747) in view of Agnesi et al. (US 2019/0134382) in view of Mandwal et al. (US 2020/0005481) in view of Ghosh (US 2019/0269926) in view of Hegi et al. (US 2010/0305660).
In re claim 12, the proposed combination yields (all mapping directed to Serrano Carmona unless otherwise stated)
wherein the processor is further configured to:
determine a Root Mean Square (RMS) value of the stored data [0057]; and
compare the RMS value of the stored data corresponding to a first subset of contact points of the plurality of contact points to the RMS value of the stored data corresponding to a threshold [0057].
designating the first subset of contact points of the plurality of contact points as one of
a left subset of contact points ([0054]: spinal electrodes left of the physiological midline),
a right subset of contact points ([0054]: spinal electrodes right of the physiological midline), or
a midpoint based on the comparison ([0054]: lateral position is determined);
repeating the determining, the comparing, and the designating for each data corresponding to each subset of contact points of the plurality of contact points ([0054]: process repeated for all spinal electrodes 16; [0057]; fig. 9).
The proposed combination fails to yield wherein the processor is further configured to: … compare the RMS value of the stored data corresponding to a first subset of contact points of the plurality of contact points to the RMS value of the stored data corresponding to another one subset of contact points of the plurality of contact points.
Hegi teaches an analogous spinal cord stimulation system [0002] comprising of a plurality of contact points (fig. 3: plurality of contact points are all electrodes disposed along stimulation leads 310 and 320 (note: left lead labeled “320” should be labeled “310”); [0027]), wherein a processor [0021] is further configured to compare an RMS value [0048] of stored data corresponding to a first subset of contact points (fig. 3: first subset of contact points are electrodes 341-348 and are on the left side of the patient; [0027]) of the plurality of contact points ([0048]: RMS value obtained from the left side of the patient; fig. 3) to an RMS value of stored data corresponding to another one subset of contact points (fig. 3: another subset of contact points are electrodes 349-536 and are on the right side of the patient; [0027]) of the plurality of contact points ([0048]: RMS value obtained from the right side of the patient; fig. 3).
Hegi further teaches that comparing the RMS calculations from the left subset and from the right subset provides a comparison of the effect of stimulation on the left and right sides of the patient [0048], and comparing the effect of stimulation of the left and right sides of the patient provides an estimation of an electrode’s position relative to the midline [0048].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the electrode positioning system yielded by the proposed combination, to provide wherein the processor is further configured to: compare the RMS value of the stored data corresponding to a first subset of contact points of the plurality of contact points to the RMS value of the stored data corresponding to another one subset of contact points of the plurality of contact points, as taught by Hegi, because doing so provides a comparison of the effect of stimulation on the left and right sides of the patient, and comparing the effect of stimulation of the left and right sides of the patient is another way of estimating an electrode’s position relative to the midline.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Zhang et al. (US 2019/0009094) discloses a system for delivering neurostimulation (abstract) and teaches adjusting stimulation [0112] based on safety rules [0112].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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