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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-17 and 30-34 in the reply filed on 07/13/2026 is acknowledged. Claims 1-17 and 30-34 are pending in this action.
Information Disclosure Statement
The information disclosure statement(s) filed 06/21/2024 has/have been considered by the Examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract recites, “Disclosed are…”, which is considered implied phraseology and should be removed. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 101
Claims 1-17 and 30-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter (abstract ideas) without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Step 1):
Claims 1-17 and 30-34 recite an implantable device/system, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Step 2a) Prong One:
Independent claim 1 recites:
An implantable device for controllably delivering neural stimuli, the device comprising:
a stimulus source configured to provide neural stimuli to be delivered via one or more stimulus electrodes of a plurality of electrodes to a neural pathway of a patient in order to evoke a neural response from the neural pathway;
measurement circuitry configured to capture signal windows sensed on the neural pathway via one or more sense electrodes of the plurality of electrodes subsequent to respective neural stimuli; and
a control unit configured to:
control the stimulus source to provide a neural stimulus according to a stimulus intensity parameter;
measure an intensity of an evoked neural response in the captured signal window subsequent to the provided neural stimulus;
compute a feedback variable from the measured intensity of the evoked neural response; and
implement a feedback controller configured to use the computed feedback variable to control the stimulus intensity parameter so as to maintain the feedback variable at a target value;
compute a quality score from the captured signal window;
determine whether the quality score meets one or more criteria indicative of satisfactory quality; and
take mitigation action based on the determining.
Independent claim 30 recites:
A neural stimulation system comprising:
an implantable device for controllably delivering neural stimuli, the device comprising:
a stimulus source configured to provide neural stimuli to be delivered via one or more stimulus electrodes of a plurality of electrodes to a neural pathway of a patient in order to evoke a neural response from the neural pathway; and
measurement circuitry configured to capture signal windows sensed on the neural pathway via one or more sense electrodes of the plurality of electrodes subsequent to respective neural stimuli; and
a control unit configured to control the stimulus source to provide each neural stimulus according to a stimulus intensity parameter;
a processor configured to:
instruct the control unit to control the stimulus source to provide a neural stimulus according to a stimulus intensity parameter;
measure an intensity of an evoked neural response in the captured signal window subsequent to the provided neural stimulus;
compute a feedback variable from the measured intensity of the evoked neural response;
implement a feedback controller configured to use the computed feedback variable to control the stimulus intensity parameter so as to maintain the feedback variable at a target value;
compute a quality score from the captured signal window;
determine whether the quality score meets one or more criteria indicative of satisfactory quality; and
take mitigation action based on the determining.
Independent claims 1 and 30 is/are all directed to abstract ideas, specifically to mental processes and mathematical concepts.
MENTAL PROCESSES: Claims 1 and 30 are directed to mental processes, where nothing in the claim elements precludes the steps from practically being performed in the human mind or by a human using pen and paper. In the instant case, a person could mentally determine whether the quality score meets one or more criteria indicative of satisfactory quality by looking at a quality score and mentally analyzing the score with the satisfactory quality criteria. A person could mentally control a stimulus parameter by identifying or determining the appropriate stimulation parameters. A person could mentally take mitigation action by mentally planning, setting goals and analyzing situations based on present circumstances.
MATHEMATICAL CONCEPTS: claims 1 and 30 are directed to mathematical concepts, specifically to calculation/computations in which the claims use mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. In the instant case, claims 1 and 30 require mathematical computations of a feedback variable and a quality score as stated above.
Dependent claims 2-17 and 31-34 contain no additional elements that integrate the abstract ideas into practical application, or amount to significantly more than the abstract idea itself. Specifically, dependent claims 2-17 and 31-34 only further define the abstract ideas (mental processes) in determining first pacing rates and receiving first blood pressures, and do not amount to significantly more than the abstract idea itself.
Dependent claims 2-15 and 31-34 are all further directed to mathematical concepts (i.e. computing). Dependent claims 16-17 are all further directed to mental processes (i.e. determine, taking mitigation action). Accordingly, the dependent claims are also directed to non-statutory subject matter.
Step 2a) Prong Two:
This judicial exception is not integrated into a practical application because mere instruction to implement on a computer, or merely using a computer as a tool to perform the abstract idea, adding insignificant extra solution activity, and/or generally linking the use of the abstract idea to a technological environment or field of use is not considered integration into a practical application. The Court defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
This judicial exception is not integrated into a practical application because claims 1-17 and 30-34 do not disclose using the result of the mental process steps and mathematical concepts for prophylactic treatment of a particular medical condition under MPEP 2106.05(e). In the instant case, there is no specific treatment in the form of stimulation/pacing pulses, drug therapy, radiation therapy, or other forms of treatment that is ultimately used to treat a particular condition as a result of the mental process steps of determining a first pacing rate. There is no specific treatment delivered to treat a particular condition that is specified in the claims, but is only directed to mental processes/mathematical concepts without significantly more. Accordingly, claims 1-17 and 30-34 do not disclose using the result of the mental processes steps for prophylactic treatment of a particular medical condition under MPEP 2106.05(e).
This judicial exception is not integrated into a practical application because claims 1-17 and 30-34 do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Specifically, the claims recite the elements of a pacing device comprising generic computer elements (control unit), but these elements have not been described with sufficient detail to constitute an improvement in the tech field, as such these features merely define the field of use for the current invention by generally linking mental processes to generic computer elements as a tool to execute the abstract ideas (mental processes/mathematical concepts). By failing to explain how these elements are different from conventional computer elements, it is reasonable that the broadest reasonable interpretation of the additional elements is just a conventional computer performing generic functions (e.g., data analysis). Conventional computer elements performing basic data analysis is directed to the components of a system amounting to merely field of use type limitations and/or extra solution activity to implement the abstract idea as identified above, and merely including instructions to implement abstract ideas on a computer does not integrate the judicial exception into practical application, see MPEP 2106.04(d) Integration of a Judicial Exception into a Practical Application.
Additional elements further include a stimulus source configured to provide neural stimuli, and measurement circuitry to capture signal windows, all of which can be considered insignificant extra-solution activities. Specifically, these additional elements can be considered pre-solution activity as a data-gathering step by administering the stimulus to gather neural response data. As such, these additional elements are merely nominal or tangential additions to the claims as they do not impose any meaningful limits on the claim, see MPEP 2106.05(g) Insignificant Extra-Solution Activity.
Accordingly, dependent claims 2-17 and 31-34 do not recite additional elements which practically integrate the judicial exception(s) of the current invention.
Step 2b)
Step 2B in the analysis requires us to determine whether the claims do significantly more than
simply describe that abstract method. Mayo, 132 S. Ct. at 1297. We must examine the limitations of the
claims to determine whether the claims contain an "inventive concept" to "transform" the claimed
abstract idea into patent-eligible subject matter. Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at
1294, 1298). The transformation of an abstract idea into patent-eligible subject matter "requires 'more
than simply stat[ing] the [abstract idea] while adding the words 'apply it."' Id. (quoting Mayo, 132 S. Ct.
at 1294) (alterations in original). "A claim that recites an abstract idea must include 'additional features'
to ensure 'that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].'" Id.
(quoting Mayo, 132 S. Ct. at 1297) (alterations in original). Those "additional features" must be more
than "well-understood, routine, conventional activity." Mayo, 132 S. Ct. at 1298.
The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited additional element(s) as stated above is/are recognized as generic computer interfaces and generic computers (or computer components), because the claims do not describe these features as having distinguishing element(s) over their generic counterparts, which are well-understood, routine and conventional activities previously known in the industry, as shown in the reference as taught by Parker (WO 2021007615 A1) used in the rejection below, which teaches an implantable device (paragraph 0018) which includes a stimulus source (figure 2, pulse generator 124), control circuitry (figure 2, controller 116), and measurement circuitry to sense neural responses (paragraph 0037).
Additionally, Pei (US 20200162948 A1) similarly teaches a stimulation system comprising a pulse generator (paragraph 0019), controller (paragraph 0022), and circuitry used to sense evoked response windows (paragraph 0028).
Thus, the present claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. When looked at individually and as a whole, the claim limitations are determined to be an abstract idea without significantly more, and thus claims 1-17 and 30-34 are not patent eligible under 35 USC § 101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 8-11, 16-17, 30-33 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Parker (WO 2021007615 A1 – hereinafter Parker).
Re. claim 1, Parker teaches an implantable device (paragraph 0018 – “Preferred embodiments may comprise an implant and/or associated clinical software configured to test in an automated manner all possible configurations of stimulation and recording, whereby all implanted electrodes are sequentially used for stimulation…”) for controllably delivering neural stimuli (abstract – “Neural recordings of electrical activity in neural tissue are obtained by application of stimuli, using a single configuration of stimulation and recording”; paragraph 0002 – “The present invention relates to electrical recording of neural activity such as compound action potentials evoked by neurostimulation, and in particular to systems and methods for improved detection of neural responses in a recording when the recording is obtained in the presence of stimulus artefact, noise and the like”), the device comprising:
a stimulus source (figure 2, pulse generator 124) configured to provide neural stimuli to be delivered via one or more stimulus electrodes of a plurality of electrodes to a neural pathway of a patient in order to evoke a neural response from the neural pathway (paragraph 0037 – “Controller 116 controls a pulse generator 124 to generate stimuli in the form of current pulses in accordance with the patient settings 120 and control programs 122. Electrode selection module 126 switches the generated pulses to the appropriate electrode(s) of electrode array 150, for delivery of the current pulse to the tissue surrounding the selected electrode(s)”);
measurement circuitry configured to capture signal windows sensed on the neural pathway via one or more sense electrodes of the plurality of electrodes subsequent to respective neural stimuli (paragraph 0037 – “Measurement circuitry 128 is configured to capture measurements of neural responses sensed at sense electrode(s) of the electrode array as selected by electrode selection module 126”);
and a control unit (figure 2, controller 116) configured to:
control the stimulus source to provide a neural stimulus according to a stimulus intensity parameter (paragraph 0037 – “Controller 116 controls a pulse generator 124 to generate stimuli in the form of current pulses in accordance with the patient settings 120 and control programs 122”);
measure an intensity of an evoked neural response in the captured signal window subsequent to the provided neural stimulus (paragraph 0050 – “In order to measure ECAP amplitude we filter out most of the artefact using the detector, which assumes that the artefact has a regular exponential-like shape”; paragraph 0121 – “Embodiments of the invention may provide particular benefits in relation to neuromodulation utilising closed loop feedback on the basis of observed outcomes, such as ECAP amplitude”);
compute a feedback variable from the measured intensity of the evoked neural response (ECAP amplitude can be used as a stimulation feedback variable, paragraph 0121 – “Embodiments of the invention may provide particular benefits in relation to neuromodulation utilising closed loop feedback on the basis of observed outcomes, such as ECAP amplitude…In such feedback systems, a possible behaviour of the loop is that if the ECAP signal is lost or the signal to noise ratio becomes too low in some way (e.g. due to significant lead migration or an additional noise source) and the measured ECAP amplitude is reduced due to such effects (but not necessarily due to an actual reduction in recruitment), then the system will increase the stimulus current in order to bring the measured ECAP amplitude back up to a specific target”);
and implement a feedback controller configured to use the computed feedback variable to control the stimulus intensity parameter so as to maintain the feedback variable at a target value (paragraph 0121 – “Embodiments of the invention may provide particular benefits in relation to neuromodulation utilising closed loop feedback on the basis of observed outcomes, such as ECAP amplitude…In such feedback systems, a possible behaviour of the loop is that if the ECAP signal is lost or the signal to noise ratio becomes too low in some way (e.g. due to significant lead migration or an additional noise source) and the measured ECAP amplitude is reduced due to such effects (but not necessarily due to an actual reduction in recruitment), then the system will increase the stimulus current in order to bring the measured ECAP amplitude back up to a specific target”);
compute a quality score from the captured signal window (paragraph 0018 – “The ECAP quality score may be used to assess a selected configuration of stimulation and recording. A distinct ECAP quality score may additionally be obtained in relation to one or more other configurations of stimulation and recording, for example by altering selection of stimulation electrode(s) and/or selection of recording electrode(s) and generating a new ECAP quality score in relation to the new configuration”);
determine whether the quality score meets one or more criteria indicative of satisfactory quality and take mitigation action based on the determining (paragraph 0034 – “Further embodiments of the invention may utilise the signal quality score for ongoing control of operation of a feedback loop of an implanted neuromodulation device. For example, such embodiments may cause a feedback loop to cease operation, or to respond more slowly, at times when an ECAP signal quality score is low. Such embodiments may additionally or alternatively cause a feedback loop to commence operation, or to respond more quickly, at times when an ECAP signal quality score is high”).
Re. claim 2, Parker further teaches wherein the control unit is configured to compute the quality score by computing a difference between the captured signal window and a predetermined noise model for the captured signal windows (paragraph 00104 – “It is to be noted that alternative embodiments may derive an ECAP signal quality score by reference-to-reference ECAPs which are derived by other means. For example, a residual signal may be obtained by subtraction of an artefact estimate from a recorded signal, and may simply be compared to a clinically verified template ECAP saved in the device since a time of fitting”; see also paragraph 0046).
Re. claim 8, Parker further teaches wherein the control unit is further configured to remove stimulus artefact from the captured signal window before computing the difference (paragraph 0085 – “The parametric ECAP basis is determined using the recorded signal with the initial Artefact removed and any residual baseline subtracted. Let this signal be called the ‘refined recording’. A correlation mesh is determined by sweeping a range of basis ECAP frequencies and offsets and taking the dot product between the refined recording and each parametric basis function”).
Re. claim 9, Parker further teaches wherein the control unit is configured to compute the quality score by:
computing a normalised correlation function representing a resemblance of the captured signal window to a correlation template (paragraph 0029 – “An ECAP signal quality score may be normalised, for example to a range [0: 1], by any suitable function, such as a sigmoid function. The Normalised Score may for example be determined by: Normalised Score = 1 - 1 / (1 + a * Score)”; see also paragraph 0113).
Re. claim 10, Parker further teaches wherein the control unit is configured to compute the quality score by:
computing a plurality of component correlation functions, each component correlation function representing a resemblance of the captured signal window to a portion of a correlation template (computing matrices, paragraph 0018 – “Additionally or alternatively, some embodiments may provide for a matrix or set of ECAP quality scores to be produced or updated for some or all possible electrode configurations on an ongoing basis during operation of the implanted device”);
And combining the component correlation functions into a combined correlation function (paragraph 0070 – “A set of signal features is derived from the estimates produced by both models and combined with signal features from the recorded signal”).
Re. claim 11, Parker further teaches wherein a peak value of the combined correlation function is the quality score (paragraph 0006 – “Depending on stimulus polarity and the recording electrode(s) configuration, the measured profile of some CAPs may be of reversed polarity, with two negative peaks and one positive peak”).
Re. claim 16, Parker further teaches wherein the control unit is configured to determine whether the quality score meets one or more criteria indicative of satisfactory quality by comparing the quality score with a threshold (paragraph 0016 – “The indication of the quality of the neural response recordings output by the processor may be a binary indication of either high or low quality, for example wherein the spread is compared to a threshold”; paragraph 0121 – “For example, a simple step would be to halt feedback loop operation entirely at times when the ECAP signal quality is below a threshold, and to resume feedback loop operation at times when the ECAP signal quality is above that threshold or another threshold”).
Re. claim 17, Parker further teaches wherein the control unit is configured to take mitigation action by suspending the operation of the feedback controller (paragraph 0034 – “Further embodiments of the invention may utilise the signal quality score for ongoing control of operation of a feedback loop of an implanted neuromodulation device. For example, such embodiments may cause a feedback loop to cease operation, or to respond more slowly, at times when an ECAP signal quality score is low. Such embodiments may additionally or alternatively cause a feedback loop to commence operation, or to respond more quickly, at times when an ECAP signal quality score is high”).
Re. claim 30, Parker teaches a neural stimulation system (abstract – “Neural recordings of electrical activity in neural tissue are obtained by application of stimuli, using a single configuration of stimulation and recording”; paragraph 0002 – “The present invention relates to electrical recording of neural activity such as compound action potentials evoked by neurostimulation, and in particular to systems and methods for improved detection of neural responses in a recording when the recording is obtained in the presence of stimulus artefact, noise and the like”) comprising:
an implantable device for controllably delivering neural stimuli (paragraph 0018 – “Preferred embodiments may comprise an implant and/or associated clinical software configured to test in an automated manner all possible configurations of stimulation and recording, whereby all implanted electrodes are sequentially used for stimulation…”), the device comprising:
a stimulus source (figure 2, pulse generator 124) configured to provide neural stimuli to be delivered via one or more stimulus electrodes of a plurality of electrodes to a neural pathway of a patient in order to evoke a neural response from the neural pathway (paragraph 0037 – “Controller 116 controls a pulse generator 124 to generate stimuli in the form of current pulses in accordance with the patient settings 120 and control programs 122. Electrode selection module 126 switches the generated pulses to the appropriate electrode(s) of electrode array 150, for delivery of the current pulse to the tissue surrounding the selected electrode(s)”);
and measurement circuitry configured to capture signal windows sensed on the neural pathway via one or more sense electrodes of the plurality of electrodes subsequent to respective neural stimuli (paragraph 0037 – “Measurement circuitry 128 is configured to capture measurements of neural responses sensed at sense electrode(s) of the electrode array as selected by electrode selection module 126”);
and a control unit (figure 2, controller 116) configured to control the stimulus source to provide each neural stimulus according to a stimulus intensity parameter (paragraph 0037 – “Controller 116 controls a pulse generator 124 to generate stimuli in the form of current pulses in accordance with the patient settings 120 and control programs 122”);
a processor configured to:
instruct the control unit to control the stimulus source to provide a neural stimulus according to a stimulus intensity parameter (paragraph 0015 – “According to a further aspect the present invention provides a non-transitory computer readable medium for automated assessment of neural response recordings, comprising instructions which, when executed by one or more processors…”; paragraph 0018 – “For example the processor of the implanted device may be configured to produce or update a matrix or set of ECAP quality scores at predefined time intervals, or after a certain number of stimuli have been delivered, and/or at other times as appropriate. On the basis of such ECAP quality scores which are produced during ongoing operation of the device, the device may be configured to adopt an updated stimulation configuration…”);
measure an intensity of an evoked neural response in the captured signal window subsequent to the provided neural stimulus (paragraph 0050 – “In order to measure ECAP amplitude we filter out most of the artefact using the detector, which assumes that the artefact has a regular exponential-like shape”; paragraph 0121 – “Embodiments of the invention may provide particular benefits in relation to neuromodulation utilising closed loop feedback on the basis of observed outcomes, such as ECAP amplitude”);
compute a feedback variable from the measured intensity of the evoked neural response (ECAP amplitude can be used as a stimulation feedback variable, paragraph 0121 – “Embodiments of the invention may provide particular benefits in relation to neuromodulation utilising closed loop feedback on the basis of observed outcomes, such as ECAP amplitude…In such feedback systems, a possible behaviour of the loop is that if the ECAP signal is lost or the signal to noise ratio becomes too low in some way (e.g. due to significant lead migration or an additional noise source) and the measured ECAP amplitude is reduced due to such effects (but not necessarily due to an actual reduction in recruitment), then the system will increase the stimulus current in order to bring the measured ECAP amplitude back up to a specific target”);
implement a feedback controller configured to use the computed feedback variable to control the stimulus intensity parameter so as to maintain the feedback variable at a target value (paragraph 0121 – “Embodiments of the invention may provide particular benefits in relation to neuromodulation utilising closed loop feedback on the basis of observed outcomes, such as ECAP amplitude…In such feedback systems, a possible behaviour of the loop is that if the ECAP signal is lost or the signal to noise ratio becomes too low in some way (e.g. due to significant lead migration or an additional noise source) and the measured ECAP amplitude is reduced due to such effects (but not necessarily due to an actual reduction in recruitment), then the system will increase the stimulus current in order to bring the measured ECAP amplitude back up to a specific target”);
compute a quality score from the captured signal window (paragraph 0018 – “The ECAP quality score may be used to assess a selected configuration of stimulation and recording. A distinct ECAP quality score may additionally be obtained in relation to one or more other configurations of stimulation and recording, for example by altering selection of stimulation electrode(s) and/or selection of recording electrode(s) and generating a new ECAP quality score in relation to the new configuration”);
determine whether the quality score meets one or more criteria indicative of satisfactory quality and take mitigation action based on the determining (paragraph 0034 – “Further embodiments of the invention may utilise the signal quality score for ongoing control of operation of a feedback loop of an implanted neuromodulation device. For example, such embodiments may cause a feedback loop to cease operation, or to respond more slowly, at times when an ECAP signal quality score is low. Such embodiments may additionally or alternatively cause a feedback loop to commence operation, or to respond more quickly, at times when an ECAP signal quality score is high”).
Re. claim 31, Parker further teaches wherein the processor is configured to compute the quality score by computing a difference between the captured signal window and a predetermined noise model for the captured signal windows (paragraph 00104 – “It is to be noted that alternative embodiments may derive an ECAP signal quality score by reference-to-reference ECAPs which are derived by other means. For example, a residual signal may be obtained by subtraction of an artefact estimate from a recorded signal, and may simply be compared to a clinically verified template ECAP saved in the device since a time of fitting”; see also paragraph 0046).
Re. claim 32, Parker further teaches wherein the processor is configured to compute the quality score by computing a normalised correlation function representing a resemblance of the captured signal window to a correlation template (paragraph 0029 – “An ECAP signal quality score may be normalised, for example to a range [0: 1], by any suitable function, such as a sigmoid function. The Normalised Score may for example be determined by: Normalised Score = 1 - 1 / (1 + a * Score)”; see also paragraph 0113).
Re. claim 33, Parker further teaches wherein the processor is configured to compute the quality score by:
computing a plurality of component correlation functions, each component correlation function representing a resemblance of the captured signal window to a portion of a correlation template (computing matrices, paragraph 0018 – “Additionally or alternatively, some embodiments may provide for a matrix or set of ECAP quality scores to be produced or updated for some or all possible electrode configurations on an ongoing basis during operation of the implanted device”);
and
combining the component correlation functions into a combined correlation function (paragraph 0070 – “A set of signal features is derived from the estimates produced by both models and combined with signal features from the recorded signal”).
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.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parker (WO 2021007615 A1 – hereinafter Parker) in view of DiCarlo (US 20200345968 A1 – hereinafter DiCarlo).
Re. claims 6-7, Parker teaches the claimed invention of claim 2, but does not expressly teach wherein the predetermined noise model is a Gaussian model having a mean and a standard deviation, and wherein the control unit is further configured to estimate the mean and the standard deviation from signal windows captured without preceding neural stimuli.
DiCarlo teaches a system which measures neural responses (abstract – “Techniques for non-invasively controlling targeted neural activity of a subject are provided herein. The techniques include applying a stimulus input to the subject, the stimulus input being formed by a deep artificial neural network (ANN) model and being configured to elicit targeted neural activity within a brain of the subject”), and further teaches the known technique of creating a Gaussian data distribution, which is known to include mean and standard deviation, based on the measured neural responses (paragraph 0087 – “To estimate the cRF of each neural site, approximately 1°×1° white squares were flashed across the central 8° of the monkeys' visual field. The corresponding neural responses were measured and a 2D Gaussian fitted to the data”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the noise model of Parker, to incorporate the Gaussian model as taught by DiCarlo, since such modification would predictably result in ensuring good quality neural responses.
Allowable Subject Matter
Claims 3-5, 12-15 and 34 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art of record could not anticipate and/or render obvious to claims 3, 12 and 34. Dependent claims 4-5 and 13-15 are further objected to for their dependencies. However, all claims are at least rejected under 35 USC 101 as stated above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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