DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments filed 06/13/2025 have been fully considered but are not persuasive or are moot in view of new grounds of rejection.
Applicant argues, “based on this two-prong analysis, even if the claims recite an abstract idea, the claims integrate any recited judicial exception into a practical application of the exception.”
Examiner respectfully disagrees. Specifically, amended claim 1 recites, “configure the implantable stimulation device to deliver ongoing therapy according to the selected configuration”.
Under broadest reasonable interpretation, the recited limitation does not require delivering or applying stimulation to a patient, nor does it require providing a particular prophylaxis. There is nothing in the claims which shows how configuring the implantable stimulation device to deliver ongoing therapy according to the selected configuration amounts to a particular prophylaxis or integrates the abstract ideas into a practical application.
Applicant argues, “amended claim 1 positively recites an implantable stimulation device that is configured to apply a plurality of stimuli to neural tissue. Amended claim 1 further recites selecting between a first and second configuration of local stimulation and recording, and then configuring the implantable stimulation device to deliver ongoing therapy according to the selected configuration. The first configuration includes a first stimulation electrode and a first recording electrode, and the second configuration includes a second stimulation electrode and a second recording electrode different from the first recording electrode. Accordingly, both the recited first and second configuration of local stimulation and recording positively recite features related to the local stimulation.”
Examiner respectfully disagrees. Although amended claim positively recited an implantable stimulation device that is configured to apply a plurality of stimuli to neural tissue, under broadest reasonable interpretation, the limitation directed to the ongoing therapy does not require that stimulation is applied to neural tissue (see above). There is nothing in the claims which shows how configuring the implantable stimulation device to deliver ongoing therapy according to the selected configuration amounts to a particular prophylaxis or integrates the abstract ideas into a practical application.
Applicant argues “the recited selection and configuration of the recited implantable device that delivers ongoing therapy recites a particular treatment for a disease or medical condition. For example, as described in Applicant's Specification, electrical neuromodulation may be "used or envisaged for use to treat a variety of disorders including chronic pain, Parkinson's disease, and migraine, and to restore function such as hearing function and motor function." Id. ¶ [0002]. As further described in Applicant's Specification, "Delivery of an appropriate stimulus to the nerve 180 evokes a neural response comprising a compound action potential which will propagate along the nerve 180 as illustrated, for therapeutic purposes which in the case of a spinal cord stimulator for chronic pain might be to create paraesthesia at a desired location." Id. ¶ [0039] (emphasis added). Applicant's Specification further discloses, "the presently described embodiments provide means for automated assessment of the device fitting on the basis of ECAP quality scores, including the stimulation configuration and recording configuration." Id. (emphasis added). Accordingly, claim 1 recites a particular treatment (e.g., positively recited implantable stimulation device configured according to selected stimulation and recording configuration, including positively recited stimulation electrodes, for ongoing therapy) for a disease or medical condition (e.g., chronic pain).”
Examiner respectfully disagrees. As stated above, there is nothing in the claims which shows how configuring the implantable stimulation device to deliver ongoing therapy according to the selected configuration amounts to a particular prophylaxis or integrates the abstract ideas into a practical application.
Applicant argues, “Additionally, amended claim 1 recites several improvements to technology or a technical field, and in particular recites improvements to the efficiency and/or the therapeutic outcomes of neurostimulation.”
Examiner respectfully states that even if the claimed invention provides an improvement, the claimed invention still does not overcome the 35 U.S.C. 101 rejection since claims 1-4 and 7-23 are still directed to abstract ideas and are therefore not patent eligible. The combination of the recited additional elements is no more than insignificant extra solution activity, mere data gathering, and mere instruction to apply the exception using generic computer components without providing a particular prophylaxis. Furthermore, as stated above, configuring the implantable stimulation device according to the selected configuration does not integrate the abstract idea into a practical application.
Applicant argues, “Applying the Step 2B analysis, amended claims 1, 21, and 22 recite additional elements that, in combination, are not well-understood, routine, or conventional activity. For example, as described above in connection with Step 2A, Prong Two, amended claim 1 recites a particular treatment to a disease or medical condition and/or improvements to a technology or technical field (e.g., improvements to neurostimulation devices and neurostimulation therapy). Therefore, the claims are not directed to an abstract idea, and thus Applicant respectfully requests that the § 101 rejections of claims 1-4 and 7-22 be withdrawn.”
Examiner respectfully disagrees. As best understood, the limitations directed to the implantable stimulation device configured to apply a plurality of stimuli to neural tissue, the first and second stimulation electrodes, and the first and second recording electrodes, are well-understood, routine, and conventional, as evidenced by the references below:
Perryman et al. (US 2015/0297900) discloses an implantable stimulation device [0046] configured to apply a plurality of stimuli [0046-0047] to neural tissue [0046-0047] and comprising of two stimulation electrodes ([0167]: stimulation electrodes that are different from recording/sensing electrodes) and two recording electrodes ([0167]: recording/sensing electrodes that are different from stimulation electrodes).
Parramon et al. (US 2010/0331916) discloses an implantable stimulation device [0004] configured to apply a plurality of stimuli [0008] to neural tissue [0008] and comprising of two stimulation electrodes ([0008]: electrodes that stimulate neural tissue) and two recording electrodes ([0008]: electrodes which sense electrical parameter in response to transmission of pulses).
Therefore, none of the claims 1-4 and 7-23 amounts to significantly more than the abstract idea itself. Accordingly, claims 1-4 and 7-23 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas which use mathematical concepts, mental processes, mere data gathering and outputting, mere instructions to apply the exception using generic computer components, and do not provide a particular prophylaxis, as further discussed in the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al., MPEP 2106.04(a)(2), and MPEP 2106.05(g).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 and 7-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1:
Independent claims 1, 21, and 22 recite a system, method, and non-transitory computer readable medium for an automated assessment of neural response recordings. Thus, they are directed to statutory categories of invention.
Step 2A, Prong 1:
Claims 1, 21, and 22 recite the following claim limitations which are directed to mathematical concepts (see MPEP § 2106.04(a)(2), subsection I):
Claim 1:
“a set of basis functions comprising at least one of (a) a compound action potential basis function and (b) an artefact basis function”; (mathematical formulas or equations),
“repeatedly determine a plurality of values of the at least one parameter for each respective one of the plurality of neural recordings” (mathematical formulas or equations),
“determine a spread of the plurality of values” (mathematical relationships, mathematical formulas or equations, and mathematical calculations)
Claims 21 and 22: see in re claim 1 above.
These limitations, under their broadest reasonable interpretation, cover mathematical concepts. For instance, a compound action potential basis function and an artefact basis function each consist of a basis function which is a “mathematical tool for deconstructing composite signals”, as explained in the Applicant’s specifications [0050]. Furthermore, the specifications [0019] disclose that a “spread may be calculated as being the standard deviation of the parameters, a variance of the parameters, an inter-quartile or inter-decile range of the parameters, or may comprise any other suitable statistical measure of data spread”, which further implies that the spread is a mathematical concept, specifically a mathematical relationship between the measured data and a mathematical calculation to calculate statistical parameters such as standard deviation. Therefore, since the claim limitations can be broken down into mathematical relationships, formulas or equations, and calculations, the claim limitations fall within the ‘mathematical concepts’ grouping of abstract ideas.
Claims 1, 21, and 22 recite the following claim limitations which are directed to mental processes:
“decompose each neural recording using the set of basis functions by determining at least one parameter which characterizes at least one of a locally evoked compound action potential (ECAP) and an artefact in the neural recording” (mental process – person can decompose neural recording by determine a parameter that characterizes either an ECAP or an artefact);
“output a first indication that the neural response recordings are of higher quality if the spread is small and that the neural response recordings are of lower quality if the spread is large,
the first indication comprising a quality score for the first configuration” (mental process – person can output whether the neural response recordings are of higher or lower quality);
“output a second indication of the quality of neural response recordings received from the implantable stimulation device subsequent to respective stimuli using a second configuration of local stimulation and recording,… the second indication comprising a quality score for the second configuration” (mental process – person can output an indication of the quality of the neural response recording),
“select a configuration from the first and second configurations for ongoing therapy by comparing the quality scores for the first and second configurations” (mental process – person can select a configuration for therapy by comparing the quality scores).
The above recited limitations are directed to abstract ideas, specifically mental processes, since they require evaluation and judgement of a person (mentally or via pen and paper) to output an indication and to select a configuration for therapy based on the quality of neural response records and the quality scores, respectively.
Additionally, regarding the recited “quality score”, according to Applicant’s specification, a quality score may be an output indicating the quality of the neural response recordings [0025], and that “determination of a quality score may be calibrated by reference to clinician scoring of a test set of neural recordings. Similarly, normalisation of the quality score may be calibrated by reference to clinician scoring of a test set of neural recordings, for example the clinician may use the test set to define a midpoint, spread, growth rate or the like of a normalising function such as a sigmoid” [0025].
Additionally, Applicant’s specifications also disclose that “in one embodiment, a quality score may be determined as follows: Score=(Detection Rate*Correlation)/(Frequency spread+Offset spread)” [0033]. This further shows that a quality score is an output which indicates whether the neural response recordings are of lower or higher quality, and that the quality score is determined based on calculations between various parameters.
Under broadest reasonable interpretation, the recited “quality score” may be considered a mental process, such as a clinician providing a rating of quality, or, it may also be considered as a mathematical calculation, as shown in Applicant’s specification above.
These limitations, under their broadest reasonable interpretation, cover abstract ideas, specifically mental processes and mathematical concepts.
Step 2A, Prong 2:
Claims 1, 21, and 22 recite the following additional elements:
Claim 1:
an implantable stimulation device configured to apply a plurality of stimuli to neural tissue;
a memory storing…;
an input for receiving a plurality of neural recordings of electrical activity in the neural tissue,
the neural recordings being received from the implantable stimulation device subsequent to respective local stimuli using a first configuration of local stimulation and recording,
the first configuration comprising a first stimulation electrode and a first recording electrode; and
a processor…:
the second configuration comprising a second stimulation electrode and a second recording electrode,
wherein the second recording electrode is different from the first recording electrode,
configure the implantable stimulation device to deliver ongoing therapy according to the selected configuration.
Claim 21 and 22: see in re claim 1 above.
Regarding the limitations, “a memory” and “a processor”, these are directed to generic computer components, and the claim recites mere instructions to apply the exception in a generic manner using a computer.
Regarding the limitation, “an input for receiving a plurality of neural recordings of electrical activity in the neural tissue” Examiner asserts that the recited limitation is considered an insignificant extra-solution activity (see MPEP 2106.05(g)). Specifically, the above recited limitation is part of pre-solution activities (see MPEP §2106.05(g)) because it’s used to obtain information so that a determination can be made regarding quality of the neural recordings.
Regarding the limitations:
an implantable stimulation device configured to apply a plurality of stimuli to neural tissue;
the neural recordings being received from the implantable stimulation device subsequent to respective local stimuli using a first configuration of local stimulation and recording,
the first configuration comprising a first stimulation electrode and a first recording electrode; and
the second configuration comprising a second stimulation electrode and a second recording electrode,
wherein the second recording electrode is different from the first recording electrode,
the above recited limitations are merely used to establish an environment for which data is gathered (see factor ‘c’ in MPEP §2106.04(d)(2)).
Regarding the limitation, “configure the implantable stimulation device to deliver ongoing therapy according to the selected configuration”, under broadest reasonable interpretation, the recited limitation does not require delivering or applying stimulation to a patient, nor does it require providing a particular prophylaxis. Specifically, there is nothing in the claims which shows how configuring the implantable stimulation device to deliver ongoing therapy according to the selected configuration amounts to a particular prophylaxis or integrates the abstract ideas into a practical application.
The combination of these additional elements is no more than insignificant extra solution activity, mere data gathering, and mere instruction to apply the exception using generic computer components without providing a particular prophylaxis. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A Prong Two, the additional elements in the claims amount to no more than insignificant extra solution activity and mere data gathering combined with mathematical concepts and mental processes that are done using generic computer components such as a memory, an input, and a processor. The same analysis applies here in 2B and does not provide an inventive concept.
Additionally, regarding the limitations directed to an implantable stimulation device configured to apply a plurality of stimuli to neural tissue, Applicant’s specification disclose “Figure 1 schematically illustrates an implanted spinal cord stimulator 100. Stimulator 100 comprises an electronics module 110 implanted at a suitable location in the patient's lower abdominal area or posterior superior gluteal region, and an electrode assembly 150 implanted within the epidural space and connected to the module 110 by a suitable lead. Numerous aspects of operation of implanted neural device 100 are reconfigurable by an external control device 192. Moreover, implanted neural device 100 serves a data gathering role, with gathered data being communicated to external device 192”. [0035]
Regarding the limitations directed to the first stimulation electrode, the first recording electrode, the second stimulation electrode, and the second recording electrode, Applicant’s specifications do not provide structure or detailed drawings regarding the first stimulation electrode, the first recording electrode, the second stimulation electrode, and the second recording electrode.
Regarding the implantable stimulation device configured to apply a plurality of stimuli to neural tissue and comprising of two stimulation electrodes and two recording electrodes, see the below references that disclose similar structure:
Perryman et al. (US 2015/0297900) discloses an implantable stimulation device [0046] configured to apply a plurality of stimuli [0046-0047] to neural tissue [0046-0047] and comprising of two stimulation electrodes ([0167]: stimulation electrodes that are different from recording/sensing electrodes) and two recording electrodes ([0167]: recording/sensing electrodes that are different from stimulation electrodes).
Parramon et a. (US 2010/0331916) discloses an implantable stimulation device [0004] configured to apply a plurality of stimuli [0008] to neural tissue [0008] and comprising of two stimulation electrodes ([0008]: electrodes that stimulate neural tissue) and two recording electrodes ([0008]: electrodes which sense electrical parameter in response to transmission of pulses).
As best understood, the limitations directed to the implantable stimulation device configured to apply a plurality of stimuli to neural tissue, the first and second stimulation electrodes, and the first and second recording electrodes, are well-understood, routine, and conventional, as evidenced by the references above.
Therefore, none of the claims 1-4 and 7-23 amounts to significantly more than the abstract idea itself. Accordingly, claims 1-4 and 7-23 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas which use mathematical concepts, mental processes, mere data gathering and outputting, mere instructions to apply the exception using generic computer components, and do not provide a particular prophylaxis, as further discussed in the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al., MPEP 2106.04(a)(2), and MPEP 2106.05(g).
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 1-4, 11, 13-16, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Parker et al. (WO 2016/077882) in view of Litvak et al. (US 2006/0287609) in view of Fayram et al. (US 2018/0085593).
In re claim 1, Parker (‘882) discloses a system (Fig. 2) for automated assessment of neural response recordings ([0030]: Fig. 2 shows a schematic of a feedback controller to effect stimulus control based on whether a detected evoked neural response is present), the system comprising:
an implantable stimulation device (fig. 1: 100; [0029]) configured to apply a plurality of stimuli [0029, 0031] to neural tissue [0031];
a memory [0029] storing a function comprising at least one of
(a) a compound action potential function ([0006]; [0047]: CAP function is the energy/amplitude ratio of the CAP) and
(b) an artefact basis function;
an input ([0034]: first measurement 212 and second measurement 214 of the neural response) for receiving a plurality of neural recordings of electrical activity in neural tissue [0034],
the neural recordings being received from the implantable stimulation device ([0029]: implantable device controls application of neural stimuli and measures neural response using electrodes) subsequent to respective local stimuli ([0032]: subsequent to local stimuli of E1, E2 measured a neural response 212; fig. 2: E1 delivers local stimuli which is measured by E2; [0034]) using a first configuration ([0032]: first configuration of E1 and E2; [0037]: within a first 3 second interval) of local stimulation and recording
([0037]: E1 repeatedly delivers a stimulus during a time period using the first configuration of stimulation and recording as seen in Fig. 2 to determine if there was a locally evoked neural response; [0032]: neural response evoked by stimulus at E1 and sensed at electrodes close to E1 is considered as local stimulation and recording; fig. 3; [0037, 0034-0035]);
the first configuration comprising a first stimulation electrode (fig. 2: E2; [0032]) and a first recording electrode (E2; [0032]); and
a processor ([0029]: control unit 110 includes a processor) configured to decompose* each neural recording using the function ([0019]: each neural measurement of a set of neural measurement is decomposed into components such as amplitude and width) by determining at least one parameter ([0035]: the neural response decay values; [0024]: determines if a locally evoked response is present) which characterizes at least one of a locally evoked compound action potential (ECAP) [0024, 0026] and an artefact in the neural recording [0026, 0048],
repeatedly determine a plurality of values of the at least one parameter for each respective one of the plurality of neural recordings ([0024]: plurality of ratios is used to determine an indication of whether a locally evoked response is present; [0037]: ratios are based on the R values); and
determine a spread of the plurality of values (Fig. 4b: band 402; [0037]: a band 402 consists of the location where most of the ratios lie and is used for measurement optimization depending on the tightness of the band); and
output a first indication ([0037]: an average of R values taken from the band which defines a valid measurement for a specific patient; [0024]) that the neural response recordings are of higher quality if the spread is small ([0037]: when multiple R values (ratios) are produced around a range defined by the band (i.e., a small spread), then the measurements are an indication of higher quality since the measurements can be retained for measurement optimization and they verify the presence of a locally evoked neural response as opposed to a distally evoked neural response which may originate from the brain or due to noise as further disclosed in [0039]) and
output an indication that the neural response recordings are of lower quality if the spread is large ([0038]: the presence of random noise in the measurements will result in R values not consistently in band 402 (i.e., resulting in a greater spread) and therefore is an indication of lower quality),
the first indication comprising a quality score for the first configuration [0037-0038]:
wherein the processor is further configured to:
output a second indication of the quality of neural response recordings received from the implantable stimulation device subsequent to respective local stimuli ([0037-0038]: next 3 second interval is used to provide a second indication and is received after a local stimuli from E1 since E1 repeatedly delivers a stimuli; [0032]) using a second configuration of local stimulation and recording ([0037-0038]: second configuration is the next 3 second interval where values of R are calculated and an average R is produced within a range to determine a locally evoked neural response)
the second configuration comprising a second stimulation electrode (fig. 1: E1) and a second recording electrode ([0037]: E2 is considered as a recording electrode for the second configuration; [0032]: neural response comprises responses from recording electrode E2 and sensing electrodes E3 and E4),
the second indication comprising a quality score for the second configuration ([0037-0038]: second indication comprising a quality score is based on the second 3 second interval).
Parker (‘882) fails to disclose:
a memory storing a set of basis functions comprising at least one of
(a) a compound action potential basis function
a processor configured to decompose each neural recording using the set of basis functions by determining at least one parameter which estimates at least one of a locally evoked compound action potential and an artefact from the set of basis functions…
wherein the processor is further configured to:…
wherein the second recording electrode is different from the first recording electrode,
select a configuration from the first and second configurations for ongoing therapy by comparing the quality scores for the first and second configuration; and
configure the implantable stimulation device to deliver ongoing therapy according to the selected configuration.
Litvak teaches an analogous neural recording system (Fig. 8) that automatically identifies whether a neural recording includes a neural response signal [0013], wherein a memory [0110] stores a set of basis functions [0076-0077], wherein each basis function represents a locally evoked compound action potential ([0085]: basis functions are chosen to represent the set of evoked neural recording signals; [0064]: evoked neural recording signals are compound action potential since they include a sum of action potentials of a number of nerve cells; [0042]: recording electrode E2 records stimulus from stimulating electrode E1, therefore there is a locally evoked compound action potential since the electrical activity is recorded close to the stimulation site; fig. 1: E1 and E2).
Litvak further teaches that having a set of basis function help describe a given set of data [0077], and the basis functions also help to denoise the neural recording signal [0076, 0089].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the automated neural response system taught by Parker (‘882) , to provide wherein the locally evoked compound action potential function of Parker (‘882) is instead a set of locally evoked compound action potential basis functions, as taught by Litvak, because doing so will help to decrease or remove noise from a neural recording signal.
*The broadest reasonable interpretation of “decompose” is breaking a function down into components, parameters, or characteristics. Therefore, although Parker (‘882) teaches the BRI of “decompose”, Litvak could also be used to teach the limitation “a processor configured to decompose each neural recording by determining at least one parameter which estimates at least one of a compound action potential and an artefact from the set of basis functions”. For instance, Litvak further teaches a processor [0087] configured to decompose each neural recording ([0077]: principle component analysis decomposes data into essential features called principal components and is used to derive basis functions; [0087-0092]) by determining at least one parameter ([0087-0088]: weights are the parameters since they assist in denoising the neural recording signal by multiplying the weights with the basis functions) which estimates at least one of a compound action potential ([0089-0091]: evoked neural response signal is represented by ‘s’, which is denoised by multiplying the weights with the basis functions) and an artefact [0096] from the set of basis functions (Fig. 8 and Fig. 9).
Similarly as explained above, it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the automated neural response system taught by Parker (‘882) , to provide a processor configured to decompose each neural recording by determining at least one parameter which estimates at least one of a locally evoked compound action potential and an artefact from the set of basis functions, as taught by Litvak, because doing so will help to decrease or remove noise from a neural recording signal.
Regarding the limitations, "wherein the processor is further configured to:…
wherein the second recording electrode is different from the first recording electrode,
select a configuration from the first and second configurations for ongoing therapy by comparing the quality scores for the first and second configuration; and
configure the implantable stimulation device to deliver ongoing therapy according to the selected configuration”,
Fayram teaches an analogous therapy delivery device [0206] for neural stimulation [0206] comprising of
an implantable stimulation device [0206] configured to apply a plurality ([0206]: signal pulses) of stimuli to neural tissue ([0206]: provides neural tissue; [0750]: target tissue may be neural tissue),
a first configuration ([0239]: first configuration is a first group of electrodes comprising a stimulation electrode to stimulate therapy and a pair of sensing electrodes from SE0-SE3) comprising a first stimulation electrode ([0206]: energy delivery members are electrostimulation electrodes) and a first recording electrode ([0239]: first pair of sensing electrodes),
a second configuration comprising a second stimulation electrode ([0222]: farfield signal information corresponds to a delivered therapy signal; [0239]: stimulation electrode that emits farfield signal; [0206]: therapy signals are delivered using an electrostimulation electrode; [0239]) and a second recording electrode ([0239]: one of the sensing electrodes from another pair of sensing electrodes that was chosen in the first pair of sensing electrodes),
wherein the second recording electrode is different from the first recording electrode ([0239]: best sensing electrode pair is chosen, which means at least one of the sensing electrodes from the second configuration must be different from the sensing electrodes from the first configuration; [0222]: multiple different electrode combination selections are tested),
select a configuration from the first and second configurations for ongoing therapy by comparing quality scores for the first and second configuration ([0239]: electrode pair is selected based on detected highest signal to noise ratio of a received signal, which is an indicator of signal quality); and
configure the implantable stimulation device to deliver ongoing therapy according to the selected configuration ([0687]: optimal electrode selection procedure is used to deliver an optimal configuration for at least a portion of a therapy event).
Fayram further teaches that multiple different electrode combination selections are tested so that an optimal configuration for sensing is identified [0222], such as one that has a higher signal to noise ratio [0239].
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 automated neural response system yielded by the proposed combination , to provide wherein the second recording electrode is different from the first recording electrode, select a configuration from the first and second configurations for ongoing therapy by comparing the quality scores for the first and second configuration; and configure the implantable stimulation device to deliver ongoing therapy according to the selected configuration, as taught by Fayram, because testing multiple different electrode combination allows an optimal configuration for sensing to be identified, such as one that has a higher signal to noise ratio.
In re claim 2, Parker (‘882) fails to disclose wherein the first indication of the quality of the neural response recordings is a binary indication of either high quality or low quality.
Litvak teaches wherein a first indication of a quality of the neural response recordings ([0103-0105]: SOR metric is an indication of quality of the neural response recordings since it determines whether or not a neural recording signal actually includes a neural response signal as opposed to noise and artifact signals) is a binary indication of either high quality or low quality ([0105]: depending on the SOR metric, there are two potential outcomes: either “the SOR metric exceeds a pre-determined threshold, [and] the neural recording signal is identified as including a neural response signal“ which indicates high quality, or “the SOR metric is below the predetermined threshold, [and] the neural recording signal is identified as not including a neural response signal” which indicates low quality).
Litvak further teaches that whether or not the neural recording signal includes a neural response signal can automatically be identified when the SOR metric is above the pre-determined threshold value [0039].
Therefore, it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the automated neural response system taught by Parker (‘882) , to provide wherein the first indication of the quality of the neural response recordings is a binary indication of either high quality or low quality, as taught by Litvak, because doing so will be faster and automatic compared to the band 402 in Parker (‘882) where one has to use the band’s tightness as an indication of lower or higher quality.
In re claim 3, Parker (‘882) discloses wherein the first indication of the quality of the neural response recordings is defined on a continuum, from high quality to low quality ([0037]: band 402 provides an indication of high quality and low quality based on a continuum of the band’s tightness).
In re claim 4, Parker (‘882) discloses wherein the first indication of the quality of the neural response recordings is calibrated by reference to clinician scoring of a test set of neural recordings ([0040]: boundary range of band 402 is calibrated by a clinician using a feedback experiment).
In re claim 11, Parker (‘882) fails to disclose wherein the at least one parameter comprises a correlation of an observed ECAP with a predefined basis function comprising an analytically defined compound action potential basis function.
Litvak teaches wherein at least one parameter comprises a correlation of an observed ECAP with a predefined basis function ([0088]: incoming neural recording signal is correlated with the basis functions) comprising an analytically defined compound action potential basis function ([0077]: analytically defined compound actional potential basis functions are basis functions which are derived using principal component analysis on a previously collected neural recording signal).
Similarly as explained in re claim 1 above, it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the automated neural response system taught by Parker (‘882) , to provide wherein a parameter comprises a correlation of an observed ECAP with a predefined basis function comprising an analytically defined compound action potential basis function, as taught by Litvak, because doing so will help to decrease or remove noise from a neural recording signal when the observed ECAP is correlated with an analytically defined compound action potential basis function.
In re claim 13, Parker (‘882) discloses wherein the at least one parameter comprises a time offset of an observed ECAP relative to a time of a stimulus ([0032]: the evoked neural response travels through electrodes E1, E2, and E3 at their respective times t1, t2, and t3, which are measured time offsets corresponding to the decay in the neural response signal as it travels from the stimulus site).
In re claim 14, regarding the limitation “wherein the basis function comprises an analytically defined compound action potential basis function”, see in re claim 7 above. Regarding the limitation “wherein the processor is further configured to use a rate at which an ECAP is detected in the plurality of recordings to define a quality of the neural response recordings”, Parker (‘882) discloses wherein the processor is further configured to use a rate at which an ECAP is detected in the plurality of recordings to define a quality of the neural response recordings ([0032]: rate is the time that is takes for the neural response signal to reach the second electrode E2 and the third electrode E3 at times t2 and t3 respectively, which are used to determine if the evoked neural response was locally evoked or distally evoked [0018]).
In re claim 15, Parker (‘882) discloses wherein the processor is further configured to obtain two or more neural recordings of each ECAP ([0032]: each evoked response travels from electrode E1 to E2 to E3 and results in a neural recording at each sensed electrode), and to use one or more comparative parameters derived from a comparison of the two or more recordings to assess ECAP quality ([0032]: the neural recordings from each electrode position is compared; [0018]: this comparison is used to determine if an evoked response was locally evoked or distally evoked which assesses ECAP quality since the origin of the signal can be verified).
In re claim 16, Parker (‘882) discloses wherein the comparative parameters comprise a conduction velocity of each ECAP determined from two or more neural recordings of that ECAP ([0018]: conduction velocity taken at each electrode i.e. from two or more neural recordings of an evoked response is used to determine is an evoked response is locally evoked (decaying signal strength sensed from the electrodes) or distally evoked (constant neural signal strength to both electrodes); [0032]), and wherein a spread of the conduction velocity is used to derive ECAP signal quality ([0018]: comparing multiple conduction velocities (i.e., a spread) between the electrodes is used to determine if a signal is locally evoked or distally evoked).
In re claim 21, regarding the limitations “a method for automated assessment of neural response recordings, the method comprising:
applying, by an implantable stimulation device, a plurality of stimuli to neural tissue;
providing a set of basis functions comprising at least one compound action potential basis function and at least one artefact basis function;
receiving a plurality of neural recordings of electrical activity in neural tissue,
the neural recordings being received from the implantable stimulation device by subsequent to respective local stimuli using a first configuration of local stimulation and recording,
the first configuration comprising
a first stimulation electrode and
a first recording electrode;
decomposing each neural recording using the set of basis functions by determining at least one parameter which characterizes at least one of a locally evoked compound action potential (ECAP) and an artefact in the neural recording;
repeatedly determining a plurality of values of the at least one parameter for each respective one of the plurality of neural recordings;
determining a spread of the plurality of values;
outputting a first indication
that the neural response recordings are of higher quality if the spread is small, and
that the neural response recordings are of lower quality if the spread is large,
the first indication comprising a quality score for the first configuration;
outputting a second indication of the quality of neural response recordings received from the implantable stimulation device subsequent to respective stimuli using a second configuration of local stimulation and recording,
the second configuration comprising
a second stimulation electrode and
a second recording electrode,
wherein the second recording electrode is different from the first recording electrode
the second indication comprising a quality score for the second configuration;
selecting a configuration from the first and second configurations for ongoing therapy by comparing the quality scores for the first and second configurations; and
configuring the implantable stimulation device to deliver ongoing therapy according to the selected configuration,”
see in re claim 1 above.
In re claim 22, Parker (‘882) discloses a non-transitory computer readable medium [0017] for automated assessment of neural response recordings ([0007: stimulator is controlled by neural response feedback and therefore provides an automated assessment of neural recordings; [0037]: E1 repeatedly delivers a stimulus and R was determined for each iteration), comprising instructions which, when executed by one or more processors, causes performance of a method [0017].
Regarding the limitations, “a method comprising:
applying, by an implantable stimulation device, a plurality of stimuli to neural tissue;
providing a set of basis functions comprising at least one compound action potential basis function and at least one artefact basis function;
receiving a plurality of neural recordings of electrical activity in the neural tissue,
the neural recordings being received from the implantable stimulation device subsequent to respective local stimuli using a first configuration of local stimulation and recording,
the first configuration comprising a
first stimulation electrode and
a first recording electrode;
decomposing each neural recording using the set of basis functions by determining at least one parameter which characterizes at least one of a locally evoked compound action potential (ECAP) and an artefact in the neural recording,
repeatedly determining a plurality of values of the at least one parameter for each respective one of the plurality of neural recordings;
determining a spread of the plurality of values;
outputting an indication
that the neural response recordings are of higher quality if the spread is small, and
that the neural response recordings are of lower quality if the spread is large,
the indication comprising a quality score for the first configuration;
outputting a second indication of the quality of neural response recordings received from the implantable stimulation device subsequent to respective stimul using a second configuration of local stimulation and recording,
the second configuration comprising a
second stimulation electrode and a
second recording electrode,
wherein the second recording electrode is different from the first recording electrode
the second indication comprising a quality score for the second configuration;
selecting a configuration from the first and second configurations for ongoing therapy by comparing the quality scores for the first and second configurations; and
configuring the implantable stimulation device to deliver ongoing therapy according to the selected configuration,”
see in re claim 1 above.
In re claim 23, regarding the limitation, “further comprising delivering, by the implantable stimulation device, ongoing therapy according to the selected configuration”, see the proposed combination yielded in re claim 1 above.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Parker et al. (WO 2016/077882) in view of Litvak et al. (US 2006/0287609) in view of Fayram et al. (US 2018/0085593) in view of Compagnone et al. (US 2016/0223525).
In re claim 7, Parker (‘882) fails to disclose wherein the spread is calculated as being the standard deviation of the parameters.
Compagnone teaches an analogous diagnostic medical system [0009] wherein a dispersion descriptor can be calculated using standard deviation [0071]. Compagnone further teaches that calculating this value is commonly known by the skilled person and that it’s used to measure how stretched or squeezed a distribution of values are [0071].
Therefore, it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the automated neural response system taught by Parker (‘882) , to provide wherein the spread is calculated as being the standard deviation of the parameters, as taught by Compagnone, because doing so is a commonly known way to measure how stretched or squeezed a distribution of values are.
In re claim 8, Parker (‘882) fails to disclose wherein the spread is calculated as being the variance of the parameters.
Compagnone teaches wherein a dispersion descriptor can be calculated based off of variance [0071].
For the same reasons as shown in re claim 7 above, it would have been it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the automated neural response system taught by Parker (‘882) , to wherein the spread is calculated as being the variance of the parameters, as taught by Compagnone, because doing so is a commonly known way to measure how stretched or squeezed a distribution of values are.
In re claim 9, Parker (‘882) fails to disclose wherein the spread is calculated as being the inter-quartile range of the parameters.
Compagnone teaches wherein a dispersion descriptor can be calculated based off of an inter-quartile range of values [0071].
For the same reasons as shown in re claim 7 above, it would have been it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the automated neural response system taught by Parker (‘882) , to provide wherein the spread is calculated as being the inter-quartile range of the parameters, as taught by Compagnone, because doing so is a commonly known way to measure how stretched or squeezed a distribution of values are.
In re claim 10, Parker (‘882) fails to disclose wherein the spread is calculated as being the inter-decile range of the parameters.
Compagnone teaches wherein a dispersion descriptor can be calculated based off of an inter-decile range of values [0071].
For the same reasons as shown in re claim 7 above, it would have been it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the automated neural response system taught by Parker (‘882) , to provide wherein the spread is calculated as being the inter-decile range of the parameters, as taught by Compagnone, because doing so is a commonly known way to measure how stretched or squeezed a distribution of values are.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Parker et al. (WO 2016/077882) in view of Litvak et al. (US 2006/0287609) in view of Fayram et al. (US 2018/0085593) in view of Parker (US 2018/0110987).
In re claim 12, Parker (‘882) fails to disclose wherein the at least one parameter comprises a frequency of an observed ECAP.
Parker(‘987) teaches an analogous neuromodulation system [0004] wherein at least one parameter [0019] comprises a frequency of an observed ECAP ([0028]: ECAP peak width may be measured using frequency components). Parker(‘987) further teaches that frequency enables a measure of dispersion to be obtained without reliance on amplitude of the ECAP, for instance when manual user feedback or automated feedback is operated at a constant level [0028].
It would have been it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the automated neural response system taught by Parker (‘882) , to provide wherein a parameter comprises a frequency of an observed ECAP, as taught by Parker(‘987), because doing so enables a measure of dispersion without having to rely on the amplitude of the ECAP such as when manual user feedback or operated feedback controls recruitment at a constant level.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over P